[Federal Register: December 16, 2002 (Volume 67, Number 241)]
[Notices]
[Page 77034-77035]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16de02-25]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 02-092-1]
Aventis CropScience; Availability of Petition and Environmental
Assessment for Determination of Nonregulated Status for Cotton
Genetically Engineered for Glufosinate Herbicide Tolerance
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 a petition from Aventis CropScience
seeking a determination of nonregulated status for cotton designated as
Transformation Event LLCotton25, which has been genetically engineered
for tolerance to the herbicide glufosinate. The petition has 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 this cotton presents a plant pest risk. We are also making
available for public comment an environmental assessment for the
proposed determination of nonregulated status.
DATES: We will consider all comments that we receive on or before
February 14, 2003.
ADDRESSES: You may submit comments by postal mail/commercial delivery
or by e-mail. If you use postal mail/commercial delivery, please send
four copies of your comments (an original and three copies) to Docket
No. 02-092-l, Regulatory Analysis and Development, PPD, APHIS, Suite
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state
that your comments refer to Docket No. 02-092-1. If you use 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.
02-092-1'' on the subject line.
You may read the petition, the environmental assessment, and any
comments we receive on this notice of availability in our reading room.
The reading room is located in room 1141, 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 that someone is available to help you, please call (202)
690-2817 before coming.
APHIS documents published in the Federal Register, and related
information, including the names of organizations and individuals who
have commented on APHIS dockets, are available on the Internet at
http://www.aphis.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 a copy of the
petition or the environmental assessment, contact Ms. Kay Peterson at
(301) 734-4885; e-mail: Kay.Peterson@aphis.usda.gov.
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 12, 2002, APHIS received a petition (APHIS Petition No.
02-042-01p) from Aventis CropScience (Aventis) of Research Triangle
Park, NC, requesting a determination of nonregulated status under 7 CFR
part 340 for cotton (Gossypium hirsutum L.) designated as
Transformation Event LLCotton25 (LLCotton25), which has been
genetically engineered for tolerance to the herbicide glufosinate. The
Aventis petition states that the subject cotton should not be regulated
by APHIS because it does not present a plant pest risk.
As described in the petition, LLCotton25 has been genetically
engineered to contain a stably integrated bar gene isolated from
Streptomyces
[[Page 77035]]
hygroscopicus, strain ATCC21705. The bar gene encodes phosphinothricin-
N-acetyltransferase (PAT), and the PAT enzyme catalyzes the conversion
of L-phosphinothricin, the active ingredient in glufosinate, to an
inactive form, thus conferring resistance to the herbicide. Expression
of the added genes is controlled in part by gene sequences from the
plant pathogens cauliflower mosaic virus and Agrobacterium tumefaciens.
Agrobacterium-mediated gene transfer was used to transfer the added
genes into the recipient Coker 312 cotton variety.
LLCotton25 has been considered a regulated article under the
regulations in 7 CFR part 340 because it contains gene sequences from
plant pathogens. This cotton has 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 containment 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, Aventis has submitted a pesticide
petition to EPA to expand the registration of glufosinate to include
use on LLCotton25.
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.
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. The
petitioner has begun consultation with FDA on the subject cotton.
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 petition for determination 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 (EA) prepared
to provide the public with documentation of APHIS' review and analysis
of any potential environmental impacts and plant pest risk associated
with a proposed determination of nonregulated status for Aventis'
LLCotton25.
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' NEPA Implementing Procedures (7 CFR part 372). The petition and
the environmental assessment and any comments received are available
for public review, and copies of the petition and the environmental
assessment may be ordered (see 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 petition and the environmental
assessment and other data and information, APHIS will furnish a
response to the petitioner, either approving the petition in whole or
in part, or denying the petition. APHIS will then publish a notice in
the Federal Register announcing the regulatory status of Aventis'
herbicide-tolerant LLCotton25 and the availability of APHIS' written
decision.
Authority: 7 U.S.C. 166, 1622n, 7756, and 7761-7772; 31 U.S.C.
9701;7 CFR 2.22, 2.80, and 371.3.
Done in Washington, DC, this 10th day of December 2002.
Peter Fernandez,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 02-31567 Filed 12-13-02; 8:45 am]
BILLING CODE 3410-34-P
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