[Federal Register Volume 61, Number 160 (Friday, August 16, 1996)]
[Notices]
[Pages 42581-42582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-20921]
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Notices
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.
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Federal Register / Vol. 61, No. 160 / Friday, August 16, 1996 /
Notices
[[Page 42581]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 96-019-2]
AgrEvo USA Company; Availability of Determination of Nonregulated
Status for Soybeans 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 certain
soybean lines developed by AgrEvo USA Company that have been
genetically engineered for glufosinate herbicide tolerance are no
longer considered regulated articles 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,
an analysis of other scientific data, and our review of comments
received from the public in response to a previous notice announcing
our receipt of the AgrEvo USA Company's petition. This notice also
announces the availability of our written determination document and
its associated environmental assessment and finding of no significant
impact.
EFFECTIVE DATE: July 31, 1996.
ADDRESSES: The determination, an environmental assessment and finding
of no significant impact, the petition, and all written comments
received regarding 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.
FOR FURTHER INFORMATION CONTACT: Dr. Sivramiah Shantharam,
Biotechnology Permits, BBEP, APHIS, 4700 River Road Unit 147,
Riverdale, MD 20737-1237; (301) 734-7612. To obtain a copy of the
determination or the environmental assessment and finding of no
significant impact, contact Ms. Kay Peterson at (301) 734-7612; E-mail:
mkpeterson@aphis.usda.gov.
SUPPLEMENTARY INFORMATION:
Background
On March 8, 1996, the Animal and Plant Health Inspection Service
(APHIS) received a petition (APHIS Petition No. 96-068-01p) from AgrEvo
USA Company (AgrEvo) of Wilmington, DE, seeking a determination that
Glufosinate Resistant Soybean (GRS) Transformation Events W62, W98,
A2704-12, A2704-21, and A5547-35 that have been genetically engineered
for resistance, or tolerance, to the herbicide glufosinate, do not
present a plant pest risk and, therefore, are not regulated articles
under APHIS' regulations in 7 CFR part 340.
On April 29, 1996, APHIS published a notice in the Federal Register
(61 FR 18718-18719, Docket No. 96-019-1) 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
soybean lines and food products derived from them. In the notice, APHIS
solicited written comments from the public as to whether these soybean
lines posed a plant pest risk. The comments were to have been received
by APHIS on or before June 28, 1996.
During the designated 60-day comment period, APHIS received eight
comments on the subject petition from universities, cooperative
extension service research centers, and a seed company. All of the
comments were favorable to the petition.
Analysis
GRS Transformation Events W62 and W98 have been genetically
engineered to contain the bar gene derived from Streptomyces
hygroscopicus and the gus marker gene derived from Escherichia coli.
The bar gene encodes the enzyme phosphinothricin-N-acetyltransferase
(PAT), which confers tolerance to glufosinate. Expression of the added
genes is controlled in part by gene sequences from the plant pathogens
Agrobacterium tumefaciens, alfalfa mosaic virus, and cauliflower mosaic
virus (CaMV). GRS Transformation Events A2704-12, A2704-21, and A5547-
35 contain a synthetic version of the pat gene derived from
Streptomyces viridochromogenes, which encodes the PAT enzyme and
confers tolerance to glufosinate. Expression of the synthetic pat gene
is controlled by a 35S promoter and terminator derived from CaMV. The
particle acceleration method was used to transfer the added genes into
the GRS parental soybean cultivars.
The subject GRS Transformation Events have been considered
regulated articles under APHIS' regulations in 7 CFR part 340 because
they contain gene sequences derived from plant pathogens. However,
evaluation of field data reports from field tests of these lines
conducted under APHIS permits or notifications indicates that there
were no deleterious effects on plants, nontarget organisms, or the
environment as a result of the environmental release of the soybean
lines.
Determination
Based on its analysis of the data submitted by AgrEvo and a review
of other scientific data, comments received, and field tests of the
subject soybean lines, APHIS has determined that GRS Transformation
Events W62, W98, A2704-12, A2704-21, and A5547-35: (1) Exhibit no plant
pathogenic properties; (2) are no more likely to become weeds than
soybean lines developed by traditional breeding techniques; (3) are
unlikely to increase the weediness potential for any other cultivated
or wild species with which they 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 soybean lines and any progeny derived from hybrid crosses
with other nontransformed soybean varieties will be as safe to grow as
soybeans in traditional breeding programs that are not subject to
regulation under 7 CFR part 340.
The effect of this determination is that AgrEvo's GRS
Transformation Events W62, W98, A2704-12, A2704-21, and
[[Page 42582]]
A5547-35 are no longer considered regulated articles under APHIS'
regulations in 7 CFR part 340. Therefore, the requirements pertaining
to regulated articles under those regulations no longer apply to the
field testing, importation, or interstate movement of the subject
soybean lines or their progeny. However, importation of the subject
soybean lines 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)(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 GRS Transformation Events W62, W98, A2704-
12, A2704-21, and A5547-35 and lines developed from them 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 13th day of August 1996.
Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-20921 Filed 8-15-96; 8:45 am]
BILLING CODE 3410-34-P
