[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]
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