Monsanto Co. and 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. 97-052-1]

Monsanto Co. and 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 Monsanto Company

and Dekalb Genetics Corporation seeking a determination of nonregulated

status for a corn line designated as GA21, which has been genetically

engineered for tolerance to the herbicide glyphosate. 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 14, 1997.

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

Docket No. 97-052-1, 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. 97-052-1. 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

to facilitate entry into the reading room.

FOR FURTHER INFORMATION CONTACT: Dr. Ray Dobert, Biotechnology

Evaluation, BSS, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 146,

Riverdale, MD 20737-1236; (301) 734-8365. To obtain a copy of the

petition, contact Ms. Kay Peterson at (301) 734-4885; 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 April 9, 1997, APHIS received a petition (APHIS Petition No. 97-

099-01p) from the Monsanto Company of St. Louis, MO, and Dekalb

Genetics Corporation of Mystic, CT (Monsanto/Dekalb), requesting a

determination of nonregulated status under 7 CFR part 340 for a

glyphosate-tolerant corn line designated as GA21. The Monsanto/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 GA21 has been genetically

engineered to contain a modified corn 5-enolpyruvylshikimate-3-

phosphate synthase (EPSPS) protein, which, when expressed in the plant,

confers tolerance to glyphosate, the active ingredient in the herbicide

Roundup. The modified corn EPSPS gene was introduced into

the parental inbred (AT) corn line by the particle acceleration method

and its expression is controlled in part by the rice actin promoter and

intron and the NOS 3' termination sequence derived from the plant

pathogen Agrobacterium tumefaciens.

The Monsanto/Dekalb corn line GA21 is currently considered a

regulated article under the regulations in 7 CFR part 340 because it

contains a gene sequence derived from a plant pathogen. The subject

corn line has been evaluated in field trials conducted since 1994 under

APHIS notifications. In the process of reviewing the notifications for

field trials of this corn line, 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 herbicides, be registered prior

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

which genetically modified plants allow for a new or different use

pattern for the herbicide, EPA must approve the new or different use.

Accordingly, Monsanto submitted to the EPA an application to register

Roundup herbicide for use over-the-top on glyphosate-

tolerant corn, and EPA has approved a label for such use.

[[Page 43312]]

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), as amended (21 U.S.C. 301 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.

Monsanto has begun consultation with the FDA on the subject corn line.

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 petitioners, 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

petitioners, 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 the Monsanto/Dekalb corn

line GA21 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 6th day of August 1997.

Terry L. Medley,

Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 97-21371 Filed 8-12-97; 8:45 am]

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