Calgene, Inc.; Receipt of Petition for Determination of Nonregulated Status for Genetically Engineered Cotton

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 97-006-1]

Calgene, Inc.; 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 Calgene, Inc., seeking

a determination of nonregulated status for cotton lines designated as

BXN with Bt cotton lines derived from transformation events

31807 and 31808 that have been genetically engineered for tolerance to

the herbicide bromoxynil and for resistance to lepidopteran insect

pests. 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 April 22, 1997.

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

Docket No. 97-006-1, 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. 97-006-1. 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. James White, 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. 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 January 13, 1997, APHIS received a petition (APHIS Petition No.

97-013-01p) from Calgene, Inc., (Calgene) of Davis, CA, requesting a

determination of nonregulated status under 7 CFR part 340 for

bromoxynil-tolerant and lepidopteran insect-resistant cotton lines

designated as BXN with BT derived from transformation events

31807 and 31808 (events 31807 and 31808). The Calgene petition states

that the subject cotton lines should not be regulated by APHIS because

they do not present a plant pest risk.

As described in the petition, events 31807 and 31808 have been

genetically engineered to express a nitrilase enzyme isolated from

Klebsiella pneumoniae subsp. ozaenae which degrades the herbicide

bromoxynil, and a CryIA(c) insect control protein originally derived

from Bacillus thuringiensis subsp. kurstaki HD-73 (Bt). The subject

cotton lines also contain the nptII gene which

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codes for the enzyme neomycin phosphotransferase and has been used as a

selectable marker in the development of the transgenic cotton plants.

Expression of the introduced genes is controlled in part by noncoding

DNA sequences derived from the plant pathogens Agrobacterium

tumefaciens and cauliflower mosaic virus. The Agrobacterium

transformation system was used to transfer the added genes into the

Gossypium hirsutum (var. Coker 130) parental plants.

The subject cotton lines are currently considered regulated

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

gene sequences derived from plant pathogenic sources. Events 31807 and

31808 have been evaluated in field trials conducted since 1994 under

APHIS notifications. In the process of reviewing the notifications for

field trials of these cotton lines, 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 and herbicides, be

registered prior to distribution or sale, unless exempt by EPA

regulation. Accordingly, the plant pesticide active ingredient Bt

CryIA(c) delta-endotoxin will be regulated by EPA under an existing

registration. In cases in which the genetically modified plant allows

for a new or different use pattern for an herbicide, the EPA must

approve the new or different use. 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 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.

Calgene has entered into the consultative process with the FDA on the

subject cotton lines.

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 Calgene's BXN with Bt

cotton lines derived from transformation events 31807 and 31808 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 14th day of February 1997.

Terry L. Medley,

Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 97-4308 Filed 2-20-97; 8:45 am]

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