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

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 95-023-1]

Receipt of Petition for Determination of Nonregulated Status for

Genetically Engineered Cotton

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

seeking a determination of nonregulated status for cotton lines

designated as 1445 and 1698 that have been genetically engineered for

tolerance to [[Page 16429]]

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 these cotton

lines present a plant pest risk.

DATES: Written comments must be received on or before May 30, 1995.

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

Docket No. 95-023-1, Regulatory Analysis and Development, PPD, APHIS,

Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1228. Please

state that your comments refer to Docket No. 95-023-1. 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, Branch

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

Unit 147, Riverdale, MD 20737-1228; (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 February 14, 1995, APHIS received a petition (APHIS Petition No.

95-045-01p) from the Monsanto Company of St. Louis, MO, requesting a

determination of nonregulated status under 7 CFR part 340 for cotton

lines designated as 1445 and 1698 that have been genetically engineered

for tolerance to the herbicide glyphosate. As described in the

petition, cotton (Gossypium hirsutum L.) lines 1445 and 1698 contain

the gene for CP4 EPSPS (5-enolpyruvylshikimate-3-phosphate synthase)

isolated from Agrobacterium sp. strain CP4, which encodes an enzyme

conferring tolerance to glyphosate, the active ingredient in

Roundup herbicide. Cotton lines 1445 and 1698 also contain

the nptII gene, which encodes the selectable marker neomycin

phosphotransferase II, and the aad gene, which encodes the bacterial

selectable marker 3''(9)-O-aminoglycoside adenylyltransferase.

Expression of the nptII gene is driven by the 35S promoter derived from

the plant pathogen cauliflower mosaic virus. The subject cotton lines

were produced through the use of Agrobacterium tumefaciens

transformation, a full description of which is provided in the

petition.

The subject cotton lines are currently considered regulated

articles under the regulations in 7 CFR part 340 because they contain

gene sequences (vectors, vector agents, promoters, and terminators)

derived from plant pathogens. Cotton lines 1445 and 1698 were evaluated

in field trials conducted under APHIS permits or notifications in 1992,

1993, and 1994. In the process of reviewing the applications for those

field trials, APHIS determined that the vectors were disarmed, and that

the trials did 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.

Cotton lines 1445 and 1698 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 resistance to herbicides are not regulated under 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, 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

(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, [[Page 16430]] 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 the Monsanto Company's

cotton lines 1445 and 1698 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 March 1995.

Terry L. Medley,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 95-7835 Filed 3-29-95; 8:45 am]

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