Escolar Documentos
Profissional Documentos
Cultura Documentos
U.S. GOVERNMENT
INFORMATION
Title 40—Protection of
Environment
(This book contains parts 150 to 189)
Part
CHAPTER I—Environmental Protection Agency (Continued) 150
CHAPTER I—ENVIRONMENTAL PROTECTION
AGENCY (CONTINUED)
EDITORIAL NOTE: Nomenclature changes to chapter I appear at 65 FR 47324, 47325, Aug. 2, 2000, and at
66 FR 34375, 34376, June 28, 2001.
Part Page
150 General ................................................................................................... 5
151 [Reserved]
152 Pesticide registration and classification proce
dures ............................................................................................. 5
153 Registration policies and interpretations .................................... 43
154 Special review procedures .............................................................. 45
155 Registration standards and registration review ......... 53
156 Labeling requirements for pesticides and devices ... 61
157 Packaging requirements for pesticides and devices 83
158 Data requirements for pesticides .................................................. 87
159 Statements of policies and interpretations ............................... 196
160 Good laboratory practice standards ........................................... 210
162 State registration of pesticide products ................................... 222
164 Rules of practice governing hearings, under the
Federal insecticide, Fungicide, and Rodenticide Act,
arising from refusals to register, cancellations of
registrations, changes of classifications, suspensions of
registrations and other hearings called pursuant to
section 6 of the Act ................................................................... 230
165 Pesticide management and disposal ......................................... 248
166 Exemption of Federal and State agencies for use of
pesticides under emergency conditions .............................. 274
167 Registration of pesticide and active ingredient pro
ducing establishments, submission of pesticide reports . 284
168 Statements of enforcement policies and interpreta
tions ............................................................................................... 287
169 Books and records of pesticide production and dis
tribution ............................................................................. 297
170 Worker protection standard ........................................................ 300
171 Certification of pesticide applicators ......................................... 327
Part Page
172 Experimental use permits ............................................................. 343
173 Procedures governing the rescission of State pri
mary enforcement responsibility for pesticide use violations
........................................................................................................... 360
174 Procedures and requirements for plant-incor
porated protectants ................................................................... 362
176 Time-limited tolerances for emergency exemptions 371
178 Objections and requests for hearings ....................................... 373
179 Formal evidentiary public hearing .............................................. 376
180 Tolerances and exemptions for pesticide chemical
residues in food ........................................................................... 388
181-189 [Reserved]
SUBCHAPTER E—PESTICIDE PROGRAMS
Acrolein.............As sole active ingredient. No mix- All uses .................. Restricted ........ Inhalation hazard to hu-
tures registered. mans. Residue effects on
avian species and aquatic
organisms.
Aldicarb.............As sole active ingredient .................. Ornamental uses ..... do .............. Other hazards—accident
history.
(indoor and outdoor).
No mixtures registered ..................... Agricultural crop Under further
uses. evaluation.
Aluminum As sole active ingredient. No mix- .... do ...................... ..... do .............. Inhalation hazard to hu-
phosphide. tures registered. mans.
Azinphos methylAll liquids with a concentration great- .... do ...................... ..... do .............. Do.
er than 13.5 pct.
All other formulations ........................ .... do ...................... Under futher
evaluation..
Carbofuran ....... .... do ...................... ..... do .............. Acute inhalation toxicity.
All concentrate suspensions and wettable
powders 40% and greater.
All granular formulations ................... Rice ....................... Under evalua-
tion.
All granular and fertilizer formula- All uses except rice ..... do.
tions.
Chloropicrin .....All formulations greater than 2% ...... All uses ................... ..... do .............. Acute inhalation toxicity.
All formulations ................................ Rodent control ....... ..... do .............. Hazard to non-target orga-
nisms.
All formulations 2% and less ............ Outdoor uses (other Unclassified.
All granulars and wettable powders Molluscide uses ...... Restricted......... Effects on aquatic orga-
nisms.
Pressurized sprays 0.55% and less Hospital antiseptics Unclassified.
Dicrotophos .....All liquid formulations 8% and great- All uses .................. Restricted ........ Acute dermal toxicity; res-
er. idue effects on avian species
(except for tree injections).
Active ingredient Formulation Use pattern Classification1 Criteria influencing restriction
MethamidophosLiquid formulations 40% and greater .... do ..................... Restricted ........ Acute dermal toxicity; residue
effects on avian species.
Dust formulations 2.5% and greater .... do ...................... .... do ............... Residue effects on avian
species.
Methidathion ....All formulations ................................ All uses except .... do ............... Do.
nursery stock,
safflower and
sunflower.
All formulations ................................ Nursery stock, Unclassified.
safflower and
sunflower.
Methomyl ......... As sole active ingredient in 1 pct to 2.5 Nondomestic Restricted ........ Residue effects on
baits (except 1 pct fly bait). outdoors- mammalian species.
agricultural crops,
ornamental and
turf. All other
All concentrated solution formulations. .... do
registered
......................
uses. .... do ............... Other hazards-accident
history.
90 pct wettable powder formulations (not in Do.
water soluble bags). .... do ...................... .... do ...............
90 pct wettable powder formulation in water
soluble bags. .... do ...................... Unclassified.
All granular formulations ...................
25 pct wettable powder formulations In .... do ...................... .... do.
1.24 pct to 2.5 pct dusts as sole active .... do ...................... .... do.
ingredient and in mixtures with .... do ..................... .... do.
fungicides and chlorinated
hydrocarbon, inorganic phosphate and
biological insecticides.
Methyl bromide All formulations in containers greater than Restricted ......... Do.
1.5 lb. All uses....................
Containers with not more than 1.5 lb of Unclassified.
methyl bromide with 0.25 pct to 2.0 pct Single applications
chloropicrin as an indicator. (nondomestic use)
for soil treatment in
closed systems.
Container with not more than 1.5 lb having All uses.................... Restricted ......... Do.
no indicator.
Active ingredient Formulation Use pattern Classification1 Criteria influencing restriction
Methyl parathion All dust and granular formulations .... do ..................... .... do ............... Other hazards-accident his-
less than 5 pct. tory. All foliar applications
restricted based on
residue effects on
mammalian and avian
Microencapsulated ........................... .... do ...................... .... do ............... Residue effects on avian
species.
species. Hazard to bees.
All dust and granular formulations 5 .... do ..................... .... do ............... Acute dermal toxicity. Res-
pct and greater and all wettable idue effects on mamma-
powders and liquids. lian and avian species.
Nicotine (alka- Liquid and dry formulations 14% and Indoor (greenhouse) .... do ............... Acute inhalation toxicity.
loid). above.
All formulations ................................. Applications to cran- .... do ............... Effects on aquatic orga-
berries. nisms.
Liquid and dry formulations 1.5% All uses (domestic Unclassified.
and less. and nondomestic).
Paraquat (di- All formulations and concentrations All uses ................... Restricted ........ Other hazards. Use and ac-
chloride) and except those listed below. cident history, human toxi-
paraquat cological data.
bis(methyl
sulfate).
Pressurized spray formulations con- Spot weed and .... do.
grass control.
taining 0.44 pct Paraquat bis(methyl
sulfate) and 15 pct petroleum distillates
as active ingredients.
Liquid fertilizers containing con- All uses ................... Unclassified.
Zinc Phosphide All formulations 2% and less ............ All domestic uses Unclassified.
and non-domestic
uses in and around
buildings.
All dry formulations 60% and greater..
All bait formulations .......................... Non-domestic out- ..... do .............. Hazard to non-target orga-
door uses (other nisms.
than around
buildings).
All dry formulations 10% and greater Domestic uses ........ ..... do .............. Acute oral toxicity.
1
‘‘Under evaluation'' means no classification decision has been made and the use/formulatlon In question Is still under active
review within EPA.
2
Percentages given are the total of dioxathion plus related compounds.
3
(NOTE—M-44 sodium cyanide capsules may only be used by certified applicators who have also taken the required additional
training.)
[43 FR 5790, Feb. 9, 1978, as amended at 44 FR 45132, Aug. 1, 1979; 46 FR 5698, Jan. 19, 1981. Redesignated
and amended at 53 FR 15988, May 4, 1988; 60 FR 32096, June 19, 1995]
Subpart A [Reserved]
conform to the following policies and (2) To assert a claim of confidentiality for all
procedures: or any part of a written submission concerning
(a) Purpose. Meetings and a Registration Standard under development,
communications may be for the purpose of the submitter must furnish three copies of the
receiving and considering information, material. Two copies must be complete, with
exchanging views, exploring factual and claimed confidential business information
substantive positions, discussing regulatory clearly marked in the text. Items in the
options or for any other purpose deemed document that are claimed confidential should
appropriate by the Agency in its deliberations be numbered consecutively throughout the
concerning development of a Registration document. The third copy must have the
Standard. The Agency will not commit to take claimed confidential business information
any particular action concerning a Registration excised from the text without closing up or
Standard under development during paraphrasing the remaining text. The deletions
discussions with any person or party outside of should be consecutively numbered to
government. The Agency will make its final correspond to the numbering of the complete
administrative decision on a wholly copies. Each copy must be marked on the
independent basis, and in accordance with cover as to whether it contains claimed
law. confidential business information.
(b) Meetings with persons or parties (3) Any written material received by the
outside of government. Requests by Agency that is not marked as confidential will
responsible persons or parties outside of be deemed to be nonconfidential, and may be
government to meet with Agency personnel made available through the public docket or
concerning a Registration Standard under
otherwise disclosed without prior notice to the
development should be directed in writing to
submitter.
the Registration Division. Reasonable requests
(d) Memorandum of meeting. For each
will ordinarily be granted on a timely basis. EPA
will decide the time and place of such meeting with a person or party outside of
meetings, and the Agency personnel who will government, the Agency will prepare, based
attend. EPA may decline to meet with persons on notes taken at the meeting, a
or parties who assert unreasonable claims of memorandum of the meeting. The
confidential business information for the memorandum will be prepared within 10
purpose of circumventing the docketing working days of the meeting and will include
procedures in §155.32. EPA may also decline to all of the following information:
meet if the number or frequency of meetings (1) The date and time of the meeting.
would delay unduly the issuance of the (2) The name of the person who requested
Registration Standard. Further, no person or the meeting.
party outside government will be accorded (3) The names and affiliations of the
special or preferential access to Agency participants.
pesticide decisionmaking or to the Agency’s (4) The subject matter of the meeting.
decisional process. (5) A full and accurate description of all
(c) Information submitted to the Agency significant positions taken, facts presented,
concerning a Registration Standard under and arguments made by each participant
development. (1) Information, comments, data, (except that any discussion of claimed
or other written material submitted to the confidential business information will be
Agency at any time concerning a Registration identified in meeting notes, and referenced in
Standard under development may be claimed the memorandum).
by the submitter to be confidential business (6) Identification of all documents,
information. The burden of identifying claimed proposals, or other materials (other than
confidential business information rests with information claimed to be confidential
the submitter, or, in meetings, with the business information) distributed or
participants from outside of government who exchanged at the meeting.
wish to assert a claim of confidentiality.
(7) The name of the person who prepared or separately (within 10 working days after
the memorandum. receipt, or 15 working days if the submitter has
[50 FR 49001, Nov. 27, 1985, as amended at 58 FR asserted a confidential business information
34203, June 23, 1993] claim concerning the material).
(5) A copy of each document, proposal, or
§ 155.32 Public docket. other item of written material concerning the
(a) When created. (1) A docket will be Registration Standard provided by the Agency
created for each Registration Standard under to any person or party outside of government
development when the Agency begins review (within 15 working days after the item is made
of data for the Registration Standard or upon available to such person or party).
publication of the notice described in §155.25 (6) A copy of the Registration Standard;
setting out the list and sequence of (7) With respect to a Registration Standard
Registration Standards, whichever is earlier. for which the Agency has determined that a
The Agency will announce in its annual
substantially complete chronic health and
schedule notice the dockets that are available
for Registration Standards under teratology data base exists, a copy of the
development. FEDERAL REGISTER notice concerning availability of
(2) If the Agency notifies registrants a proposed Registration Standard, and a copy
privately in accordance with 40 CFR 154.21 that of each comment received in response to that
one or more risk criteria set forth in 40 CFR notice (within 10 working days after receipt by
154.7 (leading to a special review) may have the Agency, or 15 working days if the submitter
been exceeded, that notification and any has asserted a confidential business
subsequent communications concerning that information claim concerning the material).
notification will be placed in a separate docket (8) A copy of the FEDERAL REGISTER notice
pertaining to possible special review in announcing the issuance of the Registration
accordance with the provisions of § 154.15. Standard (within 10 working days after the
(b) Contents of docket. The docket will publication of the notice).
contain, within the time frames indicated, all of (c) Index of the docket. The Agency will
the following documents and information establish and keep current an index to the
(except that information claimed to be docket for each Registration Standard. The
confidential business information will not be index will include, but is not limited to:
included): (1) A list of each meeting between the
(1) An index of its contents (refer to Agency and any person or party outside of
paragraph (c) of this section). government, containing the date and subject
(2) A copy of each comment received in of the meeting, the names of participants and
response to the notice described in § 155.25 the name of the person requesting the
that pertains to a pesticide for which the notice meeting.
indicated a Registration Standard was under (2) A list of each document in the docket by
development (within 10 working days after title, source or recipient(s), and the date the
receipt by the Agency, or 15 working days if the document was received or provided by the
submitter has asserted a confidential business Agency.
information claim concerning the material). (d) Availability of docket and indices. (1)
(3) A copy of each memorandum of a The Agency will make available to the public
meeting between the Agency and persons or for inspection and copying the docket and
parties outside of government, prepared in index for any Registration Standard.
accordance with § 155.30(d) (within 10 working (2) The Agency will establish and maintain a
days after the meeting). mailing list of persons who have specifically
(4) A copy of each document, comment, requested that they receive indices for
item of correspondence or other written Registration Standard dockets. On a quarterly
material concerning the Registration Standard basis, EPA
submitted to the Agency by any person or
party outside of government, whether in a
meeting
will distribute the Indices of new materials tlon 3(g). Registration review Is the periodic
placed in the public docket to these persons. review of a pesticide’s registration to ensure
Annually, EPA will require that persons on the that each pesticide registration continues to
list renew their requests for inclusion on the satisfy the FIFRA standard for registration.
list. Under FIFRA section 3(g), each pesticide is
(3) The Agency will issue annually in the required to be reviewed every 15 years.
FEDERAL REGISTER (in conjunction with the annual (1) Among other things, FIFRA requires
schedule notice specified in §155.25) a notice that a pesticide generally will not cause
announcing the availability of docket indices. unreasonable adverse effects on the
(4) Each FEDERAL REGISTER notice of availability environment. Registration review is intended
of a Registration Standard will announce the to ensure that each pesticide’s registration is
availability of the docket index for that based on current scientific and other
Standard. knowledge regarding the pesticide, including
its effects on human health and the
§ 155.34 Notice of availability. environment.
(a) The Agency will issue in the FEDERAL (2) If a product fails to satisfy the FIFRA
REGISTER a notice announcing the issuance and standard for registration, the product’s
availability of Registration Standard which: registration may be subject to cancellation or
(1) Concerns a previously unregistered other remedies under FIFRA.
active ingredient; or (b) Applicability. This subpart applies to
(2) Concerns a previously registered active every pesticide product registered under
ingredient, and the Registration Standard FIFRA section 3 as well as all pesticide products
states that registrants will be required (under registered under FIFRA section 24(c). It does
FIFRA section 3(c)(2)(B)) to submit chronic not apply to products whose sale or
health (including, but not limited to, chronic distribution is authorized under FIFRA section
feeding, oncogenicity and reproduction) or 5 or section 18.
teratology studies. (c) Limitations. (1) At any time, the Agency
(b) interested persons may submit may undertake any other review of a pesticide
comments concerning any Registration under FIFRA, irrespective of the pesticide’s
Standard described by paragraph (a) of this past, ongoing, scheduled, or not yet scheduled
section at any time. registration review.
(c) The Agency will issue in the FEDERAL (2) When the Agency determines that new
REGISTER a notice announcing the availability of, data or information are necessary for a
and providing opportunity for comment on, pesticide’s registration review, it will require
each proposed Registration Standard which such data under FIFRA section 3(c)(2)(B).
concerns a previously registered active
ingredient for which the Agency has [71 FR 45732, Aug. 9, 2006, as amended at 73 FR
determined that a substantially complete 75595, Dec. 12, 2008]
chronic health and teratology data base exists. § 155.42 Registration review cases.
Following the comment period and issuance of
(a) Establishing registration review cases. A
the Registration Standard, the Agency will
registration review case will be composed of
issue in the FEDERAL REGISTER a notice of
one or more active ingredients and all the
availability of the Registration Standard.
products containing such ingredient(s). The
Subpart C—Registration Review Agency may group related active ingredients
into a registration review case when the active
Procedures ingredients are so closely related in chemical
SOURCE: 71 FR 45732, Aug. 9, 2006, unless
structure and toxicological profile as to allow
otherwise noted. common use of some or all required data for
hazard assessment.
§ 155.40 General.
(1) Existing pesticides. The Agency will (c) Closing a registration review case. The
assign each pesticide registered on or before Agency will close a registration review case if
the effective date of this regulation to a all products in the case are canceled.
registration review case. (d) Establishing a baseline date for a
(2) New pesticides. The Agency will assign registration review case. For the purpose of
each pesticide registered after the effective scheduling registration reviews, the Agency
date of this regulation to an existing will establish a baseline date for each
registration review case or to a new registration review case. In general, the
registration review case. baseline date will be the date of initial
(3) A pesticide product that contains registration of the oldest pesticide product in
multiple active ingredients will belong to the the case or the date of reregistration,
registration review cases for each of its active whichever is later. For the purpose of these
ingredients. procedures, the date of reregistration is the
(b) Modifying registration review cases. date on which the Reregistration Eligibility
New data or information may suggest that a Decision or Interim Reregistration Decision
registration review case should be modified. was signed, whichever date the Agency
The Agency may modify a registration review determines to be more appropriate based on
case in the following ways: the comprehensiveness of the review.
(1) Add a new active ingredient to a (1) The Agency generally will not change
registration review case. The Agency may the baseline date for a registration review case
determine that a new active ingredient is when it modifies a case by adding or deleting
chemically and toxicologically similar to active ingredients or products.
ingredients in an existing registration review (2) When the Agency splits a registration
case and should be grouped with the
review case into two or more cases, the new
ingredients in the existing registration review
case(s) generally will have the baseline date of
case.
(2) Split a registration review case into two the original registration review case.
or more registration review cases. For (3) When the Agency merges two or more
example, new data or information may registration review cases into a single case, the
suggest that active ingredients in a registration Agency generally will use the earliest baseline
review case are not as similar as previously date as the baseline date for the new case.
believed and that they belong in two or more (e) Announcing registration review cases
separate registration review cases. and baseline dates. The Agency will maintain a
(3) Move an ingredient from one list of registration review cases, including
registration review case to another. For baseline dates, on its website.
example, new data or information might § 155.44 Establish schedules for registration
suggest that an ingredient should not be review.
grouped with the other ingredients in the
registration review case and that it belongs in The Agency will develop schedules for
a different registration review case. registration review that are generally based on
(4) Merge two or more registration review the baseline date of the registration review
cases into a single registration review case. For case or on the date of the latest registration
example, new data or information might review of the registration review case. The
suggest that the active ingredients in two or Agency may also take into account other
more registration review cases should be factors, such as achieving process efficiencies
grouped together for registration review. by reviewing related cases together, when
(5) Delete an active ingredient from a developing schedules for registration review.
registration review case. For example, the The Agency will maintain schedules for the
Agency will remove the ingredient from the current year and at least two subsequent years
case if the registrations of all products on its website.
containing an active ingredient in a
registration review case are canceled.
§ 155.46 Deciding that a registration review is including, but not limited to, the following
complete and additional review is not needed. information:
The Agency may determine that there is no (1) An overview of registration review case
need to reconsider a previous decision that a status;
pesticide satisfies the standard of registration (2) A list of current registrations and
in FIFRA. In such cases, instead of establishing registrants, any FEDERAL REGISTER notices
a pesticide registration review case docket as regarding pending registration actions, and
described in §155.50, the Agency may propose current or pending tolerances;
that, based on its determination that a (3) Risk assessment documents;
pesticide meets the FIFRA standard for (4) Bibliographies concerning current
registration, no further review will be registrations;
necessary. In such circumstances, the Agency (5) summaries of incident data; and
will publish a notice in the FEDERAL REGISTER (6) Any other pertinent data or information.
announcing the availability of the proposed (b) Public review of the registration review
decision and provide a comment period of at case docket. The Agency will publish a notice
least 60 calendar days. The Agency will publish in the FEDERAL REGISTER announcing the
a notice in the FEDERAL REGISTER announcing the availability for public review of the information
availability of a final version of the decision, an described in paragraph (a) of this section and
explanation of any changes to the proposed establishing a comment period of at least 60
decision and its response to any comments. days. During this comment period, interested
The date of the final notice of availability would persons may identify any additional
be used as the date of the latest registration information they believe the Agency should
review for the purpose of scheduling consider in the course of the registration
subsequent registration reviews. review.
(c) Submission of data and other
§ 155.48 Data Call-In.
information during the comment period. The
The Agency may issue a Data Call-In notice Agency may identify, either in the notice
under FIFRA section 3(c)(2)(B) at any time if the published under paragraph (b) of this section,
Agency believes that the data are needed to or at any other time, data or information that
conduct the registration review. The provisions it does not have but which may be useful, if
in FIFRA section 3(c)(1), (c)(2)(B), and available, for consideration in the registration
(c) (2)(D) apply to the submission, review. Any person may submit data or
compensation, and exemption of data information in response to such identification.
required to conduct a registration review. In order to be considered during a pesticide’s
§ 155.50 Initiate a pesticide’s registration review. registration review, the submitted data or
The Agency will initiate a pesticide’s information must meet the requirements listed
registration review by establishing a docket for below.
each registration review case, except for cases (1) In order to ensure that the Agency will
covered under §155.46, and opening it for consider data or information in the conduct of
public review. a registration review, interested persons must
(a) Contents of the registration review case submit the data or information during the
docket. The Agency will place in this docket comment period established in the notice
information that will assist the public in described in paragraph (b) of this section. The
understanding the types of information and Agency may, at its discretion, consider data or
issues that the Agency may consider in the information submitted at a later date.
course of the registration review. The Agency (2) The data or information must be
may include information from its files presented in a legible and useable form. For
example, an English translation must
accompany any material that is not in English
and a written transcript must accompany any
information submitted as an audiographic or
videographic record. Written material may be public. The Agency will place a copy of any
submitted in paper or electronic form. such document or other written material in the
(3) Submitters must clearly identify the docket along with the minutes of the meeting
source of any submitted data or information. where the materials were exchanged.
(4) Submitters may request the Agency to (c) Confidential business information. The
reconsider data or information that the Agency will identify, but not include in the
Agency rejected in a previous review. docket, any confidential business information
However, submitters must explain why they whose disclosure is prohibited by FIFRA
believe the Agency should reconsider the data section 10.
or information in the pesticide’s registration [71 FR 45732, Aug. 9, 2006, as amended at 73 FR
review. 75596, Dec. 12, 2008]
(d) For the purposes of this subpart, the § 155.53 Conduct of a pesticide’s registration
provisions of subpart B do not apply. review.
§ 155.52 Stakeholder engagement. The Agency will review data and
In addition to the public participation information described in § 155.50(a), (b), and
opportunities described in §155.50 and § (c) or submitted in response to a Data Call-In
155.53(c), the Agency may meet with notice that it believes should be considered in
stakeholders regarding a forthcoming or the pesticide’s registration review.
ongoing registration review. For example, (a) Assess changes since a pesticide’s last
before conducting a pesticide’s registration review. The Agency will assess any changes
review, the Agency may consult with that may have occurred since the Agency’s last
registrants or pesticide users regarding the use registration decision in order to determine the
and usage of the pesticide. The Agency may significance of such changes and whether the
consult with registrants, pesticide users, or pesticide still satisfies the FIFRA standard for
other persons during a pesticide’s registration registration. The Agency will consider whether
review with regard to developing risk to conduct a new risk assessment to take into
management options for a pesticide. The account, among other things, any changes in
Agency may informally consult with officials of statutes or regulations, policy, risk assessment
Federal, State or Tribal agencies regarding a procedures or methods, or data requirements.
forthcoming or ongoing registration review. The Agency will consider whether any new
(a) Minutes of meetings with persons data or information on the pesticide, including
outside of government. Subject to paragraph any data or information submitted under
(c) of this section, if the Agency meets with one §155.50 or in response to a Data Call-In notice,
or more individuals that are not government warrant conducting a new risk assessment or a
employees to discuss matters relating to a new risk/ben- efit assessment. The Agency will
registration review, the Agency will place in the also consider whether any new data or
docket a list of meeting attendees, minutes of information regarding an individual pesticide
the meeting, and any documents exchanged product, including any data or information
at the meeting, not later than the earlier of: submitted under §155.50 or in response to a
(1) 45 days after the meeting; or Data Call-In notice, such as data or information
(2) The date of issuance of the registration about an inert ingredient in the pesticide
review decision. product or other information or data relating
(b) Exchange of documents or other to the composition, labeling or use of the
written material. In the course of a meeting pesticide product, warrant additional review of
with a person outside of government, the a pesticide product’s registration.
Agency or that person may provide the other (b) Conduct new assessments as
with a copy of a document or other written needed.
material that has not yet been released to the (1) Active ingredient(s) in the registration
review case. If the Agency finds that a new
assessment of the pesticide is needed, it will
determine whether it
can base the new assessment on available data stakeholders or members of the public, poses
or information, including data or information low risk, and/or requires little or no risk
submitted under §155.50 or in response to a mitigation. In such cases, the Agency will make
Data Call-In notice. If sufficient data or a draft risk assessment available for public
information are available, the Agency will review and comment when it issues a
conduct the new risk assessment or risk/ proposed decision on the registration review
benefit assessment. If the Agency determines case.
that additional data or information are needed (2) If the Agency finds that it is not
to conduct the review, the Agency will issue a necessary to conduct a new risk assessment, it
Data Call-In notice under FIFRA section will issue a proposed decision on the
3(c)(2)(B). registration review case as described in
(2) Individual product registrations. If the §155.58.
Agency finds that additional review of an
individual product’s registration is needed, it § 155.56 Interim registration review decision.
will review the pesticide product label, The Agency may issue, when it determines
confidential statement of formula, product- it to be appropriate, an interim registration
specific data, or other pertinent data or review decision before completing a
information, as appropriate, to determine registration review. Among other things, the
whether the registration of the individual interim registration review decision may
product meets the FIFRA standard for require new risk mitigation measures, impose
registration. If the Agency determines that interim risk mitigation measures, identify data
additional data or information are needed to or information required to complete the
conduct the review, the Agency will issue a review, and include schedules for submitting
Data Call-In notice under FIFRA section the required data, conducting the new risk
3(c)(2)(B). assessment and completing the registration
(c) Public participation during a pesticide’s review. A FIFRA 3(c)(2)(B) notice requiring the
registration review. The Agency will generally needed data or information may precede,
make available for public review and comment accompany, or follow issuance of the interim
a draft risk assessment for a pesticide if a new registration review decision. The Agency will
risk assessment has been conducted. The follow procedures in § 155.58 when issuing an
Agency will publish a notice in the FEDERAL interim registration review decision.
REGISTER announcing the availability of the draft
risk assessment and provide a comment § 155.57 Registration review decision.
period of at least 30 calendar days. The A registration review decision is the
Agency will publish a notice in the FEDERAL Agency’s determination whether a pesticide
REGISTER announcing the availability of a revised meets, or does not meet, the standard for
risk assessment, an explanation of any changes registration in FIFRA.
to the proposed document, and its response § 155.58 Procedures for issuing a decision on a
to comments. If the revised risk assessment registration review case.
indicates risks of concern, the Agency may, in (a) The Agency will publish a notice in the
the notice announcing the availability of the FEDERAL REGISTER announcing the availability of a
revised risk assessment, provide a comment proposed registration review decision or a
period of at least 30 calendar days for the proposed interim registration review decision.
public to submit suggestions for mitigating the At that time, the Agency will place in the
risk identified in the revised risk assessment. pesticide’s registration review docket the
(1) The Agency might not request Agency’s proposed decision and the bases for
comments on a draft risk assessment in cases the decision. There will be a comment period
where the Agency’s initial screening of a of at least 60 calendar days on the proposed
pesticide indicates that it has low use/usage, decision.
affects few if any (b) In its proposed decision, the Agency
will, among other things:
(1) State Its proposed findings with respect Subpart D—Human Hazard and
to the FIFRA standard for registration and Precautionary Statements
describe the basis for such proposed findings. 156.60 General.
(2) Identify proposed risk mitigation 156.62 Toxicity Category.
measures or other remedies as needed and 156.64 Signal word.
describe the basis for such proposed 156.66 Child hazard warning.
requirements. 156.68 First aid statement.
156.70 Precautionary statements for human hazards.
(3) State whether it believes that additional 156.78 Precautionary statements for physical or
data are needed and, if so, describe what is chemical hazards.
needed. A FIFRA 3(c)(2)(B) notice requiring Subpart E—Environmental Hazard and
such data may be issued in conjunction with a Precautionary Statements
proposed or final decision on the registration
156.80 General.
review case or a proposed or final interim
decision on a registration review case. 156.85 Non-target organisms.
(4) Specify proposed labeling changes; and
(5) Identify deadlines that it intends to set Subparts F-G [Reserved]
for completing any required actions. Subpart H—Container Labeling
(c) After considering any comments on the 156.140 Identification of container types. 156.144
proposed decision, the Agency will issue a Residue removal instructions—general.
registration review decision or interim 156.146 Residue removal instructions for
registration review decision. This decision will nonrefillable containers—rigid containers with
include an explanation of any changes to the dilutable pesticides.
proposed decision and the Agency’s response 156.156 Residue removal instructions for re- fillable
containers.
to significant comments. The Agency will 156.159 Compliance date.
publish a notice in the FEDERAL REGISTER
Subparts I-J [Reserved]
announcing the availability of a registration
review decision or interim registration review Subpart K—Worker Protection Statements
decision. The registration review case docket 156.200 Scope and applicability.
will remain open until all actions required in 156.203 Definitions.
the final decision on the registration review 156.204 Modification and waiver of requirements.
156.206 General statements.
case have been completed. 156.208 Restricted-entry statements.
(d) If the registrant fails to take the action 156.210 Notification-to-workers statements. 156.212
required in a registration review decision or Personal protective equipment statements.
interim registration review decision, the AUTHORITY: 7 U.S.C. 136-136y.
Agency may take appropriate action under
FIFRA. Subpart A—General Provisions
PART 156—LABELING REQUIRE § 156.3 Definitions.
MENTS FOR PESTICIDES AND Terms used in this part have the same
DEVICES meaning as in the Act and part 152 of this
chapter. In addition, as used in this part, the
Subpart A—General Provisions following terms shall have the meanings set
Sec. forth below.
156.3 Definitions. Dilutable means that the pesticide product’s
156.10 Labeling requirements. labeling allows or requires the pesticide
product to be mixed with a liquid diluent prior
Subparts B-C [Reserved] to application or use.
Transport vehicle means a cargo-carrying
vehicle such as an automobile, van, tractor,
truck, semitrailer, tank
(3) Language to be used. All required label
or labeling text shall appear in the English
language. However, the Agency may require
[73 FR 64224, Oct. 29, 2008] or the applicant may propose additional text in
§ 156.10 Labeling requirements. other languages as is considered necessary to
(a) General—(1) Contents of the label. Every protect the public. When additional text in
pesticide product shall bear a label containing another language is necessary, all labeling
the information specified by the Act and the requirements will be applied equally to both
regulations in this part. The contents of a label the English and other-language versions of the
must show clearly and prominently the labeling.
following: (4) Placement of Label—(i) General. The
(1) The name, brand, or trademark under label shall appear on or be securely attached
which the product is sold as prescribed in to the immediate container of the pesticide
paragraph (b) of this section; product. For purposes of this section, and the
(ii) The name and address of the producer, misbranding provisions of the Act, ‘‘securely
registrant, or person for whom produced as attached’’ shall mean that a label can
prescribed in paragraph (c) of this section; reasonably be expected to remain affixed
(iii) The net contents as prescribed in during the foreseeable conditions and period
paragraph (d) of this section; of use. If the immediate container is enclosed
(iv) The product registration number as within a wrapper or outside container through
prescribed in paragraph (e) of this section; which the label cannot be clearly read, the
(v) The producing establishment number label must also be securely attached to such
as prescribed in paragraph (f) of this section; outside wrapper or container, if it is a part of
(vi) An ingredient statement as prescribed the package as customarily distributed or sold.
in paragraph (g) of this section; (ii) Tank cars and other bulk con- tainers—
(vii) Hazard and precautionary statements (A) Transportation. While a pesticide product
as prescribed in subpart D of this part for is in transit, the appropriate provisions of 49
human and domestic animal hazards and CFR parts 170189, concerning the
subpart E of this part for environmental transportation of hazardous materials, and
hazards. specifically those provisions concerning the
(viii) The directions for use as prescribed labeling, marking and placarding of hazardous
in paragraph (i) of this section; and materials and the vehicles carrying them,
(ix) The use classification(s) as prescribed define the basic Federal requirements. In
in paragraph (j) of this section. addition, when any registered pesticide
(2) Prominence and legibility. (i) All words, product is transported in a tank car, tank truck
statements, graphic representations, designs or other mobile or portable bulk container, a
or other information required on the labeling copy of the accepted label must be attached
by the Act or the regulations in this part must to the shipping papers, and left with the
be clearly legible to a person with normal consignee at the time of delivery.
vision, and must be placed with such (B) Storage. When pesticide products are
conspicuousness (as compared with other stored in bulk containers, whether mobile or
words, statements, designs, or graphic matter stationary, which remain in the custody of the
on the labeling) and expressed in such terms user, a copy of the label of labeling, including
as to render it likely to be read and understood all appropriate directions for use, shall be
by the ordinary individual under customary securely attached to the container in the
conditions of purchase and use. immediate vicinity of the discharge control
(ii) All required label text must: valve.
(A) Be set in 6-point or larger type; (5) False or misleading statements.
(B) Appear on a clear contrasting Pursuant to section 2(q)(1)(A) of the Act, a
background; and pesticide or a device declared subject
(C) Not be obscured or crowded.
to the Act pursuant to §152.500, Is misbranded label texts have been provisionally accepted by
If its labeling is false or misleading in any the Agency.
particular including both pesticidal and non- (ii) Clearly legible reproductions or photo
pesticidal claims. Examples of statements or reductions will be accepted for unusual labels
representations in the labeling which such as those silk- screened directly onto glass
constitute misbranding include: or metal containers or large bag or drum
(i) A false or misleading statement labels. Such reproductions must be of
concerning the composition of the product; microfilm reproduction quality.
(ii) A false or misleading statement (b) Name, brand, or trademark. (1) The
concerning the effectiveness of the product as name, brand, or trademark under which the
a pesticide or device; pesticide product is sold shall appear on the
(iii) A false or misleading statement about front panel of the label.
the value of the product for purposes other (2) No name, brand, or trademark may
than as a pesticide or device; appear on the label which:
(iv) A false or misleading comparison with (1) Is false or misleading, or
other pesticides or devices; (ii) Has not been approved by the
(v) Any statement directly or indirectly Administrator through registration or
implying that the pesticide or device is supplemental registration as an additional
recommended or endorsed by any agency of name pursuant to §152.132.
the Federal Government; (c) Name and address of producer,
(vi) The name of a pesticide which registrant, or person for whom produced. An
contains two or more principal active unqualified name and address given on the
ingredients if the name suggests one or more label shall be considered as the name and
but not all such principal active ingredients address of the producer. If the registrant’s
even though the names of the other name appears on the label and the registrant
ingredients are stated elsewhere in the is not the producer, or if the name of the
labeling; person for whom the pesticide was produced
(vii) A true statement used in such a way appears on the label, it must be qualified by
as to give a false or misleading impression to appropriate wording such as ‘‘Packed for * * *,’’
the purchaser; ‘‘Distributed by * * *,’’ or ‘‘Sold by * * *’’ to show
(viii) Label disclaimers which negate or that the name is not that of the producer.
detract from labeling statements required (d) Net weight or measure of contents.
under the Act and these regulations; (1) The net weight or measure of content
(ix) Claims as to the safety of the shall be exclusive of wrappers or other
pesticide or its ingredients, including materials and shall be the average content
statements such as ‘‘safe,’’ ‘‘nonpoisonous,’’ unless explicitly stated as a minimum quantity.
‘‘noninjurious,’’ ‘‘harmless’’ or ‘‘nontoxic to (2) If the pesticide is a liquid, the net
humans and pets’’ with or without such a content statement shall be in terms of liquid
qualifying phrase as ‘‘when used as directed’’; measure at 68 °F (20 °C) and shall be
and expressed in conventional American units of
(x) Non-numerical and/or comparative fluid ounces, pints, quarts, and gallons.
statements on the safety of the product, (3) If the pesticide is solid or semisolid,
including but not limited to: viscous or pressurized, or is a mixture of liquid
(A) ‘‘Contains all natural ingredients’’; and solid, the net content statement shall be in
(B) ‘‘Among the least toxic chemicals terms of weight expressed as avoirdupois
known’’ pounds and ounces.
(C) ‘‘Pollution approved’’ (4) In all cases, net content shall be stated
(6) Final printed labeling. (i) Except as in terms of the largest suitable units, i.e., ‘‘1
provided in paragraph (a)(6)(ii) of this section, pound 10 ounces’’ rather than ‘‘26 ounces.’’
final printed labeling must be submitted and
accepted prior to registration. However, final
printed labeling need not be submitted until
draft
(5) In addition to the required units to 40 CFR 165.65(h) or 165.70(i) prior to
specified, net content may be expressed in distribution or sale of the pesticide.
metric units. (g) Ingredient statement—(1) General. The
(6) Variation above minimum content or label of each pesticide product must bear a
around an average is permissible only to the statement which contains the name and
extent that it represents deviation unavoidable percentage by weight of each active
in good manufacturing practice. Variation ingredient, the total percentage by weight of
below a stated minimum is not permitted. In all inert ingredients; and if the pesticide
no case shall the average content of the contains arsenic in any form, a statement of
packages in a shipment fall below the stated the percentages of total and water-soluble
average content. arsenic calculated as elemental arsenic. The
(7) For a pesticide product packaged in a active ingredients must be designated by the
refillable container, an appropriately sized area term ‘‘active ingredients’’ and the inert
on the label may be left blank to allow the net ingredients by the term ‘‘inert ingredients,’’ or
weight or measure of content to be marked in the singular forms of these terms when
by the refiller according to 40 CFR 165.65(h) or appropriate. Both terms shall be in the same
165.70(i) prior to distribution or sale of the type size, be aligned to the same margin and
pesticide. As required in paragraph (a)(1)(iii) of be equally prominent. The statement ‘‘Inert
this section, the net contents must be shown Ingredients, none’’ is not required for
clearly and prominently on the label. pesticides which contain 100 percent active
(e) Product registration number. The ingredients. Unless the ingredient statement is
registration number assigned to the pesticide a complete analysis of the pesticide, the term
product at the time of registration shall appear ‘‘analysis’’ shall not be used as a heading for
on the label, preceded by the phrase ‘‘EPA the ingredient statement.
Registration No.,’’ or the phrase ‘‘EPA Reg. (2) Position of ingredient statement. (i) The
No.’’ The registration number shall be set in ingredient statement is normally required on
type of a size and style similar to other print on the front panel of the label. If there is an
that part of the label on which it appears and outside container or wrapper through which
shall run parallel to it. The registration number the ingredient statement cannot be clearly
and the required identifying phrase shall not read, the ingredient statement must also
appear in such a manner as to suggest or appear on such outside container or wrapper.
imply recommendation or endorsement of the If the size or form of the package makes it
product by the Agency. impracticable to place the ingredient
(f) Producing establishment’s registration statement on the front panel of the label,
number. The producing establishment permission may be granted for the ingredient
registration number preceded by the phrase statement to appear elsewhere.
‘‘EPA Est.’’, of the final establishment at which (ii) The text of the ingredient statement
the product was produced may appear in any must run parallel with other text on the panel
suitable location on the label or immediate on which it appears, and must be clearly
container. It must appear on the wrapper or distinguishable from and must not be placed
outside container of the package if the EPA in the body of other text.
establishment registration number on the (3) Names to be used in ingredient
immediate container cannot be clearly read statement. The name used for each ingredient
through such wrapper or container. For a shall be the accepted common name, if there
pesticide product packaged in a refillable is one, followed by the chemical name. The
container, an appropriately sized area on the common name may be used alone only if it is
label may be left blank after the phrase ‘‘EPA well known. If no common name has been
Est.’’ to allow the EPA establishment established, the chemical name alone shall be
registration number to be marked in by the used. In no case will the use of a trademark or
refiller according proprietary name be permitted unless such
name has been
accepted as a common name by the the label provided that they are conspicuous
Administrator under the authority of section enough to be easily read by the user of the
25(c)(6). pesticide product. Directions for use may
(4) Statements of percentages. The appear on printed or graphic matter which
percentages of ingredients shall be stated in accompanies the pesticide provided that:
terms of weight-to-weight. The sum of (A) if required by the Agency, such printed
percentages of the active and the inert or graphic matter is securely attached to each
ingredients shall be 100. Percentages shall not package of the pesticide, or placed within the
be expressed by a range of values such as ‘‘22- outside wrapper or bag;
25%.’’ if the uses of the pesticide product are (B) The label bears a reference to the
expressed as weight of active ingredient per directions for use in accompanying leaflets or
unit area, a statement of the weight of active circulars, such as ‘‘See directions in the
ingredient per unit volume of the pesticide enclosed circular:’’ and
formulation shall also appear in the ingredient (C) The Administrator determines that it is
statement. not necessary for such directions to appear on
(5) Accuracy of stated percentages. The the label.
percentages given shall be as precise as (iii) Exceptions to requirement for
possible reflecting good manufacturing direction for use. (A) Detailed directions for use
practice. if there may be unavoidable variation may be omitted from labeling of pesticides
between manufacturing batches, the value which are intended for use only by
stated for each active ingredient shall be the manufacturers of products other than
lowest percentage which may be present. pesticide products in their regular
(6) Deterioration. Pesticides which change manufacturing processes, provided that:
in chemical composition significantly must
(1) The label clearly shows that the product
meet the following labeling requirements:
is intended for use only in manufacturing
(i) in cases where it is determined that a
pesticide formulation changes chemical processes and specifies the type(s) of products
composition significantly, the product must involved.
bear the following statement in a prominent (2) Adequate information such as technical
position on the label: ‘‘Not for sale or use after data sheets or bulletins, is available to the
[date].’’ trade specifying the type of product involved
(ii) The product must meet all label claims and its proper use in manufacturing processes;
up to the expiration time indicated on the (3) The product will not come into the
label. hands of the general public except after
(7) Inert ingredients. The Administrator incorporation into finished products; and
may require the name of any inert ingredient(s) (4) The Administrator determines that such
to be listed in the ingredient statement if he directions are not necessary to prevent
determines that such ingredient(s) may pose a unreasonable adverse effects on man or the
hazard to man or the environment. environment.
(h) [Reserved] (B) Detailed directions for use may be
(i) Directions for Use—(1) General omitted from the labeling of pesticide
requirements—(i) Adequacy and clarity of products for which sale is limited to physicians,
directions. Directions for use must be stated in veterinarians, or druggists, provided that:
terms which can be easily read and understood (1) The label clearly states that the product
by the average person likely to use or to is for use only by physicians or veterinarians;
supervise the use of the pesticide. When (2) The Administrator determines that such
followed, directions must be adequate to directions are not necessary to prevent
protect the public from fraud and from unreasonable adverse effects on man or the
personal injury and to prevent unreasonable environment; and
adverse effects on the environment. (3) The product is also a drug and
(ii) Placement of directions for use. regulated under the provisions of the Federal
Directions may appear on any portion of Food, Drug and Cosmetic Act.
(C) Detailed directions for use may be in accordance with subpart H of this part.
omitted from the labeling of pesticide These instructions must be grouped and
products which are intended for use only by appear under the heading, ‘‘Storage and
formulators in preparing pesticides for sale to Disposal.’’ This heading must be set in type of
the public, provided that: the same minimum sizes as required for the
(1) There is information readily available to child hazard warning. (See table in § 156.60(b))
the formulators on the composition, toxicity, (x) Any limitations or restrictions on use
methods of use, applicable restrictions or required to prevent unreasonable adverse
limitations, and effectiveness of the product effects, such as:
for pesticide purposes; (A) Required intervals between application
(2) The label clearly states that the product and harvest of food or feed crops.
is intended for use only in manufacturing, (B) Rotational crop restrictions.
formulating, mixing, or repacking for use as a (C) Warnings as required against use on
pesticide and specifies the type(s) of pesticide certain crops, animals, objects, or in or
products involved; adjacent to certain areas.
(3) The product as finally manufactured, (D) For total release foggers as defined in
formulated, mixed, or repackaged is § 156.78(d)(1), the following statements must
be included in the ‘‘Directions for Use.’’
registered; and
(4) The Administrator determines that such DO NOT use more than one fogger per room. DO
directions are not necessary to prevent NOT use in small, enclosed spaces such as closets,
cabinets, or under counters or tables. Do not use in
unreasonable adverse effects on man or the a room 5 ft.x5 ft. or smaller; instead, allow fog to
environment. enter from other rooms. Turn off ALL ignition sources
(2) Contents of Directions for Use. The such as pilot lights (shut off gas valves), other open
directions for use shall include the following, flames, or running electrical appliances that cycle off
under the headings ‘‘Directions for Use’’: and on (i.e., refrigerators, thermostats, etc.). Call your
(i) The statement of use classification as gas utility or management company if you need
prescribed in paragraph (j) of this section assistance with your pilot lights.’’
immediately under the heading ‘‘Directions for (E) For restricted use pesticides, a
Use.’’ statement that the pesticide may be applied
(ii) Immediately below the statement of under the direct supervision of a certified
use classification, the statement ‘‘It is a applicator who is not physically present at the
violation of Federal law to use this product in site of application but nonetheless available to
a manner inconsistent with its labeling.’’ the person applying the pesticide, unless the
(iii) The site(s) of application, as for Agency has determined that the pesticide may
example the crops, animals, areas, or objects only be applied under the direct supervision of
to be treated. a certified applicator who is physically present.
(iv) The target pest(s) associated with (F) Other pertinent information which the
each site. Administrator determines to be necessary for
(v) The dosage rate associated with each the protection of man and the environment.
site and pest. (j) Statement of use classification. Any
(vi) The method of application, including pesticide product for which some uses are
instructions for dilution, if required, and type(s) classified for general use and others for
of application apparatus or equipment restricted use shall be separately labeled
required. according to the labeling standards set forth in
(vii) The frequency and timing of this subsection, and shall be marketed as
applications necessary to obtain effective separate products with different registration
results without causing unreasonable adverse numbers, one bearing directions only for
effects on the environment. general use(s) and the other bearing directions
(viii) Worker protection statements for restricted use(s) except that, if a
meeting the requirements of subpart K of this
part.
(ix) Specific directions concerning the
storage, residue removal and disposal of the
pesticide and its container,
product has both restricted use(s) and general fine the appropriate wording for the terms of
use(s), both of these uses may appear on a restriction by regulation.
product labeled for restricted use. Such [40 FR 28268, July 3, 1975; 40 FR 32329, Aug. 1, 1975;
products shall be subject to the provisions of 40 FR 36571, Aug. 21, 1975, as amended at 43 FR
paragraph (j)(2) of this section. 5786, Feb. 9, 1978. Redesignated and amended at 53
(1) General Use Classification. Pesticide FR 15991, 15999, May 4, 1988; 57 FR 38146, Aug. 21,
products bearing directions for use(s) classified 1992; 60 FR 32096, June 19, 1995; 63 FR 9082, Feb. 23,
1998; 66 FR 64764, Dec. 14, 2001; 71 FR 47420, Aug.
general shall be labeled with the exact words 16, 2006; 73 FR 75596, Dec. 12, 2008]
‘‘General Classification’’ immediately below the
heading ‘‘Directions for Use.’’ And reference to Subparts B-C [Reserved]
the general classification that suggests or
implies that the general utility of the pesticide Subpart D—Human Hazard and
extends beyond those purposes and uses Precautionary Statements
contained in the Directions for Use will be
considered a false or misleading statement SOURCE: 66 FR 64764, Dec. 14, 2001, unless
under the statutory definitions of misbranding. otherwise noted.
(2) Restricted Use Classification. Pesticide
products bearing direction for use(s) classified § 156.60 General.
restricted shall bear statements of restricted Each product label is required to bear
use classification on the front panel as hazard and precautionary statements for
humans and domestic animals (if applicable) as
described below:
prescribed in this subpart. Hazard statements
(i) Front panel statement of restricted use describe the type of hazard that may occur,
classification. (A) At the top of the front panel while precautionary statements will either
of the label, set in type of the same minimum direct or inform the user of actions to take to
sizes as required for human hazard signal avoid the hazard or mitigate its effects.
words (see table in paragraph (h)(1)(iv) of this (a) Location of statements—(1) Front panel
section), and appearing with sufficient statements. The signal word, child hazard
prominence relative to other text and graphic warning, and, in certain cases, the first aid
material on the front panel to make it unlikely statement are required to appear on the front
to be overlooked under customary conditions panel of the label, and also in any
of purchase and use, the statement ‘‘Restricted supplemental labeling intended to accompany
Use Pesticide’’ shall appear. the product in distribution or sale.
(B) Directly below this statement on the (2) Statements elsewhere on label. Hazard
front panel, a summary statement of the terms and precautionary statements not required on
of restriction imposed as a precondition to the front panel may appear on other panels of
registration shall appear. If use is restricted to the label, and may be required also in
certified applicators, the following statement is supplemental labeling. These include, but are
required: ‘‘For retail sale to and use only by not limited to, the human hazard and
Certified Applicators or persons under their precautionary statements, domestic animal
direct supervision and only for those uses statements if applicable, a Note to Physician,
and physical or chemical hazard statements.
covered by the Certified Applicator’s
(b) Placement and prominence—(1) Front
certification.’’ If, however, other regulatory panel statements. All required front panel
restrictions are imposed, the Administrator will warning statements shall be grouped together
de on the label, and shall appear with sufficient
prominence relative to other front panel text
and graphic material to make them unlikely to
be overlooked under customary conditions of
purchase and use. The table below shows the
minimum
type size requirements for the front panel § 156.62 Toxicity Category.
warning statements for various front panel This section establishes four Toxicity
sizes. Categories for acute hazards of pesticide
products, Category I being the highest toxicity
TYPE SIZES FOR FRONT PANEL WARNING category. Most human hazard, precautionary
STATEMENTS statements, and human personal protective
equipment statements are based upon the
Point Size Toxicity Category of the pesticide product as
Signal sold or distributed. In addition, toxicity
Size of Label Front Panel (Square Inches) Word child
Hazard categories may be used for regulatory
purposes other than labeling, such as
(All Warn
Capital ing
Letters) classification for restricted use and
5 and under .............................................. 6 6
requirements for child-resistant packaging. In
Over 5 to 10 ............................................. 10 6 certain cases, statements based upon the
Over 10 to 15 ........................................... 12 8 Toxicity Category of the product as diluted for
Over 15 to 30 ........................................... 14 10 use are also permitted. A Toxicity Category is
Over 30 ..................................................... 18 12 assigned for each of five types of acute
exposure, as specified in the table in this
(2) Other required statements. All other paragraph.
hazard and precautionary statements must be
at least 6 point type.
Oral LD50 ................ Up to and including 50 >50 thru 500 mg/kg >500 thru 5,000 mg/kg >5,000 mg/kg
mg/kg
Dermal LD50 ........... Up to and including 200 >200 thru 2000 mg/kg >2000 thru 20,000 mg/ >20,000 mg/kg
mg/kg kg
Inhalation LC50 ....... Up to and including 0.2 >0.2 thru 2 mg/liter >2 thru 20 mg/liter >20 mg/liter
mg/liter
Eye irritation ............ Corrosive; corneal opacity Corneal opacity No corneal opacity; No irritation
not reversible within 7 reversible within 7 irritation reversible
days days; irritation within 7 days
persisting for 7 days
Skin irritation ........... Corrosive Severe irritation at 72 Moderate irritation at 72 Mild or slight irritation at 72
hours hours hours
§ 156.64 Signal word. from skin and eye irritation), the word “Poison”
must appear in red on a background of
(a) Requirement. Except as provided in distinctly contrasting color, and the skull and
paragraph (a)(4), each pesticide product must crossbones symbol must appear in immediate
bear on the front panel a signal word, proximity to the word ‘‘Poison.’’
reflecting the highest Toxicity Category (2) Toxicity Category II. Any pesticide
(Category I is the highest toxicity category) to product meeting the criteria of Toxicity
which the product is assigned by any of the Category II as the highest category by any
five routes of exposure in §156.62. The signal route of exposure must bear on the front panel
word must also appear together with the the signal word ‘‘WARNING.’’
heading for the human precautionary (3) Toxicity Category III. Any pesticide
statement section of the labeling (see §156.70). product meeting the criteria of Toxicity
(1) Toxicity Category I. Any pesticide Category III as the highest category by any
product meeting the criteria of Toxicity route of exposure must bear on the front panel
Category I for any route of exposure must bear the signal word ‘‘CAUTION.’’
on the front panel the signal word ‘‘DANGER.’’ (4) Toxicity Category IV. A pesticide
In addition, if the product is assigned to product meeting the criteria of Toxicity
Toxicity Category I on the basis of its oral, Category IV by all routes of exposure is not
inhalation or dermal toxicity (as distinct required to bear a signal
word. If a signal word is used, it must be or eye irritation effects in Category I or II.
“CAUTION.” (b) Product as diluted for use. If the
(b) Use of signal words. In no case may a product labeling bears directions for dilution
product: with water prior to use, the label may also
(1) Bear a signal word reflecting a higher include a statement describing how the first
Toxicity Category than indicated by the route aid measures may be modified for the diluted
of exposure of highest toxicity, unless the product. Such a statement must reflect the
Agency determines that such labeling is Toxicity Category(ies) of the diluted product,
necessary to prevent unreasonable adverse based upon data for the route of exposure (or
effects on man or the environment; calculations if appropriate). If the labeling
(2) Bear a signal word reflecting a lesser provides for a range of use dilutions, only that
Toxicity Category associated with a diluted use dilution representing the highest
product. Although precautionary statements concentration allowed by labeling may be
for use dilutions may be included on label, the used as the basis for a statement pertaining to
signal word must reflect the toxicity of the the diluted product. The statement for a
product as distributed or sold; or diluted product may not substitute for the
(3) Bear different signal words on different statement for the concentrate, but augments
parts of the label. the information provided for the concentrate.
(c) Heading. The heading of the statement
§ 156.66 Child hazard warning. may be ‘‘First Aid’’ or “Statement of Practical
(a) Each pesticide product must bear on Treatment.’’
the front panel of the label the statement (d) Location of first aid statement. The first
‘‘Keep Out of Reach of Children.” That aid statement must appear on the front panel
statement, or any alternative statement of the label of all products assigned to Toxicity
approved by EPA, must appear on a separate Category I by any route of exposure. Upon
line in close proximity to the signal word, if review, the Agency may permit reasonable
required. The statement is required on Toxicity variations in the placement of the first aid
Category IV products that do not otherwise statement if a reference such as ‘‘See first aid
require a signal word. statement on back panel’’ appears on the front
(b) In its discretion, EPA may waive the panel. The first aid statement for products
requirement, or require or permit an assigned to Toxicity Categories II or III may
alternative child hazard warning, if: appear on any panel of the label.
(1) The applicant can demonstrate that the § 156.70 Precautionary statements for human
likelihood of exposure of children to the hazards.
pesticide during distribution, marketing, (a) Requirement. Human hazard and
storage or use is remote (for example, an precautionary statements as required must
industrial use product); or appear together on the label or labeling under
(2) The pesticide is approved for use on the general heading ‘‘Precautionary
children (for example, an insect repellent). Statements’’ and under appropriate
(c) EPA may approve an alternative child subheadings similar to ‘‘Humans and
hazard warning that more appropriately Domestic Animals,’’ ‘‘Environmental Hazards’’
reflects the nature of the pesticide product to (see subpart E of this part) and ‘‘Physical or
which children may be exposed (for example, Chemical Hazards.’’ The phrase ‘‘and Domestic
an impregnated pet collar). In this case, EPA Animals’’ may be omitted from the heading if
may also approve placement on other than the domestic animals will not be exposed to the
front panel. product.
(b) Content of statements. When data or
§ 156.68 First aid statement. other information show that an acute hazard
(a) Product as sold and distributed. Each may exist to humans or domestic animals, the
product must bear a first aid statement if the label must bear
product has systemic effects in Category I, II,
or III, or skin
precautionary statements describing the ard and precautionary statements. Specific
particular hazard, the route(s) of exposure and statements pertaining to the hazards of the
the precautions to be taken to avoid accident, product and its uses must be approved by the
injury or toxic effect or to mitigate the effect. Agency. With Agency approval, statements
The precautionary paragraph must be may be augmented to reflect the hazards and
immediately preceded by the appropriate precautions associated with the product as
signal word. diluted for use. Refer to § 156.68(b) for
(c) Typical precautionary statements. The requirements for use dilution statements.
table below presents typical haz
(d) Total release fogger products. (1) A hazard and precautionary statements may
total release fogger Is defined as a pesticide appear on any panel of the label and may be
product in a pressurized container designed to required also in supplemental labeling. The
automatically release the total contents in one environmental hazard statements must appear
operation, for the purpose of creating a together under the heading ‘‘Environmental
permeating fog within a confined space to Hazards.’’ Typically the statements are
deliver the pesticide throughout the space. grouped as a sub-category within the
(2) If a pesticide product is a total release ‘‘Precautionary Statements’’ section of the
fogger containing a propellant with a flash labeling.
point at or below 20 °F, then the following (c) Type size. All environmental hazard and
special instructions must be added to the precautionary statements must be at least 6
‘‘Physical and Chemical Hazards’’ warning point type.
statement, in addition to any flammability § 156.85 Non-target organisms.
statement required by paragraph (b) of this
section: (a) Requirement. Where a hazard exists to
This product contains a highly flammable non-target organisms, EPA may require
ingredient. It may cause a fire or explosion if precautionary statements of the nature of the
not used properly. Follow the Directions for hazard and the appropriate precautions to
Use on this label very carefully. avoid potential accident, injury, or damage.
(3) A graphic symbol depicting fire, such as (b) Examples. The statements in this
illustrated in this paragraph, or an equivalent paragraph illustrate the types of hazard
symbol, must be displayed along with the statements that EPA may require and the
required language adjoining the ‘‘Physical and circumstances under which
they are typically required. These statements the container, they must be durably marked on
are not comprehensive; other statements may the container. Durable marking includes, but is
be required if more appropriate to the not limited to etching, embossing, ink jetting,
formulation or use. stamping, heat stamping, mechanically
(1) If a pesticide intended for outdoor use attaching a plate, molding, or marking with
contains an active ingredient with a durable ink.
mammalian acute oral LD50 of 100 mg/kg or (a) Nonrefillable container. For non-
less, the statement, ‘‘This pesticide is toxic to refillable containers, the statements in
wildlife’’ is required. paragraphs (a)(1) through (a)(4) of this section
(2) If a pesticide intended for outdoor use are required except as provided in paragraphs
contains an active ingredient with a fish acute (a)(5), (c), (d), and (e) of this section. If placed
LC50 of 1 ppm or less, the statement, ‘‘This on the label, the statements in paragraphs
pesticide is toxic to fish’’ is required. (a)(1) through (a)(3) of this section must be
(3) If a pesticide intended for outdoor use under an appropriate heading under the
contains an active ingredient with an avian heading ‘‘Storage and Disposal.’’ If any of the
acute oral LD50 of 100 mg/kg or less, or a statements in paragraphs (a)(1) through (a)(3)
subacute dietary LC50 of 500 ppm or less, the of this section are placed on the container, an
statement, ‘‘This pesticide is toxic to wildlife’’ is appropriate referral statement such as ‘‘See
required. container for recycling [or other descriptive
(4) If either accident history or field studies word] information.’’ must be placed on the
demonstrate that the use of the pesticide may label under the heading ‘‘Storage and
result in fatality to birds, fish or mammals, the Disposal.’’
statement, ‘‘This pesticide is extremely toxic to (1) Statement identifying a nonrefillable
wildlife (fish)’’ is required.
container. The following phrase is required:
(5) If a product is intended for or involves
‘‘Nonrefillable container.’’
foliar application to agricultural crops, forests
or shade trees, or mosquito abatement (2) Reuse statement. One of the following
treatments, and contains a pesticide toxic to statements is required. Products with labels
pollinating insects, the label must bear that allow household/ residential use must use
appropriate label cautions. the statement in paragraph (a)(2)(i) or (a)(2)(iii)
(6) If a product is intended for outdoor use of this section. All other products must use the
other than aquatic applications, the label must statement in paragraph
bear the caution, ‘‘Keep out of lakes, ponds or (a) (2)(i), (a)(2)(ii), or (a)(2)(iii) of this section.
streams. Do not contaminate water by (i) ‘‘Do not reuse or refill this container.’’
cleaning of equipment or disposal of wastes.’’ (ii) ‘‘Do not reuse this container to hold
materials other than pesticides or dilute
Subparts F-G [Reserved] pesticides (rinsate). After emptying and
cleaning, it may be allowable to temporarily
Subpart H—Container Labeling hold rinsate or other pesticide-related
SOURCE: 71 FR 47420, Aug. 16, 2006, unless
materials in the container. Contact your state
otherwise noted. regulatory agency to determine allowable
practices in your state.’’
§ 156.140 Identification of container types. (iii) The following statement may be used
For products other than plant-incorporated if a product is ‘‘ready-to-use’’ and its directions
protectants, the following statements, as for use allow a different product (that is a
applicable, must be placed on the label or similar, but concentrated formulation) to be
container. The information may be located on poured into the container and diluted by the
any part of the container except the closure. If end user: ‘‘Do not reuse or refill this container
the statements are placed on unless the directions for use allow a different
(concentrated) product to be diluted in the
container.’’
(3) Recycling or reconditioning statement. (lx) One-time use semlochemlcal dispersion
One of the following statements Is required: devices.
(i) ‘‘Offer for recycling if available.’’ (x) Any container that is destroyed by the
(ii) ‘‘Once cleaned, some agricultural use of the product contained.
plastic pesticide containers can be taken to a (xi) Any container that would be destroyed
container collection site or picked up for if reuse of the container were attempted.
recycling. To find the nearest site, contact your (b) Refillable container. For refillable
chemical dealer or manufacturer or contact [a containers, one of the following statements is
pesticide container recycling organization] at required, except as provided in paragraphs (c),
[phone number] or [web site]. For example, (d), and (e) of this section. If placed on the
this statement could be ‘‘Once cleaned, some label, the statement must be under the
agricultural plastic pesticide containers can be heading ‘‘Storage and Disposal.’’ If the
taken to a container collection site or picked statement is placed on the container, an
up for recycling. To find the nearest site, appropriate referral statement, such as
contact your chemical dealer or manufacturer “Refilling limitations are on the container.’’
or contact the Ag Container Recycling Council must be placed under the heading ‘‘Storage
(ACRC) at 1-877-9522272 (toll-free) or and Disposal.’’
www.acrecycle.org.’’ (1) ‘‘Refillable Container. Refill this
(iii) A recycling statement approved by container with pesticide only. Do not reuse this
EPA and published in an EPA document, such container for any other purpose.’’
as a Pesticide Registration Notice. (2) ‘‘Refillable Container. Refill this
(iv) An alternative recycling statement that container with [common chemical name] only.
has been reviewed and approved by EPA. Do not reuse this container for any other
purpose.’’
(v) ‘‘Offer for reconditioning if
(c) Modification. EPA may, on its own
appropriate.’’
initiative or based on data or information
(4) Batch code. A lot number, or other submitted by any person, modify or waive the
code used by the registrant or producer to requirements of this section or permit or
identify the batch of the pesticide product require alternative labeling statements.
which is distributed and sold is required. (d) Exemption for articles. Pesticidal articles
(5) Exemptions. Pesticide products in the that are not exempted from FIFRA regulation
following types of nonrefillable containers, and by § 152.25(a) of this chapter are exempt from
their packaging, are exempt from the the requirements of this section.
requirements in paragraphs (a)(1) and (a)(2) of (e) Exemption for transport vehicles.
this section: Transport vehicles are exempt from the
(i) Aerosol cans. requirements of this section.
(ii) Devices as defined in §152.500 of this [71 FR 47420, Aug. 16, 2006, as amended at 73 FR
chapter. 64224, Oct. 29, 2008]
(iii) One-time use caulking tubes and
§ 156.144 Residue removal instructions—general.
other one-time use squeezable tube
(a) General. Except as provided by
containers for paste, gel, or other similar
paragraphs (c) through (g) of this section, the
substances. label of each pesticide product must include
(iv) Foil packets for water soluble the applicable instructions for removing
packaging, repellent wipes, and other one- pesticide residues from the container prior to
time use products. container disposal that are specified in
(v) One-time use portion control packets, §156.146 and §156.156. The residue removal
such as polyethylene sleeve packages, or instructions are required for both nonrefillable
rodenticide placepacks. and refillable containers.
(vi) One-time use bait stations. (b) Placement of residue removal
(vii) One-time use cages for repellent or statements. All residue removal instructions
trapping strips.
(viii) Pet collars or animal ear tags, such as
cattle ear tags.
tainers must include one of the following sets
of instructions.
(c) Exemption for residential/household (1) For liquid dilutable pesticide products in
use products. Residential/household use containers small enough to shake, use the
pesticide products are exempt from the following instructions: ‘‘Triple rinse as follows:
residue removal instruction requirements in Empty the remaining contents into application
this section through §156.156. equipment or a mix tank and drain for 10
(d) Modification. EPA may, on its own seconds after the flow begins to drip. Fill the
initiative or based on data submitted by any container 14 full with water and recap. Shake
person, modify or waive the requirements of for 10 seconds. Pour rinsate into application
this section through § 156.156, or permit or equipment or a mix tank or store rinsate for
require alternative labeling statements. later use or disposal. Drain for 10 seconds after
(e) Exemption for gases. Pesticide products the flow begins to drip. Repeat this procedure
that are gaseous at atmospheric temperature two more times.’’
and pressure are exempt from the residue (2) For solid dilutable pesticide products in
removal instruction requirements in this containers small enough to shake, use the
section through § 156.156. following instructions: ‘‘Triple rinse as follows:
(f) Exemption for articles. Pesticidal articles Empty the remaining contents into application
that are not exempted from FIFRA regulation equipment or a mix tank. Fill the container 1/4
by § 152.25(a) of this chapter are exempt from full with water and recap. Shake for 10 seconds.
the residue removal instruction requirements Pour rinsate into application equipment or a
in this section through §156.156. mix tank or store rinsate for later use or
(g) Exemption for transport vehicles. disposal. Drain for 10 seconds after the flow
Transport vehicles are exempt from the begins to drip. Repeat this procedure two
requirements in this section through §156.156. more times.’’
[71 FR 47420, Aug. 16, 2006, as amended at 73 FR (3) For containers that are too large to
64224, Oct. 29, 2008] shake, use the following instructions: ‘‘Triple
§ 156.146 Residue removal instructions for rinse as follows: Empty remaining contents into
nonrefillable containers—rigid containers application equipment or a mix tank. Fill the
with dilutable pesticides. container 1/4 full with water. Replace and
The label of each dilutable (liquid or solid) tighten closures. Tip container on its side and
pesticide product packaged in a rigid roll it back and forth, ensuring at least one
nonrefillable container must include the complete revolution, for 30 seconds. Stand the
following residue removal instructions as container on its end and tip it back and forth
appropriate. several times. Turn the container over onto its
(a) Timing of the residue removal other end and tip it back and forth several
procedure. One of the following statements times. Empty the rinsate into application
must immediately precede the instructions equipment or a mix tank or store rinsate for
required in paragraph (b) of this section and later use or disposal. Repeat this procedure
must be consistent with the instructions in two more times.’’
paragraphs (b) and (c) of this section: (c) Pressure rinse instructions. The label of
(1) ‘‘Clean container promptly after each dilutable pesticide product packaged in
emptying.’’ rigid nonrefillable containers may include one
(2) ‘‘Triple rinse or pressure rinse container of the following sets of instructions, and one of
(or equivalent) promptly after emptying.’’ them must be used if the statement in
(3) ‘‘Triple rinse container (or equivalent) paragraph (a)(2) of this section is used. If one
promptly after emptying.’’ of these statements is included on the label, it
(b) Triple rinse instructions. The label of must immediately follow the triple rinse
each dilutable pesticide product packaged in instructions specified in paragraph (b) of this
rigid nonrefillable con section.
(1) For liquid dilutable pesticide products, (3) EPA may approve the request If EPA
use the following label instruction: ‘‘Pressure finds that the proposed Instructions are
rinse as follows: Empty the remaining contents necessary and appropriate.
into application equipment or a mix tank and § 156.156 Residue removal instructions for
continue to drain for 10 seconds after the flow refillable containers.
begins to drip. Hold container upside down The label of each pesticide product
over application equipment or mix tank or packaged in a refillable container must include
collect rinsate for later use or disposal. Insert the residue removal instructions in this section.
pressure rinsing nozzle in the side of the Instructions must be given for all pesticide
container, and rinse at about 40 PSI for at least products that are distributed or sold in
30 seconds. Drain for 10 seconds after the flow refillable containers, including those that do
begins to drip.’’ not require dilution prior to application.
(2) For solid dilutable pesticide products, (a) Timing of the residue removal
use the following label instruction: ‘‘Pressure procedure. One of the following statements
rinse as follows: Empty the remaining contents must immediately precede the instructions
into application equipment or a mix tank. Hold required in paragraph (b) of this section and
container upside down over application must be consistent with the instructions in
equipment or mix tank or collect rinsate for paragraph (b) of this section:
later use or disposal. Insert pressure rinsing (1) ‘‘Cleaning the container before final
nozzle in the side of the container, and rinse at disposal is the responsibility of the person
about 40 PSI for at least 30 seconds. Drain for disposing of the container. Cleaning before
10 seconds after the flow begins to drip.’’ refilling is the responsibility of the refiller.’’
(d) Non-water diluent. (1) A registrant who (2) ‘‘Pressure rinsing the container before
wishes to require users to clean a container final disposal is the responsibility of the person
with a diluent other than water (e.g., solvents) disposing of the container. Cleaning before
must submit to EPA a written request to refilling is the responsibility of the refiller.’’
modify the residue removal instructions of this (b) Residue removal instructions prior to
section. The registrant may not distribute or container disposal. (1) Instructions for cleaning
sell the pesticide with the modified residue each refillable container prior to disposal are
removal instructions until EPA approves the required. The residue removal instructions
request in writing. must be appropriate for the characteristics and
(2) The registrant must indicate why a non- formulation of the pesticide product and must
water diluent is necessary for efficient residue be adequate to protect human health and the
removal, and must propose residue removal environment.
instructions and disposal instructions that are (2) Subject to meeting the standard in
appropriate for the characteristics and paragraph (b)(1) of this section, the statement
formulation of the pesticide product and non- on residue removal instructions could include
water diluent. The proposed residue removal any one of the following:
instructions must identify the diluent. If the (i) The refilling residue removal procedure
Directions for Use permit the application of a developed by the registrant for the pesticide
mixture of the pesticide and the non-water product.
diluent, the instructions may allow the rinsate (ii) Standard industry practices for
to be added to the application equipment or cleaning refillable containers.
mix tank. If the Directions for Use do not (iii) For pesticides that require dilution
identify the nonwater diluent as an allowable prior to application, the following statement:
addition to the pesticide, the instructions must ‘‘To clean the container before final disposal,
empty the remaining contents from this
require collection and storage of the rinsate in
container into application equipment or a mix
a rinsate collection system. tank. Fill the container about 10 percent full
with water. Agitate vigorously or recirculate
water with the pump for 2
minutes. Pour or pump rinsate Into application the production of any agricultural plant on any
equipment or rinsate collection system. agricultural establishment as defined in §170.3
Repeat this rinsing procedure two more of this chapter, or whose labeling reasonably
times.’’ permits such use.
(iv) Any other statement the registrant (2) The requirements of this subpart do not
considers appropriate. apply to a product that bears directions solely
§ 156.159 Compliance date. for uses excepted by § 170.202(b) of this
Any pesticide product released for shipment chapter.
by a registrant after August 16, 2011 must bear (c) Effective dates. No product to which
a label that complies with §§ this subpart applies shall be distributed or sold
156.10(d)(7), 156.10(f), without amended labeling by any registrant
156.10(i)(2)(ix), 156.140, 156.144, 156.146 and after April 21,
156.156. 1994, or by any person after October 23,
[75 FR 62326, Oct. 8, 2010] 1995.
[57 FR 38146, Aug. 21, 1992, as amended at 73 FR
Subparts I-J [Reserved] 75596, Dec. 12, 2008]
§ 156.203 Definitions.
Subpart K—Worker Protection Terms in this subpart have the same
Statements meanings as they do in the Federal Insecticide,
SOURCE: 57 FR 38146, Aug. 21, 1992, unless Fungicide, and Rodenticide Act, as amended.
otherwise noted. In addition, the following terms, as used in this
§ 156.200 Scope and applicability. subpart, shall have the meanings stated below:
(a) Scope. (1) This subpart prescribes Fumigant means any pesticide product that
statements that must be placed on the is a vapor or gas or forms a vapor or gas on
pesticide label and in pesticide labeling. These application and whose method of pesticidal
statements incorporate by reference the action is through the gaseous state.
Worker Protection Standard, part 170 of this Restricted-entry interval or REI means the
chapter. The requirements addressed in these time after the end of a pesticide application
statements are designed to reduce the risk of during which entry to the treated area is
illness or injury resulting from workers’ and restricted.
pesticide handlers’ occupational exposures to [57 FR 38146, Aug. 21, 1992, as amended at 73 FR
pesticides used in the production of 75596, Dec. 12, 2008]
agricultural plants on agricultural § 156.204 Modification and waiver of requirements.
establishments as defined in §170.3 of this
chapter. These statements refer to specific (a) Modification on Special Review. If the
workplace practices designed to reduce or Agency concludes in accordance with §
eliminate exposure and to respond to 154.25(c) of this chapter that a pesticide should
emergencies that may arise from the be placed in Special Review because the
exposures that may occur. pesticide meets or exceeds the criteria for
(2) This subpart prescribes interim human health effects of § 154.7(a)(1)(2) or (6)
requirements that must be placed on the of this chapter, the Agency may modify the
pesticide label and in pesticide labeling. These personal protective equipment required for
interim requirements pertain to restricted- handlers or early-entry workers or both, the
entry intervals, personal protective equipment, restricted-entry intervals, or the notification to
and notification. On a case-by-case basis, workers requirements.
these interim requirements will be reviewed (b) Other modifications. The Agency,
and may be revised during reregistration or pursuant to this subpart and authorities
other agency review processes. granted in FIFRA sections 3, 6, and 12, may, on
(b) Applicability. (1) The requirements of its initiative or based on data submitted by any
this subpart apply to each pesticide product person, modify
that bears directions for use in
or waive the requirements of this subpart, or (3) If the statements in paragraph
permit or require alternative labeling (b) (2) of this section are included in
statements. Supporting data may be either supplemental labeling rather than on the label
data conducted according to Subdivisions U or of the pesticide container, the container label
K of the Pesticide Assessments guidelines or must contain this statement immediately
data from medical, epidemiological, or health following the statement required in paragraph
effects studies. A registrant who wishes to (b)(1) of this section: ‘‘Refer to supplemental
modify any of the statements required in labeling entitled AGRICULTURAL USE
§156.206, §156.208, §156.210, or §156.212 must REQUIREMENTS in the DIRECTIONS FOR USE
submit an application for amended section of the labeling for information about
registration unless specifically directed this standard.’’
otherwise by the Agency. (4) If the statements in paragraph
[57 FR 38146, Aug. 21, 1992, as amended at 73 FR (b) (2) of this section are included in
75596, Dec. 12, 2008] supplemental labeling, they must be preceded
immediately by the statement in paragraph
§ 156.206 General statements. (b)(1) of this section under the heading
(a) Application restrictions. Each product AGRICULTURAL USE REQUIREMENTS in the
shall bear the statement: ‘‘Do not apply this labeling.
product in a way that will contact workers or (c) Product-type identification. (1) If
other persons, either directly or through drift. the product contains an organophosphate
Only protected handlers may be in the area (i.e., an
during application.’’ This statement shall be organophosphorus ester that inhibits
near the beginning of the DIRECTIONS FOR cholinesterase) or an N-methyl carbamate (i.e.,
USE section of the labeling under the heading an N-methyl carbamic acid ester that inhibits
AGRICULTURAL USE REQUIREMENTS. cholinesterase), the label shall so state. The
(b) 40 CFR part 170 reference statement. statement shall be associated with the product
(1) Each product shall bear the reference name or product-type identification or shall be
statement: ‘‘Use this product only in in the STATEMENT OF PRACTICAL
accordance with its labeling and with the TREATMENT or FIRST AID section of the label.
Worker Protection Standard, 40 CFR part 170.’’ (2) If the product is a fumigant, the label
This statement shall be placed on the product shall so state. The identification shall appear:
label under the heading AGRICULTURAL USE (i) As part of the product name; or
REQUIREMENTS. (ii) Close to the product name, as part of
(2) Each product shall bear the statement: the product-type identification or as a
‘‘This standard contains requirements for the separate phrase or sentence.
protection of agricultural workers on farms, (d) State restrictions. Each product shall
forests, nurseries, and greenhouses, and bear the statement: ‘‘For any requirements
handlers of agricultural pesticides. It contains specific to your State, consult the agency in
requirements for training, decontamination, your State responsible for pesticide
notification, and emergency assistance. It also regulation.’’ This statement shall be under the
contains specific instructions and exceptions heading AGRICULTURAL USE REQUIREMENTS
pertaining to the statements on this label [in in the labeling.
this labeling] about [use any of the following (e) Spanish warning statements. If the
that are applicable] personal protective product is classified as toxicity category I or
equipment, restricted-entry interval, and toxicity category II according to the criteria in
notification to workers.’’ These statements §156.62, the signal word shall appear in
shall be placed immediately following the Spanish in addition to English followed by the
reference statement required by paragraph statement, ‘‘Si Usted no entiende la etiqueta,
(b)(1) of this section, or they shall be placed in busque a alguien para que se la explique a
the supplemental product labeling under the Usted en detalle. (If you do not understand the
heading AGRICULTURAL USE REQUIREMENTS. label, find some one to explain it to you in
detail.)’’ The
Spanish signal word ‘‘PELIGRO’’ shall be used each active ingredient shall be used to
for products in toxicity category I, and the determine the restricted-entry interval for that
Spanish signal word ‘‘AVISO’’ shall be used for product. If no acute dermal toxicity data are
products in toxicity category II. These obtainable, data on acute oral toxicity also
statements shall appear on the label close to shall be considered in this comparison. If no
the English signal word. applicable acute toxicity data are obtainable
[57 FR 38146, Aug. 21, 1992, as amended at 58 FR on the active ingredient, the toxicity category
34203, June 23, 1993; 73 FR 75596, Dec. 12, 2008] corresponding to the signal word of any
registered manufacturing- use product that is
§ 156.208 Restricted-entry statements. the source of the active ingredient in the end-
(a) Requirement. Each product with a use product shall be used. If no acute toxicity
restricted-entry interval shall bear the data are obtainable on the active ingredients
following statement: ‘‘Do not enter or allow and no toxicity category of a registered
worker entry into treated areas during the manufacturing-use product is obtainable, the
restricted-entry interval (REI).’’ This statement toxicity category of the end-use product
shall be under the heading AGRICULTURAL (corresponding to the signal word on its
USE REQUIREMENTS in the labeling. labeling) shall be used.
(b) Location of specific restricted-entry (2) Restricted-entry interval for sole active
interval statements. (1) If a product has one ingredient products. (i) If the product contains
specific restricted-entry interval applicable to only one active ingredient and it is in toxicity
all registered uses of the product on category I by the criteria in paragraph (c)(1) of
agricultural plants, the restricted-entry interval this section, the restricted-entry interval shall
for the product shall appear as a continuation be 48 hours. If, in addition, the active
of the statement required in paragraph (a) of ingredient is an organophosphorus ester that
this section and shall appear as follows: ‘‘of X inhibits cholinesterase and that may be
hours’’ or ‘‘of X days’’ or ‘‘until the acceptable applied outdoors in an area where the average
exposure level of X ppm or mg/m3 is reached.’’ annual rainfall for the application site is less
(2) If different restricted-entry intervals than 25 inches per year, the following
have been established for some crops or some statement shall be added to the restricted-
uses of a product, the restricted-entry entry interval statement: ‘‘(72 hours in outdoor
statement in paragraph (b)(1) of this section areas where average annual rainfall is less than
shall be associated on the labeling of the 25 inches a year).’’
product with the directions for use for each (ii) If the product contains only one active
crop each use to which it applies, immediately ingredient and it is in toxicity category II by the
preceded or immediately followed by the criteria in paragraph
words ‘‘Restricted-entry interval’’ (or the letters (c) (1) of this section, the restricted- entry
‘‘REI’’). interval shall be 24 hours.
(c) Restricted-entry interval based on (iii) If the product contains only active
toxicity of active ingredient—(1) Determination ingredients that are in toxicity category III or IV
of toxicity category. A restricted-entry interval by the criteria in paragraph (c)(1) of this
shall be established based on the acute toxicity section, the restricted-entry interval shall be 12
of the active ingredients in the product. For the hours.
purpose of setting the restricted-entry interval, (3) Restricted-entry interval for multiple
the toxicity category of each active ingredient active ingredient products. If the product
in the product shall be determined by contains more than one active ingredient, the
comparing the obtainable data on the acute restricted-entry interval (including any
dermal toxicity, eye irritation effects, and skin associated statement concerning use in arid
irritation effects of the ingredient to the criteria areas under paragraph (c)(2)(i) of this section)
of §156.62. The most toxic of the applicable shall be based on the active ingredient that
toxicity categories that are obtainable for requires the longest restricted-entry interval as
determined by the criteria in this section.
(d) Exception for fumigants. The criteria for (b) Notification to workers of pesticide
determining restricted-entry intervals in application. (1) Each product that contains any
paragraph (c) of this section shall not apply to active ingredient classified as toxicity category
any product that is a fumigant. For fumigants, I for either acute dermal toxicity or skin
any existing restricted-entry interval (hours, irritation potential under the criteria in §156.62
days, or acceptable exposure level) shall be shall bear the statement: ‘‘Notify
retained. Entry restrictions for fumigants have workers of the application by warning them
been or shall be established on a case-by-case orally and by posting warning signs at
basis at the time of registration, reregistration, entrances to treated areas.’’ If no acute dermal
or other Agency review process. toxicity data are obtainable, data on acute oral
(e) Existing product-specific restricted- toxicity of the active ingredient shall be
entry intervals. (1) A product-specific considered instead. If no data on acute dermal
restricted-entry interval, based on data toxicity, skin irritation potential, or acute oral
collected in accordance with §158.1070 or toxicity are obtainable on the active ingredient,
§161.390 of this chapter and Subdivision K of the toxicity category corresponding to the
the Pesticide Assessment Guidelines, shall signal word of any registered manufacturing-
supersede any restricted-entry interval use product that is the source of the active
applicable to the product under paragraph (c) ingredient in the end-use product shall be
of this section. used. If none of the applicable acute toxicity
(2) Product-specific restricted-entry data are obtainable on the active ingredient
intervals established for pesticide products or and no toxicity category of the registered
pesticide uses that are not covered by part 170 manufacturing- use product is obtainable, the
of this chapter shall remain in effect and shall toxicity category of the end-use product
not be placed under the heading corresponding to the product’s signal word
AGRICULTURAL USE REQUIREMENTS in the shall be used.
labeling. (2) Each product that is a fumigant and is
(f) Existing interim restricted-entry registered for use in a greenhouse (or whose
intervals. (1) An interim restricted-entry interval labeling allows use in a greenhouse) shall bear
established by the Agency before the effective the statement: ‘‘For greenhouse applications,
date of this subpart will continue to apply notify workers of the application by warning
unless a longer restricted-entry interval is them orally and by posting warning signs
required by paragraph (c) of this section. outside all entrances to the greenhouse.’’
(2) Existing interim restricted-entry intervals [57 FR 38146, Aug. 21, 1992, as amended at 58 FR
established by the Agency for pesticide 34203, June 23, 1993; 73 FR 75596, Dec. 12, 2008]
products or pesticide uses not covered by part
170 of this chapter shall remain in effect and § 156.212 Personal protective equipment
shall not be placed under the heading statements.
AGRICULTURAL USE REQUIREMENTS in the (a) Requirement. Each product shall bear
labeling. the personal protective equipment statements
[57 FR 38146, Aug. 21, 1992, as amended at 58 FR prescribed in paragraphs (d) through (j) of this
34203, June 23, 1993; 72 FR 61028, Oct. 26, 2007; 73 section.
FR 75596, Dec. 12, 2008] (b) Exceptions. (1) If personal protective
§ 156.210 Notification-to-workers statements. equipment were required for a product before
the effective date of this subpart, the existing
(a) Requirement. Each product that meets requirements shall be retained on the labeling
the requirements of paragraph (b) of this wherever they are more specific or more
section shall bear the posting and oral protective (as specified in EPA guidance
notification statements prescribed below. The materials) than the requirements in the table in
statements shall be in the DIRECTIONS FOR paragraph (e) of this section.
USE section of the labeling under the heading
AGRICULTURAL USE REQUIREMENTS.
(2) Any existing labeling statement that fined in §170.240 of this chapter) and work
prohibits the use of gloves or boots overrides clothing for pesticide handlers. This personal
the corresponding requirement in paragraph protective equipment requirement applies to
(e) of this section and must be retained on the any product that presents a hazard through
labeling. any route of exposure identified in the table
(3) If the product labeling contains uses (acute dermal toxicity, skin irritation potential,
that are not covered by part 170 of this acute inhalation toxicity, and eye irritation
chapter, the registrant may adopt the personal potential).
protective equipment required in this section (2) The requirement for personal protective
for those uses. However, if the personal equipment is based on the acute toxicity
protective equipment required in this section category of the end-use product for each
would not be sufficiently protective or would route of exposure as defined by §156.62. If data
be onerously overprotective for uses not to determine the acute dermal toxicity or the
covered by part 170 of this chapter, the acute inhalation toxicity are not obtainable, the
registrant must continue to apply the existing acute oral toxicity shall be used as a surrogate
personal protective equipment requirements to determine the personal protective
to those uses. The labeling must indicate which equipment requirements for that route of
personal protective equipment requirements exposure. If data to determine the acute
apply to uses covered by part 170 of this toxicity of the product by a specific route of
chapter and which personal protective exposure (including acute oral toxicity in lieu of
equipment requirements apply to other uses. acute dermal or acute inhalation toxicity) are
(c) Location of personal protective not obtainable, the toxicity category
equipment statements—(1) Personal corresponding to the signal word of the end-
protective equipment statements for pesticide use product shall be used to determine
handlers. Personal protective equipment personal protective equipment requirements
statements for pesticide handlers shall be in for that route of exposure. If the signal word is
the HAZARDS TO HUMANS (AND DOMESTIC ‘‘CAUTION,’’ toxicity category III will be used.
ANIMALS) section of the labeling. The required (3) The minimum personal protective
statements may be combined to avoid equipment and work clothing requirements
redundancy as long as the requirements and specified in this section shall be included in a
conditions under which they apply are statement such as the following: ‘‘Applicators
identified. and other handlers must wear: (body
(2) Personal protective equipment protection
statements for early-entry workers. Personal statement); (glove statement, if applicable);
protective equipment statements for early- (footwear statement, if applicable); (protective
entry workers shall be placed in the eyewear statement, if applicable); (respirator
DIRECTIONS FOR USE section of the labeling statement, if applicable).’’ The format of
under the heading AGRICULTURAL USE statements given in this paragraph is optional,
REQUIREMENTS and immediately after the but it is recommended for clarity.
restricted-entry statement required in § (e) Summary of personal protective
156.208(a). equipment requirements. The following table 1
(d) Personal protective equipment summarizes the personal protective
statements for pesticide handlers. (1) The table equipment requirements by route of exposure
in paragraph (e) of this section specifies and toxicity category:
minimum requirements for personal protective
equipment (as de
TABLE 1—MINIMUM PERSONAL PROTECTIVE EQUIPMENT (PPE) AND WORK CLOTHING FOR HANDLING
ACTIVITIES
Subpart V— Microbial Pesticides FIFRA secs. 3, 4, and 5 about the risks and
158.2100 Microbial pesticides definition and
benefits of pesticide products. Further, this
applicability. part specifies the data and information needed
158.2110 Microbial pesticides data requirements. to determine the safety of pesticide chemical
158.2120 Microbial pesticides product analysis data residues under FFDCA sec. 408.
requirements table. (b) Scope. (1) This part describes the
158.2130 Microbial pesticides residue data minimum data and information EPA typically
requirements table. requires to support an application for pesticide
158.2140 Microbial pesticides toxicology data registration or amendment; support the
requirements table.
158.2150 Microbial pesticides nontarget organisms
reregistration of a pesticide product; support
and environmental fate data requirements table. the maintenance of a pesticide registration by
158.2160 Microbial pesticides product performance means of the data call-in process, e.g., as used
data requirements. in the registration review program; or establish
158.2170 Experimental use permit data or maintain a tolerance or exemption from the
requirements—microbial pesticides. requirements of a tolerance for a pesticide
158.2171 Experimental use permit microbial chemical residue.
pesticides product analysis data requirements (2) This part establishes general policies
table.
158.2172 Experimental use permit microbial
and procedures associated with the
pesticides residue data requirements table. submission of data in support of a pesticide
158.2173 Experimental use permit microbial regulatory action.
pesticides toxicology data requirements table. (3) This part does not include study
158.2174 Experimental use permit microbial protocols, methodology, or standards for
pesticides nontarget organisms and conducting or reporting test results; nor does
environmental fate data requirements table. this part describe how the Agency uses or
Subpart W—Antimicrobial Pesticide Data evaluates the data and information in its risk
Requirements assessment and risk management decisions,
or the regulatory determinations that may be
158.2200 Applicability. based upon the data.
158.2201 Antimicrobial use patterns. (c) Scope of individual subparts. (1)
158.2203 Definitions. Conventional pesticides. Subparts A, B, C, D, F,
158.2204 Public health and nonpublic health claims. G, K, L, N, and O apply to conventional
158.2210 Product chemistry.
158.2220 Product performance. pesticides.
158.2230 Toxicology. (2) Biochemical pesticides. Subparts A, B
158.2240 Nontarget organisms. and U apply to biochemical pesticides.
158.2250 Nontarget plant protection. (3) Microbial pesticides. Subparts A, B and
158.2260 Applicator exposure. V apply to microbial pesticides.
158.2270 Post-application exposure. (4) Antimicrobial pesticides. Subparts A, B,
158.2280 Environmental fate.
158.2290 Residue chemistry. C, D, and W of this part apply to antimicrobial
pesticides.
Subpart X-Z [Reserved] [72 FR 60957, Oct. 26, 2007, as amended at 78 FR
158.2300-158.2500 [Reserved] 26978, May 8, 2013]
AUTHORITY: 7 U.S.C. 136-136y; 21 U.S.C. 346a.
SOURCE: 72 FR 60957, Oct. 26, 2007, unless § 158.3 Definitions.
otherwise noted. All terms defined in sec. 2 of the Federal
Insecticide, Fungicide, and Rodenticide Act
Subpart A—General Provisions apply to this part and are used with the
§ 158.1 Purpose and scope. meaning given in the Act. Applicable terms
from the Federal Food, Drug, and Cosmetic
(a) Purpose. The purpose of this part Is to
Act also apply to this part. Individual subparts
specify the kinds of data and information EPA
may contain definitions that pertain solely to
requires in order to make regulatory
that subpart. The following additional terms
judgments under apply to this part:
Applicant means any person or entity, ulatory judgments for pesticide products. EPA
including for the purposes of this part a has the authority to establish or modify data
registrant, who submits, or is required to needs for individual pesticide chemicals. The
submit, to the Agency any application, actual data required may be modified on an
petition, or submission intended to persuade individual basis to fully characterize the use
EPA to grant, modify, or leave unmodified a and properties, characteristics, or effects of
registration or other approval required as a specific pesticide products under review. The
condition of sale or distribution of a pesticide. Agency encourages each applicant to consult
Such submissions may include, but are not with EPA to discuss the data requirements
limited to, the following: particular to its product prior to and during the
(1) An application for registration or registration process.
amended registration of a pesticide product (b) The Agency cautions applicants that
under FIFRA sec. 3 or 24. the data routinely required in this part may not
(2) A submission of data required in be sufficient to permit EPA to evaluate the
conjunction with reregistration of a currently potential of the product to cause
registered product under FIFRA sec. 4. unreasonable adverse effects to man or the
(3) An application for an experimental use environment. EPA may require the submission
permit under FIFRA sec. 5. of additional data or information beyond that
(4) A submission of data in response to a specified in this part if such data or information
notice issued by EPA under FIFRA sec. are needed to appropriately evaluate a
3(c)(2)(B). pesticide product.
(5) A petition to establish or modify a (c) This part will be updated as needed to
tolerance or an exemption from the reflect evolving program needs and advances
requirement of a tolerance for a pesticide
in science.
chemical residue under FFDCA sec. 408.
Registration includes a new registration, § 158.32 Format of data submissions.
amended registration and reregistration,
(a) General. (1) All data submitted under
unless stated otherwise.
this part must be formatted in accordance with
§ 158.5 Applicability. this section.
(a) The requirements of this part apply to (2) The requirements of this section do not
the following submissions: apply to administrative materials
(1) An application for new or amended accompanying a data submission, including
registration under FIFRA sec. 3 or 24. forms, labeling, and correspondence.
(2) An application for experimental use (b) Transmittal document. Each submission
permit under FIFRA sec. 5. in support of a regulatory action must be
(3) A submission of data or information to accompanied by a transmittal document,
support the continuation of a registration which includes:
under FIFRA sec. 3, 4, or 24. (1) Identity of the submitter.
(4) A petition to establish, modify or revoke (2) The transmittal date.
a tolerance or exemption from a tolerance (3) Identification of the regulatory action
under FFDCA sec. 408. with which the submission is associated, e.g.,
(b) The information specified in this part the registration or petition number.
must be furnished with each submission (4) A list of the individual documents
described in paragraph (a) of this section if it included in the submission.
has not been submitted previously, or if any (c) Individual documents. Unless otherwise
previous submission is not accurate or specified by the Agency, each submission
complete. must be in the form of individual documents
§ 158.30 Flexibility. or studies. Previously submitted documents
should not be resubmitted unless specifically
requested by the Agency, but should be cited
with adequate information to
Identify the previously submitted document. degradation products, and any Information
Each study or document should include the concerning the effects of such pesticide on any
following: organism or the behavior of such pesticide in
(1) A title page including the following the environment, including, but not limited to,
information: data on safety to fish and wildlife, humans and
(1) The title of the study, including other mammals, plants, animals, and soil, and
identification of the substance(s) tested and studies on persistence, translocation and fate
the test name or data requirement addressed. in the environment, and metabolism.
(ii) The author(s) of the study. (b) Applicability. (1) This section applies to
(iii) The date the study was completed. information submitted pursuant to this part. It
(iv) If the study was performed in a supplements the general confidentiality
laboratory, the name and address of the procedures in 40 CFR part 2, subpart B,
laboratory, project numbers or other including FIFRA confidentiality procedures at
identifying codes. 40 CFR 2.307. To the extent that provisions in
(v) If the study is a commentary on or this section conflict with those in 40 CFR part
supplement to another previously submitted 2, subpart B, the provisions in this section take
study, full identification of the other study with precedence. The provisions of 40 CFR 2.308 do
which it should be associated in review. not apply to information to which this section
(vi) If the study is a reprint of a published applies. In addition to complying with the
document, all relevant facts of publication, requirements of this section, any
such as the journal title, volume, issue, inclusive confidentiality claims for information subject to
page numbers, and date of publication. 40 CFR part 174 (plant- incorporated
(2) The appropriate statement(s) regarding protectants) must be substantiated at the time
any data confidentiality claims as described in of submission as described in §174.9 of this
§158.33. chapter.
(3) A statement of compliance or (2) FFDCA sec. 408(i) protects confidential
noncompliance with respect to Good information submitted in connection with an
Laboratory Practice Standards as required by application for a tolerance or exemption to the
40 CFR 160.12, if applicable. same extent as FIFRA sec. 10. References in this
(4) A complete and accurate English section to FIFRA sec. 10 are deemed to apply
translation must be included for any equally to information submitted pursuant to
information that is not in English. FFDCA sec. 408, pursuant to the authority in
(5) A flagging statement as prescribed by sec. 408(i).
§158.34, if applicable. (c) Method of asserting business
§ 158.33 Confidential data. confidentiality claims—(1) Claim required.
(a) Definitions. For the purposes of this Information to which this section applies (and
section: which is submitted on or after the effective
(1) Registered or previously registered date of this regulation) will be deemed as not
pesticide means any pesticide containing an subject to a confidentiality claim unless a claim
active ingredient contained in a product that for that information is made in accordance
is, or has ever been, an active ingredient in a with the procedures specified in this
product registered under sec. 3 of FIFRA. A paragraph. Information not subject to a
registered pesticide that is the subject of an confidentiality claim may be made available to
application for a new use falls within the the public without further notice, subject to the
category of ‘‘registered or previously requirements of FIFRA sec. 10(g).
registered pesticide.’’ (2) Statement required. Upon submission to
(2) Safety and efficacy information means EPA, each document must be accompanied by
information concerning the objectives, a signed and dated document containing
methodology, results, or significance of any either the statements in paragraph (c)(2)(i) or
test or experiment performed on or with a (ii) of this section. No claims or markings on the
registered or previously registered pesticide or document or any attachments,
its separate ingredients, impurities, or
other than these statements and attachments within the scope of FIFRA sec.
submitted In accordance with paragraph (c)(3) 10(d)(1)(C).
of this section, will be recognized as asserting (v) Information in the confidential
a claim of confidentiality. The format of data attachment that is designated in accordance
submissions is set forth in §158.32. with paragraphs (c)(3)(ii) -
(i) No claim of confidentiality. (iv) of this section must be on a separate
No claim of confidentiality, on any basis page from information that is not so
whatsoever, is made for any information contained designated.
in this document. I acknowledge that information not (4) Voluntary release of information to
designated as within the scope of FIFRA sec.
10(d)(1)(A), (B), or (C) and which pertains to a
States and foreign governments. (i) Submitters
registered or previously registered pesticide is not are encouraged to include with the statement
entitled to confidential treatment and may be required under paragraph (c)(2) of this section
released to the public, subject to the provisions an additional statement to allow EPA to share
regarding disclosure to multinational entities under information with State and foreign
FIFRA sec. 10(g). governments. EPA will not consider such a
(ii) Claim of confidentiality. statement to be a waiver of confidentiality or
proprietary claims for the information. The
Information claimed as confidential has been statement is as follows:
removed to a confidential attachment.
(3) Confidential attachment. (i) All I authorize the Environmental Protection Agency
information claimed as confidential must be to release any information contained in this
document to State or foreign governments, without
submitted in a separate confidential relinquishing proprietary rights or any confidentiality
attachment to the document and cross claims asserted above.
referenced to the specific location in the
document from which it was removed. The (ii) Information designated as releasable to
confidential attachment must have its own title state or foreign governments in accordance
page and be paginated separately from the with this section may be released to such a
non-confidential document. government without further notice to the
(ii) All information in the confidential submitter. EPA will inform the State or foreign
attachment that consists of (or whose government of any of the confidentiality
disclosure would in turn disclose) claims associated with the information.
manufacturing or quality control processes (d) Release of information. (1) Safety and
must be individually identified in the efficacy information that was submitted to EPA
confidential attachment as a claim for on or after May 4, 1988 and that has not been
information within the scope of FIFRA sec. designated by the submitter as FIFRA sec.
10(d)(1)(A). 10(d)(1)(A), (B), or (C) information in
(iii) All information in the confidential accordance with the applicable requirements
attachment that consists of (or whose of this section is not entitled to confidential
disclosure would in turn disclose) the details of treatment and may be disclosed to the public
any methods for testing, detecting, or without further notice to the submitter, in
measuring the quantity of any deliberately accordance with paragraph (d)(2) of this
added inert ingredient of a pesticide, must be section. Safety and efficacy information which
individually identified in the confidential has been designated by the submitter as FIFRA
attachment as a claim for information within sec. 10(d)(1) (A), (B), or (C) information is
the scope of FIFRA sec. 10(d)(1)(B). entitled to confidential treatment only to the
(iv) All information in the confidential extent provided by FIFRA sec. 10(b), this
attachment that consists of (or whose section, and 40 CFR 2.208.
disclosure would in turn disclose) the identity (2) Information that is not entitled to be
or percentage quantity of any deliberately protected as confidential in accordance with
added inert ingredient of a pesticide must be FIFRA sec. 10(b), this section and with EPA
individually identified in the confidential confidentiality regulations at 40 CFR part 2,
attachment as a claim for information subpart B,
may be released to the public without the of this section must submit with the study a
affirmation of non-multinational status statement in accordance with paragraph (c) of
provided under FIFRA sec. 10(g), provided that this section.
the information does not contain or consist of (b) The following table indicates the study
any complete unpublished report submitted types and the criteria to be applied to each.
to EPA, or excerpts or restatements of any Column 1 lists the study types by name.
such report which reveal the full methodology Column 2 lists the associated Pesticide
and complete results of the study, test, or Assessment Guideline number. Column 3 lists
experiment, and all explanatory information the criteria applicable to each type of study.
necessary to understand the methodology or Column 4 lists the reporting code to be
interpret the results.
included in the statement specified in
§ 158.34 Flagging of studies for potential adverse paragraph
effects. (c) of this section when any criterion is met
(a) Any applicant who submits a study of or exceeded.
a type listed in paragraph (b)
TABLE-FLAGGING CRITERIA
Study Type(s) Guideline No. Criteria: Treated animals show any of the following: Criteria No.
4
A decrease in the time to development of any type of neoplasms
in any test group, males or females at any dose level,
compared to concurrent controls of the same sex.
(c) Identification of studies. For each study of (1) Study does not meet or exceed criteria.
a type identified in paragraph I have applied the criteria of 40 CFR 158.34 for
(b) of this section, the applicant shall include flagging studies for potential adverse effects to the
the appropriate one of the following two results of the attached study. This study neither
statements, together with the signature of the meets nor exceeds any of the applicable criteria.
authorized representative of the company,
and the date of signature:
(2) Study meets or exceeds criteria. quest to waive a data requirement is a final
I have applied the criteria of 40 CFR 158.34 for Agency action.
flagging studies for potential adverse effects to the § 158.60 Minor use data policies.
results of the attached study. FIFRA sec. 2(ll) defines the term ‘‘minor
This study meets or exceeds the criteria numbered use’’and FIFRA provides a number of statutory
[insert all applicable reporting codes]. provisions concerning minor uses. In addition,
§ 158.45 Waivers. EPA has established policies with respect to
minor uses of pesticides, including, but not
(a) The data requirements specified in this limited to, the following:
part as applicable to a category of products (a) A new data requirement pertinent to
will not always be appropriate for every both an unregistered minor use and a
product in that category. Some products may registered major use will not be applied to a
have unusual physical, chemical, or biological minor use applicant until it is applied to the
properties or atypical use patterns which major use registration.
would make particular data requirements (b) EPA will accept appropriate and
inappropriate, either because it would not be adequate extrapolations and regional data to
possible to generate the required data or support establishment of individual minor use
because the data would not be useful in the tolerances.
Agency’s evaluation of the risks or benefits of
the product. The Agency will waive data § 158.70 Satisfying data requirements.
requirements it finds are inappropriate, but will (a) General policy. The Agency will
ensure that sufficient data are available to determine whether the data submitted or cited
make the determinations required by the to fulfill the data requirements specified in this
applicable statutory standards. part are acceptable. This determination will be
(b) (1) Applicants are encouraged to based on the design and conduct of the
discuss a data waiver request with the Agency experiment from which the data were derived,
before developing and submitting supporting and an evaluation of whether the data fulfill
data, information, or other materials. the purpose(s) of the data requirement. In
(2) All waiver requests must be submitted evaluating experimental design, the Agency
to the Agency in writing. The request must will consider whether generally accepted
clearly identify the data requirement(s) for methods were used, sufficient numbers of
which a waiver is sought along with an measurements were made to achieve
explanation and supporting rationale why the statistical reliability, and sufficient controls
applicant believes the data requirement were built into all phases of the experiment.
should be waived. In addition, the applicant The Agency will evaluate the conduct of each
must describe any unsuccessful attempts to experiment in terms of whether the study was
generate the required data, furnish any other conducted in conformance with the design,
information which the applicant(s) believe(s) good laboratory practices were observed, and
would support the request, and when results were reproducible. The Agency will not
appropriate, suggest alternative means of reject data merely because they were derived
obtaining data to address the concern which from studies which, when initiated, were in
underlies the data requirement. accordance with an Agency-recommended
(c) The Agency will review each waiver protocol, even if the Agency subsequently
request and subsequently inform the applicant recommends a different protocol, as long as
in writing of its decision. If the decision could the data fulfill the purposes of the
apply to more than the requested product, the requirements as described in this paragraph.
Agency, in its discretion, may choose to send (1) The provisions in this part 158 should be
a notice to all registrants or publish a notice in read in conjunction with the provisions in
the FEDERAL REGISTER announcing the decision. §152.85 to claim eligibility for the formulators’
An Agency decision denying a written re exemption.
(2) [Reserved]
(b) Good laboratory practices. Applicants animals as well as reduce the cost of studies.
must adhere to the good laboratory practice EPA encourages this practice by including
(GLP) standards described in 40 CFR part 160 standards for acceptable combined tests in the
when conducting studies. Applicants must also Pesticide Assessment Guidelines. Registrants
adhere to GLP standards when conducting a and applicants are encouraged to consider
study in support of a waiver request of any combining other tests when practical and likely
data requirement which is within the scope of to produce scientifically acceptable results.
the GLP requirements. Registrants and applicants, however, must
(c) Agency guidelines. EPA has published consult with the EPA before initiating
Test Guidelines that contain standards for combined studies.
conducting acceptable tests, guidance on the
§ 158.75 Requirements for additional data.
evaluation and reporting of data, definition of
terms, and suggested study protocols. Copies The data routinely required by this part may
of the Test Guidelines may be obtained by not be sufficient to permit EPA to evaluate
visiting the agency’s website at every pesticide product. If the information
www.epa.gov/pesticides. required under this part is not sufficient to
(d) Study protocols—(1) General. Any evaluate the potential of the product to cause
appropriate protocol may be used to generate unreasonable adverse effects on man or the
the data required by this part, provided that it environment, additional data requirements will
meets the purpose of the test standards be imposed. However, EPA expects that the
specified in the pesticide assessment information required by this part will be
guidelines, and provides data of suitable adequate in most cases for an assessment of
quality and completeness as typified by the the properties and effects of the pesticide.
protocols cited in the guidelines. Applicants § 158.80 Use of other data.
should use the test procedure which is most (a) Data developed in foreign countries.
suitable for evaluation of the particular With certain exceptions, laboratory and field
ingredient, mixture, or product. Accordingly, study data developed outside the United
failure to follow a suggested protocol will not States may be submitted in support of a
invalidate a test if another appropriate pesticide registration. Data generated in a
methodology is used.
foreign country which the Agency will not
(2) Organization for Economic Co-
consider include, but are not limited to, data
Operation and Development (OECD)
protocols. Tests conducted in accordance with from tests which involved field test sites or a
the requirements and recommendations of the test material, such as a native soil, plant, or
applicable OECD protocols can be used to animal, that is not characteristic of the United
develop data necessary to meet the States. Applicants submitting foreign data
requirements specified in this part. Applicants must take steps to ensure that U.S. materials
should note, however, that certain of the are used, or be prepared to supply data or
OECD recommended test standards, such as information to demonstrate the lack of
test duration and selection of test species, are substantial or relevant differences between the
less restrictive than those recommended by selected material or test site and the U.S.
EPA. Therefore, when using OECD protocols, material or test site. Once submitted, the
care should be taken to observe the test Agency will determine whether or not the data
standards in a manner such that the data meet the data requirements.
generated by the study will satisfy the (b) Data generated for other purposes.
requirements of this part. Data developed for purposes other than
(e) Combining studies. Certain toxicology satisfaction of FIFRA data requirements, such
studies may be combined to satisfy data as monitoring studies, may also satisfy data
requirements. For example, carcinogenicity requirements in
studies in rats may be combined with the rat
chronic toxicity study. Combining appropriate
studies may be expected to reduce usage of
test
able from the Agency or may be obtained
from the Agency’s Web site at
http://www.epa.gov/pesticides.
(c) Antimicrobial pesticide use patterns.
Subpart B—How To Use Data The general use patterns for antimicrobial
pesticides are described in §158.2201.
Tables (d) Pesticide use site index for
§ 158.100 Pesticide use patterns. antimicrobial pesticides. The Pesticide Use Site
(a) General use patterns for conventional, Index for Antimicrobial Pesticides is a
biochemical, and microbial pesticides. There comprehensive list of specific antimicrobial
are six broad use categories used in the data use sites. The index is alphabetized by
tables. The six broad categories include antimicrobial use sites, and associates each
terrestrial outdoor uses, aquatic outdoor uses, antimicrobial use site with one or more of the
greenhouse uses, forestry uses, residential antimicrobial use patterns. It may be used in
outdoor uses, and indoor uses of all types. The conjunction with the data tables to determine
6 broad use categories are further subdivided the applicability of data requirements to
into 12 general use patterns which are the specific uses. The Pesticide Use Site Index for
bases for data requirements established by Antimicrobial Pesticides will be updated
use pattern. Within the data tables, general periodically, and is available from the Agency
use patterns have been combined into single or may be obtained from the Agency’s Web
columns when the data requirements are the site at http://www.epa.gov/pes- ticides.
same for the combined uses. If there are no (e) Determination of use pattern.
data requirements for a specific use, the Applicants unsure of the correct use pattern
column for that use is not included in the table. for their particular product should consult the
The 12 general use pattern groups used in the Agency.
data table in this part are: [72 FR 60957, Oct. 26, 2007, as amended at 78 FR
(1) Terrestrial food crop use. 26978, May 8, 2013]
(2) Terrestrial feed crop use. §158.110 Required and conditionally required data.
(3) Terrestrial nonfood crop use.
(4) Aquatic food crop use. The tables in this part use the descriptors R
(5) Aquatic nonfood use. (required), CR (conditionally required), and NR
(6) Greenhouse food crop use. (not required) as a general indication of the
(7) Greenhouse nonfood crop use. applicability of a data requirement. In all cases,
(8) Forestry use. the test notes referred to in the table must be
(9) Residential outdoor use. consulted to determine the actual applicability
(10) Residential indoor use. of the data requirement.
(11) Indoor food use. (a) EPA requires data designated as
(12) Indoor nonfood use. ‘‘required’’(R) for products with a given use
(b) Pesticide use site index for pattern in order to evaluate the risks or
conventional, biochemical, and microbial benefits of a product having that use pattern
pesticides. The Pesticide Use Site Index for under any conditions established by the test
Conventional, Biochemical, and Microbial notes.
Pesticides is a comprehensive list of specific (b) Data designated as ‘‘conditionally
pesticide use sites. The index is alphabetized required’’ (CR) for products with a given use
separately by site for all agricultural and all pattern are required by EPA to evaluate the
nonagricultural uses. The Pesticide Use Site risks or benefits of a product having that use
Index associates each pesticide use site with pattern if the product meets the conditions
one or more of the 12 general use patterns. It specified in the notes accompanying the
may be used in conjunction with the data requirement. The determination of whether
tables to determine the applicability of data the data must be submitted is based on the
requirements to specific uses. The Pesticide product’s use pattern, physical or
Use Site Index for Conventional, Biochemical,
and Microbial Pesticides will be updated
periodically, and is avail
chemical properties, expected exposure of ed to support the registration use of each
nontarget organisms, and/or results of pesticide product, the applicant may:
previous testing (for example, tier testing). (1) Refer to the applicable subpart(s) of this
Applicants must evaluate each applicable test part. These subparts describe the data
note for the conditions and criteria to be requirements including data tables for each
considered in determining whether subject area.
conditionally required data must be submitted. (2) Select the general use pattern(s) that
(c) Data not required for the Agency’s best cover the use pattern(s) specified on the
assessment of the risks and benefits of a pesticide product label as explained in
particular use pattern are designated ‘‘not §158.100. All applicable use patterns must be
required’’ (NR) in data tables. included.
§ 158.120 Determining data requirements. (3) Proceed down the appropriate general
As with current practice, the actual data and use pattern column in the table and note
studies required may be modified on an which tests are required (R), conditionally
individual basis to fully characterize the use required (CR), or not required (NR). Required
and properties of specific pesticide products and conditionally required studies are
under review. While EPA is attempting to assist described in §158.110.
the applicant in this subpart, it is important to (4) Review the notes for each requirement
emphasize that it is the applicant’s obligation to determine its applicability to the specific
under FIFRA to demonstrate that an individual product proposed for registration.
product meets the standard under FIFRA and/ (5) (i) Proceed down the Test substance
or FFDCA. Accordingly, applicants are columns and determine the appropriate test
encouraged to consult with the Agency on the substance needed for that study. If the data are
appropriate data requirements as set forth intended to support a manufacturing-use
here as they relate to their specific product product, use the MP column. If the data are
prior to and during the registration process. intended to support an end-use product, use
(a) Finding the appropriate data table. the EP column.
(1) Pesticide data requirements for (ii) The test substances columns specify
conventional chemical active ingredients and which substance is to be used for testing.
related substances are presented in subparts Applicants should note that the substance that
D, E, F, G, K, L, N, and O of this part in the form must be used when performing the study may
of a series of data tables, each addressing a or may not be the product itself. For example,
particular scientific discipline or data topic. the data from a certain study may be required
Data requirements for biochemical and to support the registration of an end-use
microbial pest control agents are contained product, but the test substance column may
and are described separately within sub parts state that the particular test shall be performed
U and V of this part, respectively. using the technical grade of the active ingre-
(2) Key to table notations. R = required
dient(s) in the end-use product.
data; CR = conditionally required data; NR =
(iii) Manufacturing-use products (MP)
Not required; MP = manufacturing-use
product; EP = end- use product; TEP = typical and end-use products (EP) containing a single
end-use product; TGAI = technical grade of active ingredient and no intentionally added
the active ingredient; PAI = pure active inert ingredients are considered identical in
ingredient; PAIRA = pure active ingredient, composition to each other, and to the
radiolabeled; Choice = choice of several test technical grade of the active ingredient (TGAI)
substances depending on studies required. from which they were derived. Therefore, the
(b) Identifying required studies. To data from a test conducted using any one of
determine the specific kinds of data need these as the test substance is also suitable to
meet the requirement (if any) for the same test
to be conducted using either of the other
substances.
(6) Refer to the Pesticide Assessment will not occur as a result of the use of
Guideline reference number for each study ineffective products. Specific performance
located in the first column. See § 158.70(c) for standards are used to validate the efficacy data
information pertaining to the guidelines and in the public health areas, including
how to obtain copies. disinfectants used to control microorganisms
§ 158.130 Purposes of the registration data infectious to man in any area of the inanimate
requirements. environment and those pesticides used to
(a) General. The data requirements for control vertebrates (such as rodents, birds,
registration are intended to generate data and bats and skunks) that may directly or indirectly
information necessary to address concerns transmit diseases to humans.
pertaining to the identity, composition, (d) Toxicology-humans and domestic
potential adverse effects and environmental animals. Data required to assess hazards to
fate of each pesticide. humans and domestic animals are derived
(b) Product chemistry—(1) Product from a variety of acute, subchronic and chronic
composition. Data on product composition are toxicity tests, and tests to assess mutagenicity
needed: and pesticide metabolism.
(1) To support the conclusions expressed in (1) Acute studies. Determination of acute
the statement of formula; oral, dermal and inhalation toxicity is usually
(ii) To compare to the composition of the initial step in the assessment and
materials used in required testing under this evaluation of the toxic characteristics of a
part; and pesticide. These data provide information on
(iii) To determine whether a product is health hazards likely to arise soon after, and as
‘‘identical or substantially similar’’to another a result of, short-term exposure. Data from
product, a determination that involves the acute studies serve as a basis for classification
comparison of product composition. and precautionary labeling. For example, acute
(2) Nominal concentration and certified toxicity data are used to calculate farmworker
limits. The nominal concentration of a product, reentry intervals and to develop precautionary
defined as that concentration that is expected label statements pertaining to protective
to be present in a product as a result of the clothing requirements for applicators. They
production or formulation process, is used to also provide information used in establishing
gauge the acceptability of the certified limits, the appropriate dose levels in subchronic and
which define the outer limits of the range of other studies; provide initial information on the
the product’s ingredients. The certified limits mode of toxic action(s) of a substance; and
are used to enforce the composition of the determine the need for child resistant
product and to ensure the accuracy of hazard packaging. Information derived from primary
assessments. eye and primary dermal irritation studies
(3) Physical and chemical characteristics. serves to identify possible hazards from
The physical and chemical characteristics of an exposure of the eyes, associated mucous
active ingredient or product are used: membranes and skin.
(i) To confirm or provide supportive (2) Subchronic studies. Subchronic tests
information on the identity and composition of provide information on health hazards that
the product; may arise from repeated exposures over a
(ii) To assess the hazards of the ingredient limited period of time. They provide
or product; and information on target organs and
(iii) To trigger or evaluate certain other accumulation potential. The resulting data are
studies required by this part. also useful in selecting dose levels for chronic
(c) Product performance. Requirements to studies and for establishing safety criteria for
develop data on product performance provide human exposure. These tests are not capable
a mechanism to ensure that pesticide products of detecting those effects that have a long
will perform as intended and that unnecessary latency period for expression (e.g.,
pesticide exposure to the environment carcinogenicity).
(3) Chronic studies. Chronic toxicity studies to man. The main purpose of metabolism
(usually conducted by feeding the test studies is to produce data which increases the
substance to the test species) are intended to Agency’s understanding of the behavior of the
determine the effects of a substance in a chemical when considering the human
mammalian species following prolonged and exposure anticipated from intended uses of
repeated exposure. Under the conditions of the pesticide.
this test, effects which have a long latency (e) Hazards to nontarget organisms—(1)
period or are cumulative should be detected. General. The information required to assess
The purpose of long-term carcinogenicity hazards to nontarget organisms is derived
studies is to observe test animals over most of from tests to determine pes- ticidal effects on
their life span for the development of birds, mammals, fish, terrestrial and aquatic
neoplastic lesions during or after exposure to invertebrates and plants. These tests include
various doses of a test substance by an shortterm acute, subacute, reproduction,
appropriate route of administration. simulated field, and full field studies arranged
(4) Developmental toxicity and in a hierarchical or tier system which
reproduction studies. The developmental progresses from the basic laboratory tests to
toxicity study is designed to determine the the applied field tests. The results of each tier
potential of the test substance to induce of testing must be evaluated to determine the
structural and/or other abnormalities to the potential of the pesticide to cause adverse
fetus as the result of exposure of the mother effects, and to determine whether further
during pregnancy. Two-generation testing is required. A purpose common to all
reproduction testing is designed to provide data requirements is to provide data which
information concerning the general effects of determine the need for (and appropriate
a test substance on gonadal function, estrus wording for) precautionary label statements to
cycles, mating behavior, conception, minimize the potential adverse effects to
parturition, lactation, weaning, and the growth nontarget organisms.
and development of the offspring. The study (2) Short-term studies. The short-term
may also provide information about the effects acute and subchronic laboratory studies
of the test substance on neonatal morbidity, provide basic toxicity information which serves
mortality, and preliminary data on prenatal as a starting point for the hazard assessment.
developmental toxicity and serve as a guide for These data are used: To establish acute toxicity
subsequent tests. levels of the active ingredient to the test
(5) Mutagenicity studies. For each test organisms; to compare toxicity information
substance a battery of tests is required to with measured or estimated pesticide residues
assess the potential to affect the mammalian in the environment in order to assess potential
cell’s genetic components. The objectives impacts on fish, wildlife and other nontarget
underlying the selection of a battery of tests organisms; and to indicate whether further
for mutagenicity assessment are: laboratory and/or field studies are needed.
(i) To detect, with sensitive assay methods, (3) Long-term and field studies. Additional
the capacity of a chemical to alter genetic studies (i.e., avian, fish, and invertebrate
material in cells. reproduction, life cycle studies and plant field
(ii) To determine the relevance of these studies) may be required when basic data and
mutagenic changes to mammals. environmental conditions suggest possible
(iii) When mutagenic potential is problems. Data from these studies are used to:
demonstrated, to incorporate these findings in Estimate the potential for chronic effects,
the assessment of heritable effects, taking into account the measured or estimated
carcinogenicity, and, possibly, other health residues in the environment; and to determine
effects. if additional field or laboratory data are
(6) Metabolism studies. Data from studies necessary to further evaluate hazards.
on the absorption, distribution, metabolism, Simulated field and/or field data are
and excretion of a pesticide aid in the valuation
of test results from other toxicity studies and in
the extrapolation of data from animals
used to examine acute and chronic adverse Another specific purpose of the environmental
effects on captive or monitored fish and fate data requirements is to help applicants
wildlife populations under natural or near- and the Agency estimate expected
natural environments. Such studies are environmental concentrations of pesticides in
required only when predictions as to possible specific habitats where threatened or
adverse effects in less extensive studies cannot endangered species or other wildlife
be made, or when the potential for adverse populations at risk are found.
effects is high. (2) Degradation studies. The data from
(f) Applicator and post-application hydrolysis and photolysis studies are used to
exposure. Data are used to evaluate exposures determine the rate of pesticide degradation
to persons in occupational and non- and to identify pesticides that may adversely
occupational settings, including agricultural, affect nontarget organisms.
residential, commercial, institutional and (3) Metabolism studies. Data generated
recreational sites. Data include oral, dermal from aerobic and anaerobic metabolism
and inhalation exposure data, post-application studies are used to determine the nature and
residue data, post-application monitoring availability of pesticides to rotational crops
data, use information, and human activity and to aid in the evaluation of the persistence
information. These data, together with of a pesticide.
toxicology data, are used to determine (4) Mobility studies. These data
whether application or post-application risks requirements pertain to leaching, adsorp-
are of concern, and, where appropriate, to tion/desorption, and volatility of pesticides.
develop post-application restrictions such as They provide information on the mode of
reentry restrictions. transport and eventual destination of the
(g) Pesticide spray drift evaluation. Data pesticide in the environment. This information
required to evaluate pesticide spray drift are is used to assess potential environmental
derived from studies of droplet size spectrum hazards related to: Contamination of human
and spray drift field evaluations. These data and animal food; loss of usable land and water
contribute to the development of the overall resources to man through contamination of
exposure estimate and, along with data on water (including ground water); and habitat
toxicity for humans, fish and wildlife, or plants, loss of wildlife resulting from pesticide residue
are used to assess the potential hazard of movement or transport in the environment.
pesticides to these organisms. A purpose (5) Dissipation studies. The data generated
common to all these tests is to provide data from dissipation studies are used to assess
which will be used to determine the need for potential environmental hazards (under actual
(and appropriate wording for) precautionary field use conditions) related to: Reentry into
labeling to minimize the potential adverse treated areas; hazards from residues in
effect to nontarget organisms. rotational crops and other food sources; and
(h) Environmental fate—(1) General. The the loss of land as well as surface and ground
data generated by environmental fate studies water resources.
are used to: Assess the toxicity to man through (1) Residue chemistry. (1) Residue chemistry
exposure of humans to pesticide residues data are used by the Agency to estimate the
remaining after application, either upon exposure of the general population to
reentering treated areas or from consuming pesticide residues in food and for setting and
inadvertantly-contaminated food; assess the enforcing tolerances for pesticide residues in
presence of widely distributed and persistent food or feed.
pesticides in the environment which may result (2) Information on the chemical identity
in loss of usable land, surface water, ground and composition of the pesticide product, the
water, and wildlife resources; and, assess the amounts, frequency and time of the pesticide
potential environmental exposure of other application, and results of tests on the amount
nontarget organisms, such as fish and wildlife, of residues remaining on or in the treated food
to pesticides. or feed, are needed to support a
finding as to the magnitude and identity of requirements for a particular pesticide
residues which result in food or animal feed as product. Notes that apply to an individual test
a consequence of a proposed pesticide usage. and include specific conditions, qualifications,
(3) Residue chemistry data are also needed or exceptions to the designated test are listed
to support the adequacy of one or more at the end of each table. Refer to 40 CFR part
methods for the enforcement of the tolerance, 172 for further information on experimental
and to support practicable methods for use permits.
removing residues that exceed any proposed § 158.210 Experimental use permit data
tolerance. requirements for product chemistry.
(4) Accumulation studies. Accumulation All product chemistry data, as described in
studies indicate pesticide residue levels in food §158.310, must be submitted to support a
supplies that originate from wild sources or request for an experimental use permit.
from rotational crops. Rotational crop studies
are necessary to establish realistic crop § 158.220 Experimental use permit data
rotation restrictions and to determine if requirements for product performance.
tolerances may be needed for residues on All product performance data, as described
rotational crops. Data from irrigated crop in paragraph (c) of this section, must be
studies are used to determine the amount of submitted to support a request for an
pesticide residues that could be taken up by experimental use permit.
representative crops irrigated with water (a) Use patterns. (1) The terrestrial use
containing pesticide residues. These studies pattern includes products classified under the
allow the Agency to establish label restrictions general use patterns of terrestrial food crop
regarding application of pesticides on sites and terrestrial nonfood crop. The aquatic use
where the residues can be taken up by pattern includes products classified under the
irrigated crops. These data also provide general use patterns of aquatic food crop and
information that aids the Agency in aquatic nonfood crop. The greenhouse use
establishing any corresponding tolerances that pattern includes products classified under the
would be needed for residues on such crops. general use patterns of greenhouse food crop
Data from pesticide accumulation studies in and greenhouse nonfood crop. The indoor use
fish are used to establish label restrictions to pattern includes products classified under the
prevent applications in certain sites so that general use patterns of indoor food and
there will be minimal residues entering edible indoor nonfood use.
fish or shellfish. These residue data are also (2) Data are also required for forestry and
used to determine if a tolerance or action level residential outdoor uses.
is needed for residues in aquatic animals eaten (b) Key. CR=Conditionally required;
by humans. NR=Not required; R=Required;
MP=Manufacturing-use product;
Subpart C—Experimental Use EP=End-use product; TEP=Typical end-use
Permits product.
(c) Table. The following table shows the
§ 158.200 Experimental use permit data experimental use data requirements for
requirements tables.
product performance. The test notes are
Sections 158.200 through 158.270 describe shown in paragraph (d) of this section.
how to use these tables to determine the
experimental use permit data
§ 158.220
Use Pattern Test substance to
support Test Note
Aquatic Resi
Guideline No. Data Requirement dential No.
Food Nonfood Food Nonfood Food Nonfood For- Indoor MP EP
Out
Crop Crop Crop Crop Crop Crop estry doors
Acute Testing
Subchronic Testing
870.3100 90-day Oral - rodent R NR TGAI TGAI
870.3150 R NR TGAI TGAI
90-day Oral - non-rodent
Chronic Testing
Use Pattern Test substance to support Test Note
Guideline Number Data Requirement
Food Nonfood MP EP No.
Mutagenicity Testing
CO
o
870.5375 assay
(d) Test notes. The following test notes 9. At a minimum, an initial battery of
apply to the data requirements in the table to mutagenicity tests with possible confirmatory testing
paragraph (c) of this section. is required. Other relevant mutagenicity tests that
may have been performed, plus a complete
1. Not required if test material is a gas or a highly reference list must also be submitted.
volatile liquid. 10. Choice of assay using either:
2. Not required if test material is corrosive to skin
i. Mouse lymphoma L5178Y cells, thymidine
or has a pH of less than 2 or greater than 11.5.
3. Required if the product consists of, or under kinase (tk) gene locus, maximizing assay conditions
conditions of use will result in, a respirable material for small colony expression or detection;
(e.g., gas, vapor, aerosol, or particulate). 11. Chinese hamster ovary (CHO) or Chinese
4. Required if repeated dermal exposure is likely hamster lung fibroblast (V79) cells, hypoxanthine-
to occur under conditions of use. guanine phosphoribosyl transferase (hgprt) gene
5. Required if the test material is an locus, accompanied by an appropriate in vitro test
organophosphorus substance, which includes for clastogenicity; or
uncharged organophosphorus esters, thioesters, or iii. CHO cells strains AS52, xanthine-guanine
anhydrides of phosphoribosyl transferase (xprt) gene locus.
organophosphoric, organophosphonic, or 11. The micronucleus rodent bone marrow assay is
organophosphoramidic acids, or of related preferred; however, rodent bone marrow assays
phosphorothioic, phosponothioic, or using metaphase analysis (aberrations) are
phosphorothioamidic acids, or is structurally related acceptable.
to other substances that may cause the delayed
neurotoxicity sometimes seen in this class of [72 FR 60957, Oct. 26, 2007, as amended at 73 FR
chemicals. 75596, Dec. 12, 2008]
6. These studies are seldom required to support § 158.240 Experimental use permit data
EUPs. They may be required if the dietary exposure requirements for ecological effects.
for these EUPs occupies a large part, e.g., greater
than 50%, of the reference dose. All data for terrestrial nontarget organisms
7. The oral route, by oral intubation, is preferred and aquatic nontarget organisms as described
unless the chemical or physical properties of the test in §158.243 must be submitted to support a
substance or the pattern of exposure suggests a request for an experimental use permit. No
more appropriate route of exposure.
8. May be combined with the 2-generation
data for nontarget plant protection must be
reproduction study in rodents by utilizing a second submitted to support a request for an
mating of the parental animals in either generation. experimental use permit.
§ 158.243 Experimental use permit data
requirements for terrestrial and aquatic
nontarget organisms.
All terrestrial and aquatic nontarget
(2) Data are also required for the general
organism data, as described in paragraph (c)
of this section, must be submitted to support use patterns of forestry and residential
a request for an experimental use permit. outdoor use.
(a) Use patterns. (1) The terrestrial use (b) Key. CR=Conditionally required;
pattern includes products classified under the NR=Not required; R=Required; TEP=Typical
general use patterns of terrestrial food crop, end-use product; TGAI=Technical grade of the
terrestrial feed crop, and terrestrial nonfood active ingredient; commas between the test
crop. The aquatic use pattern includes substances (e.g. TGAI, TEP) indicate that data
products classified under the general use may be required on the TGAI or TEP
patterns of aquatic food crop and aquatic depending on the conditions set forth in the
nonfood. The greenhouse use pattern includes test note.
products classified under the general use (c) Table. The following table shows the
patterns of greenhouse food crop and experimental use data requirements for
greenhouse nonfood crop. The indoor use terrestrial and aquatic nontarget organisms.
pattern includes products The test notes are shown in paragraph (d) of
this section.
TGAI, 1, 2, 5,
850.1075 Freshwater fish toxicity R R R NR NR NR TEP 6, 11
850.1010 R R R NR NR NR
Acute toxicity freshwater TGAI, 1, 2, 6,
invertebrates TEP 7, 11
Accumulation Study
(d) Test notes. The following test 1. Data using the TGAI are required to support all
notes apply to the data requirements outdoor end-use product uses including, but not
in the table to paragraph (c) of this limited to, turf. Data are generally not required to
support end-use products in the form of a gas, a
section.
highly volatile
liquid, a highly reactive solid, or a highly corrosive ii. There are no potential exposures to fish and
material. other nontarget aquatic organisms; or
2. For greenhouse and indoor end-use products, iii. The hydrolytic half-life is <5 days at pH 5, 7
data using the TGAI are required to support and 9.
manufacturing-use products to be reformulated into 11. The freshwater fish test species for the TEP
these same end-use products or to support end-use testing is the most sensitive of the species tested with
products when there is no registered manufacturing- the TGAI. A freshwater invertebrate must also be
use product. Avian acute oral data are not required tested with the EP or TEP using the same species
for liquid formulations for greenhouse and indoor tested with the TGAI.
uses. The study is not required if there is no potential [72 FR 60957, Oct. 26, 2007, as amended at 73 FR
for environmental exposure. 75596, Dec. 12, 2008]
3. Data are required on one passerine species
and either one waterfowl species or one upland § 158.250 Experimental use permit data
game bird species for terrestrial, aquatic, forestry, requirements for human exposure.
and residential outdoor uses. Data are preferred on No data for applicator exposure and post-
waterfowl or upland game bird species for indoor application exposure must be submitted to
and greenhouse uses. support a request for an experimental use
4. Data are required on waterfowl and upland permit.
game bird species.
5. Data are required on one coldwater fish and § 158.260 Experimental use permit data
one warmwater fish for terrestrial, aquatic, forestry, requirements for environmental fate.
and residential outdoor uses. For indoor and All environmental fate data, as described in
greenhouse uses, testing with only one of either fish paragraph (c) of this section, must be
species is required.
6. EP or TEP testing is required for any product
submitted to support a request for an
which meets any of the following conditions: experimental use permit.
i. The end-use pesticide will be introduced (a) Use patterns. (1) The terrestrial
directly into an aquatic environment (e.g., aquatic use pattern includes products classified under
herbicides and mosquito larvicides) when used as the general use patterns of terrestrial food
directed. crop, terrestrial feed crop, and terrestrial
ii. The maximum expected environmental nonfood. The aquatic use pattern includes the
concentration (MEEC) or the estimated general use patterns of aquatic food crop,
environmental concentration (EEC) in the aquatic
environment is >one-half the LC50 or EC50 of the
aquatic nonfood residential,
TGAI when the EP is used as directed. and aquatic
iii. An ingredient in the end-use formulation nonfood outdoors. The greenhouse use
other than the active ingredient is expected to pattern includes both food and nonfood uses.
enhance the toxicity of the active ingredient or to The indoor use pattern includes food,
cause toxicity to aquatic organisms. nonfood, and residential indoor uses.
7. Data are required on one freshwater aquatic (2) Data are also required for the general
invertebrate species. use patterns of forestry use and residential
8. Data are generally not required for outdoor
residential uses, other than turf, unless data indicate
outdoor use.
that pesticide residues from the proposed use(s) can (b) Key. CR=Conditionally required;
potentially enter waterways. NR=Not required; R=Required; PAIRA=Pure
9. Data are required on one freshwater fish active ingredient radiolabeled; TGAI=Technical
species. If the test species is different from the two grade of the active ingredient.
species used for the freshwater fish acute toxicity (c) Table. The following table shows the
tests, a 96 hour LC50 on that species must also be experimental use data requirements for
provided. environmental fate. The test notes are shown
10. Not required when:
i. The octanol/water partition coefficients of the in paragraph (d) of this section.
pesticide and its major degradates are <1,000; or
Use Pattern
Guideline No. Data Requirement Resi Test Test Note No.
den- sub
Green In For stance
Terrestrial Aquatic tial
house doors estry Out
doors
Mobility Study
(d) Test notes. The following test notes mental use permit issued on a crop-de- struct
apply to the data requirements in the table to basis.
paragraph (c) of this section.
1. Study is required for indoor uses in cases §§158.280-158.290 [Reserved]
where environmental exposure is likely to occur.
Such sites include, but are not limited to, agricultural Subpart D—Product Chemistry
premises, in or around farm buildings, barnyards,
and beehives. § 158.300 Definitions.
2. Required for aquatic uses for aquatic sites that The following terms are defined for the
are intermittently dry. Such sites include, but are not purposes of this subpart:
limited to cranberry bogs and rice paddies.
3. Adsorption and desorption using a batch Active ingredient means any substance (or
equilibrium method is preferred. However, in some group of structurally similar substances, if
cases, for example, where the pesticide degrades specified by the Agency) that will prevent,
rapidly, soil column leaching with unaged or aged destroy, repel or mitigate any pest, or that
columns may be more appropriate to fully functions as a plant regulator, desiccant,
characterize the potential mobility of the parent defoliant, or nitrogen stabilizer, within the
compound and major transformation products. meaning of FIFRA sec. 2(b).
[72 FR 60957, Oct. 26, 2007, as amended at 73 FR
75596, Dec. 12, 2008] End-use product means a pesticide product
whose labeling:
§ 158.270 Experimental use permit data (1) Includes directions for use of the
requirements for residue chemistry. product (as distributed or sold, or after
All residue chemistry data, as described in combination by the user with other
§158.1410, are required for an experimental use substances) for controlling pests or defoliating,
permit for which a temporary tolerance under desiccating or regulating growth of plants, or
FFDCA section 408(r) is sought. Residue as a nitrogen stabilizer, and
chemistry data are not required for an experi (2) does not state that the product may be
used to manufacture or formulate other
pesticide products.
Formulation means:
(1) The process of mixing, blending, or ple of a pesticide product at the time the
dilution of one or more active ingredients with product is produced, expressed as a
one or more other active or inert ingredients, percentage by weight.
without an intended chemical reaction, to Starting material means a substance used to
obtain a manufacturing-use product or an synthesize or purify a technical grade of active
end-use product, or ingredient (or the practical equivalent of the
(2) The repackaging of any registered technical grade ingredient if the technical
product. grade cannot be isolated) by chemical
Impurity means any substance (or group of reaction.
structurally similar substances if specified by Technical grade of active ingredient means
the Agency), in a pesticide product other than a material containing an active ingredient:
an active ingredient or an inert ingredient, (1) Which contains no inert ingredient,
including unreacted starting materials, side other than one used for purification of the
reaction products, contaminants, and active ingredient; and
degradation products. (2) Which is produced on a commercial or
Impurity associated with an active pilot plant production scale (whether or not it
ingredient means: is ever held for sale).
(1) Any impurity present in the technical
grade of active ingredient; and § 158.310 Product chemistry data requirements
table.
(2) Any impurity which forms in the
pesticide product through reactions between (a) General. Sections 158.100 through
the active ingredient and any other 158.130 describe how to use this table to
component of the product or packaging of the determine the product chemistry data
product. requirements for a particular pesticide
Inert ingredient means any substance (or product. Notes that apply to an individual test
group of structurally similar substances if and include specific conditions, qualifications,
designated by the Agency), other than the or exceptions to the designated test are listed
active ingredient, which is intentionally in paragraph (f) of the section.
included in a pesticide product. (b) Use patterns. Product chemistry data
Integrated system means a process for are required for all pesticide products and are
producing a pesticide product that: not use-specific.
(1) Contains any active ingredient derived (c) Test substance. Data requirements that
from a source that is not an EPA- registered list only the manufacturing-use product as the
product; or test substance apply to products containing
(2) Contains any active ingredient that was solely the technical grade of the active
produced or acquired in a manner that does ingredient and manufacturing-use products to
not permit its inspection by the Agency under which other ingredients have been
FIFRA sec. 9(a) prior to its use in the process. intentionally added.
Manufacturing-use product means any (d) Key. R=Required;
pesticide product other than an end-use CR=Conditionally required;
product. A product may consist of the MP=Manufacturing-use product;
technical grade of active ingredient only, or NR=Not required; EP=End-use product;
may contain inert ingredients, such as TGAI=Technical grade of the active ingredient;
stabilizers or solvents. PAI=Pure active ingredient.
Nominal concentration means the amount (e) Table. The following table shows the
of an ingredient which is expected to be data requirements for product chemistry. The
present in a typical sam table notes are shown in paragraph (f) of this
section.
830.1900 Submittal of samples CR MP, PAI and TGAI EP, PAI, TGAI 9, 11
830.6315 Flammability CR MP EP 14
830.6316 Explodability CR MP EP 15
830.6319 Miscibility CR MP EP 16
830.7100 Viscosity CR MP EP 19
(f) Test notes. The following test notes are 21. Required when the TGAI is liquid at room
applicable to the product chemistry data temperature.
requirements in the table to paragraph (e) of 22. Required when the test substance contains an
this section: acid or base functionality (organic or inorganic) or an
alcoholic functionality (organic).
1. Data must be provided in accordance 23. Required for water insoluble test substances
with §158.320. (>10_6 g/l) and fibrous test substances with diameter
2. Data must be provided in accordance of >0.1 gm.
with §158.325. 24. Required if technical chemical is organic and
3. Data must be provided in accordance non-polar.
with §158.330. 25. Not required for salts.
4. Data must be provided in accordance 26. Data on stability of the MP and TGAI to
with §158.335. storage at normal temperatures are required. Data
5. Data must be provided in accordance on the stability of the TGAI to high temperatures are
with §158.340. required if the TGAI is expected to be subjected to
6. Data must be provided in accordance temperatures >50 °C (122 °F) during production or
with §158.345. storage.
7. Data must be provided in accordance
with §158.350. § 158.320 Product identity and composition.
8. Data must be provided in accordance Information on the composition of the
with §158.355. pesticide product must be furnished. The
9. If the TGAI cannot be isolated, data are required
on the practical equivalent of the TGAI. information required by paragraphs (a), (b),
and (f) of this section must be provided for
10. Data are required if the product is produced each product. In addition, if the product is
by an integrated system. produced by an integrated system, the
11. Basic manufacturers are required to provide information on impurities required by
the Agency with a sample of each TGAI used to
formulate a product produced by an integrated paragraphs (c) and (d) of this section must be
system when the new TGAI is first used as a provided.
formulating ingredient in products registered under (a) Active ingredient. The following
FIFRA. A sample of the active ingredient (PAI) information is required for each active
suitable for use as an analytical standard is also ingredient in the product:
required at this time. Samples of end-use products
produced by an integrated system must be
(1) If the source of any active ingredient in
submitted on a case-by-case basis. the product is an EPA-reg- istered product:
12. Data on the stability to metals and metal ions (1) The chemical and common name (if
are required only if the TGAI is expected to come into any) of the active ingredient, as listed on the
contact with either material. source product.
13. Required when the product contains an (ii) The nominal concentration of the
oxidizing or reducing agent.
14. Required when the product contains active ingredient in the product, based upon
combustible liquids. the nominal concentration of active ingredient
15. Required when the product is potentially in the source product.
explosive. (iii) Upper and lower certified limits of the
16. Required when the product is an emul- active ingredient in the product, in accordance
sifiable liquid and is to be diluted with petroleum
solvent. with §158.350.
17. Required when the EP is a liquid and is to be (2) If the source of any active ingredient in
used around electrical equipment. the product is not an EPA-reg- istered product:
18. Required when the test substance is soluble
or dispersible in water.
19. Required when the product is a liquid.
20. Required when the TGAI is solid at room
temperature.
(i) The chemical name according to (4) A certified upper limit, in accordance
Chemical Abstracts Society (CAS) with §158.350.
nomenclature, the CAS Registry Number, and (d) Other impurities associated with the
any common names. active ingredient. For each other impurity
(ii) The molecular, structural, and associated with an active ingredient that was
empirical formulae and the molecular weight found to be present in any sample at a level
or weight range. >0.1 percent by weight of the technical grade
(iii) The nominal concentration. active ingredient the following information is
(iv) Upper and lower certified limits of the required:
active ingredient in accordance with §158.350. (1) Identification of the ingredient as an
(v) The purpose of the ingredient in the impurity.
formulation. (2) The chemical name of the impurity.
(b) Inert ingredients. The following (3) The nominal concentration of the
information is required for each inert impurity in the final product.
ingredient (if any) in the product: (e) Impurities associated with an inert
(1) The chemical name of the ingredient ingredient. [Reserved]
according to Chemical Abstracts Society (f) Ingredients that cannot be
nomenclature, the CAS Registry Number, and characterized. If the identity of any ingredient
any common names (if known). If the chemical or impurity cannot be specified as a discrete
identity or chemical composition of an chemical substance (such as mixtures that
ingredient is not known to the applicant cannot be characterized or isomer mixtures),
because it is proprietary or trade secret the applicant must provide sufficient
information, the applicant must ensure that information to enable EPA to identify its source
the supplier or producer of the ingredient and qualitative composition.
submits to the Agency (or has on file with the
Agency) information on the identity or § 158.325 Description of materials used to produce
the product.
chemical composition of the ingredient.
Generally, it is not required that an applicant The following information must be
know the identity of each ingredient in a submitted on the materials used to produce
mixture that he uses in his product. However, the product:
in certain circumstances, the Agency may (a) Products not produced by an
require that the applicant know the identity of integrated system. (1) For each active
a specific ingredient in such a mixture. If the ingredient that is derived from an EPA-reg-
Agency requires specific knowledge of an istered product:
ingredient, it will notify the applicant in writing. (1) The name of the EPA-registered
(2) The nominal concentration. product.
(3) Upper and lower certified limits in (ii) The EPA registration number of that
accordance with §158.350. product.
(4) The purpose of the ingredient in the (2) For each inert ingredient:
formulation. (i) Each brand name, trade name, common
(c) Impurities of toxicological significance name, or other commercial designation of the
associated with the active ingredient. For each ingredient.
impurity associated with the active ingredient (ii) All information that the applicant
that is determined by EPA to be toxicologically knows (or that is reasonably available to him)
significant, the following information is concerning the composition (and, if requested
required: by the Agency, chemical and physical
(1) Identification of the ingredient as an properties) of the ingredient, including a copy
impurity. of technical specifications, data sheets, or
(2) The chemical name of the impurity. other documents describing the ingredient.
(3) The nominal concentration of the (iii) If requested by the Agency, the name
impurity in the product. and address of the producer of the ingredient
or, if that information is not known to the
applicant, the name
and address of the supplier of the ingredient. uous (a single reaction process from starting
(b) Products produced by an integrated materials to active ingredient), but is
system. (1) The information required by accomplished in stages or by different
paragraph (a)(1) of this section concerning producers, the information must be provided
each active ingredient that is derived from an for each such production process.
EPA-registered product (if any). (b) The following information must be
(2) The following information concerning provided for each process resulting in a
each active ingredient that is not derived from separately isolated substance:
an EPA-registered product: (1) The name and address of the producer
(i) The name and address of the producer who uses the process, if not the same as the
of the ingredient (if different from the applicant.
applicant). (2) A general characterization of the
(ii) Information about each starting process (e.g., whether it is a batch or
material used to produce the active ingredient, continuous process).
as follows: (3) A flow chart of the chemical equations
(A) Each brand name, trade name, or other of each intended reaction occurring at each
commercial designation of the starting step of the process, and of the duration of
material. each step and of the entire process.
(B) The name and address of the person (4) The identity of the materials used to
who produces the starting material or, if that produce the product, their relative amounts,
information is not known to the applicant, the and the order in which they are added.
name and address of each person who (5) A description of the equipment used
supplies the starting material. that may influence the composition of the
(C) All information that the applicant substance produced.
knows (or that is reasonably available to him), (6) A description of the conditions (e.g.,
concerning the composition (and if requested temperature, pressure, pH, humidity) that are
by the Agency, chemical or physical controlled during each step of the process to
properties) of the starting material, including a affect the composition of the substance
copy of all technical specifications, data sheets, produced, and the limits that are maintained.
or other documents describing it. (7) A description of any purification
(3) The information required by paragraph procedures (including procedures to recover
(a)(2) of this section concerning each inert or recycle starting materials, intermediates or
ingredient. the substance produced).
(c) Additional information. On a case- by- (8) A description of the procedures used to
case basis, the Agency may require additional assure consistent composition of the
information on substances used in the substance produced, e.g., calibration of
production of the product. equipment, sampling regimens, analytical
§ 158.330 Description of production process. methods, and other quality control methods.
If the product is produced by an integrated § 158.335 Description of formulation process.
system, the applicant must submit information
on the production (reaction) processes used to The applicant must provide information on
produce the active ingredients in the product. the formulation process of the product (unless
The applicant must also submit information the product consists solely of a technical grade
about the formulation process, in accordance of active ingredient) as required by the
with §158.335. following sections:
(a) Information must be submitted for the (a) Section 158.330(b)(2), pertaining to
current production process for each active characterization of the process.
ingredient that is not derived from an EPA- (b) Section 158.330(b)(4), pertaining to
registered product. If the production process ingredients used in the process.
is not contin (c) Section 158.330(b)(5), pertaining to
process equipment.
(d) Section 158.330(b)(6), pertaining to the (v) Post-production reactions between the
conditions of the process. ingredients in the product.
(e) Section 158.330(b)(8), pertaining to (vi) The possible migration of components
quality control measures. of packaging materials into the pesticide.
§ 158.340 Discussion of formation of impurities. (vii) The possible carryover of
The applicant must provide a discussion of contaminants from use of production
the impurities that may be present in the equipment previously used to produce other
product, and why they may be present. The products or substances.
discussion should be based on established (viii) The process control, purification and
chemical theory and on what the applicant quality control measures used to produce the
knows about the starting materials, technical product.
grade of active ingredient, inert ingredients, (b) Products not produced by an
and production or formulation process. If the integrated system. Each impurity associated
applicant has reason to believe that an with the active ingredient which the applicant
impurity that EPA would consider has reason to believe may be present in the
toxicologically significant may be present, the product at any time before use at a level >0.1
discussion must include an expanded percent (1,000 ppm) by weight of the product
discussion of the possible formation of the based on what he knows about the following:
impurity and the amounts at which it might be (1) The possible carryover of impurities
present. The impurities which must also be present in any registered product which serves
discussed are the following, as applicable: as the source of any of the product’s active
(a) Technical grade active ingredients and ingredients. The identity and level of impurities
products produced by an integrated system. in the registered source need not be discussed
(1) Each impurity associated with the active or quantified unless known to the formu- lator.
ingredient which was found to be present in (2) The possible carryover of impurities
any analysis of the product conducted by or present in the inert ingredients in the product.
for the applicant. (3) Possible reactions occurring during the
(2) Each other impurity which the registrant formulation of the product between any of its
or applicant has reason to believe may be active ingredients, between the active
present in his product at any time before use ingredients and inert ingredients, or between
at a level >0.1 percent (1,000 ppm) by weight the active ingredient and the production
of the technical grade of the active ingredient, equipment.
based on what he knows about the following: (4) Post-production reactions between any
(i) The composition (or composition of the product’s active ingredients and any
range) of each starting material used to other component of the product or its
produce his product. packaging.
(ii) The impurities which the applicant (5) Possible migration of packaging
knows are present (or believes are likely to be materials into the product.
present) in the starting materials, and the
(6) Possible contaminants resulting from
known or presumed level (or range of levels)
earlier use of equipment to produce other
of these impurities.
(iii) The intended reactions and side products.
reactions which may occur in the production (c) Expanded discussion. On a case-bycase
of the product, and the relative amounts of basis, the Agency may require an expanded
byproduct impurities produced by such discussion of information on impurities:
reactions. (1) From other possible chemical reactions.
(iv) The possible degradation of the (2) Involving other ingredients.
ingredients in the product after its production (3) At additional points in the production or
but prior to its use. formulation process.
§ 158.345 Preliminary analysis. a certain date, the certified limits will apply
(a) If the product is produced by an only until that date.
integrated system, the applicant must provide (a) Ingredients for which certified limits are
a preliminary analysis of each technical grade required. Certified limits are required on the
of active ingredient contained in the product following ingredients of a pesticide product:
to identify all impurities present at 0. 1 percent (1) An upper and lower limit for each active
or greater of the technical grade of the active ingredient.
ingredient. The preliminary analysis should be (2) An upper and lower limit for each inert
conducted at the point in the production ingredient.
process after which no further chemical (3) If the product is a technical grade of
reactions designed to produce or purify the active ingredient or is produced by an
substances are intended. integrated system, an upper limit for each
(b) Based on the preliminary analysis, a impurity of toxicological significance
statement of the composition of the technical associated with the active ingredient and
grade of the active ingredient must be found to be present in any sample of the
provided. If the technical grade of the active product.
ingredient cannot be isolated, a statement of (4) On a case-by-case basis, certified limits
the composition of the practical equivalent of for other ingredients or impurities as specified
the technical grade of the active ingredient by EPA.
must be submitted. (b) EPA determination of standard certified
§ 158.350 Certified limits. limits for active and inert ingredients. (1) Unless
the applicant proposes different limits as
The applicant must propose certified limits provided in paragraph (c) of this section, the
for the ingredients in the product. Certified upper and lower certified limits for active and
limits become legally binding limits upon inert ingredients will be determined by EPA.
approval of the application. Certified limits will EPA will calculate the certified limits on the
apply to the product from the date of basis of the nominal concentration of the
production to date of use. If the product label ingredient in the product, according to the
bears a statement prohibiting use after table in paragraph (b)(2) of this section.
(2) Table of standard certified limits.
If the nominal concentration (N) for the ingredient and The certified limits for that ingredient will be as follows:
percentage by weight for the ingredient is: Upper Limit Lower Limit
(c) Applicant proposed limits. (1) The ingredient in the product when good
applicant may propose a certified limit for an manufacturing practices and normal quality
active or inert ingredient that differs from the control procedures are used.
standard certified limit calculated according to (ii) Allow for all sources of variability likely
paragraph (b)(2) of this section. to be encountered in the production process.
(2) If certified limits are required for (iii) Take into account the stability of the
impurities, the applicants must propose a ingredient in the product and the possible
certified limit. The standard certified limits may formation of impurities between production
not be used for such substances. and sale or distribution.
(3) Certified limits should: (4) The applicant may include an
(i) Be based on a consideration of the explanation of the basis of his proposed
variability of the concentration of the
certified limits, including how the certified § 158.355 Enforcement analytical method.
limits were arrived at (e.g., sample analysis, An analytical method suitable for
quantitative estimate based on production enforcement purposes must be provided for
process), and its accuracy and precision. This each active ingredient in the product and for
will be particularly useful if the range of the each other ingredient or impurity that the
certified limit for an active or inert ingredient is Agency determines to be toxicologically
greater than the standard certified limits. significant.
(d) Special cases. If the Agency finds
unacceptable any certified limit (either Subpart E—Product Performance
standard, or applicant proposed), the Agency
will inform the registrant or applicant of its § 158.400 Product performance data requirements
determination and will provide supporting table.
reasons. The Agency may also recommend (a) General. Sections 158.100 through
alternative limits to the applicant. The Agency 158.130 describe how to use this table to
may require, on a case-by-case basis, any or determine the product performance data
all of the following: requirements for a particular pesticide
(1) More precise limits. product. Notes that apply to an individual test,
(2) More thorough explanation of how the including specific conditions, qualifications, or
certified limits were determined. exceptions to the designated test are listed in
(3) A narrower range between the upper paragraph (e) of this section.
and lower certified limits than that proposed. (b) Use patterns. The terrestrial use pattern
(e) Certification statement. The applicant includes products classified under the general
must certify the accuracy of the information use patterns of terrestrial food crop and
presented, and that the certified limits of the terrestrial nonfood crop. The aquatic use
ingredients will be maintained. The following pattern includes products classified under the
statement, signed by the authorized general use patterns of aquatic food crop and
representative of the company, is acceptable: aquatic nonfood. The greenhouse use pattern
includes products classified under the general
I hereby certify that, for purposes of FIFRA sec. use patterns of greenhouse food crop and
12(a)(1)(C), the description of the composition of
[insert product name], EPA Reg. No. [insert greenhouse nonfood crop. Data are also
registration number], refers to the composition set required for the general use patterns of
forth on the Statement of Formula and supporting forestry use, residential outdoor use, and
materials. This description includes the indoor use, which includes both food and
representations that: (1) no ingredient will be present nonfood uses.
in the product in an amount greater than the upper (c) Key. CR=Conditionally required;
certified limit or in an amount less than the lower NR=Not required; R=Required; EP=End-use
certified limit (if required) specified for that product;
ingredient in a currently approved Statement of
Formula (or as calculated by the Agency); and (2) if MP=Manufacturing-use product;
the Agency requires that the source of supply of an TEP=Typical end-use product.
ingredient be specified, that all quantities of such (d) Table. The following table lists the data
ingredient will be obtained from the source specified requirements that pertain to product
in the Statement of Formula. performance. The table notes are shown in
paragraph (e) of this section.
§ 158.400
TABLE—PRODUCT PERFORMANCE DATA REQUIREMENTS
96-12
Rodenticides on farm and
rangelands
R R NR NR NR NR NR R NR NR EP 1
Acute Testing
870.1100 Acute oral toxicity - rat R R TGAI and 1, 2
TGAI, EP,
MP
and
possibly
diluted
EP
TGAI and
870.1200 Acute dermal toxicity R R TGAI, EP 1, 2, 3
MP
Subchronic Testing
TGAI and
870.3250 90-day Dermal CR R TGAI 11, 12
EP
Chronic Testing
870.3700 Prenatal Developmental toxicity - rat and R R TGAI TGAI 22, 23, 24,
rabbit, preferred 25, 26
Mutagenicity Testing
Special Testing
PAI or PAI or
870.7485 Metabolism and pharmacokinetics R CR 33
PAIRA PAIRA
(e) Test notes. The following test notes the EP meet the criteria for restricted use
apply to the requirements in the table to classification under §152.170(b) or special review
paragraph (d) of this section: consideration under §154.7(a)(1).
3. Not required if the test material is corrosive to
1. Not required if test material is a gas or a highly
skin or has a pH of less than 2 or greater than 11.5.
volatile liquid.
2. Diluted EP testing is required to support the
end product registration if results using
4. Required if the product consists of, or under 15. Required if results of acute neurotoxicity
conditions of use will result in, a respirable material study indicate significant statistical or biological
(e.g., gas, vapor, aerosol, or particulate). effects, or if other available data indicate the
5. Required if repeated dermal exposure is likely potential for this type of delayed neurotoxicity, as
to occur under conditions of use. determined by the Agency.
6. Required if the test material is an 16. All 90-day subchronic studies in rats can be
organophosphorus substance, which includes designed to simultaneously fulfill the requirements
uncharged organophosphorus esters; thioesters or of the 90-day neurotoxicity study using separate
anhydrides of groups of animals for testing. Although the
organophosphoric, organophosphonic, or subchronic guidelines include the measurement of
organophosphoramidic acids; or of related neurological endpoints, they do not meet the
phosphorothioic, phosponothioic, or requirement of the 90-day neurotoxicity study.
phosphorothioamidic acids; or is structurally related 17. Required if either of the following are met:
to other substances that may cause the delayed (i) The use of the pesticide is likely to result in
neurotoxicity sometimes seen in this class of repeated human exposure over a considerable
chemicals. portion of the human lifespan, as determined by the
7. As determined by the Agency, additional Agency;
measurements may also be required, such as (ii) The use requires a tolerance or an exemption
cholinesterase activity for certain pesticides, e.g., from the requirement of a tolerance.
organophosphates and some carbamates. The route 18. Based on the results of the acute and
of exposure must correspond with the primary route subchronic neurotoxicity studies, or other available
of exposure. data, a combined chronic toxicity and neurotoxicity
8. Required for nonfood use pesticides if oral study may be required.
exposure could occur. 19. Studies which are designed to simultaneously
9. The 90-day study is required in the rat for fulfill the requirements of both the chronic oral and
hazard characterization (possibly endpoint selection) carcinogenicity studies (i.e., a combined study) may
and dose-setting for the chronic/carcinogenicity be conducted. Minimum acceptable study durations
study. It is not required in the mouse, but the Agency are:
would strongly encourage the registrant to conduct (i) Chronic rodent feeding study (food use) - 24
a 90-day range finding for the purposes of dose months.
selection for the mouse carcinogenicity study to (ii) Chronic rodent feeding study (nonfood use)
achieve adequate dosing and an acceptable study. - 12 months.
The registrant is also encouraged to consult with the (iii) Mouse carcinogenicity study - 18 months.
Agency on the results of the 90-day mouse study (iv) Rat carcinogenicity study - 24 months.
prior to conducting the carcinogenicity study. 20. Required if any of the following, as
10. Required for agricultural uses or if repeated determined by the Agency, are met:
human dermal exposure may occur. Not required if (i) The use of the pesticide is likely to result in
an acceptable 90-day dermal toxicity study is significant human exposure over a considerable
performed and submitted. portion of the human life span which is significant in
11. EP testing is required if the product, or any terms of either frequency, duration, or magnitude of
component of it, may increase dermal absorption of exposure;
the active ingredient(s) as determined by testing (ii) The use requires a tolerance or an exemption
using the TGAI, or increase toxic or pharmacologic from the requirement of a tolerance; or
effects. (iii) The active ingredient, metabolite,
12. Required for food uses if either of the degradate, or impurity (a) is structurally related to a
following criteria is met: recognized carcinogen, (b) causes mutagenic effects
(i) The use pattern is such that the dermal route as demonstrated by in vitro or in vivo testing, or (c)
would be the primary route of exposure; or produces a morphologic effect in any organ (e.g.,
(ii) The active ingredient is known or expected to hyperplasia, metaplasia) in subchronic studies that
be metabolized differently by the dermal route of may lead to a neoplastic change.
exposure than by the oral route, and a metabolite is 21. If this study is modified or waived, a
the toxic moiety. subchronic 90-day oral study conducted in the same
13. Required if there is the likelihood of significant species may be required.
repeated inhalation exposure to the pesticide as a 22. Testing in two species is required for all uses.
gas, vapor, or aerosol. 23. The oral route, by oral intubation, is preferred
14. Based on estimates of the magnitude and unless the chemical or physical properties of the test
duration of human exposure, studies of shorter substance or the pattern of exposure suggests a
duration, e.g., 21- or 28-days, may be sufficient to more appropriate route of exposure.
satisfy this requirement. Registrants should consult
with the Agency to determine whether studies of
shorter duration would meet this requirement.
24. Additional testing by other routes may be assay conditions for small colony expression or
required if the pesticide is determined to be a detection;
prenatal developmental toxicant after oral dosing. (ii) Chinese hamster ovary (CHO) or Chinese
25. May be combined with the 2-generation hamster lung fibroblast (V79) cells, hypoxanthine-
reproduction study in rodents by utilizing a second guanine phosphoribosyl transferase (hgprt) gene
mating of the parental animals in either generation. locus, accompanied by an appropriate in vitro test
26. Required to support products intended for for clastogenicity; or
food uses and to support products intended for (iii) CHO cells strains AS52, xanthine-guanine
nonfood uses if use of the product is likely to result phosphoribosyl transferase (xprt) gene locus.
in significant human exposure over a portion of the 32. The micronucleus rodent bone marrow assay
human life span in terms of frequency, magnitude or is preferred; however, rodent bone marrow assays
duration of exposure. using metaphase analysis (aberrations) are
27. An information-based approach to testing is acceptable.
preferred, which utilizes the best available 33. Required when chronic or carcinogenicity
knowledge on the chemical (hazard, studies are required. May be required if significant
pharmacokinetic, or mechanistic data) to determine adverse effects are seen in available toxicology
whether a standard guideline study, an enhanced studies and these effects can be further elucidated
guideline study, or an alternative study should be by metabolism studies.
conducted to assess potential hazard to the 34. May be required if the product’s use will result
developing animal, or in some cases to support a in exposure to domestic animals through, but not
waiver for such testing. Registrants should submit limited to, direct application.
any alternative proposed testing protocols and 35. A risk assessment assuming that dermal
supporting scientific rationale to the Agency prior to absorption is equal to oral absorption must be
study initiation. performed to determine if the study is required, and
28. Study required using a weight-of-evi- dence to identify the doses and duration of exposure for
approach considering: which dermal absorption is to be quantified.
(i) The pesticide causes treatment-related 36. A 1-year non-rodent study (i.e., 1-year dog
neurological effects in adult animal studies (i.e., study) would be required if the Agency finds that a
clinical signs of neurotoxicity, pesticide chemical is highly bioaccumulating and is
neuropathology, functional or behavioral effects). eliminated so slowly that it does not achieve steady
(ii) The pesticide causes treatment-related state or sufficient tissue concentrations to elicit an
neurological effects in developing animals, following effect during a 90-day study. EPA would require the
pre- and postnatal exposure (i.e., nervous system appropriate tier II metabolism and pharmacokinetic
malformations or neuropathy, brain weight changes studies to evaluate more precisely bioavailability,
in offspring, functional or behavioral changes in the half-life, and steady state to determine if a longer
offspring). duration dog toxicity study is needed.
(iii) The pesticide elicits a causative association § 158.510 Tiered testing options for nonfood
between exposures and adverse neurological effects pesticides.
in human epidemiological studies.
(iv) The pesticide evokes a mechanism that is For nonfood use pesticides only, applicants
associated with adverse effects on the development have two options for generating and
of the nervous system (e.g., SAR relationship to submitting required toxicology (§158.500) and
known neurotoxicants, altered neuroreceptor or human exposure (§158.1020, §158.1070, and
neurotransmitter responses). §158.1410) studies. Applicants are to select one
29. The use of a combined study that utilizes the of the following:
2-generation reproduction study in rodents as a
basic protocol for the addition of other endpoints or (a) Acute, subchronic, chronic, and other
functional assessments in the immature animal is toxicological studies on the active ingredient
encouraged. must be submitted together. The specific
30. At a minimum, an initial battery of makeup of the set of toxicology study
mutagenicity tests with possible confirmatory testing requirements is based on the anticipated
is required. Other relevant mutagenicity tests that exposure to the pesticide as determined by
may have been performed, plus a complete the Agency. If hazards are identified based
reference list must also be submitted. upon review of these studies, specific exposure
31. Choice of assay using either:
(i) Mouse lymphoma L5178Y cells, thymidine data will be required to evaluate risk.
kinase (tk) gene locus, maximizing
(b) Certain toxicological and exposure (b) Use patterns. (1) The terrestrial use
studies must be submitted simultaneously with pattern includes products classified under the
the toxicology data submitted in a tiered general use patterns of terrestrial food crop,
system. Exposure data must be submitted terrestrial feed crop, and terrestrial nonfood
along with first tier toxicology data. The crop. The aquatic use pattern includes
requirement for additional second and third products classified under the general use
level toxicology testing will be determined by patterns of aquatic food crop and aquatic
the Agency based on the results of the first nonfood use patterns. The greenhouse use
tiered studies. pattern includes products classified under the
(1) The required first-tier toxicology studies general use patterns of greenhouse food crop
consist of: and greenhouse nonfood crop. The indoor use
(1) Battery of acute studies. pattern includes products classified under the
(ii) A subchronic 90-day dermal study or a general use patterns of indoor food and
subchronic 90-day inhalation study. indoor nonfood use.
(iii) An acute and subchronic (2) Data are also required for the general
neurotoxicity screening battery in the rat. use patterns of forestry and residential
(iv) Prenatal developmental toxicity
studies in both the rat and rabbit. outdoor use.
(v) Reproduction and fertility studies in (3) In general, for all outdoor end- uses,
rats. including turf, the following studies are
(vi) Battery of mutagenicity studies. required: Two avian oral LD50, two avian
(vii) Immunotoxicity study. dietary LC50, two avian reproduction studies,
(2) The conditionally required second-tier two freshwater fish LC50, one freshwater
studies include: invertebrate EC50, one honeybee acute contact
(i) Subchronic 90-day feeding studies in LD50, one freshwater fish early-life stage, one
both the rodent and nonrodent. freshwater invertebrate life cycle, and three
(ii) Dermal penetration study. estuarine acute LC50/EC50 studies -- fish,
(3) The conditionally required third- tier mollusk and invertebrate. All other outdoor
studies include: residential uses, i.e., gardens and ornamental
(i) Chronic feeding studies in the rodent. will not usually require the freshwater fish
(ii) Carcinogenicity. early-life stage, the freshwater invertebrate
(iii) Metabolism study. lifecycle, and the acute estuarine tests.
(iv) Additional mutagenicity testing. (c) Key. R=Required;
CR=Conditionally required; NR=Not required;
Subpart G— Ecological Effects TGAI=Technical grade of the active ingredient;
TEP=Typical end- use product; PAI=Pure
§ 158.630 Terrestrial and aquatic nontarget active ingredient; EP=end-use product.
organisms data requirements table.
Commas between the test substances (i.e.,
(a) General. Sections 158.100 through TGAI, TEP) indicate that data may be required
158.130 describe how to use this table to on the TGAI or the TEP depending on the
determine the terrestrial and aquatic conditions set forth in the test note.
nontarget data requirements for a particular (d) Table. The following table shows the
pesticide product. Notes that apply to an data requirements for nontarget terrestrial and
individual test including specific conditions, aquatic organism. The table notes are shown
qualifications, or exceptions to the designated in paragraph (e) of this section.
test are listed in paragraph (e) of this section.
TERRESTRIAL AND AQUATIC NONTARGET ORGANISM DATA REQUIREMENTS
Use Pattern
Test
Guideline Number Data Requirement Residentia Test
l Outdoor Green sub
Terres stance Note No.
Aquatic Forestry Indoor
trial house
850.2500 CR CR CR CR NR NR TEP 6, 7
Simulated or actual
field testing
Sediment Testing
Honeybee acute
850.3020 R CR R R NR NR TGAI 1
contact toxicity
850.3030 CR CR CR CR NR NR TEP 24
Honey bee toxicity
of residues on
foliage
Field testing for
850.3040 CR CR CR CR NR NR TEP 25
pollinators
(e) Test notes. The following test notes sessment indicates a concern based on laboratory
apply to terrestrial and aquatic nontarget toxicity endpoints and refined exposure
organisms data requirements in the table to assessments.
7. Environmental chemistry methods used to
paragraph (d) of this section: generate data associated with this study must
1. Data using the TGAI are required to support all include results of a successful confirmatory method
outdoor end-use product uses including, but not trial by an independent laboratory. Test standards
limited to turf. Data are generally not required to and procedures for independent laboratory
support end-use products in the form of a gas, a validation are available as addenda to the guideline
highly volatile liquid, a highly reactive solid, or a for this test requirement.
highly corrosive material. 8. Data are required on one coldwater fish and
2. For greenhouse and indoor end-use products, one warmwater fish for terrestrial, aquatic, forestry,
data using the TGAI are required to support and residential outdoor uses. For indoor and
manufacturing-use products to be reformulated into greenhouse uses, testing with only one of either fish
these same end-use products or to support end-use species is required.
products when there is no registered manufacturing- 9. EP or TEP testing is required for any product
use product. Avian acute oral data are not required which meets any of the following conditions:
for liquid formulations for greenhouse and indoor i. The end-use pesticide will be introduced
uses. The study is not required if there is no potential directly into an aquatic environment (e.g., aquatic
for environmental exposure. herbicides and mosquito larvicides) when used as
3. Data are required on one passerine species directed.
and either one waterfowl species or one upland ii. The maximum expected environmental
game bird species for terrestrial, aquatic, forestry, concentration (MEEC) or the estimated
and residential outdoor uses. Data are preferred on environmental concentration (EEC) in the aquatic
waterfowl or upland game bird species for indoor environment is >one-half the LC50 or EC50 of the
and greenhouse uses. TGAI when the EP is used as directed.
4. Data are required on waterfowl and upland iii. An ingredient in the end-use formulation
game bird species. other than the active ingredient is expected to
5. Tests are required based on the results of lower enhance the toxicity of the active ingredient or to
tier toxicology studies, such as the acute and cause toxicity to aquatic organisms.
subacute testing, intended use pattern, and 10. Data are required on one freshwater aquatic
environmental fate characteristics that indicate invertebrate species.
potential exposure. 11. Data are required on one estuarine/ma- rine
6. Higher tier testing may be required for a mollusk, one estuarine/marine invertebrate and one
specific use pattern when a refined risk as estuarine/marine fish species.
12. Data are generally not required for outdoor tics that indicate significant potential exposure.
residential uses, other than turf, unless data indicate 21. Data are required if:
that pesticide residues from the proposed use(s) can i. The half-life of the pesticide in the sediment is
potentially enter waterways. <10 days in either the aerobic soil or aquatic
13. Data are required on one freshwater fish metabolism studies and if any of the following
species. If the test species is different from the two conditions exist:
species used for the freshwater fish acute toxicity A. The soil partition coefficient (Kd) is >50.
tests, a 96-hour LC50 on that species must also be B. The log Kow is >3.
provided.
C. The Koc >1,000.
14. Data are required on one estuarine/ma- rine
invertebrate species. ii. Registrants must consult with the Agency on
15. Data are required on estuarine/marine appropriate test protocols prior to designing the
species if the product meets any of the following study.
conditions: 22. Data are required if:
i. Intended for direct application to the estuarine i. The estimated environmental concentration
or marine environment. (EEC) in sediment is >0.1 of the acute LC50/EC50
ii. Expected to enter this environment in values and
significant concentrations because of its expected ii. The half-life of the pesticide in the sediment is
use or mobility patterns. >10 days in either the aerobic soil or aquatic
iii. If the acute LC50 or EC50 <1 milligram/ liter metabolism studies and if any of the following
(mg/l). conditions exist:
iv. If the estimated environmental concentration A. The soil partition coefficient (Kd) is >50.
(EEC) in water is >0.01 of the acute EC50 or LC50 or if B. The log Kow is >3.
any of the following conditions exist: C. The Koc >1,000.
A. Studies of other organisms indicate the iii. Registrants must consult with the Agency on
reproductive physiology of fish and/or invertebrates
appropriate test protocols prior to designing the
may be affected.
B. Physicochemical properties indicate study.
bioaccumulation of the pesticide. 23. Sediment testing with estuarine/marine test
C. The pesticide is persistent in water (e.g., half- species is required if the product is intended for
life in water >4 days). direct application to the estuarine or marine
16. Data are required on one estuarine/ma- rine environment or the product is expected to enter this
fish species. environment in concentrations which the Agency
17. Data are required on estuarine/marine believes to be significant, either by runoff or erosion,
species if the product is intended for direct because of its expected use or mobility pattern.
application to the estuarine or marine environment, 24. Data are required only when the formulation
or the product is expected to enter this environment contains one or more active ingredients having an
in significant concentrations because of its expected acute LD50 of <11 micrograms per bee as determined
use or mobility patterns. in the honey bee acute contact study and the use
18. Data are required on freshwater species if the pattern(s) indi- cate(s) that honey bees may be
end-use product is intended to be applied directly to exposed to the pesticide.
water, or is expected to be transported to water from 25. Required if any of the following conditions are
the intended use site, and when any of the following
conditions apply: met:
i. If the estimated environmental concentration i. Data from other sources (Experimental Use
(EEC) is >0.1 of the no-observed- effect level in the Permit program, university research, registrant
fish early-life stage or invertebrate life cycle test; submittals, etc.) indicate potential adverse effects on
ii. If studies of other organisms indicate that the colonies, especially effects other than acute mortality
reproductive physiology of fish may be affected. (reproductive, behavioral, etc.);
19. Not required when: ii. Data from residual toxicity studies indicate
i. The octanol/water partition coefficients of the extended residual toxicity.
pesticide and its major degradates are <1,000; or iii. Data derived from studies with terrestrial
ii. There are no potential exposures to fish and arthropods other than bees indicate potential
other nontarget aquatic organisms; or chronic, reproductive or behavioral effects.
iii. The hydrolytic half-life is <5 days at pH 5, 7 26. The freshwater fish test species for the TEP
and 9. testing is the most sensitive of the species tested with
20. Data are required based on the results of the TGAI. Freshwater invertebrate and acute
lower tier studies such as acute and chronic aquatic estuarine and marine organisms must also be tested
organism testing, intended use pattern, and with the EP or TEP using the same species tested with
environmental fate characteris
the TGAI.
§ 158.660 Nontarget plant protection data and terrestrial nonfood. The aquatic use
requirements table. pattern includes only the general use patterns
(a) General. Sections 158.100 of aquatic food crops and aquatic nonfood.
through158.130 describe how to use this table (2) Data are also required for the general
to determine the nontarget plant data use patterns of forestry use and residential
requirements for a particular pesticide outdoor use.
product. Notes that apply to an individual test (c) Key. R=Required;
and include specific conditions, qualifications, CR=Conditionally required; NR=Not required;
or exceptions to the designated test are listed TGAI=Technical grade of the active ingredient;
in paragraph (e) of this section. TEP=Typical end- use product.
(b) Use patterns. (1) The terrestrial use (d) Table. The following table shows the
nontarget plant protection data requirements.
pattern includes products classified under the
The table notes are shown in paragraph (e) of
general use patterns of terrestrial food crop, this section.
terrestrial feed crop,
Use Pattern
Guideline Number Data Requirement Forestry and Test Test Note No.
Terrestrial Aquatic Residential substance
outdoor
(e) Test notes. The following test notes 4. Required for known phytotoxicants such as
apply to the table in paragraph (d) of this herbicides, desiccants and defoliants.
section. 5. Required if a tested terrestrial species exhibits
a 25 percent or greater detrimental effect in the Tier
1. Not required for contained pesticide I study. When Tier II testing is required, the test
treatments such as bait boxes and pheromone traps species should be the species that showed
unless adverse effects reports are received by the detrimental effects in the Tier I testing.
Agency. 6. Required if the tested aquatic species exhibits
2. Not required for known phytotoxicants. a 50 percent or greater detrimental effect in the Tier
3. Generally not required for granular I study. When Tier II testing is required, the test
formulations. May be requested on a case-bycase species should be the
basis.
species that showed detrimental effects in the tier I § 158.1010 Applicator exposure—cri
testing. teria for testing.
7. Not required for aquatic residential uses.
Applicator exposure data described in
8. Environmental chemistry methods used to
generate data must include the results of a successful paragraph (d) of this section are required
confirmatory method trial by an independent based on toxicity and exposure criteria. Data
laboratory. are required if a product meets, as determined
9. Tests are required on a case-by-case basis by the Agency, at least one of the toxicity
based on the results of lower tier phytotoxicity criteria in paragraph (a) of this section and
studies, adverse incident reports, intended use either or both of the exposure criteria in
pattern, and environmental fate characteristics that paragraph (b) of this section.
indicate potential exposure. (a) Toxicity criteria. (1) Evidence of
10. Registrants must consult with the Agency on potentially significant adverse effects have
appropriate test protocols prior to designing the been observed in any applicable toxicity study.
study. (2) Scientifically sound epidemiological or
poisoning incident data indicate that adverse
Subparts H-J [Reserved] health effects may have resulted from handling
of the pesticide.
§§ 158.700-158.900 [Reserved]
(b) Exposure criteria. (1) Dermal exposure
Subpart K—Human Exposure may occur during the prescribed use.
(2) Respiratory exposure may occur during
§ 158.1000 Applicator exposure—general the prescribed use.
requirements. § 158.1020 Applicator exposure data requirements
(a) If EPA determines that industrial table.
standards, such as the workplace standards set (a) General. Sections 158.100 through
by the Occupational Safety and Health 158.130 describe how to use this table to
Administration (OSHA), provide adequate determine the applicator exposure data
protection from risk under FIFRA for a requirements for a particular pesticide
particular pesticide use pattern, exposure data product. Notes that apply to an individual test
may not be required for that use pattern. and include specific conditions, qualifications,
Applicants should consult with the Agency on or exceptions to the designated test are listed
appropriate testing prior to the initiation of in paragraph (e) of this section.
studies. (b) Use patterns. (1) Occupational use
(b) The Agency may accept surrogate patterns include products classified under the
exposure data estimations from other sources general use patterns of terrestrial food crop,
to satisfy applicator exposure data terrestrial feed crop, terrestrial nonfood crop,
requirements if the data meet the basic quality aquatic food, aquatic nonfood use, forestry,
assurance, quality control, good laboratory greenhouse food, greenhouse nonfood,
practice, and other scientific requirements set indoor food use, and indoor nonfood use.
by EPA. In order to be acceptable, the Agency Occupational use patterns also include
must find that the surrogate exposure data commercial (‘‘for hire’’) applications to
estimations have adequate information to residential outdoor and indoor sites.
address applicator exposure data (2) Residential use patterns include
requirements and contain adequate replicates residential outdoor use and residential indoor
of acceptable quality data to reflect the specific use. These use patterns are limited to
use prescribed on the label and the applicator nonoccupational, i.e., nonprofessional,
activity of concern, including formulation type, pesticide applications.
application methods and rates, type of activity, (c) Key. R=Required;
and other pertinent information. The Agency CR=Conditionally required;
will consider using such surrogate data for TEP=Typical end-use product.
evaluating human exposure on a case- by- (d) Table. The data requirements listed
case basis. pertain to pesticide products that meet the
testing criteria outlined in
§158.1010. The table notes are shown in
paragraph (e) of this section.
TABLE-APPLICATOR EXPOSURE DATA REQUIREMENTS
(e) Test notes. The following notes apply to good laboratory practice, and other sci- entlfle
the data requirements in the table to needs of EPA. In order to be acceptable,
paragraph (d) of this section: among other things, the Agency must find that
1. Protocols must be submitted for approval prior the surrogate exposure data have adequate
to the initiation of the study. Details for developing information to address post-application
protocols are available from the Agency. exposure data requirements and contain
2. Biological monitoring data may be submitted adequate replicates of acceptable quality data
in addition to, or in lieu of, dermal and inhalation to reflect the specific use prescribed on the
exposure data, provided the human label and the post-application activity of
pharmacokinetics of the pesticide and/or
metabolite/analog compounds (i.e., whichever concern, including formulation type,
method is selected as an indicator of body burden application methods and rates, type of activity,
or internal dose) allow for the back calculation to and other pertinent information. The Agency
actual dose. will consider using such surrogate data for
3. Data are required if the product is applied evaluating human exposure on a case- by-
outdoors. case basis.
4. Data are required if the product is applied
indoors. § 158.1060 Post-application exposure— criteria for
5. Data reporting and calculations are required testing.
when handler exposure data are submitted. Exposure data described in § 158.1070(d) are
§ 158.1050 Post-application exposure— general required based upon toxicity and exposure
requirements. criteria. Data are required if a product meets,
(a) If EPA determines that industrial as determined by the Agency, either or both of
standards, such as the workplace standards set the toxicity criteria in paragraph (a) of this
by the Occupational Safety and Health section and either or both of the exposure
Administration, provide adequate protection criteria in paragraph (b) of this section.
for a particular pesticide use pattern, post- (a) Toxicity criteria. (1) Evidence of
application exposure data may not be potentially significant adverse health effects
required for that use pattern. Applicants have been observed in any applicable toxicity
should consult with the Agency on appropriate study.
testing before the initiation of studies. (2) Scientifically sound epidemiological or
(b) The Agency may accept surrogate poisoning incident data indicate that adverse
exposure data from other sources to satisfy health effects may have resulted from post-
post-application exposure data requirements application exposure to the pesticide.
if the data meet the basic quality assurance, (b) Exposure criteria. The need for data
quality control, from potential exposure resulting
from situations not covered by this paragraph § 158.1070 Post-application exposure data
should be discussed with the Agency. requirements table.
(1) For outdoor uses. (i) Occupational (a) General. Sections 158.100 through
human post-application exposure to pesticide 158.130 describe how to use this table to
residues on plants or in soil could occur as the determine the post-application data
result of cultivation, pruning, harvesting, requirements for a particular pesticide
mowing or other work-related activity. Such product. Notes that apply to an individual test
uses include agricultural food, feed, and fiber and include specific conditions, qualifications,
commodities, forest trees, ornamental plants, or exceptions to the designated test are listed
and turf grass. in paragraph (e) of this section.
(ii) Residential human post-application (b) Use patterns. (1) Occupational use
exposure to pesticide residues on plants or in patterns include products classified under the
soil could occur. Such uses may include turf general use patterns of terrestrial food crop,
grass, fruits, vegetables, and ornamentals terrestrial feed crop, terrestrial nonfood use,
grown at sites, including, but not limited to, aquatic food, aquatic nonfood use, forestry,
homes, parks, and recreation areas. greenhouse food, greenhouse nonfood,
(2) For indoor uses. (i) Occupational human indoor food, and indoor nonfood.
post-application exposure to pesticide Occupational use patterns also include
residues could occur following the application commercial (‘‘for hire’’) applications to
of the pesticide to indoor spaces or surfaces at residential outdoor and indoor sites.
agricultural or commercial sites, such as, but (2) Residential use patterns include
not limited to, agricultural animal facilities and residential outdoor use and indoor residential
industrial or manufacturing facilities. use. These use patterns are limited to
(ii) Residential human post-application nonoccupational, i.e., nonprofessional,
exposure to pesticide residues could occur pesticide applications.
following the application of the pesticide to (c) Key. R=Required;
indoor spaces or surfaces at residential sites, CR=Conditionally required; NR=Not required;
such as, but not limited to homes, daycare TEP=Typical end-use product.
centers, hospitals, schools, and other public (d) Table. The data requirements listed in
buildings. the following table pertain to pesticide
products that meet the testing criteria outlined
in §158.1060. The table notes are shown in
paragraph (e) of this section.
co
o
Use Pattern
Test
Guideline Number Data Requirement Residentia sub Test
Terres Green l Outdoor stance Note No.
Aquatic Indoor Forestry
trial house
TGAI or
835.4100 Aerobic soil R CR R NR R R 5
PAIRA
TGAI or
835.4200 Anaerobic soil R NR NR NR NR NR
PAIRA
TGAI or
835.4300 Aerobic aquatic R R NR NR R NR
PAIRA
TGAI or
835.4400 Anaerobic aquatic R R NR NR R NR
PAIRA
Mobility Studies
835.6200 CR R NR NR NR NR TEP 7, 8
Aquatic (sediment)
835.6300 Forestry NR NR NR NR CR NR TEP 7, 9, 12
Combination and
835.6400 CR CR NR NR NR NR TEP 10
tank mixes
(e) Test notes. The following test notes must include results of a successful confirmatory
apply to the requirements in the table to method trial by an independent laboratory. Test
paragraph (d) of this section: standards and procedures for independent
1. Study is required for indoor uses in cases laboratory validation are available as addenda to the
where environmental exposure is likely to occur. guideline for this test requirement.
Such sites include, but are not limited to, agricultural 8. Requirement for terrestrial uses is based on
premises, in or around farm buildings, barnyards, potential for aquatic exposure and if pesticide
and beehives. residues have the potential for persistence, mobility,
2. Not required when the electronic absorption nontarget aquatic toxicity or bioaccumulation. Not
spectra, measured at pHs 5, 7, and 9, of the chemical required for aquatic residential uses. Field testing
and its hydrolytic products, if any, show no under the terrestrial field dissipation requirement
absorption or tailing between 290 and 800 nm. may be more appropriate for some aquatic food
3. Not required when the chemical is to be crops, such as rice and cranberry uses, that are
applied only by soil injection or is incorporated in the managed to have a dry-land period for production.
soil. The registrant is encouraged to consult with the
4. Requirement based on use patterns and other
Agency on protocols.
pertinent factors including, but not limited to, the
Henry’s Law Constant of the chemical. In view of 9. Agency approval of a protocol is necessary
methodological difficulties with the study of prior to initiation of the study.
photodegradation in air, prior consultation with the 10. This study may be triggered if there is specific
Agency regarding the protocol is recommended evidence that the presence of one pesticide can
before the test is performed. affect the dissipation characteristics of another
5. Required for aquatic food and nonfood crop pesticide when applied simultaneously or serially.
uses for aquatic sites that are intermittently dry. Such 11. Required if the weight-of-evidence indicates
sites include, but are not limited to, cranberry bogs that the pesticide and/or its degradates is likely to
and rice paddies. leach to ground water, taking into account other
6. Adsorption and desorption using a batch factors such as the toxicity of the chemicals(s),
equilibrium method is preferred. However in some available monitoring data, and the vulnerability of
cases, for example, where the pesticide degrades ground water resources in the pesticide use area.
rapidly, soil column leaching with unaged or aged 12. If the terrestrial dissipation study cannot
columns may be more appropriate to fully assess all of the major routes of dissipation, the
characterize the potential mobility of the parent forestry study will be required.
compound and major transformation products.
7. Environmental chemistry methods used to
generate data associated with this study
Environmental Protection Agency §158.1410
Subpart O—Residue Chemistry (b) Use patterns. (1) Data are required or
conditionally required for all pesticides used in
§ 158.1400 Definitions.
or on food and for residential outdoor uses
The following terms are defined for the
where food crops are grown. Food use
purposes of this subpart:
Livestock, for the purposes of this section, patterns include products classified under the
includes all domestic animals that are bred for general use patterns of terrestrial food crop
human consumption, including, but not use, terrestrial feed crop use, aquatic food
limited to, cattle, swine, sheep, and poultry. crop use, greenhouse food crop use, and
Plant or animal metabolite means a indoor food use.
pesticide chemical residue that is the result of (2) Data may be required for nonfood uses
biological breakdown of the parent pesticide if pesticide residues may occur in food or feed
within the plant or animal. as a result of the use. Data requirements for
Residue of concern means the parent these nonfood uses will be determined on a
pesticidal compound and its metabolites, case-by-case basis. For example, most
degradates, and impurities of toxicological products used in or near kitchens require
concern. residue data for risk assessment purposes even
Tolerance, for the purposes of this section, though tolerances may not be necessary in all
includes the establishment of a new tolerance cases.
or tolerance exemption, or amended tolerance (c) Key. R=Required;
or tolerance exemption. CR=Conditionally required; NR=Not required;
§ 158.1410 Residue chemistry data requirements
TGAI=Technical grade of the active ingredient;
table. PAI=Pure active ingredient; PAIRA=Pure active
ingredient radio-labeled; Residue of concern=
(a) General. Sections 158.100 through
the active ingredient and its metabolites,
158.130 describe how to use this table to
determine the residue chemistry data degradates, and impurities of toxicological
requirements for a particular pesticide concern; TEP=Typical end-use product.
product. Notes that apply to an individual test (d) Table. The following table list the data
and include specific conditions, qualifications, requirements for residue chemistry related to
or exceptions to the designated test are listed food uses. The table notes are shown in
in paragraph (e) of this section. paragraph (e) of this section.
Use Pattern
Guideline Number Data Requirement Terres Resi Test Test
trial Green dential substance Note
Food or Aquatic Indoor
house Out No.
Food Food
Feed Food door
Supporting Information
Analytical methods
860.1340 Residue analytical methods R R R CR CR
Residue of 1, 3, 8,
concern 9, 10, 25
860.1480 Meat/milk/poultry/eggs CR CR CR CR NR
TGAI or 1, 16, 17,
plant 18,
metabolite 25
(e) Test notes. The following test notes expected to produce higher residues based on the
apply to the data requirements in the table to label directions.
paragraph (d) of this section. 4. Required for indoor uses where the pesticide is
applied directly to food, in order to determine
1. Required if indoor use could result in pesticide metabolites and/or degradates. Not required when
residues in or on food or feed. only indirect contact with food would occur (e.g.,
2. Material safety data sheets must accompany crack and crevice treatments).
standards as specified by OSHA in 29 CFR 1910.1200. 5. Data for fish are required for all pesticides
3. Required for residential outdoor uses on food applied directly to water inhabited, or which will be
crops if the corresponding agricultural use is not inhabited, by fish that may be caught or harvested
approved or the residential use is for human consumption.
6. Required when a pesticide is to be applied and eggs at the maximum expected exposure level
directly to livestock, to livestock premises, to livestock for the animals.
drinking water, or to crops used for livestock feed. If 18. If results from the plant metabolism study
results from the plant metabolism study show show differing metabolites in plants from those
differing metabolites in plants from those found in found in animals, an additional livestock feeding
animals, an additional livestock metabolism study study involving dosing with the plant metabolite(s)
involving dosing with the plant me- tabolite(s) may may also be required.
also be required. 19. Data are required whenever a pesticide may
7. Required when the Agency determines that it be applied directly to water, unless it can be
is reasonably foreseeable that a food or feed crop demonstrated that the treated water would not be
could be subsequently planted on the site of available for human or livestock consumption.
pesticide application after harvest or failure of the 20. Data are required when a pesticide is to be
treated crop. Typically not required for pesticide uses applied directly to water that could be used for
in permanent food crops (e.g., various tree crops, irrigation or to irrigation facilities such as irrigation
vines) or semi-permanent crops (e.g., asparagus, ditches.
pineapples).
21. Data are required whenever a pesticide may
8. A residue analytical method suitable for
be used in a food handling or feed handling
enforcement purposes is required whenever a
numeric tolerance (including temporary and time- establishment.
limited tolerances) is proposed. 22. Required when residues at the tolerance level
9. New analytical methods to be used for may result in a risk of concern. These data may
enforcement purposes must include results from an include washing, cooking, processing or degradation
independent laboratory validation. studies as well as market basket surveys for a more
10. A residue method, storage stability data, and precise residue determination.
crop field trials are required for the nonfood crop 23. Typically required if pesticide residues of
tobacco (green, freshly harvested). Depending on concern greater than 0.01 ppm are found in crops at
the level of residues found on the green tobacco, the appropriate plant back intervals (taking into
additional data may be required on cured/dried account plant back restrictions on product labels) in
tobacco and pyrolysis products. the confined rotational crop study. If residues of
11. Data are required to determine whether concern in the confined study are greater than 0.01
FDA/USDA multiresidue methodology would detect ppm but less than the limit of quantitation of the
and identify the pesticides and any metabolites. analytical method to be used on field trial samples,
12. Data are required for any magnitude of the the Agency will consider not requiring, on a case-by-
residue study unless analytical samples are stored case basis, the limited field trials. If there are
frozen for 30 days or less, and the active ingredient particular toxicological concerns with the parent
is not known to be volatile or labile. pesticide or any metabolites, limited field studies
13. Studies using single serving samples of a raw may be needed if such residues are identified at
agricultural commodity may be needed for acutely levels below 0.01 ppm in the confined study.
toxic pesticides and/or their metabolites. These 24. Crop field trials are required to establish
residue studies must be conducted using a statistical tolerances on rotational crops when quantifiable
design accepted by the Agency. residues of concern are observed in the field
14. Required for indoor uses which are direct rotational crops study.
postharvest treatments of raw agricultural 25. Not required for an exemption from a
commodities (e.g., fungicidal waxes or stored grain tolerance provided that dietary exposure estimates
fumigants). are not needed due to low toxicity or that theoretical
15. Data on the nature and level of residues in estimates of exposure are adequate to assess dietary
processed food/feed are required if residues could risk.
potentially concentrate on processing thus requiring 26. Not required for an exemption from a
the establishment of a separate tolerance higher
tolerance.
than that of the raw agricultural commodity.
16. Required when the pesticide use is a direct
application to livestock. Subparts P-T [Reserved]
17. Data are required if pesticide residues are
present in or on livestock feed items or intentionally §§ 158.1500-158.1900 [Reserved]
added to drinking water. These studies, however,
may not be required in cases where the livestock Subpart U—Biochemical
metabolism studies indicate negligible transfer of the Pesticides
pesticide’s residues of concern to tissues, milk,
clearly meet the definition of a biochemical
pesticide in an effort to ensure, to the greatest
extent possible, that only the minimum testing
This subpart applies to all biochemical
sufficient to make scientifically sound
pesticides as defined in paragraphs (a), (b), and
(c) of this section. regulatory decisions would be conducted. The
(a) Definitions. The following terms are Agency will review applications for registration
defined for the purposes of subpart U of this of naturally-occurring pesticides to determine
part. whether to review the pesticide under this
subpart U.
(1) A biochemical pesticide is a pesticide
that: § 158.2010 Biochemical pesticides data
(1) Is a naturally-occurring substance or requirements.
structurally-similar and functionally identical to (a) Sections 158.2030 through 158.2070
a naturally-occurring substance; identify the data requirements that are
(ii) Has a history of exposure to humans required to support registration of
and the environment demonstrating minimal biochemical pesticides. Sections 158.2080
toxicity, or in the case of a synthetically- through 158.2084 identify the data
derived biochemical pesticides, is equivalent to requirements that are required to support
a naturally-occurring substance that has such Experimental Use Permits (EUPs). Variations in
a history; and the test conditions are identified within the test
(iii) Has a non-toxic mode of action to the notes. Definitions that apply to all biochemical
target pest(s). data requirements can be found in §158.2000.
(2) A Pheromone is a compound produced (b) Each data table includes ‘‘use patterns”
by a living organism or is a synthetically under which the individual data are required,
derived substance that is structurally similar with variations including food and nonfood
and functionally identical to a naturally- uses for terrestrial and aquatic applications,
occurring pheromone, which, alone or in greenhouse, indoor, forestry, and residential
combination with other such compounds, outdoor applications under certain
modifies the behavior of other individuals of circumstances.
the same species. (c) The categories for each data
(i) An Arthropod Pheromone is a requirement are ‘‘R’’, which stands for
pheromone produced by a member of the required, and ‘‘CR’’ which stands for
taxonomic phylum Arthropoda. conditionally required. Generally, ‘‘R’’ indicates
(ii) A Lepidopteran Pheromone is an
that the data are more likely required than for
arthropod pheromone produced by a member
those data requirements with ‘‘CR.’’ However,
of the insect order Lepidop- tera.
(iii) A Straight Chain Lepidopteran in each case, the regulatory text preceding the
Pheromone is a lepidopteran pheromone data table and the test notes following the
consisting of an unbranched aliphatic chain data table must be used to determine whether
(between 9 and 18 carbons) ending in an the data requirement must be satisfied.
alcohol, aldehyde, or acetate functional group (d) Each table identifies the test substance
and containing up to three double bonds in that is required to be tested to satisfy the data
the aliphatic backbone. requirement. Test substances may include:
(b) Examples. Biochemical pesticides technical grade active ingredient (TGAI),
include, but are not limited to: manufacturing-use product (MP), end-use
(1) Semiochemicals (insect product (EP), typical end-use product (TEP),
pheromones and kairomones), residue of concern, and pure active ingredient
(2) Natural plant and insect regulators, (PAI) or all of the above (All). Commas
(3) Naturally-occurring repellents and between the test substances (i.e., TGAI, EP)
attractants, and indicate that data may be required on the TGAI
(4) Enzymes. or
(c) Applicability. The Agency may review,
on a case-by-case basis, naturally-occurring
pesticides that do not
EP or both depending on the conditions set istry data requirements for a particular
forth in the test note. pesticide product. Notes that apply to an
(e) The data requirements are organized individual test and include specific conditions,
into a tier-testing system with specified qualifications, or exceptions to the designated
additional studies at higher tiers being test are listed in paragraph (e) of the section.
required if warranted by adverse effects (2) Definitions in §158.300 apply to data
observed in lower tier studies. The lower tier requirements in this section.
studies are a subset of those required for (b) Use patterns. Product chemistry data
conventional pesticides, and the studies are required for all pesticide products and are
overall are generally selected from those not use specific.
required for conventional pesticides. (c) Key. R=Required;
(f) Two sets of guideline numbers are CR=Conditionally required; NR=Not required;
provided for some of the environmental fate MP=Manufacturing-use product; EP=End-use
data requirements. For ease of understanding, product; TEP=Typical end-use
the current guidelines will be used as an product; TGAI=Technical
interim measure until the new guidelines (in grade of the active ingredient; Residue of
parentheses) are finalized. concern=the active ingredient and its
metabolites, degradates, and impurities of
§ 158.2030 Biochemical pesticides toxicological concern; All=All of the above.
product chemistry data requirements table.
(d) Table. The following table shows the
(a) General. (1) Sections 158.100 through data requirements for biochemical pesticides
158.130 describe how to use this table to product chemistry. The test notes are shown in
determine the product chem paragraph (e) of this section.
Test Substance
All Use
Guideline Number Data Requirement Test Notes
Patterns MP EP
TGAI, TGAI,
880.1100 Product identity and composition R 1, 2
MP EP
830.6315 Flammability CR MP EP 9
830.6319 Miscibility CR MP EP 10
TGAI TGAI
830.7000 pH CR 8, 11
and MP and EP
830.7100 Viscosity CR MP EP 12
TGAI TGAI
830.7300 Density/relative density/bulk density R 8, 18
and MP and EP
830.7520 Particle size, fiber length, and diameter distribution CR TGAI TGAI 8, 15
Partition coefficient (n-Octanol /Water) CR TGAI TGAI
830.7550
830.7560 16
830.7570
(e) Test notes. The following test notes are 10. Required if the product is an emulsi- fiable
applicable to the data requirements for liquid and is to be diluted with petroleum solvents.
11. Required if the test substance is soluble or
biochemical pesticides product chemistry and dispersible in water.
are referenced in the last column of the table 12. Required if the product is a liquid.
in paragraph (d) of this section. 13. Required when the technical chemical is a
1. Data must be provided in accordance with solid at room temperature.
14. Required when the technical chemical is a
§158.320.
liquid at room temperature.
2. If the MP and EP are produced by an 15. Required for water insoluble test substances
integrated formulation system (non-registered (>10_6g/l) and fibrous test substances with diameter
source), these data are also required on TGAI. >0.1 ^m.
3. Data must be provided in accordance with 16. Required for organic chemicals unless they
§§158.325, 158.330, and §158.335. dissociate in water or are partially or completely
4. Data must be provided in accordance with soluble in water.
§158.340. 17. Data on the stability to metals and metal ions
5. Data must be provided in accordance with is required only if the active ingredient is expected to
§158.345. Also, required to support the registration come in contact with either material during storage.
of each manufacturing-use product (including 18. True density or specific density are required
registered TGAIs) and end-use products produced for all test substances. Data on bulk density is
by an integrated formulation system. Data on other required for MPs or EPs that are solid at room
end-use products would be required on a case-by- temperature.
case basis. 19. Not required for salts.
6. Data must be provided in accordance with § 158.2040 Biochemical pesticides residue data
§158.350. requirements table.
7. Data must be provided in accordance with (a) General. Sections 158.100 through
§158.355. 158.130 describe how to use this table to
8. If the TGAI cannot be isolated, data are determine the biochemical pesticides residue
required on the practical equivalent of the TGAI. EP
testing may also be appropriate.
data requirements for a particular pesticide
9. Required if the product contains combustible product and the substance that needs to be
liquids. tested. These
data requirements apply to all biochemical the use. Data requirements for these nonfood
pesticides, i.e., naturally occurring insect uses would be determined on a case-by-case
repellents and attractants, semiochemicals basis. For example, most products used in or
(e.g., insect pheromones), natural and plant near kitchens require residue data for risk
growth regulators. Notes that apply to an assessment purposes even though tolerances
individual test and include specific conditions, may not be necessary in all cases.
qualifications, or exceptions to the designated (c) Key. R=Required;
test are listed in paragraph (e) of this section. CR=Conditionally required; NR=Not required;
(b) Use patterns. (1) Data are required or MP=Manufacturing end-use product;
conditionally required for all pesticides used in EP=End-use product; TEP=Typical end-use
or on food and for residential outdoor uses product; TGAI=Technical grade of the active
where food crops are grown. Food use ingredient; Residue of concern=the active
patterns include products classified under the ingredient and its metabolites, degradates,
general use patterns of terrestrial food crop and impurities of toxicological concern; All=All
use, terrestrial feed crop use, aquatic food of the above. Specific conditions,
crop use, greenhouse food crop use, and qualifications, or exceptions to the designated
indoor food use. Data are also conditionally test procedures appear in paragraph (e) of this
required for aquatic nonfood use if there is section, and apply to the individual tests in the
direct application to water that could following table:
subsequently result in exposure to food. (d) Data requirements table. The following
(2) Data are conditionally required for table shows the data requirements for
nonfood uses if pesticide residues may occur biochemical pesticides residue. The test notes
in food or feed as a result of are shown in paragraph (e) of this section.
use patterns
Residue of
860.1340 Residue analytical method CR CR R CR 4, 9, 10
concern
Residue of
860.1360 Multiresidue method CR CR R CR 10, 11
concern
Residue of
860.1540 Anticipated residues CR CR CR CR 1, 10, 17
concern
(e) Test notes. The following test notes are 8. If results from the plant metabolism study
applicable to the data requirements for show differing metabolites in plants from those
biochemical pesticides product chemistry and found in animals, an additional livestock metabolism
study involving dosing with the plant metabolite(s)
are in the last column of the table contained in may also be required.
paragraph (d) of this section. 9. A residue analytical method suitable for
1. Residue chemistry data requirements apply to enforcement of tolerances is required whenever a
biochemical pesticide products when Tier II or Tier III numeric tolerance (including temporary and time-
toxicology data are required, as specified for limited tolerances) is proposed.
biochemical agents in the biochemical human health 10. Required if indoor use could result in pesticide
assessment data requirements, §158.2050. residues in or on food or feed.
2. The same chemical identity data are required 11. Data are required to determine whether
for biochemical product chemistry data FDA/USDA multiresidue methodology would detect
requirements, §158.2030, with an emphasis on and identify the pesticides and any metabolites.
impurities. 12. Data are required whenever a pesticide may
3. Required information includes crops to be be applied directly to water, unless it can be
treated, rate of application, number and timing of demonstrated that the treated water would not be
applications, preharvest intervals, and relevant available for human or livestock consumption.
restrictions. 13. Data on fish are required for all pesticides
4. Required for residential outdoor uses on food applied directly to water inhabited, or which will be
crops if the corresponding agricultural use is not inhabited by fish that may be caught or harvested for
approved or the residential use is expected to human consumption.
produce higher residues based on the label 14. Data are required when a pesticide is to be
directions. applied directly to water that could be used for
5. Required unless it is an arthropod pheromone irrigation or to irrigation facilities such as irrigation
applied at a rate less than or equal to 150 grams ditches.
active ingredient per acre. 15. Data are required whenever a pesticide may
6. Required for indoor uses where the pesticide is be used in food/feed handling establishments.
applied directly to food, in order to determine 16. Data on the nature and level of residue in
metabolites and/or degradates. Not required when processed food/feed are required when detectible
only indirect contact with food would occur (e.g., residues could potentially concentrate on processing
crack and crevice treatments). thus requiring the establishment of a separate
7. Required when a pesticide is to be applied tolerance higher
directly to livestock, to livestock premises, to
livestock drinking water, or to crops used for
livestock feed.
than that of the raw agricultural commodity. (2) Nonfood use patterns include products
17. Required when residues at the tolerance level classified under the general use patterns of
may result in risk of concern. These data may include
washing, cooking, processing, or degradation terrestrial nonfood crop use; aquatic nonfood
studies as well as market basket surveys for a more residential use; aquatic nonfood outdoor use;
precise residue determination. aquatic nonfood industrial use; greenhouse
18. The proposed tolerance must reflect the nonfood crop use; forestry use; residential
maximum residue likely to occur in crops, in meat, outdoor use; residential indoor use; indoor
milk, poultry, or eggs.
19. Required when a residue analytical method is food use; indoor nonfood use; indoor medical
required. use.
(c) Key. R=Required;
§ 158.2050 Biochemical pesticides CR=Conditionally required; NR=Not required;
human health assessment data requirements
table.
MP=Manufacturing-use product; EP=End-use
(a) General. (1) Sections 158.100 through product; TEP=Typical end-use product;
158.130 describe how to use this table to TGAI=Technical grade of the active ingredient;
determine the biochemical human health Residue of concern=the active ingredient and
assessment data requirements for a particular its metabolites, degradates, and impurities of
biochemical pesticide product. toxicological concern; All=All of the above.
(2) The data in this section are not required Specific conditions, qualifications, or
for straight chain lepidopteran pheromones exceptions to the designated test procedures
when applied up to a maximum use rate of 150 appear in paragraph (e) of this section, and
grams active ingredient/acre/year. apply to the individual tests in the following
(b) Use patterns. (1) Food use patterns, in table:
general, include products classified under the (d) Table. The following table shows the
following general uses: terrestrial food crop data requirements for biochemical pesticides
use; terrestrial feed crop use; aquatic food human health assessment. The test notes are
crop use; greenhouse food crop use. shown in paragraph
(e) of this section.
Tier I
Acute Testing
TGAI and
870.1100 Acute oral toxicity - rat R R TGAI and EP 1
MP
TGAI and
870.1200 Acute dermal toxicity R R TGAI and EP 1, 2
MP
TGAI and
870.1300 Acute inhalation toxicity - rat R R TGAI and EP 3
MP
TGAI and
870.2400 Primary eye irritation - rabbit R R TGAI and EP 2
MP
TGAI and
870.2500 Primary dermal irritation R R TGAI and EP 1, 2
MP
TGAI and
870.2600 Dermal sensitization R R TGAI and EP 2, 4
MP
Subchronic Testing
870.3100 90-day oral (one species) R CR TGAI TGAI 6
TABLE-BIOCHEMICAL PESTICIDES HUMAN HEALTH ASSESSMENT DATA REQUIREMENTS—Continued
Guideline Num- use Patterns Test Substance
Data Requirement Test Notes
ber Food Nonfood MP EP
Developmental Toxicity
870.3700 Prenatal developmental - rat preferably R CR TGAI TGAI 9
Mutagenicity Testing
870.5100 Bacterial reverse mutation test R CR TGAI TGAI 10
Tier II
Developmental Toxicity
870.3700 Prenatal developmental CR CR TGAI TGAI 9
Special Tests
880.3550 immunotoxlclty CR CR TGAI TGAI 12, 13
Applicator/user Exposure
875.1100 Dermal outdoor exposure CR CR TGAI TGAI 15
Tier III
Special Testing
(e) Test notes. The following test notes are in the last column of the table in paragraph (d)
applicable to the data requirements for of this section.
biochemical pesticides human health 1. Required unless the test material is a gas or
assessment as referenced highly volatile (vapor pressure >10~4torr (mm/Hg)).
2. Required unless the test material is corrosive to ferase (hgprt) gene locus, accompanied by an
skin or has pH <2 or >11.5. appropriate in vitro test for clastogenicity; or
3. Required when the pesticide, under conditions iii. CHO cells strains AS52, xanthine-guanine
of use, would result in respirable material (e.g., gas, phosphoribosyl transferase (xprt) gene locus.
volatile substance or aer- osol/particulate), unless it 12. Required if there are effects on hematology,
is a straight chain lepidopteran pheromone. clinical chemistry, lymphoid organ weights, and
4. Required if repeated contact with human skin histopathology are observed in the 90-day studies.
is likely to occur under conditions of use. 13. The micronucleus rodent bone marrow assay
5. Hypersensitivity incidents must be reported as is preferred; however, rodent bone marrow assays
adverse effects data. using metaphase analysis (aberrations) are
6. Required for non-food uses that are likely to acceptable.
result in repeated oral exposure to humans. 14. Required if adverse effects are observed in the
7. Required to support uses involving purposeful Tier II immunotoxicity study. The protocol for
application to the human skin or which would result evaluating adverse effects to the immune response
in comparable prolonged human exposure to the should be developed after evaluating the effects
product (e.g., insect repellents) and if any of the noted in the immunotoxicity study.
following criteria are met: 15. These data are required when the data used
i. Data from a 90-day oral study are not required. for the human health assessment indicates that the
ii. The active ingredient is known or expected to biochemical may pose a potential hazard to the
be metabolized differently by the dermal route of applicator/user.
exposure than by the oral route and the metabolite 16. Required if there is evidence of:
is of toxicological concern. i. Endocrinological effects from the subchronic
iii. The use pattern is such that the dermal route toxicity studies.
would be the primary route of exposure. ii. Developmental effects in the prenatal
8. Required if there is a likelihood of significant developmental toxicity study(s), or
levels of repeated inhalation exposure to the iii. Genotoxicity to mammals based on results
pesticide as a gas, vapor, or aerosol. from the mutagenicity tests.
9. Required if the use of the product under The use of a combined study that utilizes the two-
widespread and commonly recognized practice may generation reproduction study in rodents (guideline
reasonably be expected to result in significant 870.3800) as a basic protocol for the addition of
exposure to female humans (e.g., occupational other endpoints or functional assessments in the
exposure or repeated application of insect repellents immature animal is encouraged.
directly to the skin). Tier II data is required on a 17. Required if the potential for adverse chronic
different test species from Tier I data when effects is indicated based on any of the following:
developmental effects are observed in the first study i. The subchronic effect level established in the
and information on species-to-species extrapolation following Tier I studies: 90-day oral toxicity study, 90-
is needed. day dermal toxicity study, or 90-day inhalation
10. Required to support nonfood uses if either: toxicity study.
i. The use is likely to result in significant human ii. The pesticide use pattern (e.g., rate, frequency,
exposure; or and site of application).
11. The active ingredient (or its metabolites) is iii. The frequency and level of repeated human
structurally related to a known mutagen or belongs exposure that is expected.
to any chemical class of compounds containing a 18. Required if the product meets either of the
known mutagen. Additional mutagenicity tests that following criteria:
may have been performed plus a complete reference i. The active ingredient (or any of its metabolites,
list must also be submitted. Subsequent testing may degradation products, or impurities) produce(s) in
be required based on the available evidence. Tier I subchronic studies a morphologic effect (e.g.,
11. Choice of assay using either: hyperplasia or metaplasia) in any organ that
i. Mouse lymphoma L5178Y cells, thymidine potentially could lead to neoplastic change.
kinase (tk) gene locus, maximizing assay conditions ii. Adverse cellular effects suggesting
for small colony expression or detection; carcinogenic potential are observed in Tier II
ii. Chinese hamster ovary (CHO) or Chinese immunotoxicity and Tier III immune response study
hamster lung fibroblast (V79) cells, hypoxanthine- or in Tier II mammalian mutagenicity assays.
guanine phosphoribosyl trans In addition, a 90-day range finding study in both
rats and mice is required to determine the dose
levels if carcinogenicity studies are required. If the
mouse carcinogenicity study is not required, the 90-
day mouse subchronic study is likewise not required.
19. Required if results from lower tiered mutation (b) Use patterns. The terrestrial use pattern
or reproductive studies indicate there is potential for includes products classified under the general
chromosomal aberration to occur. use patterns of terrestrial food crop, terrestrial
20. May be required if the product’s use will result
in exposure to domestic animals through, but not
feed crop, and terrestrial nonfood/nonfeed
limited to, direct application or consumption of crop. The greenhouse use pattern includes
treated feed. products classified under the general use
patterns of greenhouse food crop and
§ 158.2060 Biochemical pesticides nontarget greenhouse nonfood crop. The indoor use
organisms and environmental fate data pattern includes products classified under the
requirements table.
general use patterns of indoor food and
(a) General. (1) Sections 158.100 through nonfood use. The remaining terrestrial uses
158.130 describe how to use this table to include: forestry and residential outdoor use.
determine the terrestrial and aquatic Data are also required for the general use
nontarget organisms and fate data patterns of aquatic food and nonfood crop
requirements for a particular biochemical use.
pesticide product. Notes that apply to an (c) Key. R=Required;
individual test including specific conditions, CR=Conditionally required; NR=Not required;
qualifications, or exceptions to the designated MP=Manufacturing-use product; EP=End-use
test are listed in paragraph (e) of this section. product; TEP=Typical end-use
In general, for all outdoor end-use products product; TGAI=Technical
including turf, the following studies are grade of the active ingredient; Residue of
required: one avian acute oral, one avian concern=the active ingredient and its
dietary, one acute freshwater fish, one acute metabolites, degradates, and impurities of
freshwater invertebrate study, plant toxicity toxicological concern; All=All of the above.
testing, and a honeybee acute contact study. Specific conditions, qualifications, or
(2) The data in this section are not required exceptions to the designated test procedures
for arthropod pheromones when applied at up appear in paragraph (e) of this section, and
to a maximum use rate of 150 grams active apply to the individual tests in the following
ingredient/ acre/year except when the product table:
is expected to be available to avian species (d) Table. The following table shows the
(he., granular formulation). data requirements for biochemical pesticides
nontarget organisms and environmental fate.
The test notes are shown in paragraph (e) of
this section.
Use Patterns
For
Terres Green estry, Test
Guideline Data Requirement trial Aquatic house Resi indoor Sub- Test Notes
Number dential stance
Food/
Feed/ Food/ Food/ Out Food/
Nonfood Nonfood Nonfood door Nonfood
Tier I
Avian Testing
TGAI,
850.2100 Avian acute oral toxicity R R CR R CR 1, 2, 3, 4
EP
TGAI,
850.2200 Avian dietary toxicity R R CR R CR 1, 2, 3, 4
EP
Insect Testing
Tier II
162-4
Aerobic aquatic metabolism CR CR CR CR NR TGAI 6
(835.4300)
Nontarget Plant
Tier III
Use Patterns
Terrestrial Wildlife
Beneficial Insects
Nontarget Plants
(e) Test notes. The following test notes are 5. Required for the EP when the end-use
applicable to the data requirements for formulation may contain other ingredients that may
biochemical pesticides nontarget organisms be toxic to nontarget organisms.
6. Required on a case-by-case basis when results
and environmental fate as referenced in the from Tier I studies indicate adverse effects.
last column of the table contained in 7. Required when results of any one or more of
paragraph (d) of this section. the nontarget organism studies in Tier I indicate
1. Required for the EP when any end-use potential adverse effects on nontarget organisms
formulation may contain other ingredients that may and the pesticide is to be applied on land. In view of
be toxic to nontarget organisms or to support methdological difficulties with the study of
arthropod pheromones that would be available to photodegradation in air, prior consultation with the
avian wildlife, (e.g., a granular product). Agency regarding the protocol is recommended
2. Tests for pesticides intended solely for indoor before the test is performed.
application would be required on a case-by-case 8. Required when results of any one or more of
basis, depending on use pattern, physical/chemical the nontarget organism studies in Tier I indicate
properties, production volume, and other pertinent potential adverse effects on nontarget organisms
factors. and the pesticide is to be applied in a passive
3. Not required for any use groups if the pesticide dispenser.
is highly volatile (estimated volatility >5 x10_5atm 9. Required to support registration of known
m /mol).
3 phytotoxicants, i.e., herbicides, desiccants, defoliants,
4. Preferred test species are Upland game, and plant growth regulators.
waterfowl, or passerine for avian acute oral toxicity 10. Required if environmental fate characteristics
studies; Upland game and waterfowl for avian indicate that the estimated environmental
dietary studies; and coldwater fish species for acute concentration of the pesticide in the aquatic
freshwater fish studies. environment is >0.01 of any EC50
or LC50 determined in the aquatic nontarget on a case-by-case basis, submission of efficacy
organism testing. data for any pesticide product registered or
11. Required if either of the following criteria are proposed for registration.
met:
i. Environmental fate characteristics indicate that § 158.2080 Experimental use permit data
the estimated concentration of the pesticide in the requirements—biochemical
terrestrial environment is >0.20 the avian dietary LC50 pesticides.
or equal to >0.20 the avian oral single dose LD50
(converted to ppm). (a) Sections 158.2081 through 158.2084
ii. The pesticide or any of its metabolites or describe the experimental use permit (EUP)
degradation products are stable in the environment data requirements for biochemical pesticides.
to the extent that potentially toxic amounts may Variations in the test conditions are identified
persist in the avian or mammalian feed. within the test notes. Definitions that apply to
12. Required when results of Tier I nontarget
organism studies indicate potential adverse effects all biochemical data requirements can be
on nontarget insects and results of Tier II tests found in §158.2000.
indicate exposure of nontarget insects. Additional (b) For general information on the data
insect species may have to be tested if necessary to requirement tables, see §158.2010(b)-(f).
address issues raised by use patterns and potential
exposure of important nontarget insect species, (e.g., § 158.2081 Experimental use permit biochemical
threatened or endangered species). pesticides product chemistry data
13. Required if the product is expected to be requirements table.
transported from the site of application by air, soil, (a) General. (1) Sections 158.100 through
or water. The extent of movement would be 158.130 describe how to use this table to
determined by the results of the Tier II environmental
fate studies. determine the product chemistry data
14. Required depending on pesticide mode of requirements for a particular biochemical
action, method and timing of application, and results pesticide product. Notes that apply to an
of any available efficacy data. Typically the honeybee individual test and include specific conditions,
acute toxicity guideline (guideline 850.3020) satisfies qualifications, or exceptions to the designated
this requirement, however, additional nontarget
insect species may have to be tested if necessary to test are listed in paragraph (e) of the section.
address issues raised by use patterns and potential (2) Depending on the results of the required
exposure of important nontarget insect species, (e.g., product chemistry studies, appropriate use
endangered species.) restrictions, labeling requirements, or special
§ 158.2070 Biochemical pesticides packaging requirements may be imposed.
product performance data requirements. (b) Use patterns. Product chemistry data
Product performance data must be are required for all pesticide products and are
developed for all biochemical pesticides. not use specific.
However, the Agency typically does not (c) Key. R=Required;
require applicants to submit such efficacy data CR=Conditionally required; NR=Not required;
unless the pesticide product bears a claim to MP=Manufacturing-use product; EP=End-use
control public health pests, such as pest product; TEP=Typical end-use product;
microorganisms infectious to man in any area TGAI=Technical grade of the active ingredient;
of the inanimate environment or a claim to Residue of concern=the active ingredient and
control vertebrates (including but not limited its metabolites, degradates, and impurities of
to: rodents, birds, bats, canids, and skunks) or toxicological concern; All=All of the above.
invertebrates (including but not limited to: Specific conditions, qualifications, or
mosquitoes and ticks) that may directly or exceptions to the designated test procedures
indirectly transmit diseases to humans. appear in paragraph (e) of this section, and
However, each registrant must ensure through apply to the individual tests in the following
testing that his products are efficacious when table:
used in accordance with label directions and (d) Table. The following table shows the
commonly accepted pest control practices. data requirements for experimental
The Agency reserves the right to require,
use permit biochemical pesticides product
chemistry. The test notes are shown in
paragraph (e) of this section.
TABLE—EUP BIOCHEMICAL PESTICIDES PRODUCT CHEMISTRY DATA REQUIREMENTS
830.6315 Flammability CR MP EP 9
830.6319 Miscibility CR MP EP 10
830.7100 Viscosity CR MP EP 12
(e) Test notes. The following test notes are chemistry and are referenced in the last
applicable to the data requirements for column of the table in paragraph
experimental use permit biochemical (d) of this section.
pesticides product
1. Data must be provided in accordance with ticular pesticide product and the substance
§158.320. that needs to be tested. These data
2. If the MP and EP are produced by an requirements apply to all biochemical
integrated formulation system (non-registered
source), these data are also required on TGAI.
pesticides, i.e., naturally occurring insect
3. Data must be provided in accordance with repellents and attractants, semiochemicals
§158.325, §158.330, and §158.335. (e.g., insect pheromones), natural and plant
4. Data must be provided in accordance with growth regulators. Notes that apply to an
§158.340. individual test and include specific conditions,
5. Data must be provided in accordance with qualifications, or exceptions to the designated
§158.345. Also, required to support the registration test are listed in paragraph (e) of this section.
of each manufacturing-use product (including (b) Use patterns. (1) Data are required or
registered TGAIs) and end-use products produced
by an integrated formulation system. Data on other conditionally required for all pesticides used in
end-use products would be required on a case-by- or on food and for residential outdoor uses
case basis. For pesticides in the production stage, a where food crops are grown. Food use
preliminary product analytical method and data patterns include products classified under the
would suffice to support an experimental use permit. general use patterns of terrestrial food crop
6. Data must be provided in accordance with use, terrestrial feed crop use, aquatic food
§158.350. crop use, greenhouse food crop use, and
7. Data must be provided in accordance with indoor food use. Data are also conditionally
§158.355.
8. If the TGAI cannot be isolated, data are required for aquatic nonfood use if there is
required on the practical equivalent of the TGAI. EP direct application to water that could
testing may also be appropriate. subsequently result in exposure to food.
9. Required if the product contains combustible (2) Data are conditionally required for
liquids. nonfood uses if pesticide residues may occur
10. Required if the product is an emulsi- fiable in food or feed as a result of the use. Data
liquid and is to be diluted with petroleum solvents. requirements for these nonfood uses would be
11. Required if the test substance is soluble or determined on a case-by-case basis. For
dispersible in water.
12. Required if the product is a liquid. example, most products used in or near
13. Required when the technical chemical is a kitchens require residue data for risk
solid at room temperature. assessment purposes even though tolerances
14. Required when the technical chemical is a may not be necessary in all cases.
liquid at room temperature. (c) Key. R=Required;
15. Required for water insoluble test substances CR=Conditionally required; NR=Not required;
(>10~sg/l) and fibrous test substances with diameter MP=Manufacturing end-use product;
>0.1 gm. EP=End-use product; TEP=Typical end-use
16. Required for organic chemicals unless they
dissociate in water or are partially or completely product; TGAI=Technical grade of the active
soluble in water. ingredient; Residue of concern=the active
17. Data on the stability to metals and metal ions ingredient and its metabolites, degradates,and
is required only if the active ingredient is expected to impurities of toxicological concern. All=All of
come in contact with either material during storage. the above. Specific conditions, qualifications,
18. True density or specific density are required or exceptions to the designated test
for all test substances. Data on bulk density is procedures appear in paragraph (e) of this
required for MPs or EPs that are solid at room section, and apply to the individual tests in the
temperature.
19. Not required for salts. following table:
(d) Data table. The following table shows
§ 158.2082 Experimental use permit biochemical the data requirements for biochemical
pesticides residue data requirements table. pesticides residue. The test notes are shown in
(a) General. Sections 158.100 through paragraph (e) of this section.
158.130 describe how to use this table to
determine the biochemical pesticides residue
data requirements for a par
TABLE—EUP BIOCHEMICAL PESTICIDES RESIDUE DATA REQUIREMENTS
Use Patterns
Supporting Information
Nature of Residue
TGAI or plant
860.1480 Meat/milk/poultry/eggs CR CR CR CR 1, 7, 8, 9
metabolites
Residue of
860.1540 Anticipated residues CR CR CR CR 1, 9, 16
concern
(e) Test notes. The following test notes are timing of applications, preharvest intervals, and
applicable to the data requirements for relevant restrictions.
biochemical pesticides product chemistry and 4. Required for residential outdoor uses on food
are referenced referenced in the last column crops if the corresponding agricultural use is not
approved or the residential use is expected to
of the table contained in paragraph (d) of this produce higher residues based on the label
section. directions.
1. Residue chemistry data requirements apply to 5. Required unless it is an arthropod pheromone
biochemical pesticide products when Tier II or Tier III applied at a rate less than or equal to 150 grams
toxicology data are required, as specified for active ingredient per acre.
biochemical agents in the biochemical human health 6. Required for indoor uses where the pesticide is
assessment data requirements, §158.2050. applied directly to food, in order to determine
2. The same chemical identity data are required metabolites and/or degradates. Not required when
for biochemical product chemistry data only indirect contact with food would occur (e.g.,
requirements,§ 158.2030 with an emphasis on crack and crevice treatments).
impurities. 7. Required when a pesticide is to be applied
3. Required information includes crops to be directly to livestock, to livestock premises, to
treated, rate of application, number and livestock drinking water, or to crops used for
livestock feed. If results from
the plant metabolism study show differing § 158.2083 Experimental use permit biochemical
metabolites in plants form those found in animals, an pesticides human health assessment data
additional livestock metabolism study involving requirements table.
dosing with the plant me- tabolite(s) may also be (a) General. (1) Sections 158.100 through
required. 158.130 describe how to use this table to
8. Livestock feeding studies are required determine the human health assessment data
whenever a pesticide residue is present in livestock
feed or when direct application to livestock uses
requirements for a particular biochemical
occurs. pesticide product.
9. Required if indoor use could result in pesticide (2) The data in this section are not required
residues in or on food or feed. for straight chain lepidopteran pheromones
10. Data are required to determine whether when applied up to a maximum use rate of 150
FDA/USDA multiresidue methodology would detect grams active ingredient/acre/year.
and identify the pesticides and any metabolites. (b) Use patterns. (1) Food use patterns, in
11. Data are required whenever a pesticide may general, include products classified under the
be applied directly to water, unless it can be following general uses: terrestrial food crop
demonstrated that the treated water would not be use; terrestrial feed crop use; aquatic food
available for human or livestock consumption. crop use; greenhouse food crop use.
12. Data on fish are required for all pesticides
applied directly to water inhabited, or which will be (2) Nonfood use patterns include products
inhabited, by fish that may be caught or harvested classified under the general use patterns of
for human consumption. terrestrial nonfood crop use; aquatic nonfood
13. Data are required when a pesticide is to be residential use; aquatic nonfood outdoor use;
applied directly to water that could be used for aquatic nonfood industrial use; greenhouse
irrigation or to irrigation facilities such as irrigation nonfood crop use; forestry use; residential
ditches. outdoor use; residential indoor use; indoor
14. Data are required whenever a pesticide may food use; indoor nonfood use; indoor medical
be used in food/feed handling establishments. use.
15. Data on the nature and level of residue in (c) Key. R=Required;
processed food/feed are required when detectible CR=Conditionally required; NR=Not required;
residues could potentially concentrate on processing
thus requiring the establishment of a separate MP=Manufacturing-use product; EP=End-use
tolerance higher than that of the raw agricultural product; TEP=Typical end-use product;
commodity. TGAI=Technical grade of the active ingredient;
16 Anticipated residue data are required when the Residue of concern=the active ingredient and
assumption of tolerance level residues would result its metabolites, degradates, and impurities of
in predicted exposure at an unsafe level of exposure. toxicological concern; All=All of the above.
Data, using single serving samples of a raw Specific conditions, qualifications, or
agricultural commodity, on the level or residue in exceptions to the designated test procedures
food as consumed would be used to obtain a more appear in paragraph (e) of this section, and
precise estimate of potential dietary exposure. These apply to the individual tests in the following
data may also include washing, cooking, processing table:
or degradation studies as well as market basket
surveys for a more precise residue determination. (d) Table. The following table shows the
17. The proposed tolerance must reflect the data requirements for experimental use permit
maximum residue likely to occur in crops, in meat, biochemical pesticides human health
milk, poultry, or eggs. assessment. The test notes are shown in
18. Required when a residue analytical method is paragraph (e) of this section.
required.
Tier I
TABLE—EUP BIOCHEMICAL PESTICIDES HUMAN HEALTH ASSESSMENT DATA REQUIREMENTS—
Continued
Acute Testing
TGAI and
870.1100 Acute oral toxicity - rat R R TGAI and EP 1
MP
TGAI and
870.1200 Acute dermal toxicity R R TGAI and EP 1, 2
MP
TGAI and
870.1300 Acute inhalation toxicity - rat R R TGAI and EP 3
MP
TGAI and
870.2400 Primary eye irritation - rabbit R R TGAI and EP 2
MP
TGAI and
870.2500 Primary dermal irritation R R TGAI and EP 1, 2
MP
Subchronic Testing
870.3100 90-day oral (one species) R NR TGAI TGAI
Developmental Toxicity
Mutagenicity Testing
870.5100 Bacterial reverse mutation test R CR TGAI TGAI 6
Tier II
Developmental Toxicity
870.3700 Prenatal developmental CR CR TGAI TGAI 5
(e) Test notes. The following test notes are significant exposure to female humans (e.g.,
applicable to the data requirements for occupational exposure or repeated application of
experimental use permit biochemical insect repellents directly to the skin). Tier II data is
pesticides human health assessment as required on a different test species from Tier I data
when developmental effects are observed in the first
referenced in the last column of the table in study and information on species-to-species
paragraph (d) of this section. extrapolation is needed.
1. Required unless the test material is a gas or 6. Required to support nonfood uses if either:
highly volatile (vapor pressure >10_4torr (mm/Hg)). i. The use is likely to result in significant human
2. Required unless the test material is corrosive to exposure; or
skin or has pH <2 or >11.5. ii. The active ingredient (or its metabolites) is
structurally related to a known mutagen or belongs
3. Required when the pesticide, under conditions to any chemical class of compounds containing a
of use, would result in respirable material (e.g., gas, known mutagen.
volatile substance or aer- osol/particulate), unless it Additional mutagenicity tests that may have been
is a straight chain lepidopteran pheromone. performed plus a complete reference list must also
4. Hypersensitivity incidents must be reported as be submitted. Subsequent testing may be required
adverse effects data. based on the available evidence.
5. Required if the use of the product under 7. Choice of assay using either:
widespread and commonly recognized practice may i. Mouse lymphoma L5178Y cells, thymidine kinase
reasonably be expected to result in (tk) gene locus, maximizing
assay conditions for small colony expression or (b) Use patterns. The terrestrial use pattern
detection; includes products classified under the general
ii. Chinese hamster ovary (CHO) or Chinese use patterns of terrestrial food crop, terrestrial
hamster lung fibroblast (V79) cells, hypoxanthine- feed crop, and terrestrial nonfood/nonfeed
guanine phosphoribosyl transferase (hgprt) gene crop. The greenhouse use pattern includes
locus, accompanied by an appropriate in vivo test for products classified under the general use
clastogenicity; or
iii. CHO cells strains AS52, xanthine-guanine
patterns of greenhouse food crop and
phosphoribosyl transferase (xprt) gene locus. greenhouse nonfood crop. The indoor use
pattern includes products classified under the
§ 158.2084 Experimental use permit biochemical general use patterns of indoor food and
pesticides nontarget organisms and nonfood use. The remaining terrestrial uses
environmental fate data requirements table.
include forestry and residential outdoor use.
(a) General. (1) Sections 158.100 through Data are also required for the general use
158.130 describe how to use this table to patterns of aquatic food and nonfood crop
determine the terrestrial and aquatic use.
nontarget organisms and fate data (c) Key. R=Required;
requirements for a particular biochemical CR=Conditionally required; NR=Not required;
pesticide product. Notes that apply to an MP=Manufacturing-use product; EP=End-use
individual test including specific conditions, product; TEP=Typical end-use
qualifications, or exceptions to the designated product; TGAI=Technical
test are listed in paragraph (e) of this section. grade of the active ingredient; Residue of
In general, for all outdoor end-use products concern=the active ingredient and its
including turf, the following studies are metabolites, degradates, and impurities of
required: one avian acute oral, one avian toxicological concern; All=All of the above.
dietary, one acute freshwater fish, and one Specific conditions, qualifications, or
acute freshwater invertebrate study. exceptions to the designated test procedures
(2) The data in this section are not required appear in paragraph (e) of this section, and
for arthropod pheromones when applied at up apply to the individual tests in the following
to a maximum use rate of 150 grams active table:
ingredient/ acre/year except when the product (d) Table. The following table shows the
is expected to be available to avian species data requirements for experimental use permit
(i.e., granular formulation). biochemical pesticides nontarget organisms
and environmental fate. The test notes are
shown in paragraph (e) of this section.
Use Patterns
Avian Testing
Terres For
Green Test
trial Aquatic estry, indoor
Guideline Number Data Requirement house Sub Test Notes
Resi stance
Food/ dential
Feed/ Food/ Food/ Out Food/
Nonfood Nonfood Nonfood door Nonfood
850.1010 R R NR R NR TGAI, 2, 4
Aquatic invertebrate EP
acute toxicity,
freshwater
(e) Test notes. The following test notes are (2) Is a procaryotic microorganism,
applicable to the data requirements for including, but not limited to, Eubacteria and
experimental use permit biochemical Archaebacteria; or
pesticides nontarget organisms and (3) Is a parasitically replicating microscopic
environmental fate as referenced in the last element, including, but not limited to, viruses.
column of the table contained in paragraph (d) (c) Applicability. (1) This subpart applies to
of this section. microbial pesticides as specified in paragraphs
1. Required for the EP when any end-use
formulation may contain other ingredients that may (c)(2), (c)(3), and
be toxic to nontarget organisms or to support (c) (4) of this section.
arthropod pheromones that would be available to (2) Each new isolate of a microbial pesticide
avian wildlife, (e.g., a granular product). is a new active ingredient and must be
2. Not required for any use groups if the pesticide registered independently of any similarly
is highly volatile (estimated volatility >5x10_5atm
m3/mol). designated and already registered microbial
3. Preferred test species are: upland game, pesticide active ingredient. Each new isolate
waterfowl, or passerine for avian acute oral toxicity for which registration is sought must have a
studies; upland game or waterfowl for avian dietary unique identifier following the taxonomic
studies; and coldwater fish for acute freshwater fish name of the microorganism, and the
studies.
4. Required for the EP when the end-use
registration application must be supported by
formulation may contain other ingredients that may data required in this subpart. This does not
be toxic to nontarget organisms. preclude the possibility of using data from
another isolate, provided sufficient similarity is
Subpart V—Microbial Pesticides established, to support registration.
(3) Genetically modified microbial
SOURCE: 72 FR 61002, Oct. 26, 2007, unless pesticides may be subject to additional data or
otherwise noted. information requirements on a case-by-case
§ 158.2100 Microbial pesticides definition and basis depending on the particular microbial
applicability. agent and/or its parental strains, the proposed
(a) This subpart applies to all living or dead pesticide use pattern, and the manner and
microbial pesticides as described in extent to which the organism has been
paragraphs (b) and (c) of this section. genetically modified.
(b) Definition. Microbial pesticide is a (4) Pest control organisms such as insect
microbial agent intended for preventing, predators, nematodes, and macroscopic
destroying, repelling, or mitigating any pest, or parasites are exempt from the requirements of
intended for use as a plant regulator, defoliant, FIFRA as authorized by section 25(b) of FIFRA
or desiccant, that: and specified in §152.20 (a) of this chapter.
(1) Is a eucaryotic microorganism including,
[72 FR 61002, Oct. 26, 2007, as amended at 77 FR
but not limited to, protozoa, algae, and fungi;
52612, Aug. 30, 2012]
§ 158.2110 Microbial pesticides data requirements. solely the technical grade of the active
(a) For all microbial pesticides. (1) The ingredient and manufacturing-use products to
following §158.2120 through §158.2150 identify which other ingredients have been
the data requirements that are required to intentionally added. Data requirements listing
support registration of microbial pesticides. the EP as the test substance apply to any EP
The variations in the test conditions are with an ingredient in the end-use formulation
identified within the test notes. other than the active ingredient that is
(2) Each data table includes ‘‘use patterns” expected to enhance the toxicity of the
under which the individual data are required, product.
with variations including all use patterns, food (b) Additional data requirements for
and nonfood uses for terrestrial and aquatic genetically modified microbial pesticides.
applications, greenhouse, indoor, forestry, and Additional requirements for genetically
residential outdoor applications under certain modified microbial pesticides may include but
circumstances. are not limited to: genetic engineering
(3) The categories for each data techniques used; the identity of the inserted or
requirement are “R,” which stands for required, deleted gene segment (base sequence data or
and “CR” which stands for conditionally enzyme restriction map of the gene);
required. If a bracket appears around the ‘‘R’’ information on the control region of the gene
or ‘‘CR,’’ the data are required for both the in question; a description of the ‘‘new’’ traits or
registration and experimental use permit characteristics that are intended to be
requests. Generally, ‘‘R’’ indicates that the data expressed; tests to evaluate genetic stability
are more likely required than for those data and exchange; and selected Tier II
requirements with ‘‘CR.’’ However, in each environmental expression and toxicology tests.
case, the regulatory text preceding the data
table and the test notes following the data § 158.2120 Microbial pesticides product
table must be used to determine whether the analysis data requirements table.
data requirement must be satisfied. (a) General. Sections 158.100 through
(4) Each table identifies the test substance 158.130 describe how to use this table to
that is required to be tested to satisfy the data determine the product analysis data
requirement. Test substances may include: requirements and the substance to be tested
technical grade active ingredient (TGAI), for a particular microbial pesticide. Notes that
manufacturing-use product (MP), end-use apply to an individual test and include specific
product (EP), typical end-use product (TEP), conditions, qualifications, or exceptions to the
residue of concern, and pure active ingredient designated test are identified in paragraph (d)
(PAI) or all of the above (All). Commas of this section.
between the test substances (i.e., TGAI, EP) (b) Key. R = Required; CR = Conditionally
indicate that data may be required on the TGAI required; NR = Not required; MP =
or EP or both depending on the conditions set Manufacturing-use product; EP = End-use
forth in the test note. Data requirements which product; TEP = Typical end- use product; TGAI
list two test substances (i.e., TGAI and EP) = Technical grade of the active ingredient; All
indicate that both are required to be tested. = All of the above.
Data requirements that list only MP as the test (c) Table. The table in this paragraph
substance apply to products containing shows the data requirements for microbial
pesticides product analysis. The test notes are
shown in paragraph (d) of this section.
TABLE-MICROBIAL PESTICIDES PRODUCT ANALYSIS DATA REQUIREMENTS
Test substance
Test guideline No. Data requirement All use Test
patterns MP EP notes
885.1400 ............ Analysis of samples ............................ R TGAI and MP ...... TGAI and EP........ 2
885.1500 ............ Certification of limits ........................... R MP ........................ EP.
(d) Test notes. The following test notes are § 158.2130 Microbial pesticides residue data
applicable to the data requirements for requirements table.
microbial pesticides product analysis as (a) General. Sections 158.100 through
referenced in the last column of the table 158.130 describe how to use this table to
contained in paragraph (c) of this section. determine the residue chemistry data
1. Required for each isolate of a microbial requirements and the substance to be tested
pesticide. Isolates must be deposited with an for a particular microbial pesticide. Specific
agreement to ensure that the sample will be conditions, qualifications, or exceptions to the
maintained and will not be discarded for the duration designated test appear in paragraph (d) of this
of the associated registration(s).
2. Required to support registration of each section, and the procedures appear in
manufacturing-use product and end-use product. paragraph (e) of this section.
This analysis must be conducted at the point in the (b) Key. R=required;
production process after which there would be no CR=Conditionally required; NR=Not required;
potential for microbial contamination or microbial MP=Manufacturing-use product; EP=End-use
regrowth. For full registration, generally an analysis product; TEP=Typical end-use product;
of samples is a compilation of batches, over a period TGAI=Technical grade of the active ingredient;
of time, depending on the frequency of
manufacturing.
All=All of the above. Specific conditions,
3. Only required for emulsifiable liquid forms of qualifications, or exceptions to the designated
microbial pesticides. test procedures appear in paragraph (d) of this
4. Required when microbial pesticides are section, and apply to the individual tests in the
packaged in metal, plastic, or paper containers. following table:
5. Only required for liquid forms of microbial (c) Table. The following table shows the
pesticides. data requirements for microbial pesticides
[72 FR 61002, Oct. 26, 2007, as amended at 77 FR residue. The test notes are shown in paragraph
52612, Aug. 30, 2012] (d) of this section.
TABLE-MICROBIAL PESTICIDES RESIDUE DATA REQUIREMENTS
Test Substance
Guideline Number Data Requirement All Use Patterns Data to Support Test Notes
MP or EP
(d) Test notes. The following test note is (c) Table. The following table shows the
applicable to the data requirements for data requirements for microbial pesticides
microbial pesticides residue as referenced in toxicology. The test notes are shown in
the last column of the table contained in paragraph (d) of this section.
paragraph (c) of this section.
1. Required when the results of testing:
i. Indicate the potential to cause adverse human TABLE-MICROBIAL PESTICIDES TOXICOLOGY
health effects or the product characterization DATA REQUIREMENTS
indicates the microbial pesticide has a significant
potential to produce a mammalian toxin; and All Test
ii. The use pattern is such that residues may be Guideline
Number Data Requirement Use
Pat Sub Test
Notes
present in or on food or feed crops. terns stance
MP ,
870.1300 Acute inhalation toxicity R 5, 6
EP
MP ,
870.2400 Acute eye irritation R 5
EP
TABLE-MICROBIAL PESTICIDES TOXICOLOGY inhalable material (e.g., gas, volatile substances, or
DATA REQUIREMENTS—Continued aerosol particulate).
7. Data required when significant toxicity, in the
All absence of pathogenicity and significant infectivity, is
Guideline Data Requirement Use Test
Sub Test observed in acute oral, injection, or pulmonary
Number Pat stance Notes studies (Tier I). Route(s) of exposure correspond to
terns
route(s) where toxicity was observed in Tier I studies.
870.2500 Primary dermal irrita- R MP , 5 The toxic component of the TGAI is to be tested.
tion EP 8. Data required when significant infec- tivity
and/or unusual persistence is observed in the
Tier II absence of pathogenicity or toxicity in Tier I studies.
Routes of exposure (oral and/ or pulmonary)
885.3550 Acute toxicology CR TGAI 7 correspond to routes in Tier I studies where adverse
effects were noted. Data may also be required to
885.3600 Subchronic toxicity/
pathogenicity
CR TGAI 8
evaluate adverse effects due to microbial
contaminants or to toxic byproducts.
Tier III 9. Data are required when one or more of the
following criteria are met:
885.3650
Reproductive fertility
CR TGAI 9, 13 i. Significant infectivity of the microbial pest
effects control agent (MPCA) was observed in test animals
870.4200 Carcinogenicity CR TGAI 10, 13
in the Tier II subchronic study and in which no
significant signs of toxicity or pathogenicity were
870.7800 Immunotoxicity CR TGAI 11, 13 observed.
ii. The microbial pesticide is a virus which can
885.3000
I nfectivity/pathoge-
CR TGAI 12, 13
persist or replicate in mammalian cell culture lines.
nicity analysis iii. The microbial pesticide is not amenable to
thorough taxonomic classification, and is related to
(d) Test notes. The following test notes are organisms known to be parasitic for mammalian
applicable to the data requirements for cells.
microbial pesticides toxicology as referenced iv. The microbial pesticide preparation is not
in the last column of the table contained in well purified, and may contain contaminants which
are parasitic for mammals.
paragraph (c) of this section: 10. Data may be required for products
1. The acute oral toxicity/pathogenicity study is known to contain or suspected to contain
required to support the TGAI. However, it can be carcinogenic viruses or for microbial components
combined with the unit dose portion of the acute that are identified as having significant toxicity in Tier
oral toxicity study, with an EP or MP test material to II testing.
fulfill the requirement for the TGAI and the MP or EP 11. Data may be required for products
in a single study, if the new protocol is designed to known to contain or suspected to contain viruses
address the endpoints of concern. that can interact in an adverse manner with
2. Data not required for products whose active components of the mammalian immune system.
ingredient is a virus. For test materials whose size or 12. An analysis of human infectivity/patho-
consistency may prevent use of an intravenous genicity potential using scientific literature, genomic
injection, the intraperitoneal injection procedure may analysis, and/or actual specific cell culture/animal
be employed. data may be required for products known to contain
3. Hypersensitivity incidents, including immediate or suspected of containing intracellular parasites of
type and delayed-type reactions of humans or mammalian cells for products that exhibit
domestic animals, occur during the testing or pathogenic characteristics in Tier I and/or Tier II, for
production of the TGAI, MP, or EP, or are otherwise products which are closely related to known human
known to the applicant must be reported if they pathogens based on the product analysis data, or for
occur. known human pathogens that have been ‘‘disarmed’’
4. Data must be submitted only for products or rendered non-pathogenic for humans.
whose active ingredient is a virus. 13. Test standards may have to be modified
5. The 870 series studies for the MP and EP are depending on the characteristics of the
intended to provide data on the acute toxicity of the microorganism. Requirements may vary for these
product. Waivers for any or all of these studies may studies depending on the active ingredient being
be granted when the applicant can demonstrate that tested. Consultation with the Agency is advised
the combination of inert ingredients is not likely to before performing these Tier III studies.
pose any significant human health risks. Where
appropriate, the limit dose approach to testing is
recommended.
6. Required when the product consists of, or
under conditions of use would result in, an
§ 158.2150 Microbial pesticides nontarget organisms greenhouse (food and food), Indoor (food and
and environmental fate data requirements nonfood), and Industrial.
table. (c) Key. R=Required;
(a) General. Sections 158.100 through CR=Conditionally required; NR=Not required;
158.130 describe how to use this table to MP=Manufacturing-use product; EP=End-use
determine the terrestrial and aquatic product; TEP=Typical end-use product;
nontarget organisms data requirements for a TGAI=Technical grade of the active ingredient;
particular microbial pesticide product. Notes All=All of the above. Specific conditions,
that apply to an individual test including qualifications, or exceptions to the designated
specific conditions, qualifications, or test procedures appear in paragraph (e) of this
exceptions to the designated test are listed in section, and apply to the individual tests in the
paragraph (e) of this section. following table:
(d) Table. The following table shows the
(b) Use patterns. Aquatic uses include:
data requirements for microbial pesticides
food and feed, nonfood uses (e.g., outdoor, nontarget organisms and environmental fate.
residential, and industrial). Terrestrial uses The test notes are shown in paragraph (e) of
include: Food, Feed, NonFood, Forestry, this section.
Residential outdoor,
Use Patterns
Terrestrial
Aquatic Res Test
Guideline Green Test
Data Requirement indoor Sub
Number Food/ For den- house In Notes
stance
Feed/ est- tial dus-
Nonfood ry trial
Food/ Out Food/ Food/
Nonfood
Feed door Nonfood Nonfood
Tier I
885.4300 CR CR CR R CR NR CR CR TEP 1, 7
Nontarget plant testing
885.4340 R R R R R CR NR CR TGAI 1, 8
Nontarget insect testing
Tier II
Terrestrial
Res Test
Guideline Aquatic Test
Data Requirement Green Sub
Number Indoor Notes
Food/ For den- house In stance
Feed/ est- tial dus-
Nonfood ry trial
Food/ Out Food/ Food/
Nonfood
Feed door Nonfood Nonfood
885.5300 CR CR CR CR CR NR NR CR
TGAI
Freshwater environmental
or 10
expression tests
TEP
885.5400 CR CR CR CR CR NR NR CR
Marine or estuarine TGAI
11,
environmental expression or 12
tests TEP
Tier III
885.4600 CR CR CR CR CR NR NR CR TGAI
Avian chronic
12,
pathogenicity and 13
reproduction test
885.4650 CR CR CR CR CR NR NR CR TGAI
Aquatic invertebrate 12,
range testing 14
885.4700 Fish life cycle studies CR CR CR CR CR NR NR CR TGAI
12,
14
Tier IV
850.2500 CR CR CR CR CR NR NR CR TGAI 11,
850.1950 Field testing for terrestrial 16
or
wildlife and Field
TEP
testing for aquatic
organisms
850.2500 CR CR CR CR CR NR NR CR TEP
Simulated or actual field 16,
tests (birds, 17,
mammals) 20
850.1950 Simulated or actual field CR CR CR CR CR NR NR CR TEP
16,
test (aquatic
18,
organisms)
19,
20
850.2500 Simulated or actual field tests CR CR CR CR CR NR NR CR TEP
16,
(insect predators, 18,
parasites) 19,
20
850.3040 CR CR CR CR CR NR NR CR TEP
16,
Simulated or actual field
18,
tests (insect
19,
pollinators)
20
850.4300 Simulated or actual field CR CR CR CR CR NR NR CR TEP
16,
tests (plants) 18,
19,
20
(e) Test notes. The following test notes are the table contained in paragraph (d) of this
applicable to the data requirements for section.
microbial pesticides nontarget organism and
environmental fate as referenced in the last
column of
case-by-case basis, depending on use pattern, more Tier I tests and results of Tier II tests indicate
production volume, and other pertinent factors. exposure of the microbial agent to the affected
2. The preferred species for the avian oral study nontarget terrestrial wildlife or aquatic organisms.
is either the upland game or waterfowl. The The protocols for these tests may have to be
preferred species for the avian inhalation modified in accordance with results from the
toxicity/pathogenicity study and the avian chronic nontarget organism and environmental expression
toxicity/pathogenicity study is the upland game. studies.
There is also the option to test the passerine if there 13. Required when one or more of the following
is a concern. The coldwater fish is preferred for are present:
freshwater fish testing. However, two species i. Pathogenic effects are observed in Tier I avian
(coldwater and warmwater fish species are the studies.
preferred species) must be tested for uses involving ii. Tier II environmental expression testing
direct freshwater exposure. Freshwater invertebrate indicate that long-term exposure of terrestrial
testing is also required. animals is likely.
3. Data required when the nature of the microbial 14. Required when product is intended for use in
pesticide and/or its toxins indicates potential water or expected to be transported to water from
pathogenicity to birds. the intended use site, and when pathogenicity or
4. Required on a case-by-case basis if results of infectivity was observed in Tier I aquatic studies.
tests required by §158.2140 are inadequate or 15. Required if, after an analysis of the microbial
inappropriate for assessment of hazards to wild pesticide’s ability to survive and multiply in the
mammals. environment and what ecological habitat it would
5. Required when there will be significant occupy, the intended use patterns, and the results of
exposure to aquatic organisms (fish and previous nontarget organisms and environmental
invertebrates). expression tests, it is determined that use of the
6. Required if the product is intended for direct microbial agent may result in adverse effects on the
application into the estuarine or marine environment nontarget organisms in aquatic environments.
or expected to enter this environment in significant Testing is to determine if applications of the
concentrations because of expected use or mobility microbial pest control would be expected to disrupt
pattern. the balance of populations in the target ecosystem.
7. Required if the microbial pesticide is 16. Tier IV studies may be conducted as a
taxonomically related to a known plant pathogen. condition of registration as post-registration
8. Data are not required unless an active monitoring if the potential for unreasonable adverse
microbial ingredient controls the target insect pest effects appears to be minimal during that period of
by a mechanism of infectivity; i.e., may create an use due to implementation of mitigation measures.
epizootic condition in nontarget insects. 17. Required when both of the following
9. Required if toxic or pathogenic effects are conditions occur:
observed in one or more of the following tests for i. Pathogenic effects observed at actual or
microbial pesticides: expected field residue exposure levels are reported
i. Avian acute oral or avian inhalation studies. in Tier III; and
ii. Wild mammal studies. ii. The Agency determines that quarantine
iii. Nontarget plant studies (terrestrial). methods would not prevent the microbial pesticide
iv. Honey bee studies. from contaminating areas adjacent to the test area.
v. Nontarget insect studies. 18. Short term simulated or actual field studies
10. Required when toxic or pathogenic effects are are required when it is determined that the product
observed in any of the following Tier I tests for is likely to cause adverse short-term or acute effects,
microbial pest control agents: based on consideration of available laboratory data,
i. Freshwater fish studies. use patterns, and exposure rates.
11. Freshwater invertebrate studies. 19. Data from a long-term simulated field test
iii. Nontarget plant studies (aquatic). (e.g., where reproduction and growth of confined
11. Required if product is applied on land or in populations are observed) and/or an actual field test
fresh water or marine/estuarine environments and (e.g., where reproduction and growth of natural
toxic or pathogenic effects are observed in any of the populations are observed) are required if laboratory
following Tier I tests for microbial pesticides: data indicate that adverse long-term, cumulative, or
i. Estuarine and marine animal toxicity and life-cycle effects may result from intended use.
pathogenicity. 20. Since test standards would be developed on
ii. Plant studies - estuarine or marine species. a case-by-case basis, consultation with the Agency
12. An appropriate dose-response toxicity test is and development of a protocol is advised before
required when toxic effects on nontarget terrestrial performing these Tier IV studies.
wildlife or aquatic organisms (including plants) are
reported in one or
Additional requirements for genetically
modified microbial pesticides may include but
Product performance data must be are not limited to: genetic engineering
developed for all microbial pesticides. techniques used; the identity of the inserted or
However, the Agency has waived all deleted gene segment (base sequence data or
requirements to submit efficacy data unless enzyme restriction map of the gene);
the pesticide product bears a claim to control information on the control region of the gene
public health pests, such as pest in question; a description of the ‘‘new’’ traits or
microorganisms infectious to man in any area characteristics that are intended to be
of the inanimate environment or a claim to expressed; tests to evaluate genetic stability
control vertebrates (including but not limited and exchange; and selected Tier II
to: rodents, birds, bats, canids, and skunks) or environmental expression and toxicology tests.
invertebrates (including but not limited to: § 158.2171 Experimental use permit microbial
mosquitoes and ticks) that may directly or pesticides product analysis data requirements
indirectly transmit diseases to humans. table.
However, each registrant must ensure through (a) General. Sections 158.100 through
testing that his products are efficacious when 158.130 describe how to use this table to
used in accordance with label directions and determine the product analysis data
commonly accepted pest control practices. requirements and the substance to be tested
The Agency reserves the right to require, on a for a particular microbial pesticide. Notes that
case-by-case basis, submission of efficacy data apply to an individual test and include specific
for any pesticide product registered or conditions, qualifications, or exceptions to the
proposed for registration. designated test are identified in paragraph (d)
§ 158.2170 Experimental use permit data of this section.
requirements—microbial pesticides. (b) Key. R = Required; CR = Conditionally
(a) For all microbial pesticides. (1) The required; NR = Not required; MP =
following §158.2171 through §158.2174 identify Manufacturing-use product; EP = End-use
the data requirements that are required to product; TEP = Typical end- use product; TGAI
support experimental use permits for = Technical grade of the active ingredient; All
microbial pesticides. The variations in the test = All of the above.
conditions are identified within the test notes. (c) Table. The table in this paragraph
(2) For general information on the data shows the data requirements for experimental
requirement tables, see § 158.2110(a)(2)-(4). use permit microbial pesticides product
(b) Additional data requirements for analysis. The test notes are shown in
genetically modified microbial pesticides. paragraph (d) of this section.
885.1400 ............ Analysis of samples ............................ R TGAI and MP ...... TGAI and EP........ 2, 4
885.1500 ............ Certification of limits ........................... R MP ....................... EP.
TABLE—EUP MICROBIAL PESTICIDES PRODUCT ANALYSIS DATA REQUIREMENTS—Continued
(d) Test notes. The following test notes are 7. Only required for liquid forms of microbial
applicable to the data requirements for pesticides.
experimental use permit microbial pesticides [72 FR 61002, Oct. 26, 2007, as amended at 77 FR
52613, Aug. 30, 2012]
product analysis as referenced in the last
column of the table contained in paragraph (c) § 158.2172 Experimental use permit microbial
of this section. pesticides residue data requirements table.
1. If an experimental use permit is being sought, (a) General. Sections 158.100 through
and if the pesticide is not already under full-scale 158.130 describe how to use this table to
production, a schematic diagram and/or description determine the residue chemistry data
of the manufacturing process suffices. requirements and the substance to be tested
2. If an experimental use permit is being sought, for a particular microbial pesticide. Specific
and if the product is not already under full-scale conditions, qualifications, or exceptions to the
production, a discussion of unintentional ingredients designated test appear in (d) of this section,
is required to be submitted to the extent this
and the procedures appear in paragraph (e) of
information is available.
3. Required for each isolate of a microbial this section.
pesticide. Isolates must be deposited with an (b) Key. R=Required;
agreement to ensure that the sample will be CR=Conditionally required; NR=Not required;
maintained and will not be discarded for the duration MP=Manufacturing-use product; EP=End-use
of the associated experimental use permit(s). product; TEP=Typical end-use product;
4. Required to support registration of each TGAI=Technical grade of the active ingredient;
manufacturing-use product and end-use product. All=All of the above. Specific conditions,
This analysis must be conducted at the point in the qualifications, or exceptions to the designated
production process after which there would be no
test procedures appear in paragraph (d) of this
potential for microbial contamination or microbial
regrowth. For pesticides in the production stage, a section, and apply to the individual tests in the
preliminary product analytical method and data following table:
would suffice to support an experimental use permit. (c) Table. The following table shows the
For full registration, generally an analysis of samples data requirements for experimental use permit
is a compilation of batches, over a period of time, microbial pesticides residue. The test notes are
depending on the frequency of manufacturing. shown in paragraph (d) of this section.
5. Only required for emulsifiable liquid forms of
microbial pesticides.
6. Required when microbial pesticides are
packaged in metal, plastic, or paper containers.
TABLE—EUP MICROBIAL PESTICIDES RESIDUE quired; MP=Manufacturing-use product;
DATA REQUIREMENTS EP=End-use product; TEP=Typical end-use
Test product; TGAI=Technical grade of the active
Substanc ingredient; All=All of the above. Specific
conditions, qualifications, or exceptions to the
e Data to
All Support
Guideline
Number Data Requirement Use
Pat
MP or Test
Notes designated test procedures appear in
paragraph (d) of this section, and apply to the
EP
terns
individual tests in the following table:
(c) Table. The following table shows the
885.2100 Chemical Identity CR EP 1 data requirements for microbial pesticide
toxicology. The test notes are shown in
885.2200 Nature of the Residue in
plants
CR EP 1
paragraph (d) of this section.
Nature of the Residue in
885.2250 CR EP 1
animals
residue as referenced in the last column of the 885.3500 Cell culture R TGAI 4
table contained in paragraph (c) of this
section.
870.1100 Acute oral toxicity R MP, EP 1, 5
1. Required when the results of testing: 870.1200 Acute dermal toxicity R MP, EP 5
i. Indicate the potential to cause adverse human
health effects or the product characterization 870.1300 R MP, EP 5, 6
indicates the microbial pesticide has a significant Acute inhalation toxicity
potential to produce a mammalian toxin; and 870.2400 Acute eye irritation R MP, EP 5
ii. The use pattern is such that residues may be
present in or on food or feed crops. 870.2500 Primary dermal irritation CR MP, EP 5
§ 158.2173 Experimental use permit microbial
pesticides toxicology data requirements table. (d) Test notes. The following test notes are
(a) General. Sections 158.100 through applicable to the data requirements for
158.130 describe how to use this table to experimental use permit microbial pesticides
determine the toxicology data requirements toxicology as referenced in the last column of
for a particular microbial pesticide product. the table contained in paragraph (c) of this
Notes that apply to an individual test and section:
include specific conditions, qualifications, or 1. The acute oral toxicity/pathogenicity study is
exceptions to the designated test are listed in required to support the TGAI. However, it can be
paragraph (d) of this section. combined with the unit dose portion of the acute
(b) Key. R=Required; oral toxicity study, with an EP or MP test material to
CR=Conditionally required; NR=Not re fulfill the requirement for the TGAI and the MP or EP
in a single study, if the new protocol is designed to
address the endpoints of concern.
2. Data not required for products whose active ments for a particular microbial pesticide
ingredient is a virus. For test materials whose size or product. Notes that apply to an individual test
consistency may prevent use of an intravenous including specific conditions, qualifications, or
injection, the intraperitoneal injection procedure may
be employed. exceptions to the designated test are listed in
3. Hypersensitivity incidents, including immediate paragraph (e) of this section.
type and delayed type reactions of humans or (b) Use patterns. Aquatic uses include:
domestic animals occur during the testing or food and feed, nonfood uses (e.g., outdoor,
production of the TGAI, MP, or EP, or are otherwise residential, and industrial). Terrestrial uses
known to the applicant must be reported if they
occur. include: Food, Feed, NonFood, Forestry,
4. Data must be submitted only for products Residential outdoor, greenhouse (food and
whose active ingredient is a virus. food), Indoor (food and nonfood), and
5. The 870 series studies for the MP and EP are Industrial.
intended to provide data on the acute toxicity of the (c) Key. R=Required;
product. Waivers for any or all of these studies may CR=Conditionally required; NR=Not required;
be granted when the applicant can demonstrate that
the combination of inert ingredients is not likely to MP=Manufacturing-use product; EP=End-use
pose any significant human health risks. Where product; TEP=Typical end-use product;
appropriate, the limit dose approach to testing is TGAI=Technical grade of the active ingredient;
recommended. All=All of the above. Specific conditions,
6. Required when the product consists of, or qualifications, or exceptions to the designated
under conditions of use that would result in an
inhalable material (e.g., gas, volatile substances, or test procedures appear in paragraph (e) of this
aerosol particulate). section, and apply to the individual tests in the
following table:
§158.2174 Experimental use permit microbial (d) Table. The following table shows the
pesticides nontarget organisms and
environmental fate data requirements table.
data requirements for experimental use permit
(a) General. Sections 158.100 through microbial pesticides nontarget organisms and
158.130 describe how to use this table to environmental fate. The test notes are shown
determine the terrestrial and aquatic in paragraph
nontarget organisms data require (e) of this section.
Use Patterns
Terrestrial
Res Test
Guideline Aquatic Sub Test
Data Requirement Green
Number indoor stance Notes
Food/ For den- house In
Feed/ est- tial dus-
Nonfood ry trial
Food/ Out Food/ Food/
Nonfood
Feed door Nonfood Nonfood
885.4050 NR R R R R NR NR NR TGAI 1, 2
Avian oral toxicity
Freshwater fish tox-
885.4200 NR R R R NR NR NR NR TGAI 1, 2, 3
icity/pathogenicity
885.4240 NR R R R NR NR NR NR TGAi
Freshwater invertebrate
1, 2, 3
toxicity/patho-
genicity
885.4300 NR NR NR R NR NR NR NR TEP 1, 4
Nontarget plant testing
885.4340 R R R R NR NR NR NR TGAI 1, 5
Nontarget insect testing
885.4380 Honey bee testing R R R R NR NR NR NR TGAI 1
(e) Test notes. The following test notes are antimicrobial use, purpose or function; the
applicable to the data requirements for exclusion in FIFRA sec. 2(mm)(1)(B) does not
microbial pesticides nontarget organism and exclude products from the data requirements
environmental fate as referenced in the last of this subpart.
column of the table contained in paragraph (d) (b) A product that bears both antimicrobial
of this section. and non-antimicrobial uses or claims. Such a
1. Tests for pesticides intended solely for indoor product is subject to the data requirements for
application would be required on a case-by-case pesticides in subparts C through O, and U or V
basis, depending on use pattern, production volume,
and other pertinent factors. Tests to support EUP’s of this part with respect to its non-
are based on the application timing and acreage. antimicrobial uses and claims, and to the
2. The preferred species for the avian oral study requirements of this subpart with respect to its
is either the upland game or waterfowl. The antimicrobial uses and claims.
preferred species for the avian inhalation (c) A wood preservative, including a
toxicity/pathogenicity study and the avian chronic product that is intended to prevent wood
toxicity/pathogenicity study is the upland game.
There is also the option to test a passerine species if degradation problems due to fungal rot or
there is a concern. The coldwater fish is preferred for decay, sapstain, or molds.
freshwater fish testing. However, two species (d) An antifoulant, including a product that
(coldwater and warmwater fish are the preferred is intended to kill or repel organisms that can
species) must be tested for uses involving direct attach to underwater surfaces, such as boat
freshwater exposure. Freshwater invertebrates are bottoms.
preferred for invertebrate testing.
3. Required when there will be significant § 158.2201 Antimicrobial use patterns.
exposure to aquatic organisms (fish and
invertebrates). (a) Antimicrobial use patterns. The 12
4. Required if the microbial pesticide is general use patterns used in the data tables in
taxonomically related to a known plant pathogen. this subpart are:
5. Data are not required unless an active (1) Agricultural premises and equipment.
microbial ingredient controls the target insect pest (2) Food-handling/storage establishments,
by a mechanism of infectivity; i.e., may create an
epizootic condition in nontarget insects. premises and equipment.
(3) Commercial, institutional and industrial
Subpart W—Antimicrobial premises and equipment.
Pesticide Data Requirements (4) Residential and public access premises.
(5) Medical premises and equipment.
SOURCE: 78 FR 26978, May 8, 2013, unless (6) Human drinking water systems.
otherwise noted.
(7) Materials preservatives.
§ 158.2200 Applicability. (8) Industrial processes and water systems.
Part 158, subpart W establishes data (9) Antifoulant paints and coatings.
requirements for any pesticide product that is: (10) Wood preservatives.
(a) A pesticide that is intended for use as an (11) Swimming pools.
“antimicrobial pesticide’’ within the meaning of (12) Aquatic areas.
FIFRA sec. 2(mm)(1)(A), regardless of whether (b) Use site index. The Pesticide Use Site
it also meets the criterion of FIFRA sec. Index for Antimicrobial Pesticides is a
2(mm)(1)(B). That criterion excludes from the comprehensive list of specific antimicrobial use
definition any antimicrobial product that is sites. The Index associates antimicrobial use
intended for a food-use requiring a tolerance sites with one or more of the 12 antimicrobial
or exemption under FFDcA sec. 408 or a food use patterns. It is to be used in conjunction
additive regulation or clearance under FFDcA with the data tables in this subpart to
sec. 409. EPA will apply this subpart to all determine the applicability of data
products intended for an requirements to specific uses. The
Antimicrobial Pesticide Use Site Index, which
will be updated periodically, is available from
the Agency or may be
obtained from the Agency’s Web site at including but not limited to, microorganisms
http://www.epa.gov/pesticides. infectious to man in any area of the inanimate
§ 158.2203 Definitions. environment. A product makes a public health
The following terms are defined for the claim if one or more of the following apply:
purposes of this subpart: (1) A claim is made for control of spe
Disinfectant means a substance, or mixture cific microorganisms that are directly or
of substances, that destroys or irreversibly indirectly infectious or pathogenic to man (or
inactivates bacteria, fungi and viruses, but not both man and animals). Examples of specific
necessarily bacterial spores, in the inanimate microorganisms include, but are not limited to:
environment. Mycobacterium tuberculosis,
Fungicide means a substance, or mixture of Pseudomonas aeruginosa, Escherichia coli (E.
substances, that destroys fungi (including coli), human immunodeficiency virus (HIV),
yeasts) and fungal spores pathogenic to man Streptococcus, and Staphylococcus aureus.
or other animals in the inanimate Claims for control of microorganisms
environment. infectious or pathogenic only to animals (such
Microbiological water purifier means any as canine distemper virus or hog cholera virus)
unit, water treatment product or system that are not considered public health claims.
removes, kills or inactivates all types of (2) A claim is made for the pesticide
disease-causing microorganisms from the product as a sterilant, disinfectant, virucide,
water, including bacteria, viruses and sanitizer, or tuberculocide against
protozoan cysts, so as to render the treated microorganisms that are infectious or
water safe for drinking. pathogenic to man.
Sanitizer means a substance, or mixture of (3) A claim is made for the pesticide
substances, that reduces the bacteria product as a fungicide against fungi infectious
population in the inanimate environment by or pathogenic to man, or the product does not
significant numbers, but does not destroy or clearly state that it is intended for use only
eliminate all bacteria. Sanitizers meeting Public against nonpublic health fungi.
Health Ordinances are generally used on food (4) A claim is made for the pesticide
contact surfaces and are termed sanitizing product as a microbiological water purifier or
rinses. microbial purification system.
Sterilant means a substance, or mixture of (5) A non-specific claim is made that the
substances, that destroys or eliminates all pesticide product will beneficially impact or
forms of microbial life in the inanimate affect public health at the site of use or in the
environment, including all forms of vegetative environment in which it is applied, and:
bacteria, bacterial spores, fungi, fungal spores, (i) The pesticide product contains one or
and viruses. more ingredients that, under the criteria in 40
Tuberculocide means a substance, or CFR 153.125(a), is an active ingredient with
mixture of substances, that destroys or respect to a public health microorganism and
irreversibly inactivates tubercle bacilli in the there is no other functional purpose for the
inanimate environment. ingredient in the product; or
Virucide means a substance, or mixture of (ii) The pesticide product is similar in
substances, that destroys or irreversibly composition to a registered pesticide product
inactivates viruses in the inanimate that makes antimicrobial public health claims.
environment. (b) Nonpublic health claim. An antimicrobial
§ 158.2204 Public health and nonpublic health pesticide is considered to make a nonpublic
claims. health claim if the pesticide product bears a
(a) Public health claim. An antimicrobial claim to control microorganisms of economic
pesticide is considered to make a public health or aesthetic significance, where the presence
claim if the pesticide product bears a claim to of the microorganism would not normally lead
control pest microorganisms that pose a to infection or disease in humans. Examples of
threat to human health, and whose presence nonpublic health
cannot readily be observed by the user,
claims Include, but are not limited to: Product performance data must be submitted
Algaecides, slimicides, preservatives and with any application for registration or
products for which a pesticidal claim with amended registration.
respect to odor sources is made. (3) Product performance data for each
§ 158.2210 Product chemistry. product that bears a nonpublic health claim.
The product chemistry data requirements of Each product that bears a nonpublic health
subpart D of this part apply to antimicrobial claim, as described in § 158.2204(b), must be
products covered by this subpart. supported by product performance data. Each
registrant must ensure through testing that his
§ 158.2220 Product performance.
(a) General—(1) Product performance product is efficacious when used in accordance
requirement for all antimicrobial pesticides. with label directions and commonly accepted
Each applicant must ensure through testing practices. The Agency reserves the right to
that his product is efficacious when used in require, on a case-by-case basis, submission of
accordance with label directions and product performance data for any pesticide
commonly accepted pest control practices. product registered or proposed for
The Agency may require, on a case-by-case registration or amendment.
basis, submission of product performance (4) Determination of data requirements.
data for any pesticide product registered or Subpart B of this part and §158.2201 describe
proposed for registration or amendment. how to use the table in paragraph (c) of this
(2) Product performance data for each section to determine the product performance
product that bears a public health claim. Each data requirements for antimicrobial pesticide
product that bears a public health claim, as products.
described in § 158.2204(a), must be supported (b) Key. R = Required; EP = End-use
by product performance data, as listed in the product.
table in paragraph (c) of this section. (c) Antimicrobial product performance
data requirements table. The following table
shows the data requirements for antimicrobial
product performance.
§ 158.2230
870.6300 .... Develop CR .............. CR .............. CR .............. CR .............. CR .............. TGAI ..... TGAI ...... 28, 29, 30
mental
neurotoxi
city.
§ 158.2230
Food uses Nonfood uses Test substance
Guideline Swimming
No. pools,
Data Direct food Indirect food Indirect food aquatic areas, All other
uses uses (>200 uses (<200 wood MP EP Test note No.
requirement ppb) ppb) preservatives, nonfood uses
metal working
fluids
Mutagenicity
870.5100 .... R ................. R .................. R ................ R ................. R ................ TGAI ..... TGAI ...... 31, 32
Reverse
mutation
assay.
870.5300 .... In vitro R ................. R .................. R ................ R ................. R ................ TGAI ..... TGAI ...... 31, 33
870.5375 .... mammali
an gene
mutation.
870.5385 .... In vivo R ................ R .................. R ................ R ................ R ................ TGAI ..... TGAI ...... 31, 34
-d
870.5395 .... cytogenet
bO ics.
Special Testing
870.7485 .... R ................. R .................. CR .............. R ................ CR .............. PA I or PAI or 35, 39
Metabolism PAIRA. PAIRA.
and
pharmaco
kinetics.
Avian Testing
850.2200 .... CR .............. CR .............. CR .............. CR .............. CR .............. TGAI ..... TGAI ...... 4
Avian dietary
toxicity.
850.2300 .... Avian CR .............. CR .............. CR .............. CR .............. CR .............. TGAI ..... TGAI ......
reproduction. 1, 6
§ 158.2240
toxicity.
Acute CR .............. CR .............. CR .............. CR .............. CR .............. TEP .......
freshwater
850.1075 .... fish toxicity.
§ 158.2240
TABLE—ANTIMICROBIAL NONTARGET ORGANISM DATA REQUIREMENTS—Continued
850.1025 .... Acute estua- CR .............. R .................. CR .............. CR .............. CR .............. TGAI ..... TGAI ...... 8, 9
rine and
marine
organism
s toxicity.
850.1035
850.1045
850.1055 .... CR .............. CR .............. CR .............. CR .............. CR .............. TEP .......
rine and
marine
organism
s toxicity.
850.1075 5, 7, 8 10
850.1400 .... Fish early- R ................ R ................. R ................ R ................. R ................ TGAI ..... TGAI ......
life stage.
850.1300 .... Aquatic in- R ................ R ................. R ................ R ................. R ................ TGAI ..... TGAI ...... 10
vertebrate
life-cycle.
850.1350
850.1500 .... Fish life- CR .............. CR .............. CR .............. CR .............. CR .............. TGAI ..... TGAI ...... 11, 12
§ 158.2240
s.
(d) Test notes. The following test notes extent that a potentially toxic amount may
apply to the data requirements in the table to persist in avian feed.
paragraph (c) of this section: iii. The pesticide or any of its major
1. For industrial processes and water metabolites or degradation products are
systems, antifoulant paints and coatings, wood stored or accumulated in plant or animal
preservatives, and aquatic areas, data are tissues, as indicated by the oc- tanol/water
required for two avian species: one waterfowl partition coefficient (Kow is greater than or
species and one upland game bird species. For equal to 1,000), accumulation studies, metabolic
the all other use patterns category (as release and retention studies, or as indicated
specified in § 158.2240(a)(5)), data are required by structural similarity to known
for one avian species. bioaccumulative chemicals.
2. Data are required on one freshwater iv. Any other information, such as that
aquatic invertebrate species. derived from mammalian reproduction
3. For the industrial processes and water studies, indicates that reproduction in
systems, antifoulant paints and coatings, wood terrestrial vertebrates may be adversely
preservatives, and aquatic use pattern areas, affected by the anticipated use of the pesticide
data are required on two species of fish, one product.
cold water species and one warm water 7. TEP testing is required for any product
species. For the all other use patterns category which meets one or more of the following
(as specified in § 158.2240(a)(5)), data are conditions:
required on one species of fish, either one cold i. When based on deterministic modeling
water species or one warm water species. results: If the Estimated Environmental
Testing on a second species is required if the Concentration (EEC) in the aquatic
environment is equal to or greater than one-
active ingredient or principal transformation
half the LC50/EC50 of the TGAI.
products are stable in the environment and the
ii. When based on probabilistic modeling
LC50 in the first species is less than or equal to results: If the estimated 10th percentile 7Q10
1 ppm or 1 mg/L. Surface Water Concentration exceeds the
4. Data are required on one avian species, acute concentration of concern (i.e., one-half
either one waterfowl species or one upland the LC /EC50).
game bird species, if the avian acute oral LD50
50
850.4225 .... CR .............. CR .............. CR .............. CR .............. CR .............. TEP ....... TEP ....... 1, 2
Seedling
emergenc
e, Tier
II— dose
response.
850.4250 .... Vegetative CR .............. NR .............. CR .............. CR .............. CR .............. TEP ....... TEP ....... 1, 3
vigor, Tier
II—dose
response.
850.4400 .... Aquatic plant R ................ R .................. R ................ R ................. CR .............. TGAI, TEP TGAI, TEP 4, 10
growth
(aquatic
vascular
plant)
Tier II—
dose
response.
850.5400 .... Aquatic plant R ................ R .................. R ................ R ................. R ................ TGAI, TEP TGAI, TEP 4, 5, 6
growth
(algal)
Tier II
(dose
response)
.
850.4300 .... T errestrial CR .............. CR .............. CR .............. CR .............. CR .............. TEP ....... TEP ....... 7, 8, 9
field.
850.4450 .... Aquatic field CR .............. CR .............. CR .............. CR .............. CR .............. TEP ....... TEP ....... 7, 8, 9
§ 158.2250
(g) Test notes. The following test notes 9. Protocols must be approved by the
apply to the data requirements in the table to Agency prior to the Initiation of the study.
paragraph (f) of this section: 10. For the all other use patterns category
1. Data on only one plant species (rice, (as specified in § 158.2250(c)), data are
Oryza sativa) are required. required if the aquatic (algal) plant growth Tier
2. Data are required if the risk quotient II study demonstrates detrimental effects at
from any aquatic plant growth Tier II study less than 1.0 ppm or mg/L.
exceeds a level of concern for aquatic plants.
3. Not required when: § 158.2260 Applicator exposure.
i. There are no potential exposures to (a) General. Subpart B of this part and
plants; §158.2201 describe how to use the table in
ii. The hydrolytic half-life is less than 5 days paragraph (d) of this section to determine the
at pH 5, 7, and 9; or applicator exposure data requirements for
iii. The results of a biodegradation study antimicrobial pesticide products. Notes that
indicate that the active ingredient or principal apply to an individual test including specific
degradation products are not biodegradable conditions, qualifications, or exceptions are
in 28 days, i.e., the biodegradation curve has listed in paragraph (e) of this section.
not reached a plateau for at least three (1) The Agency may accept surrogate
determinations within the 28 days. exposure data estimations and/or modeling
4. For TEP testing, data are required for the estimations from other sources to satisfy
applicant’s end-use product if an ingredient in exposure data requirements. The surrogate
the end-use product, other than the active data must meet the basic quality assurance,
ingredient, is expected to enhance the toxicity quality control, good laboratory practice, and
of the active ingredient. other scientific requirements set by EPA. To be
5. One Tier II (dose response) study, acceptable, the Agency must find that the
conducted with Selenastrum surrogate exposure data estimations have
capricornutum, is required for the all other use adequate information to address the
patterns category (as specified in § applicable exposure data requirements and
158.2250(c)). If the results of this study exhibit contain adequate monitoring events of
detrimental effects (EC50 less than 1.0 ppm or acceptable quality. The data must reflect the
mg/L), then additional Tier II (dose response) specific use prescribed on the label and the
studies are required on three species activity of concern, including formulation type,
(Anabaena flos-aquae, Navicula application methods and rates, type of activity,
pelliculosa, and Skeletonema costatum). and other pertinent information.
6. For industrial processes and water (2) Occupational uses include not only
systems, antifoulant coatings and paints, wood handlers, mixers, loaders, and applicators, but
preservatives, and aquatic areas, Tier II (dose also commercial applications to residential
response) studies are required on four species sites. Residential uses are limited to non-
(Anabaena flos-aquae, Navicula occupational, i.e., non-professional,
pelliculosa, antimicrobial applications. Both occupational
Skeletonema costatum, and Selenastrum and residential applicator data may be
capricornutum). required for the same product.
7. Environmental chemistry methods used (b) Criteria for testing. Applicator exposure
to generate data must include the results of a data described in the table to paragraph (d) of
successful confirmatory method trial by an this section are required based on toxicity and
independent laboratory. exposure criteria. Data are required if at least
8. Tests are required on a case-bycase basis one of the toxicity criteria in paragraph (b)(1)
based on the results of lower tier plant of this section, and at least one of the exposure
protection studies, adverse incident reports, criteria in paragraph (b)(2) of this section are
intended use pattern, and environmental fate met.
characteristics that indicate potential exposure.
(1) Toxicity criteria. (i) Evidence of (ii) Respiratory exposure may occur during
potentially significant adverse effects have product use.
been observed in any applicable toxicity (c) Key. R = Required; CR = Conditionally
studies. required; TEP = Typical end- use product.
(ii) Scientifically sound epidemiological or (d) Antimicrobial applicator exposure data
poisoning incident data with a clear cause- requirements table. The following table shows
effect relationship indicating that adverse the data requirements for applicator exposure.
health effects may have resulted from The test notes appear in paragraph (e) of this
exposure to the pesticide. section.
(2) Exposure criteria. (i) Dermal exposure
may occur during product use.
(e) Test notes. The following test notes ment create potential for increased dermal or
apply to the data requirements in the table to inhalation exposure in outdoor versus indoor
paragraph (d) of this section: use sites). In certain cases, when a pesticide
1. Prior to initiation of the study, protocols may be used both indoors and outdoors under
involving intentional exposure of human dissimilar conditions of use, the Agency may
subjects must be submitted for review by EPA require submission of applicator exposure
and then the Human Studies Review Board data for both use patterns.
(HSRB) according to 40 CFR 26.1125. Examples 4. EPA will consider waiving this data
of proposed human study research can be requirement for antimicrobials applied via
found in various reviews provided by the closed loading systems if the antimicrobial has
Human Studies Review Board a low vapor pressure.
(http://www.epa.gov/osa/hsrb/index.htm). 5. Data reporting and calculations are
2. Biological monitoring data may be required only if handler exposure data are
submitted in addition to, or in lieu of, dermal
required.
and inhalation passive dosimetry exposure
data, provided the human pharmacokinetics of § 158.2270 Post-application exposure.
the pesticide or metabolite/analog (a) General. Subpart B of this part and
compounds (i.e., whichever method is selected §158.2201 describe how to use the table in
as an indicator of body burden or internal paragraph (d) of this section to determine the
dose) allow for the back calculation to the total post-application exposure data requirements
internal dose. for antimicrobial pesticide products. The data
3. For products with both indoor and generated during these studies are used to
outdoor uses, and similar conditions of use, determine the quantity of pesticide to which
data are generally required for the indoor people may be exposed after application.
applications only. However, data for outdoor Notes that apply to an individual test, including
uses are required if the Agency expects
specific conditions, qualifications, or
outdoor uses to result in greater exposure than
indoor uses (e.g., higher use rates and exceptions to the designated test, are listed in
application frequency, or longer exposure paragraph (e) of this section.
duration, or application methods/equip
(1) Post-application exposure data are have resulted from exposure to the pesticide.
required when certain toxicity criteria are met (2) Exposure criteria—(i) Outdoor uses. (A)
and the human activities associated with the Occupational human post-application or
pesticide’s use pattern can lead to potential bystander exposure to residues of
adverse exposures. antimicrobial pesticides could occur as the
(2) The Agency may accept surrogate result of, but is not limited to, worker reentry
exposure data estimations and/or modeling into treatment sites, clean-up and equipment
estimations from other sources to satisfy maintenance tasks, handling wood
exposure data requirements. The surrogate preservative- treated wood, or other work-
data must meet the basic quality assurance, related activity.
quality control, good laboratory practice, and (B) Residential human post-application or
other scientific requirements set by EPA. To be bystander exposure to residues of
acceptable, the Agency must find that the antimicrobial pesticides could occur following
surrogate exposure data estimations have the application of antimicrobial pesticides to
adequate information to address the outdoor areas and spaces at residential sites,
applicable exposure data requirements and such as, but not limited to homes, daycare
contain adequate monitoring events of centers, and other public buildings.
acceptable quality. The data must reflect the (ii) Indoor uses. (A) Occupational human
specific use prescribed on the label and the post-application or bystander exposure to
activity of concern, including formulation type, pesticide residues could occur following the
application methods and rates, type of activity, application of the antimicrobial pesticide to
and other pertinent information. indoor spaces or surfaces.
(b) Criteria for testing. Post-application (B) Residential human post-application or
exposure data described in the table to bystander exposure to pesticide residues
paragraph (d) of this section are required could occur following the application of the
based on toxicity and exposure criteria. Data antimicrobial pesticide to indoor spaces or
are required if at least one of the toxicity surfaces at residential sites, such as, but not
criteria in paragraph (b)(1) of this section, and limited to homes, daycare centers, hospitals,
at least one of the exposure criteria in schools, and other public buildings.
paragraph (b)(2) of this section are met. (c) Key. R = Required; CR = Conditionally
(1) Toxicity criteria. (i) Evidence of potentially required; NR = Not required; TEP = Typical
significant adverse effects have been observed end-use product.
in any applicable toxicity studies. (d) Antimicrobial post-application
(ii) Scientifically sound epidemiological or exposure data requirements table. The
poisoning incident data with a clear cause- following table shows the data requirements
effect relationship indicating that adverse for post-application exposure. The test notes
health effects may appear in paragraph (e) of this section.
Use sites
Guideline Test
Data requirement Test note No.
No. occupational Residential substance
(e) Test notes. The following test in the table to paragraph (d) of this notes apply to the
data requirements section:
1. Prior to initiation of the study, 9. Data are required for occupational and
protocols involving intentional exposure of residential uses if there is the potential for
human subjects must be submitted for review bystander exposure and the pesticide use
by EPA and then the Human Studies Review could result in respirable and/or inhalable
Board (HSRB) according to 40 CFR 26.1125. material (e.g., gas, vapor, aerosol, or
Examples of proposed human study research particulates).
can be found in various reviews provided by 10. Data reporting and calculations are
the Human Studies Review Board (HSRB) required only if post-application exposure
(http://www.epa.gov/osa/hsrb/ data are required.
index.htm). § 158.2280 Environmental fate.
2. For residential wood preservative uses, (a) General. Subpart B of this part and
data may be required if soil has the potential §158.2201 describe how to use the table in
to be an important exposure pathway, and soil paragraph (c) of this section to determine the
is in contact with or adjacent to treated wood, environmental fate data requirements for
including but not limited to decks, play sets, antimicrobial pesticide products. Notes that
and gazebos, apply to an individual test including specific
3. Protocols must be approved by the conditions, qualifications, or exceptions are
Agency prior to the initiation of the study. listed in paragraph (d) of this section.
4. For wood preservatives, data are (1) Environmental fate data are required to
required for treated wood surfaces where support the registrations of all end-use and
post-application contact with treated wood is manufacturing-use antimicrobial products.
anticipated. (2) Data on transformation/degrada- tion
5. For occupational uses, data are required products or leachate residues of the parent
if the pesticide may be applied to or around compound are also required to support
surfaces, and if the human activity data registration, if the trans-
indicate that workers are likely to have post- formation/degradation products or leachate
application dermal contact with treated residues meet one of the following criteria:
surfaces while participating in typical activities. (i) More toxic, persistent, or
6. Data are required for residential use sites, bioaccumulative than the parent;
schools, and daycare institutions. This includes (ii) Have been shown to cause adverse
but is not limited to the following: Residential effects in mammalian or aquatic reproductive
and public access premises; material studies; or
preservatives (including those used in (iii) The moiety of concern (i.e., functional
residential products, including but not limited group in the parent chemical molecule that
to clothing and plastic toys) and wood imparts adverse effects) remains intact.
preservatives (when contact with treated wood (3) For the purpose of determining data
is likely to occur). requirements, the all other use patterns
7. Data are required for occupational and category includes the following use patterns:
residential uses if the human activity data (i) Agricultural premises and equipment.
indicate the potential for post-application (ii) Food-handling/storage
dermal and/or inhalation exposures while establishments, premises, and equipment.
participating in typical activities and no (iii) Commercial, institutional and
acceptable modeling options are available. industrial premises and equipment.
8. Biological monitoring data may be (iv) Residential and public access
submitted in addition to, or in lieu of, dermal premises.
and inhalation passive dosimetry exposure (v) Medical premises and equipment.
data provided the human pharmacokinetics of (vi) Human drinking water systems.
the pesticide or metabolite/analog (vii) Materials preservatives.
compounds (i.e., (viii) Swimming pools.
whichever method is selected as an indicator (b) Key. MP = Manufacturing use product;
of body burden or internal dose) allow for a EP = End-use product; R = Required; CR =
back-calculation to the total internal dose. Conditionally required;
NR = Not required; TGAI = Technical grade of (c) Antimicrobial environmental fate data
the active ingredient; TEP = Typical end-use requirements table. The following table shows
product; PAIRA = Pure active ingredient the data requirements for environmental fate.
radiolabeled; ROC = residue of concern. The test notes appear in paragraph (d) of this
section.
Environmental Protection Agency
Use pattern Test substance
Guideline No. Data Industrial All other use Test note No.
requirement processes and Antlfoulant coatings Wood patterns category
Aquatic areas MP EP
water systems and paints preservatives
Degradation Studies—Laboratory
835.2120 ....... Hydrolysis................... R ........................ R......................... R ........................ R ....................... R ....................... TGAI or TGAI or 1
PAIRA. PAIRA.
835.2240 ....... Photodegradation in R ......................... R......................... R ........................ R ....................... R ....................... TGAI or TGAI or
2
water. PAIRA. PAIRA.
835.2410 ....... Photodegradation in soil. NR ...................... NR ..................... R ........................ NR .................... NR .................... TGAI or TGAI or 10
PAIRA. PAIRA.
Toxicity and Fate in Wastewater Systems
850.6800 .......
Activated Sludge,
R ........................ R ........................ R ........................ NR .................... R ........................ TGAI ........... TGAI ........... 21
Respiration Inhibition
Test.
OECD 209.
835.1110 ....... Activated Sludge CR ...................... CR ..................... CR .................... NR .................... CR .................... TGAI ........... TGAI ........... 19, 20
Sorption Isotherm.
CO 835.3110 ....... Ready CR ...................... CR ..................... CR .................... NR .................... CR .................... TGAI ........... TGAI ........... 3, 4, 18
CO Biodegradability.
835.3220 ....... Porous Pot Study ....... CR ...................... CR ..................... CR .................... NR .................... CR .................... TGAI ........... TGAI ........... 3, 18
835.3280 ....... Simulation Tests to CR ...................... CR ..................... CR .................... NR .................... CR .................... TGAI ........... TGAI ........... 3, 18
Assess the
Biodegradability of
Chemicals
Discharged in
Waste- water.
835.3240 ....... Simulation Test— CR ...................... CR ..................... CR .................... NR .................... CR .................... TGAI ........... TGAI ........... 3, 18
Aerobic Sewage
Treatment: A.
Activated Sludge
Units.
Mobility Studies
835.1240
§ 158.2280
Metabolism Studies—Laboratory
835.4300 ....... Aerobic aquatic R ......................... R......................... R ........................ R ....................... CR .................... TGAI or TGAI or 5, 8
metabolism. PAIRA. PAIRA.
835.4400 ....... Anaerobic aquatic R ......................... R......................... R ........................ R ....................... CR .................... TGAI or TGAI or 5, 8
metabolism. PAIRA. PAIRA.
Dissipation Studies—Field
835.6200 Aquatic (sediment) ..... CR ..................... R ........................ CR .................... R ....................... CR .................... TEP ............ TEP ............. 11, 12, 13
None .............. Monitoring of rep- CR ..................... CR ..................... CR .................... CR .................... CR .................... ROC ........... ROC ............ 11, 14, 17
resentatlve U.S.
waters.
Special Studies
CO
O None ...................... Special leaching ......... NR ...................... R......................... R ........................ NR .................... NR .................... TGAI ........... TEP ............. 15, 16
860.1460 ....... Food-handling ............................................................... CR ...................... CR ..................... CR ..................... CR ...................... TEP .................... 3
None ............. Nature of residue on surfaces ....................................... CR ...................... CR ..................... CR ..................... CR ...................... PAIRA or TGAI ... 4
None ............. Migration studies .......................................................... CR ...................... CR ..................... CR ..................... CR ...................... TEP .................... 5
860.1340 ....... Residue analytical method for data collection .............. CR ...................... CR ..................... CR ..................... CR ...................... ROC .................. 6
860.1380 ....... Storage stability ............................................................. R ........................ R ........................ R ........................ R ....................... TEP or ROC ....... 7
860.1300 ....... Nature of the residue in plants ....................................... CR ...................... CR ..................... CR ..................... CR ...................... PAIRA ................ 8
860.1300 ....... Nature of the residue in livestock................................... CR ...................... CR ..................... CR ..................... CR ...................... PAIRA ................ 9
860.1340 ....... Residue analytical methods for tolerance/tolerance CR ...................... CR ..................... CR ..................... CR ...................... ROC ..................
10
exemption enforcement.
860.1360 ....... Multiresidue method testing .......................................... CR ...................... CR ..................... CR ..................... CR ...................... ROC .................. 11
860.1400 ....... Potable water ................................................................ CR ...................... CR ..................... CR ..................... CR ..................... TEP ....................
Subpart A—General
Sec.
164.1 Number of words.
APPEALS (d) The term Agency, unless otherwise
164.100 Appeals from or review of interlocutory specified, means the United States
orders or rulings. Environmental Protection Agency.
164.101 Appeals from or review of initial decisions.
164.102 Appeals from accelerated decisions.
(e) The term Applicant means any person
164.103 Final decision or order on appeal or review. who has made application to have a pesticide
164.110 Motion for reopening hearings; for registered or classified pursuant to the
rehearing; for reargument of any proceeding; provisions of the Act.
or for reconsideration of order. (f) The term Committee means a group of
164.111 procedure for disposition of motions. qualified scientists designated by the National
Subpart C—General Rules of Practice for Academy of Sciences according to agreement
Expedited Hearings under the Act to submit an independent report
164.120 Notification.
to the Administrative Law Judge on questions
164.121 Expedited hearing. of scientific fact referred from a hearing under
164.122 Final order and order of suspension. subpart B of this part.
164.123 Emergency order. (g) Environmental Appeals Board shall
Subpart D—Rules of Practice for mean the Board within the Agency described
Applications Under Sections 3 and 18 To in §1.25 of this title. The Administrator
Modify Previous Cancellation or delegates authority to the Environmental
Suspension Orders Appeals Board to issue final decisions in
appeals filed under subparts B and C of this
164.130 General. part. An appeal directed to the Administrator,
164.131 Review by Administrator.
164.132 procedures governing hearing.
rather than to the Environmental Appeals
164.133 Emergency waiver of hearing. Board, will not be considered. This delegation
does not preclude the Environmental Appeals
AUTHORITY: 7 U.S.C. 136d.
SOURCE: 38 FR 19371, July 20, 1973, unless
Board from referring an appeal or a motion
otherwise noted. under subparts B and C to the Administrator
when the Environmental Appeals Board, in its
Subpart A—General discretion, deems it appropriate to do so.
When an appeal or motion is referred to the
§ 164.1 Number of words. Administrator, all of the parties shall be so
As used In this part, a word In the singular notified and the rules in subparts B and C
form shall be deemed to import the plural, and referring to the Environmental Appeals Board
vice versa, as the case may require. shall be interpreted as referring to the
§ 164.2 Definitions. Administrator.
For the purposes of this part, the following (h) The term Expedited Hearing means a
terms shall be defined, as listed below: hearing commenced as the result of the
(a) The term Act means the Federal issuance of a notice of intention to suspend or
insecticide, Fungicide, and Rodenticide Act, as the suspension of a registration of a pesticide
amended (86 Stat. 973) and other legislation by an emergency order, and is limited to a
supplementary thereto and amendatory consideration as to whether a pesticide
thereof. presents an imminent hazard which justifies
(b) The term Administrative Law Judge such suspension.
means an Administrative Law Judge appointed (i) The term Hearing means a public
pursuant to 5 U.S.C. 3105 (see also 5 CFR part hearing which is conducted pursuant to the
930, as amended), and such term is provisions of chapter 5, subchapter ii of title 5
synonymous with the term ‘‘Hearing of the United States Code and the regulations
Examiner’’ as used in the Act or in the United of this part.
States Code. (j) The term Hearing Clerk means the
(c) The term Administrator means the Hearing Clerk, Environmental Protection
Administrator of the United States Agency, Washington, DC 20460.
Environmental Protection Agency. (k) The term Initial Decision means the
decision of the Administrative Law Judge
supported by findings of fact and conclusions
regarding all material
issues of law, fact, or discretion, as well as poration, and any organized group of persons,
reasons therefor. Such decision shall become whether incorporated or not.
the final decision and order of the (o) The term Petitioner means any person
Administrator without further proceedings adversely affected by a notice of the
unless an appeal therefrom is taken or the Administrator who requests a public hearing.
Administrator orders review thereof as herein (p) The term Presiding Officer means any
provided. person designated by the Administrator to
(l) The term Judicial Officer means an officer conduct an expedited hearing.
or employee of the Agency designated as a (q) The term Recommended Decision
judicial officer, pursuant to these rules, who means the recommended findings and
shall meet the qualifications and perform
conclusions of the Presiding Officer in an
functions as herein provided.
(1) Office. There may be designated for the expedited hearing.
Agency one or more judicial officers, one of (r) The term Registrant means any person
whom may be Chief Judicial Officer. As work who has registered a pesticide pursuant to the
requires, there may be a judicial officer provisions of the Act.
designated to act for the purpose of a (s) The term Respondent means the
particular case. All prior designations of judicial Assistant Administrator of the Office of
officer shall stay in force until further notice. Chemical Safety and Pollution Prevention.
(2) Qualification. A judicial officer shall be a Terms defined in the act and not explicitly
permanent or temporary employee or officer defined herein are used herein with the
of the Agency who may perform other duties meanings given in the act.
for the Agency. Such judicial officer shall not [38 FR 19371, July 20, 1973, as amended at 57 FR
be employed by the Office of Chemical Safety 5342, Feb. 13, 1992; 57 FR 30657, July 10, 1992; 73 FR
and Pollution Prevention or have any 75597, Dec. 12, 2008; 77 FR 46292, Aug. 3, 2012]
connection with the preparation or § 164.3 Scope and applicability of this part.
presentation of evidence for a hearing. The provisions of subpart B of this part shall
(3) Functions. The Administrator may govern proceedings, conducted pursuant to
delegate any or part of his authority to act in a the provisions of the Act, concerning refusals
given case under subparts B and C of this part to register, cancellations of registration,
to a judicial officer. The Administrator can changes of classifications or hearings called by
separately delegate his authority to rule on the Administrator; the provisions of subpart C
interlocutory orders and motions, and may of this part shall govern suspension
also delegate his authority to make findings of proceedings conducted pursuant to the
fact and draw conclusions of law in a particular provisions of the Act.
proceeding, providing that this delegation
shall not preclude the Judicial Officer from § 164.4 Arrangements for examining Agency
referring any motion or case to the records, transcripts, orders, and decisions.
Administrator when the Judicial Officer (a) Reporting of orders, decisions, and
determines such referral to be appropriate. other signed documents. All orders, decisions,
The Administrator, in deciding a case himself, or other signed documents required by the
may consult with and assign the preliminary rules in this part, whether issued by the
drafting of conclusions of law and findings of Environmental Appeals Board or the Presiding
fact to any judicial officer. Officer shall be made available to the public.
(m) The term Party means any person, (b) Establishment of an Agency repository.
group, organization, or Federal agency or In addition, all transcripts and docket entries
department that participates in a hearing. shall become part of the official docket and
(n) The term Person includes any shall be retained by the hearing clerk. At least
individual, partnership, association, cor two copies
of all final orders, decisions and a notification the registrations Included under that docket
of any appeals taken therefrom shall be number, the registration number or file symbol
retained by the hearing clerk and filed of each product which is the subject of the
chronologically and shall be periodically document.
bound and indexed. All the above documents (c) In addition to copies served on all other
shall be made available to the public for parties, each party shall file an original and two
reasonable inspections during Agency copies of all papers with the hearing clerk.
business hours. §164.6 Time.
(c) Whenever any information or data is (a) Computation. In computing any period
required to be produced or examined and any of time prescribed or allowed by these rules,
party to the proceeding claims that such except as otherwise provided, the day of the
information is a trade secret or commercial or act, event, or default from which the
financial information, other than information designated period of time begins to run shall
relating to the formulas of a pesticide, the not be included. Saturdays, Sundays, and legal
Administrative Law Judge, the Presiding holidays shall be included in computing the
Officer, or the Environmental Appeals Board time allowed for the filing of any document or
may require production or testimony in paper, except that when such time expires on
camera and sealed to all but the parties. a Saturday, Sunday, or legal holiday, such
(d) All orders, decisions, or other period shall be extended to include the next
documents made or signed by the following business day.
Administrative Law Judge, the Presiding (b) Enlargement. When by these rules or by
Officer, or the Environmental Appeals Board order of the Administrative Law Judge, the
shall be filed with the hearing clerk. The Presiding Officer, or the Environmental
hearing clerk shall immediately serve all parties Appeals Board, an act is required or allowed to
with a copy of such order, decision, or other be done at or within a specified time, the
document. Administrative Law Judge (before his initial
[38 FR 19371, July 20, 1973, as amended at 57 FR decision is filed), or the Presiding Officer
5342, Feb. 13, 1992] (before his recommended decision is filed), or
§ 164.5 Filing and service. the Environmental Appeals Board (after the
(a) All documents or papers required or Administrative Law Judge’s initial decision or
authorized to be filed, shall be filed with the the presiding officer’s recommended decision
hearing clerk, except as provided otherwise in is filed), for cause shown may at any time in
this part. At the same time that a party files their discretion: with or without motion or
documents or papers with the clerk, it shall notice, order the period enlarged if request
serve upon all other parties copies thereof, therefor, which may be made ex parte, is made
with a certificate of service on each document before the expiration of the period originally
or paper, including those filed with the hearing prescribed or as extended by a previous order;
clerk. If filing is accomplished by mail or on motion made after the expiration of the
addressed to the clerk, filing shall be deemed specified period, permit the act to be done
timely if the papers are postmarked on the due where the failure to act was the result of
date except as to initial filings requesting a excusable neglect. In this connection,
public hearing or responding to a notice of consideration shall be given to the fact that,
intent to hold a hearing, in which case such under the provisions of the act, the
filings must be received by the hearing clerk Administrator must issue his order not later
either within the time required by statute or by than 90 days after the completion of the
the notice of intent to hold a hearing. hearing, unless all parties agree by stipulation
(b) Each document filed, other than papers to extend this period of time pursuant to
commencing a proceeding, shall contain the §164.103.
FIFRA docket number and, if the document (c) Additional time after service by mail. A
affects less than all of prescribed period of time within which a party
is required or permitted
to do an act shall be computed from the time of registrations, all together with the reasons
of service, except that when the service is (including the factual basis therefor), and all
made by mail, 3 days shall be added to the notices of intention by the Administrator to
prescribed period. Such addition for service by hold a hearing, together with the statement of
mail shall not apply in the case of filing initial issues as provided by § 164.20(b) shall be sent
requests for hearings or responding to a notice to the registrant or applicant by registered or
of intent to hold a hearing, in which cases certified mail (return receipt requested), and
statutory filing times will run from the date of published by appropriate announcement in
the return receipt pursuant to §164.8. the FEDERAL REGISTER by the Administrator. The
[38 FR 19371, July 20, 1973, as amended at 57 FR Administrative Law Judge shall cause to be
5342, Feb. 13, 1992] published in the FEDERAL REGISTER by appropriate
announcement, a notice of the filing of any
§ 164.7 Ex parte discussion of proceeding. objections, pursuant to § 164.20(b) or
At no stage of a proceeding shall the responses pursuant to §164.24, and a notice of
Administrator, the members of the the public hearing as provided by §164.80 et
Environmental Appeals Board, the Presiding seq. Said notice of public hearing shall
Officer, or the Administrative Law Judge designate the place where the hearing will be
discuss ex parte the merits of the proceeding held and specify the time when the hearing will
with any party or with any person who has commence. The hearing shall convene at the
been connected with the preparation or place and time announced in the notice, unless
presentation of the proceeding as an amended by subsequent notice published in
advocate, or in an investigative or expert the FEDERAL REGISTER, but thereafter it may be
capacity, or with any representative of such moved to a different place and may be
person, Provided, That the Environmental continued from day to day or recessed to a
Appeals Board, the Presiding Officer, or the later day without other notice than
Administrative Law Judge may discuss the announcement thereof at the hearing.
merits of the case with any such person if all
parties to the proceeding, or their Subpart B—General Rules of Practice
representatives, have been given reasonable Concerning Proceedings (Other
notice and opportunity to be present. Any Than Expedited Hearings)
memorandum or other communication
addressed to the Administrator, the COMMENCEMENT OF PROCEEDING
Environmental Appeals Board, the Presiding § 164.20 Commencement of proceeding.
Officer, or the Administrative Law Judge (a) A proceeding shall be commenced
during the pendency of the proceeding, and whenever a hearing is requested by any
relating to the merits thereof, by or on behalf person adversely affected by a notice of the
of any party, shall be regarded as an argument Administrator of his refusal to register or of his
made in the proceeding. The Administrator, intent to cancel the registration or to change
the Environmental Appeals Board, the the classification of a pesticide. A proceeding
Presiding Officer, or the Administrative Law shall likewise be commenced whenever the
Judge shall cause any such communication to Administrator decides to call a hearing to
be filed with the hearing clerk and served upon determine whether or not the registration of a
all other parties to the proceeding who will be pesticide should be canceled or its
given the opportunity to file an answer thereto. classification changed. Such request or notice
[57 FR 5342, Feb. 13, 1992] of intent to hold a hearing shall be timely filed
§ 164.8 Publication. with the hearing clerk, and the matter shall be
docketed and assigned a FIFRA docket
number.
(b) If a request for a hearing is filed, the
person filing the request shall, at
the same time, file a document stating his relevant allegations of fact concerning the
objections to the Administrator’s refusal to pesticide under consideration. The document
register or his intent to cancel the registration shall indicate the registration number of the
or to change the classification of a pesticide. If pesticide, if applicable, a copy of the currently
a notice of intent to hold a hearing is filed by accepted and/or proposed labeling and a list
the Administrator, he shall, at the same time, of the currently registered or proposed uses of
file a statement of issues. said pesticide.
(c) Upon the filing of any objections or (b) Amendments to objections byleave.
notice of intent to hold a hearing, the Objections may be amended at any time prior
proceeding shall be referred to the Chief to the commencement of the public hearing
Administrative Law Judge by the hearing clerk. by leave of the Administrative Law Judge or by
The Chief Administrative Law Judge shall refer written consent of all parties. The
the proceeding to himself or another Administrative Law Judge shall freely grant
Administrative Law Judge who shall thereafter such leave when justice so requires. If the
be in charge of all further matters concerning Administrative Law Judge determines that
the proceedings, except as otherwise provided additional time is necessary to permit a party
for by order of the Chief Administrative Law to prepare for matters raised by amendments
Judge, the Administrator, or the Environmental to objections, the commencement of the
Appeals Board. hearing shall be delayed for an appropriate
[38 FR 19371, July 20, 1973, as amended at 38 FR period. This subsection shall not permit the
34117, Dec. 11, 1973; 57 FR 5342, Feb. 13, 1992] addition, beyond the statutory deadline, of
§ 164.21 Contents of a denial of registration, notice registered pesticides which are not included in
of intent to cancel a registration, or notice of the objections filed pursuant to paragraph (a)
intent to change a classification. of this section.
(a) Contents. The denial of registration or a (c) Amendments to objections as a matter
notice of intent to cancel a registration or to of right. Objections may be amended as a
change a classification shall be accompanied matter of right within 30 days, or in such time
by the reasons (including the factual basis) for as the Administrator shall designate, after the
the action. Administrator amends his notice of intent to
(b) Amendments to contents of denials cancel a registration, change a classification, or
and notices. Such documents under this his refusal to register a pesticide.
section may be amended or enlarged by the
§ 164.23 Contents of the statement of issues to
Administrator at any time prior to the accompany notice of intent to hold a hearing.
commencement of the public hearing. If the (a) Concise statement required. The
Administrative Law Judge determines that statement of issues by the Administrator shall
additional time is necessary to permit a party set a time in which any person wishing to
to prepare for matters raised by such participate in the hearing shall file a written
amendments, the commencement of the response to the statement of issues as
hearing shall be delayed for an appropriate provided by §164.24. The statement of issues
period. shall include questions as to which evidence
§ 164.22 Contents of document setting forth shall be taken at the hearing. Those questions
objections. may include questions concerning whether a
(a) Concise statement required. Any pesticide’s registration should be canceled or
document containing objections to an order of its classification changed, whether its
the Administrator of his refusal to register, or composition is such as to warrant the claims
his intent to cancel the registration, or change for it, whether its labeling and other material
the classification of a pesticide, shall clearly submitted comply with the requirements of
and concisely set forth such objections and the the Act, whether it will perform its intended
basis for each objection, including function without unreasonable adverse effects
on the environment, and whether, when used APPEARANCES,INTERVENTION, AND
in accordance with widespread and commonly CONSOLIDATION
recognized practice, it will or will not generally § 164.30 Appearances.
cause unreasonable adverse effects on the Representatives. Parties may appear in
environment. person or by counsel or other representative.
(b) Amendment to statement of issues. The Persons who appear as counsel or in a
statement of issues may be amended or representative capacity must conform to the
enlarged by the Administrator at any time standards of ethical conduct required of
prior to the commencement of the public practitioners before the courts of the United
hearing. If the Administrative Law Judge States.
determines that additional time is necessary to
permit a party to prepare for matters raised by § 164.31 Intervention.
amendments or enlargements to the (a) Motion. Any person may file a motion
statement of issues, the commencement of the for leave to intervene in a hearing conducted
hearing shall be delayed for an appropriate under this subpart. A motion must set forth the
period. grounds for the proposed intervention, the
position and interest of the movant in the
§ 164.24 Response to the Administrator’s notice of proceeding and the documents proposed to
intention to hold a hearing.
be filed pursuant to either §164.22 or § 164.24.
Any person wishing to participate in any (b) When filed. A motion for leave to
proceeding commenced pursuant to any intervene in a hearing must ordinarily be filed
notice by the Administrator of intention to prior to the commencement of the first
hold a hearing, shall file with the hearing clerk, prehearing conference. Any motion filed after
within the time set by the Administrator in the that time must contain, in addition to the
notice (in no case less than 30 days from the information set forth in paragraph (a) of this
date of the notice), a written response to the section, a statement of good cause for the
statement of issues which shall include the failure to file the motion prior to the
position and interest of such person with commencement of the first prehearing
respect thereto. If any such person is a conference, and shall be granted only upon a
registrant or an applicant for registration, he finding (1) that extraordinary circumstances
shall also file the registration number of the justify the granting of the motion, or (2) that
pesticide, if applicable, a copy of the currently the intervenor shall be bound by agreements,
accepted and/or proposed labeling and a list arrangements, and other matters previously
of the currently registered or proposed uses of made in the proceeding.
said pesticide. (c) Disposition. Leave to intervene will be
§ 164.25 Filing copies of notification of intent to freely granted but only insofar as such leave
cancel registration or change classification or raises matters which are pertinent to and do
refusal to register, and statement of issues. not unreasonably broaden the issues already
After a copy of the document setting forth presented. if leave is granted, the movant shall
the objections and requesting a public hearing thereby become a party with the full status of
is filed with the hearing clerk or a response to the original parties to the proceedings. if leave
the statement of issues is filed, the hearing is denied, the movant may request that the
clerk shall serve a copy of the document upon ruling be certified to the Environmental
Respondent and the Office of the General Appeals Board, pursuant to §164.100 for a
Counsel of the Agency, Respondent shall, by speedy appeal.
counsel, thereupon file with the hearing clerk (d) Amicus curiae. Persons not parties to
a copy of the appropriate notice of intention the proceedings wishing to file briefs may do
to cancel, the notice of intention to change the so by leave of the Administrative Law Judge
classification or the registration refusal order. granted on motion. A motion for leave shall
identify the interest of the applicant and shall
state the reasons why the proposed amicus
brief Is desirable. Unless all parties otherwise the precepts of the Canons of Judicial Ethics of
consent, an amicus curiae shall file its brief the American Bar Association.
within the time allowed the party whose (d) Power. Subject to review, as provided
position the brief will support. Upon a showing elsewhere in this part, the Administrative Law
of good cause, the Administrator or Judge shall have power to take actions and
Administrative Law Judge may grant decisions in conformity with statute or in the
permission for later filing. interests of justice. The Administrative Law
[38 FR 19371, July 20, 1973, as amended at 57 FR Judge shall not interrupt the recording of the
5342, Feb. 13, 1992] proceedings on the record over the objection
§ 164.32 Consolidation.
of any party.
The Chief Administrative Law Judge, by (e) Absence or change of the
motion or sua sponte, may consolidate two or Administrative Law Judge. In the case of the
more proceedings whenever it appears that absence or unavailability of the Administrative
this will expedite or simplify consideration of Law Judge, or his inability to act, or his removal
the issues. Consolidation shall not affect the by disqualification or withdrawal, the powers
right of any party to raise issues that could and duties to be performed by him under this
have been raised if consolidation had not part in connection with a hearing assigned to
occurred. At the conclusion of proceedings him may, unless otherwise directed by the
consolidated under this section, the Administrator, be assigned to another
Administrative Law Judge shall issue one Administrative Law Judge so designated to act
decision under §164.90 unless one or more of by the Chief Administrative Law Judge, the
the consolidated proceedings have been Administrator or the Environmental Appeals
dismissed pursuant to §164.91. Board.
[38 FR 19371, July 20, 1973, as amended at 38 FR
ADMINISTRATIVE LAW JUDGE 34117, Dec. 11, 1973; 57 FR 5342, Feb. 13, 1992]
§ 164.40 Qualifications and duties of
Administrative Law Judge. PREHEARING PROCEDURES AND
DISCOVERY
(a) Qualifications. The Administrative Law
Judge shall have the qualifications required by § 164.50 Prehearing conference and primary
statute. He shall not decide any matter in discovery.
connection with a proceeding where he has a (a) Purpose of the prehearing conference.
financial interest in any of the parties or a Except as otherwise provided in paragraph (d)
relationship with a party that would make it of this section, the Administrative Law Judge
otherwise inappropriate for him to act. shall, prior to the commencement of the
(b) Disqualification of the Administrative hearing and for the purpose of expediting the
Law Judge. (1) Any party may, by motion made hearing, file with the hearing clerk an order for
to the Administrative Law Judge, as soon as a prehearing conference. More than one such
practicable, request that he disqualify himself conference may be held. such order or orders
and withdraw from the proceeding. The shall direct the parties or their counsel to
Administrative Law Judge shall then rule upon appear at a specified time and place to
the motion and, upon request of the movant, consider:
shall certify an adverse ruling for appeal. (1) The simplification of issues including
(2) withdrawal sua sponte. The listing of specific uses to be contested;
Administrative Law Judge may at any time (2) The necessity or desirability of
withdraw from any proceedings in which he amendments to the objections or statement of
deems himself disqualified for any reason. issues, or any document filed in response
(c) Conduct. The Administrative Law Judge thereto;
shall conduct the proceeding in a fair and (3) The possibility of obtaining stipulations
impartial manner subject to of fact and documents which will avoid
unnecessary delay;
(4) Matters of which official notice may be
taken;
(5) The limitation of the number of expert ference unnecessary, or Impracticable, or upon
and other witnesses; a finding that a prehearing conference would
(6) Procedure at the hearing except as so serve primarily to delay the proceedings rather
provided in § 164.80(a); than to expedite them, the Administrative Law
(7) The use of verified written statements in Judge, on motion or sua sponte, may order
lieu of oral direct testimony; that the prehearing conference not be held. In
(8) The intent of any party to request a these circumstances he may request the
scientific advisory committee as defined in § parties to correspond with him for the purpose
164.2(f); of accomplishing any of the objectives set
(9) The issuance of subpoenas and forth in this section. Such correspondence shall
subpoenas duces tecum for discovery and not be made a part of the record, but the
hearing purposes; Administrative Law Judge shall submit a
(10) A setting of a time and place for the written summary for the record if any action is
public hearing, after giving careful taken.
consideration to the convenience of all the (e) Submission of questions to an advisory
parties, the witnesses, the public interest and committee—(1) General. At any prehearing
the necessity for notice in the FEDERAL REGISTER as conference, or if none is held prior to the
provided by § 164.8; and public hearing, except as herein provided, the
(11) Any other matter that may expedite Administrative Law Judge shall determine
the hearing or aid in the disposition of the whether any party desires that questions of
proceeding. scientific fact be referred to a committee
(b) Primary discovery (Exchange of witness designated by the National Academy of
lists and documents). At a prehearing Sciences.
conference or within some reasonable time set
(2) Preparation of questions. On
by the Administrative Law Judge prior to the
determining an affirmative intent, the
hearing, each party shall make available to the
other parties the names of the expert and Administrative Law Judge shall direct all parties
other witnesses the party expects to call, to file and serve, within a time period subject
together with a brief narrative summary of to his discretion, proposed questions of
their expected testimony and a list of all scientific fact accompanied by reasons
documents and exhibits which the party supporting their submission to said
expects to introduce into evidence. Thereafter, committee. Within 10 days of the service of
witnesses, documents, or exhibits may be such proposed questions, together with their
added and narrative summaries of expected supporting reasons, any party may respond in
testimony amended upon motion by a party. writing to the proposed submission of the
(c) Record of the prehearing conference. questions to the said committee. The
No transcript of any prehearing conference Administrative Law Judge shall determine
shall be made unless a request therefor by one whether or not a reference of questions of
of the parties is granted by the Administrative scientific fact to said committee is necessary or
Law Judge. such party shall bear the cost of the desirable. In the event he decides such
taking of the transcript unless otherwise reference is necessary or desirable, he shall so
ordered by the Administrative Law Judge. The inform the National Academy in writing, and
Administrative Law Judge shall prepare and file shall prepare in his discretion appropriate
for the record a written report of the action questions. If any of the questions prepared are
taken at each conference, which shall not in substance based upon the submissions
incorporate any stipulations or agreements of the parties, the Administrative Law Judge
made by the parties at or as a result of such shall permit any party 10 days after their
conference, all rulings upon matters preparation to respond in writing to the
considered at such conference and proposed submission of said question or
appropriate orders. questions. He shall then determine whether
(d) Unavailability of a prehearing such questions should be referred to the
conference. Upon a finding that circumstances committee.
render a prehearing con
(3) Reference and report. Not less than 30 stantial reason to believe that relevant and
days after he has Informed the National probative evidence may otherwise not be
Academy that questions of scientific fact will be preserved for presentation by a witness at the
referred to it, the Administrative Law Judge hearing.
shall refer the questions of scientific fact as (c) Procedure. (1) Any party to the
prepared. The committee shall report in proceeding desiring discovery shall make a
writing to the Administrative Law Judge within motion or motions therefor. Such a motion
60 days after such referral on these questions shall set forth (i) the circumstances warranting
of scientific fact and the report, its record and the taking of the discovery, (ii) the nature of
any other matter transmitted as provided for the information expected to be discovered and
by the Administrator’s agreement with the (iii) the proposed time and place where it will
National Academy of Sciences shall be made be taken.
public and considered as part of the hearing (2) If the Administrative Law Judge
record. determines the motion should be granted, he
(4) Request and submission subsequent to shall issue an order and appropriate
prehearing conference. At any time before the subpoenas, if necessary, for the taking of such
hearing is closed, the Administrative Law discovery together with the conditions and
Judge or a party by motion may request that terms thereof.
questions of scientific fact not previously
referred be referred, or that questions MOTIONS
previously referred be amended or expanded. § 164.60 Motions.
The Administrative Law Judge may refer such
questions if he finds that good cause exists and (a) General. All motions, except those
that reference of such questions is necessary made orally during the course of a public
or desirable. hearing or as otherwise provided by this part,
shall be in writing and shall state with
[38 FR 19371, July 20, 1973, as amended at 39 FR
11884, Apr. 1, 1974] particularity the grounds therefor, shall set
forth the relief or order sought, and shall be
§ 164.51 Other discovery. filed with the hearing clerk and served on all
(a) General. Except as so provided by § parties.
164.50(b) supra, further discovery, under this (b) Response to motions. Within 10 days
subpart, shall be permitted only upon after service of any motion filed pursuant to
determination by the Administrative Law this part, or within such other time as may be
Judge (1) that such discovery shall not in any fixed by the Administrator, his designee, or the
way unreasonably delay the proceeding, (2) Administrative Law Judge, any party may serve
that the information to be obtained is not and file an answer to the motion. The movant
otherwise obtainable and (3) that such shall, if requested by the Administrator, his
information has significant probative value. designee, or the Administrative Law Judge,
The Administrative Law Judge shall be guided serve and file reply papers within the time set
by the procedures set forth in the Federal by the request.
Rules of Civil Procedure, where practicable, (c) Decision. The Administrative Law Judge
and the precedents thereunder, except that no shall rule upon all motions filed or made prior
discovery shall be undertaken except upon to the filing of his initial or accelerated decision
order of the Administrative Law Judge or upon at the time of filing on ex parte motions or
agreement of the parties. where the movant has stated that no party
(b) Depositions upon oral questions. The objects to the granting of such motion.
Administrative Law Judge shall order
otherwise, such decision shall await the
depositions upon oral questions only upon a
answering papers and reply papers if
showing of good cause and upon a finding
that (1) the information sought cannot be permitted. The Environmental Appeals Board
obtained by alternative methods, or (2) there shall rule upon all motions filed after the filing
is a sub of the initial or accelerated decision. oral
argument of motions will be permitted only if
the
Administrative Law Judge or the has the burden of going forward to present an
Environmental Appeals Board deems it affirmative case for the cancellation or change
necessary. in classification of the registration. in the case
[38 FR 19371, July 20, 1973, as amended at 57 FR of the denial of an application for registration,
5343, Feb. 13, 1992] the applicant shall have the burden of going
forward. in the case of a hearing called by the
SUBPOENAS AND WITNESS FEES
Administrator, the Respondent has the burden
§ 164.70 Subpoenas. of going forward to present an affirmative case
(a) The attendance of witnesses or the as to the statement of issues. The party having
production of documentary evidence may, by the burden of going forward shall have the
subpoena, be required at any designated opportunity to submit evidence on rebuttal.
place of hearing or place of discovery. (b) on all issues arising in connection with
Subpoenas may be issued by the the hearing, the ultimate burden of persuasion
Administrative Law Judge sua sponte or upon shall rest with the proponent of the
a showing by an applicant that evidence registration.
sought for hearing is relevant and material to (c) if any party, other than Respondent,
the issues involved in the hearing or that the after being duly notified, fails to appear at the
sought discovery pursuant to §164.51 meets hearing, he shall be deemed to have
the standards set forth therein. The authorized the Administrative Law Judge to
Administrative Law Judge shall be guided by dismiss the proceeding with or without
the principles of the Federal Rules of Civil prejudice, as the Administrative Law Judge
Procedure in making any order for the may determine, unless a motion excusing the
protection of a witness or the content of the failure to appear has been made and granted.
documents produced. in the event that a party appears at the hearing
(b) Motion for subpoena duces tecum. and no representative of the Agency appears,
Subpoenas for the production of documentary the Administrative Law Judge shall proceed ex
evidence, unless issued by the Administrative parte to hear the evidence of the party:
Law Judge sua sponte, shall be issued only Provided, That failure on the part of
upon a written motion. Such motion shall Respondent to appear at a hearing shall not be
specify, as exactly as possible, the documents deemed to be a waiver of Respondent’s right
desired. to file proposed findings of fact, conclusions of
(c) Service of subpoenas. Subpoenas shall law and orders, to be served with a copy of the
be served as provided by the Federal Rules of Administrative Law Judge’s initial or
Civil Procedure. accelerated decision, and to file exceptions
§ 164.71 Fees of witnesses. with and to submit argument before the
Witnesses summoned before the Administrator with respect thereto.
Administrative Law Judge shall be paid the § 164.81 Evidence.
same fees and mileage that are paid witnesses (a) General. The Administrative Law Judge
in the courts of the United States, and persons shall admit all relevant, competent and
whose depositions are taken, and the persons material evidence, except evidence that is
taking the same, shall be entitled to the same unduly repetitious. Relevant, competent and
fees as are paid for like services in the courts material evidence may be received at any
of the United States. Fees shall be paid by the hearing even though inadmissible under the
party at whose instance the witness appears or rules of evidence applicable to judicial
the deposition is taken. proceedings. The weight to be given evidence
THE HEARINGS shall be determined by its reliability and
§ 164.80 Order of proceeding and burden of proof. probative value. In all hearings the testimony
of witnesses shall be taken orally, except as
(a) At the hearing, the proponent of otherwise provided by these rules or by the
cancellation or change in classification
Administrative Law Judge. Parties, however, of the evidence excluded. If the evidence
shall have the right to crossexamine a witness consists of a document or exhibit, it shall be
who appears at the hearing, provided that inserted in the record in total. In the event the
such cross examination is not unduly Environmental Appeals Board decides that the
repetitious. Administrative Law Judge’s ruling in excluding
(b) Report of a committee of the National the evidence was erroneous and prejudicial,
Academy of Sciences. If questions have been the hearings may be reopened to permit the
submitted to a committee designated by the taking of such evidence, or where appropriate,
National Academy pursuant to § 164.50(e), the the Environmental Appeals Board may
report of the committee, other material that evaluate the evidence and proceed to a final
may be required by the Administrator and a decision.
list of witnesses and evidence relied upon shall (g) Verified statements. With the approval of
be received into evidence and made part of the Administrative Law Judge, a witness may
the record of the hearing. Objections to the insert into the record, as his testimony,
report may also be made part of the record statements of fact or opinion prepared by him
and go to the weight of its evidentiary value. or written answers to interrogatories of
(c) Objections. If a party objects to the counsel, or may submit as an exhibit his
admission or rejection of any evidence or the prepared statement, provided that such
limitation of the scope of any examination or statements or answers must not include legal
cross-examination, he shall state briefly the argument. Before any such statement or
grounds for such objection. The transcript shall answer is read or admitted into evidence the
include any argument or debate thereon, witness shall deliver to the Administrative Law
unless the Administrative Law Judge, with the Judge, the reporter, and opposing counsel a
consent of all parties, orders that such copy of such. The admissibility of the evidence
argument not be transcribed. The ruling and contained in such statement shall be subject to
the reasons given therefor by the the same rules as if such testimony were
Administrative Law Judge on any objection produced in the usual manner and the witness
shall be a part of the transcript. An automatic shall be subject to oral cross-examination on
exception to that ruling will follow. the contents of such statements. Approval for
(d) Exhibits. Except where the such a procedure may be denied when it
Administrative Law Judge finds that the appears to the Administrative Law Judge that
furnishing of copies is impracticable, a copy of the memory or the demeanor of the witness is
each exhibit filed with the Administrative Law of importance.
Judge shall be furnished to each other party. A [38 FR 19371, July 20, 1973, as amended at 40 FR
true copy of an exhibit may, in the discretion 25815, June 19, 1975; 57 FR 5343, Feb. 13, 1992]
of the Administrative Law Judge, be § 164.82 Transcripts.
substituted for the original. (a) Filing and certification. Hearings shall be
(e) Official Notice. Official notice may be stenographically reported, transcribed and
taken of Agency proceedings, any matter made available to the public as required by
judicially noticed in the Federal courts, and of statute or Agency regulations. As soon as
other facts within the specialized knowledge practicable after the taking of the last
and experience of the Agency. Any active party evidence, the Administrative Law Judge shall
shall be given adequate opportunity to show certify (1) that the original transcript is a true
that such facts are erroneously noticed by transcript of the testimony offered or received
presenting evidence to the contrary. at the hearing, except in such particulars as he
(f) Offer of proof. Whenever evidence is shall specify and (2) that the exhibits
deemed inadmissible, the party offering such accompanying the transcript are all the
evidence may make an offer of proof, which exhibits introduced at the hearing, with such
shall be included in the transcript. The offer of exceptions as he shall specify. A copy of
proof for excluded oral testimony shall consist
of a brief statement describing the nature
(3) Failure to comply with prehearing
orders;
(4) Failure to appear or to proceed at
prehearing conferences;
INITIAL OR ACCELERATED DECISION (5) Failure to appear at the hearing;
§ 164.90 Initial decision. (6) Failure to state a claim upon which relief
(a) Proposed findings of fact, conclusions, can be granted, or direct or collateral estoppel.
and order. Within 20 days after the last (7) Theat there is no genuine issue of any
evidence is taken in a hearing, each party may material fact and that the respondent is
file with the hearing clerk proposed orders, entitled to judgment as a matter of law; or
findings of fact, and conclusions of law based (8) Such other and further reasons as are
solely on the record, and a brief in support just.
thereof. Within 10 days thereafter, each party (b) Effect. A decision rendered under this
may file a reply brief. The Administrative Law section shall have the same force and effect as
Judge may, in his discretion, extend the total an initial decision entered under §164.90.
time period for filing any proposed findings, APPEALS
conclusions, orders or briefs for an additional
§ 164.100 Appeals from or review of interlocutory
30 days. In such instances, briefs and replies orders or rulings.
shall be due at such time as the Administrative Except as provided herein, appeals as a
Law Judge may fix by order. The hearing shall matter of right shall lie to the Environmental
be deemed closed at the conclusion of the Appeals Board only from an initial or
briefing period. accelerated decision of the Administrative Law
(b) Initial decision. The Administrative Law Judge. Appeals from other orders or rulings
Judge, within 25 days after the close of the shall, except as provided in this section, lie only
hearing, shall evaluate the record before him, if the Administrative Law Judge certifies such
and prepare and file his initial decision with the orders or rulings for appeal, or otherwise as
hearing clerk. A copy of the initial decision provided. The Administrative Law Judge may
shall be served upon each of the parties, and certify an order or ruling for appeal to the
the hearing clerk shall immediately transmit a Environmental Appeals Board when: (a) The
copy to the Environmental Appeals Board. The order or ruling involves an important question
initial decision shall become the decision of of law or policy about which there is
the Environmental Appeals Board without substantial ground for difference of opinion;
further proceedings unless an appeal is taken and (b) either (1) an immediate appeal from
from it or the Environmental Appeals Board the order and ruling will materially advance the
orders review of it, pursuant to §164.101.
ultimate termination of the proceeding or
[38 FR 19371, July 20, 1973, as amended at 57 FR (2) review after the final judgment is issued
5343, Feb. 13, 1992] will be inadequate or ineffective. The
Administrative Law Judge shall certify orders or
§ 164.91 Accelerated decision. rulings for appeal only upon the request of a
(a) General. The Administrative Law Judge, party. If the Environmental Appeals Board
in his discretion, may at any time render an determines that certification was improvidently
accelerated decision in favor of Respondent as granted, or takes no action within thirty (30)
to all or any portion of the proceeding, days of the certification, the appeal shall be
including dismissal without further hearing or deemed dismissed. When an order or ruling is
upon such limited additional evidence such as not certified by the Administrative Law Judge,
affidavits as he may receive, under any of the it shall be reviewed by the Environmental
following conditions: Appeals Board only upon appeal from the
(1) Untimely or insufficient objections filed initial or accelerated decision except when the
pursuant to §164.20; Environmental Appeals
(2) Failure to comply with discovery orders;
Board determines, upon request of a party and trator 30 days from the date of filing of the
in exceptional circumstances, that delaying Administrative Law Judge’s initial decision.
review would be deleterious to vital public or Within 10 days after said notification, the
private interests. Except in extraordinary Environmental Appeals Board shall issue an
circumstances proceedings will not be stayed order either declining review of the initial
pending an interlocutory appeal; where a stay decision or expressing its intent to review said
is granted, a stay of more than 30 days must initial decision. Such order may include a
be approved by the Environmental Appeals statement of issues to be briefed by the parties
Board. Ordinarily, the interlocutory appeal will and a time schedule concerning service and
be decided on the basis of the submission filing of briefs adequate to allow the
made to the Administrative Law Judge, but the Environmental Appeals Board to issue a final
Environmental Appeals Board may allow order within 90 days from the close of the
further briefs and oral argument. hearing.
[57 FR 5343, Feb. 13, 1992] (c) Argument before the Environmental
§ 164.101 Appeals from or review of initial Appeals Board. (1) A party, if he files exceptions
decisions. and a brief, shall state in writing whether he
(a) Exceptions and request for oral desires to make an oral argument thereon
argument. (1) Within 20 days after the filing of before the Environmental Appeals Board;
the Administrative Law Judge’s initial decision, otherwise, he shall be deemed to have waived
each party may take exception to any matter such oral argument. The Environmental
set forth in such decision or to any adverse Appeals Board shall, however, on its own
order or ruling to which he objected during the initiative, have the right to set an appeal for
hearing and may appeal such exceptions to oral argument.
the Environmental Appeals Board for decision (2) If the Environmental Appeals Board
by filing them in writing with the hearing clerk, determines that additional exceptions should
including a section containing proposed be argued, counsel for the parties shall be
findings of fact, conclusions, orders, or rulings. given reasonable written notice of such
Within the same period of time each party determination so as to permit preparation of
filing exceptions and amicus curiae shall file adequate argument on all of the exceptions to
with the hearing clerk a brief concerning each be argued.
of the exceptions being appealed. The party [38 FR 19371, July 20, 1973, as amended at 57 FR
shall include, in its brief, page references to the 5343, Feb. 13, 1992]
relevant portions of the record and to the § 164.102 Appeals from accelerated decisions.
Administrative Law Judge’s initial decision.
(2) Within 7 days of the service of (a) Within 20 days after filing of an
exceptions, and of a brief under paragraph accelerated decision by the Administrative Law
(a)(1) of this section, any other party or amicus Judge, any party may file exceptions and a
curiae may file and serve a brief responding to supporting brief with the hearing clerk, stating
exceptions or arguments raised by any other with particularity the grounds upon which he
party. Such brief shall include references to the asserts that the decision is incorrect. The party
relevant portions of the record. Such brief shall shall include in its brief page references to the
not, however, raise additional exceptions. relevant portions of the record, if applicable.
(3) Five copies of all material filed under (b) Within 7 days of the service of
this section shall be filed with the hearing clerk. exceptions and brief under paragraph (a) of
(b) Review by Administrator when no this section, any other party or amicus curiae
exceptions are filed. If no exceptions are filed may file and serve a brief responding thereto,
within the time provided, the hearing clerk with appropriate page references to the
shall notify the Adminis relevant portions of the record, if applicable.
(c) Ordinarily, the appeal from an
accelerated decision will be decided on the
basis of the submission of briefs, but the
Environmental Appeals Board
to, and heard by, the Environmental Appeals
Board. Motions under this section directed to
the Administrator will not be considered,
[38 FR 19371, July 20, 1973, as amended at 57 FR
5343, Feb. 13, 1992]
except in cases that the Environmental Appeals
Board has referred to the Administrator
§ 164.103 Final decision or order on appeal or pursuant to § 164.2(g) and in which the
review. Administrator has issued the final order. A
Within 90 days after the close of the hearing motion for reconsideration shall not stay the
or within 90 days from the filing of an effective date of the final order unless
accelerated decision, unless otherwise specifically so ordered by the Environmental
stipulated by the parties, the Environmental Appeals Board.
Appeals Board shall, on appeal or review from [38 FR 19371, July 20, 1973, as amended at 57 FR
an initial or accelerated order of the 5343, Feb. 13, 1992]
Administrative Law Judge, issue its final
decision and order, including its rulings on any § 164.111 Procedure for disposition of
motions.
exceptions filed by the parties; such final order
may accept or reject all or part of the initial or Within 7 days following the service of any
accelerated decision of the Administrative Law motion provided for in §164.110, any other
Judge even if acceptable to the parties. party to the proceeding may file with the
[57 FR 5343, Feb. 13, 1992] hearing clerk an answer thereto. As soon as
practicable thereafter, the Environmental
§ 164.110 Motion for reopening hearings; for Appeals Board shall announce its decision
rehearing; for reargument of any proceeding; whether to grant or to deny the motion. Unless
or for reconsideration of order.
the Environmental Appeals Board shall
(a) Filing; service. A motion for reopening determine otherwise, operation of the order
the hearing to take further evidence, or for shall not be stayed pending the decision to
rehearing or reargument of any proceeding or grant or to deny the motion. In the event that
for reconsideration of the order, must be made any such motion is granted by the
by motion to the Environmental Appeals Environmental Appeals Board, the applicable
Board filed with the hearing clerk. Every such rules of practice, as set out elsewhere herein,
motion must state specifically the grounds shall be followed.
relied upon.
(b) Motion to reopen hearings. A motion to [38 FR 19371, July 20, 1973, as amended at 57 FR
reopen a hearing to take further evidence may 5344, Feb. 13, 1992]
be filed at any time prior to the issuance of the
Administrator’s final order. Every such motion Subpart C—General Rules of
shall state briefly the nature and purpose of Practice for Expedited Hearings
the evidence to be adduced, shall show that § 164.120 Notification.
such evidence is not merely cumulative, and (a) Whenever the Administrator
shall set forth good reason why such evidence determines that action is necessary to prevent
was not adduced at a hearing. an imminent hazard during the time required
(c) Motions to rehear or reargue for cancellation or change in classification
proceedings, or to reconsider final orders. A proceedings, but that the hazard does not
motion to rehear or reargue the proceeding or constitute an emergency, he shall notify the
to reconsider the final order shall be filed registrant of his intention to suspend
within 10 days after the date of service of the registration of the pesticide at issue.
final order. Every such motion must state (b) Such notice shall include findings
specifically the matters claimed to have been pertaining to the question of imminent hazard
erroneously decided, and alleged errors must and shall either be personally served on the
be briefly stated. Motions to rehear or reargue registrant or be sent to the registrant by
proceedings or to reconsider final orders shall registered or certified mail, return receipt
be directed requested, and filed with the hearing clerk.
§ 164.121 Expedited hearing. (2) A movant denied permission to
(a) Request. (1) An expedited hearing shall intervene under this section but who otherwise
be held whenever the Administrator has meets the standards of §164.31 and who is
received from the registrant a timely request adversely affected may file proposed findings
for such hearing in response to the and conclusions and briefs in support thereof
Administrator’s notice of intention to suspend. pursuant to paragraph (j) of this section. Any
(2) A request for an expedited hearing is person filing under this subsection shall be
timely if made in writing or by telegram and deemed to have been a party to the
filed with the office of the hearing clerk within proceeding, for all purposes of its further
5 days of the registrant’s receipt of the notice review.
of intention to suspend. (3) When an ‘‘emergency order’’ is issued
(3) At the time of filing a request for an pursuant to §164.123, no person other than the
expedited hearing, the registrant shall also file
respondent and the registrant shall participate
a document setting forth objections to the
Administrator’s notice of intention to suspend in the hearing except that any person adversely
and its findings pertaining to the question of affected may file proposed findings and
imminent hazard. Such objections shall conclusions and briefs in support thereof
conform to the requirements of §164.21. pursuant to paragraph (j) of this section. Any
(b) Presiding officer. (1) An expedited person filing under this subsection shall be
hearing shall be conducted by a presiding deemed to have been a party to the
officer appointed by the Administrator, and proceeding for all purposes of its further
such officer need not be an Administrative Law review.
Judge. (f) Appearances and consolidation. The
(2) The presiding officer shall not have the provisions of §§164.30 and 164.32 apply to an
authority to make an initial decision on the expedited hearing insofar as may be
merits but shall make a recommended practicable.
decision only. (g) Order of proceeding and burden of
(c) The issue. The expedited hearing shall proof. At the hearing, the proponent of
address only the issue of whether an imminent suspension shall have the burden of going
hazard exists. forward to present an affirmative case for the
(d) Time of hearing. The hearing shall suspension. However, the ultimate burden of
commence within 5 days after the filing of the persuasion shall rest with the proponent of the
request with the office of the hearing clerk registration.
unless the registrant and respondent agree
(h) Evidence. The provisions of §164.81,
that it shall commence at a later time. As soon
as possible, the presiding officer shall publish where applicable, apply to an expedited
in the FEDERAL REGISTER notice of such hearing. hearing.
(e) Intervention. Any person adversely (i) Transcripts. The presiding officer shall
affected by the Administrator’s notice may make provision for daily transcripts and
move to intervene within 5 days after the otherwise comply with the provisions of
receipt by the registrant of said notice or at any §164.82.
time prior to the conclusion of the (j) Proposed findings or conclusions;
presentation of the evidence, upon good recommended decision. (1) Within 4 days of
cause found, except the conclusion of the presentation of evidence,
(1) Leave to intervene will be granted only the parties may propose findings and
if the motion to intervene meets the standards conclusions to the Presiding Officer. Such
of §164.31 and, in addition, indicates that the proposed findings and conclusions shall be
movant would raise matters or introduce accompanied by a brief with supporting
evidence pertinent to the issue of imminent reasons.
hazard which would substantially assist in its (2) Within 8 days of the conclusion of the
resolution. presentation of evidence, the Presiding Officer
shall submit to the parties his proposed
recommended findings and conclusions and a
statement of the reasons on which they are
based.
(3) Within 10 days of the conclusion of the Subpart D—Rules of Practice for
presentation of evidence the Presiding Officer Applications Under Sections 3 and
shall submit to the Environmental Appeals 18 To Modify Previous Cancellation
Board his recommended findings and or Suspension Orders
conclusions, together with the record.
(4) Within 12 days of the conclusion of the AUTHORITY: Sec. 25(a) and 6 of the Federal
presentation of evidence the parties shall Insecticide, Fungicide, and Rodenticide Act, as
submit to the Environmental Appeals Board amended by the Federal Environmental Pesticide
their objections to the Presiding Officer’s Control Act of 1972 (86 Stat. 997).
recommended findings and conclusions and SOURCE: 40 FR 12265, Mar. 18, 1975, unless
written briefs in support thereof. otherwise noted.
§ 164.130 General.
[38 FR 19371, July 20, 1973, as amended at 57 FR
5344, Feb. 13, 1992]
EPA has determined that any application
under section 3 or section 18 of the Act to
§ 164.122 Final order and order of suspension. allow use of a pesticide at a site and on a pest
(a) Final order. Within 7 days of receipt of for which registration has been finally
the record and of the Presiding Officer’s cancelled or suspended by the Administrator
recommended findings and conclusions, the constitutes a petition for reconsideration of
Environmental Appeals Board shall issue a final such order. Because of the extensive notice
decision and order. Such final order may and hearing opportunities mandated by FIFRA
accept or reject in whole or in part the and the Administrative Procedures Act before
recommendations of the Presiding Officer. a final cancellation or suspension order may be
(b) Order of suspension. No final order of issued, EPA has determined that such orders
suspension shall be issued unless the may not be reversed or modified without
Environmental Appeals Board has issued or at affording interested parties— who may in fact
have participated in lengthy cancellation
the same time issues a notice of its intention to
proceedings— similar notice and hearing
cancel the registration or change the opportunities. The procedures set forth in this
classification of the pesticide. Such notice shall subpart D shall govern all such applications.
be given as provided in §164.8.
§ 164.131 Review by Administrator.
[38 FR 19371, July 20, 1973, as amended at 57 FR (a) The Administrator will review
5344, Feb. 13, 1992] applications subject to this subpart D and
§ 164.123 Emergency order. supporting data submitted by the applicant to
(a) Whenever the Environmental Appeals determine whether reconsideration of the
Board determines that an emergency exists Administrator’s prior cancellation or
that does not permit him to hold a hearing suspension order is warranted. The
before suspension, the Environmental Appeals Administrator shall determine that such
Board may issue a suspension order in reconsideration is warranted when he finds
advance of notification to the registrant. that: (1) The applicant has presented
(b) The Environmental Appeals Board shall substantial new evidence which may materially
immediately notify the registrant of the affect the prior cancellation or suspension
suspension order. The registrant may then order and which was not available to the
request a hearing in accordance with §§164.121 Administrator at the time he made his final
and 164.122, but the suspension order shall cancellation or suspension determination and
(2) such evidence could not, through the
remain in effect during the hearing pending
exercise of due diligence, have been
the issuance of a final order on suspension. discovered by the parties to the cancellation or
suspension proceeding prior to the issuance of
the final order.
(b) If after review of the application and granting of a particular petition for use may
other supporting data submitted by the not in itself pose a significant risk to man or the
applicant, the Administrator determines, in environment, but the cumulative impact of
accordance with paragraph (a) of this section, each additional use of the cancelled or
that reconsideration of his prior order is not suspended pesticide may re-establish, or serve
warranted, then the application will be denied to maintain, the significant risks previously
without requirement for an administrative found by the Administrator.
hearing. The Administrator shall publish notice (b) The presiding officer shall make
in the FEDERAL REGISTER of the denial briefly recommendations, including findings of fact
describing the basis for his determination as and conclusions and to the extent feasible, as
soon as practicable. such denial shall
determined by the presiding officer, the
constitute final agency action.
(c) If after review of the application and procedures at the hearing shall follow the
other supporting data submitted by the Rules of Practice, set forth in subparts A and B
applicant, the Administrator determines, in of this part 164.
accordance with paragraph (a) of this section, §164.133 Emergency waiver of hearing.
that reconsideration of his prior order is
warranted, he will then publish notice in the (a) In the case of an application subject to
FEDERAL REGISTER setting forth his determination this subpart D which is filed under section 18
and briefly describing the basis for the of FIFRA, and regulations thereunder, and for
determination. such notice shall announce that which a hearing is required pursuant to
a formal public hearing will be held in §164.131, the Administrator may dispense with
accordance with 5 U.S.C. section 554. The the requirement of convening such a hearing
notice shall specify: (1) The date on which the in any case in which he determines:
hearing will begin and end, (2) the issues of (1) That the application presents a situation
fact and law to be adjudicated at the hearing, involving need to use the pesticide to prevent
(3) the date on which the presiding officer shall an unacceptable risk:
submit his recommendations, including
(i) To human health, or (ii) to fish or wildlife
findings of fact and conclusions, to the
Administrator, and (4) the date on which a populations when such use would not pose a
decision by the Administrator is anticipated. human health hazard; and
(2) That there is no other feasible solution
§ 164.132 Procedures governing hearing. to such risk; and
(a) The burden of proof in the hearing (3) That the time available to avert the risk
convened pursuant to §164.131 shall be on the to human health or fish and wildlife is
applicant and he shall proceed first. The issues
in the hearing shall be whether: (1) substantial insufficient to permit convening a hearing as
new evidence exists and (2) such substantial required by § 164.131; and
new evidence requires reversal or modification (4) That the public interest requires the
of the existing cancellation or suspension granting of the requested use as soon as
order. The determination of these issues shall possible.
be made taking into account the human and (b) Notice of any determination made by
environmental risks found by the the Administrator pursuant to paragraph (a) of
Administrator in his cancellation or suspension this section shall be published in the FEDERAL
determination and the cumulative effect of all REGISTER as soon as practicable after granting
past and present uses, including the requested the requested use and shall set forth the basis
use, and uses which may reasonably be for the Administrator’s determination.
anticipated to occur in the future as a result of
granting the requested reversal or
modification. The
PART 165—PESTICIDE 165.97 States with existing containment programs.
MANAGEMENT AND DISPOSAL AUTHORITY: 7 U.S.C. 136 through 136y.
SOURCE: 71 FR 47422, Aug. 16, 2006, unless
Subpart A—General otherwise noted.
Sec.
165.1 Scope. Subpart A—General
165.3 Definitions.
165.4-165.19 [Reserved] § 165.1 Scope.
Subpart B—Nonrefillable Container The part 165 regulations establish standards
Standards: Container Design and and requirements for pesticide containers,
Residue Removal repackaging pesticides, and pesticide
165.20 General provisions. containment structures.
165.23 Scope of pesticide products included. § 165.3 Definitions.
165.25 Nonrefillable container standards. Terms used in this part have the same
165.27 Reporting and recordkeeping. meaning as in the Act and part 152 of this
165.28-165.39 [Reserved] chapter. in addition, as used in this part, the
Subpart C—Refillable Container Standards: following terms shall have the meanings set
Container Design forth below.
165.40 General provisions. Act means the Federal Insecticide,
165.43 Scope of pesticide products included. Fungicide, and Rodenticide Act.
165.45 Refillable container standards. Agricultural pesticide means any pesticide
165.47 What information must I report about my product labeled for use in or on a farm, forest,
refillable containers? nursery, or greenhouse.
165.48-165.59 [Reserved]
Appurtenance means any equipment or
Subpart D—Standards for Repackaging device which is used for the purpose of
Pesticide Products into Refillable transferring a pesticide from a stationary
Containers pesticide container or to any refillable
165.60 General provisions. container, including but not limited to, hoses,
165.63 Scope of pesticide products included. fittings, plumbing, valves, gauges, pumps and
165.65 Registrants who distribute or sell pesticide metering devices.
products in refillable containers.
165.67 Registrants who distribute or sell pesticide Capacity means, as applied to containers,
products to refillers for repackaging. the rated capacity of the container.
165.70 Refillers who are not registrants. Container means any package, can, bottle,
165.71-165.79 [Reserved] bag, barrel, drum, tank, or other containing-
Subpart E—Standards for Pesticide device (excluding any application tanks) used
Containment Structures to enclose a pesticide. Containers that are
used to sell or distribute a pesticide product
165.80 General provisions.
165.81 Scope of stationary pesticide containers
and that also function in applying the product
included. (such as spray bottles, aerosol cans and
165.82 Scope of pesticide dispensing areas containers that become part of a direct
included. injection system) are considered to be
165.83 Definition of new and existing structures. containers for the purposes of this part.
165.85 Design and capacity requirements for new Containment pad means any structure that
structures. is designed and constructed to intercept and
165.87 Design and capacity requirements for
existing structures. contain pesticides, rinsates, and equipment
165.90 Operational, inspection and maintenance wash water at a pesticide dispensing area.
requirements for all new and existing Containment structure means either a
containment structures. secondary containment unit or a containment
165.92 What if I need both a containment pad and a pad.
secondary containment unit?
165.95 What recordkeeping do I have to do as a
facility owner or operator?
Custom blending means the service of tainers are considered to be nonrefill- able
mixing pesticides to a customer’s containers.
specifications, usually a pesticide(s)-fer- One-way valve means a valve that is
tilizer(s), pesticide-pesticide, or a pesticide- designed and constructed to allow virtually
animal feed mixture, when: unrestricted flow in one direction and no flow
(1) The blend is prepared to the order of in the opposite direction, thus allowing the
the customer and is not held in inventory by withdrawal of material from, but not the
the blender; introduction of material into, a container.
(2) The blend is to be used on the Operator means any person in control of, or
customer’s property (including leased or having responsibility for, the daily operation of
rented property); a facility at which a containment structure is
(3) The pesticide(s) used in the blend bears located.
end-use labeling directions which do not Owner means any person who owns a
prohibit use of the product in such a blend; facility at which a containment structure is
(4) The blend is prepared from registered required.
pesticides; and Pesticide compatible as applied to
(5) The blend is delivered to the enduser containers means that the container
along with a copy of the end-use labeling of construction materials will not chemically react
each pesticide used in the blend and a with the formulation. A container is not
statement specifying the composition of the compatible with the formulation if, for
mixture. example, the formulation:
Dilutable means that the pesticide product’s (1) Is corrosive to the container;
labeling allows or requires the pesticide (2) Causes softening, premature aging, or
product to be mixed with a liquid diluent prior embrittlement of the container;
to application or use. (3) Otherwise causes the container to
Dry pesticide means any pesticide that is in weaken or to create the risk of discharge;
solid form and that has not been combined (4) Reacts in a significant chemical,
with liquids; this includes formulations such as electrolytic, or galvanic manner with the
dusts, wet- table powders, dry flowables, container, or
water- soluble powders, granules, and dry (5) Interacts in a way, such as the active
baits. ingredient permeating the container wall, that
Establishment means any site where a would cause the formulation to differ from its
pesticidal product, active ingredient, or device composition as described in the statement
is produced, regardless of whether such site is required in connection with its registration
independently owned or operated, and under FIFRA section 3.
regardless of whether such site is domestic and Pesticide compatible as applied to
producing a pesticidal product for export only, containment means that the containment
or whether the site is foreign and producing construction materials are able to withstand
any pesticidal product for import into the anticipated exposure to stored or transferred
United States. substances without losing the capability to
Facility means all buildings, equipment, provide the required containment of the same
structures, and other stationary items which or other substances within the containment
are located on a single site or on contiguous area.
or adjacent sites and which are owned or Pesticide dispensing area means an area in
operated by the same person (or by any which pesticide is transferred out of or into a
person who controls, who is controlled by, or container.
who is under common control with such Portable pesticide container means a
person). refillable container that is not a stationary
Nonrefillable container means a container pesticide container.
that is not a refillable container and that is Produce means to manufacture, prepare,
designed and constructed for one-time use propagate, compound, or process any
and is not intended to be filled again with a pesticide, including any pesticide produced
pesticide for sale or distribution. pursuant to section 5 of the
Reconditioned con
Act, and any active Ingredient or device, or to van, tractor, truck, semitrailer, tank car or rail
package, repackage, label, relabel, or car used for the transportation of cargo by any
otherwise change the container of any mode.
pesticide or device. Washwater means the liquid resulting from
Producer means any person, as defined by the rinsing of the exterior of any equipment or
the Act, who produces any pesticide, active containers that have or may have come in
ingredient, or device (including packaging, direct contact with any pesticide or system
repackaging, labeling and relabeling). maintenance compound, such as oil or
Refillable container means a container that antifreeze.
is intended to be filled with pesticide more [71 FR 47422, Aug. 16, 2006, as amended at 73 FR
than once for sale or distribution. 64224, Oct. 29, 2008]
Refiller means a person who engages in the
activity of repackaging pesticide product into §§ 165.4-165.19 [Reserved]
refillable containers. This could include a
registrant or a person operating under Subpart B—Nonrefillable Con
contract to a registrant. tainer Standards: Container Design
Refilling establishment means an and Residue Removal
establishment where the activity of § 165.20 General provisions.
repackaging pesticide product into refill- able (a) What is the purpose of the regulations
containers occurs. in this subpart? The regulations in this subpart
Repackage means, for the purposes of this establish design and construction
part, to transfer a pesticide formulation from requirements for nonrefill- able containers
one container to another without a change in used for the distribution or sale of some
the composition of the formulation, the pesticide products.
labeling content, or the product’s EPA (b) Do I have to comply with the
registration number, for sale or distribution. regulations in this subpart? You must comply
Rinsate means the liquid resulting from the with the regulations in this subpart if you are a
rinsing of the interior of any equipment or registrant who distributes or sells a pesticide
container that has come in direct contact with product in nonrefill- able containers. If your
any pesticide. pesticide product is subject to the regulations
Runoff means surface water leaving the in this subpart as set out in §165.23, your
target site. pesticide product must be distributed or sold
Secondary containment unit means any in a nonrefillable container that meets the
structure, including rigid diking, that is standards of these regulations.
designed and constructed to intercept and (c) When do I have to comply? Any
contain pesticide spills and leaks and to pesticide product packaged in a nonrefill- able
prevent runoff and leaching from stationary container and released for shipment by you
pesticide containers. after August 16, 2009 must be packaged in a
Stationary pesticide container means a nonrefillable container that complies with the
refillable container that is fixed at a single regulations of this subpart.
facility or establishment or, if not fixed, remains
at the facility or establishment for at least 30 [71 FR 47422, Aug. 16, 2006, as amended at 73 FR
consecutive days, and that holds pesticide 64225, Oct. 29, 2008]
during the entire time. § 165.23 Scope of pesticide products included.
Suspension concentrate means a stable
suspension of solid particulate active (a) Are manufacturing use products
ingredients in a liquid intended for dilution
subject to the regulations in this subpart? No,
the regulations in this subpart do not apply to
with water before use.
manufacturing use products, as defined in §
Tamper-evident device means a device
158.153(h) of this chapter.
which can be visually inspected to determine if
(b) Are plant-incorporated protectants
a container has been opened.
Transport vehicle means a cargo-carrying subject to the regulations in this subpart? No,
the regulations in this subpart do
vehicle such as an automobile,
not apply to plant-incorporated protectants, (1) EPA may determine that an antimicrobial
as defined in §174.3 of this chapter. pesticide product otherwise exempted by
(c) Which antimicrobial pesticide products paragraph (c) of this section must be subject
are not subject to the regulations in this to the nonrefill- able container regulations in
subpart? The regulations in this subpart do not this subpart to prevent an unreasonable
apply to a pesticide product if it satisfies all of adverse effect on the environment if all of the
the following conditions: following conditions exist:
(1) The pesticide product meets one of the (1) EPA obtains information, data or other
following two criteria: evidence of a problem with the containers of a
(1) The pesticide product is an antimicrobial certain pesticide product or related group of
pesticide as defined in FIFRA section 2(mm); or products.
(ii) The pesticide product: (A) Is intended (ii) The information, data or other
to: disinfect, sanitize, reduce or mitigate evidence is reliable and factual.
growth or development of microbiological (iii) The problem causes or could
organisms; or protect inanimate objects, reasonably be expected to cause an
industrial processes or systems, surfaces, unreasonable adverse effect on the
water, or other chemical substances from environment.
contamination, fouling, or deterioration (iv) Complying with the container
caused by bacteria, viruses, fungi, protozoa, regulations could reasonably be expected to
algae, or slime; and eliminate the problem.
(B) In the intended use is subject to a (2) If EPA determines that an antimicrobial
tolerance under section 408 of the Federal pesticide product otherwise exempted by
Food, Drug, and Cosmetic Act or a food paragraph (c) of this section must be subject
additive regulation under section 409 of such
to the nonrefill- able container regulations in
Act.
this subpart to prevent an unreasonable
(2) The labeling of the pesticide product
includes directions for use on a site in at least adverse effect on the environment, EPA may
one of the following antimicrobial product use require, by rule, that the product be
categories: food handling/storage distributed or sold in nonrefillable containers
establishments premises and equipment; that comply with all or some of the
commercial, institutional, and industrial requirements in this subpart. Alternatively, EPA
premises and equipment; residential and may notify the applicant or registrant of its
public access premises; medical premises and intent to make such a determination. After
equipment; human drinking water systems; allowing the applicant or registrant a
materials preservatives; industrial processes reasonable amount of time to reply, EPA may
and water systems; antifouling coatings; wood require, by notification and as a condition of
preservatives; or swimming pools. registration, that the product be distributed or
(3) The pesticide product is not a sold in non- refillable containers that comply
hazardous waste as set out in part 261 of this with all or some of the requirements in this
chapter when the pesticide product is subpart. For the purpose of the previous
intended to be disposed. sentence, 60 days would be a reasonable
(4) EPA has not specifically determined that amount of time to reply, although EPA may, in
the pesticide product must be subject to the its discretion, provide more time. EPA may
regulations in this subpart to prevent an deny registration or initiate cancellation
unreasonable adverse effect on the proceedings if the registrant fails to comply
environment according to the provisions of with the nonrefillable container regulations
paragraph within the time frames established by EPA in
(d) of this section. the rule or in its notification.
(d) How will EPA determine if an (e) What other pesticide products are
antimicrobial pesticide product otherwise subject to the regulations in this subpart? (1)
exempted must be subject to the regulations Except for manufacturing use products, plant-
in this subpart to prevent an unreasonable incorporated protectants,
adverse effect on the environment?
and antimicrobial products that are exempt cable requirements of 49 CFR part 107 subpart
under paragraph (c) of this section, all of the B. The requirements in this paragraph apply to
regulations in this subpart apply to a pesticide the pesticide product as it is packaged for
product if it satisfies at least one of the transportation in commerce.
following criteria: (b) What DOT standards do my non-
(1) The pesticide product meets the refillable containers have to meet under this
criteria of Toxicity Category I as set out in part if my pesticide product is a DOT
§156.62 of this chapter. hazardous material? (1) If your pesticide
(ii) The pesticide product meets the product meets the definition of a hazardous
criteria of Toxicity Category II as set out in material in 49 CFR 171.8, the DOT requires your
§156.62 of this chapter. pesticide product to be packaged according to
(iii) The pesticide product is classified for 49 CFR parts 171-180 or, if subject to a special
restricted use as set out in §§152.160 - 152.175 permit, according to the applicable
of this chapter. requirements of 49 CFR part 107 subpart B.
(2) Except for manufacturing use (2) For the purposes of these regulations, a
products, plant-incorporated pesticide product that meets the definition of
protectants, antimicrobial products that are a hazardous material in 49 CFR 171.8 must be
exempt under (c) of this section, and other packaged in a nonrefillable container that, if
pesticide products that are regulated under portable, is designed, constructed, and
paragraph (e)(1) of this section, a pesticide marked to comply with the requirements of 49
product must be packaged in compliance with CFR parts 171-180 or, if subject to a special
49 CFR permit, according to the applicable
173.24. If the pesticide product meets the requirements of 49 CFR part 107 subpart B. The
definition of a hazardous material in 49 CFR requirements in this paragraph apply to the
171.8, the Department of Transportation pesticide product as it is packaged for
requires it to be packaged according to 49 CFR transportation in commerce.
parts 171-180. (c) What will EPA do if DOT proposes to
(f) What does “pesticide product” or change any of the cross-referenced
“pesticide” mean in the rest of this subpart? In regulations? If the DOT proposes to change
§§165.25 through 165.27, the term ‘‘pesticide any of the regulations that are incorporated in
product’’ or ‘‘pesticide’’ refers only to a paragraphs (a) and (b) of this section, EPA will
pesticide product or a pesticide that is subject provide notice of the proposed changes and
to the regulations in this subpart as described an opportunity to comment in the FEDERAL
in paragraphs (a) through (e) of this section. REGISTER. Following notice and comment, EPA
[71 FR 47422, Aug. 16, 2006, as amended at 73 FR will take final action regarding whether or not
64225, Oct. 29, 2008] to revise its rules, and the extent to which any
§ 165.25 Nonrefillable container standards. such revision will correspond with revised DOT
(a) What Department of Transportation regulations.
(DOT) standards do my nonrefillable (d) What standards for closures do my
containers have to meet under this part if my nonrefillable containers have to meet? If your
pesticide product is not a DOT hazardous nonrefillable container is a rigid container with
material? A pesticide product that does not a capacity equal to or greater than 3.0 liters
meet the definition of a hazardous material in (0.79 gallons), if the container is not an aerosol
49 CFR 171.8 must be packaged in a container or a pressurized container, and if the
nonrefillable container that, if portable, is container is used to distribute or sell a liquid
designed, constructed, and marked to comply agricultural pesticide, each nonrefillable
with the requirements of 49 CFR 173.4, 173.5, container must have at least one of the
173.6, following standard closures:
173.24, 173.24a, 173.24b, 173.28, 173.155, (1) Bung, 2 inch pipe size (2.375 inches in
173.203, 173.213, 173.240(c), 173.240(d), diameter), external threading, 11.5
173.241(c), 173.241(d), part 178, and part 180
that are applicable to a Packing Group III
material, or, if subject to a special permit,
according to the appli
threads per Inch, National Pipe Straight (NPS) this section, percent removal represents the
standard. percent of the original concentration of the
(2) Bung, 2 inch pipe size (2.375 inches in active ingredient in the pesticide product when
diameter), external threading, 5 threads per compared to the concentration of that active
inch, buttress threads. ingredient in the fourth rinse. Percent removal
(3) Screw cap, 63 millimeters, at least one is calculated by the formula:
thread revolution at 6 threads per inch. percent removal = [1.0 - RR] x 100.0, where
(4) Screw cap, 38 millimeters, at least one RR = rinsate ratio = Active ingredient concentration
thread revolution at 6 threads per inch. The in fourth rinsate/Original concentration of active
cap may fit on a separate rigid spout or on a ingredient in the product
flexible pull-out plastic spout. (g) Can I obtain a waiver from or a
(e) What standards for dispensing do my modification to any of the nonrefillable
nonrefillable containers have to meet? If your container standards? Yes, it is possible for you
nonrefillable container has a capacity of 5 to obtain a waiver from or a modification to
gallons (18.9 liters) or less, if the container is the nonrefillable container standards, as
not an aerosol container, a pressurized follows:
container, or a spray bottle, and if the (1) EPA may waive or modify the
container holds a liquid pesticide, your requirements of paragraph (a) of this section
nonrefillable container must do both of the regarding the DOT standards for pesticide
following: products that are not DOT hazardous
(1) Allow the contents of the non- refillable materials if EPA determines that an alternative
container to pour in a continuous, coherent (partial or modified) set of standards or pre-
stream. existing requirements achieves a level of safety
(2) Allow the contents of the non- refillable that is at least equal to that specified in the
container to be poured with a minimum requirements of paragraph (a) of this section.
amount of dripping down the outside of the (2) EPA may waive or modify the
container. requirements of paragraph (b) of this section
(f) What standards for residue removal do regarding the DOT standards for pesticide
my nonrefillable containers have to meet? products that are DOT hazardous materials if
Each nonrefillable container and pesticide EPA determines that an alternative (partial or
formulation combination must meet the modified) set of standards or pre-existing
applicable residue removal standard of this requirements achieves a level of safety that is
section. at least equal to that specified in the
(1) If the nonrefillable container is rigid and requirements of paragraph (b) of this section.
has a capacity less than or equal to 5 gallons EPA will modify or waive the requirements of
(18.9 liters) for liquid formulations or 50 paragraph (b) of this section only after
pounds (22.7 kilograms) for solid formulations consulting with DOT to ensure consistency
and if the pesticide product’s labeling allows or with DOT regulations and exemptions.
requires the pesticide product to be mixed (3) EPA may approve a non-standard
with a liquid diluent prior to application (that closure (that is, a closure not listed in
is, if the pesticide is dilutable), each paragraph (d) of this section) if EPA determines
container/formulation combination must be that both of the following conditions are
capable of attaining at least 99.99 percent satisfied:
removal of each active ingredient when tested (i) The non-standard closure is necessary
using the EPA test procedure ‘‘Rinsing for the proper mixing, loading, or application
Procedures for Dilutable Pesticide Products in of the pesticide product.
Rigid Containers.’’ (ii) The non-standard closure offers
(2) The test must be conducted only if the exposure protection to handlers during mixing
pesticide product is a suspension concentrate and loading that is the same or greater than
or if EPA specifically requests the records on a that provided by the standard closures.
case by case basis.
(3) For the rigid container/dilutable
product standard in paragraph (f)(1) of
(4) EPA may waive or modify the container (4) A description of the nonrefillable
dispensing capability standards in paragraph container or containers for which the waiver or
(e) of this section if EPA determines that at modification is requested.
least one of the following conditions is (5) Documentation or justification to
satisfied: demonstrate that the applicable waiver or
(i) The product is typically removed from modification criteria in paragraph
the container by a method other than pouring. (g) of this section are satisfied.
(ii) Compliance with the container [71 FR 47422, Aug. 16, 2006, as amended at 73 FR
dispensing capability standards would increase 64225, Oct. 29, 2008]
exposure to the pesticide container handler.
(5) EPA may waive or modify the § 165.27 Reporting and recordkeeping.
requirements of paragraph (f) of this section (a) What information must I report about
regarding the residue removal standard if EPA my nonrefillable containers? You are not
determines that both of the following required to report to EPA with information
conditions are satisfied: about your nonrefillable containers under the
(i) The residue remaining in the container regulations in this subpart. You should refer to
would not cause an unreasonable adverse the reporting standards in part 159 of this
effect on the environment; and chapter to determine if information on
(ii) The product offers significant benefits container failures or other incidents involving
and cannot be economically reformulated or pesticide containers must be reported to EPA
repackaged. under FIFRA section 6(a)(2) (7 U.S.C.
(h) How do I obtain a waiver from or a 136d(a)(2)).
modification to any of the nonrefillable (b) What recordkeeping do I have to do for
container standards? To obtain a waiver from my nonrefillable containers? For each pesticide
or a modification to any of the nonrefillable product that is subject to §§165.25 through
container standards, you must submit a written 165.27 and is distributed or sold in nonrefillable
request for a waiver or a modification to the containers, you must maintain the records
EPA to the following address: Office of listed in this section for as long as a non-
Pesticide Programs (7504P); U.S. refillable container is used to distribute or sell
Environmental Protection Agency; Ariel Rios the pesticide product and for 3 years after that.
Building; 1200 Pennsylvania Avenue, N.W., You must furnish these records for inspection
Washington, DC 20460. You cannot distribute and copying upon request by an employee of
or sell the pesticide product in a nonrefillable EPA or any entity designated by EPA, such as
container that does not comply with all of the a State, another political subdivision or a Tribe.
nonrefillable container standards unless and You must keep the following records:
until EPA approves the request for the waiver (1) The name and EPA registration number
or modification in writing. You must include of the pesticide product.
two copies of the following information (which (2) A description of the nonrefillable
may be part of an application for registration container(s) in which the pesticide product is
or amended registration) with your written distributed or sold.
request: (3) At least one of the following records to
(1) The name and address of the registrant; document compliance with the requirement
the date; and the name, title, signature, and for closures in § 165.25(d) for each nonrefillable
phone number of the company official making container used to distribute or sell the
the request. pesticide product that must comply with
(2) The name and EPA registration number §165.25(d):
of the pesticide product for which the waiver (i) A letter or document from the container
or modification is requested. supplier that describes the closure.
(3) A statement specifying the requirement (ii) A specification about the closure in the
or requirements from which you are contract between the registrant or applicant
requesting a waiver or a modification. and the container supplier.
(iii) A copy of EPA’s approval of any non- §§ 165.28-165.39 [Reserved]
standard closure.
(4) At least one of the following records Subpart C—Refillable Container
pertaining to the container dispensing Standards: Container Design
capability requirements in § 165.25(e) for each
nonrefillable container used to distribute or § 165.40 General provisions.
sell the pesticide product that must comply (a) What is the purpose of the regulations
with § 165.25(e): in this subpart? The regulations in this subpart
(i) Test data or documentation establish design and construction
demonstrating that the nonrefillable container requirements for refillable containers used for
the distribution or sale of some pesticide
meets the standards in § 165.25(e) when it
products.
contains the pesticide product.
(b) Do I have to comply with the
(ii) Test data or documentation regulations in this subpart? (1) You must
demonstrating that a different nonrefill- able comply with all of the regulations in this
container meets the standards in § 165.25(e) subpart if you are a registrant who distributes
when it contains the pesticide product or even or sells a pesticide product in refillable
a different pesticide product and a written containers. If your pesticide product is subject
explanation of why such data or to the regulations in this subpart as set out in
documentation demonstrates that the §165.43, your pesticide product must be
container meets the standards in § 165.25(e) distributed or sold in a refillable container that
for the pesticide product. meets the standards of these regulations. This
(iii) A copy of EPA’s approval of a request includes your pesticide products that are
for a waiver from the container dispensing repackaged according to subpart D of this
requirement. part.
(5) At least one of the following records (2) You must comply with the regulations in
pertaining to the nonrefillable container § 165.45(f) for stationary pesticide containers if
residue removal requirement in § 165.25(f) if you are a refiller of a pesticide product and you
the pesticide product is a suspension are not the registrant of the pesticide product.
concentrate or if EPA specifically requests the If the pesticide product is subject to the
records on a case- by-case basis: regulations in this subpart as set out in §
(i) Test data showing that the non- 165.43, the stationary pesticide containers
refillable container and pesticide formulation used to distribute or sell the product must
meet the standard in § 165.25(f) . meet the standards of § 165.45(f).
(ii) Test data showing that a different (3) If you are a refiller of a pesticide product
nonrefillable container with the same or a and you are not a registrant of the pesticide
different pesticide formulation meets the product, § 165.45(a)(2) provides an exemption
standard in § 165.25(f), together with a written from some of the requirements in § 165.45(a)(1)
explanation of why such data demonstrate .
that the nonrefillable container and pesticide (c) When do I have to comply? Any
formulation meet the standard in § 165.25(f). pesticide product packaged in a refillable
(iii) A copy of EPA’s approval of a request container and released for shipment by you
for a waiver from the residue removal standard after August 16, 2011 must be packaged in a
requirement. refillable container that complies with the
regulations of this subpart.
[71 FR 47422, Aug. 16, 2006, as amended at 73 FR
64225, Oct. 29, 2008] [71 FR 47422, Aug. 16, 2006, as amended at 73 FR
64226, Oct. 29, 2008]
§ 165.43 Scope of pesticide products included.
not apply to manufacturing use products, as cording to the provisions of paragraph
defined in § 158.153(h) of this chapter. (e) of this section.
(b) Are plant-incorporated protectants (d) Which requirements must an
subject to the regulations in this subpart? No, antimicrobial swimming pool product comply
the regulations in this subpart do not apply to with if it is not exempt from these regulations?
plant-incorporated protectants, as defined in An antimicrobial swimming pool product that
§174.3 of this chapter. is not exempt by paragraph (a), (b), or (c) of
(c) Which antimicrobial pesticide products this section must comply with all of the
are not subject to the regulations in this regulations in this subpart except § 165.45(d)
subpart? The regulations in this subpart do not regarding marking and § 165.45(e) regarding
apply to a pesticide product if it satisfies all of openings. For the purposes of this subpart, an
the following conditions: antimicrobial swimming pool product is a
(1) The pesticide product meets one of the pesticide product that satisfies both of the
following two criteria: following conditions:
(1) The pesticide product is an antimicrobial (1) The pesticide product is intended to:
pesticide as defined in FIFRA section 2(mm); or disinfect, sanitize, reduce or mitigate growth or
(ii) The pesticide product: (A) Is intended to: development of microbiological organisms; or
disinfect, sanitize, reduce or mitigate growth or protect inanimate objects, industrial processes
development of microbiological organisms; or or systems, surfaces, water, or other chemical
protect inanimate objects, industrial processes substances from contamination, fouling, or
or systems, surfaces, water, or other chemical deterioration caused by bacteria, viruses,
substances from contamination, fouling, or fungi, protozoa, algae, or slime.
deterioration caused by bacteria, viruses, (2) The labeling of the pesticide product
includes directions for use on only a site or
fungi, protozoa, algae, or slime; and
sites in the antimicrobial product use category
(B) In the intended use is subject to a
of swimming pools.
tolerance under section 408 of the Federal (e) How will EPA determine if an
Food, Drug, and Cosmetic Act or a food antimicrobial pesticide product otherwise
additive regulation under section 409 of such exempted must be subject to the regulations
Act. in this subpart to prevent an unreasonable
(2) The labeling of the pesticide product adverse effect on the environment? (1) EPA
includes directions for use on a site in at least may determine that an antimicrobial pesticide
one of the following antimicrobial product use product otherwise exempted by paragraph (c)
categories: food handling/storage of this section must be subject to the refillable
establishments premises and equipment; container regulations in this subpart to prevent
commercial, institutional, and industrial an unreasonable adverse effect on the
premises and equipment; residential and environment if all of the following conditions
public access premises; medical premises and exist:
equipment; human drinking water systems; (1) EPA obtains information, data or other
materials preservatives; industrial processes evidence of a problem with the containers of a
and water systems; antifouling coatings; wood certain pesticide product or related group of
preservatives; or swimming pools. products.
(3) The pesticide product is not a (ii) The information, data or other
hazardous waste as set out in part 261 of this evidence is reliable and factual.
chapter when the pesticide product is (iii) The problem causes or could
intended to be disposed. reasonably be expected to cause an
(4) EPA has not specifically determined that unreasonable adverse effect on the
the pesticide product must be subject to the environment.
regulations in this subpart to prevent an (iv) Complying with the container
unreasonable adverse effect on the regulations could reasonably be expected to
environment ac eliminate the problem.
(2) If EPA determines that an antimicrobial
pesticide product otherwise
exempted by paragraph (c) of this section must tlcldes that are gaseous at atmospheric
be subject to the refillable container temperature and pressure.
regulations in this subpart to prevent an [71 FR 47422, Aug. 16, 2006, as amended at 73 FR
unreasonable adverse effect on the 64226, Oct. 29, 2008]
environment, EPA may require, by rule, that § 165.45 Refillable container standards.
the product be distributed or sold in refillable (a) What Department of Transportation
containers that comply with all or some of the (DOT) standards do my refillable containers
requirements in this subpart. Alternatively, EPA have to meet under this part if my pesticide
may notify the applicant or registrant of its product is not a DOT hazardous material? (1)
intent to make such a determination. After A pesticide product that does not meet the
allowing the applicant or registrant a definition of a hazardous material in 49 CFR
reasonable amount of time to reply, EPA may 171.8 must be packaged in a refillable container
require, by notification and as a condition of that, if portable, is designed, constructed, and
registration, that the product be distributed or marked to comply with the requirements of 49
sold in refillable containers that comply with all CFR 173.4, 173.5, 173.6, 173.24, 173.24a,
or some of the requirements in this subpart. 173.24b, 173.28,
For the purpose of the previous sentence, 60 173.155, 173.203, 173.213, 173.240(c),
days would be a reasonable amount of time to 173.240(d), 173.241(c), 173.241(d), part 178, and
reply, although EPA may, in its discretion, part 180 that are applicable to a Packing Group
provide more time. EPA may deny registration III material, or, if subject to a special permit,
or initiate cancellation proceedings if the according to the applicable requirements of 49
registrant fails to comply with the refillable CFR part 107 subpart B. The requirements in
container regulations within the time frames this paragraph apply to the pesticide product
established by EPA in the rule or in its as it is packaged for transportation in
notification. commerce.
(f) What other pesticide products are (2) A refiller is not required to comply with
subject to the regulations in this subpart? The 49 CFR 173.28(b)(2) for pesticide products that
regulations in this subpart apply to all pesticide are not DOT hazardous materials if the
products other than manufacturing use refillable container to be reused complies with
products, plant-incorporated protectants, and the refillable container regulations in this
antimicrobial products that are exempt by subpart and the refilling is done in compliance
paragraph (c) of this section. Antimicrobial with the repackaging regulations in subpart D
products covered under paragraph (d) of this of this part.
section are subject to the regulations indicated (b) What DOT standards do my refill- able
in paragraph containers have to meet under this part if my
(d) of this section. pesticide product is a DOT hazardous
(g) What does “pesticide product” or material? (1) If your pesticide product meets
“pesticide” mean in the rest of this subpart? In the definition of a hazardous material in 49
§ 165.43(h) through §165.47, the term CFR 171.8, the DOT requires your pesticide
‘‘pesticide product’’ or ‘‘pesticide’’ refers only product to be packaged according to 49 CFR
to a pesticide product or a pesticide that is parts 171-180 or, if subject to a special permit,
subject to the regulations in this subpart as according to the applicable requirements of 49
described in paragraphs (a) through (f) of this CFR part 107 subpart B.
section. (2) For the purposes of these regulations, a
(h) Are there any other exceptions? (1) The pesticide product that meets the definition of
regulations in this subpart do not apply to a hazardous material in 49 CFR 171.8 must be
transport vehicles that contain pesticide in packaged in a refillable container that, if
pesticide-holding tanks that are an integral portable, is designed, constructed, and
part of the transport vehicle and that are the marked to comply with the requirements of 49
primary containment for the pesticide. CFR parts 171-180 or, if subject to a special
(2) The regulations in this subpart do not permit, according to the applicable
apply to containers that hold pes-
requirements of 49 CFR part 107 subpart B. The stationary pesticide container designed to
requirements in this paragraph apply to the hold undivided quantities of pesticides equal
pesticide product as it is packaged for to or greater than 500 gallons (1,890 liters) of
transportation in commerce. liquid pesticide or equal to or greater than
(c) What will EPA do if DOT proposes to 4,000 pounds (1,818 kilograms) of dry pesticide
change any of the cross-referenced is located at the refilling establishment of a
regulations? If the DOT proposes to change refiller operating under written contract to you,
any of the regulations that are incorporated in the stationary pesticide container must meet
paragraphs (a) and (b) of this section, EPA will the following standards:
provide notice of the proposed changes and (1) Except during a civil emergency or any
an opportunity to comment in the FEDERAL unanticipated grave natural disaster or other
REGISTER. Following notice and comment, EPA natural phenomenon of an exceptional,
will take final action regarding whether or not inevitable and irresistible character, the effects
to revise its rules, and the extent to which any of which could not have been prevented or
such revision will correspond with revised DOT avoided by the exercise of due care or
regulations. foresight, each stationary pesticide container
(d) What standards for marking do my (for liquid and dry pesticides) and its
refutable containers have to meet? Each appurtenances must meet both of the
refillable container must be marked in a following standards:
durable and clearly visible manner with a serial (1) Each stationary pesticide container and
number or other identifying code that will its appurtenances must be resistant to extreme
distinguish the individual container from all changes in temperature and constructed of
other containers. Durable marking includes, materials that are adequately thick to not fail
but is not limited to, etching, embossing, ink and that are resistant to corrosion, puncture,
jetting, stamping, heat stamping, mechanically or cracking.
attaching a plate, molding, and marking with (ii) Each stationary pesticide container
durable ink. The serial number or other must be capable of withstanding all operating
identifying code must be located on the stresses, taking into account static heat,
outside part of the container except on a pressure buildup from pumps and
closure. Placement on the label or labeling is compressors, and any other foreseeable
not sufficient unless the label is an integral, mechanical stresses to which the container
permanent part of or permanently stamped on may be subjected in the course of operations.
the container. (2) Each stationary container of liquid
(e) What standards for openings do my pesticides must meet all of the following
refillable containers have to meet? If your standards:
refillable container is a portable pesticide (i) Each stationary container of liquid
container that is designed to hold liquid pesticides must be equipped with a vent or
pesticide formulations and is not a cylinder other device designed to relieve excess
that complies with the DOT Hazardous pressure, prevent losses by evaporation, and
Materials Regulations in 49 CFR parts 171-180, exclude precipitation.
each opening of the container other than a (ii) External sight gauges, which are
vent must have a one-way valve, a tamper- pesticide-containing hoses or tubes that run
evident device or both. A oneway valve may be vertically along the exterior of the container
located in a device or system separate from the from the top to the bottom, are prohibited on
container if the device or system is the only stationary containers of liquid pesticides.
reasonably foreseeable way to withdraw (iii) Each connection on a stationary
pesticide from the container. A vent must be container of liquid pesticides that is below the
designed to minimize the amount of material normal liquid level must be equipped with a
that could be introduced into the container shutoff valve which is capable of being locked
through it. closed. A shutoff valve must be located within
(f) What standards do my stationary a secondary containment unit if one is
pesticide containers have to meet? If a required by subpart E of this part.
(g) Can I obtain a waiver from or a (2) The name and EPA registration number
modification to any of the refillable container of the pesticide product for which the waiver
standards? Yes, it is possible for you to obtain or modification is requested.
a waiver from or a modification to some of the (3) A statement specifying the requirement
refillable container standards, as follows: or requirements from which you are
(1) EPA may waive or modify the requesting a waiver or a modification.
requirements of paragraph (a) of this section (4) A description of the refillable container
regarding the DOT standards for pesticide or containers for which the waiver or
products that are not DOT hazardous modification is requested.
materials if EPA determines that an alternative (5) Documentation or justification to
(partial or modified) set of standards or pre- demonstrate that the applicable waiver or
existing requirements achieves a level of safety modification criteria in paragraph (g) of this
that is at least equal to that specified in the section are satisfied.
requirements of paragraph (a) of this section. [71 FR 47422, Aug. 16, 2006, as amended at 73 FR
(2) EPA may waive or modify the 64226, Oct. 29, 2008]
requirements of paragraph (b) of this section § 165.47 What information must I report about my
regarding the DOT standards for pesticide refillable containers?
products that are DOT hazardous materials if
You are not required to report to EPA with
EPA determines that an alternative (partial or
information about your re- fillable containers
modified) set of standards or pre-existing under the regulations in this subpart. You
requirements achieves a level of safety that is should refer to the reporting standards in part
at least equal to that specified in the 159 of this chapter to determine if information
requirements of paragraph (b) of this section. on container failures or other incidents
EPA will modify or waive the requirements of involving pesticide containers must be
paragraph (b) of this section only after reported to EPA under FIFRA section 6(a)(2) (7
consulting with DOT to ensure consistency U.S.C. 136d(a)(2)).
with DOT regulations and exemptions.
(h) How do I obtain a waiver from or a §§ 165.48-165.59 [Reserved]
modification to any of the refillable container
standards? To obtain a waiver from or a Subpart D—Standards for Repackaging
modification to any of the re- fillable container Pesticide Products into Refillable
standards, you must submit a written request Containers
for a waiver or a modification to the EPA to the § 165.60 General provisions.
following address: Office of Pesticide (a) What is the purpose of the regulations
Programs (7504P); U.S. Environmental in this subpart? The regulations in this subpart
Protection Agency; Ariel Rios Building; 1200 establish requirements for repackaging some
Pennsylvania Avenue, N.W., Washington, DC pesticide products into refillable containers for
20460. You cannot distribute or sell the distribution or sale.
pesticide product in a refillable container that (b) Do I have to comply with the
does not comply with all of the refillable regulations in this subpart? You must comply
container standards unless and until EPA with the regulations in this subpart if you are a
approves the request for the waiver or registrant who distributes or sells a pesticide
modification in writing. You must include two product in refillable containers, if you are a
copies of the following information (which may registrant who distributes or sells pesticide
be part of an application for registration or products to a refiller (that is not part of your
amended registration) with your written company) for repackaging into refill- able
request: containers, or if you are a refiller of a pesticide
(1) The name and address of the registrant; product and you are not the registrant of the
the date; and the name, title, signature, and pesticide product. Each pesticide product that
phone number of the company official making is subject to the regulations in this subpart as
the request. set out in §165.63 and that is distributed or
sold In a refillable container must be chemical substances from contamination,
distributed or sold in compliance with the fouling, or deterioration caused by bacteria,
standards of these regulations. viruses, fungi, protozoa, algae, or slime; and
(c) When do I have to comply? Any pesticide (B) In the intended use is subject to a
product repackaged into a refill- able tolerance under section 408 of the Federal
container and released for shipment by you Food, Drug, and Cosmetic Act or a food
after August 16, 2011 must be repackaged in additive regulation under section 409 of such
compliance with the regulations of this Act.
subpart. (2) The labeling of the pesticide product
[71 FR 47422, Aug. 16, 2006, as amended at 73 FR includes directions for use on a site in at least
64227, Oct. 29, 2008] one of the following antimicrobial product use
categories: food handling/storage
§ 165.63 Scope of pesticide products included.
establishments premises and equipment;
(a) Are manufacturing use products commercial, institutional, and industrial
subject to the regulations in this subpart? No, premises and equipment; residential and
the regulations in this subpart do not apply to public access premises; medical premises and
manufacturing use products, as defined in § equipment; human drinking water systems;
158.153(h) of this chapter. materials preservatives; industrial processes
(b) Are plant-incorporated protectants and water systems; antifouling coatings; wood
subject to the regulations in this subpart? No, preservatives; or swimming pools.
the regulations in this subpart do not apply to (3) The pesticide product is not a
plant-incorporated protectants, as defined in hazardous waste as set out in part 261 of this
§174.3 of this chapter. chapter when the pesticide product is
(c) Which antimicrobial pesticide products intended to be disposed.
are not subject to the regulations in this (4) EPA has not specifically determined that
subpart? The regulations in this subpart do not the pesticide product must be subject to the
apply to a pesticide product if it satisfies all of regulations in this subpart to prevent an
the following conditions: unreasonable adverse effect on the
(1) The pesticide product meets one of the environment according to the provisions of
following two criteria: paragraph
(i) The pesticide product is an (e) of this section.
antimicrobial pesticide as defined in FIFRA (d) Which requirements must an
section 2(mm); or antimicrobial swimming pool product comply
(ii) The pesticide product: (A) Is intended with if it is not exempt from these regulations?
to: disinfect, sanitize, reduce or mitigate (1) An antimicrobial swimming pool product
growth or development of microbiological that is not exempt by paragraph (a), (b), or (c)
organisms; or protect inanimate objects, of this section must comply with all of the
industrial processes or systems, surfaces, regulations in this subpart except for the
water, or other following requirements:
§ 168.65 Applicability.
(a) This subpart describes the labeling
requirements applicable to pes
(c) The labeling of pesticide products and (b) For the purposes of this subpart, a
devices intended solely for export must registered export pesticide product is
comply with this regulation no later than considered to be any of the following:
January 21, 2014. (1) A pesticide product of composition,
[78 FR 4077, Jan. 18, 2013] packaging and labeling as described in its
EFFECTIVE DATE NOTE: At 79 FR 24350, Apr. 30, 2014, registration under FIFRA section 3;
§168.66 was revised, effective July 29, 2014. For the (2) A pesticide product that has been
convenience of the user, the revised text is set forth modified in compliance with the notification or
as follows:
non-notification provisions of § 152.46 of this
§ 168.66 Labeling of pesticide products and devices for
export.
chapter, and any associated procedures issued
under § 156.10(e) of this chapter, regardless of
Any label and labeling information requirements
in §§168.69, 168.70, and 168.71 that are not met fully whether such modification has been made for
on the product label attached to the immediate the pesticide product’s registration under
product container may be met by collateral labeling FIFRA section 3;
that is either: (3) A pesticide product initially registered
(a) Attached to the immediate product by a State under FIFRA section 24(c), and
(container label); or
(b) Attached to or accompanies the shipping whose Federal registration has not been
container of the export pesticide or export device at disapproved by EPA under § 162.164 of this
all times when it is shipped or held for shipment in chapter.
the United States. (c) The text of the labeling of the export
pesticide product must be provided in English
§ 168.67 Definitions. and, if applicable, the following foreign
Terms used in this subpart have the same languages:
meanings as in the Act and as in § 152.3 of this (1) The predominant or official language of
chapter, unless otherwise defined in this the country of final destination, if known; and
section. (2) The predominant or official language of
Export pesticide device means a device, as the importing country.
defined in FIFRA section 2(h), that is intended [78 FR 4077, Jan. 18, 2013]
solely for export from the United States to
another country. EFFECTIVE DATE NOTE: At 79 FR 24350, Apr. 30, 2014,
§168.69 was amended by revising paragraph (a),
Export pesticide product means a pesticide effective July 29, 2014. For the convenience of the
product, as defined in §152.3 of this chapter, user, the revised text is set forth as follows:
that is intended solely for export from the
United States to another country. § 168.69 Registered export pesticide products.
(a) Each export pesticide product that is registered
[78 FR 4077, Jan. 18, 2013]
under FIFRA section 3 or FIFRA section 24(c) must
§ 168.68 Applicability. bear labeling approved by EPA for its registration or
This subpart applies to all export pesticide collateral labeling in compliance with § 168.66.
products and export pesticide devices that are * * * * *
exported for any purpose, including any
research purpose. § 168.70 Unregistered export pesticide products.
[78 FR 4077, Jan. 18, 2013] (a) Any export pesticide product that does
EFFECTIVE DATE NOTE: At 79 FR 24350, Apr. 30, 2014, not meet the terms of § 168.69 is an
§168.68 was removed and reserved, effective July 29, unregistered export pesticide product for
2014. purposes of this subpart.
(b) Each unregistered export pesticide
§ 168.69 Registered export pesticide products.
product must bear labeling that complies with
(a) Each export pesticide product that is all requirements of this section and § 168.66(b).
registered under FIFRA section 3 or FIFRA
section 24(c) must bear labeling approved by
EPA for its registration and comply with the
requirements of § 168.66(b).
(1) The labeling must comply with all of the (1) The transfer, distribution or sale occurs
prominence and legibility requirements of § between a point in the United States and a
156.10(a)(2) of this chapter. point outside the United States, or
(2) The labeling must comply with all the (2) The transfer occurs within the United
language requirements in §§ 168.69(c) and States solely for the purpose of export from
156.10(a)(3) of this chapter. the United States.
(3) The labeling must bear the following
information: [78 FR 4077, Jan. 18, 2013]
(i) The name and address of the producer, EFFECTIVE DATE NOTE: At 79 FR 24350, Apr. 30, 2014,
in accordance with the requirements of § §168.70 was amended by revising paragraph (b),
156.10(c) of this chapter; effective July 29, 2014. For the convenience of the
(ii) The net weight or measure of contents, user, the revised text is set forth as follows:
in accordance with the requirements of §
156.10(d) of this chapter; § 168.70 Unregistered export pesticide products.
(iii) The pesticide producing
* * * * *
establishment number, in accordance with the
requirements of § 156.10(f) of this chapter; (b) Each unregistered export pesticide product
(iv) An ingredients statement, in must bear labeling that complies with all
accordance with the requirements of § requirements of this section or collateral labeling in
156.10(g) of this chapter, except that: compliance with § 168.66.
(A) The ingredients statement need not
appear in a second language besides English if *****
English is the official or predominant language § 168.71 Export pesticide devices.
in the importing country and the country of
final destination, if known; and (a) Each export pesticide device sold or
(B) An export pesticide product intended distributed anywhere in the United States must
solely for research and development purposes, bear labeling that complies with all
(and which bears the statement ‘‘For research requirements of this section and § 168.66(b).
and development purposes only. Not for (b) The labeling of each export pesticide
distribution, sale, or use,’’ or similar language) device must meet all of the prominence and
may bear coded ingredient information to legibility requirements of § 156.10(a)(2) of this
protect confidentiality. chapter.
(v) Human hazard and precautionary (c) The labeling must also comply with all
statements in accordance with the the language requirements in § 168.69(c) and §
requirements of subpart D of part 156 of this 156.10(a)(3) of this chapter.
chapter. The statements must be true and (d) The labeling must bear the following
accurate translations of the English statements. information:
(vi) The statement ‘‘Not Registered for Use (1) The name and address of the producer,
in the United States of America,’’ which may be meeting the requirements of § 156.10(c) of this
amplified by additional statements accurately chapter;
describing the reason(s) why the export
(2) The producing establishment number,
pesticide product is not registered in the
United States, or is not registered for particular meeting the requirements of § 156.10(f) of this
uses in the United States. chapter;
(c) This section also applies to all (3) The statement ‘‘Not Registered for Use
unregistered pesticide products and devices in the United States of America,’’ which may be
that are intended solely for export and that are amplified by additional statements describing
transferred, distributed, or sold between the reason why the export pesticide device is
registered establishments operated by the not registered in the United States, such as
same producer according to § 152.30(a) of this ‘‘because pesticide devices are not required to
chapter if: be registered in the United States.’’
(e) An export pesticide device is not for use in the United States in the form that
required to bear an ingredients statement. they are produced for export, are considered
[78 FR 4077, Jan. 18, 2013] to be unregistered pesticides. This includes
EFFECTIVE DATE NOTE: At 79 FR 24350, Apr. 30, 2014, pesticides which are of a different formulation,
§168.71 was amended by revising paragraph (a), including composition (except for variation
effective July 29, 2014. For the convenience of the within certified limits), or type of formulation,
user, the revised text is set forth as follows: and pesticides which are packaged for use
§168.71 Export pesticide devices. patterns for which they are not registered,
(a) Each export pesticide device sold or distributed which may be evidenced by package type or
anywhere in the United States must bear labeling label use statements. This also includes
that complies with all requirements of this section or unregistered products which are under
collateral labeling in compliance with §168.66. development as pesticidal products and which
are being exported for research testing.
* * * * * (b) Exceptions. Under the specific
§ 168.75 Procedures for exporting unregistered
circumstances discussed below, EPA will not
pesticides—purchaser treat a registered product which has been
acknowledgement statements. modified slightly for export purposes, as
This section describes how EPA interprets unregistered for the purposes of the purchaser
and will enforce requirements of FIFRA section acknowledgement statement requirement.
17(a)(2). Section 17(a)(2) provides that any Any changes to the registered product for
person exporting a pesticide other than a export purposes must be documented in
pesticide registered for use under FIFRA accordance with the record-keeping
section 3 or sold under FIFRA section 6(a)(1), requirements at §169.2 of this chapter and this
shall obtain a statement signed by the foreign policy.
purchaser prior to export, acknowledging that (1) Labeling on immediate product. EPA
the purchaser understands that such pesticide will not treat as unregistered for the purposes
is not registered for use in the United States of section 17(a)(2), a registered pesticide
and cannot be sold in the United States. product which cannot be sold or distributed
Section 17(a)(2) requires that a copy of the for use in the United States because its
statement be transmitted to an appropriate immediate product container does not bear a
official of the government of the importing label approved under a FIFRA section 3
country. registration, but which could be sold or
(a) Products subject to the requirement. distributed in the United States with the
EPA will not consider an exporter of an approved label attached to the immediate
unregistered pesticide to be in violation of product container, provided that the label and
FIFRA section 17(a)(2) if, prior to export of the labeling approved under a current FIFRA
pesticide, the exporter submits to EPA a section 3 registration for the product is either
statement signed by the foreign purchaser attached to the immediate product container
which affirms that the purchaser is aware that or accompanies the product at all times as
the pesticide is not registered for use in the supplemental labeling as provided in
United States and cannot be sold for use in the paragraph (c) of this section.
United States. The exporter must also include (2) Packaging. (i) certain changes may be
with the submission of the purchaser made to a product’s labeling or packaging
acknowledgement statement to EPA, a without affecting the registration status of the
certification signed by the exporter affirming product, as specified in § 152.46(b) of this
that the export did not occur until the chapter and this policy. These changes include
statement signed by the foreign purchaser was any changes in package size and label net
obtained by the exporter. Except as provided contents, provided no change in use directions
in paragraph (b) of this section, all pesticide or requirement for child-resistant packaging
products produced for export which cannot be would be necessary for the product to be
sold registered for use
In the United States. For example, If child- atory language falsely represents or is
resistant packaging is required for a particular misleading regarding the U.S. use
pesticide product in the United States, and the classification, the product will be considered
product will be exported without child- misbranded. In addition, a use classification
resistant packaging, the product would be can only be listed if one has been assigned
considered unregistered and therefore subject pursuant to the U.S. registration.
to all the requirements of FIFRA section 17(a), (ii) An exporter who is also the
as described in §168.75 of this chapter manufacturer of a U.S. registered pesticide
including the requirement for a purchaser may add new uses to the label of that product
acknowledgement statement. for export purposes, without triggering the
(ii) If an exporter needed to repackage a requirements of section 17(a)(2), as long as the
product in a size to meet a foreign purchaser’s new uses are within the same general use
specifications, that modification would not patterns as those for the registered product.
affect the registration status of the export The general pesticide use patterns are:
product. Other modifications to the label used terrestrial food crop and terrestrial nonfood
for export purposes which will not affect the crop; greenhouse food crop and greenhouse
export product’s registration status are: the nonfood crop; aquatic food crop and aquatic
use of metric units for net contents, dosages, nonfood crop’ indoor use’ and forestry use.
and other numeric expressions; the use of a Adding new uses to the label which change the
different format for the label, provided that the use pattern, such as changes from nonfood to
information does not contradict the U.S. label; food use, outdoor to indoor use, or terrestrial
revision of nonmandatory U.S. label to aquatic use, render the product
statements, consistent with 40 CFR part 156, unregistered and subject to the requirements
including additions or changes required by of section 17 for unregistered products. If the
other Federal statutes or regulations; a change new use added to the label is a food or feed
of the name or address of the registrant, use, a tolerance must already be established
except for a change resulting from transfer of for the use of that pesticide in or on that
ownership, which requires that a registrant commodity.
keep his name and address current with the (4) Composition. EPA will not treat a
Agency; and any correction of typographical registered product as unregistered for the
or printing errors that appeared on the U.S. purposes of the purchaser acknowledgement
labeling. (See § 152.46(b)). statement requirement under the following
(3) Labeling statements. The following specific circumstances:
statements which appear on any of the (i) The formula of the exported product is
product labels or labeling will not affect the within certified limits of the formula of the U.S.
status of the product, provided that they do registered product.
not contradict the approved FIFRA section 3 (ii) An exporter, who is also the
labeling: manufacturer of a U.S. registered pesticide,
(i) It is permissible to add explanatory may decrease the percentage of the active
language which accurately explains the ingredient(s) of that product by adding a List 4
meaning of a use classification. For example, inert ingredient, without causing the product
the statement ‘‘restricted use pesticide’’ may to be treated as ‘‘unregistered’’ and triggering
be expanded to read: ‘‘Restricted in the United the requirement to obtain a purchaser
States of America to use by certified acknowledgement statement as a condition
applicators’’ or ‘‘Restricted Use Pesticide. In for export. In EPA’s Policy Statement on Inert
The United States this product is restricted to Ingredients in Pesticide Products, EPA included
use by applicators determined by each state to inert ingredients on List 4-a list of inert
be competent in pesticide application and the ingredients posing minimal hazard or risk-if
human health and environmental the inert ingredients were generally regarded
consequences of misuse.’’ If the explan as innocuous. The provisions of this paragraph
do not apply to those pesticide products
intended for public
health uses which are required or conditionally (A) Would not involve land uses of more
required to submit efficacy data pursuant to than 10 acres (4.05 hectares), or be used on or
§158.400 or §161.640 of this chapter, as affect food or feed crops which are intended
applicable. Any differences in formula or for consumption.
composition caused by adding a List 4 inert (B) Would not involve aquatic uses of
must be reflected in records which show the more than 1 acre (0.405 hectares), or any
complete formula of the export product in aquatic uses which involve water used for
accordance with the requirements of §169.2 irrigation, drinking or recreation, or be used on
and this policy. or affect plants or animals taken for food or
(iii) A change in the color or fragrance of feed from such waters.
the export product will not affect the product’s (C) Would not involve tests on animals
registration status as long as the following intended for food or feed.
conditions are met. The change in color must (ii) Shipments to different purchasers, to
result only from the addition of a dye included different countries of final destination, or
on the list of the chemicals exempted from the which occur more than a calendar year apart
requirement of a tolerance at 40 CFR 180.910, will be evaluated separately. When
180.920, 180.930, and 180.950, and the dye determining whether total shipments exceed
must not be a List 1 inert. (List 1 inerts are those the criteria described in this paragraph, EPA
inerts which the Agency has identified as will evaluate the total amount of shipments by
presenting toxicological concerns. The a single exporter during a calendar year for use
classification of inerts is explained in EPA’s in a particular country.
Policy Statement on Inert Ingredients in (iii) An exporter bears the burden of
Pesticide Products. The change in fragrance demonstrating that the product meets these
must result only from the addition of a
criteria before the research product is shipped.
chemical included on the list of the chemicals
This may be met by documenting before the
exempted from the requirement of a tolerance
at 40 CFR 180.910, 180.920, 180.930, and product is shipped and maintaining records for
180.950, and the chemical must not be a List 1 the time period required by § 169.2(h) of this
inert. The change in fragrance must not result chapter from the date of the last shipment
in a pesticide product containing a food or relevant to such records. The records to be
food-like fragrance. (See ‘‘Food Fragrances in maintained consist of:
Pesticide Formulations,’’ EPA’s Office of (A) The identity of the purchaser and
Pesticide Programs Policy and Criteria Notice country of intended use of the research
number 2155.1, November 20, 1975.) Any product.
difference in color or fragrance of the export (B) The amount shipped.
product in accordance with this section must (C) The intended research use by the
be reflected in records which show the purchaser, including the type of application
complete formula of the export product in site, rate of application, and measures taken
accordance with the requirements of §169.2 for protection of humans from direct or dietary
and this policy. exposure.
(5) Research and development products. (c) Procedures. An exporter of an
An unregistered pesticide product exported unregistered pesticide product must submit a
only for research and development purposes purchaser acknowledgement statement to
is subject to the notification requirements of EPA containing the information stated in
this section, unless its use fits within the criteria paragraph (c)(1) of this section, and a
described in this paragraph. statement signed by the exporter certifying
(i) An unregistered pesticide product that the exportation did not occur until the
exported solely for research and development signed acknowledgement statement had been
purposes will not be considered to be in obtained from the purchaser. If the foreign
violation of the notification requirements if the purchaser signs a purchaser
export of the research and development acknowledgement statement in their own
product: language, it must be accompanied by an
English translation when it is submitted to EPA
by the exporter. These
statements shall be submitted In accordance be met on a per-shipment or annual basis, as
with one of the two options for submission stated in paragraphs (c)(2)(i) and (c)(2)(ii) of
described in paragraph this section. If the procedures in paragraph
(c) (2) of this section. (c)(2)(ii) of this section are not followed, EPA
(1) Contents of the purchaser will consider paragraph (c)(2)(i) of this section,
acknowledgement statements. The purchaser requiring pershipment purchaser
acknowledgement statement must include the acknowledgement statements, to be
following information in a format that is clearly applicable in full. Where paragraph
understandable: (c) (2)(i) of this section is applicable,
(1) Name, address, and EPA identification each shipment which does not meet the
number, if applicable, of the exporter. requirements of that paragraph will be
(ii) Name and address of the foreign considered to be a separate violation of FIFRA.
purchaser. (i) Per-shipment purchaser
(iii) Identity of the product and the active acknowledgment statement. Unless the
ingredient(s), including: exporter chooses to follow the procedures
(A) The Chemical Abstract Services (CAS) described in paragraph (c)(2)(ii) of this section
Registry number for each active ingredient. for the annual reporting procedures, the
(B) The chemical nomenclature for each exporter must obtain and submit to EPA, a
active ingredient as used by the International signed purchaser acknowledgement
Union of Pure and Applied Chemists (IUPAC). statement prior to each shipment of an
(C) Other known chemical or common unregistered pesticide according to the
names; or if the export involves a research following procedures:
product, a code name or identification number (A) Prior to each shipment in a calendar
that can be used by EPA to identify the year of an unregistered pesticide product to a
product from the exporter’s records. If a code particular purchaser in a foreign country, the
name or identification number is used, exporter must provide the foreign purchaser
additional information must be attached to the with instructions about the required
certification statement submitted with the information on a purchaser acknowledgement
purchaser acknowledgement statement which statement, and inform the foreign purchaser
will enable EPA to identify the product. This that the pesticide product cannot be exported
attached information may be claimed as from the United States until the exporter has
confidential, and EPA will not forward this received from the foreign purchaser a properly
information with the purchaser completed, signed, and dated
acknowledgement statement to foreign acknowledgment statement.
governments. (B) The exporter must obtain, prior to each
(iv) If known or reasonably ascertainable, shipment in a calendar year of an unregistered
the country or countries of final destination of pesticide product to a particular purchaser in a
the export shipment, i.e., where the exported foreign country, a signed purchaser
pesticide is intended to be used, if different acknowledgment statement which contains
from the country of the foreign purchaser’s the information set forth in paragraph (c)(1) of
address. this section.
(v) A statement that indicates that the (C) The exporter must sign a statement
foreign purchaser understands that the certifying that export did not take place until a
product is not registered for use in the United signed purchaser acknowledgement
States and cannot be sold in the United States. statement was received. The exporter must
(vi) The signature of the foreign also specify the chemical identity of any
purchaser. research product which is referred to by code
(vii) The date of the foreign purchaser’s in the purchaser acknowledgement statement.
signature. The information regarding the specific identity
(2) Reporting options. At the discretion of of research products, which may be included
the exporter, the requirements of paragraph in the statement or consist of an attachment to
(c)(1) of this section may
the certification, may be claimed as is for the first shipment to a particular
confidential. purchaser in a specific country for that
(D) The exporter must submit the signed calendar year, and that the exporter will meet
acknowledgement statement from the foreign all the purchaser acknowledgement statement
purchaser, and the accompanying certification requirements as described in this paragraph
by the exporter including attachments, to EPA (c)(2)(ii) of this section. The exporter must also
within 7 working days of the exporter’s receipt specify the chemical identity of any research
of the purchaser acknowledgement statement, product which is referred to by code in the
or by the date of export, whichever occurs first. purchaser acknowledgement statement. The
This information must be transmitted to the information regarding the specific identity of
Office of Pesticide Programs’ Document research products, which may be included in
Processing Desk at the appropriate address as the statement or consist of an attachment to
set forth in 40 CFR 150.17(a) or the certification, may be claimed as
(b) , Attention: confidential.
Purchaser Acknowl (D) The exporter must submit the
edgement Statement. signed acknowledgement statement from the
(ii) Annual reporting procedures. Unless the foreign purchaser, and the accompanying
exporter chooses to follow the per-shipment certification by the exporter including
reporting option described in paragraph attachments, to EPA within 7 working days of
(c)(2)(i) of this section, the exporter must follow the exporter’s receipt of the purchaser
the procedures for annual summary reporting acknowledgement statement, or by the date of
which include the requirement of a purchaser export, whichever occurs first. This information
acknowledgement statement for the first must be transmitted to the Office of Pesticide
shipment each calendar year of an Programs’ Document Processing Desk at the
unregistered pesticide product to a particular appropriate address as set forth in 40 CFR
purchaser, and an annual summary of 150.17(a) or (b), Attention: Purchaser
shipments to that purchaser. The annual Acknowl
summary reporting procedures are as follows: edgement Statement.
(A) Prior to the first shipment each (E) The exporter, who has chosen to
calendar year of an unregistered pesticide comply with the requirements of this
product to a particular purchaser in a foreign paragraph instead of providing per- shipment
country, the exporter must provide the foreign purchaser acknowledgement statements in
purchaser with instructions about the required accordance with paragraph (c)(2)(i) of this
information on a purchaser acknowledgement section, must submit an annual summary
statement, and inform the foreign purchaser report to EPA. An annual summary report is
that the pesticide product cannot be exported required for each unregistered pesticide
from the United States until the exporter has exported within the preceding calendar year.
received from the foreign purchaser a properly The report must be in writing, signed by the
completed, signed, and dated purchaser exporter, and include the following
acknowledgement statement. information:
(B) The exporter must obtain, prior to the (1) Name, address, and EPA identification
first shipment each calendar year of an number if applicable, of the exporter.
unregistered pesticide product to a particular (2) Name and address of the foreign
purchaser in a foreign country, a signed purchaser, and the date the purchaser
purchaser acknowledgement statement which acknowledgement statement, submitted to
contains the information set forth in EPA during the previous calendar year, was
paragraph (c)(1) of this section. signed by the purchaser.
(C) The exporter must sign a statement (3) The identity of the product and the
certifying that export did not take place until a active ingredients, including: the Chemical
signed purchaser acknowledgement Abstract Services (CAS) registry number for
statement was received, indicating that this each active ingredient, the chemical
statement nomenclature for each active ingredient used
by the
International Union of Pure and Applied maintain certain records pertaining to
Chemists (IUPAC), and other known chemical pesticide products intended for export. In
or common names, or if the export involves a addition to the requirement that a copy of the
research product, the code name or purchaser acknowledgement statement be
identification number that can be used by EPA kept, as stated at § 169.2(h)(3) of this chapter,
to identify the product from the exporter’s the following records must be maintained:
records. (i) Copies of the instructions provided to
(4) The dates of each shipment of the foreign purchasers in accordance with
pesticide exported to the foreign purchaser paragraphs (c)(2)(i)(A) and
during that calendar year. (c) (2)(ii)(A) of this section.
(5) If known, or reasonably ascertainable, (ii) Copies of signed purchaser
the country or countries of final destination of acknowledgement statements obtained
the export shipments, i.e., where the exported according to paragraphs (c)(2)(i)(B) and
pesticide was intended to be used, if different (c)(2)(ii)(B) of this section.
from the foreign purchaser’s address. (iii) Copies of the certification from the
(F) The exporter shall submit the annual exporter; and copies of any accompanying
summary no later than March 1st of the information regarding the identity of coded
following calendar year. The annual summary R&D products.
shall be sent to the Office of Pesticide (d) Agency transmission of purchaser
Programs’ Document Processing Desk at the acknowledgement statements. EPA will
appropriate address as set forth in 40 CFR transmit a copy of each purchaser
150.17(a) or (b), Attention: Annual Summary of acknowledgement statement to the
Exports. appropriate government official in each of the
(iii) Confidentiality claims. Persons intended destination countries. After receipt of
submitting the information specified in the the Annual Summary the following calendar
purchaser acknowledgement statement may year, EPA will also transmit a copy of that
assert a claim of business confidentiality by document to the appropriate government
marking the information claimed confidential official in each of the intended destination
as ‘‘FIFRA Confidential Business Information.’’ countries. In the case that no Annual Summary
Information so claimed will not be disclosed, has been received within 30 days of the date
with the exception of disclosure to the foreign at which such summary is required to be
governments, except in accordance with the submitted, EPA will send written notification to
procedures set forth in 40 CFR part 2, 7 U.S.C. the appropriate government official indicating
136(h), and this policy statement. If such claim that no summary was submitted, and may also
is not asserted, EPA may disclose the take enforcement action against the exporter.
information to the public without providing [58 FR 9085, Feb. 18, 1993, as amended at 69 FR
further notice prior to disclosure or an 23117, Apr. 28 , 2004 ; 71 FR 35546, June 21, 2006; 72
opportunity to object. Notwithstanding any FR 61029, Oct. 26, 2007]
claim of confidentiality, the purchaser § 168.85 Other export requirements.
acknowledgement statement will continue to This section describes other requirements
be forwarded to the appropriate foreign found in regulations that apply to exporters of
government officials in its entirety, as required pesticides, devices, and active ingredients
by section 17(a)(2). used in producing a pesticide.
(3) Recordkeeping. Except as specifically (a) Recordkeeping and inspection.
stated, the requirement to retain records Exporters of pesticides, devices and active
under part 169 of this chapter applies to all ingredients must keep records and permit
pesticide producers, regardless of whether a inspections of those records in accordance
particular product is intended for export. All with part 169 of this chapter. Exporters must
records shall be maintained in accordance with keep records of the product labeling used,
the time period required by § 169.2(h) of this including the EPA registered labeling, any
chapter. Producers must also foreign labeling on or attached to the product
when shipped, and, as applicable, any
supplemental labeling used. Producers of solid products and as weight or volume of
pesticides for export shall maintain these liquid products.
records in a manner that shows exactly which (b) Batch. The term ‘‘batch’’ means a
labels and labeling accompanied each quantity of a pesticide product or active
shipment of a pesticide product to a foreign ingredient used in producing a pesticide made
country. As stated at § 168.75(c), when in one operation or lot or if made in a
research product identity information appears continuous or semi-continuous process or
on the labeling in an encoded manner, cycle, the quantity produced during an interval
information translating the code shall be of time to be specified by the producer.
maintained in records. These records shall be (c) Device. The term ‘‘device’’ means any
maintained for the time period required by § device or class of device as defined by the Act
169.2(h) of this chapter following the last and determined by the Administrator to be
export of such pesticides. All records required subject to the provisions of the Act.
by part 169 of this chapter shall be made (d) Inability. The term ‘‘inability’’ means the
available for inspection and copying by EPA or incapacity of any person to maintain, furnish
its duly authorized representatives. or permit access to any records under this Act
(b) Pesticide production establishment and regulations, where such incapacity arises
requirements. Exporters of pesticides, devices, out of causes beyond the control and without
and active ingredients must submit annual the fault or negligence of such person. Such
reports to EPA in accordance with part 167 of causes may include, but are not restricted to
this chapter, concerning those products that acts of God or of the public enemy, fires,
are exported. All products required to be floods, epidemics, quarantine restrictions,
labeled ‘‘Not Registered for Use in the United strikes, and unusually severe weather, but in
States of America’’ must be reported as every case, the failure must be beyond the
unregistered production regardless of whether control and without the fault or negligence of
a purchaser acknowledgement statement is said person.
required. (e) Producer. The term ‘‘producer’’ means
the person, as defined by the Act, who
PART 169—BOOKS AND RECORDS OF produces or imports any pesticide or device or
PESTICIDE PRODUCTION AND active ingredient used in producing a
DISTRIBUTION pesticide.
Sec. § 169.2 Maintenance of records.
169.1 Definitions. All producers of pesticides, devices, or
169.2 Maintenance of records. active ingredients used in producing
169.3 Inspection. pesticides subject to this Act, including
AUTHORITY: 7 U.S.C. 136f and 136w. pesticides produced pursuant to an
SOURCE: 45 FR 54338, Aug. 15, 1980, unless
experimental use permit and pesticides,
otherwise noted. devices, and pesticide active ingredients
produced for export, shall maintain the
§ 169.1 Definitions. following records:
Terms used in this part shall have the (a) Records showing the product name, EPA
meanings set forth for such terms in the Registration Number, Experimental Permit
Federal Insecticide, Fungicide, and Number if the pesticide is produced under an
Rodenticide Act, as amended. In addition, as Experimental Use Permit, amounts per batch
used in this part, the following terms shall have and batch identification (numbers, letters, etc.)
the meanings set forth below: of all pesticides produced. In cases where the
(a) Amount of pesticide or active product is an active ingredient used in
ingredient. The term ‘‘amount of pesticide or producing a pesticide or where the product is
active ingredient’’ means the weight or volume a pesticide which is not registered, is not the
of the pesticide or active ingredient used in subject of an application for registration, or is
producing a pesticide expressed as weight for not produced under an Experimental Use
solid or semi Permit, the records shall
also show the complete formula. The batch such as invoices, freight bills, receiving tickets,
identification shall appear on all production etc., which provide the required information
control records. These records shall be will be considered satisfactory for purposes of
retained for a period of two (2) years. this section. These records shall be retained for
(b) Records showing the brand names and a period of two (2) years.
quantities of devices produced. These records (e) Inventory records with respect to the
shall be retained for a period of two (2) years. types and amounts of pesticides or pesticide
(c) Records showing the following active ingredients, or quantities of devices in
information regarding the receipt, by the stock which he has produced. These records
producer, of all pesticides, devices, and active may be disposed of when a more current
ingredients used in producing pesticides: inventory record is prepared.
(1) Brand name of the pesticide or device, (f) Copies of all domestic advertising of the
or common or chemical name of the pesticide restricted uses of any pesticide registered for
active ingredient; restricted use which the producer caused to
(2) Name and address of shipper; have prepared, including any radio or
(3) Name of delivering carrier; television scripts for all such pesticides. These
(4) Date received; and records shall be retained for a period of two
(5) Quantities received. (2) years.
These records are not intended to cover (g) Copies of all guarantees given pursuant
receipt of pesticides used for in-plant to section 12(a)(2)(C) of the Act. These records
maintenance, extermination, or sanitation shall be retained for a period of one (1) year
programs, etc. Shipping and receiving after expiration of the guarantee.
documents such as invoices, freight bills, (h) In the case of all pesticides, devices, and
receiving tickets, etc., which provide the
active ingredients used in producing pesticides
required information will be considered
intended solely for export to any foreign
satisfactory for the purposes of this section.
These records shall be retained for a period of country:
two (2) years. (1) Copies of the specification or directions
(d) Records showing the following of the foreign purchaser for the production of
information regarding the shipment of all such pesticides, devices, or pesticide active
pesticides, devices, and active ingredients used ingredients;
in producing pesticides: (2) Copies of labels or labeling required to
(1) Brand name of pesticide or device, or comply with section 17(a)(1) of the Act; and
the common or chemical name of the (3) For any pesticide other than a pesticide
pesticide active ingredient; registered under section 3 or sold under
(2) Name and address of consignee; section 6(a)(1) of the Act, copies of a statement
(3) Where the pesticide is produced signed by the foreign purchaser of the
pursuant to an experimental use permit (FIFRA pesticide acknowledging that the purchaser
section 5), a special exemption (section 18), or understands that such pesticide is not
a special local need (section 24), the registered for use in the United States and
information required under these sections and cannot be sold in the United States under this
any regulations promulgated thereto Act.
regarding the distribution of such pesticides; These records shall be retained for a period of
(4) Name of originating carrier; 2 years after expiration of the contract.
(5) Date shipped or delivered for shipment; (i) Records on the method of disposal
and (burial, incineration, etc.) date or dates of
(6) Quantities shipped or delivered for disposal, location of the disposal sites, and the
shipment. types and amounts of pesticides or pesticide
Such records are required regardless of active ingredients disposed of by the producer
whether any shipment or receipt of shipment or his contractor. With regard to the disposal
is between plants owned or otherwise
controlled by the same person. Shipping and
receiving documents
of containers accumulated during production, Protection Agency Regional Administrator for
the Agency will consider satisfactory a maintenance.
statement, attested to by a responsible firm (k) Records containing research data
official, describing in general terms the relating to registered pesticides including all
method and location of disposal, e.g., all test reports submitted to the Agency in
containers are taken periodically to a certain support of registration or in support of a
site. Records of deviations from normal tolerance petition, all underlying raw data, and
practice must be maintained. In addition, any interpretations and evaluations thereof,
records on the disposal of pesticides or whether in the possession of the producer or
pesticide active ingredients and/or containers in the possession of the independent testing
specified pursuant to section 19 of the Act and facility or laboratory (if any) which performed
any regulations promulgated thereto shall also such tests on behalf of the producer. These
be maintained. The above requirements apply records shall be retained as long as the
to those products bearing label instructions for registration is valid and the producer is in
disposal and to any other products specified business.
under any regulations promulgated pursuant [45 FR 54338, Aug. 15, 1980, as amended at 58 FR
to section 19. These records shall be retained 9090, Feb. 18, 1993]
for twenty (20) years or may be forwarded
after three (3) years to the Environmental § 169.3 Inspection.
Protection Agency Regional Administrator for (a) Producers. Any producer of any
maintenance. Notwithstanding these record pesticide, device, or active ingredient used in
keeping requirements, whenever any producer producing a pesticide which is subject to this
of pesticides or pesticide active ingredients is Act shall, upon request of any officer or
complying with a rule promulgated under the employee of the Agency or of any State or
authority of the Resource Conservation and political subdivision, duly designated by the
Recovery Act of 1976 (RCRA) (Pub. L. 94-580, Administrator, furnish or permit such person at
90 Stat. 2795, October 21, 1976), for the all reasonable times to have access to and to
handling or disposal of hazardous wastes, as copy all records required to be maintained by
defined by RCRA or any regulations this part, including records in the possession
promulgated thereunder, such producer will of an independent testing facility or laboratory
which performed tests on behalf of the
no longer be required to maintain records in
producer. Such inspection will be conducted in
accordance with this subsection.
accordance with procedures detailed in
(j) Records of any tests conducted on section 8(b) of the Act.
human beings whether performed by the (b) Distributors, carriers, dealers, etc. Any
producer himself or authorized and/ or paid distributor, carrier, dealer, or any other person
for by the producer. Such records shall include: who sells or offers for sale, delivers or offers
The names and addresses of subjects tested, for delivery any pesticide, device, or active
dates of tests, types of tests, written consent of ingredient used in producing a pesticide which
subjects to test, and all information and is subject to this Act, shall, upon request of any
instructions given to the subjects regarding the officer or employee of the Agency or of any
nature and purpose of the tests and of any State or political subdivision, duly designated
physical and mental health consequences by the Administrator, furnish or permit such
which were reasonably foreseen therefrom, person at all reasonable times to have access
and any adverse effects of the test on the to and copy all records showing the delivery or
subjects, including any such effects coming to holding of such pesticide, device, or active
the attention of the producer after completion ingredient used in producing a pesticide,
of the tests. These records shall be retained for including the quantity, the date of shipment
twenty (20) years or may be forwarded after and receipt, and the name and address of the
three (3) years to the Environmental consignor and consignee, and any guarantee
received pursuant to section 12(b)(1) of the Act.
(c) Confidentiality. Any record which is 170.224 Notice of applications to agricultural
subject to the regulations under this part, and employers.
which may be confidential, shall be treated in 170.230 Pesticide safety training for handlers.
170.232 Knowledge of labeling and site-specific
accordance with the provisions of section 10 of information.
the Act. The availability to the public of 170.234 Safe operation of equipment.
information provided to, or otherwise 170.235 Posted pesticide safety information.
obtained by, the Administrator under this part 170.240 Personal protective equipment. 170.250
shall be governed by part 2 of this chapter. Decontamination.
(d) Inability. (1) In the event of the inability 170.260 Emergency assistance.
of any person to produce records containing AUTHORITY: 7 U.S.C. 136w.
the information required to be maintained, SOURCE: 57 FR 38151, Aug. 21, 1992, unless
furnished for inspection, or given access to, all otherwise noted.
other records and information regarding the
same shall be provided. Subpart A—General Provisions
(2) Where no such inability exists and any
such person fails to give access to and permit § 170.1 Scope and purpose.
copying of such records as required, such This part contains a standard designed to
failure shall be deemed a refusal to keep reduce the risks of illness or Injury resulting
records required or a refusal to allow the from workers’ and handlers’ occupational
inspection of any such records or both. exposures to pesticides used in the production
of agricultural plants on farms or in nurseries,
PART 170—WORKER PROTECTION greenhouses, and forests and also from the
STANDARD accidental exposure of workers and other
persons to such pesticides. It requires
Subpart A—General Provisions workplace practices designed to reduce or
Sec. eliminate exposure to pesticides and
170.1 Scope and purpose. establishes procedures for responding to
170.3 Definitions. exposure-related emergencies.
170.7 General duties and prohibited actions. 170.9
Violations of this part. § 170.3 Definitions.
Subpart B—Standard for Workers Terms used in this part have the same
170.102 Applicability of this subpart. meanings they have in the Federal Insecticide,
170.103 Exceptions. Fungicide, and Rodenticide Act, as amended.
170.104 Exemptions. In addition, the following terms, when used in
170.110 Restrictions associated with pesticide this part, shall have the following meanings:
applications. Agricultural employer means any person
170.112 Entry restrictions. who hires or contracts for the services of
170.120 Notice of applications.
170.122 Providing specific information about workers, for any type of compensation, to
applications. perform activities related to the production of
170.124 Notice of applications to handler employers. agricultural plants, or any person who is an
170.130 Pesticide safety training for workers. owner of or is responsible for the management
170.135 Posted pesticide safety information. 170.150 or condition of an agricultural establishment
Decontamination. that uses such workers.
170.160 Emergency assistance.
Agricultural establishment means any farm,
Subpart C—Standard for Pesticide forest, nursery, or greenhouse.
Handlers Agricultural plant means any plant grown or
maintained for commercial or research
170.202 Applicability of this subpart. purposes and includes, but is not limited to,
170.203 Exceptions. food, feed, and fiber plants; trees; turfgrass;
170.204 Exemptions.
170.210 Restrictions during applications. 170.222 flowers, shrubs; ornamentals; and seedlings.
Providing specific information about applications. Chemigation means the application of
pesticides through irrigation systems.
Commercial pesticide handling limited to, harvesting, detasseling, thinning,
establishment means any establishment, other weeding, topping, planting, sucker removal,
than an agricultural establishment, that: pruning, disbudding, roguing, and packing
(1) Employs any person, including a self- produce into containers in the field. Hand
employed person, to apply on an agricultural labor does not include operating, moving, or
establishment, pesticides used in the repairing irrigation or watering equipment or
production of agricultural plants. performing the tasks of crop advisors.
(2) Employs any person, including a self- Handler means any person, including a self-
employed person, to perform on an employed person:
agricultural establishment, tasks as a crop (1) Who is employed for any type of
advisor. compensation by an agricultural establishment
Crop advisor means any person who is or commercial pesticide handling
assessing pest numbers or damage, pesticide establishment to which subpart C of this part
distribution, or the status or requirements of applies and who is:
agricultural plants. The term does not include (1) Mixing, loading, transferring, or
any person who is performing hand labor applying pesticides.
tasks. (ii) Disposing of pesticides or pesticide
Early entry means entry by a worker into a containers.
treated area on the agricultural establishment (iii) Handling opened containers of
after a pesticide application is complete, but pesticides.
before any restricted-entry interval for the (iv) Acting as a flagger.
pesticide has expired. (v) Cleaning, adjusting, handling, or
Farm means any operation, other than a repairing the parts of mixing, loading, or
nursery or forest, engaged in the outdoor application equipment that may contain
production of agricultural plants. pesticide residues.
Forest means any operation engaged in the (vi) Assisting with the application of
outdoor production of any agricultural plant to pesticides.
produce wood fiber or timber products. (vii) Entering a greenhouse or other
Fumigant means any pesticide product that enclosed area after the application and before
is a vapor or gas, or forms a vapor or gas on the inhalation exposure level listed in the
application, and whose method of pesticidal labeling has been reached or one of the
action is through the gaseous state. ventilation criteria established by this part (§
Greenhouse means any operation engaged 170.110(c)(3)) or in the labeling has been met:
in the production of agricultural plants inside (A) To operate ventilation equipment.
any structure or space that is enclosed with (B) To adjust or remove coverings used in
nonporous covering and that is of sufficient fumigation.
size to permit worker entry. This term includes, (C) To monitor air levels.
but is not limited to, polyhouses, mushroom (viii) Entering a treated area outdoors
houses, rhubarb houses, and similar structures. after application of any soil fumigant to adjust
It does not include such structures as malls, or remove soil coverings such as tarpaulins.
atriums, conservatories, arboretums, or office (ix) Performing tasks as a crop advisor:
buildings where agricultural plants are present (A) During any pesticide application.
primarily for aesthetic or climatic modification. (B) Before the inhalation exposure level
Hand labor means any agricultural activity listed in the labeling has been reached or one
performed by hand or with hand tools that of the ventilation criteria established by this
causes a worker to have substantial contact part (§ 170.110(c)(3)) or in the labeling has been
with surfaces (such as plants, plant parts, or met.
soil) that may contain pesticide residues. These (C) During any restricted-entry interval.
activities include, but are not (2) The term does not include any person
who is only handling pesticide containers that
have been emptied or
cleaned according to pesticide product § 170.7 General duties and prohibited actions.
labeling instructions or, in the absence of such (a) General duties. The agricultural
instructions, have been subjected to triple- employer or the handler employer, as
rinsing or its equivalent. appropriate, shall:
Handler employer means any person who is (1) Assure that each worker subject to
self-employed as a handler or who employs subpart B of this part or each handler subject
any handler, for any type of compensation. to subpart C of this part receives the
Immediate family includes only spouse, protections required by this part.
children, stepchildren, foster children, parents, (2) Assure that any pesticide to which
stepparents, foster parents, brothers, and subpart C of this part applies is used in a
sisters. manner consistent with the labeling of the
Nursery means any operation engaged in pesticide, including the requirements of this
the outdoor production of any agricultural part.
plant to produce cut flowers and ferns or (3) Provide, to each person who supervises
plants that will be used in their entirety in any worker or handler, information and
another location. Such plants include, but are directions sufficient to assure that each worker
not limited to, flowering and foliage plants or or handler receives the protections required by
this part. Such information and directions shall
trees; tree seedlings; live Christmas trees;
specify which persons are responsible for
vegetable, fruit, and ornamental transplants; actions required to comply with this part.
and turfgrass produced for sod. (4) Require each person who supervises
Owner means any person who has a present any worker or handler to assure compliance by
possessory interest (fee, leasehold, rental, or the worker or handler with the provisions of
other) in an agricultural establishment covered this part and to assure that the worker or
by this part. A person who has both leased handler receives the protections required by
such agricultural establishment to another this part.
person and granted that same person the right (b) Prohibited actions. The agricultural
and full authority to manage and govern the employer or the handler employer shall not
use of such agricultural establishment is not an take any retaliatory action for attempts to
owner for purposes of this part. comply with this part or any action having the
Restricted-entry interval means the time effect of preventing or discouraging any
after the end of a pesticide application during worker or handler from complying or
which entry into the treated area is restricted. attempting to comply with any requirement of
Treated area means any area to which a this part.
pesticide is being directed or has been § 170.9 Violations of this part.
directed. (a) Under the Federal Insecticide,
Worker means any person, including a self- Fungicide, and Rodenticide Act (7 U.S.C. 136 et
employed person, who is employed for any seq.) (FIFRA) section 12(a)(2)(G) it is unlawful
type of compensation and who is performing for any person ‘‘to use any registered pesticide
activities relating to the production of in a manner inconsistent with its labeling.’’
agricultural plants on an agricultural When this part is referenced on a label, users
establishment to which subpart B of this part must comply with all of its requirements except
applies. While persons employed by a those that are inconsistent with product-
commercial pesticide handling establishment specific instructions on the labeling. For the
purposes of this part, EPA interprets the term
are performing tasks as crop advisors, they are
‘‘use’’ to include:
not workers covered by the requirements of (1) Preapplication activities, including, but
subpart B of this part. not limited to:
(i) Arranging for the application of the
pesticide;
(ii) Mixing and loading the pesticide; and Subpart B—Standard for Workers
(iii) Making necessary preparations for the
§ 170.102 Applicability of this subpart.
application of the pesticide, including
responsibilities related to worker notification, Except as provided by §§170.103 and 170.104,
training of handlers, decontamination, use and this subpart applies when any pesticide
care of personal protective equipment, product is used on an agricultural
emergency information, and heat stress establishment in the production of agricultural
management. plants.
(2) Application of the pesticide. [60 FR 21952, May 3, 1995]
(3) Post-application activities necessary to
§ 170.103 Exceptions.
reduce the risks of illness and injury resulting
from handlers’ and workers’ occupational Exceptions. This subpart does not apply
exposures to pesticide residues during the when any pesticide is applied on an
restricted-entry interval plus 30 days. These agricultural establishment in the following
activities include, but are not limited to, circumstances:
responsibilities related to worker training, (a) For mosquito abatement,
notification, and decontamination. Mediterranean fruit fly eradication, or similar
(4) Other pesticide-related activities, wide-area public pest control programs
including, but not limited to, providing sponsored by governmental entities;
emergency assistance, transporting or storing (b) On livestock or other animals, or in or
pesticides that have been opened, and about animal premises;
disposing of excess pesticides, spray mix, (c) On plants grown for other than
equipment wash waters, pesticide containers, commercial or research purposes, which may
and other pesticide-containing materials. include plants in habitations, home fruit and
(b) A person who has a duty under this vegetable gardens, and home greenhouses;
part, as referenced on the pesticide product (d) On plants that are in ornamental
label, and who fails to perform that duty, gardens, parks, and public or private lawns and
violates FIFRA section 12(a)(2)(G) and is subject grounds that are intended only for aesthetic
to a civil penalty under section 14. A person purposes or climatic modification;
who knowingly violates section 12(a)(2)(G) is (e) By injection directly into agricultural
subject to section 14 criminal sanctions. plants. Direct injection does not include ‘‘hack
(c) FIFRA section 14(b)(4) provides that a and squirt,’’ ‘‘frill and spray,’’ chemigation, soil-
person is liable for a penalty under FIFRA if incorporation, or soil-injection;
another person employed by or acting for that (f) In a manner not directly related to the
person violates any provision of FIFRA. The
production of agricultural plants, including,
term ‘‘acting for’’ includes both employment
but not limited to, structural pest control,
and contractual relationships.
(d) The requirements of this part, including control of vegetation along rights-of-way and
the decontamination requirements, shall not, in other noncrop areas, and pasture and
for the purposes of section 653(b)(1) of title 29 rangeland use;
of the U.S. Code, be deemed to be the exercise (g) For control of vertebrate pests;
of statutory authority to prescribe or enforce (h) As attractants or repellents in traps;
standards or regulations affecting the general (i) On the harvested portions of
sanitary hazards addressed by the OSHA Field agricultural plants or on harvested timber; and
Sanitation Standard, 29 CFR 1928.110, or other (j) For research uses of unregistered
agricultural, nonpesticide hazards. pesticides.
[57 FR 38151, Aug. 21, 1992. Redesignated at 60 FR
21952, May 3, 1995]
§ 170.104 Exemptions. (2) Conditions of exemption. (i) The
The workers listed In this section are exempt certification or licensing program requires
from the specified provisions of this subpart. pesticide safety training that includes, at least,
(a) Owners of agricultural establishments. all the information in § 170.230(c)(4).
(1) The owner of an agricultural establishment (ii) Applies only when performing crop
is not required to provide to himself or advising tasks in the treated area.
members of his immediate family who are (iii) The crop advisor must make specific
performing tasks related to the production of determinations regarding the appropriate
agricultural plants on their own agricultural personal protective equipment, appropriate
establishment the protections of: decontamination supplies, and how to
(1) Section 170.112(c)(5) through (9). conduct the tasks safely. The crop advisor
(ii) Section 170.112(c)(5) through (9) as must convey this information to each person
referenced in §§170.112(d)(2)(iii) and 170.112(e). under his direct supervision in a language that
(iii) Section 170.120. the person understands.
(iv) Section 170.122. (iv) Before entering a treated area, the
(v) Section 170.130. certified or licensed crop advisor must inform,
(vi) Section 170.135. through an established practice of
(vii) Section 170.150. communication, each person under his direct
(viii) Section 170.160. supervision of the pesticide product and active
ingre- dient(s) applied, method of application,
(2) The owner of the agricultural
time of application, the restricted entry
establishment must provide the protections
interval, which tasks to undertake, and how to
listed in paragraph (a)(1)(i) through (viii) of this
contact the crop advisor.
section to other workers and other persons [60 FR 21952, May 3, 1995, as amended at 73 FR
who are not members of his immediate family. 75598, Dec. 12, 2008]
(b) Crop advisors. (1) Provided that the
conditions of paragraph (b)(2) of this section §170.110 Restrictions associated with pesticide
are met, a person who is certified or licensed applications.
as a crop advisor by a program acknowledged (a) Farms and forests. During the
as appropriate in writing by EPA or a State or application of any pesticide on a farm or in a
forest, the agricultural employer shall not allow
Tribal lead agency for pesticide enforcement,
or direct any person, other than an
and persons performing crop advising tasks
appropriately trained and equipped handler,
under such qualified crop advisor’s direct to enter or to remain in the treated area.
supervision, are exempt from the provisions of: (b) Nurseries. In a nursery, during any
(i) Section 170.150. pesticide application described in column A of
(ii) Section 170.160. Table 1 of this paragraph, the agricultural
A person is under the direct supervision of a employer shall not allow or direct any person,
crop advisor when the crop advisor exerts the other than an appropriately trained and
supervisory controls set out in paragraphs equipped handler, to enter or to remain in the
(b)(2)(iii) and (iv) of this section. Direct area specified in column B of Table 1 of this
supervision does not require that the crop paragraph. After the application is completed,
advisor be physically present at all times, but until the end of any restricted-entry interval,
the crop advisor must be readily accessible to the entry-restricted area is the treated area.
the employees at all times.
(b) Applied as a:
(I) Fumigant,
or
(ii) Smoke, or
(ill) Mist, or
(iv) Fog, or
(v) Aerosol. Treated are plus 25 feet in all
(2) (a) Applied directions on the nursery
downward(i)using:
A height of greater than 12 inches from the planting medium, or
(ii) A fine spray, or
(iii) A spray pressure greater than 40 psi and less than 150 psi.
(b) Not as in 1 or 2(a) above but for which a respiratory protection device is required for
application by the product labeling.
(3) Applied otherwise. Treated area
(c) Greenhouses. (1) When a pesticide the air concentration is measured to be equal
application described in column A of Table 2 to or less than the inhalation exposure level
under paragraph (c)(4) of this section takes the labeling requires to be achieved. If no
place in a greenhouse, the agricultural inhalation exposure level is listed on the
employer shall not allow or direct any person, labeling, ventilation shall continue until after:
other than an appropriately trained and (i) Ten air exchanges are completed; or
equipped handler, to enter or to remain in the (ii) Two hours of ventilation using fans or
area specified in column B of Table 2 until the other mechanical ventilating systems; or
time specified in column C of Table 2 has (iii) Four hours of ventilation using vents,
expired. windows or other passive ventilation; or
(2) After the time specified in column C of (iv) Eleven hours with no ventilation
Table 2 under paragraph (c)(4) of this section followed by 1 hour of mechanical ventilation;
has expired, until the expiration of any or
restricted-entry interval, the agricultural (v) Eleven hours with no ventilation
employer shall not allow or direct any worker followed by 2 hours of passive ventilation; or
to enter or to remain in the treated area as (vi) Twenty-four hours with no ventilation.
specified in column D of Table 2 under (4) The following Table 2 applies to
paragraph (c)(4) of this section, except as paragraphs (c) (1), (2), and (3) of this section.
provided in §170.112.
(3) When column C of Table 2 under
paragraph (c)(4) of this section specifies that
ventilation criteria must be met, ventilation
shall continue until
(1) AS a fumigant Entire greenhouse plus any ad- The ventilation criteria of para- No entry restrictions after criteria
jacent structure that cannot be graph (c)(3) of this section are met in column C are met
sealed off from the treated area
(2) As a Entire enclosed area The ventilation criteria of paragraph Entire enclosed area is the treated
(c)(3) of this section are met area
(i) smoke, or
(ii) Mist, or
(iii) Fog, or
(iv) Aerosol
TABLE 2—GREENHOUSE ENTRY RESTRICTIONS ASSOCIATED WITH PESTICIDE APPLICATIONS—
Continued
D. After the Expiration of Time in
Column C Until the Restricted-
A. When a Pesticide is B. Workers are Prohibited in: C. Until: Entry Interval Expires, the Entry-
Applied: Restricted Area is:
EC01MY92.111
(2) The standard sign shall be at least 14 less a smaller sign is necessary because the
inches by 16 inches with letters at least 1 inch treated area is too small to accommodate a
in height. Farms and forests shall use the sign of this size. In nurseries
standard size sign un
and greenhouses, the agricultural employer ners of the treated area or In any other
may, at any time, use a sign smaller than the location affording maximum visibility.
standard size sign. Whenever a small sign is (6) The signs shall:
used on any establishment, there are specific (i) Be posted no sooner than 24 hours
posting distances depending on the size of the before the scheduled application of the
lettering and symbol on the sign. If a sign is pesticide.
used with DANGER and PELIGRO in letters at (ii) Remain posted throughout the
least % inch in height and the remaining letters application and any restricted-entry interval.
at least 12 inch in height and a red circle at least (iii) Be removed within 3 days after the
3 inches in diameter containing an upraised end of the application and any restricted-entry
hand and a stern face, the signs shall be no interval and before agricultural-worker entry is
further than 50 feet apart. If a sign is used with permitted, other than entry permitted by
DANGER and PELIGRO in letters at least 7/i6 §170.112.
inch in height and the remaining letters at least (7) The signs shall remain visible and
14 inch in height and a red circle at least 112 legible during the time they are posted.
inches in diameter containing an upraised (8) When several contiguous areas are to
hand and a stern face, the signs shall be no be treated with pesticides on a rotating or
further than 25 feet apart. A sign with DANGER sequential basis, the entire area may be
and PELIGRO in letters less than 7/ie inch in posted. Worker entry, other than entry
height or with any words in letters less than 14 permitted by §170.112, is prohibited for the
inch in height or a red circle smaller than 112 entire area while the signs are posted.
inches in diameter containing an upraised (d) Oral warnings. The agricultural employer
hand and a stern face will not satisfy the shall provide oral warnings to workers in a
requirements of the rule. All signs must meet manner that the worker can understand. If a
the requirements of paragraph (c)(1) of this worker will be on the premises during the
section. application, the warning shall be given before
(3) The employer may replace the Spanish the application takes place. Otherwise, the
portion of the warning sign with a non-English warning shall be given at the beginning of the
language read by the largest group of workers worker’s first work period during which the
who do not read English. The replacement sign application is taking place or the restricted-
must be in the same format as the original sign entry interval for the pesticide is in effect. The
and be visible and legible. warning shall consist of:
(4) On farms and in forests and nurseries, (1) The location and description of the
the signs shall be visible from all usual points treated area.
of worker entry to the treated area, including (2) The time during which entry is
at least each access road, each border with any restricted.
labor camp adjacent to the treated area, and (3) Instructions not to enter the treated
each footpath and other walking route that area until the restricted-entry interval has
enters the treated area. When there are no expired.
usual points of worker entry, signs shall be [57 FR 38151, Aug. 21, 1992, as amended at 61 FR
posted in the corners of the treated area or in 33207, June 26, 1996]
any other location affording maximum § 170.122 Providing specific information about
visibility. applications.
(5) In greenhouses, the signs shall be When workers are on an agricultural
posted so they are visible from all usual points establishment and, within the last 30 days, a
of worker entry to the treated area including pesticide covered by this subpart has been
each aisle or other walking route that enters applied on the establishment or a restricted-
the treated area. When there are no usual entry interval has been in effect, the
points of worker entry to the treated area, agricultural employer shall display, in
signs shall be posted in the cor accordance with this section, specific
information about the pesticide.
(a) Location, accessibility, and legibility. § 170.130 Pesticide safety training for workers.
The Information shall be displayed In the (a) General requirement—(1) Agricultural
location specified for the pesticide safety employer assurance. The agricultural employer
poster in § 170.135(d) and shall be accessible shall assure that each worker, required by this
and legible, as specified in § 170.135 (e) and (f). section to be trained, has been trained
(b) Timing. (1) If warning signs are posted according to this section during the last 5
for the treated area before an application, the years, counting from the end of the month in
specific application information for that which the training was completed.
application shall be posted at the same time or (2) Requirement for workers performing
earlier. early-entry activities. Before a worker enters a
(2) The information shall be posted before treated area on the agricultural establishment
the application takes place, if workers will be during a restricted-entry interval to perform
on the establishment during application. early-entry activities permitted by § 170.112 and
Otherwise, the information shall be posted at contacts anything that has been treated with
the beginning of any worker’s first work the pesticide to which the restricted-entry
period. interval applies, including but not limited to,
(3) The information shall continue to be soil, water, or surfaces of plants, the
displayed for at least 30 days after the end of agricultural employer shall assure that the
the restricted-entry interval (or, if there is no worker has been trained.
restricted-entry interval, for at least 30 days (3) Requirements for other agricultural
after the end of the application) or at least until workers—(i) Information before entry. Except
workers are no longer on the establishment, as provided in paragraph (a)(2) of this section,
whichever is earlier. before a worker enters any areas on the
(c) Required information. The information agricultural establishment where, within the
shall include: last 30 days a pesticide to which this subpart
(1) The location and description of the applies has been applied or the restricted-
treated area. entry interval for such pesticide has been in
(2) The product name, EPA registration effect, the agricultural employer shall assure
number, and active ingredient(s) of the that the worker has been provided the
pesticide. pesticide safety information specified in
(3) The time and date the pesticide is to be paragraph (c) of this section, in a manner that
applied. agricultural workers can understand, such as
(4) The restricted-entry interval for the by providing written materials or oral
pesticide. communication or by other means. The
agricultural employer must be able to verify
§ 170.124 Notice of applications to handler
employers.
compliance with this requirement.
Whenever handlers who are employed by a (ii) Training before the 6th day of entry.
commercial pesticide handling establishment Except as provided in paragraph
will be performing pesticide handling tasks on (a) (2) of this section, before the 6th day
an agricultural establishment, the agricultural that a worker enters any areas on the
employer shall provide to the handler agricultural establishment where, within the
employer, or assure that the handler employer last 30 days a pesticide to which this subpart
is aware of, the following information applies has been applied or a restricted-entry
concerning any areas on the agricultural interval for such pesticide has been in effect,
establishment that the handler may be in (or the agricultural employer shall assure that the
may walk within 1/4 mile of) and that may be worker has been trained.
treated with a pesticide or that may be under (b) Exceptions. The following persons need
a restricted-entry interval while the handler will not be trained under this section:
be on the agricultural establishment: (1) A worker who is currently certified as an
(a) Specific location and description of any applicator of restricted-use
such areas; and
(b) Restrictions on entering those areas.
pesticides under part 171 of this chapter. senter also shall respond to workers’
(2) A worker who satisfies the training questions.
requirements of part 171 of this chapter. (2) The person who conducts the training
(3) A worker who satisfies the handler shall meet at least one of the following criteria:
training requirements of § 170.230(c). (i) Be currently certified as an applicator of
(4) A worker who is certified or licensed as restricted-use pesticides under part 171 of this
a crop advisor by a program acknowledged as chapter; or
appropriate in writing by EPA or a State or (ii) Be currently designated as a trainer of
Tribal lead agency for pesticide enforcement, certified applicators or pesticide handlers by a
provided that a requirement for such State, Federal, or Tribal agency having
certification or licensing is pesticide safety jurisdiction; or
training that includes all the information set (iii) Have completed a pesticide safety
out in § 170.230(c)(4). train-the-trainer program approved by a State,
(c) Pesticide safety information. The Federal, or Tribal agency having jurisdiction; or
pesticide safety information required by (iv) Satisfy the training requirements in
paragraph (a)(3)(i) shall be presented to part 171 of this chapter or in § 170.230(c).
workers in a manner that the workers can (3) Any person who issues an EPA-ap-
understand. At a minimum, the following proved Worker Protection Standard worker
information shall be provided: training certificate must assure that the worker
(1) Pesticides may be on or in plants, soil, who receives the training certificate has been
irrigation water, or drifting from nearby trained in accordance with paragraph (d)(4) of
applications. this section.
(2) Prevent pesticides from entering your (4) The training materials shall convey, at a
minimum, the following information:
body by:
(i) Where and in what form pesticides may
(i) Following directions and/or signs about
be encountered during work activities.
keeping out of treated or restricted areas. (ii) Hazards of pesticides resulting from
(ii) Washing before eating, drinking, using toxicity and exposure, including acute and
chewing gum or tobacco, or using the toilet. chronic effects, delayed effects, and
(iii) Wearing work clothing that protects sensitization.
the body from pesticide residues. (iii) Routes through which pesticides can
(iv) Washing/showering with soap and enter the body.
water, shampoo hair, and put on clean clothes (iv) Signs and symptoms of common
after work. types of pesticide poisoning.
(v) Washing work clothes separately from (v) Emergency first aid for pesticide
other clothes before wearing them again. injuries or poisonings.
(vi) Washing immediately in the nearest (vi) How to obtain emergency medical
clean water if pesticides are spilled or sprayed care.
on the body. As soon as possible, shower, (vii) Routine and emergency
shampoo, and change into clean clothes. decontamination procedures, including
(3) Further training will be provided within emergency eyeflushing techniques.
5 days. (viii) Hazards from chemigation and drift.
(d) Training programs. (1) General pesticide (ix) Hazards from pesticide residues on
safety information shall be presented to clothing.
workers either orally from written materials or (x) Warnings about taking pesticides or
audiovisually. The information must be pesticide containers home.
presented in a manner that the workers can (xi) Requirements of this subpart designed
understand (such as through a translator) to reduce the risks of illness or injury resulting
using nontechnical terms. The pre from workers’ occupational exposure to
pesticides, including application and entry
restrictions, the design of the warning sign,
posting of
warning signs, oral warnings, the availability of (iv) Wash/shower with soap and water,
specific information about applications, and shampoo hair, and put on clean clothes after
the protection against retaliatory acts. work.
(e) Verification of training. (1) Except as (v) Wash work clothes separately from
provided in paragraph (e)(2) of this section, if other clothes before wearing them again.
the agricultural employer assures that a worker (vi) Wash immediately in the nearest clean
possesses an EPA-approved Worker water if pesticides are spilled or sprayed on the
Protection Standard worker training certificate, body. As soon as possible, shower, shampoo,
then the requirements of paragraph (a) and (c) and change into clean clothes.
of this section will have been met. (vii) Follow directions about keeping out
(2) If the agricultural employer is aware or of treated or restricted areas.
has reason to know that an EPA-approved (2) There are Federal rules to protect
Worker Protection Standard worker training workers and handlers, including a requirement
certificate has not been issued in accordance for safety training.
with this section, or has not been issued to the (c) Emergency medical care
worker bearing the certificate, or the training information.
was completed more than 5 years before the (1) The name, address, and telephone
beginning of the current month, a worker’s number of the nearest emergency medical
possession of that certificate does not meet care facility shall be on the safety poster or
the requirements of paragraph (a) of this displayed close to the safety poster.
section. (2) The agricultural employer shall inform
[57 FR 38151, Aug. 21, 1992, as amended at 60 FR workers promptly of any change to the
21947 , 21952, May 3, 1995; 73 FR 75598, Dec. 12, information on emergency medical care
2008] facilities.
§ 170.135 Posted pesticide safety information. (d) Location. (1) The information shall be
displayed in a central location on the farm or
(a) Requirement. When workers are on an in the nursery or greenhouse where it can be
agricultural establishment and, within the last readily seen and read by workers.
30 days, a pesticide covered by this subpart (2) The information shall be displayed in a
has been applied on the establishment or a location in or near the forest in a place where
restricted- entry interval has been in effect, the it can be readily seen and read by workers and
agricultural employer shall display, in where workers are likely to congregate or pass
accordance with this section, pesticide safety by, such as at a decontamination site or an
information. equipment storage site.
(b) Pesticide safety poster. A safety poster (e) Accessibility. Workers shall be informed
must be displayed that conveys, at a minimum, of the location of the information and shall be
the following basic pesticide safety concepts: allowed access to it.
(1) Help keep pesticides from entering your (f) Legibility. The information shall remain
body. At a minimum, the following points shall legible during the time it is posted.
be conveyed:
(i) Avoid getting on your skin or into your § 170.150 Decontamination.
body any pesticides that may be on plants and (a) (1) Requirement. The agricultural
soil, in irrigation water, or drifting from nearby employer must provide decontamination
applications. supplies for workers in accordance with this
(ii) Wash before eating, drinking, using section whenever:
chewing gum or tobacco, or using the toilet. (i) Any worker on the agricultural
(iii) Wear work clothing that protects the establishment is performing an activity in the
body from pesticide residues (long-sleeved area where a pesticide was applied or a
shirts, long pants, shoes and socks, and a hat restricted-entry interval (REI) was in effect
or scarf). within the last 30 days, and;
(ii) The worker contacts anything that has
been treated with the pesticide, including, but
not limited to
soil, water, plants, plant surfaces, and plant (11) The agricultural employer may permit
parts. workers to use clean water from springs,
(2) Exception. The 30-day time period streams, lakes, or other sources for
established in paragraph (a)(1)(i) of this section decontamination at the remote work site, if
shall not apply if the only pesticides used in the such water is more accessible than the water
treated area are products with an REI of 4 located at the nearest place of vehicular
hours or less on the label (but not a product access.
without an REI on the label). When workers are (3) The decontamination supplies shall not
in such treated areas, the agricultural employer be maintained in an area being treated with
shall provide decontamination supplies for not pesticides.
less than 7 days following the expiration of any (4) The decontamination supplies shall not
applicable REI. be maintained in an area that is under a
(b) General conditions. (1) The agricultural restricted-entry interval, unless the workers for
employer shall provide workers with enough whom the supplies are provided are
water for routine washing and emergency performing early- entry activities permitted by
eyeflushing. At all times when the water is §170.112 and involving contact with treated
available to workers, the employer shall assure surfaces and the decontamination supplies
that it is of a quality and temperature that will would otherwise not be reasonably accessible
not cause illness or injury when it contacts the to those workers.
skin or eyes or if it is swallowed. (d) Decontamination after early-entry
(2) When water stored in a tank is to be activities. At the end of any exposure period
used for mixing pesticides, it shall not be used for workers engaged in early- entry activities
for decontamination or eyeflushing, unless the permitted by §170.112 and involving contact
tank is equipped with properly functioning with anything that has been treated with the
valves or other mechanisms that prevent pesticide to which the restricted-entry interval
movement of pesticides into the tank. applies, including, but not limited to, soil,
(3) The agricultural employer shall provide water, air, or surfaces of plants, the agricultural
soap and single-use towels in quantities employer shall provide, at the site where the
sufficient to meet worker’s needs. workers remove personal protective
(4) To provide for emergency equipment, soap, clean towels, and a sufficient
eyeflushing, the agricultural employer shall amount of water so that the workers may wash
assure that at least 1 pint of water is thoroughly.
immediately available to each worker who is
performing early-entry activities permitted by [57 FR 38151, Aug. 21, 1992, as amended at 61 FR
33212, June 26, 1996]
§170.112 and for which the pesticide labeling
requires protective eyewear. The eyeflush § 170.160 Emergency assistance.
water shall be carried by the early-entry If there is reason to believe that a person
worker, or shall be on the vehicle the early- who is or has been employed on an
entry worker is using, or shall be otherwise agricultural establishment to perform tasks
immediately accessible. related to the production of agricultural plants
(c) Location. (1) The decontamination has been poisoned or injured by exposure to
supplies shall be located together and be pesticides used on the agricultural
reasonably accessible to and not more than 14 establishment, including, but not limited to,
mile from where workers are working. exposures from application, splash, spill, drift,
(2) For worker activities performed more or pesticide residues, the agricultural employer
than 1/4 mile from the nearest place of shall:
vehicular access: (a) Make available to that person prompt
(i) The soap, single-use towels, and water transportation from the agricultural
may be at the nearest place of vehicular establishment, including any labor camp on
access. the agricultural establishment, to an
appropriate emergency medical facility.
(b) Provide to that person or to treating
medical personnel, promptly upon
request, any obtainable Information on: (h) On the harvested portions of
(1) Product name, EPA registration agricultural plants or on harvested timber.
number, and active ingredients of any product (i) For research uses of unregistered
to which that person might have been pesticides.
exposed.
(2) Antidote, first aid, and other medical [57 FR 38151, Aug. 21, 1992. Redesignated at 60 FR
21952, May 3, 1995]
information from the product labeling.
(3) The circumstances of application or use § 170.204 Exemptions.
of the pesticide on the agricultural The handlers listed in this section are
establishment. exempt from the specified provisions of this
(4) The circumstances of exposure of that subpart.
person to the pesticide. (a) Owners of agricultural establishments.
(1) The owner of an agricultural establishment
Subpart C—Standard for Pesticide is not required to provide to himself or
Handlers members of his immediate family who are
§ 170.202 Applicability of this subpart. performing handling tasks on their own
Except as provided by §§170.203 and agricultural establishment the protections of:
170.204, this subpart applies when any (1) Section 170.210(b) and (c).
pesticide is handled for use on an agricultural (ii) Section 170.222.
establishment. (iii) Section 170.230.
[60 FR 21952, May 3, 1995] (iv) Section 170.232.
(v) Section 170.234.
§ 170.203 Exceptions. (vi) Section 170.235.
Exceptions. This subpart does not apply (vii) Section 170.240(e) through (g).
when any pesticide is handled for use on an (viii) Section 170.250.
agricultural establishment in the following (ix) Section 170.260.
circumstances: (2) The owner of the agricultural
(a) For mosquito abatement, establishment must provide the protections
Mediterranean fruit fly eradication, or similar listed in paragraphs (a)(1) (i) through (ix) of this
wide-area public pest control programs section to other handlers and other persons
sponsored by governmental entities. who are not members of his immediate family.
(b) On livestock or other animals, or in or (b) Crop advisors. (1) Provided that the
about animal premises. conditions of paragraph (b)(2) of this section
(c) On plants grown for other than are met, a person who is certified or licensed
commercial or research purposes, which may as a crop advisor by a program acknowledged
include plants in habitations, home fruit and as appropriate in writing by EPA or a State or
vegetable gardens, and home greenhouses. Tribal lead agency for pesticide enforcement,
(d) On plants that are in ornamental and persons performing crop advising tasks
gardens, parks, and public or private lawns and under such qualified crop advisor’s direct
grounds and that are intended only for supervision, are exempt from the provisions of:
aesthetic purposes or climatic modification. (i) Section 170.232.
(e) In a manner not directly related to the (ii) Section 170.240.
production of agricultural plants, including, (iii) Section 170.250.
but not limited to, structural pest control, (iv) Section 170.260.
control of vegetation along rights-of-way and A person is under the direct supervision of a
in other noncrop areas, and pasture and crop advisor when the crop advisor exerts the
rangeland use. supervisory controls set out in paragraphs
(f) For control of vertebrate pests. (b)(2)(iv) and (v) of this section. Direct
(g) As attractants or repellents in traps. supervision does not require that the crop
advisor be physically present at all times, but
the crop advisor must be readily accessible to
the employees at all times.
(2) Conditions of exemption. (1) The ual or voice contact with another handler.
certification or licensing program requires (2) That the other handler has immediate
pesticide safety training that includes, at least, access to the personal protective equipment
all the information in § 170.230(c)(4). required by the fumigant labeling for handlers
(ii) No entry into the treated area occurs in the event entry into the fumigated
until after application ends. greenhouse becomes necessary for rescue.
(iii) Applies only when performing crop § 170.222 Providing specific information about
advising tasks in the treated area. applications.
(iv) The crop advisor must make specific
determinations regarding the appropriate PPE, When handlers (except those employed by
appropriate decontamination supplies, and a commercial pesticide handling
how to conduct the tasks safely. The crop establishment) are on an agricultural
advisor must convey this information to each establishment and, within the last 30 days, a
person under his direct supervision in a pesticide covered by this subpart has been
language that the person understands. applied on the establishment or a restricted-
(v) Before entering a treated area, the entry interval has been in effect, the handler
certified or licensed crop advisor must inform, employer shall display, in accordance with this
through an established practice of section, specific information about the
communication, each person under his direct pesticide.
supervision of the pesticide products and (a) Location, accessibility, and legibility.
active ingre- dient(s) applied, method of The information shall be displayed in the same
application, time of application, the restricted location specified for the pesticide safety
entry interval, which tasks to undertake, and poster in § 170.235(d) of this part and shall be
how to contact the crop advisor. accessible and legible, as specified in §
[60 FR 21953, May 3, 1995, as amended at 73 FR 170.235(e) and (f) of this part.
75599, Dec. 12, 2008] (b) Timing. (1) If warning signs are posted
§ 170.210 Restrictions during applications.
for the treated area before an application, the
specific application information for that
(a) Contact with workers and other application shall be posted at the same time or
persons. The handler employer and the earlier.
handler shall assure that no pesticide is (2) The information shall be posted before
applied so as to contact, either directly or the application takes place, if handlers (except
through drift, any worker or other person, those employed by a commercial pesticide
other than an appropriately trained and handling establishment) will be on the
equipped handler. establishment during application. Otherwise,
(b) Handlers handling highly toxic the information shall be posted at the
pesticides. The handler employer shall assure
that any handler who is performing any beginning of any such handler’s first work
handling activity with a product that has the period.
skull and crossbones symbol on the front (3) The information shall continue to be
panel of the label is monitored visually or by displayed for at least 30 days after the end of
voice communication at least every 2 hours. the restricted-entry interval (or, if there is no
(c) Fumigant applications in greenhouses. restricted-entry interval, for at least 30 days
The handler employer shall assure: after the end of the application) or at least until
(1) That any handler who handles a the handlers are no longer on the
fumigant in a greenhouse, including a handler establishment, whichever is earlier.
who enters the greenhouse before the (c) Required information. The information
acceptable inhalation exposure level or shall include:
ventilation criteria have been met to monitor (1) The location and description of the
air levels or to initiate ventilation, maintains treated area.
continuous vis (2) The product name, EPA registration
number, and active ingredient(s) of the
pesticide.
(3) The time and date the pesticide Is to be written materials or audiovisually. The
applied. information must be presented in a manner
(4) The restricted-entry interval for the that the handlers can understand (such as
pesticide. through a translator). The presenter also shall
respond to handlers’ questions.
§ 170.224 Notice of applications to agricultural (2) The person who conducts the training
employers.
shall meet at least one of the following criteria:
Before the application of any pesticide on (i) Be currently certified as an applicator of
or in an agricultural establishment, the handler restricted-use pesticides under part 171 of this
employer shall provide the following chapter; or
information to any agricultural employer for (ii) Be currently designated as a trainer of
the establishment or shall assure that any certified applicators or pesticide handlers by a
agricultural employer is aware of: State, Federal, or Tribal agency having
(a) Specific location and description of the jurisdiction; or
treated area. (iii) Have completed a pesticide safety
(b) Time and date of application. train-the-trainer program approved by a State,
(c) Product name, EPA registration Federal, or Tribal agency having jurisdiction.
number, and active ingredient(s). (3) Any person who issues an EPA-ap-
(d) Restricted-entry interval. proved Worker Protection Standard handler
(e) Whether posting and oral notification training certificate must assure that the
are required. handler who receives the training certificate
(f) Any other product-specific has been trained in accordance with
requirements on the product labeling paragraph (c)(4) of this section.
concerning protection of workers or other (4) The pesticide safety training materials
persons during or after application. must convey, at a minimum, the following
information:
§ 170.230 Pesticide safety training for handlers. (i) Format and meaning of information
(a) Requirement. Before any handler contained on pesticide labels and in labeling,
performs any handling task, the handler including safety information such as
employer shall assure that the handler has precautionary statements about human health
been trained in accordance with this section hazards.
during the last 5 years, counting from the end (ii) Hazards of pesticides resulting from
of the month in which the training was toxicity and exposure, including acute and
completed. chronic effects, delayed effects, and
(b) Exceptions. The following persons need sensitization.
not be trained under this section: (iii) Routes by which pesticides can enter
(1) A handler who is currently certified as the body.
an applicator of restricted-use pesticides (iv) Signs and symptoms of common
under part 171 of this chapter. types of pesticide poisoning.
(2) A handler who satisfies the training (v) Emergency first aid for pesticide
requirements of part 171 of this chapter. injuries or poisonings.
(3) A handler who is certified or licensed as (vi) How to obtain emergency medical
a crop advisor by a program acknowledged as care.
appropriate in writing by EPA or a State or (vii) Routine and emergency
Tribal lead agency for pesticide enforcement, decontamination procedures.
provided that a requirement for such (viii) Need for and appropriate use of
certification or licensing is pesticide safety personal protective equipment.
training that includes all the information set (ix) Prevention, recognition, and first aid
out in § 170.230(c)(4). treatment of heat-related illness.
(c) Training programs. (1) General pesticide (x) Safety requirements for handling,
safety information shall be presented to transporting, storing, and disposing of
handlers either orally from pesticides, including general procedures for
spill cleanup.
(xi) Environmental concerns such as drift,
runoff, and wildlife hazards.
(xll) Warnings about taking pesticides or (b) Knowledge of site-specific information.
pesticide containers home. Whenever a handler who is employed by a
(xiii) Requirements of this sub part that must commercial pesticide handling establishment
be followed by handler employers for the will be performing pesticide handling tasks on
protection of handlers and other persons, an agricultural establishment, the handler
including the prohibition against applying employer shall assure that the handler is aware
pesticides in a manner that will cause contact of the following information concerning any
with workers or other persons, the areas on the agricultural establishment that
requirement to use personal protective the handler may be in (or may walk within 14
equipment, the provisions for training and mile of) and that may be treated with a
decontamination, and the protection against pesticide or that may be under a restricted-
retaliatory acts. entry interval while the handler will be on the
(d) Verification of training. (1) Except as agricultural establishment:
provided in paragraph (d)(2) of this section, if (1) Specific location and description of any
the handler employer assures that a handler such areas; and
possesses an EPA-approved Worker (2) Restrictions on entering those areas.
Protection Standard handler training
certificate, then the requirements of paragraph § 170.234 Safe operation of equipment.
(a) of this section will have been met. (a) The handler employer shall assure that
(2) If the handler employer is aware or has before the handler uses any equipment for
reason to know that an EPA-ap- proved mixing, loading, transferring, or applying
Worker Protection Standard handler training pesticides, the handler is instructed in the safe
certificate has not been issued in accordance operation of such equipment, including, when
with this section, or has not been issued to the relevant, chemigation safety requirements and
handler bearing the certificate, or the handler drift avoidance.
training was completed more than 5 years (b) The handler employer shall assure that,
before the beginning of the current month, a before each day of use, equipment used for
handler’s possession of that certificate does mixing, loading, transferring, or applying
not meet the requirements of paragraph (a) of pesticides is inspected for leaks, clogging, and
this section. worn or damaged parts, and any damaged
[57 FR 38151, Aug. 21, 1992, as amended at 60 FR equipment is repaired or is replaced.
21953, May 3, 1995]
(c) Before allowing any person to repair,
§ 170.232 Knowledge of labeling and site-specific clean, or adjust equipment that has been used
information. to mix, load, transfer, or apply pesticides, the
(a) Knowledge of labeling information. (1) handler employer shall assure that pesticide
The handler employer shall assure that before residues have been removed from the
the handler performs any handling activity, the equipment, unless the person doing the
handler either has read the product labeling or cleaning, repairing, or adjusting is a handler
has been informed in a manner the handler employed by the agricultural or commercial
can understand of all labeling requirements pesticide handling establishment. If pesticide
related to safe use of the pesticide, such as residue removal is not feasible, the handler
signal words, human hazard precautions, employer shall assure that the person who
personal protective equipment requirements, repairs, cleans, or adjusts such equipment is
first aid instructions, environmental informed:
precautions, and any additional precautions (1) That such equipment may be
pertaining to the handling activity to be contaminated with pesticides.
performed. (2) Of the potentially harmful effects of
(2) The handler employer shall assure that exposure to pesticides.
the handler has access to the product labeling (3) Of the correct way to handle such
information during handling activities. equipment.
the farm or in the nursery or greenhouse
where it can be readily seen and read by
(a) Requirement. When handlers (except handlers.
those employed by a commercial pesticide (2) The information shall be displayed in a
handling establishment) are on an agricultural location in or near the forest in a place where
establishment and, within the last 30 days, a it can be readily seen and read by handlers and
pesticide covered by this subpart has been where handlers are likely to congregate or
applied on the establishment or a restricted- pass by, such as at a decontamination site or
entry interval has been in effect, the handler an equipment storage site.
employer shall display, in accordance with this (e) Accessibility. Handlers shall be
section, pesticide safety information. informed of the location of the information
(b) Pesticide safety poster. A safety poster and shall be allowed access to it.
must be displayed that conveys, at a minimum, (f) Legibility. The information shall remain
the following basic pesticide safety concepts: legible during the time it is posted.
(1) Help keep pesticides from entering
§ 170.240 Personal protective equipment.
your body. At a minimum, the following points
shall be conveyed: (a) Requirement. Any person who
(1) Avoid getting on your skin or into your performs tasks as a pesticide handler shall use
body any pesticides that may be on plants and the clothing and personal protective
soil, in irrigation water, or drifting from nearby equipment specified on the labeling for use of
applications. the product.
(ii) Wash before eating, drinking, using (b) Definition. (1) Personal protective
chewing gum or tobacco, or using the toilet. equipment (PPE) means devices and apparel
(iii) Wear work clothing that protects the that are worn to protect the body from contact
body from pesticide residues (long-sleeved with pesticides or pesticide residues, including,
shirts, long pants, shoes and socks, and a hat but not limited to, coveralls, chemical-resistant
or scarf). suits, chemical-resistant gloves, chemical-
(iv) Wash/shower with soap and water, resistant footwear, respiratory protection
shampoo hair, and put on clean clothes after devices, chemical- resistant aprons, chemical-
work. resistant headgear, and protective eyewear.
(v) Wash work clothes separately from (2) Long-sleeved shirts, short-sleeved shirts,
other clothes before wearing them again. long pants, short pants, shoes, socks, and
(vi) Wash immediately in the nearest clean other items of work clothing are not
water if pesticides are spilled or sprayed on the considered personal protective equipment for
body. As soon as possible, shower, shampoo, the purposes of this section and are not
and change into clean clothes. subject to the requirements of this section,
(vii) Follow directions about keeping out although pesticide labeling may require that
of treated or restricted areas. such work clothing be worn during some
(2) There are Federal rules to protect activities.
workers and handlers including a requirement (c) Provision. When personal protective
for safety training. equipment is specified by the labeling of any
(c) Emergency medical care information. pesticide for any handling activity, the handler
(1) The name, address, and telephone number employer shall provide the appropriate
of the nearest emergency medical care facility personal protective equipment in clean and
shall be on the safety poster or displayed close operating condition to the handler.
to the safety poster. (1) When “chemical-resistant” personal
(2) The handler employer shall inform protective equipment is specified by the
handlers promptly of any change to the product labeling, it shall be made of material
information on emergency medical care that allows no measurable movement of the
facilities. pesticide being used through the material
(d) Location. (1) The information shall be during use.
displayed in a central location on
(2) When “waterproof” personal protective (6) When “chemical-resistant footwear” Is
equipment is specified by the product labeling, specified by the product labeling, one of the
it shall be made of material that allows no following types of footwear must be worn:
measurable movement of water or aqueous (i) Chemical-resistant shoes.
solutions through the material during use. (ii) Chemical-resistant boots.
(3) When a ‘‘chemical-resistant suit’’ is (iii) Chemical-resistant shoe coverings
specified by the product labeling, it shall be a worn over shoes or boots.
loose-fitting, one- or two- piece chemical- (7) When ‘‘protective eyewear’’ is specified
resistant garment that covers, at a minimum, by the product labeling, one of the following
the entire body except head, hands, and feet. types of eyewear must be worn:
(4) When ‘‘coveralls’’ are specified by the (1) Goggles.
product labeling, they shall be a loose-fitting, (ii) Face shield.
one- or two-piece garment, such as a cotton (iii) Safety glasses with front, brow, and
or cotton and polyester coverall, that covers, temple protection.
at a minimum, the entire body except head, (iv) Full-face respirator.
hands, and feet. The pesticide product labeling (8) When a ‘‘chemical-resistant apron’’ is
may specify that the coveralls be worn over specified by the product labeling, an apron
another layer of clothing. that covers the front of the body from mid-
(5) (i) Gloves shall be of the type specified chest to the knees shall be worn.
on the pesticide product labeling. Gloves (9) When a respirator is specified by the
made of leather, cotton, or other absorbent product labeling, it shall be appropriate for the
materials may not be worn while mixing, pesticide product used and for the activity to
loading, applying, or otherwise handling be performed. The handler employer shall
assure that the respirator fits correctly.
pesticides, unless gloves made of these
(10) When ‘‘chemical-resistant headgear” is
materials are listed as acceptable for such use
specified by the product labeling, it shall be
on the product labeling. either a chemical resistant hood or a chemical-
(ii) Separable glove liners may be worn resistant hat with a wide brim.
beneath chemical-resistant gloves, unless the (d) Exceptions to personal protective
pesticide product labeling specifically prohibits equipment specified on product labeling— (1)
their use. Separable glove liners are defined as Body protection. (i) A chemical-resistant suit
separate glove-like hand coverings, made of may be substituted for ‘‘coveralls,’’ and any
lightweight material, with or without fingers. requirement for an additional layer of clothing
Work gloves made from lightweight cotton or beneath is waived.
poly-type material are considered to be glove (11) A chemical-resistant suit may be
liners if worn beneath chemical-resistant substituted for ‘‘coveralls’’ and a chemical-
gloves. Separable glove liners may not extend resistant apron.
outside the chemical-resistant gloves under (2) Boots. If chemical-resistant footwear
which they are worn. Chemical-resistant gloves with sufficient durability and a tread
with nonseparable absorbent lining materials appropriate for wear in rough terrain is not
are prohibited. obtainable, then leather boots may be worn in
(iii) If used, separable glove liners must be such terrain.
discarded immediately after a total of no more (3) Gloves. If chemical-resistant gloves
than 10 hours of use or within 24 hours of with sufficient durability and suppleness are
when first put on, whichever comes first. The not obtainable, then during handling activities
liners must be replaced immediately if directly with roses or other plants with sharp thorns,
contacted by pesticide. Used glove liners shall leather gloves may be worn over chemical-
not be reused. Contaminated liners must be resistant glove liners. However, once leather
disposed of in accordance with any Federal, gloves are worn for this use, thereafter they
State, or local regulations. shall be worn only with chemical-resistant
liners and they shall not be worn for any other
use.
(4) Closed systems. If handling tasks are ventilation system which is used and
performed using properly functioning systems maintained in accordance with the
that enclose the pesticide to prevent it from manufacturer’s written operating instructions
contacting handlers or other persons, and if and which is declared in writing by the
such systems are used and are maintained in manufacturer or by a governmental agency to
accordance with that manufacturer’s written provide respiratory protection equivalent to or
operating instructions, exceptions to labeling- greater than a dust/mist filtering respirator
specified personal protective equipment for may substitute a long-sleeved shirt, long
the handling activity are permitted as provided pants, shoes, and socks for the labeling-
in paragraphs (d)(4)(i) and (ii) of this section. specified personal protective equipment. If a
(i) Persons using a closed system to mix or respiratory protection device other than a
load pesticides with a signal word of DANGER dust/mist-fil- tering respirator is specified on
or WARNING may substitute a long-sleeved the pesticide product labeling, it must be worn.
shirt, long pants, shoes, socks, chemical- (iii) Persons occupying an enclosed cab
resistant apron, and any protective gloves that has a properly functioning ventilation
specified on the labeling for handlers for the system which is used and maintained in
labeling-specified personal protective accordance with the manufacturer’s written
equipment. operating instructions and which is declared in
(ii) Persons using a closed system to mix writing by the manufacturer or by a
or load pesticides other than those in governmental agency to provide respiratory
paragraph (d)(4)(i) of this section or to perform protection equivalent to or greater than the
other handling tasks may substitute a long- vapor- or gas-removing respirator specified
sleeved shirt, long pants, shoes, and socks for on pesticide product labeling may substitute a
the labeling-specified personal protective
longsleeved shirt, long pants, shoes, and socks
equipment.
for the labeling-specified personal protective
(iii) Persons using a closed system that
operates under pressure shall wear protective equipment. If an air- supplying respirator or a
eyewear. self-contained breathing apparatus (SCBA) is
(iv) Persons using a closed system shall specified on the pesticide product labeling, it
have all labeling-specified personal protective must be worn.
equipment immediately available for use in an (iv) Persons occupying an enclosed cab
emergency. shall have all labeling-specified personal
(5) Enclosed cabs. If handling tasks are protective equipment immediately available
performed from inside a cab that has a and stored in a chemical-resistant container,
nonporous barrier which totally surrounds the such as a plastic bag. They shall wear such
occupants of the cab and prevents contact personal protective equipment if it is necessary
with pesticides outside of the cab, exceptions to exit the cab and contact pesticide- treated
to personal protective equipment specified on surfaces in the treated area. Once personal
the product labeling for that handling activity protective equipment is worn in the treated
are permitted as provided in paragraphs (d)(5) area, it must be removed before reentering the
(i) through (iv) of this section. cab.
(i) Persons occupying an enclosed cab (6) Aerial application—(i) Use of gloves.
may substitute a long-sleeved shirt, long The wearing of chemical-resistant gloves when
pants, shoes, and socks for the labeling- entering or leaving an aircraft used to apply
specified personal protective equipment. If a pesticides is optional, unless such gloves are
respiratory protection device is specified on required on the pesticide product labeling. If
the pesticide product labeling for the handling gloves are brought into the cockpit of an
activity, it must be worn. aircraft that has been used to apply pesticides,
(ii) Persons occupying an enclosed cab the gloves shall be kept in an enclosed
that has a properly functioning container to prevent contamination of the
inside of the cockpit.
(11) Open cockpit. Persons occupying an with an undiluted pesticide that has the signal
open cockpit shall use the personal protective word DANGER or WARNING on the label shall
equipment specified in the product labeling be not be reused.
for use during application, except that (3) The handler employer shall assure that
chemical-resistant footwear need not be worn. contaminated personal protective equipment
A helmet may be substituted for chemical- is kept separately and washed separately from
resistant headgear. A visor may be substituted any other clothing or laundry.
for protective eyewear. (4) The handler employer shall assure that
(iii) Enclosed cockpit. Persons occupying an all clean personal protective equipment shall
enclosed cockpit may substitute a long- be either dried thoroughly before being stored
sleeved shirt, long pants, shoes, and socks for or shall be put in a well ventilated place to dry.
labeling-specified personal protective (5) The handler employer shall assure that
equipment. all personal protective equipment is stored
(7) Crop advisors. Crop advisors entering separately from personal clothing and apart
treated areas while a restricted- entry interval from pesticide-contaminated areas.
is in effect may wear the personal protective (6) The handler employer shall assure that
equipment specified on the pesticide labeling when dust/mist filtering respirators are used,
for early- entry activities instead of the the filters shall be replaced:
personal protective equipment specified on (i) When breathing resistance
the pesticide labeling for handling activities, becomes excessive.
provided: (ii) When the filter element has physical
(1) Application has been completed for at damage or tears.
least 4 hours. (iii) According to manufacturer’s
(ii) Any inhalation exposure level listed in the
recommendations or pesticide product
labeling has been reached or any ventilation
labeling, whichever is more frequent.
criteria established by § 170.110(c)(3) or in the
labeling have been met. (iv) In the absence of any other
(e) Use of personal protective equipment. instructions or indications of service life, at the
(1) The handler employer shall assure that end of each day’s work period.
personal protective equipment is used (7) The handler employer shall assure that
correctly for its intended purpose and is used when gas- or vapor-removing respirators are
according to the manufacturer’s instructions. used, the gas- or vapor-removing canisters or
(2) The handler employer shall assure that, cartridges shall be replaced:
before each day of use, all personal protective (i) At the first indication of odor, taste, or
equipment is inspected for leaks, holes, tears, irritation.
or worn places, and any damaged equipment (ii) According to manufacturer’s
is repaired or discarded. recommendations or pesticide product
(f) Cleaning and maintenance. (1) The labeling, whichever is more frequent.
handler employer shall assure that all personal (iii) In the absence of any other
protective equipment is cleaned according to instructions or indications of service life, at the
the manufacturer’s instructions or pesticide end of each day’s work period.
product labeling instructions before each day (8) The handler employer shall inform any
of reuse. In the absence of any such person who cleans or launders personal
instructions, it shall be washed thoroughly in protective equipment:
detergent and hot water. (i) That such equipment may be
(2) If any personal protective equipment contaminated with pesticides.
cannot be cleaned properly, the handler (ii) Of the potentially harmful effects of
employer shall dispose of the personal exposure to pesticides.
protective equipment in accordance with any (iii) Of the correct way(s) to clean personal
applicable Federal, State, and local regulations. protective equipment and to protect
Coveralls or other absorbent materials that themselves when handling such equipment.
have been drenched or heavily contaminated (9) The handler employer shall assure that
handlers have a clean place(s)
away from pesticide storage and pesticide use (c) Location. The decontamination
areas where they may: supplies shall be located together and be
(1) Store personal clothing not in use. reasonably accessible to and not more than V4
(ii) Put on personal protective equipment mile from each handler during the handling
at the start of any exposure period. activity.
(iii) Remove personal protective (1) Exception for mixing sites. For mixing
equipment at the end of any exposure period. activities, decontamination supplies shall be at
(10) The handler employer shall not allow the mixing site.
or direct any handler to wear home or to take (2) Exception for pilots. Decontamination
home personal protective equipment supplies for a pilot who is applying pesticides
contaminated with pesticides. aerially shall be in the airplaine or at the
(g) Heat-related illness. When the use of aircraft loading site.
personal protective equipment is specified by (3) Exception for handling pesticides in
the labeling of any pesticide for the handling remote areas. When handling activities are
activity, the handler employer shall assure that performed more than 1/4 mile from the
no handler is allowed or directed to perform nearest place of vehicular access:
the handling activity unless appropriate (i) The soap, single-use towels, clean
measures are taken, if necessary, to prevent change of clothing, and water may be at the
heat-related illness. nearest place of vehicular access.
[57 FR 38151, Aug. 21, 1992, as amended at 69 FR (ii) The handler employer may permit
53346, Sept. 1, 2004] handlers to use clean water from springs,
streams, lakes, or other sources for
§ 170.250 Decontamination. decontamination at the remote work site, if
(a) Requirement. During any handling such water is more accessible than the water
activity, the handler employer shall provide for located at the nearest place of vehicular
handlers, in accordance with this section, access.
decontamination supplies for washing off (4) Decontamination supplies in treated
pesticides and pesticide residues. areas. The decontamination supplies shall not
(b) General conditions. (1) The handler be in an area being treated with pesticides or
employer shall provide handlers with enough in an area under a restricted-entry interval,
water for routine washing, for emergency unless:
eyeflushing, and for washing the entire body (i) The decontamination supplies are in the
in case of an emergency. At all times when the area where the handler is performing handling
water is available to handlers, the handler activities;
employer shall assure that it is of a quality and (ii) The soap, single-use towels, and clean
temperature that will not cause illness or injury change of clothing are in enclosed containers;
when it contacts the skin or eyes or if it is and
swallowed. (iii) The water is running tap water or is
(2) When water stored in a tank is to be enclosed in a container.
used for mixing pesticides, it shall not be used (d) Emergency eyeflushing. To provide for
for decontamination or eye flushing, unless emergency eyeflushing, the handler employer
the tank is equipped with properly functioning shall assure that at least 1 pint of water is
valves or other mechanisms that prevent immediately available to each handler who is
movement of pesticides into the tank.
performing tasks for which the pesticide
(3) The handler employer shall provide
labeling requires protective eyewear. The
soap and single-use towels in quantities
sufficient to meet handlers’ needs. eyeflush water shall be carried by the handler,
(4) The handler employer shall provide one or shall be on the vehicle or aircraft the
clean change of clothing, such as coveralls, for handler is using, or shall be otherwise
use in an emergency. immediately accessible.
(e) Decontamination after handling
activities. At the end of any exposure period,
the handler employer shall provide at the site
where handlers remove personal protective
equipment, soap, clean towels, and a sufficient
amount
of water so that the handlers may wash 171.10 Certification of applicators on Indian
thoroughly. Reservations.
171.11 Federal certification of pesticide applicators
[57 FR 38151, Aug. 21, 1992, as amended at 61 FR in States or on Indian Reservations where there
33213, June 26, 1996] is no approved State or Tribal certification plan
in effect.
§ 170.260 Emergency assistance.
If there Is reason to believe that a person AUTHORITY: 7 U.S.C. 136i and 136w.
who is or has been employed by an SOURCE: 39 FR 36449, Oct. 9, 1974, unless
otherwise noted.
agricultural establishment or commercial
pesticide handling establishment to perform §171.1 General.
pesticide handling tasks has been poisoned or This section deals with the certification of
injured by exposure to pesticides as a result of applicators of restricted use pesticides.
that employment, including, but not limited to, §171.2 Definitions.
exposures from handling tasks or from (а) Terms used in this subpart have the
application, splash, spill, drift, or pesticide same meaning as in the Act. In addition, the
residues, the handler employer shall: following definitions are applicable to all
(a) Make available to that person prompt aspects of the certification of pesticide
transportation from the place of employment applicator program in this part:
or the handling site to an appropriate (1) The term accident means an
emergency medical facility. unexpected, undesirable event, caused by the
(b) Provide to that person or to treating use or presence of a pesticide, that adversely
medical personnel, promptly upon request, affects man or the environment.
any obtainable information on: (2) The term Act means the Federal
(1) Product name, EPA registration Insecticide, Fungicide, and Rodenticide Act, as
number, and active ingredients of any product amended (86 Stat. 973), and other legislation
to which that person might have been supplementary thereto and amendatory
exposed. thereof.
(2) Antidote, first aid, and other medical (3) The term Administrator means the
information from the product labeling. Administrator of the Environmental Protection
(3) The circumstances of handling of the Agency, or any office or employee of the
pesticide. Agency to whom authority has heretofore
(4) The circumstances of exposure of that been delegated, or to whom authority may
person to the pesticide. hereafter be delegated, to act in his stead.
(4) The term Agency, unless otherwise
PART 171—CERTIFICATION OF specified, means the United States
PESTICIDE APPLICATORS Environmental Protection Agency.
Sec.
(5) The term agricultural commodity
171.1 General. means any plant, or part thereof, or animal, or
171.2 Definitions. animal product, produced by a person
171.3 Categorization of commercial applicators of (including farmers, ranchers, vineyardists,
pesticides. plant propagators, Christmas tree growers,
171.4 Standards for certification of commercial aquaculturists, floriculturists, orchardists,
applicators. foresters, or other comparable persons)
171.5 Standards for certification of private
applicators. primarily for sale, consumption, propagation,
171.6 Standards for supervision of noncer- tified or other use by man or animals.
applicators by certified private and commercial (б) The term calibration of equipment
applicators. means measurement of dispersal or output of
171.7 Submission and approval of State plans for application equipment and adjustment of such
certification of commercial and private equipment to control the rate of dispersal, and
applicators of restricted use pesticides.
171.8 Maintenance of State plans.
droplet or particle size of a pesticide dispersed
171.9 Submission and approval of Government by the equipment.
Agency Plan.
(7) The term certification means the (17) The term non-target organism means
recognition by a certifying agency that a a plant or animal other than the one against
person is competent and thus authorized to which the pesticide is applied.
use or supervise the use of restricted use (18) The term ornamental means trees,
pesticides. shrubs, and other plantings in and around
(8) The term certified applicator means habitations generally, but not necessarily
any individual who is certified to use or located in urban and suburban areas,
supervise the use of any restricted use including residences, parks, streets, retail
pesticides covered by his certification. outlets, industrial and institutional buildings.
(9) The term commercial applicator means (19) The term practical knowledge means
a certified applicator (whether or not he is a the possession of pertinent facts and
private applicator with respect to some uses) comprehension together with the ability to use
who uses or supervises the use of any pesticide them in dealing with specific problems and
which is classified for restricted use for any situations.
purpose or on any property other than as (20) The term private applicator means a
provided by the definition of ‘‘private certified applicator who uses or supervises the
applicator.” use of any pesticide which is classified for
(10) The term compatibility means that restricted use for purposes of producing any
property of a pesticide which permits its use agricultural commodity on property owned or
with other chemicals without undesirable rented by him or his employer or (if applied
results being caused by the combination. without compensation other than trading of
(11) The term competent means properly personal services between producers of
qualified to perform functions associated with agricultural commodities) on the property of
pesticide application, the degree of capability another person.
required being directly related to the nature of (21) The term protective equipment means
the activity and the associated responsibility. clothing or any other materials or devices that
(12) The term common exposure route shield against unintended exposure to
means a likely way (oral, dermal, respiratory) pesticides.
by which a pesticide may reach and/or enter (22) The term regulated pest means a
an organism. specific organism considered by a State or
(13) The term environment means water, Federal agency to be a pest requiring
air, land, and all plants and man and other regulatory restrictions, regulations, or control
animals living therein, and the procedures in order to protect the host, man
interrelationships which exist among them. and/or his environment.
(14) The term forest means a concentration (23) The term restricted use pesticide
of trees and related vegetation in non-urban means a pesticide that is classified for
areas sparsely inhabited by and infrequently restricted use under the provisions of section
used by humans; characterized by natural 3(d)(1)(C) of the Act.
terrain and drainage patterns. (24) The term standard means the measure
(15) The term hazard means a probability of knowledge and ability which must be
that a given pesticide will have an adverse demonstrated as a requirement for
effect on man or the environment in a given certification.
situation, the relative likelihood of danger or ill (25) The term State means a State, the
effect being dependent on a number of District of Columbia, the Commonwealth of
interrelated factors present at any given time. Puerto Rico, the Virgin Islands, Guam, the Trust
(16) The term host means any plant or Territory of the Pacific Islands, and American
animal on or in which another lives for Samoa.
nourishment, development, or protection. (26) The term susceptibility means the
degree to which an organism is affected by a
pesticide at a particular level of exposure.
(27) The term toxicity means the property
of a pesticide to cause any adverse
physiological effects.
(28) The term under the direct supervision tems of applicator Identification shall adopt
of means the act or process whereby the these categories as needed, along with such
application of a pesticide Is made by a appropriate subcategories as are necessary to
competent person acting under the meet the particular requirements of the State.
instructions and control of a certified (b) Categories—(1) Agricultural pest
applicator who is responsible for the actions of control—(i) Plant. This category includes
that person and who is available if and when commercial applicators using or supervising
needed, even though such certified applicator the use of restricted use pesticides in
is not physically present at the time and place production of agricultural crops, including
the pesticide is applied. without limiting the foregoing, tobacco,
(b) Limited. The following definitions apply peanuts, cotton, feed grains, soybeans and
only to dealers, dealerships and transactions in forage; vegetables; small fruits; tree fruits and
States or on Indian Reservations where EPA nuts; as well as on grasslands and noncrop
conducts a Federal Pesticide Applicator agricultural lands.
Certification Program. (ii) Animal. This category includes
(1) The term restricted use pesticide retail commercial applicators using or supervising
dealer means any person who makes available the use of restricted use pesticides on animals,
for use any restricted use pesticide, or who including without limiting the foregoing, beef
offers to make available for use any such cattle, dairy cattle, swine, sheep, horses, goats,
pesticide. poultry, and livestock, and to places on or in
(2) The term make available for use means which animals are confined.
to distribute, sell, ship, deliver for shipment, or Doctors of Veterinary Medicine engaged in the
receive and (having so received) deliver, to any business of applying pesticides for hire,
person. However, the term excludes
publicly holding themselves out as pesticide
transactions solely between persons who are
applicators, or engaged in large-scale use of
pesticide producers, registrants, wholesalers,
or retail sellers, acting only in those capacities. pesticides are included in this category.
(3) The term dealership means any site (2) Forest pest control. This category
owned or operated by a restricted use includes commercial applicators using or
pesticide retail dealer where any restricted use supervising the use of restricted use pesticides
pesticide is made available for use, or where in forests, forest nurseries, and forest seed
the dealer offers to make available for use any producing areas.
such pesticide. (3) Ornamental and turf pest control. This
(4) The term uncertified person means any category includes commercial applicators
person who is not holding a currently valid using or supervising the use of restricted use
certification document indicating that he is pesticides to control pests in the maintenance
certified under section 11 of FIFRA in the and production of ornamental trees, shrubs,
category of the restricted use pesticide made flowers, and turf.
available for use. (4) Seed treatment. This category includes
(5) The term principal place of business commercial applicators using or supervising
means the principal location, either residence the use of restricted use pesticides on seeds.
or office, in the State in which an individual, (5) Aquatic pest control. This category
partnership, or corporation applies pesticides. includes commercial applicators using or
[39 FR 36449, Oct. 9, 1974, as amended at 48 FR supervising the use of any restricted use
53974, Nov. 1983; 73 FR 75599, Dec. 12, 2008] pesticide purposefully applied to standing or
running water, excluding applicators engaged
§171.3 Categorization of commercial applicators of
pesticides. in public health related activities included in
category 8 below.
(a) Procedure. Categories of applicators (6) Right-of-way pest control. This
(other than private) using or supervising the category includes commercial applicators
use of restricted use pesticides are identified
below. State sys
using or supervising the use of restricted use the Administrator’s approval of additional
pesticides in the maintenance of public roads, major categories.
electric powerlines, pipelines, railway rights- §171.4 Standards for certification of commercial
of-way or other similar areas. applicators.
(7) Industrial, institutional, structural and (a) Determination of competency.
health related pest control. This category Competence in the use and handling of
includes commercial applicators using or pesticides shall be determined on the basis of
supervising the use of restricted use pesticides written examinations, and, as appropriate,
in, on, or around food handling performance testing, based upon standards
establishments, human dwellings, institutions, set forth below and which are approved by the
such as schools and hospitals, industrial Administrator. Such examination and testing
establishments, including warehouses and shall include the general standards applicable
grain elevators, and any other structures and to all categories (§ 171.4(b)) and the additional
adjacent areas, public or private; and for the standards specifically identified for each
protection of stored, processed, or category or subcategory (if any) in which an
manufactured products. applicator is to be classified (§ 171.4(c)). State
(8) Public health pest control. This category standards must conform and be at least equal
includes State, Federal or other governmental to those prescribed herein. In developing the
employees using or supervising the use of details of standards at the State level and in
restricted use pesticides in public health structuring examinations, it is important to
programs for the management and control of recognize and reflect the extent of
pests having medical and public health competency appropriate and necessary to a
importance. particular category.
(9) Regulatory pest control. This category (b) General standards for all categories of
includes State, Federal or other governmental certified commercial applicators. (1) All
employees who use or supervise the use of commercial applicators shall demonstrate
restricted use pesticides in the control of practical knowledge of the principles and
regulated pests. practices of pest control and safe use of
(10) Demonstration and research pest pesticides. Testing shall be based on examples
control. This category includes: (i) individuals of problems and situations appropriate to the
who demonstrate to the public the proper use particular category or subcategory of the
and techniques of application of restricted use applicator’s certification and the following
pesticides or supervise such demonstration, areas of competency:
and (ii) persons conducting field research with (i) Label & labeling comprehension. (a) The
pesticides, and in doing so, use or supervise general format and terminology of pesticide
the use of restricted use pesticides. Included in labels and labeling;
the first group are such persons as extension (b) The understanding of instructions,
specialists and county agents, commercial warnings, terms, symbols, and other
representatives demonstrating pesticide information commonly appearing on pesticide
products, and those individuals demonstrating labels;
methods used in public programs. The second (c) Classification of the product, general or
group includes: State, Federal, commercial and restricted; and
other persons conducting field research on or (d) Necessity for use consistent with the
utilizing restricted use pesticides. label.
(c) Other categories and subcategories. (ii) Safety. Factors including:
Any State submitting a plan pursuant to this (a) Pesticide toxicity and hazard to man
section for the certification of applicators, as and common exposure routes;
provided for below, may designate such (b) Common types and causes of pesticide
subcategories within the above 10 categories accidents;
as it deems necessary. In addition, a State may (c) Precautions necessary to guard against
delete a category not needed or may request injury to applicators and other individuals in or
near treated areas;
(d) Need for and use of protective clothing
and equipment;
(e) Symptoms of pesticide poisoning;
(f) First aid and other procedures to be (viii) Laws and regulations. Applicable State
followed in case of a pesticide accident; and and Federal laws and regulations.
(g) Proper identification, storage, transport, (c) Specific standards of competency for
handling, mixing procedures and disposal each category of commercial applicators.
methods for pesticides and used pesticide Some of the factors referenced in paragraph
containers, including precautions to be taken (b) of this section are of particular importance
to prevent children from having access to because of the different types of activities
pesticides and pesticide containers. carried out by applicators in each category.
(iii) Environment. The potential Such factors must be especially stressed and
environmental consequences of the use and specifically reflected in State certification
misuse of pesticides as may be influenced by standards, as appropriate. For example,
such factors as: practical knowledge of drift problems should
(a) Weather and other climatic conditions; be required of agricultural applicators but not
(b) Types of terrain, soil or other substrate; of seed treatment applicators. The latter,
(c) Presence of fish, wildlife and other non- however, should be particularly
target organisms; and knowledgeable of the hazards of the misuse of
(d) Drainage patterns. treated seed and the necessary precautionary
(iv) Pests. Factors such as: (a) Common techniques. Many applicators in § 171.3(b) (8),
features of pest organisms and characteristics (9), and (10) will have had considerable formal
of damage needed for pest recognition; education, training and experience in
(b) Recognition of relevant pests; and preparation for their positions. Their
(c) Pest development and biology as it may competency with respect to the use and
handling of pesticides will have been
be relevant to problem identification and
determined by examining boards of their
control. professional scientific societies utilizing
(v) Pesticides. Factors such as: standards which equal or exceed those
(a) Types of pesticides; prescribed herein. Such standards should be
(b) Types of formulations; consulted by States in developing their State
(c) Compatibility, synergism, persistence standards for certification of such applicators
and animal and plant toxicity of the under these regulations. Commercial
formulations; applicators in each category shall be
(d) Hazards and residues associated with particularly qualified with respect to the
use; practical knowledge standards elaborated
(e) Factors which influence effectiveness or below:
lead to such problems as resistance to (1) Agricultural pest control—(i) Plant.
pesticides; and Applicators must demonstrate practical
(f) Dilution procedures. knowledge of crops grown and the specific
(vi) Equipment. Factors including: (a) pests of those crops on which they may be
Types of equipment and advantages and using restricted use pesticides. The importance
limitations of each type; and of such competency is amplified by the
(b) Uses, maintenance and calibration. extensive areas involved, the quantities of
(vii) Application techniques. Factors pesticides needed, and the ultimate use of
including: many commodities as food and feed. Practical
(a) Methods of procedure used to apply knowledge is required concerning soil and
various formulations of pesticides, solutions, water problems, preharvest intervals, re-entry
and gases, together with a knowledge of which intervals, phytotoxicity, and potential for
technique of application to use in a given environmental contamination, non-target
situation; injury and community problems resulting from
(b) Relationship of discharge and the use of restricted use pesticides in
placement of pesticides to proper use, agricultural areas.
unnecessary use, and misuse; and (ii) Animal. Applicators applying pesticides
(c) Prevention of drift and pesticide loss directly to animals must demonstrate practical
into the environment. knowledge of such
animals and their associated pests. A practical mination. They must demonstrate practical
knowledge is also required concerning specific knowledge of hazards associated with
pesticide toxicity and residue potential, since handling, sorting and mixing, and misuse of
host animals will frequently be used for food. treated seed such as introduction of treated
Further, the applicator must know the relative seed into food and feed channels, as well as
hazards associated with such factors as proper disposal of unused treated seeds.
formulation, application techniques, age of (5) Aquatic pest control. Applicators shall
animals, stress and extent of treatment. demonstrate practical knowledge of the
(2) Forest pest control. Applicators shall secondary effects which can be caused by
demonstrate practical knowledge of types of improper application rates, incorrect
forests, forest nurseries, and seed production
formulations, and faulty application of
in their State and the pests involved. They
should possess practical knowledge of the restricted use pesticides used in this category.
cyclic occurrence of certain pests and specific They shall demonstrate practical knowledge of
population dynamics as a basis for various water use situations and the potential
programming pesticide applications. A of downstream effects. Further, they must have
practical knowledge is required of the relative practical knowledge concerning potential
biotic agents and their vulnerability to the pesticide effects on plants, fish, birds,
pesticides to be applied. Because forest stands beneficial insects and other organisms which
may be large and frequently include natural may be present in aquatic environments.
aquatic habitats and harbor wildlife, the These applicators shall demonstrate practical
consequences of pesticide use may be difficult knowledge of the principles of limited area
to assess. The applicator must therefore application.
demonstrate practical knowledge of control (6) Right-of-way pest control. Applicators
methods which will minimize the possibility of shall demonstrate practical knowledge of a
secondary problems such is unintended effects wide variety of environments, since rights-of-
on wildlife. Proper use of specialized way can traverse many different terrains,
equipment must be demonstrated, especially including waterways. They shall demonstrate
as it may relate to meteorological factors and practical knowledge of problems on runoff,
adjacent land use. drift, and excessive foliage destruction and
(3) Ornamental and turf pest control. ability to recognize target organisms. They
Applicators shall demonstrate practical
shall also demonstrate practical knowledge of
knowledge of pesticide problems associated
with the production and maintenance of the nature of herbicides and the need for
ornamental trees, shrubs, plantings, and turf, containment of these pesticides within the
including cognizance of potential phytotoxicity right-of-way area, and the impact of their
due to a wide variety of plant material, drift, application activities in the adjacent areas and
and persistence beyond the intended period communities.
of pest control. Because of the frequent (7) Industrial, institutional, structural and
proximity of human habitations to application health related pest control. Applicators must
activities, applicators in this category must demonstrate a practical knowledge of a wide
demonstrate practical knowledge of variety of pests, including their life cycles, types
application methods which will minimize or of formulations appropriate for their control,
prevent hazards to humans, pets, and other and methods of application that avoid
domestic animals. contamination of food, damage and
(4) Seed-treatment. Applicators shall contamination of habitat, and exposure of
demonstrate practical knowledge of types of people and pets. Since human exposure,
seeds that require chemical protection against including babies, children, pregnant women,
pests and factors such as seed coloration, and elderly people, is frequently a potential
carriers, and surface active agents which problem, applicators must demonstrate
influence pesticide binding and may affect ger practical knowledge of the specific factors
which
may lead to a hazardous condition, including should demonstrate an understanding of a
continuous exposure in the various situations pesticide-organism interactions and the
encountered in this category. Because health importance of integrating pesticide use with
related pest control may involve outdoor other control methods. In general, it would be
applications, applicators must also expected that applicators doing
demonstrate practical knowledge of demonstration pest control work possess a
environmental conditions, particularly related practical knowledge of all of the standards
to this activity. detailed in § 171.4(b). In addition, they shall
(8) Public health pest control. Applicators meet the specific standards required for
shall demonstrate practical knowledge of paragraphs (c) (1) through (7) of this section as
vector-disease transmission as it relates to and may be applicable to their particular activity.
influences application programs. A wide Persons conducting field research or method
variety of pests is involved, and it is essential improvement work with restricted use
that they be known and recognized, and pesticides should be expected to know the
appropriate life cycles and habitats be general standards detailed in 171.4(b). In
understood as a basis for control strategy. addition, they shall be expected to know the
These applicators shall have practical specific standards required for paragraphs (c)
knowledge of a great variety of environments (1) through (9) of this section, applicable to
ranging from streams to those conditions their particular activity, or alternatively, to meet
found in buildings. They should also have the more inclusive requirements listed under
practical knowledge of the importance and “Demonstration.”
employment of such non-chemical control (d) Special standards. This space reserved
methods as sanitation, waste disposal, and for possible issuance of Special Standards.
drainage. (e) The above standards do not apply to
(9) Regulatory pest control. Applicators the following persons for purposes of these
shall demonstrate practical knowledge of regulations. (1) Persons conducting laboratory
regulated pests, applicable laws relating to type research involving restricted use
quarantine and other regulation of pests, and pesticides; and
the potential impact on the environment of (2) Doctors of Medicine and Doctors of
restricted use pesticides used in suppression Veterinary Medicine applying pesticides as
and eradication programs. They shall drugs or medication during the course of their
demonstrate knowledge of factors influencing normal practice.
introduction, spread, and population
dynamics of relevant pests. Their knowledge §171.5 Standards for certification of private
applicators.
shall extend beyond that required by their
immediate duties, since their services are (a) Competence in the use and handling of
frequently required in other areas of the pesticides by a private applicator will be
country where emergency measures are determined by procedures set forth below.
invoked to control regulated pests and where State standards must conform and be at least
individual judgments must be made in new equal to those prescribed herein. As a
situations. minimum requirement for certification, a
(10) Demonstration and research pest private applicator must show that he possesses
control. Persons demonstrating the safe and a practical knowledge of the pest problems
effective use of pesticides to other applicators and pest control practices associated with his
and the public will be expected to meet agricultural operations; proper storage, use,
comprehensive standards reflecting a broad handling and disposal of the pesticides and
spectrum of pesticide uses. Many different containers; and his related legal responsibility.
pest problems situations will be encountered This practical knowledge includes ability to:
in the course of activities associated with (1) Recognize common pests to be
demonstration, and practical knowledge of controlled and damage caused by them.
problems, pests, and population levels
occurring in each demonstration situation is
required. Further, they
(2) Read and understand the label and (1) Understanding of the label and labeling
labeling information—including the common information including those items indicated in
name of pesticides he applied; pest(s) to be that subsection.
controlled, timing and methods of application; (ii) Sources of advice and guidance
safety precautions; any pre-harvest or re-entry necessary for the safe and proper use of each
restrictions; and any specific disposal pesticide related to his certification.
procedures. (2) [Reserved]
(3) Apply pesticides in accordance with
label instructions and warnings, including the §171.6 Standards for supervision of noncertified
ability to prepare the proper concentration of applicators by certified private and
pesticide to be used under particular commercial applicators.
circumstances taking into account such factors (a) Certified applicators whose activities
as area to be covered, speed at which indicate a supervisory role must demonstrate
application equipment will be driven, and the a practical knowledge of Federal and State
quantity dispersed in a given period of supervisory requirements, including labeling,
operation. regarding the application of restricted use
(4) Recognize local environmental pesticides by noncertified applicators.
situations that must be considered during The availability of the certified applicator must
application to avoid contamination. be directly related to the hazard of the
(5) Recognize poisoning symptoms and situation. In many situations, where the
procedures to follow in case of a pesticide certified applicator is not required to be
accident. physically present, ‘‘direct supervision” shall
(b) Such competence of each private include verifiable instruction to the competent
applicator shall be verified by the responsible person, as follows: (1) Detailed guidance for
State agency through the administration of a applying the pesticide properly, and (2)
private applicator certification system which provisions for contacting the certified
ensures that the private applicator is applicator in the event he is needed. In other
competent, based upon the standards set situations, and as required by the label, the
forth above, to use the restricted use actual physical presence of a certified
pesticides under limitations of applicable State applicator may be required when application
and Federal laws and regulations. A is made by a noncertified applicator.
certification system shall employ a written or (b) [Reserved]
oral testing procedure, or such other § 171.7 Submission and approval of State plans for
equivalent system as may be approved as part certification of commercial and private
of a State plan. applicators of restricted use pesticides.
(1) In any case where a person, at the time If any State, at any time, desires to certify
of testing for certification, is unable to read a applicators of restricted use pesticides, the
label, the responsible State agency may Governor of that State shall submit a State plan
employ a testing procedure, previously for that purpose. The Administrator shall
approved by the Administrator, which can approve the plan submitted by any State, or
adequately assess the competence of such any modification thereof, if the plan in his
person with regard to all of the above judgment—
standards. Certification must be related and (a) Designates a State agency as the
limited to the use and handling of each agency responsible for administering the plan
individual pesticide for which he desires throughout the State. Since several other
certification at any time. Therefore, the agencies or organizations may also be
applicator will be authorized to use only the involved in administering portions of the State
pesticide(s) for which he has demonstrated plan, all of these shall be identified in the State
competence. A specific procedure is required plan, particularly any other agencies or
for § 171.5(a)(2) relating to label organizations responsible for certifying
comprehension, with testing designed to
assure his knowledge of the following:
applicators and suspending or revoking (A) Provisions for and listing of the acts
certification. In the extent that more than one which constitute grounds for denying,
governmental agency will be responsible for suspending, and revoking certification of
performing certain functions under the State applicators, and for assessing criminal and/or
plans, the plans shall identify which functions civil penalties. Such grounds should include, at
are to be performed by which agency and a minimum, misuse of a pesticide and
indicate how the program will be coordinated falsification of any records required to be
by the lead agency to ensure consistency of maintained by the certified applicator.
programs within the State. The lead agency will (B) Provisions for reviewing an applicator’s
serve as the central contact point for the certification to determine whether suspension
Environmental Protection Agency in carrying or revocation of the certification is appropriate
out the certification program. The numbers in the event of criminal conviction under
and job titles of the responsible officials of the section 14(b) of the amended FIFRA, a final
lead agency and cooperating units shall be order imposing civil penalty under section
included. 14(a) of the amended FIFRA, or conclusion of a
(b) Contains satisfactory assurances that State enforcement action.
such lead agency has or will have the legal (C) Provisions for right-of-entry by consent
authority and qualified personnel necessary to or warrant by appropriate State officials at
carry out the plan: reasonable times for sampling, inspection, and
(1) Satisfactory assurances that the lead observation purposes.
agency or other cooperating agencies have (D) Provisions making it unlawful for
the legal authority necessary to carry out the persons other than certified applicators or
plans should be in the form of an opinion of persons working under their direct supervision
the Attorney General or the legal counsel of to use restricted use pesticides.
the lead agency. In addition: (E) Provisions requiring certified
(i) The lead agency should submit a copy commercial applicators to keep and maintain
of each appropriate State law and regulation. for the period of at least two years routine
(ii) In those States where any requisite operational records containing information on
legal authorities are pending enactment kinds, amounts, uses, dates, and places of
and/or promulgation, the Governor (or Chief application of restricted use pesticides; and for
Executive) may request that a State plan be ensuring that such records will be available to
approved contingent upon the enactment appropriate State officials.
and/or promulgation of such authorities. Plans (2) Satisfactory assurances that the lead
approved on a contingency basis will be agency and any cooperating organizations
subject to such reasonable terms and have qualified personnel necessary to carry
conditions, concerning the duration of the out the plan will be demonstrated by including
contingency approval and other matters, as the numbers, job titles and job functions of
the Administrator may impose. During the persons so employed.
period of the contingency approval, the State (c) Gives satisfactory assurances that the
will have an approved certification program State will devote adequate funds to the
and may proceed to certify applicators, who administration of the plan.
will then be permitted to use or supervise the (d) Provides that the State agency will
use of pesticides classified for restricted use make reports to the Administrator in a manner
under FIFRA, as amended. and containing information that the
(iii) The State plan should indicate by Administrator may from time to time require,
citations to specific laws (whether enacted or including:
pending enactment) and/or regulations (1) An annual report to be submitted by the
(whether promulgated or pending lead agency, at a time to be specified by the
promulgation) that the State has legal State, to include the following information:
authorities as follows:
(1) Total number of applicators, private (D) For each category and subcategory
and commercial, by category, currently listed under §171.7(e)(1)(i)(A), either submission
certified; and number of applicators, private of examinations or a description of the types
and commercial, by category, certified during and contents of examinations (e.g., multiple
the last reporting period. choice, true-false) and submission of sample
(ii) Any changes in commercial applicator examination questions; and a description of
subcategories. any performance testing used to determine
(iii) A summary of enforcement activities competency of applicators.
related to use of restricted use pesticides (ii) For private applicators:
during the last reporting period. (A) An estimate of the number of private
(iv) Any significant proposed changes in applicators expected to be certified by the
required standards of competency. State.
(v) Proposed changes in plans and (B) The standards of competency
procedures for enforcement activities related elaborated by the State. These shall conform
to use of restricted use pesticides for the next and be at least equal to those prescribed in §
reporting period. 171.5(a), including the five requirements listed
(vi) Any other proposed changes from the in § 171.5(a) (1) through (5).
State plan that would significantly affect the (C) Types and contents of examinations
State certification program. and/or submission of detailed description of
(2) Other reports as may be required by methods other than examination used to
the Administrator shall be submitted from time determine competency of private applicators.
to time to meet specific needs. (D) A description of any special procedure
(e) Contains satisfactory assurances that of testing that a State develops to determine
the competency of a private applicator who is
the State standards for the certification of
unable to read the label as prescribed in
applicators of pesticides conform to those
§171.5(b)(1).
standards prescribed by the Administrator (2) A provision for issuance by the State of
under §§171.1 through 171.6. Such assurances appropriate credentials or documents
should consist of: verifying certification of applicators.
(1) A detailed description of the State’s plan (3) If appropriate, a description of any
for certifying applicators and a discussion of existing State licensing, certification or
any special situations, problems, and needs authorization programs for private applicators
together with an explanation of how the State or for one or more categories of commercial
intends to handle them. The State plan should applicators may be included. If these programs
include the following elements as a minimum: are determined by EPA to meet standards of
(i) For commercial applicators: competency prescribed by §§171.1 through
(A) A list and description of categories and 171.6, States may certify applicators so
subcategories to be used in the State, such licensed, certified or authorized without any
categories to be consistent with those defined additional demonstration of competency
in §171.3. provided:
(B) An estimate of the number of (i) The commercial applicators who were
commercial applicators by category expected licensed, certified, or authorized have
to be certified by the State. demonstrated their competency based on
(C) The standards of competency written examinations and, as appropriate,
elaborated by the State. These shall conform performance testing, conforming to the
and be at least equal to those prescribed in standards set forth in § 171.4, and
§171.4 for the various categories of applicators (ii) The private applicators who were
utilized by the State. The standards shall also licensed, certified, or authorized have
cover each of the points listed in the general demonstrated their competency by written or
standards in § 171.4(b) and the points covered oral testing procedures or other acceptable
in the appropriate specific standards set forth equivalent system, conforming to the
in § 171.4(c). standards set forth in §171.5.
(4) A statement that the State accepts Such other regulatory activities, If described,
Federal employees qualified under the will be considered by the Administrator in
Government Agency Plan (GAP) as fully evaluating whether or not a State’s certified
meeting the requirements for certification by applicator program satisfies the requirements
that State; or a description of any additional of §171.7 (a) through (e).
requirements these employees must meet to [40 FR 11702, Mar. 12, 1975]
apply restricted use pesticides in that State.
Any such additional requirements shall be § 171.8 Maintenance of State plans.
consistent with and shall not exceed standards (a) Any State certification program
established for other comparable applicators approved under §171.7 shall be maintained in
in that State. accordance with the State plan approved
(i) Until such time as the GAP has been under that section. Accordingly, the State plan
fully developed and approved by EPA, this should include:
statement (§ 171.7(e)(4)) is not required. (1) Provisions to assure that certified
However, within 60 days after final approval of applicators comply with standards for the use
the GAP, the State should forward such a of restricted use pesticides and carry out their
statement for inclusion in its State plan. responsibility to provide adequate supervision
(5) A description of any cooperative of noncer- tified applicators.
agreements a State has made with any Indian (2) Provisions to ensure that certified
Governing Body to certify or assist in the applicators continue to meet the requirements
certification of applicators not subject to State of changing technology and to assure a
jurisdiction. (§171.10). continuing level of competency and ability to
(6) A description of any arrangements that use pesticides safely and properly.
a State has made or plans to make relating to (b) An approved State plan and the
reciprocity with other States or jurisdictions for certification program carried out under such
the acceptance of certified applicators from
plan may not be substantially modified without
those States or jurisdictions. However, those
the prior approval of the Administrator. A
arrangements should meet these conditions:
(i) The State according reciprocity should proposed change may be submitted for
provide for issuance of an appropriate approval at any time but all applicable
document verifying certification based upon requirements prescribed by these Regulations
the certifying document issued by the other must be satisfied for the modification to be
States or jurisdictions. eligible for approval by the Administrator.
(ii) The State according reciprocity should (c) Whenever the Administrator
have enforcement procedures that cover out- determines that a State is not administering
of-State applicators determined to be the certification program in accordance with
competent and certified within the State or the State plan approved under §171.7, he shall
jurisdiction. so notify the State and provide for a hearing at
(iii) The detailed State or jurisdiction the request of the State and, if appropriate
standards of competency, for each category corrective action is not taken within a
identified in the reciprocity arrangement reasonable time, not to exceed ninety days,
should be sufficiently comparable to justify the Administrator shall withdraw approval of
waiving an additional determination of the plan.
competency by the State granting reciprocity. [40 FR 11704, Mar. 12, 1975]
(f) In responding to the preceding
requirements, a State may describe in its State §171.9 Submission and approval of Government
plan other regulatory activities implemented Agency Plan.
under State laws or regulations which will This section is included to provide for
contribute to the desired control of the use of certain Federal employees including those
restricted use pesticides by certified whose duties may require
applicators.
them to use or supervise the use of restricted ment and any amendments thereto shall be
use pesticides in a number of States. incorporated in the State plan, and forwarded
(a) Sections 171.1 through 171.8 will, with to the Administrator for approval or
the necessary changes, apply to the disapproval.
Government Agency Plan (GAP) for (2) If the Indian Governing Body decides to
determining and attesting to the competency develop its own certification plan, it shall be
of Federal employees to use or supervise the based on either Federal standards (§§171.1
use of restricted use pesticides. through 171.8) or State standards for
(b) Federal employees qualified under the certification which have been accepted by EPA.
GAP shall: Such a plan shall be submitted through the
(1) Be prepared to present the Federal form
United States Department of the Interior to the
issued to them attesting to their competency
to appropriate State officials. EPA Administrator for approval.
(2) Fulfill any additional requirements (b) On Indian Reservations where the State
States may have enumerated in their State has assumed jurisdiction under other Federal
plans as provided for under §171.7(e)(4). laws, anyone using or supervising the use of
(c) The employing Federal agency shall restricted use pesticides shall be certified
ensure that certified employees using or under the appropriate State certification plan.
supervising the use of restricted use pesticides (c) Non-Indians applying restricted use
within a Federal facility are subject to the same pesticides on Indian Reservations not subject
or equivalent provisions prescribed under to State jurisdiction shall be certified either
§171.7(b)(1)(iii) (A)-(E). under a State certification plan accepted by
[40 FR 11704, Mar. 12, 1975] the Indian Governing Body or under the Indian
§171.10 Certification of applicators on Indian Reservation certification plan.
Reservations. (d) Nothing in this section is intended
This section applies to applicators on Indian either to confer or deny jurisdiction to the
Reservations. States over Indian Reservations not already
(a) On Indian Reservations1 not subject to conferred or denied under other laws or
State jurisdiction the appropriate Indian treaties.
Governing Body 2 may choose to utilize the
State certification program, with the [40 FR 11704, Mar. 12, 1975]
concurrence of the State, or develop its own §171.11 Federal certification of pesticide applicators
plan for certifying private and commercial in States or on Indian Reservations where
applicators to use or supervise the use of there is no approved State or Tribal
restricted use pesticides. certification plan in effect.
(1) If the Indian Governing Body decides to (a) Applicability. This section applies to
utilize the State certification program, it should
persons in any State and on any Indian
enter into a cooperative agreement with the
State. This agreement should include matters Reservation where, because there is no
concerning funding and proper authority for approved State or Tribal certification plan in
enforcement purposes. Such agree effect, the Administrator implements an EPA
plan for the Federal certification of applicators
of restricted use pesticides.
(b) Certification requirement. In any State
or on any Indian Reservation where this
section is applicable, any person who uses or
supervises the use of any pesticide classified
for restricted use must be certified in
accordance with this section. However, a
competent person who is not certified may use
!The term Indian Reservation means any federally- a restricted use pesticide under the
recognized reservation established by Treaty,
Agreement, Executive Order, or Act of Congress.
Cicer arietinum (chickpea, garbanzo bean); Lupinus spp. (including sweet lupine,
white sweet lupine, white lupine, and grain lupine). Phaseolus spp.
(including kidney bean, lima bean, mung bean, navy bean, pinto bean,
snap bean, and waxbean; Vicia faba (broad bean, fava bean); Vigna spp.
(including asparagus bean, blackeyed pea and cowpea).
Celery Celery, Florence fennel (sweet anise, sweet fennel, finochio) (fresh leaves and
stalks only).
Fruit, citrus Grapefruit, lemon, lime, orange, tangelo, tangerine, citrus citron, kumquat, and
hybrids of these.
Marjoram Origanum spp. (includes sweet or annual marjoram, wild marjoram or oregano,
and pot marjoram).
Melon
Muskmelon, including hybrids and/or varieties of Cucumis melo (including true
cantaloupe, cantaloupe, casaba, Santa Claus melon, crenshaw melon,
honeydew melon, honey balls, Persian melon, golden pershaw melon,
mango melon, pineapple melon, snake melon); and watermelon, including
hybrids and/or varieties of (Citrullus spp.).
§180.1 40 CFR Ch. I (7-1-14 Edition)
A B
Muskmelon
Cucumis melo (includes true cantaloupe, cantaloupe, casaba, Santa Claus
melon, crenshaw melon, honeydew melon, honey balls, Persian melon,
golden pershaw melon, mango melon, pineapple melon, snake melon, and
other varieties and/or hybrids of these.)
Onion Bulb onion; green onion; and garlic.
Onion, bulb Bulb onion; garlic; great headed garlic; serpent garlic; Chinese onion; pearl
onion; potato onion; and shallot, bulb.
Onion, green Green onion; lady's leek; leek; wild leek; Beltsville bunching onion; fresh onion;
tree onion, tops; Welsh onion; and shallot, fresh leaves.
Peach Peach, nectarine
Pea
Cajanus cajan (includes pigeon pea); Cicer spp. (includes chickpea and
garbanzo bean); Lens culinaris (lentil); Pisum spp. (includes dwarf pea,
garden pea, green pea, English pea, field pea, and edible pod pea). [Note:
A variety of pesticide tolerances have been previously established for pea
and/or bean. Chickpea/garbanzo bean is now classified in both the bean
and the pea categories. For garbanzo bean/chickpea only, the highest
established pea or bean tolerance will apply to pesticide residues found in
this commodity.]
Pepper
All varieties of pepper including pimento and bell, hot, and sweet pepper.
Radish, oriental, roots
Raphanus sativus var. longipinnatus (roots and tops), including Chinese or
Japanese radish (both white and red), winter radish, daikon, lobok, lo pak,
and other cultivars and/or hybrids of these.
Radish, oriental, tops)
Raphanus sativus var. longipinnatus (roots and tops), including Chinese or
Japanese radish (both white and red), winter radish, daikon, lobok, lo pak,
and other cultivars and/or hybrids of these.
Sorghum, grain, grain Sorghum spp. [sorghum, grain, sudangrass (seed crop), and hybrids of these
grown for its seed].
Sorghum, forage, stover Sorghum spp. [sorghum, forage; sorghum, stover; sudangrass, and hybrids of
these grown for forage and/or stover.
Annona squamosa L. (sugar apple, sweetsop, anon), and its hybrid A. squamosa
L. x A. cherimoya M. (atemoya). Also A. reticulata L. (true custard apple).
Squash, summer
Fruits of the gourd (Cucurbitaceae) family that are consumed when immature,
100% of the fruit is edible either cooked or raw, once picked it cannot be
stored, has a soft rind which is easily penetrated, and if seeds were
harvested they would not germinate; e.g., Cucurbita pepo (i.e., crookneck
squash, straightneck squash, scallop squash, and vegetable marrow);
Lagenaria spp. (i.e., spaghetti squash, hyotan, cucuzza); Luffa spp. (i.e.,
hechima, Chinese okra); Momordica spp. (i.e., bitter melon, balsam pear,
balsam apple, Chinese cucumber); Sechium edule (chayote); and other
cultivars and/or hybrids of these.
Sweet potato Sweet potato, yam.
A B
Tangerine
Tangerine (mandarin or mandarin orange); clementine; Mediterranean
mandarin; satsuma mandarin; tangelo; tangor; cultivars, varieties, and/or
hybrids of these.
Tomato Tomato, tomatillo.
Turnip tops or turnip greens Broccoli raab (raab, raab salad), hanover salad, turnip tops (turnip
greens).
Wheat Wheat, triticale.
(h) Unless otherwise specified In this (10) For processed foods consisting
paragraph or in tolerance regulations primarily of one ingredient and sold in a form
prescribed in this part for specific pesticide requiring further preparation prior to
chemicals, the raw agricultural commodity or consumption (e.g., fruit juice concentrates,
processed food to be examined for pesticide dehydrated vegetables, and powdered
residues, shall consist of the whole raw potatoes), the processed food to be examined
agricultural commodity or processed food. for residues shall be the whole processed
(1) The raw agricultural commodity commodity after compensating for or
bananas, when examined for pesticide reconstituting to the commodity’s normal
residues, shall not include any crown tissue or moisture content, unless a tolerance for the
stalk. concentrated or dehydrated food form is
(2) Shell shall be removed and discarded included in this part. If there exists a tolerance
from nuts before examination for pesticide for a specific pesticide on the processed food
residues. in its concentrated or dehydrated food form,
(3) Caps (hulls) shall be removed and for the purpose of determining whether the
discarded from strawberries before food is in compliance with that tolerance, the
examination for pesticide residues. processed food to be examined for residues
(4) Stems shall be removed and discarded shall be the whole processed commodity on
from melons before examination for pesticide an ‘‘as is’’ basis.
residues. (i) The term pesticide chemical shall have
(5) Roots, stems, and outer sheaths (or the meaning specified in FFDCA section
husks) shall be removed and discarded from 201(q)(1), as amended, except as provided in
garlic bulbs and dry bulb onions, and only the §180.4.
garlic cloves and onion bulbs shall be (j) The term negligible residue means any
examined for pesticide residues. amount of a pesticide chemical remaining in or
(6) Where a tolerance is established on a on a raw agricultural commodity or group of
root vegetable including tops and/ or with raw agricultural commodities that would result
tops, and the tops and the roots are marketed in a daily intake regarded as toxicologically
together, they shall be analyzed separately insignificant on the basis of scientific judgment
and neither the pesticide residue on the roots of adequate safety data. Ordinarily this will add
nor the pesticide residue on the tops shall to the diet an amount which will be less than
exceed the tolerance level, except that in the 1/2,000th of the amount that has been
case of carrots, parsnips, and rutabagas, the demonstrated to have no effect from feeding
tops shall be removed and discarded before studies on the most sensitive animal species
analyzing roots for pesticide residues. tested. Such toxicity studies shall usually
(7) The crowns (leaves at the top of the include at least 90-day feeding studies in two
fruit) shall be removed and discarded from species of mammals.
pineapples before examination for pesticide (k) The term nonperishable raw
residues. agricultural commodity means any raw
(8) The term lima beans means the beans agricultural commodity not subject to rapid
and the pod. decay or deterioration that would
(9) The term peanuts means the peanut
meat after removal of the hulls.
render it unfit for consumption. Examples are cological effects: Chlorinated organic
cocoa beans, coffee beans, field-dried beans, pesticides, arsenic-containing chemicals,
field-dried peas, grains, and nuts. Not included metallic dithiocarbamates, cholinesterase-
are eggs, milk, meat, poultry, fresh fruits, and inhibiting pesticides.)
vegetables such as onions, parsnips, potatoes, (b) Tolerances established for such related
and carrots. pesticide chemicals may limit the amount of a
(l) The term tolerance with regional common component (such as As2O3) that may
registration means any tolerance which is be present, or may limit the amount of
established for pesticide residues resulting biological activity (such as cholinesterase
from the use of the pesticide pursuant to a inhibition) that may be present, or may limit
regional registration. Such a tolerance is the total amount of related pesticide chemicals
supported by residue data from specific (such as chlorinated organic pesticides) that
growing regions for a raw agricultural may be present.
commodity. Individual tolerances with regional (c) (1) Where tolerances for inorganic
registration are designated in separate bromide in or on the same raw agricultural
subsections in 40 CFR 180.101 through 180.999, commodity are set in two or more sections in
as appropriate. Additional residue data which this part (example: §§180.123 and 180.199), the
are representative of the proposed use area overall quantity of inorganic bromide to be
are required to expand the geographical area tolerated from use of the same pesticide in
of usage of a pesticide on a raw agricultural different modes of application or from two or
commodity having an established “tolerance more pesticide chemicals for which tolerances
with regional registration.” Persons seeking are established is the highest of the separate
geographically broader registration of a crop applicable tolerances. For example, where the
having a ‘‘tolerance with regional registration” bromide tolerance on asparagus from methyl
should contact the appropriate EPA product bromide commodity fumigation is 100 parts
manager concerning additional residue data per million (40 CFR 180.123) and on asparagus
required to expand the use area. from methyl bromide soil treatment is 300
(m) The term pesticide chemical residue parts per million (40 CFR 180.199), the overall
shall have the meaning specified in FFDCA inorganic bromide tolerance for asparagus
section 201(q)(2), as amended, except as grown on methyl bromide-treated soil and
provided in §180.4. also fumigated with methyl bromide after
(n) The term food commodity means: harvest is 300 parts per million.
(1) Any raw agricultural commodity (food (2) Where tolerances are established in
or feed) as defined in section 201(r) of the terms of inorganic bromide residues only from
Federal Food, Drug, and Cosmetic Act use of organic bromide fumigants on raw
(FFDCA); and agricutural commodities, such tolerances are
(2) Any processed food or feed as defined sufficient to protect the public health, and no
in section 201(gg) of the FFDCA. additional concurrent tolerances for the
[36 FR 22540, Nov. 25, 1971] organic pesticide chemicals from such use are
EDITORIAL NOTE: For FEDERAL REGISTER citations necessary. This conclusion is based on
affecting §180.1, see the List of CFR Sections Affected, evidence of the dissipation of the organic
which appears in the Finding Aids section of the pesticide or its conversion to inorganic
printed volume and at www.fdsys.gov. bromide residues in the food when ready to
§ 180.3 Tolerances for related pesticide chemicals. eat.
(a) Pesticide chemicals that cause related (d) (1) Where tolerances are established for
pharmacological effects will be regarded, in both calcium cyanide and hydrogen cyanide
the absence of evidence to the contrary, as on the same raw agricultural commodity, the
having an additive deleterious action. (For total amount of such pesticides shall not yield
example, many pesticide chemicals within more residue than that permitted by the larger
each of the following groups have related of the two tolerances, calculated as hydrogen
pharma cyanide.
(2) Where tolerances are established for
residues of both O,O-diethyl S-[2-
(ethylthlo)ethyl] phosphorodlthloate and more residue than that permitted by the
demeton (a mixture of 0,0-dlethyl 0-(and higher of the two tolerances.
S-) [2-(ethylthlo)ethyl] (8) Where a tolerance is established for
phosphorothloates) on the same raw more than one pesticide having the
agricultural commodlty, the total amount of metabolites 1-(3,4-dichlorophenyl)-3-
such pestlcldes shall not yleld more resldue methylurea (DCPMU) and 3,4-
than that permltted by the larger of the two dichlorophenylurea (DCPU) found in or on a
tolerances, calculated as demeton. raw agricultural commodity, the total amount
(3) Where tolerances are establlshed for of such residues shall not exceed the highest
both terpene polychlorlnates (chlorlnated established tolerance for a pesticide having
mlxture of camphene, pl- nene, and related these metabolites.
terpenes, contalnlng 65-66 percent chlorlne) (9) Where a tolerance is established for
and toxaphene (chlorlnated camphene more than one pesticide having as metabolites
contalnlng 67-69 percent chlorlne) on the compounds containing the benzimidazole
same raw agrl- cultural commodltles, the total moiety found in or on a raw agricultural
amount of such pestlcldes shall not yleld more commodity, the total amount of such residues
resldue than that permltted by the larger of the shall not exceed the highest established
two tolerances, calculated as a chlorlnated tolerance for a pesticide having these
terpene of molecular welght 396.6 contalnlng metabolites.
67 percent chlorlne. (10) Where a tolerance is established for
(4) Where a tolerance ls establlshed for triclopyr, chloropyrifos, and chlorpyrifos-
more than one pestlclde contalnlng arsenlc methyl having the common metabolite 3,5,6-
found ln, or on a raw agrlcul- tural commodlty, trichloro-2- pyridinol on the same raw
the total amount of such pestlclde shall not
agricultural commodity, the total amount of
exceed the hlghest establlshed tolerance
such residues shall not exceed the highest
calculated as As2O3.
(5) Where tolerances are establlshed for established tolerance for any of the pesticides
more than one member of the class of having the metabolites.
dlthlocarbamates llsted ln paragraph (e)(3) of (11) Where tolerances are established for
thls sectlon on the same raw agrlcultural more than one pesticide having the metabolite
commodlty, the total resldue of such 3,5,6-trichloro-2-pyridinol found in or on the
pestlcldes shall not exceed that permltted by raw agricultural commodity, the total amount
the hlghest tolerance establlshed for any one of such residues shall not exceed the highest
member of the class, calculated as zlnc established tolerance for a pesticide having
ethyleneblsdlthlocarbamate. this metabolite.
(6) Where tolerances are establlshed (12) Where tolerances are established for
for resldues of both S,S,S-trlbutyl residues of methomyl, resulting from the use
phosphorotrlthloate and trlbutyl of thiodicarb and/or methomyl on the same
phosphorotrlthlolte ln or on the same raw raw agricultural commodity, the total amount
agrlcultural commodlty, the total amount of of methomyl shall not yield more residue than
such pestlcldes shall not yleld more resldue that permitted by the higher of the two
than that permltted by the hlgher of the two tolerances.
tolerances, calculated as S,S,S- (e) Except as noted in paragraphs (e)(1) and
trlbutyl (2) of this section, where residues from two or
phosphorotrlthloate. more chemicals in the same class are present
(7) Where tolerances are establlshed in or on a raw agricultural commodity the
for resldues of 0,S-dlmethyl tolerance for the total of such residues shall be
phosphoramldothloate, resultlng from the use the same as that for the chemical having the
of acephate (0,S-dlmethyl acetyl phos- lowest numerical tolerance in this class, unless
phoramldothloate) and/or 0,S - a higher tolerance level is specifically provided
dlmethylphosphoramldothloate on the same for the combined residues by a regulation in
agrlcultural commodlty, the total amount of this part.
0,S-dlmethyl- phosphoramldothloate shall not
yleld
(1) Where residues from two or more A mixture of 5.2 parts by weight of ammoni- ates of
chemicals in the same class are present in or [ethylenebis (dithiocarbamato)] zinc with 1 part by
on a raw agricultural commodity and there are weight ethylenebis [dithiocarbamic acid]
bimolecular and trimolecular cyclic
available methods that permit quantitative anhydrosulfides and disulfides.
determination of each residue, the quantity of 2-Chloroallyl diethyldithiocarbamate.
combined residues that are within the Coordination product of zinc ion and maneb
tolerance may be determined as follows: containing 20 percent manganese, 2.5 percent
(1) Determine the quantity of each residue zinc, and 77.5 percent
ethylenebisdithiocarbamate.
present. Ferbam.
(ii) Divide the quantity of each residue by Maneb.
the tolerance that would apply if it occurred Manganous dimethyldithiocarbamate.
alone, and multiply by 100 to determine the Sodium dimethyldithiocarbamate.
percentage of the permitted amount of Thiram.
residue present. Zineb.
Ziram.
(iii) Add the percentages so obtained for
all residues present. (4) The following are members of the class
(iv) The sum of the percentages shall not of chlorinated organic pesticides:
exceed 100 percent. Aldrin.
(2) Where residues from two or more BHC (benzene hexachloride).
chemicals in the same class are present in or 1.1- Bis(p-chlorophenyl)-2,2,2-
trichloroethanol.
on a raw agricultural commodity and there are Chlorbenside (p-chlorobenzyl p-chlorophenyl
available methods that permit quantitative sulfide).
determinations of one or more, but not all, of Chlordane.
the residues, the amounts of such residues as Chlorobenzilate (ethyl 4,4'-
may be determinable shall be deducted from dichlorobenzilate).
p-Chlorophenoxyacetic acid.
the total amount of residues present and the p-Chlorophenyl-2,4,5-trichlorophenyl sulfide.
remainder shall have the same tolerance as 2.4- D (2,4-dichlorophenoxyacetic acid).
that for the chemical having the lowest DDD (TDE).
numerical tolerance in that class. The quantity DDT.
of combined residues that are within the 1.1- Dichloro-2,2-bis(p-ethylphenyl) ethane.
tolerance may be determined as follows: 2,6- Dichloro-4-nitroaniline.
2.4- Dichlorophenyl p-nitrophenyl ether.
(i) Determine the quantity of each Dieldrin.
determinable residue present. Dodecachlorooctahydro-1,3,4-metheno-2ff-
(ii) Deduct the amounts of such residues cyclobuta[cd]pentalene.
from the total amount of residues present and Endosulfan (6,7,8,9,10,10-hexachloro-1,5,5a, 6,9,9a-
consider the remainder to have the same hexahydro-6,9-methano-2,4,3-
benzodioxathiepin-3-oxide).
tolerance as that for the chemical having the Endosulfan sulfate (6,7,8,9,10,10-hexachloro-
lowest numerical tolerance in that class. 1,5,5a,6,9,9a-hexahydro-6,9-methano-2,4,3-
(iii) Divide the quantity of each benzodioxathiepin-3,3-dioxide).
determinable residue by the tolerance that Heptachlor (1,4,5,6,7,8,8-heptachlor-3a,4,7, 7a-
would apply if it occurred alone and the tetrahydro-4,7-methanoindene).
quantity of the remaining residue by the Heptachlor epoxide (1,4,5,6,7,8,8-heptachloro- 2,3-
epoxy-2,3,3a,4,7,7a-hexahydro-4,7-
tolerance for the chemical having the lowest methanoindene).
numerical tolerance in that class and multiply Hexachlorophene (2,2'-methylenebis(3,4,6-
by 100 to determine the percentage of the trichlorophenol) and its monosodium salt.
permitted amount of residue present. Isopropyl 4,4'-dichlorobenzilate.
(iv) Add the percentages so obtained for Lindane.
Methoxychlor.
all residues present. Ovex (p-chlorophenyl p-
(v) The sum of the percentages shall not chlorobenzenesulfonate).
exceed 100 percent. Sesone (sodium 2,4-dichlorophenoxyethyl sulfate,
(3) The following pesticides are members SES).
of the class of dithiocarbamates: Sodium 2,4-dichlorophenoxyacetate.
Sodium trichloroacetate.
Sulphenone (p-chlorophenyl phenyl sulfone).
Terpene polychlorinates (chlorinated mixture of
camphene, pinene, and related terpenes 65-66
percent chlorine).
2,3,5,6- Tetrachloronitrobenzene. 0,0-Diethyl 0-(2-isoprophyl-4-methyl-6-
Tetradifon (2,4,5,4'-tetrachlorodiphenyl pyrimidinyl) phosphorothioate.
sulfone). 0,0-Diethyl 0-[p-(methylsulfinyl)phenyl]
Toxaphene (chlorinated camphene). phosphorothioate and its cholinesterase-
Trichlorobenzoic acid. inhibiting metabolites.
Trichlorobenzyl chloride. Diethyl 2-pyrazinyl phosphate.
(5) The following are members of the class 0,0-Diethyl 0-2-pyrazinyl phosphorothioate.
of cholinesterase-inhibiting pesticides: S-(0,0-Diisopropyl phosphorodithioate) of A- (2-
Acephate (0,S-dimethyl acetyl- mercaptoethyl) benzenesulfonamide
phosphoramidothioate) and its cholinesterase- S-(0,0-Diisopropyl phosphorodithioate) of A- (2-
inhibiting metabolite 0,S-di- methyl mercaptoethyl) benzenesulfonamide
phosphoramidothioate. 2-(Dimethylamino)-5.6-dimethyl-4- pyrimidinyl
Aldicarb (2-methyl-2-(methylthio) dimethylcarbamate and its metabolites 5,6-
propionaldehyde 0- dimethyl-2-
(methylcarbamoyl)oxime) and its chlorinesterase- (formylmethylamino)-4-pyrimidinyl
inhibiting metabolites 2- methyl-2- dimethylcarbamate and 5,6-dimethyl-2-
(methylsulfinyl)propionaldehyde 0- (methylamino)-4-pyrimidinyl dimethylcarbamate
(methycarbamoyl) oxime and 2-methyl- 2- (both calculated as parent).
(methylsulfonyl)propionaldehyde 0- Dimethoate (0,0-dimethyl S-(A-methyl-
(methylcarbamoyl)oxime. carbamoylmethyl) phosphorodithioate).
4- tert-Butyl-2-chlorophenyl methyl methyl Dimethoate oxygen analog (0,0-dimethyl S- (A-
phosphoramidate. methylcarbamoylmethyl) phosphorothioate).
5- [(tert-Butylthio)methyl] 0,0-diethyl 0,0-Dimethyl 0-p-(dimethylsulfamoyl)
phosphorodithioate and its cholinesterase- phenyl phosphate.
inhibiting metabolites. 0,0-Dimethyl 0-p-(dimethylsulfamoyl)
Carbaryl (1-naphthyl A-methylcarbamate).
Carbofuran (2,3,-dihydro-2,2-dimethyl-7- phenyl phosphorothioate.
benzofuranyl-A-methylcarbamate). 3,5- D
Carbofuran metabolite (2,3-dihydro-2,2-di- methyl- imethyl-4-(methylthio) phenyl
3-hydroxy-7-benofuranyl A- methylcarbamate.
methylcarbamate). 0,0-Dimethyl S-[4-oxo-1,2,3-benzotriazin-3- (4A)-
Carbophenothion (S-[(p-chlorophenyl) ylmethyl] phosphorodithioate.
thiolmethyl] 0,0-diethyl Dimethyl phosphate of 3-hydroxy-A,A-di- methyl-
phosphorodithioate) and its cholinesterase- cis-crotonamide.
inhibiting metabolites. Dimethyl phosphate of 3-hydroxy-A-methyl- cis-
Chlorpyrifos (0,0-diethyl 0-(3,5,6-trichloro- 2- crotonamide.
pyridyl)phosphorothioate). Dimethyl phosphate of a-methylbenzyl 3-hy-
Chlorpyrifos-methyl (0,0-dimethyl-0-(3,5,6- droxy-cis-crotonate.
trichloro-2-pyridyl) phosphorothioate. 0,0-Dimethyl 2,2,2-trichloro-1-hydroxyethyl
2-Chloro-1-(2,4,5-trichlorophenyl)vinyl dimethyl phosphonate.
phosphate. 0,0-Dimethyl phosphorodithioate, S-ester with 4-
2-Chloro-1-(2,4-dichlorophenyl) vinyl diethyl (mercaptomethyl)-2-methozy-D2- 1,3,4-
phosphate. thiadiazolin-5-one.
Coumaphos (0,0-diethyl 0-3-chloro-4-meth- yl-2-
oxo-2A-1-benzopyran-7-yl phosran-7-yl Dioxathion (2,3-p-dioxanedithiol S,S-bis (0,0-
phosphate). diethylphosphorodithioate)) containing
Coumaphos oxygen analog (0,0-diethyl 0-3- approximately 70 percent cis and trans isomers
chloro-4-methyl-2-oxo-2A-1- and approximately 30 percent related
benzopyphorothioate). compounds.
Dialifor (S-(2-chloro-1-phthalimidoethyl) 0,0-diethyl EPN.
phosphorodithioate). Ethephon ((2- - chloroethyl) phosphonic
Dialifor oxygen analog (S-(2-chloro-1- acid).
phthalimidoethyl) 0,0-diethyl Ethion.
phosphorothioate). Ethion oxygen analog (S-
Demeton (a mixture of 0,0-diethyl 0-(and S) [2- [[(diethoxyphosphinothioyl)thio] methyl] 0,0-
ethylthio)ethyl] phosphorothioates). diethyl phosphorothioate).
Ethiolate (S-ethyl diethylthiocarbamate). 0- Ethyl 0-[4-(methylthio) phenyl] S-propyl
2,2- Dichlorovinyl dimethyl phosphate. phosphorodithioate and its cholinesterase-
0,0-Diethyl S-[2-(ethylthio)ethyl] inhibiting metabolites.
phosphorodithioate and its cholinesterase- 0-Ethyl S,S-dipropylphosphorodithioate.
inhibiting metabolites. Ethyl 3-methyl-4-(methylthio)phenyl (1- methylethyl)
0,0-Diethyl 0-(2-diethylamino-6-methyl-4-
pyrimidinyl) phosphorothioate and its oxygen phosphoramidate and its cholinesterase-
analog diethyl 2-diethylamino-6-meth- yl-4- inhibiting metabolites.
pyrimidinyl phosphate. 0-Ethyl S-phenyl ethylphosphonodithioate.
0-Ethyl S-phenyl ethylphosphonothiolate.
m-(1-Ethylpropyl)phenyl methylcarbamate.
S-[2-Ethylsulfinyl)ethyl] 0,0-dimethyl EFFECTIVE DATE NOTE: At 79 FR 27501, May 14, 2014,
phosphorothioate and its cholinesterase- §180.3 was amended by revising paragraph (d)(5),
inhibiting metabolites, (primarily S-[2- (ethyl- effective Nov. 14, 2014. For the convenience of the
sulfonyl)ethyl] 0,0-dimethyl user, the revised text is set forth as follows:
phosphorothioate).
Fenthion (0,0-dimethyl 0-[3-methyl-4- §180.3 Tolerances for related pesticide chemicals.
(methylthio)phenyl]phosphorothioate and its
cholinesterase-inhibiting metabolites. Malathion. * * * * *
N-(Mercaptomethyl)phthalimide S-(0,0-di- methyl
phosphorodithioate). N- (d) * * *
(Mercaptomethyl)phthalimide S-(0,0-di- methyl (5) Where tolerances are established for more
phosphorothioate). than one member of the class of dithiocarbamates
Methomyl (S-methyl N- listed in paragraph (e)(3) of this section on the same
[(methylcarbamoyl)oxy]thioacetimidate). 1- raw agricultural commodity, the total residue of such
Methoxycarbonyl-1-propen-2-yl dimethyl pesticides shall not exceed that permitted by the
phosphate and its beta isomer. m-(1- highest tolerance established for any one member of
Methylbutyl)phenyl methylcarbamate. Methyl the class, calculated both as zinc
parathion. ethylenebisdithiocarbamate and carbon disulfide.
Naled (1,2-dibromo-2,2-dichloroethyl dimethyl The tolerance based on zinc
phosphate). ethylenebisdithiocarbamate shall first be multiplied
Oxamyl (methyl N',N'-dimethyl-N- by 0.6 to convert it to the equivalent carbon disulfide
[(methylcarbamoyl)oxy]-1- thiooxamimidate) tolerance, and then the carbon disulfide tolerance
Parathion. levels will be compared to determine the highest
Phorate (0,0-diethyl S-(ethylthio)methyl tolerance level per raw agricultural commodity.
phosphorodithioate) and its cholinesterase-
inhibiting metabolites. *****
Phosalone (S-(6-chloro-3-mercaptomethyl)-2-
benzoxazolinone) 0,0-diethyl § 180.4 Exceptions.
phosphorodithioate).
Phosphamidon (2-chloro-2-diethylcarbamoyl- 1- The substances listed In this section are
methylvinyl dimethyl phosphate) including all of excepted from the definitions of ‘‘pesticide
its related cholinesterase-inhibiting compounds. chemical’’ and ‘‘pesticide chemical residue’’
Pirimiphos-methyl 0-[2-diethylamino-6- methyl- under FFDCA section 201(q)(3) and are
pyrimidinyl) 0,0-dimethyl therefore exempt from regulation under
phosphorothioate
Ronnel. FFDCA section 402(a)(2)(B) and 408. These
Schradan (octamethylpyrophosphoramide). substances are subject to regulation by the
Tetraethyl pyrophosphate. 0,0,0/,0/-Tetramethyl Food and Drug Administration as food
0,0/-sulfinyldi-p- phenylene phosphorothioate. additives under FFDCA section 409.
0,0,0',0'-Tetramethyl 0,0'-thiodi-p-phen- ylene (a) Inert ingredients in food packaging
phosphorothioate. treated with a pesticide, when such inert
Tributyl phosphorotritlioite.
5.5.5- Tributyl phosphorothrithioate. ingredients are the components of the food
3.4.5- Trimethylphenyl methylcarbamate and packaging material (e.g. paper and
its isomer 2,3,5-trimethylphenyl paperboard, coatings, adhesives, and
methylcarbamate. polymers).
(6) The following pesticides are members (b) [Reserved]
of the class of dinitrophenols: [63 FR 10720, Mar. 4, 1998, as amended at 73 FR
2,4-Dinitro-6-octylphenyl crotonate and 2,6- dinitro- 54976, Sept. 24, 2008]
4-octylphenyl crotonate, mixture of.
4,6- Dinitro-o-cresol and its sodium salt. § 180.5 Zero tolerances.
Dinoseb (2-sec-butyl-4,6-dinitrophenol) and its A zero tolerance means that no amount of
alkanolamine, ammonium, and sodium salts. the pesticide chemical may remain on the raw
[41 FR 8969, Mar. 2, 1976] agricultural commodity when it is offered for
EDITORIAL NOTE: For FEDERAL REGISTER citations shipment. A zero tolerance for a pesticide
affecting §180.3, see the List of CFR Sections Affected, chemical in or on a raw agricultural commodity
which appears in the Finding Aids section of the
printed volume and at www.fdsys.gov. may be established because, among other
reasons:
(a) A safe level of the pesticide chemical In milk, eggs, meat, and/or poultry. When it is not
the diet of two different species of warm- possible to determine with certainty whether
blooded animals has not been reliably finite residues will be incurred in milk, eggs,
determined. meat, and/or poultry but there is a reasonable
(b) The chemical is carcinogenic to or has expectation of finite residues in light of data
other alarming physiological effects upon one reflecting exaggerated pesticides levels in
or more of the species of the test animals used, feeding studies, a tolerance will be established
when fed in the diet of such animals. on the raw agricultural commodity provided
(c) The pesticide chemical is toxic, but is that appropriate tolerances can be established
normally used at times when, or in such at the same time, on the basis of the
manner that, fruit, vegetables, or other raw toxicological and other data available, for the
agricultural commodities will not bear or finite residues likely to be incurred in these
contain it. foods through the feed use of the raw
(d) All residue of the pesticide chemical is agricultural commodity or its byproducts.
normally removed through good agricultural When it is not possible to determine with
practice such as washing or brushing or certainty whether finite residues will be
through weathering or other changes in the incurred in milk, eggs, meat, and/or poultry
chemical itself, prior to introduction of the raw but there is no reasonable expectation of finite
agricultural commodity into interstate residues in light of data such as those
commerce. reflecting exaggerated pesticide levels in
§ 180.6 Pesticide tolerances regarding milk, eggs, feeding studies and those elucidating the
meat, and/or poultry; statement of policy. biochemistry of the pesticide chemical in the
animal, a tolerance may be established on the
(a) When establishing tolerances for raw agricultural commodity without the
pesticide residues in or on raw agricultural necessity of a tolerance on food products
commodities, consideration is always given to derived from the animal.
possible residues of those pesticide chemicals (c) The principles outlined in paragraphs
or their conversion products entering the diet (a) and (b) of this section will also be followed
of man through the ingestion of milk, eggs,
with respect to tolerances for residues which
meat, and/or poultry produced by animals fed
will actually be incurred or are reasonably to
agricultural products bearing such pesticide
be expected in milk, eggs, meat, and/or
residues. In each instance an evaluation of all
available data will result in a conclusion either: poultry by the use of pesticides directly on the
(1) That finite residues will actually be animal or administered purposely in the feed
incurred in these foods from feed use of the or drinking water.
raw agricultural commodity including its (d) Tolerances contemplated by
byproducts; or paragraphs (a) and (b) of this section will in
(2) That it is not possible to establish with addition to toxicological considerations be
certainty whether finite residues will be conditioned on the availability of a practicable
incurred, but there is a reasonable expectation analytical method to determine the pesticide
of finite residues; or residue; that is, the method must be sensitive
(3) That it is not possible to establish with and reliable at the tolerance level or in special
certainty whether finite residues will be cases at a higher level where such level is
incurred, but there is no reasonable deemed satisfactory and safe in light of the
expectation of finite residues. toxicity of the pesticide residue and of the
(b) When the data show that finite residues unlikelihood of such residue exceeding the
will actually be incurred in milk, eggs, meat, tolerance. The analytical methods to be used
and/or poultry, a tolerance will be established for enforcement purposes will be those set
on the raw agricultural commodity used as forth in the ‘‘Pesticide Analytical Manual’’ (see
feed provided that tolerances can be § 180.101(c)). The sensitivities of these methods
established at the same time, on the basis of are expressed in that manual.
the toxicological and other data available, for
the finite residues incurred in
Subpart B—Procedural (6) Full reports of tests and investigations
Regulations made with respect to the nature and amount
of the pesticide chemical residue that is likely
§ 180.7 Petitions proposing tolerances or exemptions to remain in or on the food, including a
for pesticide residues in or on raw agricultural description of the analytical methods used.
commodities or processed foods. (See § 180.34 for further information about
(a) Petitions to be filed with the Agency residue tests.)
under the provisions of FFDCA section 408(d) (7) Proposed tolerances for the pesticide
shall be submitted in duplicate. If any part of chemical residue if tolerances are proposed.
the material submitted is in a foreign language, (8) Practicable methods for removing any
it shall be accompanied by an accurate and amount of the residue that would exceed any
complete English translation. The petition shall proposed tolerance.
be accompanied by an advance deposit for (9) A practical method for detecting and
fees described in §180.33. The petition shall measuring the levels of the pesticide chemical
state the petitioner’s mail address to which residue in or on the food, or for exemptions, a
notice of objection under FFDCA section statement why such a method is not needed.
408(g)(2) may be sent. The petition must be (10) If the petition relates to a tolerance for
signed by the petitioner or by his attorney or a processed food, reports of investigations
agent, or (if a corporation) by an authorized conducted using the processing method(s)
official. used to produce that food.
(b) Petitions shall include the following (11) Such information as the Administrator
information: may require to make the determination under
(1) An informative summary of the petition FFDCA section 408(b)(2)(C).
and of the data, information, and arguments (12) Such information as the Administrator
submitted or cited in support of the petition. may require on whether the pesticide chemical
Both a paper and electronic copy of the may have an effect in humans that is similar to
summary should be submitted. The electronic an effect produced by a naturally occurring
copy should be formatted according to the estrogen or other endocrine effects.
Office of Pesticide Programs’ current standard (13) Information regarding exposure to the
for electronic data submission as specified at pesticide chemical residue due to any
http:// tolerance or exemption already granted for
www.epa.gov/pesticides/regulating/reg- such residue.
istering/submissions/index.htm. (14) Information concerning any maximum
(2) A statement that the petitioner agrees residue level established by the Codex
that such summary or any information it Alimentarius Commission for the pesticide
contains may be published as a part of the chemical residue addressed in the petition. If a
notice of filing of the petition to be published Codex maximum residue level has been
under FFDCA section 408(d)(3) and as a part of established for the pesticide chemical residue
a proposed or final regulation issued under and the petitioner does not propose that this
FFDCA section 408. level be adopted, a statement explaining the
(3) The name, chemical identity, and reasons for this departure from the Codex
composition of the pesticide chemical residue level.
and of the pesticide chemical that produces (15) Such other data and information as the
the residue. Administrator requires by regulation to
(4) Data showing the recommended support the petition.
amount, frequency, method, and time of (16) Reasonable grounds in support of the
application of the pesticide chemical. petition.
(5) Full reports of tests and investigations (c) The data specified under paragraphs
made with respect to the safety of the pesticide (b)(1) through (b)(16) of this section should be
chemical, including full information as to the on separate sheets or sets of sheets, suitably
methods and controls used in conducting identified. If such data have already been
those tests and investigations. submitted
with an earlier application, the present petition The full text of the summary may be omitted
may incorporate it by reference to the earlier from the notice.
one. (g) The Administrator may request a
(d) Except as noted in paragraph (e) of this sample of the pesticide chemical at any time
section, a petition shall not be accepted for while a petition is under consideration. The
filing if any of the data prescribed by FFDCA Administrator shall specify in its request for a
section 408(d) are lacking or are not set forth sample of the pesticide chemical, a quantity
so as to be readily understood. The availability which it deems adequate to permit tests of
to the public of information provided to, or analytical methods used to determine residues
otherwise obtained by, the Agency under this of the pesticide chemical and of methods
part shall be governed by part 2 of this chapter. proposed by the petitioner for removing any
The Administrator shall make the full text of the residues of the chemical that exceed the
summary referenced in paragraph (b)(1) of this tolerance proposed.
section available to the public in the public (h) The Administrator shall determine, in
docket at http:// www.regulations.gov no later accordance with the Act, whether to issue an
than publication in the FEDERAL REGISTER of the order that establishes, modifies, or revokes a
notice of the petition filing. tolerance regulation (whether or not in accord
(e) The Administrator shall notify the with the action proposed by the petitioner),
petitioner within 15 days after its receipt of whether to publish a proposed tolerance
acceptance or nonacceptance of a petition, regulation and request public comment
and if not accepted the reasons therefor. if thereon under §180.29, or whether to deny the
petitioner desires, the petitioner may petition. The Administrator shall publish in the
supplement a deficient petition after FEDERAL REGISTER such order or proposed
notification as to deficiencies. If the petitioner
regulation. After receiving comments on any
does not wish to supplement or explain the
proposed regulation, the Administrator may
petition and requests in writing that it be filed
as submitted, the petition shall be filed and the issue an order that establishes, modifies, or
petitioner so notified. revokes a tolerance regulation. An order
(f) A notice of the filing of a petition published under this section shall describe
for a pesticide chemical residue tolerance that briefly how to submit objections and requests
the Administrator determines has met the for a hearing under part 178 of this chapter. A
requirements of paragraph (b) of this section regulation issued under this section shall be
shall be published in the FEDERAL REGISTER by the effective on the date of publication in the
Administrator within 30 days after such FEDERAL REGISTER unless otherwise provided in
determination. The notice shall state the name the regulation.
of the pesticide chemical residue and the [70 FR 33360, June 8, 2005, as amended at 73 FR
commodities for which a tolerance is sought 75600, Dec. 12, 2008]
and announce the availability of a description § 180.8 Withdrawal of petitions without prejudice.
of the analytical methods available to the
in some cases the Administrator will notify
Administrator for the detection and
measurement of the pesticide chemical the petitioner that the petition, while
residue with respect to which the petition is technically complete, is inadequate to justify
filed or shall set forth the petitioner’s statement the establishment of a tolerance or the
of why such a method is not needed. The tolerance requested by petitioner. This may be
notice shall explicitly reference the specific due to the fact that the data are not sufficiently
docket identification number in the public clear or complete. in such cases, the petitioner
docket at http:// may withdraw the petition pending its
www.regulations.gov where the full text of the clarification or the obtaining of additional data.
summary required in paragraph This withdrawal may be without prejudice to a
(b) of this section is located, and refer future filing. A deposit for fees as specified in
interested parties to this document for further §180.33
information on the petition.
(1) Regulations establishing general
procedures and requirements under FFDCA
section 408(e)(1)(C).
[70 FR 33361, June 8, 2005] (2) Orders issued under FFDCA section
§ 180.9 Substantive amendments to petitions. 408(f)(1)(C) requiring the submission of data.
After a petition has been filed, the petitioner (3) Orders issued under FFDCA section
may submit additional information or data in 408(g)(2)(C) ruling on objections to
support thereof, but in such cases the petition establishment, modification, or revocation of a
will be given a new filing date. tolerance or exemption under FFDCA section
[70 FR 33361, June 8, 2005] 408(d)(4), or any regulation that is the subject
§ 180.29 Establishment, modification, and of such an order. The underlying action here is
revocation of tolerance on initiative of Agency disposition of a petition seeking the
Administrator. establishment, modification, or revocation of a
(a) Upon the Administrator’s own initiative, tolerance or exemption.
the Administrator may propose, under FFDCA (4) Orders issued under FFDCA section
section 408(e), the issuance of a regulation 408(g)(2)(C) ruling on objections to the denial
establishing a tolerance for a pesticide of a petition under FFDCA section 408(d)(4).
chemical or exempting it from the necessity of (5) Orders issued under FFDCA sec
a tolerance, or a regulation modifying or tion 408(g)(2)(C) ruling on objections to the
revoking an existing tolerance or exemption. establishment, modification, suspension, or
(b) The Administrator shall provide a revocation of a tolerance or exemption under
period of not less than 60 days for persons to FFDCA section 408(e)(1)(A) or (e)(1)(B). The
comment on the proposed regulation, except underlying action here is the establishment,
that a shorter period for comment may be modification, suspension, or revocation of a
provided if the Administrator for good cause tolerance or exemption upon the initiative of
EPA including EPA actions pursuant to FFDCA
finds that it would be in the public interest to
sections 408(b)(2)(B)(v), 408(b)(2)(E)(ii),
do so and states the reasons for the finding in
408(d)(4)(C)(ii), 408(l)(4), and 408(q)(1).
the notice of proposed rulemaking. (6) Orders issued under FFDCA section
(c) After reviewing any timely comments 408(g)(2)(C) ruling on objections to the
received, the Administrator may by order revocation or modification of a tolerance or
establish, modify, or revoke a tolerance exemption under FFDCA section 408(f)(2) for
regulation, which order and regulation shall be noncompliance with requirements for the
published in the FEDERAL REGISTER. An order submission of data.
published under this section shall state that (7) Orders issued under FFDCA section
persons may submit objections and requests 408(g)(2)(C) ruling on objections to rules
for a hearing in the manner described in part issued under FFDCA sections 408(n)(3) and
178 of this chapter. 408(d) or (e) regarding determinations
(d) Any final regulation issued under this pertaining to State authority to establish
section shall be effective on the date of regulatory limits on pesticide chemical
publication in the FEDERAL REGISTER unless residues.
otherwise provided in the regulation. (8) Orders issued under FFDCA section
[70 FR 33361, June 8, 2005] 408(g)(2)(C) ruling on objections to orders
§ 180.30 Judicial review. issued under FFDCA section 408(n)(5)(C)
(a) Under FFDCA section 408(h), judicial authorizing States to establish regulatory limits
review is available in the United States Courts not identical to certain tolerances or
of Appeal as to the following actions: exemptions.
(b) Any issue as to which review is or was
obtainable under paragraph (a) of this section
shall not be the subject of judicial review under
any other provision of law. In part, this means
that, for the Agency actions subject to the
objection procedure In FFDCA section (e) Conditions under which a temporary
408(g)(2), judicial review is not available unless tolerance is established shall include:
an adversely affected party exhausts these (1) A limitation on the amount of the
objection procedures, and any petition chemical to be used on the designated crops
procedures preliminary thereto. permitted under the experimental permit.
[70 FR 33362, June 8, 2005]
(2) A limitation for the use of the chemical
on the designated crops to bona fide
§ 180.31 Temporary tolerances. experimental use by qualified persons as
(a) A temporary tolerance (or exemption indicated in the experimental permit.
from a tolerance) established under the (3) A requirement that the person or firm
authority of FFDCA section 408(r) shall be which obtains the experimental permit for
deemed to be a tolerance (or exemption from which the temporary tolerance is established
the requirement of a tolerance) for the will immediately inform the Environmental
purposes of FFDCA section 408(a)(1) or (a)(2) Protection Agency of any reports on findings
and for the purposes of §180.30. from the experimental use that have a bearing
(b) A request for a temporary tolerance or on safety.
a temporary exemption from a tolerance by a (4) A requirement that the person or firm
person who has obtained or is seeking an which obtained the experimental permit for
experimental permit for a pesticide chemical which the temporary tolerance is established
under the Federal Insecticide, Fungicide, and will keep records of production, distribution,
Rodenticide Act shall be accompanied by such and performance for a period of 2 years and,
data as are available on subjects outlined in § on request, at any reasonable time, make
180.7(b) and an advance deposit to cover fees these records available to any authorized
as provided in §180.33. officer or employee of the Environmental
(c) To obtain a temporary tolerance, a Protection Agency.
[70 FR 33362, June 8, 2005]
requestor must comply with the petition
procedures specified in FFDCA section 408(d) § 180.32 Procedure for modifying and revoking
tolerances or exemptions from tolerances.
and §180.7 except as provided in this section.
(d) A temporary tolerance or exemption (a) The Administrator on his/her own
initiative may propose the issuance of a
from a tolerance may be issued for a period
regulation modifying or revoking a tolerance
designed to allow the orderly marketing of the
for a pesticide chemical residue on raw
raw agricultural commodities produced while agricultural commodities or processed foods
testing a pesticide chemical under an or modifying or revoking an exemption from
experimental permit issued under authority of tolerance for such residue.
the Federal Insecticide, Fungicide, and (b) Any person may file with the
Rodenticide Act if the Administrator concludes Administrator a petition proposing the
that the safety standard in FFDCA section issuance of a regulation modifying or revoking
408(b)(2) or (c), as applicable, is met. Subject a tolerance or exemption from a tolerance for
to the requirements of FFDCA section 408(e), a pesticide chemical residue. The petition shall
a temporary tolerance or exemption from a furnish reasonable grounds for the action
tolerance may be revoked if the experimental sought. Reasonable grounds shall include an
permit is revoked, or may be revoked at any explanation showing wherein the person has a
time if it develops that the application for a substantial interest in such tolerance or
temporary tolerance contains a misstatement exemption from tolerance and an assertion of
of a material fact or that new scientific data or facts (supported by data if available) showing
experience with the pesticide chemical that new uses for the pesticide chemical have
indicates that it does not meet the safety been developed or old uses abandoned, that
standard in FFDCA section 408(b)(2) or (c), as new data are available
applicable.
as to toxicity of the chemical, or that tlon shall be accompanied by a fee of $4,600.
experience with the application of the (e) A petition or request for a temporary
tolerance or exemption from tolerance may tolerance for a pesticide chemical which has a
justify its modification or revocation. Evidence tolerance for other uses at the same numerical
that a person has registered or has submitted level or a higher numerical level shall be
an application for the registration of a accompanied by a fee of $16,075, plus $1,225
pesticide under the Federal Insecticide, for each raw agricultural commodity on which
Fungicide, and Rodenticide Act will be the temporary tolerance is sought.
regarded as evidence that the person has a (f) Each petition for revocation of a
substantial interest in a tolerance or exemption tolerance shall be accompanied by a fee of
from the requirement of a tolerance for a $10,125. Such fee is not required when, in
pesticide chemical that consists in whole or in connection with the change sought under this
part of the pesticide. New data should be paragraph, a petition is filed for the
furnished in the form specified in § 180.7(b) for establishment of new tolerances to take the
submitting petitions, as applicable. place of those sought to be revoked and a fee
(c) The procedures for completing action is paid as required by paragraph (a) of this
on an Administrator initiated proposal or a section.
petition shall be those specified in §§180.29 (g) If a petition or a request is not accepted
and 180.7, as applicable. for processing because it is technically
[70 FR 33362, June 8, 2005] incomplete, the fee, less $2,025 for handling
and initial review, shall be returned. If a petition
§180.33 Fees.
is withdrawn by the petitioner after initial
(a) Each petition for the establishment of a processing, but before significant Agency
new tolerance or a tolerance higher than scientific review has begun, the fee, less $2,025
already established, shall be accompanied by
for handling and initial review, shall be
a fee of $80,950, plus $2,025 for each raw
returned. If an unacceptable or withdrawn
agricultural commodity more than nine on
which the establishment of a tolerance is petition is resubmitted, it shall be
requested, except as provided in paragraphs accompanied by the fee that would be
(b), (d), and (h) of this section. required if it were being submitted for the first
(b) Each petition for the establishment of a time.
tolerance at a lower numerical level or levels (h) Each petition for a crop group
than a tolerance already established for the tolerance, regardless of the number of raw
same pesticide chemical, or for the agricultural commodities involved, shall be
establishment of a tolerance on additional raw accompanied by a fee equal to the fee
agricultural commodities at the same required by the analogous category for a
numerical level as a tolerance already single tolerance that is not a crop group
established for the same pesticide chemical, tolerance, i.e., paragraphs (a) through (f) of this
shall be accompanied by a fee of $18,500 plus section, without a charge for each commodity
$1,225 for each raw agricultural commodity on where that would otherwise apply.
which a tolerance is requested. (i) Objections under section 408(d)(5) of
(c) Each petition for an exemption from the Act shall be accompanied by a filing fee of
the requirement of a tolerance or repeal of an $4,050.
exemption shall be accompanied by a fee of (j) The person who files a petition for
$14,925. judicial review of an order under section 408(h)
(d) Each petition or request for a of the Act shall pay the costs of preparing the
temporary tolerance or a temporary record on which the order is based unless the
exemption from the requirement of a person has no financial interest in the petition
tolerance shall be accompanied by a fee of for judicial review.
$32,325 except as provided in paragraph (e) of (k) No fee under this section will be
this section. A petition or request to renew or imposed on the Interregional Research Project
extend such temporary tolerance or Number 4 (IR-4 Program).
temporary exemp-
(l) The Administrator may waive or refund Schedule (GS) pay scale. In addition,
part or all of any fee imposed by this section if processing costs and fees will periodically be
the Administrator determines in his or her sole reviewed and changes will be made to the
discretion that such a waiver or refund will schedule as necessary. When automatic
promote the public interest or that payment of adjustments are made based on the GS pay
the fee would work an unreasonable hardship scale, the new fee schedule will be published
on the person on whom the fee is imposed. A in the FEDERAL REGISTER as a final rule to become
request for waiver or refund of a fee shall be effective 30 days or more after publication, as
submitted to the Office of Pesticide Programs’ specified in the rule. When changes are made
Document Processing Desk at the appropriate based on periodic reviews, the changes will be
address as set forth in 40 CFR 150.17(a) or (b). subject to public comment.
A fee of $2,025 shall accompany every request (o) No fee required by this section shall be
for a waiver or refund, as specified in levied during the period beginning on
paragraph (m) of this section, except that the October 1, 2003, and ending September 30,
fee under this paragraph shall not be imposed 2008.
on any person who has no financial interest in [68 FR 24371, May 7, 2003, as amended at 69 FR
any action requested by such person under 12544, Mar. 17, 2004; 70 FR 33363, June 8, 2005; 71
paragraphs (a) through (j) of this section. The FR 35547, June 21, 2006]
fee for requesting a waiver or refund shall be
§ 180.34 Tests on the amount of residue remaining.
refunded if the request is granted.
(m) All deposits and fees required by the (a) Data in a petition on the amount of
regulations in this part shall be paid by money residue remaining in or on a raw agricultural
order, bank draft, or certified check drawn to commodity should establish the residue that
the order of the Environmental Protection may remain when the pesticide chemical is
Agency. All deposits and fees shall be applied according to directions registered
forwarded to the Environmental Protection under the Federal Insecticide, Fungicide, and
Agency, Headquarters Accounting Operations Rodenticide Act, or according to directions
Branch, Office of Pesticide Programs contained in an application for registration.
(Tolerance Fees), P.O. Box 360277M, These data should establish the residues that
Pittsburgh, PA 15251. The payments should be may remain under conditions most likely to
specifically labeled ‘‘Tolerance Petition Fees’’ result in high residues on the commodity.
and should be accompanied only by a copy of (b) The petition should establish the
the letter or petition requesting the tolerance. reliability of the residue data reported in it.
The actual letter or petition, along with Sufficient information should be submitted
supporting data, shall be forwarded within 30 about the analytical method to permit
days of payment to the Office of Pesticide competent analysts to apply it successfully.
Programs’ Document Processing Desk at the (c) If the pesticide chemical is absorbed
appropriate address as set forth in 40 CFR into a living plant or animal when applied (is
150.17(a) or (b). A petition will not be accepted systemic), residue data may be needed on
for processing until the required fees have each plant or animal on which a tolerance or
been submitted. A petition for which a waiver exemption is requested.
of fees has been requested will not be (d) If the pesticide chemical is not
accepted for processing until the fee has been absorbed into the living plant or animal when
waived or, if the waiver has been denied, the applied (is not systemic), it may be possible to
proper fee is submitted after notice of denial. make a reliable estimate of the residues to be
A request for waiver or refund will not be expected on each commodity in a group of
accepted after scientific review has begun on a related commodities on the basis of less data
petition. than would be required for each commodity in
(n) This fee schedule will be changed the group, considered separately.
annually by the same percentage as the
percent change in the Federal General
(e) Each of the following groups of crops grass, soybean hay, sudan grass, timothy, and
lists raw agricultural commodities that are vetch.
considered to be related for the purpose of (26) Corn forage, sorghum forage.
paragraph (d) of this section. Commodities not (27) Sugarcane, cane sorghum.
listed in this paragraph are not considered to
[36 FR 22540, Nov. 25, 1971, as amended at 39 FR
be related for the purpose of paragraph (d) of 28286, Aug. 6, 1974; 39 FR 28977, Aug. 13, 1974; 40
this section. FR 6972, Feb. 18, 1975; 45 FR 82928, Dec. 17, 1980; 48
(1) Apples, crabapples, pears, quinces. FR 29860, June 29, 1983; 60 FR 26635, May 17, 1995;
(2) Avocados, papayas. 73 FR 75600, Dec. 12, 2008]
(3) Blackberries, boysenberries,
dewberries, loganberries, raspberries. § 180.35 Tests for potentiation.
(4) Blueberries, currants, gooseberries, Experiments have shown that certain
huckleberries. cholinesterase-inhibiting pesticides when fed
(5) Cherries, plums, prunes. together to test animals are more toxic than
(6) Oranges, citrus citron, grapefruit, the sum of their individual toxicities when fed
kumquats, lemons, limes, tangelos, tangerines. separately. One substance potentiates the
(7) Mangoes, persimmons. toxicity of the other. Important toxicological
(8) Peaches, apricots, nectarines. interactions also have been observed between
(9) Beans, peas, soybeans (each in dry pesticides and other substances. Wherever
form). there is reason to believe that a pesticide
(10) Beans, peas, soybeans (each in chemical for which a tolerance is proposed
succulent form). may interact with other pesticide chemicals or
(11) Broccoli, brussels sprouts, cauliflower, other substances to which man is exposed, it
kohlrabi. may be necessary to require special
(12) Cantaloups, honeydew melons, experimental data regarding potentiation
muskmelons, pumpkins, watermelons, winter capacities to evaluate the safety of the
squash. proposed tolerance. This necessarily will be
(13) Carrots, garden beets, sugar beets, determined on a case-by-case basis.
horseradish, parsnips, radishes, rutabagas, § 180.40 Tolerances for crop groups.
salsify roots, turnips. (a) Group or subgroup tolerances may be
(14) Celery, fennel. established as a result of:
(15) Cucumbers, summer squash. (1) A petition from a person who has
(16) Lettuce, endive (escarole), Chinese submitted an application for the registration of
cabbage, salsify tops. a pesticide under the Federal Insecticide,
(17) Onions, garlic, leeks, shallots (green, or Fungicide, and Rodenticide Act.
in dry bulb form). (2) On the initiative of the Administrator.
(18) Potatoes, Jerusalem-artichokes, (3) A petition by an interested person.
sweetpotatoes, yams. (b) The tables in §180.41 are to be used in
(19) Spinach, beet tops, collards, dandelion,
conjunction with this section for the
kale, mustard greens, parsley, Swiss chard,
establishment of crop group tolerances. Each
turnip tops, watercress.
table in §180.41 lists a group of raw agricultural
(20) Tomatoes, eggplants, peppers,
pimentos. commodities that are considered to be related
(21) Pecans, almonds, brazil nuts, bush for the purposes of this section. Refer also to §
nuts, butternuts, chestnuts, filberts, hazelnuts, 180.1(g) for a listing of commodities for which
hickory nuts, walnuts. established tolerances may be applied to
(22) Field corn, popcorn, sweet corn (each certain other related and similar commodities.
in grain form). (c) When there is an established or
(23) Milo, sorghum (each in grain form). proposed tolerance for all of the
(24) Wheat, barley, oats, rice, rye (each in representative commodities for a specific
grain form).
(25) Alfalfa, Bermuda grass, blue- grass,
brome grass, clovers, cowpea hay, fescue,
lespedeza, lupines, orchard grass, peanut hay,
peavine hay, rye
group or subgroup of related commodities, a
tolerance may be established for all
commodities in the associated group or (h) Alternatively, a commodity with a
subgroup. Tolerances may be established for a residue level significantly higher or lower than
crop group or, alternatively, tolerances may be the other commodities in a group may be
established for one or more of the subgroups excluded from the group tolerance (e.g., cereal
of a crop group. grains, except corn). In this case an individual
(d) The representative crops are given as tolerance at the appropriate level for the
an indication of the minimum residue unique commodity would be established, if
chemistry data base acceptable to the Agency necessary. The alternative approach of
for the purposes of establishing a group excluding a commodity with a significantly
tolerance. The Agency may, at its discretion, higher or lower residue level will not be used
allow group tolerances when data on suitable to establish a tolerance for a commodity
substitutes for the representative crops are subgroup. Most subgroups have only two
available (e.g., limes instead of lemons). representative commodities; to exclude one
(e) Since a group tolerance reflects such commodity and its related residue data
maximum residues likely to occur on all would likely provide insufficient residue
individual crops within a group, the proposed information to support the remainder of the
or registered patterns of use for all crops in the subgroup. Residue data from crops additional
group or subgroup must be similar before a to those representative crops in a grouping
group tolerance is established. The pattern of
may be required for systemic pesticides.
use consists of the amount of pesticide
applied, the number of times applied, the (i) The commodities included in the
timing of the first application, the interval groups will be updated periodically either at
between applications, and the interval the initiative of the Agency or at the request of
between the last application and harvest. The an interested party. Persons interested in
pattern of use will also include the type of updating this section should contact the
application; for example, soil or foliar Registration Division of the Office of Pesticide
application, or application by ground or aerial Programs.
equipment. (j) When EPA amends a crop group in a
(f) When the crop grouping contains manner that expands or contracts the
commodities or byproducts that are utilized commodities that are covered by the group,
for animal feed, any needed tolerance or EPA will initially retain the pre-existing as well
exemption from a tolerance for the pesticide as the revised crop group in the CFR. The
in meat, milk, poultry and/or eggs must be revised crop group will have the same number
established before a tolerance will be granted as the pre-existing crop group; however, the
for the group as a whole. The representative revised crop group number will be followed by
crops include all crops in the group that could a hyphen and the final two digits of the year in
be processed such that residues may which it was established (e.g., if Crop Group 1
concentrate in processed food and/or feed. is amended in 2007, the revised group will be
Processing data will be required prior to designated as Crop Group 1-07). If the
establishment of a group tolerance. Tolerances preexisting crop group had crop subgroups,
will not be granted on a group basis as to these subgroups will be numbered in a similar
processed foods prepared from crops covered fashion in the revised crop group. The name
by the group tolerance. of the revised crop group will not be changed
(g) If maximum residues (tolerances) for from the pre-existing crop group unless the
the representative crops vary by more than a revision so changes the composition of the
factor of 5 from the maximum value observed crop group that the pre-existing name is no
for any crop in the group, a group or subgroup longer accurate. Once a revised crop group is
tolerance will ordinarily not be established. In established, EPA will no longer establish
this case individual crop tolerances, tolerances under the pre-existing crop group.
At
appropriate times, EPA will amend tolerances dividual tolerances must be established.
for crop groups that have been superseded by Miscellaneous commodities intentionally not
revised crop groups to conform the pre- included in any group include asparagus,
existing crop group to the revised crop group. avocado, banana, fig, globe artichoke, hops,
Once all of the tolerances for the pre-existing mango, papaya, pawpaw, peanut, persimmon,
crop group have been updated, the pre- pineapple, water chestnut, and watercress.
existing crop group will be removed from the (c) Each group is identified by a group
CFR. name and consists of a list of representative
(k) Establishment of a tolerance does not commodities followed by a list of all
substitute for the additional need to register commodity members for the group. If the
the pesticide under a companion law, the group includes subgroups, each subgroup lists
Federal Insecticide, Fungicide, and Rodenticide the subgroup name, the representative
Act. The Registration Division of the Office of commodity or commodities, and the member
Pesticide Programs should be contacted commodities for the subgroup. Subgroups,
concerning procedures for registration of new which are a subset of their associated crop
uses of a pesticide. group, are established for some but not all
[60 FR 26635, May 17, 1995, as amended at 70 FR crops groups.
33363, June 8, 2005; 72 FR 69155, Dec. 7, 2007; 75 FR (1) Crop Group 1: Root and Tuber
56014, Sept. 15, 2010] Vegetables Group.
§ 180.41 Crop group tables. (i) Representative commodities. Carrot,
(a) The tables in this section are to be used potato, radish, and sugar beet.
in conjunction with §180.40 to establish crop (ii) Table. The following table 1 lists all the
group tolerances. commodities included in Crop Group 1 and
(b) Commodities not listed are not identifies the related crop subgroups.
considered as included in the groups for the
purposes of this paragraph, and in
(111) Table. The following table 2 Identifies commodity(ies) for each subgroup, and lists all
the crop subgroups for Crop Group 1, specifies the commodities included in each subgroup.
the representative
TABLE 2—CROP GROUP 1 SUBGROUP LISTING
Representative commodities Commodities
(2) Crop Group 2. Leaves of Root and Tuber Radish, oriental (daikon) (Raphanus sativus subvar.
Vegetables (Human Food or Animal Feed) longipinnatus)
Group (Human Food or Animal Feed) Group. Rutabaga (Brassica campestris var.
(i) Representative commodities. Turnip napobrassica)
and garden beet or sugar beet. Salsify, black (Scorzonera hispanica)
(ii) Commodities. The following is a list of Sweet potato (Ipomoea batatas)
all the commodities included in Crop Group 2: Tanier (cocoyam) (Xanthosoma sagittifolium) Turnip
(Brassica rapa var. rapa)
CROP GROUP 2: LEAVES OF ROOT AND TUBER VEGETABLES Yam, true (Dioscorea spp.)
(HUMAN FOOD OR ANIMAL FEED) GROUP—
COMMODITIES (3) Crop Group 3. Bulb Vegetables (Allium
Beet, garden (Beta vulgaris) spp.) Group.
Beet, sugar (Beta vulgaris) (i) Representative commodities. onion,
Burdock, edible (Arctium lappa) green; and onion, dry bulb.
Carrot (Daucus carota) (ii) Commodities. The following is a list of
Cassava, bitter and sweet (Manihot esculenta) all the commodities in Crop Group 3.
Celeriac (celery root) (Apium graveolens var. CROP GROUP 3: BULB VEGETABLE (Allium SPP.)
rapaceum) GROUP—COMMODITIES
Chervil, turnip-rooted (Chaerophyllum Garlic, bulb (Allium sativum)
bulbosum) Garlic, great headed, (elephant) (Allium ampeloprasum var.
Chicory (Cichorium intybus) ampeloprasum)
Dasheen (taro) (Colocasia esculenta) Leek (Allium ampeloprasum, A. porrum, A. tricoccum)
Parsnip (Pastinaca sativa)
Onion, dry bulb and green (Allium cepa, A. fistulosum)
Onion, Welsh, (Allium fistulosum)
Radish (Raphanus sativus) Shallot (Allium cepa var. cepa)
(4) Crop Group 3-07. Bulb Vegetable (11) Table. The following Table 1 lists all the
Group. commodities listed in Crop Group 3-07 and
(1) Representative Commodities. Onion, identifies the related crop subgroups.
bulb and onion, green.
TABLE 1—CROP GROUP 3-07: BULB VEGETABLE GROUP
Commodities Related crop subgroups
(iii) Table. The following Table 2 identifies commodities for each subgroup and lists all
the crop subgroups for Crop Group 3-07, the commodities included in each subgroup.
specifies the representative
TABLE 2—CROP GROUP 3-07: SUBGROUP LISTING
Daylily, bulb; fritillaria, bulb; garlic, bulb; garlic, great-headed, bulb; garlic, serpent, bulb;
Crop subgroup 3-07A. Onion, bulb,
lily, bulb; onion, bulb; onion, Chinese, bulb; onion, pearl; onion, potato, bulb; shallot,
subgroup.
bulb; cultivars, varieties, and/or hybrids of these.
Onion, bulb ....................................................
Chive, fresh leaves; chive, Chinese, fresh leaves; elegans hosta; fritillaria, leaves; kurrat;
Crop subgroup 3-07B. Onion, green,
lady's leek; leek; leek, wild; Onion, Beltsville bunching; onion, fresh; onion, green;
subgroup.
onion, macrostem; onion, tree, tops; onion, Welsh, tops; shallot, fresh leaves;
Onion, green ..................................................
cultivars, varieties, and/or hybrids of these.
(5) Crop Group 4. Leafy Vegetables (Except (ii) Table. The following table 1 lists all the
Brassica Vegetables) Group. commodities included in Crop Group 4 and
(i) Representative commodities. Celery, identifies the related crop subgroups.
head lettuce, leaf lettuce, and spinach
(Spinacia oleracea).
Amaranth (leafy amaranth, Chinese spinach, tampala) (Amaranthus spp.) ............................................................. 4A
Arugula (Roquette) (Eruca sativa) ............................................................................................................................ 4A
Cardoon (Cynara cardunculus) ................................................................................................................................. 4B
Celery (Apium graveolens var. dulce) ....................................................................................................................... 4B
Celery, Chinese (Apium graveolens var. secalinum) ................................................................................................. 4B
Celtuce (Lactuca sativa var. angustana) .................................................................................................................... 4B
Chervil (Anthriscus cerefoiium) ................................................................................................................................. 4A
Chrysanthemum, edible-leaved (Chrysanthemum coronarium var. coronarium) ........................................................ 4A
Chrysanthemum, garland (Chrysanthemum coronarium var. spatiosum) ................................................................... 4A
Corn salad (Valerianella locusta) .............................................................................................................................. 4A
Cress, garden (Lepidium sativum) ............................................................................................................................ 4A
Cress, upland (yellow rocket, winter cress) (Barbarea vulgaris) ............................................................................... 4A
Dandelion (Taraxacum officinale) .............................................................................................................................. 4A
Dock (sorrel) (Rumex spp.) ..................................................................................................................................... 4A
Endive (escarole) (Cichorium endivia) ...................................................................................................................... 4A
Fennel, Florence (finochio) (Foeniculum vulgare Azoricum Group) .......................................................................... 4B
Lettuce, head and leaf (Lactuca sativa) ................................................................................................................... 4A
Orach (Atriplex hortensis).......................................................................................................................................... 4A
Parsley (Petroselinum crispum) ................................................................................................................................ 4A
Purslane, garden (Portulaca oleracea) ..................................................................................................................... 4A
Purslane, winter (Montia perfoliata) .......................................................................................................................... 4A
Radicchio (red chicory) (Cichorium intybus) ............................................................................................................. 4A
Rhubarb (Rheum rhabarbarum) ................................................................................................................................ 4B
Spinach (Spinacia oleracea) ..................................................................................................................................... 4A
Spinach, New Zealand (Tetragonia tetragonioides, T. expansa) ................................................................................ 4A
Spinach, vine (Malabar spinach, Indian spinach) (Basella alba) .............................................................................. 4A
Swiss chard (Beta vulgaris var. cicla) ....................................................................................................................... 4B
(iii) Table. The following table 2 identifies commodities for each subgroup, and lists all
the crop subgroups for Crop Group 4, the commodities included in each subgroup.
specifies the representative
TABLE 2—CROP GROUP 4 SUBGROUP LISTING
Representative commodities Commodities
(6) Crop Group 5. Brassica (Cole) Leafy (ii) Table. The following table 1 lists all the
Vegetables Group. commodities included in Crop Group 5 and
(i) Representative commodities. Broccoli or identifies the related crop subgroups.
cauliflower; cabbage; and mustard greens.
(iii) Table. The following table 2 identifies commodity(ies) for each subgroup, and lists all
the crop subgroups for Crop Group 5, the commodities included in each subgroup.
specifies the representative
TABLE 2—CROP GROUP 5 SUBGROUP LISTING
Representative commodities Commodities
(7) Crop Group 6. Legume Vegetables one succulent cultivar and one dried cultivar);
(Succulent or Dried) Group. and soybean.
(i) Representative commodities. Bean (ii) Table. The following table 1 lists all the
(Phaseolus spp.; one succulent cultivar and commodities included in Crop Group 6 and
one dried cultivar); pea (Pisum spp.; identifies the related crop subgroups.
Bean (Lupinus spp.) (includes grain lupin, sweet lupin, white lupin, and white sweet lupin) .................................... 6C
Bean (Phaseolus spp.) (includes field bean, kidney bean, lima bean, navy bean, pinto bean, runner bean,
snap bean, tepary bean, wax bean) .................................................................................................................. 6A, 6B, 6C
Bean (Vigna spp.) (includes adzuki bean, asparagus bean, blackeyed pea, catjang, Chinese longbean,
cowpea, Crowder pea, moth bean, mung bean, rice bean, southern pea, urd bean, yardlong bean) ............... 6A, 6B, 6C
Broad bean (fava bean) (Vicia faba) ....................................................................................................................... 6B, 6C
Chickpea (garbanzo bean) (Cicer arietinum) ............................................................................................................. 6C
Guar (Cyamopsis tetragonoloba) .................................................................................................................................. 6C
Jackbean (Canavalia ensiformis) ................................................................................................................................ 6A
Lablab bean (hyacinth bean) (Lablab purpureus) ....................................................................................................... 6C
Lentil (Lens esculenta) ............................................................................................................................................... 6C
Pea (Pisum spp.) (includes dwarf pea, edible-pod pea, En glish pea, field pea, garden pea, green pea, snow
pea, sugar snap pea) ........................................................................................................................................ 6A, 6B, 6C
Pigeon pea (Cajanus cajan) ...................................................................................................................................... 6A, 6B, 6C
Soybean (Glycine max) ............................................................................................................................................ N/A
Soybean (immature seed) (Glycine max) ................................................................................................................. 6A
Sword bean (Canavalia gladiata) ................................................................................................................................ 6A
(iii) Table. The following table 2 identifies commodities for each subgroup, and lists all
the crop subgroups for Crop Group 6, the commodities included in each subgroup.
specifies the representative
Crop Subgroup 6A. Edible-podded legume
vegetables subgroup.
Any one succulent cultivar of edible-podded bean Bean (Phaseolus spp.) (includes runner bean, snap bean, wax bean); bean (Vigna
(Phaseolus spp.) and any one succulent cultivar spp.) (includes asparagus bean, Chinese longbean, moth bean, yardlong bean);
of edible-podded pea (Pisum spp.).. jackbean; pea (Pisum spp.) (includes dwarf pea, edible-pod pea, snow pea,
sugar snap pea); pigeon pea; soybean (immature seed); sword bean.
(8) Crop Group 7. Foliage of Legume (ii) Table. The following table 1 lists the
Vegetables Group. commodities included in Crop Group 7.
(i) Representative commodities. Any
cultivar of bean (Phaseolus spp.), field pea
(Pisum spp.), and soybean.
TABLE 1—CROP GROUP 7: FOLIAGE OF LEGUME VEGETABLES GROUP
Any cultivar of bean (Phaseolus spp.) and field pea Plant parts of any legume vegetable included in the legume vegetables that will
(Pisum spp.), and soybean (Glycine max). be used as animal feed.
(iii) Table. The following table 2 identifies modities for the subgroup, and lists all the
the crop subgroup for Crop Group 7 and commodities included in the subgroup.
specifies the representative com
TABLE 2—CROP GROUP 7 SUBGROUP LISTING
Representative commodities Commodities
(iii) Table. The following Table 2 identifies commodities for each subgroup and lists all
the crop subgroups for Crop Group 8-10, the commodities included in each subgroup.
specifies the representative
TABLE 2—CROP GROUP 8-10. SUBGROUP LISTING
Representative commodities Commodities
Crop subgroup 8-10A. Tomato subgroup Tomato,
standard size, and one cultivar of small tomato ........................ Bush tomato; cocona; currant tomato; garden huckleberry; goji
berry; groundcherry; naranjilla; sunberry; tomatillo; tomato; tree
tomato; cultivars, varieties, and/or hybrids of these.
Crop subgroup 8-10B. Pepper/Eggplant subgroup Bell
pepper and one cultivar of small nonbell pepper ..................... African eggplant; bell pepper; eggplant; Martynia; nonbell pepper;
okra; pea eggplant; pepino; roselle; scarlet eggplant; cultivars,
varieties, and/or hybrids of these.
Crop subgroup 8-10C. Nonbell pepper/Eggplant subgroup
One cultivar of small nonbell pepper or one cultivar of small African eggplant; eggplant; martynia; nonbell pepper; okra; pea
eggplant. eggplant; pepino; roselle; scarlet eggplant; cultivars, varieties,
and/or hybrids of these.
(11) Crop Group 9. Cucurbit Vegetables (ii) Table. The following table 1 lists all the
Group. commodities included in Crop Group 9 and
(i) Representative commodities. Cucumber, identifies the related subgroups.
muskmelon, and summer squash.
TABLE 1—CROP GROUP 9: CUCURBIT VEGETABLES
Related crop
Commodities subgroups
(111) Table. The following table 2 Identifies commodities for each subgroup, and lists all
the crop subgroups for Crop Group 9, the commodities included in each subgroup.
specifies the representative
TABLE 2—CROP GROUP 9 SUBGROUP LISTING
Representative commodities Commodities
(12) Crop Group 10. Citrus Fruit Group. Lemon (Citrus jambhiri, Citrus limon)
(i) Representative commodities. Sweet Lime (Citrus aurantiifolia)
orange; lemon and grapefruit. Mandarin (tangerine) (Citrus reticulata) Orange,
(ii) Commodities. The following is a list of sour (Citrus aurantium)
all the commodities in Crop Group 10: Orange, sweet (Citrus sinensis)
Pummelo (Citrus grandis, Citrus maxima) Satsuma
CROP GROUP 10: CITRUS FRUITS (CITRUS SPP., mandarin (Citrus unshiu)
FORTUNELLA SPP.) GROUP—COMMODITIES
(13) Crop Group 10-10. Citrus Fruit Group.
Calamondin (Citrus mitisxCitrofortunella mitis) Citrus (i) Representative commodities. Orange
citron (Citrus medica)
Citrus hybrids (Citrus spp.) (includes or Tangerine/Mandarin, Lemon or Lime, and
chironja, tangelo, tangor) Grapefruit.
Grapefruit (Citrus paradisi) (ii) Commodities. The following is a list of
Kumquat (Fortunella spp.) all the commodities in Crop Group 10-10.
(111) Table. The following Table 2 Identifies tive commodities for each subgroup and lists
the crop subgroups for Crop Group 10-10, all the commodities included in each
specifies the representa subgroup.
TABLE 2—CROP GROUP 10-10: SUBGROUP LISTING
Representative commodities Commodities
(14) Crop Group 11: Pome Fruits Group. Quince (Cydonia oblonga)
(i) Representative commodities. Apple and (15) Crop group 11-10. Pome Fruit Group.
pear. (i) Representative commodities. Apple
(ii) Commodities. The following is a list of and Pear
all the commodities included in Crop Group 11: (ii) Commodities. The following is a list of
CROP GROUP 11: POME FRUITS GROUP— all the commodities in Crop Group 11-10.
COMMODITIES CROP GROUP 11-10: POME FRUIT GROUP—
Apple (Malus domestica) COMMODITIES
Crabapple (Malus spp.) Apple, Malus domestica Borkh.
Loquat (Eriobotrya japonica) Azarole, Crataegus azarolus L.
Mayhaw (Crataegus aestivalis, C. opaca, and C. Crabapple, Malus sylvestris (L.) Mill., M.
rufula) prunifolia (Willd.) Borkh.
Pear (Pyrus communis) Loquat, Eriobotrya japonica (Thunb.) Lindl.
Pear, oriental (Pyrus pyrifolia)
Mayhaw, Crataegus aestivalis (Walter) Torr. & A. CROP GROUP 12: STONE FRUITS GROUP—
Gray, C. opaca Hook. & Arn., and C. rufula Sarg. COMMODITIES
Medlar, Mespilus germanica L. Apricot (Prunus armeniaca)
Pear, Pyrus communis L.
Pear, Asian, Pyrus pyrifolia (Burm. f.) Nakai var. culta Cherry, sweet (Prunus avium),
(Makino) Nakai Pseudocydonia sinensis (Thouin) Cherry, tart (Prunus cerasus)
C.K. Schneid. Quince, Cydonia oblonga Mill. Nectarine (Prunus persica)
Quince, Chinese, Chaenomeles speciosa (Sweet) Peach (Prunus persica)
Nakai, Plum (Prunus domestica, Prunus spp.)
Quince, Japanese, Chaenomeles japonica (Thunb.) Plum, Chickasaw (Prunus angustifolia) plum,
Lindl. ex Spach Tejocote, Crataegus mexicana DC. Damson (Prunus domestica spp. insititia)
Cultivars, varieties and/or hybrids of these. Plum, Japanese (Prunus salicina)
(16) Crop Group 12. Stone Fruits Group. Plumcot (Prunus. armeniacaxP. domestica) Prune
(i) Representative commodities. Sweet (fresh) (Prunus domestica, Prunus spp.)
cherry or tart cherry; peach; and plum or fresh (17) Crop Group 12-12: Stone Fruit Group.
prune (Prunus domestica, Prunus spp.) (i) Representative commodities. Sweet
(ii) Commodities. The following is a list of cherry or Tart cherry; Peach; and Plum or
all the commodities included in Crop Group 12: Prune plum.
(ii) Commodities. The following Table 1 is
a list of all commodities included in Crop
Group 12-12.
(Ill) Crop subgroups. The following Table 2 resentative commodities for each subgroup,
identifies the crop subgroups for Crop Group and lists all the commodities included in each
12-12, specifies the rep subgroup.
TABLE 2—CROP GROUP 12-12: SUBGROUP LISTING
(18) Crop Group 13. Berries Group. (11) Table. The following table 1 lists all the
(1) Representative commodities. Any one commodities included in Crop Group 13 and
blackberry or any one raspberry; and identifies the related subgroups.
blueberry.
TABLE 1—CROP GROUP 13: BERRIES GROUP
Blackberry (Rubus eubatus) (including bingleberry, black satin berry, boysenberry, Cherokee blackberry,
Chesterberry, Cheyenne blackberry, coryberry, darrowberry, dewberry, Dirksen thornless berry, Himalayaberry,
hullberry, Lavacaberry, lowberry, Lucretiaberry, mammoth blackberry, marionberry, nectarberry, olallieberry,
Oregon evergreen berry, phenomenalberry, rangeberry, ravenberry, rossberry,
Shawnee blackberry, youngberry, and varieties and/or hybrids of these) ......................................................... 13A
Blueberry (Vaccinium spp.) ............................................................................................................................................................ 13B
Currant (Ribes spp.) ...................................................................................................................................................................... 13B
Elderberry (Sambucus spp.) ............................................................................................................................................................ 13B
Gooseberry (Ribes spp.) ................................................................................................................................................................ 13B
Huckleberry (Gaylussacia spp.) ...................................................................................................................................................... 13B
Loganberry (Rubus loganobaccus) .................................................................................................................................................. 13A
Raspberry, black and red (Rubus occidentalis, Rubus strigosus, Rubus idaeus) .......................................................... 13A
(iii) Table. The following table 2 identifies commodities for each subgroup, and lists all
the crop subgroups for Crop Group 13, the commodities included in each subgroup.
specifies the representative
TABLE 2—CROP GROUP 13 SUBGROUPS LISTING
Representative commodities Commodities
(19) Crop Group 13-07. Berry and Small Fruit berry; grape; fuzzy kiwifruit, and strawberry.
Crop Group (ii) Table. The following Table 1 lists all the
(i) Representative commodities. Any one commodities listed in Crop Group 13-07 and
blackberry or any one raspberry; highbush identifies the related crop subgroups.
blueberry; elderberry or mul
TABLE 1—CROP GROUP 13-07: BERRY AND SMALL FRUIT CROP GROUP
Commodities Related crop subgroups
(iii) Table. The following Table 2 tive commodities for each subgroup
identifies the crop subgroups for Crop and lists all the commodities included
Group 13-07, specifies the representa- in each subgroup.
TABLE 2—CROP GROUP 13-07: SUBGROUP LISTING
Representative commodities Commodities
Crop Subgroup 13-07A. Caneberry subgroup Blackberry; loganberry; raspberry, red and black; wild raspberry; cultivars,
Any one blackberry or any one raspberry.. varieties, and/or hybrids of these.
Crop Subgroup 13-07B. Bushberry subgroup.
Blueberry, highbush. Aroma berry; blueberry, highbush; blueberry, lowbush; buffalo currant; Chilean
guava; currant, black; currant, red; elderberry; European, barberry; gooseberry;
cranberry, highbush; honeysuckle, edible; huckleberry; jostaberry; Juneberry;
lingonberry; native currant; salal; sea buckthorn; cultivars, varieties, and/or
hybrids of these.
Crop Subgroup 13-07C. Large shrub/tree berry
subgroup.
Elderberry or mulberry......................... Bayberry; buffaloberry; che; chokecherry; elderberry; Juneberry; mountain pepper
berries; mulberry; phalsa; pincherry; riberry; salal; serviceberry; cultivars,
varieties, and/or hybrids of these.
Crop Subgroup 13-07D. Small fruit vine climbing
subgroup.
Grape and fuzzy kiwifruit..................... Amur river grape; gooseberry; grape; kiwifruit, fuzzy; kiwifruit, hardy; Maypop;
schisandra berry; cultivars, varieties, and /or hybrids of these.
Crop Subgroup 13-07E. Small fruit vine climbing
subgroup, except grape.
Fuzzy kiwifruit ..................................... Amur river grape; gooseberry; kiwifruit, fuzzy; kiwifruit, hardy; Maypop; schisandra
berry; cultivars, varieties, and/or hybrids of these.
Crop Subgroup 13-07F. Small fruit vine climbing
subgroup except fuzzy kiwifruit.
Grape.................................................. Amur river grape; gooseberry; grape; kiwifruit, hardy; Maypop; schisandra berry;
cultivars varieties, and/or hybrids of these.
Crop Subgroup 13-07G. Low growing berry
subgroup.
Strawberry .......................................... Bearberry; bilberry; blueberry, lowbush; cloudberry; cranberry; lingonberry;
muntries; partridgeberry; strawberry; cultivars, varieties, and/or hybrids of these.
(20) Crop Group 14. Tree Nuts Group. CROP GROUP 14-12: TREE NUT GROUP
(i) Representative commodities. Almond African nut-tree (Ricinodendron heudelotii (Baill.)
and pecan. Heckel)
(ii) Commodities. The following is a list of Almond (Prunus dulcis (Mill.) D.A. Webb)
all the commodities included in Crop Group Beechnut (Fagus grandifolia Ehrh.; F. sylvatica L.)
Brazil nut (Bertholletia excelsa Humb. & Bonpl.)
14: Brazilian pine (Araucaria angustifolia
CROP GROUP 14: TREE NUTS—COMMODITIES (Bertol.) Kuntze)
Almond (Prunus dulcis) Bunya (Araucaria bidwillii Hook.)
Beech nut (Fagus spp.) Bur oak (Quercus macrocarpa Michx.)
Brazil nut (Bertholletia excelsa) Butternut (Juglans cinerea L.)
Cajou nut (Anacardium giganteum Hance ex Engl.)
Butternut (Juglans cinerea) Candlenut (Aleurites moluccanus (L.) Willd.)
Cashew (Anacardium occidentale) Cashew (Anacardium occidentale L.)
Chestnut (Castanea spp.) Chestnut (Castanea crenata Siebold & Zucc.; C.
Chinquapin (Castanea pumila) dentata (Marshall) Borkh.; C. mollissima Blume; C.
Filbert (hazelnut) (Corylus spp.) sativa Mill.)
Hickory nut (Carya spp.) Chinquapin (Castaneapumila (L.) Mill.)
Macadamia nut (bush nut) (Macadamia spp.) pecan Coconut (Cocos nucifera L.)
(Carya illinoensis) Coquito nut (Jubaea chilensis (Molina) Baill.)
Walnut, black and English (Persian) (Juglans spp.) Dika nut (Irvingia gabonensis (Aubry- Lecomte ex
O’Rorke) Baill.)
(21) Crop Group 14-12. Tree Nut Group. Ginkgo (Ginkgo biloba L.)
(i) Representative commodities. Almond Guiana chestnut (Pachira aquatica Aubl.)
and pecan. Hazelnut (Filbert) (Corylus americana Marshall; C.
(ii) Commodities. The following is a list of avellana L.; C. californica (A. DC.) Rose; C. chinensis
Franch.)
all commodities included in Crop Group 14-12. Heartnut (Juglans ailantifolia Carriere var.
cordiformis (Makino) Rehder)
Hickory nut (Carya cathayensis Sarg.; C. glabra (Mill.) (i) Representative commodities. Corn,
Sweet; C. laciniosa (F. Michx.) W. P. C. Barton; C. wheat, and any other cereal grain crop.
myristiciformis (F. Michx.) Elliott; C. ovata (Mill.) K. (ii) Commodities. The commodities
Koch; C. tomentosa (Lam.) Nutt.)
Japanese horse-chestnut (Aesculus turbinate Blume) ineluded In Crop Group 16 are: Forage, fodder,
Macadamia nut (Macadamia integrifolia Maiden & and straw of all commodities included in the
Betche; M. tetraphylla L.A.S. Johnson) group cereal grains group.
Mongongo nut (Schinziophyton rautanenii (Schinz) (24) Crop Group 17. Grass Forage, Fodder,
Radcl.-Sm.) and Hay Group.
Monkey-pot (Lecythis pisonis Cambess.) Monkey (i) Representative commodities. Bermuda
puzzle nut (Araucaria araucana (Molina) K. Koch)
Okari nut (Terminalia kaernbachii Warb.) Pachira grass; bluegrass; and bromegrass or fescue.
nut (Pachira insignis (Sw.) Savigny) Peach palm nut (ii) Commodities. The commodities
(Bactris gasipaes Kunth var. gasipaes) included In Crop Group 17 are: Any grass,
Pecan (Carya illinoinensis (Wangenh.) K. Koch) Gramineae family (either green or cured)
Pequi (Caryocar brasiliense Cambess.; C. except sugarcane and those included in the
villosum (Aubl.) Pers; C. nuciferum L.) cereal grains group, that will be fed to or
Pili nut (Canarium ovatum Engl.; C. vulgare Leenh.) grazed by livestock, all pasture and range
Pine nut (Pinus edulis Engelm.; P. koraiensis Siebold
& Zucc.; P. sibirica Du Tour; P. pumila (Pall.) Regel; P. grasses and grasses grown for hay or silage.
gerardiana Wall. ex D. Don; P. monophylla Torr. & (25) Crop Group 18. Nongrass Animal
Frem.; P. quadrifolia Parl. ex Sudw.; P. pinea L.) Feeds (Forage, Fodder, Straw, and Hay) Group.
Pistachio (Pistacia vera L.) (i) Representative commodities. Alfalfa
Sapucaia nut (Lecythis zabucaja Aubl.) Tropical and clover (Trifolium spp.)
almond (Terminalia catappa L.) Walnut, black (ii) Commodities. The following is a list of
(Juglans nigra L.; J. hindsii Jeps. ex R. E. Sm.; J.
microcarpa Berland.) Walnut, English (Juglans regia all the commodities included in Crop Group 18:
L.) CROP GROUP 18: NONGRASS ANIMAL FEEDS (FORAGE,
Yellowhorn (Xanthoceras sorbifolium Bunge) FODDER, STRAW, AND HAY) GROUP—COMMODITIES
Cultivars, varieties, and/or hybrids of these
Alfalfa (Medicago sativa subsp. sativa)
(22) Crop Group 15. Cereal Grains Group. Bean, velvet (Mucuna pruriens var. utilis) Clover
(i) Representative commodities. Corn (Trifolium spp., Melilotus spp.)
(fresh sweet corn and dried field corn), rice, Kudzu (Pueraria lobata)
sorghum, and wheat. Lespedeza (Lespedeza spp.)
(ii) Commodities. The following is a list of Lupin (Lupinus spp.)
all the commodities included in Crop Group 15: Sainfoin (Onobrychis viciifolia);
Trefoil (Lotus spp.)
CROP GROUP 15: CEREAL GRAINS— Vetch (Vicia spp.)
COMMODITIES Vetch, crown (Coronilla varia)
Barley (Hordeum spp.) Vetch, milk (Astragalus spp).
Buckwheat (Fagopyrum esculentum) (26) Crop Group 19. Herbs and Spices
Corn (Zea mays) Group.
Millet, pearl (Pennisetum glaucum) (i) Representative commodities. Basil
Millet, proso (Panicum milliaceum)
Oats (Avena spp.) (fresh and dried); black pepper; chive; and
Popcorn (Zea mays var. everta) celery seed or dill seed.
Rice (Oryza sativa) (ii) Table. The following table 1 lists all the
Rye (Secale cereale) commodities included in Crop Group 19 and
Sorghum (milo) (Sorghum spp.) identifies the related subgroups.
Teosinte (Euchlaena mexicana)
Triticale (Triticum-Secale hybrids) TABLE 1—CROP GROUP 19: HERBS AND SPICES
Wheat (Triticum spp.) GROUP
Wild rice (Zizania aquatica) Related
(23) Crop Group 16. Forage, Fodder and Commodities Sub
Straw of Cereal Grains Group. groups
Allspice (Pimenta dioica) ........................................... 19B
Angelica (Angelica archangelica) ............................... 19A
TABLE 1—CROP GROUP 19: HERBS AND SPICES TABLE 1—CROP GROUP 19: HERBS AND SPICES
GROUP—Continued GROUP—Continued
Related Related
Commodities Sub Commodities Sub
groups groups
Anise (anise seed) (Pimpinella anisum) .................... 19B Lavender (Lavandula officinalis) ................................. 19A
Anise, star (Illicium verum) ........................................ 19B Lemongrass (Cymbopogon citratus) .......................... 19A
Annatto (seed) ................................................................... 19B Lovage (leaf) (Levisticum officinale) .......................... 19A
Balm (lemon balm) (Melissa officinalis) ...................... 19A Lovage (seed) (Levisticum officinale) ........................ 19B
Basil (Ocimum basilicum) .......................................... 19A Mace (Myristica fragrans) .......................................... 19B
Borage (Borago officinalis) ........................................ 19A Marigold (Calendula officinalis) ................................. 19A
Burnet (Sanguisorba minor) ...................................... 19A Marjoram (Origanum spp.) (includes sweet or annual
Camomile (Anthemis nobilis)................................................. 19A marjoram, wild marjoram or oregano, and
Caper buds (Capparis spinosa).................................. 19B pot marjoram) ................................................................ 19A
Caraway (Carum carvi) ......................................................... 19B Mustard (seed) (Brassica juncea, B. hirta, B. nigra) 19B
Caraway, black (Nigella sativa) ................................. 19B Nasturtium (Tropaeolum majus) ................................ 19A
Cardamom (Elettaria cardamomum) .......................... 19B
Nutmeg (Myristica fragrans) ...................................... 19B
Cassia bark (Cinnamomum aromaticum) .................... 19B
Parsley (dried) (Petroselinum crispum) ...................... 19A
Cassia buds (Cinnamomum aromaticum) .................. 19B
Pennyroyal (Mentha pulegium) ............................................. 19A
Catnip (Nepeta cataria) ........................................................ 19A
Pepper, black (Piper nigrum) ..................................... 19B
Celery seed (Apicum graveolens) .............................. 19B
Chervil (dried) (Anthriscus cerefolium) ....................... 19A Pepper, white...................................................................... 19B
Chive (Allium schoenoprasum) .............................................. 19A Poppy (seed) (Papaver somniferum) .................................... 19B
Chive, Chinese (Allium tuberosum) ........................... 19A Rosemary (Rosemarinus officinalis) .......................... 19A
Cinnamon (Cinnamomum verum) .............................. 19B Rue (Ruta graveolens) .............................................. 19A
Clary (Salvia sclarea) ................................................ 19A Saffron (Crocus sativus) ........................................... 19B
Clove buds (Eugenia caryophyllata) ........................... 19B Sage (Salvia officinalis) ........................................................ 19A
Coriander (cilantro or Chinese parsley) (leaf) Savory, summer and winter (Satureja spp.)............... 19A
(Coriandrum sativum) ....................................................... 19A Sweet bay (bay leaf) (Laurus nobilis)......................... 19A
Coriander (cilantro) (seed) (Coriandrum sativum) ... 19B Tansy (Tanacetum vulgare)................................................... 19A
Costmary (Chrysanthemum balsamita) ...................... 19A Tarragon (Artemisia dracunculus) ......................................... 19A
Culantro (leaf) (Eryngium foetidum) ........................... 19A Thyme (Thymus spp.)........................................................... 19A
Culantro (seed) (Eryngium foetidum) ......................... 19B Vanilla (Vanilla planifolia) ..................................................... 19B
Cumin (Cuminum cyminum) ................................................. 19B Wintergreen (Gaultheria procumbens) .................................. 19A
Curry (leaf) (Murraya koenigii).................................... 19A Woodruff (Galium odorata) .................................................. 19A
Dill (dillweed) (Anethum graveolens) .......................... 19A Wormwood (Artemisia absinthium) ........................................ 19A
Dill (seed) (Anethum graveolens) .......................................... 19B
Fennel (common) (Foeniculum vulgare) .................... 19B
Fennel, Florence (seed) (Foeniculum vulgare (111) Table. The following table 2 Identifies
Azoricum Group) ...........................................................
Fenugreek (Trigonella foenumgraecum) .................... 19B
19B
the crop subgroups for Crop Group 19,
Grains of paradise (Aframomum melegueta) ............. 19B specifies the representative commodities for
Horehound (Marrubium vulgare) .......................................... 19A each subgroup, and lists all the commodities
Hyssop (Hyssopus officinalis) ................................................
Juniper berry (Juniperus communis) .....................................
19A
19B
included in each subgroup.
(27) Crop Group 20. Oilseed Group. (ii) Table. The following Table 1 lists all the
(i) Representative commodities. Rapeseed commodities listed in Crop Group 20 and
(canola varieties only); sunflower, seed and identifies the related crop
cottonseed.
subgroups and includes cultivars and/or
varieties of these commodities.
Related crop
subgroups
(iii) Table. The following Table 2 identifies commodities for each subgroup and lists all
the crop subgroups for Crop Group 20, the commodities included in each subgroup.
specifies the representative
TABLE 2—CROP GROUP 20: SUBGROUP LISTING
Representative commodities Commodities
(28) Crop Group 21. Edible fungi (i) Representative commodities. White Group. button
mushroom and any one oyster
mushroom or any Shiitake mushroom.
(11) Table. The following Is a list of all the in compliance with the tolerances established
commodities in Crop Group 21. There are no in this part 180 are identified among the
related subgroups. methods contained or referenced in the Food
and Drug Administration’s ‘‘Pesticide
CROP GROUP 21—EDIBLE FUNGI GROUP- Analytical Manual’’ which is available from the
COMMODITIES Food and Drug Administration, Department of
Health, Education, and Welfare, 200 C Street
Blewitt (Lepista nuda)
Bunashimeji (Hypsizygus marrmoreus)
Chinese mushroom (Volvariella volvacea) (Bull.) Singer Enoki SW., Washington, DC 20204.
(Flammulina velutipes) (Curt.) Singer Hime-Matsutake
(Agaricus blazei) Murill Hirmeola (Auricularia auricular) § 180.103 Captan; tolerances for residues.
Maitake (Grifola frondosa)
Morel (Morchella spp.)
(a) (1) General. Tolerances are
Nameko (Pholiota nameko) established for residues of the fungicide,
Net Bearing (Dictyophora) captan (N-trichloromethylthio-4-
Oyster mushroom (Pleurotus spp.) pom pom (Hericium erinaceus)
Reishi mushroom (Ganoderma lucidum (Leyss. Fr.) Karst.)
cyclohexene-1,2-dicarboximide) in or on the
Rodman's agaricus (Agaricus bitorquis) (Quel.) Saccardo Shiitake following commodities:
mushroom (Lentinula edodes (Berk.) Pegl.)
Shimeji (Tricholoma conglobatum)
Stropharia (Stropharia spp.)
Truffle (Tuber spp.)
White button mushroom (Agaricus bisporous (Lange) Imbach) Parts per
White Jelly Fungi (Tremella fuciformis) Commodity million
[60 FR 26635, May 17, 1995, as amended at 72 FR Almond ................................................................. 0.25
69156, 69157, Dec. 7, 2007; 73 FR 52, Jan. 2, 2008; 75 Almond, hulls ...................................................... 75.0
FR 76289, Dec. 8, 2010; 77 FR 50620, Aug. 22, 2012] Animal feed, nongrass, group 18 ........................ 0.05
Apple ................................................................... 25.0
Apricot ................................................................. 10.0
Subpart C—Specific Tolerances Blueberry ............................................................ 20.0
Caneberry, subgroup 13A ................................... 25.0
EDITORIAL NOTE: Nomenclature changes to subpart Cherry, sweet ...................................................... 50.0
C of part 180 appear at 67 FR 4180341808, June 19,
Cherry, tart ........................................................... 50.0
Cotton, undelinted seed ...................................... 0.05
2002; 67 FR 42393-42397, June 21, 2002; 68 FR Dill, seed ............................................................. 0.05
39430-39435, July 1, 2003; 71 FR 74804-74812, Dec. Flax, seed .......................................................... 0.05
13, 2006; 72 FR 53137-53151, Sept. 18, 2007; 72 FR Grape .................................................................. 25.0
61536, Oct. 31, 2007; 73 FR 60155-60157, Oct. 10, Grain, cereal, forage, fodder and straw, group
2008; 75 FR 56014, Sept. 15, 2010; and 76 FR 34885, 16 .................................................................... 0.05
June 15, 2011. Grain, cereal, group 15 .......................................
Grass, forage ......................................................
0.05
0.05
Grass, hay ........................................................... 0.05
§ 180.101 Specific tolerances; general provisions. Nectarine ............................................................. 25.0
(a) The tolerances established for pesticide okra ..................................................................... 0.05
chemicals in this subpart C apply to residues peach .................................................................. 15.0
resulting from their application prior to harvest peanut .................................................................
peanut, hay .........................................................
0.05
0.05
or slaughter, unless otherwise stated. pear ..................................................................... 25.0
Tolerances are expressed in terms of parts by plum, prune, fresh ............................................... 10.0
weight of the pesticide chemical per one Rapeseed, forage ............................................... 0.05
million parts by weight of the raw agricultural
Rapeseed, seed ................................................. 0.05
Safflower, seed ................................................... 0.05
commodity. Sesame, seed ..................................................... 0.05
(b) The poisonous and deleterious Strawberry ........................................................... 20.0
substances for which tolerances are Sunflower, seed ..................................................
Vegetable, brassica leafy, group 5 .......................
0.05
0.05
established by the regulations in this subpart C Vegetable, bulb, group 3 ...................................... 0.05
are named by their common names wherever Vegetable, cucurbit, group 9 ............................... 0.05
practicable, otherwise by their chemical Vegetable, foliage of legume, group 7..................
Vegetable, fruiting, group 8 .................................
0.05
0.05
names. Vegetable, leafy, except brassica, group 4 .......... 0.05
(c) The analytical methods to be used for Vegetable, leaves of root and tuber, group 2 ...... 0.05
determining whether pesticide residues, Vegetable, legume, group 6 ................................
Vegetable, root and tuber, group 1 .....................
0.05
0.05
including negligible residues, in or on raw
agricultural commodities are (2) Tolerances are established for the
combined residues of the fungicide, captan
(N-trichloromethylthio-4-
cyclohexene-1,2-dicarboximide) and its
metabolite 1,2,3,6-
tetrahydrophthalimide (THPi), measured at
THPi, in or on the following commodities:
Commodity Parts per Commodity Parts per
million million
the tolerance levels specified in this paragraph Alfalfa, hay, postharvest .................. 50.0 10/31/11
is to be determined by measuring only methyl Almond, postharvest ....................... 200.0 None
parathion, 0,0-dimethyl 0-(4- nitrophenyl) Apple, postharvest ..........................
Apricot, postharvest ........................
5.0
20.0
None
None
phosphorothioate, in or on the commodity. Artichoke, jerusalem, postharvest ... 30.0 None
Asparagus, postharvest .................. 100.0 None
Avocado, postharvest ..................... 75.0 None
Barley, grain, postharvest ............... 50.0 None
Bean, lima, postharvest .................. 50.0 None
Expiration/ Bean, postharvest ........................... 50.0 None
Parts per
Commodity Revocation Bean, snap, succulent, postharvest 50.0 None
million
date Bean, succulent, postharvest .......... 50.0 None
Beet, garden, roots, postharvest ..... 30.0 None
Alfalfa, forage .................................. 1.25 12/31/13 Beet, sugar, roots, postharvest ....... 30.0 None
Alfalfa, hay ....................................... 5.0 12/31/13 Blueberry, postharvest .................... 20.0 None
Almond ............................................ 0.1 12/31/13 Butternut, postharvest ..................... 200.0 None
Almond, hulls .................................. 3.0 12/31/13 Cabbage, postharvest ..................... 50.0 None
Barley .............................................. 1.0 12/31/13 Cacao bean, roasted bean,
Corn, field, forage ............................ 1.0 12/31/13 postharvest ................................. 50.0 None
Corn, field, grain .............................. 1.0 12/31/13 Cantaloupe, postharvest ................. 20.0 None
Corn, pop, grain .............................. 1.0 12/31/13 Carrot, roots, postharvest ............... 30.0 None
Corn, sweet, forage .......................... 12/31/13 Cashew, postharvest ...................... 200.0 None
1.0
Cherry, sweet, postharvest ............. 20.0 None
Corn, sweet, kernel plus cob with
Cherry, tart, postharvest ................. 20 None
husks removed ........................... 1.0 12/31/13 Chestnut, postharvest ..................... 200.0 None
Cotton, undelinted seed .................. 0.75 12/31/13 Cippolini, bulb, postharvest ............. 50.0 None
Grass, forage ................................... 1.0 12/31/13 Citron, citrus, postharvest ............... 30.0 None
Oat .................................................. 1.0 12/31/13 Coconut, copra, postharvest ........... 100.0 None
Onion .............................................. 1.0 12/31/13 Coffee, bean, green, postharvest .... 75.0 None
Pea, field, vines ............................... 1.0 12/31/13 Corn, field, grain, postharvest ......... 50.0 None
Potato .............................................. 0.1 12/31/13 Corn, pop, postharvest .................... 240.0 None
Rapeseed, seed .............................. 0.2 12/31/13 Corn, sweet, kernel plus cob with
Rice, grain ....................................... 12/31/13 husks removed, postharvest ....... 50.0 None
1.0
Soybean, hay .................................. 12/31/13 Cotton, undelinted seed,
1.0
Soybean, seed ................................ 12/31/13 postharvest ................................. 200.0 10/31/11
0.1
Cucumber, postharvest ................... 30.0 None
Sunflower, seed ............................... 0.2 12/31/13
Cumin, seed, postharvest ............... 100.0 None
Sweet potato, roots ......................... 0.1 12/31/13 Eggplant, postharvest ..................... None
20.0
Walnut ............................................. 0.1 12/31/13 Garlic, postharvest .......................... 50.0 None
Wheat .............................................. 1.0 12/31/13 Ginger, postharvest ......................... None
100.0
Grape, postharvest ......................... 20.0 None
(b) Section 18 emergency exemptions. Grapefruit, postharvest ................... 30.0 None
[Reserved] Hazelnut, postharvest ...................... 200.0 None
(c) Tolerances with regional registrations.
Horseradish, postharvest ................ 30.0 None
Kumquat, postharvest ..................... 30.0 None
[Reserved] Lemon, postharvest ......................... 30.0 None
(d) Indirect or inadvertent residues. Lime, postharvest ........................... 30.0 None
[Reserved]
Melon, honeydew, postharvest ....... 20.0 None
Muskmelon, postharvest ................. 20.0 None
[66 FR 1245, Jan. 5, 2001, as amended at 66 FR 38955, Nectarine, postharvest .................... 20.0 None
July 26, 2001; 67 FR 38603, June 5, 2002; 72 FR 35666, Nut, brazil, postharvest ...................
Nut, hickory, postharvest ................
200.0 None
None
June 29, 2007; 73 FR 54959, Sept. 24, 2008; 74 FR Nut, macadamia, postharvest .........
200.0
200.0 None
46372, Sept. 9, 2009; 76 FR 56652, Sept. 14, 2011; 78 Oat, postharvest ............................. 50.0 None
FR 60721, Oct. 2, 2013] Okra, postharvest ........................... 30.0 None
§ 180.123 Inorganic bromide residues resulting from Onion, bulb, postharvest ................. 20.0 None
Onion, green, postharvest ............... 20.0 None
fumigation with methyl bromide; tolerances Orange, postharvest ....................... 30.0 None
for residues. Parsnip, roots, postharvest ............. 30.0 None
(a) General. (1) Tolerances are established Peach, postharvest ......................... 20.0 None
for residues of inorganic bromides (calculated Peanut, postharvest ........................
Pear, postharvest ............................
200.0
5.0
None
None
as Br) in or on the following food commodities Pea, blackeyed, postharvest ........... 50.0 None
which have been fumigated with the Pea, postharvest ............................. 50.0 None
antimicrobial agent and insecticide methyl Pecan, postharvest ......................... 200.0 None
bromide after harvest (with the exception of
Pepper, postharvest ........................ 30.0 None
Pimento, postharvest ...................... 30.0 None
strawberry): Pineapple, postharvest ................... 20.0 None
Pistachio, postharvest ..................... 200.0 None
Plum, postharvest ........................... 20.0 None
Pomegranate, postharvest .............. 100.0 None
Potato, postharvest ......................... 75.0 None
Expiration/ tion, unless a higher level is established
Commodity Parts per
million Revocation elsewhere in this part.
Date
(3) Tolerances are established for residues
Pumpkin, postharvest...................... 20.0 None of inorganic bromides (calculated as Br) as
Quince, postharvest ........................ 5.0 None follows:
Radish, postharvest ........................
Rice, grain, postharvest .................
30.0
50.0
None
None (i) 400 parts per million for residues in or
Rutabaga, roots, postharvest ......... 30.0 None on dog food, resulting from fumigation with
Rutabaga, tops, postharvest .......... 30.0 None methyl bromide.
Rye, grain, postharvest .................. 50.0 None (ii) 125 parts per million for residues in or
on processed commodities for animal
Salsify, roots, postharvest ............... 30.0 None
Sorghum, grain, grain, postharvest 50.0 None
Soybean, postharvest ...................... 200.0 None feedstuffs from barley, corn, grain sorghum,
Squash, summer, postharvest ........ 30.0 None oat, rice, rye and wheat, resulting directly from
fumigation with methyl bromide or from
Squash, winter, postharvest ............. 20.0 None
Squash, zucchini, postharvest ........ 20.0 None
Strawberry, postharvest .................. 60.0 None carryover and concentration of residues of
Sweet potato, postharvest................ 75.0 None inorganic bromides from fumigation of the
Tangerine, postharvest .................... 30.0 None grains with methyl bromide.
(b) Section 18 emergency exemptions.
Timothy, hay, postharvest ............... 50.0 10/19/10
Tomato, postharvest ........................ 20.0 None
Turnip, roots, postharvest ............... 30.0 None [Reserved]
Walnut, postharvest ......................... 200.0 None (c) Tolerances with regional registrations.
Watermelon, postharvest ................
Wheat ..............................................
20.0
50.0
None
None
A tolerance with regional registration, as
defined in §180.1(l), is established for residues
(2) Inorganic bromide may be present as a of inorganic bromides (calculated as Br) in or
residue in certain processed food in on the following food commodity grown in soil
accordance with the following conditions: fumigated with methyl bromide.
(i) When inorganic bromide residues are
present as a result of fumigation of the
processed food with methyl bromide or from
such fumigation in addition to the authorized Commodity Parts per
use of methyl bromide on the source raw million
[Reserved]
Poultry, meat ...................................................... 3
Poultry, meat byproducts .................................... 3
(d) Indirect or inadvertent residues. Raspberry, postharvest ...................................... 8
[Reserved] Rice, postharvest ................................................ 20
Rye, postharvest ................................................. 20
[77 FR 35298, June 13, 2012] Sheep, fat ............................................................ 0.1
§ 180.127 Piperonyl butoxide; tolerances for Sheep, meat ........................................................ 0.1
Sheep, meat byproducts .....................................
residues. 0.1
Sorghum, grain, postharvest ............................... 8
(a) General. (1) Tolerances for residues of Sweet potato, postharvest.................................... 0.25
the insecticide piperonyl butoxide [(butyl Tomato, postharvest ............................................ 8
carbityl)(6-propyl piperonyl)ether] are Walnut, postharvest .............................................
Wheat, postharvest ..............................................
8
established in or on the following food 20
(trichloromethyl)benzenemethanol, in or on
Beet, sugar, roots ............................ 0.5 None
Beet, sugar, tops ............................. 25 None
the commodity. Bushberry subgroup 13-07B ........... 3.0 None
Cabbage ......................................... 21 None
Cactus, fruit ..................................... 5.0 None
Cactus, pads ................................... 12 None
Expiration/
Parts per Caneberry subgroup 13-07A............ 12.0 None
Commodity Revocation
million Citrus, oil ......................................... 20 None
Date
Clover, forage ................................. 50 None
Cattle, fat ......................................... 50.0 10/31/16 Clover, hay ...................................... 70 None
Cattle, liver ...................................... 5.0 10/31/16 Corn, field, forage ........................... 30 None
Cattle, meat ..................................... 3.0 10/31/16 Corn, field, grain ............................. 0.02 None
Cattle, meat byproducts, except liver Corn, field, stover ............................ 20 None
.................................................... 3.0 10/31/16 Corn, pop, grain .............................. 0.02 None
Egg ................................................. 0.05 10/31/16 Corn, pop, stover ............................ 20 None
Goat, fat ........................................... 50.0 10/31/16 Corn, sweet, forage ......................... 185 None
Goat, liver ........................................ 5.0 10/31/16 Corn, sweet, kernel plus cob with
Goat, meat ....................................... 3.0 10/31/16 husks removed ........................... 0.1 None
Goat, meat byproducts, except liver 3.0 10/31/16 Corn, sweet, stover ......................... 215 None
Hog, fat ............................................ 50.0 10/31/16 Cotton, undelinted seed .................. 5.0 10/31/09
Hog, liver ......................................... 5.0 10/31/16 Cranberry ........................................ 3.0 None
Hog, meat ........................................ 3.0 10/31/16 Dandelion, leaves ............................ 22 None
Hog, meat byproducts, except liver 3.0 10/31/16 Endive ............................................. 10 None
Horse, fat ......................................... 50.0 10/31/16 Flax, seed ....................................... 0.5 None
Horse, liver ...................................... 5.0 10/31/16 Fruit, citrus, group 10 ...................... 10 None
Horse, meat ..................................... 3.0 10/31/16 Fruit, pome, group 11 ...................... 12 None
Horse, meat byproducts, except liver Fruit, stone, group 12 ...................... 10 None
.................................................... 3.0 10/31/16 Grain, aspirated fractions ................ 70 None
Milk, fat (reflecting 0.75 ppm in whole Grape .............................................. 10 None
milk) ............................................ 22.0 10/31/16 Grape, raisin ................................... 12 None
Poultry, fat ....................................... 0.1 10/31/16 Grass, forage .................................. 100 None
Poultry, meat ................................... 0.1 10/31/16 Grass, hay ...................................... 15 None
Poultry, meat byproducts ................ 0.1 10/31/16 Leaf petiole subgroup 4B ................ 3.0 None
Sheep, fat ........................................ 50.0 10/31/16 Lettuce ............................................. 10 None
Sheep, liver ..................................... 5.0 10/31/16 Millet, proso, grain ........................... 1.0 None
Sheep, meat .................................... 3.0 10/31/16 Millet, proso, straw .......................... 20 None
Sheep, meat byproducts, except liver Nut, tree group 14, except walnut ... 0.1 None
.................................................... 3.0 10/31/16 Okra ................................................. 4.0 None
Olive ................................................ 10 None
(b) Section 18 emergency exemptions. Oyster ............................................. 0.25 None
[Reserved] Parsley, leaves ............................... 22 None
Potato .............. 30
Potato, wet peel 40
Cattle, meat byproducts, except liver Nut, macadamia .............................. 0.2 7/31/12
.................................................... 1.0 7/31/16 Peach .............................................. 2.0 7/31/12
Cauliflower ....................................... 2.0 7/31/12 Pear ................................................ 2.0 7/31/13
Celery .............................................. 8.0 7/31/12 Pineapple ......................................... 1.0 7/31/16
Cherry, sweet .................................. 2.0 7/31/12 Pineapple, process residue .............. 20.0 7/31/16
Cherry, tart ...................................... 2.0 7/31/12 Plum ................................................ 2.0 7/31/12
Collards ........................................... 2.0 7/31/12 Plum, prune ..................................... 2.0 7/31/12
Cotton, gin byproducts .................... 30.0 7/31/12 Sheep, fat ........................................ 13.0 7/31/16
Cotton, undelinted seed .................. 1.0 7/31/12 Sheep, liver ..................................... 5.0 7/31/16
Cucumber ....................................... 1.0 7/31/12 Sheep, meat .................................... 7/31/16
2.0
Eggplant .......................................... 1.0 7/31/12 Sheep, meat byproducts, except liver
Goat, fat ........................................... 13.0 7/31/16 1.0 7/31/16
....................................................
Goat, liver ........................................ 5.0 7/31/16
Squash, summer ............................. 1.0 7/31/12
Goat, meat ....................................... 2.0 7/31/16 Strawberry ....................................... 7/31/16
2.0
Goat, meat byproducts, except liver 1.0 7/31/16 Sweet potato, roots ......................... 0.15 7/31/12
Hazelnut .......................................... 0.2 7/31/12
Walnut ............................................. 0.2 7/31/12
Hog, fat ............................................ 13.0 7/31/16 Watermelon ..................................... 7/31/12
Hog, liver ......................................... 5.0 7/31/16 1.0
Hog, meat ........................................ 2.0 7/31/16
Hog, meat byproducts, except liver 1.0 7/31/16 (2) A tolerance is established for the
Horse, fat ......................................... 13.0 7/31/16 combined residues of the insecticide
Horse, liver ...................................... 5.0 7/31/16 endosulfan, 6,7,8,9,10,10-hexachloro-
1,5,5a,6,9,9a-hexahydro-6,9-methano-2, 4,3-
Horse, meat ..................................... 2.0 7/31/16
Horse, meat byproducts, except liver
.................................................... 1.0 7/31/16 benzodioxathiepin-3-oxide (alpha and beta
Kale ................................................. 2.0 7/31/12 isomers), and its metabolite endosulfan
Lettuce, head ...................................
Lettuce, leaf .....................................
11.0
6.0
7/31/12
7/31/12
sulfate, 6,7,8,9,10,10- hexachloro-1,5,5a,6,9,9a-
Milk, fat ............................................ 2.0 7/31/16 hexahydro-6,9- methano-2, 4,3-
Muskmelon ...................................... 1.0 7/31/12 benzodioxathiepin-3,3- dioxide in or on the
Mustard greens ...............................
Mustard, seed ..................................
2.0
0.2
7/31/12
7/31/12
commodity in the following table:
Nectarine ......................................... 2.0 7/31/12
Expiration/
Commodity Parts per million revocation
date
24 (reflecting less than 0.1 ppm in beverage tea) resulting from application of the insecticide to
Tea, dried ............ 7/31/16
growing tea.
[63 FR 2165, Jan. 14, 1998, as amended at 63 FR Parsnip, tops ....................................................... 0.05
57073, Oct. 26, 1998; 66 FR 38955, July 26, 2001; 67 Pea, dry, seed .................................................... 0.09
FR 41806, June 19, 2002; 67 FR 49615, July 31, 2002; Rhubarb ............................................................. 0.5
70 FR 44492, Aug. 3, 2005; 73 FR 54960, Sept. 24 , Sheep, fat ........................................................... 0.2
2008; 74 FR 46697, Sept. 11, 2009; 75 FR 60240, Sept. Sheep, kidney...................................................... 2.0
29, 2010] Sheep, liver .........................................................
Sheep, meat .......................................................
2.0
0.1
§ 180.184 Linuron; tolerances for residues. Sheep, meat byproducts except kidney and liver 0.1
(a) General. Tolerances are established for Sorghum, grain, forage ........................................
Sorghum, grain, grain ..........................................
1.0
0.25
residues of the herbicide linuron (3- Sorghum, grain, stover ........................................ 1.0
(3,4-dichlorophenyl)-1- Soybean, seed .................................................... 1.0
methoxy-1-methylurea), including its Soybean, vegetable............................................. 1.0
metabolites and degradates, in or on the
commodities in the table below. Compliance (b) Section 18 emergency exemptions.
with the tolerance levels specified below is to Time-limited tolerances are estab-
be determined by measuring only those lished for residues of the herbicide
linuron residues convertible to 3,4- linuron [3-(3,4-dichlorophenyl)-1-
dichloroaniline, calculated as the methoxy-1-methylurea], including its
stoichiometric equivalent of linuron, in or on metabolites and degradates, in or on
the commodity: the commodities in the table below, re-
sulting from use of the pesticide pursu-
ant to FIFRA section 18 emergency ex-
emptions. Compliance with the toler-
ance levels specified below is to be de-
Commodity Parts per termined by measuring only those
million
linuron residues convertible to 3.4-
Asparagus ........................................................... 7.0 dichloroaniline, calculated as the stoi-
Carrot, roots ........................................................ 1.0 chiometric equivalent of linuron, in or
Cattle, fat ............................................................ 0.2 on the commodity. The tolerance ex-
Cattle, kidney ......................................................
Cattle, liver ..........................................................
2.0
2.0 pires and is revoked on the date speci-
Cattle, meat ........................................................ 0.1 fied in the table.
Cattle, meat byproducts except kidney and liver 0.1
Celeriac ............................................................... 1.0
Expiration/
Cilantro, dried leaves .......................................... 10 Parts per
Commodity revocation
Cilantro, fresh leaves .......................................... 3.0 million date
Coriander, seed .................................................. 0.01
Corn, field, forage ................................................ 1.0 Lentil ............................................... 0.1 12/31/14
Corn, field, grain ................................................. 0.1
Corn, field, stover ............................................... 6.0
(c) Tolerances with regional registrations.
Tolerances with regional registrations, as
Corn, sweet, forage ............................................ 1.0
Corn, sweet, kernel plus cob with husks re-
moved ............................................................. 0.25 defined in §180.1(l), are established for residues
Corn, sweet, stover ............................................ 6.0 of the herbicide linuron (3-(3,4-
Cotton, gin byproducts .......................................
Cotton, undelinted seed .....................................
5.0
0.25 dichlorophenyl)-1- methoxy-1-methylurea),
Dill, oil ................................................................. 2.0 including its metabolites and degradates, in or
Dill, seed ............................................................. 0.5 on the commodities in the table below.
Dillweed, dried leaves ........................................
Dillweed, fresh leaves ........................................
5.0
1.5
Compliance with the tolerance levels specified
Goat, fat .............................................................. 0.2 below is to be determined by measuring only
Goat, kidney ....................................................... 2.0 those linuron residues convertible to 3,4-
Goat, liver ........................................................... 2.0 dichloroaniline, calculated as the
stoichiometric equivalent of linuron, in or on
Goat, meat .......................................................... 0.1
Goat, meat byproducts except kidney and liver.. 0.1
Hog, fat ............................................................... 0.05 the commodity.
Hog, meat ........................................................... 0.05
Hog, meat byproducts ........................................ 0.1
Horse, fat ............................................................ 0.2
Horse, kidney ...................................................... 2.0
Horse, liver ......................................................... 2.0 Parts per
Commodity
Horse, meat......................................................... 0.1 million
Horse, meat byproducts except kidney and liver 0.1
Horseradish ........................................................ 0.05 Celery ................................................................. 0.5
Milk ..................................................................... 0.05 Potato ................................................................. 0.2
Parsley, dried leaves .......................................... 9.0 Wheat, forage ...................................................... 0.5
Parsley, leaves ................................................... 4.0 Wheat, grain ....................................................... 0.05
Parsnip, roots ..................................................... 0.05 Wheat, hay ......................................................... 0.5
Parts per its metabolites monomethyl
Commodity million tetrachloroterephthalate acid (MTP) and
Wheat, straw ....................................................... terachlorophthalic acid (TCP) (calculated as
2.0 DCPA) in or on the following food
commodities:
(d) Indirect or inadvertent residues.
[Reserved] Parts per
Commodity million
[64 FR 41822, Aug. 2, 1999, as amended at 72 FR Basil, dried leaves .............................................. 20.0
37653, July 11, 2007; 73 FR 51727, Sept. 5, 2008; 76 Basil, fresh leaves .............................................. 5.0
FR 81396, Dec. 28, 2011; 79 FR 8307, Feb. 12, 2014] Bean, dry ............................................................ 2.0
Bean, mung, seed .............................................. 2.0
§ 180.185 DCPA; tolerances for residues. Bean, snap, succulent ........................................ 2.0
Celeriac ............................................................... 2.0
(a) General. Tolerances for the combined Chicory, roots ..................................................... 2.0
residues of the herbicide dimethyl Chicory, tops ....................................................... 5.0
tetrachloroterephthalate Chive ................................................................... 5.0
(DCPA) and its metabolites
Coriander, leaves ............................................... 5.0
Corn, field, forage ................................................ 0.4
monomethyltetrachloroterephthalate (MTP) Corn, field, grain ................................................. 0.05
and tetrachloroterephthalic acid (TCP) Corn, field, stover ............................................... 0.4
(calculated as dimethyl Corn, pop, forage ...............................................
Corn, pop, grain ..................................................
0.4
0.05
tetrachloroterephthalate) are established in or Corn, pop, stover................................................. 0.4
on the following food commodities: Corn, sweet, forage ............................................ 0.4
Corn, sweet, kernel plus cob with husks re-
moved ............................................................. 0.05
Corn, sweet, stover ............................................ 0.4
Cotton, undelinted seed ..................................... 0.2
Parts per Cucumber ........................................................... 1.0
Commodity Dill ....................................................................... 5.0
million
Eggplant .............................................................. 1.0
Cantaloupe ......................................................... 1.0 Lettuce ............................................................... 2.0
Garlic .................................................................. 1.0 Marjoram ............................................................. 5.0
Ginseng .............................................................. 2.0 Parsley, dried leaves .......................................... 20.0
Horseradish ........................................................ 2.0 Parsley, leaves ................................................... 5.0
Muskmelon ......................................................... 1.0 Pea, blackeyed, seed ......................................... 2.0
Onion, bulb ......................................................... 1.0 Pepper ................................................................ 2.0
Onion, green........................................................ 1.0 Pimento ............................................................... 2.0
Strawberry .......................................................... 2.0 Potato ................................................................. 2.0
Tomato ................................................................ 1.0 Radicchio ........................................................... 5.0
Vegetable, brassica, leafy, group 5 ..................... 5.0 Radish, oriental, roots ........................................ 2.0
Watermelon ........................................................ Radish, oriental, tops .......................................... 2.0
1.0
Rutabaga ............................................................ 2.0
(b) Section 18 emergency exemptions.
Soybean ............................................................. 2.0
Squash, summer ................................................ 1.0
[Reserved] Squash, winter .................................................... 1.0
(c) Tolerances with regional registrations. Sweet potato ....................................................... 2.0
Tolerances with regional registration, as Turnip, roots .......................................................
Turnip, tops .........................................................
2.0
5.0
defined in §180.1(l), are established for the Yam, true, tuber ................................................... 2.0
combined inadvertent residues of the
herbicide dimethyl tetrachloroterephthalate [72 FR 52018, Sept. 12, 2007, as amended at 73 FR
(DCPA) and its metabolites monomethyl 53737, Sept. 17, 2008; 73 FR 80302, Dec. 31, 2008; 74
tetrachloroterephthalate acid (MTP) and FR 14744, Apr. 1, 2009]
terachlorophthalic acid (TCP) (calculated as § 180.189 Coumaphos; tolerances for residues.
DCPA) in or on the following food (a) General. Tolerances for residues of the
commodities: insecticide coumaphos (O,O-diethyl 0-3-
chloro-4-methyl-2-oxo-2H-1- benzopyran-7-
yl phosphorothioate and its oxygen analog
(0,0-diethyl 0-3- chloro-4-methyl-2-oxo-2H-
Parts per
Commodity million
1- benzopyran-7-yl phosphate) in or on food
Radish, roots ......................................................
Radish, tops ........................................................
2.0
15.0 commodities as follows:
Cattle, meat ........................................................ 1.0 [64 FR 25848, May 13, 1999, as amended at 66 FR
Cattle, meat byproducts ...................................... 1.0 63198, Dec. 5, 2001; 72 FR 16283, Apr. 4, 2007; 76 FR
Goat, fat............................................................... 1.0 34885, June 15, 2011]
Goat, meat .......................................................... 1.0
Goat, meat byproducts ....................................... 1.0
§ 180.191 Folpet; tolerances for residues.
Hog, fat ............................................................... 1.0 (a) General. Tolerances are established for
Hog, meat ........................................................... 1.0 the fungicide folpet (N-
(trichloromethylthio)phthalimide) in or on raw
Hog, meat byproducts ........................................ 1.0
Honey ................................................................. 0.15
Honeycomb ........................................................ 45.0 agricultural commodities as follows:
Horse, fat ............................................................ 1.0
Horse, meat ........................................................ 1.0
Horse, meat byproducts ..................................... 1.0
Milk, fat (-n in whole milk) ................................... 0.5
Sheep, fat ........................................................... 1.0 Parts per
Sheep, meat ....................................................... 1.0 Commodity million
Sheep, meat byproducts ..................................... 1.0
Apple1 ............... 5.0
(b) Section 18 emergency exemptions. Cranberry1 ........ 15.0
[Reserved] Cucumber1 ........ 2.0
(c) Tolerances with regional registrations. Grape1 ..............
Grape, raisin1 ....
50.0
80.0
[Reserved] Hop, dried cones 120.0
(d) Indirect or inadvertent residues. Lettuce1 ............ 50.0
[Reserved] Melon1 .............. 3.0
Onion,bulb1 ....... 2.0
[64 FR 39077, July 21, 1999, as amended at 65 FR Strawberry1 ....... 5.0
49936, Aug. 16, 2000; 67 FR 46883, July 17, 2002; 69 Tomato1 ............ 25.0
FR 29458, May 24, 2004; 72 FR 28876, May 23, 2007] 1
No U.S. registrations.
Expiration/
Parts per
Commodity revocation Parts per
million Commodity
date milliOn
Apricot ............................................. 20 None Alfalfa, forage ...................................................... 2.0
Bean, snap, succulent ..................... 20 None Alfalfa, hay ........................................................... 2.0
Carrot, roots ................................... 10 11/2/11 Bean, dry, seed .................................................. 2.0
Celery ............................................. 15 None Bean, lima ........................................................... 2.0
Cherry, sweet ................................. 20 None Bean, snap, succulent ........................................ 2.0
Cucumber ....................................... 5 None Blueberry1 .......................................................... 1.0
Endive ............................................. 10 None Broccoli .............................................................. 2.0
Garlic .............................................. 5 None Cattle, meat byproducts ...................................... 0.02
Grape .............................................. 10 None Cauliflower ........................................................... 2.0
Lettuce ............................................ 10 None Celery .................................................................. 2.0
Nectarine ........................................ 20 None Citrus, dried pulp ................................................. 5.0
Onion .............................................. 10 None Corn, field, forage................................................. 1.0
Peach ............................................. 20 None Corn, field, grain .................................................. 0.1
Plum, prune, fresh .......................... 15 None Corn, field, stover ................................................ 1.0
Potato ............................................. 0.25 12/31/14 Corn, pop, grain ................................................... 0.1
Rhubarb .......................................... 10 None Corn, pop, stover.................................................. 1.0
Sweet potato, roots ........................ 10 None Corn, sweet, forage ............................................. 1.0
Tomato ........................................... 5 None Cotton, undelinted seed ...................................... 0.1
Egg ..................................................................... 0.02
(b) Section 18 emergency exemptions. Endive ................................................................. 2.0
[Reserved] Goat, meat byproducts ........................................
Grapefruit .............................................................
0.02
Pea and bean, succulent shelled, subgroup 6B 0.05 Cassava ............................................................. 0.05
Pea, field, hay ..................................................... 0.8 Pea, pigeon, seed .............................................. 0.05
Pea, field, vines .................................................. 0.2 Tanier ................................................................. 0.05
Peanut ................................................................ 0.05 Taro, corm .......................................................... 0.1
Peanut, hay ........................................................ 0.5
Tyfon .................................................................. 0.05
Peppermint, tops ................................................ 0.5 Yam, true, tuber ................................................... 0.05
Persimmon ......................................................... 0.05
Pineapple ........................................................... 0.05
Pineapple, process residue ................................ 0.25 (d) Indirect or inadvertent residues.
Pistachio ............................................................. 0.05 [Reserved]
Pomegranate ...................................................... 0.05
Potato ................................................................. 0.5 [46 FR 51614, Oct. 21, 1981]
Pulasan .............................................................. 0.05 EDITORIAL NOTE: For FEDERAL REGISTER citations
Rambutan ........................................................... 0.05 affecting §180.205, see the List of CFR Sections
Rhubarb ............................................................. 0.05 Affected, which appears in the Finding Aids section
Rice, grain .......................................................... 0.05 of the printed volume and at www.fdsys.gov.
Rice, straw ......................................................... 0.06
§ 180.206 Phorate; tolerances for residues.
Safflower, seed .................................................. 0.05
Sapodilla ............................................................ 0.05 (a) General. Tolerances are established for
Sapote, black ...................................................... 0.05 the combined residues of the insecticide
Sapote, mamey .................................................. 0.05
phorate (O,O-diethyl S (ethylthio) meth-
yl]phosphorodithioate), phorate sulfoxide,
Sapote, white ..................................................... 0.05
Sheep, fat ........................................................... 0.05
Sheep, kidney .................................................... 0.5 phorate sulfone, phorate oxygen analog,
Sheep, meat ....................................................... 0.05 phorate oxygen analog sulfoxide, and phorate
Sheep, meat byproducts, except kidney.............. 0.05 oxygen analog sulfone in or on the following
Sorghum, forage, forage ....................................
Sorghum, grain, forage .......................................
0.1 food commodities:
0.1
Sorghum, grain, grain ......................................... 0.05
Soursop .............................................................. 0.05
Soybean, forage ................................................. 0.4
Soybean, hay ..................................................... 10.0
Soybean, hulls .................................................... 4.5
Soybean, seed ................................................... 0.7
Spanish lime ....................................................... 0.05
Spearmint, tops .................................................. 0.5
Parts per
Star apple ........................................................... 0.05 Commodity million
Starfruit ............................................................... 0.05
Strawberry .......................................................... 0.25
Bean, dry, seed .................................................. 0.05
Sugar apple ........................................................ 0.05
Bean, succulent .................................................. 0.05
Sugarcane, cane ................................................ 0.5
Beet, sugar, roots ............................................... 0.3
Sugarcane, molasses ......................................... 3.0
Beet, sugar, tops ................................................ 3.0
Sunflower, seed .................................................. 2.0
Coffee, green bean 1 .......................................... 0.02
Turnip, greens .................................................... 0.05
Turnip, roots ....................................................... 0.05 Corn, field, forage ............................................... 0.5
Vegetable, brassica, leafy, group 5 ...................... 0.05 Corn, field, grain ................................................. 0.05
Vegetable, cucurbit, group 9 ............................... 0.05 Corn, sweet, forage ............................................ 0.5
Vegetable, fruiting, group 8 .................................. 0.05 Corn, sweet, kernel plus cob with husks removed
Vegetable, legume, edible podded, subgroup 6A 0.05 ....................................................................... 0.05
Wax jambu ........................................................... 0.05 Cotton, undelinted seed ..................................... 0.05
Wheat, forage ....................................................... 0.5 Hop, dried cones ................................................ 2.0
Wheat, grain ........................................................ 1.1 Peanut ................................................................ 0.1
Wheat, hay .......................................................... 3.5 Potato ................................................................. 0.2
Wheat, straw ....................................................... 50.0
Sorghum, grain, grain ......................................... 0.05
Sorghum, grain, stover ....................................... 0.1
(b) Section 18 emergency exemptions. Soybean, seed ................................................... 0.05
[Reserved] Sugarcane, cane ................................................ 0.05
(c) Tolerances with regional registra Wheat, forage ...................................................... 1.5
tions. Tolerances with regional registration as Wheat, grain ........................................................ 0.05
defined in §180.1(l), are established for residues Wheat, hay .......................................................... 1.5
of the pesticide paraquat (1,1'-dimethyl-
Wheat, straw ....................................................... 0.05
4,4'
1
There are no U.S. registrations as of September 1, 1993 for
the use of phorate on the growing crop, coffee.
bipyridinium ion) derived from application of
either the bis(methyl sulfate) or the dichloride (b) Section 18 emergency exemptions.
salt (both calculated as the cation) in or on the [Reserved]
following food commodities: (c) Tolerances with regional registrations.
[Reserved]
(d) Indirect or inadvertent residues. (c) Tolerances with regional registrations.
[Reserved] [Reserved]
[58 FR 62038, Nov. 24, 1993, as amended at 63 FR (d) Indirect or inadvertent residues.
2165, Jan. 14, 1998; 63 FR 57074, Oct. 26, 1998; 66 FR [Reserved]
50833, Oct. 5, 2001; 67 FR 49616, July 31, 2002; 71 FR [45 FR 42619, June 25, 1980, as amended at 45 FR
74816, Dec. 13, 2006; 73 FR 53738, Sept. 17, 2008] 56346, Aug. 25, 1980; 45 FR 86493, Dec. 31, 1980; 46
§ 180.207 Trifluralin; tolerances for residues. FR 37250, July 20, 1981; 47 FR 13524, Mar. 31, 1982;
47 FR 20309, May 12, 1982; 63 FR 57074, Oct. 26,
(a) General. Tolerances are established for 1998; 64 FR 39082, July 21, 1999; 70 FR 21643, Apr.
residues of trifluralin, including its metabolites 27, 2005; 71 FR 54433, Sept. 15, 2006; 78 FR 46274,
and degradates, in or on the commodities in July 31, 2013]
the following table. Compliance with the § 180.208 Benfluralin; tolerances for residues.
tolerance levels specified in the following table
(a) General. Tolerances are established for
is to be determined by only trifluralin a,a,a- residues of the herbicide benfluralin, N-
trifluoro-2,6-dinitro- butyl-N-ethyl-aaa-
N,N-dipropyl-p-toluidine, in or on the trifluoro-2,6-dinitro-p-toluidine, in or on the
commodity.
following food commodities:
Parts per
Commodity million
Parts per
Commodity million Alfalfa, forage ...................................................... 0.05
Alfalfa, hay ........................................................... 0.05
Alfalfa, forage ...................................................... 3.0 Clover, forage ...................................................... 0.05
Alfalfa, hay ........................................................... 2.0 Clover, hay .......................................................... 0.05
Almond, hulls ....................................................... 0.05 Lettuce ............................................................... 0.05
Asparagus ........................................................... 0.05
Trefoil, forage ...................................................... 0.05
Barley, grain ....................................................... 0.05 Trefoil, hay ........................................................... 0.05
Barley, hay .......................................................... 0.05
(b) Section 18 emergency exemptions. (2) Tolerances are established for residues
[Reserved] of the fungicide streptomycin from treatment
(c) Tolerances with regional exemptions. of seedling plants before transplanting in or on
[Reserved] the following food commodities:
(d) Indirect or inadvertent residues.
[Reserved]
[42 FR 32783, June 28, 1977] Commodity Parts per
EDITORIAL NOTE: For FEDERAL REGISTER citations million
affecting §180.242, see the List of CFR Sections Celery 0.25
Affected, which appears in the Finding Aids section Pepper 0.25
of the printed volume and at www.fdsys.gov. Tomato 0.25
§ 180.243 Propazine; tolerances for residues.
(3) Tolerances are established for residues
(a) General. Tolerances are established for
residues of the herbicide propazlne,2-chloro- of the fungicide streptomycin from treatment
4,6- of seed pieces in or on
bis(isopropylamino)-s-triazine, including its the following food commodity:
metabolites and degradates, in or on the
commodities in the following table. Commodity
Parts per
million
Compliance with the tolerance levels specified
in this paragraph is to be determined by Potato ................................................................. 0.25
measuring only the sum of propazine, 2-
chloro-4,6- bis(isopropylamino)-s-triazine, (a) Section 18 emergency exemptions.
and its two chlorinated degradates, 2-amino- Time-limited tolerances are established for
4- chloro-6-isopropylamino-s-triazine and residues of streptomycin, in or on the
2,4-diamino-6-chloro-s-triazine, calculated as agricultural commodities, as specified in the
the stoichiometric equivalent of propazine, in following table, resulting from use of the
or on the commodity. pesticide pursuant to FIFRA section 18
emergency exemptions. Compliance with the
tolerance levels listed in the following table is
to be determined by measuring the levels of
streptomycin only, in or on the commodities
listed in the table. The tolerances expire on the
Parts per dates specified in the table.
Commodity million
Expiration/
Parts per
Commodity Revocation
million Date
Parts per
Commodity million Apple1 ............................................. 10.0 9/30/13
Cherry1 ........................................... 15.0 9/30/13
Grape1 ............................................ 10.0 9/30/13
Banana ............................................................... 0.02
Peach1 ............................................ 15.0 9/30/13
Bean, lima ........................................................... 0.02 Pear1 ............................................... 10.0 9/30/13
Bean, snap, succulent ........................................ 0.02 Plum, prune, fresh1 ......................... 15.0 9/30/13
Cabbage ............................................................. 0.02 1
There are no U.S. registrations since 1992.
Corn, field, forage ................................................ 0.02
Corn, field, grain ................................................. 0.02 (b) Section 18 emergency exemptions.
Corn, field, stover ............................................... 0.02 [Reserved]
Corn, sweet, forage ............................................ 0.02 (c) Tolerances with regional registrations.
[Reserved]
Corn, sweet, kernel plus cob with husks re-
moved ............................................................. 0.02
Corn, sweet, stover ............................................ 0.02 (d) Indirect or inadvertent residues.
Cucumber ........................................................... 0.02 [Reserved]
Hop, dried cones ................................................ 0.02 [74 FR 46698, Sept. 11, 2009]
Peppermint, tops ................................................ 0.02
Pineapple1 ..........................................................
§ 180.269 Aldicarb; tolerances for residues.
(a) General. Tolerances are established for
0.02
Potato ................................................................. 0.02
Spearmint, tops .................................................. 0.02 combined residues of the insecticide and
Sugarcane, cane ................................................ 0.02 nematocide aldicarb (2-
methyl-2-(methylthio)propionaldehyde O- Commodity Parts per
(methylcarbamoyl) oxlme and Its million
cholinesterase-inhibiting metabolites 2- Milk ..................................................................... 0.01
methyl 2-(methylsulfinyl) Sheep, fat ............................................................ 0.15
propionaldehyde O-(methylcarbamoyl) oxime Sheep, meat ........................................................ 0.02
and 2-methyl-2-(methylsulfonyl) Sheep, meat byproducts ..................................... 0.02
propionaldehyde O-(methylcarbamoyl) oxime (b) Section 18 emergency exemptions.
in or on the following food commodities:
[Reserved]
(c) Tolerances with regional registrations.
Parts per [Reserved]
(d) Indirect or inadvertent residues.
Commodity million
Parts per
Commodity million
Parts per
Commodity million Artichoke, globe ................................................... 0.01
Beet, sugar, roots ............................................... 0.04
Beet, garden, roots .............................................. 0.2 Beet, sugar, tops ................................................ 0.02
Beet, garden, tops .............................................. 0.2
(d) Indirect or inadvertent residues.
Beet, sugar, dried pulp ....................................... 0.5
Beet, sugar, molasses ......................................... 0.2
Beet, sugar, roots ............................................... 0.1 [Reserved]
Beet, sugar, tops ................................................ 0.1
Spinach ............................................................... 4.0 [63 FR 45182, Aug. 25, 1998, as amended at 63 FR
67799, Dec. 9, 1998; 64 FR 40772, July 28, 1999; 64 FR
(b) Section 18 emergency exemptions. 61791, Nov. 15, 1999; 65 FR 8874, Feb. 23, 2000; 65 FR
[Reserved] 49941, Aug. 16, 2000; 65 FR 62634, Oct. 19, 2000; 66
(c) Tolerances with regional registrations. FR 64773, Dec. 14, 2001; 68 FR 2247, Jan. 16, 2003; 68
[Reserved] FR 56195, Sept. 30, 2003; 70 FR 7046, Feb. 10, 2005;
74 FR 46373, Sept. 9, 2009; 76 FR 34885, June 15,
(d) Indirect or inadvertent residues. 2011]
[Reserved]
[72 FR 28888, May 23, 2007] § 180.287 Amitraz; tolerances for residues.
§ 180.284 Zinc phosphide; tolerances for residues. (a) General. Tolerances are established for
(a) General. Tolerances are established for residues of the insecticide amitraz (N’-
residues of the phosphine resulting from the [2,4-dimethyl phenyl]-N-
use of the rodenticide zinc phosphide in or on [[(2,4-dimethylphenyl)imino]methyl]]- N-
the raw agricultural commodities as follows: methylmethanimidamide), including its
metabolites and degradates, in or on the
commodities in the following table.
Compliance with the tolerance levels specified
is to be determined by measuring amitraz
Parts per residues convertible to 2,4-dimethylaniline,
Commodity million expressed as the stoichiometric equivalent of
Alfalfa, forage ...................................................... 0.2
amitraz, in or on the following raw agricultural
Alfalfa, hay ........................................................... 0.2 commodities:
Barley, grain ....................................................... 0.05
Barley, hay .......................................................... 0.2
Barley, straw ....................................................... 0.2
Bean, dry, seed .................................................. 0.05
Parts per (b) Section 18 emergency exemptions.
[Reserved]
Commodity million
Commodity
Parts per
million (b) Section 18 emergency exemptions.
[Reserved]
Collards ............ 0.2 (c) Tolerances with regional registrations.
Kale ..................
Mustard, greens
0.2
0.2 [Reserved]
(d) Indirect or inadvertent residues.
(d) Indirect or inadvertent residues. [Reserved]
[Reserved] [41 FR 19221, May 11, 1976, as amended at 47 FR
[74 FR 47456, Sept. 16, 2009] 53005, Nov. 24, 1982; 64 FR 425, Jan. 5, 1999; 64 FR
39082, July 21, 1999; 72 FR 41930, Aug. 1, 2007; 75 FR
§ 180.292 Picloram; tolerances for residues. 60243, Sept. 29, 2010]
(a) General. Tolerances are established for § 180.293 Endothall; tolerances for residues.
residues of the herbicide picloram, 4-amino-
3,5,6- (a) General. (1) Tolerances are established
trichloropicolinic acid, including its metabolites for the residues of endothall, including its
and degradates, in or on the commodities in metabolites and degradates, in or on the
the following table from its application in the commodities in the table, below. Compliance
acid form or in the form of its salts. Compliance with the tolerance levels specified, below, is to
with the tolerance levels specified in this be determined by measuring only endothall
paragraph is to be determined by measuring (7- oxabicylco [2.2.1] heptanes-2,3-
only picloram, 4-amino- 3,5,6- dicarboxylic acid) and its mono-methyl ester.
trichloropicolinic acid, in or on the commodity.
Parts per
Commodity million
Parts per
Commodity Apple ................................................................... 0.05
million
Apple, wet pomace .............................................. 0.15
Barley, grain ....................................................... 0.5 Cotton, undelinted seed ..................................... 0.1
Barley, pearled barley ......................................... 3.0 Fish .................................................................... 0.1
Barley, straw........................................................ 1.0 Hop, dried cones ................................................ 0.1
Cattle, fat ............................................................ 0.4 Potato ................................................................. 0.1
Cattle, meat ........................................................ 0.4 Rice, grain .......................................................... 0.05
Cattle, meat byproducts ...................................... 15 Rice, straw........................................................... 0.05
Egg ..................................................................... 0.05
Goat, fat............................................................... 0.4 (2) An interim tolerance of 0.2 parts per
million is established for residues of the
Goat, meat ........................................................... 0.4
Goat, meat byproducts ....................................... 15
Grain, aspirated fractions ................................... 4.0 herbicide endothall (7 -
Grass, forage....................................................... 400 oxabicyclo[2.2.1] heptane-2,3-
Grass, hay ..........................................................
Hog, fat ...............................................................
225
0.05 dicarboxylic acid) in water, potable from use of
Hog, meat ........................................................... 0.05 its potassium, sodium, diN, N-
Hog, meat byproducts ........................................ 0.05 dimethylalkylamine, and mono-N- N,-
Horse, fat ............................................................
Horse, meat .........................................................
0.4
0.4
dimethylalkylamine salts as algicides or
Horse, meat byproducts ..................................... 15 herbicides to control
aquatic plants in canals, lakes, ponds, and Parts per
other potential sources of water, potable. Commodity million
(b) Section 18 emergency exemptions. Pea and bean, succulent shelled, subgroup 6B 2.0
[Reserved] Peppermint, tops .............................................. 5.0
(c) Tolerances with regional registrations. Pistachio .......................................................... 0.05
[Reserved] Poultry, fat ........................................................ 0.015
(d) Indirect or inadvertent residues. Poultry, liver ..................................................... 0.05
Tolerances are established for the indirect or Poultry, meat .................................................... 0.015
herbicide, endothall (7 -
8.0
oxabicyclo[2.2.1] heptane-2,3-
Sheep, fat .......................................................... 0.005
Sheep, kidney .................................................... 0.15
dicarboxylic acid) in potable water from use of Sheep, liver ....................................................... 0.05
its potassium, sodium, diN, N - Sheep, meat ...................................................... 0.015
dimethylalkylamine, and mono- N-N, - Soybean, hulls ................................................... 0.5
dimethylalkylamine salts as algicides or Soybean, seed .................................................. 0.2
herbicides to control aquatic plants in canals, Spearmint, tops .................................................
Tomato, paste ....................................................
5.0
lakes, ponds, and other potable water sources Tomato, puree ...................................................
0.1
Expiration/
Parts per
Commodity revocation
million date
Commodity Parts per
Almond, hulls .................................. 6.0 12/31/16 million
Artichoke, globe ............................... 0.05 12/31/16
Citrus, oil ......................................... 420.0 12/31/16 Cotton, gin byproducts ........................................ 2.0
Cotton, undelinted seed .................. 0.2 12/31/16 Cotton, undelinted seed ...................................... 0.2
Fruit, citrus, group 10, except
tangerine .................................... 4.0 12/31/16 (b) Section 18 emergency exemptions.
Fruit, pome, group 11 ..................... 0.05 12/31/16 [Reserved]
Fruit, stone, group 12 ..................... 0.05 12/31/16 (c) Tolerances with regional registrations.
[Reserved]
Mango ............................................. 0.05 12/31/16
Raw Expiration/
Substances Uses Tolerance in parts per million agricultural revocation
commodity date
Coordination product of zinc ion and Fungicide ............ 1.0 (Calculated as zinc ethylene- Potato ................. None
maneb. bisdithio-carbamate).
Endothall (7-oxabicyclo- (2,2,1)heptane Herbicide ........... 0.2 ............................................... Beet, sugar .......... None
2,3-dicarboxylic acid.
Methyl parathion .......................... Herbicide ........... 0.5 ................................................ Rye ..................... 12/31/13
Parts per
Commodity million Parts per
Commodity
million
Cattle, fat ............................................................ 0.1
Cattle, meat ........................................................ 0.1 Alfalfa, forage ..................................................... 3.0
Cattle, meat byproducts ...................................... 0.1 Alfalfa, hay ........................................................... 13
Goat, fat .............................................................. 0.1 Almond ................................................................ 0.2
Goat, meat .......................................................... 0.1 Almond, hulls ...................................................... 12
Goat, meat byproducts ....................................... 0.1 Apple .................................................................. 0.01
Hog, fat ............................................................... 0.1 Apple, wet pomace .............................................. 0.02
Hog, meat ........................................................... 0.1 Banana ............................................................... 0.1
Hog, meat byproducts ........................................ 0.1 Beet, sugar, dried pulp ....................................... 5.0
Horse, fat ............................................................ 0.1 Beet, sugar, molasses ........................................ 15
Horse, meat ........................................................ 0.1 Beet, sugar, roots ............................................... 1.0
Horse, meat byproducts ..................................... 0.1 Beet, sugar, tops ................................................ 8.0
Milk ..................................................................... 0.1 Cattle, fat ............................................................ 0.3
Sheep, fat ........................................................... 0.1 Cattle, meat ........................................................ 0.05
Sheep meat ........................................................ 0.1 Cattle, meat byproducts ...................................... 0.05
Sheep meat byproducts ...................................... 0.1 Cherry, sweet ..................................................... 1.0
Cherry, tart .......................................................... 1.0
(b) Section 18 emergency exemptions. Citrus, dried pulp ................................................ 5.0
[Reserved] Citrus, oil ............................................................. 20
(c) Tolerances with regional registra- Corn, field, forage ............................................... 8.0
tions. [Reserved]
Corn, field, grain ................................................. 0.05
Corn, field, refined oil .......................................... 0.25
(d) Indirect or inadvertent residues. Corn, field, stover ............................................... 8.0
[Reserved] Corn, sweet, forage ............................................ 8.0
Corn, sweet, kernel plus cob with husk removed 0.05
[72 FR 28888, May 23, 2007, as amended at 73 Corn, sweet, stover ............................................. 8.0
FR 5109, Jan. 29, 2008] Cotton, undelinted seed ...................................... 0.2
Cranberry ............................................................ 1.0
§ 180.341 2,4-Dinitro-6-octylphenyl cro- Cucumber ........................................................... 0.05
tonate and 2,6-dinitro-4-octylphenyl Egg ..................................................................... 0.01
crotonate; tolerances for residues. Fig ....................................................................... 0.01
(a) General. Tolerances are estab- Fruit, citrus, group 10 ..........................................
Goat, fat ...............................................................
1.0
0.2
lished for combined negligible residues Goat, meat ........................................................... 0.05
of a fungicide and insecticide that is a Goat, meat byproducts ....................................... 0.05
mixture of 2,4-dinitro-6-octylphenyl Hazelnut .............................................................. 0.2
crotonate and 2,6-dinitro-4-octylphenyl
Hog, fat ............................................................... 0.2
Hog, meat ........................................................... 0.05
crotonate in or on raw agricultural Hog, meat byproducts ........................................ 0.05
Horse, fat ............................................................ 0.25
commodities as follows: Horse, meat ........................................................
Horse, meat byproducts .....................................
0.25
0.25
Kiwifruit ............................................................... 2.0
Parts per
Commodity Milk, fat (Reflecting 0.01 ppm in whole milk) ....... 0.25
million
Nectarine ............................................................ 0.05
0.1 Onion, bulb ......................................................... 0.5
Grape1 ................................................................ 0.1 Peach ................................................................. 0.05
1 Peanut ................................................................ 0.2
There are no U.S. registrations on apple and grape as of Peanut, refined oil ............................................... 0.2
October 24, 2002.
Pear .................................................................... 0.05
(b) Section 18 emergency exemptions. Pecan ................................................................. 0.2
[Reserved] Pepper ................................................................
Peppermint, tops ................................................
1.0
0.8
(c) Tolerances with regional registrations. Peppermint, oil .................................................... 8.0
[Reserved] Plum, prune, fresh .............................................. 0.05
Parts per are not to be placed ln exposed areas where
Commodity million dlrect contact wlth food, uten- slls, and food-
Poultry, fat .......................................................... 0.1
contact surfaces would be llkely to occur.
Poultry, meat ...................................................... 0.1 (vl) To assure safe use of the lnsectl- clde, lts
Poultry, meat byproducts ..................................... 0.1 label and labellng shall conform to that
Pumpkin ..............................................................
Radish .................................................................
0.05
2.0
reglstered by the U.S. En- vlronmental
Rutabaga ............................................................ 0.5 Protectlon Agency, and lt shall be used ln
Sheep, fat ........................................................... 0.2 accordance wlth such label and labellng.
Sheep, meat ....................................................... 0.05 (3) A tolerance of 0.1 part per mllllon ls
establlshed for resldues of chlorpyrlfos, per se,
Sheep, meat byproducts ..................................... 0.05
Spearmint, tops .................................................. 0.8
Spearmint, oil ...................................................... 8.0 ln or on food com- modltles (other than those
Sorghum, grain, forage ........................................ 0.5 already covered by a hlgher tolerance as a
result of use on growlng crops) ln food servlce
Sorghum, grain, grain .......................................... 0.5
Sorghum, grain, stover ........................................ 2.0
Soybean, seed .................................................... 0.3 establlshments where food and food products
Strawberry .......................................................... 0.2 are prepared and served, as a result of the
Sunflower, seed...................................................
Sweet potato, roots ............................................
0.1
0.05 appllcatlon of chlorpyrlfos ln
Turnip, roots ....................................................... 1.0 mlcroencapsulated form.
Turnip, tops ......................................................... 0.3 (I) Appllcatlon of a mlcroencap- sulated
Vegetable, brassica, leafy, group 5 .....................
Vegetable, legume, group 6. except soybean ....
1.0
0.05
product shall be llmlted solely to spot and/or
Walnut ................................................................ 0.2 crack and crevlce treatment ln food handllng
Wheat, forage ..................................................... 3.0 establlshments where food and food products
Wheat, grain ....................................................... 0.5 are prepared and served. All treatments shall
be applled ln such a manner as to avold
Wheat, straw ...................................................... 6.0
[65 FR 33711, May 24, 2000, as amended at 67 FR Carrot, roots ........................................................ 7.0
49617, July 31, 2002; 71 FR 74817, Dec. 13, 2006; 73 FR
53739, Sept. 17, 2008; 76 FR 56656, Sept. 14, 2011] (d) Indirect or inadvertent residues.
[Reserved]
§ 180.345 Ethofumesate; tolerances for residues.
(a) General. Tolerances for the combined [63 FR 34828, June 26, 1998, as amended at 71 FR
51516, Aug. 30, 2006; 72 FR 52019, Sept. 12, 2007]
residues of the herbicide ethofumesate (2-
ethoxy-2,3-dihydro-3,3- dimethyl-5- § 180.349 Fenamiphos; tolerances for residues.
benzofuranyl methanesulfonate) and its (a) General. Tolerances are established for
metabolites 2-hydroxy-2,3-dihydro-3,3- residues of the nematicide/in- secticide
dimethyl-5- benzofuranyl methanesulfonate fenamiphos, ethyl 3-methyl-4-
and 2,3- dihydro-3,3-dimethyl-2-oxo-5- (methylthio)phenyl 1-
benzofuranyl methanesulfonate both (methylethyl)phosphoramidate, including its
calculated as parent compound in or on the metabolites and degradates, in or on the
following food commodities: commodities in the following table.
Compliance with the tolerance levels specified
in this paragraph is to be determined by
measuring only the sum of fenamiphos, ethyl
3-methyl-4- (methylthio)phenyl 1-
(methylethyl)phosphoramidate, and its
Parts per
Commodity million
cholinesterase inhibiting metabolites ethyl 3-
Beet, garden, roots ..............................................
Beet, garden, tops ..............................................
0.5
5.0 methyl-4-
Beet, sugar, molasses ......................................... 0.5
Beet, sugar, refined sugar ................................... 0.2
Beet, sugar, roots ............................................... 0.3
Beet, sugar, tops ................................................ 4.0
Cattle, fat ............................................................ 0.05
Cattle, meat ........................................................ 0.05 (methylsulfinyl)phenyl 1-
Cattle, meat byproducts ..................................... 0.05 (methylethyl)phosphoramidate and
ethyl 3-methyl-4-
Garlic .................................................................. 0.25
Goat, fat ............................................................. 0.05
Goat, meat ......................................................... 0.05 (methylsulfonyl)phenyl i-
Goat, meat byproducts ....................................... 0.05 (methylethyl)phosphoramidate, cal-
culated as the stoichiometric equiva-
Grass, straw ....................................................... 1.0
Horse, fat ............................................................ 0.05
Horse, meat ......................................................... 0.05 lent of fenamiphos, in or on the com-
Horse, meat byproducts ..................................... 0.05 modity.
Onion, bulb ......................................................... 0.25
Shallot, bulb ....................................................... 0.25
Parts per
Shallot, fresh leaves ........................................... 0.25 Commodity million
Sheep, fat ........................................................... 0.05
Sheep, meat ....................................................... 0.05 Banana1 ............................................................. 0.1
Sheep, meat byproducts .................................... 0.05
Grape1 ................................................................. 0.1
Grape, raisin1 ......................................................
(b) Section 18 emergency exemptions.
0.3
Pineapple1 .......................................................... 0.3
[Reserved]
(c) Tolerances with regional registration.
1
There are no U.S. registrations as of May 31, 2007.
ethyl-6- methylphenyl)-N-(2-methoxy-1-
0.02
Sheep, meat byproducts, except kidney and liver
methylethyl)acetamide, and its metabolites, 0.04
determined as the derivatives, 2- Sorghum, grain, forage........................................ 1.0
[(2-ethyl-6- Sorghum, grain, grain ..........................................
Sorghum, grain, stover ........................................
0.30
4.0
methylphenyl)amino]-1-propanol and 4- (2- Soybean, forage ................................................. 5.0
ethyl-6-methylphenyl)-2- hydroxy-5- methyl- Soybean, hay ...................................................... 8.0
3-morpholinone, each expressed as the parent Soybean, seed .................................................... 0.20
compound in the following raw agricultural Tomato ................................................................ 0.10
commodities:
Vegetable, foliage of legume, subgroup 7A, except
soybean ......................................................... 15.0
Vegetable, legume, group 6 ................................. 0.30
Pepper, tabasco ................................................. 0.50 Animal feed, nongrass, group 18 ........................ 1.0
Barley, grain ....................................................... 0.10
(d) Indirect or inadvertent residues. (1) Barley, hay .......................................................... 0.50
Tolerances are established for the Indirect or
Barley, straw ....................................................... 0.50
Buckwheat, grain ................................................ 0.10
inadvertent combined residues (free and Millet, forage ....................................................... 0.50
bound) of the herbicide metolachlor, 2- Millet, grain ......................................................... 0.10
chloro-N-(2-ethyl-6- Millet, hay ........................................................... 0.50
methylphenyl)-N-(2-methoxy-1- Millet, straw .........................................................
Oat, forage ...........................................................
0.50
0.50
methylethyl)acetamide, and its metabolites, Oat, grain ............................................................. 0.10
determined as the derivatives, 2-[(2-ethyl-6- Oat, hay ............................................................... 0.50
methylphenyl)amino]-1-propanol and 4- (2- Oat, straw ............................................................ 0.50
ethyl-6-methylphenyl)-2- hydroxy-5- methyl- Rice, grain ..........................................................
Rye, forage .........................................................
0.10
0.50
3-morpholinone, each expressed as the parent Rye, grain ........................................................... 0.10
compound in the following raw agricultural Rye, straw ........................................................... 0.50
commodities: Wheat, forage ...................................................... 0.50
Wheat, grain ........................................................ 0.10
Wheat, hay .......................................................... 0.50
Wheat, straw ........................................................ 0.50
Parts per
Commodity million
[73 FR 53740, Sept. 17, 2008, as amended at 74 FR
Animal feed, nongrass, group 18 ........................ 1.0 48412, Sept. 23, 2009; 75 FR 56903, Sept. 17, 2010; 77
Barley, grain ....................................................... 0.10 FR 48906, Aug. 15, 2012; 77 FR 59127, Sept. 26, 2012;
Barley, hay .......................................................... 0.80 79 FR 17441, Mar. 28, 2014]
Barley, straw ....................................................... 0.80
Buckwheat, grain ................................................ 0.10
§ 180.370 5-Ethoxy-3-(trichloromethyl)- 1,2,4-
Millet, forage........................................................ 0.50
Millet, grain ......................................................... thiadiazole; tolerances for residues.
0.10
Millet, hay ........................................................... 0.80 (a) General. Tolerances are established for
Millet, straw ......................................................... 0.80 residues of the fungicide 5- ethoxy-3-
Oat, forage .......................................................... 0.50 (trichloromethyl)-1,2,4- thiadiazole and its
monoacid metabolite 3-carboxy-5-
Oat, grain ............................................................ 0.10
Oat, hay...............................................................
ethoxy-1,2,4-
0.80
Oat, straw ........................................................... 0.80
Rice, grain .......................................................... 0.10 thiadiazole in or on the following raw
Rye, forage.......................................................... 0.50 agricultural commodities:
Rye, grain ........................................................... 0.10
Rye, straw ........................................................... 0.80
Wheat, forage....................................................... 0.50 Parts per
Wheat, grain ........................................................ Commodity
0.10 million
Wheat, hay .......................................................... 0.80
Wheat, straw ........................................................ 0.80 Barley, grain ....................................................... 0.1
Barley, hay .......................................................... 0.1
(2) Tolerances for are established for the Corn, field, forage................................................. 0.1
indirect or inadvertent residues of S-
Corn, field, grain .................................................. 0.1
Corn, field, stover ................................................ 0.1
metolachlor, including its metabolites and Corn, sweet, forage ............................................. 0.1
degradates, in or on the commodities Corn, sweet, stover ............................................. 0.1
identified in the following table below. Cotton, gin byproducts ........................................ 0.1
Compliance with the tolerance levels specified
Cotton, undelinted seed ...................................... 0.1
Peanut ................................................................ 0.1
in the following table below is to be Peanut, hay ........................................................ 0.1
determined by measuring only the sum of free Safflower, seed .................................................... 0.1
and bound S-metolachlor, S-2-chloro-N-(2- Sorghum, grain, forage ........................................ 0.1
ethyl-6-methylphenyl)-N-(2-methoxy-1- Sorghum, grain, grain...........................................
Tomato .................................................................
0.1
0.15
methylethyl)acetamide, its R- enantiomer, and Vegetable, foliage of legume, group 7.................. 0.1
its metabolites, determined as the derivatives, Vegetable, legume, group 6 ................................. 0.1
2-(2-ethyl-6- methylphenyl)amino-1-propanol Wheat, forage ...................................................... 0.1
and 4- (2-ethyl-6-methylphenyl)-2-hydroxy- Wheat, grain ........................................................
Wheat, straw ........................................................
0.1
2.0
Horse, meat byproducts ..................................... 4.0
Sheep, fat ........................................................... 0.1 Almond, hulls ......................................................
Sheep, meat ....................................................... 0.5 Almond ................................................................. 0.3
Sheep, meat byproducts .................................... 4.0 Apricot .................................................................. 20.0
Bean, dry, seed .................................................. 2.0
(3) A tolerance is established for residues of Bean, forage ....................................................... 90.0
[Reserved]
yl)aminocarbonyl]
benzenesulfonamide) in or on the following
raw agricultural commodities.
[62 FR 44595, Aug. 22, 1997, as amended at 75 FR
Parts per 60245, Sept. 29, 2010]
Commodity million
§ 180.408 Metalaxyl; tolerances for residues.
Cattle, fat ............................................................ 0.3 (a) General. Tolerances are established for
Cattle, meat ........................................................
Cattle, meat byproducts ......................................
0.3
0.3
the combined residues of the fungicide
Goat, fat............................................................... 0.3 metalaxyl [N-(2,6-
Goat, meat ........................................................... 0.3 dmethylphyenyl)-N-(methoxyacetyl) alanine
Goat, meat byproducts ....................................... 0.3 methylester] and its metabolites containing
the 2,6- dimethylaniline moiety, and N-(2-hy-
Grass, forage ....................................................... 11.0
Grass, hay .......................................................... 19.0
Hog, fat ............................................................... 0.3 droxy methyl-6-methylphenyl)-N-
Hog, meat ........................................................... 0.3 (methoxyacetyl)-alanine methyl ester, each
expressed as metalaxyl equivalents, in or on
Hog, meat byproducts ........................................ 0.3
Horse, fat ............................................................ 0.3
Horse, meat ........................................................ 0.3 the following food commodities:
Horse, meat byproducts ..................................... 0.3
Milk ..................................................................... 0.1
Sheep, fat ........................................................... 0.3
Sheep, meat ....................................................... 0.3
Sheep, meat byproducts ..................................... 0.3
Parts per
Commodity million
Parts per
Commodity million
Parts per
Commodity Parts per
million Commodity million
Bean, snap, succulent ........................................ 0.05 Honey .................................................................
Brassica, head and stem, subgroup 5A ................. 0.10 0.02
Cotton, undelinted seed .....................................
Cowpea, forage ..................................................
0.05
0.05 (b) Section 18 emergency exemptions.
Cowpea, hay ....................................................... 0.05 [Reserved]
Cucumber ........................................................... 0.1 (c) Tolerances with regional registrations.
Pea, southern, dry seed ..................................... 0.05 [Reserved]
Pea, southern, succulent seed ............................ 0.05 (d) Indirect and inadvertent residues.
Pea, succulent.....................................................
Pepper ................................................................
0.05
0.05
[Reserved]
[65 FR 33701, May 24, 2000, as amended at 67 FR
Peppermint, tops ................................................ 0.05
49617, July 31, 2002; 73 FR 52616, Sept. 10, 2008]
Pumpkin .............................................................. 0.1
Rhubarb ............................................................. 0.30 § 180.428 Metsulfuron methyl; tolerances for
Rice, grain .......................................................... 0.02 residues.
Rice, straw .......................................................... 0.02 (a) General. (1) Tolerances are established
Soybean ............................................................. 0.05 for the combined residues of the herbicide
Spearmint, tops .................................................. 0.05 metsulfuron methyl (methyl 2-[[[[(4-methoxy-
Squash, summer ................................................ 0.1 6-methyl-1,3,5- triazin- 2-
yl)amino]carbonyl]amino] sulfonyl] benzoate)
Squash, winter .................................................... 0.1
Sugarcane, cane ................................................ 0.05
Sweet potato, roots ............................................ 0.05 and its metabolite methyl 2- [[[[(4-methoxy-6-
Vegetable, cucurbit, group 9 ............................... 0.05 methyl-1-,3,5- triazin- 2-
Vegetable, tuberous and corm, except potato, yl)amino]carbonyl]amino] sulfonyl]- 4-
subgroup 1D ................................................... 0.05
hydroxybenzoate in or on the following raw
material agricultural commodities:
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional registrations.
[Reserved]
(d) Indirect or inadvertent residues.
[Reserved] Commodity Parts per
million
[51 FR 9446, Mar. 19, 1986]
EDITORIAL NOTE: For FEDERAL REGISTER citations Barley, grain ....................................................... 0.1
affecting §180.425, see the List of CFR Sections Barley, hay .......................................................... 20.0
Affected, which appears in the Finding Aids section Barley, straw ....................................................... 0.3
of the printed volume and at www.fdsys.gov. Grass, forage ....................................................... 15.0
Grass, hay ........................................................... 15.0
§ 180.426 2-[4,5-Dihydro-4-methyl-4-(1- Grass, straw ........................................................ 15.0
methylethyl)-5-oxo-1H-imidazol-2- yl]-3- Sorghum, grain, forage ........................................ 0.2
quinoline carboxylic acid; tolerance for Sorghum, grain, grain........................................... 0.1
residues. Sorghum, grain, stover ......................................... 0.2
A tolerance is established for residues of Sugarcane, cane ................................................. 0.05
the herbicide 2-[4,5-dlhydro-4- methyl-4-(1- Wheat, forage ...................................................... 5.0
methylethyl)-5-oxo-1H- imidazol-2-yl]-3- Wheat, grain ........................................................ 0.1
quinoline carboxylic acid, in or on the raw Wheat, hay ..........................................................
Wheat, straw ........................................................
20.0
0.3
agricultural commodity soybean at 0.05 part
per million. (2) Tolerances are established for residues
[51 FR 13309, Apr. 2, 1986] of metsulfuron methyl (methyl- 2[[[[(4-
methoxy- 6-methyl-1,3,5-triazin- 2-
yl)amino]carbonyl]amino] sulfonyl] benzoate)
in or on the following raw agricultural
commodities:
Commodity Parts per (d) Indirect or inadvertent residues.
million [Reserved]
Cattle, fat ............................................................ 0.1 [74 FR 10494, Mar. 11, 2009, as amended at 74 FR
Cattle, kidney....................................................... 0.5 67087, Dec. 18, 2009]
Cattle, meat ........................................................ 0.1
Cattle, meat byproducts ..................................... 0.1 § 180.430 Fenoxaprop-ethyl; tolerances for
Goat, fat .............................................................. 0.1 residues.
(a) General. Tolerances are established for
Goat, kidney ....................................................... 0.5
Goat, meat........................................................... 0.1
Goat, meat byproducts ....................................... 0.1 residues of the herbicide fenoxaprop-ethyl,
Hog, fat ............................................................... 0.1 including its metabolites and degradates, in or
on the commodities in the table in this
Hog, kidney ......................................................... 0.5
Hog, meat ........................................................... 0.1
Hog, meat byproducts ........................................ 0.1 paragraph. Compliance with the tolerance
Horse, fat ............................................................ 0.1 levels specified in this paragraph is to be
Horse, kidney ......................................................
Horse, meat .........................................................
0.5
0.1 determined by measuring only the sum of
Horse, meat byproducts ..................................... 0.1 fenoxaprop-ethyl, (±)-ethyl 2-[4- [(6-chloro-2-
Milk ..................................................................... 0.05 benzoxazolyl)oxy]phenoxy]propanoate, and
Sheep, fat ...........................................................
Sheep, kidney......................................................
0.1
0.5
its metabolites, 2-[4-[(6-chloro-2-
Sheep, meat ....................................................... 0.1 benzoxazolyl)oxy]phenoxy]propanoic acidand
Sheep, meat byproducts .................................... 0.1 6-chloro-2,3-
dihydrobenzoxazol-2-one, calculated as the
(b) Section 18 emergency exemptions. stoichiometric equivalent of fenoxaprop-ethyl,
[Reserved] in or on the commodity.
(c) Tolerances with regional registrations.
[Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
[64 FR 70191, Dec. 16, 1999, as amended at 66 FR
64773, Dec. 14, 2001; 67 FR 51097, Aug. 7, 2002] Commodity Parts per
million
§ 180.429 Chlorimuron ethyl; tolerances for
residues. Barley, grain ....................................................... 0.05
Barley, straw ....................................................... 0.1
(a) General. Tolerances are established for Cattle, fat ............................................................ 0.05
residues of the herbicide chlorimuron ethyl, Cattle, meat byproducts .....................................
Cattle, meat ........................................................
0.05
0.05
including its metabolites and degradates, in or Cotton, undelinted seed ..................................... 0.05
on the commodities in the table below. Goat, fat .............................................................. 0.05
Compliance with the tolerance levels specified Goat, meat byproducts ....................................... 0.05
in the following table is to be determined by
Goat, meat .......................................................... 0.05
Hog, fat ............................................................... 0.05
measuring only chlorimuron ethyl, ethyl 2- Hog, meat byproducts ........................................ 0.05
[[[[(4- chloro-6-methoxypyrimidin- Hog, meat ........................................................... 0.05
2yl)amino]carbonyl]sulfonyl]benzoate] in or
Horse, fat ............................................................ 0.05
Horse, meat byproducts ..................................... 0.05
on the following commodities: Horse, meat ......................................................... 0.05
Milk ..................................................................... 0.02
Peanut ................................................................ 0.05
Peanut, hulls ....................................................... 0.05
Rice, grain .......................................................... 0.05
Sheep, fat ........................................................... 0.05
Sheep, meat byproducts .................................... 0.05
Parts per Sheep, meat ....................................................... 0.05
Commodity Soybean ............................................................. 0.05
million
Wheat, grain ........................................................ 0.05
Berry, low growing, except strawberry, subgroup Wheat, straw ........................................................ 0.50
13-07H ........................................................... 0.02
Corn, field, forage ................................................ 0.5 (b) Section 18 emergency exemptions.
Corn, field, grain .................................................
Corn, field, stover ...............................................
0.01
2.0
Time-limited tolerances are established for
Grain, aspirated fractions ................................... 3.0 residues of the herbicide fenoxaprop-ethyl,
Peanut ................................................................ 0.02 including its metabolites and degradates, in or
Soybean, forage ................................................. 0.45 on the commodities in the table in this
Soybean, hay ......................................................
Soybean, seed ....................................................
1.8
0.05 paragraph in connection with use of
fenoxaprop-ethyl under section 18 emergency
(b) Section 18 emergency exemptions. exemptions granted by EPA. Compliance with
[Reserved] the tolerance levels specified in this paragraph
(c) Tolerances with regional registrations. is to
[Reserved]
be determined by measuring only the sum of and degradates, in or on the commodities in
fenoxaprop-ethyl, (±)-ethyl 2-[4- [(6-chloro-2- the table below from its application in the acid
benzoxazolyl)oxy]phenoxy]propanoate, and form or in the form of its salts. Compliance
its metabolites, 2-[4-[(6-chloro-2- with the tolerance levels specified below is to
benzoxazolyl)oxy]phenoxy]propanoic acidand be determined by measuring only clopyralid,
6-chloro-2,3- (3,6-dichloro-2-pyridinecarboxylic acid), in or
dihydrobenzoxazol-2-one, calculated as the on the following commodities:
stoichiometric equivalent of fenoxaprop-ethyl,
in or on the commodity. The tolerances expire
and are revoked on the dates specified in the Commodity
Parts per
million
table in this paragraph.
Apple ................................................................... 0.05
Asparagus .......................................................... 1.0
Barley, bran ........................................................ 12
Barley, grain ....................................................... 3.0
Expiration/ Barley, hay........................................................... 9.0
Parts per Barley, pearled barley ......................................... 12
Commodity revocation
million date Barley, straw ........................................................ 9.0
Beet, garden, tops .............................................. 3.0
Grass, forage ................................... 0.05 12/31/16 Beet, garden, roots .............................................. 4.0
Grass, hay ...................................... 0.05 12/31/16 Beet, sugar, molasses ......................................... 10
Beet, sugar, roots ............................................... 2.0
(c) Tolerances with regional registra- Beet, sugar, tops ................................................. 3.0
tions. Tolerances with regional reg-
Brassica, head and stem, subgroup 5A ............... 2.0
Brassica, leafy greens, subgroup 5B .................. 5.0
istration, as defined in §180.1(1), are es- Bushberry subgroup 13-07B ............................... 0.50
tablished for residues of the herbicide Canola, meal ...................................................... 6.0
fenoxaprop-ethyl, including its me-
Canola, seed ...................................................... 3.0
Cattle, fat ............................................................ 1.0
tabolites and degradates, in or on the Cattle, liver ........................................................... 3.0
commodities in the table in this para- Cattle, meat ........................................................ 1.0
graph when fenoxaprop-ethyl is used in
Cattle, meat byproducts, except liver ................... 36.0
Corn, field, forage ................................................ 3.0
the states of Oregon, Washington, and Corn, field, grain ................................................. 1.0
Utah. Compliance with the tolerance Corn, field, milled byproducts .............................. 1.5
levels specified in this paragraph is to
Corn, field, stover ................................................ 10.0
Corn, pop, grain ................................................... 1.0
be determined by measuring only the Corn, pop, stover ................................................. 10.0
sum of fenoxaprop-ethyl, (±)-ethyl 2-[4- Corn, sweet, forage ............................................ 7.0
[(6-chloro-2-
Corn, sweet, kernel plus cob with husks re-
moved ............................................................ 1.0
benzoxazolyl)oxy]phenoxy]propanoate, Corn, sweet, stover ............................................. 10.0
and its metabolites, 2-[4-[(6-chloro-2- Cranberry............................................................. 4.0
0.1
benzoxazolyl)oxy]phenoxy]propanoic
Egg .....................................................................
Flax, meal ........................................................... 6.0
acid and 6-chloro-2,3- Fruit, stone, group 12 .......................................... 0.5
dihydrobenzoxazol-2-one, calculated as Goat, fat ............................................................... 1.0
3.0
the stoichiometric equivalent of
Goat, liver ...........................................................
Goat, meat ........................................................... 1.0
fenoxaprop-ethyl, in or on the com- Goat, meat byproducts, except liver ................... 36.0
Grass, forage ....................................................... 500.0
modity Grass, hay .......................................................... 500.0
Hog, fat ............................................................... 0.2
Parts per Hog, meat ........................................................... 0.2
Commodity million Hog, meat byproducts ......................................... 0.2
Hop, dried cones ................................................. 5.0
Grass, hay .......................................................... 0.09 Horse, fat ............................................................ 1.0
Horse, liver ......................................................... 3.0
(d) Indirect or inadvertent residues. Horse, meat ......................................................... 1.0
[Reserved] Horse, meat byproducts, except liver................... 36.0
Milk ..................................................................... 0.2
[63 FR 1377, Jan. 9, 1998, as amended at 63 FR 19837, Oat, forage ........................................................... 9.0
3.0
Apr. 22, 1998; 73 FR 33718, June 13, 2008; 75 FR
Oat, grain .............................................................
Oat, groats/rolled oats ........................................ 12
80346, Dec. 22, 2010; 76 FR 23495, Apr. 27, 2011; 78 Oat, straw ........................................................... 9.0
FR 78748, Dec. 27, 2013; 79 FR 26164, May 7, 2014] Peppermint, tops ................................................. 3.0
Plum, prune, dried .............................................. 1.5
§ 180.431 Clopyralid; tolerances for residues. Poultry, fat .......................................................... 0.2
Poultry, meat ....................................................... 0.2
Poultry, meat byproducts ..................................... 0.2
Rapeseed, forage ............................................... 3.0
Rapeseed, meal .................................................. 6.0
Rapeseed, subgroup 20A, except gold of pleas-
ure .................................................................. 3.0
Parts per lactofen, including its metabolites and
degradates, in or on the commodities in the
Commodity million
Sheep, fat ........................................................... 1.0 table in this paragraph. Compliance with the
Sheep, liver.......................................................... 3.0 tolerance levels specified in this paragraph is
Sheep, meat .......................................................
Sheep, meat byproducts, except liver ..................
1.0
36.0
to be determined by measuring only lactofen,
Spearmint, tops .................................................. 3.0 2-ethoxy-1- methyl-2-oxoethyl 5-[2-
Spinach ............................................................... 5.0 chloro-4-
Strawberry ..........................................................
Swiss chard ........................................................
4.0
3.0
(trifluoromethyl)phenoxy]-2- nitrobenzoate, in
Teff, forage ......................................................... 9.0 or on the commodity.
Teff, grain ........................................................... 3.0
Teff, hay .............................................................. 9.0 Parts per
Teff, straw ............................................................ 9.0 Commodity million
Turnip, greens .................................................... 4.0
Turnip, roots ....................................................... 1.0 Okra ....................................... 0.02
Wheat, bran ........................................................ 12 Vegetables, fruiting, group 08 0.02
Wheat, forage ...................................................... 9.0
Wheat, germ ........................................................ 12
Wheat, grain ....................................................... 3.0 (d) Indirect or inadvertent residues.
Wheat, middling ................................................... 12 [Reserved]
Wheat, shorts ..................................................... 12
Wheat, straw........................................................ 9.0 [69 FR 57216, Sept. 24 , 2004, as amended at 72 FR
33906, June 20, 2007; 76 FR 23496, Apr. 27, 2011]
(b) Section 18 emergency exemptions. § 180.433 Fomesafen; tolerances for residues.
[Reserved]
(c) Tolerances with regional registrations. (a) General. Tolerances are established for
[Reserved] residues of the herbicide fomesafen, including
(d) Indirect or inadvertent residues. its metabolites and degradates, in or on the
[Reserved] following commodities. Compliance with the
[52 FR 10566, Apr. 2, 1987] tolerance levels specified in the following table
EDITORIAL NOTE: For FEDERAL REGISTER citations below is to be determined by measuring only
affecting §180.431, see the List of CFR Sections fomesafen, 5-[2-chloro- 4-
Affected, which appears in the Finding Aids section
of the printed volume and at www.fdsys.gov.
(trifluoromethyl)phenoxy]-N-
(methylsulfonyl)-2-nitrobenzamide, in or on
§ 180.432 Lactofen; tolerances for residues.
the commodity.
(a) General. Tolerances are established for
residues of the herbicide lactofen, including its
metabolites and degradates, in or on the
commodities in the table in this paragraph.
Compliance with the tolerance levels specified
in this paragraph is to be determined by Commodity Parts per
million
measuring only lactofen, 2-ethoxy-1- methyl-
2-oxoethyl 5-[2-chloro-4- Bean, dry .............................................................. 0.05
(trifluoromethyl)phenoxy]-2- nitrobenzoate, in Bean, lima, succulent ........................................... 0.05
or on the commodity. Bean, snap, succulent .......................................... 0.05
Cantaloupe ........................................................... 0.025
Cotton, gin byproducts .......................................... 0.025
Cotton, undelinted seed ........................................ 0.025
Cucumber ............................................................. 0.025
Pea, succulent ...................................................... 0.025
Pepper, bell .......................................................... 0.025
Parts per Pepper, non-bell ................................................... 0.025
Commodity million Potato ................................................................... 0.025
Beans, snap, succulent, except lima bean ......... 0.01 Pumpkin ............................................................... 0.025
Cotton, gin byproducts ........................................ Soybean ............................................................... 0.05
0.02
Cotton, undelinted seed ...................................... 0.01 Soybean, vegetable, succulent ............................. 0.05
Peanut ................................................................ 0.01 Squash, summer .................................................. 0.025
Soybean, seed..................................................... 0.01 Squash, winter....................................................... 0.025
Tomato .................................................................. 0.025
(b) Section 18 emergency exemptions.
[Reserved] (b) Section 18 emergency exemptions.
(c) Tolerances with regional registrations. [Reserved]
Tolerances with regional registration, as (c) Tolerances with regional registrations.
defined in §180.1(l), are established for residues [Reserved]
of the herbicide
Parts per
Commodity million
alpha-cyano-m-
Wheat, bran ........................................................ 5.0
phenoxybenzy1(1R,3S)-3-(2,2- dibromoviny1)-
*There are no U.S. registrations for use of deltamethrin on
starfruit and lychee.
2,2-
dlbromovlnyl)-2,2- (e) Tolerances with regional registrations.
dlmethyleyelopropaneearboxylle acld (S)- [Reserved]
alpha-eyano-3-phenoxybenzyl ester and lts (d) Indirect or inadvertent residues.
major metabolltes, trans deltamethrln (S)- [Reserved]
alpha-eyano-m- [62 FR 63001, Nov. 26, 1997, as amended at 63 FR
phenoxybenzyl-(1R,3R)-3-(2,2- dlbromovlnyl)- 45414, Aug. 26, 1998; 69 FR 62614, Oet. 27, 2004; 74
2,2- FR 46375, Sept. 9, 2009; 76 FR 34885, June 15, 2011]
dlmethyleyelopropaneearboxylate and alpha- § 180.436 Cyfluthrin and the isomer beta-cyfluthrin;
R-deltamethrln[(R)-alpha-eyano- m- tolerances for residues.
phenoxybenzyl-(1R,3R)-3-(2,2- dlbromovlnyl)- (a) General. (1) Toleranees are estab-
2,2- llshed for resldues of the lnseetlelde eyfluthrln
dlmethyleyelopropaneearboxylate] as follows: (eyano(4-fluoro-3-
(I) In or on all food/feed ltems (other than phenoxyphenyl)methyl-3-(2,2-
those eovered by a hlgher toler- anee as a dlehloroethenyl)-2,2dlmethyl- eyelopropane-
result of use on growlng erops) ln food/feed earboxylate; CAS No. 68359-37-5) ln or on
handllng establlsh- ments. the followlng raw agrleultural eommodltles:
(II) The lnseetlelde may be present as a
resldue from applleatlon of deltamethrln ln
food handllng estab- llshments, lneludlng food
servlee, man- ufaeturlng and proeesslng
establlsh- ments, sueh as restaurants,
eafeterlas, supermarkets, bakerles, brewerles, Commodity Parts per
dalrles, meat slaughtering and paeklng plants, million
(iii) To ensure safe use of the insecticide, its Grain, cereal, forage, fodder and hay, group 16, 25
label and labeling shall conform to that forage, except rice ...........................................
registered by EPA, and it shall be used in Grain, cereal, forage, fodder and hay, group 16,
hay, except rice ................................................
6.0
accordance with such label and labeling. Grain, cereal, forage, fodder and hay, group 16, 30
(4) Tolerances are established for residues stover, except rice ............................................ 7.0
of the isomer, beta-cyfluthrin, cyano(4-fluoro- Grain, cereal, forage, fodder and hay, group 16, 1.0
3- phenoxyphenyl)methyl-3-(2,2-
straw, except rice ............................................. 3.5
Grape ..................................................................
dichloroethenyl)-2,2-dimethyl-
12 50
Grape, raisin ....................................................... 0.5
cyclopropanecarboxylate [mixture comprising Grass, forage, fodder and hay, group 17, forage 0.01
the enantiomeric pair (R)- a-cyano-4-fluoro- Grass, forage, fodder and hay, group 17, hay ....
Hog, fat ...............................................................
0.01
3-phenoxybenzyl (1^,3^)-3-(2,2- Hog, meat ...........................................................
20.0
4.0
dichlorovinyl)-2,2- Hog, meat byproducts ........................................ 2.0
dimethylcyclopropanecarboxylate and Hop, dried cones ................................................ 0.05
(S)-a-cyano-4-fluoro-3-phenoxybenzyl
Hop, vines ........................................................... 0.05
Horse, fat ............................................................
(lR,3R)-3-(2,2-dichlorovinyl)-2,2-
2.0
Horse, meat ........................................................ 3.0
dimethylcyclopropanecarboxylate with the Horse, meat byproducts ..................................... 0.2
enantiomeric pair (R)-a-cyano-4- fluoro-3- Lettuce, head .......................................................
Lettuce, leaf .........................................................
5.0
phenoxybenzyl (1^,3R)-3-(2,2- Milk .....................................................................
0.15
7.0
dichlorovinyl)-2,2- Milk, fat ............................................................... 0.01
dimethylcyclopropanecarboxylate and (^)-a- Millet, grain ......................................................... 0.5
cyano-4-fluoro-3-phenoxybenzyl (1R,3^)-3- Mustard greens ...................................................
Nut, tree, group 14 ..............................................
0.15
(2,2-dichlorovinyl)-2,2- Oat, bran.............................................................. 0.15
dimethylcyclopropanecarboxylate], in or on Oat, grain ............................................................. 0.15
the following raw agricultural commodities: Pea and bean, dried shelled, except soybean,
subgroup 6C ....................................................
0.25
0.01
Pea, dry, seed .................................................... 6.0
Pea, southern, succulent .................................... 0.50
Peanut ................................................................ 0.01
Peanut, hay ........................................................ 0.01
Pepper ................................................................ 0.01
Pistachio ............................................................. 0.01
Poultry, fat .......................................................... 1.0
Poultry, meat ...................................................... 0.5
Parts per Poultry, meat byproducts ....................................
Commodity 0.15
million
Radish, roots ...................................................... 2.0
Rye, bran ............................................................ 0.05
Alfalfa .................................................................. 5.0
Rye, grain ........................................................... 0.05
Alfalfa, forage ..................................................... 5.0
Alfalfa, hay ........................................................... 13 Sheep, fat ........................................................... 3.5
Almond, hulls ...................................................... 0.5 Sheep, meat ....................................................... 8.0
Sheep, meat byproducts ..................................... 4.0
Barley, bran ........................................................ 0.5
Barley, grain ....................................................... 0.15 Sorghum, grain, grain ......................................... 0.03
Soybean, forage ................................................. 0.05
Beet, sugar, dried pulp ....................................... 1.0
Soybean, hay ...................................................... 0.20
Beet, sugar, roots ............................................... 0.10
Soybean, seed .................................................... 5.0
Brassica, head and stem, subgroup 5A ............... 2.5
Brassica, leafy greens, subgroup 5B .................. 7.0 Sugarcane, cane ................................................ 0.02
Sugarcane, molasses .........................................
Buckwheat, grain ................................................ 0.15
Sunflower, forage ...............................................
Carrot, roots......................................................... 0.20
Cattle, fat ............................................................ Sunflower, seed ..................................................
2.0
Parts per dimethylcyclopropanecarboxylate and (R)-a-
cyano-3-phenoxybenzyl-(Z)- (1S,3S)-3-(2-
Commodity million
§ 180.447 Imazethapyr; tolerances for residues. Cattle, meat byproducts ..................................... 0.10
(a) General. (1) Tolerances are established Corn, field, forage ................................................ 0.1
for residues of the herbicide imazethapyr, 2-
Corn, field, grain ................................................. 0.1
Corn, field, stover ............................................... 0.1
[4,5-dihydro-4-methyl-4- (1-methylethyl)-5- Crayfish ............................................................... 0.15
oxo- 1H-imidazol-2- yl]-5-ethyl-3-pyridine Goat, meat byproducts ....................................... 0.10
carboxylic acid, Hog, meat byproducts ........................................ 0.10
Horse, meat byproducts ..................................... 0.10
Sheep, meat byproducts .................................... 0.10
(b) Section 18 emergency exemptions. Parts per
[Reserved]
Commodity million
(c) Tolerances with regional registra Fruit, stone, group 12 ......................................... 1.0
tions. Tolerances with regional registration, as Goat, fat............................................................... 0.05
defined in §180.1(l) of this chapter, are Goat, meat byproducts ....................................... 0.5
established for the sum of residues of the Grain, aspirated fractions ................................... 5
herbicide imazethapyr, 2- [4,5-dihydro-4- Hog, fat ............................................................... 0.02
methyl-4-(1- Hog, meat byproducts ........................................ 0.05
methylethyl)-5-oxo-1H-imidazol-2-yl]-5-
Hop, dried cones ................................................ 2.0
Horse, fat ............................................................ 0.05
ethyl- 3-pyridine carboxylic acid, as its Horse, meat byproducts ..................................... 0.5
ammonium salt, and its metabolite, 2- [4,5- Milk ..................................................................... 0.05
dihydro-4-methyl-4-(1- methylethyl)-5-oxo- Nut, tree, group 14 .............................................. 0.30
1H-imidazol-2-yl]-5- (1- hydroxyethyl)-3- Pepper/eggplant subgroup 8-10B ........................ 1.5
pyridine carboxylic acid, both free and Peppermint, tops ................................................
Pistachio .............................................................
2.0
0.30
conjugated, applied as its acid or ammonium Plum, prune, dried .............................................. 1.3
salt, in or on the following raw agricultural Poultry, fat .......................................................... 0.05
commodities: Poultry, meat byproducts ..................................... 0.05
Sheep, fat ........................................................... 0.05
Sheep, meat byproducts ..................................... 0.5
Commodity Parts per Spearmint, tops .................................................. 2.0
million Tomato ................................................................ 0.50
Endive.......... 0.1
Lettuce, head 0.1 (b) Section 18 emergency exemptions. Time-
Lettuce, leaf . 0.1 limited tolerances are established for residues
of hexythiazox, including its metabolites and
(d) Indirect or inadvertent residues. [Reserved] degradates, in connection with use of the
[67 FR 55331, Aug. 29, 2002, as amended at 68 FR pesticide under section 18 emergency
13849, Mar. 21, 2003; 71 FR 6359, Feb. 8, 2006; 76 FR exemptions granted by EPA. Compliance with
34885, June 15, 2011]
the tolerance levels specified below is to be
§ 180.448 Hexythiazox; tolerance for residues. determined by measuring only hexythiazox
(a) General. Tolerances are established for and its metabolites containing the (4-
residues of hexythiazox, including its chlorophenyl)-4-methyl- 2-oxo-3-thiazolidine
metabolites and degradates, in or on the moiety, calculated as the stoichiometric
commodities in the table below. Compliance equivalent of hexythiazox. These tolerances will
with the tolerance levels specified below is to expire and are revoked on the dates specified
be determined by measuring only hexythiazox in the following table:
and its metabolites containing the (4-
chlorophenyl)-4-methyl-2-oxo-3- thiazolidine
moiety, calculated as the stoichiometric
equivalent of hexythiazox. Parts per Expiration/
Commodity revocation
million date
Alfalfa, forage (EPA Regions 9-11 only) .............. 15 Citrus ................................................................. 0.02
Alfalfa, hay (EPA Regions 9-11 only) ................... 30 Cotton, gin byproducts ...................................... 1.0
Bean, dried, seed (EPA Regions 7-12 only) ....... 0.4 Cotton, undelinted seed .................................... 0.02
Bean, succulent (EPA Regions 7-12 only) .......... 0.3 Food products in food handling establishments
Corn, field, forage ................................................ 6.0 (other than those already covered by higher
Corn, field, grain ................................................. 0.02 tolerances as a result of use on growing
Corn, field, stover ............................................... 2.5 crops, and other than those already covered
Corn, sweet, forage (EPA Regions 7-12 only) ... 4.0 by tolerances on milk, meat, and meat by-
Corn, sweet, kernel plus cob with husks re- products) ....................................................... 0.01
moved (EPA Regions 7-12 only) ..................... 0.1 Fruit, stone, group 12 ....................................... 0.09
Cotton, gin byproducts, CA and AZ only ............ 3.0 Goat, fat ............................................................. 0.01
Cotton, undelinted seed, CA and AZ only .......... 0.20 Goat, meat ......................................................... 0.02
Fruit, citrus group 10 (CA, AZ, TX only) ............. 0.35 Goat, meat byproducts ...................................... 0.02
Potato ................................................................. 0.02 Grape ................................................................ 0.02
Sorghum, grain, forage (EPA Regions 6-8 only) 5 Herb subgroup 19A, except chive ..................... 0.030
Sorghum, grain, grain (EPA Regions 6-8 only) .. 3 Hog, fat ............................................................ 0.01
Sorghum, grain, stover (EPA Regions 6-8 only) 6 Hog, meat ........................................................ 0.02
Timothy, forage (EPA Regions 9-11 only) .......... 40
Hog, meat byproducts ...................................... 0.02
Timothy, hay (EPA Regions 9-11 only) ............... 40
Hop, dried cones .............................................. 0.20
Horse, fat ......................................................... 0.01
(d) Indirect or inadvertent residues. [Reserved] Horse, meat ...................................................... 0.02
[54 FR 17948, Apr. 26, 1989] Horse, meat byproducts ...................................
Milk ...................................................................
0.02
0.005
EDITORIAL NOTE: For FEDERAL REGISTER citations Nut, tree, group 14 ........................................... 0.01
affecting §180.448, see the List of CFR Sections Onion, bulb, subgroup 3-07A ............................ 0.01
Affected, which appears in the Finding Aids section Pear ................................................................. 0.02
of the printed volume and at www.fdsys.gov. Peppermint, tops .............................................. 0.010
Pistachio .......................................................... 0.01
§ 180.449 Avermectin Bi and its delta- 8,9-isomer;
Plum, prune, dried ............................................ 0.025
tolerances for residues. Poultry, meat .................................................... 0.02
(a) General. Tolerances are established for Poultry, meat byproducts ................................. 0.02
residues of abamectin, including its Sheep, fat .......................................................... 0.01
metabolites and degradates, in or on the
Sheep, meat ...................................................... 0.02
Sheep, meat byproducts ................................... 0.02
commodities in the following table. Spearmint, tops ................................................. 0.010
Compliance with the tolerance levels specified Strawberry ......................................................... 0.05
in the following table is to be determined by Vegetable, cucurbit, group 9 ............................. 0.005
measuring only avermectin B1 a mixture of
Vegetable, fruiting, group 8 ................................ 0.020
Vegetable, leafy, except brassica, group 4 ....... 0.10
avermectins containing greater than or equal Vegetable, tuberous and corm, subgroup 01C 0.01
to 80% avermectin B1 a (5-0- demethyl
avermectin A1) and less than or equal to 20% (b) Section 18 emergency exemptions.
avermectin B1b (5-0- demethyl-25-de(1- [Reserved]
methylpropyl)-25-(1- methylethyl) avermectin (c) Tolerances with regional registrations.
A1) and its delta-8,9-isomer in or on the [Reserved]
following commodities: (d) Indirect or inadvertent residues. [Reserved]
[62 FR 44095, Aug. 19, 1997]
EDITORIAL NOTE: For FEDERAL REGISTER citations
affecting §180.449, see the List of CFR Sections
Affected, which appears in the Finding Aids section
of the printed volume and at www.fdsys.gov.
§ 180.450 Beta-(4-Chlorophenoxy)- alpha-(1,1-
Parts per dimethylethyl)-1H-1,2,4- triazole-1-ethanol;
Commodity million tolerances for residues.
Almond, hulls ..................................................... 0.10 (a) General. Tolerances are established for
Apple ................................................................. 0.020 the combined residues of the fungicide
Apple, wet pomace ............................................ 0.10 b-(4-chlorophenoxy)-a-(1,1-
Avocado ............................................................
Bean, dry, seed ................................................
0.020
0.01
dimethylethyl)-1_ff-1,2,4-triazole-1-eth- anol
Cattle, fat .......................................................... 0.03 (triadimenol) and its butanediol metabolite,
Cattle, meat ...................................................... 0.02 4-(4-chlorophenoxy)-2,2-di- methyl-4-(1_ff-
Cattle, meat byproducts ...................................
Celeriac, roots ..................................................
0.06
0.05
1,2,4-triazol-l-yl)-1,3-
Celeriac, tops ................................................... 0.05
Chive, dried leaves ........................................... 0.02
Chive, fresh leaves ........................................... 0.01
Citrus, dried pulp .............................................. 0.10
Citrus, oil .......................................................... 0.10
butanediol, calculated as triadimenol, in or on Parts per
the following commodities: Commodity million
the tolerance levels specified in this paragraph (b) Section 18 emergency exemptions. Time-
is to be determined by measuring only limited tolerances are established for residues
quinclorac, 3,7-dichloro-8- of the herbicide quinclorac, including its
quinolinecarboxylic acid, in or on the metabolites and degradates, in or on the
commodity. commodity in the table in this paragraph.
Compliance with the tolerance level specified
in this paragraph is to be determined by
measuring only quinclorac, 3,7-dichloro-8-
Commodity Parts per
million
quinolinecarboxylic acid, in or on the
commodity. The tolerance expires and is
Barley, grain ..................................................... 2.0 revoked on the date specified in the table in
Berry, low growing, except strawberry, sub-
group 13-07H ................................................ 1.5
this paragraph.
Cattle, fat .......................................................... 0.7
Cattle, meat byproducts ................................... 1.5
Cattle, meat ...................................................... 0.05
Egg ................................................................... 0.05
Parts per Expiration/
Goat, fat ............................................................ 0.7 Commodity revocation
Goat, meat byproducts ..................................... 1.5 million
date
Goat, meat......................................................... 0.05
Grain, aspirated fractions ................................. 1200 Cranberry ....................................... 15.0 12/31/12
Grass, forage..................................................... 150
Grass, hay ........................................................
Hog, fat .............................................................
130
0.7 (c) Tolerances with regional registrations.
Hog, meat byproducts ...................................... 1.5 [Reserved]
Hog, meat ......................................................... 0.05 (d) Indirect or inadvertent residues. [Reserved]
Horse, fat .......................................................... 0.7
Horse, meat byproducts ................................... 1.5 [57 FR 47996, Oct. 21, 1992, as amended at 64 FR
Horse, meat ....................................................... 0.05 6548 , 6549, Feb. 10, 1999; 64 FR 14632, Mar. 26, 1999;
Milk ................................................................... 0.05 65 FR 33701, May 24, 2000; 67 FR 35049, May 17,
Poultry, fat ........................................................ 0.05 2002; 72 FR 55073, Sept. 28, 2007; 74 FR 51490, Oct.
Poultry, meat byproducts ...................................
Poultry, meat ....................................................
0.1
0.05
7, 2009; 74 FR 67090, Dec. 18, 2009; 76 FR 23497,
Rhubarb ........................................................... 0.5 Apr. 27, 2011; 77 FR 75566, Dec. 21, 2012; 78 FR 71528,
Rice, bran ......................................................... 15.0 Nov. 29, 2013]
Rice, grain ........................................................ 5.0 § 180.464 Dimethenamid; tolerances for residues.
Rice, straw......................................................... 12.0
Sheep, fat ......................................................... 0.7 (a) General. Tolerances are established for
Sheep, meat byproducts .................................. 1.5 residues of the herbicide dimethenamid,
1(R,S)-2-chloro-N-[(1-
Sheep, meat ..................................................... 0.05
Sorghum, grain, forage ...................................... 3.0
Sorghum, grain, grain ........................................ 6.0 methyl-2-methoxy)ethyl]-N-(2,4-
Sorghum, grain, stover ...................................... 1.0 dimethylthien-3-yl)-acetamide, applied as
Wheat, forage ....................................................
Wheat, germ ......................................................
1.0
0.75 either the 90:10 or 50:50 S:R isomers, in or on
Wheat, grain ..................................................... 0.5 the following food commodities:
Wheat, hay ....................................................... 0.5
Wheat, straw ..................................................... 0.1
Corn, field, forage .............................................. 0.05 Sorghum, grain, forage ...................................... 1.6
Corn, field, grain ............................................... 0.05 Sorghum, grain, grain ........................................ 0.05
Corn, field, stover ............................................. 0.05 Sorghum, grain, stover ...................................... 1.7
Corn, pop, grain ................................................. 0.05 Soybean, meal .................................................. 1.2
Corn, pop, stover ............................................... 0.05 Soybean, seed .................................................. 1.0
Corn, sweet, forage .......................................... 0.05
Corn, sweet, kernel plus cob with husks removed (b) Section 18 emergency
0.05
exemptions.
[Reserved]
......................................................................
Corn, sweet, stover ........................................... 0.05
(c) Tolerances with regional registrations.
(b) Section 18 emergency exemptions. [Reserved]
[Reserved] (d) Indirect or inadvertent residues. Tolerances
(c) Tolerances with regional registrations. are established for indirect or inadvertent
[Reserved] residues of acetochlor, including its
(d) Indirect or inadvertent residues. [Reserved] metabolites and degradates, in or on the raw
[65 FR 16149, Mar. 27, 2000, as amended at 67 FR agricultural commodities in the table to this
51105, Aug. 7, 2002; 69 FR 58290, Sept. 30, 2004; 70 paragraph when present therein as a result of
FR 76699, Dec. 28, 2005; 74 FR 37623, July 29, 2009; application of acetochlor to the growing crops
76 FR 16310, Mar. 23, 2011] in the table to paragraph (a) of this section.
§ 180.470 Acetochlor; tolerances for residues. Compliance with the tolerance levels specified
(a) General. Tolerances are established for below is to be determined by measuring only
residues of acetochlor, including its acetochlor, 2-chloro-2’-methyl-6- ethyl-N-
metabolites and degradates, in or on the ethoxymethylacetanilide, and its metabolites
commodities in the table below. Compliance containing the ethyl methyl aniline (EMA)
with the tolerance levels specified below is to moiety and the hydroxyethyl methyl aniline
be determined by measuring only acetochlor, (HEMA) moiety. Both parent and the named
2- chloro-2’-methyl-6-ethyl-A- metabolites shall be determined as ethyl
ethoxymethylacetanilide, and its metabolites methyl aniline (EMA) and hy- droxyethyl
containing the ethyl methyl aniline (EMA) methyl aniline (HEMA), and calculated as the
moiety and the hydroxy- ethyl methyl aniline stoichiometric equivalents of acetochlor, in or
(HEMA) moiety. Both parent and the named on the following commodities.
metabolites shall be determined as ethyl
methyl aniline (EMA) and hydroxy- ethyl
methyl aniline (HEMA), and calculated as the
stoichiometric equivalents of acetochlor, in or
on the following commodities:
Parts per
Commodity
million
(2) Tolerances are established for residues stoichiometric equivalent of the parent
of difenoconazole, including its metabolites compound.
and degradates, in the commodities in the
table below. Compliance with the tolerance
levels specified below is to be determined by
measuring the sum of difenoconazole, 1-[2-
[2-chloro-4-(4-chlorophenoxy)phenyl]-4-
methyl-1,3-dioxolan-2-ylmethyl]-1.ff-
1,2,4- triazole, and its Commodity Parts per
metabolite, CGA- 205375, 1-[2-chloro-4-
million
Parts per
Commodity million
Parts per
Parts per Commodity
Commodity million
million
Wheat, bran ......................................................... 0.20
Cattle, fat .......................................................... 0.10 Wheat, forage....................................................... 2.5
Cattle, kidney .................................................... 1.00 Wheat, grain ........................................................ 0.05
Cattle, liver ........................................................ 2.00 Wheat, hay .......................................................... 1.2
Cattle, meat byproducts ................................... 0.05 Wheat, straw ....................................................... 0.20
Cattle, meat ...................................................... 0.05
Cotton, gin byproducts ..................................... 0.20
Cotton, undelinted seed ................................... 0.20 [60 FR 42458, Aug. 16, 1995, as amended at 61 FR
Egg ................................................................... 0.05 33044, June 26, 1996; 63 FR 42256, 42257, Aug. 7,
Goat, fat ............................................................ 0.10 1998; 66 FR 10825, Feb. 20, 2001; 71 FR 74818, Dec.
Goat, kidney ..................................................... 1.00 13, 2006; 72 FR 35665, June 29, 2007; 73 FR 33017,
Goat, liver ......................................................... 2.00 June 11, 2008; 75 FR 17570, Apr. 7, 2010; 75 FR 80350,
Goat, meat byproducts .....................................
Goat, meat ........................................................
0.05
0.05
Dec. 22, 2010]
Hog, fat ............................................................. 0.10 § 180.485 Cyproconazole; tolerances for residues.
(a) General. (1) Tolerances are established
Hog, kidney ....................................................... 1.00
Hog, liver .......................................................... 2.00
Hog, meat byproducts ...................................... 0.05 for residues of the free and conjugated forms
Hog, meat ......................................................... 0.05 of the fungicide cyproconazole, including its
Horse, fat .......................................................... 0.10
metabolites and degradates, in or on the
commodities in the table below. Compliance
Horse, kidney .................................................... 1.00
Horse, liver ....................................................... 2.00
Horse, meat byproducts ................................... 0.05 with the proposed tolerance levels specified
Horse, meat ....................................................... 0.05 below is to be determined by measuring only
Milk ...................................................................
Peanut ..............................................................
0.05
0.5 cyproconazole (a-(4- chlorophenyl)-a-(1-
Peanut, hay ...................................................... 15.0 cyclopropylethyl)- 1#-1,2,4-triazole-1-ethanol)
Peanut, meal .................................................... 1.0 in or on the following commodities:
Potato ............................................................... 0.20
Potato, wet peel ................................................ 0.30
Poultry, fat ........................................................ 0.05
Poultry, meat .................................................... 0.05
Poultry, meat byproducts................................... 0.05
Rice, bran ......................................................... 10.0
Rice, grain ........................................................ 7.0 Parts per
Commodity
Rice, hulls ......................................................... 25.0 million
Rice, straw ........................................................ 10.0
Sheep, fat ......................................................... 0.10 Aspirated grain fractions .................................... 2.5
Sheep, kidney ................................................... 1.00 Cattle, fat ........................................................... 0.01
Sheep, liver ....................................................... 2.00 Cattle, meat byproducts (except liver) ............... 0.01
Sheep, meat ..................................................... 0.05 Coffee bean, green (Imported)1 ........................ 0.1
Sheep, meat byproducts .................................. 0.05 Corn, field, forage .............................................. 0.60
Corn, field, grain ................................................ 0.01
Soybean, forage ............................................... 8.0
Corn, field, stover .............................................. 1.2
Soybean, hay .................................................... 2.5
Goat, fat ............................................................ 0.01
Soybean, seed .................................................. 0.20 Goat, meat byproducts (except liver) ................ 0.01
Turnip, greens .................................................. 0.1 Horse, fat ......................................................... 0.01
Vegetable, brassica, leafy, group 5 .................... 0.1 Horse, meat byproducts (except liver) .............. 0.01
Peanut .............................................................. 0.01
(b) Section 18 emergency exemptions. Peanut, hay ...................................................... 6.0
[Reserved] Sheep, fat .......................................................... 0.01
(c) Tolerances with regional registrations. Sheep, meat byproducts (except liver) .............. 0.01
[Reserved]
Soybean, forage ................................................ 1.0
Soybean, hay .................................................... 3.0
Parts per
Commodity million
(3) Tolerances are established for the (b) Section 18 emergency exemptions.
combined residues of the free and conjugated [Reserved]
forms of the fungicide cyproconazole, (c) Tolerances with regional registrations.
including its metabolites and degradates, in or [Reserved]
on the commodities in the table below. (d) Indirect or inadvertent residues. [Reserved]
Compliance with the tolerance level specified [76 FR 23498, Apr. 27, 2011]
below is to be determined by measuring only
the sum of cyproconazole (a-(4-
chlorophenyl)-a-(1-cyclopropylethyl)- 1H- § 180.487 Pyrithiobac sodium; tolerances for
1,2,4-triazole-1-ethanol) and its metabolite residues.
2-(4-chlorophenyl)-3-
(a) General. Tolerances are established for
cyclopropyl-1-[1,2,4]triazol-1-yl-butane- 2,3-
residues of the herbicide, pyrithiobac sodium,
diol, calculated as the stoichiometric
(sodium 2-chloro- 6-[(4,6-
equivalent of cyproconazole, in or on the
dimethoxypyrimidin-2- yl)thio]benzoate),
following commodities:
resulting from the application of the pesticide
chemical in or on the following foods/feeds:
Parts per
Commodity million
Parts per
Cattle, liver ........................................................ 0.50 Commodity million
Goat, liver ......................................................... 0.50
Hog, liver .......................................................... 0.01 Cotton, gin byproducts . 0.15
Horse, liver ....................................................... 0.50 0.02
Sheep, liver ....................................................... 0.50 Cotton, undelinted seed
[62 FR 54783, Oct. 22, 1997, as amended at 64 FR Goat, fat ............................................................ 0.1
56469, Oct. 20, 1999; 67 FR 72110, Dec. 4, 2002] Goat, kidney ......................................................
Goat, meat byproducts, except kidney ..............
1.0
0.1
Goat, meat ........................................................ 0.1
§ 180.490 Imazapic; tolerances for residues. Horse, fat ......................................................... 0.1
(a) General. (1) Tolerances are established Horse, kidney .................................................... 1.0
for residues of the herbicide imazapic, Horse, meat byproducts, except kidney ...........
Horse, meat ......................................................
0.1
0.1
including its metabolites and degradates, in Milk ................................................................... 0.1
or on the commodities listed in the following Sheep, fat .......................................................... 0.1
table. Compliance with the tolerance levels Sheep, kidney ................................................... 1.0
specified is to be determined by measuring
Sheep, meat byproducts, except kidney ........... 0.1
Sheep, meat ...................................................... 0.1
the sum of imazapic (2-[4,5-dihydro-4-meth-
yl-4-(1-methylethyl)-5-oxo-1#-imidazol- 2-yl]- (b) Section 18 emergency exemptions.
5-methyl-3-pyridinecarboxylic acid) and its [Reserved]
metabolites (±)-2-[4,5- dihydro-4-methyl-4- (c) Tolerances with regional registrations.
(1-methylethyl)-5- oxo-1H-imidazol-2-yl]-5- [Reserved]
hydroxymethyl-3-pyridinecarboxylic acid and (d) Indirect or inadvertent residues. [Reserved]
(±)-2-[4,5-dihydro-4-methyl-4- (1- [64 FR 54224, Oct. 6, 1999, as amended at 66 FR
methylethyl)-5-oxo-1H-imidazol-2- yl]-5-(b- 64774, Dec. 14, 2001; 66 FR 66332, Dec. 26, 2001; 78
D-glucopyranosyloxy)methyl-3- FR 49932, Aug. 16, 2013; 79 FR 18818, Apr. 4, 2014; 79
pyridinecarboxylic acid, calculated as the FR 32170, June 4, 2014]
stoichiometric equivalent of imazapic. § 180.491 Propylene oxide; tolerances for residues.
(a) General. (1) Tolerances are established
for residues of the fumigant propylene oxide,
including its metabolites and degradates, in or
on the commodities in the table in this
paragraph. Compliance with the tolerance
levels specified in this paragraph is to be
Commodity Parts per
million determined by measuring only propylene
oxide, when used as a postharvest fumigant, in
Grass, forage ....................................................
Grass, hay ........................................................
15
30
or on the commodity.
Peanut .............................................................. 0.1
Soybean, seed1 ................................................ 0.40
Sugarcane, cane2 ............................................. 0.03
1
There are no US registrations as of April 4, 2014.
2
There are no U.S. registrations as of June 4, 2014.
acid, calculated as the stoichiometric (2) Tolerances are established for residues
equivalent of of the reaction product, propylene
imazapic. chlorohydrin, including its metabolites and
degradates, in or on the commodities in the
table in this paragraph. Compliance with the
Commodity Parts per
million tolerance levels specified in this paragraph is
to be determined by measuring only the sum
Cattle, fat .......................................................... 0.10 of propylene chlorohydrin (1- chloro-2-
Cattle, kidney ....................................................
Cattle, meat byproducts, except kidney.............
1.0
0.1
propanol), and its isomer 2-
Cattle, meat ...................................................... 0.1
chloro-1-propanol, calculated as the
stoichiometric equivalent of propylene
chlorohydrln (1-chloro-2-propanol), that [67 FR 40196, June 12, 2002, as amended at 76 FR
results from the use of propylene oxide as a 22625, Apr. 22, 2011]
postharvest fumigant, in or on the commodity.
§ 180.493 Dimethomorph; tolerances for residues.
(a) General. Tolerances are established for
the residues of the fungicide dimethomorph,
Parts per
Commodity million
(E,Z) 4-[3-(4-
Basil, dried leaves .............................................. 6000 chlorophenyl)-3-(3,4-dimethoxyphenyl)- 1-
Cacao bean, cocoa powder ................................
Cacao bean, dried bean ......................................
20.0
20.0
oxo-2-propenyl]morpholine, in or on the
Fig ....................................................................... 3.0 following commodities:
Garlic, dried ........................................................ 6000
Grape, raisin ....................................................... 4.0
Herbs and spices, group 19, dried, except basil 1500 Parts per
Nut, pine ............................................................. Commodity
10.0 million
Nut, tree, group 14 ............................................. 10.0
Nutmeat, processed, except peanuts .................. 10.0 Brassica, head and stem, subgroup 5A ............ 6.0
Onion, dried ........................................................ 6000 Brassica, leafy greens, subgroup 5B ................ 30.0
Pistachio ............................................................. 10.0 Ginseng ............................................................. 0.90
Grape ................................................................. 3.0
Plum, prune, dried .............................................. 2.0
Grape, raisin ...................................................... 7.0
(b) Section 18 emergency exemptions. Hop, dried cones ..............................................
Lettuce, head ....................................................
60
10
[Reserved] Lettuce, leaf....................................................... 10
(c) Tolerances with regional registrations. Onion, bulb, subgroup 3-07A ............................ 0.6
[Reserved] Onion, green, subgroup 3-07B ..........................
Potato ...............................................................
15.0
0.05
(d) Indirect or inadvertent residues. [Reserved] Potato, wet peel ................................................ 0.20
[65 FR 33702, May 24, 2000, as amended at 68 FR Taro, corm ......................................................... 0.5
Taro, leaves ....................................................... 6.0
39430, July 1, 2003; 72 FR 49651, Aug. 29, 2007; 73 Turnip, greens ................................................... 20.0
FR 54963, Sept. 24 , 2008; 76 FR 38037, June 29, 2011; Vegetable, cucurbit, group 9 ............................. 0.5
77 FR 28495, May 15, 2012] Vegetable, fruiting, group 8 ................................ 1.5
§ 180.492 Triflusulfuron-methyl; tolerances for Vegetable, leafy (except Brassica) group 4 ....... 30.0
residues.
(b) Section 18 emergency exemptions.
(a) General. Tolerances are established for [Reserved]
residues of triflusulfuron- methyl, including its (c) Tolerances with regional registrations.
metabolites and degradates, in or on the Tolerances with regional registrations are
commodities listed in the table below. established for residues of the fungicide
Compliance with the tolerance levels specified dimethomorph, (E,Z) 4- [3-(4-chlorophenyl)-3-
below is to be determined by measuring only (3,4- dimethoxyphenyl)-1-oxo-2-pro-
triflusulfuron-methyl (methyl 2- [[[[[4- penyl]morpholine, in or on the following
(dimethylamino)-6-(2,2,2- trifluoroethoxy)- commodities:
1,3,5-triazin-2-
yl]amino]carbonyl]amino]sulfonyl]-3-
methylbenzoate) in or on the following Parts per
commodities: Commodity million
Beet, garden, roots ............................................ 0.01 Compliance with the following tolerance levels
Beet, garden, tops ............................................ 0.02 specified in the following table is to be
Beet, sugar, roots .............................................
Beet, sugar, tops ..............................................
0.05
0.05
determined by measuring only dimethomorph
Chicory, roots ................................................... 0.05 (E,Z)-4-[3-(4- chlorophenyl)-3-(3,4-
dimethoxyphenyl)acryloyl]morpholine
(b) Section 18 emergency exemptions. calculated in or on the following commodities:
[Reserved]
(c) Tolerances with regional registrations.
[Reserved]
Parts per Parts per Revoca-
Commodity Commodity
million million tion/expira-
tion date
Wheat, forage ...................................................... 0.15
Wheat, hay ......................................................... 0.15 Strawberry ....................................... 2.5 None
Wheat, straw........................................................ 0.4 Tomato ............................................ 0.15 None
Expiration/
Parts per
Commodity revocation
million date
Expiration/
Parts per
Commodity revocation
million date Grain, cereal, forage, fodder and straw,
group 16, except rice, sweet corn,
Cattle, fat ........................................ 0.04 7/14/12 wheat, and wild rice; forage......... 4.0 7/14/12
Cattle, kidney................................... 10.0 7/14/12 Grain, cereal, forage, fodder and straw,
Cattle, meat .................................... 0.15 7/14/12 group 16, except rice, sweet corn,
Cattle, meat byproducts, except kid- wheat, and wild rice; hay ............
ney .............................................. 0.5 7/14/12 15.0 7/14/12
Egg ................................................. 1.0 7/14/12
Grain, cereal, forage, fodder and straw,
Goat, fat........................................... 0.04 7/14/12
group 16, except rice, sweet corn,
Goat, kidney ................................... 10.0 7/14/12
wheat, and wild rice; stover ........
Goat, meat....................................... 0.15 7/14/12
1.0 7/14/12
Goat, meat byproducts, except kid-
ney .............................................. 0.5 7/14/12
Hog, fat ............................................ 0.04 7/14/12 Grain, cereal, forage, fodder and straw,
Hog, kidney .................................... 10.0 7/14/12 group 16, except rice, sweet corn,
0.15 7/14/12 wheat, and wild rice; straw ......... 4.0 7/14/12
Hog, meat ........................................
Hog, meat byproducts, except kid- Grain, cereal group 15, except rice, sweet
ney .............................................. 0.5 7/14/12 corn, wheat, and wild rice 20.0 7/14/12
Horse, fat ......................................... 0.04 7/14/12 Soybean .......................................... 30.0 7/14/12
Horse, kidney ................................. 10.0 7/14/12 Soybean, forage .............................. 10.0 7/14/12
Horse, meat ..................................... 0.15 7/14/12 Soybean, hay .................................. 7/14/12
10.0
Horse, meat byproducts, except kid-
ney .............................................. 0.5 7/14/12
Milk ................................................. 0.02 7/14/12 [76 FR 56656, Sept. 14, 2011]
Poultry, fat ...................................... 0.04 7/14/12
Poultry, meat .................................. 0.15 7/14/12
§ 180.498 Sulfentrazone; tolerances for residues. Parts per
(a) (1) General. Tolerances are
Commodity million
established for the combined residues of the Melon, subgroup 9A ......................................... 0.15
free and conjugated forms of sulfentrazone, Nut, tree, group 14 ........................................... 0.15
including its metabolites and degradates, in or Pea and bean, dried shelled, except soybean,
on the commodities in the table below. subgroup 6C .................................................. 0.15
dihydro-3-methyl-5-oxo-1H-1,2,4-triazol- 1- 2.0
Grain, cereal (excluding sweet corn), Hulls ...... 0.30 Bean, lima, succulent ......................................... 2.0
Grain, cereal, forage, fodder and straw, group
16, except sweet corn; forage ......................
Grain, cereal, forage, fodder and straw, group
0.2 (d) Indirect or inadvertent residues.
16, except sweet corn; hay ............................ 0.2
[Reserved]
Grain, cereal, forage, fodder and straw, group
[62 FR 15620, Apr. 2, 1997, as amended at 62 FR
26966, May 16, 1997; 63 FR 32136, June 12,
16, except sweet corn; stover ........................ 0.1
Grain, cereal, forage, fodder and straw, group
16, except sweet corn; straw ......................... 0.6
1998; 64 FR 16843, Apr. 7, 1999; 65 FR 58399, Sept.
Grain, cereal, group 15, except sweet corn .......
29, 2000; 66 FR 37598, July 19, 2001; 66 FR 48585,
Grain, cereal, group 15, except sweet corn;
0.1 Sept. 21, 2001; 67 FR 35049, May 17, 2002; 69 FR
bran ............................................................... 0.15 47022, Aug. 4 , 2004 ; 70 FR 7047, Feb. 10, 2005; 78
FR 33736, June 5, 2013]
[62 FR 10708, Mar. 10, 1997]
§ 180.500 Imazapyr; tolerances for residues.
EDITORIAL NOTE: For FEDERAL REGISTER citations
affecting §180.498, see the List of CFR Sections (a) General. Tolerances are established for
Affected, which appears in the Finding Aids section residues of the herbicide, imazapyr, including
of the printed volume and at www.fdsys.gov. its metabolites and degradates, in or on the
commodities in the following table.
Compliance with the tolerance levels specified
§ 180.499 Propamocarb; tolerances for residues. in the following table is to be determined by
(a) General. Tolerances are established for measuring only the residues of imazapyr [2-
the residues of propamocarb, including its [4,5-dihydro-4-methyl-4-(1- methylethyl)-5-
metabolites and degradates, in or on the oxo-1H-imidazol-2-yl]-3- pyridinecarboxylic
commodities specified in the following table acid].
resulting from the application of the
hydrochloride salt of propamocarb.
Compliance with the following tolerance levels
is to be determined by measuring only Commodity Parts per
million
propamocarb (propyl N-[3-
(dimethylamino)propyl]carbamate): Cattle, fat .......................................................... 0.05
Cattle, kidney .................................................... 0.20
Cattle, meat ...................................................... 0.05
Cattle, meat byproducts, except kidney ............ 0.05
Corn, field, forage .............................................. 0.05
Parts per Corn, field, grain ............................................... 0.05
Commodity million Corn, field, stover ............................................. 0.05
Fish .................................................................. 1.0
Lettuce, head..................................................... 50 Goat, fat ............................................................ 0.05
Parts per minimum distance of 3 feet from exposed
Commodity million foods.
Goat, kidney ...................................................... 0.20
(2) To assure safe use of the insect growth
Goat, meat ......................................................... 0.05 regulator, the label and labeling shall conform
Goats, meat byproducts, except kidney ............. 0.05 to that registered by the U.S. Environmental
Grass, forage .....................................................
Grass, hay .........................................................
100
30
Protection Agency, and it shall be used in
Horse, fat ......................................................... 0.05 accordance with such label and labeling.
Horse, kidney .................................................... 0.20 (b) Section 18 emergency exemptions.
Horse, meat....................................................... 0.05 [Reserved]
(c) Tolerances with regional registrations.
Horse, meat byproducts, except kidney ............ 0.05
Lentil1 ............................................................... 0.2
Milk ................................................................... 0.01 [Reserved]
Rapeseed subgroup 20A1 ................................ 0.05 (d) Indirect or inadvertent residues. [Reserved]
Sheep, fat ..........................................................
Sheep, kidney ....................................................
0.05
0.20
[62 FR 61647, Nov. 19, 1997, as amended at 71 FR
Sheep, meat ...................................................... 0.05 74818, Dec. 13, 2006]
Sheep, meat byproducts, except kidney ............ 0.05
Shellfish ............................................................ 0.10 § 180.502 Aminoethoxyvinylglycine hydrochloride
Soybean, meal1 ................................................ 4.5 (aviglycine HCl); tolerances for residues.
Soybean, seed1 ................................................ 4.0 (a) General. Tolerances are established for
Sunflower subgroup 20B1 ................................. 0.05
residues of
aminoethoxyvinylglycine hydro
1
There are no U.S. Registrations.
(a) General. A tolerance of 0.2 part per (b) Section 18 emergency exemptions.
million Is established for residues of [Reserved]
hydroprene [(S)-(Ethyl (2E,4E,7S)- 3,7,11- (c) Tolerances with regional registrations.
trimrthyl-2,4-dodecadienoate)], (CAS Reg. [Reserved]
No. 65733-18-8) on food commodities in (d) Indirect or inadvertent residues. [Reserved]
food-handling establishments in accordance [62 FR 24838, May 7, 1997, as amended at 64 FR
with the following prescribed conditions: 31129, June 10, 1999; 66 FR 36481, 36484, July 12,
(1) Application shall be limited to spot, crack 2001; 69 FR 7606, Feb. 18, 2004]
and crevice, perimeter and ultra low volume § 180.503 Cymoxanil, tolerance for residues.
(ULV) fogging treatment in food storage or (a) General. Tolerances are established for
food-handling establishments, including residues of the fungicide, cymoxanil, 2-
warehouses, food service, manufacturing, and cyano -N-
processing establishments such as restaurants, [(ethylamino)carbonyl]-2- (methoxyimino)
cafeterias, supermarkets, bakeries, breweries, acetamide, in or on the following food
dairies, meat slaughtering and packing plants, commodities:
and canneries where food and food products
are held, processed, and served: Provided that
the food is removed or covered prior to such
use, and food-processing surfaces are covered
during treatment or thoroughly cleaned Commodity Parts per
before using, or in the case of point-source million
device treatments, devices must not come into Caneberry, subgroup 13A-07 ............................. 4.0
direct contact with food preparation surfaces Cilantro, leaves .................................................. 19
and must be in a Hop, dried cones ..............................................
Leafy greens, subgroup 4A ............................... 19
7.0
acetamide) in or on the raw agricultural There are no U.S. registrations for use of emamectin on
grape, wine.
commodities:
(2) Tolerances are established for
emamectin, including its metabolites and
Commodity Parts per degradates, in or on the commodities in the
following table. Compliance with the tolerance
million
Grape ................................................................
0.10
levels specified in the following table is to be
determined by measuring only the sum of
(d) Indirect or inadvertent residues. emamectin (MABJa + MABJb isomers) and the
[Reserved] associated 8,9-Z isomers (8,9- ZBJa and 8,9-
ZBJb).
[62 FR 26411, May 14, 1997, as amended at 62 FR
39956, July 25, 1997; 63 FR 24949, May 6, 1998; 63 FR
66464, Dec. 2, 1998; 64 FR 6539, Feb. 10, 1999; 64 FR Parts per
47689, Sept. 1, 1999; 66 FR 37598, July 19, 2001; 67 FR Commodity million
35049, May 17, 2002; 68 FR 41936, July 16, 2003; 70
FR 7047, Feb. 10, 2005; 72 FR 37646, July 11, 2007; 73 Cattle, fat .......................................................... 0.010
FR 58885, Oct. 8, 2008; 76 FR 34885, June 15, 2011] Cattle, liver ........................................................
Cattle, meat ......................................................
0.050
0.003
Cattle, meat byproducts, except liver ............... 0.020
§ 180.504 [Reserved] Goat, fat ........................................................... 0.010
Goat, liver ......................................................... 0.050
§ 180.505 Emamectin; tolerances for residues. Goat, meat ........................................................ 0.003
Goat, meat byproducts, except liver ................. 0.020
(a) General. (1) Tolerances are established Hog, fat ............................................................. 0.003
for emamectin, including its metabolites and Hog, liver .......................................................... 0.020
degradates, in or on the commodities in the Hog, meat .........................................................
Hog, meat byproducts (except liver) .................
0.002
0.005
table below. Compliance with the tolerance Horse, fat .......................................................... 0.010
levels specified below is to be determined by Horse, liver ....................................................... 0.050
measuring only the sum of emamectin (a Horse, meat ......................................................
Horse, meat byproducts, except liver ...............
0.003
0.020
mixture of a minimum of 90% 4'-epi- Milk ................................................................... 0.003
methylamino-4'-deoxyavermectin Bia Sheep, fat ......................................................... 0.010
and maximum of 10% 4'-epi- Sheep, liver ......................................................
Sheep, meat .....................................................
0.050
0.003
methylamino-4'-deoxyavermectin BJb) and its Sheep, meat byproducts, except liver .............. 0.020
metabolites 8,9-isomer of the Bia and BJb
component of the parent (8,9-ZMA), or (b) Section 18 emergency exemptions.
4'-deoxy-4'-epi-amino- [Reserved]
avermectin BJa and 4’-deoxy-4’-epi- amino- (c) Tolerances with regional registrations.
avermectin BJb; 4'-deoxy-4'-epi- amino [Reserved]
avermectin BJa (ABJa); 4'-deoxy- 4'-epi-(N- (d) Indirect and inadvertant residues.
formyl-N-methyl)amino- avermectin (MFBJa); [Reserved]
and 4'-deoxy-4'- epi-(N-formyl)amino- [71 FR 18649, Apr. 12, 2006, as amended at 74 FR
avermectin BJa 2873, Jan. 16, 2009; 78 FR 18511, Mar. 27, 2013; 78 FR
(FABJa), calculated as the stoichiometric 49939, Aug. 16, 2013]
equivalent of emamectin. § 180.506 Cyclanilide; tolerances for residues.
(a) General. Tolerances are established for
residues of the plant growth
regulator, cyclanilide, [1-(2,4- Parts per
dichlorophenylaminocarbonyl)- cyclopropane Commodity million
carboxylic acid] determined as 2,4-
dichloroaniline (calculated as cyclanilide) in or Almond, hulls ............................... 4.0
on the following food commodities and Animal feed, nongrass, group 18,
processed feed: forage ..................................... 45
Animal feed, nongrass, group 18, 120
Artichoke,
hay globe .......................... 4.0
Parts Per
Asparagus .................................. 0.04
Commodity Million Atemoya ..................................... 2.0
Avocado ..................................... 2.0
Cattle, fat .......................................................... 0.10 Banana ....................................... *
Cattle, meat ...................................................... 0.02 Barley, bran ................................ 6.0
Cattle, meat byproducts, except kidney ............ 0.2 Barley, forage ............................. 25
Cattle, kidney .................................................... 2.0
Cotton, undelinted seed ................................... 0.60 Barley, grain ............................... 3.0
Cotton, gin byproducts ..................................... 25.0 Barley, hay ................................. 10.0
Goat, fat ............................................................ 0.10 Barley, straw ............................... 15.0
Goat, meat ........................................................ 0.02 Berry, low growing, subgroup 13-
Goat, meat byproducts, except kidney .............. 0.20 07G, except cranberry ............ 10.0
Goat, kidney ..................................................... 2.0 Biriba .......................................... 2.0
Horse, fat .......................................................... 0.10 Brassica, head and stem,
Horse, meat....................................................... 0.02
subgroup 5A ........................... 3.0
Horse, meat byproducts, except kidney ............ 0.20
Horse, kidney .................................................... 2.0 Brassica, leafy greens, subgroup 25
Hog, fat ............................................................. 0.10 Bushberry
5B .. subgroup 13-07B ....... 5.0
Hog, meat ......................................................... 0.02 Caneberry subgroup 13-07A ....... 5.0
Hog, meat byproducts, except kidney ............... 0.20 Canistel ...................................... 2.0
Hog, kidney ....................................................... 2.0 Cherimoya .................................. 2.0
Milk ................................................................... 0.04
Sheep, fat ......................................................... 0.10
Cilantro, leaves ........................... 30.0
Sheep, meat ..................................................... 0.20
Citrus, dried pulp ........................ 20.0
Sheep, meat byproducts, except kidney ........... 0.20 Citrus, oil .................................... 40.0
Sheep, kidney ................................................... 2.0 Corn, field, forage ....................... 12.0
Corn, field, grain ......................... 0.05
(b) Section 18 emergency exemptions. Corn, field, refined oil .................. 0.3
[Reserved] Corn, field, stover ....................... 25.0
(c) Tolerances with regional registrations. Corn, pop, grain .......................... 0.05
[Reserved] Corn, pop, stover ........................
Corn, sweet, forage .....................
25.0
12.0
(d) Indirect or inadvertent residues. [Reserved] Corn, sweet, kernel plus cob with
[62 FR 28355, May 23, 1997; 62 FR 34182, June 25, husks removed ....................... 0.05
1997] Corn, sweet, stover ..................... 25.0
Cotton, gin byproducts ................ 45
§ 180.507 Azoxystrobin; tolerances for residues.
Cottonseed subgroup 20C .......... 0.7
(a) General. (1) Tolerances are established Cranberry ................................... 0.50
for residues of the fungicide, azoxystrobin, Custard apple ............................. 2.0
including its metabolites and degradates, in or Dragon fruit ................................. 2.0
on the commodities in the following table. Feijoa .......................................... 2.0
Compliance with the tolerance levels specified Fruit, citrus, group 10-10 ............. 15.0
Fruit, small vine climbing, except
in the table is to be determined by measuring fuzzy kiwifruit, subgroup 13-07F 2.0
only the sum of azoxystrobin, [methyl(_E)-2- ................................................
Fruit, stone, group 12 .................. 1.5
(2-(6-(2-cyanophenoxy) pyrimidin-4- Ginseng1 ..................................... 0.5
yloxy)phenyl)-3- methoxyacrylate], and the Z- Grain, aspirated fractions ............ 420
isomer of azoxystrobin [methyl(Z)-2-(2- Grass, forage .............................. 15
(6-(2- Grass, hay .................................. 20
cyanophenoxy)pyrimidin-4- yloxy)phenyl)-3 Guava ......................................... 2.0
methoxyacrylate] in or Herb Subgroup 19A, dried leaves 260
Herb Subgroup 19A, fresh leaves 50
Hop, dried cones ........................ 20.0
llama............................................ 2.0
Jaboticaba .................................. 2.0
Jackfruit ...................................... 2.0
on the commodity. Longan ....................................... 2.0
Loquat ........................................ 2.0
Parts per Lychee ........................................ 2.0
Commodity million Mango ........................................ 2.0
Nut, tree, group 14 ...................... 0.02
Acerola ....................................... 2.0 Oats, forage ................................ 5.0
Commodity Parts per Commodity Parts per
million million
Oats, grain .................................. 1.5 Wasabi, dry ................................ 260
Oats, hay .................................... 10.0 Wasabi, fresh ............................. 50
Oats, straw ................................. 3.0 Watercress ................................. 3.0
Onion, bulb, subgroup 3-07A ...... 1.0 Wax jambu ................................. 2.0
Onion, green, subgroup 3-07B .... 7.5 Wheat, forage ............................. 15.0
Papaya ....................................... 2.0 Wheat, grain ............................... 0.2
Passionfruit ................................. 2.0 Wheat, hay ................................. 30.0
Pawpaw ...................................... 2.0 Wheat, straw .............................. 10.0
Pea and bean, dried shelled, except
soybean, subgroup 6C ............. 0.5 *2.0 (of which not more than 0.1 is contained
in the pulp)
Pea and bean, succulent shelled, 1
There are no United States registrations for
group 6B ..................................
sub- 0.5 use of azoxystrobin on ginseng.
Peanut ........................................ 0.2
Peanut, hay ................................ 15.0 (2) Tolerances are established for residues
Peanut, refined oil ....................... 0.6 of the fungicide, azoxystrobin, including its
Pepper/eggplant subgroup 8-10B 3.0 metabolites and degradates, in or on the
....................................................
Peppermint, tops ........................ 30 commodities in the following table.
Persimmon ................................. 2.0 Compliance with the tolerance levels specified
Pistachio ..................................... 0.50
Pulasan ...................................... 2.0 in the table is to be determined by measuring
Rambutan ................................... 2.0 only azoxystrobin, [methyl(E)-2-(2-(6-(2-
Rapeseed subgroup 20A ............ 1.0 cyanophenoxy) pyrimidin-4-
Rice, grain .................................. 5.0 yloxy)phenyl)-3-methoxyacrylate] in or on the
Rice, hulls ................................... 20 commodity.
Rice, straw ................................. 12
Rice, wild, grain .......................... 5.0
Rye, forage ................................. 7.0 Parts per
Rye, grain ................................... 0.2 Commodity million
Rye, straw .................................. 1.5
Sapodilla .................................... 2.0 Cattle, fat ............................................................ 0.03
Sapote, black .............................. 2.0 Cattle, meat ........................................................ 0.01
Cattle, meat byproducts ..................................... 0.07
Sapote, mamey .......................... 2.0 Goat, fat .............................................................. 0.03
Sapote, white .............................. 2.0 Goat, meat .......................................................... 0.01
Sorghum, grain, forage ............... 25 Goat, meat byproducts ....................................... 0.07
Sorghum, grain, grain ................. 11 Hog, fat ............................................................... 0.010
Sorghum, grain, stover ................ 40 Hog, meat ........................................................... 0.01
Soursop ...................................... 2.0 Hog, meat byproducts ........................................ 0.010
Soybean, hay ............................. 55.0 Horse, fat ............................................................ 0.03
Soybean, hulls ............................ 1.0 Horse, meat ......................................................... 0.01
Soybean, seed ........................... 0.5 Horse, meat byproducts ..................................... 0.07
Milk...................................................................... 0.006
Spanish lime ............................... 2.0 Sheep, fat ........................................................... 0.03
Spearmint, tops .......................... 30 Sheep, meat ....................................................... 0.01
Spice Subgroup 19B, except black Sheep, meat byproducts .................................... 0.07
pepper ..................................... 38
Star apple ................................... 2.0 (b) Section 18 emergency exemptions.
Starfruit ....................................... 2.0 [Reserved]
Sugar apple ................................ 2.0 (c) Tolerances with regional registration.
Sugarcane, cane ........................ 0.2 [Reserved]
Sunflower subgroup 20B ............ 0.5
Tamarind .................................... 2.0 (d) Indirect or inadvertent residues. [Reserved]
Tomato, paste ............................ 0.6 [62 FR 32235, June 13, 1997]
Tomato subgroup 8-10A ............. 0.2 EDITORIAL NOTE: For FEDERAL REGISTER citations
Turnip, greens ............................ 25 affecting §180.507, see the List of CFR Sections
Vegetable, cucurbit, group 9 ....... 0.3 Affected, which appears in the Finding Aids section
Vegetable, foliage of legume, group 30.0 of the printed volume and at www.fdsys.gov.
Vegetable,
7 leafy, except brassica,
group 4 .................................... 30.0 § 180.509 Mefenpyr-diethyl; tolerance for residues.
Vegetable, leaves of root and tuber, (a) General. Tolerances are established for
group 2 .................................... 50.0 residues of the safener,
Vegetable, legume, edible podded,
subgroup 6A, except soybean . 3.0
Vegetable, root, subgroup 1A ..... 0.5
Vegetable, tuberous and corm, sub-
group 1C ................................. 8.0
mefenpyr-diethyl, Including Its metabolites Parts per
and degradates, when applied at a rate no Commodity million
greater than 0.053 pound safener per acre per Soybean, forage .................................................. 0.1
growing season in or on the commodities in Soybean, hay ....................................................... 0.1
the table below. Compliance with the Soybean, seed ..................................................... 0.02
tolerance levels specified below is to be
determined by measuring only the sum of [73 FR 74977, Dec. 10, 2008, as amended at 76 FR
mefenpyr-diethyl (1-(2,4- 23903, Apr. 29, 2011]
dichlorophenyl)-4,5-dihydro-5-methyl- 1H-
pyrazole-3,5-dicarboxylic § 180.510 Pyriproxyfen; tolerances for residues.
aci (a) General. (1) Tolerances are established
d, for residues of pyriproxyfen, including its
diethyl ester) and its 2,4- dichlorophenyl- metabolites and degradates, in or on the
pyrazoline metabolites, calculated as the commodities in the following table.
stoichiometric equivalent of mefenpyr-diethyl, Compliance with the tolerance levels specified
in or on the commodity. is determined by measuring only pyriproxyfen,
2-[1- methyl-2-(4-phenoxyphenoxy)
Commodity Parts per
million
ethoxy]pyridine, in or on the commodity.
Parts per
Commodity million
Parts per
Commodity Parts per
million Commodity million
0.1
Berry, low growing, subgroup 13-07G ................. 0.15 Cattle, liver ........................................................ 1.50
Onion, bulb, subgroup 3-07A .............................. 0.1 Cattle, meat ...................................................... 0.01
Spinach ............................................................... 1.0 Cattle, meat byproducts, except liver ................ 0.01
Tomato, paste ..................................................... 3.0 Goat, liver ......................................................... 1.50
Vegetable, brassica, leafy, group 5 ..................... 1.0 Goat, meat ........................................................ 0.01
Vegetable, cucurbit, group 9 ............................... 2.0 Goat, meat byproducts, except liver ................. 0.01
Vegetable, fruiting, group 8 ................................. 1.0 Hog, liver .......................................................... 1.50
Vegetable, leafy, group 4 ................................... 0.25 Hog, meat ......................................................... 0.01
1
There are no United States registrations for banana. Hog, meat byproducts, except liver ................... 0.01
Horse, liver ....................................................... 1.50
(2) Tolerances are established for residues Horse, meat ....................................................... 0.01
of acibenzolar- S -methyl, Horse, meat byproducts, except liver ................ 0.01
benzo(1,2,3)thiadiazole-7-carbothioic acid- S - Milk ................................................................... 0.005
methyl ester, including its metabolites and Sheep, liver .......................................................
Sheep, meat .....................................................
1.50
0.01
degradates, in or on the commodities in the Sheep, meat byproducts, except liver ............... 0.01
table below. Compliance with the tolerance Wheat, forage..................................................... 0.30
levels specified below is to be determined by Wheat, grain ...................................................... 0.01
measuring only those acibenzolar- S -methyl Wheat, hay ........................................................
Wheat, straw ......................................................
0.10
0.05
residues convertible to
benzo(1,2,3)thiadiazole-7-carboxylic (b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional registrations. Parts per
[Reserved]
Commodity million
(d) Indirect or inadvertant residues. [Reserved] Berry, low growing, except strawberry, subgroup
[70 FR 67915, Nov. 9, 2005, as amended at 71 FR 13-07H ............................................................ 1
76931, Dec. 22, 2006] Bushberry subgroup 13-07B ............................... 1.5
Cattle, fat ............................................................ 1.5
§ 180.563 Ethametsulfuron-methyl; tolerances for Cattle, meat ........................................................ 0.05
residues. Cattle, meat byproducts ..................................... 0.03
Corn, sweet, forage ............................................
(a) General. A tolerance Is established for
10
Corn, sweet, kernel plus cob with husk removed 0.02
residues of ethametsulfuron methyl (methyl2- Corn, sweet, stover ............................................ 15
((((4-ethoxy-6- Cotton, gin byproducts ....................................... 15
(methylamino)-1,3,5- triazin-2-yl) Cotton, undelinted seed .....................................
Cowpea, forage .................................................. 50
2.0
and its R-enantiomer, (R)-methyl 7- chloro- (2) Tolerances are established for residues
2,5-dihydro-2-[[(methoxycar- bonyl)[4- of indoxacarb, including its metabolites and
(trifluoromethoxy)phenyl] degradates, in or on the commodities in the
amino]carbonyl]indeno[1,2-e][1,3,4] table below. Compliance with the tolerance
[oxadiazine-4a(3H)-carboxylate. levels specified below is to be determined by
measuring only the sum of indoxacarb, (S)-
methyl-7-chloro-2,5-dihydro-2-[[(me-
thoxycarbonyl)[4-(trifluoromethoxy)-
phenyl]amino]carbonyl]indeno[1,2e]
[1.3.4] oxadiazine-4a(3.ff)-carboxylate, its R-
enantiomer, (R)-methyl 7-chloro-2,5-
dihydro-2-[[(methoxycarbonyl)[4-
Parts per
Commodity million
(trifluoromethoxy)
Apple, wet pomace ..............................................
Alfalfa, forage .....................................................
3.0 phenyl]amino]carbonyl]indeno [1,2-e]
[1.3.4] oxadiazine-4a(3.ff)-carboxylate, and
10
Alfalfa, hay........................................................... 50
Bean, dry, seed .................................................. 0.2 the metabolites: IN-JT333, methyl 7-chloro-
Bean, succulent ................................................... 0.9 2,5-dihydro-2-[[[4-
Beet, garden, roots .............................................. 0.30
Beet, garden, tops .............................................. 6.0
(trlfluoromethoxy)phenyl]- Commodity
Parts per
amlno]carbonyl]lndeno[1,2- million
e][1,3,4]oxadiazine-4a(3.ff)-carboxylate; Alfalfa, forage ...................................................... 0.05
IN-KT319, (E)-methyl 5-chloro-2,3,- Alfalfa, hay ........................................................... 0.12
dlhydro-2-hydroxy-1-[[[(methoxycar- Almond, hulls ......................................................
Artichoke, globe ...................................................
1.2
0.45
bonyl)[4- Avocado .............................................................. 0.40
(trlfluoromethoxy)phenyl]amlno]-car- Barley, grain ....................................................... 0.4
bonyl]hydrazono]-1#-lndene-2- carboxylate; Barley, hay...........................................................
Barley, straw ........................................................
0.40
0.40
IN-JU873, methyl 5- chloro-2,3-dlhydro-2- Bean, succulent ................................................... 0.02
hydroxy-1-[[[[4- (trlflurormethoxy)- Berry, low growing, subgroup 13-07G, except
phenyl]amlno]carbonyl]hydrazono]-1_ff- cranberry..........................................................
Borage, seed ......................................................
0.30
0.02
lndene-2-carboxylate; IN-KG433, methyl 5- Brassica, head and stem, subgroup 5-A .............. 4.5
chloro-2,3,-dlhydro-2-hydroxy-1- Brassica, leafy greens, subgroup 5-B ................. 3.0
[[[(methoxycarbonyl)[4- Buckwheat, forage ...............................................
Buckwheat, hay ..................................................
0.50
0.02
(trlfluoromethoxy)phenyl] amlno]carbonyl]- Buckwheat, straw ................................................ 0.02
hydrazono]-1ff-lndene- 2-carboxylate; and Bushberry subgroup 13-07B, except lingonberry
IN-KB687, methyl [4- and blueberry, lowbush ....................................
Caneberry subgroup 13-07A ..............................
0.20
0.35
(trlfluoromethoxy)phenyl]carbamate, Canistel................................................................ 0.40
calculated as the stolchlometrlc equlv- alent Canola, seed ...................................................... 0.02
of lndoxacarb ln the commodlty. Cattle, meat ........................................................
Cattle, meat byproducts ......................................
0.02
0.04
Citrus, dried pulp ................................................. 0.60
Coffee, green, bean1 ........................................... 0.20
Corn, field, forage ................................................ 0.10
Parts per Corn, field, stover ................................................ 0.05
Commodity Corn, pop, forage ................................................ 0.10
million
Corn, pop, stover ................................................. 0.05
Egg ..................................................................... 0.20 Corn, sweet, forage ............................................ 0.10
Poultry, fat .......................................................... 0.20 Corn, sweet, kernel plus cob with husks re-
Poultry, meat ...................................................... 0.06
Poultry, meat byproducts ..................................... 0.06 moved ............................................................ 0.02
Corn, sweet, stover ............................................. 0.05
(c) Tolerances with regional registrations. Cotton, gin byproducts ........................................ 1.5
[Reserved] Cotton, undelinted seed ......................................
Crambe, seed .....................................................
0.10
0.02
(d) Indirect or inadvertent residues. [Reserved] Cranberry............................................................. 0.02
[65 FR 58424, Sept. 29, 2000, as amended at 67 FR Flax, seed ...........................................................
Food commodities and feed commodities (other
0.02
41807, June 19, 2002; 67 FR 47309, July 18, 2002; 67 than those covered by a higher tolerance as a
FR 58730, Sept. 18, 2002; 68 FR 25830, May 14, 2003; result of use on growing crops) in food/feed
68 FR 27746, May 21, 2003; 69 FR 28842, May 19, handling establishments ................................. 0.02
2004 ; 69 FR 29459, May 24, 2004; 69 FR 32282, June Fruit, citrus, group 10 .......................................... 0.40
9 , 2004 ; 72 FR 37641, July 11, 2007; 74 FR 33165, July Fruit, pome, group 11 ......................................... 0.2
10, 2009; 77 FR 8749, Feb. 15, 2012; 78 FR 78738, Dec. Fruit, small, vine climbing, subgroup 13-07F,
0.20
27, 2013] except fuzzy kiwifruit .......................................
Fruit, stone, group 12 .........................................
0.5
0.02
§ 180.565 Thiamethoxam; tolerances for residues. Goat, meat ...........................................................
0.04
(a) General. Tolerances are estab- llshed for Goat, meat byproducts .......................................
Grain, aspirated fractions ...................................
2.0
resldues of the lnsectlclde thlamethoxam, Grain, cereal, group 15, except barley.................
0.02
lncludlng lts metabo- lltes and degradates, ln
0.30
Grape, raisin .......................................................
0.02
or on the fol- lowlng commodltles. Hog, meat ...........................................................
Hog, meat byproducts ........................................
0.02
Compllance wlth the tolerance levels speclfled Hop, dried cones ................................................
0.10
below ls to be determlned by measuring only Horse, meat .........................................................
0.02
0.04
thlamethoxam 3-[(2-chloro-5- Horse, meat byproducts .....................................
0.40
thlazolyl)methyl]tetrahydro-5-methyl- N- Mango .................................................................
Milk .....................................................................
0.02
nltro-4H-1,3,5-oxadlazln-4-lmlne and lts Millet, pearl, forage ..............................................
0.02
metabollte CGA-322704 N-[(2-chloro-
0.02
Millet, pearl, stover .............................................
0.02
thlazol-5-yl)methyl]-N'-methyl-N"- nltro- Millet, proso, forage .............................................
0.02
guanldlne, calculated as the stol- chlometrlc
Millet, proso, stover ............................................
0.02
Millet, proso, straw ..............................................
equlvalent of Mustard, seed ......................................................
0.02
0.02
thlamethoxam, ln or on the followlng Nut, tree, group 14 ..............................................
0.50
commodltles: Oat, forage...........................................................
Oat, hay ...............................................................
0.02
0.02
Oat, straw ...........................................................
0.03
Onion, dry bulb ....................................................
0.40
Papaya ...............................................................
0.05
Peanut ................................................................
Parts per amino]oxy]methyl]benzoate, calculated as the
Commodity million stoichiometric equivalent of fenpyroximate.
Peanut, hay ........................................................ 0.25
Peanut, meal ...................................................... 0.15
Peppermint, tops ................................................ 1.5 Parts per
Commodity
Pistachio ............................................................. 0.02 million
Potato ................................................................. 0.25
Almond, hulls ..................................................... 3.0
Radish, tops ........................................................ 0.80
Avocado ............................................................ 0.15
Rapeseed, seed ................................................. 0.02
Bean, snap, succulent ...................................... 0.40
Rye, forage .......................................................... 0.50
Rye, straw ........................................................... Berry, low growing, subgroup 13-07G ............... 1.0
0.02
Canistel ............................................................. 0.15
Safflower, seed.................................................... 0.02
Citrus, dried pulp .............................................. 2.5
Sapodilla ............................................................ 0.40 Citrus, oil ........................................................... 10
Sapote, black....................................................... 0.40 Corn, field, forage .............................................. 2.0
Sapote, mamey .................................................. 0.40 Corn, field, grain ............................................... 0.02
Sheep, meat ....................................................... 0.02 Corn, field, refined oil ....................................... 0.05
Sheep, meat byproducts .................................... 0.04 Corn, field, stover ............................................. 7.0
Sorghum, forage.................................................. 0.02 Corn, pop, forage ............................................. 2.0
Sorghum, grain, stover ........................................ 0.02 Corn, pop, grain ................................................ 0.02
Soybean, hulls .................................................... 0.08 Corn, pop, stover............................................... 7.0
Spearmint, tops .................................................. 1.5 Cotton, gin byproducts ..................................... 10
Star apple ........................................................... 0.40 Cotton, undelinted seed ................................... 0.10
Sunflower ............................................................ 0.02 Cucumber ......................................................... 0.40
20 Fruit, citrus, group 10-10 .................................. 0.50
Tomato, paste ..................................................... 0.80 Fruit, pome, group 11-10 ................................... 0.30
Vegetable, cucurbit, group 9 ............................... 0.2 Fruit, small, vine climbing, except fuzzy
Vegetable, fruiting, group 8 ................................. 0.25 kiwifruit, subgroup 13-07F .............................. 1.0
Vegetable, leafy, except brassica, group 4 .......... 4.0 Fruit, stone, group 12-12 .................................. 2.0
Vegetable, legume, group 6 ................................ 0.02 Grain, aspirated fractions ................................. 0.40
Vegetable, root, subgroup 1A ............................. 0.05 Hop, dried cones .............................................. 10
Vegetable, tuberous and corm, except potato, Mango ............................................................... 0.15
subgroup 1D .................................................... 0.02 Melon subgroup 9A .......................................... 0.10
Wheat, forage ...................................................... 0.50 Nut, tree, group 14 ........................................... 0.10
Wheat, hay ......................................................... 0.02 Papaya ............................................................. 0.15
Wheat, straw ....................................................... 0.02 Peppermint, tops .............................................. 7.0
1 Pistachio ........................................................... 0.10
There are no U.S. registrations as of March 27, 2013.
Sapodilla .......................................................... 0.15
(b) Section 18 emergency exemptions. Sapote, black ....................................................
Sapote, mamey ................................................
0.15
0.15
[Reserved] Spearmint, tops ................................................ 7.0
(c) Tolerances with regional registrations. Star, apple ........................................................ 0.15
[Reserved] Tea, dried1 ........................................................ 20
(d) Indirect or inadvertent residues. [Reserved]
Vegetable, fruiting, group 8-10 .......................... 0.20
Vegetable, tuberous and corm, subgroup 1C ... 0.10
[65 FR 79762, Dec. 20, 2000] 1
There are no U.S. Registrations.
EDITORIAL NOTE: For FEDERAL REGISTER citations
affecting §180.565, see the List of CFR Sections (2) Tolerances are established for residues
Affected, which appears in the Finding Aids section of the insecticide fenpyroximate, including its
of the printed volume and at www.fdsys.gov. metabolites and degradates, in or on the
§ 180.566 Fenpyroximate; tolerances for residues. commodities in the table below. Compliance
with the tolerance levels specified in the table
(a) General. (1) Tolerances are established is to be determined by measuring only the
for residues of the insecticide fenpyroximate, sum of fenpyroximate, (_E)-1,1- dimethylethyl
including its metabolites and degradates, in or 4-[[[[(1,3-dimethyl-5- phenoxy-1#-pyrazol-4-
on the commodities in the table below. yl)methylene] amino]oxy]methyl]benzoate
Compliance with the tolerance levels specified and its metabolites (_E)-4-[(1,3-dimethyl-5-
in the table is to be determined by measuring phenoxypyrazol-4-yl)-methyleneamino
only the sum of fenpyroximate, (_E)-1,1- oxymethyl]benzoic acid and (E)-1,1-
dimethylethyl 4- [[[[(1,3-dimethyl-5-phenoxy- dimethylethyl-2-hydroxyethyl 4-[[[[(1,3-
1_ff-pyrazol- 4- dimethyl-5-phenoxy-1H-pyrazol-4-yl)
yl)methylene]amino]oxy]methyl]ben- zoate methylene]amino]oxy]methyl]ben- zoate,
and its Z-isomer, (Z)-1,1- dimethylethyl 4- calculated as the stoichiometric equivalent of
[[[[(1,3-dimethyl-5- fenpyroximate.
phenoxy-1H-pyrazol-4-yl)methylene]
Parts per
Commodity million
(3) Tolerances are established for residues § 180.567 Zoxamide; tolerances for residues.
of the insecticide fenpyroximate, including its (a) General. (1) Tolerances are established
metabolites and degradates, in or on the for residues of zoxamide (3,5- dichloro-A-(3-
commodities in the table below. Compliance chloro-1-ethyl-1-methyl-
with the tolerance levels specified in the table
is to be determined by measuring only the sum 2- oxopropyl)-4-methylbenzamide) in
of fenpyroximate, (_E)-1,1- dimethylethyl 4- or on the following commodities:
[[[[(1,3-dimethyl-5- phenoxy-1#-pyrazol-4-
yl)methylene] amino]oxy]methyl]benzoate and Parts per
its metabolite (_E)-4-[(1,3-dimethyl-5-
Commodity million
phenoxypyrazol-4-yl)-methyleneamino
oxymethyl]benzoic acid, calculated as the
Grape .................................................................. 3.0
Grape, raisin ....................................................... 15.0
stoichiometric equivalent of fenpyroximate. Tomato ................................................................ 2.0
Vegetable, cucurbit, group 9 ............................... 1.0
Pear ................................................
Pistachio .........................................
0.01 12/31/15
12/31/15
[66 FR 33187, June 21, 2001, as amended at 66 FR
0.01
Plum, prune, fresh .......................... 12/31/15 40141, Aug. 2, 2001; 67 FR 12878, Mar. 20, 2002; 69
0.01
FR 29890, May 26, 2004; 72 FR 63997, Nov. 14, 2007]
(b) Section 18 emergency exemptions. § 180.571 Mesotrione; tolerances for residues.
[Reserved]
(c) Tolerances with regional restrictions. (a) General. Tolerances are established for
residues of the herbicide mesotrione,
[Reserved]
including its metabolites and degradates, in or
(d) Indirect or inadvertent residues. [Reserved]
on the commodities in the table below.
[66 FR 22936, May 7, 2001, as amended at 69 FR Compliance with the tolerance levels specified
48805, Aug. 11, 2004; 69 FR 58322, Sept. 30, 2004; 73 below is to be determined by measuring only
FR 47846, Aug. 15, 2008; 78 FR 46283, July 31, 2013; mesotrione, 2-[4-(methylsulfonyl)- 2-
79 FR 18471, Apr. 2, 2014]
nitrobenzoyl]-1,3-cyclohexanedione, in or on
§ 180.570 Isoxadifen-ethyl; tolerances for residues. the following raw agricultural commodities:
(a) General. (1) Tolerances are established
for residues of isoxadifen-ethyl (ethyl 5,5-di
phenyl-2-isoxazoline-3-
carboxylate, (CAS No. 163520-33-0), and its
metabolite: 4,5-dihydro-5,5-di-
phenyl-3-isoxazolecarboxylic acid,
when used as an inert ingredient (safener) in Parts per
or on the following raw agricultural
Commodity million
commodities: Asparagus ........................................................... 0.01
Berry, group 13 ................................................... 0.01
Corn, field, forage ................................................ 0.01
Corn, field, grain ................................................. 0.01
Corn, field, stover ............................................... 0.01
Parts per
Commodity Corn, pop, grain .................................................. 0.01
million
Corn, pop, stover................................................. 0.01
Corn, field, forage ................................................ 0.20 Corn, sweet, forage ............................................ 0.5
Corn, field, grain ................................................. 0.08 Corn, sweet, kernel plus cob with husks re-
Corn, field, stover ............................................... 0.40 moved ............................................................. 0.01
Corn, oil .............................................................. 0.50 Corn, sweet, stover ............................................ 1.5
Corn, pop, grain................................................... 0.04 Cranberry ............................................................ 0.02
Corn, pop, stover ................................................. 0.25 Flax, seed ........................................................... 0.01
Corn, sweet, forage ............................................ 0.30 Grass, forage ...................................................... 0.01
Corn, sweet, kernel plus cob with husk removed 0.04 Grass, hay .......................................................... 0.01
Corn, sweet, stover ............................................ 0.45 Grass, seed screenings....................................... 0.10
Grass, straw ....................................................... 0.10
(2) Tolerances are established for the Lingonberry ......................................................... 0.01
residues of isoxadifen-ethyl (3- Millet, forage........................................................ 0.01
isoxazolecarboxylic acid, 4,5-dihydro- 5,5- Millet, grain ......................................................... 0.01
diphenyl-, ethyl ester (CAS No. 164520-33-0)), Millet, hay ........................................................... 0.02
Parts per
Commodity million
(a) General. Tolerances are established for § 180.578 Acetamiprid; tolerances for residues.
residues of cyhalofop-butyl, including its (a) General. (1) Tolerances are established for
metabolites and degradates, in or on the residues of the insecticide acetamiprid (1E)-N-
commodities listed in the table below. [(6-chloro-3-
Compliance with the tolerance levels specified pyridinyl)methyl]-N’-cyano-N-
below is to be determined by measuring methylethanimidamide, including its
cyhalofop butyl [R-(+)-n-butyl-2-(4(4- cyano- metabolites and degradates, in or on the
2-fluorophenoxy)- phenoxy)propionate], commodities in the table below as a result of
cyhalofop acid the application of
acetamiprid. Compliance with the tolerance Parts per
levels specified below is to be determined by
Commodity million
measuring only acetamiprid in or on the Cattle, meat ...................................................... 0.30
following commodities. Cattle, meat byproducts .................................... 0.70
Egg ................................................................... 0.010
Goat, fat ............................................................ 0.20
Parts per Goat, meat ........................................................ 0.30
Commodity million
Goat, meat byproducts ..................................... 0.70
Hog, fat ............................................................. 0.10
Almond, hulls .................................................... 5.0
Hog, meat ......................................................... 0.10
Asparagus ........................................................ 0.80
Berry, low growing subgroups 13-07G .............. 0.60 Hog, meat byproducts ...................................... 0.20
Brassica, head and stem, subgroup 5A ............... 1.20 Horse, fat .......................................................... 0.20
Brassica, leafy greens, subgroup 5B ................ 15 Horse, meat ...................................................... 0.30
Bushberry subgroup 13-07B .............................. 1.6 Horse, meat byproducts ................................... 0.70
Caneberry subgroup 13-07A ............................ 1.6 Milk ................................................................... 0.30
Canola, seed .................................................... 0.010
Poultry, fat ........................................................ 0.010
Citrus, dried pulp .............................................. 1.20
Poultry, liver ...................................................... 0.050
Corn, sweet, forage .......................................... 15
Corn, sweet, kernel plus cob with husks re- Poultry, meat .................................................... 0.010
moved ........................................................... 0.01 Sheep, fat ......................................................... 0.20
Corn, sweet, stover ........................................... 30 Sheep, meat ..................................................... 0.30
Cotton, gin byproducts ...................................... 20.0 Sheep, meat byproducts ................................... 0.70
Cotton, undelinted seed .................................... 0.60
Fruit, citrus, group 10-10 ..................................
Fruit, pome, group 11-10 ...................................
1.0
1.0
(3) A tolerances of 0.01 ppm is established
Fruit, small, vine climbing, except fuzzy for residues of the insecticide acetamiprid,
kiwifruit, subgroup 13-07F ............................ 0.35 including its metabolites and degradates, in or
Fruit, stone, group 12, except plum, prune .......
Grain, aspirated fractions .................................
1.20
5.0
on all food/feed items (other than those
Mustard, seed .................................................... 0.010 covered by a higher tolerance in paragraph
Nut, tree, group 14 ............................................ 0.10 (a)(1) or
Onion, bulb, subgroup 3-07A ............................
Onion, green, subgroup 3-07B .........................
0.02
4.5
(a) (2) of this section as a
Pea and bean, succulent shelled, subgroup 6B 0.40 result of the use on growing crops) as a result
Pistachio ........................................................... 0.10 of the application of acetamiprid in food/feed
Plum, prune, dried ............................................
Plum, prune, fresh ............................................
0.40
0.20
handling establishments. Compliance with the
Soybean, hulls .................................................. 0.04 0.01 ppm tolerance level is to be determined
Soybean, seed .................................................. 0.03 by measuring only acetamiprid (1E)-N-
Tea, dried1 ........................................................
Tomato, paste ...................................................
50.0
0.40
[(6-chloro-3-
Turnip greens ................................................... 15 pyridinyl)methyl]-N'-cyano-N-
Vegetable, cucurbit, group 9 ............................. 0.50 methylethanimidamide in or on the
Vegetable, fruiting, group 8-10 .........................
Vegetable, leafy, except brassica, group 4 .......
0.20
3.00
commodities.
Vegetable, legume, edible podded, subgroup (b) Section 18 emergency exemptions.
6A ..................................................................
0.60 [Reserved]
(c) Tolerances with regional registra
Vegetable, tuberous and corm, group 1 ........... 0.01
[Reserved]
6.0
Bean, succulent shelled ................................... 0.5
(d) Indirect or inadvertent residues. [Reserved] Beet, sugar, dried pulp ..................................... 1.0
Beet, sugar, roots ............................................. 0.2
[67 FR 57532, Sept. 11, 2002, as amended at 74 FR Beet, sugar, tops .............................................. 8.0
23644, May 20, 2009] Berry, low growing, subgroup 13-07G, except
cranberry ....................................................... 1.2
§ 180.581 Iprovalicarb; tolerances for residues.
Brassica, head and stem, subgroup 5A ........... 5.0
(a) General. Tolerances are established for Brassica, leafy greens, subgroup 5B ................ 16.0
residues of iprovalicarb, [2- methyl-1[[[(1S)-(4- Bushberry subgroup 13-07B ............................. 4.0
methylphenyl) ethyl] amino]carbonyl] Caneberry subgroup 13-07A .............................
Canistel .............................................................
4.0
0.6
propyl]carbamic acid methylethylester, in or Citrus, dried pulp ............................................... 12.5
on the following commodities. Citrus, oil ........................................................... 9.0
Coffee, green bean ........................................... 0.3
Corn, field, forage .............................................. 5.0
Corn, field, grain ................................................ 0.1
Corn, field, refined oil ........................................ 0.2
Corn, field, stover .............................................. 17.0
Corn, pop, grain ................................................ 0.1
Parts per Corn, pop, stover ............................................... 17.0
Commodity million Corn, sweet, forage ........................................... 5.0
Corn, sweet, kernel plus cob with husks re-
Grape1 ................................................................ moved ........................................................... 0.04
Tomato1 .............................................................. 2.0
1.0 Corn, sweet, stover ........................................... 23.0
■'There is no U.S. registration as of September 1, 2005. Cotton, gin byproducts ...................................... 30
Endive, belgium................................................. 4.0
(b) Section 18 emergency exemptions. Fruit, citrus, group 10-10 .................................. 2.0
[Reserved] Fruit, pome, group 11-10................................... 1.5
(c) Tolerances with regional registrations. Fruit, small vine climbing, except fuzzy
kiwifruit, subgroup 13-07F ..............................
[Reserved]
2.0
Fruit, stone, group 12 ....................................... 2.5
(d) Indirect or inadvertent residues. [Reserved] Grain, aspirated fractions .................................. 2.5
Grape, raisin ...................................................... 7.0
[67 FR 54359, Aug. 22, 2002, as amended at 70 FR Grass, forage .................................................... 10
55281, Sept. 21, 2005] Grass, hay ......................................................... 4.5
§ 180.582 Pyraclostrobin; tolerances for residues. Grass, seed screenings .................................... 27
Grass, straw ...................................................... 14
(a) General. (1) Tolerances are established Hop, dried cones .............................................. 23.0
for residues of the fungicide pyradostrobin, Mango ............................................................... 0.6
including its metabolites and degradates, in or Nut, tree, group 14 ...........................................
Oat, grain ...........................................................
0.04
1.2
on the commodities in the table below. Oat, hay ............................................................. 18
Compliance with the tolerance levels specified Oat, straw .......................................................... 15
Oilseed group 20 ............................................... 0.45
Papaya ............................................................. 0.6
Pea, succulent................................................... 0.2
Pea and bean, dried shelled, except soybean,
subgroup 6C .................................................. 0.5
Commodity Parts per Commodity Parts per
million million
Compliance with the tolerance levels specified (b) Section 18 emergency exemptions.
below is to be determined by measuring only [Reserved]
clothianidin, (_E)-N-[(2-Chloro-5- (c) Tolerances with regional registrations.
thiazolyl)methyl]-N' -methyl-N" [Reserved]
-nitroguanidine, in or on the following raw (d) Indirect and inadvertant residues.
agricultural commodities: Tolerances are established for the indirect or
inadvertent residues of the insecticide
clothianidin, including its metabolites and
degradates. Compliance with the tolerance
Commodity Parts per
million levels specified below is to be determined by
measuring only clothianidin, (E)-1-(2-chloro-
Almond, hulls ....................................................... 1.5 1,3- thiazol-5-ylmethyl)-3-methyl-2-
Beet, sugar, dried pulp .......................................
Beet, sugar, molasses .........................................
0.03
0.05 nitroguanidine, in or on the following raw
Beet, sugar, roots ............................................... 0.02 agricultural commodities when present therein
Berry, low-growing, subgroup 13-07H, except as a result of the application of clothianidin to
strawberry ...................................................... 0.01 crops listed in paragraph (a) of this section:
Canola, seed ...................................................... 0.01
Cotton, gin byproducts ....................................... 4.5
Cotton, undelinted seed ..................................... 0.20
Fig ....................................................................... 0.05
Fruit, pome ......................................................... 1.0 Parts per
Commodity
Grain, cereal, forage, fodder and straw, group 16, million
except rice, forage .......................................... 0.35
Grain, cereal, forage, fodder and straw, group 16, Animal feed, nongrass, group 18 ........................ 0.02
Grass, forage, fodder and hay, group 17 ............. 0.02
except rice, hay ............................................. 0.07
Soybean, forage .................................................. 0.02
Grain, cereal, forage, fodder and straw, group 16, Soybean, hay ....................................................... 0.02
except rice, stover ......................................... 0.1
Grain, cereal, forage, fodder and straw, group 16,
except rice, straw............................................ 0.05 [74 FR 65028, Dec. 9, 2009, as amended at 76 FR
Grain, cereal, group 15, except rice .................... 0.01 7718, Feb. 11, 2011; 76 FR 25246, May 4, 2011; 76 FR
Grape .................................................................. 0.60 34886, June 15, 2011; 77 FR 52252, Aug. 29, 2012; 78
Milk ..................................................................... 0.01 FR 19136, Mar. 29, 2013]
Mustard, seed ..................................................... 0.01
Nut, tree, group 14 ............................................. 0.01 § 180.587 Famoxadone; tolerance for residues.
Peach ................................................................. 0.80
(a) General. Tolerances are established for
residues of the fungicide famoxadone (3-
Pepper ................................................................ 0.80
Pomegranate ...................................................... 0.20
Potato, chips ....................................................... 0.6 anilino-5-methyl-5-(4- phenoxyphenyl)-1,3-
Potato, granules/flakes ....................................... 1.5 oxazolidine-2,4- dione) in or on the following
Rice, grain ..........................................................
Soybean, seed ....................................................
0.01 commodities:
0.02
70
Vegetable, brassica, leafy, group 5 ...................... 1.9
Vegetable, bulb, group 3-07 ................................. 0.45
Vegetable, cucurbit, group 9 ............................... 0.06
Vegetable, fruiting, group 8, except pepper .......... 0.20 Parts per
Commodity
Vegetable, leafy, except brassica, group 4 ........... 3.0 million
Vegetable, root, except sugar beet, subgroup 1B
Caneberry subgroup 13-07A ............................... 10
0.8
Cattle, fat ............................................................. 0.02
Vegetable, tuberous and corm, subgroup 1C ...... 0.3
Cattle, liver ........................................................... 0.05
1
No U.S. registrations. Cilantro, leaves .................................................... 25
Goat, fat ............................................................... 0.02
(2) Time-limited tolerances are established Goat, liver ............................................................ 0.05
for residues of the insecticide clothianidin, Grape, raisin1 ..................................................... 4.0
including its metabolites and degradates. Hop, dried cone ...................................................
Horse, fat ...........................................................
80
0.02
Compliance with the tolerance levels specified Horse, liver ......................................................... 0.05
below is to be determined by measuring only Milk, fat (reflecting negligible residues in whole
clothianidin, (E)-1-(2-chloro-1,3-thiazol- 5- milk) .................................................................
Onion, bulb, subgroup 3-07A ..............................
0.06
0.45
ylmethyl)-3-methyl-2-nitroguanidine, in or on Onion, green, subgroup 3-07B ............................ 40
the following raw agricultural commodity: Potato ................................................................. 0.02
Sheep, fat ............................................................ 0.02
Sheep, liver .......................................................... 0.05
Spinach ................................................................ 50
Commodity Parts per (d) Indirect or inadvertent residues. [Reserved]
million
[68 FR 55858, Sept. 29, 2003, as amended at 70 FR
Tomato ................................................................ 1.0 4032, Jan. 28, 2005; 71 FR 50354, Aug. 25, 2006; 74
Vegetable, cucurbit, group 9 ............................... 0.30 FR 14743, Apr. 1, 2009; 78 FR 57280, Sept. 18, 2013]
Vegetable, fruiting, group 8, except tomato .......... 4.0
Vegetable, leafy, except Brassica, group 4, ex-
§ 180.589 Boscalid; tolerances for residues.
cept spinach .................................................... 25 (a) General. (1) To1erances are estab- 1ished
1
There are no U.S. registrations as of May 15, 2003. for residues of the fungicide bosca1id,
inc1uding its metabo1ites and degradates, in
(b) Section 18 emergency exemptions.
or on the commodities 1isted be1ow.
[Reserved]
Comp1iance with the to1- erance 1eve1s
(c) Tolerances with a regional registra- specified be1ow is to be determined by
tions. Tolerances with a regional reg- measuring on1y bosca1id, 3-
istration as defined in §180.1(1) are es- pyridinecarboxamide, 2- ch1oro-N-(4'-
tablished for the residues of the fun- ch1oro[1,1’-bipheny1]-2-y1), in or on the
gicide famoxadone, 3-ani1ino-5-methy1- fo11owing raw agricu1tura1 commodities:
5-(4-phenoxypheny1)-1,3-oxazo1idine-2,4-
dione) in or on the raw agricu1tura1
commodities:
Parts per
Commodity million
Parts per
Grape .................................................................. 2.5 Commodity million
(2) Tolerances are established for residues residues of the herbicide mesosulfuron-
of the herbicide flufenpyr-ethyl; acetic acid, methyl, (methyl 2- [[[[(4,6-dimethoxy-2-
[2-chloro-4-fluoro-5-[5- methyl-6-oxo-4- pyrimidinyl) amino]carbonyl]amino]sulfonyl] -
(trifluoromethyl)-1- (6H)-pyridazinyl]- 4- [[(methylsulfonyl)amino] meth-
phenoxy]-ethyl ester], and its metabolite, S- yl]benzoate]) in or on the following raw
3153 acid- 4-OH; [2-chloro-4-hydroxy-5-[5- agricultural commodities:
methyl- 6- oxo-4-(trifluoromethyl)-1-
(6H)-
pyridazinyl]-phenoxy]-acetic acid, free and
conjugated, in or on the following Parts per
commodities: Commodity million
(2) Tolerances are established for residues (b) Section 18 emergency exemptions. Time-
of the herbicide limited tolerances are established for residues
propoxycarbazone methyl 2-[[[(4,5- dihydro- of the fungicide cyazofamid, including its
4-methyl-5-oxo-3-propoxy-1H- metabolites and degradates, in or on the
1,2,4- triazol-1- commodities in the following table.
yl)carbonyl]amino]sulfonyl]benzoate in/on Compliance with the tolerance levels specified
the following raw agricultural commodities: in the following table is to be determined
by measuring only the sum of cyazofamid,
4-chloro-2-cyano-N,N-di-
methyl-5-(4-methylphenyl)-1H-imid- azole-1-
sulfonamide and its metabolite CCIM, 4- Commodity Parts per
million
chloro-5-(4-methylphenyl)-1H- imidazole-2-
carbonitrile, calculated as the stoichiometric Artichoke, globe, import1 ..................................... 0.7
Asparagus1 .......................................................... 0.05
equivalent of cyazofamid, resulting from use of Banana (import) .................................................. 3.0
the pesticide under FIFRA section 18 Grape (import) ..................................................... 1.0
emergency exemptions. The tolerances expire Hop, dried cones ................................................ 50
Vegetable, fruiting , crop group 81 .......................
and are revoked on the date specified in the 1.2
table.
1
No U.S. registration as of December 1, 2010.
Parts per
Commodity million
[69 FR 58299, Sept. 30, 2004, as amended at 73 FR Berry, low growing, except strawberry, subgroup
21839, Apr. 23, 2008; 74 FR 32453, July 8, 2009; 75 13-07H .......................................................... 0.2
FR 40751, July 14, 2010; 77 FR 4252, Jan. 27, 2012; 77 Brassica, head and stem, subgroup 5A .............. 1.4
FR 59119, Sept. 26, 2012] Brassica, leafy greens, subgroup 5B .................. 15.0
Cotton, undelinted seed ...................................... 0.4
Cotton, gin byproducts ........................................ 8.0
§ 180.602 Spiroxamine; tolerances for residues. Fruit, small vine climbing, except fuzzy kiwifruit,
subgroup 13-07F ........................................... 0.9
(a) General. Tolerances are established for Grape, raisin ........................................................ 2.5
residues of the fungicide spiroxamine, Onion, bulb, subgroup 3-07A ..............................
Onion, green, subgroup 3-07B ............................
0.15
5.0
including its metabolites and degradates, in or Peach ................................................................. 1.0
on the commodities in the table below. Potato, chips ....................................................... 0.1
Compliance with the tolerance levels specified Potato, granules/flakes ....................................... 0.15
in the following table is to be determined by
Rice, grain .......................................................... 9.0
Tea, dried1 ........................................................... 50
measuring only spiroxamine, [(8- (1,1- Tomato, paste ...................................................... 1.0
dimethylethyl)-N-ethyl-N-propyl- Turnip, greens ..................................................... 15.0
1,4- dioxaspiro[4,5]decane-2- Vegetable, fruiting, group 8 ..................................
Vegetable, cucurbit, group 9 ...............................
0.7
0.5
Vegetable, leafy, except Brassica, group 4 ......... 5.0
Vegetable, tuberous and corm, subgroup 1C ...... 0.05
Parts per resulting from use of the pesticide pursuant to
Commodity million FIFRA section 18 emergency exemptions.
Watercress ........................................................... Compliance with the tolerance levels specified
1
There are no U.S. registrations for tea.
8.0
below is to be determined by measuring only
the sum of dinotefuran and its metabolites DN,
(2) Tolerances are established for residues 1- methyl-3-(tetrahydro-3-
of dinotefuran, (_RS)-1-methyl-2- nitro-3- furylmethyl)guanidine, and UF, 1- methyl-3-
((tetrahydro-3- furanyl)methyl)guanidine, (tetrahydro-3- furylmethyl)urea, calculated as
including its metabolites and degradates, in or the stoichiometric equivalent of dinotefuran, in
on the commodities listed in the following or on the commodities listed in the table
table. Compliance with the tolerance levels below. The tolerances expire and are revoked
specified below is to be determined by on the dates specified in the table.
measuring only the sum of dinotefuran, (RS)-
1-methyl-2-nitro-3- ((tetrahydro-3-
furanyl)methyl)guanidine in or on the
commodities listed in the table below:
Expiration/
Parts per
Commodity revocation
million date
Parts per Fruit, pome, Group 11 .................... 2.0 12/31/15
Commodity million Fruit, stone, Group 12 .................... 2.0 12/31/15
the herbicide, penoxsulam (2- (2,2- Corn, field, stover ................................................ 8.0
difluoroethoxy)-N-(5,8- dimethoxy[1,2,4] Corn, pop, grain ................................................... 0.02
triazolo[1,5- Corn, pop, stover.................................................. 4.0
c]pyrimidin-2-yl)-6-
Corn, sweet, forage ............................................. 17
Corn, sweet, kernel plus cob with husks re-
(trifluoromethyl)benzenesulfonamide) in/on moved ............................................................. 0.02
the following raw agricultural commodities: Corn, sweet, stover ............................................. 12
Cotton, gin byproducts ........................................ 15
Cotton, undelinted seed ...................................... 0.50
Cowpea, forage ................................................... 30
Cowpea, hay ........................................................ 86
Parts per Leaf petiole subgroup 4B ................................... 6.0
Commodity million Leafy greens subgroup 4A .................................. 12
Pea, dry, seed .................................................... 0.20
Almond, hulls ....................................................... 0.01
Fish .................................................................... 0.01 Peppermint, tops ................................................ 45
Spearmint, tops ................................................... 45
Fish, shellfish, crustacean .................................. 0.01
Fish, shellfish, mollusc ....................................... 0.02 Tea, dry ............................................................... 40
Grape .................................................................. 0.01 Tomato, paste ...................................................... 0.80
Nut, tree, group 14 ............................................. 0.01 Vegetable, cucurbit, group 9 ............................... 0.10
Pistachio ............................................................. 0.01 Vegetable, fruiting, group 8 .................................. 0.45
Rice, grain .......................................................... 0.02 Vegetable, tuberous and corm, subgroup 1C ...... 0.02
Rice, straw .......................................................... 0.50
(2) Tolerances are established for residues
(b) Section 18 emergency exemptions. of the insecticide/miticide spiromesifen,
[Reserved] including its metabolites and degradates, in or
(c) Tolerances with regional registrations. on the commodities listed below. Compliance
[Reserved] with the tolerance levels specified below is to
(d) Indirect or inadvertent residues. [Reserved] be determined by measuring only the sum of
[69 FR 57197, Sept. 24 , 2004, as amended at 72 FR spiromesifen [2-oxo-3-(2,4,6-
40763, July 25, 2007; 74 FR 18648, Apr. 24, 2009] trimethylphenyl)-1-oxaspiro[4.4]non-3- en-4-
§ 180.607 Spiromesifen; tolerances for residues. yl 3,3-dimethylbutanoate] and its metabolites
containing the 4-hydroxy-
(a) General. (1) Tolerances are established 3- (2,4,6-trimethylphenyl)-1-
for residues of the insecticide/ miticide oxaspiro[4.4]non-3-en-2-one and 4-hy-
spiromesifen, including its metabolites and droxy-3-[4-(hydroxymethyl)-2,6-
degradates, in or on the commodities listed dimethylphenyl]-1-oxaspiro[4.4]non-3- en-2-
below. Compliance with the tolerance levels one moieties, calculated as the stoichiometric
specified below is to be determined by equivalent of spiromesifen, in the following
measuring only the sum of spiromesifen [2- livestock commodities:
oxo-3- (2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-4-yl 3,3-
dimethylbutanoate] and 4-hydroxy-3- (2,4,6-
trimethylphenyl)-1- oxaspiro[4.4]non-3-en-2- Parts per
one, calculated as the stoichiometric Commodity million
equivalent of spiromesifen, in or on the
following primary crop commodities: Cattle, fat .............................................................
Cattle, meat .........................................................
0.10
0.02
Cattle, meat byproducts ...................................... 0.20
Goat, fat ............................................................... 0.10
Goat, meat ........................................................... 0.02
Goat, meat byproducts ........................................ 0.20
Horse, fat ........................................................... 0.10
Horse, meat......................................................... 0.02
Horse, meat byproducts ..................................... 0.20
Milk ..................................................................... 0.01
Parts per Milk, fat ............................................................... 0.25
Commodity million Sheep, fat ............................................................ 0.10
Sheep, meat ........................................................ 0.02
Bean, dry ............................................................ 0.02 Sheep, meat byproducts ..................................... 0.20
Bean, edible podded .......................................... 0.80
Bean, succulent...................................................
Berry and small fruit, low growing berry, sub-
0.10 (b) Section 18 emergency exemptions. Time-
group 13-07G .................................................. 2.0 limited tolerances specified in the following
Brassica, head and stem, subgroup 5A............... 2.0 table are established for residues of the
Brassica, leafy greens, subgroup 5B .................. 12 insecticide/miticide spiromesifen, including its
metabolites
Corn, field, forage ................................................ 5.0
Corn, field, grain ................................................. 0.02
and degradates, In or on the commodities Parts per
listed below. Compliance with the tolerance Commodity million
levels specified below is to be determined by Wheat, straw ........................................................ 0.25
measuring only the sum of spiromesifen [2-
oxo-3-(2,4,6- trimethylphenyl)-1-
[70 FR 43283, July 27, 2005, as amended at 72 FR
oxaspiro[4.4]non-3- en-4-yl 3,3- 3079, Jan. 24, 2007; 73 FR 13140, Mar. 12, 2008; 73 FR
dimethylbutanoate] and 4- hydroxy-3-(2,4,6- 52606, Sept. 10, 2008; 74 FR 8492, Feb. 25, 2009; 74
trimethylphenyl)-1- oxaspiro[4.4]non-3-en-2- FR 15886, Apr. 8, 2009; 75 FR 5526, Feb. 3, 2010; 75
one, calculated as the stoichiometric FR 53586, Sept. 1, 2010; 76 FR 81396, Dec. 28, 2011;
equivalent of spiromesifen, in or on the 78 FR 3337, Jan. 16, 2013]
specified agricultural commodities, resulting
from use of the pesticide pursuant to FIFRA
section 18 emergency exemptions. The § 180.608 Spirodiclofen; tolerances for residues.
tolerances expire and are revoked on the date General. (1) Tolerances are established for
specified in the table. residues of spirodiclofen, including its
metabolites and degradates, in or on the
Expiration/
commodities listed below. Compliance with
Commodity Parts per
million revocation the following tolerance levels is to be
date determined by measuring only spirodiclofen
Soybean, forage ............................. 30 12/31/14 (3-(2,4- dichlorophenyl)-2-oxo-1-
Soybean, hay ................................. 86 12/31/14 oxaspiro[4.5]dec-3-en-4-yl 2,2-
Soybean, seed ............................... 0.02 12/31/14 dimethylbutanoate).
(c) Tolerances with regional registrations.
[Reserved]
(d) Indirect or inadvertent residues.
Tolerances are established for the Inadvertent
Parts per
Commodity
million
or indirect residues of the in- secticide/miticide
spiromesifen, including its metabolites and Almond, hulls ....................................................... 20.0
degradates, in or on the commodities listed Apple, wet pomace ............................................... 2.4
[74 FR 67113, Dec. 18, 2009, as amended at 75 FR [70 FR 46428, Aug. 10, 2005, as amended at 75 FR
60333, Sept. 30, 2010; 76 FR 50898, Aug. 17, 2011; 77 17584, Apr. 7, 2010]
FR 26471, May 4, 2012; 77 FR 64915, Oct. 24, 2012; 79 § 180.611 Pinoxaden; tolerances for residues.
FR 20105, Apr. 11, 2014]
General. (1) Tolerances are established for
§180.610 Aminopyralid; tolerances for residues.
the combined residues of pinoxaden (8-
(2,6-diethyl-4-
General. (1) Tolerances are established for methylphenyl)-1,2,4,5-tetrahydro-7-oxo- 7H-
residues of the herbicide aminopyralid, 4- pyrazolo[1,2-d][1,4,5] oxadiazepin-9- yl 2,2-
amino-3,6-dichloro-2- pyridinecarboxylic acid, dimethylpropanoate), and its metabolites
including its metabolites and degradates, in or 8-(2,6-diethyl-4-methyl-
on the commodities in the table below. phenyl)-tetrahydro-pyrazolo[1,2-
Compliance with the tolerance levels specified d][1,4,5]oxadiazepine-7,9-dione (M2), and
below is to be determined by measuring only free and conjugated forms of 8-(2,6- diethyl-
free and conjugated aminopyralid. 4-hydroxymethyl-phenyl)- tetrahydro-
pyrazolo[1,2-d][1,4,5] oxadiazepine-7,9-dione
(M4), and 4-(7,9- dioxo-hexahydro-
pyrazolo[1,2-d] [1,4,5]oxadiazepin-8-yl)-3,5-
Parts per
diethyl-ben- zoic acid (M6), calculated as
Commodity million pinoxaden, in/on the following commodities:
Corn, field, forage ............................................... 0.30
Corn, field, grain ................................................. 0.20
Corn, field, stover ............................................... 0.20
Grain, aspirated fractions ................................... 0.2
Grass, forage ..................................................... 25
Grass, hay .......................................................... 50
Wheat, bran ......................................................... 0.1
Parts per
Wheat, forage ....................................................... 2.0 Commodity million
Wheat, grain ........................................................ 0.04
Wheat, hay .......................................................... 4.0 Barley, bran ........................................................ 1.6
Wheat, straw ....................................................... 0.25 Barley, grain ....................................................... 0.9
Barley, hay .......................................................... 1.5
(2) Tolerances are established for residues Barley, straw ....................................................... 1.0
of the herbicide aminopyralid, 4- amino-3,6- Egg ..................................................................... 0.06
dichloro-2- pyridinecarboxylic acid, including Poultry, fat ..........................................................
Poultry, meat ......................................................
0.06
its
0.06
Poultry, meat byproducts .................................... 0.06
Commodity Parts per Commodity Parts per
million million
(2) Tolerances are established for the [70 FR 51614, Aug. 31, 2005, as amended at 71 FR
residues of the insecticide flonicamid, 15608, Mar. 29, 2006; 73 FR 17923, Apr. 2, 2008; 77
including its metabolites and degradates, in or FR 67776, Nov. 14, 2012; 78 FR 75266, Dec. 11, 2013]
on the commodities in the table below. § 180.614 Kasugamycin; tolerances for residues.
Compliance with the tolerance levels specified General. Tolerances are established for
below is to be determined by measuring only residues of kasugamycin, 3-
the sum of flonicamid, N- O-[2-amino-4-
(cyanomethyl)-4-(trifluoromethyl)-3- [(carboxyiminomethyl)amino]-2,3,4,6-
pyridinecarboxamide, and its metabolites, tetradeoxy-a-D-arabino- hexopyranosyl]-D-
TFNA (4- chiro-inositol in or on the following raw
trifluoromethylnicotinic acid), and TFNA-AM agricultural commodity:
(4-
trifluoromethylnicotinamide), calculated as the
Stoichiometric equivalent of flonicamid, in or
on the following commodities.
Parts per
Commodity million
Parts per
Commodity million Vegetable, fruiting, group 81 ................................ 0.04
1
There is no U.S. registration as of September , 2005.
Cattle, fat ............................................................. 0.03
Cattle, meat ......................................................... 0.08 Section 18 emergency exemptions. Time-limited
Cattle, meat byproducts ...................................... 0.08 tolerances specified in the following table are
Egg .....................................................................
Goat, fat ...............................................................
0.04
0.03
established for residues of kasugamycin, 3-O-
Goat, meat ........................................................... 0.08 [2-amino-
Goat, meat byproducts ........................................ 0.08 4- [(carboxyiminomethyl)amino]-
Hog, fat ..............................................................
Hog, meat ..........................................................
0.03
0.03
2,3,4,6- tetradeoxy-a-D-arabino-
Hog, meat byproducts ........................................ 0.03 hexopyranosyl]-D-chiro-inositol in or on the
Horse, fat ........................................................... 0.03 specified agricultural commodities, resulting
Horse, meat......................................................... 0.08 from use of the pesticide pursuant to FFIFRA
section 18 emergency exemptions. The
Horse, meat byproducts ..................................... 0.08
Milk ..................................................................... 0.05
Poultry, fat .......................................................... 0.03 tolerances expire and are revoked on the date
Poultry, meat ...................................................... 0.03 specified in the table.
Poultry, meat byproducts .................................... 0.03
Sheep, fat ............................................................ 0.03
Parts per
Commodity million
Parts per
Commodity million
agricultural commodities:
11
[73 FR 44162, July 30, 2008] Cattle, meat byproducts ...................................... 0.02
Goat, meat byproducts ........................................ 0.02
§ 180.643 Uniconazole; tolerances for residues. Horse, meat byproducts ..................................... 0.02
General. Tolerances are established for
Sheep, meat byproducts ..................................... 0.02
Parts per
Commodity million
Parts per
Commodity million
Parts per
Melon subgroup 9A ............................................ 0.02 Commodity million
Pepper, bell ........................................................ 0.02
Pepper, non-bell ................................................. 0.02 Almond, hulls ...................................................... 0.15
Rice, grain .......................................................... 0.02 Banana1 ............................................................. 0.01
Tomato ............................................................... 0.02 Coffee, green bean 1 .......................................... 0.01
Vegetable, tuberous and corm, subgroup 1C ...... 0.02 Fruit, citrus, group 10-10 .................................... 0.01
Fruit, pome, group 11-10..................................... 0.01
Section 18 emergency exemptions. [Reserved] Fruit, stone, group 12 ......................................... 0.01
Grape ...................................................................
Tolerances with regional registrations. Nut, tree, group 14 .............................................
0.01
0.01
[Reserved] Olive ..................................................................... 0.01
Indirect or inadvertent residues. [Reserved] Palm, oil 1 ........................................................... 0.03
Pistachio ............................................................ 0.01
[75 FR 81884, Dec. 29, 2010, as amended at 78 FR Sugarcane, refined sugar1 ................................. 0.01
44444, July 24, 2013] 1
No U.S. Registrations as of 12/02/2013.
2
Tolerance without a corresponding U.S. registration.
§ 180.652 Ethiprole; tolerances for residues.
Section 18 emergency exemptions. [Reserved]
General. Tolerances (without U.S. Tolerances with regional registrations.
registrations) are established for residues of [Reserved]
the insecticide ethiprole, including its Indirect or inadvertent residues. [Reserved]
metabolites and degradate, in or on the [76 FR 18905, Apr. 6, 2011, as amended at 79 FR 4630,
following commodities listed in the table. Jan. 29, 2014]
Compliance with the tolerance levels specified
§ 180.654 Isopyrazam; tolerances for residues.
in the table is to be determined by measuring
General. Tolerances are established for
only ethiprole [5-amino-1-[2,6-dichloro- 4-
(trifluoromethyl)phenyl]-4-[(ethyl)- sulfinyl]- residues of the fungicide isopyrazam,
1ff-pyrazole-3-carbonitrile], in or on the including its metabolites and degradates, in or
following commodities: on the commodities listed in the following
table. Compliance with the tolerance levels
specified in the following table is to be
determined by measuring only isopyrazam (3-
(difluoromethyl)-1-meth- yl-N-[1,2,3,4-
tetrahydro-9-(1- methylethyl)-1,4-methano-
naphthalen- 5-yl]-1ff-pyrazole-4-
Commodity Parts per
million carboxamide), as
the sum of its syn-isomer (3-
Rice, grain1 ......................................................... 1.7
30
1
There are no U.S. registrations for rice and tea.
[76 FR 61596, Oct. 5, 2011, as amended at 78 FR § 180.657 Metaflumizone; tolerances for residues.
78745, Dec. 27, 2013] General. Tolerances are established for
§ 180.655 Flazasulfuron; tolerances for residues. residues of the insecticide metaflumizone,
General. Tolerances are established for including its metabolites and degradates, in or
residues of flazasulfuron, including its on the commodities listed in the following
metabolites and degradates, in or on the table. Compliance with the tolerance levels
commodities in the table below. Compliance specified in the following table is to be
with the tolerance levels specified below is to determined by measuring only the sum of
be determined by measuring only metaflumizone (E and Z isomers; 2- [2-(4-
flazasulfuron (N-[[(4,6-dimethoxy-2- cyanophenyl)-1-[3- (trifluoromethyl)
pyrimidinyl)amino]carbonyl]-3- phenyl]ethylidene]- N-[4-
(trifluoromethyl)-2- pyridinesulfonamide). (trifluoromethoxy)phenyl]
hydrazinecarboxamide) and its metabolite
4-{2-oxo-2-[3-(trifluoromethyl)
phenyl]ethyl}-benzonitrile, calculated as the
stoichiometric equivalent of metaflumizone, in
Parts per
or on the following commodities:
Commodity million
........................................................................ 3.0
Vegetable, tuber and corm, subgroup 1C ........... 0.06
Wheat, forage....................................................... 40
Parts per Wheat, grain ........................................................ 0.15
Commodity Wheat, hay .......................................................... 80
million
Wheat, milled byproducts .................................... 0.30
Alfalfa, forage ...................................................... 7.0 Wheat, straw ....................................................... 1.0
Alfalfa, hay ........................................................... 20
Almond, hulls .......................................................
Apple, wet pomace ...............................................
6.0
1.5
(2) Tolerances are established for residues
Barley, grain ....................................................... 0.15 of penthiopyrad, including its metabolites and
Barley, hay .......................................................... 80 degradates, in or on the commodities in the
Barley, milled byproducts ................................... 0.90 table below. Compliance with the tolerance
levels specified below is to be determined by
Barley, straw ....................................................... 1.0
Beet, sugar, dried pulp ....................................... 1.5
Beet, sugar, roots ............................................... 0.5 measuring only the sum of penthiopyrad (N-
Berry, low growing, subgroup 13-07G ................. 3.0 [2-(1,3-dimethylbutyl)-
Brassica, head and stem, subgroup 5A...............
Brassica, leafy greens, subgroup 5B .................. 50
5.0
thienyl]-1-methyl-3- (trifluoromethyl)-1H-
Buckwheat, grain ................................................ 0.15 pyrazole-4- carboxamide) and its metabolite
Canola ................................................................ 1.5 (1- methyl-3-trifluoromethyl-1H-pyrazole-
Corn, field, forage ................................................ 40 carboxamide), calculated as the stoichiometric
equivalent of penthiopyrad, in or on the
Corn, field, grain ................................................. 0.01
Corn, field, refined oil ......................................... 0.05
Corn, field, stover ............................................... 15 commodity.
Corn, pop, grain .................................................. 0.01
Corn, sweet, kernel plus cob with husks re-
moved ............................................................. 0.01
Cotton, seed ....................................................... 1.5
Cotton, gin byproducts ....................................... 15 Parts per
Commodity million
Fruit, pome, group 11-10 ..................................... 0.50
Fruit, stone, group 12 ......................................... 4.0
Cattle, fat ............................................................. 0.03
Grain, aspirated fractions ................................... 30
Millet, spp ............................................................. Cattle, meat ......................................................... 0.03
0.80
Nut, tree, group 14 ............................................. 0.06 Cattle, meat byproducts ...................................... 0.09
Oat, forage .......................................................... 40 Goat, fat .............................................................. 0.03
Oat, grain ............................................................ 0.15 Goat, meat .......................................................... 0.03
Oat, hay............................................................... 80 Goat, meat byproducts ........................................ 0.09
Oat, straw ........................................................... 1.0 Horse, fat ........................................................... 0.03
Pea and bean, dried shelled, except soybean, Horse, meat......................................................... 0.03
subgroup 6C .................................................... 0.40 Horse, meat byproducts ..................................... 0.09
Peanut ................................................................ 0.04 Milk ..................................................................... 0.02
Peanut, hay ........................................................ 30 Sheep, fat ............................................................ 0.03
Peanut, refined oil .............................................. 0.06 Sheep, meat ........................................................ 0.03
Pistachio ............................................................. 0.06 Sheep, meat byproducts ..................................... 0.09
Potato, processed potato waste .......................... 0.20
Rye, forage.......................................................... 40 Section 18 emergency exemptions. [Reserved]
Tolerances with regional registrations.
Rye, grain ........................................................... 0.15
Rye, straw ........................................................... 1.0
Sorghum, forage.................................................. 40 [Reserved]
Sorghum, grain, grain .......................................... 0.80 Indirect or inadvertent residues. [Reserved]
Sorghum, stover ................................................. 15
Soybean, seed .................................................... 0.40 [77 FR 14297, Mar. 9, 2012]
Sunflower, seed .................................................. 1.5
Teosinte, grain .................................................... 0.15
Tomato, paste ..................................................... 3.5
§ 180.659 Pyroxasulfone; tolerances for residues. Parts per
Commodity
General. (1) Tolerances are established for million
with the tolerance levels specified below is to Soybean, seed ......................................... .......... 0.06
be determined by measuring only the sum of
pyroxasulfone, 3-[[[5- (difluoromethoxy)-1- Tolerances are established for residues of
methyl-3- (trifluoromethyl)-1_ff-pyrazol-4- the herbicide pyroxasulfone, including its
yl]methyl]sulfonyl]-4,5-dihydro-5,5- metabolites and degradates, in or on the
dimethylisoxazole, and its metabolites, 5- commodities in the following table.
(difluoromethoxy)-1-methyl-3- Compliance with the tolerance levels specified
(trifluoromethyl)-1_ff-pyrazol-4- in the following table is to be determined by
yl]methanesulfonic acid (M-1); 5- measuring only the sum of pyroxasulfone [3-
(difluoromethoxy)-1-methyl-3- [[[5-
(trifluoromethyl)-1_ff-pyrazol-4-car- boxylic (difluoromethoxy)-1-methyl-3-
acid (M-3); and [5- (trifluoromethyl)-1H-pyrazol-4-
(difluoromethoxy)-3-(trifluoromethyl)- 1.ff- yl]methyl]sulfonyl]-4,5-dihydro-5,5-
pyrazol-4-yl]methanesulfonic acid dimethylisoxazole] and its metabolites [5-
(M-25), calculated as the stoichiometric (difluoromethoxy)-1-methyl-3-
equivalent of pyroxasulfone, in or on the (trifluoromethyl)-1H-pyrazol-4-
commodity. yl]methanesulfonic acid (M-1) and 5-
(difluoromethoxy)-1-methyl-3-
(trifluoromethyl)-1H-pyrazol-4-car- boxylic
acid (M-3), calculated as the stoichiometric
Commodity Parts per equivalent of pyroxasulfone, in or on the
million
commodity.
Corn, field, forage .............................................. 0.09
Corn, field, stover ............................................. 0.15
Corn, pop, stover ............................................... 0.15
Parts per
Corn, sweet, forage .......................................... 0.10 Commodity million
Corn, sweet, stover .......................................... 0.15
Cotton, gin byproducts ..................................... 0.20 Milk ................................................................... 0.003
Soybean, forage ............................................... 1.0
Section 18 emergency exemptions. [Reserved] Parts per
Tolerances with regional registrations. Commodity million
[Reserved] Beet, sugar, root ................................................. 0.04
Indirect or inadvertent residues. [Reserved] Cherry ................................................................ 0.60
[77 FR 12213, Feb. 29, 2012, as amended at 78 FR Grape, wine ........................................................ 2.0
13257, Feb. 27, 2013; 78 FR 46279, July 31, 2013; 79
Nut, tree, group 14 ............................................. 0.05
Peanut ................................................................ 0.02
FR 34633, June 18, 2014] Pistachio ............................................................. 0.05
§ 180.660 Pyriofenone; tolerances for residues. Potato ................................................................. 0.02
Parts per
Commodity million
Parts per
Commodity million
Grape1 ................................................................ 0.30
Grape, raisin1 ..................................................... 0.50 Cattle, fat ............................................................ 0.11
1
There are no U.S. registrations for grape and grape, raisin. Cattle, meat ........................................................ 0.15
Cattle, meat byproducts ..................................... 1.1
Section 18 emergency exemptions. [Reserved]
Egg ..................................................................... 0.25
Goat, fat ............................................................. 0.11
Tolerances with regional registrations. Goat, meat ......................................................... 0.15
[Reserved] Goat, meat byproducts ....................................... 1.1
Indirect or inadvertent residues. [Reserved] Hog, fat ............................................................... 0.05
Hog, meat ........................................................... 0.05
[77 FR 13506, Mar. 7, 2012] Hog, meat byproducts ........................................ 0.70
Horse, fat ............................................................ 0.11
§ 180.661 Fluopyram; tolerances for residues.
Horse, meat ........................................................ 0.15
General. (1) Tolerances are established for Horse, meat byproducts ..................................... 1.1
residues of the fungicide Fluopyram, N-[2- Milk ..................................................................... 0.07
[3-chloro-5- Poultry, fat .......................................................... 0.20
(trifluoromethyl)-2-pyridinyl]ethyl]-2-
Poultry, meat ...................................................... 0.15
Poultry, meat byproducts .................................... 0.60
(trifluoromethyl)benzamide, including its Sheep, fat ........................................................... 0.11
metabolites and degradates in or on the Sheep, meat ....................................................... 0.15
commodities in the table below. Compliance Sheep, meat byproducts .................................... 1.1
with the tolerance levels specified in the table Section 18 emergency exemptions. [Reserved]
is to be determined by measuring only Tolerances with regional registrations.
fluopyram in or on the commodity. [Reserved]
Indirect or inadvertent residues. It is
recommended that tolerances be established
for indirect or inadvertent residues of fungicide
fluopyram, N-[2- [3-chloro-5-
(trifluoromethyl)-2- pyridinyl]ethyl]-2-
Commodity Parts per (trifluoromethyl)benzamide, including its
million metabolites and degradates, in or on the
Almond, hull......................................................... 8.0 commodities in the table below. Compliance
Apple ................................................................... 0.30 with the tolerance levels
Apple, wet pomace .............................................. 0.60
Banana1 .............................................................. 1.0
Bean, dry ............................................................ 0.09
specified In the table Is to be determined by Parts per
measuring only fluopyram in or on the
Commodity million
commodity. Sheep, meat ........................................................ 0.02
Sheep, meat byproducts ..................................... 0.04
Parts per Sugarcane, cane ................................................. 0.8
Commodity million Sugarcane, molasses .......................................... 2.5
Wheat, bran ........................................................ 6.0
Alfalfa, forage ...................................................... 0.45 Wheat, forage ...................................................... 1.0
Alfalfa, hay ........................................................... 1.1 Wheat, grain ........................................................ 4.0
Canola, seed ...................................................... 1.8 Wheat, hay .......................................................... 1.5
Cotton, gin byproducts ....................................... 0.05 Wheat, middlings ................................................. 10.5
Cotton, undelinted seed ..................................... 0.01 Wheat, straw ........................................................ 0.9
Grain, cereal, forage, fodder and straw, group
Section 18 emergency exemptions. [Reserved]
16, except rice; forage ...................................... 4.0
Grain, cereal, forage, fodder and straw, group
16, except rice; hay, straw and stover ............. 7.0 Tolerances with regional registrations.
Grain, cereal, group 15, except rice .................... 1.5 [Reserved]
Soybean, forage ................................................. 4.0 Indirect or inadvertent residues. [Reserved]
Soybean, hay ...................................................... 15
Soybean, seed .................................................... 0.10 [77 FR 12745, Mar. 2, 2012, as amended at 77 FR
60919, Oct. 3, 2012]
[77 FR 10975, Feb. 24 , 2012]
§ 180.663 Ametoctradin; tolerances for residues.
§ 180.662 Trinexapac-ethyl; tolerances for residues. General. Tolerances are established for
residues of the fungicide ametoctradin,
General. Tolerances are established for including its metabolites and degradates, in or
residues of the plant growth inhibitor, on the commodities in the following table.
trinexapac-ethyl, including its metabolites and Compliance with the tolerance levels specified
degradates, in or on the commodities in the in the following table is to be determined by
table below. Compliance with the tolerance measuring only ametoctradin (5-ethyl-6-
levels specified below is to be determined by octyl[1,2,4]triazolo[1,5-a]pyrimidin-7- amine).
measuring both trinexapac-ethyl, ethyl 4-
(cyclopropylhydroxymethylene)-3,5-
dioxocyclohexanecarboxylate and the
associated metabolite, trinexpac, 4-
(cyclopropylhydroxymethylene)-3,5-
dioxocyclohexanecarboxylic acid, calculated as
the stoichiometric equivalent of trinexapac-
ethyl, in or on the commodity.
Parts per
Commodity million
Parts per
Commodity
Parts per million
Commodity million
Almond, hulls .................................................... 4.0
Barley, grain ..................................................... 0.01 Apple, wet pomace ........................................... 2.0
Barley, hay ........................................................ 0.04 Beet, sugar ....................................................... 0.1
Barley, straw .................................................... 0.01 Beet, sugar, dried pulp ..................................... 0.1
Canola, seed .................................................... 0.01 Beet, sugar, tops .............................................. 7.0
Corn, field, forage ............................................. 0.01 Berry, low growing, subgroup 13-07G ............... 4.0
Corn, field, grain ............................................... 0.01 Bushberry, subgroup 13-07B............................. 7.0
Corn, field, stover ............................................. 0.01 Caneberry, subgroup 13-07A ........................... 5.0
Corn, pop, grain ............................................... 0.01 Cattle, fat .......................................................... 0.05
Corn, pop, stover .............................................. 0.01 Cattle, meat ...................................................... 0.01
Corn, sweet, forage .......................................... 0.01 Cattle, meat byproducts ................................... 0.03
Corn, sweet, kernel plus cob with husks removed Corn, field, grain ............................................... 0.01
..................................................................... 0.01 Corn, oil ............................................................ 0.03
Corn, sweet, stover .......................................... 0.01 Corn, pop, grain ................................................ 0.01
Oat, forage ....................................................... 0.015 Corn, sweet, kernels plus cobs with husks
Oat, grain ......................................................... 0.01 removed ....................................................... 0.15
Oat, hay ............................................................ 0.06 Cotton, gin byproducts ..................................... 0.01
Parts per termlned by measuring only fluxapyroxad, 3-
Commodity million (difluoromethyl)-1- methyl-N-(3',4',5'-
Cotton, undelinted seed ................................... 0.01 trifluoro[1,1'- biphenyl]-2-yl)-1H-pyrazole-4-
Egg ................................................................... 0.002 carboxamlde in or on the commodity.
Fish-freshwater finfish ...................................... 0.01
Fish-shellfish, crustacean ................................. 0.01
Fruit, pome, group 11 ....................................... 0.8
Parts per
Fruit, small, vine climbing, except fuzzy Commodity million
kiwifruit, subgroup 13-07F .............................. 2.0
Fruit, stone, group 12-12 .................................. 3.0 Nongrass animal feeds, group18 ....................... 0.30
Goat, fat ............................................................ 0.05 Peppermint, tops ................................................ 0.01
Goat, meat ........................................................ 0.01
Spearmint, tops ................................................... 0.01
Goat, meat byproducts ..................................... 0.03
Grain, aspirated fractions ................................. 20.0
Grain, cereal, forage, fodder and straw, group [77 FR 28275, May 14, 2012, as amended at 77 FR
16 .................................................................. 20 46307, Aug. 3, 2012; 79 FR 10677, Feb. 26, 2014]
Grain, cereal, group 15, (except corn, field,
grain; except corn, pop, grain; except corn, § 180.667 Cyflufenamid, tolerance for residues.
kernels plus cobs with husks removed; ex-
General. Tolerances are established for
residues of the fungicide cyflufenamid,
cept rice; except wheat................................... 3.0
Grape, raisin ..................................................... 5.7
Hog, meat byproducts ...................................... 0.01 including its metabolites and degradates, in or
Horse, fat .......................................................... 0.05 on the commodities in the table below.
Compliance with the tolerance levels specified
Horse, meat....................................................... 0.01
Horse, meat byproducts ................................... 0.03
Milk ................................................................... 0.005 below is to be determined by measuring only
Nut, tree, group 14-12 ...................................... 0.06 cyflufenamid, [A^-Z^-
Oilseeds, group 20 (except cottonseed) ...........
Pea and bean, dried shelled except soybean,
0.9
N-
subgroup 6C .................................................. 0.4 [[(cyclopropylmethoxy)amino][2,3- difluoro-6-
Pea and bean, succulent shelled, subgroup 6B 0.5 (trifluoromethyl)phenyl]
Peanut .............................................................. 0.01 methylene]benzeneacetamide.
Peanut, refined oil ............................................ 0.02
Plum, prune, dried ............................................ 3.0
Potato, wet peel ................................................ 0.1
Rice, bran ......................................................... 4.5
Rice, bran ......................................................... 8.5
Rice, grain ........................................................ 5.0 Parts per
Commodity
Rice, hulls ......................................................... 8.0 million
Rice, hulls ......................................................... 15.0
Sheep, fat ......................................................... 0.05 Apple, wet pomace .............................................. 0.10
Sheep, meat ..................................................... 0.01 Berry, low growing, subgroup 13-07G, except
Sheep, meat byproducts .................................. 0.03 cranberry ......................................................... 0.20
Soybean, hulls .................................................. 0.3 Fruit, pome, group 11 ......................................... 0.06
Soybean, seed .................................................. 0.15 Fruit, small vine climbing, except fuzzy kiwifruit,
Sugarcane, cane .............................................. 3.0 subgroup 13-07F ............................................. 0.15
Vegetable, brassica leafy, group 5 ..................... 4.0 Grape, raisin ....................................................... 0.30
Vegetable, bulb, group 3-07 ............................... 1.5 Vegetable, cucurbit, group 9 ............................... 0.07
Vegetable, cucurbit, group 9 ............................. 0.50
Vegetable, foliage of legume, group 7 ................ 30 Section 18 emergency exemptions. [Reserved]
Vegetables, fruiting, group 8 .............................
Vegetable, leafy, except brassica, group 4.........
0.7
30
Tolerances with regional registrations.
Vegetable, legume, edible podded, subgroup [Reserved]
6A ................................................................... 2.0 Indirect or inadvertent residues. [Reserved]
Vegetable, root, except sugarbeet, subgroup
1B .................................................................. 0.90 [77 FR 38210, June 27, 2012]
Vegetable, tuberous and corm, subgroup 1C ... 0.02
Wheat, bran ....................................................... 0.6 § 180.668 Sulfoxaflor; tolerances for residues.
General. Tolerances are established for
Wheat, grain ...................................................... 0.3
Parts per
Commodity million
Bicyclo[3.1.1]hept-2-ene, 2,6,6-trimethyl-,
homopolymer (Alpha-pinene, homopolymer)(CAS
Reg. No. 25766-18-1). Surfactants, related adjuvants of surfactants
Bicyclo[3.1.1]heptane, 6,6-dimethyl-2-methylene-,
homopolymer (Beta-pinene, homopolymer) (CAS
Reg. No. 25719-60-2). Surfactants, related adjuvants of surfactants
Bicyclo[3.1.1]hept-2-ene, 2,6,6-trimethyl-, polymer
with 6,6- dimethyl-2- methylenebicyclo [3.1.1]
heptane (Copolymer of alpha- and beta-pinene) Surfactants, related adjuvants of surfactants
(CAS Reg. No. 31393-98-3).
2-Bromo-2-nitro-1,3-propanediol (CAS Reg. No. 52- In-can preservative
51-7). 0.04% or less by weight of the total
Butane ................................................................. pesticide formulation.
Propellant Solvent, cosolvent
Do.
Calcareous shale ................................................
Calcite ................................................................. Do.
Calcium carbonate .............................................. Do.
Calcium chloride ..................................................
Calcium phosphate .............................................
Solid diluent, carrier Do.
Calcium hypochlorite ...........................................
Calcium lactate pentahydrate (CAS Reg. No. 5743-47-
5).
Calcium salt of partially dimerized rosin, conforming to Sanitizing and bleaching agent Nutrient, stabilizer
21 CFR 172.210.
Solid diluent, carrier Coating agent
Calcium silicate ...................................................
Calcium stearate ................................................. Solid diluent, carrier Do.
Carbon Dioxide (CAS Reg. No. 124-38-9) .......... None .................................. Propellant
Minimum molecular weight (in
Carrageenan, conforming to 21 CFR 172.620 .... amu): 100,000. Thickener
Not more than 5.0% of
Cetyl alcohol (CAS Reg. No. 36653-82-4) ........... pesticide formulation. Evaporation retardant Carrier
Meets specifications in the
Charcoal, activated ............................................. Food Chemical Codex.
Coconut shells .....................................................
Cod liver oil .........................................................
Solvent, cosolvent
Croscarmellose sodium (CAS Reg. No. 7481165-7). Disintegrant, solid diluent, carrier, and thickener
n-Decyl alcohol (CAS Reg. No. 112-30-1) ........... Solvent or co-solvent
Inert ingredients Limits Uses
Dialkyl (Cs-Cis) dimethyl ammonium chloride ..... Not more than 0.2% in sili- Flocculating agent In the manufacture of silica,
ca, hydrated silica. hydrated silica for use as a solid diluent, carrier
Solid diluent carrier Surfactant
Diatomite (diatomaceous earth) ..........................
Diethylaminoethanol, ethoxylated, propoxylated,
reaction products with fatty acid dimers,
minimum number average molecular weight (in
amu), 1,200 (CAS Reg. No. 1173188-75-4).
Diethylaminoethanol, ethoxylated, propoxylated, Surfactant
reaction products with fatty acid trimers,
minimum number average molecular weight (in
amu), 1,200 (CAS Reg. No. 1173188-83-4).
Diethylaminoethanol, ethoxylated, reaction prod- Surfactant
uct with fatty acid dimers, minimum number
average molecular weight (in amu), 1,200 (CAS
Reg. No. 1173188-72-1). Diethylaminoethanol,
ethoxylated, reaction prod- Surfactant
ucts with fatty acid trimers, minimum number
average molecular weight (in amu), 1,200 (CAS
Reg. No. 1173188-81-2).
Diethylene glycol abietate ................................... Surfactants, related adjuvants of surfactants
1,1-Difluoroethane (CAS Reg. No. 75-37-6) ....... For aerosol pesticide formu- Aerosol propellant
lations used for insect
control in food- and
feedhandling
establishments and
1,2-Dihydro-6-ethoxy-2,2,4-trimethylquinolene .... animals. Antioxidant
Not pesticide
more thanformulation.
0.02% of 40%
Diisopropyl adipate (CAS Reg. No. 6938-94-9) in mosquito control Solvent, co-solvent.
formulations.
Dimethyl adipate (CAS no. 627-93-0) ................. None .................................. Solvent/co-solvent
Dimethylaminoethanol, ethoxylated, Surfactant
propoxylated, reaction products with fatty acid
dimers, minimum number average molecular
weight (in amu), 1,200 (CAS Reg. No. 1173188-42-
5).
Dimethylaminoethanol, ethoxylated, Surfactant
propoxylated, reaction products with fatty acid
trimers, minimum number average molecular
weight (in amu), 1,200 (CAS Reg. No. 1173188-67-
4).
Dimethylaminoethanol, ethoxylated, reaction Surfactant
products with fatty acid dimers, minimum
number average molecular weight (in amu), 1,200
(CAS Reg. No. 1173188-38-9).
Dimethylaminoethanol, ethoxylated, reaction Surfactant
products with fatty acid trimers, minimum
number average molecular weight (in amu), 1,200
(CAS Reg. No. 1173188-49-2). Dimethyl ether
(methane, oxybis-) (CAS Reg. Propellant
No. 115-10-6).
Dimethyl glutarate (CAS no. 1119-40-0) ............. None .................................. Solvent/co-solvent
3,6-Dimethyl-4-octyn-3,6-diol .............................. Not more than 2.5% of pes- Surfactants, related adjuvants of surfactants
ticide formulation.
Dimethyl succinate (CAS no. 106-65-0) ............. None .................................. Solvent/co-solvent
Dipropylene glycol .............................................. Solvent, cosolvent
Disodium phosphate ........................................... Anticaking agent, conditioning agent
Disodium zinc ethylenediaminetetraacetate Sequestrant
dihydride.
Dolomite .............................................................
Epoxidized linseed oil .........................................
Epoxidized soybean oil ........................................ Solid diluent, carrier
Ethyl acetate ....................................................... Surfactants, related adjuvants of surfactants Do.
Ethyl alcohol ....................................................... Solvent, cosolvent Do.
Ethyl esters of fatty acids derived from edible Solvent, cosolvent
fats and oils.
Ethyl maltol (CAS Reg. No.4940-11-8) ............... Not more than 0.2 % of the Odor masking agent
pesticide formulation.
Ethylene glycol (CAS Reg. No. 107-21-1) .......... Without limitation ............... Encapsulating agent for pesticides being ap-
plied post-harvest as residual, and crack and
crevice sprays in and around food and nonfood
areas of residential and nonresidential structures,
including food handling establishments
Inert ingredients Limits Uses
Synthetic paraffin and its succinic derivatives Carrier, binder, and carrying agent
conforming to 21 CFR 172.275.
Synthetic petroleum wax, conforming to 21 CFR Binder, carrier, and coating agent
172.888.
Talc ..................................................................... Solid diluent, carriers
Tall oil; fatty acids not less than 58%, rosin Surfactants, related adjuvants of surfactants
acids not more than 44%, unsaponifiables not more
than 8%.
Tartrazine ........................................................... Dye
Terpenes and terpenoids, turpentine oil, alpha- Surfactants, related adjuvants of surfactants
pinene fraction, polymd. (CAS Reg. No. 70750-57-
1).
1,1,1,2-Tetrafluoroethane, (CAS Reg. No. 811- Aerosol propellant
97-2).
Tetrahydrofurfuryl alcohol (THFA) (CAS Reg. No Expires February 9, 2008 ... Solvent/cosolvent
97-99-4).
N,N,N',N",-tetrakis-(2-hydroxypropyl) ethylene- Concentration in formulated Stabilizer for formulation.
diamine (CAS Reg. No. 102-60-3). end-use products not to
exceed 20% by weight in
pesticide formulations. Not to
a-[p-(1,1,3,3-tetramethylbutyl)phenyl]-w- exceed 7% of pes- Surfactants related adjuvants of surfactants
hydroxypoly(oxyethylene) produced by the ticide formulation.
condensation of 1 mole of p-(1,1,3,3-
tetramethylbutyl)phenol with a range of 1-14 or 30-
70 moles of ethylene oxide: If a blend of products is
used, the average range number of moles of
ethylene oxide reacted to produce any product that
is a component of the blend shall be in the range of
1-14 or 3070 (CAS Reg. Nos. 9036-19-5, 9002-93-
1).
2,4,7,9-Tetramethyl-5-decyn-4, 7-diol ................. Not more than 2.5% of pes- Surfactants, related adjuvants of surfactants
ticide formulation.
Tetrasodium pyrophosphate ............................... Anticaking agent, conditioning agent
Thiosulfuric acid, disodium salt, anhydrous. Dechlorinator, reducing agent
(CAS Reg. No 7772-98-7).
Thiosulfuric acid, disodium salt, pentahydrate. Do.
(CAS Reg. No. 10102-17-7). d-Alpha
tocopherol (CAS Reg. No. 9-02-9 ....................... None .................................. Safener
d-Alpha tocopheryl acetate (CAS Reg. No. 58- None .................................. Do.
95-7).
Inert ingredients Limits Uses
§ 180.920 Inert ingredients used preharvest; when used In accordance with good
exemptions from the requirement of a agricultural practice as inert (or occasionally
tolerance. active) ingredients in pesticide formulations
The following materials are exempted from applied to growing crops only:
the requirement of a tolerance
Inert ingredients Limits Uses
Acetophenone................................... Attractant
Adenosine (CAS Reg. No. 58-61-7) Maximum of 0.5% of Synergist
formulation.
Alder bark ........................................................... Seed germination stimulator
Alkyl (C12-C16) dimethyl ammonlo acetate (CAS 20% by weight in pesticide Surfactant
Reg. Nos. 683-10-3, 2601-33-4 and 69333-4. formulation.
a-Alkyl (minimum C6 linear, branched, saturated Not to exceed 30% of Surfactants, related adjuvants of surfactants
and/or unsaturated)-w-hydroxypolyoxyethylene pesticide formulation.
polymer with or without polyoxypropylene,
mixture of di- and monohydrogen phosphate
esters and the corresponding ammonium,
calcium, magnesium, monoethanolamine,
potassium, sodium, and zinc salts of the
phosphate esters; minimum oxyethylene
content is 2 moles; minimum oxypropylene
content is 0 moles (CAS Reg. Nos. 9046-01-9,
3728082-3, 39464-66-9, 42612-52-2, 50643-
204, 52019-36-0, 58318-92-6, 60267-55-2,
61837-79-4, 67711-84-6, 68070-99-5,
68071-35-2, 68071-17-0, 68130-47-2,
68186-37-8, 68186-36-7, 68311-02-4,
68425-73-0, 68458-48-0, 68511-37-5,
68610-65-1, 68585-36-4, 68649-29-6,
68815-11-2, 68908-64-5, 68891-13-4,
73038-25-2, 78330-24-2, 108818-88-8,
154518-39-5, 317833-96-8, 873662-29-4,
936100-29-7, 936100-30-0).
/V-alkyl(Cs-Ci8) dimethylamidopropylamines Not to exceed 20% by weight Surfactants, related adjuvants of surfactants
where the alkyl group is linear and may be in herbicide formulations.
saturated and/or unsaturated (CAS Reg. Nos.
109-28-4, 3179-80-4, 7651-02-7, 2289010-4,
22890-11-5, 39669-97-1, 45267-194, 68140-01-
2, 1147459-12-8, 146987-986).
N-alkyl (C8-C18) primary amines and their acetate
salts where the alkyl group is linear and may be Concentration in formulated Surfactants, related adjuvants of surfactants
saturated and/or unsaturated (CAS Reg. Nos. end-use products not to
61790-57-6, 61790-58-7, 6179059-8, 61790-60- exceed 10% by weight in
1, 61788-46-3, 61790-338, 68155-38-4). herbicide products, 4%
by weight in insecticide
products, and 4% by
weight in fungicide
products.
N,N-Bis-a-ethyl-w-hydroxypoly(oxy-1,2- ethanediyl) Not to exceed 25% in Surfactants, related adjuvants of surfactants
C8-C18 saturated and unsaturated alkylamines; herbicide formulations and
the poly(oxy-1,2-ethanediyl) content is 2-60 10% in insecticide and
moles (CAS Reg. Nos. 10213-78-2,25307-17- fungicide formulations.
9, 26635-92-7,
26635-93-8, 288259-52-9, 58253-49-9,
82-7, 61791-14-8,61791-24-0,
26-2, 61791-31-9,61791-44-4,
68155-33-9, 68155-39-5, 68155-40
8,70955-14-5, 73246-96-5, 1266162-49-5).
N,W-Bis-a-ethyl-w-hydroxypoly(oxy-1,2- Not to exceed 25% in Surfactants, related adjuvants of surfactants
ethanediyl/oxy(methyl-1,2-ethanediyl) C8-C18 herbicide formulations and
saturated and unsaturated alkylamines; the 10% in insecticide and
poly(oxy-1,2-ethanediyl/oxy(methyl-1,2- ethanediyl) fungicide formulations.
content is 2-60 moles (CAS Reg. Nos. 68213-26-3,
68153-97-9, 75601-76-2). Aluminum sulfate .......
Safener adjuvant
Ammonium chloride (CAS Reg. No. 12125-029). Carrier/nutrient
Ammonium formate (CAS Reg. No. 540-69-2) ..
Complexing or fixing agent
Ammonium nitrate (CAS Reg. No. 6484-52-2) ..
Adjuvant/ intensifier for herbicides
Ammonium polyphosphate (CAS Reg. No. 68333-
Sequestrant, buffer, or surfactant
79-9).
Choline hydroxide (CAS Reg No. 123-41-1) ....... Without limitation ............... Neutralizer
Cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-1- Maximum of 0.14% by Preservative
azoniaadamantane chloride (CAS Reg. No. weight of formulation.
51229-78-8).
Copper naphthenate ........................................... Not more than 2.5% of for- Mercaptan scavenger in technical pesticide
mulation; application
limited to before edible
portions of plants begin to
form.
Cyclohexane .......................................................
§ 180.930 Inert ingredients applied to animals; when used In accordance with good
exemptions from the requirement of a agricultural practice as inert (or occasionally
tolerance. active) ingredients in pesticide formulations
The following materials are exempted from applied to animals:
the requirement of a tolerance
Acetic acid (CAS Reg. No. 64-19-7) ................... Not more than 0.5% of pesticide Catalyst
formulation.
Acetic anhydride ................................................. Solvent, cosolvent, stabilizer
Acetone (Cas Reg. No. 67-64-1) ........................
Iron oxide (CAS Reg. No. 1309-37-1) Colorant in pesticide formulations for animal
tags
Isobutane (CAS Reg. No. 75-28-5) .................... None Propellant
Isopropyl myristate, CAS Reg. No. 110-27-0 ... Solvent
Kaolinite-type clay .............................................. Solid diluent, carrier Solvent, cosolvent Solvent
Kerosene, U.S.P. reagent ................................... Solvent
Lactic acid...........................................................
Lactic acid, 2-ethylhexyl ester (CAS Reg. No. Solvent
6283-86-9). Solvent
Lactic acid, 2-ethylhexyl ester, (2S)- (CAS Reg.
No. 186817-80-1). Surfactant, related adjuvants of surfactants Do.
Lactic acid, n-propyl ester, (S); (CAS Reg. No. Do.
53651-69-7).
Lignin (CAS Reg. No. 9005-53-2) ...................... Do.
Lignin, alkali (CAS Reg. No. 8068-05-1) ............
Lignin, alkali, oxidized, sodium salt (CAS Reg. No.
68201-23-0).
Lignin alkali reaction products with disodium
sulfite and formaldehyde (CAS Reg. No.
105859-97-0).
Lignin alkali reaction products with formaldehyde Do.
and sodium bisulfite (CAS Reg. No. 68512-35-
6).
Lignosulfonic acid (CAS Reg. No. 8062-15-5) Do.
Lignosulfonic acid, ammonium calcium salt
(CAS Reg. No. 12710-04-2). Do.
Lignosulfonic acid, ammonium magnesium salt
(CAS Reg. No. 123175-37-1). Do.
Lignosulfonic acid, ammonium salt (CAS Reg. No.
8061-53-8). Do.
Lignosulfonic acid, ammonium sodium salt
(CAS Reg. No. 166798-73-8). Do.
Lignosulfonic acid, calcium magnesium salt
(CAS Reg. No. 55598-86-2). Do.
Lignosulfonic acid, calcium salt (CAS Reg. No.
8061-52-7). Do.
Lignosulfonic acid, calcium sodium salt (CAS Reg.
No. 37325-33-0). Do.
Lignosulfonic acid, ethoxylated, sodium salt
(CAS Reg. No. 68611-14-3). Do.
Lignosulfonic acid, magnesium salt (CAS Reg.
No. 8061-54-9). Do.
Lignosulfonic acid, potassium salt (CAS Reg. No.
37314-65-1). Do.
Lignosulfonic acid, sodium salt (CAS Reg. No. Do.
8061-51-6).
Lignosulfonic acid, sodium salt, oxidized (CAS Do.
Reg. No. 68855-41-4).
Lignosulfonic acid, sodium salt, polymer with Do.
formaldehyde and phenol (CAS Reg. No.
37207-89-9).
Lignosulfonic acid, sodium salt, sulfomethylated Do.
(CAS Reg. No. 68512-34-5). Do.
Lignosulfonic acid, zinc salt (CAS Reg. No. 57866-
49-6). Solvent, fragrance
d-Limonene (CAS Reg. No. 5989-27-5) ............. Solid diluent, carrier
Magnesium carbonate ....................................... Do.
Magnesium silicate, hydrated magnesium silicate.
Methyl alcohol .................................................... Solvent, cosolvent
Methyl n-amyl ketone (CAS Reg. No. 110-430). Solvent, cosolvent
Methyl esters of higher fatty acids conforming
Antidusting agent
to 21 CFR 573.640.
Methyl-p-hydroxybenzoate (Methyl paraben) Meets specifications of Food Preservative
Chemicals Codex; not to
exceed 0.1% in
formulations.
Methyl isobutyl ketone....... Solvent, cosolvent
2-methyl-2,4-pentanediol (CAS Reg. No.-107- Without limitation
41-5). Growing crops and food animals
2-methyl-1,3-propanediol (CAS Reg. No. 2163-
42-0). Solvent, surfactant
Mineral oil, U.S.P., or conforming to 21 CFR
172.878 or 178.3620(a), (b). Solvent, diluent
Montmorillonite-type clay ........ Solid diluent, carrier Surfactant
Nonyl, decyl, and undecyl glycoside mixture
with a mixture of nonyl, decyl, and undecyl
oligosaccharides and related reaction prod-
ucts (primarily decanol and undecanol) pro-
duced as an aqueous-based liquid (50 to
65% solids) from the reaction of primary alco-
hols (containing 15 to 20% secondary alcohol
isomers) in a ratio of 20% C9, 40% C10, and
40% C11 with carbohydrates (average glu-
cose to alkyl chain ratio 1.3 to 1.8).
a-(p-Nonylphenol)-w-hydroxypoly(oxyethylene)
mixture of dihydrogen phosphate and Not to exceed 7% of pesticide Surfactants, related adjuvants of surfactants
monohydrogen phosphate esters and the cor- formulation.
responding ammonium, calcium, magnesium,
potassium, sodium, and zinc salts of the
phosphate esters; the nonyl group is a pro-
pylene trimer isomer and the
poly(oxyethylene) content averages 4-14 or
30 moles (CAS Reg. Nos. 51811-79-1,
59139-23-0, 67922-57-0,
68954-84-7, 68412-53-3,
68553-97-9, 51609-41-7, 99821-14-4,
152143-22-1, 68584-47-4, 37340-60-6,
106151-63-7, 52503-15-8,
68458-49-1).
a-(p-Nonylphenol)-w-hydroxypoly(oxyethylene) Not to exceed 7% of pesticide Surfactants, related adjuvants of surfactants
sulfate, ammonium, calcium, magnesium, po- formulation.
tassium, sodium, and zinc salts the nonyl
group is propylene trimer isomer and the
poly(oxyethylene) content averages 4 moles
(CAS Reg. Nos. 9014-90-8, 9051-57-4,
9081-17-8, 68649-55-8, 68891-33-8.
a-(p-Nonylphenyl)-w-hydroxypoly(oxyethylene) Surfactants, emulsifier, related adjuvants of
produced by the condensation of 1 mole of surfactants.
nonylphenol (nonyl group is a propylene trimer
isomer) with an average of 4-15 or 3090 moles
of ethylene oxide; if a blend of products is used,
the average number of moles of ethylene oxide
reacted to produce any product that is a
component of the blend shall be in the range of
4-15 or 30-90 moles.
Octadecyl 3,5-di-tert-butyl-4-hydroxyhydro Not more than 0.5% by weight Thermal stabilizer/antioxidant in animal tag and
cinnamate (CAS Reg. No. 2082-79-3). of pesticide formulation. similar slow-release devices
Not more than 0.2% of the
Octanal (CAS Reg. No. 124-13-0)....................... pesticide formulation. Odor masking agent
Octyl and decyl glucosides mixture with a mixture Thermal stabilizer/antioxidant in animal tag and
of octyl and decyl oligosaccharides and related similar slow-release devices
reaction products (primarily n- decanol)
produced as an aqueous-based liquid (68-72%
solids) from the reaction of straight chain
alcohols (Cs(45%), C10) with anhydrous
glucose.
Octyl epoxytallate (CAS Reg. No. 61788-72-5)
Oleic acid, conforming to 21 CFR 172.862 (CAS Plasticizer, component animal tag Defoaming
Reg. No. 112-80-1). a-Oleoyl-w- agent
hydroxypoly(oxyethylene), average molecular
weight (in amu) of 600. a-Oleoyl-w- Emulsifier
(oleyloxy)poly(oxyethylene) derived from a-hydro-
Emulsifier, defoaming agent
w-hydroxypoly(oxyethylene),
molecular weight (in amu) 600.
Petroleum hydrocarbons, light, odorless, Solvent, diluent Do.
conforming to 21 CFR 172.884 or 178.3650. Solvent, cosolvent Stabilizer
Petroleum hydrocarbons, synthetic isoparaffinic,
conforming to 21 CFR 172.882 or 178.3530. Component of plastic slow release tag
Phenol ................................................................
a-Pinene ............................................................. Surfactants, related adjuvants of surfactants
Not more than 2% of
Polyethylene (CAS Reg. No. 9002-88-4)
conforming to 21 CFR 172.615. formulation by weight.
Polyethylene glycol [a-hydro-w-
hydroxypoly(oxyethylene)]; mean molecular
weight (in amu) 194 to 9,500 conforms to 21
CFR 178.3750.
Potassium benzoate (Cas No. 582-25-2) ...........
Potassium hydroxide ..........................................
None .............................. Preservative
Propane ............................................................. Meeting Food Chemicals, Neutralizer
1,2,3-Propanetriol, homopolymer Codex specifications. Propellant
diisooctadecanoate (CAS Reg. No. 6370503- Emulsifier
3).
n-Propanol ..........................................................
Propenoic acid, 2-methyl-, polymer with ethyl 2-
propenoate and methyl 2-methyl-2- Solvent, for blended emulsifiers Encapsulating
propenoate, ammonium salt (CAS Registration agent,dispensers, resins, fibers and beads
No. 55989-05-4), minimum number average
molecular weight (in amu), 18,900..
Propylene glycol .................................................
Propylene glycol monomethyl ether ...................
Propyl gallate ..................................................... Solvent, cosolvent Deactivator, emmolient
Propyl p-hydroxybenzoate (Propyl paraben) ....... Antioxidant Preservative
§ 180.940 Tolerance exemptions for active and inert semi-permanent or permanent food- contact
ingredients for use in antimicrobial surface (other than being applied on food
formulations (Food- contact surface sanitizing packaging) with adequate draining before
solutions).
contact with food.
Resldues of the following chemical The following chemical substances when
substances are exempted from the used as ingredients in an antimicrobial
requirement of a tolerance when used in pesticide formulation may be applied to:
accordance with good manufacturing practice Food-contact surfaces in public eating places,
as ingredients in an antimicrobial pesticide
dairyprocessing equipment, and food-
formulation, provided that the substance is
applied on a processing equipment and utensils.
Acetic acid 64-19-7 When ready for use, the end-use concentra-
tion is not to exceed 290 ppm
a-alkyl-w-hydroxypoly (oxypropylene) and/or 9002-92-0; 9004-95-9;
poly (oxyethylene) polymers where the alkyl 9004-98-2; 9005-00-9;
chain contains a minimum of six carbons. 9035-85-2; 9038-29-3;
9038-43-1; 9040-05-5;
9043-30-5; 9087-53-0;
25190-05-0 24938-91-8;
25231-21-4 26183-52-8;
26468-86-0 26636-39-5;
27252-75-1 27306-79-2;
31726-34-8 34398-01-1;
34398-05-5 37251-67-5;
37311-00-5 37311-01-6;
37311-02-7 37311-04-9;
39587-22-9 50861-66-0;
52232-09-4 52292-17-8;
52609-19-5 57679-21-7;
59112-62-8 60828-78-
6; 61702-78-1; 61725-
89-1;.
CAS Reg. No.
61791-13-7; 61791-20-6;
61791-28-4 61804-34-0;
61827-42-7 61827-84-7;
62648-50-4 63303-01-5;
63658-45-7 63793-60-2;
64366-70-7 64415-24-3;
64415-25-4 64425- 86-1;
65104-72-5 65150-81-4;
66455-14-9 66455-15-0;
67254-71-1; 67763-08-0;
68002-96-0; 68002-97-1;
68131-39-5; 68131-40-8;
68154-96-1 97-2;
68154-98-3; 01-1; 68213-
68213-23-0 24-1; 68238-
68238-81-3; 82-4; 68409-
68409-58-5; 59-6; 68439-
68439-30-5; 45-2; 68439-
68439-46-3; 48-5; 68439-
68439-49-6; 50-9; 68439-
68439-51-0; 53-2; 68458-
68439-54-3; 88-8; 68526-
68526-94-3; 95-
4; 68551-12-2; 68551-
13-3 68551-14-4 68603-
20-3 68603-25-8 68920-
66-1 68920-69-4 68937-
66-6 68951-67-7 68954-
94-9 68987-81-5 68991-
48-0 69011-36-5 69013-
18-9 69013-19-0 69227-
20-9 69227-21-0 69227-
22-1 69364-63-2 70750-
27-5 70879-83-3
70955-07-6 71011-10-4;
71060-57-6 71243-46-4;
72066-65-0 72108-90-8;
72484-69-6 72854-13-8;
72905-87-4 73018-31-2;
73049-34-0 74432-13-6:
74499-34-6 78330-19-5;
78330-20-8 78330-21-9;
78330-23-1 79771-03-2:
84133-50-6 85422-93-1
97043-91-9 97953-22-5;
102782-43-4; 103331-868;
103657-84-7; 10365785-8;
103818-93-5;
103819-03-0; 106232-83-
1; 111905-54-5; 116810-
31-2; 116810-32-3;
116810-33-4; 120313-48-
6; 120944-68-5; 121617-
09-2; 126646-02-4;
126950-62-7; 127036-24-
2; 139626-71-4; 152231-
44-2; 154518-36-2;
157627-86-6; 157627-88-
8; 157707-41-0; 157707-
43-2; 159653-49-3;
160875-66-1; 160901-202;
160901-09-7; 16090119-9;
161025-21-4; 161025-22-5;
166736-089; 169107-21-5;
17258843-1; 176022-76-7;
196823-11-7; 287935-46-
0; 288260-45-7; 303176-
75-2; 954108-36-2.
Ammonium chloride 12125-02-9 When ready for use, the end-use concentration
is not to exceed 48 ppm None
Amylopectin, acid-hydrolyzed, 1- 113894-85-2
oxtenylbutanedioate
Pesticide Chemical CAS Reg. No. Limits
Quaternary ammonium compounds n-alkyl (C12- C18) None When ready for use, the end-use concentration of all
dimethyl ethylbenzyl ammonium chloride average quaternary chemicals in the solution is not to
molecular weight (in amu) 384 exceed 200 ppm of active quaternary compound
Pesticide Chemical CAS Reg. No. Limits
Quaternary ammonium compounds, Di-n-Alkyl (Cs-io) None
When ready for use, the end-use concentration of
dimethyl ammonium chloride, average molecular
these specific in quaternary ammonium
weight (in amu) 332 to 361
compounds is not to exceed 240 ppm of active
quaternary ammonium compound; the end-use
concentration of all quaternary chemicals in the
solution is not to exceed 400 ppm of active
quaternary compound
Quaternary ammonium compounds, didecyl dimethyl 148788-55-0/148812-654-1 When ready for use, the end-use concentration of
ammonium carbonate/didecyl dimethyl ammonium these specific ammonium compounds is not to
bicarbonate exceed 400 ppm of active quaternary ammonium
compound
Silver ions resulting from the use of electro- lytically- 14701-21-4 When ready for use, the end-use concentration of
generated silver ions stabilized in citric acid as silver ions is not to exceed 50 ppm of active silver
silver dihydrogen citrate (does not
include metallic silver)
Sodium bisulfate 7681-38-1 When ready for use, the end-use concentration is
not to exceed 2,000 ppm.
Sorbitan, mono-9-octadecenoate, poly(oxy-1,2- 9005-65-6 None
ethanediyl) derivs., (Z)-
Sulfuric acid monododecyl ester, sodium salt (sodium 151-21-3 When ready for use, the end-use concentration is
lauryl sulfate) not to exceed 350 ppm
1,3,5-Triazine-2,4,6(1 H,3H,5H)-trione, 1,3- dichloro-, 2893-78-9 When ready for use, the end-use concentration of all
sodium salt di- or trichloroisocyanuric acid chemicals in the
solution is not to exceed 100 ppm determined as
total available chlo-
The following chemical substances when may be applied to: Dairy processing
used as ingredients in an antimicrobial equipment, and food-processing equipment
pesticide formulation and utensils.
Pesticide Chemical CAS Reg. No. Limits
Acetic acid 64-19-7 When ready for use, the end-use concentration is
not to exceed 686 ppm
Acetic acid, chloro-, sodium salt, reaction products 68608-66-2
with 4,5-dihydro-2-undecyl-1H-imidazole- 1- When ready for use, the end-use concentration is
ethanol and sodium hydroxide not to exceed 42 ppm chloroacetic acid
Benzenesulfonic acid, dodecyl- 27176-87-0 When ready for use, the end-use concentration is
not to exceed 5.5 ppm
Butanedioic acid, octenyl- 28805-58-5 When ready for use, the end-use concentration is
not to exceed 156 ppm
Butoxy monoether of mixed (ethylene-pro- None None
pylene) polyalkylene glycol, minimum average
molecular weight (in amu), 2400
Calcium chloride 10043-52-4 When ready for use, the end-use concentration is
not to exceed 17 ppm
n-Carboxylic acids (C6-C12), consisting of a mixture None When ready for use, the end-use concentration is
of not less than 56% octanoic acid and not to exceed 39 ppm
not less than 40% decanoic acid
Decanoic acid 334-48-5 When ready for use, the end-use concentration is
not to exceed 90 ppm
Ethanesulfonic acid, 2-[cyclohexyl (1- oxohexadecyl) 132-43-4 When ready for use, the end-use concentration is
amino]-, sodium salt not to exceed 237 ppm
Ethylenediaminetetraacetic acid (EDTA), disodium 139-33-3 When ready for use, the end-use concentration is
salt not to exceed 1400 ppm
FD&C Yellow No. 5 (Tartrazine) (conforming to 1934-21-0 None
21 CFR 74.705)
D-Gluconic acid, monosodium salt 527-07-1 When ready for use, the end-use concentration is
not to exceed 760 ppm
Hydriodic acid 10034-85-2 When ready for use, the total end-use concentration
of all iodide-producing chemicals is not to exceed
25 ppm of titratable iodine
Hydrogen peroxide 7722-84-1 When ready for use, the end-use concentration is
not to exceed 465 ppm
Hypochlorous acid 7790-92-3 When ready for use, the end-use concentration of all
hypochlorous acid chemicals in the solution is
not to exceed 200 ppm determined as total
available chlorine
Pesticide Chemical CAS Reg. No. Limits
Iodine 7553-56-2
When ready for use, the total end-use concentration
of all iodide-producing chemicals in the solution
is not to exceed 25 ppm of titratable iodine
Lactic acid 50-21-5 When ready for use, the end-use concentration is
not to exceed 138 ppm
Nonanoic acid 112-05-0 When ready for use, the end-use concentration is
not to exceed 90 ppm
1-Octanamine, N,N-dimethyl- 7378-99-6 When ready for use, the end-use concentration is
not to exceed 113 ppm
1,2-Octanedisulfonic acid 113669-58-2 When ready for use, the end-use concentration is
not to exceed 102 ppm
1-Octanesulfonic acid 3944-72-7 When ready for use, the end-use concentration is
not to exceed 172 ppm
1-Octanesulfonic acid, sodium salt 5324-84-5 When ready for use, the end-use concentration is
not to exceed 297 ppm
1-Octanesulfonic acid, 2-sulfino- 113652-56-5 When ready for use, the end-use concentration is
not to exceed 102 ppm
Octanoic acid 124-07-2 When ready for use, the end-use concentration is
not to exceed 176 ppm
Oxychloro species (including chlorine dioxide) None When ready for use, the end-use concentration is
generated by acidification of an aqueous solution not to exceed 200 ppm of chlorine dioxide as
of sodium chlorite determined by the method titled, lodometric
Method for the Determination of Available
Chlorine Dioxide (50-250 ppm available chlorine
dioxide)
Peroxyacetic acid 79-21-0 When ready for use, the end-use concentration is
not to exceed 315 ppm
Peroxyoctanoic acid 33734-57-5 When ready for use, the end-use concentration is
not to exceed 122 ppm
Phosphonic acid, (1-hydroxyethylidene)bis- 2809-21-4 When ready for use, the end-use concentration is
not to exceed 34 ppm
Phosphoric acid 7664-38-2 None
Phosphoric acid, monosodium salt 7558-80-7 When ready for use, the end-use concentration is
not to exceed 350 ppm
Potassium iodide 7681-11-0
When ready for use, the total end-use concentration
of all iodide-producing chemicals in the solution
is not to exceed 25 ppm of titratable iodine
Propanoic acid 79-09-4 When ready for use, the end-use concentration is
not to exceed 297 ppm
2,6-Pyridinedicarboxylic acid 499-83-2 When ready for use, the end-use concentration is
not to exceed 1.2 ppm
Sulfuric acid 7664-93-9 When ready for use, the end-use concentration is
not to exceed 288 ppm
Sulfuric acid monododecyl ester, sodium salt (sodium 151-21-3 When ready for use, the end-use concentration is
lauryl sulfate) not to exceed 350 ppm
The following chemical sub- may be applied to: Food-processing stances when used as
ingredients in an equipment and utensils. antimicrobial pesticide formulation
Acetic acid 64-19-7 When ready for use, the end-use concentration
is not to exceed 686 ppm
Acetic acid, chloro-, sodium salt, reaction prod- 68608-66-2 When ready for use, the end-use concentra-
ucts with 4,5-dihydro-2-undecyl-1H-imidazole- 1-
ethanol and sodium hydroxide tion is not to exceed 42 ppm chloroacetic acid
Ammonium chloride 12125-02-9 When ready for use, the end-use concentration
is not to exceed 48 ppm
Benzenesulfonic acid, dodecyl- 27176-87-0 When ready for use, the end-use concentration
is not to exceed 400 ppm
Benzenesulfonic acid, dodecyl-, sodium salt 25155-30-0 When ready for use, the end-use concentration
is not to exceed 430 ppm
[1,1'-Biphenyl]-2-ol 90-43-7 When ready for use, the end-use concentration
is not to exceed 400 ppm
Boric acid, sodium salt 7775-19-1 None
Butanedioic acid, octenyl- 28805-58-5 When ready for use, the end-use concentration
is not to exceed 156 ppm
Pesticide Chemical CAS Reg. No. Limits
Nonanoic acid 112-05-0 When ready for use, the end-use concentration
is not to exceed 90 ppm
a-(p-Nonylphenyl)-w-hydroxypoly (oxyethylene) None None
maximum average molecular weight (in amu), 748
Propanoic acid 79-09-4 When ready for use, the end-use concentration is
not to exceed 297 ppm
2,6-Pyridinedicarboxylic acid 499-83-2 When ready for use, the end-use concentration is
not to exceed 1.2 ppm
Quaternary ammonium compounds, alkyl (C12- Cis) 8001-54-5 When ready for use, the end-use concentration of
benzyldimethyl, chlorides this specific quaternary compound is not to
exceed 200 ppm within the end-use total
concentration that is not to exceed 400 ppm
active quaternary compound
Quaternary ammonium compounds, n-alkyl (C12-C14) None When ready for use, the end-use concentration of
dimethyl ethylbenzyl ammonium chloride, average this specific quaternary compound is not to
molecular weight (in amu), 377 to 384 exceed 200 ppm within the end-use total
concentration that is not to exceed 400 ppm
active quaternary compound
Quaternary ammonium compounds, n-alkyl (C12-C18) None When ready for use, the end-use concentration of
dimethyl ethylbenzyl ammonium chloride average this specific quaternary compound is not to
molecular weight (in amu) 384 exceed 200 ppm within the end-use total
concentration that is not to exceed 400 ppm
active quaternary compound
Quaternary ammonium compounds, di-n-Alkyl (C8- None When ready for use, the end-use concentration of
C10) dimethyl ammonium chloride, average this specific quaternary compound is not to
molecular weight (in amu), 332 to 361 exceed 240 ppm within the end-use total
concentration that is not to exceed 400 ppm
active quaternary compound
Sodium-a-alkyl(C12-C15)-w-hydroxypoly (oxy- None None
ethylene) sulfate with the poly(oxyethylene)
content averaging one mole
Sodium bromide 7647-15-6
When ready for use, the end-use concentration of all
bromide-producing chemicals in the solution is
not to exceed 200 ppm total available halogen
Sodium iodide 7681-82-5 When ready for use, the total end-use concentration
of all iodide-producing chemicals in the solution
is not to exceed 25 ppm of titratable iodine
Sulfuric acid 7664-93-9 When ready for use, the end-use concentration is
not to exceed 228 ppm
Sulfuric acid monododecyl ester, sodium salt 151-21-3 None
(sodium lauryl sulfate)
1,3,5-Triazine-2,4,6(1 H,3H,5H)-trione, 1,3- dichloro- 2782-57-2 When ready for use, the end-use concentration of all
di- or trichloroisocyanuric acid chemicals in the
solution is not to exceed 100 ppm determined as
total available chlorine
[69 FR 23136, Apr. 28, 2004, as amended at 71 FR 30811, May 31, 2006; 71 FR 45423, Aug. 9, 2006; 71 FR 46125, Aug. 11, 2006;
72 FR 51186, Sept. 6, 2007; 73 FR 37858, July 2, 2008; 73 FR 49107, Aug. 20, 2008; 73 FR 53725, Sept. 17, 2008; 74 FR 27454,
June 10, 2009; 74 FR 38944, Aug. 5, 2009; 74 FR 40509, Aug. 12, 2009; 75 FR 40735, July 14, 2010; 76 FR 55267, Sept. 7, 2011;
77 FR 45498, Aug. 1, 2012; 77 FR 50617, Aug. 22, 2012; 77 FR 53150, Aug. 31, 2012; 77 FR 68692, Nov. 16, 2012; 78 FR 35147,
June 12, 2013; 78 FR 46264, July 31, 2013; 78 FR 48621, Aug. 9, 2013; 78 FR 59269, Sept. 26, 2013; 78 FR 65565, Nov. 1, 2013;
78 FR 67042, Nov. 8, 2013; 78 FR 78731, Dec. 27, 2013; 79 FR 6096, Feb, 3, 2014; 79 FR 26152, May 7, 2014; 79 FR 32666, June
6, 2014; 79 FR 33473, June 11, 2014]
§ 180.950 Tolerance exemptions for minimal risk Animal feed items. Animal feed items
active and inert ingredients. means meat meal and all items derived from
Unless specifically excluded, residues field crops that are fed to livestock excluding
resulting from the use of the following both the raw and processed forms of peanuts,
substances as either an inert or an active tree nuts, milk, soybeans, eggs, fish, crustacea,
ingredient in a pesticide chemical formulation, and wheat. Meat meal is an animal feed
including antimicrobial pesticide chemicals, composed of dried animal fat and protein that
are exempted from the requirement of a has been sterilized. Other than meat meal, the
tolerance under FFDCA section 408, if such use term animal feed item does not extend to any
is in accordance with good agricultural or item designed to be fed to animals that
manufacturing practices. contains, to any extent, components of
(a) Commonly consumed food animals. Included within the term animal feed
commodities. Commonly consumed food items are:
commodities means foods that are commonly The hulls and shells of the commodities
consumed for their nutrient properties. The specified in paragraph (a)(2)(ii) of this section,
and cocoa bean.
term commonly consumed food commodities
Bird feed such as canary seed.
shall only apply to food commodities (whether
Any feed component of a medicated feed
a raw agricultural commodity or a processed meeting the definition of an animal feed item.
commodity) in the form the commodity is sold Edible fats and oils. Edible fats and oils
or distributed to the public for consumption. means all edible (food or feed) fats and oils,
Included within the term commonly derived from either plants or animals, whether
consumed food commodities are: or not commonly consumed, including
Sugars such as sucrose, lactose, dextrose products derived from hydrogenating (food or
and fructose, and invert sugar and syrup. feed) oils, or liquefying (food or feed) fats.
Spices such as cinnamon, cloves, and red Included within the term edible fats and oils
pepper. are oils (such as soybean oil) that are derived
Herbs such as basil, anise, or fenugreek. from the commodities specified in paragraph
Excluded from the term commonly (a)(2)(ii) of this section when such oils are
consumed food commodities are: highly refined via a solvent extraction
Any food commodity that is adulterated procedure.
under 21 U.S.C. 342. Excluded from the term edible fats and oils
Both the raw and processed forms of are plant oils used in the pesticide chemical
peanuts, tree nuts, milk, soybeans, eggs, fish, formulation specifically to impart their
crustacea, and wheat. characteristic fragrance and/or flavoring.
Alcoholic beverages. [Reserved]
Dietary supplements.
Specific chemical substances. Residues microbial pesticide chemicals, are exempted
resulting from the use of the following from the requirement of a tolerance under
substances as either an inert or an active FFDCA section 408, if such use is in accordance
ingredient in a pesticide chemical formulation, with good agricultural or manufacturing
including anti- practices.
Chemical CAS No.
[67 FR 36537, May 24, 2002] definition of a polymer and the criteria
EDITORIAL NOTE: For FEDERAL REGISTER citations affecting specified for defining a low-risk polymer in 40
§180.950, see the List of CFR Sections Affected, which appears
in the Finding Aids section of the printed volume and at
CFR 723.250, as an inert ingredient in a
www.fdsys.gov. pesticide chemical formulation, including
§ 180.960 Polymers; exemptions from the antimicrobial pesticide chemical formulations,
requirement of a tolerance. are exempted from the requirement of a
Residues resulting from the use of the tolerance under FFDCA section 408, if such use
following substances, that meet the is in accordance with good agricultural or
manufacturing practices.
Acetic acid ethenyl ester, polymer with oxirane, minimum number average 25820-49-9
molecular weight (in amu), 17,000
924892-37-5
Acetic acid ethenyl ester, polymer with sodium 2-methyl-2-[(1-oxo-2- propen-
1-yl)amino]-1-propanesulfonate (1:1), hydrolyzed, minimum number
average molecular weight (in amu), 61,000
1152297-42-1
Acrylic acid-benzyl methacrylate-1-propanesulfonic acid, 2-methyl-2- [(1-oxo-
2-propenyl)amino]-, monosodium salt, minimum number average
molecular weight (in amu), 1500
Acrylic acid, polymerized, and its ethyl and methyl esters None
Acrylic acid, styrene, a-methyl styrene copolymer, ammonium salt, minimum 89678-90-0
number average molecular weight (in amu), 1,250
Acrylic acid terpolymer, partial sodium salt, minimum number average
151006-66-5
molecular weight (in amu), 2,400
Polymer CAS No.
None
Acrylic polymers composed of one or more of the following monomers: Acrylic
acid, methyl acrylate, ethyl acrylate, butyl acrylate, hydroxy- ethyl acrylate,
hydroxypropyl acrylate, hydroxybutyl acrylate, carboxyethyl acrylate,
methacrylic acid, methyl methacrylate, ethyl methacrylate, butyl
methacrylate, isobutyl methacrylate, hydroxyethyl methacrylate,
hydroxypropyl methacrylate, hydroxybutyl methacrylate, lauryl
methacrylate, and stearyl methacrylate; with none and/or one or more of
the following monomers: Acrylamide, N-methyl acrylamide, N,N-dimethyl
acrylamide, N-octylacrylamide, maleic anhydride, maleic acid, monoethyl
maleate, diethyl maleate, monooctyl maleate, dioctyl maleate; and their
corresponding sodium, potassium, ammonium, isopropylamine,
triethylamine, monoethanolamine, and/or triethanolamine salts; the
resulting polymer having a minimum number average molecular weight (in
amu), 1,200
9003-18-3
Acrylonitrile-butadiene copolymer conforming to 21 CFR 180.22, minimum
average molecular weight (in amu), 1,000
Castor oil, ethoxylated, dioleate, minimum number average molecular weight 110531-96-9
(in amu), 1260.
Castor oil, ethoxylated, oleate, minimum number average molecular weight 220037-02-5
(in amu), 1,600
1357486-09-9
Castor oil, polymer with adipic acid, linoleic acid, oleic acid and ricin- oleic
acid, minimum number average molecular weight (in amu), 3,500
Castor oil, polyoxyethylated; the poly(oxyethylene) content averages 5-54
None
moles
Dimethyl silicone polymer with silica, minimum number average molecular 67762-90-7
weight (in amu), 1,100,000
9014-93-1
a-(o,p-Dinonylphenyl)-w-hydroxypoly(oxyethylene) produced by
condensation of 1 mole of dinonylphenol (nonyl group is a propylene trimer
isomer) with an average of 140-160 moles of ethylene oxide
None
Docosyl methacrylate-acrylic acid copolymer, or docosyl methacrylate-
octadecyl methacrylate-acrylic acid copolymer, minimum number average
molecular weight (in amu), 3,000
Ethylene glycol dimethacrylate polymer, minimum molecular weight (in amu), None
100,000
Hexamethyl disilizane, reaction product with silica, minimum number average 68909-20-6
molecular weight (in amu), 645,000
Isodecyl alcohol ethoxylated (2-8 moles) polymer with chloromethyl oxirane, None
minimum number average molecular weight (in amu) 2,500
Maleic acid monobutyl ester-vinyl methyl ether copolymer, minimum average 25119-68-0
molecular weight (in amu), 52,000
Maleic acid monoethyl ester-vinyl methyl ether copolymer, minimum average 25087-06-3
molecular weight (in amu), 46,000
Maleic anhydride-methyl vinyl ether, copolymer, average molecular weight (in None
amu), 250,000
100934-04-1
Methacrylic acid-methyl methacrylate-polyethylene glycol methyl ether
methacrylate copolymer, minimum number averge molecular weight (in
amu), 3,700
111740-36-4
Methacrylic acid-methyl methacrylate-polyethylene glycol monomethyl ether
methacrylate graft copolymer, minimum number average molecular weight
(in amu), 1,800
Methacrylic copolymer, minimum number average molecular weight (in amu), 63150-03-8
15,000
119724-54-8
Methyl methacrylate-methacrylic acid-monomethoxypolyethylene glycol
methacrylate copolymer,) minimum number average molecular weight (in
amu), 2,730
None
Methyl methacrylate-2-sulfoethyl methacrylate-
dimethylaminoethylmethacrylate-glycidyl methacrylate-styrene-2-
ethylhexyl acrylate graft copolymer, minimum average molecular weight
(in amu), 9,600
Methyl vinyl ether-maleic acid copolymer, calcium sodium salt, minimum 62386-95-2
number average molecular weight (in amu), 900,000
None
Monophosphate ester of the block copolymer a-hydro-w-
hydroxypoly(oxyethylene) poly(oxypropylene) poly(oxyethylene); the
poly(oxypropylene) content averages 37-41 moles, average molecular
weight (in amu), 8,000
Polymer CAS No.
None
Oxirane, 2-methyl-, polymer with oxirane, dimethyl ether, minimum number 61419-46-3
average molecular weight (in amu), 2,800
903890-90-4
Polyamide polymer derived from sebacic acid, vegetable oil acids with or None
without dimerization, terephthalic acid and/or ethylenediamine
Polymer CAS No.
39444-87-6
Poly(oxy-1,2-ethanediyl), a-hydro-w-hydroxy-, polymer with 1, 1'-meth- ylene-
bis-[4-isocyanatocyclohexane], minimum number average molecular
weight (in amu), 1800
None
Polyoxyethylated primary amine (C14-C18); the fatty amine is derived from an
animal source and contains 3% water; the poly(oxyethylene) content
averages 20 moles
None
Polyoxyethylated sorbitol fatty acid esters; the polyoxyethylated sorbitol
solution containing 15% water is reacted with fatty acids limited to C12,
C14, C16, and Ci$, containing minor amounts of associated fatty acids; the
poly(oxyethylene) content averages 30 moles.
None
None
Polyoxymethylene copolymer, minimum number average molecular weight
(in amu), 15,000
None
Poly(oxypropylene) block polymer with poly(oxyethylene), molecular weight
(in amu), 1,800-16,000
Polytetrafluoroethylene 9002-84-0
Polymer CAS No.
None
Polyvinyl chloride, minimum number average molecular weight (in amu), 9002-86-2
29,000
2-propenoic acid, butyl ester, polymer with ethenylbenzene, methyl 2- methyl- 27306-39-4
2-propenoate and 2-propenoic acid (in amu), 1900.
33438-19-6
2-Propenoic acid, butyl ester, polymer with ethyl 2-propenoate and N-
(hydroxymethyl)-2-propenamide, minimum number average molecular
weight (in amu), 30,000
2-Propenoic acid, 2-ethylhexyl ester, polymer with ethenylbenzene 14,000
25153-46-2
daltons
68240-06-2
2-Propenoic acid, 2-ethylhexyl ester, polymer with ethenylbenzene and 2-
methylpropyl 2-methyl-2-propenoate, minimum number average molecular
weight (in amu), 18,000
1007234-89-0
2-Propenoic acid, 2-hydroxyethyl ester, polymer with a-[4- (ethenyloxy)butyl]-
w-hydroxypoly (oxy-1,2-ethanediyl), minimum number average molecular
weight (in amu), 17,000
950207-35-9
[2-propenoic acid, 2-methyl-, C12-16-alkyl esters, telomers with 1-
dodecanethiol, polyethylene-polypropylene glycol ether with propylene
glycol monomethacrylate (1:1), and styrene 2,2'-(1,2- diazenediyl)bis[2-
methylbutanenitrile]-initiated, minimum number average molecular weight
(in amu), 4,000
2-Propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, 886993-11-9
sodium salts
1283712-50-4
2-Propenoic acid, 2-methyl-, 2-ethylhexyl ester, telomer with 1-
dodecanethiol, ethenylbenzene and 2-methyloxirane polymer with oxirane
monoether with 1,2-propanediol mono(2-methyl-2- propenoate), hydrogen
2-sulfobutanedioate, sodium salt, 2, 2'-(1,2- diazenediyl)bis[2-
methylpropanenitrile]-initiated, minimum number average molecular
weight (in amu), 1,200
Polymer CAS No.
CASRN 1246766-57-3
2-Propenolc acid, 2-methyl-, phenylmethyl ester, polymer with 2-prope- noic
acid and sodium 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-
propanesulfonate (1:1), peroxydisulfuric acid ([HO)S(O)2]202) sodium salt
(1:2)-initiated minimum number average molecular weight >1,000 Daltons;
maximum number average molecular weight 10,000 Daltons
25036-16-2
2-Propenoic acid, 2-methyl-, polymer with butyl 2-propenoate and
ethenylbenzene, minimum number average molecular weight (in amu),
17,000
153163-36-1
2-Propenoic acid, 2-Methyl-, Polymer with Butyl 2-Propenoate, Methyl 2-
Methyl-2-Propenoate, Methyl 2-Propenoate and 2-Propenoic Acid, graft,
Compound with 2-Amino-2-Methyl-1-Propanol
146753-99-3
2-Propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol 888969-14-0
methylacrylate C18-22 alkyl ethers
Silane, dichloromethyl- reaction product with silica minimum number average 68611-44-9
molecular weight (in amu), 3,340,000
Silicic acid, sodium salt, reaction products with chlorotrlmethylsllane and iso-
propyl alcohol, reaction with poly(oxypropylene)- poly(oxyethylene) glycol,
minimum number average molecular weight (in amu), 75,000
Starch, oxidized, polymers with Bu acrylate, tert-Bu acrylate and styrene, 204142-80-3
minimum number average molecular weight (in amu), 10,000
Styrene, copolymers with acrylic acid and/or methacrylic acid, with none
and/or one or more of the following monomers: Acrylamidopropyl methyl
sulfonic acid, methallyl sulfonic acid, 3- sulfopropyl acrylate, 3-sulfopropyl
methacrylate, hydroxypropyl methacrylate, hydroxypropyl acrylate,
hydroxyethyl methacrylate, hy- droxyethyl acrylate, and/or lauryl
methacrylate; and its sodium, potassium, ammonium, monoethanolamine,
and triethanolamine salts; the resulting polymer having a minimum number
average molecular weight (in amu), 1200
None
a-[p-(1,1,3,3-Tetramethylbutyl)phenyl] poly(oxypropylene) block polymer with
poly(oxyethylene); the poly(oxypropylene) content averages 25 moles, the
poly(oxyethylene) content averages 40 moles, the molecular weight (in
amu) averages 3,400
None
a-[2,4,6-Tris[1-(phenyl)ethyl]phenyl]-w-hydroxy poly(oxyethylene)
poly(oxypropylene) copolymer, the poly(oxypropylene) content averages
2-8 moles, the poly(oxyethylene) content averages 16- 30moles, average
molecular weight (in amu), 1,500
Vinyl acetate polymer with none and/or one or more of the following
monomers: Ethylene, propylene, N-methyl acrylamide, acrylamide,
monoethyl maleate, diethyl maleate, monooctyl maleate, dioctyl ma- leate,
maleic anhydride, maleic acid, octyl acrylate, butyl acrylate, ethyl acrylate,
methyl acrylate, acrylic acid, octyl methacrylate, butyl methacrylate, ethyl
methacrylate, methyl methacrylate, methacrylic acid, carboxyethyl
acrylate, and diallyl phthalate; and their corresponding sodium, potassium,
ammonium, isopropylamine, triethylamine, monoethanolamine and/or
triethanolamine salts; the resulting polymer having a minimum number
average molecular weight (in amu), 1,200
None
Vinyl acetate-vinyl alcohol-alkyl lactone copolymer, minimum number
average molecular weight (in amu), 40,000; minimum viscosity of 18
centipoise
§180.1150 6-Benzyladenine; exemption from the § 180.1156 Cinnamaldehyde; exemption from the
requirement of a tolerance. requirement of a tolerance.
The biochemical plant regulator 6- Cinnamaldehyde (3-phenyl-2-
benzyladenine (6-BA) is exempt from the propenal) is exempted from the requirement
requirement of a tolerance in or on apple and of a tolerance in or on all food commodities,
pear when applied at a rate of <182 grams of when used as a fungicide, insecticide, and
active ingredient per acre per season, and in or algaecide in accordance with good agricultual
on pistachio when applied at a rate of <60 practices.
grams of active ingredient per acre per season.
§180.1157 Cytokinins; exemption from the concentration of pelargonic acid up to 170
requirement of a tolerance. ppm per application on food contact surfaces
An exemption from the requirement of a such as equipment, pipelines, tanks, vats,
tolerance is established for residues of fillers, evaporators, pasteurizers and aseptic
cytokinins (specifically: aqueous extract of equipment in restaurants, food service
seaweed meal and kinetin) in or on all food operations, dairies, breweries, wineries,
commodities when used as plant regulators on beverage and food processing plants.
plants, seeds, or cuttings and on all food [62 FR 28364, May 23, 1997, as amended at 64 FR 31505, June
commodities after harvest in accordance with 11, 1999; 68 FR 7935, Feb. 19, 2003]
good agricultural practices.
[64 FR 31505, June 11, 1999]
§180.1160 Jojoba oil; exemption from the
§180.1158 Auxins; exemption from the requirement requirement of a tolerance.
of a tolerance. The insecticide and spray tank adjuvant
An exemption from the requirement of a jojoba oil is exempted from the requirement of
tolerance is established for residues of auxins a tolerance in or on all raw agricultural
(specifically: indole-3- acetic acid and indole- commodities when applied at the rate of 1.0%
3-butyric acid) in or on all food commodities or less of the final spray in accordance with
when used as plant regulators on plants, good agricultural practices, provided the
seeds, or cuttings and on all food commodities jojoba oil does not contain simmondsin,
after harvest in accordance with good simmondsin-2-ferulate, and related
agricultural practices. conjugated organonitriles including demethyl
[64 FR 31505, June 11, 1999]
simmondsin and didemethylsimmondsin.
§180.1159 Pelargonic acid; exemption from the
requirement of tolerances. [61 FR 2121, Jan. 25, 1996]
An exemption from the requirement of a §180.1161 Clarified hydrophobic extract of neem oil;
tolerance is established for residues of exemption from the requirement of a tolerance.
pelargonic acid in or on all food commodities
Clarified hydrophobic extract of neem oil is
when used as a plant regulator on plants,
exempt from the requirement of a tolerance
seeds, or cuttings and on all food commodities
on all food commodities when used as a
after harvest in accordance with good
botanical fun- gicide/insecticide/miticide.
agricultural practices.
Pelargonic acid when used as an herbicide [67 FR 43552, June 28, 2002]
is exempt from the requirement of a tolerance
§180.1162 Acrylate polymers and copolymers;
on all plant food commodities provided that: exemption from the requirement of a tolerance.
Applications are not made directly to the
food commodity except when used as a Acrylate polymers and copolymers are
harvest aid or desiccant to: any root and tuber exempt from the requirement of a tolerance
vegetable, bulb vegetable or cotton. when used as inert ingredients in pesticidal
When pelargonic acid is used as a harvest formulations applied to growing, raw
aid or desiccant, applications must be made agricultural commodities. This tolerance
no later than 24 hours prior to harvest. exemption covers the acrylate
An exemption from the requirement of a polymers/copoly- mers that are intrinsically
tolerance is established for residues of safe and already listed in TSCA inventory or will
pelargonic acid in or on all raw agricultural meet the polymer tolerance exemption from
commodities and in processed commodities, requirements of
when such residues result from the use of premanufacturing notification under 40 CFR
pelargonic acid as an antimicrobial treatment 723.250. Polymers exempted can be used as
in solutions containing a diluted end-use dispensers, resins, fibers, and beads, as long as
the fibers, beads and resins particle sizes are
greater than 10 microns and insoluble in water.
This
exemption pertains to the acrylate qulrement of a tolerance for residues when
polymers/copolymers used as inert used as a component of food grade oil of
ingredients for sprayable and dispenser mustard, in or on all raw agricultural
pesticide formulations that are applied on commodities, when applied according to
food crops. Any acrylate polymers/ approved labeling.
copolymers used for encapsulating material [61 FR 24894, May 17, 1996]
must be cleared as an inert ingredient when
used in pesticide formulation applied on food §180.1176 Sodium bicarbonate; exemption from the
crops. requirement of a tolerance.
For the purposes of this exemption, acrylate The biochemical pesticide sodium
polymers/copolymers used as inert bicarbonate is exempted from the
ingredients in an end-use formulation must requirement of a tolerance in or on all raw
meet the definition for a polymer as given in agricultural commodities when applied as a
40 CFR 723.250(b), are not automatically fungicide or post-harvest fungicide in
excluded by 40 723.250(d), and meet the accordance with good agricultural practices.
tolerance exemption criteria in 40 CFR
723.250(e)(1), 40 CFR 723.250 (e)(2) or 40 CFR [61 FR 67473, Dec. 23, 1996]
723.250(e)(3). Therefore, acrylate polymers §180.1177 Potassium bicarbonate; exemption from
and copolymers that are already listed in the the requirement of a tolerance.
TSCA inventory or will meet the polymer
tolerance exemption under 40 CFR 723.250 as The biochemical pesticide potassium
amended on March 29, 1995 are covered by bicarbonate is exempted from the
this exemption. requirement of a tolerance in or on all raw
agricultural commodities when applied as a
[61 FR 6551, Feb. 21, 1996]
fungicide or post-harvest fungicide in
§180.1163 Killed Myrothecium accordance with good agricultural practices.
verrucaria; exemption from the requirement of [61 FR 67473, Dec. 23, 1996]
a tolerance.
Killed Myrothecium verrucaria is exempted §180.1178 Formic acid; exemption from the
from the requirement of a tolerance in or on requirement of a tolerance.
all raw agricultural commodities when applied The pesticide formic acid is exempted from
as a preseed or pre- or post-planting soil the requirement of a tolerance in or on honey
treatment alone or mixed with water and the and honeycomb when used to control tracheal
mixed suspension be applied through drip or mites and suppress varroa mites in bee
border irrigation systems and the indicator colonies, and applied in accordance with label
mycotoxin levels do not exceed 15 ppm. use directions.
[61 FR 11315, Mar. 20, 1996, as amended at 61 FR 58332, Nov. [74 FR 26535, June 3, 2009]
14, 1996]
§180.1179 Plant extract derived from Opuntia
§180.1165 Capsaicin; exemption from the lindheimeri, Quercus falcata, Rhus aromatica,
requirement of a tolerance. and Rhizophoria mangle; exemption from the
requirement of a tolerance.
Capsaicin is exempt from the requirement
of a tolerance in or on all food commodities The biochemical pesticide plant extract
when used in accordance with approved label derived from Opuntia lindheimeri, Quercus falcata,
rates and good agricultural practice. Rhus aromatica, and Rhizophoria mangle is
[63 FR 39521, July 23, 1998]
exempted from the requirement of a tolerance
in or on all raw agricultural commodities when
§180.1167 Allyl isothiocyanate as a component of applied as a nematicide/plant regulator
food grade oil of mustard; exemption from the
requirement of a tolerance.
The insecticide and repellent Allyl
isothiocyanate is exempt from the re-
In accordance with good agricultural practices.
[62 FR 24842, May 7, 1997]
§180.1180 Kaolin; exemption from the requirement L-glutamic acid is exempt from the
of a tolerance. requirement of a tolerance on all food
The biochemical pesticide kaolin is commodities when used in accordance with
temporarily exempted from the requirement good agricultural practices.
of a tolerance for residues of the insecticide [66 FR 33198, June 21, 2001]
Kaolin, when used on crops (apples, apricots, §180.1188 Gamma aminobutyric acid; exemption
bananas, beans, cane berries, citrus fruits, corn, from the requirement of a tolerance.
cotton, cranberries, cucurbits, grapes, melons,
Gamma aminobutyric acid is exempt from
nuts, ornamentals, peaches, peanuts, pears, the requirement of a tolerance on all food
peppers, plums, potatoes, seed crops, small commodities when used in accordance with
grains, soybeans, strawberries, sugar beets, good agricultural practices.
and tomatoes) to control certain insect,
fungus, and bacterial damage to plants. This [66 FR 33198, June 21, 2001]
temporary exemption from the requirement of § 180.1189 Methyl salicylate; exemption from the
a tolerance will permit the marketing of the requirement of a tolerance.
food commodities in this paragraph when The biochemical pesticide methyl salicylate
treated in accordance with the provisions of is exempt from the requirement of a tolerance
experimental use permit 70060-EUP-1, which is for residues in or on food or feed when used
being issued under the Federal Insecticide, as an insect repellant in food packaging and
Fungicide, and Rodenticide Act (FIFRA), as animal feed packaging at an application rate
amended (7 U.S.C. 136). This temporary that does not exceed 0.2 mg of methyl
exemption from the requirement of a salicylate per square inch of packaging
tolerance expires and is revoked December 31, materials.
1999. This temporary exemption from the [62 FR 61639, Nov. 19, 1997]
requirement of a tolerance may be revoked at §180.1191 Ferric phosphate; exemption from the
any time if the experimental use permit is requirement of a tolerance.
revoked or if any experience with or scientific An exemption from the requirement of a
data on this pesticide indicate that the tolerance is established for residues of the
tolerance is not safe. biochemical pesticide, ferric phosphate
Kaolin is exempted from the requirement of (FePO4, CAS No. 1104586-0) in or on all food
a tolerance for residues when used on or in commodities.
food commodities to aid in the control of [62 FR 56105, Oct. 29, 1997]
insects, fungi, and bacteria (food/feed use). §180.1193 Potassium dihydrogen phosphate;
[62 FR 19685, Apr. 23, 1997, as amended at 63 FR 9430, Feb. exemption from the requirement of a tolerance.
25, 1998] Potassium dihydrogen phosphate is
exempted from the requirement of a tolerance
§180.1181 Bacillus cereus strain BPO1; exemption in or on all food commodities when applied as
from the requirement of a tolerance. a fungicide in accordance with good
An exemption from the requirement of a agricultural practices.
tolerance for residues of the Bacillus cereus [63 FR 43085, Aug. 12, 1998]
strain BPO1 in or on all raw agricultural
commodities when ap- plied/used in § 180.1195 Titanium dioxide.
accordance with label directions.
or on growing crops, when used as an Inert dues of hydrogen peroxide In or on all food
ingredient (UV protectant) in commodities at the rate of <1% hydrogen
microencapsulated formulations of the peroxide per application on growing and
insecticide lambda cyhalothrin at no more postharvest crops.
than 3.0% by weight of the formulation and as [67 FR 41844, June 20, 2002]
an inert ingredient (UV- stabilizer) at no more
than 5% in pesticide formulations containing §180.1198 Gliocladium catenulatum strain J1446;
the active ingredient napropamide. exemption from the requirement of a
tolerance.
[77 FR 44155, July 27, 2012]
An exemption from the requirement of a
§180.1196 Peroxyacetic acid; exemption from the tolerance is established for residues of the
requirement of a tOlerance.
microbial pesticide, Gliocladium catenulatum
An exemption from the requirement of a strain J1446 when used in or on all food
tolerance is established for residues of commodities.
peroxyacetic acid in or on all food
commodities, when such residues result from [63 FR 37288, July 10, 1998]
peroxy- acetic acid up to 500 ppm, and § 180.1200 Pseudomonas fluorescens strain PRA-25;
applied to tableware, utensils, dishes, temporary exemption from the requirement of
pipelines, tanks, vats, fillers, evaporators, a tolerance.
pasteurizers, aseptic equipment, milking A temporary exemption from the
equipment, and other food processing requirement of a tolerance is established for
equipment in food handling establishments residues of the microbial pesticide,
including, but not limited to dairies, dairy pseudomonas fluorescens strain PRA-25 when
barns, restaurants, food service operations, used on peas, snap beans and sweet corn and
breweries, wineries, and beverage and food will expire July 31, 2001.
processing plants.
An exemption from the requirement of a [63 FR 38498, July 17, 1998]
tolerance is established for residues of the § 180.1201 Trichoderma harzianum strain T-39;
biochemical pesticide peroxyacetic acid and its exemption from the requirement of a
metabolites and degradates, including tolerance.
hydrogen peroxide and acetic acid, in or on all Trichoderma harzianum strain T-39 is exempt
food commodities, when used in accordance from the requirement of a tolerance on all
with good agricultural practices. food commodities.
[74 FR 26535, June 3, 2009, as amended at 76 FR 11969, Mar. [65 FR 38757, June 22, 2000]
4, 2011]
§ 180.1202 Bacillus sphaericus; exemption from the
§180.1197 Hydrogen peroxide; exemption from the requirement of a tolerance.
requirement of a tolerance.
An exemption from the requirement of a
An exemption from the requirement of a tolerance is established for residues of the
tolerance is established for resi microbial pesticides, Bacillus sphaericus when
used in or on all food crops.
§ 180.1204 Harpin protein; exemption from the § 180.1206 Aspergillus flavus AF36; exemption from
requirement of a tolerance. the requirement of a tolerance.
An exemption from the requirement of a An exemption from the requirement of a
tolerance is established for residues of tolerance is established for residues of the
individual harpin proteins that meet specified microbial pesticide Aspergillus flavus AF36 in or
physiochemical and toxicological criteria when on cotton, gin byproducts; cotton, hulls;
used as biochemical pesticides on all food cotton, meal; cotton, refined oil; cotton,
commodities to enhance plant growth, quality undelinted seed.
and yield, to improve overall plant health, and An exemption from the requirement of a
to aid in pest management. The tolerance is established for residues of
physiochemical and toxicological criteria Aspergillus flavus AF36 in or on pistachio when
identifying harpin proteins are as follows: applied as an antifungal agent and used in
Consists of a protein less than 100 kD in size, accordance with good agricultural practices.
that is acidic (pI<7.0), glycine rich (>10%), and An exemption from the requirement of a
contains no more than one cystine residue. tolerance is established for residues of
The source(s) of genetic material encoding Aspergillus flavus AF36 in or on corn, field,
the protein are bacterial plant pathogens not forage; corn, field, grain; corn, field, stover;
known to be mammalian pathogens. corn, field, aspirated grain fractions; corn,
Elicits the hypersensitive response (HR) sweet, kernel plus cob with husk removed;
which is characterized as rapid, localized cell corn, sweet, forage; corn, sweet, stover; corn,
death in plant tissue after infiltration of harpin pop, grain; and corn, pop, stover, when
into the intercellular spaces of plant leaves. applied/used as an antifungal agent.
Possesses a common secondary structure [68 FR 41541, July 14, 2003, as amended at 72 FR 28871, May
consisting of a and b units that form an HR 23, 2007; 72 FR 72965, Dec. 26, 2007; 74 FR 26535, 26546,
domain. June 3, 2009; 76 FR 16301, Mar. 23, 2011; 77 FR 14291, Mar. 9,
N-acyl sarcosines.
N-cocoyl sarcosine mixture ........................... 68411-97-2
N-lauroyl sarcosine ........................................ 97-78-9
N-myristoyl sarcosine .................................... 52558-73-3
N-oleoyl sarcosine ......................................... 110-25-8
N-stearoyl sarcosine ...................................... 142-48-3
Sodium N-acyl sarcosinates.
N-cocoyl sarcosine sodium salt mixture ........ 61791-59-1
N-methyl-N-(1-oxo-9-octodecenyl) glycine .... 3624-77-9
N-methyl-N-(1-oxododecyl) glycine ............... 137-16-6
N-methyl-N-(1-oxooctadecyl) glycine ............ 5136-55-0
N-methyl-N-(1-oxotetradecyl glycine ............. 30364-51-3
§ 180.1209 Bacillus subtilis strain QST 713 and strain § 180.1219 Foramsulfuron; exemption from the
QST 713 variant soil; exemption from the requirement of a tolerance.
requirement of a tolerance. The pesticide foramsulfuron is exempted
An exemption from the requirement of a from the requirement of a tolerance in corn,
tolerance is established for residues of the field, grain/corn, field, forage/ corn, field,
microbial pesticides Bacillus subtilis strain QST stover/corn, pop, grain/corn, pop,
713 and strain QST 713 variant soil when used forage/corn, pop, stover; corn, sweet, forage;
in or on all food commodities. corn, sweet, kernel plus cob with husks
removed; corn, sweet, stover when applied as
a herbicide in accordance with good
[77 FR 73937, Dec. 12, 2012]
per application) on food contact surfaces such § 180.1233 Potassium sorbate; exemption from the
as equipment, pipelines, tanks, vats, fillers, requirement of a tolerance.
evaporators, pasteurizers and aseptic An exemption from the requirement of a
equipment in restaurants, food service tolerance is established for residues of
operations, dairies, breweries, wineries, potassium sorbate.
beverage and food processing plants. [70 FR 33363, June 8, 2005]
[68 FR 7939, Feb. 19, 2003; 68 FR 17308, Apr. 9, 2003]
§ 180.1234 Sodium carbonate; exemption from the
requirement of a tolerance.
§ 180.1226 Bacillus pumilus strain QST2808;
temporary exemption from the requirement of An exemption from the requirement of a
a tolerance. tolerance is established for residues of sodium
A temporary exemption from the carbonate.
requirement of a tolerance is established for [70 FR 33363, June 8, 2005]
residues of the microbial pesticide Bacillus § 180.1235 Sodium hypochlorite; exemption from
pumilus strain QST2808 when used in or on all the requirement of a tolerance.
agricultural commodities when applied/used
An exemption from the requirement of a
in accordance with label directions. tolerance is established for residues of sodium
hypochlorite.
§ 180.1241 Eucalyptus oil; exemption from the
requirement of a tolerance.
Time-limited exemptions from the
An exemption from the requirement of a requirement of a tolerance are established for
tolerance is established for residues of sulfur. residues of eucalyptus oil on honey and
honeycomb in connection with use of the
[70 FR 33363, June 8, 2005]
§ 180.1237 Sodium metasilicate; exemption from the pesticide under section 18 emergency
requirement of a tolerance. exemptions granted by the EPA. These time-
An exemption from the requirement of a limited exemptions from the requirement of a
tolerance is established for residues of sodium tolerance for residues of eucalyptus oil will
metasilicate in or on all food commodities expire and are revoked on June 30, 2007.
when used in accordance with approved label
[70 FR 37696, June 30, 2005]
rates and good agricultural practices as a plant § 180.1243 Bacillus subtilis var. amyloliquefaciens
desiccant, so long as the sodium metasilicate strain FZB24; exemption from the requirement
of a tolerance.
does not exceed 4% by weight in aqueous An exemption from the requirement of a
solution. tolerance for residues of the Bacillus subtilis
An exemption from the requirement of a var. amyloliquefaciens strain FZB24 in or on all
tolerance is established for residues of sodium agricultural commodities when applied/used
metasilicate in or on all food commodities in accordance with label directions.
when used in accordance with approved label [68 FR 44640, July 30, 2003]
rates and good agricultural practices as an § 180.1244 Ammonium bicarbonate; exemption
insecticide and fungicide, so long as the from the requirement of a tolerance.
sodium metasilicate does not exceed 2.41% by An exemption from the requirement of
weight in aqueous solution. tolerance is established for residues of
[71 FR 19441, Apr. 14, 2006] ammonium bicarbonate used in or on all food
commodities when used in accordance with
§ 180.1240 Thymol; exemption from the
requirement of a tolerance.
good agricultural practices.
[69 FR 13745, Mar. 24, 2004]
Time-limited exemptions from the
§ 180.1245 Rhamnolipid biosurfactant; exemption
requirement of a tolerance are established for from the requirement of a tolerance.
residues of thymol on honey and honeycomb An exemption from the requirement of a
in connection with use of the pesticide under tolerance is established for residues of
section 18 emergency exemptions granted by rhamnolipid biosurfactant when used in
the EPA. These time-limited exemptions from accordance with good agricultural practices as
the requirement of a tolerance for residues of a fungicide in or on all food commodities.
thymol will expire and are revoked on June 30, [69 FR 16800, Mar. 31, 2004]
2007. § 180.1246 Yeast Extract Hydrolysate from
An exemption from the requirement of a Saccharomyces cerevisiae: exemption from the
tolerance for residues of the thymol (as requirement of a tolerance.
present in thyme oil) in or on food This regulation establishes an exemption
commodities when applied/used in/on public from the requirement of a tolerance for
eating places, dairy processing equipment, residues of the biochemical pesticide Yeast
and/or food processing equipment and Extract Hydrolysate from Saccharomyces
utensils. cerevisiae on all
[70 FR 37696, June 30, 2005, as amended at 71 FR 2895, Jan.
18, 2006; 74 FR 12617, Mar. 25, 2009]
food commodities when applled/used for the 21882 on peanut; peanut, hay; peanut, meal;
management of plant diseases. and peanut, refined oil.
[69 FR 9958, Mar. 3, 2004] An exemption from the requirement of a
§ 180.1248 Exemption of citronellol from the tolerance is established for residues of
requirement of a tolerance. Aspergillus flavus NRRL 21882 on corn, field,
An exemption from the requirement of a forage; corn, field, grain; corn, field, stover;
tolerance is established for residues of the corn, field, aspirated grain fractions; corn,
biochemical pesticide citronellol in or on all sweet, kernel plus cob with husk removed;
food commodities. corn, sweet, forage; corn, sweet, stover; corn,
[69 FR 23146, Apr. 28, 2004] pop, grain; and corn, pop, stover.
§ 180.1250 C8, C10, and C12 fatty acid monoesters [75 FR 6576, Feb. 10, 2010]
of glycerol and propylene glycol; exemption § 180.1255 Bacillus pumilus strain QST 2808;
from the requirement of a tolerance. exemption from the requirement of a
The C8, C10, and C12 straight-chain fatty tolerance.
acid monoesters of glycerol (glycerol An exemption from the requirement of a
monocaprylate, glycerol monocaprate, and tolerance is established for residues of the
glycerol microbial pesticide Bacillus pumilus strain QST
monolaurate) and propylene glycol (propylene 2808 when used in or on all agricultural
glycol monocaprylate, propylene glycol commodities when applied/used in
monocaprate, and propylene glycol accordance with label directions.
monolaurate) are exempt from the [69 FR 63954, Nov. 3, 2004]
requirement of a tolerance in or on all food § 180.1256 Alternaría destruens strain 059;
commodities when used in accordance with exemption from the requirement of a
approved label rates and good agricultural tolerance.
practice. An exemption from the requirement of a
[69 FR 34944, June 23, 2004] tolerance is established for residues of the
§ 180.1251 Geraniol; exemption from the microbial pesticide Alternaria destruens Strain
requirement of a tolerance. 059 when used in or on all raw agricultural
An exemption from the requirement of a commodities when applied/used in
tolerance is established for residues of the accordance with label directions.
biochemical pesticide geraniol in or on all food [70 FR 28459, May 18, 2005]
commodities. § 180.1257 Paecilomyces lilacinus
[69 FR 23151, Apr. 28, 2004] strain 251; exemption from the requirement of
§ 180.1253 Streptomyces lydicus WYEC 108; a tolerance.
exemption from the requirement of a An exemption from the requirement of a
tolerance. tolerance is established for residues of the
An exemption from the requirement of a microbial pesticide Paecilomyces lilacinus strain
tolerance is established for residues of the 251 when used in or on all agricultural
microbial pesticide Streptomyces lydicus WYEC commodities when applied/used in
108 when used in or on all agricultural accordance with label directions.
commodities when applied/used in [70 FR 19283, Apr. 13, 2005]
accordance with label directions. § 180.1258 Acetic acid; exemption from the
[69 FR 31301, June 3, 2004] requirement of a tolerance.
§ 180.1254 Aspergillus flavus NRRL 21882; (a) An exemption from the requirement of a
exemption from the requirement of a tolerance is established for residues of the
tolerance. biochemical pesticide acetic acid when used as
(a) An exemption from the requirement of a a preservative on post-harvest agricultural
tolerance is established for residues of commodities intended for animal feed,
Aspergillus flavus NRRL including Alfalfa, seed; alfalfa, hay; barley,
grain; bermudagrass, hay; bluegrass, hay; § 180.1262 Sorbitol octanoate; exemption from the
bromegrass, hay; clover, hay; corn, field, grain; requirement of a tolerance.
corn, pop, grain; cowpea, hay; fescue, hay; An exemption from the requirement of a
lespedeza, hay; lupin; oat, grain; orchardgrass, tolerance is established for residues of sorbitol
hay; peanut, hay; timothy, hay; vetch, hay; and octanoate in or on all food commodities when
wheat, grain, or commodities described as used in accordance with label directions.
grain or hay. [71 FR 4518, Jan. 27, 2006]
§ 180.1261 Xanthomonas campestris pv. vesicatoria § 180.1268 Potassium silicate; exemption from the
and Pseudomonas syringae pv. tomato specific requirement of a tolerance.
Bacteriophages. Potassium silicate is exempt from the
An exemption from the requirement of a requirement of a tolerance in or on all food
tolerance is established for residues of commodities so long as the potassium silicate
Xanthomonas campestris pv. vesicatoria and is not applied at rates exceeding 1% by weight
Pseudomonas syringae pv. tomato specific in aqueous solution and when used in
bacteriophages in or on pepper and tomato. accordance with good agricultural practices.
§ 180.1269 Bacillus mycoides isolate J; exemption
from the requirement of a tolerance.
Bacillus mycoides Isolate J Is temporarily
exempt from the requirement of a tolerance Tris (2-ethylhexyl) phosphate (TEHP, CAS
when used as a fungicide on potatoes in
Reg. No. 78-42-2) is exempt from the
accordance with a valid Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) section requirement of a tolerance for residues in
18 emergency exemption. This temporary grain, aspirated fractions; barley, grain, barley,
exemption from the requirement of a hay, barley, straw; wheat, grain; wheat, forage;
tolerance expires and is revoked on December wheat, hay; wheat, straw when used under the
31, 2015. following conditions:
[78 FR 24353, Apr. 25, 2013] The use is in accordance with good
§ 180.1270 Isophorone; exemption from the agricultural practices;
requirement of a tolerance. Tris (2-ethylhexyl) phosphate is used as an
Isophorone (CAS Reg. No. 78-59-1) is inert ingredient in pesticide formulations with
exempt from the requirement of a tolerance the active ingredients pinoxaden, clodinafop-
when used as an inert ingredient in pesticide propargyl, and tralkoxydium;
formulations applied to beets, ginseng, rice, Tris (2-ethylhexyl) phosphate is applied no
spinach, sugar beets, and Swiss chard. more than twice per season; and
The applications occur no later than the
[71 FR 45408, Aug. 9, 2006]
§ 180.1271 Eucalyptus oil; exemption from the pre-boot stage (prior to formation of edible
requirement of a tolerance. grain).
An exemption from the requirement of [72 FR 5624, Feb. 7, 2007, as amended at 74 FR 26536, June 3,
tolerance is established for residues of 2009]
eucalyptus oil in or on honey, honeycomb, and
honeycomb with honey when used at 2g or § 180.1275 Pythium; exception from the requirement
less eucalyptus oil per hive, where the of a tolerance.
eucalyptus oil contains 80% or more An exemption from the requirement of
eucalyptol. tolerance is established on all food/ feed
[71 FR 53979, Sept. 13, 2006] commodities, for residues of pythium
§ 180.1272 Pantoea agglomerans strain E325; oligandrum DV 74 when the pesticide is used on
exemption from the requirement of a tolerance. food crops.
An exemption from the requirement of a [72 FR 27452, May 16, 2007]
tolerance is established for residues of Pantoea
agglomerans strain E325 when used on apples §180.1276 Tobacco mild green mosaic tobamovirus
(TMGMV); temporary exemption from the
and pears. requirement of a tolerance.
[71 FR 54933, Sept. 20, 2006]
A temporary exemption from the
§ 180.1273 Beauveria bassiana HF23; exemption
from the requirement of a tolerance. requirement of a tolerance is established for
Residues of Beauveria bassiana HF23 are residues of tobacco mild green mosaic
exempt from the requirement of a tolerance tobamovirus in or on all grass, forage and
on all food/feed commodities, when the grass, hay.
pesticide is used for the treatment of chicken
[74 FR 26536, June 3, 2009]
and livestock facilities, including the treatment § 180.1277 Dibasic esters; exemption from the
of chicken and livestock manure. requirement of a tolerance.
Dibasic esters (CAS Reg. No. 95481-622) is
exempted from the requirement of a tolerance
for residues when used as an inert ingredient
(solvent and/or anti-freeze) at 10% W/W or
less in
microencapsulated pesticide formulations with § 180.1282 Bacillus firmus I-1582; exemption from
the active ingredient cyfluthrin. the requirement of a tolerance.
An exemption from the requirement of a
tolerance is established in/on all food/feed
[73 FR 10398, Feb. 27, 2008]
§ 180.1278 Quillaja saponaria extract (saponins); commodities, for residues of Bacillus firmus I-
exemption from the requirement of a 1582 when used as a soil application or seed
tolerance. treatment.
[73 FR 25528, May 7, 2008]
Residues of the biochemical pesticide
Quillaja saponaria extract (saponins) are § 180.1283 (Z)-7,8-epoxy-2-
methyloctadecane (Disparlure); exemption
exempt from the requirement of a tolerance in from the requirement of a tolerance.
or on all food commodities. An exemption from the requirement of a
[72 FR 41935, Aug. 1, 2007] tolerance is established for residues of
(Z)-7,8-epoxy-2-
§ 180.1279 Zucchini yellow mosaic virus—weak methyloctadecane on all food and feed crops
strain; exemption from the requirement of a that occur when it is used to treat trees, shrubs,
tolerance. and pastures and such use results in
An exemption from the requirement of a unintentional spray and drift to non-target
tolerance for residues of the ZYMV-WK strain vegetation including non-food, food, and feed
in or on all raw cucurbit when applied/used in crops. This active ingredient is also known as
accordance with label directions. Disparlure.
[73 FR 33714, June 13, 2008]
[74 FR 26536, June 3, 2009]
§ 180.1284 Ammonium salts of higher fatty acids
§ 180.1280 (Cs-C-is saturated; Cs-Ci2 unsaturated);
Poly(hexamethylenebiguanide) exemption from the requirement of a tolerance.
hydrochloride (PHMB); exemption from the Ammonium salts of C8-CJ8 saturated and C8-
requirement of a tolerance. C12 unsaturated higher fatty acids are
Poly(hexamethylenebiguanide) exempted from the requirement of a tolerance
hydrochloride (PHMB)(CAS Reg. No. 32289- for residues in or on all food commodities
when used in accordance with good
58-0) is exempt from the requirement of a
agricultural practice.
tolerance for residues of the antimicrobial in or [74 FR 47457, Sept. 16, 2009]
on all food commodities when the residues are § 180.1285 Polyoxin D zinc salt; exemption from the
the result of the lawful application of a food requirement of a tolerance.
contact surface sanitizer containing PHMB at An exemption from the requirement of a
550 parts per million (ppm). tolerance is established for the residues of
[73 FR 1517, Jan. 9, 2008] polyoxin D zinc salt in or on all food
commodities when applied as a fungicide and
§ 180.1281 S-Abscisic Acid, (S)-5-(1-hy- droxy-2,6,6- used in accordance with good agricultural
trimethyl-4-oxo-1- cyclohex-2-enyl)-3-methyl- practices.
penta- (2Z,4E)-dienoic Acid; exemption from [77 FR 56133, Sept. 12, 2012]
the requirement of a tolerance. § 180.1287 Extract of Chenopodium ambrosioides
An exemption from the requirement of a near ambrosioides; exemption from the
tolerance is established for residues of S- requirement of a tolerance.
Abscisic Acid in or on all food commodities
when applied or used preharvest as a plant
regulator.
ambrosioides near ambrosioides when used as
an Insectlclde/acarlelde on all food
commodities.
An exemption from the requirement of a
[74 FR 634, Jan. 7, 2009]
They constitute no more than 10.0% of the § 180.1294 Trichoderma asperellum strain ICC 012;
formulated pesticide product. exemption from the requirement of a tolerance.
[74 FR 12625, Mar. 25, 2009] Trichoderma asperellum strain ICC 012 is
exempted from the requirement of a tolerance
§ 180.1289 Candida oleophila Strain O; exemption
from the requirement of a tolerance.
in or on all food and feed commodities when
An exemption from the requirement of a applied pre-harvest and used in accordance
tolerance is established for the residues of the with good agricultural practices.
[75 FR 9530, Mar. 3, 2010]
microbial pesticide, Candida oleophila Strain
O, on apples and pears when applied/used as § 180.1295 Laminarin; exemption from the
requirement of a tolerance.
a postharvest biofungicide.
[74 FR 22464, May 13, 2009] An exemption from the requirement of a
tolerance is established for residues of
§ 180.1290 Pasteuria usgae; exemption from the laminarin in or on all food commodities when
requirement of a tolerance. laminarin is applied preharvest.
An exemption from the requirement of a [75 FR 8256, Feb. 24, 2010]
tolerance is established for residues of § 180.1296 Terpene Constituents a-ter- pinene, d-
Pasteuria usgae in or on all food commodities limonene and p-cymene, of the Extract of
when applied preharvest and used as a Chenopodium ambrosioides near
nematicide in accordance with good ambrosioides as Synthetically Manufactured;
agricultural practices. exemption from the requirement of a tolerance.
[75 FR 37737, June 30, 2010] An exemption from the requirement of a
tolerance is established for the residues of the
§ 180.1291 Cold pressed neem oil; exemption from
the requirement of a tolerance.
biochemical pesticide Terpene Constituents a-
Residues of the biochemical pesticide cold terpinene, d-limo- nene and p-cymene, of the
pressed neem oil are exempt from the Extract of Chenopodium ambrosioides near
requirement of a tolerance in or on all food
commodities.
ambrosioides as Synthetically Manufactured O157:H7, sequence negative for shiga toxins I
when used as an insecticide/acar- icide in or and II, and grown on atoxigenic host bacteria
on all food commodities. when used/ap- plied on food contact surfaces
[75 FR 39455, July 9, 2010] in food processing plants in accordance with
§ 180.1297 Homobrassinolide; exemption from the the terms of Experimental Use Permit (EUP)
requirement of a tolerance. No. 74234-EUP-2. This temporary exemption
An exemption from the requirement of a expires on April 1, 2013.
tolerance is established for the residues of [76 FR 20546, Apr. 13, 2011]
homobrassinolide in or on all food
commodities when applied/used as a plant § 180.1302 Sodium Ferric Ethylene-
growth regulator in accordance with good diaminetetraacetate (EDTA); exemption from
agricultural practices. the requirement of a tolerance.
[75 FR 39459, July 9, 2010] An exemption from the requirement of a
§ 180.1298 Trichoderma hamatum isolate 382; tolerance is established for residues of sodium
exemption from the requirement of a tolerance. ferric EDTA in or on all food commodities
An exemption from the requirement of a when applied as a molluscicide and used in
tolerance is established for residues of accordance with good agricultural practices.
Trichoderma hamatum isolate 382 in or on all
food commodities when applied as a fungicide [76 FR 17561, Mar. 30, 2011]
and used in accordance with good agricultural § 180.1303 Metarhizium anisopliae strain F52;
practices. exemption from the requirement of a
[75 FR 43076, July 23, 2010]
tolerance.
§ 180.1299 Prohydrojasmon; exemption from the An exemption from the requirement of a
requirement of a tolerance. tolerance is established for residues of
An exemption from the requirement of a Metarhizium anisopliae strain F52 in or on all
tolerance is established for residues of the food commodities when applied as an
biochemical pesticide prohydrojasmon (PDJ),
insecticide, miticide, or ixodicide and used in
propyl-3-oxo-2- pentylcyclo-pentylacetate,
accordance with good agricultural practices.
when used as a plant growth regulator in or on
apple and grape pre-harvest, in accordance [76 FR 26198, May 6, 2011]
with label directions and good agricultural
§ 180.1304 Pseudomonas fluorescens strain
practices.
[78 FR 75257, Dec. 11, 2013] CL145A; exemption from the requirement of a
tolerance.
§ 180.1300 Potassium hypochlorite; exemption from
the requirement of a tolerance. An exemption from the requirement of a
An exemption from the requirement of a tolerance is established for residues of
tolerance is established for residues of Pseudomonas fluorescens strain CL145A in or on
potassium hypochlorite in or on all all food commodities when applied as a
commodities. molluscicide.
[76 FR 11343, Mar. 2, 2011] [76 FR 52875, Aug. 24, 2011]
§180.1301 Escherichia coli O157:H7 specific
bacteriophages; temporary exemption from § 180.1305 Chromobacterium
the requirement of a tolerance. subtsugae strain PRAA4-1T; exemption from
A temporary exemption from the the requirement of a tolerance.
requirement of a tolerance is established for An exemption from the requirement of a
residues of lytic bacteriophages that are tolerance is established for residues of
specific to Escherichia coli Chromobacterium subtsugae strain PRAA4-1T in
or on all food commodities when applied as
an insecticide or miticide and used in
accordance with good agricultural practices.
§ 180.1306 Isaria fumosorosea (formerly
Paecilomyces fumosoroseus) Apopka strain
97; exemption from the requirement of a
tolerance. An exemption from the requirement of a
An exemption from the requirement of a tolerance is established for residues of
tolerance is established for residues of Isaria Trichoderma virens strain G-41, in or on all food
fumosorosea (formerly Paecilomyces commodities, when applied as a fungicide and
fumosoroseus) Apopka strain 97 in or on all food used in accordance with good agricultural
commodities when applied as an insecticide or practices.
miticide and used in accordance with good [77 FR 4908, Feb. 1, 2012]
agricultural practices.
§180.1311 Pasteuria nishizawae—Pn1; exemption
[76 FR 59905, Sept. 28, 2011] from the requirement of a tolerance.
§ 180.1307 Bacteriophage of An exemption from the requirement of a
Clavibacter michiganensis subspecies tolerance is established for residues of Pasteuria
michiganensis; exemption from the nishizawae—Pn1 in or on all food commodities
requirement of a tolerance. when applied as a nematicide and used in
An exemption from the requirement of a accordance with good agricultural practices.
tolerance is established for residues of lytic [77 FR 8741, Feb. 15, 2012]
bacteriophage of Clavibacter michiganensis
subspecies michiganensis produced in § 180.1312 Aureobasidium pullulans
strains DSM 14940 and DSM 14941; exemption
Clavibacter michiganensis subspecies from the requirement of a tolerance.
michiganensis in or on tomato when applied
An exemption from the requirement of a
as a bactericide in accordance with good tolerance is established for residues of the
agricultural practices. microbial pesticides, Aureobasidium pullulans
[76 FR 66192, Oct. 26, 2011] strains DSM 14940 and DSM 14941 in or on all
food commodities when applied preharvest
§ 180.1308 Bacillus amyloliquefaciens strain D747; and used in accordance with good agricultural
exemption from the requirement of a tolerance. practices.
An exemption from the requirement of a [77 FR 8736, Feb. 15, 2012]
tolerance is established for residues of the
microbial pesticide, Bacillus amyloliquefaciens § 180.1313 Bacillus pumilus strain GHA 180;
strain D747 in or on all food commodities exemption from the requirement of a
when used in accordance with good tolerance.
agricultural practices. An exemption from the requirement of a
tolerance is established for residues of Bacillus
pumilus strain GHA 180 in or on all food
[77 FR 749, Jan. 6, 2012. Redesignated at 77 FR 2911, Jan. 20,
2012]
commodities when used in accordance with
§ 180.1309 Bacillus subtilis strain CX- 9060; good agricultural practices.
exemption from the requirement of a tolerance. [77 FR 19112, Mar. 30, 2012]
An exemption from the requirement of a § 180.1314 Killed, nonviable
tolerance is established for residues of the Streptomyces acidiscabies strain RL-110T;
microbial pesticide Bacillus subtilis strain CX- exemption from the requirement of a
9060, in or on all food commodities, when tolerance.
applied or used in accordance with good An exemption from the requirement of a
agricultural practices. tolerance is established for residues of killed,
nonviable Streptomyces acidiscabies strain RL-
110T in or on all food commodities when
applied as a pre- or post-emergent herbicide
and
used In accordance with good agricultural § 180.1319 Banda de Lupinus albus doce (BLAD);
practices. exemption from the requirement of a
tolerance.
[77 FR 35295, June 13, 2012]
An exemption from the requirement of a
§ 180.1315 Natamycin; exemption from the tolerance is established for the residues of
requirement of a tolerance. Banda de Lupinus albus doce (BLAD), a naturally
occurring polypeptide from the catabolism of
An exemption from the requirement of a
a seed storage protein (b-conglutin) of sweet
tolerance is established for residues of lupines (Lupinus albus), in or on all food
natamycin in or on mushrooms when applied commodities when applied as a fungicide and
as a fungistat to prevent the germination of used in accordance with label directions and
fungal spores on mushrooms produced in good agricultural practices.
enclosed mushroom production facilities. [78 FR 17604, Mar. 22, 2013]
[77 FR 29548, May 18, 2012] § 180.1320 Methyl jasmonate; exemption from the
requirement of a tolerance.
§ 180.1316 Pasteuria spp. An exemption from the requirement of a
(Rotylenchulus reniformis nematode)—Pr3; tolerance is established for residues of methyl
exemption from the requirement of a jasmonate in or on all food commodities when
tolerance. methyl jasmonate is applied pre-harvest.
An exemption from the requirement of a [78 FR 22794, Apr. 17, 2013]
tolerance is established for residues of Pasteuria § 180.1321 Complex Polymeric
spp. (Rotylenchulus reniformis nematode)—Pr3 Polyhydroxy Acids; exemption from the
in or on all food commodities when applied as requirement of a tolerance.
a nematicide and used in accordance with An exemption from the requirement of a
label directions and good agricultural tolerance is established for the residues of
practices. complex polymeric polyhydroxy acids in or on
all food commodities when applied as a plant
[77 FR 40276, July 9, 2012] growth regulator and used in accordance with
good agricultural practices.
§ 180.1317 Pesticide chemicals; exemption from the [78 FR 46267, July 31, 2013]
requirements of a tolerance.
§ 180.1322 Bacillus pumilus strain BU F-33;
An exemption from the requirement of a exemption from the requirement of a
tolerance is established for residues of Didecyl tolerance.
dimethyl ammonium chloride in or on broccoli An exemption from the requirement of a
resulting from the use of Didecyl dimethyl tolerance is established for residues of Bacillus
ammonium chloride as a seed treatment at a pumilus strain BU F-33 in or on all food
treatment concentration of 1200 ppm prior to commodities when applied to elicit induced
planting by immersion. systemic resistance in plants and used in
accordance with label directions and good
[77 FR 47296, Aug. 8, 2012]
agricultural practices.
[78 FR 35149, June 12, 2013]
§ 180.1318 3-decen-2-one; exemption from the
requirement of a tolerance. § 180.1323 Ethyl-2E,4Z-decadienoate (Pear Ester);
exemption from the requirement of a
An exemption from the requirement of a tolerance.
tolerance is established for residues of the An exemption from the requirement of a
biochemical pesticide, 3- decen-2-one, in or tolerance is established for residues of the
on potatoes when applied as a potato sprout biochemical pesticide, ethyl-2E,4Z-
inhibitor and used in accordance with label decadienoate (pear ester),
directions and good agricultural practices.
in or on all food commodities, when used in § 180.2000 Scope.
accordance with label directions and good This subpart sets forth the pesticide
agricultural practices. chemicals for use in agricultural or other food-
[78 FR 53054, Aug. 28, 2013]
related settings for which neither a tolerance
§ 180.1324 GS-omega/kappa-Hxtx-Hv1a; nor an exemption is deemed to be needed by
exemption from the requirement of a EPA.
tolerance.
§ 180.2003 Definitions.
An exemption from the requirement of a
tolerance is established for residues of the Food uses are the uses of a pesticide
pesticide GS-omega/kappa- Hxtx-Hvla in or chemical that are likely to yield residues in
on all food commodities when applied or used food or feed crops, meat, milk, poultry or egg.
in accordance with label directions and good Non-food uses are those uses that are not
agricultural practices. likely to yield residues in food or feed crops,
[79 FR 10685, Feb. 26, 2014] meat, milk, poultry or egg.
§ 180.1325 Heat-killed Burkholderia spp. strain A396 [66 FR 66772, Dec. 27, 2001, as amended at 73 FR 60158, Oct.
cells and spent fermentation media exemption 10, 2008]
from the requirement of a tolerance. § 180.2010 Threshold of regulation determinations.
An exemption from the requirement of a
tolerance is established for residues of heat- The following pesticide chemical uses on
killed Burkholderia spp. strain A396 cells and food or feed, or food or feed crops, do not
spent fermentation media in or on all food need a tolerance or exemption from the
commodities when applied as a biological requirement of a tolerance, and may be
insecticide to agricultural crops and used in registered under the Federal Insecticide,
accordance with label directions and good Fungicide, and Rodenticide Act, 7 U.S.C. 136 et
agricultural practices. seq., without obtaining such tolerance or
[79 FR 15704, Mar. 21, 2014] exemption, based on EPA’s determination that
the uses are below the threshold of regulation.
Subpart E—Pesticide Chemicals Not
Requiring a Tolerance or an
Exemption From a Tolerance
Thiabendazole 148-79-8 As a seed treatment for dry pea (including field pea, pigeon High Perform-
pea, chickpea or lentil), using a maximum application rate of ance Liquid
0.075 pounds of active ingredient per 100 pounds of seed. Chroma-
Vines or hay grown from treated seed may not be fed to live- tography/Flo-
stock.. rescence
Detector
method1;
Modification of
Ion-Pairing Liquid
Chromatographic
Determination of
Benzimidazole
Fungicides in
Foods, Gilvydis
and Walters,
JAOAC, vol.
73, no. 5,
1990.
1
Available from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 207555350;
telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov
Methyl bromide 74-83-9 When applied as a pre-plant soil fumigant All pre-plant soil
uses
Potassium 12298-68-9 When applied to growing crops in foreign countries Bananas, grapes,
triiodide (KI3) and melons
Rhodamine B 81-88-9 Not to exceed 2% by weight of the formulated product and 60 ppm on the Dye for seed
treated seed treatment
[66 FR 66772, Dec. 27, 2001, as amended at 70 FR 40201, July 13, 2005; 71 FR 45402, Aug. 9, 2006]