Receipt of Petition for Determination of Nonregulated Status for Genetically Engineered Corn

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 95-011-1]

Receipt of Petition for Determination of Nonregulated Status for

Genetically Engineered Corn

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 AgrEvo USA Company

seeking a determination of nonregulated status for corn designated as

``Glufosinate Resistant Corn Transformation Events T14 and T25''

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 this corn presents a plant pest risk.

DATES: Written comments must be received on or before April 28, 1995.

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

Docket No. 95-011-1, Animal and Plant Health Inspection Service, Policy

and Program Development, Regulatory Analysis and Development, 4700

River Road Unit 118, Riverdale, MD 20737-1238. Please state that your

comments refer to Docket No. 95-011-01. 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. David Heron, Biotechnologist, Animal and Plant Health Inspection

Service, Biotechnology, Biologics, and Environmental Protection,

Biotechnology Permits, 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) 734-7601.

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 December 23, 1994, APHIS received a petition (APHIS Petition No.

94-357-01p) from AgrEvo Company USA (AgrEvo) of Wilmington, DE,

requesting a determination of nonregulated status under 7 CFR part 340

for herbicide-tolerant corn designed as ``Gulfosinate Resistant Corn

(GRC) Transformation Events T14 and T25.'' As described in the

petition, GRC Events T14 and T25 are yellow dent corn plants

genetically engineered with a stably integrated gene that encodes the

enzyme phosphinothricin-N-aceyltransferase (PAT). The PAT enzyme

catalyzes the conversion of L-phosphinothricin, the active ingredient

in gulfosinate-ammonium, to an inactive form, thereby conferring

resistance to herbicides in the phosphinothricin class. The PAT gene in

GRC Events T14 and T25 is a synthetic version of the gene isolated from

the bacterium Streptomyces viridochromogenes. Expression of the pat

gene is regulated by the 35S promoter and the 35S terminator derived

from the plant pathogen cauliflower mosaic virus.

The subject of corn is currently considered a regulated article

under the regulations in 7 CFR part 340 because it contains gene

sequences (promoters, and terminators) derived from a plant pathogen.

GRC Events T14 and T25 [[Page 10538]] were evaluated in field trials

conducted under APHIS permits in 1992 and 1993, and under APHIS

notifications in 1993 and 1994. In the process of reviewing the

applications for those field trials, APHIS determined that these plants

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 insect, 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.

Several issues associated with GRC Events T14 and T25 are also

currently subject to regulation by other agencies. 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. 135 et seq.). FIFRA requires that all

pesticides, including herbicides, be registered prior to distribution

or sale, unless exempt by regulation. Plants that have been genetically

modified for tolerance or resistant to herbicides are not regulated

under FIFRA because the plants themselves are not themselves considered

pesticides.

In cases in which the 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. In conducting

such an approval, EPA considers the possibility of adverse effects to

human health and the environment from the use of this herbicide.

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 the EPA under the Federal Food, Drug, and Cosmetic Act

(FEDCA) (21 U.S.C. 201 et seq.), and the Food and Drug Administration

(FDA) enforces tolerances set by the EPA under the FFDCA.

The FDA publishes a statement of policy on foods derived from new

plant varities 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 FFDCA, and provides

guidance to industry on the scientific considerations associated with

the development of foods derived from new plant varities, including

those 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 GRC Events T14 and T25 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 2.17, 2.51, and 371.2(c).

Done in Washington, DC, this 21st day of February 1995.

Terry L. Medley,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 95-4741 Filed 2-24-95; 8:45 am]

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