[Federal Register Volume 68, Number 228 (Wednesday, November 26, 2003)]
[Notices]
[Pages 66422-66425]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-29185]



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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0350; FRL-7332-8]


Bacillus Thuringiensis VIP3A Insect Control Protein as Expressed 
in Event COT102; Notice of Filing a Pesticide Petition to Establish an 
Exemption from the Requirement of 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 identification (ID) number OPP-
2003-0350, must be received on or before December 26, 2003.

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: Leonard Cole, Biopesticides and 
Pollution Prevention Division (7511C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; 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 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 manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (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 ID number OPP-2003-0350. 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. 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 EPA's 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 as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-

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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-2003-0350. 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-2003-0350. 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-2003-0350.
    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-2003-0350. 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. 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: November 12, 2003.
 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.

Syngenta Seeds, Incorporated

PP 3F6756

    EPA has received a pesticide petition (3F6756) from Syngenta Seeds, 
Incorporated, P.O. Box 12257, 3054 Cornwallis Road, Research Triangle 
Park, NC 27709-2257, 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 plant-pesticide Bacillus

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thuringiensis VIP3A Insect Control Protein as Expressed in Event COT102 
and the genetic material necessary for its production in or on cotton.
    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, 
Syngenta Seeds, Incorporated has submitted the following summary of 
information, data, and arguments in support of their pesticide 
petition. This summary was prepared by Syngenta Seeds, Incorporated 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

    Syngenta has developed a new cotton line that expresses an insect 
control protein designated VIP3A. It has been genetically incorporated 
into a cotton plant product identified as Bacillus thuringiensis (Bt) 
VIP3A Insect Control Protein as Expressed in Event COT102. VIP3A is one 
of a novel class of recently discovered insecticidal proteins that 
occur naturally in Bacillus thuringiensis. The VIPs (vegetative 
insecticidal proteins) are produced during vegetative bacterial growth.
    Other than its demonstrated insecticidal activity, VIP3A is not 
known to have any other biological or catalytic function. Although 
VIP3A protein shares no homology with known Cry proteins, extensive 
testing has established that VIP3A is similarly very specific in its 
activity, and has demonstrated toxicity only to the larvae of certain 
lepidopteran species, including key pests of cotton. Further, because 
VIP3A appears to target a different receptor than Cry proteins in 
sensitive species, it represents a potentially useful tool in the 
prevention or management of pest resistance to Cry proteins.
    Upon commercial introduction, the use of transgenic VIP3A cotton 
plants is expected to offer an important new option in lepidopteran 
pest control and integrated pest management programs. Moreover, VIP3A 
cotton will be an attractive, biologically based alternative to the use 
of foliar insecticides. The use of VIP3A cotton plants is expected to 
offer substantial environmental and worker safety benefits associated 
with the reduced need for broad-spectrum insecticides. Additionally, 
benefits to cotton growers will likely include greater profitability, 
convenience and predictability in producing a high-yielding cotton 
crop.
    VIP3A expressing cotton plants derived from transformation event 
COT102 have been field tested under U.S. Department of Agriculture 
(USDA) Notifications and in compliance with the guidelines for USDA 
regulated plantings in 2000, 2001, and 2002. The overall results of 
those trials have indicated that cotton plants derived from event 
COT102 have significant and specific insecticidal activity against 
several lepidopteran pests including, but not limited to, Helicoverpa 
zea (cotton bollworm), Heliothis virescens (tobacco budworm), and 
Pectinophora gossypiella (pink bollworm).

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. Cotton, 
Gossypium hirsutum, has been genetically modified to be resistant to 
selected lepidopteran insect pests. Insect protection was accomplished 
by the insertion of the VIP3A(a) gene, which was cloned from Bacillus 
thuringiensis strain AB88. The identity of the active pesticidal 
ingredient in cotton plants derived from transformation event COT102 
includes the protein VIP3A and the genetic material necessary for its 
production in cotton. Research has demonstrated the specific 
insecticidal properties of VIP3A to certain lepidopteran insects in 
cotton as well as its lack of effects on nontarget organisms such as 
mammals, birds, fish, and beneficial insects.
    2. Magnitude of residue at the time of harvest and method used to 
determine the residue. A determination of the magnitude of residue at 
harvest is not required for residues exempt from tolerances. However, 
the petitioner has provided data on the quantity of VIP3A protein 
measured in various plant parts including seeds of VIP3A cotton, as 
measured by enzyme linked immunosorbent assay (ELISA). Additionally, 
the petitioner has provided data on the quantity or presence of VIP3A 
protein in processed cottonseed products.
    3. A statement of why an analytical method for detecting and 
measuring the levels of the pesticide residue are not needed. An 
analytical method is not required because this petition requests an 
exemption from tolerances. However, the petitioner has submitted an 
analytical method for detection of the VIP3A protein in cottonseed by 
ELISA analysis.

C. Mammalian Toxicological Profile

    The VIP3A(a) gene expressed in Event COT102 cotton is very similar 
(ca. 99% homology) to VIP3A or VIP3A--like genes that appear to occur 
commonly in Bt strains from a variety of sources. In addition, it has 
been determined that the VIP3A protein demonstrates insect specific 
toxicity and must be ingested to be active. Once in the insect gut, the 
VIP3A protein binds to specific receptors (different from those bound 
by Cry1A proteins), inserts into the membrane and forms ion-specific 
pores. These events disrupt the digestive processes and cause death of 
the insect. The lack of mammalian toxicity has been confirmed in 
numerous safety studies conducted in laboratory animals, which are 
traditional experimental surrogates for humans. These studies, 
summarized herein, demonstrate the lack of toxicity of the VIP3A 
protein following high-dose acute oral exposures to mice, rapid 
degradation of VIP3A upon exposure to simulated gastric fluid, and the 
lack of amino acid sequence similarity of the VIP3A protein to proteins 
known to be mammalian toxins or human allergens. It can be concluded 
from these studies that the VIP3A protein will be non-toxic to humans.
    When proteins are toxic, they are known to act via acute mechanisms 
and at very low doses (Sjoblad, R.D., J.T. McClintock and R. Engler 
(1992) ``Toxicological Considerations for Protein Components of 
Biological Pesticide Products.'' Regulatory Toxicol. Pharmacol. 15: 3-
9). Therefore, when a protein demonstrates no acute oral toxicity in 
high-dose testing using a standard laboratory mammalian test species, 
this supports the determination that the protein will be non-toxic to 
humans and other mammals, and will not present a hazard under any 
realistic exposure scenario, including long-term exposures.
    Studies conducted to assess the mammalian safety of VIP3A protein 
have demonstrated no toxicity. Four acute oral toxicity studies in mice 
have been completed. Three of the VIP3A test substances used were 
produced via microbial expression systems and one prepared by 
extracting protein from leaves of VIP3A event Pacha-derived corn 
plants. The four test substances contained VIP3A protein that differed 
from the VIP3A protein expressed in event COT102 by zero to two amino 
acids. At maximum dosage the microbially expressed test substance was 
administered at a level of 5,000 milligrams/kilogram (mg/kg) with an 
estimated acute lethal dose (LD)50 by gavage determined to 
be >3,675 mg VIP3A/kg (mg/kg body weight). Because toxicity was not 
observed at this dose, it can be concluded that the LD50 for

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pure VIP3A protein is >3,675 mg/kg body weight. The VIP3A protein in 
both the microbial and plant derived test substance was determined to 
be substantially equivalent to VIP3A produced in event COT102 derived 
cotton plants, as measured by biological activity, protein size, 
immunreactivity, mass spectral analysis of amino acid sequence, and 
apparent lack of post-translational modifications.
    The amino acid sequence of VIP3A is not homologous to that of any 
known or putative allergens described in public databases. The VIP3A 
protein is not derived from a known source of allergens and does not 
display characteristics commonly associated with allergens, including 
glycosylation or stability to heat and food processing. Additionally, 
VIP3A is susceptible to gastric digestion by pepsin and did not provoke 
an allergic response in an experimental atopic dog model of human food 
allergy.
    VIP3A protein appears to be present in multiple commercial 
formulations of Bt microbial insecticides at concentrations estimated 
to be ca. 0.4, 32 ppm. This conclusion is based on the presence of 
proteins of the appropriate molecular weight and immunoreactivity (by 
SDS-PAGE and western blot), and quantitation by ELISA. Therefore, it is 
conceivable that small quantities of VIP3A protein are present in the 
food supply because VIP3A (or a very similar protein, based on size and 
immunoreactivity) appears to be present in currently registered 
insecticide products used on food crops, including fresh market 
produce. These commercial Bt products are all exempt from food and feed 
tolerances.

D. Aggregate Exposure

    1. Dietary exposure--i. Food. Food products derived from cotton 
(refined cottonseed oil and cellulose ``linters'' fiber) are highly 
processed and are essentially devoid of any proteins. Moreover, no 
VIP3A protein was detected in refined cottonseed oil or cotton fiber 
produced from event COT102-derived VIP3A cotton plants. Therefore, no 
human dietary exposure to VIP3A protein is expected to occur via VIP3A 
cotton. Even if dietary exposure to VIP3A protein were to occur, data 
derived from bioinformatic analyses as well as direct in vitro and in 
vivo testing collectively indicate that the VIP3A protein is unlikely 
to have allergenic potential. The amino acid sequence of VIP3A is not 
homologous to that of any known or putative allergens described in 
public databases. The VIP3A protein is not derived from a known source 
of allergens and does not display characteristics commonly associated 
with allergens, including glycosylation or stability to heat and food 
processing. Additionally, VIP3A is susceptible to gastric digestion by 
pepsin and did not provoke an allergic response in an experimental 
atopic dog model of human food allergy.
    ii. Drinking water. No exposure to VIP3A and the genetic material 
necessary for its production in cotton via drinking water is expected. 
The proteins are incorporated into the plant and will not be available. 
However, if exposure were to occur by this route, no risk would be 
expected because the VIP3A protein is not toxic to mammals
    2. Non-dietary exposure. Non-dietary exposure is not anticipated, 
due to the proposed use pattern of the product. Exposure via dermal or 
inhalation routes is unlikely because the plant-incorporated protectant 
is contained within plant cells. However, if exposure were to occur by 
non-dietary routes, no risk would be expected because the VIP3A protein 
is not toxic to mammals.

E. Cumulative Exposure

    Because there is no indication of mammalian toxicity to the VIP3A 
protein, it is reasonable to conclude that there are no cumulative 
effects for this plant-incorporated protectant.

F. Safety Determination

    1. U.S. population. The lack of mammalian toxicity at high levels 
of exposure to the VIP3A protein demonstrates the safety of the product 
at levels well above possible maximum exposure levels anticipated via 
consumption of processed food products produced from VIP3A cotton. 
Moreover, little to no human dietary exposure to VIP3A protein is 
expected to occur via VIP3A cotton. Due to the lack of toxicity of the 
VIP3A protein and its very low potential for allergenicity, dietary 
exposure is not anticipated to pose any harm for the U.S. population. 
No special safety provisions are applicable for consumption patterns or 
for any population sub-groups.
    2. Infants and children. The plant-incorporated protectant active 
ingredient, Bacillus thuringiensis VIP3A insect control protein and the 
genetic material necessary for its production in cotton, demonstrates 
no mammalian toxicity. Thus, there are no threshold effects of concern 
and, consequently, there is no need to apply an additional margin of 
safety.

G. Effects on the Immune and Endocrine Systems

    The safety data submitted show no adverse effects in mammals, even 
at very high dose levels, and support the prediction that the VIP3A 
protein would be non-toxic to humans. Therefore no effects on the 
immune or endocrine systems are predicted. When proteins are toxic, 
they are known to act via acute mechanisms and at very low dose levels. 
Sjoblad, Roy D., et al. ``Toxicological Considerations for Protein 
Components of Biological Pesticide Products,'' Regulatory Toxicology 
and Pharmacology 15, 3-9 (1992). Further, the VIP3A protein is derived 
from a source that is not known to exert an influence on the endocrine 
system.

H. Existing Tolerances

    There are no existing tolerances for the Bt VIP3A protein and the 
genetic material necessary for its production. Other Bt-based pesticide 
products are exempt from tolerances.

I. International Tolerances

    There are no existing international tolerances or exemptions from 
tolerance for the Bt VIP3A protein and the genetic material necessary 
for its production.
[FR Doc. 03-29185 Filed 11-25-03; 8:45 am]
BILLING CODE 6560-50-S