[Federal Register Volume 67, Number 41 (Friday, March 1, 2002)]
[Notices]
[Pages 9431-9432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-4909]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 01-101-1]


Aventis CropScience; Availability of Environmental Assessment for 
Extension of Determination of Nonregulated Status for Canola 
Genetically Engineered for 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 one additional 
canola event our determination that a canola event developed by Aventis 
CropScience, which has been genetically engineered for tolerance to the 
herbicide glufosinate, 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. 01-101-1, Regulatory Analysis and Development, PPD, APHIS, Station 
3C71, 4700 River

[[Page 9432]]

Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment 
refers to Docket No. 01-101-1. 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. 01-101-1'' 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.

FOR FURTHER INFORMATION CONTACT: Dr. Hanu Pappu, Plant Protection and 
Quarantine, APHIS, Suite 5B05, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-5299. 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.

Background

    On July 25, 2001, APHIS received a request for an extension of a 
determination of nonregulated status (APHIS No. 01-206-02p) from 
Aventis CropScience (Aventis) of Research Triangle Park, NC, for a 
canola (Brassica napus L.) transformation event designated as Topas 19/
2 (event Topas 19/2), which has been genetically engineered for 
tolerance to the herbicide glufosinate. The Aventis request seeks an 
extension of a determination of nonregulated status issued for 
glufosinate-tolerant canola transformation event T45, the antecedent 
organism, in response to APHIS petition number 97-205-01p (see 63 FR 
6703-6704, Docket No. 97-091-2, published February 10, 1998). Based on 
the similarity of canola event Topas 19/2 to the antecedent organism, 
Aventis requests a determination that glufosinate-tolerant canola event 
Topas 19/2 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 Topas 19/2 has been 
genetically engineered to contain a pat gene derived from Streptomyces 
viridochromogenes. The pat gene encodes the enzyme phosphinothricin-N-
acetyltransferase (PAT), which confers tolerance to the herbicide 
glufosinate. The subject canola event and the antecedent organism were 
developed through use of the Agrobacterium tumefaciens method, and 
expression of the added genes in Topas 19/2 and the antecedent organism 
is controlled in part by gene sequences derived from the plant pathogen 
cauliflower mosaic virus. In summary, the Aventis extension request 
states that canola event Topas 19/2 and the antecedent organism contain 
the same genetic elements with the exception of the antibiotic 
resistance marker gene nptII in Topas 19/2, which was used as a 
transformant selection tool during the developmental process. The 
parental variety used to develop the antecedent organism was the B. 
napus var. AC EXCEL, while the B. Napus cultivar Topas was used for 
transforming canola event Topas 19/2.
    Canola event Topas 19/2 and the antecedent organism were 
genetically engineered using the same transformation method and contain 
the same enzyme that makes the plants tolerant to the herbicide 
glufosinate. Accordingly, we have determined that canola event Topas 
19/2 is similar to the antecedent organism in APHIS petition number 97-
205-01p, and we are proposing that canola event Topas 19/2 should no 
longer be regulated under the regulations in 7 CFR part 340.
    The subject canola event has been considered a regulated article 
under APHIS' regulations in 7 CFR part 340 because it contains gene 
sequences derived from plant pathogens. However, canola event Topas 19/
2 has been extensively field tested in Canada, and after having 
received the appropriate Canadian approvals, has been marketed 
commercially in Canada since 1995 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 event Topas 19/2 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 
event or its 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 event. 
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 25th day of February 2002.
W. Ron DeHaven,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 02-4909 Filed 2-28-02; 8:45 am]
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