[Federal Register: August 11, 2004 (Volume 69, Number 154)]
[Notices]
[Page 48870-48873]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11au04-77]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: cole.leonard@epa.gov.
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 opp-docket@epa.gov,
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
[[Page 48873]]
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