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

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 96-098-1]

Dupont Agricultural Products; Receipt of Petition for

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 that the Animal and Plant Health

Inspection Service has received a petition from Dupont Agricultural

Products seeking a determination of nonregulated status for soybeans

designated as sublines G94-1, G94-19, and G168 derived from

transformation event 260-05 that have been genetically engineered to

produce high oleic acid oil. The petition has been submitted in

accordance with our regulations concerning the introduction of certain

genetically engineered organisms and products. In accordance with those

regulations, we are soliciting public comments on whether these soybean

sublines present a plant pest risk.

DATES: Written comments must be received on or before April 29, 1997.

ADDRESSES: Please send an original and three copies of your comments to

[[Page 9156]]

Docket No. 96-098-1, Regulatory Analysis and Development, PPD, APHIS,

Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please

state that your comments refer to Docket No. 96-098-1. A copy of the

petition and any comments received may be inspected at USDA, room 1141,

South Building, 14th Street and Independence Avenue SW., Washington,

DC, between 8 a.m. and 4:30p.m., Monday through Friday, except

holidays. Persons wishing access to that room to inspect the petition

or comments are asked to call in advance of visiting at (202) 690-2817.

FOR FURTHER INFORMATION CONTACT: Dr. Ved Malik, BSS, PPQ, APHIS, Suite

5B05, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-

7612. To obtain a copy of the petition, contact Ms. Kay Peterson at

(301) 734-7612; e-mail: [email protected].

SUPPLEMENTARY INFORMATION: The regulations in 7 CFR part 340,

``Introduction of Organisms and Products Altered or Produced Through

Genetic Engineering Which Are Plant Pests or Which There Is Reason to

Believe Are Plant Pests,'' regulate, among other things, the

introduction (importation, interstate movement, or release into the

environment) of organisms and products altered or produced through

genetic engineering that are plant pests or that there is reason to

believe are plant pests. Such genetically engineered organisms and

products are considered ``regulated articles.''

The regulations in Sec. 340.6(a) provide that any person may submit

a petition to the Animal and Plant Health Inspection Service (APHIS)

seeking a determination that an article should not be regulated under 7

CFR part 340. Paragraphs (b) and (c) of Sec. 340.6 describe the form

that a petition for determination of nonregulated status must take and

the information that must be included in the petition.

On January 8, 1997, APHIS received a petition (APHIS Petition No.

97-008-01p) from Dupont Agricultural Products (Dupont) of Wilmington,

DE, requesting a determination of nonregulated status under 7 CFR part

340 for high oleic acid soybean sublines G94-1, G94-19, and G168

(sublines G94-1, G94-19, and G168) derived from transformation event

260-05. The Dupont petition states that the subject soybean sublines

should not be regulated by APHIS because they do not present a plant

pest risk.

As described in the petition, sublines G94-1, G94-19, and G168 have

been genetically engineered to contain the GmFad 2-1 gene, which causes

a coordinate silencing of itself and the endogenous GmFad 2-1 gene.

Suppression of the GmFad 2-1 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. The resulting oil

contains an abundance of monosaturated oleic acid (82-85%), 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 transgenic 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

derived from the plant pathogens Agrobacterium tumefaciens and

cauliflower mosaic virus.

Dupont's soybean sublines G94-1, G94-19, and G168 are currently

considered regulated articles under the regulations in 7 CFR part 340

because they contain gene sequences derived from plant pathogenic

sources. The subject soybean sublines have been evaluated in field

trials conducted since 1995 under APHIS notifications. In the process

of reviewing these notifications for field trials, APHIS determined

that the vectors and other elements were disarmed and that the trials,

which were conducted under conditions of reproductive and physical

containment or isolation, would not present a risk of plant pest

introduction or dissemination.

In the Federal Plant Pest Act, as amended (7 U.S.C. 150aa et seq.),

``plant pest'' is defined as ``any living stage of: Any insects, mites,

nematodes, slugs, snails, protozoa, or other invertebrate animals,

bacteria, fungi, other parasitic plants or reproductive parts thereof,

viruses, or any organisms similar to or allied with any of the

foregoing, or any infectious substances, which can directly or

indirectly injure or cause disease or damage in any plants or parts

thereof, or any processed, manufactured or other products of plants.''

APHIS views this definition very broadly. The definition covers direct

or indirect injury, disease, or damage not just to agricultural crops,

but also to plants in general, for example, native species, as well as

to organisms that may be beneficial to plants, for example, honeybees,

rhizobia, etc.

The Food and Drug Administration (FDA) published a statement of

policy on foods derived from new plant varieties in the Federal

Register on May 29, 1992 (57 FR 22984-23005). The FDA statement of

policy includes a discussion of the FDA's authority for ensuring food

safety under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 201 et

seq.), and provides guidance to industry on the scientific

considerations associated with the development of foods derived from

new plant varieties, including those plants developed through the

techniques of genetic engineering. Dupont has begun the consultative

process with FDA on the subject soybean sublines.

In accordance with Sec. 340.6(d) of the regulations, we are

publishing this notice to inform the public that APHIS will accept

written comments regarding the Petition for Determination of

Nonregulated Status from any interested person for a period of 60 days

from the date of this notice. The petition and any comments received

are available for public review, and copies of the petition may be

ordered (see the ADDRESSES section of this notice).

After the comment period closes, APHIS will review the data

submitted by the petitioner, all written comments received during the

comment period, and any other relevant information. Based on the

available information, APHIS will furnish a response to the petitioner,

either approving the petition in whole or in part, or denying the

petition. APHIS will then publish a notice in the Federal Register

announcing the regulatory status of Dupont's high oleic acid soybean

sublines G94-1, G94-19, and G168 derived from transformation event 260-

05 and the availability of APHIS' written decision.

Authority: 7 U.S.C. 150aa-150jj, 151-167, and 1622n; 31 U.S.C.

9701; 7 CFR 2.22, 2.80, and 371.2(c).

Done in Washington, DC, this 24th day of February 1997.

Terry L. Medley,

Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 97-5023 Filed 2-27-97; 8:45 am]

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