[Federal Register Volume 67, Number 226 (Friday, November 22, 2002)]
[Notices]
[Pages 70392-70393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-29754]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 01-100-2]
Aventis CropScience; Extension of Determination of Nonregulated
Status for Canola Genetically Engineered for Male Sterility, Fertility
Restoration, and 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 decision to extend to
additional canola events our determination that certain canola events
developed by Aventis CropScience, which have been genetically
engineered for male sterility, fertility restoration, and tolerance to
the herbicide glufosinate, are no longer considered regulated articles
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. 01-206-01p) from
Aventis CropScience (Aventis) of Research Triangle Park, NC, for canola
(Brassica napus L.) transformation events designated as MS1 and RF1 and
RF2, which have been genetically engineered for male sterility (MS1),
fertility restoration (RF1 and RF2), and tolerance
[[Page 70393]]
to the herbicide glufosinate (MS1, RF1, and RF2). Aventis requested an
extension of a determination of nonregulated status issued in response
to APHIS petition number 98-278-01p for male sterile canola
transformation event MS8 and fertility restoration canola
transformation event RF3, the antecedent organisms (see 64 FR 15337-
15338, Docket No. 98-114-2, published March 31, 1999), which are also
tolerant to the herbicide glufosinate. Based on the similarity of
canola events MS1 and RF1 and RF2 to the antecedent organisms, Aventis
requested a determination that MS1 and RF1 and RF2 do not present a
plant pest risk and, therefore, are not regulated articles under APHIS'
regulations in 7 CFR part 340.
On February 25, 2002, APHIS published a notice in the Federal
Register (67 FR 8509-8510, Docket No. 01-100-1), 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 30-day public comment
period, which ended March 27, 2002. The comment, which was from a
consumer organization, cited alleged deficiencies in the EA prepared
for the antecedent organism and the EA for events MS1 and RF1 and RF2.
APHIS has provided a response to this comment as an attachment to the
finding of no significant impact (FONSI). The EA and FONSI are
available from the person listed under FOR FURTHER INFORMATION CONTACT.
Analysis
Like the antecedent organisms, canola events MS1 and RF1 and RF2
have been genetically engineered to contain a barnase gene (MS1) for
male sterility or a barstar gene (RF1 and RF2) for fertility
restoration. The barnase gene expresses a ribonuclease that blocks
pollen development and results in a male-sterile plant, and the barstar
gene encodes a specific inhibitor of this ribonuclease and restores
fertility. The barnase and barstar genes were derived from Bacillus
amyloliquefaciens, and are linked in the subject canola events to the
bar gene derived from Streptomyces hygroscopicus. The bar gene encodes
the enzyme phosphinothricin-N-acetyltransferase (PAT), which confers
tolerance to the herbicide glufosinate. The subject canola events and
the antecedent organisms were developed through use of the
Agrobacterium tumefaciens method, and expression of the added genes in
MS1 and RF1 and RF2 and the antecedent organisms is controlled in part
by gene sequences derived from the plant pathogen A. tumefaciens. In
summary, the Aventis extension request states that canola events MS1
and RF1 and RF2 and the antecedent organisms contain the same genetic
elements with the exception of the antibiotic resistance marker gene
nptII in MS1 and RF1 and RF2, which was used as a transformant
selection tool during the developmental process. The parental variety
Drakkar was used to develop both the antecedent organisms and MS1 and
RF1 and RF2.
Canola events MS1 and RF1 and RF2 and the antecedent organisms were
genetically engineered using the same transformation method and contain
the same enzymes for male sterility, fertility restoration, and
glufosinate herbicide tolerance. Accordingly, we have determined that
canola events MS1 and RF1 and RF2 are similar to the antecedent
organisms in APHIS petition number 98-278-01p, and that canola events
MS1 and RF1 and RF2 should no longer be regulated under the regulations
in 7 CFR part 340.
The subject canola events have been considered regulated articles
under APHIS' regulations in 7 CFR part 340 because they contain gene
sequences derived from a plant pathogen. However, canola events MS1 and
RF1 and RF2 have been field tested in numerous countries, including the
United States and Canada, and after having received the appropriate
Canadian approvals, have been marketed commercially in Canada since
1996 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 events MS1
and RF1 and RF2: (1) Exhibit no plant pathogenic properties; (2) are no
more likely to become a weed than canola varieties developed by
traditional breeding techniques and are unlikely to increase the
weediness potential for any other cultivated or wild species with which
they can interbreed; (3) will not cause damage to raw or processed
agricultural commodities; (4) will not harm threatened or endangered
species or other organisms, such as bees, that are beneficial to
agriculture; and (5) are unlikely to have any significant adverse
impact on agricultural practices. Therefore, APHIS has concluded that
canola events MS1 and RF1 and RF2 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 events do not
present a plant pest risk based on their similarity to the antecedent
organisms, Aventis' canola events MS1 and RF1 and RF2 will be no longer
be considered regulated articles 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 events or their progeny.
However, importation of canola events MS1 and RF1 and RF2 and seeds
capable of propagation are 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 proposed extension of a determination of
nonregulated status for the subject canola events. 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 events MS1
and RF1 and RF2 and events developed from them 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 19th day of November 2002.
Peter Fernandez,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 02-29754 Filed 11-21-02; 8:45 am]
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