[Federal Register Volume 63, Number 27 (Tuesday, February 10, 1998)]
[Notices]
[Pages 6703-6704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3312]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 97-091-2]


AgrEvo USA Co.; Availability 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 of our determination that AgrEvo 
USA Company's canola designated as Transformation Event T45, 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. 
Our determination is based on our evaluation of data submitted by 
AgrEvo USA Company in its petition for a determination of nonregulated 
status and an analysis of other scientific data. This notice also 
announces the availability of our written determination document and 
its associated environmental assessment and finding of no significant 
impact.

EFFECTIVE DATE: January 29, 1998.

ADDRESSES: The determination, an environmental assessment and finding 
of no significant impact, and the petition may be inspected at USDA, 
room 1141, South Building, 14th Street and Independence Avenue SW., 
Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, 
except holidays. Persons wishing to inspect those documents are asked 
to call in advance of visiting at (202) 690-2817 to facilitate entry 
into the reading room.

FOR FURTHER INFORMATION CONTACT: Dr. James Lackey, Biotechnology 
Evaluation, BSS, PPQ, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-6748. To obtain a copy of the determination or 
the environmental assessment and finding of no significant impact, 
contact Ms. Kay Peterson at (301) 734-4885; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    On July 24, 1997, the Animal and Plant Health Inspection Service 
(APHIS) received a petition (APHIS Petition No. 97-205-01p) from AgrEvo 
USA Company (AgrEvo) of Wilmington, DE, seeking a determination that 
canola (Brassica napus L.) designated as Transformation Event T45 
(event T45), which has been genetically engineered for tolerance to the 
herbicide glufosinate, does not present a plant pest risk and, 
therefore, is not a regulated article under APHIS' regulations in 7 CFR 
part 340.
    On September 30, 1997, APHIS published a notice in the Federal 
Register (62 FR 51081-51082, Docket No. 97-091-1) announcing that the 
AgrEvo petition had been received and was available for public review. 
The notice also discussed the role of APHIS, the Environmental 
Protection Agency, and the Food and Drug Administration in regulating 
the subject canola and food products derived from it. In the notice, 
APHIS solicited written comments from the public as to whether this 
canola posed a plant pest risk. The comments were to have been received 
by APHIS on

[[Page 6704]]

or before December 1, 1997. APHIS received no comments on the subject 
petition during the designated 60-day comment period.

Analysis

    Event T45 canola 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. Expression of the pat gene is 
controlled by a 35S promoter and terminator derived from the plant 
pathogen cauliflower mosaic virus. The Agrobacterium tumefaciens method 
was used to transfer the added genes into the parental cultivar B. 
napus var. AC EXCEL.
    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, evaluation of field data reports 
from field tests of this canola conducted under APHIS permits since 
1996 indicates that there were no deleterious effects on plants, 
nontarget organisms, or the environment as a result of the 
environmental release of event T45 canola.

Determination

    Based on its analysis of the data submitted by AgrEvo, and a review 
of other scientific data and field tests of the subject canola, APHIS 
has determined that event T45 canola: (1) Exhibits no plant pathogenic 
properties; (2) is no more likely to become a weed than canola 
developed by traditional breeding techniques; (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 the 
subject canola and any progeny derived from hybrid crosses with other 
nontransformed canola varieties will be as safe to grow as canola in 
traditional breeding programs that are not subject to regulation under 
7 CFR part 340.
    The effect of this determination is that AgrEvo's event T45 canola 
is no longer 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 subject canola 
of its progeny. However, importation of the subject canola or seeds 
capable of propagation are still subject to the restrictions found in 
APHIS' foreign quarantine notices in 7 CFR part 319.

National Environmental Policy Act

    An environmental assessment (EA) has been prepared to examine the 
potential environmental impacts associated with this determination. 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 finding of no significant impact (FONSI) with regard to its 
determination that AgrEvo's event T45 canola and lines developed from 
it are no longer regulated articles under its regulations in 7 CFR part 
340. Copies of the EA and the FONSI are available upon request from the 
individual listed under FOR FURTHER INFORMATION CONTACT.

    Done in Washington, DC, this 4th day of January 1998.
Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 98-3312 Filed 2-9-98; 8:45 am]
BILLING CODE 3410-34-P