[Federal Register Volume 69, Number 168 (Tuesday, August 31, 2004)]
[Notices]
[Pages 53060-53063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-19720]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0225; FRL-7369-7]


Bacillus Thuringiensis Cry34Ab1 and Cry35Ab1 Proteins and the 
Genetic Material Necessary for Their Production in Corn; Notice of 
Filing a Pesticide Petition to Establish a Tolerance for Certain 
Pesticide Chemicals 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-
2004-0225, must be received on or before September 30, 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: Mike Mendelsohn, Biopesticides and 
Pollution Prevention Division (7511C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington,

[[Page 53061]]

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 a 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     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-2004-0225. 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, 1801 S. Bell St., 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-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-2004-0225. 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.

[[Page 53062]]

    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID Number OPP-2004-0225. 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 theofficial 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-2004-0225.
    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, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
Number OPP-2004-0225. 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 pesticide 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 
pesticide petition. Additional data may be needed before EPA rules on 
the pesticide petition.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: August 23, 2004.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

Summary of Petition

    The petitioner's summary of the pesticide petition (PP) 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.

Mycogen Seeds c/o Dow AgroSciences LLC

PP 3F6785

    EPA has received a pesticide petition (3F6785) from Mycogen Seeds 
c/o Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268, 
proposing pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), 
to amend 40 CFR part 174 to establish an exemption from the requirement 
of a tolerance for the plant-incorporated protectant Bacillus 
thuringiensis Cry34Ab1 and Cry35Ab1 proteins and the genetic material 
necessary for their production in corn. 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. This 
summary was prepared by Mycogen Seeds c/o Dow AgroSciences 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

    B.t. Cry34/35Ab1 inductively coupled plasma (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,

[[Page 53063]]

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.

B. Product Identity/Chemistry

    Identity of the pesticide and corresponding residues. 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; master 
record identification number ((MRID) 45383401). Quantitative 
analytical methods enzyme linked immunosorbent assay (ELISA) for the 
detection of Cry34Ab1 and detection of Cry35Ab1 have been submitted 
(MRID 45833201).

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 Cry34/
35Ab1 ICP demonstrated that the proteins have very low toxicity. The 
acute oral lethal dose (LD)50 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 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 [deg]C, 75 C[deg], and 90 [deg]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 deoxyribonucleic 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

    Dietary 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 are 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 Systems

    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

    A temporary exemption from the requirement of a tolerance is in 
effect through April 30, 2006.

I. International Tolerances

    No Codex maximum residue levels exists for the plant-incorporated 
protectant modified Cry3A Bacillus thuringiensis protein and the 
genetic material necessary for its production in corn.
[FR Doc. 04-19720 Filed 8-30-04; 8:45 am]
BILLING CODE 6560-50-S