Dekalb Genetics Corp.; Receipt of Petition for Determination of Nonregulated Status for Genetically Engineered Corn

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 96-079-1]

Dekalb Genetics Corp.; 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 the Dekalb Genetics

Corporation seeking a determination of nonregulated status for a corn

line designated as DBT418 that has been genetically engineered for

insect resistance. 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 January 27, 1997.

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

Docket No. 96-079-1, 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. 96-079-1. 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. Subhash Gupta, Biotechnologist,

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.

[[Page 60258]]

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 October 17, 1996, APHIS received a petition (APHIS Petition No.

96-291-01p) from the Dekalb Genetics Corporation (Dekalb) of Mystic,

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

340 for an insect-resistant corn line designated as DBT418. 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 DBT418 has been genetically

engineered to express a CryIA(c) insect control protein derived from

the common soil bacterium Bacillus thuringiensis subsp. kurstaki (Bt).

The petitioner states that the Bt delta-endotoxin protein is expressed

at an effective level in plant tissue in the subject corn line and is

effective in controlling the European corn borer throughout the growing

season. Corn line DBT418 also expresses 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 herbicides Basta, Rely,

Finale, and Liberty. The cryIA(c) and bar genes

were introduced into the subject corn line by microprojectile

bombardment and their expression is controlled in part by gene

sequences derived from the plant pathogens cauliflower mosaic virus and

Agrobacterium tumefaciens.

Dekalb's corn line DBT418 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 1993 under

APHIS 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.

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 insecticides, be registered

prior to distribution or sale, unless exempt by EPA regulation.

Accordingly, Dekalb has submitted to the EPA an application to register

insect-resistant corn containing the plant pesticide active ingredient

Bt CryIA(c) delta-endotoxin and the genetic material necessary for its

production in corn. 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. Dekalb has also

submitted pesticide petitions to the EPA for exemptions from tolerance

requirements for residues of the Bt CryIA(c) delta-endotoxin active

ingredient and the PAT enzyme inert ingredient in corn.

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 DBT418 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 21st day of November 1996.

Terry L. Medley,

Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 96-30319 Filed 11-26-96; 8:45 am]

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