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

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