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bacillus pumilus GB34 Pesticide Petition Filing 12/01

 

ENVIRONMENTAL PROTECTION AGENCY

[PF-1062; FRL-6813-8]


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 PF-1062, must be
received on or before January 30, 2002.

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-1062 in the subject line on the first page of your
response.

FOR FURTHER INFORMATION CONTACT: By mail: Anne Ball, Biopesticides and
Pollution Prevention Division (7511C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 308-8717; e-mail address:
ball.anne@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,'' ``Regulations and Proposed Rules,'' 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-1062. 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 PF-1062 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 PF-1062. 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: December 14, 2001.
Janet L. Andersen,
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 petition 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.

Gustafson LLC

PP 1F6344

    EPA has received a pesticide petition (PP 1F6344) from Gustafson
LLC, 1400 Preston Road, Suite 400, Plano, TX 75093, proposing pursuant
to section 408(d) of the 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 Bacillus pumilus GB34 when used as a seed
treatment in or on all raw agricultural commodities and on all food
commodities after harvest.
    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended,
Gustafson LLC has submitted the following summary of information, data,
and arguments in support of their pesticide petition. This summary was
prepared by Gustafson LLC 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

    The active ingredient Bacillus pumilus GB34 is formulated into the
technical product, GB34 Technical Biological Fungicide and the end use
product GB34 Concentrate Biological Fungicide. GB34 concentrate
contains bacteria which colonize the developing root system of soybeans
suppressing disease organisms such as Rhizoctonia and Fusarium that
attack root systems. GB34 concentrate is used as a seed treatment
before planting.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. Bacillus
pumilus GB34 is a naturally occurring isolate from the soil.
    2. Magnitude of residue at the time of harvest and method used to
determine the residue. Two processing studies with soybeans were
conducted. The studies showed no uptake of Bacillus pumilus GB34 beyond
the seed hull. No residues were found in meal, oil, soymilk, or tofu.
    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 enumeration of microorganisms is available but is
not required since the petitioner is requesting an exemption from the
requirement of a tolerance.

C. Mammalian Toxicological Profile

    Bacillus pumilus GB34 was not found to be toxic or pathogenic from
acute intravenous administration of 1.1 x 107 cfu of
technical grade material. The oral LD50 of GB34 technical
was greater than 5,000 milligrams/kilograms (mg/kg) of body weight.
GB34 technical was classified non-irritating to the skin and mildly
irritating to the eye in primary skin irritation and eye irritation
studies. The oral LD50 of GB34 concentrate was greater than
5,000 mg/kg of body weight. GB34 concentrate was classified as non-
irritating to the skin and minimally irritating to the eye in primary
skin irritation and eye irritation studies. An avian oral pathogenicity
and toxicity study in northern Bobwhite showed no evidence of
pathogenicity during gross necropsy. The no observed adverse effect
level (NOAEL) was approximately 3.4 x 1011 cfu/kg/day for 5
days.

D. Aggregate Exposure

    1. Dietary exposure--i. Food. Bacillus pumilus GB34 does not
exhibit any

[[Page 67524]]

mammalian toxicity. Therefore, any dietary exposure would not be
harmful to humans. Also Bacillus pumilus GB34 is a naturally occurring,
ubiquitous microorganism indigenous to the United States.
    ii. Drinking water. Bacillus pumilus is found in the soil and the
use rate of GB34 concentrate is 0.1 ounces per 100 pounds of seed,
equivalent to 1.7 grams per acre. Bacillus pumilus GB34 is unlikely to
leach from the treated seed and would not be distinguishable from other
naturally occurring Bacillus pumilus.
    2. Non-dietary exposure. As a commercial seed treatment for
soybeans, the general population, including infants and children, will
have a very low possibility of exposure. Occupational exposure will be
limited to employees in commercial facilities handling the seed
treatment product. Commercial seed treating equipment minimizes
occupational exposure. Wearing protective equipment will also minimize
occupational exposure. Non-dietary exposure would not be expected to
pose a quantifiable risk.

E. Cumulative Exposure

    The product strain belongs to the bacterial genus of Bacillus.
Bacillus pumilus GB34 may have a similar mode of action in mammals as
Bacillus subtilis that has been shown to be non-toxic and non-
pathogenic in mammalian species. A similar mode of action of Bacillus
pumilus GB34 and Bacillus subtilis would not be expected to result in
an increased adverse effect since both were shown to be non-toxic and
non-pathogenic in intravenous toxicity and pathogenicity studies.

F. Safety Determination

    1. U.S. population. Based on the low treating rate of seed
treatment use, little evidence of toxicity or pathogenicity and limited
exposure potential, Gustafson LLC believes there is a reasonable
certainty of no harm to the U.S. population in general from aggregate
exposure to Bacillus pumilus GB34 residue from all anticipated dietary
and non-dietary exposures.
    2. Infants and children. Based on the lack of toxicity and low
exposure there is a reasonable certainty that no harm to infants,
children or adults will result from aggregate exposure to Bacillus
pumilus GB34.

G. Effects on the Immune and Endocrine Systems

    Gustafson LLC has no information to suggest that Bacillus pumilus
GB34 will have any effect on the immune and endocrine systems.

H. Existing Tolerances

    There are no existing tolerances for Bacillus pumilus GB34.

I. International Tolerances

    Gustafson LLC is not aware of any international tolerances,
exemptions from tolerance or maximum residue levels for Bacillus
pumilus GB34.
[FR Doc. 01-32109 Filed 12-28-01; 8:45 am]