Rule: Pesticide Programs: Pesticide Container and Containment Standards

Wednesday,
August 16, 2006
Part II
Environmental
Protection Agency
40 CFR Parts 9, 156 and 165
Pesticide Management and Disposal;
Standards for Pesticide Containers and
Containment; Final Rule
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47330 Federal Register / Vol. 71, No. 158 / Wednesday, August 16, 2006 / Rules and Regulations
ENVIRONMENTAL PROTECTION available in hard copy, at the Office of Units II.D., III., V.B., VI.C., VII.B., VIII.C.
AGENCY Pesticide Programs (OPP) Regulatory and IX.A. of this document. If you have
Public Docket in Rm. S–4400, One any questions regarding the
40 CFR Parts 9, 156 and 165 Potomac Yard (South Building), 2777 S. applicability of this action to a
[EPA–HQ–OPP–2005–0327; FRL–8076–2] Crystal Drive, Arlington, VA. The hours particular entity, consult the person
of operation of this Docket Facility are listed under FOR FURTHER INFORMATION
RIN 2070–AB95 from 8:30 a.m. to 4 p.m., Monday CONTACT.
through Friday, excluding legal
Pesticide Management and Disposal; B. How Can I Access Electronic Copies
holidays. The Docket telephone number
Standards for Pesticide Containers of this Document and Other Related
is (703) 305–5805.
and Containment Information?
FOR FURTHER INFORMATION CONTACT:
AGENCY: Environmental Protection Nancy Fitz, Field and External Affairs In addition to accessing an electronic
Agency (EPA). Division (7506P), Office of Pesticide copy of this Federal Register document
Programs, Environmental Protection through the electronic docket at
ACTION: Final rule.
Agency, 1200 Pennsylvania Ave., NW., www.regulations.gov, you may access
SUMMARY: With this final rule, EPA is Washington, DC 20460–0001; telephone this Federal Register document
establishing regulations for the safe number: (703) 305–7385; fax number: electronically through the EPA Internet
storage and disposal of pesticides as a (703) 308–2962; e-mail address: under the Federal Register listings at
means of protecting human health and fitz.nancy@epa.gov. http://www.epa.gov/fedrgstr/. You may
the environment pursuant to the Federal also access a frequently updated
SUPPLEMENTARY INFORMATION: electronic version of the Code of Federal
Insecticide, Fungicide, and Rodenticide
Act. This final rule establishes I. General Information Regulations (CFR) through the
requirements for pesticide container Government Printing Offices pilot e-CFR
A. Does this Action Apply to Me? site at http://www.gpoaccess.gov/ecfr/.
design, and procedures, standards and
label language to facilitate removal of You may be potentially affected by
II. Background
pesticides from containers prior to this action if you are a pesticide
disposal or recycling. This final rule formulator, agrichemical dealer, or an A. Statutory Authority
also establishes requirements for independent commercial applicator. These final regulations are issued
containment of stationary pesticide Potentially affected categories and pursuant to the authority given the
containers and procedures for container entities may include, but are not limited Administrator of EPA in sections 3, 8,
refilling operations. In addition, in order to: 19 and 25 of the Federal Insecticide,
to display the OMB control number for • Pesticide formulators (NAICS Fungicide, and Rodenticide Act
the information collection requirements 35232, former SIC code 2879), e.g., (FIFRA), 7 U.S.C. 136a, 136f, 136q and
contained in this final rule, EPA is establishments that formulate and 136w.
amending the table of OMB approval prepare insecticides, fungicides, Sections 19(e) and (f) of FIFRA grant
numbers for EPA regulations that herbicides or other pesticides from EPA broad authority to establish
appears in 40 CFR part 9. technical chemicals or concentrates standards and procedures to assure the
produced by pesticide manufacturing safe use, reuse, storage, and disposal of
DATES: This final rule is effective on
establishments. Some formulating pesticide containers. FIFRA section
October 16, 2006. For purposes of
establishments are owned by the large 19(e) requires EPA to promulgate
judicial review, this rule shall be
basic pesticide producers and others are regulations for the design of pesticide
promulgated at 1pm eastern daylight/
independent. containers that will promote the safe
standard time on August 30, 2006 (See • Agrichemical dealers (NAICS
40 CFR 23.6). storage and disposal of pesticides. The
44422, former SIC code 5191), e.g., retail regulations must ensure, to the fullest
ADDRESSES: EPA has established a dealers that distribute or sell pesticides
docket for this action under docket extent practicable, that the containers:
to agricultural users. (1) Accommodate procedures used for
identification (ID) number EPA–HQ– • Independent commercial removal of pesticides from the
OPP–2005–0327. Please note that the applicators (NAICS 115112, former SIC containers and rinsing of the containers.
docket material for the proposed rule code 0721), e.g., businesses that apply (2) Facilitate safe use of the
and supplemental notice, identified pesticides for compensation (by aerial containers, including elimination of
previously by docket ID number OPP– and/or ground application) and that are splash and leakage.
190001, is included as part of the not affiliated with agrichemical dealers. (3) Facilitate safe disposal of the
official docket for this action, although • Custom blenders (NAICS 44422, containers.
the material in the legacy docket is former SIC code 5191), e.g., most (4) Facilitate safe refill and reuse of
available only in hard copy. All custom blenders are also dealers. the containers.
documents in the docket are listed on This listing is not intended to be FIFRA section 19(f) requires EPA to
the regulations.gov web site. Although exhaustive, but rather provides a guide promulgate regulations prescribing
listed in the index, some information is for readers regarding entities likely to be procedures and standards for the
not publicly available, e.g., Confidential affected by this action. Other types of removal of pesticides from containers
Business Information (CBI) or other entities not listed in this unit could also prior to disposal. The statute states that
information whose disclosure is be affected. The North American the regulations may:
restricted by statute. Certain other Industrial Classification System (1) Specify, for each major type of
material, such as copyrighted material, (NAICS) codes have been provided to pesticide container, procedures and
is not placed on the Internet and will be assist you and others in determining standards for, at a minimum, triple
publicly available only in hard copy whether this action might apply to rinsing or the equivalent degree of
form. Publicly available docket certain entities. To determine whether pesticide removal.
materials are available either in the you or your business may be affected by (2) Specify procedures that can be
electronic docket at http:// this action, you should carefully implemented promptly and easily in
www.regulations.gov, or if only examine the applicability provisions in various circumstances and conditions.
Federal Register / Vol. 71, No. 158 / Wednesday, August 16, 2006 / Rules and Regulations 47331
(3) Provide for reuse, whenever containers. The proposal also included 50114), the comment period was
practicable, or disposal of rinse water standards for containment structures, extended for 30 days. (Ref. 32) The
and residue. which would promote safe storage by public comment period closed on
(4) Be coordinated with requirements facilitating the safe use, refill, and reuse September 15, 2004. EPA received about
imposed under the Resource of refillable containers. Additionally, 50 comments, mainly from individual
Conservation and Recovery Act (RCRA) the proposed rule contained entities or trade associations
for rinsing containers. amendments to the labeling regulations representing pesticide manufacturers,
Section 19(f) provides that the EPA, at in 40 CFR part 156 to ensure adequate agricultural pesticide retailers and State
the discretion of the Administrator, may levels of residue removal from regulatory agencies.
exempt products intended solely for containers. On December 17, 1993 (58 FR 65989),
household use. The public comment period for the EPA published an interim
Section 19(f)(2) states that after NPRM closed on July 11, 1994. EPA determination of adequacy for States
December 24, 1993, a State may not received about 1,900 pages of comments with primary enforcement responsibility
exercise primary enforcement from more than 200 commenters, and/or certification programs because
responsibility under section 26, or including many trade associations and EPA had not promulgated regulations
certify an applicator under section 11, individual companies from the pesticide under section 19(f)(1) by December 24,
unless the Administrator determines manufacturing, pesticide retail, and 1993. (Ref. 69) To avoid having the
that the State is carrying out an container manufacturing industries as provisions of section 19(f)(2) adversely
adequate program to ensure compliance well as many State regulatory agencies. impact the States and EPA, the Agency
with regulations promulgated under the EPA received numerous comments on
authority of section 19(f)(1). published a policy in the Federal
a few particular issues; specifically the
Section 19(h), titled Relationship to Register on August 18, 1993 (58 FR
scope of the container standards and the
Solid Waste Disposal Act, specifies that 43994), which set forth a process for
relationship between the 1994 proposed
nothing in section 19 shall diminish the EPA to make such an interim
rule and the U.S. Department of
authorities or requirements of RCRA. determination. (Ref. 68) EPA’s interim
Transportation (DOT) standards for
Also, the Food Quality Protection Act determination of adequacy was based on
hazardous materials packaging. A third
(FQPA) of 1996 amended section 19(h) an initial commitment by a State to
issue arose from the 1996 passage of the
of FIFRA to add an exemption for FQPA, which amended section 19(h) of conduct a number of activities which
certain antimicrobial pesticides. FIFRA to add an exemption for certain will position the State to have an
antimicrobial pesticides. To solicit adequate program in place by the time
B. Regulatory Background compliance with the regulations
comment on EPA’s interpretation of the
Prior to 1995, recommendations new statutory language on exempting promulgated under section 19(f)(1) is
regarding procedures for storage and antimicrobial pesticides and to reopen required. The December 17 notice stated
disposal of pesticides and pesticide comment on the scope of the container that the determination of adequacy is
containers were listed under 40 CFR regulations and an approach for temporary and will expire 2 years after
part 165. On June 19, 1995, as part of incorporating DOT’s standards, EPA promulgation of a final rule issued
the Federal government’s initiative to published a supplemental notice in the under section 19(f)(1). Thereafter, States
streamline regulations, part 165 was Federal Register on October 21, 1999 must have a program to ensure
deleted as unnecessary (60 FR 32094) (64 FR 56918). (Ref. 53) The compliance with the section 19(f)
because it contained recommendations supplemental notice also provided an regulations. Related Federal Register
rather than requirements. (Ref. 62) alternative definition of small business notices were published on February 25,
Subpart A of part 165 covered the scope for certain sectors of the pesticide 1994 (59 FR 9214) regarding New
and definitions in the industry for use in analyzing the Mexico and May 10, 1995 (60 FR 24855)
recommendations. Subpart B dealt with potential impacts to small businesses regarding the Virgin Islands. (Refs. 60
EPA’s disposal of suspended and that were presented as part of the and 67) The criteria and process for
canceled pesticides, and EPA has economic analysis. evaluating State programs to ensure that
completed disposal of all pesticides for The public comment period for the they have adequate compliance
which it was responsible under those supplemental notice closed on March programs for regulations promulgated
regulations. Subparts C and D contained 20, 2000. EPA received comments from under section 19(f) will be published in
recommended procedures for storage about 70 respondents, including many a separate Federal Register notice.
and disposal of pesticide containers. trade associations and individual C. Additional Container Issues Under
Subparts A, B, C, and D were companies from the pesticide Consideration for Potential Regulation
superseded by the passage of the manufacturing, pesticide retail, and
Resource Conservation and Recovery container manufacturing industries as Since the 2004 public comment
Act in 1976. FIFRA section 19, as well as many State regulatory agencies. period closed, EPA has gathered
revised in 1988 and 1996, contains On June 30, 2004 (69 FR 39392), EPA information from a variety of sources
authority for EPA in the area of reopened the public comment period for about the status and robustness of
pesticide storage and disposal, and the this rulemaking for 45 days because existing pesticide container recycling
container and containment regulations significant time had passed since the programs. Over the past decade, the Ag
promulgated today are being inserted proposed rule in 1994 and supplemental Container Recycling Council (ACRC)
into a newly established part 165. notice in 1999. (Ref. 33) The purpose of has demonstrated that pesticide
In a Notice of Proposed Rulemaking the reopening was to solicit public input containers can be safely and efficiently
(NPRM) issued on February 11, 1994 (59 on any policies, market practices, recycled, and their success in recycling
FR 6712), EPA proposed standards for technology or other issues relating to more than 80 million pounds of plastic
pesticide containers and containment this rule’s requirements which would since 1992 is commendable. However,
structures. (Ref. 66) This proposal not have been available or could not the current voluntary container
included requirements for nonrefillable have been addressed at the time of recycling system is showing signs of
and refillable containers that would either the proposal or supplemental instability and non-sustainability,
ensure the safe use and disposal of the notice. On August 13, 2004 (69 FR largely because it is financially
supported by only a portion of the specific sets of requirements or products. The criteria that define which
pesticide industry. standards: pesticide products are subject to which
EPA has an interest in promoting • Nonrefillable containers (container regulations (and which ones are exempt
recycling to minimize the use of less design and residue removal); from them) are relatively complex, but
environmentally-sound methods of • Refillable containers (container some key points are:
disposing of these containers, such as by design and residue removal); • The new label standards apply to
landfill or burning, and to reduce the • Repackaging pesticide products; all pesticide products.
amount of solid waste produced • Containment structures; and • The containment regulations apply
• Container labeling. to agricultural pesticides only.
annually. After considering and
Table 1 provides a brief overview of • The nonrefillable container,
evaluating a number of alternatives to
each portion of today’s final rule. For refillable container and repackaging
sustain and increase the current level of
each section of the regulations, the table regulations apply to the same subset of
container recycling, EPA has initiated
identifies the types of businesses that pesticide products. These products are
development of proposed regulations for
must comply, the major requirements described in Table 2 below.
the recycling of plastic pesticide and the compliance date. The • For the refillable container and
containers to ensure equitable, safe, regulations, along with a summary of repackaging regulations, antimicrobial
effective and robust implementation of comments on major issues and products that are used only in
recycling programs. We are exploring a comments that led to changes to the swimming pools (and closely related
range of regulatory options for requiring final regulations and EPA’s responses, sites like hot tubs, spas and/or whirl
participation in pesticide recycling are discussed in later units of this pools) are subject to a reduced set of the
programs and we will work with preamble. EPA has also prepared a requirements.
stakeholders to evaluate and pursue the Response to Comment document that • For the nonrefillable container
most efficacious of these approaches. provides additional details with regard regulations, some products are subject
D. Summary of the Final Rule to the comments and EPA’s responses to all of the regulations, while others
(Ref. 19). must comply only with the basic
The Container and Containment Rule Each portion of the regulations Department of Transportation packaging
is composed of the following five applies to a different subset of pesticide requirements in 49 CFR 173.24.
TABLE 1.—OVERVIEW OF THE PESTICIDE CONTAINER AND CONTAINMENT STRUCTURE REGULATIONS

Nonrefillable Con- Repackaging Pesticide Containment Struc-
Category Refillable Containers Container Labeling
tainers Products tures
Who must com- Registrants Registrants Registrants Registrants Ag retailers

ply Refillers (retailers, dis- Refillers (retailers, dis- Pesticide users (must Ag commercial appli-
tributors) tributors) follow new direc- cators
tions) Ag custom blenders
Major Require- DOT container design, DOT container design, Registrants develop in- Identify container as Secondary contain-
ments construction and construction and formation nonrefillable or refill- ment structures
marking standards marking standards Registrants and others able (all) (dikes) around sta-
Container dispensing Serial number marking comply with speci- Statements to prohibit tionary tanks
capability One-way valves or fied conditions reuse and offer for Containment pads for
Standardized closures tamper-evident de- Refillers (registrants recycling; batch pesticide dispensing
Residue removal vices and others) obtain code (all areas
Recordkeeping Stationary container and follow registrant nonrefillables) Good operating proce-
requirements information, and Cleaning instructions dures
clean, inspect and (some nonrefillables) Monthly inspections of
label containers be- Cleaning instructions tanks and structures
fore refilling them before final disposal Recordkeeping
(all refillables) Provisions for States
with existing pro-
grams
Compliance August 17, 2009 August 16, 2011 August 16, 2011 August 17, 2009 August 17, 2009
Date
TABLE 2.—PRODUCTS THAT ARE SUBJECT TO THE NONREFILLABLE CONTAINER, REFILLABLE CONTAINER AND
REPACKAGING REGULATIONS
Category Nonrefillable Containers Refillable Containers Repackaging Pesticide Products
Products that are not (1) Manufacturing use prod- (1) Manufacturing use products, (1) Manufacturing use products,
subject to the regula- ucts, (2) Plant-incorporated protectants, and (2) Plant-incorporated protectants, and
tions. (2) Plant-incorporated (3) Antimicrobial pesticide products that (3) Antimicrobial pesticide products that
protectants, and satisfy all four of the criteria listed in satisfy all four of the criteria listed in
(3) Antimicrobial pesticide prod- the nonrefillable container column. the nonrefillable container column.
ucts that satisfy all four of
these criteria:
The product is an antimicrobial
pesticide (as defined in
FIFRA section 2(mm)) or it
has antimicrobial properties
(as defined in FIFRA section
2(mm)(1)(A)) and is subject
to a tolerance or a food addi-
tive regulation.
Its label includes directions for
use on a site in at least one
of the 10 antimicrobial prod-
uct use categories identified
as household, industrial or
institutional.
It is not a hazardous waste
when it is intended to be dis-
posed, as defined in 40 CFR
part 261.
EPA has not specifically found
that the product must be
subject to these provisions to
prevent an unreasonable ad-
verse effect on the environ-
ment.
Products that are sub- A product is subject to ALL All products not listed above. All products not listed above.
ject to the regulations nonrefillable container re-
quirements if it satisfies at
least one of the following cri-
teria:
It meets the criteria of Toxicity
Category I in 40 CFR
156.62.
It meets the criteria of Toxicity
Category II in 40 CFR
156.62.
It is a restricted use product.
If a product does not meet any

of these criteria, the product
is subject to only the basic
Department of Transportation
requirements in the nonrefill-
able container regulations.
E. Summary of the Major Changes Since questions and answers; use of ‘‘you’’ to regulatory text. The word ‘‘must’’
Proposal identify the person who must comply; indicates a requirement. Words like
1. Plain language format. Many of the use of ‘‘we’’ to identify EPA; and ‘‘should,’’ ‘‘could,’’ or ‘‘encourage’’
comments on the proposed rule and the ‘‘must’’ rather than ‘‘shall.’’ This new indicate a recommendation or guidance.
supplemental notice made clear that the format, which minimizes the layers of In this preamble, as in the rule text,
scope of parties and products subject to subparagraphs, should also allow the we often use the pronoun ‘‘he’’ as a
the rule was complex and potentially reader to easily locate specific generic term. ‘‘He’’ does not necessarily
confusing. We have rewritten the provisions of the regulation. While we mean a man; it may be a woman, or in
some cases, a business organization
Container and Containment rule in a have made substantive changes in some

plain language format to make it clearer provisions, the plain language changes when referring to an owner or operator.
and easier to use. A plain language are only editorial. The legal The plain language approach also
format includes maximum use of the implications of plain English leads to more separate sections than
active voice; short, clear sentences; regulations are the same as traditional traditional regulatory language.
Therefore, we had to reorganize and Some sections of today’s regulation was not used in these existing
renumber the regulations to are presented in the traditional language provisions in an attempt to avoid any
accommodate the increased number of or format because these sections are possible confusion or disruption in the
separate sections. The changes are amending or changing existing flow of the regulations.
shown in Table 3. regulations. The plain language format
TABLE 3.—COMPARISON OF PROPOSED RULE AND FINAL RULE SECTION NUMBERS

Format in Proposed Rule Format in Final Rule
Subpart Section Numbers Subpart Section Numbers
Part 156
Subpart H: Container Labeling §§ 156.140 - 156.144 Subpart H: Container Labeling §§ 156.140 - 156.159
Part 165
Subpart A: General §§ 165.1 - 165.16 Subpart A: General §§ 165.1 - 165.3
Subpart B Reserved Subpart B: Nonrefillable Con- §§ 165.20 - 165.27

tainers
Subpart C Reserved Subpart C: Refillable Containers §§ 165.40 - 165.47
Subpart D Reserved Subpart D: Repackaging §§ 165.60 - 165.70
Subpart E Reserved Subpart E: Containment Struc- §§ 165.80 - 165.97

tures
Subpart F: Nonrefillable Con- §§ 165.100 - 165.119 Subpart F Reserved

tainers
Subpart G: Refillable Containers §§ 165.120 - 165.139 Subpart G Reserved
Subpart H: Containment Struc- §§ 165.140 - 165.157 Subpart H Reserved

tures
2. Reorganization of the rule. In the container-related regulations, although antimicrobial product is exempt from
final rule, we split the refillable the number of applicable standards is the container standards if meets all four
container standards and the repackaging greatly reduced for some products. of the following criteria:
standards into two separate subparts to These changes apply only to the • The product is an antimicrobial
reinforce and clarify the differences container-related sections of the rule. As pesticide as defined in FIFRA section
between these requirements. The we proposed, all pesticide products are 2(mm) or it has antimicrobial properties
refillable container regulations are subject to the container labeling (as defined in FIFRA section
mostly technical and apply mostly to requirements in today’s final rule and 2(mm)(1)(A)) and is subject to a
pesticide registrants. On the other hand, only agricultural pesticide products are tolerance or a food additive regulation.
the repackaging requirements are mostly subject to the containment • The product includes directions for
procedural and apply to registrants and requirements. use on a site in one of the antimicrobial
refillers (who could be registrants, 4. Exemption from container-related product use categories identified as
distributors or retailers). EPA believes regulations for certain antimicrobial household, industrial or institutional.
that separating these regulations into products. The FQPA amended section • The product is not a hazardous
different subparts will better illustrate 19 of FIFRA to exempt certain types of waste when it is intended to be
the differences and make it easier for the antimicrobial pesticides from the disposed.
regulated parties to understand. pesticide container provisions. The • EPA has not specifically
3. Scope of products subject to amendment exempted household, determined that the product must be
container-related regulations. In the industrial, or institutional antimicrobial subject to the container regulations to
February 1994 NPRM, EPA proposed products which are not subject to the prevent an unreasonable adverse effect
that the container standards would Solid Waste Disposal Act (SWDA) from on the environment.
generally apply to all pesticides and all the container regulations unless the EPA In addition, antimicrobial products that
containers except for manufacturing use Administrator determines that the would not otherwise be exempt from the
products (MUPs). The 1999 product causes an unreasonable adverse regulations and that are used only in
supplemental notice proposed several effect on the environment. Because the swimming pools (and closely related
options for exempting specific subsets definition of an antimicrobial product is sites like hot tubs, spas and/or whirl
of products from the container complex, the phrase ‘‘subject to the pools) are subject to a reduced set of the
standards. Today’s final rule exempts SWDA’’ is unclear and ‘‘unreasonable refillable container and repackaging
MUPs, plant-incorporated protectants adverse effects on the environment’’ requirements.

and certain antimicrobial products from from pesticide containers need to be 5. Scope of container-related
the nonrefillable container, refillable clarified, EPA conducted many analyses regulations for products other than
container and repackaging regulations. based on the comments received. antimicrobial products. As proposed in
All other products are subject to the According to today’s final rule, an 1994, MUPs are exempt from the
container regulations. Plant- material or the limited quantity/ the hydraulic conductivity standard
incorporated protectants, which were consumer commodity exception. which was perceived to be too
not discussed in the proposed rule, are • All pesticide products must comply restrictive, not achievable and too
also exempt from the container with the pesticide-specific requirements costly. The requirement for a numeric
regulations. According to today’s final in the nonrefillable and refillable hydraulic conductivity standard was
rule, all other pesticide products, except container regulations. dropped from the final rule, but all
antimicrobial pesticides that are • EPA may modify or waive these existing and new structures are required
exempt, are subject to the nonrefillable requirements under certain, limited to be liquid-tight, with cracks and seams
container, refillable container and conditions. sealed.
repackaging regulations. For the • If DOT proposes to change any of 10. Scope of products subject to label
nonrefillable container regulations, a the regulations that are incorporated by regulations. The final labeling
product is subject to all of the these regulations, EPA will provide regulations in today’s rule cover the
requirements if it classified in at least notice to the public in the Federal same statements and topics that were
one of the following categories: Register. included in the proposed rule. Unlike
• Toxicity Category I; 7. Residue removal standard for the container-related regulations, all
• Toxicity Category II; nonrefillable containers. The 1994 products must comply with the
• Restricted use pesticide. NPRM required that registrants container labeling requirements — the
Products that do not meet at least one demonstrate at least 99.9999 (six 9’s) labeling regulations do not exempt
of these criteria (i.e., products that are percent residue removal using a MUPs or certain antimicrobial products.
classified in Toxicity Category III or IV prescribed testing methodology for One exception is that plant-incorporated
and that are not restricted use dilutable products in rigid containers. protectant container-related labeling
pesticides) are excluded from all of the Testing would have been required on 19 instructions will be determined by EPA
nonrefillable container standards except representative samples in accordance on a case-by-case basis until specific
the basic DOT requirements. with Good Laboratory Practice (GLP) labeling guidance for plant-incorporated
In general, products other than MUPs, standards in 40 CFR part 160. We protectants are promulgated under 40
plant-incorporated protectants and received many comments opposing CFR part 174.
exempt antimicrobial products are virtually every aspect of this proposed While today’s label requirements
subject to all of the refillable container requirement. Today’s final rule requires generally apply to all pesticide
and repackaging regulations. One rigid containers of dilutable liquid products, the specific label
exception is that antimicrobial products formulations to be capable of achieving requirements apply to different groups
that are used only in swimming pools at least 99.99 percent (four 9’s) residue of products and containers. In
and closely related sites are subject to a removal using a defined laboratory particular:
reduced set of the refillable container triple rinse method conducted on three • A statement identifying a container
and repackaging requirements. representative containers. In addition, as nonrefillable or refillable is required
6. Referring to and adopting some testing and recordkeeping is only on the labels of all products and all
Department of Transportation required for flowable concentrate containers.
regulations. In the 1994 proposed rule, formulations or if EPA requests the tests • Statements to prohibit reuse and
EPA clarified that compliance with on a case-by-case basis. offer for recycling and a batch code are
EPA’s container regulations would not 8. Consistency with existing State required on the labels or container of all
exempt registrants from complying with containment regulations. At least 19 products distributed or sold in
applicable DOT Hazardous Materials States have already promulgated and nonrefillable containers.
Regulations, and that compliance with implemented State bulk containment • Rinsing instructions are required on
DOT’s marking and drop test regulations. EPA’s proposed rule the labels of some products distributed
requirements would satisfy the included basic standards generally or sold in nonrefillable containers.
corresponding EPA requirement for similar to State standards, although Specifically, the requirement for rinsing
refillable containers. Also, the preamble some were more rigorous and others less instructions applies to dilutable
of the proposed rule requested comment stringent than certain State standards. products in rigid nonrefillable
on several options for determining who Today’s containment standards are containers. Residential/household use
would be responsible for ensuring that intended to introduce substantial pesticide products are exempt from this
containers meet the standards. In the safeguards in States that currently lack requirement.
1999 supplemental notice, we discussed containment regulations and to • Instructions for cleaning before
the comments on the proposal and harmonize with containment final disposal (not before refilling) are
discussed a new approach, namely to requirements in States where adequate required on the labels of all products
adopt and refer to the DOT Packing containment safety programs already distributed or sold in refillable
Group III criteria for both nonrefillable exist. While EPA believes a national containers.
and refillable containers. Today’s final standard must provide substantial
environmental protection, a mechanism III. Container Regulations—Scope
rule includes the same basic approach
as described in the supplemental notice. is being provided to accommodate The purpose of Unit III. is to describe
Specifically: States that have successfully the scope of the container-related
• Pesticide products that are DOT implemented bulk containment regulations, including the standards for
hazardous materials must be packaged programs. nonrefillable containers in 40 CFR part
as required by DOT. 9. Hydraulic conductivity standard for 165, subpart B, refillable containers in
• Pesticide products that are not DOT containment structures. The proposed subpart C and repackaging pesticide
hazardous materials must be packaged rule would have required that existing products in subpart D. The regulations
in containers that are designed, and new structures demonstrate themselves are discussed in more detail
constructed, and marked to comply with compliance with a hydraulic in Units V., VI. and VII. for nonrefillable
the cross-referenced and adopted conductivity standard of 1 x 10-6 cm/sec containers, refillable containers and
requirements of DOT regulations, as and 1 x 10-7 cm/sec, respectively. EPA repackaging, respectively. Unit IV.
applicable to a Packing Group III received many comments opposed to discusses the relationship between
EPA’s container-related regulations and B. Exempt Plant-Incorporated plant-incorporated protectants do not

the Department of Transportation’s Protectants (§§ 165.23(b), 165.43(b) and have containers like most pesticides.
Hazardous Materials Regulations. 165.63(b)) Therefore, EPA believes it is appropriate
EPA is exempting some pesticides 1. Final regulations. Plant- to exempt plant-incorporated
and containers from today’s rule based protectants from the requirements of the
incorporated protectants, as defined in
on the statutory language and the container-related regulations.
40 CFR 174.3, are exempt from the
relative risk posed by the pesticides and
container regulations. C. Exempt Certain Antimicrobial
containers. The 1994 NPRM proposed 2. Changes. EPA did not specifically
that the container regulations would Products (§§ 165.23(c), 165.43(c) and
mention plant-incorporated protectants 165.63(c))
generally apply to all end use pesticides
in either the proposed rule or the
and all containers, regardless of the The 1996 FQPA amended section 19
supplemental notice because there were
pesticide market sector. The NPRM of FIFRA to exempt certain types of
either no registrations for these products
proposed to exempt MUPs from the antimicrobial pesticide products from
or they were uncommon at that time;
container requirements. Many the pesticide container provisions under
these types of products are relatively
commenters opposed the broad scope of certain circumstances. Specifically,
new to the marketplace. In the June 30,
the regulations and requested EPA to FQPA added the following to FIFRA
2004 Federal Register notice (69 FR
exempt one or more subsets of section 19(h):
39393), EPA cited plant-incorporated
pesticides from the container A household, industrial, or institutional
protectants as an example of a topic that
requirements. antimicrobial product that is not subject to
The 1996 FQPA amended section 19 would be appropriate to comment on
regulation under the Solid Waste Disposal
of FIFRA to exempt certain types of during the 2004 reopening of the Act (42 U.S.C. 6901 et seq.) shall not be
antimicrobial pesticides from the comment period. (Ref. 33) As explained subject to the provisions of subsections (a),
container provisions under certain below, EPA believes it is appropriate to (e), and (f), unless the Administrator
circumstances. In the October 1999 exempt plant-incorporated protectants determines that such product must be subject
Supplemental Notice, EPA proposed a from the container requirements in the to such provisions to prevent an
regulatory option for exempting certain final rule. unreasonable adverse effect on the
In comments on the 2004 Federal environment.
pesticides, and requested comment on
the applicability and interpretation of Register notice, two registrant groups Because this language was added after
the antimicrobial exemption to FIFRA. and five registrants urged EPA to the pesticide container and containment
As described in this unit, the exempt plant-incorporated protectants rule was proposed in 1994, EPA
container-related provisions in the final from the container and containment solicited public comment on the
rule apply only to a subset of end use regulations. These commenters stated applicability of this provision to the
pesticide products. All MUPs and plant- that plant-incorporated protectants fit proposed container regulations in the
incorporated protectants are exempt the three conditions of EPA’s treated 1999 supplemental Federal Register
from the container-related requirements. article policy and therefore should be notice. In addition, the supplemental
The container regulations define criteria exempt from all provisions of FIFRA notice described EPA’s interpretation
for antimicrobial products that are when used in the manner described. and response to the following two broad
subject to the container-related They also concurred with EPA’s questions relating to the antimicrobial
standards. Other than MUPs, plant- assessment in the 2004 Federal Register exemption provision:
incorporated protectants and exempt notice that plant-incorporated • What is the scope of household,
antimicrobial products, all products are protectants are not sold and distributed industrial, or institutional antimicrobial
subject to the nonrefillable container, in containers like other pesticides; they products that are not subject to
refillable container and repackaging are distributed as parts of seeds or regulation under the Solid Waste
regulations. However, some products plants. Disposal Act?
are subject to a reduced number of The regulations for plant-incorporated • Which products must be subject to
requirements. The discussion in Unit III. protectants in 40 CFR parts 152 and 174 the container provisions to prevent an
applies only to the nonrefillable were finalized in the Federal Register unreasonable adverse effect on the
container, refillable container and on July 19, 2001 (66 FR 37771). (Ref. 50) environment?
repackaging regulations. The A plant-incorporated protectant is a Based on comments on the proposed
containment and labeling regulations pesticidal substance that is intended to rule and supplemental notice and on
have different scopes, as described in be produced and used in a living plant, several additional analyses, EPA is
Units VIII. and IX. or in the produce thereof, and the making a number of changes in the
genetic material necessary for approach for regulating antimicrobial
A. Exempt Manufacturing Use Products production of such a pesticidal products in the final regulations. The
(§§ 165.23(a), 165.43(a) and 165.63(a)) substance. As explained in the preamble approach in the final rule is briefly
1. Final regulations. MUPs, as defined to the final rule for plant-incorporated described here and the details are
in 40 CFR 158.153(h), are exempt from protectants (66 FR 37774), ‘‘[p]lant- provided in the issue-by-issue sections
the container regulations. As described incorporated protectants are primarily below.
in the preamble to the proposed rule, distinguished from other types of • All four of the following criteria
this exemption applies to technical pesticides because they are intended to must be met for a product to be exempt
grade products and formulation be produced and used in a living plant. from the container regulations:
intermediates intended only for This difference in use pattern dictates in (1) The product is an antimicrobial
formulation into other pesticide some instances differences in pesticide as defined in FIFRA section
products and labeled for formulation approach.’’ (Ref. 50) Plant-incorporated 2(mm) or it has antimicrobial properties
use only. protectants are not sold and distributed (as defined in FIFRA section
2. Changes. This exemption is in containers as distinct substances (e.g., 2(mm)(1)(A)) and is subject to a
identical to the exemption in the 1994 liquids, solids or gels) like other tolerance or a food additive regulation.
proposed rule and the 1999 pesticides; they are distributed as part of (2) The product includes directions
Supplemental Notice. the seeds or plants. In other words, for use on a site in one of the
antimicrobial product use categories (ii) In the intended use is subject to pesticide container regulations and that
identified as household, industrial or a tolerance under section 408 of the exempting these pesticides should not
institutional. Federal Food, Drug, and Cosmetic Act significantly increase the risk posed by
(3) The product is not a hazardous or a food additive regulation under containers of these pesticides.
waste when it is intended to be section 409 of such Act. Therefore, it is very unlikely that such
disposed. ii. Changes. In the supplemental an exemption would pose an
(4) EPA has not specifically notice, this criterion was limited to unreasonable adverse effect on the
determined that the product must be ‘‘The product meets the definition of an environment. We believe the provisions
subject to the container regulations to antimicrobial pesticide in FIFRA section of FIFRA sections 19 and 25 authorize
prevent an unreasonable adverse effect 2(mm).’’ EPA continues to believe that such an exemption.
on the environment. the most straightforward approach for While EPA is identifying pesticides
• EPA will determine which products defining antimicrobial products is to use with antimicrobial properties that are
must be subject to the container the FIFRA definition of antimicrobial subject to a tolerance or food additive
provisions to prevent an unreasonable pesticide. The second criterion was regulation as being eligible for
adverse effect on the environment on a added because, after thorough analysis exemption from the container
case-by-case basis as described in the of the definition of antimicrobial regulations, they are not automatically
regulations. pesticide, EPA believes that some exempt. Pesticides with antimicrobial
• The final rule exempts refillable pesticides that are excluded from the properties that are subject to a tolerance
containers used to distribute definition should be eligible for or food additive regulation must also
antimicrobials used in swimming pools exemption from the container meet the other criteria identified by
(and that are subject to the regulations regulations. Specifically, FIFRA section Congress in the FIFRA section 19(h)
because they do not meet all of the 2(mm)(1)(B) explicitly excludes language: (1) It is a household,
exemption criteria) from some of the pesticides with antimicrobial properties industrial or institutional product; (2) it
refillable container and repackaging as identified in section 2(mm)(1)(A) is not a hazardous waste when
standards (including, but not limited to, from being FIFRA section 2(mm) disposed; and (3) EPA has not
serial number markings, one-way valves antimicrobial pesticides if they are determined it must be subject to the
or tamper-evident devices, and some subject to a tolerance or a food additive regulations to prevent an unreasonable
recordkeeping). regulation in their intended use. EPA adverse effect. While EPA believes it is
believes that these pesticides should be reasonable to make pesticides with
The four criteria that identify which
eligible for exemption from the antimicrobial properties that are subject
antimicrobial products are exempt from
container regulations along with to a tolerance or food additive
the container regulations are discussed
pesticides that are FIFRA section regulation eligible for exemption from
in greater detail in Units III.C.1. - III.C.4.
2(mm)-defined antimicrobial pesticides. the pesticide container regulations, we
The other aspects of the approach Although there is no official
toward regulating antimicrobials are see no reason that these pesticides
legislative history documenting the shouldn’t be subject to the other criteria
discussed in Units III.D. - III.F. intent of the definition of antimicrobial
Throughout the preamble, the term that Congress established for
pesticide in FQPA, EPA acknowledges antimicrobial pesticides.
‘‘antimicrobial’’ is intended to be that FQPA also established time periods EPA is not implementing similar
interpreted broadly with the property of in FIFRA section 3 for registration exemption provisions for the other
destroying or inhibiting the growth of review and action for various kinds of pesticide types excluded from the
microorganisms (and as identified in antimicrobial pesticides. EPA believes it definition of antimicrobial pesticide in
FIFRA section 2(mm)(1)(A)) unless is reasonable to conclude that pesticides FIFRA section 2(mm), which include:
specified otherwise. In other words, we subject to a tolerance or food additive • Wood preservatives with claims for
specify ‘‘FIFRA 2(mm) antimicrobial regulation were excluded from the pests other than micro-organisms;
pesticides’’ if we are referring to the FIFRA section 2(mm) definition of • Antifouling paint products with
more limited definition of antimicrobial antimicrobial pesticide at least partly claims for pesticides other than micro-
pesticides in FIFRA section 2(mm). because these pesticides require more organisms;
1. Exemption criteria: definition of an data and analysis than other • Agricultural fungicide products;
antimicrobial pesticide—i. Final antimicrobial pesticides and, therefore, and
regulations. The first of the four criteria should not be subject to the registration • Aquatic herbicide products.
that must be met for an antimicrobial time periods established in FIFRA EPA does not believe that the
product to be exempt from the container section 3. pesticides in this list generally pose a
regulations is: More importantly, EPA believes that limited risk to human health and the
The pesticide product meets one of the containers of pesticides with environment, as is the case with
the following two criteria: antimicrobial properties that are subject pesticides with antimicrobial properties
(1) The pesticide product is an to a tolerance or food additive that are subject to a tolerance or food
antimicrobial pesticide as defined in regulation generally pose a limited risk additive regulation. EPA analyzed one
FIFRA section 2(mm); or to human health and the environment. of its pesticide data bases (Reference
(2) The pesticide product: If either EPA or the Food and Drug File System or REFS) and identified the
(i) Is intended to: disinfect, sanitize, Administration (FDA) determine that a wood preservative and antifouling paint
reduce or mitigate growth or pesticide with antimicrobial properties products that claim to control pests
development of microbiological can be safely used on food or on food other than micro-organisms. Many of
organisms; or protect inanimate objects, contact surfaces, the containers holding the wood preservative products that
industrial processes or systems, these pesticides are unlikely to pose a claim to control pests other than micro-
surfaces, water, or other chemical significant risk or even a risk greater organisms also would be hazardous
substances from contamination, fouling, than the pesticides that are FIFRA wastes when they are disposed and
or deterioration caused by bacteria, 2(mm) antimicrobial pesticides. EPA many of these are also restricted use
viruses, fungi, protozoa, algae, or slime; believes that these pesticides should products, such as those containing
and also be eligible for exemption from the arsenic acid, arsenic pentoxide, chromic
acid, coal tar, creosote and antimicrobial product use categories container regulations to prevent an
pentachlorophenol. Many of the that are not identified as ‘‘household, unreasonable adverse effect on the
antifouling paint products that claim to industrial or institutional’’ are environment. Because EPA may subject
control pests other than micro- ‘‘agricultural premises and equipment’’ certain antimicrobial products to the
organisms are also restricted use and ‘‘aquatic areas.’’ Multiple-use container regulations in the future, a
pesticides, such as products containing products with labels that include fourth criterion is necessary for the list
copper (I) oxide, bis(tributyltin oxide) directions for use on a site in one of the of criteria for the antimicrobial products
and tributyltin methacrylate. EPA does excluded categories (‘‘agricultural that are exempt from the container
not believe that products containing premises and equipment’’ and ‘‘aquatic regulations. Respondents provided
these active ingredients meet the areas’’) and in at least one of the ten extensive comments (described in Unit
criterion of generally posing a limited antimicrobial use product categories III.E.) about how EPA should make
risk to human health and the identified as ‘‘household, industrial and these determinations.
environment, as is the case with institutional’’ would be eligible for
D. Antimicrobial Swimming Pool
pesticides with antimicrobial properties exemption.
3. Exemption criteria: not subject to Products That Are Not Exempt
that are subject to a tolerance or food
RCRA—i. Final regulations. The third of (§§ 165.43(d), 165.63(d))
additive regulation.
2. Exemption criteria: household, four criteria that must be met for an 1. Final regulations. An antimicrobial
institutional or industrial products—i. antimicrobial product to be exempt from swimming pool product that is not
Final regulations. The second of four the container regulations is: otherwise exempt (because it is a
criteria that must be met for an The pesticide product is not a manufacturing use product, plant-
antimicrobial product to be exempt from hazardous waste as set out in 40 CFR incorporated product or an exempt
the container regulations is: part 261 when the pesticide product is antimicrobial product) is subject to a
The product includes directions for intended to be disposed. reduced set of the refillable container
use on a site in one of the following 10 ii. Changes. This criterion is nearly and repackaging regulations. Comments
antimicrobial product use categories the same as in the supplemental notice, on the supplemental notice and an
identified as ‘‘household, industrial or but EPA modified the language slightly analysis of antimicrobial products
institutional:’’ in response to a few comments to clarify indicated that some antimicrobial
(1) Food handling/storage that antimicrobials that are household swimming pool products are hazardous
establishments premises and waste are eligible for exemption. Rather wastes when they are disposed and,
equipment. than specifying that ‘‘the pesticide therefore, would be subject to the
(2) Commercial, institutional, and product does not meet the criteria for pesticide container regulations because
industrial premises and equipment. hazardous waste as set out in part they do not meet all four criteria for
(3) Residential and public access 261...’’ as discussed in the supplemental exemption.
premises. notice, the final rule uses broader For the purposes of subparts C and D,
(4) Medical premises and equipment. language (‘‘the pesticide product is not an antimicrobial swimming pool
(5) Human drinking water systems. a hazardous waste as set out in part product is a pesticide product that
(6) Materials preservatives. 261...’’) that clearly includes all of the satisfies both of the following
(7) Industrial processes and water criteria, exclusions and other provisions conditions:
systems. in 40 CFR part 261. • The pesticide product is intended
(8) Antifouling coatings. 4. Exemption criteria: EPA has not
to: disinfect, sanitize, reduce or mitigate
(9) Wood preservatives. specifically determined the product
growth or development of
(10) Swimming pools. must be subject to the regulations—i.
microbiological organisms; or protect
ii. Changes. Prompted by comments Final regulations. The fourth of four
inanimate objects, industrial processes
and after re-evaluating the antimicrobial criteria that must be met for an
or systems, surfaces, water, or other
product use categories, EPA is antimicrobial product to be exempt from
chemical substances from
modifying the approach in the the container regulations is that EPA has
contamination, fouling, or deterioration
supplemental notice by adding a tenth not specifically determined that the
caused by bacteria, viruses, fungi,
category, human drinking water pesticide product must be subject to the
protozoa, algae, or slime.
systems, to the list of ‘‘household, regulations to prevent an unreasonable
industrial or institutional’’ uses. EPA adverse effect on the environment • The labeling of the pesticide
agrees with commenters that the according to the provisions discussed in product includes directions for use only
category of human drinking water Unit III.F. on a site or sites in the antimicrobial
systems includes use in individual ii. Changes. This criterion is product use category of swimming
water systems, which could be used in necessary to implement Option 1 in the pools.
homes. Additionally, human drinking supplemental notice. The sample Antimicrobial swimming pool
water systems include use in public regulatory text in the supplemental products that are not exempt must
water systems and the drinking water notice did not specifically have a comply with all of the refillable
treatment facilities that use the provision for subjecting antimicrobial container regulations in subpart C
pesticides for this purpose fit into a products to the container regulations on except for:
reasonable understanding of industrial a case-by-case basis because the sample • § 165.45(d) regarding marking; and
use. Therefore, 10 of the 12 regulatory text reflected Option 3. As • § 165.45(e) regarding openings.
antimicrobial product use categories discussed in Unit III.F, the final rule Antimicrobial swimming pool
will be ‘‘household, industrial or must define conditions and procedures products that are not exempt must
institutional’’ uses, compared to the for EPA to determine that an comply with all of the repackaging
nine categories identified in the antimicrobial product or group of regulations in subpart D except for the
supplemental notice. The two products must be subject to the following requirements:
Requirement for registrants who distribute or sell di-

Requirement Requirement for refillers who are not registrants
rectly in refillable containers
Recordkeeping specific to § 165.65(i)(2) § 165.70(j)(2)

each instance of repack-
aging
Container inspection: cri- § 165.65(e)(3) § 165.70(f)(3)

teria regarding a serial
number or other identi-
fying code
Container inspection: cri- § 165.65(e)(4) § 165.70(f)(4)

teria regarding one-way
valve or tamper-evident
device
Cleaning requirement: cri- § 165.65(f)(1) § 165.70(g)(1)

teria regarding one-way
device
Cleaning if the one-way § 165.65(g) § 165.70(h)

device is not intact
2. Changes. The supplemental notice would have to comply with the full set provision that allows EPA to determine,
included a similar provision, but it of refillable container and repackaging on a case-by-case basis, that a specific
would have applied only to products requirements. Alternatively, the product or group of products must be
eligible for exemption. Based on the registrant of such a product could subject to the regulations to prevent an
comments and further analysis, EPA remove the use site(s) other than those unreasonable adverse effect on the
realized that the products for which in the antimicrobial product use environment if a problem becomes
relief was intended (those with sodium category of swimming pools from the evident. The specifics of this provision
hypochlorite) may be hazardous wastes label, in which case the product would are discussed in Unit III.F.
when disposed and, therefore, would be subject to the reduced set of refillable 2. Changes. The approach in the final
not be eligible for either full or partial container and repackaging rule is a change from the approach that
exemption according to the approach in requirements. was identified as our preferred approach
the supplemental notice. Today’s final Many antimicrobial swimming pool (Option 3) in the supplemental notice,
rule subjects antimicrobial swimming products are completely exempt from which would have subjected all
pool products to a reduced set of the the nonrefillable container, refillable antimicrobials eligible for exemption
refillable container and repackaging container and repackaging regulations that were classified in Toxicity Category
requirements if they are sold and by §§ 165.23(c), 165.43(c) and 165.63(c). I to a subset of the container regulations.
distributed in refillable containers. However, some antimicrobial swimming In the supplemental notice, EPA
Specifically, antimicrobial swimming pool products are subject to the described four options for determining
pool products would not have to container-related regulations because which antimicrobial products that are
comply with some of the standards, they do not meet all of the criteria in eligible for exemption would be subject
including, but not limited to, serial these sections, for example, because to the container provisions to prevent an
number markings, one-way valves or they are hazardous wastes when they unreasonable adverse effect on the
tamper-evident devices, and some are disposed. The partial exemption in environment. Today’s final rule
recordkeeping. Currently, EPA is aware §§ 165.43(d) and 165.63(d) provides establishes Option 1 as the procedure to
of sodium hypochlorite products that fit some regulatory relief from the refillable be implemented, which exempts all
these criteria and that are sold and container and repackaging requirements eligible antimicrobials, but includes a
distributed in refillable containers. for such antimicrobial swimming pool provision to require a specific product
However, the partial exemption was products. Antimicrobial swimming pool or group of products to comply with the
drafted to be general so it would apply products that are not completely exempt container regulations if a problem
to any products that fit the criteria. must comply with all of the becomes evident. The four options in
A description of an antimicrobial nonrefillable container requirements. the supplemental notice were:
swimming pool product was added to
subparts C and D for clarity. The E. EPA Determinations that Products • Option 1: Exempt all eligible
regulatory text was modified to clarify Must be Subject to the Container antimicrobials, but include a provision
that the reduced set of requirements Regulations to Prevent an Unreasonable to require a specific product or group of
applies to products labeled for use on a Adverse Effect on the Environment products to comply with the container
site or sites only in the antimicrobial 1. Final regulations. The final regulations if a problem becomes
product use category of swimming pools regulations exempt all antimicrobial evident.
(which includes swimming pools, spas, products that are eligible for exemption • Option 2: Subject eligible
hot tubs, and whirlpools). In other according to the criteria described in antimicrobials classified in Toxicity
words, a product that is labeled for use Unit III.C. from needing to comply with Category I to all of the container
in swimming pools (and/or spas, hot the nonrefillable container, refillable regulations.
tubs and whirlpools) and another site, container and repackaging regulations. • Option 3: Subject eligible
such as human drinking water systems, The final regulations also include a antimicrobials classified in Toxicity
Category I to a subset of the container and therefore all registered products, 4. EPA response. EPA has decided to
regulations. including those in Toxicity Category I, change its approach for determining
• Option 4: Apply the scope criteria have been determined to meet a which antimicrobial products that are
being considered for other pesticides to standard of no UAE. These commenters eligible for exemption must be subject to
eligible antimicrobials. further argued that information on the container regulations to prevent an
3. Comments. Two state agencies specific exposures, leakage or other unreasonable adverse effect. The final
supported EPA’s approach in the problems is needed to overturn the rule will implement Option 1 rather
supplemental notice (Option 3). registration decision of no UAE and to than Option 3.
Eighteen commenters, representing the determine that an UAE must be EPA believes that Option 1 is
antimicrobial and/or the swimming prevented. Another respondent acceptable because it is a legitimate,
pool/spa industries, strongly opposed commented that Congress didn’t reasonable interpretation of the
EPA’s approach, and most supported provide additional insight into what statutory language. In addition, making
Option 1. An agricultural registrant constitutes an UAE in the context of determinations for subjecting products
stated that the language in section 19(h) section 19, so it must have the same to the container regulations based on
is not a blanket exemption, and that meaning as in the FIFRA registration specific information, data or other
focusing on only Toxicity Category I (as standard in section 3(c)(5) and the evidence of a problem to prevent
opposed to Toxicity Categories I and II obligation to report information on UAE unreasonable adverse effects on the
in the applicability for all other in section 6(a)(2). environment is more straightforward
products) is unfair and inconsistent. v. FIFRA section 6(a)(2) reporting. than making such a determination based
Many commenters opposed EPA’s Several commenters stated that the on arguments supporting the fact that
approach and supported Option 1, section 6(a)(2) obligation for registrants there could be unreasonable effects.
either by specifically identifying it as to submit factual information regarding In changing the approach to Option 1,
the option EPA should adopt or by UAE to EPA provides an adequate EPA was partly convinced by the
describing and supporting an approach mechanism for EPA to identify UAEs comments and observations relating to
that is consistent with Option 1. These caused by antimicrobials eligible for the standard of unreasonable adverse
commenters supported their positions exemption. A few of these respondents effect. The process of registration
with the following claims: pointed out that the UAE standard in (including the submission and review of
i. Statutory intent. Some commenters section 6(a)(2) is exactly the same as the data plus establishing label restrictions)
stated that only Option 1 is consistent standard in section 19(h)(2). is intended to ensure that the pesticide
with the statutory language. Several vi. Minimal threat to the environment. will not cause UAEs on the
respondents specifically disagreed with Several commenters specifically environment. In other words, all
EPA’s general criteria approach, saying addressed sodium hypochlorite and registered products have been
it was unnecessary, inappropriate and commented that it is not a threat to the determined to meet a standard of not
inconsistent with the statutory language. environment because: it has a short half causing UAEs on the environment. This
ii. Congress’s intent. Similarly, many life; it’s final fate is sodium chloride determination can be re-visited and
commenters stated that only Option 1 is (table salt); it is used widely without changed by EPA if UAEs are identified
consistent with Congress’s intent. The evidence that it is problematic; it’s only during the process of reregistration or
commenters generally argued that in Toxicity Category I for eye effects, other review, under the ongoing
Congress’s clear intent was to exempt unlike the toxic and persistent mechanisms of FIFRA section 6(a)(2) (as
nearly all eligible antimicrobials. One agricultural pesticides; it’s an inorganic implemented by 40 CFR part 159) or
commenter referred to testimony chemical; the institutional/industrial when other relevant information is
received and comments made at various formulation is only slightly more received by EPA.
committee hearings to support its concentrated than common household If all eligible Toxicity Category I
interpretation of the congressional bleach; it’s less toxic than many antimicrobial products needed to be
intent. Several commenters stated that automotive and household chemicals; subject to the container regulations to
EPA’s approach is contrary to the and the resultant liquid from hosing prevent UAEs on the environment
position of EPA negotiators during pre- down a spill is indistinguishable from (according to options 2 and 3 in the
FQPA discussions, which was that the drinking water. An industry association supplemental notice), then currently we
provision constituted essentially a argued that many of these claims apply should be seeing UAEs from the
complete exemption. to institutional and industrial sanitizers containers of these products. This is
iii. No information about and disinfectants in general. especially true given the relatively large
unreasonable adverse effects. Many vii. No need for additional quantities of antimicrobial pesticides
respondents pointed out that EPA does regulations. Several commenters stated used annually. As described in the
not have concrete information, such as that there is no need for EPA to regulate supplemental notice, in 1995
documented incidents, of unreasonable institutional and industrial disinfectants approximately 3,290 million pounds of
adverse effects (UAEs) caused by because these products are already antimicrobial active ingredients were
antimicrobial pesticides. In addition, adequately regulated by EPA waste used in the United States, compared to
several pool supply companies said that regulations, DOT’s packaging 1,222 million pounds of non-
there are no reports of accidents with requirements, and OSHA’s health and antimicrobial active ingredients.
refillable containers used for pool safety standards. One commenter stated However, EPA is unaware of a
chemicals and mentioned that they have that most manufacturers and substantial number of UAEs resulting
used these containers safely for many formulators of antimicrobial products from the containers of antimicrobial
years and for large volumes of sodium use containers that meet at least the pesticides. Data from the California
hypochlorite. DOT Packing Group III standards for all Pesticide Illness Surveillance Program
iv. Standard of unreasonable adverse materials, because it’s not feasible to use indicate only a limited number of cases
effect on the environment. Several certain containers for DOT hazardous where exposure to antimicrobial
commenters stated that the process of materials and other containers for pesticides was very likely to be
registration is intended to ensure that products that aren’t DOT hazardous prevented if the container regulations
the pesticide will not cause an UAE, materials. had been in place. (Ref.22) Given the
limited number of incidents, we do not standards by which EPA may determine 2. Changes. Because we are finalizing
believe it is appropriate to require all that an antimicrobial pesticide product Option 1 rather than Option 3 in the
eligible Toxicity Category 1 that would otherwise be exempt must be supplemental notice, the final rule
antimicrobial products to be subject to subject to the container regulations to provides more specific criteria and a
the container regulations, and we prevent an unreasonable adverse effect better-defined process for EPA to make
believe that a case-by-case approach is on the environment. EPA may make this determinations to prevent an
better suited to the issue. determination if all of the following unreasonable adverse effect on the
Because Congress didn’t provide conditions exist: environment. The criteria and process
additional insight into what constitutes • EPA obtains information, data or are outgrowths of comments on the
an unreasonable adverse effect in the other evidence of a problem with the supplemental notice and the following
context of section 19, EPA agrees with containers of a certain pesticide product potential regulatory provision from the
the comment that it should have the or related group of products. supplemental notice:
same meaning as in the FIFRA • The information, data or other EPA may determine that an antimicrobial
registration standard in section 3(c)(5) evidence is reliable and factual. product or products must comply with the
and the obligation for registrants to • The problem causes or could container standards. EPA may consider
report information about UAEs on the reasonably be expected to cause an evidence such as field studies, use history,
environment in FIFRA section 6(a)(2). unreasonable adverse effect on the accident data, monitoring data, or other
While some of the public comments environment. pertinent evidence in deciding whether the
were persuasive, EPA does not agree product must comply with the container
• Complying with the container standards to prevent an unreasonable adverse
with all of the comments submitted in regulations could reasonably be
support of Option 1. For example, EPA effect on the environment.
expected to eliminate the problem.
stands by the statements in the 3. Comments. Many commenters
The process in the final rule for
supplemental notice that the statutory provided suggestions and information
making these determinations is based on
language ‘‘unless the Administrator about how they believe the case-by-case
the regulations in 40 CFR 152.164 for
determines that [an eligible determinations should be made. While
classifying products as restricted use
antimicrobial] product must be subject
pesticides. If EPA determines that an the actual language varied among
to [the container] provisions to prevent
antimicrobial pesticide product that commenters, the respondents agreed
an unreasonable adverse effect on the
would otherwise be exempt must be that EPA needs specific evidence of a
environment’’ provides considerable
subject to the container regulations to problem related to containers before
flexibility for EPA to implement it by
prevent an unreasonable adverse effect EPA can determine a product must be
establishing general criteria or by
on the environment, EPA may: subject to the container regulations to
product-specific decisions. In addition,
the lack of significant documented • Require, by rule, that the product be prevent an unreasonable adverse effect.
legislative or statutory history on the repackaged (if applicable) and 4. EPA response. EPA believes that
FQPA amendment to FIFRA section distributed or sold in containers that the criteria and process in the final
19(h) makes it impossible to identify comply with all or some of the regulations for making determinations
Congress’s intent one way or another on requirements in these regulations; or to prevent an UAE represent a
this issue. Moreover, the fact that this • Notify the applicant or registrant of legitimate, reasonable, straightforward
language was added toward the end of EPA’s intent to make such a interpretation of the statutory language.
the legislation’s adoption indicates that determination. After allowing the In addition, we think these criteria and
commenters’ statements regarding the applicant or registrant a reasonable the process for making determinations
intent of section 19(h) may not be an amount of time to reply, EPA may are similar to EPA’s current systems.
altogether accurate depiction of how require, by notification and as a EPA has the ability to re-visit a
Congress intended this portion of condition of registration, that the product’s registration standard of not
section 19(h) to be interpreted. EPA product be repackaged (if applicable) causing UAEs and change it if UAEs are
believes that some antimicrobial and distributed or sold in containers identified during the process of
products may need to be subject to the that comply with all or some of the reregistration or other review, under the
container regulations to protect human requirements in these regulations. ongoing mechanisms of FIFRA section
health and the environment. These For the purposes of notification, 60 days 6(a)(2) (as implemented by 40 CFR part
products will be identified and would be a reasonable amount of time 159, PR Notice 98–3 (Ref. 55), PR Notice
regulated by the process described in to reply, although EPA may, in its 98–4 (Ref. 54) and other guidance
Unit III.F. below. Finally, EPA believes discretion, provide more time. This documents) or when other relevant
that the other regulations cited by process allows EPA to apply all of the information is received by EPA. The
commenters including EPA waste requirements in the nonrefillable criteria and process included in the
regulations, DOT’s packaging container, refillable container and final rule are consistent with most
requirements, and the OSHA health and repackaging subparts to the product. comments received on the supplemental
safety standards overlap to some degree Alternatively, EPA could apply a subset notice.
with the pesticide container regulations of the container-related requirements to It is difficult to precisely identify the
but generally address different stages of the product if compliance with some kind of information that EPA would
a container’s life cycle. Also, these but not necessarily all of the consider sufficient and to characterize
regulations apply to other pesticides requirements would eliminate the in great detail the problems that could
and therefore do not uniquely affect problem. trigger this regulatory provision,
antimicrobials. EPA may deny registration or initiate because we cannot anticipate every
cancellation proceedings if the situation that might arise in the future.
F. Process for EPA to Make These
registrant fails to comply with the However, the following items are
Determinations (§§ 165.23(d),165.43(e) container and, if appropriate, the intended to provide some guidance on
and 165.63(e)) repackaging regulations within the time the different factors that EPA will
1. Final regulations. The final frames established by EPA in the rule or consider in making determinations
regulations describe the process and in its notification. about whether an antimicrobial product
or products must be subject to the problem back to a certain facility or a kind of container material. In this case,
container regulations: limited number of facilities. the solution may be to require the
• What kind of information, data or • What is the company’s history in product to be distributed in a certain
other evidence of a problem with terms of reacting to problems of container material or a container
containers has EPA obtained? This concern? material that has been treated, e.g.,
could be descriptions of cases, incidents • Do the problems cause an fluorinated high density polyethylene. It
or examples of problems or it could be unreasonable adverse effect on the is possible that some of these alternative
some other kind of information. environment? approaches may have other impacts
• How severe are the problems • Could the problems reasonably be with respect to the container
identified in the information, data or expected to cause an unreasonable regulations. For example, requiring a
other evidence obtained by EPA? The adverse effect on the environment if product to be distributed in a
6(a)(2) regulations in 40 CFR part 159 they continue to occur? For example, nonrefillable container that is rigid
define severity categories assigned to about a decade ago, EPA received a
rather than non-rigid would increase the
incidents and PR Notice 98–3 (Ref. 55) significant number of reports of a
number of nonrefillable container
expands the definitions for incidents household pesticide that exploded over
standards the product must comply
involving humans and domestic time. While these initial incidents may
with.
animals. not have directly led to a severe human
• How prevalent are the problems injury or illness, it is reasonable to G. Summary Table of the Scope for
identified in the information, data or expect that someone could have been Antimicrobial Products
other evidence obtained by EPA? Are injured or become ill if they were in a
the problems isolated or are they garage or storage area when a container The following tables compare the
widespread? EPA will evaluate the exploded. approach for regulating antimicrobial
prevalence of the problems and the • Would complying with the products in the final regulations and the
severity of the problems before taking container regulations reasonably be supplemental notice. Table 4 compares
any action to subject the product or expected to eliminate the problem? If the exemption criteria in the final rule
products to the container regulations. the container regulations don’t address with the criteria discussed in the
• Where do the problems occur in the the problem or would not mitigate the supplemental notice. Table 5 compares
distribution chain? In other words, problem, then EPA could consider other whether certain kinds of products
whether the incidents occur approaches (such as establishing (assuming they would otherwise be
predominantly at the facilities of conditions specific to that registration) exempt) are exempt from or subject to
manufacturers, retailers or end users to mitigate the problem. As an example, the container standards in the final
may affect our decision. Also, this it is possible that a problem could be regulations and the supplemental notice
information may allow EPA to trace a caused by a problem with a specific approach.
TABLE 4.—EXEMPTION CRITERIA FOR ANTIMICROBIAL PRODUCTS IN THE FINAL RULE COMPARED TO THE SUPPLEMENTAL
NOTICE
Criterion for Exemption Approach in the Final Rule Approach in the Supplemental Notice
FIFRA section 2(mm) antimicrobial As defined in FIFRA section 2(mm) As defined in FIFRA section 2(mm)
pesticide
Antimicrobial products that are not Criterion is included as an additional criterion allow- Criterion wasn’t included; these would have been
FIFRA 2(mm) antimicrobial pes- ing exemption subject to the container regulations
ticides because they are subject
to a tolerance or food additive
regulation
Antimicrobial product use cat- 10 antimicrobial product use categories are house- 9 antimicrobial product use categories were identi-
egories that are considered hold, institutional or industrial. The additional fied as household, institutional or industrial. The
household, industrial, or institu- antimicrobial product use categories are: additional antimicrobial product use categories
tional • aquatic areas; and were:
• agricultural premises and equipment • aquatic areas;
• agricultural premises and equipment; and
• human drinking water systems
Is not a hazardous waste when it Is not a hazardous waste as set out in 40 CFR part Does not meet the criteria for hazardous waste in
is intended to be disposed 261 when intended to be disposed 40 CFR part 261 when intended to be disposed
EPA has not specifically deter- Criteria and a process for making the determination Making case-by-case determinations was dis-
mined product must be subject are included in the final rule cussed as an option, but was not specifically in-
to container regulations to precluded in the potential regulatory language
vent an unreasonable adverse
effect
TABLE 5.—ANALYSIS OF WHETHER CERTAIN TYPES OF ANTIMICROBIAL PRODUCTS1 WOULD BE SUBJECT TO OR EXEMPT
FROM THE CONTAINER REGULATIONS - COMPARING THE FINAL RULE TO THE SUPPLEMENTAL NOTICE2
Antimicrobial Product Description Final Rule Supplemental Notice(Option 3)
Products that are subject to a tol- Exempt from the regulations3 Subject to the regulations according to 2(mm) defi-
erance or food additive regula- nition
tion
Products that are exempt from, or Exempt from the regulations according to 2(mm) Exempt from the regulations according to 2(mm)
otherwise not subject to a toler- definition3 definition3
ance or food additive regulation
Wood preservative or antifouling Exempt from the regulations according to 2(mm) Exempt from the regulations according to 2(mm)
paint intended to control only definition3 definition3
micro-organisms
Wood preservative or antifouling Subject to the regulations according to 2(mm) defi- Subject to the regulations according to 2(mm) defi-
paint intended to control macro- nition nition
organisms as well as micro-or-
ganisms
Agricultural fungicide or aquatic Subject to the regulations according to 2(mm) defi- Subject to the regulations according to 2(mm) defi-
herbicide nition nition
Product in Toxicity Category I Exempt from the regulations3 Subject to all nonrefillable container requirements
except the residue removal standard; subject to
all refillable container requirements unless used
in swimming pools according to determination to
prevent UAE
Product in Toxicity Category II, III Exempt from the regulations3 Exempt from the regulations3
or IV
Product used only in swimming Exempt from some refillable container and repack- Exempt from some refillable container and repack-
pools and closely related sites aging requirements if subject to the regulations aging requirements if it met all of the exemption
for any reason criteria and is in Toxicity Category I
1 Inthis table, the term antimicrobial has a broad interpretation, i.e., as described in FIFRA section 2(mm)(1)(A).
2 Allantimicrobial products must comply with the new labeling requirements. (See Unit IX. for more details about the label regulations.) This
table refers only to complying with the container-related regulations, i.e., standards for nonrefillable containers, refillable containers and repack-
aging.
3 The product is exempt from the regulations unless it would be subject because of other triggers, such as it is a hazardous waste when in-
tended to be disposed.
H. Other Pesticide Products Subject to product meets the definition of a reclosing securely and a drop test, and
These Regulations (§§ 165.23 (e), hazardous material in 49 CFR 171.8, the some requirements that are pesticide-
165.43(f) and 165.63(f)) DOT requires it to be packaged specific, such as standard closures, one-
according to 49 CFR parts 171–180. way valves, and the residue removal
1. Overview—i. Final regulations. For The final rule does not distinguish standard. Many commenters opposed
nonrefillable containers, all pesticide between higher risk and lower risk the broad scope of the regulations and
products other than MUPs, plant- products for the refillable container and requested EPA to exempt one or more
incorporated protectants and exempt repackaging regulations. In other words, subsets of pesticides from the container
antimicrobial products are subject to the pesticide products other than MUPs, requirements.
nonrefillable container standards. plant-incorporated protectants and In the 1999 supplemental notice, EPA
However, only the ‘‘higher risk’’ exempt antimicrobial products must described a potential regulatory option
products are subject to all of the comply with all of the refillable for products other than antimicrobials
nonrefillable container requirements. container and repackaging standards. that would exempt some pesticides and
The ‘‘lower-risk’’ products are subject The only exception is that antimicrobial containers from the final rule. Rather
only to the basic DOT requirements. In products that are used in swimming than exempt products based on the
particular: pools and closely related sites are pesticide market sector or the type of
• A product must comply with all of subject to a reduced number of the pesticide (as specified by the
the nonrefillable container requirements requirements, as described in Unit III.D. commenters on the proposal), EPA’s
if it is classified in at least one of the ii. Changes. The 1994 NPRM approach was to exempt pesticides
following categories: (1) Toxicity proposed that the container regulations based on the relative risk they posed.
Category I; (2) Toxicity Category II; or would generally apply to all end use The regulatory approach in the
(3) Restricted use product. pesticide products and all containers, supplemental notice would have
• All other products (those in
regardless of the pesticide market sector. exempted manufacturing use products,

Toxicity Category III or IV that are not The proposed container regulations as we proposed in 1994, and included
restricted use products) must comply included requirements that are a previously described set of standards
only with the basic DOT requirements equivalent to some DOT requirements, for antimicrobial products that would be
in 49 CFR 173.24. If the pesticide such as marking, container integrity, eligible for exemption. For all other
products, a product would be subject to repackaging standards. One exception is criteria, but questioned the viability of
the regulations if it met any one of the that antimicrobial products that are using these criteria because of the wide
following criteria: used in swimming pools and closely range of combinations of toxicity
• The product is classified in Toxicity related sites are subject to a reduced (human health and environmental),
Category I or II; number of the requirements. container sizes and distribution and
• The capacity of the container is 2. Alternative approach and rationale handling practices. This commenter
equal to or larger than 5 liters (1.3 gal) for changes. The final rule approach for supports establishing the DOT Packing
for liquids or 5 kilograms (11.0 lbs) for regulating pesticide products that are Group III standards as a minimum for
solids; not otherwise exempt was developed agricultural pesticides in nonrefillable
• The product’s labeling permits based on the comments on the containers. A registrant group and a
outdoor use and includes at least one of supplemental notice and on an analysis registrant stated that DOT limited
the specified environmental hazard conducted by EPA. The broad quantity provisions should be
statements. comments related to substantial changes authorized for pesticides that are not
The container size and environmental in the approach are described in this DOT hazardous materials. The
hazard label statement criteria would subunit, while comments on the specific regulatory language recommended by
have captured many products in criteria in the supplemental notice are one of these commenters would require
Toxicity Category III and IV so they discussed individually in subunits pesticide products to comply with all
would have been subject to the below. nonrefillable container standards unless
regulations. i. Comments - overall approach. EPA they were specifically exempt or subject
About 18 respondents provided posed six questions in the supplemental to a limited quantity exception. Four
comments on these general (non- notice related to the scope of products commenters--a registrant group and
antimicrobial) scope criteria in the subject to the container regulations. The three registrants--strongly opposed the
supplemental notice, consisting largely first question was ‘‘Is it appropriate to environmental hazard statement
of individual registrants and registrant apply the container standards only to criterion because they don’t believe the
groups. The commenters generally the higher-risk pesticides?’’ Eight environmental hazard statements on the
agreed that it was appropriate to respondents specifically addressed this label are appropriate indicators of risk.
differentiate the stringency of the question and seven of them generally One of them said that toxicity category
regulations based on the relative risk agreed with EPA that it is reasonable to alone should be used to distinguish
posed by the products and containers. apply different levels of regulation to between higher-risk and lower-risk
None of the commenters wholly higher-risk and lower-risk pesticides. pesticides. A non-agricultural registrant
supported the approach in the However, the commenters differed in group questioned the appropriateness of
supplemental notice and there was no their recommendations for regulating human toxicity characteristics for
general agreement in an approach the lower-risk pesticides. Only one of packaging regulations that, it claims,
among the suggestions provided by the the eight commenters, a non-agricultural deal primarily with storage and
respondents. Some commenters stated registrant group, specifically supported disposal. This commenter urged EPA to
that certain standards (either the DOT a complete exemption for the lower-risk develop alternate criteria, such as the
Packing Group III standards or the pesticides. Some commenters took a potential for the product to leak from
standards in a DOT limited quantity middle ground. In particular, the containers and/or to persist in the
exception) should apply to all products. comments from a registrant group and environment.
Many commenters suggested changes to three registrants were a bit vague, In addition, a registrant group and a
the Toxicity Category and container size stating that it is appropriate to apply the registrant who addressed the above
criteria. None of the commenters container standards only to the higher question provided more detailed
supported the environmental hazard risk pesticides and that lower-risk comments on an alternate approach.
statement criteria. A few commenters pesticides should not be subject to the These commenters stated that all
suggested other exemptions that should same requirements. Several commenters agricultural pesticides distributed in
be included, such as exempting all opposed the approach of completely nonrefillable containers should comply
residential use products. exempting some products. Two with the DOT packaging standards.
After carefully reviewing these registrant groups explicitly supported Under this option, pesticides that are
comments and conducting an analysis an option where lower risk pesticides not DOT hazardous materials would
of the products that would be regulated would be subject to some regulations, comply with the Packing Group III
using the supplemental notice criteria, although different standards would be standards or, if appropriate, one of the
EPA decided to revise the approach in appropriate. Also, the commenter who limited quantity exceptions. The
the final rule for regulating pesticide didn’t support distinguishing between registrant group stated that having
products other than MUPs, plant- risk levels was a registrant who stated minimum requirements on pesticide
incorporated protectants and that the requirements for DOT Class 9 integrity is in the best interest of
antimicrobials that are exempt. As materials should apply to all pesticides agriculture, the public and our industry.
described above, the approach for the that are not DOT hazardous materials. Another registrant provided a detailed
nonrefillable container standards, which The second question was ‘‘Are the description of an alternate approach.
differentiates between ‘‘higher risk’’ and criteria being considered by EPA to This commenter split the regulations
‘‘lower risk’’ products, is different from distinguish between higher-risk and into two primary issues - (1) container
the approach for the refillable container lower-risk pesticides appropriate?’’ The design and integrity testing and (2)
and repackaging requirements, which same eight commenters addressed this container residue removal standards
do not make that distinction. question and none of them believed that and others - based on the goals of the
iii.Refillable container and the criteria in the supplemental notice rule and their financial impact. This
repackaging regulations. Pesticide were appropriate for distinguishing agricultural registrant strongly believes
products other than MUPs, plant- between higher-risk and lower-risk that all pesticides in nonrefillable
incorporated protectants and exempt pesticides. An agricultural registrant containers should be required to use
antimicrobial products must comply group commented that toxicity and DOT Packing Group III containers as a
with all of the refillable container and container size are generally appropriate minimum safety standard. On the other
hand, this respondent believes that it closures and outage/filling limits. These Category I and II pose a significant
may be reasonable and appropriate to DOT standards cover the same areas as enough risk in these situations that
consider exempting lower-risk the proposed requirements for these products should be subject to the
pesticides from some standards, such as nonrefillable container integrity/ nonrefillable container requirements.
the residue removal requirement. compatibility in § 165.102(b) and EPA is participating in a global effort
ii. EPA response - overall approach. reclosing containers securely in to harmonize the classification and
These comments prompted EPA to § 165.102(d)(3). EPA believes that all labeling of chemicals for human and
reconsider the approach discussed in nonrefillable containers should easily be environmental hazards, which is being
the supplemental notice where lower- able to comply with these requirements, led by international agencies such as the
risk pesticides would be completely yet they provide a standard that we Organization for Economic Co-operation
exempt from the nonrefillable container could enforce in situations where and Development (OECD), the
standards. EPA agrees with the point container problems may arise. International Labor Organization and
made by some commenters that all Therefore, the final rule references the the UN Committee of Experts on the
containers should meet standards for general requirements for packagings and Transportation of Dangerous Goods. The
integrity and compatibility and is packages in 49 CFR 173.24 as the basic global harmonization effort resulted in
modifying the final rule accordingly. standards for all nonrefillable new definitions for toxicity
However, EPA believes that the containers, unless the pesticide product characteristics and a new Category V.
minimum standards for integrity are is exempt from the regulations. The categories and rationale were
different between nonrefillable and On the other hand, EPA believes that described in OECD Series on Testing
refillable containers. the DOT Packing Group III standards, and Assessment Number 33,
In general, DOT has two different sets including the performance-oriented Harmonized Integrated Classification
of package integrity standards. The most packaging tests, are an appropriate System for Human Health and
thorough set of requirements are the minimum standard for refillable Environmental Hazards of Chemical
performance-oriented packaging containers. Refillable containers need to Substances and Mixtures. That
standards, which include drop, be sturdier, stronger and able to document has since been superceded by
leakproofness, hydrostatic pressure, withstand more stress than a consolidated document published by
stacking and vibration tests. These tests nonrefillables because they spend more the United Nations Economic
may vary in stringency depending on time in use (i.e., full of pesticide) and Commission for Europe (UNECE)
the packing group of the material. For in the lanes of transportation. Because entitled Globally Harmonized System of
example, a Packing Group I test involves refillable containers are returned to the Classification and Labeling of
a drop from 1.8 meters (5.9 feet) while refiller and/or registrant repeatedly over Chemicals (GHS) and is available at the
a Packing Group III test has a drop from the useful life of the containers, they are following Web site: http://
0.8 meters (2.6 feet). The other set of subject to more wear and tear than www.unece.org/trans/danger/publi/ghs/
requirements are the packaging containers that are used once. Therefore, ghslrev01/01filesle.html. (Ref. 16)
standards in 49 CFR part 173 subpart B, EPA believes that it is appropriate to Each country will select elements of the
which are referenced in DOT limited require refillable containers to be system deemed appropriate for
quantity exceptions. In other words, capable of meeting DOT’s packaging regulating transport, worker and
packages that are subject to a limited standards at the Packing Group III level, environmental protection. When EPA
quantity exception must comply with if the pesticide product is not a DOT modifies its definitions of toxicity
the standards in subpart B of part 173, hazardous material. If the pesticide categories in 40 CFR part 156 to
even though they are exempt from the product is a DOT hazardous material, it harmonize with the OECD guidelines,
full array of performance-oriented must comply with the relevant DOT EPA plans to revise the toxicity category
packaging tests and other standards. standards. criteria in § 165.23(e) to incorporate the
The requirements in 49 CFR part 173 3. Nonrefillable containers: human new toxicity categories. The criteria and
subpart B include many different toxicity criterion—i. Final regulations. signal words associated with the GHS
standards related to ‘‘Preparation of For pesticide products other than MUPs, toxicity categories are different than
Hazardous Materials for plant-incorporated protectants, and EPA’s existing criteria and signal words.
Transportation.’’ Some of these exempt antimicrobial products, a Therefore, the universe of products
requirements address aspects of pesticide product must comply with all subject to the full set of nonrefillable
transportation other than packaging, the nonrefillable container requirements container standards and the universe of
such as the loading and unloading of if it is classified in Toxicity Category I products subject only to the basic DOT
transport vehicles, or establish or II, as set out in 40 CFR 156.62. packaging requirements will likely
requirements for specific modes of ii. Changes. For pesticide products in change.
transportation, such as general nonrefillable containers, this criterion is 4. Nonrefillable containers: other
requirements for transportation by identical to the one set forth in the toxicity criterion—i. Final regulations.
aircraft. Therefore, it would not be potential alternative regulatory text in For pesticide products other than MUPs,
appropriate for EPA to reference all of the 1999 supplemental notice. EPA plant-incorporated protectants, and
part 173 subpart B, because we are only continues to believe that the most exempt antimicrobial products, a
interested in incorporating the DOT hazardous groups of pesticides in terms pesticide product must comply with all
standards that address packaging of human toxicity - those in Toxicity the nonrefillable container requirements
design, construction and marking. After Category I and Toxicity Category II - if it is classified by EPA as a restricted
analyzing the subpart B regulations, should be subject to the nonrefillable use product.
EPA believes that the general container standards. Most problems ii. Changes. This criterion is different
requirements for packagings and with handling containers will lead to than the criterion described in the
packages in 49 CFR 173.24 are human exposure, as a result of dripping, supplemental notice that would have
appropriate basic standards that all glugging, leaking, or container failures, required a product to comply with the
nonrefillable containers must meet. The so EPA believes that human toxicity is nonrefillable container regulations if its
standards in 49 CFR 173.24 address an appropriate criterion. Furthermore, labeling allowed outdoor use and
container integrity, compatibility, EPA believes that products in Toxicity included at least one of the specified
environmental hazard statements. factors when evaluating the risks posed mitigated by restricted use
Rather than relying on the by pesticide containers. After classification.
environmental hazard statements on considering the comments and re- An analysis of products in EPA’s
pesticide labels, such as ‘‘This pesticide evaluating the environmental hazard REFS data base shows that many
is toxic to birds,’’ EPA decided to statement approach described in the restricted use products are also
change this criterion to products that are supplemental notice, EPA is changing classified in Toxicity Category I or II.
classified as restricted use products, the approach in the final regulations. However, there are about 225 restricted
which was discussed as an option in the EPA believes that the environmental use products in Toxicity Category III or
supplemental notice. According to an hazard statement option, as described in IV and all of these products were
EPA analysis, fewer than 250 restricted the supplemental notice, would be restricted at least partly for
use products are in Toxicity Category III difficult to implement because each environmental/ecological reasons. (Ref.
or IV (i.e., that are not already captured label would have to be evaluated and 45) In particular, the criteria for
by the human toxicity criteria). (Ref. 45) because the ‘‘catch-all’’ standard restricting the Toxicity Category III/IV
iii. Comments. Many commenters--all included in the supplemental notice products include ground water
registrant groups and registrants-- (‘‘Any environmental hazard statement contamination; toxicity to fish, birds, or
commented on the environmental pertaining to wildlife, fish, birds or aquatic organisms; and hazard to
toxicity criterion in the supplemental groundwater’’) raises some ambiguity wildlife or non-target organisms.
notice. One non-agricultural registrant about which products would be 5. Nonrefillable containers: container
group stated that some of the criteria included by this criterion. Also, while size criterion—i. Final regulations.
covered by the hazard statements, such EPA doesn’t necessarily agree with all of Container size is not a criterion in the
as whether a pesticide leaches through the comments, an EPA analysis (Ref. 78) final regulations for determining
the soil to groundwater, are appropriate raised questions about whether using whether a pesticide product is subject to
and should be substituted for the human the environmental hazard statements on the nonrefillable container regulations.
toxicity criteria. A registrant group and the label would capture the highest-risk ii. Changes. The approach in the
a registrant opposed any environmental pesticides. Finally, the final rule uses supplemental notice included a
criteria. A registrant group and two the criterion of restricted use container size limit as one of the criteria
registrants opposed the environmental classification to distinguish between for being subject to the nonrefillable
hazard criterion because they did not levels of regulation (subject to all of the container regulations. Specifically, a
agree that the actual use (indoor or nonrefillable container standards versus product would have been subject to the
outdoor) of a pesticide is a realistic basis subject to the basic DOT standards) nonrefillable container regulations if the
for determining exemptions from the rather than to distinguish between container’s capacity was equal to or
container regulations. These whether the product is regulated or larger than 5.0 liters (1.3 gallons) for
commenters said that a spill or release exempt. Therefore, we can afford to set liquid formulations or 5.0 kilograms
could happen at any point during the criterion at a level that would focus (11.0 pounds) for solid formulations.
transportation, storage or handling and on the most environmentally risky EPA decided not to incorporate the
that all pesticide products share the products, because the other products container size criterion into the final
same lanes of transportation. Therefore, will be subject to basic container rule for nonrefillable containers because
these commenters believe the integrity and compatibility standards, of other changes in the structure of the
distinction between whether the rather than being completely exempt. final regulations. In particular, the final
pesticide is used indoors or outdoors is The criteria that EPA utilizes to rule uses the scope criteria to
irrelevant. Several commenters opposed restrict an end use product to use by distinguish between levels of regulation
the environmental hazard criterion certified applicators (or persons under (subject to all of the nonrefillable
because they don’t believe the their direct supervision) are described container standards versus subject to the
environmental hazard statements on the in 40 CFR 152.170. The general criteria basic DOT standards) rather than to
label are appropriate indicators of risk. for restricting the use of a product are distinguish between whether the
Several commenters addressed the that EPA determines that: product is regulated or exempt. The
option discussed in the supplemental • The product’s toxicity exceeds one criteria in the final rule subject the most
notice for including a criterion for or more of the specific hazard criteria in toxic and most risky pesticides — those
pesticides that are classified as 152.170, or evidence substantiates that in Toxicity Categories I and II and any
restricted use for environmental or the product or use poses a serious others that are restricted use products —
ecological reasons. In particular, a hazard that may be mitigated by to the full set of nonrefillable container
registrant group and several registrants restricting its use; requirements. All other products that
commented that ‘‘while it is true that • The product’s labeling is not are not specifically exempt are subject
compounds that are restricted in their adequate to mitigate these hazards; to basic container integrity and
use for ecological reasons would have • Restriction of the product would compatibility standards, rather than
some of the specified environmental decrease the risk of adverse effects; and being completely exempt. EPA believes
hazard statements ..., it is also true that • The decrease in risks of the the basic DOT packaging standards offer
many compounds with little or no pesticide as a result of restriction would an acceptable level of protection for the
potential for risk could easily contain exceed the decrease in benefits. products that are in Toxicity Categories
such language.’’ This statement implies Section 152.170 lists specific human III and IV and that are not restricted use
that these respondents distinguish and ecological toxicity endpoints that products. Therefore, a container size
between the risks posed by pesticides cause a product to be considered for criterion is not necessary for
that are restricted in their use for restricted use classification. In addition, nonrefillable containers.
ecological reasons - which are higher - the regulations state that EPA may 6. Refillable containers and
and the risks posed by other pesticides. consider evidence such as field studies, repackaging—i. Final regulations.
iv. EPA response. As stated in the use history, accident data, monitoring Pesticide products other than MUPs,
supplemental notice, EPA continues to data or other pertinent evidence in plant-incorporated protectants and
believe that it is important and deciding whether the product or use exempt antimicrobial products must
necessary to account for environmental may pose a serious hazard that could be comply with all of the refillable
container and repackaging standards. having registrants develop cleaning EPA believes that it is appropriate to
One exception is that antimicrobial procedures, and requiring refillers to require refillable containers to be
products that are used in swimming clean containers if necessary - are capable of meeting DOT’s packaging
pools and closely related sites are necessary for preventing cross- standards at the Packing Group III level,
subject to a reduced number of the contamination in all products. All if the pesticide product is not a DOT
requirements. products that are distributed or sold hazardous material. If the pesticide
ii. Changes. The regulatory language must have the composition as stated in product is a DOT hazardous material, it
is different than the approach described their confidential statements of formula must comply with the relevant DOT
in the supplemental notice, which and not be adulterated. This standard standards.
described the criteria of Toxicity does not differ based on the toxicity of 7. Changes to the container vs. label
Category I or II, container size and the product, the container size or any regulations—i. Final regulations. In
environmental hazard statements for other factor. Therefore, minimizing the general, all products must comply with
subjecting a pesticide product to the chance of cross-contamination is one the container labeling requirements —
refillable container and repackaging reason that the final regulations were the labeling regulations do not exempt
regulations. However, the net effect of changed so that the refillable container MUPs or certain antimicrobial products.
the scope language in the supplemental and repackaging regulations apply to all One exception is that plant-incorporated
notice is very similar to the scope of the products that are not specifically protectant container-related labeling
final rule. Because nearly all, if not all, exempt. Note that certain antimicrobial instructions will be determined by EPA
refillable containers are larger than the products are subject to a reduced on a case-by-case basis until specific
container size identified in the number of requirements, as described in labeling guidance for plant-incorporated
supplemental notice of 5 liters (1.3 Unit III.D. protectants are promulgated under 40
gallons) or 5 kilograms (11 pounds), the Second, the repackaging regulations CFR part 174. This approach is
supplemental notice criteria would have assign responsibility for certain discussed in more detail in Unit IX.
subjected nearly all, if not all, products requirements to registrants and to ii. Changes. This is the same approach
in refillable containers to the refillers, in addition to setting out the described in the 1999 supplemental
regulations. procedures that both parties must follow notice except for the case-by-case
iii. Comments. Respondents did not
for pesticide products to be repackaged handling of plant-incorporated
specifically address how the general
into refillable containers. EPA believes protectants.
scope criteria should apply to refillable
that it is important for all products that
containers. A few commenters I. Flow Chart/Summary
specifically limited some points to are not specifically exempt to be
handled consistently under the The full scope of the final pesticide
nonrefillable containers, although most
repackaging regulations. We think that container and containment rule is
did not. Therefore, EPA believes that the
this consistency will facilitate summarized in this section. Different
comments described in Units III.H.1.
compliance by both the registrants and sections of the final rule apply to
though III.H.5. generally also apply to
refillers. different subsets of products:
refillable containers.
iv. EPA response. Under the Third, as stated earlier, the final rule • The label requirements apply to all
supplemental notice approach, nearly takes the approach that all containers products.
all refillable containers would have should meet standards for integrity and • The containment structure
been subject to the refillable container compatibility. EPA believes that the requirements apply to agricultural
and repackaging regulations because of DOT Packing Group III standards, products (stored in stationary pesticide
the container size criterion of 5 liters for including the performance-oriented containers by retailers, custom
liquids and 5 kilograms for solids. packaging tests, are an appropriate applicators and custom blenders).
Although the container size criterion is minimum standard for refillable • The nonrefillable container,
not being incorporated into the final containers. Refillable containers need to refillable container and repackaging
regulations, EPA believes it is necessary be sturdier, stronger and able to requirements apply to products other
for products that are not specifically withstand more stress than than MUPs, plant-incorporated
exempt to comply with the refillable nonrefillables because they spend more protectants and certain antimicrobial
container and repackaging regulations. time in use (i.e., full of pesticide) and products, as shown in Figure 1.
First, one of the goals of the refillable in the lanes of transportation. Because Within Figure 1, there is a box with
container and repackaging regulations is refillable containers are returned to the the question ‘‘Is it an antimicrobial
to minimize cross-contamination in refiller and/or registrant repeatedly over product that meets all four criteria?’’
refillable containers. The regulatory the useful life of the containers, they are This box represents a placeholder for
standards in the final rule - including subject to more wear and tear than the flow chart in Figure 2.
one-way valves, tamper-evident devices, containers that are used once. Therefore, BILLING CODE 6560–50–S
ER16AU06.006</GPH>
BILLING CODE 6560–50–C

ER16AU06.007</GPH>
IV. Container Regulations— venting, and filling limits. The HMR Some products, including MUPs, plant-
Relationship with the Department of also set out performance standards and incorporated protectants, and some
Transportation Regulations related tests that packaging must meet, antimicrobial products are completely
including drop, leakproofness, exempt from the container regulations
A. Background
hydrostatic pressure, stacking, and and are not included in the following
1. Department of Transportation vibration tests. The stringency of these discussion because they are exempt. All
Hazardous Materials Regulations. The tests varies according to the packing other products are subject to the final
U.S. Department of Transportation group (PG) of the material being regulations.
(DOT) Hazardous Materials Regulations transported. The packing group For pesticide products that are lower
(HMR) are based on the authority in the represents a measure of the relative risk (in Toxicity Category III or IV and
Federal hazardous materials hazards, where PG I includes materials not restricted use products) in
transportation law, the Hazardous that pose a relatively great hazard and nonrefillable containers, the
Materials Transportation Act, and are PG III includes materials that pose a nonrefillable containers must comply
found in 49 CFR parts 171 through 180. relatively minor hazard. Within a given only with the general requirements for
The HMR establish standards governing hazard class or division, the DOT HMR packagings and packages in 49 CFR
a wide range of the safety aspects of assign packing groups based on the 173.24. No other requirements in EPA’s
transportation, including requirements materials characteristics, or the pesticide container regulations apply to
for the classification of materials, regulations refer to the hazardous these lower risk products. Of course, if
packaging (including manufacture, materials table in 49 CFR 172.101 for any of these products are DOT
continuing qualification and substance-specific assignments of hazardous materials, they must comply
maintenance), hazard communication packing groups. Most pesticide products with all applicable DOT regulations. For
(i.e., package marking, labeling, that are classified as DOT hazardous the purpose of enforcing the pesticide
placarding, and shipping materials are in Packing Group III, container regulations, however, EPA is
documentation), transportation, although some are in PG II and a few are only referring to and adopting 49 CFR
handling and incident reporting. in PG I. 173.24 for any lower risk products that
Some, but not all, pesticide products The HMR include exceptions from are subject to the regulations, regardless
are defined as DOT hazardous materials some portions of the overall regulatory of whether or not they are classified as
by 49 CFR 171.8. A pesticide product scheme in certain situations, e.g., for DOT hazardous materials.
may be classified as a DOT hazardous damaged packages placed in salvage Pesticide products that are higher risk
material for displaying any of the drums (49 CFR 173.3), for small (in Toxicity Category I or II or a
hazards identified in the DOT quantities of hazardous materials (49 restricted use product) in nonrefillable
regulations, which are defined in nine CFR 173.4) and for the shipment of containers and all products in refillable
different classes. Some DOT hazard waste materials (49 CFR 173.12). Also, containers must be packaged in a
classes include several different the regulations in 49 CFR 173.150
container that is designed, constructed,
divisions. The most common hazard through 173.156 set out limited quantity
and marked to comply with the
classes and divisions for pesticide and consumer commodity exceptions
requirements of 49 CFR 173.24, 173.24a,
products include: for different hazard classes. The limited
173.24b, 173.28, 173.155, 173.203,
• Class 3: flammable or combustible quantity exceptions provide relief from
173.213, 173.240(c), 173.240(d),
liquids; some of the HMR requirements,
173.241(c), 173.241(d), part 178 and part
• Division 6.1: poisonous materials; specifically the labeling requirements
• Class 8: corrosive materials; and 180 that apply to a Packing Group III
(unless the package is transported by
• Class 9: miscellaneous hazardous material. These portions of the DOT
aircraft), the placarding provisions, and
materials, such as marine pollutants. regulations, which are described in
the testing standards in 49 CFR part 178.
Pesticide products that are DOT Also, if a limited quantity meets the more detail in later sections of this
hazardous materials are required under definition of consumer commodity, preamble unit, include:
existing DOT regulations to comply relief from the shipping paper • General requirements for
with all applicable regulations in all of requirements is provided in many cases. packagings and packages (§§ 173.24,
the safety areas mentioned above - Pesticide products that are classified 173.24a, 173.24b);
classification, packaging, hazard as DOT hazardous materials must • Reuse, reconditioning and
communication, transportation and continue to be packaged in accordance remanufacture of packagings (§ 173.28),
handling. For pesticide products that with the DOT HMR. Nothing in the except for the leakproofness test
are not DOT hazardous materials, EPA pesticide container regulations changes specified in § 173.28(b)(2);
has focused on the DOT requirements the specific requirements in the HMR • Exceptions for Class 9 materials,
for package design (and manufacture, that apply to pesticide products based miscellaneous hazardous materials
continuing qualification, and on the criteria in the DOT regulations. (§ 173.155);
maintenance) and package marking, Additionally, the pesticide container • Non-bulk packagings for hazardous
because these are the areas that overlap regulations do not change the stringency materials in Packing Group III
with the proposed pesticide container of the DOT HMR. If a pesticide product (§ 173.203 for liquids and § 173.213 for
regulations. In other words, EPA is not is categorized as a PG II material, it solids);
adopting the HMR standards for DOT would continue to have to meet the PG • Portable tanks, closed bulk bins and
labeling, placarding, shipping II standards and likewise for products in intermediate bulk containers for certain
documentation, transportation and PG I or PG III. low hazard materials (§§ 173.240(c) and
handling, and incident reporting 2. Final regulations (§§ 165.25(a), (b) 173.240(d) for low hazard solid
because these areas are generally and (c), and 165.45(a), (b) and (c)). The materials and §§ 173.241(c) and
outside the scope of the pesticide final regulations adopt and refer to some 173.241(d) for low hazard liquid and
container regulations. of the HMR for pesticides that are solid materials);
The DOT HMR include general subject to this final rule. The approach • Specifications for Packagings (part
packaging requirements that address in the final rule is closely tied to the 178), including non-bulk performance-
areas such as compatibility, closures, changes in scope described in Unit III. oriented packaging standards (subpart
L), testing of non-bulk packagings and and adopts some DOT standards for and registrant groups generally
packages (subpart M), intermediate bulk pesticide products that are not DOT supported the overall approach, while
container (IBC) performance-oriented hazardous materials and requires that registrants and registrant groups from
standards (subpart N), and testing of these products be packaged in the non-agricultural pesticide sector
IBCs (subpart O); and containers that are designed, generally opposed the overall approach.
• Continuing qualification and constructed, and marked to comply with i. Support. Several State regulatory
maintenance of packagings (part 180) the adopted requirements for Packing agencies and an agricultural registrant
Again, products that are DOT Group III materials. However, a number group supported EPA’s approach of
hazardous materials must comply with of changes are made in the final rule adopting some DOT requirements for
all applicable DOT regulations. For the approach: pesticide products that are not DOT
purposes of enforcing the pesticide • The biggest change is related to the hazardous materials. These commenters
container regulations, the final rule changes in the scope of the nonrefillable stated that consistency with DOT
states that a pesticide product that container standards. Rather than should facilitate compliance and
meets the definition of a hazardous completely exempt the lower risk minimize confusion in the regulated
material in 49 CFR 171.8 must be pesticide products (e.g., lower toxicity community and will avoid conflicting
packaged in a container that is in small containers without an regulations.
‘‘designed, constructed and marked’’ to environmental hazard statement on the In addition, a few agricultural
comply with the requirements of 49 CFR label), the final rule mandates that the registrant groups and some agricultural
parts 171–180. Including the phrase lower risk products must comply with registrants supported EPA’s overall
‘‘designed, constructed and marked’’ the general packaging requirements in approach, if EPA incorporates the
allows EPA to focus on the DOT 49 CFR 173.24. changes included in their comments on
requirements for package design (and • Some of the specific 49 CFR the supplemental notice. These
manufacture, continuing qualification, standards that are adopted for the higher comments recommended changing
and maintenance) and package marking, risk products in nonrefillable containers several sections of the DOT regulations
as described above, rather than the HMR and for all products in refillable that are adopted and extending the
standards for DOT labeling, placarding, containers are different in the final rule compliance period for refillable
shipping documentation, transportation than in the supplemental notice containers. One of the registrants
and handling, and incident reporting. approach. In particular, the final commented that all pesticides in
Because the pesticide container regulations include an exception from nonrefillable containers should meet the
regulations refer to and adopt certain 49 CFR 173.28(b)(2), which requires DOT PG III standards at a minimum to
DOT requirements, these requirements leakproofness testing every time a non- provide an updated level of protection
also are EPA standards that can be bulk packaging is refilled. The final for the environment and for all who use,
enforced by EPA and the State agencies regulations specify that this store, display, buy or distribute
that implement EPA’s pesticide leakproofness testing is not required for pesticide products.
programs. However, EPA and the State products that are not DOT hazardous ii. Oppose. About 10 respondents
pesticide programs will enforce only the materials if containers comply with the clearly opposed the supplemental notice
49 CFR requirements that are referred to 40 CFR part 165, subpart C regulations approach of adopting some DOT
and adopted in the pesticide container and the repackaging is done in Packing Group III standards for products
regulations; not the full DOT HMR. compliance with the 40 CFR part 165, that are not DOT hazardous materials,
Clearly, DOT maintains authority to subpart D regulations. Also, the final including several nonagricultural
enforce all of its regulations against rule refers to and adopts only portions registrant groups, a group representing
parties that are subject to the HMR. of 49 CFR 173.240 and 173.241 (bulk agricultural formulators and
The final rule includes two other packaging for certain low hazard distributors, an institutional formulator/
provisions related to the DOT standards. materials) to clarify that the pesticide distributor group and some non-
These provisions are discussed in more container regulations do not regulate agricultural registrants. These
detail in Units IV.E. and IV.F. First, if transport vehicles. By referring to and respondents opposed EPA’s approach
DOT proposes to change any of the adopting only paragraphs (c) and (d) in because they claim that:
regulations that are incorporated into both sections, the final rule incorporates • There is no need to regulate
the pesticide container regulations, EPA the standards for portable tanks, bulk pesticides that are not DOT hazardous
will provide notice of the proposed bins and intermediate bulk containers, materials. Several commenters stated
changes and an opportunity to comment but not for rail cars, motor vehicles or that DOT requirements take into
in the Federal Register. Following cargo tanks. consideration the seriousness of
notice and comment, EPA will take final • The final regulations specifically transporting the substances and that
action regarding whether or not to revise refer to and adopt the terms of the DOT chose not to regulate these
its rules and the extent to which any exceptions for Class 9 miscellaneous substances. Several others questioned
such revision will correspond with materials in 49 CFR 173.155 instead of whether there is evidence of a problem
revised DOT regulation. Second, the incorporating the relevant text from that with shipping non-DOT hazardous
regulations include a provision for section into the pesticide container pesticides.
modifying or waiving the adopted regulations, as discussed in the • Costs of packaging would increase,
standards if EPA determines that an supplemental notice. which respondents state would be
alternative (partial or modified) set of 4. Comments on the overall approach. burdensome for small businesses. Costs
standards or pre-existing requirements More than 20 respondents commented mentioned were $2,500 for design plate
achieves a level of safety that is at least on the approach of adopting some DOT changes and about the same amount per
equal to that specified in the adopted requirements at the Packing Group III package type to maintain the required
requirements. level in the supplemental notice. The certification files.

3. Changes. The same general comments can be split into two • This approach would be
approach that was described in the 1999 categories according to the type of burdensome for EPA to monitor DOT
supplemental notice is included in the commenter. State regulatory agencies regulatory changes and to render
final regulations. The final rule refers to and agricultural pesticide registrants exemption decisions. A commenter also
questioned whether EPA had the DOT and UN standards; (2) eliminate • It would pose practical problems
expertise to make exemption decisions. the potential burden of complying with and increased costs because refillers and
• EPA’s approach would be confusing two different, overlapping regulatory possibly farmers would have to obtain
because it incorporates some, but not schemes; and (3) not establish the training and equipment required to
all, of DOT’s standards. additional trade barriers. Most of the do the leakproofness test.
• EPA’s regulations could be different commenters on the DOT issue in the • Due to the logistical and cost
than DOT’s. Several commenters cited proposed rule specifically favored the problems, the registrant believes that
the waiver provision and the lack of a use of DOT’s Packing Group III criteria many non-bulk refillable containers
consumer commodity exemption in as the minimum standard for pesticide would be replaced by nonrefillable
EPA’s approach as examples. products not regulated by DOT as containers, contrary to EPA’s stated
iii. EPA response. EPA continues to hazardous materials. goals of pollution prevention.
believe that the general approach of • This commenter believes that the
referring to and adopting the DOT B. Leakproofness Testing Before Reuse general packaging requirements in 49
Packing Group III packaging design, (49 CFR 173.28(b)(2)) CFR 173.24 and the container
construction and marking requirements 1. Final regulations. The final inspection provisions in subpart D of
is the best approach for regulating regulations retain the reference to 49 EPA’s regulations are sufficient to
pesticide containers. CFR 173.28, which establishes ensure the integrity of non-bulk
Commenters who opposed this standards for the reuse, reconditioning refillable containers.
approach in the supplemental notice
and remanufacture of packagings. Also, • In addition to a leakproofness test,
must recognize that the alternative to 49 CFR 173.28(b)(2) specifies a marking
the final rule adds a provision that
the supplemental notice approach of requirement, which could be interpreted
exempts refillers from the leakproofness
referring to and adopting some of DOT’s to impose a testing requirement because
test requirement in 49 CFR 173.28(b)(2)
standards is not an option of declining of other DOT provisions (such as 49
for products that are not DOT hazardous
to establish regulations for container CFR 171.2(c)), even if the packaging is
materials if the refillable container
integrity and construction. Instead, as used to transport only non-hazardous
complies with the refillable container
described in the supplemental notice, materials. The commenter stated that
regulations and the refilling is done in
the alternative is to finalize the DOT provided a verbal interpretation
compliance with the repackaging
standards from the 1994 proposed rule that 49 CFR 171.2(c) does not require
that address container integrity and regulations.
such testing of non-bulk containers used
construction. These standards include 2. Changes. The major change to this to transport only non-hazardous
container integrity and compatibility, part of the approach is that the final materials. The registrant recommended
marking, and reclosing securely for regulations add a provision that that EPA consult with DOT to confirm
nonrefillable containers and container exempts refillers (which includes the approach on this topic. This
integrity, marking and a drop test for registrants and independent refillers) commenter and a few registrant groups
refillable containers. EPA is separately from the leakproofness test requirement recommended deleting the reference to
required under FIFRA to promulgate in 49 CFR 173.28(b)(2) for products that 49 CFR 173.28 to avoid confusion about
such regulations for all pesticides. If are not DOT hazardous materials if the whether a container must be
Congress had believed that existing refillable container is in compliance leakproofness tested before it is refilled.
Federal requirements promulgated by with the subpart C refillable container 4. EPA response. EPA agrees with the
DOT were sufficient, or that EPA should regulations and the refilling is done in commenter’s concerns about the
restrict its regulation to pesticides compliance with the subpart D problems that might be caused by
covered as DOT hazardous materials, repackaging regulations. This exception requiring a leakproofness test each time
Congress could have restricted FIFRA was added in response to comments on a non-bulk refillable container is refilled
section 19 to that extent. Instead, it the supplemental notice. with a pesticide product that is not a
appears that, with limited exceptions, 3. Comments. Some commenters - DOT hazardous material. However, EPA
Congress intended all pesticides to be including several registrant groups and disagrees with the commenters that the
regulated under section 19. several registrants - opposed the solution is to delete the reference to 49
In fact, the approach to refer to and requirement in 49 CFR 173.28(b)(2) for CFR 173.28. EPA believes that § 173.28
adopt the DOT Packing Group III non-bulk packaging to pass a includes useful provisions that will help
packaging design, construction and leakproofness test before every time it is ensure the safe reuse of pesticide
marking requirements was based on refilled. The test involves applying a containers. In addition, § 173.28
suggestions from commenters on the raised internal air pressure to the includes provisions for reconditioning
proposed rule, who urged EPA to be container and ensuring that no air leaks and remanufacturing containers, which
consistent with the DOT regulations. from it. The test method for the will clarify and allow the reconditioning
More than 20 respondents, including leakproofness test described in 49 CFR of certain kinds of packaging, such as
individual companies and trade groups 178.604 specifies restraining the drums. Many commenters on the
from the pesticide registrant and container under water to determine if proposed rule and supplemental notice
container manufacturing industries, air leaks from the container, although identified the lack of a regulatory option
provided commentary on the DOT HMR alternatives are provided in an appendix for reconditionable containers as an
and the United Nations (UN) to part 178. The commenters generally issue. Including the reference to
Recommendations on the Transport of requested EPA to delete the reference to § 173.28 solves this problem and allows
Dangerous Goods. All of the 49 CFR 173.28, although they did not drums to be reconditioned and then
commenters agreed that EPA should be point out problems with any other reused under the pesticide container
consistent with the DOT HMR and the provisions of 49 CFR 173.28. One of the regulations.
UN standards in terms of definitions, registrants provided the most precise Rather than deleting the reference to
requirements, and testing. Respondents and detailed description of the potential 49 CFR 173.28, EPA is modifying the
argued that such consistency would: (1) problems that could result from final regulations to exempt refillers from
Facilitate compliance because the requiring leakproofness testing before the leakproofness test requirement in 49
industry is already familiar with the every refill, including: CFR 173.28(b)(2) for products that are
not DOT hazardous materials if the • DOT provides greater latitude on proposed definitions for dry and liquid
refillable container complies with the the construction and less frequent minibulks were developed to
refillable container regulations and the testing requirements for bulk packages intentionally include container sizes in
refilling is done in compliance with the because of their size and sturdier both DOT’s non-bulk and intermediate
repackaging regulations. This provision construction. EPA should follow the bulk container categories. As mentioned
is similar to one in DOT’s regulations, same approach and authorize the same above, under the DOT regulations,
specifically 49 CFR 173.28(b)(7), which standards for bulk containers used to intermediate bulk containers are a
allows a package to be reused without distribute pesticides that are not DOT subset of bulk containers. EPA is not
being leakproofness tested with air if hazardous materials. finalizing the definitions of dry and
four criteria are met, including being • These sections of the DOT liquid minibulk (and bulk) containers in
refilled and offered for transportation by regulations authorize the use of certain the final rule, as described in Unit V.
the original filler. EPA believes that the non-DOT specification bulk packaging, EPA intended to refer to and adopt
refillable container requirements in including portable tanks and bulk bins. DOT Packing Group III packaging
subpart C, including the adopted DOT A few of these commenters stated that standards for DOT non-bulk containers
standards, and the repackaging non-DOT specification packagings that and intermediate bulk containers. EPA
requirements in subpart D, including are authorized for DOT Class 9 materials disagrees with the commenters who
the container inspection standards, should also be acceptable for pesticides support the DOT standards for non-bulk
provide for the safe refill and reuse of that are not DOT hazardous materials. containers (less than 119 gallons for
refillable pesticide containers without The non-specification packagings must liquids or 882 pounds for solids) but not
requiring leakproofness testing before comply with the general packaging for the next largest size, intermediate
each refill. requirements in 49 CFR part 173, but bulk containers. Minibulk containers
not all of the testing and marking used for pesticides include ones with
C. Regulating DOT Intermediate Bulk standards in other portions of the HMR. capacities in the non-bulk classification,
and Bulk Containers (49 CFR 173.240 In addition, the registrant explained e.g., 60 to 110 gallons, and containers in
and 173.241) that the HMR do not require non-DOT the intermediate bulk container sizes,
1. Final regulations. The final specification packagings (which are e.g., 150 to 250 gallons. EPA believes
regulations refer to and adopt only authorized by 49 CFR 173.240 and that it is not logical to require smaller
certain paragraphs of the DOT 173.241) to have the UN symbol marked minibulks to comply with the DOT
regulations that authorize bulk on them. This commenter requested Packing Group III testing standards, and
packagings for certain low hazard EPA to confirm that the pesticide to not specify any testing standards for
materials. In particular, the final container regulations authorize the use larger minibulks, which could lead to a
container rule refers to and adopts 49 of these non-DOT specification bigger spill. EPA believes strongly that
CFR 173.240(c), 173.240(d), 173.241(c), packagings. both non-bulk and intermediate bulk
On the other hand, a non-agricultural containers holding pesticides that are
and 173.241(d), so it incorporates
registrant group and several agricultural not DOT hazardous materials should
standards for portable tanks, bulk bins
registrants opposed the reference to 49 comply with the applicable Packing
and intermediate bulk containers, but CFR 173.240 and 173.241. Several of the
not for rail cars, motor vehicles or cargo Group III packaging construction,
registrants stated that the intent of their testing and marking requirements.
tanks. DOT defines bulk packagings to comments on the proposed rule was for Upon re-evaluation of the reference to
be larger than 119 gallons for liquids EPA to adopt the DOT Packing Group III 40 CFR 173.240 and 173.241, however,
and 882 pounds for solids. standards for non-bulk packagings, not EPA realized that there may be some
2. Changes. The approach described for bulk containers (which includes confusion caused by the paragraphs that
in the supplemental notice would have intermediate bulk containers by authorize rail cars, motor vehicles and
incorporated all of 49 CFR 173.240 and definition). The registrant group stated cargo tanks. EPA has never intended to
173.241. The final regulations were that the requirements in §§ 173.240 and regulate transport vehicles. The
changed to refer to and adopt only the §§ 173.241 would be burdensome and proposed rule (in § 165.122(b)(2)) and
portions of those sections that authorize are not necessary from a safety the final rule (in § 165.43(h)) state that
portable tanks, closed bulk bins and standpoint. This commenter also the pesticide container regulations do
intermediate bulk containers (IBCs). The believes that adopting these not apply to transport vehicles that
portions of 49 CFR 173.240 and 173.241 requirements would lead to a decrease contain pesticide in pesticide holding
that are not included in the final in the use of refillable containers. tanks that are an integral part of the
regulations authorize rail cars, motor A registrant requested that EPA re- transport vehicle and that are the
vehicles and cargo tanks, which are not evaluate the reference to these sections primary containment for the pesticide.
regulated by the container regulations. because they authorize bulk and To eliminate potential confusion, EPA
3. Comments - supplemental notice. intermediate bulk containers and the changed the final rule to only include
The comments from eight respondents definitions of these kinds of containers the portions of 49 CFR 173.240 and
(registrants and registrant groups) were are very different than the ones 173.241 that authorize portable tanks,
split fairly evenly on this topic, even customarily used within the agricultural bulk bins and intermediate bulk
though these commenters tended to pesticide industry. A few other containers.
provide similar comments on other commenters also addressed the 5. Comments - UN marking. In
parts of the approach to incorporate definition issue by pointing out that the response to the 2004 reopening of the
some DOT regulations. term minibulk (used in the agricultural comment period, some commenters
A few registrant groups and a pesticide industry and in the proposed provided new information and
registrant (all from the agricultural regulations) has no DOT regulatory comments regarding the approach of
pesticide sector) supported the reference definition. referring to and adopting a subset of
to 49 CFR 173.240 and 173.241. These 4. EPA response - supplemental DOT’s hazardous materials packaging
respondents supported authorizing bulk notice. EPA is aware that the DOT regulations. A registrant group and two
packagings by adopting these sections regulations do not include a definition registrants commented that, since the
for the following reasons: of minibulk container. However, the supplemental notice was published in
1999, several manufacturers have a certification process similar to Child 3. Comments. About 11 commenters
voluntarily changed their packaging Resistant Packaging approval or placing addressed the idea of including a
specifications for all products, the specification packaging designation provision such as a limited quantity
hazardous materials and nonhazardous for non-hazardous materials on the exception in the pesticide container
materials, to meet DOT Packing Group product label (like the EPA Registration regulations and all but one strongly
III standards. Number) rather than the large and supported this kind of provision. The
These three respondents and two prominent marking required by 49 CFR opposing commenter, a registrant, stated
other commenters (a registrant group part 178. that it did not believe that incorporating
and a registrant) supported the marking 6. Response - UN marking. EPA wants the Class 9 limited quantity exception
that would be required by adopting the to clarify that the approach of referring was appropriate. The other commenters,
DOT standards. One registrant group to and adopting a subset of the DOT mainly registrant groups and registrants,
stated that ‘‘It is important to have the requirements would require the marking varied a bit in the specific approach
UN marks to provide a minimum that is specified in the DOT regulations. they recommended, but all supported
performance standard to those in the UN markings would be required only for the idea of including this kind of
channels of distribution that purchase, those containers that require UN exception in the pesticide container
fill, and sell crop protection products in markings for DOT Packing Group III regulations.
refillable containers.’’ The other hazardous materials. If DOT does not Several commenters specifically
commenters also supported adopting require the UN marking but allows the requested that EPA add a reference to 49
the DOT marking, but asked for use of the packaging for Packing Group CFR 173.155, the limited quantity and
clarification about which containers III materials (e.g., limited quantities, consumer commodity exceptions for
would need the UN mark. The DOT consumer commodities and non-DOT Class 9 materials, to the pesticide
regulations do not require UN markings specification portable tanks), the EPA container regulations to be more
on certain kinds of containers, such as regulations would allow the use of these consistent with the DOT regulations.
non-DOT specification portable tanks packagings and would not require the Several respondents supported the
and containers holding limited UN marking. However, EPA is not limited quantity exception as described
quantities or consumer commodities. modifying the final regulations to add in the supplemental notice. Several
One of the registrants stated that their the suggested additional sentence other commenters recommended that
understanding of the DOT reference is because we do not believe it provides EPA incorporate both the limited
that EPA is proposing UN markings only additional clarification. In addition, quantity exception and the consumer
for those kinds of containers that require
EPA believes that the preamble and commodity exception in 49 CFR
UN markings for DOT Packing Group III
guidance documents are the proper 173.155. As defined in the HMR,
hazardous materials. In other words,
vehicles for providing this kind of consumer commodity means a material
when DOT regulations require UN
clarification. EPA disagrees with the that is packaged and distributed in a
marking for a container holding a DOT
commenters who opposed using form intended or suitable for sale
hazardous material, that same marking
containers with the UN mark for non- through retail sales agencies or
would also be required for the same
DOT hazardous materials. As other instrumentalities for consumption by
kind of containers that hold pesticides
commenters stated, several companies individuals for purposes of personal
that are not DOT hazardous materials.
have voluntarily switched to use DOT care or household use. This term also
Most of the respondents recommended
adding a statement to the regulatory text Packing Group III (presumably with the includes drugs and medicines. Two
referring to the DOT regulations such as UN mark) since 1999 and have not registrant groups who urged EPA to also
‘‘This includes certain containers which reported any of the potential problems adopt the consumer commodity
require UN markings (e.g., 2 x 2.5 gallon described by the respondents who exception said that the consumer
cartons, 50 pound multiwall paper bags, oppose using the UN mark. Further, commodity exception is necessary to
5, 30 and 55 gallon drums) and certain EPA clarifies that the UN mark would prevent increased costs and unnecessary
other containers which do not require only be required if required by the DOT complications caused by complying
UN markings (e.g., limited quantities, regulations. with EPA and DOT regulations that
consumer commodities and non-DOT would be different.
D. Limited Quantity/Consumer
specification portable tanks).’’ Commodity Exception (49 CFR 173.155) 4. EPA response. As stated in the
On the other hand, a registrant group supplemental notice, EPA continues to
and two registrants stated that the 1. Final regulations. The final believe that it is necessary to
marking size and location requirements regulations refer to and adopt 49 CFR incorporate a DOT limited quantity
of 49 CFR 178.3 should not apply to 173.155, which establish limited exception to maintain consistency with
non-hazardous materials, claiming that quantity and consumer commodity the HMR and to provide regulatory
placing the UN mark on the containers exceptions for Class 9 materials relief for relatively small quantities of
of these materials could create (miscellaneous hazardous materials). pesticides. However, after reviewing the
confusion among carriers and 2. Changes. The potential alternative comments and re-evaluating the
emergency responders. They expressed regulatory text in the supplemental regulations, EPA believes it is better to
concern that non-certified transporters notice would have incorporated the simply refer to and adopt 49 CFR
may refuse entire loads of non- relevant portions of the limited quantity 173.155 in its entirety because it is more
hazardous materials marked with the exception in 49 CFR 173.155 into the straightforward. In addition, the final
circle UN mark since this is an text of the pesticide container rule approach adds the benefit of
indication of a DOT regulated material. regulations. After reviewing the including the consumer commodity
These commenters also said that comments and re-evaluating the exception for Class 9 materials, which
emergency responders may assume the regulations, EPA believes it is more will provide clarity and consistency for
cargo is a hazardous material and straightforward to simply refer to and registrants of products that are not DOT
handle the situation accordingly if there adopt the entire section of the DOT hazardous materials and that meet
was an accident involving such regulatory exceptions for Class 9 DOT’s definition of consumer
materials. These respondents suggested materials in 49 CFR 173.155. commodity.
E. Waiving or Modifying the pesticides that are DOT hazardous regarding whether or not to revise its
Requirement to Comply with Some DOT materials. It is possible that EPA rules, and the extent to which any such
Regulations (§§ 165.25(g) and 165.45(g)) modifications to the adopted DOT revision will correspond with revised
1. Final regulations. The final requirements for a pesticide that is a DOT regulations.
regulations include provisions that DOT hazardous material could create a 2. Changes. This is similar to the
would allow EPA to modify or waive set of requirements that conflict with approach described in the supplemental
the requirements of the regulatory DOT’s regulations. In this case, it would notice.
sections that refer to and adopt the DOT not be possible to package a pesticide
3. Comments. A registrant group
requirements if EPA determines that the such that it could meet both EPA’s and
questioned whether OPP has the
alternative (partial or modified) set of DOT’s standards. To prevent this kind
resources for the on-going effort of
of situation, EPA modified the final
standards or pre-existing conditions monitoring DOT’s regulatory changes
regulation in several ways. First, a
achieves a level of safety that is at least and constantly proposing and
separate waiver provision is included
equal to that specified in the promulgating its own revisions to mirror
for pesticides that are DOT hazardous
requirements of this section. Section the DOT actions. This respondent also
materials and for pesticides that are not
165.25(g) establishes the waiver/ expressed concern that there would be
DOT hazardous materials. Second, the
modification standard for nonrefillable lag times between DOT’s and EPA’s
waiver provision for pesticides that are
containers and § 165.45(g) provides it regulatory changes, creating confusion
DOT hazardous materials specifies that
for refillable containers. and putting registrants in the position of
EPA will modify or waive the
2. Changes. This is the same basic being subject to conflicting Federal
requirements only after consulting with
approach that was described in the standards.
DOT to ensure consistency with DOT
supplemental notice. EPA made a few 4. EPA response. EPA does not
regulations and exemptions. A similar
adjustments in the final regulations, believe that the notification process in
provision is not necessary for pesticides
such as clarifying that EPA must the pesticide container regulations will
that are not DOT hazardous materials,
determine that the alternative set of be overly burdensome. An OPP staff
because these pesticides aren’t subject
standards achieves an acceptable level to DOT’s requirements, so there won’t member currently monitors the DOT
of safety before a waiver is granted be a conflict. regulatory changes. Increased
(rather than being based on the EPA plans to coordinate with DOT as communication with DOT resulting
registrant submitting information.) In much as possible and hopes to benefit from these final regulations should
addition, EPA reorganized the final from their great experience in regulating provide advanced notice of any changes,
regulations so all of the waiver requests packaging and their relationships with which would make any monitoring
are grouped together to simplify the other organizations. EPA is very familiar efforts even easier. In addition, EPA
process of applying for a waiver from with regulating pesticides. Through our believes the commenter misunderstood
any of the container standards. Finally, authority in FIFRA to regulate pesticide the point of this notification provision.
EPA changed the wording of the products (which includes the pesticides, EPA does not anticipate changing its
regulations to clarify that, for pesticide the labeling and the containers), we regulations based on proposed changes
products that are DOT hazardous have directly or indirectly set packaging by DOT in most situations. Instead, the
materials, we will modify or waive the standards for a number of pesticide purpose of EPA’s notifications will be to
requirements regarding the DOT products. We also have established let EPA’s regulated community know
standards only after consulting with relationships with pesticide that DOT has proposed to modify the
DOT to ensure consistency with DOT manufacturers and have developed DOT regulations adopted by the
regulations and exemptions. expertise with pesticide handling and pesticide container regulations.
3. Comments - DOT regulations. Some use practices. It is possible that at some Therefore, pesticide registrants and
commenters (registrant groups and point, compliance with one of the related parties will be able to monitor
registrants) supported the DOT waiver adopted DOT standards may conflict the DOT rule process themselves and
provision set out in the potential with safe use and handling practices for can provide comments to DOT if they
alternative regulatory text in the 1999 pesticides. For pesticides that are not believe it is warranted. If a DOT rule
supplemental notice, stating they DOT hazardous materials, EPA believes change creates a significant obstacle to
believed it was sufficient. A few we should have the ability to modify or compliance or another substantial
registrant groups opposed the suggested waive the adopted DOT standards if we problem for pesticide containers, EPA
DOT waiver provision in the determine (based on information would consider changing the pesticide
supplemental notice. In particular, these provided) that an alternative set of container regulations that refer to and
commenters opposed EPA modifying standards achieves a level of safety that adopt the DOT requirements. However,
DOT’s standards for pesticides subject is at least equal to that specified in the EPA believes the chances of this
to DOT standards, because these adopted DOT standards. happening are very small because it
pesticides could be rendered out of defeats the purpose of referring to and
compliance with DOT standards and F. Providing Public Notice of Changes in
the Adopted DOT Regulations adopting the DOT requirements to
could not be transported legally. One of provide a consistent set of packaging
these commenters also expressed (§§ 165.25(c) and 165.45(c))
requirements.
concern about EPA’s ability to make 1. Final regulations. The final
waiver decisions, questioning EPA’s regulations include a provision that says V. Nonrefillable Container Standards
resources, lack of expertise similar to EPA will provide notice to the public in A. Purpose (§ 165.20(a))
DOT’s, and the absence of the kinds of the Federal Register, and an
relationships that DOT has with opportunity to comment, if DOT 1. Final regulations. The purpose of
transportation-related standard setting proposes to change any of the the nonrefillable container standards is
organizations. regulations that are referred to and to establish design and construction
4. EPA response - DOT regulations. adopted in EPA’s pesticide container requirements for nonrefillable
EPA understands some of the concerns regulations. Following notice and containers used for the distribution or
expressed by commenters regarding comment, EPA will take final action sale of some pesticide products.
2. Changes. This is nearly the same as compliance date for registrants to burden of implementing the rule. EPA
the proposed purpose (in § 165.100). submit certifications is not being does not believe that current products
One minor change was to acknowledge finalized because the certification and containers pose a large enough
the reduced number of products that are requirement from the proposal is not hazard (compared to the containers that
subject to the final regulations by stating being finalized, as described in Unit would be used to comply with the
that the rule applies only to the V.M. requirements) to justify the costs of
distribution or sale of some pesticide 3. Comments - length of compliance recalling them from retailers and
products. The proposed regulations period. About 15 commenters, including distributors to either repackage or
would have applied to all products. registrants, registrant groups, a dealer dispose of them. EPA believes that
Another modification was to delete the group, and a State regulatory agency, setting a date for when products
term ‘‘standards’’ from the phrase stated that 2 years would not be enough distributed or sold by registrants must
‘‘establish standards and requirements’’ time to comply with the proposed comply is sufficient. Products that are
because it is redundant. standards, especially the nonrefillable distributed and sold before this date can
container residue removal standard. adequately work their way through the
B. Who Must Comply (§ 165.20(b)) Many of the respondents commented distribution system.
1. Final regulations. You must comply that 2 years is not long enough to test
with the nonrefillable container containers initially and, for containers D. Pesticide Products Included
regulations if you are a registrant who that fail the residue removal standard, to (§ 165.23)
distributes or sells a pesticide product redesign containers, reformulate the 1. Final regulations. As described in
in nonrefillable containers. If your product, or obtain EPA approval for a detail in Unit III., only certain products
product is subject to the nonrefillable waiver. Also, many commenters have to comply with the nonrefillable
container regulations as described in expressed concerns about delays caused container standards. MUPs, plant-
Unit V.D., the product must be by EPA in providing necessary incorporated protectants, and certain
distributed or sold in nonrefillable implementation information, processing antimicrobial products are completely
containers that comply with these waiver requests, and reviewing exempt from the nonrefillable container
regulations. This statement applies to reformulated products. requirements. All other pesticide
each and every nonrefillable container 4. EPA response - length of products are subject to the nonrefillable
used to sell or distribute the product. compliance period. EPA agrees with container regulations.
2. Changes. This is the same approach some of the commenters that a longer There are different tiers of regulation
that we proposed in § 165.100. As compliance period will make it easier for products that are subject to the
described in Unit V.D., the final rule for registrants to comply with the nonrefillable container regulations. A
exempts some products from the final nonrefillable container standards. To product is subject to all of the
rule and subjects some products to only facilitate compliance while trying to nonrefillable container requirements if
the basic DOT general packaging minimize the impact on companies, it satisfies at least one of the following
standards. However, the approach of EPA lengthened the compliance period criteria:
registrants being responsible for for the nonrefillable container • It meets the criteria of Toxicity
complying with the nonrefillable requirements to 3 years. EPA believes a Category I.
container standards is unchanged. 3–year period is sufficient based on the • It meets the criteria of Toxicity
results of the economic analysis and Category II.
C. Compliance Date (§ 165.20(c)) • It is classified for restricted use as
because some of the changes made to
1. Final regulations. The final the regulations facilitate compliance. set out in 40 CFR 152.160 - 152.175.
regulations provide a 3–year period after These changes include: (1) Some If a product does not satisfy any of
the date of publication of the final rule products are completely exempt from these criteria (and it is not an MUP,
in the Federal Register before the nonrefillable container plant-incorporated protectant or an
compliance with the nonrefillable requirements; (2) many products must exempt antimicrobial), it must be
container standards is required. comply only with basic DOT packaged in accordance with 49 CFR
Specifically, within 3 years from today’s requirements, not the full set of 173.24. These products do not have to
date, registrants must distribute or sell nonrefillable container requirements; comply with any other nonrefillable
all subject pesticide products in and (3) changes in the residue removal container requirements. However, if any
nonrefillable containers in compliance requirement, discussed in Unit V.H., of these products are DOT hazardous
with these regulations. which reduce the burden of that materials, they are separately obligated
2. Changes. EPA made several requirement. under DOT regulations to comply with
significant changes to the compliance 5. Comments - channels of trade. all applicable DOT requirements. In
date for nonrefillable containers in the Some commenters — registrant groups other words, nothing in EPA’s
final rule. First, the final regulations and registrants — urged EPA to delete regulations changes the requirements in
provide a 3–year period after today’s the channels of trade provision, the DOT HMR for products that meet
date before compliance is required, generally stating that current products/ DOT’s criteria for hazardous materials.
compared to the 2–year period in the containers don’t pose a large enough 2. Changes. In the proposal, only
proposed rule. Second, the proposed hazard to justify the costs of a recall. A MUPs would have been exempt from
rule specified (in § 165.117(b)) that 5 few State regulatory agencies and a the nonrefillable container regulations
years after the date of publication of the container manufacturer requested (in § 165.100). All other products would
final rule, all products distributed or clarification of this requirement, i.e., have been subject to the standards. The
sold in nonrefillable containers by who would be included and who would 1999 supplemental notice discussed
persons other than the registrant would be responsible for compliance and/or regulatory options for exempting some
have had to comply with these disposition of ‘‘expired’’ products. products (antimicrobials and non-
standards. This ‘‘channels of trade’’ date 6. EPA response - channels of trade. antimicrobials) from the full set of
affecting persons other than the EPA is not finalizing the 5–year refillable container regulations and for
registrant is not being finalized in channels of trade provision in the final exempting certain antimicrobial
today’s final regulations. Third, the rule to minimize the disruption and products from specific requirements.
The criteria in the final rule for level of regulation subject to all Table 6 describes the provisions for
exempting antimicrobials are somewhat nonrefillable container requirements determining which pesticide products
different from those we indicated as our compared to the basic DOT packaging are subject to which nonrefillable
preferred approach in the supplemental requirements rather than to determine container regulations and a brief
notice. The final rule exempts plant- whether the product is subject to or explanation of how (or if) this provision
incorporated protectants. Also, the final exempt from the nonrefillable container changed from the proposal and/or the
rule uses toxicity category and restricted regulations. supplemental notice.
use product status to determine the
TABLE 6.—CHANGES TO THE SCOPE OF THE NONREFILLABLE CONTAINER REGULATIONS

Regulatory Provision in the Final Rule Changes
Manufacturing use products are exempt. No change from proposed rule or supplemental notice.
Plant-incorporated protectants are exempt. Plant-incorporated protectants would have been subject to the pro-
posed rule. The regulations for plant-incorporated protectants were
finalized in 2001. We are exempting them from the final rule be-
cause of their unique nature.
Certain antimicrobial products are exempt. Antimicrobial products would have been subject to the proposed rule.
The final rule implements an approach similar to option 1 in the
supplemental notice, although some of the details are different.
All other products are subject to the regulations as follows:1
Products in Toxicity Category I or II are subject to all of the nonrefill- No change from the supplemental notice approach.
able container requirements.
Restricted use products are subject to all of the nonrefillable container This is different from the other two criteria discussed most thoroughly
requirements. in the supplemental notice, which were: (1) container capacity
equal to or larger than 5 liters or 5 kilograms and (2) having a
specified environmental hazard statement on the label of an out-
door use product.
All other products (those in Toxicity Category III or IV and that are not This category of lowest regulation is different from the supplemental
restricted use products) must comply only with the basic DOT pack- notice in two ways. First, these products are subject to the basic
aging requirements in 49 CFR 173.24. DOT requirements rather than being completely exempt from the
nonrefillable container regulations. Second, more products are in
this category of lowest regulation because there are fewer Toxicity
Category III or IV products subject to all of the nonrefillable con-
tainer requirements in the final rule (restricted use products) than
under the supplemental notice (products in small containers and
outdoor use products with a specified environmental hazard state-
ment on the label).
1The rest of the changes focus on changes from the supplemental notice. All of these products would have been subject to the proposed rule
because the proposed rule would have applied to all products except for manufacturing use products.
E. DOT Standards (§ 165.25(a) - (c)) final rule because they were replaced by • Bung, 2 inch pipe size (2.375 inches
1. Final regulations. As discussed in equivalent DOT requirements. in diameter), external threading, 5
detail in Unit IV., nonrefillable threads per inch, buttress threads.
F. Closures (§ 165.25(d))
containers must comply with the DOT • Screw cap, 63 millimeters, at least
Hazardous Materials Regulations that 1. Final regulations. A nonrefillable one thread revolution at 6 threads per
are referred to and adopted into EPA’s container must have at least one of the inch.
regulations. These incorporated four closures listed below if it meets all • Screw cap, 38 millimeters, at least
regulations establish requirements for of the following criteria: one thread revolution at 6 threads per
container design, construction and • The container is used to distribute inch. The cap may fit on a separate rigid
marking. or sell a liquid, agricultural pesticide; spout or on a flexible pull-out plastic
2. Changes. This is a significant • The container is rigid; spout.
change from the proposed regulation, • The capacity of the container is 2. Changes. The scope of the
although the approach of referring to equal to or greater than 3.0 liters (0.79 requirement for standardized closures is
and adopting a subset of the DOT gal); and unchanged from the proposal; it applies
standards was discussed in detail in the to liquid agricultural pesticides in rigid
1999 supplemental notice. See Unit IV. • The container is not an aerosol containers with capacities equal to or
for a detailed discussion. As discussed container or a pressurized container. greater than 3.0 liters. The closure
in Unit V.M., three of the proposed The four closures specified in the standard does not apply to aerosol or
regulations are:
requirements for nonrefillable pressurized containers. The final

containers (container integrity, marking • Bung, 2 inch pipe size (2.375 inches regulation made several changes in the
the material of construction and in diameter), external threading, 11.5 dimensions and other specifications of
ensuring that the container recloses threads per inch, National Pipe Straight the closures based on comments and
securely) are not being finalized in the (NPS) standard. additional research to accurately reflect
the closures that are most commonly standards. To clarify our intent, EPA equivalent DOT standard that is being
used in the agricultural pesticide modified the final rule to clearly state adopted, as explained in Unit V.M.
industry. Also, the proposed provision that the dispensing standards do not
H. Residue Removal (§ 165.25(f))
that would allow the use of non- apply to aerosol containers and
standard closures was moved to a pressurized containers. As mentioned 1. Overview—i. Final rule. Rigid
separate section of the final rule above, the dispensing standard is containers with capacities less than or
(§ 165.25(g)) along with the other waiver intended to minimize exposure to equal to 5 gallons for liquid
and modification provisions, as pesticides when they are poured from formulations or 50 pounds for solid
described in Unit V.I. containers, which is not how pesticides formulations holding dilutable
are dispensed from aerosol or formulations must be capable of
G. Dispensing Capability - Glugging and attaining at least 99.99 percent removal
pressurized containers.
Dripping (§ 165.25(e)) Third, the requirement in the final for each active ingredient when tested
1. Final regulations. A nonrefillable rule was modified to also exclude spray using the EPA testing methodology.
container with a capacity of 5 gallons bottles. During a review of products that Percent removal represents the percent
(18.9 liters) or less, that is not an aerosol would be subject to the final regulation, of the original concentration of an active
or pressurized container or a spray EPA realized that spray bottles should ingredient in the pesticide product
bottle, and that holds a liquid pesticide also be exempt from the dispensing formulation when compared to the
must do both of the following: requirements because the container concentration of that active ingredient
• Allow the contents of the contents are sprayed out by a trigger in an extra rinse following
nonrefillable container to pour in a mechanism, rather than poured. administration of the triple rinse
continuous, coherent stream. Fourth, the requirement regarding procedure specified in the testing
• Allow the contents of the dripping in the final rule specifies that methodology, i.e., in the fourth rinse.
nonrefillable container to be poured the contents of a container must be All dilutable products in these smaller
with a minimum amount of dripping poured with a minimum amount of rigid containers must be capable of
down the outside of the container. dripping, rather than no dripping as meeting the 99.99 percent removal
2. Changes. The final rule includes proposed. Fifth, the dripping standard standard, although the testing must be
several substantial changes from the was clarified to specify ‘‘dripping down done only if products are flowable
proposal. First, the dispensing the outside of the container’’ to concentrate formulations or if EPA
requirements in the proposed rule distinguish this from when the pesticide requests the test data on a case-by-case
would have applied to all nonrefillable drips out of the container into its target basis.
containers for liquid pesticides, when the material is poured from the ii. Changes. EPA made many
regardless of the size of the container. container. Many commenters substantive changes to the nonrefillable
The final rule only applies the (registrants, registrant groups, a grower container residue removal standard in
dispensing requirements to containers group, a container manufacturer, and a the final rule based on public comments
that are less than 5 gallons (18.9 liters) State regulatory agency) supported and a re-evaluation of currently
in size. This change was made in modifying this standard from available data. The significant changes
response to the comments that said large ‘‘eliminating’’ dripping to ‘‘minimizing’’ are listed briefly in this subsection and
containers should not be subject to the dripping. Most of these respondents are described in more detail below in
dispensing standards. Because these commented that completely eliminating the response to comment summaries.
standards are intended to minimize dripping is impractical or impossible The major changes in the residue
exposure to pesticides when they are and that the amount of pesticide on the removal standard are:
poured from containers, EPA agrees that outside of the container is largely a • The performance standard was
the requirements should not apply to function of user care. EPA agrees with changed from 99.9999 percent removal
containers that are too large to allow the commenters that the proposed (‘‘six 9’s’’) in the proposal to 99.99
their contents to be poured from them. standard of eliminating dripping is not percent removal (‘‘four 9’s’’) in the final
The dispensing requirements in the practical, particularly without a specific rule.
final rule apply only to containers with testing procedure and considering the • The wording was changed from
capacities of 5 gallons (18.93 liters) or significant role of user handling ‘‘The registrant shall demonstrate for
less, which we believe are the practices in whether the containers drip. each container/formulation combination
containers that can be picked up and the Therefore, EPA is modifying the that the standard is achieved’’ in the
contents poured out. dripping standard to minimize rather proposal to ‘‘Each container/formulation
Second, the final rule clarifies that, than eliminate dripping. The structure combination must be capable of
like the nonrefillable container closure of the standard was revised to be similar attaining the standard.’’ The language in
requirement, the glugging and dripping to the glugging standard so it would be the final rule provides more flexibility
standards do not apply to aerosol clear that the dripping standard applies in showing compliance with the
containers or pressurized containers. when the contents are poured from the standard, while still placing the
The proposed dispensing requirements container. Finally, the requirement responsibility of meeting the standard
would have applied only to liquid refers to minimizing the amount of on the registrant.
pesticides, and the final rule maintains ‘‘dripping down the outside of the • Testing (and the corresponding
this approach. EPA did not intend that container.’’ EPA believes this phrase recordkeeping in § 165.27(b)(5)) is only
these requirements would apply to clarifies that the dripping that should be required for flowable concentrate
aerosol or pressurized containers. The minimized is the trickle or drops of formulations or if EPA specifically
proposed closure regulation specifically liquid on the container exterior; not the requests the records on a case by case
excluded aerosols and pressurized last few drops of material or rinsate that basis.
• The test procedure will be
containers, so the lack of similar leave the container when the contents
language in the dispensing requirements are poured. established as an OPP test procedure
led some commenters to believe that Lastly, the proposed standard for titled ‘‘Rinsing Procedures for Dilutable
aerosol and pressurized containers are reclosing securely is not being finalized Pesticide Products in Rigid Containers,’’
subject to the dripping and glugging in the final rule, because there is an which is incorporated into the
regulations. (Ref. 20) The proposed facilitate residue removal is reasonable, these points will be discussed in Unit
regulatory language provided some but did not support the proposed V.H.5.
details of the test procedure, which EPA standard. However, EPA still believes that the
intended to supplement with guidance. Many respondents (from nearly all first step in adequate container cleaning
The final rule does not include the commenter categories, but mostly the - and a responsibility of the registrant -
specific testing requirements because pesticide registrant industry) opposed is making sure that the containers can
we believe it is more appropriate to the establishment of any numeric come clean. Therefore, EPA is retaining
provide these detailed procedures in a standard for residue removal for the a residue removal performance standard
test protocol rather than in the following reasons (which are described in the final regulations for rigid
regulations. in more depth in the Response to nonrefillable containers with dilutable
• The residue removal standard only Comment document (Ref. 19)): formulations. Additional information
applies to containers that are small • EPA doesn’t demonstrate a about the many variables observed in
enough to be shaken because the final problem; more than 20 rinsing studies and about
test procedure and the supporting data • Much of the information cited by the FIFRA Section 19 mandates is in the
involved shaking the containers during EPA isn’t relevant/applicable; Response to Comment document. (Ref.
triple rinsing. As stated in Unit IX.I., • The problem is that users don’t 19)
EPA generally believes that the largest rinse containers; not the container 2. Numeric residue removal standard.
containers that users can shake during designs; and EPA decided to change the performance
a triple rinse are those with capacities • The solution is educating users and standard from 99.9999 percent removal
of 5 gallons for liquids and 50 pounds enforcing rinsing standards. (‘‘six 9’s’’) in the proposal to 99.99
for solids. Many commenters specifically percent removal (‘‘four 9’s’’) in the final
In addition, the final residue removal rule.
opposed the six 9’s standard as too
test procedures, incorporated in i. Comments. Several State regulatory
stringent. These comments claimed that
‘‘Rinsing Procedures for Dilutable agencies and an environmental group
the six 9’s standard is overly ambitious
Pesticide Products in Rigid Containers,’’ specifically expressed support for the
and that the standard would be too
(Ref. 20) contain several key changes. ‘‘six 9’s’’ standard. One State regulatory
• In the final test procedure, the test costly for the benefit obtained. In many
cases, commenters said the standard agency said their data show that 99.9999
must be conducted on three containers, percent removal is achievable under
rather than the proposed approach of a would be impossible to achieve. While
some respondents acknowledged that field conditions. Another said that the
minimum of 19 containers. standard is achievable for most
• Rather than the proposed statistical the six 9’s standard is technologically
feasible, they said it would not be containers, but not for flat-topped metal
standard (at least 95 percent confidence cans — a container type it feels is not
that at least 85 percent of containers practical in application.
suited for use with pesticides.
tested will meet the standard), the final iv. EPA response. EPA believes that
On the other hand, many commenters
test procedure specifies that all three ensuring adequate residue removal at
opposed the proposed six 9’s standard,
containers tested must meet the four 9’s the user level to achieve the goal of
stating that it was overly ambitious and
standard in the final rule. The final rule containers that can be safely managed
too burdensome. Specific comments
approach is similar to the standards for for disposal or recycling involves the
include:
complying with DOT’s drop tests and following steps: • Almost 20 commenters, mostly
other performance tests. (1) The use of container designs and registrants and registrant groups,
• The final rule does not specify that formulations that facilitate effective objected to EPA’s interpretation of the
the testing must be conducted in residue removal; residue removal data and particularly
compliance with the full set of Good (2) Defining proper cleaning opposed EPA’s assessment that a level
Laboratory Practice Standards in 40 CFR procedures; of six 9’s was technologically
part 160. While registrants may comply (3) Educating users about proper practicable.
with the GLP standards, it is not cleaning procedures; • About 20 commenters (mostly
required. However, some key GLP (4) Motivating users to properly clean registrants and registrant groups) urged
requirements are specified in the final containers; and EPA to base the standard on the risks
test procedure to accomplish the goals (5) Enforcing proper cleaning in the involved. Many of these respondents
of ensuring adequate quality of the field. commented that there is no risk analysis
testing and the resulting data. Problems and breakdowns can occur showing that residues in existing
iii. Comments. Several State with any of these steps. If problems do containers pose a theoretical or real
regulatory agencies and a container occur, containers will not be adequately threat or that reaching a six 9’s standard
manufacturer group supported EPA’s clean when they are offered for disposal would substantially reduce this risk.
proposal to require a laboratory or recycling. EPA acknowledges the • Many commenters, including
standard for removing residue from commenters’ point that much of the registrants, registrant groups, State
nonrefillable containers. These problem with inadequately cleaned regulatory agencies, a dealer and a
commenters stated that such a standard containers lies with the fact that the dealer group, questioned the cost-
would enhance safe use and recycling, users don’t rinse them properly, effectiveness of the six 9’s standard.
facilitate management of empty implying a breakdown in items 2, 3, • Some registrants who opposed the
containers and provide flexibility to and/or 4. EPA believes that the label six 9’s standard favored adopting a less
registrants. standards associated with these stringent four 9’s requirement. They
A registrant and a registrant group regulations establish proper and clear termed it more practical, in line with
supported consideration of a residue cleaning procedures, as described in industry expectations, and the only
removal performance standard but Units IX.F. - IX.K. EPA agrees that it is achievable level of removal.
opposed the stringency of EPA’s important and appropriate to dedicate One registrant group provided
proposal. Additionally, a few registrants adequate resources to user education comprehensive comments during the
commented that encouraging the use of and motivation and to enforcing the 2004 reopening of the comment period
containers and formulations that rinsing standards. Additional efforts on based on the Ag Container Recycling
Council’s (ACRC’s) experience over the after use. A registrant expanded on this removal data and factoring in the
past 10 years. This commenter idea by stating that recent experience experiences of pesticide container
described ACRC’s efforts to assess and with pesticide container collection collection and recycling programs over
control the risk from using the recycled programs has shown substantial the past decade, EPA believes the
plastic and noted that, since ACRC’s improvement in the cleanliness of residue removal standard should be
inception in 1992, there have been no incoming containers and that it has revised from 99.9999 percent to 99.99
reports of incidents where public health become obvious that problems with percent removal.
or safety has been compromised as a dirty containers are not caused by Of the many rinsing studies, four sets
result of exposure to the minimal product that is not able to be rinsed, but of data were developed using a standard
residues found in recycled plastic by users who do not rinse, or do not testing procedure (similar to the final
pesticide containers. Further, ACRC’s rinse in a timely manner. The registrant test procedure) to test currently used
study indicated that the risk to human contrasted this experience with EPA’s formulations and container designs.
health and the environment from focus in the proposed rule on ensuring Two sets of data focused on containers
recycling emptied pesticide containers that products will rinse easily from their and formulations typical of the
that remove 99.99 percent of residue containers, which seems to have been agricultural pesticide market and the
from containers is within acceptable based the reports of poorly rinsed other two were intended to represent
levels for recycling. containers from early container containers and formulations in the
This registrant group also stated that collection programs. The registrant said household, institutional and industrial
ACRC’s experience with recycling clean, that great strides have been made in the market. Table 7 summarizes the results
rinsed one way pesticide containers for growth of State container return/recycle of these studies in terms of the standard
more than a decade leads them to programs and in grower, applicator, and that the container/formulation would
believe that residue removal is an issue user education since that period. meet based on the concentration of
of instructing applicators to triple or ii. EPA response. After considering active ingredient in the rinsate from the
pressure rinse containers immediately the comments, re-evaluating the residue fourth rinse.
TABLE 7.—ANALYSIS OF RESIDUE REMOVAL DATA

Number of Container/Formulations That Meet*
Total Cntr/Form Com-
Study Name binations Tested Four 9’s Five 9’s Six 9’s
Formulogics (agricultural) (Refs. 8

and 36) 19 19 17 13
NACA (triple rinse) (Refs. 15 and

39) 24 24 19 12
Subtotal: agricultural market 43 43 (100%) 36 (84%) 25 (58%)
Formulogics (nonagricultural)
(Refs. 6 and 37) 29 29 26 16
CSMA (Refs. 35 and 77) 7 6 4 1
Subtotal: nonagricultural market 36 35 (97%) 30 (83%) 17 (47%)
Total 79 78 (99%) 66 (84%) 42 (53%)

*Note: Some container/formulation combinations were tested on one container; others on two or three (identical) containers for that formula-
tion. Formulations tested on more than one container were classified in the highest standard that all of the containers met. For example, a con-
tainer/formulation would be classified as four 9’s if the results for the formulation in three containers were 99.9988, 99.9996 and 99.9995. For ref-
erence, the structure of the studies were: (1) Formulogics (ag): all 19 tests on 1 container; (2) NACA (triple rinse): 9 tests on 1 container, 15
tests on 3 containers; (3) Formulogics (nonag): 3 tests on 2 containers, 6 tests on 3 containers but the rinsates had to be composited to provide
adequate volume, and 21 tests on 3 containers; and (4) CSMA: all 7 tests on 1 container.
While a more thorough discussion of household pesticide container. recycling programs over the past
these data and the comments regarding Therefore, EPA does not believe that decade. When the regulations were
them is included in the next section, this data point represents a formulation/ proposed, the experiences and
EPA believes that the data show that a container that is actually distributed in observations of some of the earliest
standard of four 9’s adequately the marketplace. After reconsidering the container collection and recycling
represents the results from a careful available data, EPA believes that the programs were available. This
laboratory triple rinse. Of the 79 proposed standard of six 9’s would be information led to the statement in the
container/formulations tested, only one a ‘‘technology-forcing standard,’’ preamble of the proposed rule that
did not meet a 99.99 percent removal whereas the final standard of four 9’s ‘‘Pesticide container recycling programs
standard. The Consumer Specialties accomplishes the goal stated in the and municipal waste facilities report the
Manufacturers Association (CSMA, now preamble of the proposed rule and frequent rejection of certain pesticide
the Consumer Products Manufacturers mandated in FIFRA section 19(f)(1)(B) formulation and container combinations
Association) provided information to establish a standard that is equivalent because of unacceptable pesticide
indicating that the container/ to triple rinsing. residues.’’ The data from some of the
formulation that failed was an EPA also considered the experiences earliest container collections are shown
agricultural pesticide product in a and results of pesticide container and in Table 8.
TABLE 8.—RESULTS FROM EARLY PESTICIDE CONTAINER COLLECTION PROGRAMS (REF. 43)
Number of Containers Rejection
State Year Rate Reference
Brought
Accepted Rejected (percent)
In
Florida (South Florida) 1991 1,594 231 1,825 12.7 (Ref. 4)
Florida (Jackson County) 1991 991 113 1,104 10.2 (Ref. 3)
Illinois 1993 57,086 3,451 60,537 5.7 (Ref. 2)
Iowa 1990 64,000 ND ND 50 (Ref. 9)
Michigan 1992 18,959 2,990 21,949 13.6 (Ref. 12)
Minnesota 1990 9,192 2,136 11,328 18.9 (Ref. 17)
Minnesota 1991 56,928 4,646 61,574 7.5 (Ref. 17)
However, more recent information rejection rate around 28 percent. After representative of the agricultural
provided by several States shows that receiving a grant in 1995 which allowed market, we would expect to find a
the container rejection rate decreases the county to expand the program to 12 rejection rate of over 40 percent if a six
over time. This is generally attributed to convenient sites and to provide 9’s standard was necessary for adequate
pesticide users becoming more aware of additional training on proper rinsing, cleaning. Data from several States show
proper rinsing procedures and the the county collected about 21,000 that currently a maximum of 2 percent
container cleanliness standards because containers and the rejection rate of containers are rejected, which is
of outreach, training and education dropped to 3 percent. (Ref. 10) Nebraska much lower than 40 percent. EPA
efforts. One example is the decrease in and South Carolina report current interprets this to indicate that meeting
the rejection rate experienced in rejection rates of 2 percent on their web a standard of six 9’s is not necessary to
Minnesota from 1990 (18.9 percent) to sites. Virginia reported a rejection rate ensure that a container is clean enough
1991 (7.5 percent) despite a large of 0.5 percent in 2002, which was to be recycled safely.
increase in the number of containers higher than the 2000 rate but still EPA disagrees with commenters who
collected, as shown in Table 8. Out of deemed to be acceptable. (Ref. 43) stated that the residue removal standard
the five Minnesota counties that had EPA believes this information shows should be based solely on toxicological
programs both years and for which data that the main reason containers are significance, because establishing and
are available (Ref. 17), the rejection rate rejected from pesticide container proving compliance with such a
in four of them decreased substantially collection programs is because they standard would be very complex. In
in 1991 while one stayed constant: were not rinsed properly. EPA agrees addition, any amount of residue in a
• Isanti County: The rejection rate with the States that the container container could cause a disruption to its
decreased from 20.9 percent in 1990 to rejection rates decreased substantially proper disposal or recycling because of
12.9 percent in 1991; over time as pesticide users improved the perception of risk the concentration
• Polk, Pennington and Red Lake their rinsing techniques, rinsed the of active ingredient may not be relevant
Counties: 9.5 percent in 1990 to 2.3 containers before residue dried, and in such a situation. However, toxicity
percent in 1991; gained understanding of the cleanliness and relative risk are indirectly taken
• Pope County: 13.8 percent in 1990
criteria used by the Ag Container into account for the nonrefillable
to 14.1 percent in 1991;
• Stevens County: 25.0 percent in Recycling Council (ACRC) recycling residue removal standard in the final
1990 to 0.2 percent in 1991; and contractors. The ACRC contractors have rule because of the changes in the scope
• Swift County: 14.6 percent in 1990 a strong incentive to carefully inspect of the container regulations. The less
to 2.7 percent in 1991. (Ref. 17) containers to ensure they are clean toxic/risky pesticide products (those in
A 1996 report from the Minnesota because contamination increases the Toxicity Categories III and IV and that
Department of Agriculture confirms that risk to the contractor’s workers and are not restricted use pesticides) are
this trend continued over time. (Ref. 13) reduces the value of the collected subject only to the basic DOT standards,
From 1990 through 1995, the container plastic. Therefore, we think it is and are exempt from some of the
rejection rate in Minnesota ranged from accurate to conclude that the lower container requirements, including this
10 percent to 20 percent, with a high of rejection rates in recent years are not a one. Only products that are in Toxicity
35 percent. The report stated that reflection of relaxed or reduced Category I and II and others that are
‘‘Pesticide users had a difficult time inspection standards. restricted use products are subject to the
rinsing containers to acceptable EPA also believes that the container residue removal standard in the final
standards. Timing of the rinse, poor rejection rates from the container rule.
equipment for rinsing and inadequate collection and recycling programs show Setting the residue removal standard
rinsing techniques resulted in many that containers do not have to meet a at four 9’s in the final rule will reduce
containers not being accepted.’’ The standard of six 9’s to be adequately the costs of implementing the
rejection rate for 1996 ranged from 0 cleaned. Table 7 shows that almost 60 regulations because a higher percentage
percent to 2 percent. percent of the agricultural formulations of existing container/formulations will
Before 1995, a county in North and containers tested met a standard of comply with the standard. Therefore,
Carolina collected about 2,500 six 9’s. Assuming that the tested fewer container design changes, re-
containers per year and had a container formulations/containers are formulations, and modification or
waiver requests will be needed. rinse than currently used containers and group stated that EPA (Formulogics) did
Reducing the stringency of the residue formulations. not test formulations containing active
removal standard does not reduce the 3. Rinsing data—i. Comments. Some ingredient concentrations lower than 38
testing costs. However, the testing costs commenters specifically addressed the percent by weight. This respondent also
attributed to the final rule are reduced triple rinsing data discussed in the added that the data provided by CSMA
from those in the proposal because preamble of the proposed rule. A cover a small but representative number
fewer containers/formulations are registrant group and a registrant of nonagricultural container/
subject to the standard (due to the questioned the relevancy of some of the formulation combinations and that most
changes in the scope). In addition, container cleaning data cited by EPA. of them (10 out of 12) would not meet
changes in the final test procedure (see These respondents pointed out that the six 9’s standard.
Unit V.H.4.) and the final some of the data were 6 to 10 years old,
and cited a widespread move to plastic ii. EPA response. EPA agrees that
implementation approach (discussed in residue removal data produced using a
Unit V.H.5.) of only requiring testing for jugs, making data on metal pails
obsolete. rinsing procedure other than the one
flowable concentrate formulations and if identified in the EPA standard
requested on a case-by-case basis will Several commenters expressed the
following specific concerns about the methodology are not relevant to
greatly reduce testing costs.
residue removal data that EPA cited to supporting or changing a regulatory
EPA believes that a 99.99 percent standard. As stated in Unit V.H.2., four
removal standard is consistent with the support the proposed six 9’s standard:
results from triple rinsing current • A registrant group and a registrant sets of data were developed using a
commented that several transcription standard testing procedure (that is very
containers/formulations, which we similar to the final test procedure) to
errors were made in constructing Table
generally believe can be adequately
1 (triple rinsing data for agricultural test currently used formulations and
cleaned if they are properly rinsed.
containers/formulations) in the container designs. Two sets of data
In summary, EPA believes that most focused on containers and formulations
preamble of the proposed rule. One of
containers/formulations can meet a four the respondents added that these errors typical in the agricultural pesticide
9’s standard. However, we do believe undermine the credibility of the data market and the other two were intended
that a standard is necessary and and the arguments developed that use to represent containers and formulations
appropriate for several reasons. First, the data as their basis. in the household, institutional and
the initial step in ensuring clean • A registrant questioned whether the industrial market. Even though the
containers is to use container designs research data were generated under testing to develop these four sets of data
and formulations that facilitate residue GLPs. was done in the early 1990’s, EPA
removal. This is a responsibility of the • Two registrants questioned whether believes that the formulations and
registrant and a standard ensures that the data are truly representative of containers tested are still commonly
the registrants appropriately facilitate containers/formulations that are subject used.
safe and proper residue removal. to the regulations.
Second, the rinsing data show that there • A registrant commented that data Table 7 presents the results of these
is a difference in how easily residues other than EPA’s (Formulogics), NACA’s studies in terms of the standard that the
can be removed from containers, based and CSMA’s are not relevant because container/formulation would meet
on the formulation and container they are not generated from the same based on the concentration of active
characteristics, meaning that there is the test procedures. ingredient in the rinsate from the fourth
potential for problems in removing A registrant group and a few rinse. The following table presents the
residues. Third, observations from State registrants expressed concerns that the information in a somewhat different
pesticide container collection programs EPA data for non-agricultural pesticide format. In Table 9, each container/
have noted a problem over time (i.e., not markets (in Table 2 of the preamble of formulation combination is included
just when collections were initiated) the proposal) are not representative of only once per row in the column for the
with certain pesticide formulations as the household, industrial and most stringent standard it would meet.
discussed in more detail in Unit V.H.5. institutional markets. All of these For example, if the percent removal for
Lastly, a four 9’s standard maintains the commenters pointed out that the EPA a container/formulation combination
current level of rinsability and prevents data do not include tests on dilutable was 99.9992 percent, it would be listed
the use of formulations or containers antimicrobial products or similar only in the five 9’s column (even though
that retain more residue or are harder to formulations. In addition, the registrant it also meets a standard of four 9’s).
TABLE 9.—ANALYSIS OF RESIDUE REMOVAL DATA

Total Number of Container/Formulation Combinations That:1
Cntr/Form
Study Name Combina- Don’t meet Four
tions Meet Four 9’s Meet Five 9’s Meet Six 9’s
9’s
Tested
Formulogics (agricultural) 19 0 (0%) 2 (11%) 4 (21%) 13 (68%)
NACA (triple rinse) 24 0 (0%) 5 (21%) 7 (29%) 12 (50%)
Formulogics (nonagricultural) 29 0 (0%) 3 (10%) 10 (34%) 16 (55%)

CSMA 7 1 (14%) 2 (29%) 3 (43%) 1 (14%)
Total 79 1 (1%) 12 (15%) 24 (30%) 42 (53%)

1 Same note as Table 7.
Looking at the presentation of the 4. Final test protocol. Many pesticides. Of the subset of requirements
results of the four studies in Tables 7 respondents commented on the identified in 160.135, we identified
and 9, it can be seen that a higher proposed testing methodology and some requirements that residue removal
percentage of the container/ particularly its relationship to the testing must meet. These GLP
formulations tested by Formulogics for protocol developed for EPA by requirements are identified in the final
EPA meet a standard of six 9’s than the Formulogics prior to proposing the rule. test protocol. (Ref. 20)
containers/formulations tested by the Most of these comments are addressed iii. Comments - number of containers.
industry associations. This is especially in the Response to Comment document, All of the many (nearly 20) commenters
true for the tests of nonagricultural although the comments regarding GLP (registrants, registrant groups and a
products. However, there is no standards and the number of containers container manufacturer group) who
difference or minimal difference in the tested are summarized below. addressed this issue were opposed to
results between EPA’s data and i. Comments - GLP standards. Many testing 19 containers per formulation/
industry’s data in terms of whether the commenters (registrants, registrant container combination. Many registrants
containers/formulations meet a standard groups, and a consultant) objected to the and a registrant group urged EPA to
of four 9’s. As described earlier, only GLP testing requirement as require testing of only three replicates of
one container-formulation combination unnecessarily burdensome, each container/formulation
(which isn’t actually distributed in the substantially increasing the cost of combination, rather than the proposed
marketplace) did not meet a four 9’s testing without increasing the validity of 19. A registrant group and a few
standard. the data. However, one respondent (a registrants suggested starting with three
EPA acknowledges that there were consultant) commented that all studies and testing more if necessary to achieve
discrepancies between the data in the should be done under GLPs in some a predetermined level of statistical
Report to Congress and the data in Table form to ensure data quality. A registrant significance. Commenters said testing of
1 in the proposed rule’s preamble. group and a registrant suggested that it 19 containers is not statistically
These discrepancies were due to would be sufficient to require a justified, not cost effective, and not
corrections made to the NACA data company official to certify the data. necessary for achieving the data
reported to EPA; the earlier (and Several registrants commented that GLP requirements. Some of these
incorrect) data were presented in the testing would force them to have commenters pointed out that EPA used
Report to Congress and the more recent, outside labs conduct the testing and only three containers to generate the
correct data (which should have been claimed that this would dramatically preamble data and asked why the same
cited) were included in the preamble for increase the costs. One registrant said standard is not sufficient for registrants.
the proposal. Reference 42 explains that many container testing labs are not iv. EPA response - number of
these discrepancies in more detail. familiar with EPA’s GLP regulations. containers. EPA changed the test
Tables 7 and 9 present the correct data. Another stated that because labs cannot protocol for the final rule to specify that
EPA acknowledges that the sample dispose of rinsate properly, they will the test must be conducted on a
size of 79 container/formulation send it back to the registrants, minimum of three containers, rather
combinations is relatively small, but we increasing costs and waste generation. A than the proposed approach of a
believe that the formulation types and registrant group and a registrant pointed minimum of 19 containers. The main
container designs tested to produce the out that the data used to develop EPA’s reason for changing the number of
data in Tables 7 and 9 are representative proposal were not generated under GLP containers that must be tested is that the
of the formulations and containers that and asked that the GLP requirement be testing conducted to produce the data
are currently used. Some formulations dropped from the final rule. supporting the residue removal standard
(such as dilutable sanitizers and ii. EPA response - GLP standards. EPA was conducted on three containers. The
disinfectants) may be under-represented changed the test protocol for the final supporting data was not conducted on
numerically, since only the CSMA rule in several ways to address some of 19 containers, so it is unclear whether
testing included these kinds of the problems described by commenters. the available data could support a
formulations. However, the CSMA tests First, the final rule does not specify that standard based on testing 19 containers.
done on the dilutable sanitizers and the testing must be conducted in Upon re-evaluation, EPA agrees that the
disinfectants show that these kinds of compliance with the full set of GLP test procedure used to produce the
products can attain a standard of four standards in 40 CFR part 160. While supporting data and the test procedure
9’s. Also, only a limited number of registrants may comply with the GLP for the regulatory standard should be
antimicrobial products will be subject to standards, it is not required. EPA very similar if not identical. In addition,
the container regulations (and therefore believes that the container residue EPA believes that testing three
the residue removal standard) based on removal testing can adequately be containers offers cost reduction benefits
the revised scope of the final rule. accomplished by registrants at their including less time to actually conduct
Therefore, the proportion of facilities; the intent was not to have this the testing with one-sixth the number of
antimicrobial product formulation types testing contracted to outside labs, containers to be rinsed, one-sixth the
that were tested may be similar to the although a registrant may choose that number of analyses that need to be
proportion that are subject to the option. conducted, and one-sixth the amount of
residue removal standard in the final While EPA does not believe that rinsate that needs to be managed or
regulation. compliance with the full GLP standards disposed. The final rule approach of
The supporting data were not in 40 CFR part 160 is necessary, we testing three containers is similar to the
generated according to GLPs. think that it is necessary to incorporate standards for complying with DOT’s
Additionally, the supporting studies some of the key GLP requirements to drop tests and other performance tests.
were conducted on one, two or three ensure that the data are of sufficient 5. Implementation—i. Comments. In
containers per formulation; not 19 quality. EPA reviewed the part 160 the preamble of the proposed rule, EPA
containers. As described in Unit V.H.4., regulations and particularly the subset requested comments on the
the methodology in the final rule was of requirements specified in 40 CFR circumstances under which submission
changed to be consistent with the 160.135 for certain studies to determine of residue removal data from pesticide
supporting data. physical and chemical characteristics of products with substantially similar
container/formulation characteristics ii. EPA response. Many of the changes meet a standard of 99.99 percent
would be sufficient in lieu of data in the residue removal standard removal, and therefore is requiring
generation for every pesticide product. discussed in the previous sections testing only in limited circumstances. In
EPA also requested comments on the reduce the cost of complying with this particular, registrants only have to
factors to be considered in determining standard, including: conduct the residue removal testing if
when container and formulation • Changing the scope of the the products are flowable concentrate
characteristics should be considered nonrefillable container regulations so formulations or if EPA requests the test
‘‘substantially similar’’ for the purposes only dilutable products in Toxicity data on a case-by-case basis.
of this requirement. The following Category I or II or that are restricted use • Accordingly, the recordkeeping
comments address these issues: products have to comply with the standards in § 165.27(b)(5) were
• Too many tests required: Some residue removal standard; changed so recordkeeping of test results
respondents, including registrants, • Reducing the standard from 99.9999 is only required for flowable concentrate
registrant groups, and a container percent to 99.99 percent removal; and formulations or if EPA specifically
manufacturer group, expressed concern • Changing the testing protocol.
Despite these changes, the estimated requests the records on a case-by-case
that the proposed residue removal basis.
costs of complying with the residue
standard and the interpretation of EPA chose to require testing of
removal standard were still a fairly large
design type as expressed in the flowable concentrate formulations for
percentage of the overall annual costs
proposed rule would necessitate testing several reasons. First, the results of the
and costs per facility. Rather than trying
for virtually every container/ four studies in Table 7 show that there
to minimize the burden to registrants by
formulation combination in every size is a difference in rinsing efficiency
trying to identify and define
and variation. They said the costs to between the formulation types that were
substantially similar containers and
registrants would be crippling and tested, specifically flowable
formulations, EPA believes it is better to
asked EPA to consider alternatives. concentrates, emulsifiable concentrates,
require testing only for formulations and
• Design type clarification: Several containers that have shown to be aqueous solutions, and encapsulated
commenters asked for clarification of difficult to clean. As stated earlier, EPA formulations. Tables 10, 11, and 12
EPA’s criteria for determining whether believes the data show that most show the data from the studies in Table
containers are the same or different. containers/formulations can meet a four 7 with the residue removal performance
They urged a broad definition of design 9’s standard although practical broken down by formulation type. The
type to reduce the testing burden. experience with container recycling results - particularly for the studies with
• Formulation similarities: Several programs shows that there are problems the most testing - show that flowable
commenters suggested ways to with certain formulations. Because a concentrate formulations had the biggest
eliminate duplicative testing on the universal approach (testing all products difference between meeting four 9’s and
basis of formulation, such as granting subject to the regulations) to identify the five 9’s, which suggests that these kinds
waivers to products that meet certain exceptions (the problematic of products may generally be a little
physical property criteria or to formulations) is inefficient, EPA more difficult to remove from containers
formulations similar to ones that have believes there is a more efficient yet due to characteristics of the formulation
already passed. effective way to implement the residue type in general. The emulsifiable
• Industry task force: Some removal standard in the final concentrates tested generally reached a
agricultural registrants and a registrant regulations. five 9’s level of residue removal but
group voiced support for a plan to In particular, the final rule takes the showed a similar difficulty as flowable
establish an industry task force that following approach: concentrates in reaching the six 9’s level
would conduct studies to determine the • All dilutable liquid products in of residue removal in the Formulogics
physical properties of formulations and rigid containers must be capable of study of agricultural formulations and
containers that meet the four 9’s meeting the 99.99 percent removal containers. While not completely
standard. Combinations matching those standard. This sets a minimum standard conclusive, EPA believes these data
criteria would be exempted from testing; for all products. support the observation that flowable
necessary testing would be limited to • On the basis of the Formulogics and concentrates may generally be more
broad categories of product/container NACA data, EPA is making the difficult to remove from containers than
combinations developed by the studies. assumption that nearly all products other kinds of formulations.
TABLE 10.—ANALYSIS OF RESIDUE REMOVAL DATA BY FORMULATION TYPE - AGRICULTURAL FORMULATIONS AND
CONTAINERS (FORMULOGICS & NACA)
Total Cntr/Form Number of Containers/Formulations That Meet:
Formulation Combinations
Tested Four 9’s Five 9’s Six 9’s
Flowable concentrate 15 15 11 10
Emulsifiable concentrate 20 20 18 12
Encapsulated 4 4 3 1
Aqueous Solution 3 3 3 1
Dry Flowable 1 1 1 1
Total 43 43 36 25
TABLE 11.—ANALYSIS OF RESIDUE REMOVAL DATA BY FORMULATION TYPE—HOUSEHOLD, INDUSTRIAL AND INSTITUTIONAL
CONTAINERS (FORMULOGICS)
Flowable concentrate 10 10 7 1
Emulsifiable concentrate 9 9 9 8
Encapsulated 10 10 10 7
Total 29 29 26 16
TABLE 12.—ANALYSIS OF RESIDUE REMOVAL DATA BY FORMULATION TYPE—HOUSEHOLD CONTAINERS (CSMA)

Flowable concentrate1 1 1 1 0
Emulsifiable concentrate1 2 2 1 0 0
Aqueous solution1 4 4 3 1
Total 7 6 4 1
1Based on the description of the formulations, we assumed that the CSMA data included one flowable concentrate, two emulsifiable con-
centrates and four aqueous solutions.
2 The container/formulation that did not meet four 9’s was an agricultural emulsifiable concentrate in a small (16 ounce) container.
Second, the Minnesota Department of recycling confirmed commenters’ laboratory testing. EPA believes that the
Agriculture (DOA) developed a report assertions that the main reasons for field observations indicated that specific
that summarized the observations of unclean containers at recycling products - in any formulation type - may
inspectors and the experiences of programs are lack of effort by the end be more difficult to remove by rinsing
pesticide users regarding rinsing users when rinsing containers and than other products. Therefore, the final
containers that held pesticide products because of pesticide product drying regulations also provide EPA the option
formulated as flowable concentrates. along the inside of the container if the to require residue removal testing (and
(Ref. 18) These containers tended to be material in the container is not used all keeping records of it) on a case-by-case
rejected at a higher rate than other types at once. (Ref. 26) Neither of these basis. EPA anticipates using this option
of formulations. The Minnesota DOA problems would be addressed by the if we receive credible information about
observed that about 60 percent of the residue removal standard. Based on a wide-spread problem with a specific
containers of one specific flowable their observations, these people believe container/formulation combination
concentrate formulation contained that any container with any formulation being difficult to clean.
pesticide residue, even when the overall type can be adequately cleaned if the
container rejection rate at the collection container is emptied completely at one I. Waiver and Modification Criteria
site was less than 1 percent. To make time (all contents are used initially), if (§ 165.25(g))
the containers holding the studied the end user rinses the container 1. Final regulations. Section 165.25(g)
formulation come clean, users had to promptly after emptying it and if the of the final rule explains that registrants
take extra measures beyond triple end user rinses it properly (either may request waivers from or
rinsing, such as power rinsing for a long pressure or triple rinsing). On the other modifications to the nonrefillable
time, using hot water, cutting the hand, these people also commented that container standards. This section sets
containers open to allow access to hard- specific products may need a little extra out the criteria that must be met for EPA
to-reach areas, soaking the containers, effort into rinsing (more time in a to approve a waiver/modification
using soap or another material and pressure rinse or an extra rinse after the request. The criteria are different for
conducting extra rinses. While we do triple rinse procedure) to completely each of the nonrefillable container
not have laboratory triple rinsing data clean the container. requirements, as described below.
on this product to confirm whether or Based on this information, EPA • § 165.25(a): DOT standards for
not it meets a 99.99 percent standard, believes the final regulations should be pesticide products that are not DOT
the description in Minnesota’s report implemented in a way that minimizes hazardous materials. EPA may waive or
clearly documents a problem with the required testing because the modify the requirements of § 165.25(a) if
cleaning the containers used for this laboratory data and field observations EPA determines that an alternative
product, which was a flowable do not support a widespread problem (partial or modified) set of standards or
concentrate. The Minnesota DOA report with residue removal that could be pre-existing requirements achieves a
mentioned several other products that it solved by the residue removal standard. level of safety that is at least equal to
also categorizes as more difficult to Therefore, EPA decided to only require that specified in the requirements of
rinse. residue removal testing for flowable § 165.25(a).
Third, recent conversations with concentrates, which showed the most • § 165.25(b): DOT standards for
people active in pesticide container difficulty in being removed in the pesticide products that are DOT
hazardous materials. EPA may waive or removal requirement was modified to J. Procedure for Applying for a Waiver
modify the requirements of § 165.25(b) add specific criteria that must be met. or Modification (§ 165.25(h))
if EPA determines that an alternative This change was made partly because 1. Final regulations. Section 165.25(h)
(partial or modified) set of standards or the proposed criterion for waiving or describes the procedure for registrants
pre-existing requirements achieves a modifying the residue removal standard to follow if they want to obtain a waiver
level of safety that is at least equal to was very broad and partly because a from or a modification to any of the
that specified in the requirements of more specific and limited waiver/ nonrefillable container standards. The
§ 165.25(b). EPA will modify or waive modification standard is appropriate regulations specify that a registrant
the requirements of § 165.25(b) only with the less stringent residue removal cannot distribute or sell a pesticide
after consulting with DOT to ensure standard in the final rule. The final rule product in a nonrefillable container that
consistency with DOT regulations and incorporates a DOT waiver provision does not comply with all of the
exemptions. similar to the one set out in the nonrefillable container standards unless
• § 165.25(d): Container closures. potential alternative regulatory text in and until EPA approves the request for
EPA may approve a non-standard the 1999 supplemental notice. EPA the waiver or modification in writing.
closure (that is, a closure not listed in modified the DOT waiver provision in To obtain a waiver or modification, a
§ 165.25(d)) if EPA determines that both several ways to address a few comments registrant must submit a written request
of the following conditions are satisfied: about the problems that could be caused for a waiver or a modification to the
(1) The non-standard closure is
if EPA changed the adopted DOT EPA’s Office of Pesticide Programs at
necessary for the proper mixing,
requirements for pesticides that are DOT the address provided in the regulations.
loading, or application of the pesticide
hazardous materials. First, a separate Two copies of the following information
product.
(2) The non-standard closure offers waiver/modification provision is (which may be part of an application for
exposure protection to handlers during included for pesticides that are not DOT registration or amended registration)
mixing and loading that is the same or hazardous materials and for pesticides must be included with the request:
that are DOT hazardous materials. • The name and address of the
greater than that provided by the
Second, the waiver/modification registrant; the date; and the name, title,
standard closures.
• § 165.25(e): Container dispensing provision for pesticides that are DOT signature, and phone number of the
capability. EPA may waive or modify hazardous materials specifies that EPA company official making the request.
the standards in § 165.25(e) if EPA will modify or waive the requirements • The name and EPA registration
determines that at least one of the in § 165.25(b) only after consulting with number of the relevant pesticide
following conditions is satisfied: DOT to ensure consistency with DOT product.
(1) The product is typically removed regulations and exemptions. The final • A statement specifying the
from the container by a method other rule also adds waiver/modification requirement(s) from which the waiver or
than pouring. provisions for the container dispensing a modification is requested.
(2) Compliance with the container standards. • A description of the relevant
dispensing capability standards would nonrefillable container(s).
The waiver/modification provisions • Documentation or justification to
increase exposure to the pesticide are included to address situations where
container handler. demonstrate that the applicable waiver
the nonrefillable container requirements or modification criteria in § 165.25(g)
• § 165.25(f): Residue removal
might compromise the success, safety are satisfied.
standard. EPA may waive or modify the
and effectiveness of currently used 2. Changes. The procedure for
requirements of § 165.25(f) if EPA
containers or those developed in the obtaining all waivers and modifications
determines that both of the following
future. While EPA has attempted to is essentially the same as the procedure
conditions are satisfied:
(1) The residue remaining in the focus each nonrefillable container proposed (in § 165.119) for obtaining a
container would not cause an requirement on containers and waiver of the standard closure
unreasonable adverse effect on the pesticides for which it is appropriate, requirement. No specific procedure was
environment; and we are not familiar with every container identified for the residue removal
(2) The product offers significant used for every product. It is likely that waiver in the proposed rule or for the
benefits and cannot be economically there are some problematic situations waiver from DOT requirements in the
reformulated or repackaged. where existing containers that are 1999 supplemental notice.
2. Changes. The final rule is specifically designed for a certain use or Consolidating all of the waiver criteria
significantly different than the proposal. adaptation may have difficulty in § 165.25(g) and using the same
Additional waiver/modification complying with the final regulations. procedure for all waivers requests
provisions were added and all of the We may not be aware of these situations should facilitate the process for
criteria were consolidated into one and they may not have been mentioned registrants and EPA. Therefore, the
section. The proposed rule included by commenters. In general, waivers or significant change to the waiver
waiver/modification provisions only for modifications are intended to provide procedure requirements in the final rule
the standard closure and residue relief for a limited number of situations, is that they clearly apply to all waiver
removal requirements. The waiver/ and we wanted to provide a mechanism requests. Several additional minor
modification criteria for the standard to account for these situations without modifications were made to the final
closure requirement in the final rule are having to amend the regulations. rule, including updating the address,
similar to the proposed regulations, Waivers and modifications are clarifying the statement requiring EPA
although a few minor editorial changes appropriate in a limited number of approval before a pesticide product can
were made. Also, the final rule clarifies situations, such as the use of non- be sold or distributed in containers with
that both criteria must be met before standard closures, since the point of the waived or modified requirements,
EPA will approve the use of an requirement is to limit the number of broadening several of the information
alternative closure, which was the closures (and therefore adapters) to items to accommodate the additional
intent of the proposed rule. The waiver/ encourage the use of closed transfer waiver provisions, and clarifying that a
modification provision for the residue systems. waiver request could apply to more than
one nonrefillable container design for • Documentation of compliance with are subject to the nonrefillable container
the identified pesticide product. the dispensing requirement, if standards.
Because the waiver and modification applicable. • Because the requirement for
requests are part of an application for • Documentation of compliance with registrants to submit a certification is
registration or amended registration, the residue removal requirement, if not being finalized, the need to keep a
each waiver request must apply to only applicable. record of the certification is no longer
one product. The registrant must make these necessary.
records available for inspection or
K. Reporting (§ 165.27(a)) • For the closure-related records,
copying upon request by an employee of
several minor changes were made to
1. Final regulations. This section EPA or any entity designated by EPA,
further describe the kinds of
clarifies that the pesticide container such as a State, another political
documentation that would be
regulations do not require registrants to subdivision or a Tribe.
2. Changes. The requirements are acceptable.
report to EPA with information about
their nonrefillable containers. It refers substantially the same as proposed. M. Proposed Standards That Are Not
registrants to the reporting standards in Several minor modifications were made Being Finalized
40 CFR part 159 to determine if in the final rule to improve the clarity
of the recordkeeping requirements, 1. Final regulation/changes. The
information on container failures or
including: following requirements relating to
other incidents involving pesticide
• Deleting ‘‘design type’’ in several container design from the proposed
containers must be reported to EPA
places to clarify that the requirements regulation are not being finalized in the
under FIFRA section 6(a)(2).
2. Changes. The intent and substance apply to the containers used to final rule:
of this standard is the same as in the distribute or sell the product. However, • § 165.102(b): Container integrity
proposal. However, the wording was the specific records for the dispensing and compatibility;
changed to clarify that this is simply a and residue removal recordkeeping • § 165.102(c)(1): Permanently
reference to the existing 6(a)(2) allow information for different marking the EPA registration number;
standards and that it does not add any containers and products to be used to • § 165.102(c)(2): Permanently
new requirements. document compliance, under the marking the container’s material of
specified conditions. construction;
L. Recordkeeping (§ 165.27(b)) • The first sentence in the
• § 165.102(d)(3): Requiring the
1. Final regulations. For each product recordkeeping requirement in the final
container to reclose securely; and
that is subject to the full set of rule was revised to clarify that the
recordkeeping applies to pesticide • § 165.106: Residue removal
nonrefillable container regulations and
products distributed or sold in methodology for dilutable products in
is distributed and sold in nonrefillable
nonrefillable containers and that are rigid containers
containers, registrants must keep the
following records for as long as a subject to the full set of nonrefillable • § 165.111: Certification.
nonrefillable container is used for the container regulations in §§ 165.25 - Three of these proposed requirements
product and for 3 years thereafter: 165.27. In other words, products that are for nonrefillable containers are not
• The name and EPA registration completely exempt and products that being finalized because they were
number of the product. must comply only with the standards in replaced by equivalent DOT
• A description of the container(s) 49 CFR 173.24 do not have any requirements. The following table lists
used to distribute or sell the product. recordkeeping requirements. This the non-finalized requirements from the
• Documentation of compliance with change was necessary because of the proposed rule and the DOT equivalent
the closure requirement, if applicable. changes in the scope of products that regulations:
TABLE 13.—PROPOSED NONREFILLABLE CONTAINER STANDARDS THAT WERE NOT FINALIZED AND THEIR DOT
EQUIVALENTS
Proposed Pesticide Container Require- Proposed 40 CFR Cite Equivalent 49 CFR Cite
ment
Container integrity and compatibility § 165.102(b) §§ 173.24(b), 173.24(e)
Permanently marking the material of § 165.102(c)(2) §§ 178.3(a), 178.503(a)

construction
Requiring the container to reclose se- § 165.102(d)(3) § 173.24(f)

curely
As discussed in Units V.H.1. and language provided some details of the permanently marked with the EPA
V.H.4., the residue removal testing test procedure, which EPA intended to registration number of the pesticide in
methodology that was proposed in supplement with guidance. The final the final rule. Also, EPA is not finalizing
§ 165.106 is not being finalized in the rule does not include the specific testing the proposed requirement in § 165.111
regulatory language and will be requirements because we believe it is for registrants to certify that their
incorporated into EPA’s testing more appropriate to provide these nonrefillable containers meet the
guidelines. The test procedure is details in a test protocol than in the standards and to submit the
established as an OPP test procedure regulations. certifications to EPA.
titled ‘‘Rinsing Procedures for Dilutable EPA decided not to finalize the 2. Comments - EPA registration
Pesticide Products in Rigid Containers.’’ proposed requirement in § 165.102(c)(1) number. Several State regulatory
(Ref. 20) The proposed regulatory that each nonrefillable container be agencies supported requiring the EPA
registration number, saying it would a good practice and we encourage VI. Refillable Containers
help in the identification and disposal registrants to do this (or continue doing
A. Key Terms
of unwanted and/or abandoned it), although it is not required.
pesticides. One acknowledged that the 1. Overview. The following terms,
4. Comments - certification. A
container might not hold its original defined in § 165.3 of subpart A, are key
registrant group commented that to understanding the refillable container
contents, but that the benefits outweigh
registrants would be able to certify standards in subpart C.
the disadvantages. One commenter
compliance if appropriate standards are (1) Dry pesticide
suggested imbedding identification
stripes in bags to identify the contents established. Another registrant group (2) One-way valve
and another recommended requiring the commented that current registration (3) Portable pesticide container
year the pesticide was manufactured in guidelines make the certification (4) Refillable container
addition to the EPA registration number. redundant and claimed that the (5) Stationary pesticide container
Almost 30 commenters, including requirement to certify was not in (6) Tamper-evident device
almost 20 registrants, some registrant compliance with the Paperwork (7) Transport vehicle.
groups, a few container manufacturer Reduction Act. A registrant group and a Three of these definitions--dry
groups, and a State regulatory agency, registrant urged EPA to develop pesticide, tamper-evident device, and
opposed requiring the EPA registration guidance to define what registrants transport vehicle--are identical to the
number to be permanently marked on should certify, because it is unclear proposed definitions. The definition of
the container because the container may what must be certified and when. A refillable container was slightly
not hold its original contents, the registrant group and a registrant/ modified to clarify that refillable
number is already on the pesticide label, distributor said that formulators and containers are used for sale or
it would be too expensive, and it would subregistrants should be allowed to distribution. As discussed below, a
create inventory and container ordering definition of portable pesticide
meet this requirement by a data
problems. container has been added to the final
certification process.
3. EPA response - EPA Registration rule and the other two definitions were
Number. This requirement was intended 5. EPA response - certification. EPA changed substantively.
to help the managers of State pesticide considered modifying the certification The following proposed definitions
collection and disposal programs (often requirement to clarify the intent. that were relevant to the proposed
called Clean Sweep programs) identify However, EPA decided not to finalize refillable container standards are not
unknown pesticides when they receive the certification requirement because, in being finalized: dry bulk container; dry
containers without labels. However, this case, we believe that the benefits of minibulk container; liquid bulk
based on the comments, we no longer having registrants certify compliance are container; and liquid minibulk
believe that the benefits of this standard outweighed by the paperwork burden container. These are discussed below in
would outweigh the costs. EPA believes on industry and EPA. EPA believes that conjunction with stationary pesticide
that many commenters misunderstood having a high level official certify container.
the intent of the proposed interpretation compliance with the regulations 2. One-way valve—i. Final regulation.
of permanent marking because the generally facilitates compliance by One-way valve means a valve that is
comments implied that the EPA having companies focus on the designed and constructed to allow
registration number would have to be regulations up-front and by creating an virtually unrestricted flow in one
embossed in the container. This was not incentive for that official to ensure direction and no flow in the opposition
the intent of the proposal, which would compliance because of the direction, thus allowing the withdrawal
have allowed ink jetting, so the responsibility of signing such a of material from, but not the
comments regarding inventory problems statement. However, the registrants will introduction of material into a
and some of the costs are not relevant. already be sending in a submission with container.
However, even the estimates for ink jet an official’s signature because of the ii. Changes. EPA incorporated the
printing and the costs to alter a filling following phrase, as suggested by a
changes to the pesticide storage and
line are substantial when extrapolated registrant: ‘‘to allow virtually
disposal label statements. Therefore, we
to all of the formulators, particularly unrestricted flow in one direction and
believe that some of the benefits of the
when the actual benefits are unclear. no flow in the opposition direction.’’
label submissions will carry over onto
EPA doesn’t question the benefit of EPA believes this improves the
the container standards. Also, this
helping State pesticide disposal definition by clarifying what we mean
approach should eliminate potential by one-way.
programs identify pesticides to facilitate
confusion about submitting label 3. Stationary pesticide container—i.
and minimize the cost of disposing of
unwanted pesticides. However, there changes and certifications if a product Final regulation. Stationary pesticide
are many legitimate questions about must comply with the label changes in container means a refillable container
how often this might happen and how this rule but not the nonrefillable that is fixed at a single facility or
much confidence a pesticide disposal container standards (because of different establishment or, if not fixed, remains at
program manager would have that the scopes). Lastly, the container the facility or establishment for at least
container holds its original contents. regulations, promulgated under the 30 consecutive days, and that holds
(See the discussion of good stewardship authority of FIFRA section 19, are pesticide during the entire time.
for service containers in Unit VII.L. of directly enforceable by section ii. Changes. The proposed definition
this preamble.) Also, the EPA 12(a)(2)(S) of FIFRA, which states that it for ‘‘stationary bulk container’’ was
registration number is required on the is unlawful to violate any regulation revised in several ways, as discussed in
pesticide’s label. Therefore, EPA is not issued under section 3(a) or 19. In other detail in Unit VIII.E. of this preamble,
finalizing this requirement in today’s words, the certifications are not which describes the containers that are
final nonrefillable container regulations. necessary to enforce these regulations. subject to the containment
EPA continues to believe that durably For all of these reasons, EPA decided requirements. The final rule changes the
marking a product’s EPA registration not to finalize the certification term from ‘‘stationary bulk container’’ to
number on its nonrefillable containers is requirement in today’s final rule. ‘‘stationary pesticide container’’ because
the changes to the final containment tamper-evident requirement in The final rule clarifies that refillers
regulations eliminated the need for the § 165.45(e) as ‘‘a refillable container that must comply with the requirements for
proposed definitions of minibulk and is a portable pesticide container that is stationary pesticide containers in
bulk containers. designed to hold liquid pesticide § 165.45(f). EPA believes it is reasonable
The proposed containment formulations...’’ to hold both the registrants and refillers
regulations would have required each responsible for meeting the stationary
stationary bulk container to be protected B. Purpose (§ 165.40(a)) pesticide container standards in
by a secondary containment unit. The 1. Final regulations. The purpose of § 165.45(f) because they are both selling
proposed rule defined stationary bulk the refillable container standards is to and distributing the pesticide that is
container to be ‘‘a liquid bulk container establish design and construction held in those containers.
or a dry bulk container that is fixed at requirements for refillable containers
a single facility or establishment...’’ The D. Compliance Dates (§ 165.40(c))
used for the distribution or sale of some
proposed rule also defined liquid bulk pesticide products. 1. Final regulations. The final
and dry bulk containers by size. For 2. Changes. This is nearly the same as regulations provide a 5–year period after
example, liquid bulk container was the proposed purpose (in § 165.120(a)). the date of publication of the final rule
defined as ‘‘a refillable container One minor change was to acknowledge in the Federal Register before
designed and constructed to hold liquid the reduced number of products that are compliance with the refillable container
pesticide formulations with the capacity subject to the final regulations by stating standards is required. Specifically,
to hold undivided quantities of greater that the rule applies only to the within 5 years from today’s date,
than 3,000 liters (793 gallons).’’ distribution or sale of some pesticide registrants must distribute or sell all
The final containment regulations products. The proposed regulations pesticide products in refillable
take a different approach of delineating would have applied to all products. containers in compliance with these
the containers that must be within regulations.
Another insignificant modification was
secondary containment units. Section 2. Changes. Based on the comments,
to delete the term ‘‘standards’’ from the
165.81(b) states that ‘‘Stationary EPA decided to extend the compliance
phrase ‘‘establish standards and period from the 2–year time frame that
pesticide containers designed to hold requirements’’ because it is redundant.
undivided quantities of agricultural was proposed in § 165.139. Also, the
pesticides equal to or greater than 500 C. Who Must Comply (§ 165.40(b))? compliance date for registrants to
gallons (1,890 liters) of liquid pesticide submit certifications is not being
1. Final regulations. You must comply finalized because the certification
or equal to or greater than 4,000 pounds
with all of the refillable container requirement from the proposal is not
(1,818 kilograms) of dry pesticide are
regulations if you are a registrant who being finalized, as described in Unit
subject to the regulations in this subpart
distributes or sells a pesticide product VI.M.
and must have a secondary containment
in refillable containers. If your product 3. Comments. A few commenters
unit that complies with the provisions
is subject to the refillable container (registrant groups, a registrant and a
of this subpart ...’’ Because the container
regulations as described in Unit VI.E., State) on the proposed rule supported a
sizes are a regulatory criterion in
the product must be distributed or sold 2–year compliance period if EPA adopts
§ 165.81(b), the definitions of liquid
in refillable containers that comply with a grandfather clause or references the
bulk container and dry bulk container
are no longer necessary and are not these regulations. This is true regardless DOT regulations rather than the
being finalized. The definition of dry of whether you repackage the product proposed regulations. However, many
minibulk container was not used in the into the container yourself or whether commenters (mostly registrants, but also
proposed or final regulations and is also you sell or distribute the product to an a dealer group and a few States) argued
not being finalized. independent refiller, who repackages for a longer compliance period to allow
4. Portable pesticide container—i. your product into refillable containers. the continued use of sound containers
Final regulation. Portable pesticide In addition, you must comply with and to minimize the burden of
container means a refillable container the regulations in § 165.45(f) for retrofitting containers or replacing the
that is not a stationary pesticide stationary pesticide containers if you are containers in inventory. Because
container. a refiller of a pesticide product and you refillable containers can be used for
ii. Changes. The proposed regulations are not the registrant of the pesticide many years (the average life span is 5
did not define portable pesticide product. years for plastic minibulks and 15 years
container. However, this definition is 2. Changes. For registrants, this is the for steel minibulks), a 2–year phase-in
necessary in the final rule to replace the same approach that we proposed in period would require companies to
term liquid minibulk container in the §§ 165.122(a)(1)(i) and 165.122(a)(2)(i). dispose of good containers or to retrofit
refillable container regulations. As However, the wording is more them. Several of the commenters
described above, EPA is not finalizing straightforward because the regulations mentioned that it would take longer
the definitions for liquid bulk, dry bulk for refillable containers were separated than 2 years to come into compliance.
and dry minibulk containers because from the repackaging regulations in the In addition, many commenters
they are not necessary. Similarly, EPA final rule. This subpart includes only (registrants and registrant groups) on the
believes that it is logical to not finalize the refillable container standards, which supplemental notice stressed the need
the definition for liquid minibulk apply to all registrants that use refillable for an adequate transition period
container. In the proposal, the only time containers to distribute or sell their regarding the option of adopting the
the term liquid minibulk container was products. The standards for repackaging DOT Packing Group III standards in the
used in the regulatory language was to were placed in a separate subpart, final rule. The main points made by the
define the kinds of refillable containers because those regulations must commenters included:
• An adequate transition period is
that had to comply with the one-way distinguish between registrants who
valve/tamper-evident device repackage product directly into the required to design and obtain new
requirement. In the final rule, EPA containers and registrants who allow packaging, finish using existing supplies
partially describes the containers that independent refillers to repackage their of previously authorized packaging,
must comply with the one-way valve/ product into refillable containers. allow existing nonrefillable packaging to
work its way through the distribution 4. EPA response. As described above, swimming pools and closely related
system and let refillable packaging EPA is extending the compliance period sites (such as hot tubs, spas and
complete its useful life. for refillable containers to 5 years to whirlpools) are exempt from the
• An inadequate transition period provide for a smoother and less requirements for marking the serial
would significantly increase the cost of burdensome transition for companies. number and having a one-way valve
compliance with this rule. Major costs Companies that have already made and/or tamper-evident device on each
would be avoided as long as it is not significant investments in refillable opening.
necessary to dispose of packaging which containers will be able to use their
has not yet reached the end of its useful 2. Changes. In the proposed rule, only
existing containers for 5 years, which
life or to recall packaging which is still MUPs were exempt from the refillable
covers the average expected lifetime of
in the distribution channels and has not a plastic minibulk container. Also, the container regulations (in
yet reached its final destination. The changes to the refillable container § 165.122(b)(1)). All other products
suggested transition periods would standards will allow existing refillable would have been subject to the
minimize the cost impact of the EPA containers that meet the DOT Packing standards. The 1999 supplemental
container regulation. Group III standards to be retrofitted notice discussed regulatory options for
• Pesticide products change hands relatively easily (by durably marking exempting some products
several times as they move down the each container with a serial number and (antimicrobials and non-antimicrobials)
distribution chain from the basic having a one-way valve and/or tamper- from the full set of refillable container
producer to the end user (basic evident device on each opening of regulations and for exempting certain
producers, formulators, distributors, liquid minibulk containers) so they can antimicrobial products from specific
retail dealers, brokers, custom continue being used. EPA believes that requirements.
applicators and end users). In many the longer compliance period in the The criteria in the final rule for
cases, the movement of materials is final regulations is reasonable and exempting antimicrobials are different
reversed when products are not should apply equally to all products and than those discussed in the
consumed. all refillable containers. supplemental notice and the final rule
• The distribution process normally exempts plant-incorporated protectants.
is completed in a given sales year. E. Pesticide Products Included
(§ 165.43(a) - (g)) The final refillable container regulations
However, when materials are not
do not incorporate the toxicity category,
consumed, inventories build at all levels 1. Final regulations. As described in
container size or environmental hazard
of the distribution chain. Quite often detail in Unit III., only certain products
criteria from the supplemental notice.
materials may be held in inventory for have to comply with the refillable
multiple years before re-entering the Also, the final rule changes some
container standards. MUPs, plant-
distribution network. During periods aspects of the supplemental notice
incorporated protectants, and certain
when materials are being held in approach of subjecting antimicrobial
antimicrobial products are completely
inventory, the pesticide formulators and swimming pool products to a reduced
exempt from the refillable container
others are negatively impacted when set of requirements.
requirements. All other pesticide
regulatory changes are imposed on products are subject to the refillable Table 14 describes the provisions for
products in the distribution chain container regulations. determining which pesticide products
(rather than on products that will be Some of the antimicrobial pesticides are subject to which refillable container
sold or distributed at some future date), that are subject to the refillable regulations and a brief explanation of
which involves substantial expenses to container regulations are subject to a how (or if) this provision changed from
producers with, in most cases, no reduced set of regulations. In particular, the proposal and/or the supplemental
justifiable gain in safety. antimicrobial pesticides that are used in notice.
TABLE 14.—CHANGES TO THE SCOPE OF THE REFILLABLE CONTAINER REGULATIONS

Regulatory Provision Changes
Plant-incorporated protectants are exempt. Plant-incorporated protectants would have been subject to the proposed
rule. The regulations for plant-incorporated protectants were finalized in
2001. We are exempting them from the final rule because of their
unique nature.
Certain antimicrobial products are exempt. Antimicrobial products would have been subject to the proposed rule.
The final rule implements an approach similar to option 1 in the supple-
mental notice, although some of the details are different.
All other products are subject to the refillable container require- All products other than manufacturing products would have been subject
ments, except for certain antimicrobial swimming pool products. to the proposed rule. The final rule is different than the approach dis-
cussed in the supplemental notice, which would have exempted prod-
ucts in Toxicity Category III or IV in small containers and outdoor use
products without the specified environmental hazard statements on
their label.
Antimicrobial products used in swimming pools and closely related Antimicrobial products used in swimming pools would have been subject
sites are subject to a reduced set of refillable container require- to the proposed rule. The final rule is the result that was intended in
ments. the supplemental notice, although the specifics of how it is imple-
mented in the final rule are different than in the supplemental notice.
F. Other Exemptions (§ 165.43(h)) information that would have been groups) specifically supported including
Final regulations and changes. The marked on the containers and the final ink jetting as a means of permanent
refillable container regulations do not rule only includes one piece of data, the marking and one suggested adding
apply to transport vehicles that contain serial number (or other identifying rubber-stamping to the list. A few
pesticide in pesticide-holding tanks that code). Some of the proposed items--the registrants commented that many inks
container manufacturer, date of can be removed with solvent-based
are an integral part of the transport
manufacture, rated capacity, and products.
vehicle and that are the primary
material of construction--were deleted Some commenters (registrants and
containment for the pesticide. This is registrant groups) urged EPA to move
because this information is required in
identical to the exemption proposed in the list of acceptable forms of
the DOT standards. The other pieces of
§ 165.122(b)(2). In addition, the final permanent marking from the preamble
information--the model number and the
rule includes a specific exemption for to the regulations if permanent marking
phrase ‘‘Meets EPA standards for
gaseous pesticides, which is necessary is required. Respondents said this
refillable containers’’--were deleted
to implement our intent from the would prevent confusion and
from the regulations because they are no
proposal because the final rule does not misunderstanding during enforcement.
longer necessary for implementing the
use the proposed terms liquid minibulk, refillable container and repackaging One container manufacturer group
dry minibulk, liquid bulk and dry bulk requirements due to the change to refer discussed the difference between the
containers, which would have excluded to and adopt the DOT regulations and UN/DOT terms ‘‘permanent’’ and
gaseous pesticides. because commenters raised some ‘‘durable’’ and suggested that EPA’s
G. DOT Standards (§ 165.45(a) - (c)) legitimate problems with them. purposes would be met by requiring
Second, the regulatory text was durable marking. A registrant provided
1. Final regulations. As discussed in changed to clarify that the serial number similar comments and supported marks
detail in Unit IV., refillable containers (or identifying code) must be durably that are ‘‘long-lasting and persistent
must comply with the DOT Hazardous marked on the container, rather than through the life of the pesticide.’’ This
Materials Regulations that are referred permanently marked as stated in the registrant also commented that
to and adopted into EPA’s regulations. proposed regulations. EPA’s intent for permanent marking is best performed by
These incorporated regulations establish permanent marking in the proposal was container manufacturers, although
requirements for container design, described in the preamble as registrants can add durable marking,
construction and marking. ‘‘Permanent marking includes, but is not such as ink jetting and stenciling with
2. Changes. This is a change from the limited to, etching, embossing, ink paint. A container manufacturer group
proposed regulation, although the jetting, stamping, heat stamping, supported providing options because
approach of referring to and adopting a mechanically attaching a plate, molding, different types of markings are suitable
subset of the DOT standards was or marking with durable ink.’’ EPA for different container types, but
discussed in detail in the 1999 believes that durable marking is a more opposed mechanically attaching a plate
supplemental notice. See Unit IV. for a accurate term to describe our intent. The to plastic containers and expressed
detailed discussion. As discussed in text in the final regulation-- ‘‘must be concern about some of the other
Unit VI.M., some of the proposed marked in a durable and clearly visible alternatives.
requirements for refillable containers manner’’--is based on the DOT marking Some respondents (registrants and
are not being finalized in the final rule standards for intermediate bulk registrant groups) urged EPA to allow
because they were replaced by containers in 49 CFR 178.703(a)(1). the use of pressure-sensitive labels and/
equivalent DOT requirements. Third, the proposal included a or labels attached with permanent
H. Serial Number Marking (§ 165.45(d)) provision that allowed compliance with adhesive as alternative ways to comply
a similar DOT marking requirement to with the permanent marking
1. Final regulations. Each refillable satisfy the corresponding EPA pesticide requirement. A container manufacturer
container must be marked in a durable container standard. This provision is no group recommended requiring the
and clearly visible manner with a serial longer necessary because the final containers to be marked in a manner
number or other identifying code that regulation refers to and adopts some of ‘‘that at least some of the material from
will distinguish the individual the DOT standards. which the container is made must be
container from all other containers. 3. Comments - permanent marking. destroyed to remove the marking.’’ A
Durable marking includes, but is not The proposal for the container marking pesticide user commented that the
limited to etching, embossing, ink drew a large number of comments. marking should be legible after the third
jetting, stamping, heat stamping, About 20 commenters, consisting water rinse and dry cycles.
mechanically attaching a plate, molding, mainly of registrants, registrant groups, 4. EPA response - permanent marking.
and marking with durable ink. The and container manufacturer groups, EPA modified the approach toward
serial number or other identifying code addressed EPA’s interpretation of permanent marking several ways in the
must be located on the outside part of permanent marking. These comments final rule to eliminate confusion about
the container except on a closure. focused on the proposed permanent the intent and to facilitate compliance.
Placement on the label or labeling is not marking requirements for nonrefillable First, EPA changed the description of
sufficient unless the label is an integral, containers, but are applicable to the marking from ‘‘permanent’’ to ‘‘durable’’
permanent part of or permanently refillable container and label regulations marking. EPA believes that durable
stamped on the container. Antimicrobial as well. These comments are included marking is a more accurate term to
products used in swimming pools and in the refillable container section describe our intent because the
closely related sites (that are subject to because the marking requirements for description of ‘‘permanent’’ marking in
the regulations) are exempt from this nonrefillable containers are not being the preamble of the proposal included
requirement. finalized. marking methods, such as ink jetting,

2. Changes. The marking requirement One registrant supported the list of stamping and marking with durable ink,
was changed significantly from the different techniques that would qualify that are durable but not permanent.
proposal to the final rule. First, the for permanent marking. Some Second, the final rule clarifies that ink
proposed rule included seven pieces of respondents (registrants and registrant jetting and stamping are allowable
methods of marking the required swimming pool chemicals and would closely related sites (that are subject to
information on the containers. Third, quite likely cause the refillables to be the regulations) are exempt from this
the allowable methods of marking are replaced by millions of single-use, requirement.
listed in the regulations, rather than nonrefillable containers. Therefore, the 3. Comments - vents. A container
only in the preamble or guidance final rule exempts antimicrobial manufacturer group pointed out that
material, to enhance the understanding products used in swimming pools and vents are needed to provide air flow and
of the intent. closely related sites (and that are subject that a person could introduce a material
5. Comments - serial numbers. Serial to the regulations) from the serial through a vent if they tried hard enough.
numbers were uniformly opposed by number requirement. This commenter recommended
several registrants, several registrant requiring vents to be designed to
groups, and a container manufacturer I. Openings - One-Way Valves or
minimize the introduction of material
because these commenters claimed Tamper-Evident Devices (§ 165.45(e))
through them. Similarly, a State
requiring serial numbers would greatly 1. Final regulations. Like the regulatory agency urged EPA to modify
increase the cost of compliance. Several proposed rule, this standard applies the requirement to acknowledge that
commenters focused on the potential only to portable pesticide (refillable) vents are required on refillables and are
impact on plastic and steel drums and containers designed to hold liquids--not not one-way.
flexible intermediate bulk containers, portable pesticide containers for dry 4. EPA response - vents. EPA agrees
and said it would be very burdensome pesticides or stationary pesticide with the commenters that vents are
to permanently mark a serial number on containers. Also, this standard does not needed to provide air flow when
each container. Three respondents apply to cylinders that comply with the unloading material from a container and
specifically addressed swimming pool DOT HMR. Each opening of a portable that vents do not meet the definitions of
chemicals. These commenters stated pesticide container for liquid materials either one-way valves or tamper-evident
that the requirement for serial numbers (except for DOT cylinders) other than a devices. Therefore, EPA modified the
and the associated recordkeeping vent must have a one-way valve, a regulations to clarify that vents do not
requirements would be completely tamper-evident device or both. A one- need one-way valves or tamper-evident
unworkable for refillable pool chemicals way valve may be located in a device or devices, but that they must be designed
because millions of refillable containers system separate from the container if the to minimize the introduction of material
(from 1 to 55 gallons) are used each year device or system is the only reasonably through them.
and a single shipment can contain 4,000 foreseeable way to withdraw pesticide 5. Comments - chloropicrin. A group
to 5,000 bottles. This increased cost from the container. A vent must be of chloropicrin manufacturers and users
would make refillable containers designed to minimize the amount of cited several reasons why that product
uneconomical for swimming pool material that could be introduced into should be exempt from the opening
chemicals, which would lead to the the container through it. requirement. This commenter provided
registrants switching to nonrefillable 2. Changes. EPA made several the following information:
plastic jugs. modifications to this requirement. First, • Chloropicrin is a highly volatile
6. EPA response - serial numbers. EPA the description of the containers that liquid that is shipped and handled
disagrees with commenters that the cost must comply was changed to portable essentially like a gas.
of complying with the serial number pesticide containers that are designed to • End-use formulations containing
requirement (for products other than hold liquid formulations because the chloropicrin are shipped in refillable
swimming pool chemicals) would be definition of liquid minibulk container steel containers manufactured under the
overly burdensome. First, the final is not being finalized. Second, we same DOT specifications as propane
regulation clarifies that the serial changed the word ‘‘aperture’’ in the cylinders.
number must only be durably marked, proposal to ‘‘opening’’ in the final rule • Chloropicrin containers typically
not permanently marked. Therefore, it because it is a more common term that have only one specialized valve for
would not have to be done by an should facilitate understanding and filling and emptying the cylinder and
automatic marking device capable of therefore compliance with the specialized connections are required to
changing each time a new container is regulations. Third, the standard was fill them.
made. Second, this standard only changed so vents do not need to have • Chloropicrin cylinders contain
applies to containers that are refilled. It tamper-evident devices or one-way screw-on valve protections known as
does not apply to containers that are valves. Instead, a sentence was added to bonnets. The commenter stated that
being reconditioned, remanufactured or ensure that vents are designed to adding external one-way valves is not
repaired according to the DOT standards minimize the amount of material that possible due to space limitations and
in 49 CFR 173.28 or 180.352. In other could be introduced into containers increasing the size of the bonnets would
words, it does not apply to drums that through them. Fourth, the requirement reduce the ability of the bonnet to
are used once and reconditioned was amended to clarify that a one-way protect the valve.
according to DOT standards and then valve may be located in a separate In addition, the commenter claimed
filled with pesticide or another device or system, such as a coupler, if that:
substance. See the discussion in Unit that device or system is the only • The specialized valve and refilling
IV.B. that states that the reference to 49 reasonably foreseeable way to withdraw connections minimize the chance of
CFR 173.28 is included in the final pesticide from the container. This was contamination or unauthorized filling.
regulations to allow drums to be the intent of the proposed standard, as • No valves were available in 1994
reconditioned and then reused under described in the 1994 preamble, but we that were compatible with chloropicrin
the pesticide container regulations. are adding it to the regulations for and that allow filling and emptying the
EPA agrees with the commenters that clarity. Fifth, the final rule was container through a one-way valve.
applying serial numbers (and some amended to state that this requirement • Installing one-way valves on
other requirements) to refillable does not apply to cylinders that comply thousands of existing cylinders could
containers used for swimming pool with DOT’s Hazardous Materials cause unnecessary worker exposure.
pesticides would disrupt the current Regulations. Sixth, antimicrobial 6. EPA response - chloropicrin. EPA
refillable container system for products used in swimming pools and agrees that the one-way valve/tamper-
evident device requirement could be hypochlorite for swimming pool use clarify that swimming pool products are
problematic for cylinders, such as those prohibitively expensive. All of these exempt from the problematic
used to distribute chloropicrin end-use commenters favored exempting sodium requirements. Currently, EPA is aware
products and propane. The one-way hypochlorite from the pesticide of sodium hypochlorite products that fit
valve/tamper-evident device container rule. the exemption criteria and that are
requirement applies to portable The comments on the supplemental distributed and sold in refillable
pesticide containers for liquid materials, notice were similar. The trade group containers, although the partial
which we envisioned as DOT portable representing all aspects of the exemption was drafted to be general so
tanks, IBCs and the non-bulk refillable swimming pool industry stated that the it would apply to any products that fit
containers designed to hold liquids. As proposal to exempt eligible Toxicity the criteria. See Unit III.D. for a more
explained by the commenter, Category I antimicrobial products used detailed discussion.
chloropicrin is unusual in the sense that in swimming pools from most of the
it is a liquid, but it is shipped and refillable container standards is J. Stationary Pesticide Container
handled essentially like a gas. DOT laudable, but that it does not go far Standards (§ 165.45(f))
classifies chloropicrin as hazard enough. A pool supply company 1. Final regulation. Stationary
division 6.1 (poisonous material). EPA commented that using one-way valves pesticide containers that are designed to
believes that the DOT specifications for and serial numbers on its returnable hold undivided quantities of pesticides
cylinders are extremely detailed and bottles would increase the cost to the equal to or greater than 500 gallons
extensive and we do not want to add point where it could no longer compete (1,890 liters) of liquid pesticide or equal
requirements to them that would in the marketplace. A sodium to or greater than 4,000 pounds (1,818
compromise the safety and protection hypochlorite manufacturer stated that kilograms) of dry pesticide and are
provided by the DOT cylinder the relatively low value of the product located at the refilling establishment of
requirements. Note that cylinders makes the use of one-way valves a refiller operating under written
holding gases would not be subject to unaffordable. This commenter stated contract to a registrant must meet
the one-way valve/tamper-evident that one-way valves for drums cost certain standards. As discussed in Unit
device requirement because they are about $75 container, not including the VI.C., both registrants and refillers are
exempt from the refillable container connectors/adaptors that the applicators responsible for ensuring that these
regulations by § 165.43(h)(2). would need. This manufacturer requirements for stationary pesticide
EPA believes that the chloropicrin identified a one-way valve device that containers are met. First, all of these
cylinders described by the commenter could be added to the refillable jugs for stationary pesticide containers (for
should not have to comply with the one- about $3 per container, which is more liquid and dry pesticides) must be:
way valve/tamper-evident device reasonable, but noted that these devices • Resistant to extreme changes in
requirement. However, rather than could not be produced in large enough temperature,
specifically exempt containers holding quantities to account for all refillable • Constructed of materials that are
chloropicrin, the final regulations take a jugs currently in use. adequately thick and that are resistant to
more general approach and exclude 8. EPA response - sodium corrosion, puncture, or cracking, and
cylinders that comply with the DOT hypochlorite. EPA modified the • Capable of withstanding all
HMR. The more general approach was regulation to exempt antimicrobial operating stresses.
taken because there may be other highly products (that are subject to the As proposed, these requirements do
volatile liquid pesticides that are regulations) used in swimming pools not apply during a civil emergency or
distributed in DOT cylinders that would and closely related sites from this any unanticipated grave natural disaster
face the same difficulties in complying requirement for one-way valves or or other natural phenomenon of an
with this requirement. tamper-evident devices. As stated in the exceptional, inevitable and irresistible
7. Comments - sodium hypochlorite. supplemental notice, EPA acknowledges character, the effects of which could not
In comments on the proposed rule, a that applying some of the refillable have been prevented or avoided by the
registrant group stated that the one-way container standards, including this one, exercise of due care or foresight.
valves identified in their research cost to sodium hypochlorite used in Second, several other standards apply
several times more than the refillable swimming pools would disrupt the only to liquid bulk containers.
containers used to distribute sodium current refillable container system for Specifically,
hypochlorite. According to this these products. This disruption would • They must be equipped with a vent
commenter, the one-way valve costs (in probably cause the refillables to be or other device designed to relieve
1994) ranged from $10 for a 1–gallon replaced by millions of single-use, excess pressure, prevent losses by
container to $45 for a 55–gallon nonrefillable containers, which is evaporation, and exclude precipitation.
container. Another registrant group inconsistent with the goals of pollution • External sight gauges are
identified one-way valves as one aspect prevention and of facilitating the safe prohibited.
of the proposed regulations that would refill and reuse of containers (FIFRA • Each container connection below
make refillable containers economically section 19(e)). Therefore, the 1999 the normal liquid level must be
unfeasible for sodium hypochlorite in supplemental notice described a equipped with a shutoff valve, which is
the swimming pool industry. A trade regulatory option intended to exempt capable of being locked closed.
group representing all aspects of the swimming pool chemicals from some of • Shutoff valves must be located
swimming pool industry explained that the refillable container requirements. within a secondary containment unit (if
sodium hypochlorite is a relatively low Based on comments and further secondary containment is required).
value product that sold for as little as analysis, EPA realized that the products 2. Changes. There were several
$1.00 per gallon in 1994. At the time, for which relief was intended (sodium changes in this section from the
purchasers would pay a deposit of $0.50 hypochlorite) may be hazardous wastes proposed rule. First, the description of
to $1.00 per refillable container. This when disposed and, therefore, would containers that must comply with these
commenter believes that the proposed not be eligible for exemption as requirements was changed to be
regulations would make the refillable described in the supplemental notice. consistent with the quantities for
jugs used to distribute sodium Therefore, the final rule was revised to secondary containment structures
because the definitions of liquid and dry the valve close to the storage vessel, nonrefillable and refillable containers.
bulk containers are not being finalized. saying that field experience has Unit V.J. provides more details on the
Second, the requirement for shutoff demonstrated that valves are subject to process for applying for waivers and
valves on liquid bulk containers was incidental spillage due to factors such as modifications, which is the same for
amended to specify that a shutoff valve: ‘‘pipe chatter.’’ nonrefillable and refillable containers.
(1) Is only required for container 6. EPA response - location of shutoff
connections that are below the normal valve. EPA agrees with the majority of L. Reporting (§ 165.47)
liquid level; and (2) must be located the commenters that shutoff valves 1. Final regulation. This section
within a secondary containment unit, if should be located within a secondary clarifies that the pesticide container
secondary containment is required by containment unit. Therefore, this part of regulations do not require registrants to
subpart E. Third, the text for the shutoff the standard will be amended to specify report to EPA with information about
valve requirement was adjusted to make that the shutoff valve be located within their refillable containers. However, it
it clear that the valves must be capable a secondary containment unit, if refers registrants to the reporting
of being locked closed. Fourth, the secondary containment is required by standards in 40 CFR part 159 to
proposed phrase ‘‘act of God’’ is not subpart E. EPA believes that nearly all, determine if information on container
included in the final rule. The language if not all, stationary pesticide containers failures or other incidents involving
in § 165.45(f)--‘‘any unanticipated grave that are subject to § 165.45(f) will be pesticide containers must be reported to
natural disaster or other natural required to be within a secondary EPA under FIFRA section 6(a)(2).
phenomenon of an exceptional, containment unit by subpart E. 2. Changes. The intent and substance
inevitable and irresistible character, the However, subpart E applies only to of this standard is the same as in the
effects of which could not have been agricultural pesticides, so it is possible proposal. However, the wording was
prevented or avoided by the exercise of that a container holding a changed to clarify that this is simply a
due care or foresight’’--sufficiently nonagricultural pesticide could be reference to the existing 6(a)(2)
describes the kinds of events that would subject to the stationary pesticide standards and that it does not add any
be considered ‘‘acts of God,’’ so that container standards, but not the new requirements.
phrase is not necessary. containment standards.
3. Comments - shutoff valve. Some M. Proposed Standards That Are Not
K. Waivers and Modifications Being Finalized
commenters addressed the need for
(§ 165.45(g) - (h))
requiring shutoff valves and there were Final regulation/changes. The
few common themes among the 1. Final regulation. Section 165.45(g) following requirements relating to
respondents. A few registrants and a of the final rule explains that registrants refillable container design from the
registrant group supported having all may request waivers from or proposed regulation are not being
connections on stationary liquid modifications to some of the refillable finalized in today’s final rule:
pesticide containers (except for vents) container regulations and sets out the • § 165.124(b)(1)(i) - (v) and (vii):
equipped with a lockable valve. A criteria that must be met for EPA to Permanent marking other than serial
container manufacturer group asked to approve a waiver/modification request. numbers
change the language to: ‘‘Each liquid Section 165.45(g) regulations are • § 165.124(b)(2): Compliance with
bulk container connection below the identical to the corresponding portion of DOT’s marking satisfies the
normal liquid level...,’’ stating that the waiver/modification provisions corresponding EPA permanent marking
requiring valves above that level serves regarding the DOT provisions for requirement
no purpose on bulk tanks. nonrefillable containers in § 165.25(g). • § 165.124(c): General minibulk
4. EPA response - shutoff valve. EPA Section 165.45(h) describes the integrity standard
agrees with the container manufacturer procedure for registrants to follow if • § 165.124(d): Drop test for minibulk
group and will amend the final rule so they want to obtain a waiver from or containers (requirement)
the shutoff valve requirement applies to modification to the specified refillable • § 165.125: Minibulk container drop
liquid pesticide container connections container regulations. The procedure in test methodology (test procedure)
below the normal liquid level. Vents § 165.45(h) is identical to the procedure • § 165.128(a) & (b): Keep records of
and other openings on the top of the for obtaining waivers from or container descriptions, minibulk drop
container are above the normal liquid modifications to the nonrefillable test results and the GLP statement
level, so the phrase ‘‘except for vents’’ container regulations in § 165.25(h). specified for the drop test.
is no longer necessary and is not in the 2. Changes, comments and EPA • § 165.126: Certification
final regulation. responses. The proposed rule did not • § 165.128(c): Keep records of the
5. Comments - location of shutoff include any waiver or modification certification.
valve. EPA requested comments on provisions for the refillable container The first six proposed standards are
whether it is necessary to regulate the regulations. The supplemental notice not being finalized in the refillable
location of shutoff valves, and if so, discussed an approach for incorporating container regulations because the
what the location should be. Some a waiver from or modification to the approach of referring to and adopting a
commenters (registrants, registrant referenced and adopted DOT subset of the DOT standards makes
groups, dealer groups, and a State requirements. EPA made several them unnecessary. In particular:
regulatory agency) supported a general changes to the supplemental approach • Some of the items for permanent
guideline that would allow placement of before incorporating the waiver/ marking in proposed § 165.124(b)(1)--
the valve anywhere within the modification provisions into the final the container manufacturer, date of
secondary containment. These regulations. See Unit V.I. (on manufacture, rated capacity, and
commenters believed that fine-tuning nonrefillable containers) for changes, material of construction--are not being
the valve location wouldn’t increase comments and EPA responses regarding finalized because this information is
overall release protection as long as the the waivers from and modifications to required in the DOT standards that
valve was in secondary containment. the pesticide container regulations that specify marking. Two other proposed
Only one commenter, a State regulatory refer to and adopt the DOT pieces of information--the model
agency, stated a preference for locating requirements, which apply to both number and the phrase ‘‘Meets EPA
standards for refillable containers’’--are themselves often enter the pesticide implementing a combination of Option
not being finalized because they are no distribution chain separately, so 1 and Option 3 in the final rule.
longer necessary due to the change to identifying responsibility for 2. Changes. The key change from the
refer to and adopt the DOT regulations. compliance is not as straightforward as proposed rule is that the final
See Unit VI.H. for more detail about the it is for nonrefillables, which the regulations adopt and refer to the DOT
proposed marking requirements. registrants fill at their establishments. standards for container design,
• The statement proposed in In evaluating the options for container construction and marking, as discussed
§ 165.124(b)(2) is not being finalized design responsibility, EPA considered in Unit IV. Therefore, registrants only
because the final rule specifically refers the differences among the options in have to ensure that they use containers
to the DOT marking, so it is no longer terms of seeking the least burdensome that meet the cross-referenced DOT
necessary to include a provision stating approach that is also effective, standards for container integrity,
that compliance with DOT’s marking practicable, and easily enforceable. In construction and testing, rather than
satisfies the corresponding EPA marking the proposal, we identified Option 1 as being responsible for the testing
requirement. our preferred option (as indicated in the themselves. Registrants must also
• The proposed general minibulk proposed regulatory text) because we ensure compliance with the permanent
integrity standard in § 165.124(c) is not thought it was more effective, more marking (serial number) and opening
being finalized because the DOT practicable, and significantly more (one-way valve/tamper-evident device)
regulations address container integrity easily enforceable than the other two requirements. Because containers will
in 49 CFR 173.24. options. The three options are described be identifiable by the UN/DOT marking,
• The proposed drop test requirement below. some of the repackaging standards can
for minibulks in § 165.124(d) and the
• Option 1. Registrants would be be adjusted to be more flexible.
proposed minibulk container drop test Specifically, rather than requiring the
responsible for containers meeting the
in § 165.125 are not being finalized registrants to identify acceptable
design standards. The containers would
because the DOT regulations include a containers by the model numbers and
be marked ‘‘Meets EPA standards for
drop test requirement. The drop test container manufacturers, they will be
refillable pesticide containers’’ and
procedure for nonbulk packagings is able to identify acceptable containers by
registrants would maintain records for
defined in 49 CFR 178.603 and the drop the appropriate level of DOT testing
their containers. The registrants would
test procedure for intermediate bulk (Packing Group I, II or III) and the
develop a list of acceptable containers
containers is defined in 49 CFR 178.810. container materials that are compatible
• The proposed recordkeeping for each product, identified by
manufacturer and model number, and with the product. The general structure
requirements in § 165.128(a) and (b) for of the repackaging standards, though,
container descriptions, drop test results provide the list to refillers. Refillers
could repackage pesticide only in remains as proposed: (1) Registrants are
and a GLP statement for the drop test responsible for developing certain
are not being finalized because they are containers identified on the registrants
list. information and providing it to the
no longer necessary because compliance refillers; (2) refillers have certain
with the DOT requirements can be • Option 2. Anyone could produce
containers, certify to EPA that the responsibilities for inspecting, cleaning,
ensured by the structure and and labeling the container since they are
certification standards in the DOT HMR. containers meet EPA design standards,
and receive permission to mark the ones actually handling the
Because we can rely on the DOT or UN containers; and (3) both registrants and
marking to ensure compliance with the containers with EPA certification seal.
This could be container manufacturers, independent refillers have certain
applicable DOT requirements, EPA no responsibilities if an independent
longer needs to see records of the testing but it could also be registrants, refillers,
or even end users. EPA would compile refiller repackages a registrant’s product.
to confirm compliance with the drop The changes to the repackaging
test (and in the final rule) and other test a list of certified container models.
Registrants and refillers could repackage regulations are discussed in more detail
requirements. in Unit VII.
The final two proposed items listed products only into certified containers.
above--having registrants certify Registrants would develop a list of VII. Repackaging Standards
compliance with the regulations and the acceptable container construction
materials for each product and provide A. Format Changes
associated recordkeeping--are not being
finalized for the same reasons that the the list to refillers, who could refill only Final regulation and changes. In the
nonrefillable container certification and into certified containers made from proposed regulation, the refillable
recordkeeping are not being finalized, as materials identified as acceptable by the container design standards and the
described in Unit V.M. registrant. repackaging requirements were
• Option 3. Container manufacturers included in the same subpart of the
N. Options for Implementing the Rule would be responsible for containers regulations. In the final rule, EPA
1. Final regulations. In the preamble meeting EPA’s design standards and moved the repackaging requirements
to the proposed rule, EPA discussed would mark containers with a into a separate subpart because we think
three options for implementing the certification seal. Container separating the two kinds of
refillable container and repackaging manufacturers would keep records for requirements will make the regulations
standards, which were all in one containers. Registrants would develop a easier to understand. The container
subpart in the proposed rule. These list of acceptable container materials for design requirements are mostly
options covered different approaches for each product and provide the list to technical and apply mostly to
determining who would be held refillers. Registrants and refillers would registrants. The repackaging
responsible for ensuring that the repackage only into containers marked requirements are mostly procedural and
refillable containers meet the refillable with the seal and made of materials apply to registrants and to anyone who
container standards. EPA considered identified as acceptable by the repackages pesticide products into
several options because the pesticide registrant. refillable containers, which could be
products distributed or sold in refillable As discussed in the 1999 registrants, distributors, retailers, or
containers and the containers supplemental notice, EPA is other kinds of companies.
In addition, the repackaging part of your company for repackaging standards. MUPs, plant-incorporated
requirements were reorganized so all of into refillable containers. protectants, and certain antimicrobial
the requirements that apply to a certain • Refiller of a pesticide product and products are completely exempt from
kind of business are listed together. you are not the registrant of the the repackaging requirements. All other
Specifically, the requirements are listed pesticide product. pesticide products are subject to the
for: (1) Registrants who distribute or sell As explained in Units VII.J. and repackaging regulations. This is
pesticide products directly in refillable VII.K., a registrant may repackage a identical to the scope of the refillable
containers; (2) registrants who distribute product directly into refillable
container regulations.
or sell pesticide products to containers for sale or distribution and
independent refillers for repackaging; distribute or sell that same product to an Some of the antimicrobial pesticides
and (3) independent refillers. The term independent refiller for repackaging. In that are subject to the repackaging
‘‘independent refiller’’ is used to this case, the registrant must comply regulations are subject to a reduced set
identify a refiller that is not part of the with both sets of requirements. of regulations. In particular,
registrant’s company. The differences 2. Changes. The same kinds of antimicrobial pesticides that are used in
between these categories are described businesses that were included in the swimming pools and closely related
in more detail below in Unit VII.C. This proposed rule (in § 165.122(a)(1), (2) sites (such as hot tubs, spas and
format requires some standards to be and (3)) are subject to the final rule. One whirlpools) are exempt from certain
repeated. For example, the container minor modification was to clarify that recordkeeping requirements, as well as
inspection requirement applies to refillers in the last two categories are the parts of the standards for inspecting
registrants who distribute or sell refillers that are not part of the and cleaning containers that relate to
pesticide products directly in refillable registrant’s company. Registrants can
serial numbers, one-way valves, and
containers and to independent refillers, also be refillers, which is the situation
tamper-evident devices.
so the inspection requirement is described in the first category; the
repeated. Despite the repetition, EPA registrant conducts all of the packaging 2. Changes. In the proposed rule, only
believes this regulatory structure is and repackaging. Therefore, the changes MUPs were exempt from the
more clear and easier to understand. are intended to clarify that the second repackaging requirements, which were
and third category refer to independent included in the refillable container
B. Purpose (§ 165.60(a)) refillers, i.e., refillers that are not part of regulations (see § 165.122(b)(1)). All
1. Final regulations. The purpose of the registrant’s company. other products would have been subject
the repackaging standards is to establish D. Compliance Dates (§ 165.60(c)) to the standards. The 1999
requirements for repackaging some supplemental notice discussed
pesticide products into refillable 1. Final regulations. The final regulatory options for exempting some
containers for distribution or sale. regulations provide a 5–year period after
products (antimicrobials and non-
2. Changes. This is nearly the same as the date of publication of the final rule
antimicrobials) from the full set of
the proposed purpose (in § 165.120(b)). in the Federal Register before
compliance with the repackaging refillable container regulations
One minor change was to acknowledge
standards is required. Specifically, including the repackaging requirements
the reduced number of products that are
within 5 years from today’s date, all and for exempting certain antimicrobial
subject to the final regulations by stating
that the rule applies only to repackaging products sold in refillable containers products from specific requirements.
some pesticide products. The proposed must be distributed or sold in The criteria in the final rule for
regulations would have applied to all compliance with these regulations. exempting antimicrobials are different
products. Another insignificant 2. Changes. Based on the comments than those discussed in the
modification was to delete the term relating to refillable container design as supplemental notice and the final rule
‘‘standards’’ from the phrase ‘‘establish described in Unit VI.D., EPA decided to exempts plant-incorporated protectants.
standards and requirements’’ because it extend the compliance period for the The final repackaging regulations do not
is redundant. refillable container regulations from the incorporate the toxicity category,
2–year time frame that was proposed in
C. Who Must Comply (§§ 165.60(b), container size or environmental hazard
§ 165.139. The longer time frame is to
165.65(a), 165.67(a), and 165.70(a)) criteria from the supplemental notice.
provide for a smoother and less
burdensome transition for companies. Also, the final rule changes some
1. Final regulation. You must comply
with the repackaging regulations if you Because the repackaging regulations aspects of the supplemental notice
are a: require pesticide product to be approach of subjecting antimicrobial
• Registrant who distributes or sells a repackaged only into containers that swimming pool products to a reduced
pesticide product in refillable meet the refillable container standards, set of requirements.
containers. This means that you conduct the compliance date for these The following table describes the
all of the repackaging for a pesticide regulations needed to be changed for provisions for determining which
product and that you do not distribute consistency. pesticide products are subject to the
or sell your pesticide product to a repackaging regulations and a brief
refiller that is not part of your company E. Pesticide Products Included
(§ 165.63(a) - (g)) explanation of how (or if) this provision
for repackaging into refillable changed from the proposal and/or the
containers. 1. Final regulations. As described in
supplemental notice.
• Registrant who distributes or sells a detail in Unit III., only certain products
pesticide product to a refiller that is not have to comply with the repackaging
TABLE 15.—CHANGES TO THE SCOPE OF THE REPACKAGING REGULATIONS

TABLE 15.—CHANGES TO THE SCOPE OF THE REPACKAGING REGULATIONS—Continued

Plant-incorporated protectants are exempt. Plant-incorporated protectants would have been subject to the proposed rule.
The regulations for plant-incorporated protectants were finalized in 2001.
We are exempting them from the final rule because of their unique nature.
Certain antimicrobial products are exempt. Antimicrobial products would have been subject to the proposed rule. The
final rule implements an approach similar to option 1 in the supplemental
notice, although some of the details are different.
All other products are subject to all of the repackaging require- All products other than manufacturing use products would have been subject
ments, except for certain antimicrobial swimming pool prod- to the proposed rule. The final rule is different than the approach dis-
ucts. cussed in the supplemental notice, which would have exempted products
in Toxicity Category III or IV in small containers and outdoor use products
without the specified environmental hazard statements on their label.
Antimicrobial products used in swimming pools and closely re- Antimicrobial products used in swimming pools would have been subject to
lated sites are subject to a reduced set of repackaging re- the proposed rule. The final rule is the result that was intended in the sup-
quirements. plemental notice, although the specifics of how it is implemented in the
final rule are different than in the supplemental notice.
F. Other Exemptions (§ 165.63(h)) 1. Background. FIFRA section 3(a) individual container.’’ EPA developed
provides in pertinent part that ‘‘no the Policy to accommodate business
1. Final regulations. The repackaging person in any State may distribute or practices of manufacturers and
regulations do not apply to transport sell to any person any pesticide which distributors who handle pesticides in
vehicles that contain pesticide in is not registered under this Act.’’ large undivided quantities rather than in
pesticide-holding tanks that are an Registration is the principal means of small individual containers because of
integral part of the transport vehicle and ensuring that a product is brought under the environmental and logistical
that are the primary containment for the the FIFRA regulatory scheme. The benefits associated with refillable
pesticide or to containers that hold registrant must demonstrate to EPA’s containers.
gaseous pesticides. In addition, the final satisfaction that the product meets the In the Policy, EPA determined that
rule includes a statement that clearly statutory criteria for registration with repackaging of bulk pesticides could
exempts custom blending from the respect to composition, labeling, and the occur without a separate registration if
repackaging requirements. lack of unreasonable adverse effects. certain conditions were met that would
2. Changes. The exemption for The registrant must take responsibility assure that the purposes of registration
transport vehicles is identical to the for quality control of the product’s would be satisfied. The conditions are
exemption proposed in § 165.122(b)(2) composition and for adequate labeling that repackaging of the registered bulk
and the exemption included in the final describing the product, its hazards, and pesticides could involve nothing more
refillable container regulations. The its uses. Repackaging a pesticide than changing the product container;
exemption for custom blending was not produces a new pesticide product that i.e., no change in: (1) The pesticide
included in the proposed regulatory must be registered before it can be formulation, (2) the pesticide’s labeling
text. It is discussed in Unit VII.L. In distributed or sold. except to add an appropriate statement
addition, the final rule includes a Before a pesticide product that is not of net contents and a registered
specific exemption for gaseous included within the terms of an existing establishment number, and (3) the
pesticides, which is necessary to registration enters the channels of trade, identity of the party accountable for the
implement our intent from the proposal a separate registration must be obtained. product’s integrity.
because the final rule does not use the Changes in the formulation of a The Policy elaborated on the
proposed terms liquid minibulk, dry registered product, changes in accepted accountability requirement and set out
minibulk, liquid bulk and dry bulk labeling, as well as any repackaging of that the pesticide had to be: (1)
containers, which would have excluded a pesticide into another container transferred at an establishment owned
gaseous pesticides. activate the registration requirement, by the registrant; or (2) transferred at a
G. Legal Basis for Repackaging Pesticide unless the purposes of product registered establishment operated by a
Products for Distribution or Sale registration would be fully met by person under contract with the
carrying forward the Federal registration registrant; or (3) transferred at a
Before continuing with a section-by- of the constituent product. registered establishment owned by a
section analysis of the regulations, EPA In 1977, EPA issued an enforcement party not under contract to the product
believes it is necessary to address three policy for bulk shipments of pesticides. registrant, but who had been furnished
broad issues regarding repackaging (Ref. 75) The policy describes certain written authorization for use of the
pesticide products into refillable conditions in which EPA allows the product label by the registrant. The
containers: (1) The legal basis for transfer and repackaging of bulk requirement for written authorization
repackaging pesticide products (and the pesticides to occur without requiring assures that the registrant remains
related Bulk Pesticides Enforcement registration of the repackaged responsible for quality control of the
Policy); (2) the integrity and purity of pesticides. The 1977 Bulk Pesticides product’s composition and adequate
products sold or distributed in refillable Enforcement Policy (the Policy) defined labeling describing the product, its
containers; and (3) whether pesticides ‘‘bulk’’ for the purposes of the Policy as hazards, and its uses.
can be repackaged at locations other ‘‘any volume of pesticide greater than 55 The 1977 Policy only addressed the
than registered establishments. gallons or 100 pounds held in an transfer of a volume of pesticide greater
than 55 gallons or 100 pounds held in 2. Final regulations. The regulations authorization’’ with the refiller is not
an individual container. In March 1991, implementing the legal basis for being finalized for several reasons. First,
the Policy was amended (Ref. 71) to repackaging are similar to the provisions EPA believes it is not necessary to have
allow repackaging of any quantity of in the proposed rule with two two different mechanisms. It is more
pesticides into refillable containers, significant changes, described in the straightforward to specify one method,
provided that all three conditions below next section, and some minor formatting which should facilitate compliance and
are met: modifications. Specifically, §§ 165.67(b) minimize confusion. Second, EPA
(1) The container is designed and and 165.70(b) specify that a registrant believes that a ‘‘written contract’’ is
constructed to accommodate the return may allow a refiller to repackage a more familiar to the regulated
and refill of greater than 55 gallons of pesticide product into refillable community and more defined in law
liquid or 100 pounds of dry material. containers and to distribute or sell such than a ‘‘written authorization,’’ which is
(2) Either: (a) The containers are repackaged product under the existing why we chose to specify contracts as the
dedicated to and refilled with one registration if all of the following mechanism for establishing a
specific active ingredient in a conditions are satisfied: repackaging relationship between the
compatible formulation; or (b) the • The repackaging results in no registrant and refiller in the final rule.
container is thoroughly cleaned change to the pesticide formulation. Third, in the years since the Bulk
according to written instructions • One of the following conditions Pesticides Enforcement Policy was
provided by the registrant to the dealer regarding a registered refilling issued, the ‘‘written authorizations’’
prior to introducing another chemical establishment is satisfied: have become virtually indistinguishable
into the container, in order to avoid (1) The pesticide product is from ‘‘written contracts’’ in format,
cross-contamination. repackaged at a refilling establishment length and level of detail. Therefore,
(3) All other conditions of the July 11, registered with EPA as required by EPA anticipates that specifying a
1977 Policy are met. § 167.20 of this chapter. contract (and not an authorization) in
(2) The pesticide product is the final rule should not cause a
As discussed in the preamble of the
repackaged at the site of a user who substantial impact to the way
proposed rule, EPA is replacing the
intends to use or apply the product by repackaging is currently being
Bulk Pesticides Enforcement Policy
a refilling establishment registered with conducted, particularly considering the
with these regulations, specifically
EPA as required by § 167.20. 5–year implementation period for the
§§ 165.67(b) - (c) and 165.70(b) - (c). • The registrant has entered into a
These regulations provide that a refillable container and repackaging
written contract with the refiller to regulations. The other modifications
registrant may allow an independent repackage the pesticide product and to
refiller to repackage the registrant’s were minor formatting changes that
use the label of the pesticide product. were needed to accommodate: (1) the
pesticide product into any size refillable • The pesticide product is repackaged revision to plain language; (2) needing
container and to distribute or sell such only into refillable containers that meet to include the conditions in the
repackaged product under the the standards of subpart C. requirements for registrants who
registrant’s registration (i.e., the • The pesticide product is labeled distribute or sell to independent refillers
product’s EPA registration number stays with the product’s label with no and in the requirements for independent
the same), provided all conditions set changes except the addition of an refillers; and (3) clarifying that the EPA
out in the rule are met. appropriate net contents statement and establishment number added to the
These regulations do not change the the refiller’s EPA establishment number. label is the refiller’s EPA establishment
existing law; the Bulk Pesticides In addition, the regulations number.
Enforcement Policy would be replaced (§§ 165.67(c) and 165.70(c)) state that 4. Comments - implementation. One
by a regulation. The registrant remains repackaging a pesticide product for registrant urged EPA not to eliminate
responsible for the integrity, labeling, distribution or sale without either the ability of manufacturers and
and packaging of the repackaged obtaining a registration or meeting all of distributors that are not registrants of an
product. Both the registrant and the conditions listed above is a violation MUP to repackage that product for
independent refiller may be held liable of section 12 of FIFRA. Both the distribution and sale.
for violations pertaining to the registrant of the product and the refiller 5. EPA response - implementation. In
repackaged product. The repackaging that is repackaging the pesticide product the preamble to the proposed
regulations set out the requirements for under contract to the registrant may be regulations, EPA stated that the Bulk
both registrants and independent liable for violations pertaining to the Pesticides Enforcement Policy would
refillers, because they have different repackaged product. remain in effect until the date specified
roles and responsibilities in distributing 3. Changes. One significant change to for compliance with the refillable
pesticide products in refillable these conditions for repackaging container and repackaging regulations,
containers. pesticide products for distribution or at which point it would be rescinded.
The conditions set out in §§ 165.67(b) sale is to add the specification that the EPA will implement this as discussed in
- (c) and 165.70(b) - (c) do not apply to pesticide product can be repackaged by the preamble to the proposal. The
registrants repackaging their own a registered refilling establishment at refillable container and repackaging
pesticide products solely at their own the site of a user who intends to use or regulations will supersede the Bulk
establishments. As described in apply the product as an acceptable Policy for products that are subject to
Pesticide Registration (PR) Notice 98–10 alternative to the condition that the these regulations. Pesticide products
‘‘Notifications, Non-notifications and product must be repackaged at a that are exempt from the refillable
Minor Formulation Amendments,’’ the registered refilling establishment. This container and repackaging regulations--
registrant generally can modify the change is discussed in detail in Unit MUPs, plant-incorporated protectants,
package size and label net contents VII.I. below. Another change is that the and some antimicrobials--can only be
statement without notifying EPA. (Ref. final rule specifies that the registrant repackaged under the limitations
56) This would be an amendment to the must enter into a written contract with established by FIFRA, the registration
registration not requiring EPA the refiller. The proposed option for the requirements in 40 CFR part 152, and
notification or approval. registrant to enter into a ‘‘written the applicable OPP policies. A key
limitation is that the products that are pesticide product is not adulterated or contaminants that are generally
exempt from the refillable container and different from the composition considered to be toxicologically
repackaging regulations must be described in its confidential statement significant (and therefore must be
repackaged by the registrant or a person of formula that is required under FIFRA reported and accepted as part of product
under written contract to the registrant. section 3. This requirement reflects registration according to 40 CFR
EPA believes this constraint will not be current law. Under FIFRA section 158.167). The concentrations are
a problem for MUPs and exempt 12(a)(1), it is unlawful for any person to defined according to the type of
antimicrobials because we have distribute or sell to any person a pesticide that is contaminated
received information that these products pesticide which is adulterated or whose (insecticide, herbicide, low dose
are repackaged by the registrants if they composition differs from the herbicide, etc.) and the pesticide
are sold or distributed in refillable composition described in its category of the contaminant. While PR
containers. In addition, refillable confidential statement of formula. Notice 96–8 applies to all pesticide
containers are not appropriate for FIFRA Section 12(a)(1) applies to products in nonrefillable and refillable
distributing plant-incorporated pesticide distributed or sold in containers, a driving force in developing
protectants, so these products will also nonrefillable containers and in refillable the policy was the cross-contamination
not be adversely affected. containers. For pesticides distributed or found in refillable containers in the
One issue that has been raised is sold in nonrefillable containers, it is early 1990’s.
whether registrants and independent clear that the registrants are responsible 2. Final regulations. The repackaging
refillers can comply with the regulations for product integrity because there are regulations clearly hold all parties
(and specifically the conditions for no other parties involved (except for subject to the repackaging standards to
repackaging pesticide products for supplemental registrants, as regulated be responsible for product integrity.
distribution or sale) before the by 40 CFR 152.132, and parties acting as This includes:
compliance date. This is appealing to agents under contract to the registrant). (1) Registrants who distribute or sell
registrants and independent refillers Similarly, when a registrant repackages a pesticide product in refillable
because the regulations allow pesticides a product directly into a refillable containers (in § 165.65(b));
to be repackaged under written container for distribution or sale, it is (2) Registrants who distribute or sell
contracts into refillable containers of also clear that the registrant is pesticide products to independent
any size (compared to the 55 gallon responsible for product integrity. refillers for repackaging into refillable
container size limit established in the The situation is less clear when a containers (in § 165.67(e)); and
Bulk Policy and maintained in the 1991 registrant distributes or sells a product (3) Refillers of a pesticide product that
amendment). EPA believes that it is to an independent refiller for are not the registrants of the pesticide
acceptable for registrants and repackaging into refillable containers. product (in § 165.70(d)).
independent refillers to repackage Both the registrants and the Specifically, all of these businesses
pesticide products under the regulations independent refillers are selling or are responsible for the pesticide product
before the 5 year compliance date as distributing the product, so both parties that they distribute or sell not being
long as they are in full compliance with are responsible for product integrity. adulterated or different from the
the refillable container and repackaging The registrant is responsible because the composition described in the product’s
regulations. In other words, registrants registrant has authorized the confidential statement of formula that is
can enter into contracts with independent refiller to repackage the required under FIFRA section 3.
independent refillers to refill containers registrant’s pesticide product and to use 3. Changes. The language in the final
only if: (1) The containers comply with the registrant’s label according to the regulation is nearly identical to the text
the refillable container regulations, i.e., terms of the written contract (or in the proposed regulation. One slight
they meet the specified DOT standards, authorization under the Bulk Policy). modification is that the phrase
have a durable serial number or other The registrant remains accountable for ‘‘described in its confidential statement
identifying code, and have one-way its repackaged product which is of formula that is required under FIFRA
valves and/or tamper-evident devices; distributed or sold in the refillable section 3’’ is used in the final
(2) the registrant meets the repackaging container. EPA believes it is appropriate regulations because it is more
conditions and develops and provides for registrants to be held responsible for straightforward than the proposed
the necessary information, including a acts by independent refillers because phrase ‘‘described in the statement
description of acceptable containers and the repackaging is being done under the required in connection with registration
a cleaning procedure; (3) the refillers registrant’s registration and the under section 3 of the Act.’’ EPA
meet the repackaging conditions and independent refillers are agents of the considers these two phrases to mean
comply with the operational registrants for purposes of carrying out exactly the same thing.
procedures, including inspecting, the written contract. The independent However, one thing that has changed
cleaning (if necessary), and labeling the refiller is responsible for product since the proposed rule is EPA’s policy
containers; and (4) all other integrity because the refiller is the on toxicologically significant levels of
requirements specified in the refillable person who physically places the pesticide active ingredients. PR Notice
container and repackaging regulations product into the container for sale or 96–8 defines risk-based concentration
are followed. distribution. levels of contaminants that are generally
In 1996, EPA established a policy on considered to be toxicologically
H. Product Integrity ‘‘Toxicologically Significant Levels of significant. Active ingredient
1. Background. The Bulk Pesticides Pesticide Active Ingredients’’ in PR contaminants that are present at lower
Enforcement Policy and both the Notice 96–8. (Ref. 58) This document concentrations do not have to be
proposed and final rules hold the describes EPA’s interpretation of the reported by registrants and accepted by
registrant and the refiller (if different term ‘‘toxicologically significant’’ as it EPA as part of product registration. For
than the registrant) responsible for applies to contaminants in pesticide example, if an herbicide active
product integrity of the pesticide products that are also active ingredients. ingredient is detected at less than 1,000
product repackaged by the refiller. The policy provides risk-based ppm in any pesticide where the
‘‘Product integrity’’ means that the concentration levels of such contaminant is accepted for use on all
sites for which the product is labeled, Under the bulk pesticide repackaging into stationary bulk containers protected
the herbicide active ingredient is not policy, a registrant may deliver pesticides by a secondary containment structure at
considered to be toxicologically directly to a farm, even if the farm is not end user sites.
registered as a pesticide producing 2. Final Regulation. One of the
significant. As described in PR Notice establishment. Someone other than the
96–8, the purpose of this policy is to: (1) registrant could not deliver pesticides in bulk
requirements specified in §§ 165.67(b)
Recognize that cross-contamination is a to a farm unless the farm was registered as and 165.70(b) for when a registrant may
reality, and that not all cross- a pesticide producing establishment and that allow a refiller to repackage its pesticide
contamination is problematic; (2) set a person has received written authorization product into refillable containers and to
clear standard that can be readily from the registrant to deliver the pesticide to distribute or sell such repackaged
applied by EPA, States and the the specific farm. The registrant of the product under the existing registration
establishment (i.e., the farmer) would also be is:
regulated industry; (3) ensure that
required to submit annual production One of the following conditions
allowable cross-contamination does not reports. Please note that some States and
pose unreasonable adverse effects; (4) regarding a registered refilling
most registrants require containment
minimize the paperwork burden for structures for the storage of bulk pesticides. establishment is satisfied:
EPA and registrants; (5) maintain Most farmers do not have these containment (1) The pesticide product is
accountability for the product from the structures and delivery to these farms may repackaged at a refilling establishment
registrant to the end user; and (6) not not be allowed under State law. registered with EPA as required by
preclude marketplace or private § 167.20.
After discussion and debate on this (2) The pesticide product is
solutions to correct problems that do question among the regulated repackaged at the site of a user who
arise. community and regulatory agencies, intends to use or apply the product by
I. Delivery and Repackaging at End User EPA reconsidered and revised our a refilling establishment registered with
Locations position in a memo titled ‘‘Bulk EPA as required by § 167.20.
Pesticide Transfers’’ dated March 22, 3. Changes. The first condition listed
1. Background. The 1977 Bulk Policy 1995. (Ref. 59) The new question 18
(Ref. 75) provided the following two above (Unit I.2.(1)) (the product is
supersedes the question in the 1994 repackaged at a registered refilling
examples of acceptable practices for Bulk Policy Question & Answer establishment) is the same as the
shipping ‘‘bulk’’ pesticides to end users: document and is:
• A registrant ships a bulk pesticide proposed regulation. The second
18(a). May a registrant deliver pesticides in condition--the product is repackaged at
directly to an end user (custom bulk directly to a farm, even if the farm is not
applicator, farmer, etc.). The label the site of a user who intends to use or
registered as a producing establishment? May
accompanies the shipment and is placed someone other than the registrant do this?
apply the product by a registered
on the user’s tank. No new A registrant, dealer, or other authorized refilling establishment--was added to
establishment or product registration is person pursuant to the ‘‘Enforcement Policy the final rule to be consistent with
Applicable to Bulk Shipments of Pesticides’’ EPA’s revised policy as described in the
needed for the bulk container since the
(July 11, 1977) may transfer pesticides in March 22, 1995 ‘‘Bulk Pesticide
labeled product is fully registered and bulk at a farm, even if the farm is not Transfers’’ memo. The final regulation is
has been sold intact to the user. registered as a pesticide producing
• A tank car of pesticide from which consistent with EPA’s 1995 position that
establishment. final accountability for meeting the
commercial applicators meter off into 18(b). May a registrant deliver pesticides in
their own tanks, without being put into bulk directly to end use sites other than a
terms of the Bulk Policy remains with
a dealer’s holding tank, would be farm, even if such site is not registered as a the registrant and the last establishment
exempt from new producer producing establishment? May someone making a transfer associated with a
establishment registration. It is other than the registrant do this? pesticide sale (an independent refiller in
considered that the original container
Yes. See answer to question 18(a) above. this case), because the pesticide that is
However, the Agency will continue to pursue transferred at the farm or other end use
has not been changed in delivery to the enforcement actions against all end users that
applicator and the tank car label site is not being transferred and held for
use any registered pesticide in a manner further sale.
(placard) will bear the producer’s inconsistent with its labeling pursuant to
EPA has received anecdotal evidence
establishment number. FIFRA 12(a)(2)(G).
that the practice of refilling containers
In the preamble to the 1994 proposed
The March 22, 1995 memo explained (bulk containers, minibulks, application
rule, EPA stated that repackaging by the
that this revision was made because end tanks, nurse tanks, etc.) at end user sites
registrant must be done at a registered
users are not the persons repackaging has increased over the past few years
establishment, as required by 40 CFR
shipments of bulk pesticides at the farm and may continue to increase in the
part 167. In addition, EPA stated that we
and other end use sites. The memo future. Therefore, EPA is concerned
saw no reason to continue the
further stated that the terms and about the potential for spills, leaks and
exemption from the registered
conditions of the 1977 Bulk Policy and other releases during transfers at end
establishment requirement described in
1991 amendment are unchanged. Since user sites to cause soil and water
the second bullet in Unit I.1., above. We
the pesticide that is transferred at the contamination. As described in the
requested comments on the effect of
farm or other end use site is not being preamble to the proposed rule, EPA
discontinuing this exception.
On February 3, 1994, EPA released transferred and held for further sale, decided to require containment
the ‘‘Bulk Pesticide Repackaging final accountability for meeting the structures at dealers, commercial
Question & Answer Document’’ (Ref. 63) terms of the Bulk Policy remains with applicators and custom blenders with
which included the following question the registrant and the last establishment bulk storage tanks, largely because these
and answer that address the issue of making a transfer associated with a were the kinds of sites where
making a bulk delivery directly to an pesticide sale, the dealer. Registrant and contamination had been documented.
end user. dealer establishments are responsible EPA did not and still does not have
18. May a registrant deliver pesticides in for reporting repackaging as production documentation of end user site
bulk directly to a farm, even if the farm is not pursuant to 40 CFR 167.85. In the contamination due to repackaging
registered as a producing establishment? May memo, EPA recommended (but did not pesticide product. Therefore, the final
someone other than the registrant do this? require) that pesticides be transferred pesticide container and containment
regulations do not require repackaging containers were included in the pesticide products to independent
at end user sites to be done within a proposed regulation. Some of the refillers for repackaging are the two that
containment structure. However, EPA requirements were modified based on establish standards for the timing of
strongly recommends that repackaging comments and the change to refer to and when the registrant provides documents
at end user sites be conducted over adopt some of the DOT standards. The to the refiller. Under § 165.67(d), the
some kind of containment--whether it is specific changes to these requirements registrant must provide the written
a permanent concrete containment pad are discussed in other sections of Unit contract to repackage the product before
or a portable containment structure. In VII. selling or distributing the product to the
the future, EPA may revise the refiller. Section 165.67(g) specifies that
K. Registrants Who Distribute or Sell
repackaging regulations to require all the other information (cleaning
Pesticide Products to Refillers for
repackaging (including at end user sites) procedure, description of acceptable
Repackaging - Overview (§ 165.67)
to occur over a containment structure if containers, and label/labeling) can be
we become aware of a pattern of end 1. Final Regulation. The regulations in provided earlier but must be provided to
user site contamination being caused by § 165.67 apply to registrants who the refiller at the time of sale or
repackaging. distribute or sell pesticide products to distribution at the latest. These two
refillers that are not part of their provisions are identical to the proposed
J. Registrants Who Distribute or Sell companies for repackaging into regulations.
Pesticide Products in Refillable refillable containers. This is the more 2. Changes. All of these requirements
Containers - Overview (§ 165.65) common form of repackaging, where the for registrants who distribute or sell
1. Final Regulation. The regulations in registrant ships in bulk to a refiller pesticide products to refillers for
§ 165.65 apply to registrants who (normally a retailer) who repackages the repackaging were included in the
distribute or sell pesticide products in product into portable pesticide proposed regulation. Some of the
refillable containers. This means that containers. requirements were modified based on
the registrant conducts all of the As mentioned above, a registrant may comments, modifications to some EPA
repackaging for the product and does repackage a product directly into policies, and the change to refer to and
not distribute or sell the product to a refillable containers for sale or adopt some of the DOT standards. The
refiller that is not part of its company distribution and distribute or sell that specific changes to these requirements
for refilling. same product to an independent refiller are discussed in other sections of Unit
Of course, a registrant may repackage for repackaging. In this case, the VII.
a product directly into refillable registrant must comply with both sets of
containers for sale or distribution and requirements: the standards in § 165.65 L. Refillers Who Are Not Registrants -
distribute or sell that same product to an for those quantities the registrant Overview (§ 165.70)
independent refiller for repackaging. In distributes or sells directly in refillable 1. Final Regulation. The regulations in
this case, the registrant must comply containers and the requirements in § 165.70 apply to refillers who are not
with both sets of requirements: the § 165.67 for those quantities that the registrants of the products that they
standards in § 165.65 for those registrant distributes or sells to repackage for sale or distribution.
quantities the registrant distributes or independent refillers for repackaging. A refiller who repackages a product
sells directly in refillable containers and A registrant who distributes or sells a for distribution or sale and is not the
the requirements in § 165.67 for those pesticide product to an independent registrant of the product:
quantities that the registrant distributes refiller for repackaging: • Must comply with the conditions
or sells to independent refillers for • Must comply with the conditions for allowing him to repackage the
repackaging. for allowing a refiller to repackage his registrant’s product, as discussed in
A registrant who distributes or sells a product, as discussed in Unit VII.G.; Unit VII.G.;
pesticide product directly in refillable • Must provide the refiller with the
• Is responsible for the integrity of the
containers: written contract to repackage before
product, as discussed in Unit VII.H.;
• Is responsible for the integrity of the distributing or selling the product to the
product, as discussed in Unit VII.H.; refiller; • Must comply with the requirements
• Must develop a refilling residue • Is responsible for the integrity of the for refillers (including having certain
removal procedure, as discussed in Unit product, as discussed in Unit VII.H.; information and inspecting, cleaning,
VII.M.; • Must develop a refilling residue and labeling the refillable containers), as
• Must develop a description of removal procedure, as discussed in Unit discussed in Unit VII.O. through VII.R.;
acceptable containers, as discussed in VII.M.; • Must keep records, including copies
Unit VII.N.; • Must develop a description of of the contract from the registrant,
• Must comply with the requirements acceptable containers, as discussed in refilling residue removal procedure, and
for refillers (including having certain Unit VII.N.; description of acceptable containers,
information and inspecting, cleaning, • Must provide the refilling residue and certain information about each
and labeling the refillable containers), as removal procedure, description of instance of repackaging. The
discussed in Unit VII.O. through VII.R.; acceptable containers, and the product’s recordkeeping requirements are
• Must keep records, including copies label and labeling to the refiller before discussed in Unit VII.S.
of the refilling residue removal or at the time of distribution or sale to 2. Changes. All of these requirements
procedure and the description of the refiller; for independent refillers were included
acceptable containers and certain • Must keep records of the contracts, in the proposed regulation. Some of the
information about each instance of the refilling residue removal procedure, requirements were modified based on
repackaging. The recordkeeping and the description of acceptable comments, modifications to some EPA
requirements are discussed in Unit containers. The recordkeeping policies, and the change to refer to and
VII.S. requirements are discussed in Unit adopt some of the DOT standards. The
2. Changes. All of these requirements VII.S. specific changes to these requirements
for registrants who distribute or sell The requirements that are specific to are discussed in other sections of Unit
pesticide products directly in refillable registrants who distribute or sell VII.
3. Comments - whether or not to portable service containers from the the practice of custom blending rather
include custom blending in this rule. In bulk container to supply the dealer’s than the establishment at which it takes
the preamble to the proposed rule, EPA custom application operation in the place. The § 167.3 definition focuses on
discussed whether or not the field; and (3) loaded into tanks that are the establishment, because the part 167
requirements for independent refillers an integral part of application or nurse regulations then exempt custom
should apply to custom blenders, who vehicles for field nursing or to supply blenders from the requirements to
provide the service of mixing pesticides injection systems. register their establishments (in
with fertilizer, feed, or another pesticide 4. EPA response - whether or not to § 167.20(a)(1)) and to report production
to a customer’s specification. The include custom blending in this rule. In (in § 167.85(a)). The § 167.3 definition of
preamble provided two options for the the final rule, EPA decided to exempt custom blender includes a sixth
final rule: (1) Issue a regulation on custom blending from having to comply condition--that no other pesticide
refilling practices that is tailored with the repackaging requirements. As production activity is performed at the
specifically to custom blenders that stated by several of the commenters, establishment--because these other
distribute pesticide mixtures, or (2) EPA determined that there is an activities would subject a custom
exempt custom blenders from the inherent difference between custom blender to the establishment registration
repackaging requirements. EPA blending and repackaging pesticide and production reporting requirements.
requested comments on these options. products for sale or distribution. When However, this sixth condition is not
A few commenters showed lukewarm a product is repackaged for sale or relevant to the pesticide product
support for applying the repackaging distribution, it must maintain the repackaging requirements in 40 CFR
regulations to custom blenders. A characteristics of the product and meet part 165 subpart D because the subpart
registrant was unaware of pressing the ingredient contents identified on the D regulations are tied to the process or
reasons to exclude custom blenders and label and in the product’s registration. action of repackaging. As reported by
pointed out that custom blenders are On the other hand, a custom blend several commenters, a facility may
usually custom applicators. A State intentionally mixes a pesticide with conduct several different activities,
regulatory agency stated that custom another substance. While the product’s including repackaging pesticide
blenders should be required to meet the labeling must be consistent with the products into refillable containers and
refilling requirements if the criteria custom blend (i.e., the labeling custom blending. In this case, the
apply to them. This commenter also directions do not prohibit the use of the repackaging must be conducted in
pointed out that custom blends are product in such a blend) and the accordance with the regulations in this
generally placed into a spreader, not a product’s label must be delivered to the subpart, while the custom blending is
container. end-user, the material in the custom exempt from the regulations in this
A registrant group stated that custom blend is no longer just the pesticide subpart.
blenders provide valuable service in product identified on the label. In fact, It is worth noting that the
reducing pesticide container use and the custom blender must deliver a containment regulations in subpart E
applicator exposure. This respondent statement specifying the composition of apply to some custom blenders,
recommended developing standards the mixture. specifically ‘‘custom blenders of
that are specific to custom blenders and The exemption for custom blending agricultural pesticides.’’
that address items such as container was added to § 165.63(h) of the final 5. Comments - mixing diluent with
integrity and cleaning procedures. regulation, which asks ‘‘Are there any pesticides. Several commenters (dealer
A registrant distinguished between other exceptions?’’ Paragraph (h) in groups and a dealer) urged EPA to allow
custom blending and selling a pesticide § 165.63 was added to state that custom water as a blend component. One
product in a refillable container with a blending is exempt from the regulations retailer described the awkwardness of
registrant’s label on it as two different in this subpart. In addition, § 165.3 of the situation when such mixing is not
activities. A few dealer groups strongly the regulations define custom blending permitted — a dealer can put pesticide
urged EPA to exclude custom as ‘‘Custom blending means the service in a farmer’s application equipment at
applicators from the refiller of mixing pesticides to a customer’s its facility (with a containment pad), but
requirements. The retailer-related specifications, usually a pesticide(s)- the farmer has to return to his own
commenters believe it is inappropriate fertilizer(s), pesticide-pesticide, or a location to add water and finish
to address custom blenders in a section pesticide-animal feed mixture, when: preparing the application mixture. The
that focuses on maintaining the original (1) The blend is prepared to the order two dealer groups suggested or stated
integrity of repackaged pesticides. They of the customer and is not held in that using water as a custom blend
also described current custom blending inventory by the blender; component is currently practiced in the
practices in the Midwest, including the (2) The blend is to be used on the Midwest. The two dealer groups also
following points: customer’s property (including leased or recommended deleting condition #6 in
• Midwest dealers with bulk rented property); the § 167.3 definition of custom blender
pesticides are mostly all custom (3) The pesticide(s) used in the blend which specifies that ‘‘no other pesticide
blenders and custom applicators and bears end-use labeling directions which production activity is performed at the
have become repackagers recently. do not prohibit use of the product in establishment.’’
• It is common for the volume of bulk such a blend; 6. EPA response - mixing diluent with
pesticides that goes into custom blends (4) The blend is prepared from pesticides. EPA disagrees with the
to exceed the volume that is repackaged registered pesticides; and comment to delete condition #6 in the
into refillable containers. (5) The blend is delivered to the end- § 167.3 definition of custom blender that
• Custom blends may be loaded into user along with a copy of the end-use specifies ‘‘no other pesticide production
custom application and nurse vehicles labeling of each pesticide used in the activity is performed at the
of that dealer, another for-hire custom blend and a statement specifying the establishment.’’ As described above, this
applicator, or a customer. composition of the mixture.’’ condition is intended to distinguish
• On the other hand, registered bulk This description is based on the between custom blenders - who are
pesticides are: (1) Repackaged into definition of ‘‘custom blender’’ in 40 exempt from the part 167 establishment
minibulk containers; (2) moved in CFR 167.3, but was modified to reflect registration requirements - and
producing establishments, who are pesticide, or a pesticide-animal feed number of nonrefillable containers used,
required to register their establishments. mixture, when: keeping pesticides separate from water
Condition #6 does not prevent a facility (1) The blend is prepared to the order or fertilizers during transportation,
from conducting custom blending and of the customer and is not held in accommodating on-board injection
repackaging (producing). These facilities inventory by the blender; systems and allowing the applicator to
must register as establishments because (2) The blend is to be used on the adjust pesticides in the field. These
they are producing establishments. customer’s property (including leased or commenters urged EPA and industry to
Instead, condition #6 is intended to rented property); consider providing for the expanded use
describe the facilities that are exempt (3) The pesticide(s) used in the blend of service containers, with some
from the establishment registration bears end-use labeling directions which exclusions from the refillable container
requirements, i.e., facilities that custom do not prohibit use of the product in requirements, to increase the use of bulk
blend and do not repackage or otherwise such a blend; pesticides. A State regulatory agency
produce pesticides. (4) The blend is prepared from supported keeping the Bulk Policy
However, EPA considered the request registered pesticides; and because they don’t want to register each
from commenters to allow custom (5) The blend is delivered to the end- facility where bulk pesticides are
blends to be diluted with water. Various user along with a copy of the end-use metered, such as where pest control
offices and Regions within EPA, as well labeling of each pesticide used in the operators place pesticides into service
as the States, have not had a consistent blend and a statement specifying the containers.start here
policy about whether custom blends can composition of the mixture.’’ 8. EPA response - service containers.
be diluted with water or another EPA will monitor the practices and The pesticide container and repackaging
diluent. After reviewing this issue, it is procedures that develop and proliferate regulations do not regulate service
appropriate to clarify our position on in the field with this interpretation. If containers, because the container and
diluting custom blends. EPA believes problems develop, EPA will consider repackaging regulations only apply to
that the definition of custom blender in options, including revising its containers that are used to sell or
§ 167.3 provides flexibility. Custom interpretation, adding protective distribute pesticide products and to the
blenders are defined as ‘‘any conditions if diluents are added to repackaging of products for sale or
establishment which provides the custom blends, and subjecting custom distribution. For the purposes of this
service of mixing pesticides to a blending to the repackaging discussion, a service container is
customer’s specifications, usually a requirements in part 165. defined as ‘‘any container used to hold,
pesticide(s)-fertilizer(s), pesticide- In addition, EPA does not view a store, or transport a pesticide
pesticide, or a pesticide-animal feed difference between custom blending and concentrate or a pesticide use-dilution
mixture, when’’ the six conditions custom mixing from a regulatory point mixture, other than the original labeled
described above are met. In particular, of view. A custom mixer is a facility that container in which the product was
the word ‘‘usually’’ in this definition stores materials previously purchased distributed or sold, the measuring
provides flexibility and allows water (or by end-users and that custom mixes the device, or the application device.’’
other diluents when specified by the products just prior to application. A EPA does not currently regulate
labeling of the pesticide[s] in the blend) custom mixer does not own, sell or service containers. In 1976, EPA issued
to be added to custom blends. apply the product, although the a Pesticide Enforcement Policy
EPA believes that the language of conditions in the § 165.3 definition of Statement (PEPS) on ‘‘Structural Pest
§ 167.3 allows custom blends to be custom blending are met. Over the Control: Use and Labeling of Service
diluted with water or a diluent specified years, there have been different Containers for the Transportation or
on the labels of all pesticides in the interpretations of whether or not there Temporary Storage of Pesticides,’’
blend. In many ways, it is more efficient is a difference between custom blending which defined minimal labeling
and possibly more accurate for the and custom mixing. At least a few requirements and several other
facility that is measuring and blending businesses have been established as limitations for the acceptable use of
pesticides, fertilizers and/or animal feed custom mixers under the determination service containers by structural pest
to also measure and blend the diluent that they are not custom blenders. This control operators. (Ref. 76) However,
into the custom blend. In addition, final rule does not distinguish between this PEPS was later rescinded. EPA
custom blends (with diluents) that are custom blenders and custom mixers. continues to believe that it is a good
delivered to an end user as a use- Similarly, the policy of allowing management practice to ensure that the
dilution (usually in refillable diluents to be added to custom blends contents of service containers are
containers) offer worker exposure and applies to both custom blenders and identified and that the label of a
environmental protection benefits custom mixers. As discussed above, pesticide product that is in a service
including eliminating the need for end custom blending is excluded from the container is available to the person
users to mix, handle and potentially subpart D repackaging requirements. handling and/or applying the pesticide.
spill the pesticide in the field; However, custom blenders (including EPA may consider developing a separate
eliminating the need for the end user to custom mixers) would be subject to the policy on service containers while the
rinse containers in the field; allowing subpart E containment standards if they pesticide container and containment
the use of closed systems; and reducing blend (mix) agricultural pesticides. regulations are being phased in.
the number of nonrefillable containers 7. Comments - service containers. A
that must be disposed or recycled. few dealer groups noted that the M. Registrant Refilling Residue Removal
However, EPA wants to clarify that proposed rule does not address service Procedure (§ 165.65(c)(1) and
custom blends with a diluent added still containers, which are used to move 165.67(f)(1))
must comply with all five conditions in pesticides from bulk storage to end-use 1. Final Regulation. Registrants who
the definition of custom blend in applications in the field, e.g., the tanks sell or distribute pesticide products
§ 165.3: ‘‘Custom blending means the that are an integral part of application directly in refillable containers and
service of mixing pesticides to a or nurse vehicles. These commenters registrants who sell or distribute
customer’s specifications, usually a pointed out some advantages of service products to independent refillers for
pesticide(s)-fertilizer(s), pesticide- containers including: reducing the repackaging must develop a refilling
residue removal procedure that N. Registrant Description of Acceptable citing specific model numbers, the
describes how to remove pesticide Containers (§§ 165.65(c)(2) and registrants can provide refillers with a
residue from a refillable container 165.67(f)(2)) much less prescriptive approach by
(portable or stationary pesticide 1. Final regulation. Registrants who identifying characteristics, such as the
container) before it is refilled. sell or distribute pesticide products material of construction, how to
Registrants must specify a cleaning directly in refillable containers and determine if the container meets the
procedure for each product sold or registrants who sell or distribute applicable DOT standards, how to
distributed in refillable containers, products to independent refillers for comply with the serial number
although the same procedure can be repackaging must develop a description requirement, how to obtain and apply
used for multiple products. The refilling of acceptable refillable containers one-way valves and/or tamper-evident
residue removal procedure must (portable and stationary pesticide devices to the openings of portable
containers) that can be used for pesticide containers for liquids and
provide instructions for removing
distributing or selling that pesticide information for complying with the
residues from all refillable containers.
product. An acceptable container is one stationary pesticide container standards.
The same procedure can apply to 3. Comments. Several commenters
portable and stationary pesticide which the registrant has determined
(registrants and a registrant group)
containers, or the registrant can describe meets the refillable container standards
recommended that instead of a list of
different procedures if it is appropriate in subpart C and is compatible with the
acceptable containers, the registrants
and necessary. Finally, the refilling pesticide formulation intended to be
should identify acceptable containers by
residue removal procedure describes distributed and sold using the refillable
providing the compatible materials of
how to remove residue from a refillable container. The registrant must identify
construction and the necessary
container. While this generally involves the containers by specifying: (1) The
information to apply the DOT standards.
container materials of construction that
rinsing the container with water, the The registrant group and a distributor
are compatible with the pesticide
regulations do not specifically require commented that this requirement will
formulation; and (2) information
rinsing with water. If a different be helpful to ensure that formulators
necessary to confirm compliance with
procedure is appropriate for a given and subregistrants know and obtain
the refillable container requirements in
formulation, it can be used as long as it information about the proper packaging.
subpart C. The refillable container 4. EPA response. In the final rule, EPA
meets the following performance requirements include the adopted DOT
standard. changed the requirement for identifying
standards, being marked with a serial acceptable containers so registrants can
The refilling residue removal number or other identifying code, describe acceptable containers by
procedure must meet the performance having a one-way valve or tamper- specifying compatible materials of
standard of being adequate to ensure evident device on each opening (other construction and the information
that the composition of the pesticide than a vent) of a portable pesticide necessary to comply with the refillable
product does not differ at the time of its container designed for liquids, and the container requirements. This includes
distribution or sale from the stationary pesticide container information for complying with the
composition described in its requirements. adopted DOT standards, but also the
confidential statement of formula. This Similar to the refilling residue
other requirements in subpart C.
standard ensures that the products removal procedure, registrants must
specify a description of acceptable O. Requirements for All Refillers
distributed and sold in refillable
containers for each product sold or (§§ 165.65(d) and 165.70(e))
containers meet the existing product
distributed in refillable containers, 1. Final regulation. All refillers,
integrity requirements, as described in
although the same description can be including those at registrant’s facilities
Unit VII.H. used for multiple products if it meets and those who are not part of a
The refilling residue removal the standards. registrant’s company must comply with
procedure must describe how to manage 2. Changes. This requirement was the following provisions regarding
any rinsate resulting from the procedure changed significantly from the proposed repackaging a pesticide product into
in accordance with applicable Federal rule. The proposal would have required refillable containers:
and State regulations if: (1) The registrants to develop lists (not *(1) The establishment must be
procedure requires the use of a solvent descriptions) of acceptable containers, registered with EPA as a producing
other than the diluent used for applying which would have been identified by establishment as required by § 167.20 of
the pesticide, or (2) there is no diluent specifying the container manufacturer this chapter.
used for application. This information is and model number of the container. *(2) The refiller must not change the
necessary to help refillers manage This was proposed because registrants pesticide formulation unless he has a
rinsate that cannot easily be used as are responsible for ensuring that the registration for the new formulation.
make-up water in future applications. refillable containers used to sell and (3) The refiller must repackage a
distribute their products meet the pesticide product only into a refillable
2. Changes. This requirement is the requirements in the container container that is identified on the
same as it was in the proposed rule. regulations. When EPA proposed the description of acceptable containers for
Several minor editing change have been rule, specifying the container that pesticide product.
made to improve the clarity and the manufacturer and model number (4) The refiller may repackage any
different refillable containers are seemed like a relatively easy way for quantity of a pesticide product into a
described as portable and stationary registrants to identify acceptable refillable container up to the rated
pesticide containers because the containers for their refillers. capacity of the container. In addition,
definitions of minibulk and bulk are not However, the final rule’s approach of there are no general limits on the size
being finalized. These modifications referring to and adopting some DOT of the refillable containers that can be
have not changed the requirement or requirements provides an even easier used.
intent of the requirement. way for registrants to identify acceptable (5) The refiller must have all of the
containers to the refillers. Rather than following items at the establishment
before repackaging a pesticide product or reinforce key requirements in existing Specific modifications made to the
into any refillable container for regulations, including 40 CFR parts 156, inspecting, cleaning, labeling and
distribution or sale: 167 and 169 or incorporate existing recordkeeping requirements and
*(A) The written contract from the standards of the Bulk Policy (having a comments on these standards are
pesticide product’s registrant. copy of the registrant’s contract). These discussed in detail in Units VII.P. -
[Subparagraph A applies only to provisions are included here for the VII.S.
independent refillers.] sake of completeness and as a reference The refillable container regulations
*(B) The pesticide product’s label and for refillers. were modified to clarify that both
labeling. In other words, the new provisions for registrants and refillers are responsible
(C) The written refilling residue refillers are that each refiller: for complying with the stationary
removal procedure for the pesticide • Must repackage a product only into pesticide container requirements in
product. a container identified on the registrant’s § 165.45(f). The final repackaging rule
(D) The written description of description of acceptable containers; includes this provision in the list of
acceptable containers for the pesticide • May repackage any quantity of a requirements as a reminder for
product. product into a refillable container (up to independent refillers.
(6) Before repackaging a pesticide its rated capacity) and there are no
product into any refillable container for P. Inspecting Refillable Containers
general limits on the size of the
distribution or sale, the refiller must (§§ 165.65(e)and 165.70(f))
refillable containers;
identify the pesticide product • Must have certain documents before 1. Final regulation. Before
previously contained in the refillable repackaging; repackaging pesticide products into
container to determine whether a • Must identify the product refillable containers, refillers must
residue removal procedure must be previously in the container by its label; visually inspect the exterior and (if
conducted in accordance with the • Must inspect and, if necessary, possible) the interior of the container
cleaning requirements described in Unit clean the container; and and the exterior of appurtenances. The
VII.Q. The refiller may identify the • Must maintain certain records. purpose of the inspection is to
previous pesticide product by referring EPA believes that these provisions are determine whether the container meets
to the label or labeling. good management practices that are the necessary criteria with respect to
(7) The refiller must inspect each intended to ensure product and continued container integrity, required
refillable container as discussed in Unit container integrity. The second markings and openings (tamper-evident
VII.P. provision actually removes a condition devices or one-way valves). As with the
(8) The refiller must clean each on container size from the bulk policy. proposed regulations, inspecting the
refillable container, if required, as In other words, it provides more containers is the responsibility of the
discussed in Unit VII.Q. flexibility to registrants and refillers refillers, since they are the ones who are
*(9) The refiller must ensure that each than currently exists. actually handling and refilling the
refillable container is properly labeled 2. Changes. Regarding the list of containers. If any of the failure
as discussed in Unit VII.R. requirements for refillers, the final conditions in this section are observed
(10) The refiller’s establishment must regulations are very similar to the during the inspection, the container
maintain records, as discussed in Unit proposed rule. However, the structure cannot be refilled unless the problems
VII.S. and order of the final rule was revised are rectified and the associated
*(11) The refiller’s establishment to list these requirements in one section. acceptability criterion (either
must maintain records as required by 40 EPA believes this makes the regulations reconditioning according to DOT’s
CFR part 169. more clear, which should facilitate requirements or coming into compliance
*(12) The refiller’s establishment compliance. The items that refer to with the refillable container standards
must report as required by 40 CFR part existing requirements in 40 CFR parts in subpart C) is satisfied.
167. 167 and 169 were added to the list to The container fails the inspection and
(13) Stationary pesticide containers provide a more complete reference for must not be refilled (unless the
(that meet the specified size criteria) at refillers. However, these statements applicable DOT standards for
the establishments of independent simply refer to existing requirements; reconditioning are met) if the integrity
refillers must meet the standards in they don’t add new ones. of the container is compromised in any
§ 165.45(f). [Paragraph 13 is only Adjustments were made to a few of of the following ways:
included in the regulations in the provisions. Specifically, the • The container shows signs of
§ 165.70(e) for independent refillers. requirements in the proposed rule that rupture or other damage which reduces
The refillable container regulations state referred to the registrant’s list of its structural integrity. [Based on the
that both the registrant and independent acceptable containers were changed to criterion in 49 CFR 173.28(a)]
refillers are responsible for complying refer to the registrant’s description of • The container has visible pitting,
with the stationary pesticide container acceptable containers (see items 3 and 5 significant reduction in material
requirements.] above), to accommodate the changes thickness, metal fatigue, damaged
(14) Refillers may be required to described in Unit VII.N. Also, the threads or closures, or other significant
comply with the containment standards proposed regulatory text did not defects. [Based on the criterion in 49
in subpart E. [Paragraph 14 applies only explicitly allow any size refillable CFR 173.28(c)(1)(iii)]
to independent refillers.] container to be used, although the • The container has cracks, warpage,
These requirements, except for items preamble discussed removing the size corrosion or any other damage which
5(A), 13 and 14 which apply only to limit in the Bulk Policy in some detail. might render it unsafe for
independent refillers, apply to any Therefore, a sentence clarifying that transportation. [Based on the criterion
refiller that repackages a product subject there are no general limits for the size in 49 CFR 180.352(b)(2)(iii)]
to the regulations regardless of the main of refillable containers was added to the • There is damage to the fittings,
business of the refiller (registrant, statement allowing any quantity of valves, tamper-evident devices or other
retailer, etc.). Some of these conditions pesticide (up to the container’s rated appurtenances that may cause failure of
(indicated by an asterisk) simply refer to capacity) to be repackaged. (See item 4.) the container. [Similar to the criterion in
49 CFR 180.352(b)(2)(ii) for service was written so that refillers of these multiple active ingredients to be
equipment.] products are not subject to the failure cleaned even when it was refilled with
If either of the following conditions criteria that address serial numbers, that product. This is true because the
exists (or both), the container fails the one-way valves, or tamper-evident proposed rule, based on the 1991
inspection and must not be refilled until devices. amendment to the Bulk Policy, specified
the container meets the refillable a product with a single active ingredient
standards specified in subpart C. The Q. Cleaning Refillable Containers
in a compatible formulation as an
conditions are: (§§ 165.65(f) - (g) and 165.70(g) - (h))
acceptable condition for refilling
• The container does not bear the 1. Final regulation. Refillers must without cleaning. EPA corrected this
markings required by subpart C or such clean refillable containers by oversight in the final rule, because
markings are not legible. conducting the pesticide product’s refilling with the same product
• The container does not have an refilling residue removal procedure (regardless of how many active
intact and functioning one-way valve or before repackaging the product into the ingredients there are) is certainly the
tamper-evident device on each opening refillable container, unless condition #1 most clear way to ensure product
other than a vent, if required. and either condition #2 or #3 are integrity and should be allowed
Note that these two conditions are satisfied: (assuming any tamper-evident devices
written so refillers of antimicrobial (1) Each tamper-evident device and and one-way valves are intact).
products used in swimming pools and one-way valve is intact (if required). Several other minor changes include:
related sites would not have to inspect (2) The refillable container is being (1) Changing the first condition so it
for a serial number (because it’s not a refilled with the same pesticide product. includes one-way valves and not just
marking required by subpart C for these (3) Both of the following conditions tamper-evident devices like in the
products) or for an intact and are satisfied. proposal;
functioning one-way valve or tamper- (A) The container previously held a (2) Adding ‘‘if required’’ to the first
evident device on each opening, pesticide product with a single active condition, since one-way valves or
because neither is required for these ingredient and is being used to tamper-evident devices are only
products. repackage a pesticide product with the required on portable pesticide
2. Changes. The general obligation to same single active ingredient. containers for liquids and are not
inspect refillable containers before (B) There is no change that would required on the containers of
repackaging pesticide products into cause the composition of the product antimicrobial products used in
them is the same as the proposed rule. being repackaged to differ from the swimming pools;
However, EPA made several changes to composition described in its (3) Using the phrase ‘‘described in its
the details of the inspection. First, we confidential statement of formula that is confidential statement of formula that is
based the conditions for failing the required under FIFRA section 3. required under FIFRA section 3’’
inspection on conditions specified in Examples of unallowable changes because it is more straightforward than
the DOT regulations in 49 CFR 173.28 include the active ingredient the proposed phrase as described in
and 180.352(b)(2). A commenter concentration increasing or decreasing Unit VII.H.;
suggested this change and EPA believes beyond the limits established by the (4) The condition in criterion 3(B) was
it is an appropriate modification and is confidential statement of formula or a modified to be more general to account
consistent with other changes in the reaction or interaction between the for situations other than reactions or
regulation to refer to and adopt the DOT pesticide product being repackaged and interactions between the two products
standards for container design, the residue remaining in the container. such as very different active ingredient
construction and marking. While we If a tamper-evident device or one-way concentrations that could cause the
don’t think the criteria in the final rule valve is not intact, the refiller must repackaged product to differ from the
are necessarily more stringent than clean the container according to the confidential statement of formula; and
those in the proposed rule, we believe product’s refilling residue removal (5) Splitting the situation of a broken
that consistency with DOT is beneficial. procedure. In addition, the final tamper-evident device or one-way valve
Second, the inspection requirement was regulations state in § 165.65(g) for into a separate paragraph for clarity.
modified to clarify that if problems registrants who refill and in § 165.70(h)
found during the inspection are fixed for independent refillers that other R. Labeling Refillable Containers
and certain criteria are met, the procedures may be necessary in this (§§ 165.65(h) and 165.70(i))
container can be refilled. Under the case to assure that product integrity is 1. Final regulation. Before distributing
proposed standard, it was not clear that maintained. or selling a pesticide product in
a container could be reconditioned or The first condition is written so it refillable containers, refillers must
brought into compliance with the would not apply to refillers of ensure that the label of the product is
refillable container standards and then antimicrobial products used in securely attached to the refillable
refilled. Several other minor swimming pools because neither a one- containers such that the label can
modifications were made to account for way valve or tamper-evident device is reasonably be expected to remain
changes in the regulations, including: required. affixed during the foreseeable
(1) removing the reference to a standard 2. Changes. The biggest change from conditions and period of use. The label
for the age of the container and (2) the proposed regulations is adding the and labeling must comply in all respects
clarifying that vents do not need to have condition where the container is being with the requirements of 40 CFR part
one-way valves or tamper-evident refilled with the same pesticide product 156. In particular, refillers must ensure
devices. Because the refillable container as a case for not needing to clean the that the net contents statement and EPA
regulations in subpart C exempt container. Some commenters pointed establishment number appear on the
antimicrobial products used in out that the conditions in the proposed label. This part of the regulations simply
swimming pools and related sites from regulation and the 1991 amendment to re-states requirements from 40 CFR part
the serial number requirement and the the Bulk Pesticides Enforcement Policy 156 and FIFRA for clarity.
standard requiring a one-way valve or (Ref. 71) would require a refillable 2. Changes. The major change to the
tamper-evident device, the final rule container holding a product with labeling requirement was to change it
from an ‘‘active’’ standard (i.e., the refilled automatically at a rate of 100– repackaging records (listed in the last
refiller must securely attach the label) to 120 bottles per minute. three rows of Table 16) must be
a ‘‘passive’’ standard (i.e., the refiller S. Recordkeeping (§§ 165.65(i), generated each time a product is
must ensure that the label is securely 165.67(h), 165.70(j)) repackaged into a refillable container for
attached). Also, the regulatory text was distribution or sale and must be
modified to state that the net contents 1. Final regulation. All of the maintained for at least 3 years after the
companies subject to the repackaging
and EPA establishment number appear date of repackaging. All of the records
standards must keep certain records,
on the label (rather than the new label are product-specific. In other words,
although the specific records vary
as proposed). Both of these changes according to who the company is and this information must be kept for each
account for situations where the label is what it does. These records must be product distributed or sold in refillable
embossed on the container or the furnished and made available for containers. The same cleaning
container already has an intact label that inspection and copying upon request of procedure or description of containers
meets all the requirements. For EPA or our designee, such as a State or can be used for different products, but
example, a commenter said that 1– Tribe. Informational records (listed in there must be a record documenting a
gallon refillable containers for the the first few rows of Table 16) must be procedure and a description for each
swimming pool market are embossed maintained for the current operating product distributed or sold in
with label information because they are year and for 3 years after that. The refillables.
TABLE 16.—RECORDKEEPING REQUIREMENTS IN THE REPACKAGING REGULATIONS

Registrants who d/s directly in refillables1 Registrants who d/s to Refillers who aren’t registrants
refillers for repack-
Product-Specific Record aging into refillables 1
Swim pool prod- Swim pool prod- All other prod-
All other products
ucts2 ucts2 ucts
All products
Informational Records
Contract to repackage No No Yes Yes Yes
Refilling residue removal pro- Yes Yes Yes Yes Yes

cedure
Description of acceptable Yes Yes Yes Yes Yes

containers
Repackaging Records
EPA registration number of No Yes No No Yes

the product distributed or
sold in the container
Date of the repackaging No Yes No No Yes
Serial number of the con- No Yes No No Yes

tainer
1 ‘‘d/s’’=
distributed or sold.
2 Swim pool products = antimicrobial products used in swimming pools and closely related sites, that are subject to the pesticide container-re-
lated regulations.
EPA reminds registrants and refillers categories of businesses is the same in • Refillers that repackage
that the records identified in the final rule as in the proposal, antimicrobial products used only in
§§ 165.65(i), 165.6(h) and 165.70(j) of although the list of acceptable swimming pools or closely related sites
the repackaging regulations do not containers was changed to the would not have to comply with the
change other recordkeeping description of acceptable containers. repackaging recordkeeping. However,
requirements that currently apply to these refillers would have to comply
• The repackaging records in the final
them, such as restricted use product with the informational recordkeeping.
rule are a subset of what was included
records or applicable records required
in 40 CFR parts 167 and 169. in the proposed rule. The final • The proposed regulations would
regulations do not include the name or have required refillers to maintain
2. Changes. EPA made the following quantity of the product, the name and certain records of containers that were
significant changes in the recordkeeping
address of the consignee, a record that received by them to be refilled,
requirements in the final regulations:
the refiller has inspected the container including the name and address of the
• The informational records must be (and the results), and a record of person providing the container, its serial
kept for the current operating year and whether a refilling residue removal number, the date it was received and the
for 3 years after that rather than the
procedure was conducted (and, if not, name and EPA registration number of
proposed time period of as long as the

why not). Additionally, the date of the the product that was last distributed or
pesticide product is distributed or sold
distribution or sale (in the proposal) was sold in the refillable container. These
in refillable containers and for 3 years
thereafter. The specific informational changed to the date of the repackaging records are not being finalized in
records kept by each of the three in the final rule. today’s final regulations.
3. Comments - refiller records. Many 5. Comments - sodium hypochlorite. • § 165.134(f): Age of plastic liquid
commenters (registrants, registrant Several respondents from the sodium minibulk containers; and
groups, State regulatory agencies, a hypochlorite industry commented on • § 165.136(b): Records on the return
dealer, a dealer group, and an the proposed rule and stated that the of refillable containers to refillers.
equipment manufacturer) opposed the refiller recordkeeping requirements The proposed rule would have
recordkeeping requirements for refillers. would be especially burdensome for this prohibited a refiller from repackaging a
Most of these respondents commented market. One registrant group described product into a plastic liquid minibulk
that the proposed recordkeeping a typical sodium hypochlorite delivery, container more than 6 years after the
requirements were too burdensome and where a truck holding up to 4,000, 1– container’s date of manufacture. EPA
several stated that these standards will gallon refillable containers stops at decided not to finalize this provision to
discourage the use of refillable several locations, delivers various be consistent with the DOT regulations,
containers. A registrant group volumes of product, and picks up empty which do not establish a life limit for
recommended requiring refillers to containers. This commenter estimated plastic nonbulk containers (which may
maintain records of the serial number, all the recordkeeping standards could be portable pesticide containers under
the amount of product placed in the triple the time for deliveries and our regulations) or for plastic
container and the date the refilling took increase the cost of the product by 100 intermediate bulk containers (which
place. percent. An association representing also may be portable pesticide
4. EPA response - refiller records. EPA many businesses involved with containers under our regulations).
modified the refiller recordkeeping swimming pools commented that the As discussed in Unit VII.S., EPA is
requirements to minimize the requirement for individual serial not finalizing the requirement for
paperwork burden of maintaining these numbers and the recordkeeping refillers to keep records on the return of
records. However, EPA believes that requirements attendant to the serial refillable containers to minimize the
some records are necessary to ensure number marking would be completely burden on refillers. Also, this
safe repackaging and compliance with unworkable for refillable pool chemical information would have been of limited
these requirements. First, the refiller containers. These respondents and a use because it would not have been
must have the informational records, swimming pool supply company stated sufficient to conclusively identify where
including the registrant’s contract (if that the recordkeeping would a container had been and who had had
applicable), the refilling residue discourage the use of refillables in the possession of it.
removal procedure and the description pool chemical industry.
of acceptable containers. These records When commenting on the VIII. Containment
are necessary so the refiller has the supplemental notice, the registrant A. Introduction
information needed to properly group representing the sodium
repackage a product into refillable hypochlorite industry reiterated its 1. Regulatory background. In 1994,
containers and to ensure that an estimate of the increase in time and EPA proposed standards in subpart H of
independent refiller has the proper costs that could be attributed to the 40 CFR part 165 for containment of large
approval from a registrant to repackage proposed recordkeeping. In addition, a pesticide containers and procedures for
the product. sodium hypochlorite manufacturer container refilling operations. Standards
Second, certain information about requested EPA to exempt all refillable for pesticide containers, including large
when a product is repackaged into a plastic containers of sodium storage containers, are covered in Units
refillable container is needed in case hypochlorite from the requirements for III. through VII. of this notice, and apply
there is a problem with a product sold serial numbers, one-way valves, tamper- to all pesticides unless specifically
in refillable containers, i.e., it is evident devices and burdensome exempted. The requirements for a
adulterated or contaminated or it causes recordkeeping that would negatively secondary containment unit (either a
damage to the site after application. impact the currently used refillable containment structure around a
However, EPA pared the repackaging container system. stationary container, or a containment
records down to the minimum amount 6. EPA response - sodium pad under a container refilling
of information that would allow the hypochlorite. EPA was persuaded by the operation) only apply to agricultural
refiller and investigators to identify the arguments from the companies who pesticides. The requirements are
product, the container, and the date of repackage sodium hypochlorite into intended to protect human health and
the repackaging. All of this information refillable containers for use in the environment from contamination by
is readily available at the time the swimming pools. Because of the huge spills and leaks which may occur during
pesticide product is repackaged into the number of small (1– and 2.5–gallon) container filling or when a stationary
refillable container, unlike in the refillable containers used in this market container fails. Affected facilities are
proposed rule where the information segment, EPA acknowledges that required to have structures which
also included the name and address of compliance with this recordkeeping intercept and contain spills and leaks of
the person receiving the container. EPA would be burdensome. Therefore, the agricultural pesticides in areas where
deleted the requirement to record the final rule exempts refillers of stationary containers are stored and
results of the inspection and whether antimicrobials used in swimming pools agricultural containers are refilled or
the container was cleaned because these and similar sites from the repackaging cleaned.
records would probably not be useful in recordkeeping, although they must Secondary containment means a
enforcement cases. We will be able to comply with the informational structure, such as rigid diking, berms or
determine that a container was not recordkeeping. walls, designed to intercept and contain
inspected if a container in poor leaks and spills from the enclosed
condition (that did not just sustain T. Proposed Standards That Are Not containers. Some States define bulk
Being Finalized
recent damage) is found and, similarly, quantities as a pesticide container with

we’ll be able to tell if a container was Final regulation/changes. The a volume exceeding 55 gallons; others
not properly cleaned if we find high following proposed requirements use 210, 300, or 500 gallon criteria.
levels of contamination in the product relating to repackaging are not being EPA’s proposed definition of bulk
in that refillable container. finalized in today’s final rule: quantities was 3,000 liters (793 gallons)
for liquid pesticides and 2,000 critical in the proposed rule, but, as a environmental protection, a mechanism
kilograms (4,409 pounds) for dry result of comments we received on is being provided to accommodate
pesticides. The final rule establishes hydraulic conductivity, are not being States that are already successfully
quantities of 500 gallons (1,890 liters) finalized in the final rule (see implementing pesticide containment
for liquids and 4,000 pounds (1,818 discussion in VIII.H). programs.
kilograms) as the threshold for requiring Many respondents provided 4. Key terms for understanding the
secondary containment. Thus, EPA’s comments on specific provisions of the requirements of subpart E. The
regulations cover only relatively large containment regulations. EPA has made following terms, defined in § 165.3 of
containers which pose the greatest risk certain revisions to the proposed subpart A, are key to understanding the
of catastrophic contamination in case of regulations based on these comments. containment standards in subpart E:
failure. The following units of the preamble (1) Agricultural pesticide.
EPA believes the Federal containment discuss the comments received on each (2) Appurtenances.
standards, together with requirements of the major issues raised in the (3) Container.
for container design and residue proposed rule, any differences between (4) Containment pad.
removal, are essential for ensuring the the proposal and the final rule, and the (5) Containment structure.
safe use, reuse and refill of containers as Agency’s reasons for making the (6) Dry pesticide.
required by FIFRA section 19. The changes. (7) Establishment.
regulations promulgated today will be Costs and benefits of the rule have (8) Facility.
located in 40 CFR part 165 in § §165.80 been revised from those projected at the (9) Owner.
- 165.97. time of the proposed rule. Total costs (10) Operator.
2. Summary of proposed and final are predicted to be less than estimated (11) Pesticide compatible.
containment standards. The proposed in the proposal, due to the changes (12) Pesticide dispensing area.
and final standards include criteria for made as a result of comments and new (13) Refillable container.
design, maintenance and operation of information. (14) Refilling establishment.
containment structures (units and pads) 3. State secondary containment (15) Rinsate.
at certain facilities. The design criteria regulations. At least 19 States have (16) Secondary containment unit.
include standards for material of already promulgated and begun (17) Stationary pesticide container.
construction, capacity, and protection implementing their own secondary (18) Transport vehicle.
from stormwater and precipitation. The containment regulations for bulk storage (19) Washwater.
facilities subject to the requirements are of pesticides. The 1992 State of the i. Changes. Based on commenters’
agricultural pesticide refilling States Report (Pesticide Storage, suggestions and additional research, the
establishments and custom blenders (as Disposal and Transportation, Ref. 70) definitions of the following terms were
defined in § 167.3), and facilities of cited in the proposed rule showed the added to the final rule to clarify the
businesses that apply agricultural wide variety of containment regulations requirements: facility, pesticide
pesticides for compensation (also among States. There are variations in compatible, and rinsate.
referred to as for-hire applicators in this the facilities affected, the container ii. Comments. A regulatory agency in
preamble). In the preamble to the volume triggering the requirement for a State with many bulk containment
proposal, the Agency explained its secondary containment, etc. The facilities commented that the definition
rationale for choosing these facilities. economic assessment for the proposed of a stationary bulk container uses the
Although spills can occur throughout rule estimated the number of facilities words ‘‘facility’’ and ‘‘establishment,’’
the chain of pesticide commerce (from with bulk pesticide storage in each State but only defines the latter. The State
manufacturer to user), the accumulated based on commercial, State and agency advised that those trying to
evidence points to agrichemical government business census data. EPA avoid the costly container and
dealerships, custom blenders, and for- estimated that a total of 5,214 containment requirements might choose
hire applicators as facilities where agrichemical dealers in all States and to view this as a legal loophole, and that
pesticide contamination of soil and the District of Columbia have containers the term facility should also be defined.
water is most frequently documented. of a size defined in the proposed rule as Several State agencies requested that
(See 59 FR 6750 (Ref. 66) and Unit bulk (greater than 3,000 liters liquid or EPA clarify the phrase ‘‘resistant to
VIII.C. for a detailed discussion.) The 2,000 kilograms dry). (Ref. 21) EPA has pesticide,’’ because its meaning could
agricultural chemical distribution reviewed the secondary containment be either compatible or unreactive and
system has the most potential for spills regulations in all 19 States and has could be difficult or burdensome to
and a requirement for reporting spills, found that they are generally enforce. Alternatives were proposed,
and is uniquely characterized by the use comparable to or more stringent than including ‘‘chemically compatible,’’
of large tanks and container refilling the requirements in today’s final rule. defined as the ability of the containment
operations, often outdoors, while other These 19 States contain 81 percent structure materials to withstand
sectors generally use smaller containers, (4,220) of the agrichemical facilities anticipated exposure to stored or
pre-packaged indoors by a regulated by this final rule. transferred materials without losing the
manufacturer. EPA received many comments on the ability to provide the required
Standards which are considered negative impact of the proposed secondary containment of the same or
critical are required for all existing and regulations on facilities in States with other materials within the containment
new containment units and pads, and preexisting regulations. Today’s area.
some additional criteria are imposed for containment standards are intended to Several State regulatory agencies
new containment structures. For this introduce basic safeguards in States that commented that their regulations
final rule, the criteria identified as currently lack containment regulations require containment of rinsate, and
critical reflect the comments received and to harmonize with containment recommend containment for wash
and new information, and are not requirements in States where adequate waters, because hazardous waste
necessarily the same criteria used in the containment safety programs already violations at pesticide facilities are often
proposed rule. For example, hydraulic exist. While EPA believes a national linked to problems with rinsate/wash
conductivity criteria were considered standard must provide baseline waters. One State agency asked if a 300–
gallon spill mixed with 600 gallons of apply to agricultural pesticides. (See increased environmental incidents. The
cleanup water can be considered Unit VII.L. for a discussion of custom association also stated that at least 58
rinsate. Another State agency has an blending and custom mixing.) Also, a percent of U.S. farmland is not farmed
expanded definition of rinsate to description of ‘‘principal business is by the landowner, countering the belief
include recovered sedimentation, retail sale’’ — more than 50% of total that farmers are better stewards because
washwater, contaminated precipitation, annual revenue comes from retail they have a vested interest in protecting
or other contaminated debris. operations — was added to the final their farmland from contamination.
iii. EPA response. The word facility regulation for clarity. They commented that retailers are
has been added to the list of definitions. 3. Comments. Many commenters professionals trained in handling
The Agency agrees that the phrase (dealer groups, dealers, State regulatory hazardous materials compared to end
pesticide compatible is clearer than agencies, and a distributor/registrant) users, who tend to have less knowledge
pesticide resistant and has changed the responding to both the 1994 proposal and training in safety, containment, and
regulation accordingly. For the purpose and the 2004 reopening of the comment cleanup procedures. A dealer stated that
of this regulation, rinsate is being period argued for a level playing field some farmers have become tool shed
defined as the liquid (usually water) and urged EPA to expand the scope of dealers who store bulk without
used to rinse the interior of any the containment standards to include containment and repackage for
equipment or container that has come in manufacturing plants, distributors, neighboring farmers. This point was
direct contact with any pesticide. The farms, and non-agricultural facilities. reinforced by retailers during a meeting
Agency agrees that it is a good Commenters argued that there are in 2004 following the reopening of the
management practice to place rinsate similar potential risks of environmental comment period (Ref. 31), where the
tanks within containment and is contamination at any facility that meets dealer associations and individual
recommending that practice, but does the volume, time or activity criteria, dealers reiterated their submitted
not have information on the risks of regardless of the location of the facility written comments and cited a growing
storage of such dilute pesticides. or the type of pesticide, Many problem of cash and carry dealers who
commenters (State regulatory agencies, a repackage product on farms illegally
B. Purpose (§ 165.80(a)) dealer, a dealer group, an aerial without a license.
1. Final regulations. The purpose of applicator and an aerial applicator Several commenters opposed
the containment standards is to protect group) stated that there are some farms expanding the scope to include farmers.
people and the environment from which store and handle more pesticides In 2004, the Farm Bureau and associated
exposure to agricultural pesticides from than some small retailers, and that the grower groups opposed any change in
spills and leaks, and to reduce wastes regulations should focus on the activity the proposed scope. A registrant group
produced during pesticide storage, and/or the quantity stored, not the recommended that EPA work jointly
handling or refilling of pesticide individual storing it.
with State pesticide regulatory officials
containers. Commenters to the 2004 Federal
2. Changes. This is the same as the and industry to devise a method for
Register Notice reopening the comment
proposed purpose in § 165.140. period stated that there have been obtaining reliable data on the number of
changes in pesticide use patterns in the farmers storing bulk nationwide. The
C. Who Must Comply (§ 165.80(b)) Association of American Pest Control
11 years since the regulations were
1. Final regulations. You must comply proposed. They stated that equipment Officials recommended that EPA not
with these regulations if you are the technology developments in the expand the scope to farmers without
owner or operator of a facility that stores handling and application of bulk first researching the number, volumes
pesticides in a stationary pesticide agricultural chemicals have advanced and other pertinent data regarding on-
container or conducts any of the dramatically, and that these new farm bulk practices, an assessment of
regulated pesticide transferring technologies coupled with the increase the risks of on-farm operations, and an
activities and if you are a retailer, for- in the number of farms with large analysis of the costs and benefits of on-
hire applicator, or custom blender (as acreage have led to end users becoming farm bulk containment.
defined in 40 CFR 167.3) of agricultural a dramatic growth sector of purchasers Several commenters specifically
pesticides. of commercial application equipment. A supported requiring non-agricultural
2. Changes. This is the same approach dealer association stated it had surveyed pesticides stored in bulk to be subject to
and scope that we proposed in chemical equipment dealers in Kansas the rule. They state that bulk pesticide
§ 165.141. The proposed regulations and that 20 to 25 percent of all new storage presents potential hazards
included only retailers, for-hire large commercial application rigs and regardless of use or activity, and that
applicators, and custom blenders 80 percent of all used application risk may be even higher due to greater
because they are the three categories for equipment is currently purchased by population density compared to rural
which EPA has accumulated the most end users, most of whom are farmers. agricultural settings.
substantial evidence of soil and The commenter said that using such EPA response. Due to the large
groundwater contamination by equipment requires large quantities of number of commenters in 1994 and
pesticides. The final rule maintains the chemicals on site and concluded that 2004 from all sectors who supported
same scope. These facilities represent on-farm bulk storage is growing. requiring farms to have containment for
only a subset of the realm of operations Another dealer association stationary container pesticide storage,
where containment requirements might commented in 2004 that by the end of the Agency considered the option of
be appropriate. The Agency may 2006, 70 percent of all crop protection expanding the scope of the rule to
consider further containment products, mainly herbicides, will be off- include farms and other entities.
rulemaking for other elements of the patent, creating a marketing opportunity Although the Agency had solicited data
pesticide industry if further information for non-traditional suppliers and on bulk pesticide storage on farms and
indicates that such requirements are chemical brokers. They noted that end at non-agricultural facilities in both the
needed. In addition, the final rule users could become direct crop 1994 proposed rule and the 1999
revises the regulatory language to clarify protection customers without supplemental notice, only anecdotal
that the containment regulations only appropriate facilities, resulting in information was received alleging an
increase of stationary container at agricultural retailers, refilling final containment regulations to

pesticide storage on farms. (Ref. 27) establishments and commercial farmers. We believe that adding the
The Agency therefore researched the applicator sites. At least 30 of the clarification of principal business to the
issue of whether pesticide storage on references to the proposed rule were final rule will help identify the retail
farms is a significant problem. The State monitoring studies showing facilities that we intend to regulate with
Agency contacted several commenters contamination at such sites. Data § 165.180(b)(1). However, EPA wants to
to the rule for clarification and was documenting widespread contamination clarify that anyone including a farmer -
unable to confirm that the use of larger at other facilities were not submitted, who is repackaging pesticides for sale or
spray equipment relates to increased and have not been identified. distribution must comply with the
bulk pesticide storage or only to The consensus, even from existing requirements in 40 CFR part
fertilizer storage and application. In commenters who support expansion of 167 to register their establishments and
cases where bulk storage of pesticide the scope to include farmers, is that on- report their production (repackaging) to
most likely occurs on large farms, such farm bulk storage is still rare. The EPA and must also keep records of
as with metam-sodium, it is not clear Agency does not wish to regulate in pesticide production according to 40
that pesticide remains in the tank for 30 anticipation of a potential problem, CFR part 169. In addition, such facilities
days or more. The Agency asked the particularly since it is questionable that would be regulated as refillers under
USDA to contact its sources in the such a regulation could be enforced on this final rule and would have to
extension network, and Agency staff an equitable basis. We recognize the comply with the refiller requirements in
contacted regulatory representatives and staff and resource restrictions of State subpart D, Standards for Repackaging
dealers in several States, particularly agencies, and do not wish to add to their Pesticide Products into Refillable
those with large areas under field crops. burden in anticipation of a problem Containers. These facilities would have
In general, the persons contacted knew which may or may not occur in the to comply with the containment
of few, if any, farms with bulk pesticide future. requirements in subpart E if they
storage, with the definition of bulk as The Agency recognizes that all large, repackage agricultural pesticides and if
500 gallon containers or greater. stationary tanks have the potential to more than 50% of their total annual
USDA contacted Colorado, where less leak or burst, and considered requiring revenue comes from retail operations.
than 1 percent of farmers potentially all stationary tanks, regardless of
The Agency is willing to amend the
store pesticides in bulk, and where location, to conform to the containment
regulation to include such sites if a
minibulks up to 660 gallons are exempt standards. However, the Agency also
pervasive pattern of contamination or
from the requirement for containment if believes that the volume through-put of
other handling problems appear at other
they are approved by DOT or MACA. tanks used for retail sale or commercial
sites in the future. It is recommended
USDA also contacted Illinois, Kansas application of pesticides is higher than
and Nebraska. Illinois has implemented that expected for individual farms, that State and local agencies regulate
new regulations which require farmers resulting in a higher potential risk such facilities at the local level as
to have secondary containment if they associated with their usage. The Agency needed.
meet the volume criteria, so any farmers further believes that an end-user who is D. Compliance Dates (§ 165.80(c))
with large tanks are taking them out of not significantly involved in resale of
service. They learned that Kansas has product has less opportunity and 1. Final regulations. All containment
three to six farms with bulk pesticides, motivation to finance the purchase of structures subject to today’s rule must
and most farmers are using 250 gallon large tanks and the construction of comply with all applicable containment
minibulks. Nebraska representatives secondary containment. regulations for new and existing
could not estimate how many farms EPA added a description of the phrase structures within 3 years of today’s date.
have bulk pesticide, but the most ‘‘principal business is retail sale’’ to the 2. Changes. The proposed rule
commonly used containers are 85 to 250 final rule so § 165.180(b)(1) states that required new structures to comply with
gallon minibulks. The only State with refilling establishments who repackage the containment standards beginning 2
hard data was Indiana, which has 65 agricultural pesticides and whose years after publication of the final rule.
farmers with bulk storage (defined as principal business is retail sale (i.e., Existing structures would have been
larger than 55 gallons), of which 31 more than 50% of total annual revenue required to comply with interim
reportedly had tanks larger than 500 comes from retail operations) must standards for a period of 8 years,
gallons. comply with the containment beginning 2 years after publication of
EPA has no data on the existence of regulations. EPA’s intent of including the final rule, and then existing
bulk storage in non-agricultural the phrase principal business in the structures would have to comply with
facilities. EPA assumes that at such 1994 proposed rule was to distinguish the same standards as new structures.
facilities, pesticides are often stored between refilling establishments whose The interim standards were defined as
indoors, where the building itself principal business is retail sale and critical to safe containment, and
affords some measure of containment. refilling establishments whose primary considered readily implemented within
EPA is aware of some isolated mosquito- function is formulation or 2 years. The interim period was
control facilities which may store manufacturing of pesticides. The intended to allow existing structures
pesticides in large stationary tanks description of principal business was which have design or structural features
during the treatment period, but does added to the final rule to provide not amenable to upgrading without
not have any way to estimate the clarification on how to make this major modification to phase in those
existence of such facilities nationwide. distinction. In addition, the information modifications over time. The final rule
In short, EPA has not received we received during the 2004 comment has no provision for an interim period;
sufficient evidence of contamination at period about some farmers reportedly the final rule applies only one set of
manufacturing plants, distributors, repackaging pesticides for sale further requirements to existing structures over
farms and non-agricultural sites to supported the need to clarify the their life spans. Both new and existing
justify regulating them. In the proposed meaning of principal business is retail structures must comply with applicable
rule, we outlined the data available to sale. For the reasons discussed in this standards beginning 3 years after
the Agency documenting contamination section, EPA decided not to apply the publication of the final rule.
3. Comments. Many commenters had vary slightly from the proposed Federal implemented at existing structures
objections or changes to propose on the regulations. A dealer group suggested within 3 years. The proposed period of
interim period. Several respondents that EPA set the Federal standards as a 2 years before compliance may not have
commented specifically on the length of baseline, which would allow the provided ample time for facilities to
the interim period. A registrant thought proactive work of some States to stand. meet the requirements, particularly
it should be longer and a State Many dealers recommended that EPA facilities in locales with significant
regulatory agency said it should be adopt the Iowa standards in lieu of seasonal constraints on construction. In
shortened to 5 years and be based on the those in the proposal. A dealer said that addition, allowing 3 years as a
structure’s age and performance. A State making States enforce standards compliance date for both new and
regulatory agency said that the nine different from their own would cause existing structures will allow one year
critical standards were sufficient and difficulties for enforcing agencies, for States with their own containment
that the only distinction between new distributors, retailers and end users, and regulations to apply for an equivalency
and existing facilities should be the a State regulatory agency elaborated, determination, and still avoid confusion
compliance date. A dealer opposed the stating that States with containment by retaining the same compliance date
interim period because States already requirements would have to reinitiate for all facilities. EPA believes that
have containment standards and would their compliance efforts and would lose allowing one more year before
have to learn two new sets of standards credibility and trust of the regulated implementation will not have a
above and beyond existing State rule. community. A few State regulatory significant adverse impact on the
Several respondents commented on the agencies suggested adding a provision environment, particularly given the
different possibilities for an interim that would use the time during the many State regulations that are already
period discussed in the preamble. A interim period to collect data about the in effect. This is a shorter time frame
State regulatory agency supported an adequacy of State regulations. If the than the 5–year phase-in period allowed
age-based approach of setting the collected information indicated a State’s for the refillable container and
requirements weren’t adequate, EPA repackaging regulations, but given that
compliance date on a formula using 20
could justify compliance with the most States with dealerships have
years minus the existing containment
Federal standards. already implemented containment
facility’s age. Many commenters 4. EPA response. The interim period
(dealers, a dealer group and a State regulations, the Agency considers 3
was intended to allow substandard years sufficient time for facilities to
regulatory agency group) opposed facilities sufficient time to retrofit and
setting any standards that are more comply. The Agency is allowing 5 years
come into full compliance with the
stringent than existing State standards. for compliance with the refillable
regulations and for owners to recoup the
A principal reason for opposition was container standards because registrants
benefits from the depreciation of their
that interim requirements would need to phase out existing containers
capital investment and financially
comprise an extra, unnecessary set of without recalling them prior to the
prepare to upgrade their structure. EPA
requirements to be learned by regulators completion of their normal usable life.
has maintained a dialogue and
and regulated parties, particularly in The transition period helps distribute
information exchange with States and
States with containment programs in costs over time and improve regulatory
the regulated community (facilities and
place. It would also be costly for compliance.
their associations) since the rule was
existing structures to have to retrofit, published in 1994. EPA has decided not The critical standards cited in the
particularly in States where facilities to finalize the most onerous and preamble of the proposed rule (59 FR
had already been constructed to contentious standards from the 6765, February 11, 1994) for
conform with State requirements. requirements for existing facilities, such implementation during the interim
Several commenters (State regulatory as a hydraulic conductivity standard, period have been modified based on
agencies, a dealer, and a grower group) thereby significantly reducing the effort comments, additional research, and
recommended that EPA grandfather and expense needed to comply. EPA evaluation of existing State regulations.
existing containment facilities that are believes that 33 months between the The modified standards for existing
already in compliance with State reference date for new structures (3 structures are considered crucial to safe
standards. A State regulatory agency months after publication) and the containment and comprise the basic
group requested EPA to seriously compliance date (36 months after standards demonstrated to be effective
consider accepting small discrepancies publication) would provide a reasonable for existing structures in States with
in some standards due to differences in period of time for new structures to be containment regulations. The following
existing State rules and legislation. This planned and built in compliance with table compares standards in the
commenter said that national uniformity the full requirements of subpart E. If an proposed rule to today’s final standards
in regulation is desirable, although existing structure does not already for existing structures. New structures
progress toward this goal should not be comply with the standards for existing are subject to these standards plus
at the expense of States that have structures, EPA believes that the additional standards representing
already enacted rules and statutes that remaining modifications can be readily further protectiveness.
TABLE 17.—COMPARISON OF STANDARDS FOR PROPOSED AND FINAL RULE

Standard in Proposed Rule for Existing Struc- Additional Standard in Final Rule for New
Standard in Final Rule for Existing Structures
tures Structures
Construction with rigid materials. Same. NA

Use of pesticide-resistant materials. Use of pesticide-compatible materials. NA
TABLE 17.—COMPARISON OF STANDARDS FOR PROPOSED AND FINAL RULE—Continued

Standard in Proposed Rule for Existing Struc- Additional Standard in Final Rule for New
Standard in Final Rule for Existing Structures
tures Structures
Hydraulic conductivity no greater than 1 x 10-6 None. Liquid-tight. NA

cm/sec during interim, 1 x 10-7 cm/sec after
10 years.
Withstand full hydrostatic head. Same. NA
Stormwater run-on protection for a 25-year, Sufficient freeboard to contain precipitation NA

24-hour storm. and prevent water and other liquids from
seeping into or flowing onto it.
Protection of appurtenances and containers. Same. Appurtenances configured so leaks can be

observed.
Seal joints and cracks and repair any visible Same. NA

damage.
Inventory reconciliation of liquid remaining in None. NA

tank during interim only.
Pad capacity 1,000 gallons. Pad capacity 750 gallons. Sloped to liquid-tight sump.
Liquid stationary containers - unit capacity Liquid stationary containers - unit capacity Liquid stationary - outdoor capacity 110 per-
100 percent/110 percent indoor/outdoor 100 percent indoor/outdoor minimum. cent minimum.
minimum during interim, 110 percent/125
percent indoor/outdoor after 10 years.
Anchoring liquid stationary containers. Anchoring or elevating liquid stationary con- NA

tainers.
Prevent pesticide-containing material from es- Seal appurtenances, discharge outlets and Appurtenances must be configured in such a
caping from containment. gravity drains through base or wall of con- way that spills or leaks are easy to see.
tainment unit, including sump. Containment
pads may drain to a watertight sump with
method of removing accumulated liquids,
such as a pump, which transfers contents
to aboveground container.
Dry product stationary container - no capacity Dry product stationary container protected NA
requirement during interim, 100% after 10 from wind/rain with 6-inch berm at least 2
years. feet from container.
Attended transfers; locked valves; cleanup by Same. NA

the end of day of spill; monthly inspection.
E. Stationary Containers Included • The container is empty, which container size subject to the rule is
(§ 165.81) means that it has been cleared of all 4,000 pounds rather than 4,409 pounds;
pesticide that can be removed by and (3) period of time that a container
1. Final regulations. Stationary customary methods such as draining, can remain fixed or at a single facility
pesticide containers designed to hold pumping, or aspirating (whether or not in order to be considered stationary is
undivided quantities of agricultural residues have been removed by washing 30 days, rather than the 14–day period
pesticides equal to or greater than 500 or rinsing). in the proposed rule.
gallons (1,890 liters) of liquid pesticide • The container holds pesticide 3. Comments - holding capacity.
or equal to or greater than 4,000 pounds rinsates or wash waters and is so Many commenters (State regulatory
(1,818 kilograms) of dry pesticide are labeled. agencies, dealer groups, and another
subject to the containment regulations. • The container holds only pesticides government agency) urged EPA to
Containers of less than these volume/ which would be gaseous when released reduce the capacity threshold for
weight capacities are not required to be at atmospheric temperature and containers for which secondary
protected with a secondary containment pressure. containment is required. Specific
unit. The definition of stationary • The container is dedicated and alternative suggestions included: (1) 300
pesticide container includes transport labeled for non-pesticide use. gallons for liquids or 100 pounds for dry
vehicles that are fixed or remain at a 2. Changes. This is not the same products; (2) 300 gallons for liquids or
facility for at least 30 consecutive days. subset of stationary containers proposed 500 pounds for dry products; (3) 500
A stationary pesticide container is in § 165.142(a) as subject to, or exempt gallons for liquids or 2,000 pounds for
subject to the containment regulations from, the standards. The three dry products. A registrant group
and must have a secondary containment differences are that the: (1) Liquid commented in 2004 that packaging
unit unless it satisfies any one of the container size subject to the rule is 500 experts believe plastic containers larger
following conditions: gallons rather than 793 gallons; (2) dry than 330 gallons would not meet DOT
Packing Group III standards, which they after 500 gallons is 1,000 gallons) and requirement for 100 percent
cite as further evidence that containers expects that today’s rule will discourage containment capacity for dry pesticides
that size and larger need secondary demand for container sizes in that range with a requirement for a 6–inch berm in
containment. A State agency stated that in an attempt to be exempt from the the final rule.
they are already seeing a shift in containment regulations. The Agency 6. Comments - 14–day residence.
container size (below the regulatory cut- confirmed that 500–gallon tanks are Several commenters suggested
off) in order to be exempt from the common in the field, and recognizes increasing the time criterion to 30 days
State’s containment regulations. that the regulations may prompt some to account for factors beyond the control
Another State agency suggested that demand for tanks slightly smaller (e.g., of the facility. One commenter
States have geographical differences and 450 gallons) in order to be exempt from questioned the associated recordkeeping
that perhaps EPA should allow the Federal requirement. There may as burdensome and unclear as to what
individual States to mandate storage always be facilities which try to skirt the was required. A registrant requested that
limits based on their individual law in such ways, but the Agency EPA exempt packaged product in
situation. A dealer group and a intended the containment regulations to nonrefillable containers from the 14–
registrant group jointly commented that prevent the environmental day time trigger because it would
containers with a liquid capacity of consequences from the most burden small facilities.
greater than 330 gallons should be catastrophic spills. The smaller the tank 7. EPA response - 14–day residence.
protected by containment. There were size, the less contamination will result Although most large containers used at
no commenters who thought the from leaks or spills. The Agency also commercial agrichemical facilities are
container size of 793 gallons was reviewed containment regulations in the stationary, some containers are actually
appropriate or that it should be larger. 19 States which have them, and vehicles (such as tank trucks) used for
determined that the size cut-off which prolonged storage or repeated on-site
4. EPA response - holding capacity -
triggers the requirement for secondary dispensing of pesticide at one location.
liquids. The Agency recognized that the
containment varies from 55 to 550 In this case, the primary function of the
liquid capacity proposed was
gallons, with many states selecting 300– vessels shifts from pesticide transport to
substantially greater than volume
or 330–gallon tanks as the cut-off size. pesticide storage or handling, and
criteria adopted by many States with
The Agency believes that selecting a therefore containment is required. Since
containment regulations. These States
volume cut off between 55 and 500 monthly inspection is required at such
use lower limit ‘‘bulk’’ criteria ranging
gallons would conflict with some State facilities, EPA believes that it would be
from 55 to 500 gallons to trigger
regulations at a cost to both States and reasonable to allow a 30–day maximum
secondary containment requirements for
facilities, with no measurable benefit to residence time without containment
liquid pesticides. The reasoning for the
the environment (Ref. 25) and has requirements, since any transport
proposed definition (793 gallons) of
therefore selected 500 gallons as a vehicles temporarily stored would have
liquid bulk container was to be
realistic, practical and protective size to be inspected by the owner or operator
consistent with the DOT definitions in
which triggers the need for secondary within that period. The recordkeeping
distinguishing between intermediate
containment. required for stationary containers which
bulk containers and bulk containers.
do not have secondary containment
Since the final containment regulations 5. EPA response - holding capacity -
could simply be a signature of the driver
do not use definitions of bulk or dry pesticides. As with liquid
and/or facility owner/operator on a
intermediate bulk, the DOT definitions pesticides, the Agency’s goal in
paper listing the driver’s arrival date.
are irrelevant here. As discussed in Unit proposing larger weight criteria for dry
The regulation is not intended to
VI.A., EPA is not finalizing the pesticides, was to target containers that
impose burdensome recordkeeping. The
definitions of minibulk and bulk pose the greatest risk of catastrophic
regulations will not affect packaged
containers in the final rule. The consequences in the event of failure.
pesticide in small quantities used by
Agency’s intent for the secondary The proposed size criterion for dry
small entities, since the quantities
containment requirement is to prevent pesticide containers was 4,409 pounds
required that would trigger containment
the most catastrophic spills, and the (2,000 kilograms). There were many
requirements are 500 gallons liquid or
larger the container, the greater the risk comments on the size criterion for dry
4,000 pounds dry pesticide.
of contamination. The Agency believes pesticide containers in 1994. Those
contamination from failure of a 500– comments objected specifically to the F. Pesticide Dispensing Areas Included
gallon container would be significant, proposed standard for 100 percent (§ 165.82)
and agrees with commenters that a 330– containment capacity for such 1. Final regulations. Dispensing areas
gallon container is generally considered containers based on the physical nature are subject to the requirements for a
the largest size container that can be of a dry spill. The Agency has containment pad if one of the following
moved by a fork lift and can be confirmed with the packaging industry activities is conducted in the dispensing
considered mobile. The next most (Ref. 29) that dry pesticides are not area:
common size used in the field is 500 packaged in containers between the • Emptying, cleaning, and rinsing of
gallons. The Agency agrees with States sizes of 4,000 and 4,409 pounds. refillable containers that hold
that those 500 gallon tanks should be Therefore, EPA is lowering the size of agricultural pesticides.
required to have secondary the container for which containment is • Dispensing of an agricultural
containment, and is lowering the size required to 4,000 pounds (1,818 pesticide from a stationary pesticide
cut off to capture those tanks and kilograms) for simplicity and clarity, container of a size holding 500 gallons
harmonize with existing regulations. since 4,000 is an easier number to or more of liquid or 4,000 pounds or
The Agency has confirmed by personal remember for compliance and more of dry pesticide for any purpose.
communication with some State enforcement purposes, and there is no • Dispensing of an agricultural
regulators and extension staff (Ref. 28) functional difference between 4,000 and pesticide from a transport vehicle to fill
that there are few, if any, containers 4,409 pounds for refillable dry bulk a refillable container.
between the sizes of 500 and 793 containers, since neither size exists. In • Dispensing of an agricultural
gallons, (the next most common size addition, EPA has replaced the pesticide from any other container for
the purpose of refilling a refillable sites generally handle less material, An existing containment structure is
container for sale or distribution. which should result in fewer spills. one whose installation began on or
A dispensing area is exempt from 4. EPA response. As discussed above before the date 3 months after the final
subpart E requirements for a in Unit VIII.C., Who Must Comply, EPA rule is published.
containment pad if it satisfies any of the focused on commercial agrichemical 2. Changes. This is identical to the
following conditions: facilities because these have the clearest definitions of new and existing
(1) The only pesticides handled in the pattern of soil and ground water containment structures proposed in
pesticide dispensing area are pesticides contamination by pesticides. EPA did § 165.144. However, the general
which would be gaseous if released at not include farms because farms structure of the final rule is different
atmospheric temperature and pressure. conduct operations on an occasional from the proposal, as explained in more
(2) The only pesticide containers basis and would not have the same detail in Unit VIII.K. The proposed rule
refilled within the pesticide dispensing environmental impacts as refilling would have required existing structures
area are stationary pesticide containers establishments. Containment on a farm to comply with interim standards for a
protected by a secondary containment would also be expensive and require period of 8 years, beginning 2 years after
unit that complies with the year-round maintenance but only be publication of the final rule, and then
requirements of this subpart. needed on a seasonal basis. EPA does existing structures would have had to
(3) The pesticide dispensing area is not have a good estimate of the number comply with the same standards as new
used solely for dispensing pesticide of farms with stationary bulk storage, structures. Instead, the final rule
from a rail car that is not a stationary nor evidence that significant establishes critical design standards for
pesticide container. However, if a rail contamination is occurring at farm sites. both new and existing structures, and
car is used as a stationary pesticide Although it follows logically that any several additional standards for new
container, secondary containment is area where pesticides are transferred structures. In other words, certain
required. between containers and application standards in the final rule apply to all
equipment may become contaminated, existing structures for their lifetimes.
2. Changes. This is the same approach
the quantities transferred at dealer and Similar but slightly different standards
and scope that was proposed in
commercial sites for sale to multiple apply to all new containment structures.
§ 165.142(b) for including and
customers are expected to far exceed As noted earlier, these standards would
exempting pesticide dispensing areas
quantities transferred at individual not apply in States that show that their
from the requirement for a containment
farms. regulations afford environmental
pad. The language in § 165.82(a)(2) has EPA noted that the language in protection at least equivalent to that
been slightly revised to reflect the lower § 165.82(a)(4) did not fit the plain- provided by EPA’s regulations.
container sizes, and all of the conditions English standard for simplicity and Also, EPA reorganized the regulatory
have been slightly revised to be clearer. revised it to clarify that the activity of text so all the design and capacity
3. Comments. As with the scope of refilling refillable containers for sale or standards for new structures are
facilities subject to the containment distribution, even if the source grouped together in § 165.85. (See Unit
requirements above, many commenters container is smaller than the size VIII.H.) All the design and capacity
responding to both the 1994 proposal requiring secondary containment, standards for existing structures are
and the 2004 Notice (State regulatory requires a secondary containment pad. grouped together in § 165.87. (See Unit
agencies, a few dealer groups and a For example, refilling a 15–gallon VIII.I.) The regulations that follow these
registrant) urged EPA to expand the minibulk from a 400–gallon stationary two groupings of standards, including
scope to all permanent areas where the tank would still require a containment but not limited to operational,
transfer of pesticides from any container pad if the product was intended to be inspection, maintenance and
occurs, regardless of container size or sold or distributed. recordkeeping requirements, apply to
pesticide type. In particular, they argued both new and existing structures. EPA
for requiring containment pads for G. Definition of New and Existing believes this format is clearer and
mixer/loader activities by farmers or for- Structures (§ 165.83) should facilitate compliance compared
hire applicators, citing significant soil 1. Final regulations. A new to the structure of the proposed rule,
and groundwater contamination in containment structure is one whose which intermingled requirements for
agricultural States, and equivalent risk installation begins more than 3 months the interim period and for new
whenever large quantities of pesticides after the final rule is published. structures.
are handled. They noted the possibility Installation is considered to have begun
that farmers are less well-trained in if: H. Design and Capacity Requirements
pesticide management than commercial (1) You, as the owner or operator, for All New Structures (§ 165.85)
dealers. State agencies supported have obtained all Federal, State, and 1. Construction materials for new
including farmer mixer/loader pads in local approvals or permits necessary to containment structures (§ 165.85(a))—i.
order to strengthen their own begin physical construction of the Final regulations. New containment
regulations. containment structure; AND structures must be made of steel,
Arguments by State regulatory (2) You have either begun a reinforced concrete or other rigid
agencies, user groups, a registrant, and continuous on-site physical material which will withstand the full
a registrant group against including construction or installation program OR hydrostatic head, load and impact of
farmers in the scope cited the difficulty you have entered into contractual any pesticides, precipitation, other
of monitoring numerous individual obligations for physical construction of substances, equipment and
farms and lower quantities of pesticides the containment structure. The contract appurtenances placed within the
used. Two user groups opposed must be such that it cannot be canceled structure. The construction material
including farmers because the costs or modified without substantial loss, must not be natural earthen material,
would be significant to farmers and and must be for the physical unfired clay, or asphalt, and must be
could not be passed on; the costs of construction or installation of the compatible with the stored pesticide.
monitoring the large number of farm containment structure within a specific ii. Changes. The proposed rule stated
sites would be burdensome; and farm and reasonable time frame. that the construction material had to be
resistant to pesticide. The final rule and a registrant group) commented that require dike walls to be unreasonably
states that the material must be there are no on-site, non-destructive thick in order to withstand a very rare
compatible with the pesticide. The tests to verify hydraulic conductivity. but not impossible tidal wave impact of
proposed rule also had the following Respondents from a variety of a large tank rupture. A dealer group
additional requirement for new commenter categories opposed the urged EPA to replace the standard with
structures, which is not being finalized standard as too restrictive, unnecessary, the following language from the
in the final rule: unachievable, and too costly. Some Association of American Pest Control
Each new containment structure must commenters (registrants, a registrant Officials (AAPCO) model rule:
have a hydraulic conductivity less than group, and State regulatory agencies) ‘‘Secondary containment shall be
or equal to 1 x 10-7 centimeters per pointed out that RCRA-mandated wood constructed of sufficient thickness,
second. During the interim period, each preservative drip pads serve as primary density, and composition so as to
existing structure must have a hydraulic containment, whereas the proposed contain any discharged material...’’
conductivity standard less than or equal regulations apply to secondary vii. EPA response - hydraulic
to 1 x 10-6 centimeters per second. containment, arguing that the same conductivity and hydrostatic head.
iii. Comments - rigid structures. A few standard should not apply in both cases. Based on the comments and additional
State regulatory agencies supported A few State regulatory agencies research, EPA agrees that the proposed
requiring rigid structures. One expressed concern that construction hydraulic conductivity requirements
recommended allowing flexible modifications of existing structures to would be unnecessarily burdensome,
synthetic liners in the base. A university comply with the capacity and hydraulic and that rigid walls of chemically
and a registrant supported the use of conductivity standards may not be compatible material have been proven
steel structures. A few State regulatory technically feasible and could penalize effective in controlling accidental spills.
agencies and a containment materials proactive States. A few State regulatory The 1 x 10-7 cm/sec standard was based
supplier supported portable rigid or agencies and a dealer group commented on the hydraulic conductivity
non-rigid structures. that there is no evidence of pesticide requirement found in current RCRA
iv. EPA response - rigid structures. moving through concrete slabs or requirements for wood preservative drip
EPA does not believe that flexible, unsatisfactory performance by existing pads in subpart W of 40 CFR parts 264
portable, or non-rigid structures can concrete structures, and one commenter and 265. EPA agrees that secondary
adequately ensure the permanent and observed that most releases from containment structures are intended to
continuous liquid-tight containment of secondary containment are through catch and briefly retain spills and
large quantities of agricultural unsealed cracks and installed drains. releases, not store them indefinitely,
pesticides or of areas where pesticides Respondents commented on the and recognizes the difficulty in
are transferred and handled regularly. methods needed to achieve a hydraulic verifying hydraulic conductivity. The
Years of State experience with conductivity standard, such as use of Agency has therefore decided not to
secondary containment has shown that coatings, sealants, and liners. A State finalize the standards for hydraulic
structures of concrete, steel or other regulatory agency supported the use of conductivity. The Agency disagrees that
rigid material are effective in containing sealants and coatings and a few dealer the requirement to withstand full
spills and leaks. Furthermore, as stated groups acknowledged that coatings on hydrostatic head is unreasonable. It is a
in the proposed rule, key technical concrete would extend the useful life of requirement in many State containment
guidance documents recommend that the structure and make it less regulations. The final rule was modified
rigid materials, especially reinforced permeable. Many commenters expressed slightly to delete the phrase (dynamic or
concrete, be used for structural support concerns about the use of coatings and static) because that phrase adds more
in pesticide containment facilities. sealants on containment structures, for confusion than clarity. However, EPA
Industry guidance (Ref. 11) indicates reasons such as: coatings can cover believes that the standard of being
that water-tight concrete can be cracks and problems that would not be ‘‘capable of withstanding the full
achieved with nonporous aggregate, visible (dealer, dealer association and a hydrostatic head, load and impact of
high-quality cement paste, proper State regulatory agency); abrasion from any pesticides, precipitation...’’ requires
curing, etc., and that maintenance plays traffic (State regulatory agency) and the secondary containment unit to be
an important role in keeping the deterioration of sealants due to able to contain a catastrophic spill. EPA
structure impermeable to liquids. ultraviolet light (registrant group and believes that using industry
Although flexible, portable containment several registrants) could prevent a construction guidance on concrete
structures may be appropriate in certain structure from maintaining compliance; quality and reinforcement bars will
other situations, EPA believes that and high cost of maintenance and ensure that containment structure’s
durable, rigid materials should be replacement. Some commenters (dealer integrity in the case of a catastrophic
required for stationary pesticide groups, State regulatory agencies) spill of a large tank.
containment at facilities covered in suggested qualitative alternative ways to 2. General design requirements for all
today’s final rule. implement an impermeability standard: new containment structures
v. Comments - hydraulic conductivity. liquid-tight with cracks, seams and (§ 165.85(b))—i. Final regulations. These
Several State regulatory agencies joints sealed; spill retention; leakproof, are the general design requirements for
supported the hydraulic conductivity coupled with permit and other new containment structures:
standard as proposed. Many requirements; leakproof and constructed (1) You must protect appurtenances
commenters (including State regulatory with materials resistant to pesticides. A and pesticide containers against damage
agencies, another agency, registrants, a State regulatory agency observed that from operating personnel and moving
registrant group, dealer groups, and a most releases from secondary equipment. Means of protection
dealer) commented that a hydraulic containment are through unsealed include, but are not limited to, supports
conductivity standard would be difficult cracks or installed drains. to prevent sagging, flexible connections,
to implement, generally citing a lack of vi. Comments - hydrostatic head. A the use of guard rails, barriers, and
methods to verify compliance with such few State regulatory agencies argued protective cages.
a standard. Some respondents (dealers, that a requirement for construction to (2) Appurtenances, discharge outlets,
State regulatory agencies, registrants withstand full hydrostatic head would or gravity drains must not be configured
through the base or wall of the believes that, just as a 25–year, 24–hour exposed to or unprotected from
containment structure, except for direct storm is a reasonable criterion for precipitation, must have a capacity of at
interconnections between adjacent stormwater retention (prevention of run- least 110 percent of the volume of the
containment structures which meet the off), it would also serve as sufficient largest stationary container plus the
requirements of this subpart. freeboard and a reasonable standard for volume displaced by other containers
Appurtenances must be configured in prevention of stormwater seepage and and appurtenances within the unit.
such a way that spills or leaks are easy run-on from adjacent lands or a. Changes. The proposed rule
to see. structures. Such a standard allows required higher capacity of 110 percent
(3) The containment structure must be flexibility for varying climatic for units protected from precipitation
constructed with sufficient freeboard to conditions. It is also the standard and 125 percent for units exposed to
contain precipitation and prevent water required for certain tank systems storing precipitation.
and other liquids from seeping into or or treating hazardous waste. See, for b. Comments. Several State regulatory
flowing onto it from adjacent land or example, 40 CFR 265.1(e)(1)(ii) and agencies supported the proposed
structures. (e)(2)(ii). However, the Agency has standards, stating that adjusting the
(4) Multiple stationary pesticide decided not to require a 25–year, 24– standard to reflect variable rainfall
containers may be protected within a hour storm criterion here in order to be would add confusion. Many
single secondary containment unit. The consistent with the final EPA rule on commenters (dealers, dealer groups and
volume of the largest container Oil Pollution Prevention and Response: a State regulatory agency) supported
determines the capacity requirement of Non-Transportation-Related Onshore instead the standard that EPA had
the unit. and Offshore Facilities (67 FR 47042, proposed for the interim period for
ii. Changes. Requirements in Ref. 47). The Oil Prevention Rule states existing structures, namely 100 percent/
§ 165.85(b)(1) and (2) are identical to that while a 25–year, 24–hour storm 110 percent capacity (indoor/outdoor).
those proposed in § 165.146(b). event standard is appropriate for most Reasons cited included: (1) Many dikes
Paragraph (4) is added to clarify a facilities and protective of the that meet this standard have been in
statement in the proposed rule under environment, it may be difficult and place for years with no overflows; (2)
§ 165.152. The requirement in expensive for some facilities to secure EPA provides little or no justification
§ 165.85(b)(3) has been changed. In the recent information concerning such that capacity in excess of 100 percent of
proposed rule, the requirement was to storm events at this time. Recent data do the volume of the largest container is
prevent storm water run-on from not exist for all areas of the United necessary; (3) modifying a dike to add
seeping into or flowing onto it from States, or may be costly for small additional capacity would be expensive;
adjacent land or structures during a 25– operators to secure. Should recent and and (4) many Midwestern States have
year, 24–hour rainfall event. inexpensive information concerning a adopted the 100 percent/110 percent
iii. Comments - storm protection. 25–year, 24–hour storm event become standard from the AAPCO model rule.
Several respondents (a registrant and easily accessible for every part of the c. EPA response. EPA agrees with
two State regulatory agencies) supported United States, we will reconsider comments based on practical field
the stormwater control provision. proposing such a standard. Instead, at experience and has reduced the
Several others (a dealer group and two this time, we are requiring, as a few volumes needed to 100 percent and 110
State regulatory agencies) suggested commenters suggested, that the percent, respectively for indoor and
alternative language, such as diverts containment structure have sufficient outdoor units. The 110 percent criterion
water, no discharge, or constructed to freeboard to contain precipitation and for storage areas without roofing adds an
prevent any surface water from moving prevent water and other liquids from extra margin of safety for retention of
onto or across the structure. Several seeping into or flowing onto it from precipitation. An extra 10% is not
commenters (a dealer group, a registrant adjacent land or structures. Most States needed indoors as long as the displaced
group and two State regulatory agencies) with containment regulations do not use volume or other containers is added.
noted that it would be difficult to a 25–year, 24–hour storm criterion, and However, the Agency recognizes that,
comply because (1) a watershed runoff have indicated that, in their experience, for enforcement purposes, it may be
study would be needed; (2) the 25–year, requiring a numerical capacity (110 difficult to reconcile capacity with
24–hour criterion would be difficult to percent) or sufficient freeboard to climatic conditions. For example, in the
determine at different sites; (3) rainfall accommodate local precipitation case of a 2–inch rain, capacity at a new
varies substantially from year to year. A conditions provides adequate outdoor liquid pesticide facility could
few State regulatory agencies protection. be temporarily reduced to less than 110
commented that the stormwater control 3. Capacity requirements for new percent of the largest tank if that tank
standard doesn’t adequately address stationary liquid pesticide containment were full, and the facility would no
precipitation and stated that the units and new containment pads in longer be in compliance. To avoid
containment capacity requirements pesticide dispensing areas disputed calculations of capacity, the
must be based on rainfall volume, such (§ 165.85(c))—i. Capacity for new Agency recommends that facilities make
as a 25–year, 24–hour rainfall event. A stationary liquid pesticide containment allowances for additional capacity
few dealers recommended the example units—Final regulations. These are the beyond the 110 percent required, such
of the Illinois pesticide containment capacity requirements: as 125 percent, to build in a margin of
rule, which requires that stormwater be • New secondary containment units error.
diverted from containment structures. for stationary liquid containers, if ii. Capacity for new containment pads
iv. EPA response - storm protection. A protected from precipitation, must have in pesticide dispensing areas—i. Final
25–year, 24–hour storm is commonly a capacity of at least 100 percent of the regulations. These are the capacity
used as a benchmark for the capacity of volume of the largest stationary requirements:
• New containment pads in pesticide
secondary containment structures, and container plus the volume displaced by

is recommended in the National other containers and appurtenances dispensing areas subject to the
Pollution Discharge Elimination System within the unit. regulations in this subpart which have
(NPDES) Best Management Practices • New secondary containment units a pesticide container or pesticide-
Guidance Document.(Ref. 74) EPA for stationary liquid containers, if holding equipment with a volume of
750 gallons or greater must have a State regulatory agencies did not object necessary to detect leaks and may
holding capacity of at least 750 gallons. to EPA’s proposed pad capacity engender risks from inadequate support
• New containment pads in pesticide requirements, although their State devices.
dispensing areas subject to the regulations are slightly more stringent. 5. Specific requirements for new
regulations in this subpart which do A State regulatory agency noted that the containment pads in pesticide
NOT have a pesticide container or difference between 750 gallon and 1,000 dispensing areas (§ 165.85(e))—i. Final
pesticide-holding equipment with a gallon capacity would do little to regulations. In addition to meeting the
volume of at least 750 gallons must have accommodate a spill from a 3,000 gallon requirements for § 165.85(a), (b) and (c),
a holding capacity of at least 100 delivery truck. each new containment pad in a
percent of the volume of the largest iv. EPA response. The Agency did not pesticide dispensing area must:
pesticide container or pesticide-holding have a technical basis for choosing the • Be designed and constructed to
equipment used on the pad. 1,000 gallon capacity in the proposed intercept leaks and spills of pesticides
ii. Changes. The proposal required rule, but based it on a review of which may occur in the pesticide
that pads have a minimum holding proposed and actual State containment dispensing area.
capacity of 1,000 gallons, or, if no regulations. Based on comments and • Have enough surface area to extend
equipment used on the pad exceeded subsequent research, we determined completely beneath any container on it,
1,000 gallons, at least 100% of the that the criteria of 750 gallons used in with the exception of transport vehicles
capacity of the largest container or some States has proven adequate. We dispensing pesticide for sale or
equipment used on the pad. Today’s believe that in most actual situations of distribution to a stationary container.
rule reduces the minimum pad holding spillage on a pad, 750 gallons would be For such vehicles, the surface area of the
capacity to 750 gallons in the most adequate, especially since product containment pad must accommodate at
likely scenario where large (greater than transfers must be attended under the least the portion of the vehicle where
750 gallon) containers or pesticide- requirements of this subpart. In a the delivery hose or device couples to
holding equipment will be on the pad. catastrophic event, neither 750 gallons the vehicle. This exception does not
Additionally, the capacity requirement nor 1,000 gallons would be sufficient to apply to transport vehicles that are used
refers to gravity capacity, as defined in contain a large spill, and the added cost for prolonged storage or repeated on-site
oral comments by Wisconsin state of increasing capacity to 1,000 from 750 dispensing of pesticides.
regulatory officials (Ref. 46) in 2003. would exceed any marginal
• Allow, in conjunction with its
The gravity capacity of a sump or environmental benefit. The Agency also
sump, for removal and recovery of
containment structure is the capacity agrees with Wisconsin State regulators
before any method of removing or spilled, leaked, or discharged material
that a 750–gallon pad may be as small
transferring the contained liquid by and rainfall, such as by a manually
as 12 feet square, and that a top-loaded
pump or other means is employed. For activated pump. Automatically
tank may risk splashing during the
example, a facility is prohibited from activated pumps which lack automatic
refilling process. Consequently, while
claiming a capacity of 750 gallons if the overflow cutoff switches for the
we are lowering the gallon capacity to
sump or containment structure has an receiving container are prohibited.
750 gallons of gravity capacity, we are
actual capacity of less than 750 gallons recommending that the pad have a • Have its surface sloped toward a
but is serviced by a pump which minimum size of 15 feet by 15 feet (or liquid-tight sump where liquids can be
transfers accumulated liquid into 225 square feet). Additionally, for new collected for removal.
holding tanks such that the effective operational pads unprotected from ii. Changes. These requirements are
capacity would be 750 gallons. Since precipitation, we recommend identical to those in § 165.152(b) of the
achieving 750–gallon storage capacity constructing a pad with a gravity proposed rule. The proposed rule noted
under those circumstances relies on the capacity of 1,000 gallons. that tanker trucks are considerably
proper and dependable functioning of a 4. Specific requirements for new larger than containers or equipment
pump as well as a continual supply of stationary liquid pesticide containment normally used on the containment pad,
fuel or electrical current to run the units (§ 165.85(d))—i. Final regulations. but that such deliveries are not expected
pump, this is not an acceptable way of In addition to meeting the requirements to be frequent, and did not propose that
achieving the required capacity because of § 165.85(a), (b) and (c), each new the pad had to be large enough to
if these conditions are not met, a spill stationary liquid container protected by accommodate the entire vehicle. This
is more likely. a secondary containment unit must exception does not apply to transport
iii. Comments. Indiana state either be anchored or elevated to vehicles that are used for prolonged
regulators argued that the state had prevent flotation in the event that the storage or repeated on-site dispensing of
spent three difficult years and had secondary containment unit fills with pesticides, since the primary function of
invested considerable resources in liquid. such a vehicle would be pesticide
implementing its regulations, which ii. Changes. The proposed rule storage rather than transport. EPA
require a pad capacity of 750 gallons. required that the containment unit had reasons that the full containment
They stated that to get the cooperation to allow for observation of leakage from requirements imposed on fixed
and voluntary compliance of the the base of any enclosed stationary containers would also apply to non-
impacted industries, they had to suggest pesticide container. Thus, a flat- fixed containers that remain at an
to those making the investment that bottomed container would have had to applicable facility for at least 30 days.
there would be no significant changes in be elevated so that leakage would be 6. Specific Requirements for new
requirements. To reverse themselves visible. In addition, the proposed rule stationary dry pesticide containment
now, they stated, would jeopardize their required that flotation of the container, units (§ 165.85(f))—i. Final regulations.
credibility. Illinois, a state with over in the event the containment filled with In addition to the requirements in
1,000 bulk facilities, suggested that the liquid, be prevented by either elevating § 165.85(a) and (b), each new stationary
pad capacity requirement should take or anchoring the container. The final dry pesticide containment must meet
into account the additional volume of a rule requires either elevation or the following requirements:
6–inch rainfall (the volume expected anchoring in response to comments that • The stationary dry pesticide
from a 24–year, 25–hour storm). A few argued that elevating containers is not containers within the containment unit
must be protected from wind and arguments of commenters regarding containment structure must meet the
precipitation. protection from precipitation, elevation, hydraulic conductivity standard for new
• Stationary dry pesticide containers and the flow properties of dry material, structures of less than or equal to 1 x
must be placed on pallets or a raised and has changed the dry containment 10-7 centimeters per second.
concrete platform to prevent the requirement accordingly. In regard to iii. Comments. General comments and
accumulation of water in or under the roofing, EPA believes that the EPA’s response on construction material
pesticide. advantages of keeping rainwater out of are discussed in Unit VIII.H.1. EPA
• The stationary dry pesticide containment will outweigh the cost of believes that existing structures should
container storage area must be enclosed installing a roof. However, in arid easily meet these requirements based on
by a curb that is a minimum of a 6 regions, a roof may not be cost-effective, the information we have gathered. We
inches high and that extends at least 2 and if EPA provided roofing are not aware of secondary containment
feet beyond the perimeter of the specifications, it is possible that they units being constructed of any of the
container. would conflict with local construction prohibited materials. We are aware of
ii. Changes. The proposal required requirements and building codes. the existence of some asphalt
that dry bulk secondary containment Therefore, the final rule requires containment pads, but we believe these
units have a capacity of 100 percent of protection from wind and precipitation are mostly used by aerial applicators
the largest container plus the volume rather than specifically requiring a roof that probably are not subject to these
displaced by other containers and to allow some flexibility. The Agency regulations because they do not have
appurtenances within the containment. agrees that 100 percent capacity, given large stationary pesticide containers.
The Agency was concerned that dry that dry materials spread differently that 2. General design requirements for all
pesticide could still mix with rainwater, liquids, would be excessive. We also existing containment structures
fire suppression water, etc., to reach and recognize that significant quantities of (§ 165.87(b))—i. Final regulations. These
contaminate groundwater and soil. The dust may be generated during the are the general design requirements for
proposed rule did not have any refilling process, where the dry product existing containment structures:
provisions for protection from wind and is a dust, granules or flowable (1) Protect appurtenances and
precipitation, nor for elevated storage to formulation. While today’s rule makes pesticide containers against damage
prevent water accumulation under the no requirement for dust minimization or from operating personnel and moving
pesticide, but did request comment on collection, we recommend that every equipment. Means of protection
such options. The final rule does not effort be made to contain the dust include, but are not limited to, supports
have a numerical capacity requirement. generated, both for the respiratory to prevent sagging, flexible connections,
iii. Comments. Several commenters protection of the persons attending the the use of guard rails, barriers, and
(State regulatory agencies and a dealer transfer and for the preservation of air protective cages.
group) opposed the 100 percent and soil quality in the vicinity of the (2) Seal (permanently close) all
proposed capacity as excessive, since facility. appurtenances, discharge outlets and
dry materials do not spread and gravity drains through the base or wall
disperse like liquid materials. Several I. Design and Capacity Requirements for of the containment structure, except for
State regulatory agencies suggested that Existing Structures (§ 165.87) direct interconnections between
dry bulk secondary containment should 1. Construction Materials for all adjacent containment structures which
be protected by roofing or similar cover existing containment structures meet the requirements of this subpart.
from wind and precipitation, which (§ 165.87(a))—i. Final regulations. (3) Construct the containment
would make 100 percent capacity Existing containment structures must be structure with sufficient freeboard to
unnecessary. One State noted that it made of steel, reinforced concrete or contain precipitation and prevent water
already has dry bulk containment other rigid material which will and other liquids from seeping into or
regulations which require that the withstand the full hydrostatic head, flowing onto it from adjacent land or
containers be raised off the floor, and load and impact of any pesticides, structures.
several States require at least a 6–inch precipitation, other substances, (4) Multiple stationary pesticide
curb around an area extending at least equipment and appurtenances placed containers may be protected within a
2 feet beyond the perimeter of the bulk within the structure. The construction single secondary containment unit.
tank. A registrant stated that the typical material must not be natural earthen ii. Changes. Requirements are similar
practice is to store dry pesticides under material, unfired clay, or asphalt, and to those proposed in proposed
a roof. Some commenters offered must be compatible with the stored § 165.146, except that (4) is added to
alternative strategies, generally based on pesticide. clarify a statement in the proposed rule
existing State regulations, including a ii. Changes. The requirements in under § 165.152. The requirement in
curb 6 inches high at least 2 to 3 feet § 165.87(a) for existing structures are paragraph (2) was proposed for existing
beyond the perimeter. identical to the requirements for structures 10 years after the publication
iv. EPA response. EPA has reviewed construction materials for new date of the rule (at the expiration of an
State bulk storage regulations and best containment structures in § 165.85(a). interim period that was proposed for
management practices for storing dry The proposed rule stated that the existing units. See discussion on
bulk pesticides and has noted that construction material had to be resistant compliance dates in Unit VIII.D. above.)
States require storage under a roof and, to pesticide, while the final rule In addition, at the end of the interim
if outdoors, on pallets or raised concrete requires the material to be compatible period, existing structures had to meet
platforms, and that the most common with the stored pesticides. In addition, the requirements for new structures,
requirement for dry bulk is a 6–inch the following proposed standard for including configuring appurtenances in
berm at least 2 to 3 feet from the existing structures is not being finalized: such a way that leaks and spills could
container. (Ref. 34) Given that the States During the interim period, each be readily observed. The final rule
with the most experience with dry bulk existing structure must have a hydraulic requires facilities with existing
storage have the most practical conductivity standard less than or equal structures to seal appurtenances,
experience with dry spill containment, to 1 x 10-6 centimeters per second. After discharge outlets and gravity drains at
EPA agrees with the common sense the interim period, each new the base and walls. EPA believes it is
necessary for existing structures to d. EPA response. As discussed in Unit would have had to allow for the
comply with this requirement because VIII.H.3., EPA agrees, based on field observation of leakage from the base of
some studies cited in the proposed rule experience, that the proposed capacity all stationary bulk containers after the
estimated that 30 percent of the reported requirements were excessive and has interim period expired. As explained in
pesticide spill incidents resulted from reduced the capacity requirements in Unit VIII.H.4., the standard for
appurtenance failure, and many releases the final rule. In addition, the Agency is observing leakage from the base of
were reported from discharge outlets not requiring a numerical standard of stationary bulk containers is not being
and gravity drains. Requirements in 110 percent for existing unprotected finalized.
paragraph (3) have also been changed. units (in contrast to the requirements for 5. Specific design requirements for
In the proposed rule, the requirement new unprotected units) in order to existing containment pads in pesticide
was to prevent storm water run-on from harmonize with existing State dispensing areas (§ 165.87(e))—i. Final
seeping into or flowing onto it from containment regulations which have regulations. In addition to meeting the
adjacent land or structures during a 25– chosen to require unprotected units to requirements for § 165.87(a), (b) and (c),
year, 24–hour rainfall event. The have 100 percent capacity plus either a each existing containment pad in a
requirement has been changed to 6–inch freeboard or capacity to pesticide dispensing area must:
ensuring sufficient freeboard to prevent withstand a 25–year/24–hour storm. • Be designed and constructed to
run-on. The comments on general The Agency understands that some intercept leaks and spills of pesticides
design requirements and EPA’s existing units would need to retrofit to which may occur in the pesticide
responses are discussed in Unit VIII.H.2. meet a 110 percent capacity dispensing area.
requirement, and that the burden of • Have enough surface area to extend
3. Capacity requirements for existing
adding the extra capacity appears to completely beneath any container on it,
stationary liquid pesticide containment
outweigh any benefit of the extra with the exception of transport vehicles
units and existing containment pads in
capacity. The Agency recognizes that dispensing pesticide for sale or
pesticide dispensing areas
States may have existing structures in distribution to a stationary container.
(§ 165.87(c))—i. Capacity for existing
low-precipitation areas, and is allowing For such vehicles, the surface area of the
stationary liquid pesticide containment
them the flexibility to define capacity containment pad must accommodate at
units—a. Final regulations. Each
requirements above 100 percent least the portion of the vehicle where
existing stationary liquid pesticide the delivery hose or device couples to
containment unit must have a capacity according to local conditions.
ii. Capacity for Existing containment the vehicle. This exception does not
of at least 100 percent of the volume of apply to transport vehicles that are used
the largest stationary pesticide container pads in pesticide dispensing areas— a.
Final regulations. Existing containment for prolonged storage or repeated on-site
plus the volume displaced by other dispensing of pesticides.
pads with pesticide-holding equipment
containers and appurtenances within • Allow, in conjunction with its
with a volume of 750 gallons or greater
the unit. sump, for removal and recovery of
must have a holding capacity of at least
b. Changes. The proposed rule 750 gallons. Pads which do not have a spilled, leaked, or discharged material
required a capacity of 100 percent for pesticide container or pesticide-holding and rainfall, such as by a manually
existing liquid bulk containment units equipment with a volume of at least 750 activated pump. Automatically-
protected from precipitation and 110 gallons must have a holding capacity of activated pumps which lack automatic
percent for units exposed to at least 100 percent of the volume of the overflow cutoff switches for the
precipitation for the 8–year interim largest pesticide container or pesticide- receiving container are prohibited.
compliance period. At the expiration of holding equipment used on the pad. ii. Changes. The requirements in the
the interim period, the capacity b. Changes. The proposal required final rule are identical to those in the
requirements would be the same as that existing pads have a minimum proposal. The proposed rule noted that
those proposed for new structures, that holding capacity of 1,000 gallons or 100 tanker trucks are considerably larger
is, 110 percent for units protected from percent of the capacity of the largest than containers or equipment normally
precipitation and 125 percent for container or equipment used on the pad. used on the containment pad, but that
outdoor, unprotected units. The The final rule reduces the minimum pad such deliveries are not expected to be
approach of having an interim period is holding capacity to 750 gallons in the frequent, and did not propose that the
not being finalized. The final rule most likely scenario where large (greater pad had to be large enough to
requires existing liquid pesticide than 750 gallon) containers or pesticide- accommodate the entire vehicle. This
containment units to have capacities of holding equipment will be on the pad. exception does not apply to transport
100 percent whether protected from Comments and EPA responses apply as vehicles that are used for prolonged
precipitation or not. discussed in Unit VIII.H.3. for new storage or repeated on-site dispensing of
c. Comments. The comments on containment pads. pesticides, since the primary function of
capacity requirements for new and 4. Specific design requirements for such a vehicle would be pesticide
existing stationary liquid pesticide existing stationary liquid pesticide storage rather than transport. In
containment units are discussed in the containment units (§ 165.87(d))—i. addition, the proposed rule required
comment section under Unit VIII.H.3.a. Final regulations. In addition to the that, at the expiration of the interim
In addition, many commenters noted requirements in § 165.87(a), (b) and (c), period, each existing containment pad
that changes in capacity requirements each existing stationary liquid pesticide would be sloped to a liquid-tight sump
for existing structures would require container protected by a secondary where liquids can be collected for
major modification, re-certification by containment unit must be adequately removal. The interim period has been
an engineer and significant costs. A few elevated or anchored to prevent deleted, and the requirement for sloped
State regulatory agencies noted that flotation in the event that the secondary pads is not being finalized for existing
little if any additional benefit will be containment unit fills with liquid. containment pads. The requirement for
afforded by requiring extra capacity, and ii. Changes. This requirement is sloped pads applies only to new
that they had never experienced a identical to that proposed in containment pads in the final rule.
breach of containment structure based § 165.148(b)(2). In the proposed rule, 6. Specific design requirements for
on existing laws. existing secondary containment units existing stationary dry pesticide
containment units (§ 165.87(f))—i. Final managed according to label instructions K. Combined Pads and Units (§ 165.92)
regulations. In addition to the and applicable Federal, State and local 1. Final Regulation. Facility owners
requirements in § 165.87(a) and (b), each laws and regulations. and operators may combine
existing dry stationary pesticide • Ensure that transfers of pesticides containment pads and secondary
containment must meet the following between containers, or between containment units as an integrated
requirements: containers and transport vehicles are system provided the requirements set
• The containment must protect attended at all times. out in this subpart for pads and units in
stationary dry pesticide containers • Ensure that each lockable valve on §§ 165.85(a) and (b), 165.87(a) and (b)
within it from wind and precipitation. a stationary pesticide container, if it is
• Dry stationary pesticide containers and 165.190, and as applicable,
required by § 165.45(f), is closed and §§ 165.85(c)-(f) and 165.87(c)-(f) are
must be stored on pallets or a raised locked whenever the facility is
concrete platform to prevent the satisfied separately.
unattended. 2. Changes. This provision for
accumulation of water in or under the ii. Changes. These requirements are
pesticide. allowing integrated containment
substantially the same as those systems is substantially the same as that
• The container storage area must be proposed in § 165.146(c). The order of
enclosed by a minimum of a 6–inch proposed in § 165.153.
the standards and several minor
high curb that extends at least 2 feet wording modifications were made to L. Recordkeeping (§ 165.95)
beyond the perimeter of the container. improve the clarity of the requirements.
ii. Changes. The proposal required 1. Final regulations. Facility owners
2. Inspection and maintenance of all and operators subject to the
that dry bulk secondary containment
new and existing pesticide containment requirements of this rule must maintain
units have a capacity of 100 percent of
structures (§ 165.90(b))—i. Final the following records, and must furnish
the largest container plus the volume
regulations. The owner or operator of these records for inspection and copying
displaced by other containers and
each pesticide containment structure upon request by any employee of EPA
appurtenances within the containment.
must: or any entity designated by EPA, such
The proposed rule did not have any
• Inspect each stationary pesticide as a State, another political subdivision
provisions for protection from wind and
container and its appurtenances at least or a Tribe:
precipitation, nor for elevated storage to
prevent water accumulation under the
monthly during periods when pesticides • Records of inspection and
are being stored or dispensed on the maintenance for each containment
pesticide. The final rule does not have
containment structure. Your inspection structure and for each stationary
a numerical capacity requirement. All
must look for visible signs of wetting, pesticide container and its
modifications must now be made within
discoloration, blistering, bulging, appurtenances must be kept for 3 years
3 years instead of the 10 years in the
corrosion, cracks or other signs of and must include the following
proposed rule, but the requirements are
damage or leakage. information:
modified and simplified such that the
• Immediately repair any areas • name of the person conducting the
Agency believes they are feasible within
showing visible signs of damage and inspection or maintenance;
the 3–year period. See Unit VIII.H.6. for
a summary of the significant comments
seal any cracks and gaps in the • date the inspection or maintenance
containment structure or appurtenances was conducted;
and EPA’s responses.
with material compatible with the • conditions noted;
J. Operational, Inspection and pesticide being stored or dispensed. • specific maintenance performed.
Maintenance Requirements (§ 165.90) • Not store any pesticide on a • Records for any non-stationary
1. Operating procedures for all new containment structure if the structure container designed to hold undivided
and existing pesticide containment fails to meet the requirements of this quantities of agricultural pesticides
structures (§ 165.90(a))—i. Final subpart until suitable repairs have been equal to or greater than 500 gallons
regulations. An owner or operator of a made. Prompt removal of pesticides, (1,890 liters) of liquid pesticide or equal
new or existing pesticide containment including emptying of stationary to or greater than 4,000 pounds (1,818
structure must: containers, in order to effect repairs or kilograms) of dry pesticide that holds
• Manage the structure in a manner recovery of spilled material is pesticide but is not protected by a
that prevents pesticides or materials acceptable. secondary containment unit meeting
containing pesticides from escaping ii. Changes. These inspection and today’s regulations must be kept for 3
from the containment structure maintenance requirements are years. Records on these non-stationary
(including, but not limited to, pesticide substantially the same as those pesticide containers must include the
residues washed off the containment proposed in § 165.146(d). A few minor time period that the container remains
structure by rainfall or cleaning liquids modifications were made to improve the at the same location.
used within the structure.) clarity of the language. In addition, • Records of the construction date of
• Ensure that pesticide spills and several changes were made to be the containment structure must be kept
leaks on or in any containment structure consistent with other changes in the for as long as the pesticide containment
are collected and recovered in a manner regulations. In particular, EPA decided structure is in use, and for 3 years
that ensures protection of human health not to finalize the hydraulic afterwards.
and the environment (including surface conductivity standard, so the 2. Changes. The proposed rule
water and ground water) and maximum corresponding inspection and required additional recordkeeping of
practicable recovery of the pesticide maintenance requirement is also not inventory reconciliation for existing
spilled or leaked. Cleanup must occur being finalized. Also, the final rule bulk liquid containers that were not
no later than the end of each day on specifies that the containment structure elevated during the interim period. The
which pesticides have been spilled or be compatible with the pesticides, proposed rule also required owners and
leaked. rather than resistant as proposed. The operators to maintain records of written
• Ensure that all materials resulting corresponding inspection and confirmation of hydraulic conductivity
from spills and leaks and any materials maintenance standard was changed and statements of resistance to pesticide
containing pesticide residue are accordingly. for as long as the structure was in use,
and for 3 years thereafter. These months of any revision to the State structures have not had failures when
requirements are not being finalized, so containment regulations. EPA will built to State standards. They
the corresponding recordkeeping inform the State by letter if it recommended that the final rule be
requirements are also not being determines that the State’s containment crafted to harmonize with State or other
finalized. Since the standards differ regulations are no longer adequate based environmental statutes, and that it
depending on whether the facility was on the revisions. The State containment should not penalize States which have
considered existing or new at the time regulations will remain in effect, unless spent years building effective
of this final rule, a new recordkeeping and until EPA sends the State a letter relationships with the regulated
requirement has been added: each making this determination. community for safe pesticide handling.
facility must maintain records of the 2. Changes. The proposed rule made Similarly, many commenters to the
construction date of the containment no provision for States to implement 2004 Notice reiterated these arguments
structure for as long as the pesticide their own containment regulations in and said States have taken a pro-active
containment structure is in use, and for lieu of EPA’s rule. role and have enacted pesticide
3 years afterwards. 3. Comments. Many commenters to containment regulations which have
the 1994 proposed rule (dealers, a dealer proven to be protective of the
M. States With Existing Containment group, a State regulatory agency group environment and which EPA should
Programs (§ 165.97) and individual State regulatory accept by a grandfather clause. A few
1. Final regulations. States that have agencies) opposed setting any Federal commenters in 2004 pointed out that in
promulgated containment regulations standards that are more stringent than some States it is not the State lead
effective prior to August 16, 2006, and existing State requirements. They pesticide regulatory agency (usually,
which also have primary enforcement requested that EPA accept current State department of agriculture) that has
responsibility and/or certification rules and statutes where the authority for regulating the storage of
programs, have the option of continuing discrepancies are not significant from hazardous materials/pesticides, but
to implement their own programs in Federal standards. The State regulatory instead the State environmental
lieu of today’s Federal regulations under agency group requested EPA to protection or pollution control agency.
certain conditions. seriously consider accepting small They argued that situations where one
A State that wishes to continue discrepancies in some standards due to State agency does the comprehensive
implementing the State’s containment differences in existing State legislation, pesticide regulatory work but another is
regulations must request the authority to and said that while national uniformity charged with the containment
do so by August 16, 2007 in the in regulation is desirable, it should not regulations begs questions about
following manner: be at the expense of States that have responsibilities for and resources
• The State must submit a letter and already enacted rules that vary slightly necessary to accomplish expected
any supporting documentation to EPA. from the Federal rule. A dealer group compliance monitoring and
Supporting documentation must suggested that EPA set the Federal enforcement response.
demonstrate that the State’s program is standards as a baseline, which would 4. EPA response. The Agency agrees
providing environmental protection allow the proactive work of some States that Federal regulations should
equivalent to that expected to be to stand and would preclude dealers reinforce, rather than undermine or
provided by the Federal regulations in from incurring the same economic conflict with the efforts of proactive
40 CFR subpart E. burdens twice (i.e., to build and then States. While the Agency believes in the
• The State must identify any rebuild containment structures). need for national standards, EPA does
significant changes to State regulations Several commenters (State regulatory not want to burden proactive States and
which would be necessary in order to agencies, a dealer, and a grower group) facilities in those States with additional
provide environmental protection recommended that EPA grandfather expenditures to revise their regulatory
equivalent to the EPA regulations, and existing containment facilities that are implementation system if the
develop an estimated timetable to effect in compliance with State standards or differences between their containment
these changes. The letter must be signed that are comparable in function, design, regulations and today’s rule are
by the designated State Lead Agency and construction. Similarly, a grower minimal, and especially where State
(SLA). group said that State rules for bulk standards are more stringent than
EPA’s Office of Pesticide Programs containment should take precedence Federal standards. EPA has evaluated
(OPP), in collaboration with the EPA over this proposal. A State regulatory the pesticide containment regulations in
Regions and other EPA offices, will agency elaborated on these difficulties, those States that have promulgated
review the State’s correspondence and stating that States with containment them, and believes that the regulations
determine whether the State’s program requirements would have to reinitiate in those States have generally brought
is adequate to provide environmental their compliance efforts and would lose facilities into compliance with today’s
protection equivalent to or more credibility and the trust of the regulated regulations, with some potential
protective than these Federal industry, with whom they worked deficiencies in certain States. EPA
regulations for new and existing closely to develop and implement the recognizes that simply reading
containment structures. OPP will inform State rules. regulations without awareness of the
the State of its determination through a A dealer commented that forcing field reality, State enforcement
letter authorizing or declining to States to enforce different rules from discretion, and policy and guidance
authorize the State to continue their own would cause difficulties for directives provided to inspectors may
implementing its containment the enforcing agency, distributors, provide a less accurate reading of the
regulations and will detail any reasons retailers and end users who will have to equivalency of regulations.
for declining authorization. learn an extra set of requirements. A few Consequently, EPA expects that States
Any State that has received State regulatory agencies commented will be able to readily document their
authorization to continue implementing that millions of dollars have been spent equivalency by providing existing
its State containment regulations must by industry on compliance with State information or pre-existing documents.
inform EPA by letter signed by the regulations, some of which have been in EPA does not anticipate a significant
designated State Lead Agency within 6 place since 1985, and that containment paperwork burden for States, and is
offering this opportunity in response to • PR Notice 83–3, Label Improvement applicable’’ was added to the first
States’ requests in comments to be Program — Storage and Disposal Label sentence to accommodate the fact that
allowed to continue to implement their Statements (Ref. 73); the statements in paragraph (a) apply
own regulations. EPA believes that in • PR Notice 84–1, Clarification of only to labels on nonrefillable
States where the lead pesticide agency Label Improvement Program (Ref. 72); containers and the statements in
is not responsible for enforcing • PR Notice 94–2, Recycling Empty paragraph (b) apply only to the labels on
containment regulations, collaboration Aerosol Pesticide Containers (Ref. 65); refillable containers.
between the State’s agencies will be • PR Notice 98–10, Notifications,
Non-Notifications and Minor C. Statements Required for Nonrefillable
feasible. State regulators are encouraged Containers (§ 156.140(a))
to consult with EPA prior to preparing Formulation Amendments (Ref. 56); and
their submission. • PR Notice 2001–6, Disposal 1. Final regulations. The final rule
Instructions on Non-Antimicrobial requires all nonrefillable containers to
IX. Labeling Requirements for Residential/Household Use Pesticide have the following four items on the
Pesticides and Devices Product Labels (Ref. 49). label or the container:
A. Overview This guidance will be revised, if • The phrase ‘‘Nonrefillable
necessary, to be consistent with the container;’’
1. Final regulations. Today’s final rule requirements in today’s final regulation. • A statement regarding reuse;
changes the requirements for labeling 2. Changes. The final labeling • A statement about recycling or
pesticides in 40 CFR part 156 in several regulations in today’s rule cover the reconditioning; and
ways. First, these regulations add a new same statements and topics that were • A batch code.
subpart H, entitled Container Labeling included in the proposed rule. However, If the first three items are placed on
to part 156. The new container labeling a number of changes have been made to the label, they must be put under an
regulations include the following the regulations, including but not appropriate heading under the heading
requirements: limited to modifying specific ‘‘Storage and Disposal.’’ If any of the
• A statement identifying the statements, adding alternative first three items are placed on the
container as nonrefillable or refillable is statements, restructuring the regulations container, an appropriate referral
required on all pesticide labels. In based on the plain language format, and statement, such as the statement in
addition, nonrefillable container labels exempting household/residential § 156.140(a), must be placed on the label
must include several statements pesticide products from the under the heading ‘‘Storage and
providing basic instructions for requirements for cleaning instructions Disposal.’’
managing the container and a batch on nonrefillable container labels. The 2. Changes. These statements were
code for the product. (See Units IX.B. - specific changes are described in the reorganized by separating each phrase
IX.D. for more details.) section-by-section discussion below. or statement into a different regulatory
• Cleaning instructions for some paragraph to accommodate the addition
B. Identification of Container Types of alternative statements. The proposed
nonrefillable containers, specifically for (§ 156.140)
dilutable products that are sold or rule included all four items, but
distributed in rigid containers and that 1. Final regulations. This section included the first three as one
are not household/residential. (See applies to all pesticide products and statement: ‘‘Nonrefillable container. Do
Units IX.E. - IX.K. for more details.) requires statements that, among other not reuse or refill this container. Offer
things, identify the container as for recycling if possible.’’ Also, the final
• Instructions for cleaning all
nonrefillable or refillable. These rule specifies that if the first three
refillable containers before disposal.
statements must be placed on the label statements are placed on the label
(See Units IX.E. and IX.L. for more
or container. The regulations in 40 CFR (rather than on the container), they must
details.)
156.10(a)(4)(i) require the label to be placed under the ‘‘Storage and
In addition, today’s final rule ‘‘appear on or be securely attached to Disposal’’ heading on the label. EPA
modifies several existing requirements the immediate container of the pesticide added this language to reinforce the
in 40 CFR 156.10 to allow for blank product.’’ Therefore, the statements requirement in § 156.10(i)(2)(ix) for the
spaces on the labels of some refillable required by § 156.140 cannot be placed instructions in subpart H to appear
containers for the net contents and EPA only on labeling that is not attached to under the ‘‘Storage and Disposal’’
establishment number. In addition, the the container, because it may become heading. These three statements must be
paragraph in 40 CFR 156.10 that separated. The information may be under an appropriate heading under the
requires storage and disposal statements located on any part of the container storage and disposal heading, although
is being changed to be consistent with except the closure. If the statements are they may be in any order. EPA believes
the label requirements added to 40 CFR placed on the container, they must be it is better to provide registrants
part 156 in subpart H and the container durably marked on the container. flexibility in where to place these
regulations being added to 40 CFR part Durable marking includes, but is not statements. Some registrants may
165 in today’s rule. (See Unit IX.M.) limited to etching, embossing, ink choose to place them all together, while
Container-related labeling jetting, stamping, heat stamping, others may choose to place the recycling
instructions for plant-incorporated mechanically attaching a plate, molding, statement after the cleaning (residue
protectants will be determined on a or marking with durable ink. removal) instructions.
case-by-case basis until specific labeling 2. Changes. In the final rule, EPA has The final rule was revised to require
guidance for plant-incorporated changed the word ‘‘permanent’’ to a referral statement on the label if any
protectants are promulgated under 40 ‘‘durable’’ to describe the required of the statements except the batch code
CFR part 174. container marking. In addition, the are placed on the container. Examples of
Existing EPA guidance on label language from the preamble of the appropriate referral statements are ‘‘See
statements for cleaning, recycling and proposed rule that lists acceptable container for handling and recycling
disposing of pesticide containers, formats of the marking was added to the statements.’’; ‘‘Recycling information is
includes: regulations to clearly establish our located on the container.’’; and ‘‘See the
• The Label Review Manual (Ref. 44); intent. Finally, the phrase ‘‘as container for refill limitations.’’ The
referral statement will provide flexibility while still prohibiting the Registrants must use at least one of the
information to allow users who look for reuse of nonrefillable containers for following statements:
refill prohibitions or recycling materials other than pesticides, (1) ‘‘Offer for recycling if available.’’
statements in the storage and disposal including but not limited to water, food, (2) ‘‘Once cleaned, some agricultural
section of the label to find the feed and oil. However, EPA does not plastic pesticide containers can be taken
information. believe that household/residential to a container collection site or picked
i. Statement identifying a pesticide users are likely to be able to up for recycling. To find the nearest site,
nonrefillable container—Final properly manage rinsate and other contact your chemical dealer or
regulations and changes. The pesticide-containing materials in this manufacturer or contact [a pesticide
identifying phrase ‘‘Nonrefillable way, so this statement cannot be used container recycling organization] at
container’’ is identical to the identifying on household/residential use products. [phone number] or [web site]. For
phrase in the proposed regulations. The third statement was added in example, this statement could be ‘‘Once
ii. Reuse Statement—Final response to comments describing ready- cleaned, some agricultural plastic
regulations. Registrants must choose to to-use products in containers that are pesticide containers can be taken to a
use one of the following reuse intended to be sold or distributed only container collection site or picked up
statements, as appropriate. Products once, but that can be refilled by the end for recycling. To find the nearest site,
with labels that allow household/ user with a concentrate (a different contact your chemical dealer or
residential use must use the statement product) and then diluted. The third manufacturer or contact the Ag
in item (1) or (3). All other products statement gives registrants the option to Container Recycling Council (ACRC) at
must use one of the three statements. continue distributing products in this 1–877–952–2272 (toll-free) or
(1) ‘‘Do not reuse or refill this way, but still provides end users with www.acrecycle.org.’’
container.’’ the message that these containers (3) A recycling statement approved by
(2) ‘‘Do not reuse this container to should generally not be reused or EPA and published in an EPA
hold materials other than pesticides or refilled. document, such as a Pesticide
dilute pesticides (rinsates). After iv. Comments - refill with concentrate. Registration Notice.
emptying and cleaning, it may be Several commenters noted that a (4) An alternative recycling statement
allowable to temporarily hold rinsate or prohibition on reuse or refill would that has been reviewed and approved by
other pesticide-related materials in the make a common practice illegal. EPA.
container. Contact your state regulatory Specifically, some ready-to-use products (5) ‘‘Offer for reconditioning if
agency to determine allowable practices are distributed or sold in containers that appropriate.’’
in your state.’’ are intended to be sold or distributed ii. Changes. The final rule includes
(3) The following statement may be only once (and therefore meet the options for container recycling
used if a product is ‘‘ready-to-use’’ and definition of nonrefillable containers). statements to account for differences in
its directions for use allow a different However, these containers can be the process for recycling different kinds
product (that is a similar, but refilled by the end user (generally a of containers (e.g., aerosol cans or
concentrated formulation) to be poured household user) with a concentrate and plastic jugs) and differences in recycling
into the container and diluted by the then diluted. A few respondents among markets (agricultural or
end user: ‘‘Do not reuse or refill this suggested not requiring the reuse household). In addition, the proposed
container unless the directions for use statement on ready-to-use product rule specified the statement ‘‘Offer for
allow a different (concentrated) product containers and several others offered an recycling if possible.’’ In the final rule,
to be diluted in the container.’’ alternative statement for these products. EPA changed the word possible to
iii. Changes. The proposed rule v. EPA response - refill with available. Finally, EPA added a
required the first statement, ‘‘Do not concentrate. EPA agrees that the use of statement ‘‘Offer for reconditioning if
reuse or refill this container.’’ The containers of ready-to-use products to appropriate’’ as an alternative.
second statement was added to address be refilled with a different product (that iii. Comments - recycling. Several
a common practice where pesticide is a similar, but concentrated commenters addressed the issue of
applicators use plastic jugs to hold formulation) and diluted by the end recycling. A user group supported the
rinsate that contains the pesticide on the user should be allowed to continue. In continued development of container
label, which could be interpreted as a a relatively quick search of product collection and recycling programs. A
violation of a ‘‘Do not reuse’’ statement. labels, EPA found a number of registrant endorsed recycling but
While EPA has some concerns about the household/residential use herbicides commented that the language must
widespread storage of rinsate or other with label directions that allowed this comply with Federal Trade Commission
pesticide-containing materials in practice. This environmentally (FTC) guidance. A registrant group
pesticide containers (without proper beneficial practice reduces the amount requested that the terms of PR Notice
management practices such as marking of packaging used and packaging waste 94–2 ‘‘Recycling Empty Aerosol
the contents and date on the container), produced, since a smaller container can Pesticide Containers’’ as amended by
we acknowledge the day-to-day reality be used to distribute the concentrate. letter on June 9, 1994, be codified into
of pesticide operations that sometimes Therefore, the final regulation includes regulation. A State regulatory agency
there are materials such as rinsates or an alternative statement that allows this urged EPA to specifically direct users to
leftover tank mix that must be dealt practice to continue. Currently, we agricultural pesticide container
with. While temporarily storing these believe this situation is most commonly collection programs to prevent
materials in pesticide containers can used for household products, although agricultural pesticide containers being
create disposal problems if the material the final regulations were written to offered for household recycling
is not managed properly and promptly, allow any products (not just household/ collection. Another State regulatory
temporary storage is better than most of residential use products) to be able to agency suggested a label statement
the other low-cost, practical alternatives use the appropriate refill/reuse requiring small rinsed containers to be
such as dumping the rinsate or leftover statement on their labels. delivered to State-authorized container
material. Therefore, the second 3. Recycling or reconditioning collection programs. This commenter
statement was added to provide some statement—i. Final regulations. stated that use of the word ‘‘possible’’
would be problematic because while it containers distributed by the ACRC improved and is engaged in discussions
is possible for farmers to travel more member companies. (Ref. 1) EPA has with stakeholders to address this issue.
than 100 miles to a recycling center, it been told by ACRC recyclers and Container disposal instructions were not
would be unreasonable to expect that. A member companies and by ACRC’s State addressed in the proposed container
group of people involved with pesticide partners that participation could be and containment regulations and
container recycling in Washington State increased if the label specifically therefore are outside the scope of the
submitted suggestions for changing the referred to the ACRC program. EPA final regulations. In addition, EPA staff
storage and disposal statements on hopes to encourage the recycling of are actively working on improving the
pesticide containers. These comments pesticide containers by including this label manual.
specifically supported the efforts of the recycling statement as an option. EPA v. Comments - reconditioning. Many
Ag Container Recycling Council (ACRC) also recognizes the need for flexibility commenters on the proposed
and recommended a statement that in the label instructions, as other, regulations, including container
refers to the ACRC and provides the equally effective organizations may manufacturer and registrant groups,
ACRC web site. come into existence in the future, and stated that the regulations do not
In response to the 2004 notice, four that the organization Earth 911 account for the reconditioning of
State regulatory agencies and a (www.earth911.org), a clearinghouse of containers and opposed many proposed
registrant group urged the Agency to do information on household hazardous provisions because they would be
more to encourage recycling of pesticide waste disposal and recycling, may problematic for reconditioning. These
containers and to remove label eventually include information respondents also commented that some
references to burning or burying resources specifically for managing containers are commonly reconditioned,
containers. A few State agencies noted agricultural chemicals and containers. particularly plastic and steel drums
efforts by ACRC, Earth 911 and the EPA agrees that the word ‘‘possible’’ holding non-agricultural pesticides.
National Pesticide Stewardship Alliance may not be clear, and has replaced it vi. EPA response - reconditioning.
to promote recycling and reform label with the word ‘‘available.’’ ACRC EPA added a statement about
language. These respondents noted that programs are available that is, accessible reconditioning to the final rule as an
the Agency needs to go further than for agricultural pesticide users across alternative for containers that are
what was proposed in the rule in order much of the U.S., but not all areas have commonly reconditioned. The statement
to improve labeling such that burning local collection programs. EPA believes says ‘‘Offer for reconditioning if
and burying of containers is no longer that a reasonable interpretation of appropriate’’ because reconditioning is a
allowed. ‘‘available’’ is that pesticide containers logical, reasonable option only for
iv. EPA response - recycling. EPA are collected at a location that is the certain containers, specifically drums,
agrees with intent of the commenter same distance or closer than the and not others, such as plastic jugs and
who suggested codifying PR Notice 94– distance the user traveled to purchase aerosol cans. EPA believes this
2. The third option included in the final the pesticides. It is worth noting that the flexibility should alleviate some of the
rule, a recycling statement approved by statement ‘‘Offer for recycling if commenters’ concerns about the
EPA and published in an EPA available’’ and the other statements in apparent disregard for reconditioning.
document, is included to account for PR § 156.140(a)(3) give pesticide users an 4. Batch code—i. Final regulations. A
Notice 94–2, other PR Notices, the label option for managing the containers. lot number, or other code used by the
review manual, and other documents. These statements do not require the registrant or producer to identify the
EPA agrees with the State regulatory recycling or reconditioning of batch of the pesticide product, is
agencies and Washington container containers. EPA believes that recycling required for each nonrefillable container
recycling group that it may be beneficial or reconditioning pesticide containers is either on the label or the container.
to provide more specific information a responsible, preferable way of ii. Changes. The text specifying a lot
about pesticide container collection and managing pesticide containers. We number or other code in the final rule
recycling programs in this statement, encourage these practices to save is identical to the text in the proposal.
particularly for agricultural pesticide resources and minimize the amount of In the final rule, though, the
products. Therefore, the final material being disposed, although there introductory paragraph was modified to
regulations allow the use of a new are other legal ways of managing the clarify that the lot number/batch code
recycling statement that provides details containers. could be placed anywhere on the label
about how to obtain more information The final rule also includes the option or durably (not permanently) marked on
on agricultural pesticide container for a registrant to offer an alternative the container.
collection and recycling programs such recycling statement. This is intended to
as the ACRC. The ACRC is a non-profit allow for the possibility of changes in D. Statements Required for Refillable
organization that promotes and supports the extent to which and the manner in Containers (§ 156.140(b))
the collection and recycling of plastic which pesticide containers are recycled 1. Final regulations. For refillable
pesticide containers in the U.S. The over time. EPA must review and containers, one of the following
collection and recycling programs approve an alternative recycling statements is required on the label or
conducted by the ACRC grew statement before it can be placed on a the container:
significantly during the 1990’s, so EPA pesticide label. One part of our review (1) ‘‘Refillable Container. Refill this
is adding this statement to reflect will involve considering whether the container with pesticide only. Do not
currently available programs (that were alternative statement is consistent with reuse this container for any other
in the developmental stage when the the FTC guidelines on environmental purpose.’’
proposed regulations were being statements in 16 CFR part 260, ‘‘Guides (2) ‘‘Refillable Container. Refill this
written). For example, in 1993 the for the Use of Environmental Marketing container with [common chemical
ACRC collected about 2.5 million Claims.’’ (Ref. 5) (http://www.ftc.gov/ name] only. Do not reuse this container
pounds of plastic containers. In 2001, bcp/conline/edcams/eande/index.html) for any other purpose.’’
ACRC collected over 7 million pounds EPA agrees with commenters that If the statement is on the label, it must
of plastic containers, which represents label language regarding burning and be placed under the ‘‘Storage and
about 25 percent of the plastic burying containers needs to be Disposal’’ heading. If the statement is
put on the container, the label must made a few minor changes in the final Specific instructions to consumers to rinse
include an appropriate referral rule. The proposed rule specified a their empty containers have been left out of
statement under the ‘‘Storage and subheading entitled ‘‘Container these revised instructions. Experience has
shown that many consumers are confused by
Disposal’’ heading. Cleaning’’ under the heading ‘‘Storage rinsing procedures and often incorrectly
2. Changes. The proposed rule and Disposal.’’ In the final rule, EPA dispose of the rinse water down the drain or
specified only the first statement. In deleted this subheading because it is down sewers. States have reported some
response to comments, the second unnecessary. Section 156.144(b) detections of pesticides in drinking water
statement was added to the final rule as regarding placement of the residue that appear, in some cases, to be linked to
an option to accommodate containers removal statements was shortened by disposal or rinsing in residential waste water
that may be filled with a chemical that deleting the reference to Directions for systems. In addition, storage of rinsate is
has both pesticidal and non-pesticidal highly discouraged because of the absence of
Use, which isn’t necessary. EPA
uses. Also, the phrase ‘‘Refillable adequate labeling or packaging. There is also
believes requiring the statements to be the potential risk of adverse chemical
container’’ was added to both placed under the heading ‘‘Storage and reactions occurring when products are
statements to allow pesticide users, Disposal’’ is sufficient because poured down drains, singly, or in
registrants and government regulators to § 156.10(i)(2)(ix) requires this heading to combination with other products.
clearly identify whether a container is be included in the directions for use.
nonrefillable or refillable. The final rule One potential solution that EPA
Finally, a few editorial changes were
specifies that if the statement is placed considered but rejected when finalizing
made to shorten the phrase ‘‘residue
on the label (rather than on the PR Notice 2001–6 was to require rinsing
removal statements and instructions’’ to
container), it must be placed under the of non-antimicrobial, residential/
‘‘residue removal instructions’’ to be
‘‘Storage and Disposal’’ heading. EPA household use pesticide containers and
more precise and consistent. The rest of
added this language to reinforce the to include instructions on the label for
the requirements of § 156.144 are how to manage the rinse water. For
requirement in § 156.10(i)(2)(ix) for the identical to those in the proposed rule.
instructions in subpart H to appear example, the label statement in PR
FIFRA section 19(f) mandates Notice 2001–6 could have instructed the
under the ‘‘Storage and Disposal’’ ‘‘regulations prescribing procedures and
heading. Lastly, the final rule was user to add the rinse water to the
standards for the removal of pesticides pesticide mixture that will be applied,
revised to require a referral statement on from containers prior to disposal’’ and
the label if the statement is placed on or if that isn’t feasible, the rinse water
says that EPA ‘‘may, at the discretion of could be applied to a site on the label
the container. An example of an the Administrator, exempt products
appropriate referral statement is in accordance with the other label
intended solely for household use’’ from provisions. EPA rejected this option
‘‘Refilling limitations are on the these requirements. In the proposed
container.’’ The referral statement will because it could confuse consumers, it
rule, EPA chose not to exercise this could lead to the storage of rinse water
provide information to allow users who discretion and proposed to require
look for refill prohibitions in the storage in the absence of adequate labeling or
cleaning instructions on the labels of packaging, and it would require several
and disposal section of the label to find household products because the
the information. additional sentences on an already
preamble of the proposed rule stated crowded label.
E. Residue Removal Instructions - that, in many instances, the same Therefore, EPA has decided to omit
General (§ 156.144) pesticide product in the same container rinsing instructions from the label
is sold for agricultural or industrial use, directions specified for non-
1. Final regulations. Unless exempt as well as for use in the home, yard, or
from these requirements, the label of antimicrobial, residential/household
garden. pesticide products in PR Notice 2001–
each pesticide product must have
The 1999 Supplemental Notice (Ref. 6. In markets where empty containers of
instructions on the removal of pesticide
53) stated that the changes in scope these pesticides are recyclable, it is
residue prior to disposal, as specified in
would only apply to the container assumed that the recycling programs
§§ 156.146 and 156.156. The regulations
standards and that: will provide consumers with
in § 156.144 include the following EPA believes that it is appropriate to have
specifications: instructions to rinse the containers if the
container cleaning and disposal instructions
• Residue removal statements are recycling program believes it is
on the labels of all pesticides because of
required for both nonrefillable and safety and environmental protection necessary. Additionally, if a
refillable containers. considerations for recycling operations. It is manufacturer wants to include a rinsing
• Residue removal statements must necessary for pesticide containers to be statement on the labels of these
be placed under the heading ‘‘Storage properly emptied and cleaned prior to being pesticides, EPA would consider such a
and Disposal.’’ recycled to protect workers who handle the request. However, if a manufacturer
• Residential/household use pesticide recyclable material and to prevent releases of chooses to include a rinsing statement,
products are exempt from the residue pesticides to the environment. Because it should also include instructions about
removal statement requirements. pesticide containers from all segments of the how to manage the rinse water.
pesticide industry are currently being
• EPA may modify or waive the In the final rule, EPA is continuing
recycled, container cleaning and disposal
residue removal requirements or permit the policy to omit rinsing instructions
instructions are needed on the labels of all
or require alternative labeling pesticides. ... from the label directions for non-
statements. antimicrobial, residential/household
2. Changes. The most significant During the development of the final pesticide products. In addition, EPA
change to this section is that the final PR Notice 2001–6, ‘‘Disposal decided to extend this policy to
rule exempts residential/household use Instructions on Non-Antimicrobial, antimicrobial, residential/household
pesticide products from the residue Residential/Household Use Pesticide pesticide products in the final rule.
removal statement requirements. The Product Labels,’’ however, EPA decided Antimicrobial products were not
proposed rule would have applied to to change this position for non- included in the scope of PR Notice
the labels of all products, regardless of antimicrobial, residential/household use 2001–6 because of differences of
the pesticide market in which they are pesticide products. (Ref. 49). As stated opinions on the disposal statements in
sold, distributed and used. EPA also in PR Notice 2001–6: the PR Notice, not because of problems
with applying the no-rinsing policy to proposed rule gave registrants the containers. Many of these respondents
household/residential antimicrobial option to include either triple rinsing or suggested excluding pressure rinsing
products. EPA believes that some of the pressure rinsing or both. Based on from household product labels. A
same concerns about household/ comments, EPA changed the final rule registrant group also added institutional
residential pesticide users, including because triple rinsing is always and industrial products to this
users being confused and trying to possible, whereas pressure rinsing suggested exclusion. Similarly, another
prevent the storage of rinsate, apply requires specific equipment. Other registrant group commented that
equally to antimicrobial and non- substantial changes to the residue pressure rinsing is not common in the
antimicrobial products used by these removal instructions include: institutional sector. Alternatively, a few
household/residential pesticide users. • Adding the phrase ‘‘or equivalent’’ registrant groups and a registrant
as an option so labels allow equivalent recommended that pressure rinsing
F. Residue Removal Instructions for means of rinsing containers. This was instructions be permitted only on
Nonrefillable Containers - General added to account for systems (such as containers with capacities larger than
(§ 156.146) closed system rinsing or home-made one gallon.
1. Final regulations. Section 156.146 pressure rinsing systems) that are v. Decision making process. Some
sets out the residue removal instructions designed to clean containers thoroughly registrants and registrant groups
for nonrefillable containers. The label of but do not technically triple rinse the commented that EPA implies that some
a product must comply with these containers. This change was made to the sort of decision making process must be
instructions if all of the following statement identifying when containers used to determine if triple rinsing,
criteria are met: must be rinsed and is discussed in more pressure rinsing, or both should be
• The product must comply with the detail in Unit IX.G. included and requested EPA to clarify
residue removal instructions based on • Both the triple rinse and pressure this. For example, does a container have
§ 156.144 (i.e., it is not a residential/ rinse procedures were modified so they to meet a six 9’s standard by a
household product, EPA has not waived would take less time. For example, the laboratory pressure rinsing test for
the requirement, or EPA has not intervals of time for draining and pressure rinsing instructions to be
established an alternative requirement); shaking the containers were reduced. included on the label? If so, EPA has to
• The product is dilutable (it could be These changes are intended to make the specify the pressure rinsing test
a liquid or a solid); and procedures more practical and therefore procedure.
• The product is distributed or sold more likely to be followed by end users. vi. Effectiveness of procedures.
in a nonrefillable container that is rigid. These changes are discussed in more Several commenters addressed the
The preamble to the proposed rule detail in Unit IX.H. efficacy of pressure rinsing vs. triple
stated that EPA was holding sections in Numerous other minor modifications, rinsing. A registrant group and two
reserve for residue removal instructions which are described in Units IX.G. - registrants commented that pressure
for other formulation/container IX.K., were made to the residue removal rinsing should be recommended on
combinations, such as dilutable instructions for nonrefillable containers. labels only if it has been shown to be
products in non-rigid containers. While 3. Comments - which procedure? The as effective as triple rinsing. Another
EPA may address other kinds of proposed rule would have required the registrant stated that their studies (in
nonrefillable containers in the future, placement of either the triple rinse or addition to the work of other
the final rule establishes residue the pressure rinse procedure on the companies) shows that pressure rinsing
removal instructions only for dilutable label, with the option of including both. is not as effective as triple rinsing. A
products in rigid nonrefillable The preamble requested comments on State regulatory agency commented that
containers. this approach. The following comments pressure rinsing is a more effective
The labels of dilutable products that addressed this question. method of cleaning containers.
are subject to this requirement and that i. Both procedures. Several State vii. Advantages of pressure rinsing. A
are sold or distributed in rigid, regulatory agencies and a registrant State regulatory agency and a registrant
nonrefillable containers must comply group supported including both triple commented that pressure rinsing is
with the following standards: and pressure rinsing instructions on advantageous to the pesticide users
• A statement instructing the user to labels. A few of these commenters because it is a faster procedure.
clean the container promptly after pointed out that pressure rinsing alone 4. EPA response - which procedure?
emptying is mandatory; is not available to all applicators. EPA agrees with several of the points
• Triple rinsing instructions are ii. Alternative approach. A few dealer made by commenters, in particular, that
mandatory; groups recommended using the pressure rinsing alone is not available to
• Pressure rinsing instructions are statement ‘‘Pressure rinse or triple all applicators, that pressure rinsing
optional; and rinse’’ so users and dealers will not have isn’t appropriate for certain containers
• A registrant must obtain EPA to worry about having both rinse based on the pesticide market and/or
approval before including a rinsing systems available. container size, and that pressure rinsing
procedure that specifies a diluent other iii. Either or both procedures. A is attractive to pesticide users because it
than water. registrant group supported the approach is a faster procedure. Therefore, EPA
These requirements are discussed in of allowing the registrant to put either changed the approach so the final
more detail in Units IX.G. through IX.K. or both of the statements on the label, regulation requires labels to include the
below. because pressure rinsing would not be triple rinse procedure and gives
2. Changes. The final regulation appropriate for institutional products registrants the option to also include the
includes several changes from the and including both would crowd the pressure rinse procedure. This approach
proposal. The most significant changes label. provides a rinse procedure (triple
are that the final rule requires iv. Limit pressure rinsing. Some rinsing) that all pesticide users can
registrants to place the triple rinse commenters, including registrants, follow. It also gives registrants the
instructions on all labels and provides registrant groups, and a State regulatory option to include pressure rinsing if
registrants the option to also include the agency, expressed concern about they believe it is appropriate (with EPA
pressure-rinse instructions. The household users pressure rinsing small concurrence during the review of
labels), which is preferable to Instead, registrants have the option to that, based on results from their
establishing criteria for appropriate (or include pressure rinsing if they believe container collection and recycling
inappropriate) pressure rinsing it is appropriate (with EPA concurrence programs in the early 1990’s, it is
situations in the regulations. during the review of labels). obvious that not all containers are
EPA believes that both triple rinsing There are other integral parts to rinsed immediately. A registrant group
and pressure rinsing are effective ways achieving the goal of having clean suggested using the phrase ‘‘reasonably
for users to clean most containers (with containers before they are disposed or promptly’’ rather than ‘‘immediately’’ to
possible exceptions for size and other recycled, including educating pesticide account for industrial situations where
situations) in the field. This conclusion users on the importance of rinsing and its not practical to rinse immediately
is based on the rinsing studies described the proper procedures, potential spot such as when multiple oil wells are
in Reference 40 and on the field checks/inspections to ensure that the treated from the same drum of an
experience of people who have labels and regulations are being industrial biocide and rinsing
inspected containers over the past complied with, and creating an equipment is not available. An
decade of pesticide container recycling incentive for pesticide users to comply agricultural pesticide registrant
programs. One registrant group (or a disincentive for non-compliance). supported immediate rinsing in a farm
provided comprehensive comments EPA looks forward to working with all context so that the rinsate could be
during the 2004 reopening of the stakeholders, including State regulatory added to the application mixture, but
comment period based on the ACRC’s agencies, pesticide registrants, noted that clean water may not be
experience over the past 10 years. This distributors and dealers, pesticide users, available at every loading site.
commenter described ACRC’s efforts to pesticide educators, and trade 4. EPA response - clean promptly.
assess and control the risk from using associations in accomplishing this goal. EPA considers the timing of the residue
the recycled plastic and noted that, removal procedure to be a critical factor
since ACRC’s inception in 1992, there G. Timing of the Residue Removal in effectiveness, and is maintaining the
have been no reports of incidents where Procedure (§ 156.146(a)) approach in the proposed rule that
public health or safety has been 1. Final regulations. For products that requires users to rinse containers within
compromised as a result of exposure to are subject to the requirements for a certain (short) time period after
the minimal residues found in recycled residue removal instructions, the label emptying them. When rinsing is not
plastic pesticide containers. This of each nonrefillable container must performed soon after emptying the
registrant group also stated that ACRC’s include one of the following statements: container, the residue can dry and
experience with recycling clean, rinsed (1) ‘‘Clean container promptly after adhere to the inside and outside of the
one-way pesticide containers for more emptying.’’ container, and is then more difficult to
than a decade leads them to believe that (2) ‘‘Triple rinse or pressure rinse remove. Containers with dried residue
residue removal is an issue of container (or equivalent) promptly after are likely to be rejected by pesticide
instructing applicators to triple or emptying.’’ container recycling and collection
pressure rinse containers immediately (3) ‘‘Triple rinse container (or programs as well as at solid waste
after use. equivalent) promptly after emptying.’’ landfills.
EPA’s goal is to establish a situation The statement about timing must EPA believes that requiring pesticide
where all containers are adequately immediately precede the rinsing users to rinse containers promptly after
cleaned before they are recycled, instructions and must be consistent emptying them is the best approach for
disposed, or otherwise managed. As with the rinsing instructions (triple the final rule. Specifying that the
stated in Unit V.H.1., one regulatory rinse or both triple and pressure rinse) containers are cleaned promptly
contribution to achieving this goal is that are include on the label. accomplishes the goal of rinsing them
ensuring that pesticide users have 2. Changes. This section of the final soon after they are emptied and before
access to clear, detailed instructions for rule includes three changes from the the residue dries in the containers. Also,
how to clean the containers. In the final proposed regulation. First, the proposed prompt rinsing provides a little more
rule, pesticide labels must include triple requirement to rinse ‘‘immediately’’ flexibility than immediate rinsing. As an
rinse instructions and may also include after emptying was replaced in the final example, consider a pesticide applicator
pressure rinse instructions. rule by requiring the container to be who pours product from one container,
Another regulatory contribution is to rinsed ‘‘promptly’’ after emptying it. sets it down to pour out another
ensure the use of container designs and Second, the final rule adds the phrase container, and then rinses both
formulations that facilitate effective ‘‘(or equivalent)’’ to the two statements containers. Technically, this could be
residue removal, which is the intent of that identify a specific cleaning considered a violation if the label
the residue removal standard for procedure, e.g., triple rinsing. Third, the specified immediate rinsing, because
nonrefillable containers in § 165.25(f). proposed rule included four options for some time passed between the emptying
The residue removal test procedure statements to include on the label. EPA and the rinsing of the first container.
requires containers to be triple rinsed. is not finalizing one of these statements However, this example fits within EPA’s
In this case, triple rinsing is used as an in the final rule--‘‘Pressure rinse understanding of prompt action.
indication of how easily the pesticide container immediately after emptying’’ Requiring that containers be rinsed
can be removed from the container. The --because it is no longer needed. The promptly gives pesticide users,
residue removal test procedure does not final rule does not allow pressure regulatory agencies and inspectors some
require containers to be pressure rinsed rinsing to be the only procedure listed discretion in determining appropriate
nor is it intended to evaluate whether on the label, so this statement is time spans. It is beyond the scope of this
triple rinsing or pressure rinsing is more irrelevant. preamble to describe every situation
effective for a certain container and 3. Comments - clean promptly. Some that is or is not appropriate, so EPA is
pesticide formulation. Therefore, the State regulatory agencies supported the relying on the good judgement of
decision of whether or not to include statement regarding the timing of applicators, regulatory agencies and
pressure rinsing instructions on the rinsing, stating that it should improve inspectors to assess the specific
pesticide label is not tied to the results the management of the containers. Two conditions of the situation. However,
of laboratory residue removal testing. other State regulatory agencies stated EPA believes that situations where the
time between emptying and rinsing is pressure rinsing (changed from 30 draining times were based on the
days or weeks and where the residue seconds in the proposal); rinsing instructions of many States,
has completely dried inside the • 10 seconds to agitate/shake which were incorporated into the
container are definitely beyond the containers during triple rinsing laboratory triple rinse test methodology
boundaries of prompt rinsing. In (changed from 30 seconds in the for the proposed nonrefillable container
addition, EPA strongly recommends that proposal); residue removal standard.
pesticide users rinse containers when • 10 seconds to drain rinsate from EPA contracted for two studies on the
the application mixture is being containers after each shaking interval effectiveness of shorter triple rinse
prepared so the rinsate can be added to during triple rinsing (changed from 30 procedures. In a study conducted by
the application mixture. This provides seconds in the proposal); and Formulogics (Refs. 7 and 38), a flowable
many benefits, including getting all of • At least 30 seconds to pressure concentrate product was tested in three
the value out of the product and rinse the container during pressure containers: 1–gallon and 2.5–gallon
avoiding the creation of a potential rinsing. (The proposed rule specified 30 plastic jugs and a 5–gallon steel flathead
waste (which could happen if the seconds; the phrase ‘‘at least’’ was can. Nine different rinsing procedures
rinsate was collected separately). added to compensate for variations in were conducted for each container size
5. Comments - equivalency. In pressure rinsing equipment and in by varying the initial drain, shake and
commenting on the proposed approach pressure.) rinsate drain times between 5, 10 and 30
for residue removal instructions, a few 3. Comments. A registrant group, a seconds. The shake and rinsate drain
commenters (a State regulatory agency registrant and two State regulatory times were always the same. For
and a registrant) supported maintaining agencies commented that a shorter rinse example, the three variations for the
the current cleaning statement of time would be better and would initial drain time of 5 seconds were: 5
‘‘Triple rinse (or equivalent)’’ because it encourage user compliance, although second shake and 5 second rinsate
is sufficient if followed and it offers the two State regulatory agencies drain; 10 second shake and 10 second
flexibility. supported a shorter rinse time only if it rinsate drain; and 30 second shake and
6. EPA response - equivalency. EPA was demonstrated that the containers 30 second rinsate drain. These same
agrees with the commenters that are cleaned adequately. Another State three shake and rinsate drain times were
including the phrase ‘‘(or equivalent)’’ regulatory agency stated that, in a 1991 conducted for the initial drain times of
that is on current labels is beneficial and survey, 43 percent of private applicators 10 second and of 30 seconds. The
the final rule adds this phrase as an and 11 percent of commercial pesticide concentration in the second
option to the ‘‘rinse promptly’’ applicators responded that they did not through fifth rinses was measured. EPA
statement. This phrase was added to rinse containers because it took too concludes that all nine rinsing
account for systems (such as closed much time. A registrant group opposed procedures tested were effective in
system rinsing or home-made pressure the initial drain time of 30 seconds as cleaning all three containers because the
too long and inappropriate for closed active ingredient concentration in the
rinsing systems) that are designed to
systems. This commenter also fourth rinse showed at least 99.99%
clean containers thoroughly but do not
responded that some states have removal in all rinse time iterations. Two
technically triple rinse the containers.
requirements different than a 30–second of the rinse procedures for the 5–gallon
The alternative rinsing system should be
drain and urged EPA to consider these container (5 sec. initial drain/5 sec.
thorough and it is the responsibility of
alternatives. A registrant commented shake & rinsate drain and 30 sec. initial
the pesticide user to ensure that it is
that the times of the proposed rinsing drain/5 sec. shake & rinsate drain)
equivalent to triple rinsing.
procedures seemed reasonable and resulted in 99.99 percent removal; all
H. Duration of Triple and Pressure expressed doubts that the triple rinse other rinse procedures for all containers
Rinse Procedures (§ 156.146(b) and procedure could be shortened much. met at least five 9’s percent removal and
156.146(c)) This commenter added that a 40–second most resulted in six 9’s percent removal.
1. Final regulations. As discussed in pressure rinse is inadequate to achieve In a study conducted by the
Unit IX.I. for triple rinsing and Unit IX.J. 99.9999 percent removal. University of Florida (Refs. 14 and 41),
for pressure rinsing, the rinsing 4. EPA response. In the preamble of two formulations were tested in three
procedures for containers that are small the proposed rule, EPA estimated that containers, 1–gallon, 2.5–gallon and 5–
enough to shake that are defined in the the proposed triple rinsing instructions gallon plastic jugs. The flowable
final regulation take less time to would take approximately 5 minutes to concentrate was tested in all three
conduct than the proposed procedures. perform and the pressure rinsing containers and the emulsifiable
The key time intervals identified in the procedure would take approximately 2 concentrate was tested in the 2.5–gallon
procedures are: minutes. EPA also requested comments and 5–gallon containers. Four different
• How long to drain liquid product on the time burden of the proposed rinsing procedures were conducted for
from containers (both triple and rinsing procedures, and the voluntary each container size by varying the initial
pressure rinsing); submission of data on residue removal, drain, shake and rinsate drain times
• How long to agitate/shake including in particular the cleaning between 10 and 30 seconds where the
containers during triple rinsing; efficiency of any suggested shorter triple shake and rinsate drain times were
• How long to drain rinsate from rinse and pressure rinse procedures. always the same. Again, EPA concludes
containers after each shaking interval EPA agrees with the commenters that that all four rinsing procedures tested
during triple rinsing; and a shorter rinse time would be better and were effective in cleaning both
• How long to pressure rinse the would encourage user compliance with formulations from all of the containers
container during pressure rinsing. the requirement to rinse pesticide because the active ingredient
2. Changes. The procedures in the containers. In particular, we believe it is concentration in the fourth rinse
final rule specify the following times for relatively unlikely that a pesticide user showed at least 99.99% removal in all
each of these intervals for containers would spend about 5 minutes triple rinse time iterations.
that are small enough to shake: rinsing each container. The 30–second The triple rinse procedure for labels
• 10 seconds to drain liquid product intervals for the initial container drain in the final rule includes 10 second
from containers for both triple and time, the shaking time and the rinsate- initial drain, shake and rinsate drain
times. EPA believes the data described a mix tank. Fill the container 1/4 full...’’ EPA agrees with the registrant and
above shows that this shorter triple The rest of the procedure is identical to believes that ‘‘shake’’ is a better
rinsing procedure, which should the one for liquids. description of the intended activity than
encourage end user compliance with the For containers that are too large for ‘‘agitate.’’ We decided not to include the
requirement to triple rinse, will users to shake (i.e., containers larger qualifier ‘‘vigorously’’ to keep the
adequately clean containers prior to than 5 gallons for liquids or 50 pounds statement as succinct as possible. This
recycling or disposal. for solids), the triple rinse instructions kind of information could be passed
In addition, EPA has lowered the are: along to users during training and
residue removal requirement in the final Triple rinse as follows: Empty remaining outreach.
nonrefillable container regulations from contents into application equipment or a mix 5. Comments - large containers.
six 9’s (99.9999 percent) to four 9’s tank. Fill the container 1/4 full with water. Several commenters described problems
(99.99 percent), as discussed in Unit Replace and tighten closures. Tip container with cleaning drums according to the
on its side and roll it back and forth, ensuring proposed triple rinse statement. A
V.H. The shorter rinse procedures at least one complete revolution, for 30
reached at least 99.99 percent removal registrant group stated that it is
seconds. Stand the container on its end and
in all of the containers and formulations tip it back and forth several times. Turn the impractical to fill a 55–gallon drum one
tested. As cited by one of the State container over onto its other end and tip it quarter full because more than 40
regulatory agencies in its comments, the back and forth several times. Empty the gallons of rinsate would be produced. A
field reality is that many users who do rinsate into application equipment or a mix different registrant group and a
not rinse claim the time factor as the tank or store rinsate for later use or disposal. registrant recommended directing the
reason. By reducing the time frames in Repeat this procedure two more times. user to place the drum on its side and
the cleaning instructions, EPA hopes to roll it, because it is extremely difficult
2. Changes. One significant change
increase compliance within the to shake a large container that is one-
from the proposed rule is that the final quarter full. Another registrant
pesticide user community. regulation requires a triple rinse commented that an additional statement
I. Triple Rinse Instructions procedure to be on the label, where the that describes rinsing by recirculation
(§ 156.146(b)) proposal gave registrants the option to would be helpful, but pointed out that
include triple rinsing or pressure rinsing many drum users don’t use pumps to
1. Final regulations. For products that or both. Another modification is that the
are subject to the requirements for empty them.
final regulations provide a defined 6. EPA response - large containers.
residue removal instructions, the label procedure for containers that are too
of each nonrefillable container must EPA agrees with the suggestion by the
large for users to shake. Also, the phrase commenters who recommended
include triple rinse instructions. There ‘‘or a mix tank’’ was added as an option
are three different sets of triple rinsing directing the user to place a drum on its
for where the product or the rinsate can side and roll it. EPA is hesitant to
instructions: be placed. In addition, the following
• For containers that are small recommend a cleaning procedure for
clarifying changes were made to both larger containers that requires
enough for users to shake them, holding
sets of instructions for triple rinsing equipment that a pesticide user may not
dilutable liquid pesticides;
smaller containers that can be shaken: have, such as a pump, or an
• For containers that are small
• The introductory text specifies that appropriately sized, heavy-duty
enough for users to shake them, holding
the instructions apply to ‘‘containers pressure rinse nozzle. Therefore, we
dilutable solid pesticides; and
small enough to shake’’; decided to define a triple rinse
• For containers that are too large for
• The instruction to ‘‘agitate’’ was procedure in the final regulation for
users to shake.
In general, EPA believes that the largest changed to ‘‘shake’’; and containers that are too large to be
containers that users can shake during • As discussed in Unit IX.H., the time shaken. This is consistent with the
a triple rinse are those with capacities intervals were changed from 30 seconds approach in the final rule to require
of 5 gallons for liquids and 50 pounds to 10 seconds for the initial draining of triple rinsing because all pesticide users
for solids. the container (for liquid products only), can comply with these instructions and
The triple rinse instructions for liquid the time the container needs to be to allow pressure rinsing as an optional,
dilutable pesticide products in shaken, and for the draining of the additional statement.
containers small enough for users to rinsate.
3. Comments - general. A State J. Pressure Rinse Instructions
shake are: (§ 156.146(c))
Triple rinse as follows: Empty the regulatory agency pointed out that the
remaining contents into application directions prohibit preparing the use 1. Final regulations. For products that
equipment or a mix tank, and drain for 10 dilution in a mix tank, which is a are subject to the requirements for
seconds after the flow begins to drip. Fill the common practice. A registrant residue removal instructions, the label
container 1/4 full with water and recap. commented that the degree of agitation of each nonrefillable container may
Shake for 10 seconds. Pour rinsate into needs to be specified, e.g., shake include pressure rinse instructions. The
application equipment or a mix tank or store vigorously for 30 seconds. decision regarding whether to include
rinsate for later use or disposal. Drain for 10 4. EPA response - general. EPA did pressure rinsing instructions as an
seconds after the flow begins to drip. Repeat
this procedure two more times.
not intend to prohibit users from option is at the discretion of the
pouring a product into a mix tank or registrant, based on the registrant’s
The final rule specifies slightly diluting a product in a mix tank, and we assessment of the procedure’s
different instructions for solid dilutable have amended the triple rinse effectiveness and appropriateness for
pesticide products in ‘‘shake-able’’ procedures to address this oversight. the formulation/container combination.
containers, because solid materials do The phrase ‘‘or a mix tank’’ was added However, if the statement ‘‘Triple rinse
not ‘‘drip’’ as liquids do. The only to the instructions for emptying or pressure rinse container (or
difference for solid dilutable pesticide containers and to the rinsate equivalent) promptly after emptying’’ is
products is that the first line is ‘‘Triple management instructions to allow the used on the label as the statement about
rinse as follows: Empty the remaining product and rinsate to be placed into timing, pressure rinse instructions must
contents into application equipment or application equipment or a mix tank. be placed on the label. If a registrant
chooses to include pressure rinsing registrant group suggested inserting the L. Residue Removal Instructions for
instructions on the label as an option for nozzle ‘‘on the side of the container Refillable Containers (§ 156.156)
cleaning a liquid dilutable pesticide opposite the closure and in a direction 1. General (Introductory Text for
product, the statement must towards the bottom of the container.’’ A § 156.156)—i. Final regulations. The
immediately follow the triple rinse registrant recommended instructing the label of each pesticide product packaged
instructions. user to ‘‘Force pressure rinsing nozzle in a refillable container must include
The pressure rinse instructions for through what was the bottom of the the residue removal instructions
liquid dilutable pesticide products are: container or through the side of the specified in § 156.156. The residue
Pressure rinse as follows: Empty the container and...’’ and also recommended removal instructions must be given for
remaining contents into application that the instructions specify holding the
equipment or a mix tank and continue to
all pesticide products that are
container upside-down during the rinse distributed or sold in refillable
drain for 10 seconds after the flow begins to
drip. Hold container upside down over process. containers, including those that do not
application equipment or mix tank or collect 4. EPA response - container require dilution prior to application.
rinsate for later use or disposal. Insert orientation. EPA agrees with these ii. Changes. This requirement is
pressure rinsing nozzle in the side of the commenters that more details about substantively the same as it was in the
container, and rinse at about 40 PSI for at how to hold the container and where proposed regulation. Some minor
least 30 seconds. Drain for 10 seconds after editorial and format changes were made
the flow begins to drip. the nozzle should be inserted should be
included. Therefore, the procedure was to improve the clarity of the regulatory
Slightly different instructions are modified to instruct the user to hold the text. In addition, the second sentence,
required for pressure rinsing dilutable container upside down and to insert the which reinforces that the instructions
liquid and dilutable solid pesticide apply to all products that are distributed
rinsing nozzle in the side of the
formulations, because dry materials do or sold in refillable containers,
container.
not ‘‘drip’’ like liquids do. The pressure including those that do not require
rinsing procedure specified in the final K. Non-Water Diluents (§ 156.146(d)) dilution prior to disposal, was moved
regulations for dilutable solid pesticides from the subsection on instructions for
1. Final regulations. A registrant who residue removal to the introductory text.
is identical to the one for liquids, except wishes to require users to clean a
it does not include the initial 10–second EPA made this change because the
container with a diluent other than explanatory language applies to the
draining prior to rinsing. water (e.g. solvents) must submit a
2. Changes. One significant change is whole section (including instructions on
written request to EPA to modify the the timing of the procedures).
that pressure rinsing instructions are
residue removal instructions of this 2. Timing of residue removal
optional in the final rule, which
section. EPA may grant the request if procedures (§ 156.156(a))—i. Final
requires a triple rinse procedure to be
certain conditions are met. The regulations. The label of a pesticide
included on the labels of products that
registrant must indicate why a non- product packaged in a refillable
must comply. The proposal gave
water diluent is necessary and must container (and that is subject to this
registrants the option to include triple
propose appropriate residue removal requirement) must have one of the
rinsing or pressure rinsing or both. In following sets of instructions on the
instructions and disposal instructions
addition, the following changes were timing of container cleaning:
that identify the diluent. If the non-
made to both sets of instructions for • ‘‘Cleaning the container before final
water diluent is permitted by the label
pressure rinsing: disposal is the responsibility of the
to be used in application, the
• The phrase ‘‘or a mix tank’’ was person disposing of the container.
instructions may allow the rinsate to be
added as an option for where the Cleaning before refilling is the
added to application equipment or mix
product or the rinsate can be placed. responsibility of the refiller.’’
• As discussed in Unit IX.H., several tank. If use of the diluent in application
is not permitted, the rinsate must be • ‘‘Pressure rinsing the container
of the time intervals were changed from before final disposal is the
30 seconds to 10 seconds for the initial collected and stored for eventual
disposal. EPA must approve, in writing, responsibility of the person disposing of
draining of the container (for liquid the container. Cleaning before refilling
products only) and for the draining of the modification of the residue removal
instructions before the pesticide product is the responsibility of the refiller.’’
the rinsate after the pressure rinse. The The statement must immediately
length of the pressure rinse interval was can be distributed or sold.
precede the residue removal
changed from ‘‘30 seconds’’ to ‘‘at least 2. Changes. The final regulations are instructions and must be consistent
30 seconds.’’ almost identical to the proposed with those instructions.
• Several details about the orientation regulations regarding non-water ii. Changes. These statements were
of the container were added, including diluents. The final rule adds the expanded in the final regulation to
that the user must hold the container requirement for the registrant to propose distinguish between cleaning before
upside down and insert the rinsing disposal instructions to ensure that end disposal and cleaning before refilling in
nozzle in the side of the container. users have information about how to response to comments. The proposed
• The pressure requirement was appropriately dispose of rinsate from a statements simply said ‘‘Clean [or
changed from exactly 40 PSI to ‘‘about diluent other than water. One minor pressure rinse] container before
40 PSI’’ to allow a range of pressures in modification was to add ‘‘or mix tank’’ disposal.’’ The changes in the final rule
response to several comments as an option for where rinsate may be include adding ‘‘final’’ to the
expressing concern about requiring a added if the label allows the non-water description of disposal, adding that the
pressure of exactly 40 PSI in the field. diluent to be part of the application person disposing of the container is
3. Comments - container orientation. mixture. This change was made to be responsible for cleaning it, and
A few commenters noted that the consistent with the changes in the triple including the additional statement of
instructions are not clear in stating that rinse and pressure rinse instructions. In ‘‘Cleaning before refilling is the
the container must be inverted and that addition, several minor editorial responsibility of the refiller.’’
the rinse nozzle must be inserted on the changes were made to make this section 3. Residue removal instructions prior
side (or bottom) of the container. A more clear. to container disposal (§ 156.156(b))—i.
Final regulations. For pesticide products • The existing § 156.10(i)(2)(ix) comply with the label standards. To
sold or distributed in refillable regarding storage and disposal facilitate compliance while trying to
containers, the label must include instructions was modified to refer to the minimize the impact on companies,
instructions for cleaning the container applicable requirements in the rest of EPA lengthened the compliance period
prior to disposal. The instructions must today’s final rule. for the label standards to 3 years. EPA
be appropriate for the characteristics of 2. Changes. The most significant believes that a 3–year period is
the product and adequate to protect change to the approach taken in the sufficient based on the results of the
human health and the environment. The proposed regulation is that ‘‘shall’’ was economic analysis. In addition, 3 years
instructions could include any one of changed to ‘‘may’’ in the two paragraphs is consistent with the phase-in period
the following, as long as the instructions establishing blank spaces, thus changing for the nonrefillable container
meet the standards described in the them from requirements to options for regulations.
previous sentence: pesticide registrants. This change was
X. Relationship to Other Programs and
• The refilling residue removal made to provide flexibility to registrants
Agencies
procedure developed by the registrant in response to comments. EPA decided
for the pesticide product. to make several minor revisions to the Certain laws administered by EPA
• Standard industry practices for paragraphs allowing blank spaces to and other agencies may affect the design
cleaning refillable containers. link the 40 CFR part 156 regulations to of pesticide containers or procedures
• For pesticides that require dilution the 40 CFR part 165 repackaging and standards for removal of residue
prior to application, the following regulations and to clarify that the blank from pesticide containers. This section
statement: space does not change the requirement identifies the laws that EPA considers to
‘‘To clean container before final for having the net contents or EPA have the most significant impact on
disposal, empty the remaining contents establishment number on the label. pesticide containers and containment.
from this container into application First, the regulatory text allowing blank The description of these laws is for
equipment or a mix tank. Fill the spaces was modified to refer to the 40 informational purposes only; no
container about 10% full with water. CFR part 165 regulations that require changes are being made in the laws
Agitate vigorously or recirculate water refillers to ensure that the net contents described below. Nothing in this final
with the pump for 2 minutes. Pour or and EPA establishment number appear rule is intended to alter obligations
pump rinsate into application on the label. Second, the new paragraph under other statutes.
equipment or rinsate collection system. in § 156.10(d)(7) was amended to clarify A. Resource Conservation and Recovery
Repeat this rinsing procedure two more that § 156.10(a)(1)(iii) requires the net Act (RCRA)
times.’’ contents to be shown clearly and
• Any other statement the registrant prominently on the label. Requirements under RCRA may affect
considers appropriate. The paragraph on storage and the handling of pesticide containers
ii. Changes. The final regulations are disposal instructions was modified to under certain circumstances. RCRA
almost identical to those in the account for changes in the structure of Subtitles C and I are described briefly
proposed rule, except for a few editorial the container-related labeling, so it below.
and format changes. The phrase ‘‘To refers to subpart H of part 156 rather FIFRA sections 19(f)(3) and 19(h)
clean container before final disposal’’ than specific sections. Finally, a specify that FIFRA section 19 does not
was added to the specified procedure to requirement about the type size of the affect the requirements or authorities of
emphasize that users should only clean storage and disposal heading was added RCRA. Accordingly, today’s rule does
the container before disposal and not to § 156.10(i)(2)(ix) after the container not alter any existing RCRA
before having the container refilled. The regulations were proposed in 1994. requirements, and any applicable RCRA
phrase ‘‘into application equipment or a Today’s final rule maintains this provisions will apply in addition to the
mix tank’’ was added to be consistent requirement and corrects the reference provisions of any final rule issued under
with the emptying instructions for to the child hazard warnings, which are FIFRA section 19. In addition, FIFRA
nonrefillable containers. One sentence located in § 156.60(b). section 19(f)(1)(B)(iv) specifies that the
that helps clarify the scope of the residue removal regulations may be
N. Compliance Date (§ 156.159) coordinated with requirements for
requirement for residue removal
instructions on refillable containers was 1. Final regulations. The final container rinsing under RCRA. As
moved from this section to the regulations provide a 3–year compliance outlined below, this rule provides for
introductory text since it applies to the period. Specifically, within 3 years from coordination in this area.
whole section. today’s date, all pesticide products 1. Hazardous waste requirements.
distributed or sold by a registrant must Subtitle C of RCRA creates a cradle-to-
M. Amendments to Existing § 156.10 have labels that comply with the 40 CFR grave system for managing hazardous
1. Final regulations. The final rule part 156 requirements established in the wastes. RCRA Subtitle C regulations
modifies the existing regulations in 40 final rule. This gives registrants a phase include requirements for generators,
CFR 156.10 in the following three ways: in period of 3 years to comply with the transporters, and others who handle
• A new § 156.10(d)(7) is added that labeling requirements in §§ 156.10(d)(7), hazardous wastes. The regulations cover
allows the labels for refillable containers 156.10(f), 156.10(i)(2)(ix), 156.140, any ‘‘solid waste’’ (defined at 42 U.S.C.
to have a blank space to allow the net 156.144, 156.146, and 156.156. 1004 and 40 CFR 261.2) that is listed as
weight or contents to be marked in by 2. Changes. The most significant a hazardous waste or exhibits a
a refiller according to 40 CFR 165.65(h) change is that the phase-in period was characteristic of hazardous waste, as set
or 165.70(i); extended from 2 years to 3 years from out in part 261. Pesticides (including
• The existing § 156.10(f) was the publication of the final rule. In pesticide residues in containers that are
modified to allow labels for refillable addition, the regulatory language was not empty per the RCRA definition in
containers to have a blank space to revised to make it more clear. EPA § 261.7) that are discarded or intended
allow the EPA establishment number to agrees with some of the commenters to be discarded may qualify as
be marked in by a refiller according to that a longer compliance period will hazardous wastes, if the pesticide is a
40 CFR 165.65(h) or 165.70(i); and make it easier and less burdensome to hazardous waste as defined in § 261.33
(discarded commercial chemical pesticides is generally avoided in the refilling establishments achieve the zero
products, off-specification products or industry. Furthermore, EPA has noted, discharge requirement through water
manufacturing intermediates, container in its review of State regulations, that conservation and good housekeeping,
residues, and spill residues), or if they underground storage of pesticides is which includes repairing leaking valves
exhibit a characteristic of hazardous forbidden by States with bulk and fittings and collecting drips in pans
waste as described in part 261 subpart containment regulations. under appurtenances. Facilities that also
C, and are not otherwise exempt from provide application services typically
B. Clean Water Act
regulation. A hazardous waste reuse rinsate as make-up water for
remaining in a container is not subject EPA has issued several regulations application in accordance with the
to Subtitle C regulation if, among other under the Clean Water Act (CWA) (33 label. Compliance with today’s pesticide
things, the container is ‘‘empty’’ as U.S.C. 1251 et seq.) that are related to container and containment rule
defined in § 261.7. A container is today’s rule and that affect some sectors regarding requirements for containment
‘‘empty’’ if the wastes are removed of the pesticide industry. The goal of the structures, and adherence to the
pursuant to § 261.7(b)(1) or (b)(2), or, in CWA is to achieve zero discharge of recommendations regarding rinsate
the case of an acute hazardous waste, wastewater pollutants. collection will assist refilling
the container has been triple rinsed or 1. Pesticide chemicals category, establishments in achieving the zero
otherwise cleaned pursuant to formulating, packaging and repackaging discharge of pollutants required by the
§ 261.7(b)(3). EPA believes that the effluent limitations guidelines, effluent guidelines.
triple rinsing procedure provided in pretreatment standards, and new source Under the PFPR effluent guidelines,
today’s final rule meets the performance standards: Final rule. On
subpart C facilities (formulators,
requirements of § 261.7(b)(3), thus November 6, 1996, EPA promulgated
packagers, and repackagers) are required
meeting the directive in FIFRA section regulations governing effluents from
to either achieve zero discharge of
19(f)(1)(B)(iv). pesticide formulating, packaging and
wastewater pollutants or to implement
2. Underground storage tanks. RCRA repackaging facilities (61 FR 57518, Ref.
specific reuse, recycle, and water
Subtitle I provides for the development 57). Effluent guidelines establish
conservation practices (Pollution
and implementation of a comprehensive limitations on the pollutants discharged
Prevention Alternative). For example,
regulatory program for ‘‘underground into waters of the United States from
under the pollution prevention
storage tanks’’ (USTs), defined at 42 industrial point sources. The Pesticide
alternative, facilities must reuse their
U.S.C. 6991 and 40 CFR 280.12 as tanks Formulating, Packaging and
Repackaging (PFPR) effluent guidelines rinsates directly into the formulation or
that are used to contain an store rinsates for use in future
accumulation of ‘‘regulated substances’’ apply to facilities engaged in
formulating, packaging or repackaging formulation of the same or a compatible
and whose volume (including product.
underground pipes connected thereto) is pesticides. The PFPR effluent guidelines
regulation set limitations for facilities in When the PFPR effluent regulations
10 percent or more below ground.
two different regulatory subparts of 40 were proposed in April 1994 (Ref. 64),
Regulated substances include petroleum
CFR part 455 (subparts C and E). the scope of subpart C included all
or substances defined as hazardous
Subpart C applies to facilities that pesticide active ingredients (PAIs) (with
under the Comprehensive
discharge (or have the potential to the exception of sodium hypochlorite
Environmental Response,
discharge) wastewater from pesticide and the partial exemption of specified
Compensation, and Liability Act of 1980
formulating, packaging, and/or sanitizers) and a wide variety of
(CERCLA) (except hazardous wastes
repackaging operations. All pesticides associated wastewater sources. EPA
regulated under RCRA Subtitle C).
with the exception of a few specific published a supplemental notice on
CERCLA hazardous substances,
exemptions are included under subpart June 8, 1995 (Ref. 61) which refined the
enumerated at 40 CFR part 302, include
a number of pesticides. UST C. Subpart E applies only to refilling scope of PAIs and wastewater sources.
requirements at 40 CFR part 280 include establishments that repackage In the final rule, most sanitizer products
standards for new tanks as well as agricultural pesticides into refillable were excluded, based on a number of
requirements for leak detection, closure, containers. Subpart E does not apply to factors, such as:
corrective action, and financial facilities that repackage non-agricultural • Sanitizer products are formulated
responsibility. pesticides. The same formulators, for the purposes of their labeled end use
EPA is not aware of the extent of packagers, and repackagers (subpart E) to ‘‘go down the drain;’’
industry use of USTs to store and refilling establishments (subpart E) • Sanitizer active ingredients are
agricultural pesticides, and solicited are affected by today’s final pesticide more likely to be sent to Publicly
comment on the use of underground container and containment rule. Owned Treatment Works (POTWs) in
tanks to store agricultural pesticides and However, the PFPR effluent guidelines greater concentrations and volumes
on the preferred means of coordinating regulation does not include the other from their labeled end use than from
UST and FIFRA requirements. No types of facilities covered by today’s rinsing formulating equipment at the
comments were received on the topic. containment rule, namely commercial PFPR facility;
Because today’s final rule requires applicators and custom blenders. • Biodegradation data received with
secondary containment of any bulk Under the effluent guidelines rule, comments on some of these sanitizer
container holding pesticide, refilling establishments are required to active ingredients support the
underground storage would be achieve zero discharge of wastewater hypothesis that they do not pass
precluded unless the secondary pollutants. For these facilities, the zero through POTWs;
containment structure was also discharge regulation was based on • These sanitizer active ingredients
underground. EPA considers that the reuse, recycle and water conservation represent a large portion of the low
expense of such a construction makes it practices, as well as contract hauling of toxicity PAIs considered for regulation
unlikely that a facility would use any non-reusable wastewater for off-site at the time of proposal; and
underground storage, and assumes that disposal, if necessary. However, effluent • Many sanitizer solutions containing
since no comments were received, guidelines do not require specific these active ingredients are cleared by
underground storage of agricultural practices or control technologies. Many the Food and Drug Administration
(FDA) as indirect food additives under exposure, the NPDES permitting today’s pesticide container and
21 CFR 178.1010. authority may still require a permit if it containment rule are also subject to
The final PFPR effluent guidelines determines that there is a discharge SPCC requirements, but if any are, both
rule (subpart C) combined the pool interfering with water quality standards. today’s rule and SPCC requirements
chemicals exemption into the sanitizer This will provide an added incentive to apply. On December 12, 2005, EPA
exemption and exempted other pool place all tanks within secondary proposed two separate amendments to
chemicals in addition to the only pool containment that is protected from the the SPCC Rule. One of them (Ref. 24)
chemical in the proposal, sodium elements. Facilities that are not exempt streamlines the regulatory requirements
hypochlorite. The additional chemicals will have to get a discharge permit. for qualified facilities and equipment
that are included in the definition of 3. Effluent guidelines and standards regulated under 40 CFR part 112 and
pool chemicals in 40 CFR 455.10 for the transportation equipment proposes a separate extension of the
include calcium hypochlorite, lithium cleaning (TEC) Industry. On August 14, compliance date for farms. The other
hypochlorite, potassium hypochlorite, 2000, EPA published a final rule (65 amendment (Ref. 23) extends the SPCC
chlorinated isocyanurate compounds CFR 49665, Ref. 51) establishing compliance dates for all facilities.
and halogenated hydantoins. restrictions on the discharge of
The bulk containment requirements wastewater from cleaning the interiors C. Occupational Safety and Health
in today’s rule are consistent with the of tank trucks, rail tank cars, inland tank Administration Requirements
control technologies which are the basis barges, ocean/sea tankers, and other The Occupational Safety and Health
for the PFPR effluent guidelines for similar tanks used to transport Act (U.S.C. 2601 et seq.) addresses
refilling establishments (subpart E). In materials, including agricultural occupational safety and health hazards
addition, the repackaging and refillable chemicals and fertilizers. The TEC by establishing requirements for
container requirements of today’s rule, regulations do not apply to wastewaters employers and employees and
particularly the adherence to the generated from cleaning the interiors of authorizing the Occupational Safety and
recommendations regarding rinsate pesticide drums or intermediate bulk Health Administration (OSHA) to
collection, will aid facilities in containers (IBCs), defined as portable establish mandatory occupational safety
collecting and reusing rinsates to meet containers with 450 liters (119 gallons) and health standards.
the zero discharge/pollutant prevention to 3,000 liters (793 gallons) capacity. Tanks and containers that are used to
alternative requirements of subpart C of EPA subsequently studied the Industrial store flammable and combustible
the PFPR effluent guidelines. Container and Drum Cleaning Industry. liquids in occupational settings are
2. National Pollutant Discharge The Preliminary Data Summary - subject to OSHA requirements under 29
Elimination System (NPDES) - Storm Industrial Container and Drum Cleaning CFR 1910.106. For storage tanks,
Water Phase II Final Rule. EPA issued Industry (EPA–821–R–02–011 and Ref. § 1910.106(b) contains design and
final regulations on December 8, 1999 48) can be downloaded from the construction requirements, including
(64 FR 68722, Ref. 52) addressing storm following link: http://www.epa.gov/ standards for materials, spacing,
water discharges. The regulation waterscience/pollcontrol/drum/ venting, drainage and diking, fire and
established a ‘‘no exposure’’ exemption index.html. flood resistance, and testing for strength
for storm water discharges from 4. Spill prevention control and and tightness. Section 1910.106(c)
facilities where industrial materials and countermeasures (SPCC). On July 17, contains specifications for piping,
activities are not exposed to storm 2002, (67 FR 47042, Ref. 47), EPA valves, and fittings. Section 1910.106(d)
water. Upon review of earlier promulgated regulations under section sets out design and construction
regulations that excluded storm water 311(j)(1)(C) of the Clean Water Act requirements for containers and
discharges from certain categories of (known as the SPCC regulations) for the portable tanks, and also contains
light industry from NPDES permit prevention of oil spills into navigable specifications for storage areas. Today’s
requirements, a court invalidated the waters and adjoining shorelines. The regulations do not contradict or
light industry exemption. In 1992, the regulations apply to facilities that, supercede any existing OSHA
Ninth Circuit court concluded that the because of their location, could requirements, and any applicable OSHA
exemption impermissibly relied on the reasonably be expected to discharge oil provisions will apply in addition to the
unsubstantiated judgment of the facility into navigable waters or adjoining provisions of today’s rule.
operator to determine applicability of shorelines. Part 112 of 40 CFR outlines
the exemption. The new rule requirements for both the prevention D. Department of Transportation
established in 1999 now allows the and the response to oil spills. Facilities Hazardous Materials Regulations
exemption, but requires that the facility that are subject to the SPCC regulations The Hazardous Materials
meet certain conditions and provide a include any non-transportation-related Transportation Act of 1974, (49 U.S.C.
certification for tracking and onshore or offshore facility engaged in 1801 et seq) authorizes DOT to
accountability. ‘‘No exposure’’ means drilling, producing, gathering, storing, designate as hazardous materials those
that all industrial materials or activities processing, refining, transferring, materials that may pose unreasonable
are protected by storm-resistant distributing, using, or consuming oil risk to health and safety or property,
sheltering so they are not exposed to and oil products, which due to its and regulate the handling and
rain, snow, snowmelt or runoff. (40 CFR location, could reasonably be expected transportation of such materials. The
122.26(g)) to discharge oil, in quantities that may DOT regulations and their relationship
Pesticide refilling operations and bulk be harmful, into navigable waters of the to today’s final pesticide container and
storage operations required to apply for United States or adjoining shorelines. containment regulations are discussed
and obtain NPDES permits for storm Because the definition of ‘‘oil’’ under in detail in Unit IV. and many other
water discharges associated with such CWA section 311 is very broad places throughout this preamble.
operations may take advantage of this (including oil ‘‘of any kind and in any
exemption if they provide a certification form’’), it could potentially include XI. FIFRA Mandated Reviews
of ‘‘no exposure’’ and maintain the pesticides that contain oil or are oil- In accordance with FIFRA sec. 25(a),
certified conditions at the facility. Even based. EPA expects that comparatively the Agency submitted a draft of this
when an owner/operator certifies to no few, if any, of the facilities covered by final rule to the FIFRA Scientific
Advisory Panel (SAP), the Secretary of 37, Iowa State University, Ames, Iowa Collection Program Observations,’’
Agriculture, and the Committee on (1991). November 15 (2005).
Agriculture in the House of 12. Michigan Department of 27. U.S. EPA, 2005. ‘‘Summary of
Representatives, and the Committee on Agriculture. ‘‘Environmental Information on On-Farm Bulk Storage
Agriculture, Nutrition, and Forestry in Stewardship and the Michigan and Repackaging from State Contacts
the United States Senate. Department of Agriculture: A Report to from States with Regulations that
The FIFRA SAP waived its review of Governor John Engler’’ (1993). Include Farms,’’ February 14 (2005).
this final rule because the significant 13. Minnesota Department of 28. U.S. EPA, 2005. ‘‘Summary of
scientific issues involved have already Agriculture. ‘‘Empty Pesticide Container State Responses to EPA Inquiries About
been reviewed by the SAP and Collection and Recycling Program: Bulk Storage on Farms,’’ February 14
additional review isn’t necessary. The Annual Report,’’ (1996). (2005).
USDA did not submit any official 14. Moye, Anson H., et al. ‘‘Final 29. U.S. EPA, 2005. ‘‘Summary of
comments. Report: Work Assignment - Triple Telephone Conversations with
Rinse,’’ research conducted for U.S. Packaging Industry re: Dry Bulk
XII. References Containers,’’ February (2005).
EPA, January 31 (1995).
The following is a listing of the 30. U.S. EPA, 2006. ‘‘Supporting
15. National Agricultural Chemicals
documents that are specifically Statement for an Information Collection
Association, ‘‘NACA Container
referenced in this final rule. These Request: Standards for Pesticide
Management Task Force Empty
documents, and other supporting Containers and Containment (Final
Pesticide Container Rinsing Study: Rule), June 21, (2006).
materials, are included in the docket Product Information and Analytical
established for this rulemaking under 31. U.S. EPA, 2004. ‘‘Meeting
Results,’’ October 16 (1990). Summary,’’ July 19 (2004).
docket ID No.EPA-HQ-OPP–2005–0327 16. United Nations Economic
at http://www.regulations.gov. 32. U.S. EPA, 2004. ‘‘Standards for
Commission for Europe (UNECE). Pesticide Containers and Containment:
1. Ag Container Recycling Council. ‘‘Globally Harmonized System of
‘‘ACRC Celebrates 10 Years’’, in ‘‘News Proposed Rule; Extension of Comment
Classification and Labeling of Chemicals Period,’’ 69 FR 50114, August 13 (2004).
Bits from the Ag Container Recycling (GHS)’’ (2005). 33. U.S. EPA, 2004. ‘‘Standards for
Council,’’ Summer (2002). 17. Palmer, L. and R. Hansen.
2. Beaver, B.A. and W.D. Goetsch. Pesticide Containers and Containment:
Minnesota Department of Agriculture Proposed Rule; Partial Reopening of the
‘‘Container Recycling in Illinois,’’ 1994 [Information on pesticide container
Illinois Agricultural Pesticides Comment Period,’’ 69 FR 39392, June 30
collection programs], Personal (2004).
Conference, (1994). communication to members of the 34. U.S. EPA, 2004. ‘‘Summary Tables
3. Dwinell, S., 1992. Florida
Minnesota Pesticide Container Advisory of State Bulk Pesticide Containment
Department of Environmental
Committee, September 30 (1991). Regulations,’’ January 23 (2004).
Regulation, ‘‘Final Report: Jackson 35. U.S. EPA, 2003. ‘‘Analysis and
18. Poncin, S. Minnesota Department
County Pesticide Container Recycling Summary of CSMA Data,’’ March 5
of Agriculture. ‘‘Rinsing Problems
Demonstration Project,’’ (1992). (2003).
4. Dwinell, S., 1991. Florida Associated with Pesticides that are
Formulated as Flowable,’’ September 36. U.S. EPA, 2003. ‘‘Analysis and
Department of Environmental Summary of Formulogics Agricultural
Regulation, ‘‘Final Report: South Florida (1995).
19. U.S. EPA, 2006. ‘‘Response to Formulation/Container Data,’’ February
Pesticide Container Recycling 24 (2003).
Demonstration Project,’’ (1991). Comment Document: Standards for
Pesticide Containers and Containment,’’ 37. U.S. EPA, 2003. ‘‘Analysis and
5. Federal Trade Commission. Summary of Formulogics Household,
‘‘Guides for the Use of Environmental (2006).
20. U.S. EPA, 2006. ‘‘Rinsing Institutional and Industrial Data,’’
Marketing Claims,’’ 16 CFR 260, (2006). March 5 (2003).
6. Formulogics, 1991. ‘‘Report to Procedures for Dilutable Pesticide
Products in Rigid Containers,’’ (2006). 38. U.S. EPA, 2003. ‘‘Analysis and
Mitchell System: Data Generation - Summary of Formulogics Quick Rinse
Rinsing Studies,’’ September 24 (1991). 21. U.S. EPA, 2005. ‘‘Economic
Analysis of the Bulk Pesticide Data,’’ February 26 (2003).
7. Formulogics, 1991. ‘‘Triple Rinsing 39. U.S. EPA, 2003. ‘‘Analysis and
of Containers: Rinsing Variables,’’ Containment Structures Final
Summary of NACA Triple Rinse data,’’
results of a study conducted for U.S. Regulation,’’ November 15 (2005).
March 4 (2003).
EPA, December 2 (1991). 22. U.S. EPA, 2005. ‘‘Economic 40. U.S. EPA, 2003. ‘‘Analysis and
8. Formulogics, 1990. ‘‘Container Analysis of the Pesticide Container Summary of Pressure Rinse Data,’’
Rinsing: Methodology Support,’’ testing Design and Residue Removal March 5 (2003).
conducted for the U.S. EPA, 1990. Standards,’’ November 21 (2005). 41. U.S. EPA, 2003. ‘‘Analysis and
9. Frieberg, D. Iowa Fertilizer and 23. U.S. EPA, 2005. ‘‘Oil Pollution Summary of University of Florida Quick
Chemical Association, ‘‘Environmental Prevention; Non-Transportation Related Rinse Data,’’ February 26 (2003).
Cleanup of Fertilizer and Agricultural Onshore Facilities: Proposed Rule,’’ 70 42. U.S. EPA, 2003. ‘‘Comparison of
Chemical Dealer Sites,’’ (1991). FR 73517, December 12 (2005). Triple Rinsing Data for Proposed and
10. Hudak, C.M., North Carolina 24. U.S. EPA, 2005. ‘‘Oil Pollution Final Rule,’’ July 7 (2003).
Department of Agriculture and Prevention; Spill Prevention, Control, 43. U.S. EPA, 2003. ‘‘Information
Consumer Services. ‘‘Pesticide and Countermeasure Plan Requirements About Container Rejections from
Container Recycling in North Carolina’’ - Amendments: Proposed Rule,’’ 70 FR Recycling Programs,’’ July 15 (2003).
presented at 2000 National Pesticide 73523, December 12 (2005). 44. U.S. EPA, 2003. ‘‘Label Review
Stewardship Alliance Conference, 25. U.S. EPA, 2005. ‘‘State Bulk Manual: Third Edition,’’ EPA 735–B–
(2000). Pesticide Containment Regulations - 03–001, August (2003).

11. Kammel, D., R. Noyes, G. Scope and Definition of Bulk,’’ February 45. U.S. EPA, 2003. ‘‘Revised Scope of
Riskowski, and V. Hofman. ‘‘Designing 2 (2005). the Container Regulations (Non-
Facilities for Pesticide and Fertilizer 26. U.S. EPA, 2005. ‘‘Summary of Antimicrobial Products,’’ January 6
Containment,’’ MidWest Plan Service– Discussions re: Pesticide Container (2003).
46. U.S. EPA, 2003. ‘‘Summary of 59. U.S. EPA, 1995. ‘‘Bulk Pesticide Statements,’’ Pesticide Registration
Conference Call with Wisconsin Transfers,’’ Memorandum from Jesse Notice 83–3 (1983).
Department of Agriculture Staff on Baskerville, U.S. EPA, to U.S. EPA 74. U.S. EPA, 1979. ‘‘National
Containment Regulations,’’ July 29 Regional Pesticides and Toxics Division Pollution Discharge Elimination System
(2003). Directors and Regional Counsels, March (NPDES) Best Management Practices
47. U.S. EPA, 2002. ‘‘Oil Pollution 22 (1995). Guidance Document,’’ EPA–600/9–79–
Prevention and Response: Non- 60. U.S. EPA, 1995. ‘‘Notice of Interim 045, December (1979).
Transportation-Related Onshore and Determination of Adequacy of Certain 75. U.S. EPA, 1977. ‘‘Enforcement
Offshore Facilities: Final Rule,’’ 67 FR State and Territorial Programs,’’ 60 FR Policy Applicable to Bulk Shipment of
47042, July 17 (2002). 24855, May 10 (1995). Pesticides,’’ July 11 (1977).
48. U.S. EPA, 2002. ‘‘Preliminary Data 61. U.S. EPA, 1995. ‘‘Pesticide
76. U.S. EPA, 1976. ‘‘Pesticide
Summary for Industrial Container and Chemicals Category, Formulating,
Enforcement Policy Statement on
Drum Cleaning Industry,’’ EPA–821–R– Packaging and Repackaging Effluent
Structural Pest Control: Use and
02–011, June (2002). Limitations Guidelines, Pretreatment
49. U.S. EPA, 2001. ‘‘Disposal Labeling of Service Containers for the
Standards, and New Source
Instructions on Non-Antimicrobial Transportation or Temporary Storage of
Performance Standards: Supplemental
Residential/Household Use Pesticide Pesticides,’’ (1976).
Notice,’’ 60 FR 30217, June 8 (1995).
Product Labels,’’ Pesticide Registration 62. U.S. EPA, 1995. ‘‘Pesticides; 77. Viera, K. Clorox [Data from
Notice 2001–6, September 7 (2001). Technical Amendments: Final Rule,’’ 60 container rinsing tests conducted by
50. U.S. EPA, 2001. ‘‘Regulations FR 32094, June 19 (1995). Chemical Specialties Manufacturers
Under the Federal Insecticide, 63. U.S. EPA, 1994. ‘‘Bulk Policy Association], Personal communication
Fungicide, and Rodenticide Act for Question & Answer Document,’’ to U.S. EPA, July 13 (1993).
Plant-Incorporated Protectants February 3 (1994). 78. U.S., EPA, 2000. ‘‘Analysis of
(Formerly Plant-Pesticides): Final Rule,’’ 64. U.S. EPA, 1994. ‘‘Pesticide Products that Meet the Scope Criteria:
66 FR 37771, July 19 (2001). Chemicals Category, Formulating, Toxicity Category III Only,’’ November
51. U.S. EPA, 2000. ‘‘Effluent Packaging and Repackaging Effluent 27 (2000).
Limitations Guidelines, Pretreatment Limitations Guidelines, Pretreatment XIII. Statutory and Executive Order
Standards, and New Source Standards, and New Source Reviews
Performance Standards for the Performance Standards: Proposed
Transportation Equipment Cleaning Rule,’’ April 14 (1994). A. Executive Order 12866
Point Source Category: Final Rule,’’ 65 65. U.S. EPA, 1994. ‘‘Recycling Empty Under Executive Order 12866,
FR 49665, August 14 (2000). Aerosol Pesticide Containers,’’ Pesticide entitled Regulatory Planning and
52. U.S. EPA, 1999. ‘‘National Registration Notice 94–2, May 16 (1994). Review (58 FR 51735, October 4, 1993),
Pollutant Discharge Elimination System- 66. U.S. EPA, 1994. ‘‘Standards for
the Office of Management and Budget
Regulations for Revision of the Water Pesticide Containers and Containment:
(OMB) has determined that this final
Pollution Control Program Addressing Proposed Rule,’’ 59 FR 6712, February
rule is a ‘‘significant regulatory action’’
Storm Water Discharges: Final Rule,’’ 64 11 (1994).
67. U.S. EPA, 1994. ‘‘State Pesticide because these requirements may raise
FR 68722, December 8 (1999).
53. U.S. EPA, 1999. ‘‘Standards for Residue Removal Compliance Programs; novel legal or policy issues arising out
Pesticide Containers and Containment: Notice of Interim Determination of of legal mandates, the President’s
Proposed Rule; Partial Reopening of the Adequacy; Correction,’’ 59 FR 9214, priorities, or the principles set forth in
Comment Period,’’ 64 FR 56918, February 25 (1994). the Executive Order. Accordingly, EPA
October 21 (1999). 68. U.S. EPA, 1993. ‘‘Interim submitted a draft final rule to OMB for
54. U.S. EPA, 1998. ‘‘Additional Determination of Adequacy of State review under Executive Order 12866
Guidance on Final FIFRA Section Pesticide Residue Removal Programs,’’ and any changes made in response to
6(a)(2) Regulations for Pesticide Product 58 FR 43994, August 18 (1993). OMB recommendations have been
Registrants,’’ Pesticide Registration 69. U.S. EPA, 1993. ‘‘Notice of Interim documented in the docket for this
Notice 98–4, August 4 (1998). Determination of Adequacy of Certain rulemaking as required by sec. 6(a)(3)(E)
55. U.S. EPA, 1998. ‘‘Guidance on State Programs,’’ 58 FR 65989, of the Executive Order.
Final FIFRA Section 6(a)(2) Regulations December 17 (1993). In addition, EPA has prepared two
for Pesticide Product Registrants,’’ 70. U.S. EPA, 1992. ‘‘State of the Economic Analyses (EAs) of the
Pesticide Registration Notice 98–3, States: Pesticide Storage, Disposal and potential costs and benefits associated
April 3 (1998). Transportation,’’ prepared for EPA by with this rule, one for the container
56. U.S. EPA, 1998. ‘‘Notifications, Mitchell Systems Corporation, EPA requirements and another for the
Non-notifications and Minor publication number EPA 734–R–92–12 containment requirements. The reason
Formulation Amendments,’’ Pesticide (1992). for having two EAs is because the
Registration Notice 98–10, October 22 71. U.S. EPA, 1991. ‘‘Amendment to regulated community differs in each
(1998). the July 11, 1977 Enforcement Policy case. For example, the container
57. U.S. EPA, 1996. ‘‘Pesticide Applicable to Bulk Shipment of requirements affect pesticide
Chemicals Category, Formulating, Pesticides,’’ March 4 (1991). formulators and refillers of all pesticides
Packaging and Repackaging Effluent 72. U.S. EPA, 1984. ‘‘Clarification of while the containment requirements
Limitations Guidelines, Pretreatment Label Improvement Program for affect retailers, for-hire applicators and
Standards, and New Source Farmworker Safety and Pesticide custom blenders of agricultural
Performance Standards: Final Rule,’’ 61 Storage and Disposal Instructions,’’ pesticides. The EAs, entitled Economic
FR 57518, November 6 (1996). Pesticide Registration Notice 84–1, Analysis of the Pesticide Container
58. U.S. EPA, 1996. ‘‘Toxicologically February 17 (1984). Design and Residue Removal Standards
Significant Levels of Pesticide Active 73. U.S. EPA, 1983. Office of Pesticide (Ref. 22) and Economic Analysis of the
Ingredients,’’ Pesticide Registration Programs, ‘‘Label Improvement Program Bulk Pesticide Containment Structure
Notice 96–8, October 31 (1996). - Storage and Disposal Label Regulations (Ref. 21), are available in
the docket for this rule and are briefly Major changes resulted in cost expended by persons to generate,
summarized here. reduction from the economic analysis maintain, retain, disclose or provide
EPA estimates the total cost of the for the proposed rule. Among these is information to or for a Federal agency.
final rule to be $11.3 million ($8.37 the elimination of the requirement to This includes the time needed to review
million for containers + $2.93 million demonstrate the hydraulic conductivity instructions; develop, acquire, install,
for containment) and the total benefits of containment structures, lowering of and utilize technology and systems for
from the final rule to be $17 - 23.4 the residue removal standard from six the purposes of collecting, validating,
million. When the estimated cost of the 9’s to four 9’s, and limiting of rinse- and verifying information, processing
final rule is compared to the estimated testing requirement to those and maintaining information, and
cost for the proposed rule, there is an formulations expected to be disclosing and providing information;
annual cost reduction of approximately problematic. adjust the existing ways to comply with
$27.4 - $38.6 million. This reduction in any previously applicable instructions
B. Paperwork Reduction Act (PRA)
estimated cost is due to the choices and requirements; train personnel to be
made in the final rule that lead to a The information collection able to respond to a collection of
narrowing in the scope of regulated requirements in this final rule have been information; search data sources;
entities and products that are subject to submitted to the Office of Management complete and review the collection of
the final rule. During the first year, and Budget (OMB) under the Paperwork information; and transmit or otherwise
regulated facilities will experience an Reduction Act (PRA), 44 U.S.C. 3501 et disclose the information.
increase in total paperwork cost burden seq. The Information Collection Request In this final rule, the information
of $1 million (containment) and $7.0 (ICR) document prepared by EPA for collection requirement burden on the
million (containers) due primarily to this final rule has been assigned EPA regulated community includes the
ICR No. 1631.02, and OMB control administrative burden associated with
inspection and recordkeeping costs. For
number 2070–0133. Consistent with the keeping monthly inspection and
containers, in the second year and
procedures at 5 CFR 1320.11, EPA maintenance records for bulk pesticide
continuing thereafter, total paperwork
sought comment on two Information containment structures. The regulated
cost burden per facility will decrease to
Collection Request (ICR) documents that community’s administrative burden is
25 hours from 81 hours in the first year,
were submitted to OMB in conjunction defined as the time spent to record and
reducing paperwork burden costs to
with issuing the proposed rule file the inspection and maintenance of
$4.1 million annually.
(identified under EPA ICR No. 1631.01 the bulk pesticide containment
Over 20 respondents submitted and No. 1632.01). For the final rule, the structures per month. There is not a
general comments on the Regulatory two ICR documents were combined into requirement to submit the records or
Impact Analyses (RIAs) or EAs for the one ICR document, which reflects the reports to the Agency, however, EPA or
proposed rule. Nearly all of the information collection provisions in this its representatives may, from time to
commenters wanted EPA to reevaluate final rule. The ICR document for this time, request information under these
the economic assessments. The most final rule (identified under EPA ICR No. regulations to ensure compliance with
common comments were: 1) The costs 1631.02) (Ref. 30) is included in the the regulation.
far outweigh the benefits; 2) costs were docket for the final rule. The two ICRs for the proposed rule
underestimated; 3) benefits were Under the PRA, an agency may not were combined into a single ICR for the
overestimated; 4) this is a major rule, conduct or sponsor, and a person is not final rule. This ICR document provides
contrary to EPA’s assessment; 5) the rule required to respond to a collection of detailed presentations of the estimated
will have a significant impact on information unless it displays a annual burden and costs for 3 years,
medium and large formulators as well as currently valid OMB control number. which represents the maximum OMB
small formulators; 6) the rule will have The OMB control numbers for EPA’s approval period for any collection
a general impact on various industry regulations codified in Chapter 40 of the activity, after which the Agency must
segments; and 7) the rule does not CFR, after appearing in the preamble of seek renewal of the ICR approval from
comply with the standards of the the final rule, are listed in 40 CFR part OMB every 3 years for as long as the
Executive Order. Commenters who 9, are displayed either by publication in requirements exist.
objected to the cost estimates mainly the Federal Register or by other 1. Container burden. The public
disagreed with EPA’s estimate of the appropriate means, such as on the reporting burden for this collection of
cost of complying with the six 9’s related collection instrument or form, if information is estimated to be 66 hours
residue removal standard. State applicable. The display of OMB control in the first year of compliance with this
regulatory agencies predicted that the numbers in certain EPA regulations is rule for approximately 1,804 pesticide
rule would increase their workload and consolidated in 40 CFR part 9. For the registrant respondents, and 10 hours in
expressed the hope that EPA would ICR activity contained in this final rule, subsequent years. For an estimated
increase State funding. in addition to displaying the applicable 16,795 agricultural pesticide refiller
EPA reopened the comment period on OMB control number in this Unit, the respondents, the reporting burden is 7.5
the proposed rule on October 21, 1999 Agency is amending the table in 40 CFR hours per year. For an estimated 322
(64 FR 56918, Ref. 53) on three issues, 9.1 to list the OMB control number swimming pool supply companies, the
proposing to reduce the scope of the assigned to this ICR activity. Due to the reporting burden is 7.5 hours per year.
container standards, add an exemption technical nature of the table, EPA finds The total annual paperwork burden
for certain antimicrobial pesticides, and that further notice and comment about across all pesticide registrant
adopt some of the Department of amending the table is unnecessary. As a respondents, assuming that 1,804
Transportation (DOT) hazardous result, EPA finds that there is good facilities will be affected by the
materials regulations. These potential cause under section 553(b)(B) of the requirements, is 112,209 hours in first
changes decreased the estimated Administrative Procedures Act (APA), 5 year, and 11,185 hours in all other
economic impact by reducing the U.S.C. 553(b)(B), to amend this table years. The total annual paperwork
number of pesticide products subject to without further notice and comment. burden across all agricultural pesticide
the container requirements compared to Under the PRA, burden means the refiller respondents, assuming 16,795
the original proposal. total time, effort, or financial resources facilities will be affected by the
requirements, is 125,963 hours. The comments no later than September 15, Manufacturing sector (i.e., NAICS code
total annual paperwork burden across 2006. 325320) approximately 92% of the
all swimming pool supply companies, industries would be classified as small
C. Regulatory Flexibility Act (RFA)
assuming 322 facilities will be affected businesses under the SBA definition
by the requirements, is 2,415 hours. Pursuant to section 605(b) of the (500 or fewer employees). However,
2. Containment burden. The public Regulatory Flexibility Act (RFA) (5 60% of the SBA defined small
recordkeeping burden for this collection U.S.C. 601 et seq.), the Agency hereby companies have 1 to 19 employees,
of information is estimated to be 7.5 certifies that this final rule will not have which are considered small-small
hours for approximately 4,665 a significant adverse economic impact businesses in the Agency’s analysis. By
respondents in the first year after on a substantial number of small disaggregating the potential impacts of
promulgation of this rule, which entities. This determination is based on this final rule on small businesses, the
includes initial rule familiarization. The the Agency’s two economic analyses Agency was able to consider the
average annual burden per respondent performed for this rulemaking, which distribution of the estimated impacts
for subsequent years is estimated to be are briefly summarized in Unit XIII.A., among the universe of potentially
7.5 hours. The total annual paperwork and copies of which are available in the impacted small businesses, particularly
burden across all respondents, assuming docket for this rulemaking (Refs. 21 and potential impacts on the small-small
that 4,665 facilities will be affected by 22). The following is a brief summary of businesses.
the requirement, is 34,988 hours per the factual basis for this certification. Considering just the container
Under the RFA, small entities include requirements, the estimated costs of
year.
small businesses, small organizations, compliance for the universe of
In comments filed after reviewing the and small governmental jurisdictions.
proposed ICRs in 1994, OMB potentially impacted small businesses
For purposes of assessing the impacts of in each of the regulated industries as a
commented that EPA should consider today’s rule on small entities, small
less burdensome testing requirements proportion of their current revenues are
entity is defined in accordance with the estimated to be less than 1 percent.
that meet the objective that disposal of RFA as: (1) A small business as defined Specifically, using the SBA definition of
containers poses no unreasonable risk to by the Small Business Administration’s small businesses, the costs of
health of the environment. As discussed (SBA) regulations at 13 CFR 121.201; (2) compliance for all small businesses are
previously, EPA has modified the a small governmental jurisdiction that is estimated to be less than 0.02 percent of
requirements to be less burdensome, a government of a city, county, town, the current average entity revenues.
decreasing the total industry burden for school district, or special district with a Looking at the estimated impacts using
the final rule. The decrease in burden population of less than 50,000; and (3) the disaggregated small business sub-
results mainly from the elimination of a small organization that is any not-for- categories used in the Agency’s analysis
the hydraulic conductivity standard for profit enterprise which is independently (which further divides small businesses
containment structures, lowering of the owned and operated and is not into large-small, medium-small and
residue removal standard to four 9’s, dominant in its field. Based on the small-small business within each of the
and requiring residue removal testing industry profiles for this rulemaking regulated industries), no small-small
only for problematic formulations. that EPA prepared as part of the business is estimated to incur costs
The Agency is seeking additional Economic Analyses, EPA has which account for more than 0.04
comments on the paperwork burden determined that this final rule is not percent of current average entity
estimates related to the provision in the expected to impact any small not-for- revenues.
final rule that allows States with profit organizations or small Considering just the containment
existing regulations (§ 165.97) to request governmental jurisdictions. As such, requirements, the estimated costs of
the authority to continue implementing small entity for purposes of this final compliance for the universe of
its State containment regulations in lieu rule is synonymous with small business. potentially impacted small businesses
of EPA’s regulations. As discussed In addition, for purposes of analyzing as a proportion of their current revenues
previously, EPA added this provision in the potential impacts of this final rule are estimated to be less than 1 percent,
response to comments asking EPA to on small businesses, the Agency except for small commercial applicators.
consider existing State regulations. disaggregated the universe of potentially When only looking at commercial
Since this provision and related burden impacted small business into applicators, and using the SBA
estimates were not part of the ICRs that subcategories of large-small businesses, definition of small business, the costs of
were prepared and for which public medium-small businesses, and small- compliance for potentially impacted
comment was sought in conjunction small businesses. The analysis small commercial applicators to install
with the proposed rule, EPA is disaggregated the impacts of small new secondary containment units are
providing this opportunity for public businesses into these sub-categories estimated to be as high as 2.7 percent of
comment. Direct your comments on this because the SBA size standard for small the current average entity revenues.
to EPA using the public docket that has businesses, which are primarily Small-small commercial applicators,
been established for this final rule intended to define whether a business based on the disaggregated small
(docket ID number EPA–HQ–OPP– entity is eligible for Federal government business sub-categories used in the
2005–0327) at http:// programs and preferences reserved for Agency’s analysis, may face costs of
www.regulations.gov. In addition, send small businesses (13 CFR 121.101), may compliance that are as much as 7.8
a copy of your comments to OMB at: not be representative of all small percent of the current average entity
Office of Information and Regulatory businesses in the industry sectors revenues. However, only 6 of the 3,000
Affairs, Office of Management and impacted by this rulemaking. (See small commercial applicators were
Budget, 725 17th St., NW., Washington, section 632(a)(1) of the Small Business identified as small-small commercial
DC 20503, Attention: Desk Office for Act.) The SBA size standard is generally applicators that will need to install both
EPA ICR No. 1361.02. Since OMB is based on the number of employees an a secondary containment unit and a
required to complete its review of the entity in a particular industrial sector containment pad and thus are estimated
ICR between 30 and 60 days after may have. For example, in the Pesticide to be impacted in this way. The costs of
August 16, 2006, please submit your and Other Agricultural Chemical compliance for potentially impacted
small commercial applicators to retrofit the States, or on the distribution of activities unless to do so would be
existing containment structures are power and responsibilities among the inconsistent with applicable law or
estimated to be less than 1 percent of various levels of government, as otherwise impractical. Voluntary
the current average entity revenues. specified in the Order. Under consensus standards are technical
For agricultural pesticide refillers, the cooperative agreements with EPA, standards (e.g., materials specifications,
other industry estimated to be impacted States will be involved in compliance test methods, sampling procedures,
by the containment regulations, the monitoring and enforcement activities, business practices, etc.) that are
costs of compliance for small but are not otherwise expected to engage developed or adopted by voluntary
agricultural pesticide refillers are in the activities regulated by this rule. consensus standards bodies. NTTAA
estimated to be less than 0.18 percent of Thus, Executive Order 13132 does not directs EPA to provide Congress,
current average entity revenues using apply to this rule. through OMB, explanations when the
the SBA definition of small businesses, Agency decides not to use available and
and less than 0.34 percent of current F. Executive Order 13175
applicable voluntary consensus
average entity revenues based on the As required by Executive Order standards. This action requires
disaggregated small-small business sub- 13175, entitled Consultation and performance standards for containment
category used in the Agency’s analysis. Coordination with Indian Tribal structures and residue removal testing
Considering the overall impact of this Governments (65 FR 22951, November for containers of certain pesticide
final rule on the universe of potentially 6, 2000), EPA has determined that this formulations, but does not require
impacted small businesses using the action does not have tribal implications specific methods or standards.
SBA definition for small business, the because it will not have substantial Therefore, this action does not impose
Agency has determined that this final direct effects on tribal governments, on any technical standards that would
rule will not have a significant adverse the relationship between the Federal require Agency consideration of
economic impact on a substantial government and the Indian tribes, or on voluntary consensus standards.
number of small entities. the distribution of power and
In general, EPA strives to minimize responsibilities between the Federal J. Executive Order 12898
potential adverse impacts on small government and Indian tribes, as This action does not have an adverse
entities when developing regulations to specified in the Order. EPA is not aware impact on the environmental and health
achieve the environmental and human of any tribal governments which are conditions in low-income and minority
health protection goals of the statute pesticide registrants, refillers or dealers communities. Therefore, under
and the Agency. In doing so for this storing large quantities of pesticides. Executive Order 12898, entitled Federal
particular rule, as discussed in more Thus, Executive Order 13175 does not Actions to Address Environmental
detail previously, the major changes that apply to this action. Justice in Minority Populations and
EPA made to the proposed requirements Low-Income Populations (59 FR 7629,
resulted in significant reductions in the G. Executive Order 13045
February 16, 1994), the Agency has not
potential costs of compliance for this Executive Order 13045, entitled considered environmental justice-
rulemaking. Protection of Children from related issues. Although not directly
Environmental Health Risks and Safety impacting environmental justice-related
D. Unfunded Mandates Reform Act
Risks (62 FR 19885, April 23, 1997), concerns, the Agency believes that the
(UMRA)
does not apply to this action because it requirements in this rule will assist EPA
Pursuant to Title II of the Unfunded is not designated as an economically and others in reducing potential
Mandates Reform Act of 1995 (Public significant regulatory action as defined exposures associated with the handling,
Law 104–4), EPA has determined that by Executive Order 12866 (see Unit storage, management and disposal of
this action does not contain a Federal XIII.A.). Further, this action does not pesticide containers covered by the rule.
mandate that may result in expenditures establish an environmental standard
of $100 million or more for State, local, that is intended to have a negatively XIV. Congressional Review Act
and tribal governments, in the aggregate, disproportionate effect on children. To The Congressional Review Act, 5
or for the private sector in any one year. the contrary, this action will provide U.S.C. 801 et seq., generally provides
As described in Unit XIII.A., the annual added protection for children from that before a rule may take effect, the
costs associated with this action are pesticide risk by ensuring the integrity Agency promulgating the rule must
estimated to total $11.3 million ($8.37 of pesticide container design, as well as submit a rule report, which includes a
millioin for containers + $2.93 million secure pesticide storage and disposal. copy of the rule, to each House of the
for containment). This cost represents
H. Executive Order 13211 Congress and the Comptroller General of
the incremental cost to registrants,
the United States. EPA will submit a
pesticide dealers, commercial This rule is not subject to Executive
report containing this rule and other
applicators and custom blenders Order 13211, entitled Actions
required information to the U.S. Senate,
attributed to the requirements in this Concerning Regulations that
the U.S. House of Representatives, and
action. Accordingly, this action is not Significantly Affect Energy Supply,
the Comptroller General of the United
subject to the requirements of sections Distribution, or Use (66 FR 28355, May
States prior to publication of the rule in
202 and 205 of UMRA. 22, 2001) because it is not likely to have
the Federal Register. This rule is not a
a significant adverse effect on the
E. Executive Order 13132 major rule as defined by 5 U.S.C. 804(2).
supply, distribution, or use of energy.
Pursuant to Executive Order 13132, List of Subjects in 40 CFR Part 9
entitled Federalism (64 FR 43255, I. National Technology Transfer
August 10, 1999), EPA has determined Advancement Act (NTTAA) Environmental protection, Reporting
and recordkeeping requirements.
that this final rule does not have Section 12(d) of the National
federalism implications, because it Technology Transfer and Advancement
List of Subjects in 40 CFR Part 156
would not have substantial direct effects Act of 1995 (NTTAA), 15 U.S.C. 272
on the States, on the relationship note) directs EPA to use voluntary Environmental protection, Labeling,
between the national government and consensus standards in its regulatory Pesticides and pests.
List of Subjects in 40 CFR Part 165 PART 9—[AMENDED] 6901–6992k, 7401–7671q, 7542, 9601–9657,
11023, 11048.
Environmental protection, Packaging ■ a. The authority citation for part 9
and containers, Containment structures, continues to read as follows: ■ b. In § 9.1 the table is amended by
Pesticides and pests. adding a new center heading entitled
Authority: 7 U.S.C. 135 et seq., 136–136y; ‘‘Pesticide Management and Disposal’’
Dated: August 3, 2006. 15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671,
21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
and an entry for new part 165 after the
Stephen L. Johnson, center heading and entries for ‘‘State
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318,
Administrator. 1321, 1326, 1330, 1342, 1344, 1345 (d) and Registration of Pesticide Products,’’ to
(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, read as follows:
■ Therefore, 40 CFR chapter I is 1971–1975 Comp. p. 973; 42 U.S.C. 241,
amended as follows: 242b, 243, 246, 300f, 300g, 300g–1, 300g–2, § 9.1 OMB approvals under the Paperwork
300g–3, 300g–4, 300g–5, 300g–6, 300j–1, Reduction Act.
■ 1. Part 9 is amended as follows:
300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., * * * * *
40 CFR citation OMB Control No.
* * * * * * *
Pesticide Management and Disposal
Part 165 ........................................................................... 2070–0133
* * * * * * *
PART 156—[AMENDED] to 40 CFR 165.65(h) or 165.70(i) prior to stamping, mechanically attaching a

distribution or sale of the pesticide. plate, molding, or marking with durable
■ 2. Part 156 is amended as follows: * * * * * ink.
■ a. The authority citation for part 156 (i) * * * (a) Nonrefillable container. For
continues to read as follows: (2)* * * nonrefillable containers, the statements
Authority: 7 U.S.C. 136 through 136y. (ix) Specific directions concerning the in paragraphs (a)(1) through (a)(4) of this
storage, residue removal and disposal of section are required. If placed on the
■ b. In § 156.10 by adding paragraph the pesticide and its container, in label, the statements in paragraphs (a)(1)
(d)(7), and by revising paragraphs (f) accordance with subpart H of this part through (a)(3) of this section must be
and (i)(2)(ix) to read as follows: and part 165 of this chapter. These under an appropriate heading under the
instructions must be grouped and heading ‘‘Storage and Disposal.’’ If any
§ 156.10 Labeling requirements.
appear under the heading, ‘‘Storage and of the statements in paragraphs (a)(1)
* * * * * Disposal.’’ This heading must be set in through (a)(3) of this section are placed
(d)* * * on the container, an appropriate referral
(7) For a pesticide product packaged type of the same minimum sizes as
required for the child hazard warning. statement such as ‘‘See container for
in a refillable container, an
(See table in § 156.60(b)) recycling [or other descriptive word]
appropriately sized area on the label
* * * * * information.’’ must be placed on the
may be left blank to allow the net
■ c. By adding Subpart H entitled
label under the heading ‘‘Storage and
weight or measure of content to be
‘‘Container Labeling’’ to read as follows: Disposal.’’
marked in by the refiller according to 40 (1) Statement identifying a
CFR 165.65(h) or 165.70(i) prior to Subpart H—Container Labeling nonrefillable container. The following
distribution or sale of the pesticide. As phrase is required: ‘‘Nonrefillable
Sec.
required in paragraph (a)(1)(iii) of this 156.140 Identification of container types. container.’’
section, the net contents must be shown 156.144 Residue removal instructions - (2) Reuse statement. One of the
clearly and prominently on the label. general. following statements is required.
* * * * * 156.146 Residue removal instructions for Products with labels that allow
(f) Producing establishment’s nonrefillable containers - rigid household/residential use must use the
registration number. The producing containers with dilutable pesticides.
statement in paragraph (a)(2)(i) or
establishment registration number 156.156 Residue removal instructions for
refillable containers. (a)(2)(iii) of this section. All other
preceded by the phrase ‘‘EPA Est.’’, of products must use the statement in
156.159 Compliance date.
the final establishment at which the paragraph (a)(2)(i), (a)(2)(ii), or (a)(2)(iii)
product was produced may appear in Subpart H—Container Labeling of this section.
any suitable location on the label or (i) ‘‘Do not reuse or refill this
immediate container. It must appear on § 156.140 Identification of container types. container.’’
the wrapper or outside container of the For products other than plant- (ii) ‘‘Do not reuse this container to
package if the EPA establishment incorporated protectants, the following hold materials other than pesticides or
registration number on the immediate statements, as applicable, must be dilute pesticides (rinsate). After
container cannot be clearly read through placed on the label or container. The emptying and cleaning, it may be
such wrapper or container. For a information may be located on any part allowable to temporarily hold rinsate or
pesticide product packaged in a of the container except the closure. If other pesticide-related materials in the
refillable container, an appropriately the statements are placed on the container. Contact your state regulatory
sized area on the label may be left blank container, they must be durably marked agency to determine allowable practices
after the phrase ‘‘EPA Est.’’ to allow the on the container. Durable marking in your state.’’
EPA establishment registration number includes, but is not limited to etching, (iii) The following statement may be
to be marked in by the refiller according embossing, ink jetting, stamping, heat used if a product is ‘‘ready-to-use’’ and
its directions for use allow a different removing pesticide residues from the equipment or a mix tank. Fill the
product (that is a similar, but container prior to container disposal container 1/4 full with water and recap.
concentrated formulation) to be poured that are specified in §§ 156.146 and Shake for 10 seconds. Pour rinsate into
into the container and diluted by the 156.156. The residue removal application equipment or a mix tank or
end user: ‘‘Do not reuse or refill this instructions are required for both store rinsate for later use or disposal.
container unless the directions for use nonrefillable and refillable containers. Drain for 10 seconds after the flow
allow a different (concentrated) product (b) Placement of residue removal begins to drip. Repeat this procedure
to be diluted in the container.’’ statements. All residue removal two more times.’’
(3) Recycling or reconditioning instructions must be placed under the (3) For containers that are too large to
statement. One of the following heading ‘‘Storage and Disposal.’’ shake, use the following instructions:
statements is required: (c) Exemption for residential/ ‘‘Triple rinse as follows: Empty
(i) ‘‘Offer for recycling if available.’’ household use products. Residential/ remaining contents into application
(ii) ‘‘Once cleaned, some agricultural household use pesticide products are equipment or a mix tank. Fill the
plastic pesticide containers can be taken exempt from the residue removal container 1/4 full with water. Replace
to a container collection site or picked instruction requirements in this section and tighten closures. Tip container on
up for recycling. To find the nearest site, through § 156.156. its side and roll it back and forth,
contact your chemical dealer or (d) Modification. EPA may, on its own ensuring at least one complete
manufacturer or contact [a pesticide initiative or based on data submitted by revolution, for 30 seconds. Stand the
container recycling organization] at any person, modify or waive the container on its end and tip it back and
[phone number] or [web site]. For requirements of this section through forth several times. Turn the container
example, this statement could be ‘‘Once § 156.156, or permit or require over onto its other end and tip it back
cleaned, some agricultural plastic alternative labeling statements. and forth several times. Empty the
pesticide containers can be taken to a rinsate into application equipment or a
container collection site or picked up § 156.146 Residue removal instructions for mix tank or store rinsate for later use or
nonrefillable containers - rigid containers disposal. Repeat this procedure two
for recycling. To find the nearest site, with dilutable pesticides.
contact your chemical dealer or more times.’’
manufacturer or contact the Ag The label of each dilutable (liquid or (c) Pressure rinse instructions. The
Container Recycling Council (ACRC) at solid) pesticide product packaged in a label of each dilutable pesticide product
1–877–952–2272 (toll-free) or rigid nonrefillable container must packaged in rigid nonrefillable
www.acrecycle.org.’’ include the following residue removal containers may include one of the
(iii) A recycling statement approved instructions as appropriate. following sets of instructions, and one
by EPA and published in an EPA (a) Timing of the residue removal of them must be used if the statement
document, such as a Pesticide procedure. One of the following in paragraph (a)(2) of this section is
Registration Notice. statements must immediately precede used. If one of these statements is
(iv) An alternative recycling statement the instructions required in paragraph included on the label, it must
that has been reviewed and approved by (b) of this section and must be immediately follow the triple rinse
EPA. consistent with the instructions in instructions specified in paragraph (b)
(v) ‘‘Offer for reconditioning if paragraphs (b) and (c) of this section: of this section.
appropriate.’’ (1) ‘‘Clean container promptly after (1) For liquid dilutable pesticide
(4) Batch code. A lot number, or other emptying.’’ products, use the following label
code used by the registrant or producer (2) ‘‘Triple rinse or pressure rinse instruction: ‘‘Pressure rinse as follows:
to identify the batch of the pesticide container (or equivalent) promptly after Empty the remaining contents into
product which is distributed and sold is emptying.’’ application equipment or a mix tank
required. (3) ‘‘Triple rinse container (or and continue to drain for 10 seconds
(b) Refillable container. For refillable equivalent) promptly after emptying.’’ after the flow begins to drip. Hold
containers, one of the following (b) Triple rinse instructions. The label container upside down over application
statements is required. If placed on the of each dilutable pesticide product equipment or mix tank or collect rinsate
label, it must be under the heading packaged in rigid nonrefillable for later use or disposal. Insert pressure
‘‘Storage and Disposal.’’ If the statement containers must include one of the rinsing nozzle in the side of the
is placed on the container, an following sets of instructions. container, and rinse at about 40 PSI for
appropriate referral statement, such as (1) For liquid dilutable pesticide at least 30 seconds. Drain for 10 seconds
‘‘Refilling limitations are on the products in containers small enough to after the flow begins to drip.’’
container.’’ must be placed under the shake, use the following instructions: (2) For solid dilutable pesticide
heading ‘‘Storage and Disposal.’’ ‘‘Triple rinse as follows: Empty the products, use the following label
(1) ‘‘Refillable Container. Refill this remaining contents into application instruction: ‘‘Pressure rinse as follows:
container with pesticide only. Do not equipment or a mix tank and drain for Empty the remaining contents into
reuse this container for any other 10 seconds after the flow begins to drip. application equipment or a mix tank.
purpose.’’ Fill the container 1/4 full with water Hold container upside down over
(2) ‘‘Refillable Container. Refill this and recap. Shake for 10 seconds. Pour application equipment or mix tank or
container with [common chemical rinsate into application equipment or a collect rinsate for later use or disposal.
name] only. Do not reuse this container mix tank or store rinsate for later use or Insert pressure rinsing nozzle in the side
for any other purpose.’’ disposal. Drain for 10 seconds after the of the container, and rinse at about 40
flow begins to drip. Repeat this PSI for at least 30 seconds. Drain for 10
§ 156.144 Residue removal instructions - procedure two more times.’’ seconds after the flow begins to drip.’’
general. (2) For solid dilutable pesticide (d) Non-water diluent. (1) A registrant
(a) General. Except as provided by products in containers small enough to who wishes to require users to clean a
paragraphs (c) and (d) of this section, shake, use the following instructions: container with a diluent other than
the label of each pesticide product must ‘‘Triple rinse as follows: Empty the water (e.g., solvents) must submit to
include the applicable instructions for remaining contents into application EPA a written request to modify the
residue removal instructions of this statement on residue removal 165.67 Registrants who distribute or sell
section. The registrant may not instructions could include any one of pesticide products to refillers for
distribute or sell the pesticide with the the following: repackaging.
(i) The refilling residue removal 165.70 Refillers who are not registrants.
modified residue removal instructions
165.71–165.79 [Reserved]
until EPA approves the request in procedure developed by the registrant
writing. for the pesticide product. Subpart E—Standards for Pesticide
(2) The registrant must indicate why (ii) Standard industry practices for Containment Structures
a non-water diluent is necessary for cleaning refillable containers. 165.80 General provisions.
efficient residue removal, and must (iii) For pesticides that require 165.81 Scope of stationary pesticide
propose residue removal instructions dilution prior to application, the containers included.
and disposal instructions that are following statement: ‘‘To clean the 165.82 Scope of pesticide dispensing areas
container before final disposal, empty included.
appropriate for the characteristics and
165.83 Definition of new and existing
formulation of the pesticide product and the remaining contents from this structures.
non-water diluent. The proposed container into application equipment or 165.85 Design and capacity requirements
residue removal instructions must a mix tank. Fill the container about 10 for new structures.
identify the diluent. If the Directions for percent full with water. Agitate 165.87 Design and capacity requirements
Use permit the application of a mixture vigorously or recirculate water with the for existing structures.
of the pesticide and the non-water pump for 2 minutes. Pour or pump 165.90 Operational, inspection and
diluent, the instructions may allow the rinsate into application equipment or maintenance requirements for all new
rinsate collection system. Repeat this and existing containment structures.
rinsate to be added to the application
165.92 What if I need both a containment
equipment or mix tank. If the Directions rinsing procedure two more times.’’
pad and a secondary containment unit?
for Use do not identify the non-water (iv) Any other statement the registrant 165.95 What recordkeeping do I have to do
diluent as an allowable addition to the considers appropriate. as a facility owner or operator?
pesticide, the instructions must require 165.97 States with existing containment
§ 156.159 Compliance date.
collection and storage of the rinsate in programs.
a rinsate collection system. As of August 17, 2009, all pesticide
products distributed or sold by a Authority: 7 U.S.C. 136 through 136y.
(3) EPA may approve the request if
EPA finds that the proposed registrant must have labels that comply
Subpart A—General
instructions are necessary and with §§ 156.10(d)(7), 156.10(f),
appropriate. 156.10(i)(2)(ix), 156.140, 156.144, § 165.1 Scope.
156.146, and 156.156. The Part 165 regulations establish
§ 156.156 Residue removal instructions for ■ 3. By adding a new part 165 to read standards and requirements for
refillable containers. as follows: pesticide containers, repackaging
The label of each pesticide product pesticides, and pesticide containment
packaged in a refillable container must Part 165—Pesticide Management and structures.
include the residue removal instructions Disposal
in this section. Instructions must be § 165.3 Definitions.
given for all pesticide products that are Sec. Act means the Federal Insecticide,
distributed or sold in refillable Subpart A—General Fungicide, and Rodenticide Act.
containers, including those that do not 165.1 Scope. Agricultural pesticide means any
require dilution prior to application. 165.3 Definitions. pesticide product labeled for use in a
(a) Timing of the residue removal 165.4–165.19 [Reserved] nursery or greenhouse or for use in the
procedure. One of the following production of any agricultural
Subpart B—Nonrefillable Container
statements must immediately precede Standards: Container Design and Residue
commodity, including any plant, plant
the instructions required in paragraph Removal part, animal, or animal product
(b) of this section and must be produced by persons (including farmers,
165.20 General provisions.
consistent with the instructions in 165.23 Scope of pesticide products
ranchers, vineyardists, plant
paragraph (b) of this section: included. propagators, Christmas tree growers,
(1) ‘‘Cleaning the container before 165.25 Nonrefillable container standards. aquaculturalists, horticulturists,
final disposal is the responsibility of the 165.27 Reporting and recordkeeping. orchardists, foresters, or other
person disposing of the container. 165.28–165.39 [Reserved] comparable persons) primarily for sale,
Cleaning before refilling is the Subpart C—Refillable Container Standards:
consumption, propagation or other use
responsibility of the refiller.’’ Container Design by man or animals.
(2) ‘‘Pressure rinsing the container Appurtenance means any equipment
165.40 General provisions. or device which is used for the purpose
before final disposal is the
165.43 Scope of pesticide products
responsibility of the person disposing of included.
of transferring a pesticide from a
the container. Cleaning before refilling 165.45 Refillable container standards. stationary pesticide container or to any
is the responsibility of the refiller.’’ 165.47 What information must I report refillable container, including but not
(b) Residue removal instructions prior about my refillable containers? limited to, hoses, fittings, plumbing,
to container disposal. (1) Instructions 165.48–165.59 [Reserved] valves, gauges, pumps and metering
for cleaning each refillable container Subpart D—Standards for Repackaging
devices.
prior to disposal are required. The Pesticide Products into Refillable
Container means any package, can,
residue removal instructions must be Containers bottle, bag, barrel, drum, tank, or other
appropriate for the characteristics and containing-device (excluding any
165.60 General provisions.
formulation of the pesticide product and 165.63 Scope of pesticide products

application tanks) used to enclose a
must be adequate to protect human included. pesticide. Containers that are used to
health and the environment. 165.65 Registrants who distribute or sell sell or distribute a pesticide product and
(2) Subject to meeting the standard in pesticide products in refillable that also function in applying the
paragraph (b)(1) of this section, the containers. product (such as spray bottles, aerosol
cans and containers that become part of Reconditioned containers are Producer means any person, as
a direct injection system) are considered considered to be nonrefillable defined by the Act, who produces any
to be containers for the purposes of this containers. pesticide, active ingredient, or device
part. One-way valve means a valve that is (including packaging, repackaging,
Containment pad means any structure designed and constructed to allow labeling and relabeling).
that is designed and constructed to virtually unrestricted flow in one Refillable container means a container
intercept and contain pesticides, direction and no flow in the opposite that is intended to be filled with
rinsates, and equipment wash water at direction, thus allowing the withdrawal pesticide more than once for sale or
a pesticide dispensing area. of material from, but not the distribution.
Containment structure means either a introduction of material into, a
secondary containment unit or a Refiller means a person who engages
container.
containment pad. in the activity of repackaging pesticide
Operator means any person in control
Custom blending means the service of product into refillable containers. This
of, or having responsibility for, the daily
mixing pesticides to a customer’s could include a registrant or a person
operation of a facility at which a
specifications, usually a pesticide(s)- operating under contract to a registrant.
containment structure is located.
fertilizer(s), pesticide-pesticide, or a Owner means any person who owns a Refilling establishment means an
pesticide-animal feed mixture, when: facility at which a containment establishment where the activity of
(1) The blend is prepared to the order structure is required. repackaging pesticide product into
of the customer and is not held in Pesticide compatible means, as refillable containers occurs.
inventory by the blender; applied to containers, that the container Repackage means, for the purposes of
(2) The blend is to be used on the construction materials will not this part, to transfer a pesticide
customer’s property (including leased or chemically react with the formulation. formulation from one container to
rented property); A container is not compatible with the another without a change in the
(3) The pesticide(s) used in the blend
formulation if, for example, the composition of the formulation, the
bears end-use labeling directions which
formulation: labeling content, or the product’s EPA
do not prohibit use of the product in
(1) Is corrosive to the container; registration number, for sale or
such a blend;
(2) Causes softening, premature aging, distribution.
(4) The blend is prepared from
registered pesticides; and or embrittlement of the container; Rinsate means the liquid produced
(5) The blend is delivered to the end- (3) Otherwise causes the container to from the rinsing of the interior of any
user along with a copy of the end-use weaken or to create the risk of equipment or container that has come in
labeling of each pesticide used in the discharge; direct contact with any pesticide.
blend and a statement specifying the (4) Reacts in a significant chemical,
Runoff means surface water leaving
composition of the mixture. electrolytic, or galvanic manner with the
the target site.
Dry pesticide means any pesticide container, or
(5) Interacts in a way, such as the Secondary containment unit means
that is in solid form and that has not any structure, including rigid diking,
been combined with liquids; this active ingredient permeating the
container wall, that would cause the that is designed and constructed to
includes formulations such as dusts, intercept and contain pesticide spills
wettable powders, dry flowable formulation to differ from its
composition as described in the and leaks and to prevent runoff and
powders, granules, and dry baits. leaching from stationary pesticide
Establishment means any site where a statement required in connection with
its registration under FIFRA section 3. containers.
pesticidal product, active ingredient, or
device is produced, regardless of Pesticide compatible means, as Stationary pesticide container means
whether such site is independently applied to secondary containment, that a refillable container that is fixed at a
owned or operated, and regardless of the containment construction materials single facility or establishment or, if not
whether such site is domestic and are able to withstand anticipated fixed, remains at the facility or
producing a pesticidal product for exposure to stored or transferred establishment for at least 30 consecutive
export only, or whether the site is materials without losing the capacity to days, and that holds pesticide during
foreign and producing any pesticidal provide the required secondary the entire time.
product for import into the United containment of the same or other Tamper-evident device means a
States. materials within the containment area. device which can be visually inspected
Facility means all buildings, Pesticide dispensing area means an to determine if a container has been
equipment, structures, and other area in which pesticide is transferred opened.
stationary items which are located on a out of or into a container.
Transport vehicle means a cargo-
single site or on contiguous or adjacent Portable pesticide container means a
carrying vehicle such as an automobile,
sites and which are owned or operated refillable container that is not a
van, tractor, truck, semitrailer, tank car
by the same person (or by any person stationary pesticide container.
or rail car used for the transportation of
who controls, who is controlled by, or Pressure rinse means the flushing of
cargo by any mode.
who is under common control with the container to remove pesticide
such person). residue by using a pressure method with Triple rinse means the flushing of the
Flowable concentrate means a stable a pressure of at least 40 PSI. container three times to remove
suspension of active ingredients in a Produce means to manufacture, pesticide residue by using a non-
liquid intended for dilution with water prepare, propagate, compound, or pressurized method.
before use. process any pesticide, including any Washwater means the liquid
Nonrefillable container means a pesticide produced pursuant to section produced from the rinsing of the
container that is not a refillable 5 of the Act, and any active ingredient exterior of any equipment or containers
container and that is designed and or device, or to package, repackage, that have or may have come in direct
constructed for one time containment of label, relabel, or otherwise change the contact with any pesticide or system
a pesticide for sale or distribution. container of any pesticide or device. maintenance compound.
§§ 165.4–165.19 [Reserved] Federal Food, Drug, and Cosmetic Act allowing the applicant or registrant a
or a food additive regulation under reasonable amount of time to reply, EPA
Subpart B—Nonrefillable Container section 409 of such Act. may require, by notification and as a
Standards: Container Design and (2) The labeling of the pesticide condition of registration, that the
Residue Removal product includes directions for use on a product be distributed or sold in
§ 165.20 General provisions. site in at least one of the following nonrefillable containers that comply
antimicrobial product use categories: with all or some of the requirements in
(a) What is the purpose of the
food handling/storage establishments this subpart. For the purpose of the
regulations in this subpart? The
premises and equipment; commercial, previous sentence, 60 days would be a
regulations in this subpart establish
institutional, and industrial premises reasonable amount of time to reply,
design and construction requirements
and equipment; residential and public although EPA may, in its discretion,
for nonrefillable containers used for the
access premises; medical premises and provide more time. EPA may deny
distribution or sale of some pesticide
equipment; human drinking water registration or initiate cancellation
products.
(b) Do I have to comply with the systems; materials preservatives; proceedings if the registrant fails to
regulations in this subpart? You must industrial processes and water systems; comply with the nonrefillable container
comply with the regulations in this antifouling coatings; wood regulations within the time frames
subpart if you are a registrant who preservatives; or swimming pools. established by EPA in the rule or in its
distributes or sells a pesticide product (3) The pesticide product is not a notification.
in nonrefillable containers. If your hazardous waste as set out in part 261 (e) What other pesticide products are
pesticide product is subject to the of this chapter when the pesticide subject to the regulations in this
regulations in this subpart as set out in product is intended to be disposed. subpart? (1) Except for manufacturing
(4) EPA has not specifically use products, plant-incorporated
§ 165.23, your pesticide product must be
determined that the pesticide product protectants, and antimicrobial products
distributed or sold in a nonrefillable
must be subject to the regulations in this that are exempt under paragraph (c) of
container that meets the standards of
subpart to prevent an unreasonable this section, all of the regulations in this
these regulations.
(c) When do I have to comply? As of adverse effect on the environment subpart apply to a pesticide product if
August 17, 2009, all pesticide products according to the provisions of paragraph it satisfies at least one of the following
distributed or sold by you in (d) of this section. criteria:
(d) How will EPA determine if an (i) The pesticide product meets the
nonrefillable containers must be
‘‘antimicrobial’’ pesticide product criteria of Toxicity Category I as set out
distributed or sold in compliance with
otherwise exempted must be subject to in § 156.62 of this chapter.
these regulations.
the regulations in this subpart to (ii) The pesticide product meets the
§ 165.23 Scope of pesticide products prevent an unreasonable adverse effect criteria of Toxicity Category II as set out
included. on the environment? (1) EPA may in § 156.62 of this chapter.
(a) Are manufacturing use products determine that an antimicrobial (iii) The pesticide product is
subject to the regulations in this pesticide product otherwise exempted classified for restricted use as set out in
subpart? No, the regulations in this by paragraph (c) of this section must be §§ 152.160 - 152.175 of this chapter.
subpart do not apply to manufacturing subject to the nonrefillable container (2) Except for manufacturing use
use products, as defined in § 158.153(h) regulations in this subpart to prevent an products, plant-incorporated
of this chapter. unreasonable adverse effect on the protectants, antimicrobial products that
(b) Are plant-incorporated protectants environment if all of the following are exempt under (c) of this section, and
subject to the regulations in this conditions exist: other pesticide products that are
subpart? No, the regulations in this (i) EPA obtains information, data or regulated under paragraph (e)(1) of this
subpart do not apply to plant- other evidence of a problem with the section, a pesticide product must be
incorporated protectants, as defined in containers of a certain pesticide product packaged in compliance with 49 CFR
§ 174.3 of this chapter. or related group of products. 173.24. If the pesticide product meets
(c) Which antimicrobial pesticide (ii) The information, data or other the definition of a hazardous material in
products are not subject to the evidence is reliable and factual. 49 CFR 171.8, the Department of
regulations in this subpart? The (iii) The problem causes or could Transportation requires it to be
regulations in this subpart do not apply reasonably be expected to cause an packaged according to 49 CFR parts
to a pesticide product if it satisfies all unreasonable adverse effect on the 171–180.
of the following conditions: environment. (f) What does ‘‘pesticide product’’ or
(1) The pesticide product meets one of (iv) Complying with the container ‘‘pesticide’’ mean in the rest of this
the following two criteria: regulations could reasonably be subpart? In §§ 165.25 through 165.27,
(i) The pesticide product is an expected to eliminate the problem. the term ‘‘pesticide product’’ or
antimicrobial pesticide as defined in (2) If EPA determines that an ‘‘pesticide’’ refers only to a pesticide
FIFRA section 2(mm); or antimicrobial pesticide product product or a pesticide that is subject to
(ii) The pesticide product: (A) Is otherwise exempted by paragraph (c) of the regulations in this subpart as
intended to: disinfect, sanitize, reduce this section must be subject to the described in paragraphs (a) through (e)
or mitigate growth or development of nonrefillable container regulations in of this section.
microbiological organisms; or protect this subpart to prevent an unreasonable
inanimate objects, industrial processes adverse effect on the environment, EPA § 165.25 Nonrefillable container standards.
or systems, surfaces, water, or other may require, by rule, that the product be (a) What Department of
chemical substances from distributed or sold in nonrefillable Transportation (DOT) standards do my
contamination, fouling, or deterioration containers that comply with all or some nonrefillable containers have to meet
caused by bacteria, viruses, fungi, of the requirements in this subpart. under this part if my pesticide product
protozoa, algae, or slime; and Alternatively, EPA may notify the is not a DOT hazardous material? A
(B) In the intended use is subject to applicant or registrant of its intent to pesticide product that does not meet the
a tolerance under section 408 of the make such a determination. After definition of a hazardous material in 49
CFR 171.8 must be packaged in a meet? If your nonrefillable container has requirements achieves a level of safety
nonrefillable container that is designed, a capacity of 5 gallons (18.9 liters) or that is at least equal to that specified in
constructed, and marked to comply with less, if the container is not an aerosol the requirements of paragraph (a) of this
the requirements of 49 CFR 173.24, container, a pressurized container, or a section.
173.24a, 173.24b, 173.28, 173.155, spray bottle, and if the container holds (2) EPA may waive or modify the
173.203, 173.213, 173.240(c), a liquid pesticide, your nonrefillable requirements of paragraph (b) of this
173.240(d), 173.241(c), 173.241(d), part container must do both of the following: section regarding the DOT standards for
178, and part 180 that are applicable to (1) Allow the contents of the pesticide products that are DOT
a Packing Group III material. nonrefillable container to pour in a hazardous materials if EPA determines
(b) What DOT standards do my continuous, coherent stream. that an alternative (partial or modified)
nonrefillable containers have to meet (2) Allow the contents of the set of standards or pre-existing
under this part if my pesticide product nonrefillable container to be poured requirements achieves a level of safety
is a DOT hazardous material? (1) If your with a minimum amount of dripping that is at least equal to that specified in
pesticide product meets the definition down the outside of the container. the requirements of paragraph (b) of this
of a hazardous material in 49 CFR 171.8, (f) What standards for residue section. EPA will modify or waive the
the DOT requires your pesticide product removal do my nonrefillable containers requirements of paragraph (b) of this
to be packaged according to 49 CFR have to meet? Each nonrefillable section only after consulting with DOT
parts 171–180. container and pesticide formulation to ensure consistency with DOT
(2) For the purposes of these combination must meet the applicable regulations and exemptions.
regulations, a pesticide product that residue removal standard of this section. (3) EPA may approve a non-standard
meets the definition of a hazardous (1) If the nonrefillable container is closure (that is, a closure not listed in
material in 49 CFR 171.8 must be rigid and has a capacity less than or paragraph (d) of this section) if EPA
packaged in a nonrefillable container equal to 5 gallons (18.9 liters) for liquid determines that both of the following
that is designed, constructed, and formulations or 50 pounds (22.7 conditions are satisfied:
marked to comply with the kilograms) for solid formulations and if (i) The non-standard closure is
requirements of 49 CFR parts 171–180. the pesticide product’s labeling allows necessary for the proper mixing,
(c) What will EPA do if DOT proposes or requires the pesticide product to be loading, or application of the pesticide
to change any of the cross-referenced mixed with a liquid diluent prior to product.
regulations? If the DOT proposes to application (that is, if the pesticide is (ii) The non-standard closure offers
change any of the regulations that are dilutable), each container/formulation exposure protection to handlers during
incorporated in paragraphs (a) and (b) of combination must be capable of mixing and loading that is the same or
this section, EPA will provide notice of attaining at least 99.99 percent removal greater than that provided by the
the proposed changes and an of each active ingredient when tested standard closures.
opportunity to comment in the Federal using the EPA test procedure ‘‘Rinsing (4) EPA may waive or modify the
Register. Following notice and Procedures for Dilutable Pesticide container dispensing capability
comment, EPA will take final action Products in Rigid Containers.’’ standards in paragraph (e) of this
regarding whether or not to revise its (2) The test must be conducted only section if EPA determines that at least
rules, and the extent to which any such if the pesticide product is a flowable one of the following conditions is
revision will correspond with revised concentrate or if EPA specifically satisfied:
DOT regulations. requests the records on a case by case (i) The product is typically removed
(d) What standards for closures do my basis. from the container by a method other
nonrefillable containers have to meet? If (3) For the rigid container/dilutable than pouring.
your nonrefillable container is a rigid product standard in paragraph (f)(1) of (ii) Compliance with the container
container with a capacity equal to or this section, percent removal represents dispensing capability standards would
greater than 3.0 liters (0.79 gallons), if the percent of the original concentration increase exposure to the pesticide
the container is not an aerosol container of the active ingredient in the pesticide container handler.
or a pressurized container, and if the product when compared to the (5) EPA may waive or modify the
container is used to distribute or sell a concentration of that active ingredient requirements of paragraph (f) of this
liquid agricultural pesticide, each in the fourth rinse. Percent removal is section regarding the residue removal
nonrefillable container must have at calculated by the formula: standard if EPA determines that both of
least one of the following standard the following conditions are satisfied:
percent removal = [1.0 - RR] x 100.0, where (i) The residue remaining in the
closures:
(1) Bung, 2 inch pipe size (2.375 RR = rinsate ratio = Active ingredient container would not cause an
inches in diameter), external threading, concentration in fourth rinsate/Original unreasonable adverse effect on the
concentration of active ingredient in the environment; and
11.5 threads per inch, National Pipe product
Straight (NPS) standard. (ii) The product offers significant
(2) Bung, 2 inch pipe size (2.375 (g) Can I obtain a waiver from or a benefits and cannot be economically
inches in diameter), external threading, modification to any of the nonrefillable reformulated or repackaged.
5 threads per inch, buttress threads. container standards? Yes, it is possible (h) How do I obtain a waiver from or
(3) Screw cap, 63 millimeters, at least for you to obtain a waiver from or a a modification to any of the
one thread revolution at 6 threads per modification to the nonrefillable nonrefillable container standards? To
inch. container standards, as follows: obtain a waiver from or a modification
(4) Screw cap, 38 millimeters, at least (1) EPA may waive or modify the to any of the nonrefillable container
one thread revolution at 6 threads per requirements of paragraph (a) of this standards, you must submit a written
inch. The cap may fit on a separate rigid section regarding the DOT standards for request for a waiver or a modification to
spout or on a flexible pull-out plastic pesticide products that are not DOT the EPA to the following address: Office
spout. hazardous materials if EPA determines of Pesticide Programs (7504P); U.S.
(e) What standards for dispensing do that an alternative (partial or modified) Environmental Protection Agency; Ariel
my nonrefillable containers have to set of standards or pre-existing Rios Building; 1200 Pennsylvania
Avenue, N.W., Washington, DC 20460. container used to distribute or sell the in this subpart if you are a registrant
You cannot distribute or sell the pesticide product that must comply who distributes or sells a pesticide
pesticide product in a nonrefillable with § 165.25(d): product in refillable containers. If your
container that does not comply with all (i) A letter or document from the pesticide product is subject to the
of the nonrefillable container standards container supplier that describes the regulations in this subpart as set out in
unless and until EPA approves the closure. § 165.43, your pesticide product must be
request for the waiver or modification in (ii) A specification about the closure distributed or sold in a refillable
writing. You must include two copies of in the contract between the registrant or container that meets the standards of
the following information (which may applicant and the container supplier. these regulations. This includes your
be part of an application for registration (iii) A copy of EPA’s approval of any pesticide products that are repackaged
or amended registration) with your non-standard closure. according to subpart D of this part.
written request: (4) At least one of the following (2) You must comply with the
(1) The name and address of the records pertaining to the container regulations in § 165.45(f) for stationary
registrant; the date; and the name, title, dispensing capability requirements in pesticide containers if you are a refiller
signature, and phone number of the § 165.25(e) for each nonrefillable of a pesticide product and you are not
company official making the request. container used to distribute or sell the the registrant of the pesticide product. If
(2) The name and EPA registration pesticide product that must comply the pesticide product is subject to the
number of the pesticide product for with § 165.25(e): regulations in this subpart as set out in
which the waiver or modification is (i) Test data or documentation § 165.43, the stationary pesticide
requested. demonstrating that the nonrefillable containers used to distribute or sell the
(3) A statement specifying the container meets the standards in product must meet the standards of
requirement or requirements from § 165.25(e) when it contains the § 165.45(f).
which you are requesting a waiver or a pesticide product. (c) When do I have to comply? As of
modification. (ii) Test data or documentation August 16, 2011, all pesticide products
(4) A description of the nonrefillable demonstrating that a different distributed or sold by you in refillable
container or containers for which the nonrefillable container meets the containers must be distributed or sold in
waiver or modification is requested. standards in § 165.25(e) when it compliance with these regulations.
(5) Documentation or justification to contains the pesticide product or even
demonstrate that the applicable waiver a different pesticide product and a § 165.43 Scope of pesticide products
or modification criteria in paragraph (g) written explanation of why such data or included.
of this section are satisfied. documentation demonstrates that the (a) Are manufacturing use products
§ 165.27 Reporting and recordkeeping. container meets the standards in subject to the regulations in this
§ 165.25(e) for the pesticide product. subpart? No, the regulations in this
(a) What information must I report subpart do not apply to manufacturing
about my nonrefillable containers? You (5) At least one of the following
records pertaining to the nonrefillable use products, as defined in § 158.153(h)
are not required to report to EPA with of this chapter.
information about your nonrefillable container residue removal requirement
in § 165.25(f) if the pesticide product is (b) Are plant-incorporated protectants
containers under the regulations in this
a flowable concentrate or if EPA subject to the regulations in this
subpart. You should refer to the
specifically requests the records on a subpart? No, the regulations in this
reporting standards in part 159 of this
case by case basis: subpart do not apply to plant-
chapter to determine if information on
(i) Test data showing that the incorporated protectants, as defined in
container failures or other incidents
nonrefillable container and pesticide § 174.3 of this chapter.
involving pesticide containers must be
reported to EPA under FIFRA section formulation meet the standard in (c) Which ‘‘antimicrobial’’ pesticide
6(a)(2) (7 U.S.C. 136d(a)(2)). § 165.25(f) . products are not subject to the
(b) What recordkeeping do I have to (ii) Test data showing that a different regulations in this subpart? The
do for my nonrefillable containers? For nonrefillable container with the same or regulations in this subpart do not apply
each pesticide product that is subject to a different pesticide formulation meets to a pesticide product if it satisfies all
§ 165.25 - 165.27 and is distributed or the standard in § 165.25(f), together with of the following conditions:
sold in nonrefillable containers, you a written explanation of why such data (1) The pesticide product meets one of
must maintain the records listed in this demonstrate that the nonrefillable the following two criteria:
section for as long as a nonrefillable container and pesticide formulation (i) The pesticide product is an
container is used to distribute or sell the meet the standard in § 165.25(f). antimicrobial pesticide as defined in
pesticide product and for 3 years after FIFRA section 2(mm); or
§§ 165.28–165.39 [Reserved]
that. You must furnish these records for (ii) The pesticide product: (A) Is
inspection and copying upon request by Subpart C—Refillable Container intended to: disinfect, sanitize, reduce
an employee of EPA or any entity Standards: Container Design or mitigate growth or development of
designated by EPA, such as a State, microbiological organisms; or protect
another political subdivision or a Tribe. § 165.40 General provisions. inanimate objects, industrial processes
You must keep the following records: (a) What is the purpose of the or systems, surfaces, water, or other
(1) The name and EPA registration regulations in this subpart? The chemical substances from
number of the pesticide product. regulations in this subpart establish contamination, fouling, or deterioration
(2) A description of the nonrefillable design and construction requirements caused by bacteria, viruses, fungi,
container(s) in which the pesticide for refillable containers used for the protozoa, algae, or slime; and
product is distributed or sold. distribution or sale of some pesticide (B) In the intended use is subject to
(3) At least one of the following products. a tolerance under section 408 of the
records to document compliance with (b) Do I have to comply with the Federal Food, Drug, and Cosmetic Act
the requirement for closures in regulations in this subpart? (1) You or a food additive regulation under
§ 165.25(d) for each nonrefillable must comply with all of the regulations section 409 of such Act.
(2) The labeling of the pesticide (i) EPA obtains information, data or are an integral part of the transport
product includes directions for use on a other evidence of a problem with the vehicle and that are the primary
site in at least one of the following containers of a certain pesticide product containment for the pesticide.
antimicrobial product use categories: or related group of products. (2) The regulations in this subpart do
food handling/storage establishments (ii) The information, data or other not apply to containers that hold
premises and equipment; commercial, evidence is reliable and factual. pesticides that are gaseous at
institutional, and industrial premises (iii) The problem causes or could atmospheric temperature and pressure.
and equipment; residential and public reasonably be expected to cause an
unreasonable adverse effect on the § 165.45 Refillable container standards.
access premises; medical premises and
equipment; human drinking water environment. (a) What Department of
systems; materials preservatives; (iv) Complying with the container Transportation (DOT) standards do my
industrial processes and water systems; regulations could reasonably be refillable containers have to meet under
antifouling coatings; wood expected to eliminate the problem. this part if my pesticide product is not
preservatives; or swimming pools. (2) If EPA determines that an a DOT hazardous material? (1) A
antimicrobial pesticide product pesticide product that does not meet the
(3) The pesticide product is not a
otherwise exempted by paragraph (c) of definition of a hazardous material in 49
hazardous waste as set out in part 261
this section must be subject to the CFR 171.8 must be packaged in a
of this chapter when the pesticide
refillable container regulations in this refillable container that is designed,
product is intended to be disposed.
subpart to prevent an unreasonable constructed, and marked to comply with
(4) EPA has not specifically adverse effect on the environment, EPA the requirements of 49 CFR 173.24,
determined that the pesticide product may require, by rule, that the product be 173.24a, 173.24b, 173.28, 173.155,
must be subject to the regulations in this distributed or sold in refillable 173.203, 173.213, 173.240(c),
subpart to prevent an unreasonable containers that comply with all or some 173.240(d), 173.241(c), 173.241(d), part
adverse effect on the environment of the requirements in this subpart. 178, and part 180 that are applicable to
according to the provisions of paragraph Alternatively, EPA may notify the a Packing Group III material.
(e) of this section. applicant or registrant of its intent to (2) A refiller is not required to comply
(d) Which requirements must an make such a determination. After with 49 CFR 173.28(b)(2) for pesticide
‘‘antimicrobial’’ swimming pool product allowing the applicant or registrant a products that are not DOT hazardous
comply with if it is not exempt from reasonable amount of time to reply, EPA materials if the refillable container to be
these regulations? An antimicrobial may require, by notification and as a reused complies with the refillable
swimming pool product that is not condition of registration, that the container regulations in this subpart and
exempt by paragraph (a), (b), or (c) of product be distributed or sold in the refilling is done in compliance with
this section must comply with all of the refillable containers that comply with the repackaging regulations in subpart D
regulations in this subpart except all or some of the requirements in this of this part.
§ 165.45(d) regarding marking and subpart. For the purpose of the previous (b) What DOT standards do my
§ 165.45(e) regarding openings. For the sentence, 60 days would be a reasonable refillable containers have to meet under
purposes of this subpart, an amount of time to reply, although EPA this part if my pesticide product is a
antimicrobial swimming pool product is may, in its discretion, provide more DOT hazardous material? (1) If your
a pesticide product that satisfies both of time. EPA may deny registration or pesticide product meets the definition
the following conditions: initiate cancellation proceedings if the of a hazardous material in 49 CFR 171.8,
(1) The pesticide product is intended registrant fails to comply with the the DOT requires your pesticide product
to: disinfect, sanitize, reduce or mitigate refillable container regulations within to be packaged according to 49 CFR
growth or development of the time frames established by EPA in parts 171–180.
microbiological organisms; or protect the rule or in its notification. (2) For the purposes of these
inanimate objects, industrial processes (f) What other pesticide products are regulations, a pesticide product that
or systems, surfaces, water, or other subject to the regulations in this meets the definition of a hazardous
chemical substances from subpart? The regulations in this subpart material in 49 CFR 171.8 must be
contamination, fouling, or deterioration apply to all pesticide products other packaged in a refillable container that is
caused by bacteria, viruses, fungi, than manufacturing use products, plant- designed, constructed, and marked to
protozoa, algae, or slime. incorporated protectants, and comply with the requirements of 49 CFR
(2) The labeling of the pesticide antimicrobial products that are exempt parts 171–180.
product includes directions for use on by paragraph (c) of this section. (c) What will EPA do if DOT proposes
only a site or sites in the antimicrobial Antimicrobial products covered under to change any of the cross-referenced
product use category of swimming by paragraph (d) of this section are regulations? If the DOT proposes to
pools. subject to the regulations indicated in change any of the regulations that are
(e) How will EPA determine if an that section. incorporated in paragraphs (a) and (b) of
‘‘antimicrobial’’ pesticide product (g) What does ‘‘pesticide product’’ or this section, EPA will provide notice of
otherwise exempted must be subject to ‘‘pesticide’’ mean in the rest of this the proposed changes and an
the regulations in this subpart to subpart? In §§ 165.43(h) through 165.47, opportunity to comment in the Federal
prevent an unreasonable adverse effect the term ‘‘pesticide product’’ or Register. Following notice and
on the environment? (1) EPA may ‘‘pesticide’’ refers only to a pesticide comment, EPA will take final action
determine that an antimicrobial product or a pesticide that is subject to regarding whether or not to revise its
pesticide product otherwise exempted the regulations in this subpart as rules, and the extent to which any such
by paragraph (c) of this section must be described in paragraphs (a) through(f) of revision will correspond with revised
subject to the refillable container this section. DOT regulations.

regulations in this subpart to prevent an (h) Are there any other exceptions? (1) (d) What standards for marking do my
unreasonable adverse effect on the The regulations in this subpart do not refillable containers have to meet? Each
environment if all of the following apply to transport vehicles that contain refillable container must be marked in a
conditions exist: pesticide in pesticide-holding tanks that durable and clearly visible manner with
a serial number or other identifying and any other foreseeable mechanical distribute or sell the pesticide product
code that will distinguish the individual stresses to which the container may be in a refillable container that does not
container from all other containers. subjected in the course of operations. comply with all of the refillable
Durable marking includes, but is not (2) Each stationary liquid pesticide container standards unless and until
limited to, etching, embossing, ink container must meet all of the following EPA approves the request for the waiver
jetting, stamping, heat stamping, standards: or modification in writing. You must
mechanically attaching a plate, molding, (i) Each stationary liquid pesticide include two copies of the following
and marking with durable ink. The container must be equipped with a vent information (which may be part of an
serial number or other identifying code or other device designed to relieve application for registration or amended
must be located on the outside part of excess pressure, prevent losses by registration) with your written request:
the container except on a closure. evaporation, and exclude precipitation. (1) The name and address of the
Placement on the label or labeling is not (ii) External sight gauges, which are registrant; the date; and the name, title,
sufficient unless the label is an integral, pesticide-containing hoses or tubes that signature, and phone number of the
permanent part of or permanently run vertically along the exterior of the company official making the request.
stamped on the container. container from the top to the bottom, are (2) The name and EPA registration
(e) What standards for openings do prohibited on stationary liquid pesticide number of the pesticide product for
my refillable containers have to meet? If containers. which the waiver or modification is
your refillable container is a portable (iii) Each stationary liquid pesticide requested.
pesticide container that is designed to container connection below the normal (3) A statement specifying the
hold liquid pesticide formulations and liquid level must be equipped with a requirement or requirements from
is not a cylinder that complies with the shutoff valve which is capable of being which you are requesting a waiver or a
DOT Hazardous Materials Regulations, locked closed. A shutoff valve must be modification.
each opening of the container other than located within a secondary containment (4) A description of the refillable
a vent must have a one-way valve, a unit if one is required by subpart E of container or containers for which the
tamper-evident device or both. A one- this part. waiver or modification is requested.
way valve may be located in a device or (g) Can I obtain a waiver from or a (5) Documentation or justification to
system separate from the container if the modification to any of the refillable demonstrate that the applicable waiver
device or system is the only reasonably container standards? Yes, it is possible or modification criteria in paragraph (g)
foreseeable way to withdraw pesticide for you to obtain a waiver from or a of this section are satisfied.
from the container. A vent must be modification to some of the refillable
container standards, as follows: § 165.47 What information must I report
designed to minimize the amount of about my refillable containers?
material that could be introduced into (1) EPA may waive or modify the
the container through it. requirements of paragraph (a) of this You are not required to report to EPA
(f) What standards do my stationary section regarding the DOT standards for with information about your refillable
pesticide containers have to meet? If a pesticide products that are not DOT containers under the regulations in this
stationary pesticide container designed hazardous materials if EPA determines subpart. You should refer to the
to hold undivided quantities of that an alternative (partial or modified) reporting standards in part 159 of this
pesticides equal to greater than 500 set of standards or pre-existing chapter to determine if information on
gallons (1,890 liters) of liquid pesticide requirements achieves a level of safety container failures or other incidents
or equal to or greater than 4,000 pounds that is at least equal to that specified in involving pesticide containers must be
(1,818 kilograms) of dry pesticide is the requirements of paragraph (a) of this reported to EPA under FIFRA section
located at the refilling establishment of section. 6(a)(2) (7 U.S.C. 136d(a)(2)).
a refiller operating under written (2) EPA may waive or modify the
§§ 165.48–165.59 [Reserved]
contract to you, the stationary pesticide requirements of paragraph (b) of this
container must meet the following section regarding the DOT standards for Subpart D—Standards for
standards: pesticide products that are DOT Repackaging Pesticide Products into
(1) Except during a civil emergency or hazardous materials if EPA determines Refillable Containers
any unanticipated grave natural disaster that an alternative (partial or modified)
or other natural phenomenon of an set of standards or pre-existing § 165.60 General provisions.
exceptional, inevitable and irresistible requirements achieves a level of safety (a) What is the purpose of the
character, the effects of which could not that is at least equal to that specified in regulations in this subpart? The
have been prevented or avoided by the the requirements of paragraph (b) of this regulations in this subpart establish
exercise of due care or foresight, each section. EPA will modify or waive the requirements for repackaging some
stationary pesticide container (for liquid requirements of paragraph (b) of this pesticide products into refillable
and dry pesticides) and its section only after consulting with DOT containers for distribution or sale.
appurtenances must meet both of the to ensure consistency with DOT (b) Do I have to comply with the
following standards: regulations and exemptions. regulations in this subpart? You must
(i) Each stationary pesticide container (h) How do I obtain a waiver from or comply with the regulations in this
and its appurtenances must be resistant a modification to any of the refillable subpart if you are a registrant who
to extreme changes in temperature and container standards? To obtain a waiver distributes or sells a pesticide product
constructed of materials that are from or a modification to any of the in refillable containers, if you are a
adequately thick to not fail and that are refillable container standards, you must registrant who distributes or sells
resistant to corrosion, puncture, or submit a written request for a waiver or pesticide products to a refiller (that is
cracking. a modification to the EPA to the not part of your company) for
(ii) Each stationary pesticide following address: Office of Pesticide repackaging into refillable containers, or
container must be capable of Programs (7504P); U.S. Environmental if you are a refiller of a pesticide
withstanding all operating stresses, Protection Agency; Ariel Rios Building; product and you are not the registrant
taking into account static heat, pressure 1200 Pennsylvania Avenue, N.W., of the pesticide product. Each pesticide
buildup from pumps and compressors, Washington, DC 20460. You cannot product that is subject to the regulations
in this subpart as set out in § 165.63 and to a pesticide product if it satisfies all institutional, and industrial premises
that is distributed or sold in a refillable of the following conditions: and equipment; residential and public
container must be distributed or sold in (1) The pesticide product meets one of access premises; medical premises and
compliance with the standards of these the following two criteria: equipment; human drinking water
regulations. (i) The pesticide product is an systems; materials preservatives;
(c) When do I have to comply? As of antimicrobial pesticide as defined in industrial processes and water systems;
August 16, 2011, all pesticide products FIFRA section 2(mm); or antifouling coatings; wood
distributed or sold by you in refillable (ii) The pesticide product: (A) Is preservatives; or swimming pools.
containers must be distributed or sold in intended to: disinfect, sanitize, reduce (3) The pesticide product is not a
compliance with these regulations. or mitigate growth or development of hazardous waste as set out in part 261
§ 165.63 Scope of pesticide products microbiological organisms; or protect of this chapter when the pesticide
included. inanimate objects, industrial processes product is intended to be disposed.
(a) Are manufacturing use products or systems, surfaces, water, or other (4) EPA has not specifically
subject to the regulations in this chemical substances from determined that the pesticide product
subpart? No, the regulations in this contamination, fouling, or deterioration must be subject to the regulations in this
subpart do not apply to manufacturing caused by bacteria, viruses, fungi, subpart to prevent an unreasonable
use products, as defined in § 158.153(h) protozoa, algae, or slime; and adverse effect on the environment
of this chapter. (B) In the intended use is subject to according to the provisions of paragraph
(b) Are plant-incorporated protectants a tolerance under section 408 of the (e) of this section.
subject to the regulations in this Federal Food, Drug, and Cosmetic Act (d) Which requirements must an
subpart? No, the regulations in this or a food additive regulation under antimicrobial swimming pool product
subpart do not apply to plant- section 409 of such Act. comply with if it is not exempt from
incorporated protectants, as defined in (2) The labeling of the pesticide these regulations? (1) An antimicrobial
§ 174.3 of this chapter. product includes directions for use on a swimming pool product that is not
(c) Which antimicrobial pesticide site in at least one of the following exempt by paragraph (a), (b), or (c) of
products are not subject to the antimicrobial product use categories: this section must comply with all of the
regulations in this subpart? The food handling/storage establishments regulations in this subpart except for the
regulations in this subpart do not apply premises and equipment; commercial, following requirements:
Requirement for
registrants who Requirement for
Requirement distribute or sell refillers who are
directly in refillable not registrants
containers
Recordkeeping specific to each instance of repackaging § 165.65(i)(2) § 165.70(j)(2)
Container inspection: criteria regarding a serial number or other identifying code § 165.65(e)(3) § 165.70(f)(3)
Container inspection: criteria regarding one-way valve or tamper-evident device § 165.65(e)(4) § 165.70(f)(4)
Cleaning requirement: criteria regarding one-way valve or tamper-evident device § 165.65(f)(1) § 165.70(g)(1)
Cleaning if the one-way valve or tamper-evident device is not intact § 165.65(g) § 165.70(h)
(2) For the purposes of this subpart, prevent an unreasonable adverse effect otherwise exempted by paragraph (c) of
an antimicrobial swimming pool on the environment? (1) EPA may this section must be subject to the
product is a pesticide product that determine that an antimicrobial repackaging regulations in this subpart
satisfies both of the following pesticide product otherwise exempted to prevent an unreasonable adverse
conditions: by paragraph (c) of this section must be effect on the environment, EPA may
(i) The pesticide product is intended subject to the repackaging regulations in require, by rule, that the product be
to: disinfect, sanitize, reduce or mitigate this subpart to prevent an unreasonable repackaged in compliance with all or
growth or development of adverse effect on the environment if all some of the requirements in this
microbiological organisms; or protect of the following conditions exist: subpart. Alternatively, EPA may notify
inanimate objects, industrial processes (i) EPA obtains information, data or the applicant or registrant of its intent
or systems, surfaces, water, or other other evidence of a problem with the to make such a determination. After
chemical substances from containers of a certain pesticide product allowing the applicant or registrant a
contamination, fouling, or deterioration or related group of products. reasonable amount of time to reply, EPA
caused by bacteria, viruses, fungi, (ii) The information, data or other may require, by notification and as a
protozoa, algae, or slime. evidence is reliable and factual. condition of registration, that the
(ii) The labeling of the pesticide (iii) The problem causes or could product be repackaged in compliance
product includes directions for use on reasonably be expected to cause an with all or some of the requirements in
only a site or sites in the antimicrobial unreasonable adverse effect on the this subpart. For the purpose of the
product use category of swimming environment. previous sentence, 60 days would be a
pools. (iv) Complying with the container reasonable amount of time to reply,
(e) How will EPA determine if an regulations could reasonably be although EPA may, in its discretion,
antimicrobial pesticide product expected to eliminate the problem. provide more time. EPA may deny
otherwise exempted must be subject to (2) If EPA determines that an registration or initiate cancellation
the regulations in this subpart to antimicrobial pesticide product proceedings if the registrant fails to
comply with the repackaging composition described in its (3) The refiller must repackage a
regulations within the time frames confidential statement of formula that is pesticide product only into a refillable
established by EPA in the rule or in its required under FIFRA section 3. container that is identified on your
notification. (c) What information must I develop? description of acceptable containers for
(f) What other pesticide products are For each pesticide product distributed that pesticide product.
subject to the regulations in this or sold in refillable containers, you must (4) The refiller may repackage any
subpart? The regulations in this subpart develop both of the following quantity of a pesticide product into a
apply to all pesticide products other documents in writing. refillable container up to the rated
than manufacturing use products, plant- (1) You must develop a refilling capacity of the container. In addition,
incorporated protectants, and residue removal procedure that there are no general limits on the size
antimicrobial products that are exempt describes how to remove pesticide of the refillable containers that the
paragraph (c) of this section. residue from a refillable container refiller can use.
Antimicrobial products covered under (portable or stationary pesticide (5) The refiller must have all of the
paragraph (d) of this section are subject container) before it is refilled. following items at the establishment
to the regulations indicated in that (i) The refilling residue removal before repackaging a pesticide product
section. procedure must be adequate to ensure into any refillable container for
(g) What does ‘‘pesticide product’’ or that the composition of the pesticide distribution or sale:
‘‘pesticide’’ mean in the rest of this product does not differ at the time of its (i) The pesticide product’s label and
subpart? In §§ 165.63(h) through 165.70, distribution or sale from the labeling.
the term ‘‘pesticide product’’ or composition described in its (ii) The written refilling residue
‘‘pesticide’’ refers only to a pesticide confidential statement of formula that is removal procedure for the pesticide
product or a pesticide that is subject to required under FIFRA section 3. product.
the regulations in this subpart as (ii) If the refilling residue removal (iii) The written description of
described in paragraphs (a) through (f) procedure requires the use of a solvent acceptable containers for the pesticide
of this section. other than the diluent used for applying product.
(h) Are there any other exceptions? (1) (6) Before repackaging a pesticide
the pesticide as specified on the labeling
The regulations in this subpart do not product into any refillable container for
under ‘‘Directions for Use,’’ or if there
apply to transport vehicles that contain distribution or sale, the refiller must
is no diluent used for application, the
pesticide in pesticide-holding tanks that identify the pesticide product
refilling residue removal procedure
are an integral part of the transport previously contained in the refillable
must describe how to manage any
vehicle and that are the primary container to determine whether a
rinsate resulting from the procedure in
containment for the pesticide. residue removal procedure must be
accordance with applicable Federal and
(2) Custom blending is not subject to conducted in accordance with
State regulations.
the regulations in this subpart. paragraph (f) of this section. The refiller
(2) You must develop a description of
(3) The regulations in this subpart do may identify the previous pesticide
acceptable refillable containers (portable
not apply to containers that hold product by referring to the label or
or stationary pesticide containers) that
pesticides that are gaseous at labeling.
can be used for distributing or selling
atmospheric temperature and pressure. (7) The refiller must inspect each
that pesticide product.
refillable container according to
§ 165.65 Registrants who distribute or sell (i) An acceptable container is one that paragraph (e) of this section.
pesticide products in refillable containers. you have determined meets the (8) The refiller must clean each
(a) Must I comply with the standards standards in subpart C of this part and refillable container according to
in this section? You must comply with is compatible with the pesticide paragraph (f) or (g) of this section, if
the standards in this section if you are formulation intended to be distributed required by either paragraph.
a registrant who distributes or sells and sold using the refillable container. (9) The refiller must ensure that each
pesticide products in refillable (ii) You must identify the containers refillable container is properly labeled
containers. This means that you conduct by specifying the container materials of according to paragraph (h) of this
all of the repackaging for a pesticide construction that are compatible with section.
product and that you do not distribute the pesticide formulation and specifying (10) The establishment must maintain
or sell the pesticide product to a refiller information necessary to confirm records in accordance with paragraph (i)
that is not part of your company for compliance with the refillable container of this section.
repackaging into refillable containers. If requirements in subpart C of this part. (11) The establishment must maintain
you are a registrant that repackages a (d) What requirements must my records as required by part 169 of this
product directly into refillable individual establishments follow chapter.
containers for sale or distribution and regarding repackaging a pesticide (12) The establishment must report as
you also sell or distribute other product into refillable containers? A required by part 167 of this chapter.
quantities of that product to an refiller at your individual establishment (e) How must my individual
independent refiller for repackaging, that repackages a pesticide product into establishments inspect refillable
then you must meet the requirements in refillable containers for distribution or containers? Before repackaging a
this section for those quantities you sale must comply with all of the pesticide product into any refillable
distribute or sell directly and the following provisions. container, a refiller at your
requirements in § 165.67 for those (1) The establishment must be establishment must visually inspect the
quantities that you distribute or sell to registered with EPA as a producing exterior and (if possible) the interior of
an independent refiller. establishment as required by § 167.20 of the container and the exterior of
(b) Am I responsible for product this chapter. appurtenances. The purpose of the
integrity? Yes, you are responsible for (2) The refiller must not change the inspection is to determine whether the
the pesticide product that you distribute pesticide formulation unless the refiller container meets the necessary criteria
or sell in refillable containers not being has a registration for the new with respect to continued container
adulterated or different from the formulation. integrity, required markings, and
openings. If the condition in paragraph Examples of unallowable changes product into a refillable container and
(e)(1) of this section exists, the container include the active ingredient distributes or sells the product, the
fails the inspection and must not be concentration increasing or decreasing following records must be generated and
refilled unless the container is repaired, beyond the limits established by the maintained for at least 3 years after the
reconditioned, or remanufactured in confidential statement of formula or a date of repackaging:
compliance with the relevant DOT reaction or interaction between the (i) The EPA registration number of the
requirement. If the condition in pesticide product being repackaged and pesticide product distributed or sold in
paragraph (e)(2) or (e)(3) of this section the residue remaining in the container. the refillable container.
exists (or both), the container fails the (g) How must my individual (ii) The date of the repackaging.
inspection and must not be refilled until establishments clean a refillable (iii) The serial number of the refillable
the container meets the standards container that has a broken (non-intact) container.
specified in subpart C of this part. The tamper-evident device or one-way valve?
As required in paragraph (f) of this § 165.67 Registrants who distribute or sell
conditions are: pesticide products to refillers for
(1) The integrity of the container is section, a refiller at your establishment
repackaging.
compromised in at least one of the must clean each refillable container that
has a tamper-evident device or one-way (a) Must I comply with the standards
following ways:
(i) The container shows signs of valve that is not intact by conducting in this section? You must comply with
rupture or other damage which reduces the pesticide product’s refilling residue the standards in this section if you are
its structural integrity. removal procedure before repackaging a registrant who distributes or sells
(ii) The container has visible pitting, the pesticide product into the refillable pesticide products to a refiller that is
significant reduction in material container. In addition, other procedures not part of your company for
thickness, metal fatigue, damaged may be necessary to assure that product repackaging into refillable containers.
threads or closures, or other significant integrity is maintained in such cases. (b) Under what conditions can I allow
defects. (h) How must my individual a refiller to repackage my pesticide
(iii) The container has cracks, establishments label refillable product into refillable containers? You
warpage, corrosion or any other damage containers? Before distributing or may allow a refiller to repackage your
which might render it unsafe for selling a pesticide product in a refillable pesticide product into refillable
transportation. container, a refiller at your containers and to distribute or sell such
(iv) There is damage to the fittings, establishment must ensure that the label repackaged product under your existing
valves, tamper-evident devices or other of the pesticide product is securely registration if all of the following
appurtenances that may cause failure of attached to the refillable container such conditions are satisfied:
the container. that the label can reasonably be (1) The repackaging results in no
(2) The container does not bear the expected to remain affixed during the change to the pesticide formulation.
markings required by § 165.45(a), (b) foreseeable conditions and period of (2) One of the following conditions
and (d), or such markings are not use. The label and labeling must comply regarding a registered refilling
legible. in all respects with the requirements of establishment is satisfied:
(3) The container does not have an part 156 of this chapter. In particular, (i) The pesticide product is
intact and functioning one-way valve or the refiller at your establishment must repackaged at a refilling establishment
tamper-evident device on each opening ensure that the net contents statement registered with EPA as required by
other than a vent, if required. and EPA establishment number appear § 167.20 of this chapter.
(f) How must my individual on the label. (ii) The pesticide product is
establishments clean refillable (i) What recordkeeping must my repackaged at the site of a user who
containers? A refiller at your individual establishments do? Each of intends to use or apply the product by
establishment must clean each refillable your individual establishments that a refilling establishment registered with
container by conducting the pesticide repackages a pesticide product into EPA as required by § 167.20 of this
product’s refilling residue removal refillable containers for distribution or chapter.
procedure before repackaging the sale must maintain all of the records (3) You have entered into a written
pesticide product into the refillable listed in this section in addition to the contract with the refiller to repackage
container, unless the conditions in applicable records identified in parts the pesticide product and to use the
paragraph (f)(1) of this section and 167 and 169 of this chapter. The label of your pesticide product.
either paragraph (f)(2) or (f)(3) of this establishment must furnish these (4) The pesticide product is
section are satisfied: records for inspection and copying upon repackaged only into refillable
(1) If required, each tamper-evident request by an employee of EPA or any containers that meet the standards of
device and one-way valve is intact. entity designated by EPA, such as a subpart C of this part.
(2) The refillable container is being State, another political subdivision or a (5) The pesticide product is labeled
refilled with the same pesticide product. Tribe. with the product’s label with no
(3) Both of the following conditions (1) For each pesticide product changes except the addition of an
are satisfied: distributed or sold in refillable appropriate net contents statement and
(i) The container previously held a containers, both of the following records the refiller’s EPA establishment number.
pesticide product with a single active must be maintained for the current (c) What violations are applicable to
ingredient and is being used to operating year and for 3 years after that: illegal repackaging? Repackaging a
repackage a pesticide product with the (i) The written refilling residue pesticide product for distribution or sale
same single active ingredient. removal procedure for the pesticide without either obtaining a registration or
(ii) There is no change that would product. meeting all of the conditions in
cause the composition of the product (ii) The written description of paragraph (b) of this section is a
being repackaged to differ from the acceptable containers for the pesticide violation of section 12 of the Act. Both
composition described in its product. you and the refiller that is repackaging
confidential statement of formula that is (2) Each time a refiller at your your pesticide product under written
required under FIFRA section 3. establishment repackages a pesticide contract with you may be liable for
violations pertaining to the repackaged provide the refiller with all of the (4) The pesticide product is
product. following information and repackaged only into refillable
(d) When must I provide the written documentation before or at the time of containers that meet the standards of
contract to the refiller? If you allow a distribution or sale of your pesticide subpart C of this part.
refiller to repackage your product as product to the refiller: (5) The pesticide product is labeled
specified in paragraph (b) of this section (1) Your written refilling residue with the product’s label with no
you must provide the written contract to removal procedure for the pesticide changes except the addition of an
the refiller before you distribute or sell product. appropriate net contents statement and
the pesticide product to the refiller. (2) Your written description of the refillers EPA establishment number.
(e) Am I responsible for product acceptable containers for the pesticide (c) What violations are applicable to
integrity? Yes, for a product that you product. illegal repackaging? Repackaging a
distribute or sell to a refiller that is not (3) The pesticide product’s label and pesticide product for distribution or sale
part of your company for repackaging labeling. without either obtaining a registration or
into refillable containers, you are (h) What recordkeeping must I do? meeting all of the conditions in
responsible for the pesticide product not You must maintain all of the records paragraph (b) of this section is a
being adulterated or different from the listed in this section for the current violation of section 12 of the Act. Both
composition described in its operating year and for 3 years after that. you and the pesticide product’s
confidential statement of formula that is You must furnish these records for registrant may be liable for violations
required under FIFRA section 3. inspection and copying upon request by pertaining to the repackaged product.
(f) What information must I develop? an employee of EPA or any entity (d) Am I responsible for product
For each pesticide product distributed designated by EPA, such as a State, integrity? Yes, you are responsible for
or sold in refillable containers, you must another political subdivision or a Tribe: the pesticide product that you distribute
develop both of the following (1) Each written contract entered into or sell in refillable containers not being
documents in writing. with a refiller for repackaging your adulterated or different from the
(1) You must develop a refilling pesticide product into refillable composition described in its
residue removal procedure that containers. confidential statement of formula that is
describes how to remove pesticide (2) Your written refilling residue required under FIFRA section 3.
residue from a refillable container removal procedure for the pesticide (e) What requirements must I follow
(portable or stationary pesticide product. regarding repackaging a pesticide
container) before it is refilled. (3) Your written description of product into refillable containers? You
(i) The refilling residue removal acceptable containers for the pesticide must comply with all of the following
procedure must be adequate to ensure product. provisions.
that the composition of the pesticide (1) Your establishment must be
product does not differ at the time of its § 165.70 Refillers who are not registrants.
registered with EPA as a producing
distribution or sale from the (a) Must I comply with the standards establishment as required by § 167.20 of
composition described in its in this section? You must comply with this chapter.
confidential statement of formula that is the standards in this section if you are (2) You must not change the pesticide
required under FIFRA section 3. a refiller of a pesticide product and you formulation unless you have a
(ii) If the refilling residue removal are not the registrant of the pesticide registration for the new formulation.
procedure requires the use of a solvent product. (3) You must repackage a pesticide
other than the diluent used for applying (b) Under what conditions can I product only into a refillable container
the pesticide as specified on the labeling repackage a registrant’s pesticide that is identified on the description of
under ‘‘Directions for Use,’’ or if there product into refillable containers? A acceptable containers for that pesticide
is no diluent used for application, the registrant may allow you to repackage product provided by the registrant.
refilling residue removal procedure the registrant’s pesticide product into (4) You may repackage any quantity of
must describe how to manage any refillable containers and to distribute or a pesticide product into a refillable
rinsate resulting from the procedure in sell such repackaged product under the container up to the rated capacity of the
accordance with applicable Federal and registrant’s existing registration if all of container. In addition, there are no
State regulations. the following conditions are satisfied: general limits on the size of the
(2) You must develop a description of (1) The repackaging results in no refillable containers that you can use.
acceptable refillable containers (portable change to the pesticide formulation. (5) You must have all of the following
or stationary pesticide containers) that (2) One of the following conditions items at your establishment before
can be used for distributing or selling regarding a registered refilling repackaging a pesticide product into any
that pesticide product. establishment is satisfied: refillable container for distribution or
(i) An acceptable container is one that (i) The pesticide product is sale:
you have determined meets the repackaged at a refilling establishment (i) The written contract from the
standards in subpart C of this part and registered with EPA as required by pesticide product’s registrant.
is compatible with the pesticide § 167.20 of this chapter. (ii) The pesticide product’s label and
formulation intended to be distributed (ii) The pesticide product is labeling.
and sold using the refillable container. repackaged at the site of a user who (iii) The registrant’s written refilling
(ii) You must identify the containers intends to use or apply the product by residue removal procedure for the
by specifying the container materials of a refilling establishment registered with pesticide product.
construction that are compatible with EPA as required by § 167.20 of this (iv) The registrant’s written
the pesticide formulation and specifying chapter. description of acceptable containers for
information necessary to confirm (3) The registrant has entered into a the pesticide product.
compliance with the refillable container written contract with you to repackage (6) Before repackaging a pesticide
requirements in subpart C of this part. the pesticide product and to use the product into any refillable container for
(g) When must I provide the label of the registrant’s pesticide distribution or sale, you must identify
information to the refiller? You must product. the pesticide product previously
contained in the refillable container to which might render it unsafe for that the label can reasonably be
determine whether a residue removal transportation. expected to remain affixed during the
procedure must be conducted in (iv) There is damage to the fittings, foreseeable conditions and period of
accordance with paragraph (g) of this valves, tamper-evident devices or other use. The label and labeling must comply
section. You may identify the previous appurtenances that may cause failure of in all respects with the requirements of
pesticide product by referring to the the container. part 156 of this chapter. In particular,
label or labeling. (2) The container does not bear the you must ensure that the net contents
(7) You must inspect each refillable markings required by § 165.45(a), (b) statement and EPA establishment
container according to paragraph (f) of and (d), or such markings are not number appear on the label.
this section. legible. (j) What recordkeeping must I do? You
(8) You must clean each refillable (3) The container does not have an must maintain all of the records listed
container according to paragraph (g) or intact and functioning one-way valve or in this section in addition to the
(h) of this section, if required by either tamper-evident device on each opening applicable records identified in parts
paragraph. other than a vent, if required. 167 and 169 of this chapter. You must
(9) You must ensure that each (g) How must I clean refillable furnish these records for inspection and
refillable container is properly labeled containers? You must clean each copying upon request by an employee of
according to paragraph (i) of this refillable container by conducting the EPA or any entity designated by EPA,
section. pesticide product’s refilling residue such as a State, another political
(10) You must maintain records in removal procedure before repackaging subdivision or a Tribe.
accordance with paragraph (j) of this the pesticide product into the refillable (1) For each pesticide product
section. container, unless the conditions in distributed or sold in refillable
(11) You must maintain records as paragraph (g)(1) of this section and containers, all of the following records
required by part 169 of this chapter. either paragraph (g)(2) or (g)(3) of this must be maintained for the current
(12) You must report as required by section are satisfied: operating year and for 3 years after that:
(1) If required, each tamper-evident (i) The written contract from the
part 167 of this chapter.
device and one-way valve is intact. pesticide product’s registrant for the
(13) The stationary pesticide (2) The refillable container is being
containers at your establishment must pesticide product.
refilled with the same pesticide product. (ii) The written refilling residue
meet the standards in § 165.45(f). (3) Both of the following conditions removal procedure for the pesticide
(14) You may be required to comply are satisfied. product.
with the containment standards in (i) The container previously held a (iii) The written description of
subpart E of this part. pesticide product with a single active acceptable containers for the pesticide
(f) How must I inspect refillable ingredient and is being used to product.
containers? Before repackaging a repackage a pesticide product with the (2) Each time you repackage a
pesticide product into any refillable same single active ingredient. pesticide product into a refillable
container, you must visually inspect the (ii) There is no change that would container and distribute or sell the
exterior and (if possible) the interior of cause the composition of the product product, the following records must be
the container and the exterior of being repackaged to differ from the generated and maintained for at least 3
appurtenances. The purpose of the composition described in its years after the date of repackaging:
inspection is to determine whether the confidential statement of formula that is (i) The EPA registration number of the
container meets the necessary criteria required under FIFRA section 3. pesticide product distributed or sold in
with respect to continued container Examples of unallowable changes the refillable container.
integrity, required markings, and include the active ingredient (ii) The date of the repackaging.
openings. If the condition in paragraph concentration increasing or decreasing (iii) The serial number of the refillable
(f)(1) of this section exists, the container beyond the limits established by the container.
fails the inspection and must not be confidential statement of formula or a
refilled unless the container is repaired, §§ 165.71–165.79 [Reserved]
reaction or interaction between the
reconditioned, or remanufactured in pesticide product being repackaged and Subpart E—Standards for Pesticide
compliance with the relevant DOT the residue remaining in the container. Containment Structures
requirement. If the condition in (h) How must I clean a refillable
paragraph (f)(2) or (f)(3) of this section container that has a broken (non-intact) § 165.80 General provisions.
exists (or both), the container fails the tamper-evident device or one-way valve? (a) What is the purpose of the
inspection and must not be refilled until As required in paragraph (g) of this regulations in this subpart? The purpose
the container meets the standards section, you must clean each refillable of the containment regulations in this
specified in subpart C of this part. The container that has a tamper-evident subpart is to protect human health and
conditions are: device or one-way valve that is not the environment from exposure to
(1) The integrity of the container is intact by conducting the pesticide agricultural pesticides which may spill
compromised in at least one of the product’s refilling residue removal or leak from stationary pesticide
following ways: procedure before repackaging the containers. This protection is achieved
(i) The container shows signs of pesticide product into the refillable by the construction of secondary
rupture or other damage which reduces container. In addition, other procedures containment units or pads at certain
its structural integrity. may be necessary to assure that product facilities handling agricultural
(ii) The container has visible pitting, integrity is maintained in such cases. pesticides. These regulations will also
significant reduction in material (i) How must I label refillable reduce waste generation associated
thickness, metal fatigue, damaged containers? Before distributing or with:

threads or closures, or other significant selling a pesticide product in a refillable (1) Storage and handling of large
defects. container, you must ensure that the quantities of pesticide products.
(iii) The container has cracks, label of the pesticide product is securely (2) Pesticide dispensing and
warpage, corrosion or any other damage attached to the refillable container such container-refilling operations.
(b) Do I have to comply with the subpart? A pesticide dispensing area is (1) You, as the owner or operator,
regulations in this subpart? You must subject to the containment regulations have obtained all Federal, State, and
comply with the regulations in this in this subpart and must have a local approvals or permits necessary to
subpart if you are an owner or operator containment pad that complies with the begin physical construction of the
of one of the following businesses and requirements of this subpart if any of containment structure; AND
if you also have a stationary pesticide the following activities occur: (2) You have either begun a
container or a pesticide dispensing (1) Refillable containers of continuous on-site physical
(including container refilling) area: agricultural pesticide are emptied, construction or installation program OR
(1) Refilling establishments who cleaned or rinsed. you have entered into contractual
repackage agricultural pesticides and (2) Agricultural pesticides are obligations. The contract must be such
whose principal business is retail sale dispensed from a stationary pesticide that it cannot be canceled or modified
(i.e., more that 50% of total annual container designed to hold undivided without substantial loss, and must be for
revenue comes from retail operations). quantities of agricultural pesticides the physical construction or installation
(2) Custom blenders of agricultural equal to or greater than 500 gallons of the containment structure within a
pesticides. (1,890 liters) of liquid pesticide or equal specific and reasonable time frame.
(3) Businesses which apply an to or greater than 4,000 pounds (1,818 (b) What is an existing containment
agricultural pesticide for compensation kilograms) of dry pesticide for any structure? An existing containment
(other than trading of personal services purpose, including refilling or emptying structure is defined as one whose
between agricultural producers). for cleaning. This applies when installation began on or before
(c) When do I have to comply? You pesticide is dispensed from the November 16, 2006.
must comply with all applicable container into any vessel, including, but
containment regulations for new and not limited to: § 165.85 Design and capacity
existing structures as of August 17, requirements for new structures.
(i) Refillable containers;
2009. (ii) Service containers; (a) For all new containment
(iii) Transport vehicles; structures, what construction materials
§ 165.81 Scope of stationary pesticide
containers included. (iv) Application equipment. must I use? These are the material
(3) Agricultural pesticides are specifications for a new containment
(a) What is a stationary pesticide structure:
container? A stationary pesticide dispensed from a transport vehicle for
purposes of filling a refillable container. (1) The containment structure must be
container is a refillable container that is constructed of steel, reinforced concrete
fixed at a single facility or (4) Agricultural pesticides are
dispensed from any other container for or other rigid material capable of
establishment, or, if not fixed, remains withstanding the full hydrostatic head,
at the facility or establishment for at the purpose of refilling a refillable
container for sale or distribution. load and impact of any pesticides,
least 30 consecutive days, and that precipitation, other substances,
holds pesticide during the entire time. Containment requirements do not apply
if the agricultural pesticide is dispensed equipment and appurtenances placed
(b) What stationary pesticide
from such a container for use, within the structure. The structure must
containers are subject to the regulations
application or purposes other than be liquid-tight with cracks, seams and
in this subpart? Stationary pesticide
refilling for sale or distribution. joints appropriately sealed.
containers designed to hold undivided
(b) What pesticide dispensing areas (2) The structure must not be
quantities of agricultural pesticides
are exempt from the regulations in this constructed of natural earthen material,
equal to or greater than 500 gallons
subpart? A pesticide dispensing area is unfired clay, or asphalt.
(1,890 liters) of liquid pesticide or equal (3) The containment structure must be
to or greater than 4,000 pounds (1,818 exempt from the regulations in this
subpart if any of the following made of materials compatible with the
kilograms) of dry pesticide are subject to pesticides stored. In this case,
the regulations in this subpart and must conditions exist:
(1) The only pesticides in the compatible means able to withstand
have a secondary containment unit that anticipated exposure to stored or
complies with the provisions of this dispensing area would be gaseous when
released at atmospheric temperature and transferred materials and still provide
subpart unless any of the following secondary containment of those same or
conditions exists: pressure.
(2) The only pesticide containers other materials within the containment
(1) The container is empty, that is, all
refilled or emptied within the area.
pesticide that can be removed by
dispensing area are stationary pesticide (b) For all new containment
methods such as draining, pumping or
containers which are already protected structures, what are the general design
aspirating has been removed (whether
by a secondary containment unit that requirements? These are the general
or not the container has been rinsed or
complies with the provisions of this design requirements for new
washed).
subpart. containment structures:
(2) The container holds only pesticide
(3) The pesticide dispensing area is (1) You must protect appurtenances
rinsates or wash waters, and is labeled
used solely for dispensing pesticide and pesticide containers against damage
accordingly.
(3) The container holds only from a rail car which does not remain from operating personnel and moving
pesticides which would be gaseous at a facility long enough to meet the equipment. Means of protection
when released at atmospheric definition of a stationary pesticide include, but are not limited to, supports
temperature and pressure. container; that is, 30 days. to prevent sagging, flexible connections,
(4) The container is dedicated to non- the use of guard rails, barriers, and
§ 165.83 Definition of new and existing protective cages.
pesticide use, and is labeled structures.
accordingly. (2) Appurtenances, discharge outlets
(a) What is a new containment or gravity drains must not be configured

§ 165.82 Scope of pesticide dispensing structure? A new containment structure through the base or wall of the
areas included. is one whose installation began after containment structure, except for direct
(a) What pesticide dispensing areas November 16, 2006. Installation is interconnections between adjacent
are subject to the regulations in this considered to have begun if: containment structures which meet the
requirements of this subpart. (2) Have enough surface area to pesticides stored. In this case,
Appurtenances must be configured in extend completely beneath any compatible means able to withstand
such a way that spills or leaks are easy container on it, with the exception of anticipated exposure to stored or
to see. transport vehicles dispensing pesticide transferred materials and still provide
(3) The containment structure must be for sale or distribution to a stationary secondary containment of those same or
constructed with sufficient freeboard to pesticide container. For such vehicles, other materials within the containment
contain precipitation and prevent water the surface area of the containment pad area.
and other liquids from seeping into or must accommodate at least the portion (b) For all existing containment
flowing onto it from adjacent land or of the vehicle where the delivery hose structures, what are the general design
structures. or device couples to the vehicle. This requirements? These are the general
(4) Multiple stationary pesticide exception does not apply to transport design requirements for existing
containers may be protected within a vehicles that are used for prolonged containment structures:
single secondary containment unit. storage or repeated on-site dispensing of (1) You must protect appurtenances
(c) For new stationary liquid pesticide pesticides. and pesticide containers against damage
containment and new containment pads (3) Allow, in conjunction with its from operating personnel and moving
in pesticide dispensing areas, what are sump, for removal and recovery of equipment. Means of protection
the capacity requirements? These are spilled, leaked, or discharged material include, but are not limited to, supports
the capacity requirements: and rainfall, such as by a manually to prevent sagging, flexible connections,
(1) New secondary containment units activated pump. Automatically- the use of guard rails, barriers, and
for stationary liquid pesticide activated pumps which lack automatic protective cages.
containers, if protected from overflow cutoff switches for the (2) You must seal all appurtenances,
precipitation, must have a capacity of at receiving container are prohibited. discharge outlets and gravity drains
least 100 percent of the volume of the (4) Have its surface sloped toward an through the base or wall of the
largest stationary pesticide container area where liquids can be collected for containment structure, except for direct
plus the volume displaced by other removal, such as a liquid-tight sump or interconnections between adjacent
containers and appurtenances within a depression, in the case of a single-pour containment structures which meet the
the unit. concrete pad. requirements of this subpart.
(2) New secondary containment units (f) For new stationary dry pesticide (3) The containment structure must be
for stationary liquid pesticide containment, what are the specific constructed with sufficient freeboard to
containers, if exposed to or unprotected design requirements? These are the contain precipitation and prevent water
from precipitation, must have a capacity specific design requirements for new and other liquids from seeping into or
of at least 110 percent of the volume of stationary dry pesticide containment: flowing onto it from adjacent land or
the largest stationary pesticide container (1) The stationary dry pesticide structures.
containers within the containment unit (4) Multiple stationary pesticide
plus the volume displaced by other
must be protected from wind and containers may be protected within a
containers and appurtenances within
precipitation. single secondary containment unit.
the unit. (c) For existing stationary liquid
(3) New containment pads in (2) Stationary dry pesticide containers
must be placed on pallets or a raised pesticide containment and existing
pesticide dispensing areas which have a containment pads in pesticide
pesticide container or pesticide-holding concrete platform to prevent the
accumulation of water in or under the dispensing areas, what are the capacity
equipment with a volume of 750 gallons requirements? These are the capacity
or greater must have a holding capacity pesticide.
(3) The stationary dry pesticide requirements:
of at least 750 gallons. (1) Existing secondary containment
(4) New containment pads in container storage area must be enclosed
by a minimum of a 6–inch high curb units for stationary liquid pesticide
pesticide dispensing areas which do not containers must have a capacity of at
have a pesticide container or pesticide- that extends at least 2 feet beyond the
perimeter of the container. least 100 percent of the volume of the
holding equipment with a volume of at largest stationary pesticide container
least 750 gallons must have a holding § 165.87 Design and capacity plus the volume displaced by other
capacity of at least 100 percent of the requirements for existing structures. containers and appurtenances within
volume of the largest pesticide container (a) For all existing containment the unit.
or pesticide-holding equipment used on structures, what construction materials (2) Existing containment pads in
the pad. must I use? These are the material pesticide dispensing areas which have a
(d) For new stationary liquid pesticide specifications for an existing pesticide container or pesticide-holding
containment, what are the specific containment structure: equipment with a volume of 750 gallons
design requirements? You must either (1) The containment structure must be or greater must have a holding capacity
anchor or elevate each new stationary constructed of steel, reinforced concrete of at least 750 gallons.
liquid pesticide container protected by or other rigid material capable of (3) Existing containment pads in
a secondary containment unit to prevent withstanding the full hydrostatic head, pesticide dispensing areas which do not
flotation in the event that the secondary load and impact of any pesticides, have a pesticide container or pesticide-
containment unit fills with liquid. precipitation, other substances, holding equipment with a volume of at
(e) For new containment pads in equipment and appurtenances placed least 750 gallons must have a holding
pesticide dispensing areas, what are the within the structure. The structure must capacity of at least 100 percent of the
specific design requirements? Each new be liquid-tight with cracks, seams and volume of the largest pesticide container
containment pad in a pesticide joints appropriately sealed. or pesticide-holding equipment used on
dispensing area must: (2) The structure must not be the pad.
(1) Be designed and constructed to constructed of natural earthen material, (d) For existing stationary liquid
intercept leaks and spills of pesticides unfired clay, or asphalt. pesticide containment, what are the
which may occur in the pesticide (3) The containment structure must be specific design requirements? You must
dispensing area. made of materials compatible with the either anchor or elevate each existing
stationary liquid pesticide container from the containment structure containment units in §§ 165.85(a) and
protected by a secondary containment (including, but not limited to, pesticide (b), 165.87(a) and (b) and § 165.90, and
unit to prevent flotation in the event residues washed off the containment as applicable, §§ 165.85(c)-(f) and
that the secondary containment unit structure by rainfall or cleaning liquids 165.87(c)-(f) are satisfied separately.
fills with liquid. used within the structure.)
(2) Ensure that pesticide spills and § 165.95 What recordkeeping do I have to
(e) For existing containment pads in
do as a facility owner or operator?
pesticide dispensing areas, what are the leaks on or in any containment structure
specific design requirements? Each are collected and recovered in a manner As a facility owner or operator subject
existing containment pad in a pesticide that ensures protection of human health to the requirements of this subpart, you
dispensing area must: and the environment (including surface must maintain the following records,
(1) Be designed and constructed to water and ground water) and maximum and you must furnish these records for
intercept leaks and spills of pesticides practicable recovery of the pesticide inspection and copying upon request by
which may occur in the pesticide spilled or leaked. Cleanup must occur an employee of EPA or any entity
dispensing area. no later than the end of each day on designated by EPA, such as a State,
(2) Have enough surface area to which pesticides have been spilled or another political subdivision or a Tribe:
(a) Records of inspection and
extend completely beneath any leaked.
maintenance for each containment
container on it, with the exception of (3) Ensure that all materials resulting
structure and for each stationary
transport vehicles dispensing pesticide from spills and leaks and any materials
pesticide container and its
for sale or distribution to a stationary containing pesticide residue are
appurtenances must be kept for 3 years
pesticide container. For such vehicles, managed according to label instructions
and must include the following
the surface area of the containment pad and applicable Federal, State and local
information:
must accommodate at least the portion laws and regulations. (1) Name of the person conducting the
of the vehicle where the delivery hose (4) Ensure that transfers of pesticides inspection or maintenance;
or device couples to the vehicle. This between containers, or between (2) Date the inspection or
exception does not apply to transport containers and transport vehicles are maintenance was conducted;
vehicles that are used for prolonged attended at all times. (3) Conditions noted;
storage or repeated on-site dispensing of (5) Ensure that each lockable valve on (4) Specific maintenance performed.
pesticides. a stationary pesticide container, if it is (b) Records for any non-stationary
(3) Allow, in conjunction with its required by § 165.45(f), is closed and pesticide container designed to hold
sump, for removal and recovery of locked whenever the facility is undivided quantities of agricultural
spilled, leaked, or discharged material unattended. pesticides equal to or greater than 500
and rainfall, such as by a manually (b) What are the inspection and gallons (1,890 liters) of liquid pesticide
activated pump. Automatically- maintenance requirements for all new or equal to or greater than 4,000 pounds
activated pumps which lack automatic and existing containment structures? As (1,818 kilograms) of dry pesticide that
overflow cutoff switches for the owner or operator of a new or existing holds pesticide but is not protected by
receiving container are prohibited. pesticide containment structure, you a secondary containment unit meeting
(f) For existing stationary dry must: these regulations must be kept for 3
pesticide containment, what are the (1) Inspect each stationary pesticide years. Records on these non-stationary
specific design requirements? These are container and its appurtenances at least pesticide containers must include the
the specific design requirements for monthly during periods when pesticides time period that the container remains
existing stationary dry pesticide are being stored or dispensed on the at the same location.
containment: containment structure. Your inspection (c) Records of the construction date of
(1) The stationary dry pesticide must look for visible signs of wetting, the containment structure must be kept
containers within the containment unit discoloration, blistering, bulging, for as long as the pesticide containment
must be protected from wind and corrosion, cracks or other signs of structure is in use, and for 3 years
precipitation. damage or leakage. afterwards.
(2) Stationary dry pesticide containers (2) Immediately repair any areas
must be placed on pallets or a raised showing visible signs of damage and § 165.97 States with existing containment
seal any cracks and gaps in the programs.
concrete platform to prevent the
accumulation of water in or under the containment structure or appurtenances (a) What options are available to
pesticide. with material compatible with the States that already have containment
(3) The stationary dry pesticide pesticide being stored or dispensed. regulations? States that have
container storage area must be enclosed (3) Not store any pesticide on a promulgated containment regulations
by a minimum of a 6–inch high curb containment structure if the structure effective prior to August 16, 2006, and
that extends at least 2 feet beyond the fails to meet the requirements of this which also have primary enforcement
perimeter of the container. subpart until suitable repairs have been responsibility and/or certification
made. Prompt removal of pesticides, programs, have the option of continuing
§ 165.90 Operational, inspection and including emptying of stationary to implement their own programs in
maintenance requirements for all new and pesticide containers, in order to effect lieu of these Federal regulations.
existing containment structures. (b) How may a State request authority
repairs or recovery of spilled material is
(a) What are the operating procedures acceptable. to continue implementing its State
required for all new and existing containment regulations? A State with
containment structures? As the owner § 165.92 What if I need both a containment pesticide containment regulations may
or operator of a new or existing pad and a secondary containment unit? request the authority to continue
pesticide containment structure, you You may combine containment pads implementing State containment
must: and secondary containment units as an regulations by August 16, 2007 in the
(1) Manage the structure in a manner integrated system provided the following manner:
that prevents pesticides or materials requirements set out in this subpart for (1) The State must submit a letter and
containing pesticides from escaping containment pads and secondary any supporting documentation to EPA.
Supporting documentation must Pesticide Programs will review the Any state that has received
demonstrate that the States program is State’s correspondence and determine authorization to continue implementing
providing environmental protection whether the State program is adequate its state containment regulations must
equivalent to or more protective than to provide environmental protection inform EPA by letter signed by the
that expected to be provided by the equivalent to or more protective than designated State Lead Agency within 6
Federal regulations in this subpart. these Federal regulations for new and months of any revision to the State’s
(2) The State must identify any existing containment structures. EPA’s containment regulations. EPA will
significant changes to State regulations Office of Pesticide Programs will inform inform the state by letter if it determines
which would be necessary in order to the State of its determination through a that the State’s containment regulations
provide environmental protection letter authorizing or declining to are no longer adequate based on the
equivalent to the EPA regulations, and authorize the State to continue revisions. The State’s containment
develop an estimated timetable to effect implementing its containment regulations will remain in effect, unless
these changes. The letter must be signed regulations and will detail any reasons and until EPA sends the state a letter
by the designated State Lead Agency. for declining authorization. making this determination.
(c) How will EPA notify the State if its (d) How must a State inform EPA of [FR Doc. 06–6856 Filed 8–15–06; 8:45 am]
request is granted? EPA’s Office of revisions to its containment regulations? BILLING CODE 6560–50–S

Rule: Pesticide Programs: Pesticide Container and Containment Standards

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Rule: Pesticide Programs: Pesticide Container and Containment Standards

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Wednesday,

August 16, 2006

TABLE 1.—OVERVIEW OF THE PESTICIDE CONTAINER AND CONTAINMENT STRUCTURE REGULATIONS

Who must com- Registrants Registrants Registrants Registrants Ag retailers

If a product does not meet any

Container and Containment rule in a have made substantive changes in some

TABLE 3.—COMPARISON OF PROPOSED RULE AND FINAL RULE SECTION NUMBERS

Subpart Section Numbers Subpart Section Numbers

Subpart A: General §§ 165.1 - 165.16 Subpart A: General §§ 165.1 - 165.3

Subpart B Reserved Subpart B: Nonrefillable Con- §§ 165.20 - 165.27

Subpart C Reserved Subpart C: Refillable Containers §§ 165.40 - 165.47

Subpart D Reserved Subpart D: Repackaging §§ 165.60 - 165.70

Subpart E Reserved Subpart E: Containment Struc- §§ 165.80 - 165.97

Subpart F: Nonrefillable Con- §§ 165.100 - 165.119 Subpart F Reserved

Subpart G: Refillable Containers §§ 165.120 - 165.139 Subpart G Reserved

Subpart H: Containment Struc- §§ 165.140 - 165.157 Subpart H Reserved

MUPs, plant-incorporated protectants adverse effects on the environment’’ requirements.

EPA’s container-related regulations and B. Exempt Plant-Incorporated plant-incorporated protectants do not

Requirement for registrants who distribute or sell di-

Recordkeeping specific to § 165.65(i)(2) § 165.70(j)(2)

Container inspection: cri- § 165.65(e)(3) § 165.70(f)(3)

Container inspection: cri- § 165.65(e)(4) § 165.70(f)(4)

Cleaning requirement: cri- § 165.65(f)(1) § 165.70(g)(1)

Cleaning if the one-way § 165.65(g) § 165.70(h)

Antimicrobial Product Description Final Rule Supplemental Notice(Option 3)

regardless of the pesticide market sector. exempted manufacturing use products,

BILLING CODE 6560–50–C

requirements. level in the supplemental notice. The certification files.

TABLE 6.—CHANGES TO THE SCOPE OF THE NONREFILLABLE CONTAINER REGULATIONS

All other products are subject to the regulations as follows:1

requirements for nonrefillable pressurized containers. The final

TABLE 7.—ANALYSIS OF RESIDUE REMOVAL DATA

Formulogics (agricultural) (Refs. 8

NACA (triple rinse) (Refs. 15 and

Subtotal: agricultural market 43 43 (100%) 36 (84%) 25 (58%)

CSMA (Refs. 35 and 77) 7 6 4 1

Subtotal: nonagricultural market 36 35 (97%) 30 (83%) 17 (47%)

Total 79 78 (99%) 66 (84%) 42 (53%)

Florida (South Florida) 1991 1,594 231 1,825 12.7 (Ref. 4)

Florida (Jackson County) 1991 991 113 1,104 10.2 (Ref. 3)

Illinois 1993 57,086 3,451 60,537 5.7 (Ref. 2)

Iowa 1990 64,000 ND ND 50 (Ref. 9)

Michigan 1992 18,959 2,990 21,949 13.6 (Ref. 12)

Minnesota 1990 9,192 2,136 11,328 18.9 (Ref. 17)

Minnesota 1991 56,928 4,646 61,574 7.5 (Ref. 17)

TABLE 9.—ANALYSIS OF RESIDUE REMOVAL DATA

Formulogics (agricultural) 19 0 (0%) 2 (11%) 4 (21%) 13 (68%)

NACA (triple rinse) 24 0 (0%) 5 (21%) 7 (29%) 12 (50%)

Formulogics (nonagricultural) 29 0 (0%) 3 (10%) 10 (34%) 16 (55%)

CSMA 7 1 (14%) 2 (29%) 3 (43%) 1 (14%)

Total 79 1 (1%) 12 (15%) 24 (30%) 42 (53%)

TABLE 12.—ANALYSIS OF RESIDUE REMOVAL DATA BY FORMULATION TYPE—HOUSEHOLD CONTAINERS (CSMA)

Container integrity and compatibility § 165.102(b) §§ 173.24(b), 173.24(e)

Permanently marking the material of § 165.102(c)(2) §§ 178.3(a), 178.503(a)

Requiring the container to reclose se- § 165.102(d)(3) § 173.24(f)

TABLE 14.—CHANGES TO THE SCOPE OF THE REFILLABLE CONTAINER REGULATIONS

requirement. finalized. marking methods, such as ink jetting,

TABLE 15.—CHANGES TO THE SCOPE OF THE REPACKAGING REGULATIONS

Regulatory Provision Changes

TABLE 15.—CHANGES TO THE SCOPE OF THE REPACKAGING REGULATIONS—Continued

TABLE 16.—RECORDKEEPING REQUIREMENTS IN THE REPACKAGING REGULATIONS

Contract to repackage No No Yes Yes Yes

Refilling residue removal pro- Yes Yes Yes Yes Yes