[Federal Register Volume 67, Number 40 (Thursday, February 28, 2002)]
[Notices]
[Pages 9247-9248]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 02-4805]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 02-006-1]
Monsanto Co.; Availability of Environmental Assessment for
Extension of Determination of Nonregulated Status for Canola
Genetically Engineered for Glyphosate 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 one additional
canola event our determination that a canola line developed by Monsanto
Company, which has been genetically engineered for tolerance to the
herbicide glyphosate, is no longer considered a regulated article 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 April 1, 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. 02-006-1, 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. 02-006-1. 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.
02-006-1'' on the subject line.
You may read the extension request, the environmental assessment,
and any comments 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.
FOR FURTHER INFORMATION CONTACT: Dr. James White, Plant Protection and
Quarantine, APHIS, Suite 5B05, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-5940. 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 November 20, 2001, APHIS received a request for an extension of
a determination of nonregulated status (APHIS No. 01-324-01p) from
Monsanto Company (Monsanto) of St. Louis, MO, for a canola (Brassica
napus L.) transformation event designated as glyphosate-tolerant canola
event GT200 (GT200), which has been genetically engineered for
tolerance to the herbicide glyphosate. The Monsanto request seeks an
extension of a determination of nonregulated status that was issued for
Roundup Ready canola line RT73, the antecedent organism, in
response to APHIS petition number 98-216-01p (see 64 FR 5628-5629,
Docket No. 98-089-2, published February 4, 1999). Based on the
similarity of GT200 to the antecedent organism RT73, Monsanto requests
a determination that glyphosate-tolerant canola event GT200 does not
present a plant pest risk and, therefore, is not a regulated article
under APHIS' regulations in 7 CFR part 340.
Analysis
Like the antecedent organism, canola event GT200 has been
genetically engineered to express an enzyme, 5-enolpyruvylshikimate-3-
phosphate synthase (EPSPS), from Agrobacterium sp. strain CP4, and the
glyphosate oxidoreductase (GOX) gene/protein from Ochrobactrum anthropi
strain LBAA, both of which impart tolerance to the herbicide
glyphosate. The subject canola and the antecedent organism were
produced through use of the Agrobacterium tumefaciens method to
transform the parental canola variety Westar. Expression of the added
genes in GT200 and the antecedent organism is controlled in part by
gene sequences derived from the plant pathogen figwort mosaic virus.
Canola event GT200 and the antecedent organism were genetically
[[Page 9248]]
engineered using the same transformation method and contain the same
enzymes that make the plants tolerant to the herbicide glyphosate.
Accordingly, we have determined that canola event GT200 is similar to
the antecedent organism in APHIS petition number 98-216-01p, and we are
proposing that canola event GT200 should no longer be regulated under
the regulations in 7 CFR part 340.
The subject canola has been considered a regulated article under
APHIS' regulations in 7 CFR part 340 because it contains gene sequences
derived from plant pathogens. However, GT200 has been approved for
commercial use in Canada since 1996, with no subsequent reports of
deleterious effects on plants, nontarget organisms, or the environment
as a result of its environmental release.
Should APHIS approve Monsanto's request for an extension of a
determination of nonregulated status, canola event GT200 would 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 would no longer apply to the field
testing, importation, or interstate movement of the subject canola or
its progeny.
National Environmental Policy Act
An environmental assessment (EA) has been prepared to examine any
potential environmental impacts associated with this proposed extension
of a determination of nonregulated status. 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 Monsanto's extension request and
the EA are available upon request from the individual listed under FOR
FURTHER INFORMATION CONTACT.
Done in Washington, DC, this 22nd day of February 2002.
W. Ron DeHaven,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 02-4805 Filed 2-27-02; 8:45 am]
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