[Federal Register Volume 67, Number 241 (Monday, December 16, 2002)]
[Notices]
[Pages 77034-77035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-31567]


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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 [email protected]. 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: [email protected].

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]
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