[Federal Register: December 3, 2002 (Volume 67, Number 232)]
[Notices]
[Page 71928-71929]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03de02-45]
========================================================================
Notices
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.
========================================================================
[[Page 71928]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 02-006-2]
Monsanto Co.; Extension of Determination of Nonregulated Status
for Canola Genetically Engineered for Glyphosate Herbicide Tolerance
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public of our 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. Our decision is based on our
evaluation of data submitted by Monsanto Company 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: January 2, 2003.
ADDRESSES: You may read copies of the extension request, the
environmental assessment and finding of no significant impact, and the
comment received on an earlier notice of the availability of the
environmental assessment 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) 734-5940. 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:
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. Monsanto requested an extension
of a determination of nonregulated status that was issued for Roundup
Ready[reg] 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 requested 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.
On February 28, 2002, APHIS published a notice in the Federal
Register (67 FR 0247-0248, Docket No. 02-006-1) announcing that an
environmental assessment (EA) for the Monsanto extension request had
been prepared and was available for public comment. APHIS received one
comment on the subject EA during the 30-day comment period, which ended
April 1, 2002. The comment, which was from a consumer organization,
urged denial of the subject extension request based on alleged
deficiencies in the environmental assessments prepared for the
antecedent organism and event GT200 canola. We have provided a response
to this comment in an addendum 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 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
engineered using the same
[[Page 71929]]
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 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
unconfined environmental release and food and feed use in Canada since
1997, with no subsequent reports of deleterious effects on plants,
nontarget organisms, or the environment.
Determination
Based on an analysis of the data submitted by Monsanto and a review
of other scientific data, APHIS has determined that canola event GT200:
(1) Exhibits no plant pest characteristics; (2) is no more likely to
become a weed than non-transformed traditional varieties; (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 GT200 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, Monsanto's canola event GT200 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 GT200 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 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). Based on that EA,
APHIS has reached a FONSI with regard to the determination that
Monsanto's canola event GT200 and events developed from it are no
longer regulated articles under its regulations in 7 CFR part 340.
Copies of Monsanto's extension request and the EA and FONSI are
available upon request from the individual listed under FOR FURTHER
INFORMATION CONTACT.
Done in Washington, DC, this 26th day of November 2002.
Peter Fernandez,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 02-30514 Filed 12-2-02; 8:45 am]
BILLING CODE 3410-34-P