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Federal Register / Vol. 70, No.

100 / Wednesday, May 25, 2005 / Notices 30105

The Commission encourages (703) 308–0455; e-mail address: to submit or view public comments,
electronic submission of comments in milofsky.tessa@epa.gov. access the index listing of the contents
lieu of paper using the ‘‘eFiling’’ link at SUPPLEMENTARY INFORMATION: of the official public docket, and to
http://www.ferc.gov. Persons unable to access those documents in the public
file electronically should submit an I. General Information docket that are available electronically.
original and 14 copies of the comment A. Does this Action Apply to Me? Although not all docket materials may
to the Federal Energy Regulatory be available electronically, you may still
Commission, 888 First Street, NE., You may be potentially affected by access any of the publicly available
Washington, DC 20426. this action if you are an agricultural docket materials through the docket
All filings in this docket are producer, food manufacturer, or facility identified in Unit I.B.1. Once in
accessible online at http://www.ferc.gov, pesticide manufacturer. Potentially the system, select ‘‘search,’’ then key in
using the ‘‘eLibrary’’ link and will be affected entities may include, but are the appropriate docket ID number.
available for review in the not limited to: Certain types of information will not
Commission’s Public Reference Room in • Crop production (NAICS 111) be placed in the EPA Dockets.
Washington, DC. There is an • Animal production (NAICS 112) Information claimed as CBI and other
‘‘eSubscription’’ link on the Web site • Food manufacturing (NAICS 311) information whose disclosure is
• Pesticide manufacturing (NAICS restricted by statute, which is not
that enables subscribers to receive e-
32532) included in the official public docket,
mail notification when a document is
This listing is not intended to be will not be available for public viewing
added to a subscribed docket(s). For
exhaustive, but rather provides a guide in EPA’s electronic public docket. EPA’s
assistance with any FERC Online
for readers regarding entities likely to be policy is that copyrighted material will
service, please e-mail
affected by this action. Other types of not be placed in EPA’s electronic public
FERCOnlineSupport@ferc.gov, or call
entities not listed in this unit could also docket but will be available only in
(866) 208–3676 (toll free). For TTY, call
be affected. The North American printed, paper form in the official public
(202) 502–8659.
Industrial Classification System docket. To the extent feasible, publicly
Magalie R. Salas, (NAICS) codes have been provided to available docket materials will be made
Secretary. assist you and others in determining available in EPA’s electronic public
[FR Doc. E5–2622 Filed 5–24–05; 8:45 am] whether this action might apply to docket. When a document is selected
BILLING CODE 6717–01–P
certain entities. If you have any from the index list in EPA Dockets, the
questions regarding the applicability of system will identify whether the
this action to a particular entity, consult document is available for viewing in
the person listed under FOR FURTHER EPA’s electronic public docket.
ENVIRONMENTAL PROTECTION INFORMATION CONTACT. Although not all docket materials may
AGENCY be available electronically, you may still
B. How Can I Get Copies of this
Document and Other Related access any of the publicly available
[OPP–2005–0121; FRL–7713–1]
Information? docket materials through the docket
Pythium Oligandrum DV 74; Notice of facility identified in Unit I.B.1. EPA
1. Docket. EPA has established an intends to work towards providing
Filing a Pesticide Petition to Establish official public docket for this action
a Tolerance for a Certain Pesticide electronic access to all of the publicly
under docket ID number OPP–2005– available docket materials through
Chemical in or on Food 0121. The official public docket consists EPA’s electronic public docket.
AGENCY: Environmental Protection of the documents specifically referenced For public commenters, it is
Agency (EPA). in this action, any public comments important to note that EPA’s policy is
ACTION: Notice. received, and other information related that public comments, whether
to this action. Although a part of the submitted electronically or in paper,
SUMMARY: This notice announces the official docket, the public docket does will be made available for public
initial filing of a pesticide petition not include Confidential Business viewing in EPA’s electronic public
proposing the establishment of Information (CBI) or other information docket as EPA receives them and
regulations for residues of a certain whose disclosure is restricted by statute. without change, unless the comment
pesticide chemical in or on various food The official public docket is the contains copyrighted material, CBI, or
commodities. collection of materials that is available other information whose disclosure is
DATES: Comments, identified by docket for public viewing at the Public restricted by statute. When EPA
identification (ID) number OPP–2005– Information and Records Integrity identifies a comment containing
0121, must be received on or before June Branch (PIRIB), Rm. 119, Crystal Mall copyrighted material, EPA will provide
24, 2005. #2, 1801 S. Bell St., Arlington, VA. This a reference to that material in the
docket facility is open from 8:30 a.m. to version of the comment that is placed in
ADDRESSES: Comments may be
4 p.m., Monday through Friday, EPA’s electronic public docket. The
submitted electronically, by mail, or
excluding legal holidays. The docket entire printed comment, including the
through hand delivery/courier. Follow
telephone number is (703) 305–5805. copyrighted material, will be available
the detailed instructions as provided in 2. Electronic access. You may access in the public docket.
Unit I. of the SUPPLEMENTARY this Federal Register document Public comments submitted on
INFORMATION.
electronically through the EPA Internet computer disks that are mailed or
FOR FURTHER INFORMATION CONTACT: under the ‘‘Federal Register’’ listings at delivered to the docket will be
Tessa Milofsky, Biopesticides and http://www.epa.gov/fedrgstr/. transferred to EPA’s electronic public
Pollution Prevention Division (7511C), An electronic version of the public docket. Public comments that are
Office of Pesticide Programs, docket is available through EPA’s mailed or delivered to the docket will be
Environmental Protection Agency, 1200 electronic public docket and comment scanned and placed in EPA’s electronic
Pennsylvania Ave., NW., Washington, system, EPA Dockets. You may use EPA public docket. Where practical, physical
DC 20460–0001; telephone number: Dockets at http://www.epa.gov/edocket/ objects will be photographed, and the

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30106 Federal Register / Vol. 70, No. 100 / Wednesday, May 25, 2005 / Notices

photograph will be placed in EPA’s Attention: Docket ID Number OPP– clearly that it does not contain CBI.
electronic public docket along with a 2005–0121. In contrast to EPA’s Information not marked as CBI will be
brief description written by the docket electronic public docket, EPA’s e-mail included in the public docket and EPA’s
staff. system is not an ‘‘anonymous access’’ electronic public docket without prior
system. If you send an e-mail comment notice. If you have any questions about
C. How and to Whom Do I Submit
directly to the docket without going CBI or the procedures for claiming CBI,
Comments?
through EPA’s electronic public docket, please consult the person listed under
You may submit comments EPA’s e-mail system automatically FOR FURTHER INFORMATION CONTACT.
electronically, by mail, or through hand captures your e-mail address. E-mail
delivery/courier. To ensure proper addresses that are automatically E. What Should I Consider as I Prepare
receipt by EPA, identify the appropriate captured by EPA’s e-mail system are My Comments for EPA?
docket ID number in the subject line on included as part of the comment that is
the first page of your comment. Please placed in the official public docket, and You may find the following
ensure that your comments are made available in EPA’s electronic suggestions helpful for preparing your
submitted within the specified comment public docket. comments:
period. Comments received after the iii. Disk or CD ROM. You may submit 1. Explain your views as clearly as
close of the comment period will be comments on a disk or CD ROM that possible.
marked ‘‘late.’’ EPA is not required to you mail to the mailing address
consider these late comments. If you identified in Unit I.C.2. These electronic 2. Describe any assumptions that you
wish to submit CBI or information that submissions will be accepted in used.
is otherwise protected by statute, please WordPerfect or ASCII file format. Avoid 3. Provide copies of any technical
follow the instructions in Unit I.D. Do the use of special characters and any information and/or data you used that
not use EPA Dockets or e-mail to submit form of encryption. support your views.
CBI or information protected by statute. 2. By mail. Send your comments to:
1. Electronically. If you submit an 4. If you estimate potential burden or
Public Information and Records
electronic comment as prescribed in this Integrity Branch (PIRIB) (7502C), Office costs, explain how you arrived at the
unit, EPA recommends that you include of Pesticide Programs (OPP), estimate that you provide.
your name, mailing address, and an e- Environmental Protection Agency, 1200 5. Provide specific examples to
mail address or other contact Pennsylvania Ave., NW., Washington, illustrate your concerns.
information in the body of your DC 20460–0001, Attention: Docket ID 6. Make sure to submit your
comment. Also include this contact Number OPP–2005–0121. comments by the deadline in this
information on the outside of any disk 3. By hand delivery or courier. Deliver
notice.
or CD ROM you submit, and in any your comments to: Public Information
cover letter accompanying the disk or and Records Integrity Branch (PIRIB), 7. To ensure proper receipt by EPA,
CD ROM. This ensures that you can be Office of Pesticide Programs (OPP), be sure to identify the docket ID number
identified as the submitter of the Environmental Protection Agency, Rm. assigned to this action in the subject
comment and allows EPA to contact you 119, Crystal Mall #2, 1801 S. Bell St., line on the first page of your response.
in case EPA cannot read your comment Arlington, VA, Attention: Docket ID You may also provide the name, date,
due to technical difficulties or needs Number OPP–2005–0121. Such and Federal Register citation.
further information on the substance of deliveries are only accepted during the
your comment. EPA’s policy is that EPA docket’s normal hours of operation as II. What Action is the Agency Taking?
will not edit your comment, and any identified in Unit I.B.1. EPA has received a pesticide petition
identifying or contact information
D. How Should I Submit CBI to the as follows proposing the establishment
provided in the body of a comment will
Agency? and/or amendment of regulations for
be included as part of the comment that
is placed in the official public docket, Do not submit information that you residues of a certain pesticide chemical
and made available in EPA’s electronic consider to be CBI electronically in or on various food commodities
public docket. If EPA cannot read your through EPA’s electronic public docket under section 408 of the Federal Food,
comment due to technical difficulties or by e-mail. You may claim Drug, and Cosmetic Act (FFDCA), 21
and cannot contact you for clarification, information that you submit to EPA as U.S.C. 346a. EPA has determined that
EPA may not be able to consider your CBI by marking any part or all of that this petition contains data or
comment. information as CBI if you submit CBI on information regarding the elements set
i. EPA Dockets. Your use of EPA’s disk or CD ROM, mark the outside of the forth in FFDCA section 408(d)(2);
electronic public docket to submit disk or CD ROM as CBI and then however, EPA has not fully evaluated
comments to EPA electronically is identify electronically within the disk or the sufficiency of the submitted data at
EPA’s preferred method for receiving CD ROM the specific information that is this time or whether the data support
comments. Go directly to EPA Dockets CBI. Information so marked will not be granting of the petition. Additional data
at http://www.epa.gov/edocket/, and disclosed except in accordance with may be needed before EPA rules on the
follow the online instructions for procedures set forth in 40 CFR part 2. petition.
submitting comments. Once in the In addition to one complete version of
system, select ‘‘search,’’ and then key in the comment that includes any List of Subjects
docket ID number OPP–2005–0121. The information claimed as CBI, a copy of
Environmental protection,
system is an ‘‘anonymous access’’ the comment that does not contain the
information claimed as CBI must be Agricultural commodities, Feed
system, which means EPA will not
submitted for inclusion in the public additives, Food additives, Pesticides
know your identity, e-mail address, or
other contact information unless you docket and EPA’s electronic public and pests, Reporting and recordkeeping
provide it in the body of your comment. docket. If you submit the copy that does requirements.
ii. E-mail. Comments may be sent by not contain CBI on disk or CD ROM,
e-mail to opp-docket@epa.gov, mark the outside of the disk or CD ROM

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Federal Register / Vol. 70, No. 100 / Wednesday, May 25, 2005 / Notices 30107

Dated: May 16, 2005. application to agricultural crops, pythium oligandrum DV 74 would not
Janet L. Andersen, ornamental plants, and turf grasses. result in residues that are of
Director, Biopesticides and Pollution toxicological concern. Further, the
B. Product Identity/Chemistry
Prevention Division, Office of Pesticide application of pythium oligandrum DV
Programs. 1. Identity of the pesticide and 74 to seeds, foliage, or soil will not
corresponding residues. Pythium result in an increase in concentration in
Summary of Petition oligandrum, originally described by the environment. The level of pythium
The petitioner summary of the Charles Drechsler in 1943. Isolate to be oligandrum DV 74 in the environment
pesticide petition is printed below as registered was discovered in 1972, in following application is expected to
required by FFDCA section 408(d)(3). the Czech Republic. The pythium decrease to levels similar to naturally
The summary of the petition was oligandrum DV 74 isolate is on deposit occurring concentrations, because the
prepared by the petitioner and at the American Type Culture Collection organism does not thrive in the absence
represents the view of the petitioner. (ATCC) as ‘‘Pythium oligandrum, ATCC of sufficient nutrients.
The petition summary announces the 38472.’’ The microorganism pythium
oligandrum is naturally found in soil, C. Mammalian Toxicological Profile
availability of a description of the
analytical methods available to EPA for and is often associated with other Studies to evaluate the safety to
the detection and measurement of the mycoparasites and fungal species. It is mammals were conducted on the
pesticide chemical residues or an widely distributed around the world, technical grade active ingredient (tgai)
explanation of why no such method is including the United States for example, and are summarized as follows:
needed. pythium oligandrum was isolated from 1. Acute oral toxicity. No adverse
74 of 93 soil samples collected from 40 effects were seen on either rats or mice
Biopreparaty Co. Ltd. different counties in California that that received an oral gavage dose of
PP 4F6877 represented a wide range of 5,000 milligrams/kilogram/body weight
environmental conditions. (mg/kg/bwt) of the technical grade
EPA has received a pesticide petition The pythium family has 100 varieties, active ingredient. No effects on
(4F6877) from Biopreparaty Co., Ltd. of which pythium oligandrum is one of appearance, behavior, or body weight
(EPA Company No. 81606), Tylisovska four mycoparasites. The microorganism were observed in any rats or mice any
1, Prague 6, Czech Republic, proposing lives parasitically on plant pathogenic time after dosing. No rats or mice died
pursuant to section 408(d) of the Federal fungi, and works to induce/stimulate during the 14–day observation period,
Food, Drug, and Cosmetic Act (FFDCA), the internal defense systems of plants. and no gross pathological changes were
21 U.S.C. 346a(d), to amend 40 CFR part Testing has shown pythium oligandrum found in organs in the thoracic or
180 to establish an exemption from the is parasitic to 20 species of plant abdominal cavities at necropsy. An LD50
requirement of a tolerance for the pathogenic fungi, including: Alternaria, >5,000 mg/kg was established.
microbial pesticide pythium oligandrum Botrytis, Fusarium, Gaeumannonyces, 2. Acute dermal toxicity. No adverse
DV 74 in or on all food commodities. Ophiostoma, Phoma, effects were seen in rats that received a
Pursuant to section 408(d)(2)(A)(i) of Pseudocercosporella, Pythium, dermal dose of 5,000 mg/kg/bwt of the
FFDCA, as amended, Biopreparaty Co., Sclerotinia, and Sclerotium. technical grade active ingredient. No
Ltd., has submitted the following The active ingredient pythium effects on appearance, behavior, or body
summary of information, data, and oligandrum DV 74 colonizes the weight were observed in any rats any
arguments in support of their pesticide surroundings of treated and sown seeds, time after exposure. No rats died during
petition. This summary was prepared by and the rhizosphere of treated plants. the 14–day observation period, and no
Biopreparaty Co., Ltd., and EPA has not Because of its strong mycoparasitical gross pathological changes were found
fully evaluated the merits of the and competitive abilities, the active in organs in the thoracic or abdominal
pesticide petition. The summary may ingredient suppresses the growth and cavities at necropsy. An LD50 >5,000
have been edited by EPA if the antagonistic effects of many soil borne mg/kg was established.
terminology used was unclear, the pathogenic fungi, which cause damping- 3. Acute inhalation toxicity. No
summary contained extraneous off and seed, and root rots such as adverse effects were seen in rats that
material, or the summary phytophthora, rhizoctonia, fusarium, were exposed by inhalation for 4 hours
unintentionally made the reader etc. The active ingredient also induces to a concentration of 5 mg/liters of the
conclude that the findings reflected a defense reaction in the newly emerged technical grade active ingredient. No
EPA’s position and not the position of plant, through stimulation of the effects on appearance, behavior, or body
the petitioner. phytohormones, which are involved in weight were observed in any rats any
the resistance mechanisms of the plant time after exposure. No rats died during
A. Product Name and Proposed Use
against diseases. Pythium oligandrum the 14–day observation period, and no
Practices
DV 74 does not produce any antibiotics gross pathological changes were found
Pythium oligandrum DV 74 is the and therefore is considered a true plant in organs in the thoracic or abdominal
active ingredient in the proposed end- growth promoter for the induction of cavities at necropsy. Histological
use product ‘‘Polyversum.’’ The end-use plant resistance. The mycoparasitic analysis of the lungs and trachea taken
product polyversum is for the action and stimulation of plant from two males and two females
stimulation of plant growth, the resistance by pythium oligandrum are revealed no pathogenic response to
enhancement of plant strength, and the both associated with positive effects on inhalation of the test article. An LD50 >5
prevention of fungal attack. Polyversum plant health and viability. mg/l was established.
mobilizes plant defense mechanisms, 2. A statement of why an analytical 4. Primary eye irritation. In the
increases plant resistance to pathogenic method for detecting and measuring the primary eye irritation study on the
fungal attack, increases rate of growth, levels of the pesticide residue are not technical grade active ingredient, 3
and increases overall crop strength and needed. An analytical method for rabbits received 100 mg of test article in
yield. Polyversum can be applied as a detecting and measuring levels of 0.1 milliliter (ml) of water in the right
seed dressing, pre-plant soak, overhead pesticide residues is not applicable. It is eye. Redness of the conjunctiva and
spray or soil drench, or irrigation expected that, when used as proposed, swelling of the eyelids occurred during

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30108 Federal Register / Vol. 70, No. 100 / Wednesday, May 25, 2005 / Notices

the first 24–48 hours after exposure, (brand name: Biogama) to control environment. The level of pythium
both were rated as high as 2 on a scale psoriasis and dermatitis. These products oligandrum DV 74 in the environment
of 1 to 3 in some animals. The edema have been marketed since 1999 without following application will decrease to
resolved in all animals within 48–hours reports of adverse effects. levels similar to naturally occurring
after test article administration and the A waiver has been requested for acute concentrations, because the organism
redness resolved in all animals within oral, dermal, pulmonary, and IV/IP does not thrive in the absence of
72 hours. No changes in the cornea or toxicity/pathogenicity; dermal sufficient nutrients. Limited
iris of any animals occurred. Pythium sensitization; and the conditionally survivability once its nutrient source is
oligandrum DV 74 was rated required Tier 1 data for cell culture and exhausted will limit any dietary
‘‘moderately irritating’’ to eyes. immune response. In general, the waiver exposure.
5. Primary dermal irritation. No requests are based on the rationale that
adverse effects were seen in rabbits that ii.Drinking water. Similarly, exposure
the active ingredient:
received a subcutaneous injection of an • Produced no adverse effects in to humans from residues of pythium
extract of the technical grade active mammalian toxicity studies. oligandrum DV 74 in consumed
ingredient. In this study 3 rabbits • Is ubiquitous as a naturally drinking water would be unlikely.
received 0.2 ml of an extract of the test occurring soil colonizer whose level in Pythium oligandrum DV 74 is not
article by subcutaneous injection at 2 the environment will not significantly known to grow or thrive in aquatic
injection sites. No reaction was increase with the use of products that environments. Potential exposure to
observed between 45 minutes and 72 contain this strain. surface water would be negligible and
hours after the subcutaneous injection. • Has modes of action that are not exposure to drinking water (well or
Pythium oligandrum DV 74 was rated consistent with toxicity or pathogenicity ground water) would be impossible to
‘‘non irritant’’ to skin. to mammals. measure. The major intended use of
6. Hypersensitivity incidents. The • In an extensive literature search pythium oligandrum DV 74 is to treat
registrant has noted that no incidents of yielded no reports of adverse effects in growing plants and crops for the
hypersensitivity or any other adverse humans or other mammals. purpose of disease control. Pythium
effects have occurred through the • Is marketed in Europe as the active oligandrum DV 74 has limited
research, develop, or testing of the ingredient in over the counter products, survivability once its nutrient source is
active ingredient and its related end-use including mouth rinses, bath additives, exhausted. The risk of the
product. Should any incidents occur, and skin creams, with no reports of microorganism passing through the soil
they will be reported per the Federal adverse effects. to ground water is minimal to unlikely.
Insecticide, Fungicide and Rodenticide The results of toxicity testing indicate Additionally, the fungus would not
Act (FIFRA) section 6(a)(2). there is no risk to human health or the tolerate the conditions water is
A literature search on pythium environment from pythium oligandrum subjected to in a drinking-water facility
oligandrum demonstrates that this DV 74. There are no reports of (including: Chlorination, pH
microorganism is not infective to ecological or human health hazards adjustments, high temperatures, and/or
mammals. The literature search caused by pythium oligandrum in anaerobic conditions).
indicated that pythium oligandrum has general or the strain pythium
2. Non-dietary exposure. The
been studied for over 20 years, and the oligandrum DV 74 in specific. It does
potential for non-dietary exposure to the
only biological effects attributed to the not produce recognized toxins,
general population, including infants
organism are parasitic effects on fungal enzymes, or virulence factors normally
and children, is unlikely as the
species and stimulation of resistance to associated with mammalian
proposed use sites are application to
parasitic infection in plants. The invasiveness or toxicity. The absence of
growing plants or crops. Further,
mycoparasitic mode of action of acute toxicity or pathogenicity in
pythium oligandrum DV 74 has limited
pythium oligandrum is initiated by a laboratory animals demonstrates the
survivability once its nutrient source is
specific affinity for the cells of the benign nature of this strain. The limited
exhausted.
pathogenic fungus, followed by tight survival of pythium oligandrum DV 74
binding to the host hyphae and local and the lack of acute toxicity indicate 3. Conclusion. The results of toxicity
penetration. Pythium oligandrum that both the hazard and the exposure testing indicate there is no risk to
stimulates disease resistance in plants associated with the use of pythium human health or the environment from
by production of a small proteinaceous oligandrum DV 74 are low. Non-dietary pythium oligandrum DV 74. There are
molecule that serves as a biochemical exposures would not be expected to no reports of ecological or human health
signal in the plant. Neither the pose any quantifiable risk due to a lack hazards caused by pythium oligandrum
mechanism of mycoparasitic action nor of residues of toxicological concern. in general or the strain pythium
the stimulation of plant resistance is oligandrum DV 74 in specific. It does
associated with adverse affects in D. Aggregate Exposure not produce recognized toxins,
mammals. 1. Dietary exposure—i. Food. Dietary enzymes, or virulence factors normally
Further, pythium oligandrum DV 74 exposure from use of pythium associated with mammalian
is the active ingredient in a variety of oligandrum DV 74, as proposed, is invasiveness or toxicity. The absence of
over the counter products sold in parts minimal. The major intended use of acute toxicity or pathogenicity in
of Europe (including the Czech pythium oligandrum DV 74 is laboratory animals demonstrates the
Republic, Slovakia, and Poland). These application to growing plants and crops benign nature of this strain. The limited
products include: A footbath to control for the purposes of disease control and survival of pythium oligandrum DV 74
itching and odor (brand name: Biodeur stimulating plant defense mechanisms. and the lack of acute toxicity indicate
Deodorant); a fingernail treatment Pythium oligandrum is widely that both the hazard and the exposure
preparation to control nail fungus distributed around the world, including associated with the use of pythium
(brand name: BioBlock); a mouthwash the U.S. application of pythium oligandrum DV 74 are low. Non-dietary
rinse to control yeast infections (brand oligandrum DV 74 to seeds, foliage, or exposures would not be expected to
name: BioPlus); and a bath additive soil will not result in a substantial pose any quantifiable risk due to a lack
(brand name: Biodelta) and a skin cream increase in concentration in the of residues of toxicological concern.

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Federal Register / Vol. 70, No. 100 / Wednesday, May 25, 2005 / Notices 30109

E. Cumulative Exposure acute toxicity or pathogenicity in Whether the proposed collection of


It is not expected that, when used as laboratory animals demonstrates the information is necessary for the proper
proposed, pythium oligandrum DV 74 benign nature of this strain. The limited performance of the functions of the
would result in residues that are of survival of pythium oligandrum DV 74 Commission, including whether the
toxicological concern. Pythium and the lack of acute toxicity indicate information shall have practical utility;
oligandrum DV 74 is applied to growing that both the hazard and the exposure (b) the accuracy of the Commission’s
plants and crops for the purposes of associated with the use of pythium burden estimate; (c) ways to enhance
disease control and stimulating plant oligandrum DV 74 are low. There is a the quality, utility, and clarity of the
resistance. Pythium oligandrum is reasonable certainty of no harm to the information collected; and (d) ways to
widely distributed around the world, general U.S. population from exposure minimize the burden of the collection of
including the U.S. application of to this active ingredient. information on the respondents,
2. Infants and children. It is not including the use of automated
pythium oligandrum DV 74 to seeds,
expected that, when used as proposed, collection techniques or other forms of
foliage, or soil will not result in a
pythium oligandrum DV 74 would information technology.
substantial increase in concentration in
result in residues that are of DATES: Persons wishing to comment on
the environment. The level of pythium
toxicological concern. There is a this information collection should
oligandrum DV 74 in the environment
reasonable certainty of no harm for submit comments by July 25, 2005. If
following application will decrease to
infants and children from exposure to you anticipate that you will be
levels similar to naturally occurring
pythium oligandrum DV 74 from the submitting comments, but find it
concentrations because the organism
proposed uses. difficult to do so within the period of
does not thrive in the absence of
sufficient nutrients. The results of G. Effects on the Immune and Endocrine time allowed by this notice, you should
toxicity testing indicate there is no risk Systems advise the contact listed below as soon
to human health or the environment as possible.
To date there is no evidence to
from pythium oligandrum DV 74. There suggest that pythium oligandrum DV 74 ADDRESSES: Direct all Paperwork
are no reports of ecological or human functions in a manner similar to any Reduction Act (PRA) comments to
health hazards caused by pythium known hormone, or that it acts as an Judith B. Herman, Federal
oligandrum in general or the strain endocrine disrupter. Communications Commission, 445 12th
pythium oligandrum DV 74 in specific. Street, SW., Room 1–C804, Washington,
It does not produce recognized toxins, H. Existing Tolerances DC 20554 or via the Internet to Judith-
enzymes, or virulence factors normally There is no EPA tolerance for B.Herman@fcc.gov.
associated with mammalian pythium oligandrum DV 74. FOR FURTHER INFORMATION CONTACT: For
invasiveness or toxicity. The absence of additional information or copies of the
acute toxicity or pathogenicity in I. International Tolerances
information collections contact Judith B.
laboratory animals demonstrates the A Codex Alimentarium Commission Herman at 202–418–0214 or via the
benign nature of this strain. The limited Maximum Residue Level (MRL) is not Internet at Judith-B.Herman@fcc.gov.
survival of pythium oligandrum DV 74 required for pythium oligandrum DV 74. SUPPLEMENTARY INFORMATION: OMB
and the lack of acute toxicity indicate [FR Doc. 05–10340 Filed 5–24–05; 8:45 am] Control No.: 3060–0881.
that both the hazard and the exposure BILLING CODE 6560–50–S Title: Section 95.861, Interference.
associated with the use of pythium Form No.: N/A.
oligandrum DV 74 are low. Type of Review: Extension of a
F. Safety Determination FEDERAL COMMUNICATIONS currently approved collection.
COMMISSION Respondents: Business or other for
1. U.S. population. Acute toxicity profit.
studies have shown that pythium Notice of Public Information Number of Respondents: 460.
oligandrum DV 74 is not toxic, Collection(s) Being Reviewed by the Estimated Time Per Response: .50
pathogenic, or infective to mammals. Federal Communications Commission hours.
The major intended use of pythium for Extension Under Delegated Frequency of Response: On occasion
oligandrum DV 74 is applied to growing Authority reporting requirement, recordkeeping
plants and crops for the purposes of requirement and third party disclosure
disease control and stimulating plant May 13, 2005. requirement.
resistance. The level of pythium SUMMARY: The Federal Communications Total Annual Burden: 230 hours.
oligandrum DV 74 in the environment Commission, as part of its continuing Annual Cost Burden: $13,800.
following application will decrease to effort to reduce paperwork burden Privacy Act Impact Assessment: N/A.
levels similar to naturally occurring invites the general public and other Needs and Uses: The Commission
concentrations because the organism Federal agencies to take this will be submitting this information
does not thrive in the absence of opportunity to comment on the collection after the 60 day public
sufficient nutrients. The results of following information collection(s), as comment period in order to obtain the
toxicity testing indicate there is no risk required by the Paperwork Reduction full three year clearance from OMB. We
to human health or the environment Act of 1995, Pub. L. 104–13. An agency are requesting an extension (no change)
from pythium oligandrum DV 74. There may not conduct or sponsor a collection to the information collection
are no reports of ecological or human of information unless it displays a requirements. Section 95.861 requires
health hazards caused by pythium currently valid control number. No 218–219MHz licensees to notify all
oligandrum in general or the strain person shall be subject to any penalty households located both within a TV
pythium oligandrum DV 74 in specific. for failing to comply with a collection Channel 13 Grade B contour and a 218–
It does not produce recognized toxins, of information subject to the Paperwork 219 MHz system service area of
enzymes, or virulence factors normally Reduction Act (PRA) that does not potential interference to Channel 13 TV
associated with mammalian display a valid control number. reception. This requirement is intended
invasiveness or toxicity. The absence of Comments are requested concerning (a) to prevent interference from 219–219

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