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

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

Inspection Service has received a petition from the Dekalb Genetics

Corporation seeking a determination of nonregulated status for a corn

line designated as B16 that has been 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 line presents a plant pest risk.

DATES: Written comments must be received on or before October 2, 1995.

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

Docket No. 95-059-1, 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. 95-059-1. 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. Keith Reding, Biotechnologist,

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) 734-7601.

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 May 25, 1995, APHIS received a petition (APHIS Petition No. 95-

145-01p) from the Dekalb Genetics Corporation (Dekalb) of Mystic, CT,

requesting a determination of nonregulated status under 7 CFR part 340

for a glufosinate tolerant corn line designated as B16. The Dekalb

petition states that the subject corn line should not be regulated by

APHIS because it does not present a plant pest risk.

As described in the petition, corn line B16 has been genetically

engineered with the bar gene isolated from Streptomyces hygroscopicus

that encodes a phosphinothricin acetyltransferase (PAT) enzyme, which,

when introduced into a plant cell, inactivates glufosinate, also known

as phosphinothricin, the active ingredient in the herbicide

Liberty. The bar gene was introduced into the subject

corn line by microprojectile bombardment and its expression is under

the control of the 35S promoter derived from the plant pathogen

cauliflower mosaic virus and the Agrobacterium tumefaciens transcript 7

(Tr 7) 3' regulatory region. Dekalb's corn line B16 is currently

considered a regulated article under the regulations in 7 CFR part 340

because it contains gene sequences derived from plant pathogenic

sources. The subject corn line has been evaluated in field trials

conducted since 1991 under APHIS permits or notifications. In the

process of reviewing the applications for field trials of the subject

corn, 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.

This genetically engineered corn line is 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. 136 et seq.). FIFRA requires that all pesticides, including

herbicides, be registered prior to distribution or sale, unless exempt

by EPA regulation. Plants that have been genetically modified for

tolerance or resistance to herbicides are not regulated under the FIFRA

because the plants themselves are not 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, the EPA must approve the new or different use. In

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conducting such an approval, the 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 (FFDCA) (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 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 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 Dekalb's corn line B16 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 24th day of July 1995.

Lonnie J. King,

Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 95-18777 Filed 7-31-95; 8:45 am]

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