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Bacillus pumilus Strain QST2808 - Pesticide Petition Filing 4/01

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.

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: 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 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: 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 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.

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
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]