[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
 ________________________________________________________________________
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 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: 
[email protected].

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