[Federal Register Volume 69, Number 154 (Wednesday, August 11, 2004)]
[Notices]
[Pages 48870-48873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17894]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0251; FRL-7673-2]


Bacillus thuringiensis var. aizawai strain PS811 Cry1F 
insecticidal protein; 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-
2004-0251, must be received on or before September 10, 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: 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 
interested in agricultural biotechnology or may be required to conduct 
testing of chemical substances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA), or the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA). 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-2004-0251. 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 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

[[Page 48871]]

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-2004-0251. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID number OPP-2004-0251. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID number OPP-2004-0251.
    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-2004-0251. 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 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.


[[Page 48872]]


    Dated: July 30, 2004.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by FFDCA section 408(d)(3). The summary of the petition was 
prepared by the petitioner and represents the view of the petitioner. 
The petition summary announces the availability of a description of the 
analytical methods available to EPA for the detection and measurement 
of the pesticide chemical residues or an explanation of why no such 
method is needed.

 Mycogen Seeds c/o Dow AgroScience LLC

 PP 3F6785

    EPA has received a pesticide petition 3F6785 from Mycogen Seeds c/o 
Dow 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 174 to establish an exemption from the 
requirement of a temporary tolerance for the plant-incorporated 
protectant Bacillus thuringiensis subspecies aizawai Cry1F (synpro) 
insect control protein and the genetic material responsible for the 
production of this protein in or on cotton.
    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

    This notice of filing summarizes information submitted and cited by 
Mycogen Seeds c/o Dow AgroSciences LLC in support of a request for a 
temporary exemption from tolerance residues of the plant incorporated-
protectant Bacillus thuringiensis subspecies aizawai Cry1F (synpro) 
insect control protein and the genetic material responsible for the 
production of this protein in cotton.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. Bacillus 
thuringiensis subspecies aizawai Cry1F (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. Cry1F (synpro) transgenic plants are derived from 
transformation events that contain the insecticidal gene via a plasmid 
insert. The Cry1F (synpro) protein poses no foreseeable risks to non- 
target organisms including mammals, birds, fish, beneficial insects, 
and earthworms. Cry1F (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.
    2. Analytical method. Data submitted demonstrate the high 
quantitative performance of the enzyme linked immunosorbent assay for 
the detection of the Cry1F truncated protein. The assay had a 
reproducible sensitivity of 0.4 nanogram/milliliter (ng/mL) with an 
assay range of 0.4 to 6 ng/mL Cry1F (truncated) protein. The absorbance 
variability of this assay is less than 10% and the resulting percent 
error and accuracy are within  10%. The assay demonstrated 
no cross-reactivity to Cry1Ab, Cry1Ac, Cry2Ab, Cry9C, Cry34Ab1 (or 
PS149B1 14kD), Cry35Ab1 (or PS149B1 44kD), PAT and BAR, agriculturally 
relevant Bacillus thuringiensis proteins. The Cry1F assay kit was 
projected to be stable for approximately 1 year at 4 [deg]C based on 
extrapolations from the accelerated stability testing.

C. Mammalian Toxicological Profile

    Cry proteins have been deployed as safe and effective pest control 
agents in microbial 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 174).
    Toxicology studies conducted to determine the toxicity of Cry1F 
(synpro) insect control protein demonstrated that the protein has very 
low toxicity. In an acute oral toxicity study in the mouse (male and 
female), the estimated acute lethal dose (LD)50 was 
determined to be >2,000 milligrams/kilogram of the microbially produced 
test substance. In an in vitro study, Cry1F protein was rapidly and 
extensively degraded in simulated gastric conditions in the presence of 
pepsin at pH 1.2. Cry1F (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 Cry1F (synpro) protein exhibits no 
significant homology to the sequences of known allergens or protein 
toxins. Thus, Cry1F (synpro) is highly unlikely to exhibit an allergic 
response.
    The results of a study to determine the lability of the Cry1F 
(synpro) protein to heat demonstrated that the protein was deactivated 
after exposure to 75 [deg]C or 90 [deg]C for 30 minutes, according to 
bioassay results on tobacco budworm.
    The genetic material necessary for the production of the Cry1F 
(synpro) insect control 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 Cry1F (synpro) protein along 
with the safe use history of microbial Bacillus thuringiensis products 
establishes the safety of the plant pesticide Bacillus thuringiensis 
subspecies aizawai Cry1F (synpro) insect control 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 Cry1F (synpro) in plant tissue is deep in the plant 
matrix, which greatly reduces availability for dermal or respiratory 
exposure. Significant dietary exposure to Cry1F (synpro) protein is 
unlikely to occur. Dietary exposures at very low levels, via ingestion 
of processed commodities, although they may occur, are unlikely to

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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 Cry1F 
(synpro) protein is rapidly degraded in soil. In summary, the potential 
for significant aggregate exposure to Cry1F (synpro) protein is highly 
unlikely.

E. Cumulative Exposure

    Common modes of toxicity are not relevant to consideration of the 
cumulative exposure to Bacillus thuringiensis Cry1F (synpro) insect 
control protein. The product has demonstrated low mammalian toxicity 
and Bacillus thuringiensis 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 subspecies aizawai Cry1F (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 Cry1F (synpro) insecticidal 
crystal protein, no chronic effects are expected. Cry1F (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 
Cry1F (synpro) protein.
[FR Doc. 04-17894 Filed 8-10-04; 8:45 am]
BILLING CODE 6560-50-S