[Federal Register Volume 67, Number 226 (Friday, November 22, 2002)]
[Notices]
[Pages 70393-70395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-29755]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 01-101-2]


Aventis CropScience; Extension of Determination of Nonregulated 
Status for Canola Genetically Engineered for Glufosinate Herbicide 
Tolerance

AGENCY: Animal and Plant Health Inspection Service, USDA.

[[Page 70394]]


ACTION: Notice.

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SUMMARY: We are advising the public of our decision to extend to one 
additional canola event our determination that a canola event developed 
by Aventis CropScience, 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 decision is based on our 
evaluation of data submitted by Aventis CropScience in its request for 
an extension of a determination of nonregulated status, an analysis of 
other scientific data, and a comment received from the public in 
response to a previous notice. This notice also announces the 
availability of our finding of no significant impact.

EFFECTIVE DATE: December 23, 2002.

ADDRESSES: You may read the extension request, the environmental 
assessment and finding of no significant impact, and the comment 
received 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.
    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.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: Dr. James White, Biotechnology 
Regulatory Services, APHIS, Suite 5B05, 4700 River Road Unit 147, 
Riverdale, MD 20737-1236; (301) 734-5490. To obtain a copy of the 
extension request or the environmental assessment and finding of no 
significant impact, 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. Further, the regulations in Sec.  340.6(e)(2) 
provide that a person may request that APHIS extend a determination of 
nonregulated status to other organisms. Such a request must include 
information to establish the similarity of the antecedent organism and 
the regulated article in question.

Background

    On July 25, 2001, APHIS received a request for an extension of a 
determination of nonregulated status (APHIS No. 01-206-02p) from 
Aventis CropScience (Aventis) of Research Triangle Park, NC, for a 
canola (Brassica napus L.) transformation event designated as Topas 19/
2 (event Topas 19/2), which has been genetically engineered for 
tolerance to the herbicide glufosinate. Aventis requested an extension 
of a determination of nonregulated status issued previously for 
glufosinate-tolerant canola transformation event T45, the antecedent 
organism, in response to APHIS petition number 97-205-01p (see 63 FR 
6703-6704, Docket No. 97-091-2, published February 10, 1998). Based on 
the similarity of canola event Topas 19/2 to the antecedent organism, 
Aventis requested a determination that glufosinate-tolerant canola 
event Topas 19/2 does not present a plant pest risk and, therefore, is 
not a regulated article under APHIS--regulations in 7 CFR part 340.
    On March 1, 2002, APHIS published a notice in the Federal Register 
(67 FR 9431-9432, Docket No. 01-101-1) announcing that an environmental 
assessment (EA) for the Aventis extension request had been prepared and 
was available for public comment. APHIS received one comment on the 
subject EA during the designated comment period which ended April 1, 
2002. We have provided a response to this comment as an attachment to 
our finding of no significant impact (FONSI). The EA and FONSI, 
including the attachment, are available from the person listed under 
FOR FURTHER INFORMATION CONTACT.

Analysis

    Like the antecedent organism, canola event Topas 19/2 has been 
genetically engineered to contain a pat gene derived from Streptomyces 
viridochromogenes. The pat gene encodes the enzyme phosphinothricin-N-
acetyltransferase (PAT), which confers tolerance to the herbicide 
glufosinate. The subject canola event and the antecedent organism were 
developed through use of the Agrobacterium tumefaciens method, and 
expression of the added genes in Topas 19/2 and the antecedent organism 
is controlled in part by gene sequences derived from the plant pathogen 
cauliflower mosaic virus. In summary, canola event Topas 19/2 and the 
antecedent organism contain the same genetic elements with the 
exception of the antibiotic resistance marker gene nptII in Topas 19/2, 
which was used as a transformant selection tool during the 
developmental process. The parental variety used to develop the 
antecedent organism was the B. napus var. AC EXCEL, while the B. napus 
cultivar Topas was used for transforming canola event Topas 19/2.
    Canola event Topas 19/2 and the antecedent organism were 
genetically engineered using the same transformation method and contain 
the same enzyme that makes the plants tolerant to the herbicide 
glufosinate. Accordingly, we have determined that canola event Topas 
19/2 is similar to the antecedent organism in APHIS petition number 97-
205-01p, and, therefore, that canola event Topas 19/2 should no longer 
be regulated under the regulations in 7 CFR part 340.
    The subject canola event has been considered a regulated article 
under APHIS' regulations in 7 CFR part 340 because it contains gene 
sequences derived from plant pathogens. However, canola event Topas 19/
2 has been extensively field tested in Canada, and after having 
received the appropriate Canadian approvals, has been marketed 
commercially in Canada since 1995 with no reports of adverse effects on 
human health or the environment.

Determination

    Based on an analysis of the data submitted by Aventis and a review 
of other scientific data, APHIS has determined that canola event Topas 
19/2: (1) Exhibits no plant pathogenic properties; (2) is no more 
likely to become a weed than the parental canola variety; (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; and (5) will not harm 
threatened or endangered species or other organisms, such as bees, that 
are beneficial to agriculture. Therefore, APHIS has concluded that 
canola event

[[Page 70395]]

Topas 19/2 and any progeny derived from crosses with other canola 
varieties will be as safe to grow as canola that is not subject to 
regulation under 7 CFR part 340.
    Because APHIS has determined that the subject canola event does not 
present a plant pest risk based on its similarity to the antecedent 
organism, Aventis canola event Topas 19/2 will no longer be 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 field testing, importation, or 
interstate movement of the subject canola event or its progeny. 
However, importation of canola event Topas 19/2 and seeds capable of 
propagation is still subject to the restrictions found in APHIS' 
foreign quarantine notices in 7 CFR part 319.

National Environmental Policy Act

    An EA was prepared to examine any potential environmental impacts 
associated with the extension of a determination of nonregulated status 
for the subject canola event. 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 FONSI with regard to 
the determination that Aventis' canola event Topas 19/2 and events 
developed from it are no longer regulated articles under its 
regulations in 7 CFR part 340. Copies of the Aventis extension request 
and the EA and FONSI are available from the individual listed under FOR 
FURTHER INFORMATION CONTACT.

    Done in Washington, DC, this 19th day of November 2002.
Peter Fernandez,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 02-29755 Filed 11-21-02; 8:45 am]
BILLING CODE 3410-34-P