[Federal Register Volume 69, Number 42 (Wednesday, March 3, 2004)]
[Notices]
[Pages 10037-10040]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-4629]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0020; FRL-7343-8]


Bacillus pumilus GB34; Notice of Filing a Pesticide Petition to 
Establish an Exemption from the Requirement of a Tolerance for a 
Certain Microbial Pesticide 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 ID number OPP-2004-0020, must be 
received on or before April 2, 2004.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Anne Ball, Biopesticides and Pollution 
Prevention Division (7511C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8717;e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturer (NAICS 311)
    [sbull] Pesticide manufacturer (NAICS 32532)
    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 this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
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 Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2004-0020. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's

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electronic public docket and comment system, EPA Dockets. You may use 
EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. To the extent 
feasible, publicly available docket materials will be made available in 
EPA's electronic public docket. When a document is selected from the 
index list in EPA Dockets, the system will identify whether the 
document is available for viewing in EPA's electronic public docket. 
Although not all docket materials may be available electronically, you 
may still access any of the publicly available docket materials through 
the docket facility identified in Unit I.B.1. EPA intends to work 
towards providing electronic access to all of the publicly available 
docket materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment asprescribed 
in this unit, EPA recommends that you include your name, mailing 
address, and an e-mail address or other contact information in the body 
of your comment. Also include this contact information on the outside 
of any disk or CD ROM you submit, and in any cover letter accompanying 
the disk or CD ROM. This ensures that you can be identified as the 
submitter of the comment and allows EPA to contact you in case EPA 
cannot read your comment due to technical difficulties or needs further 
information on the substance of your comment. EPA's policy is that EPA 
will not edit your comment, and any identifying or contact information 
provided in the body of a comment will be included as part of the 
comment that is placed in the official public docket, and made 
available in EPA's electronic public docket. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2004-0020. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID number OPP-2004-0020. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID number OPP-2004-0020.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket 
ID number OPP-2004-0020. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is 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

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docket and EPA's electronic public docket. If you submit the copy that 
does not contain CBI on disk or CD ROM, mark the outside of the disk or 
CD ROM clearly that it does not contain CBI. Information not marked as 
CBI will be included in the public docket and EPA's electronic public 
docket without prior notice. If you have any questions about CBI or the 
procedures for claiming CBI, please consult the person listed 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 
ID 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 FFDCA 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: February 23, 2004.
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 FFDCA section 408(d)(3). 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.

 Gustafson LLC

 PP 1F6344

    EPA has received a pesticide petition 1F6344 from Gustafson LLC, 
1400 Preston Road, Suite 400, Plano, TX 75093, 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 Bacillus 
pumilus GB34 when used as a seed treatment in or on all food 
commodities and on soybeans 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 cotton, 
sugar beet, corn, and vegetable, legume group 06, 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 expansion of the 
existing 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/kilogram (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 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 cotton,

[[Page 10040]]

sugar beet, corn, and vegetable, legume group 06, 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 had no information to suggest that Bacillus pumilus 
GB34 will have any effect on the immune and endocrine systems.

H. Existing Tolerances

    There is an existing exemption from tolerance for Bacilluspumilus 
GB34 when used as a seed treatment in or on soybeans and soybeans after 
harvest 40 CFR 180.1224.

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. 04-4629 Filed 3-1-04; 8:45 am]
BILLING CODE 6560-50-S