[Federal Register Volume 65, Number 15 (Monday, January 24, 2000)]
[Notices]
[Pages 3696-3699]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1552]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: [email protected].

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: ``[email protected],'' 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]
BILLING CODE 6560-50-F