[Federal Register Volume 67, Number 196 (Wednesday, October 9, 2002)]
[Notices]
[Pages 62971-62974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-25585]



[[Page 62971]]

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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0244; FRL-7196--2]


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 ID number OPP-2002-0244, must be 
received on or before November 8, 2002.

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. To ensure proper 
receipt by EPA, it is imperative that you identify docket ID number 
OPP-2002-0244 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:  By mail: Leonard Cole, Biopesticide 
and Pollution Prevention Division, Office of Pesticide Programs, 
(7511C) Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-5412; 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 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. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in OPP-2002-0244. 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-2002-0244. 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 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. 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

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not use EPA Dockets or e-mail to submit CBI or information protected by 
statute.
    1. Electronically. If you submit an electronic comment as 
prescribed 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-2002-0244 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-2002-0244. 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-2002-0244.
    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-2002-0244. 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 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. Offer alternative ways to improve the notice or collection 
activity.
    7. Make sure to submit your comments by the deadline in this 
document.
    8. 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 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.

     September 24, 2002.
Janet L. Andersen,
Director, Biopesticide 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 Mycogen Seeds c/o Dow AgroSciences LLC, and 
represents the view of the Mycogen Seeds. 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.

 Mycogen Seeding c/o Dow AgroSciences LLC

 PP 2G6494

     EPA has received a pesticide petition (2G6494) from Mycogen Seeds 
c/o Dow

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AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054, 
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 plant incorporated 
protantant; bacillus thuringiensis var Kurstaki CrylAc in or on cotton. 
The plant also expresses the Cry1F protein (refer to FRL-7198-2 
published elsewhere in this issue of the Federal Register).
     Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, 
Mycogen Seeds c/o Dow AgroSciences LLC has submitted the following 
summary of information, data, and arguments in support of their 
pesticide petition. 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

     Bacillus thuringiensis subspecies kurstaki. Cry1Ac (synpro) insect 
control protein is expressed in cotton plants to provide protection 
from key lepidopteran insect pests such as the tobacco budworm and pink 
bollworm. Cry1Ac (synpro) transgenic plants are derived from 
transformation events that contain the insecticidal gene via a plasmid 
insert. The Cry1Ac (synpro) protein poses no foreseeable risks to non-
target organisms including mammals, birds, fish, beneficial insects, 
and earthworms. Cry1Ac (synpro) protected cotton provides growers with 
a highly efficacious tool for controlling important insect pests in 
cotton in a manner that is fully compatible with integrated pest 
management practices.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. The Cry1Ac 
gene was isolated from bacillus thuringiensis subspecies kurstaki and 
modified before it was inserted into cotton plants to produce a full 
length protein. The Cry1Ac (synpro) insecticidal protein has been 
adequately characterized. Several safety studies were conducted using a 
microbially produced test substance preparation that contained 14% 
Cry1Ac protein. Studies conducted to establish the equivalence of the 
Cry1Ac (synpro) protein obtained from cotton, or from a microbial 
source demonstrate that the materials are similar with respect to 
molecular weight, immunoreactivity, lack of post-translational 
glycosylation and spectrum of bioactivity.
    2. A statement of why an analytical method for detecting and 
measuring the levels of the pesticide residue are not needed. No 
analytical method is included because this petition requests a 
temporary exemption from the requirement for a tolerance.

C. Mammalian Toxicological Profile

     Cry proteins have been deployed as safe and effective pest control 
agents in microbial bacillus thuringiensis formulations for almost 40 
years. There are currently 180 registered microbial bacillus 
thuringiensis products in the United States for use in agriculture, 
forestry, and vector control. The numerous toxicology studies conducted 
with these microbial products show no significant adverse effects, and 
demonstrate that the products are practically non-toxic to mammals. An 
exemption from the requirement of a tolerance has been in place for 
these products since at least 1971 (40 CFR 180.1011).
     Toxicology studies conducted to determine the toxicity of Cry1Ac 
(synpro) insecticidal crystal protein demonstrated that the protein has 
very low toxicity. In an acute oral toxicity study in the mouse (male 
and female), the estimated acute LD50 was determined to be 
>5,000 mg/kg of the microbially produced test substance containing 14% 
Cry1Ac (synpro) protein. In an in vitro study, Cry1Ac (synpro) protein 
was rapidly and extensively degraded in simulated gastric conditions in 
the presence of pepsin at pH 1.2. Cry1Ac (synpro) was completely 
proteolyzed to amino acids and small peptide fragments in <1 minute. 
This indicates that the protein is highly susceptible to digestion in 
the human digestive tract and that the potential for adverse health 
effects from chronic exposure is virtually nonexistent. Moreover, 
proteins in general are not known to be carcinogenic. A search of 
relevant data bases indicated that the amino acid sequence of the 
Cry1Ac (synpro) protein exhibits no significant homology to the 
sequences of known allergens or protein toxins. Thus, Cry1Ac (synpro) 
is highly unlikely to exhibit an allergic response.
     The results of a study to determine the lability of the Cry1Ac 
(synpro) protein to heat demonstrated that the protein was deactivated 
after exposure to 75 oC or 90 oC for 30 minutes, 
according to bioassay results on tobacco budworm. The genetic material 
necessary for the production of the Cry1Ac (synpro) insecticidal 
crystal protein are nucleic acids (DNA) which are common to all forms 
of plant and animal life. There are no known instances of where nucleic 
acids have caused toxic effects as a result of dietary exposure.
     Collectively, the available data on Cry1Ac (synpro) protein along 
with the safe use history of microbial bacillus thuringiensis products, 
establishes the safety of the plant pesticide bacillus thuringiensis 
subspecies kurstaki, Cry1Ac (synpro) insecticidal crystal protein and 
the genetic material necessary for its production in all raw 
agricultural commodities.

D. Aggregate Exposure

     Insecticidal crystal proteins of bacillus thuringiensis are known 
to have a high degree of insect specificity via binding to specific 
receptors in the insect gut, and do not harm people, wildlife or many 
beneficial insects (Ballester et al., 1999; Aronson and Shai, 2001). 
The level of protein that is expressed in corn plants is very low. The 
small amount of Cry1Ac (synpro) in plant tissue is deep in the plant 
matrix, which greatly reduces availability for dermal or respiratory 
exposure. Significant dietary exposure to Cry1Ac (synpro) protein is 
unlikely to occur. Dietary exposures at very low levels, via ingestion 
of processed commodities, although, they may occur, are unlikely to be 
problematic because of the low toxicity and the high degree of 
digestibility of the protein. In summary the potential for significant 
aggregate exposure to Cry1Ac (synpro) protein is highly unlikely.

E. Cumulative Exposure

     Common modes of toxicity are not relevant to consideration of the 
cumulative exposure to bacillus thuringiensis Cry1Ac (synpro) 
insecticidal crystal protein. The product has demonstrated low 
mammalian toxicity, and Bt insecticidal crystal proteins are known to 
bind to specific receptors in the insect gut, such that biological 
effects do not appear to be cumulative with any other known compounds.

F. Safety Determination

    1. U.S. population. The deployment of the product in minute 
quantities within the plant, the very low toxicity of the product, the 
lack of allergenic potential, and the high degree of digestibility of 
the protein, are all factors in support of Mycogen's assertion that no 
significant risk is posed by exposure of the U.S. population to 
bacillus thuringiensis

[[Page 62974]]

subspecies kustaki Cry1Ac (synpro) insect control protein.
    2. Infants and children. Non-dietary exposure to infants and 
children is not anticipated, due to the proposed use pattern of the 
product. Due to the very low toxicity of the product, the lack of 
allergenic potential, and the high degree of digestibility of the 
protein, dietary exposure is anticipated to be at very low levels and 
is not anticipated to pose any harm to infants and children.

G. Effects on the Immune and Endocrine Systems

     Given the rapid digestibility of Cry1Ac (synpro) insecticidal 
crystal protein, no chronic effects are expected. Cry1Ac (synpro) 
insecticidal crystal protein, or metabolites of the insecticidal 
crystal protein are not known to, or are expected to have any effect on 
the immune, or endocrine systems. Proteins in general are not 
carcinogenic; therefore, no carcinogenic risk is associated with the 
Cry1Ac (synpro) protein.

H. Existing Tolerances

     There are no existing tolerances or exemptions from tolerance for 
bacillus thuringiensis subspecies kurstaki Cry1Ac (synpro) granted to 
Mycogen Seeds c/o Dow AgroSciences LLC.
[FR Doc. 02-25585 Filed 10-8-02; 8:45 am]
BILLING CODE 6560-50-S