[Federal Register Volume 67, Number 40 (Thursday, February 28, 2002)]
[Pages 9247-9248]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-4805]



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.


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 [email protected]. 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 

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: [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.


    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.


    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 

    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]