[Federal Register Volume 68, Number 55 (Friday, March 21, 2003)]
[Notices]
[Pages 13892-13893]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-6798]


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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.

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: 
[email protected].

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