[Federal Register Volume 62, Number 97 (Tuesday, May 20, 1997)]
[Notices]
[Pages 27580-27581]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13115]


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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 
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  Federal Register / Vol. 62, No. 97 / Tuesday, May 20, 1997 / 
Notices  

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 96-098-2]


Dupont Agricultural Products; Availability of Determination of 
Nonregulated Status for Genetically Engineered Soybeans

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that the 
Dupont Agricultural Products' soybeans designated as sublines G94-1, 
G94-19, and G168 derived from transformation event 260-05 which have 
been genetically engineered to produce high oleic acid oil, 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 Dupont 
Agricultural Products 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: May 7, 1997.

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.

FOR FURTHER INFORMATION CONTACT: Dr. Ved Malik, BSS, PPQ, APHIS, 4700 
River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-8761. 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 January 8, 1997, the Animal and Plant Health Inspection Service 
(APHIS) received a petition (APHIS Petition No. 97-008-01p) from Dupont 
Agricultural Products (Dupont) of Wilmington, DE, seeking a 
determination that soybeans designated as sublines G94-1, G94-19, and 
G168 derived from transformation event 260-05 (sublines G94-1, G94-19, 
and G168) which have been genetically engineered to produce high oleic 
acid oil, do not present a plant pest risk and, therefore, are not 
regulated articles under APHIS' regulations in 7 CFR part 340.
    On February 28, 1997, APHIS published a notice in the Federal 
Register (62 FR 9155-9156, Docket No. 96-098-1) announcing that the 
Dupont petition had been received and was available for public review. 
The notice also discussed the role of APHIS and the Food and Drug 
Administration in regulating the subject soybean sublines and food 
products derived from them. In the notice, APHIS solicited written 
comments from the public as to whether these soybean sublines posed a 
plant pest risk. The comments were to have been received by APHIS on or 
before April 29, 1997. APHIS received no comments on the subject 
petition during the designated 60-day comment period.

Analysis

    Sublines G94-1, G94-19, and G168 have been genetically engineered 
to contain the GmFad2-1 gene, which causes a coordinate silencing of 
itself and the endogenous GmFad2-1 gene. Suppression of the GmFad2-1 
gene in developing soybeans prevents the addition of a second double 
bond to oleic acid, resulting in a greatly increased oleic acid content 
only in the seed. Oil from this seed contains an abundance of 
monosaturated oleic acid (82-85 percent), a reduced concentration of 
polysaturated fatty acids, and lower palmitic acid content. While the 
subject soybean sublines also contain the GUS and Amp marker genes, 
tests indicate that these genes are not expressed in the soybean 
plants. The added genes were introduced into meristems of the elite 
soybean line A2396 by the particle bombardment method, and their 
expression is controlled in part by gene sequences from the plant 
pathogens Agrobacterium tumefaciens and cauliflower mosaic virus.
    The subject soybean sublines 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 soybeans 
conducted under APHIS notifications since 1995 indicates that there 
were no deleterious effects on plants, nontarget organisms, or the 
environment as a result of the environmental release of sublines G94-1, 
G94-19, and G168.

Determination

    Based on its analysis of the data submitted by Dupont and a review 
of other scientific data and field tests of the subject soybeans, APHIS 
has determined that sublines G94-1, G94-19, and G168: (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 
harm threatened or endangered species or other organisms, such as bees, 
that are beneficial to agriculture; and (5) will not cause damage to 
raw or processed agricultural commodities. Therefore, APHIS has 
concluded that the subject soybean sublines 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 Dupont's soybean sublines 
G94-1, G94-19, and G168 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 sublines or their progeny. However,

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importation of soybean sublines G94-1, G94-19, and G168 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, as amended (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 Dupont's soybean sublines G94-1, G94-19, and G168 
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 14th day of May 1997.
Donald W. Luchsinger,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-13115 Filed 5-19-97; 8:45 am]
BILLING CODE 3410-34-P