AgrEvo USA Company; Receipt of Petition for Determination of Nonregulated Status for Soybeans Genetically Engineered for Glufosinate Tolerance

SUMMARY: We are advising the public that the Animal and Plant Health

Inspection Service has received a petition from AgrEvo USA Company

seeking a determination of nonregulated status for certain soybeans

genetically engineered for tolerance to the herbicide glufosinate. 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 soybeans present a plant pest risk.

DATES: Written comments must be received on or before June 28, 1996.

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

Docket No. 96-019-1, 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. 96-019-1. 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 4:30 p.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. Sivramiah Shantharam,

Biotechnology Permits, BBEP, APHIS, Suite 5B05, 4700 River Road Unit

147, Riverdale, MD 20737-1237; (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 March 8, 1996, APHIS received a petition (APHIS Petition No. 96-

068-01p) from AgrEvo USA Company (AgrEvo) of Wilmington, DE, requesting

a determination of nonregulated status under 7 CFR part 340 for

soybeans designated as 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. The AgrEvo petition states that the subject GRS

transformation events should not be regulated by APHIS because they do

not present a plant pest risk.

As described in the petition, GRS transformation events W62 and W98

have been genetically engineered to contain the bar gene derived from

Streptomyces hygroscopicus and the gus gene derived from Escherichia

coli. The bar gene encodes the enzyme phosphinothricin-N-

acetyltransferase (PAT), which confers tolerance to glufosinate, and

the gus gene encodes the enzyme -glucuronidase, which is

useful as a selectable marker in the transformation process. Expression

of these added genes is controlled in part by gene sequences from the

plant pests Agrobacterium tumefaciens, alfalfa mosaic virus (AMV), 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 parental soybean cultivars.

GRS transformation events W62, W98, A2704-12, A2704-21, and A5547-

35 have been considered regulated articles under the regulations in 7

CFR part 340 because they contain gene sequences from the plant

pathogens mentioned above. GRS transformation events W62 and W98 have

been field tested since 1990 under APHIS permits or notifications, and

GRS transformation events A2704-12, A2704-21, and A5547-35 were field

tested in 1995 under APHIS notifications. In the process of reviewing

the applications for field trials of the subject GRS transformation

events, 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

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well as to organisms that may be beneficial to plants, for example,

honeybees, rhizobia, etc.

The U.S. Environmental Protection Agency (EPA) is responsible for

the regulation of pesticides under the Federal Insecticide, Fungicide,

and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136 et seq.). FIFRA

requires that all pesticides, including herbicides, be registered prior

to distribution or sale, unless exempt by EPA regulation. In cases in

which genetically modified plants allow for a new use of an herbicide

or involve a different use pattern for the herbicide, EPA must approve

the new or different use. When the use of the herbicide on the

genetically modified plant would result in an increase in the residues

of the herbicide in a food or feed crop for which the herbicide is

currently registered, or in new residues in a crop for which the

herbicide is not currently registered, establishment of a new tolerance

or a revision of the existing tolerance would be required. Residue

tolerances for pesticides are established by EPA under the Federal

Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 201 et seq.), and the

Food and Drug Administration (FDA) enforces tolerances set by EPA under

the FFDCA. Currently, glufosinate is not registered for use on

soybeans.

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 FDA's authority

for ensuring food safety under the FFDCA, 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.

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 AgrEvo's GRS transformation events

W62, W98, A2704-12, A2704-21, and A5547-35 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 23rd day of April 1996.

Lonnie J. King,

Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 96-10462 Filed 4-26-96; 8:45 am]

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