Notice of Filing a Pesticide Petition to Establish a Tolerance
for Certain Pesticide Chemicals in or on Food
[Federal Register: January 24, 2000 (Volume 65, Number 15)]
[Notices]
[Page 3696-3699]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24ja00-55]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-910; FRL-6484-9]
Notice of Filing a Pesticide Petition to Establish a Tolerance
for Certain Pesticide Chemicals in or on Food
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of
[[Page 3697]]
regulations for residues of a certain pesticide chemical in or on
various food commodities.
DATES: Comments, identified by docket control number PF-910, must be
received on or before February 23, 2000.
ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I.C. of the ``SUPPLEMENTARY INFORMATION.'' To ensure
proper receipt by EPA, it is imperative that you identify docket
control number PF-910 in the subject line on the first page of your
response.
FOR FURTHER INFORMATION CONTACT: By mail: Susanne Cerrelli,
Biopesticides and Pollution Prevention Division (7511C), Office of
Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg.,
1200 Pennsylvania Ave., NW.,Washington, DC 20460; telephone number:
(703) 308-8077; e-mail address: Cerrelli.susanne@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS potentially
affected entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under ``FOR FURTHER INFORMATION
CONTACT.''
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'' and then look up the entry for this document under the
``Federal Register--Environmental Documents.'' You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
2. In person. The Agency has established an official record for
this action under docket control number PF-910. The official record
consists of the documents specifically referenced in this action, any
public comments received during an applicable comment period, and other
information related to this action, including any information claimed
as confidential business information (CBI). This official record
includes the documents that are physically located in the docket, as
well as the documents that are referenced in those documents. The
public version of the official record does not include any information
claimed as CBI. The public version of the official record, which
includes printed, paper versions of any electronic comments submitted
during an applicable comment period, is available for inspection in the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall 2 (CM 2), 1921 Jefferson Davis Highway, Arlington, VA,
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The PIRIB telephone number is (703) 305-5805.
C. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number PF-910 in the subject line on the
first page of your response.
1. By mail. Submit your comments to: Public Information and Records
Integrity Branch (PIRIB), Information Resources and Services Division
(7502C), Office of Pesticide Programs (OPP), Environmental Protection
Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC
20460.
2. In person or by courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Information Resources
and Services Division (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, CM 2, 1921 Jefferson Davis
Highway, Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The PIRIB telephone
number is (703) 305-5805.
3. Electronically. You may submit your comments electronically by
e-mail to: ``opp-docket@epa.gov,'' or you can submit a computer disk as
described above. Do not submit any information electronically that you
consider to be CBI. Avoid the use of special characters and any form of
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be
identified by docket control number PF-910. Electronic comments may
also be filed online at many Federal Depository Libraries.
D. How Should I Handle CBI That I Want to Submit to the Agency?
Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI by marking any part or all of that information as
CBI. Information so marked will not be disclosed except in accordance
with procedures set forth in 40 CFR part 2. In addition to one complete
version of the comment that includes any information claimed as CBI, a
copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public version of the
official record. Information not marked confidential will be included
in the public version of the official record without prior notice. If
you have any questions about CBI or the procedures for claiming CBI,
please consult the person identified under ``FOR FURTHER INFORMATION
CONTACT.''
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used
that support your views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Make sure to submit your comments by the deadline in this
notice.
7. To ensure proper receipt by EPA, be sure to identify the docket
control number assigned to this action in the subject line on the first
page of your
[[Page 3698]]
response. You may also provide the name, date, and Federal Register
citation.
II. What Action is the Agency Taking?
EPA has received a pesticide petition as follows proposing the
establishment and/or amendment of regulations for residues of a certain
pesticide chemical in or on various food commodities under section 408
of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that this petition contains data or information
regarding the elements set forth in section 408(d)(2); however, EPA has
not fully evaluated the sufficiency of the submitted data at this time
or whether the data supports granting of the petition. Additional data
may be needed before EPA rules on the petition.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: January 5, 2000.
Janet L. Andersen,
Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
Prophyta Biologischer Pflanzenschutz GmbH
Pesticide Petition 9F6038
EPA has received a pesticide petition (PP) 9F6038 from Prophyta
Biologischer Pflanzenschutz GmbH, Inselstrabe 12, D-23999 Malchow/Poel,
Germany, proposing pursuant to section 408(d) of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part
180 to establish an exemption from the requirement of a tolerance for
the microbial pesticide Coniothyrium minitans strain CON/M/91-08.
Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended,
Prophyta Biologischer Pflanzenschutz GmbH has submitted the following
summary of information, data, and arguments in support of their
pesticide petition. This summary was prepared by Prophyta Biologischer
Pflanzenschutz GmbH and EPA has not fully evaluated the merits of the
pesticide petition. The summary may have been edited by EPA if the
terminology used was unclear, the summary contained extraneous
material, or the summary unintentionally made the reader conclude that
the findings reflected EPA's position and not the position of the
petitioner.
A. Product Name and Proposed Use Practices
Coniothyrium minitans strain CON/M/91-08 is proposed for use to
control Sclerotinia species in the soil of any agricultural crop. The
end-use product, CONTANSWG, is applied as a spray to the
soil, which is followed with mechanical incorporation (i.e., rotating)
into the first one to two inches of the top soil layer. The product is
applied as a preplant treatment, 3 to 4 months prior to planting the
crop, or as a postharvest treatment to plant residues.
B. Product Identity/Chemistry
1. Identity of the pesticide and corresponding residues.
Coniothyrium minitans strain CON/M/91-08 is the active ingredient in
the proposed end-use product CONTANS WG. CONTANS WG
is currently registered for use in Germany and Switzerland. An
application for inclusion of the active ingredient (Coniothyrium
minitans strain CON/M/91-08) in Annex I of Council Directive 91/414/EEC
on the marketing of plant-protection products was sanctioned in 1998
and was published in the European Union Gazette.
Coniothyrium minitans was first described after isolation from
sclerotia of Sclerotinia sclerotiorum in California in 1947 and has
been investigated as a pesticide over the last 20 years. The occurrence
of Coniothyrium minitans in the soil has been reported from many
countries all over the world.
Coniothyrium minitans strain CON/M/91-08 is a naturally occurring
soil fungus that primarily attacks and infects sclerotia. When the host
organism (sclerotia) is present, Coniothyrium minitans starts to
develop a vegetative organism and infects the host. The Coniothyrium
minitans population decreases when the number of vital sclerotia drops.
The vegetative organism disappears and the fungus rests in a spore
stage. The spores of Coniothyrium minitans can survive ungerminated in
disintegrated sclerotia for at least 1 year, and the fungus can be
recovered from soil in sclerotia for up to 18 months following
application. However, at soil temperatures above 25 deg.C, isolation
of Coniothyrium minitans from sclerotia is not possible after 6 months.
2. Magnitude of residue at the time of harvest and method used to
determine the residue. An analytical method for detecting and measuring
the levels of residues is not applicable. Coniothyrium minitans strain
CON/M/91-08 is applied to the soil and immediately mixed into the top
soil layer prior to planting the crop, or after harvest. It is not
applied to growing crops directly. Residues of Coniothyrium minitans
strain CON/M/91-08 are not expected on agricultural commodities.
3. A statement of why an analytical method for detecting and
measuring the levels of the pesticide residue are not needed. An
analytical method for detecting and measuring the levels of residues is
not applicable. Coniothyrium minitans strain CON/M/91-08 is applied to
the soil and immediately mixed into the top soil layer prior to
planting the crop, or after harvest. It is not applied to growing crops
directly. Residues of Coniothyrium minitans strain CON/M/91-08 are not
expected on agricultural commodities.
C. Mammalian Toxicological Profile
CONTANS WG, the end-use product which contains 5.3%
active ingredient, was evaluated for acute toxicity through oral,
dermal, inhalation and eye routes of exposure. The results of the
studies indicated Toxicity Category III or IV, which pose no
significant human health risks.
The acute oral toxicity of Coniothyrium minitans strain CON/M/91-08
in rats is greater than 2,500 milligrams per kilograms (mg/kg)
(Toxicity Category III), the highest dose tested. The acute dermal
toxicity of Coniothyrium minitans strain CON/M/91-08 in rats is greater
than 2,500 mg/kg (Toxicity Category III), the highest dose tested. The
acute intraperitoneal toxicity of Coniothyrium minitans strain CON/M/
91-08 to rats is greater than 2,000 mg/kg, the highest does tested. The
acute inhalation of Coniothyrium minitans strain CON/M/91-08 in rats is
greater than 12.74 milligrams per liter (mg/L) of air (Toxicity
Category IV). Eye irritation in rabbits was not observed at a dose of
0.1 milliliter (ml) (Toxicity Category IV). Skin irritation in rabbits
was not observed at a dose of 0.5 ml (Toxicity Category IV). No dermal
sensitization was observed in guinea pigs (Toxicity Category IV). Since
its discovery in 1947, no incidents of hypersensitivity have been
reported by researchers, manufacturers, or users.
A waiver is being requested for acute oral toxicity/pathogenicity,
acute dermal toxicity/pathogenicity and acute pulmonary toxicity/
pathogenicity data requirements, based on the fact that the active
ingredient is not able to grow at temperatures above 32 deg.C, and
thus would not be pathogenic or infective to humans. A growth
temperature study has been submitted to support the waiver request.
Additionally, acute toxicity studies have determined the end-use
product containing the organism is not toxic, irritating or
[[Page 3699]]
sensitizing to test animals. Finally, the organism has never been
reported as a pathogen of humans, or as causing any type of adverse
effect to humans, in published literature or through commercial use.
D. Aggregate Exposure
1. Dietary exposure --i. Food. Dietary exposure from use of
Coniothyrium minitans strain CON/M/91-08, as proposed, is minimal.
Coniothyrium minitans strain CON/M/91-08 is applied to the soil and
immediately mixed into the top soil layer prior to planting the crop,
or after harvest. It is not applied to growing crops directly. Residues
of Coniothyrium minitans strain CON/M/91-08 are not expected on
agricultural commodities.
ii. Drinking water. Exposure to humans from residues of
Coniothyrium minitans strain CON/M/91-08 in consumed drinking water
would be unlikely. In a study to investigate the leaching behavior of
Coniothyrium minitans strain CON/M/91-08, it was determined that there
is no motility of the organism in the soil. Thus, it would not be
possible for the organism to leach into drinking water. Also, due to
the specific requirements for growth of Coniothyrium minitans strain
CON/M/91-08, it is not likely that the organism could survive or
persist in water.
2. Non-dietary exposure. The potential for non-dietary exposure to
the general population, including infants and children, is unlikely as
the proposed use sites are commercial, agricultural and horticultural
settings. However, non-dietary exposures would not be expected to pose
any quantifiable risk due to a lack of residues of toxicological
concern.
Personal protective equipment (PPE) mitigates the potential for
exposure to applicators and handlers of the proposed products, when
used in commercial, agricultural and horticultural settings.
E. Cumulative Exposure
It is not expected that, when used as proposed, Coniothyrium
minitans strain CON/M/91-08 would result in residues that would remain
in human food items.
F. Safety Determination
1. U.S. population. Coniothyrium minitans strain CON/M/91-08 does
not grow at temperatures above 32 deg.C, and thus would not be
pathogenic or infective to humans. There have been no reports of toxins
or secondary metabolites associated with the organism, and acute
toxicity studies have shown that Coniothyrium minitans strain CON/M/91-
08 is nontoxic, nonirritating and nonsensitizing when applied to test
animals.
Coniothyrium minitans strain CON/M/91-08 is applied to soil and
immediately mixed into the top soil layer prior to planting the crop,
or after harvest. It is not applied to growing crops directly. Residues
of Coniothyrium minitans strain CON/M/91-08 are not expected on
agricultural commodities, and therefore, exposure to the general U.S.
population, from the proposed uses, is not anticipated.
2. Infants and children. As mentioned above, residues of
Coniothyrium minitans strain CON/M/91-08 are not expected on
agricultural commodities. There is a reasonable certainty of no harm
for infants and children from exposure to Coniothyrium minitans strain
CON/M/91-08 from the proposed uses.
G. Effects on the Immune and Endocrine Systems
Coniothyrium minitans strain CON/M/91-08 is a naturally occurring,
nonpathogenic soil organism. To date there is no evidence to suggest
that Coniothyrium minitans strain CON/M/91-08 functions in a manner
similar to any known hormone, or that it acts as an endocrine
disrupter.
H. Existing Tolerances
There are no existing tolerances for this ingredient.
I. International Tolerances
A Codex Alimentarium Commission Maximum Residue Level (MRL) is not
required for Coniothyrium minitans strain CON/M/91-08.
[FR Doc. 00-1552 Filed 1-21-00; 8:45 am]
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