[Federal Register: March 9, 2004 (Volume 69, Number 46)]
[Notices]
[Page 10972-10973]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09mr04-24]
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Notices
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.
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[[Page 10972]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 04-010-1]
Mycogen c/o Dow; Availability of Petitions and Environmental
Assessment for Determinations of Nonregulated Status for Cotton
Genetically Engineered for Insect Resistance
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has received two petitions from Mycogen Seeds c/o
Dow AgroSciences LLC seeking determinations of nonregulated status for
cotton lines designated as Cry1F cotton event 281-24-236 and Cry1Ac
cotton event 3006-210-23, which have been genetically engineered for
insect resistance. The petitions have been submitted in accordance with
our regulations concerning the introduction of certain genetically
engineered organisms and products. In accordance with those
regulations, we are soliciting public comments on whether these cotton
lines present a plant pest risk. We are also making available for
public comment an environmental assessment for the proposed
determinations of nonregulated status.
DATES: We will consider all comments we receive on or before May 10,
2004.
ADDRESSES: You may submit comments by any of the following methods:
Postal Mail/Commercial Delivery: Please send
four copies of your comment (an original and three copies) to Docket
No. 04-010-1, Regulatory Analysis and Development, PPD, APHIS, Station
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state
that your comment refers to Docket No. 04-010-1.
E-mail: Address your comment to
regulations@aphis.usda.gov. Your comment must be contained in the body
of your message; do not send attached files. Please include your name
and address in your message and ``Docket No. 04-010-1'' on the subject
line.
Agency Web Site: Go to http://www.aphis.usda.gov/ppd/rad/cominst.html
for a form you can use to
submit an e-mail comment through the APHIS Web site.
Federal eRulemaking Portal: Go to http://www.regulations.gov
and follow the instructions for locating this
docket and submitting comments.
Reading Room: You may read the petitions, the environmental
assessment, and any comments that we receive on this docket in our
reading room. The reading room is located in room 1141 of the USDA
South Building, 14th Street and Independence Avenue SW., Washington,
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 690-2817 before coming.
Other Information: You may view APHIS documents published in the
Federal Register and related information, including the names of groups
and individuals who have commented on APHIS dockets, on the Internet at
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Dr. Susan Koehler, Biotechnology
Regulatory Services, APHIS, Suite 5B05, 4700 River Road Unit 147,
Riverdale, MD 20737-1236; (301) 734-4886. To obtain copies of the
petitions or the environmental assessment, contact Ms. Kay Peterson at
(301) 734-4885; e-mail: Kay.Peterson@aphis.usda.gov. The petitions are
also available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/03_03601p.pdf and http://www.aphis.usda.gov/brs/aphisdocs/
s.usda.gov/brs/aphisdocs/
SUPPLEMENTARY INFORMATION: The regulations in 7 CFR part 340,
``Introduction of Organisms and Products Altered or Produced Through
Genetic Engineering Which Are Plant Pests or Which There Is Reason To
Believe Are Plant Pests,'' regulate, among other things, the
introduction (importation, interstate movement, or release into the
environment) of organisms and products altered or produced through
genetic engineering that are plant pests or that there is reason to
believe are plant pests. Such genetically engineered organisms and
products are considered ``regulated articles.''
The regulations in Sec. 340.6(a) provide that any person may
submit a petition to the Animal and Plant Health Inspection Service
(APHIS) seeking a determination that an article should not be regulated
under 7 CFR part 340. Paragraphs (b) and (c) of Sec. 340.6 describe
the form that a petition for a determination of nonregulated status
must take and the information that must be included in the petition.
On February 5, 2003, APHIS received two petitions from Mycogen
Seeds c/o Dow AgroSciences LLC (Mycogen/Dow) of Indianapolis, IN,
requesting determinations of nonregulated status under 7 CFR part 340
for cotton (Gossypium hirsutum L.) designated as Cry1F cotton event
281-24-236 (cotton event Cry1F) (APHIS Petition No. 03-036-01p) and
Cry1Ac cotton event 3006-210-23 (cotton event Cry1Ac) (APHIS Petition
No. 03-036-02p), which have been genetically engineered for resistance
to certain lepidopteran insect pests. The Mycogen/Dow petitions state
that the subject cotton events should not be regulated by APHIS because
they do not present a plant pest risk.
As described in the petitions, cotton events Cry1F and Cry1Ac have
been genetically engineered to express synthetic insecticidal proteins
derived from the common soil bacterium Bacillus thuringiensis (Bt). The
petitioner states that the Cry1F and Cry1Ac proteins are effective in
providing protection from the feeding of lepidopteran insect pests such
as tobacco budworm, beet armyworm, soybean looper, and cotton bollworm.
The subject cotton events also express the pat gene derived from
Streptomyces viridochromogenes, a non-pathogenic bacterium. The pat
gene encodes the enzyme phosphinothricin acetyltransferase (PAT), which
confers tolerance to glufosinate herbicides and is present in cotton
events Cry1F and Cry1Ac as a selectable marker. The subject cotton
events were developed through use of the Agrobacterium-mediated
transformation method.
[[Page 10973]]
Cotton events Cry1F and Cry1Ac were developed primarily so that they
could be crossed to produce a cotton line which contains both the
insecticidal proteins and thereby to maintain a range of effective
control options for lepidopteran insect pests and to reduce the
potential for the development of resistance to Bt insecticides.
Cotton events Cry1F and Cry1Ac have been considered regulated
articles under the regulations in 7 CFR part 340 because they contain
gene sequences from the plant pathogen Agrobacterium tumefaciens. These
cotton events have been field tested since 1999 in the United States
under APHIS notifications. In the process of reviewing the
notifications for field trials of the subject cotton, APHIS determined
that the vectors and other elements were disarmed and that the trials,
which were conducted under conditions of reproductive and physical
confinement or isolation, would not present a risk of plant pest
introduction or dissemination.
In Sec. 403 of the Plant Protection Act (7 U.S.C. 7701-7772),
plant pest is defined as any living stage of any of the following that
can directly or indirectly injure, cause damage to, or cause disease in
any plant or plant product: A protozoan, a nonhuman animal, a parasitic
plant, a bacterium, a fungus, a virus or viroid, an infectious agent or
other pathogen, or any article similar to or allied with any of the
foregoing. APHIS views this definition very broadly. The definition
covers direct or indirect injury, disease, or damage not just to
agricultural crops, but also to plants in general, for example, native
species, as well as to organisms that may be beneficial to plants, for
example, honeybees, rhizobia, etc.
The U.S. Environmental Protection Agency (EPA) is responsible for
the regulation of pesticides under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136 et seq.). FIFRA
requires that all pesticides, including herbicides, be registered prior
to distribution or sale, unless exempt by EPA regulation. In cases in
which genetically modified plants allow for a new use of a pesticide or
involve a different use pattern for the pesticide, EPA must approve the
new or different use. Accordingly, Mycogen/Dow has submitted a request
to EPA for registration of the stacked Cry1F and Cry1Ac protein
construct as a plant-incorporated protectant in cotton.
When the use of the pesticide on the genetically modified plant
would result in an increase in the residues in a food or feed crop for
which the pesticide is currently registered, or in new residues in a
crop for which the pesticide is not currently registered, establishment
of a new tolerance or a revision of the existing tolerance would be
required. Residue tolerances for pesticides are established by EPA
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended (21
U.S.C. 301 et seq.), and the Food and Drug Administration (FDA)
enforces tolerances set by EPA under the FFDCA. Mycogen/Dow has
submitted a request to EPA for a tolerance exemption for both the Cry1F
and Cry1Ac proteins as expressed in the subject cotton events.
FDA published a statement of policy on foods derived from new plant
varieties in the Federal Register on May 29, 1992 (57 FR 22984-23005).
The FDA statement of policy includes a discussion of FDA's authority
for ensuring food safety under the FFDCA, and provides guidance to
industry on the scientific considerations associated with the
development of foods derived from new plant varieties, including those
plants developed through the techniques of genetic engineering.
Mycogen/Dow has begun consultation with FDA on the subject cotton
events.
To provide the public with documentation of APHIS's review and
analysis of the environmental impacts and plant pest risk associated
with proposed determinations of nonregulated status for Mycogen/Dow's
cotton events Cry1F and Cry1Ac, an environmental assessment has been
prepared. The EA was prepared in accordance with (1) The National
Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et
seq.), (2) regulations of the Council on Environmental Quality for
implementing the procedural provisions of NEPA (40 CFR parts 1500-
1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4)
APHIS's NEPA Implementing Procedures (7 CFR part 372).
In accordance with Sec. 340.6(d) of the regulations, we are
publishing this notice to inform the public that APHIS will accept
written comments regarding the petitions for determinations of
nonregulated status from interested persons for a period of 60 days
from the date of this notice. We are also soliciting written comments
from interested persons on the environmental assessment prepared to
examine any environmental impacts of the proposed determinations for
the subject cotton events. The petitions and the environmental
assessment and any comments received are available for public review,
and copies of the petitions and the environmental assessment are
available as indicated in the FOR FURTHER INFORMATION CONTACT section
of this notice.
After the comment period closes, APHIS will review the data
submitted by the petitioner, all written comments received during the
comment period, and any other relevant information. After reviewing and
evaluating the comments on the petitions and the environmental
assessment and other data and information, APHIS will furnish a
response to the petitioner, either approving the petitions in whole or
in part, or denying the petitions. APHIS will then publish a notice in
the Federal Register announcing the regulatory status of the Mycogen/
Dow insect-resistant cotton events Cry1F and Cry1Ac and the
availability of APHIS's written decision.
Authority: 7 U.S.C. 1622n and 7701-7772; 31 U.S.C. 9701; 7 CFR
2.22, 2.80, and 371.3.
Done in Washington, DC, this 4th day of March, 2004.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 04-5252 Filed 3-8-04; 8:45 am]
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