[Federal Register: March 21, 2003 (Volume 68, Number 55)]
[Notices]
[Page 13892-13893]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21mr03-31]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 02-092-2]
Aventis CropScience; Availability of 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 of our determination that the
Aventis CropScience cotton designated as Transformation Event
LLCotton25, which has been genetically engineered for tolerance to the
herbicide glufosinate, is no longer considered a regulated article
under our regulations governing the introduction of certain genetically
engineered organisms. Our determination is based on our evaluation of
data submitted by Aventis CropScience in its petition for a
determination of nonregulated status, our analysis of other scientific
data, and comments received from the public in response to a previous
notice. This
[[Page 13893]]
notice also announces the availability of our written determination and
our finding of no significant impact.
EFFECTIVE DATE: March 10, 2003.
ADDRESSES: You may read a copy of the determination, an environmental
assessment and finding of no significant impact, the petition for a
determination of nonregulated status submitted by Aventis CropScience,
and all comments received on the petition and the environmental
assessment 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.
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
determination or environmental assessment and finding of no significant
impact, contact Ms. Kay Peterson at (301) 734-4885; e-mail:
Kay.Peterson@aphis.usda.gov.
SUPPLEMENTARY INFORMATION:
Background
On February 12, 2002, the Animal and Plant Health Inspection
Service (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.
On December 16, 2002, APHIS published a notice in the Federal
Register (67 FR 77034-77035, Docket No. 02-092-1) announcing that the
Aventis petition and an environmental assessment (EA) were available
for public review. This notice also discussed the role of APHIS, the
Environmental Protection Agency, and the Food and Drug Administration
in regulating the subject cotton and food products developed from it.
APHIS received two comments on the petition and the EA during the 60-
day comment period which ended February 14, 2002. The comments were
received from a cotton industry organization and a cotton farmer, and
both supported nonregulated status for LLCotton25.
LLCotton25 has been genetically engineered to contain a bar gene
isolated from Streptomyces 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 tolerance 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 confinement or isolation, would not present a risk of plant
pest introduction or dissemination.
Determination
Based on its analysis of the data submitted by Aventis, a review of
other scientific data, field tests of the subject cotton, and comments
submitted by the public, APHIS has determined that LLCotton25: (1)
Exhibits no plant pathogenic properties; (2) is no more likely to
become weedy than the non-transgenic parental line or other cultivated
cotton; (3) is unlikely to increase the weediness potential for any
other cultivated or wild species with which it can interbreed; (4) will
not cause damage to raw or processed agricultural commodities; (5) will
not harm threatened or endangered species or organisms that are
beneficial to agriculture; and (6) should not reduce the ability to
control pests and weeds in cotton or other crops. Therefore, APHIS has
concluded that the subject cotton and any progeny derived from hybrid
crosses with other nontransformed cotton varieties will be as safe to
grow as cotton in traditional breeding programs that is not subject to
regulation under 7 CFR part 340.
The effect of this determination is that Aventis' LLCotton25 is no
longer considered a regulated article under APHIS'' regulations in 7
CFR part 340. Therefore, the requirements pertaining to regulated
articles under those regulations no longer apply to the subject cotton
or its progeny. However, importation of LLCotton25 and seeds capable of
propagation are still subject to the restrictions found in APHIS''
foreign quarantine notices in 7 CFR part 319 and imported seed
regulations in 7 CFR part 361.
National Environmental Policy Act
An EA was prepared to examine the potential environmental impacts
associated with a 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). Based on that EA,
APHIS has reached a finding of no significant impact (FONSI) with
regard to its determination that LLCotton25 and lines developed from it
are no longer regulated articles under its regulations in 7 CFR part
340. Copies of the EA and FONSI are available from the individual
listed under FOR FURTHER INFORMATION CONTACT.
Done in Washington, DC, this 18th day of March, 2003.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 03-6798 Filed 3-20-03; 8:45 am]
BILLING CODE 3410-34-P