[Federal Register Volume 67, Number 232 (Tuesday, December 3, 2002)]
[Notices]
[Pages 71928-71929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30514]


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 Notices
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  Federal Register / Vol. 67, No. 232 / Tuesday, December 3, 2002 / 
Notices  

[[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.

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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 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: 
[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 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]
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