[Federal Register Volume 66, Number 244 (Wednesday, December 19, 2001)]
[Notices]
[Pages 65482-65485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-31249]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1037; FRL-6795-9]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
fora 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

[[Page 65483]]

pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket control number PF-1037, must be 
received on or before January 18, 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-1037 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: 
<a href="/cdn-cgi/l/email-protection#b5d7d4d9d99bd4dbdbd0f5d0c5d49bd2dac3"><span class="__cf_email__" data-cfemail="f694979a9ad897989893b6938697d8919980">[email protected]</span></a>.

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-1037. 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-1037 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: <a href="/cdn-cgi/l/email-protection#147b646439707b777f7160547164753a737b62"><span class="__cf_email__" data-cfemail="214e51510c454e424a4455614451400f464e57">[email protected]</span></a>, 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-1037. 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

[[Page 65484]]

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, Biopesticides, 
Feed additives, Food additives, Pesticides and pests, Pollution 
prevention, Reporting and recordkeeping requirements.


    Dated: December 11, 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. 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.

Growth Products Ltd.

PP 1G6307

    EPA has received a pesticide petition [1G6307] from Growth Products 
Ltd. , PO Box 1259, White Plains, NY 10602, 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 temporary 
tolerance for the microbial pesticide Bacillus subtilis GB03.
    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, 
Growth Products Ltd. has submitted the following summary of 
information, data, and arguments in support of their pesticide 
petition. This summary was prepared by Growth Products Ltd. 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

    Companion Liquid Biological Fungicide 00.03% Bacillus subtilis GB03 
is to be used on <ls-thn-eq>200 acres in five states to obtain efficacy 
and phytotoxicity data, evaluate application rates and evaluate timing 
to establish disease control over a large geographical area on many 
important specialty crops. Disease severity and intensity will be 
observed, as well as measurements of root growth in both length and 
mass, leaf color, and tissue analysis of nutrient levels, all of which 
are indicators of healthy plants. Food crops to be treated include 
apples, broccoli, celery, citrus, cotton, grapes (raisin, table and 
wine), lettuce (iceberg and leaf), melons, onions, potatoes, herbs and 
spices, strawberries, sunflower, tobacco and tomatoes. The proposed 
time period for the permit is 2 years.

B. Product Identity/Chemistry

    1. Identity of the pesticide. The active ingredient is Bacillus 
subtilis GB03 which is the biological pesticide Kodiak\TM\ Concentrate 
Biological Fungicide which has the EPA Reg. No. 7501-144 maintained by 
the company Gustafson LLC for use as a seed treatment of agricultural 
commodities. The company has established a tolerance exemption specific 
to that use (40 CFR 180.1111). In storage the product is stable for at 
least 1 year when stored in original packaging according to label 
directions. The mode of action of Bacillus subtilis GB03 results from 
its colonization of the developing root system of plants, thereby 
suppressing and controlling root diseases by competition. The organism 
has been shown to increase root mass and plant health on various 
agricultural commodities.
    2. Analytical method. An analytical method for residues is not 
applicable. Residues of Bacillus subtilis GB03 are not expected on 
agricultural commodities.

C. Mammalian Toxicological Profile

    Toxicological data on the active ingredient had been previously 
accepted to support the current exemption from the requirement of a 
tolerance for residues for seed treatment of agricultural commodities 
See 40 CFR 180.1111). These studies include an acute oral toxicity/
pathogenicity study in the rat, an acute dermal toxicity study in the 
rabbit, an acute pulmonary toxicity/pathogenicity study in the rat, an 
acute intravenous toxicity/pathogenicity study in the rat and a primary 
eye irritation study in the rabbit. EPA found from a review of these 
studies that the active ingredient was not toxic to test animals when 
administered via the oral, dermal, intravenous, or pulmonary routes of 
exposure. The active ingredient was not infective or pathogenic to test 
animals when administered via the oral, pulmonary, and intravenous 
routes. No reports of hypersensitivity had been reported from personnel 
working with this organism.
    Toxicological data on the end-use product Companion Liquid 
Biological Fungicide had been previously accepted to support a 
registration for non-food greenhouse use. An acute oral toxicity study 
showed no toxicity at a dose of 5,000 milligrams/kilograms (mg/kg) in 
rats (Toxicity category IV), a primary eye irritation study showed mild 
irritation at a dose of 0.1 milliliters (mL) in rabbits (Toxicity 
Category IV), and a primary dermal irritation study showed moderate 
dermal irritation at a dose of 0.5 mL in rabbits (Toxicity Category 
III). The results of the above studies indicate that there are no 
significant human health risks associated with the active ingredient or 
end use product.

D. Aggregate Exposure

    1. Dietary exposure--i. Food. Dietary exposure from use of Bacillus 
subtilis GB03 is expected to be minimal. Its use involves low levels of 
the active ingredient applied to growing plants prior to harvest. 
Residues if Bacillus subtilis GB03 are not expected to be on 
agricultural commodities. However should any residues occur they would 
not be of any toxicological concern.
    ii. Drinking water. Exposure to humans from residues of Bacillus 
subtilis GB03 in consumed drinking water would be unlikely. Bacillus 
subtilis GB03 is a naturally occurring soil micro-organism and it is 
not known to thrive in aquatic environments. Potential exposure to 
surface water would be negligible and exposure to drinking water (well 
or ground water) would be impossible to measure.
    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. However, non-dietary 
exposures would not be expected to

[[Page 65485]]

pose any quantifiable risk due to a lack of residues of toxicological 
concern.
    Personal protective equipment (PPE) mitigates the possibility of 
exposure for applicators and handlers of the proposed products, when 
used in agricultural settings.

E. Cumulative Exposure

    It is not expected that, when used as proposed, products containing 
Bacillus subtilis GB03 would result in residues that would remain in 
human food items. The organism is not pathogenic or infective to 
mammals. There have been no reports of toxins or secondary metabolites 
associated with this organism, and acute toxicity studies have shown 
that Bacillus subtilis GB03 is non-toxic and non-pathogenic.

F. Safety Determination

    1. U.S. population. Acute toxicity studies have shown that Bacillus 
subtilis GB03 is not toxic. Residues of this organism are not expected 
to be on agricultural commodities; however, should residues occur they 
would not be of toxicological concern. There is a reasonable certainty 
of no harm to the general U.S. population from exposure to this active 
ingredient.
    2. Infants and children. As mentioned above, residues of Bacillus 
subtilis GB03 are not expected to be on agricultural commodities. There 
is a reasonable certainty of no harm for infants and children from 
exposure to Bacillus subtilis GB03 from the proposed uses.

G. Effects on the Immune and Endocrine Systems

    To date there is no evidence to suggest that Bacillus subtilis GB03 
functions in a manner similar to any known hormone, or that it acts as 
an endocrine disrupter.

H. Existing Tolerances

    There is an existing EPA tolerance in 40 CFR 180.1111: Bacillus 
subtilis GB03; exemption from the requirement of a tolerance. The 
biofungicide Bacillus subtilis GB03 is exempted from the requirement of 
a tolerance in or on all raw agricultural commodities when applied as a 
seed treatment for growing agricultural crops in accordance with good 
agricultural practices (established June 30, 1992).

I. International Tolerances

    A codex Alimentarium Commission Maximum Residue Level (MRL) is not 
required for Bacillus subtilis GB03.
[FR Doc. 01-31249 Filed 12-18-01; 8:45 am]
BILLING CODE 6560-50-S


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