[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]
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