[Federal Register: February 25, 2002 (Volume 67, Number 37)]
[Notices]
[Page 8509-8510]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25fe02-20]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 01-100-1]
Aventis CropScience; Availability of Environmental Assessment for
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 that an environmental assessment
has been prepared for a proposed 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. We are making this environmental assessment
available to the public for review and comment.
DATES: We will consider all comments we receive that are postmarked,
delivered, or e-mailed by March 27, 2002.
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 comment (an original and three copies) to: Docket
No. 01-100-1, Regulatory Analysis and Development, PPD, APHIS, Station
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state
that your comment refers to Docket No. 01-100-1. If you use e-mail,
address your comment to regulations@aphis.usda.gov. 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.
01-100-1'' on the subject line.
You may read the extension request, the environmental assessment,
and any comments that we receive on this docket 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.
[[Page 8510]]
FOR FURTHER INFORMATION CONTACT: Dr. James White, Plant Protection and
Quarantine, 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, contact Ms. Kay Peterson at (301) 734-
4885; e-mail: Kay.Peterson@aphis.usda.gov.
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 September 9, 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 to the herbicide
glufosinate (MS1, RF1, and RF2). The Aventis request seeks 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). Both MS8 and RF3 are also tolerant to the
herbicide glufosinate. Based on the similarity of canola events MS1 and
RF1 and RF2 to the antecedent organisms, Aventis requests 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.
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 to in the subject transformation
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 we are proposing
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.
Should APHIS approve Aventis' request for an extension of a
determination of nonregulated status, canola events MS1 and RF1 and RF2
would no longer be considered regulated articles under APHIS'
regulations in 7 CFR part 340. Therefore, the requirements pertaining
to regulated articles under those regulations would no longer apply to
the field testing, importation, or interstate movement of the subject
canola events or their progeny.
National Environmental Policy Act
An environmental assessment (EA) has been 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). Copies of the
Aventis extension request and the EA are available from the individual
listed under FOR FURTHER INFORMATION CONTACT.
Done in Washington, DC, this 19th day of February 2002.
W. Ron DeHaven,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 02-4385 Filed 2-22-02; 8:45 am]
BILLING CODE 3410-34-P
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