[Federal Register Volume 63, Number 88 (Thursday, May 7, 1998)]
[Notices]
[Pages 25194-25195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12125]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 97-130-2]
AgrEvo USA Co.; Availability of Determination of Nonregulated
Status for Sugar Beet 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 sugar beet designated as Transformation Event T120-7,
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: April 28, 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. Ved Malik, Biotechnology and
Biological Analysis, PPQ, APHIS, 4700 River Road Unit 147, Riverdale,
MD 20737-1236; (301) 734-6774. 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:
mkpeterson@aphis.usda.gov.
SUPPLEMENTARY INFORMATION:
Background
On December 2, 1997, the Animal and Plant Health Inspection Service
(APHIS) received a petition (APHIS Petition No. 97-336-01p) from AgrEvo
USA Company (AgrEvo) of Wilmington, DE, seeking a determination that
sugar beet
[[Page 25195]]
(Beta vulgaris L.) designated as Transformation Event T120-7 (event
T120-7), 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 February 6, 1998, APHIS published a notice in the Federal
Register (63 FR 6148-6149, Docket No. 97-130-1) 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 sugar beet and food products derived from it. In the
notice, APHIS solicited written comments from the public as to whether
this sugar beet posed a plant pest risk. The comments were to have been
received by APHIS on or before April 7, 1998. APHIS received no
comments on the subject petition during the designated 60-day comment
period. Analysis
Event T120-7 sugar beet has been genetically engineered to contain
a synthetic version of the 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 35S promoter
and terminator sequences derived from the plant pathogen cauliflower
mosaic virus. Event T120-7 sugar beet also contains the aph(3')II or
nptII marker gene used in plant transformation.
Expression of the nptII gene is controlled by gene sequences
derived from Agrobacterium tumefaciens, and analysis indicates that the
NPTII protein is expressed in certain parts of the subject sugar beet
plants. The A. tumefaciens method was used to transfer the added genes
into the parental sugar beet line.
The subject sugar beet 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 sugar beet conducted under APHIS
permits since 1994 indicates that there were no deleterious effects on
plants, nontarget organisms, or the environment as a result of the
environmental release of event T120-7 sugar beet.
Determination
Based on its analysis of the data submitted by AgrEvo, and a review
of other scientific data and field tests of the subject sugar beet,
APHIS has determined that event T120-7: (1) Exhibits no plant
pathogenic properties; (2) is no more likely to become a weed than
sugar beet 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 sugar beet and any progeny derived from crosses with other
sugar beet varieties will be as safe to grow as sugar beet 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 T120-7
sugar beet 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 sugar beet or its progeny. However, importation of event T120-7
sugar beet 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 T120-7 sugar beet 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 30th day of April, 1998.
Craig A. Reed,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 98-12125 Filed 5-6-98; 8:45 am]
BILLING CODE 3410-34-P
