[Federal Register Volume 66, Number 86 (Thursday, May 3, 2001)]
[Notices]
[Pages 22225-22228]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11094]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1005; FRL-6773-9]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
for a Certain Pesticide Chemical 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 regulations for residues of a 
certain pesticide chemical in or on various food commodities.

[[Page 22226]]


DATES: Comments, identified by docket control number OPP-50878, must be 
received on or before June 4, 2001.

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 OPP-50878 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, 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 codes         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 OPP-50878. 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, 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 OPP-50878 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, 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, Crystal Mall #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 OPP-50878. 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 response. You may also provide the name, date, and Federal 
Register citation.

[[Page 22227]]

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 Cosmetic 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 support 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: April 19, 2001.
Kathleen F. Knox,
Acting Director, Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by section 408(d)(3) of the FFDCA. The summary of the 
petition was prepared by the petitioner and represents the view of the 
petitioner. EPA is publishing the petition summary verbatim without 
editing it in any way. The petitioner's summary announces the 
availability of a description of the analytical methods available to 
EPA for the detection and measurement of the pesticide chemical 
residues or an explanation of why no such method is needed.

AgraQuest, Inc.

PP 1G6240

    EPA has received a pesticide petition 1G6240 from AgraQuest, Inc., 
1530 Drew Avenue, Davis, CA 95616, proposing pursuant to section 408(d) 
of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish 
a temporary exemption from the requirement of a tolerance for the 
microbial pesticide Bacillus pumilus strain QST 2808 in or on all raw 
agricultural commodities (RAC). Pursuant to section 408(d)(2)(A)(i) of 
the FFDCA, as amended, AgraQuest, Inc. has submitted the following 
summary of information, data, and arguments in support of their 
pesticide petition. This summary was prepared by AgraQuest, Inc. 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

    SonataTM AS is proposed for use as a biofungicide to 
control various plant diseases such as downy mildew, powdery mildew, 
Phytophthera, Sclerotinia, Cercospora, and/or rust on the following 
vegetable crop groups: root and tuber, bulb, leafy except Brassica, 
Brassica, legume, fruiting, and cucurbit; on the following fruit crop 
groups: pome and stone, on the grain, cereal, group; and the following 
individual crops: grape, grasses grown for seed, hop, mint, peanuts, 
strawberry, and field grown roses. The product is applied as a foliar 
spray alone, in alternating spray programs, or in tank mixes with other 
registered crop protection products, up to and including the day of 
harvest.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. 
SonataTM AS contains the QST 2808 strain of Bacillus pumilus 
as the active ingredient. Bacillus pumilus strain QST 2808 is a 
ubiquitous, naturally occurring, non-pathogenic microorganism. It is 
commonly recovered from water, soil, air, and decomposing plant 
residue. Bacillus pumilus produces proteases and other enzymes that 
enable it to degrade a variety of natural substrates and contribute to 
nutrient recycling. Bacillus pumilus prevents spore germination by 
formation of a physical barrier and subsequently colonizes fungal 
spores. QST 2808 Technical is used to formulate SonataTM AS. 
The product will be applied at a maximum rate of 1.18 x 1013 
colony forming units per acre, which is equivalent to a maximum rate of 
3 gallons of SonataTM AS per acre.
    2. Magnitude of residue at the time of harvest and method used to 
determine the residue. AgraQuest is submitting a petition requesting 
that EPA establish a temporary exemption from the requirement of a 
tolerance for the QST strain of Bacillus pumilus, therefore, this 
section is not applicable.
    3. A statement of why an analytical method for detecting and 
measuring the levels of the pesticide residue are not needed. AgraQuest 
is submitting a petition requesting that EPA establish a temporary 
exemption from the requirement of a tolerance for the QST strain of 
Bacillus pumilus, therefore, this section is not applicable.

C. Mammalian Toxicological Profile

    The active ingredient Bacillus pumilus strain QST 2808 has been 
evaluated for toxicity through oral, dermal, pulmonary, intravenous and 
eye routes of exposure. The results of the studies have indicated there 
are no significant human health risks. The acute oral toxicity/
pathogenicity LD50 in rats is greater than 4.1 x 
109 cfu/g. The acute dermal toxicity LD50 in rats 
is greater than 2,000 milligrams/kilograms (mg/kg) (toxicity category 
III). The acute pulmonary toxicity/pathogenicity LD50 in 
rats is greater than 1.6 x 108 cfu per animal. The acute 
intravenous toxicity/pathogenicity LD50 in rats is greater 
than 1.6 x 108 cfu per animal. No pathogenic or infective 
effects were observed in the studies.
    Slight eye irritation in rabbits was observed at a dose of 0.1 mL 
(toxicity category IV) and minimal skin irritation in rabbits was 
observed at a dose of 0.5 mL (toxicity category IV). Since its 
discovery, no incidents of hypersensitivity have been reported by 
researchers, manufacturers or users of Bacillus pumilus strain QST 
2808. The formulated product is a very dilute aqueous suspension of 
Bacillus pumilus, with <3% intentionally added inert ingredients. It is 
unlikely that this product's toxicity profile will differ from that of 
the technical material. Acute toxicology studies are in progress on the 
formulated product.

D. Aggregate Exposure

    SonataTM AS is proposed for use under an experimental 
use permit to control various plant diseases on agricultural crops.
    1. Dietary exposure. Dietary exposure is not expected from the use 
of this microbial pesticide as proposed. The lack of acute oral 
toxicity/pathogenicity and the ubiquitous nature of the organism 
support the exemption from the requirement of a tolerance for this 
active ingredient.
    i. Food. Dietary exposure from use of Bacillus pumilus strain QST 
2808, as proposed, is minimal. Residues of Bacillus pumilus strain QST 
2808 are not expected on agricultural commodities. In a study conducted 
to determine the longevity of Bacillus pumilus residues on pepper leaf 
surfaces under field conditions, the results showed that the number of 
colony forming units of Bacillus pumilus decreased significantly over 
time in the first 5 days. In addition, the

[[Page 22228]]

microbial pesticide can be removed from food by peeling, washing, 
cooking, and processing.
    ii. Drinking water. Exposure to humans from residues of Bacillus 
pumilus strain QST 2808 in consumed drinking water would be unlikely. 
Bacillus pumilus strain QST 2808 is a naturally occurring microorganism 
known to exist in terrestrial habitats. Although it may be found in 
water, it is not known to thrive in aquatic environments.
    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 agricultural settings. In addition, 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 agricultural settings.

E. Cumulative Exposure

    There is no indication of mammalian toxicity of Bacillus pumilus 
and no information to indicate that toxic effects would be cumulative. 
Therefore, consideration of a common mode of action is not appropriate. 
In addition, it is not expected that, when used as proposed, 
SonataTM AS would result in residues that would remain in 
human food items.

F. Safety Determination

    Risk and exposure to humans, infants, and children is likely to be 
minimal.
    1. U.S. population. Bacillus pumilus strain QST 2808 is not 
pathogenic or infective to mammals. There have been no reports of 
toxins associated with the organism, and acute toxicity/pathogenicity 
studies have shown that Bacillus pumilus strain QST 2808 is non-toxic, 
non-pathogenic, and non-irritating. Residues of Bacillus pumilus strain 
QST 2808 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 Bacillus 
pumilus strain QST 2808 are not expected on agricultural commodities. 
There is a reasonable certainty of no harm for infants and children 
from exposure to Bacillus pumilus strain QST 2808 from the proposed 
uses.

G. Effects on the Immune and Endocrine Systems

     Bacillus pumilus strain QST 2808 is a naturally occurring, non-
pathogenic microorganism. There is no evidence to suggest that Bacillus 
pumilus strain QST 2808 functions in a manner similar to any known 
hormone, or that it acts as an endocrine disrupter.

H. Existing Tolerances

    There is no U.S. EPA tolerance for Bacillus pumilus strain QST 
2808.

I. International Tolerances

    There is no Codex Alimentarius Commission maximum residue level 
(MRL) for Bacillus pumilus strain QST 2808.
[FR Doc. 01-11094 Filed 5-2-01; 8:45 am]
BILLING CODE 6560-50-S