[Federal Register Volume 68, Number 45 (Friday, March 7, 2003)]
[Notices]
[Pages 11100-11103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5620]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0350; FRL-7285-8]


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 ID number OPP-2002-0350, must be 
received on or before April 7, 2003.

ADDRESSES: Comments may be submitted electronically, by mail, or

[[Page 11101]]

through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Mike Mendelsohn, Biopesticides and 
Pollution Prevention Division (7511C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8715; 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 categories and 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-2002-0350. 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 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. 
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 on 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-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

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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-2002-0350. 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-2002-0350. 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-2002-0350.
    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-2002-0350. 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: February 28, 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 Mycogen/Dow AgroSciences 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.

Mycogen/Dow AgroSciences PP 0G6112

     This notice of filing summarizes information submitted and cited 
by Mycogen/Dow AgroSciences in support of a request for a temporary 
exemption from tolerance residues of the plant-incorporated protectant 
Bacillus thuringiensis (B.t. Cry34/35Ab1 Insecticidal Crystal Protein 
(ICP), and the genetic material necessary for its production in corn 
(formerly known as Bacillus thuringiensis (B.t.)) 149B1 protein and the 
genetic material necessary for its production in corn). The Mycogen/Dow 
AgroSciences and Pioneer Hi-Bred experimental use permits associated 
with the petition are 68467-EUP-3, 68467-EUP-5, 68467-EUP-T, 68467-EUP-
I, 29964-EUP-1, 29964-EUP-3, 29964-EUP-U, and 29964-EUP-L.

A. Petition Summary for B.t. Cry34/35Ab1 ICP Uses

     B.t. Cry34/35Ab1 ICP is expressed in corn plants to provide 
protection from key coleopteran insect pests such as the western corn 
rootworm. B.t. Cry34/35Ab1 transgenic plants are derived from 
transformation events that contain the insecticidal genes via a plasmid 
insert. The B.t. Cry34/35Ab1 ICP poses no foreseeable risks to non-
target organisms including mammals, birds, fish, beneficial insects, 
and earthworms. B.t. Cry34/35Ab1-protected field corn provides growers 
with a highly efficacious tool for controlling important insect pests 
in corn in a manner that is fully compatible with integrated pest 
management practices.

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B. Product Identity and Chemistry

     The Cry34Ab1 and Cry35Ab1 genes were isolated from Bacillus 
thuringiensis strain PS149B1 and modified before insertion into corn 
plants. The Cry34/35Ab1 ICP has been adequately characterized. Several 
safety studies were conducted using microbially produced test 
substances that contained 54% of the Cry34Ab1 (14 kDa) protein and 37% 
of the Cry35Ab1 (44 kDa) protein. Studies conducted to establish the 
equivalence of the Cry34/35Ab1 ICP obtained from corn or from a 
microbial source demonstrate that the materials are similar with 
respect to molecular weight, immunoreactivity, lack of post-
translational modification (glycosylation) N-terminal amino acid 
sequence, and spectrum of bioactivity.
     A qualitative analytical method (lateral flow immunoassay) for the 
detection of the Cry34Ab1 (14 kDa) protein has been submitted (MRID 
45383401).

C. Mammalian Toxicity 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 Cry34/
35Ab1 ICP demonstrated that the proteins have very low toxicity. The 
acute oral LD50 of Cry34Ab1 (14 kDa) is greater than 5,000 
milligrams/kilogram (mg/kg), and at 54% purity, the acute 
LD50 for pure protein is greater than 2,700 mg/kg. The acute 
oral LD50 of Cry35Ab1 (44 kDa) is greater than 5,000 mg/kg, 
and at 37% purity, the acute LD50 for pure protein is 
greater than 1,850 mg/kg in male mice when the proteins were tested 
individually. When tested as a mixture (1:3 molar ratio of 
Cry34Ab1:Cry35Ab1 proteins), the acute oral LD50 of PS149B1 
Cry34/35Ab1 proteins in male and female mice is greater than 5,000 mg/
kg, and greater than 2,000 mg/kg of an equimolar (1:3) mixture of pure 
proteins.
     In in vitro studies, Cry34/35Ab1 ICP exhibited a high rate of 
digestibility under simulated gastric conditions (referred to as SGF) 
in the presence of pepsin. The Cry34Ab1(14 kDa protein) was greater 
than 90% digested in SGF 6.2 minutes. The Cry35Ab1 (44 kDa protein) was 
greater than 97% digested in less than 5 minutes. Also, thermolability 
testing results showed that the ICP was deactivated following exposure 
to 60 []C, 75 
[]C, and 90 []C 
for 30 minutes. A search of relevant data bases indicated that the 
amino acid sequences of the Cry34/35Ab1 ICP exhibit no significant 
homology to the sequences of known protein allergens. Thus, Cry34/35Ab1 
ICP is highly unlikely to exhibit an allergic response.
     The genetic material necessary for the production of the Cry34/
35Ab1 ICP is nucleic acid (DNA) which is common to all forms of plant 
and animal life. There are no known instances where nucleic acids have 
caused toxic effects as a result of dietary exposure.
     Collectively, the available data on Cry34/35Ab1 ICP along with the 
safe use history of microbial Bacillus thuringiensis products 
establishes the safety of the plant-incorporated protectant B.t. Cry34/
35Ab1 ICP and the genetic material necessary for its production in all 
raw agricultural commodities.

D. Aggregate Exposure

     Because B.t. Cry34/35Ab1 ICP is expressed in minute quantities and 
is retained within the plant, there is virtually no potential for 
dermal or inhalation exposure to the protein. Significant dietary 
exposure to Cry34/35Ab1 ICP 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 addition, the 
protein is not likely to be present in drinking water because the 
protein is deployed in minute quantities within the plant, and studies 
demonstrate that Cry34/35Ab1 ICP is rapidly degraded in soil. In 
summary, the potential for significant aggregate exposure to Cry34/
35Ab1 is highly unlikely.

E. Cumulative Exposure

     Common modes of toxicity are not relevant to consideration of the 
cumulative exposure to B.t. Cry34/35Ab1 ICP. The product has 
demonstrated low toxicity, and these 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 proteins, are all factors in support of Mycogen/Dow AgroSciences' 
assertion that no significant risk is posed by exposure of the U.S. 
population to B.t. Cry34/35Ab1 ICP.
    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 
proteins, 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 System

     Given the high degree of digestibility of the Cry34/35Ab1 ICP, no 
chronic effects are expected. Cry34/35Ab1 ICP, or metabolites of the 
ICP 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 Cry34/35Ab1 ICP.

H. Existing Tolerances or Exemptions from Tolerance

     There are no existing tolerances or exemptions from tolerance for 
B.t. Cry34/35Ab1 ICP.
[FR Doc. 03-5620 Filed 3-7-03; 2:17 pm]
BILLING CODE 6560-50-S