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

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 97-006-2]

Calgene, Inc.; Availability of 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 of our determination that the

Calgene, Inc., cotton lines designated as BXN with Bt

cotton lines derived from transformation events 31807 and 31808 which

have been genetically engineered for tolerance to the herbicide

bromoxynil and resistance to lepidopteran insect pests, are no longer

considered regulated articles under our regulations governing the

introduction of certain genetically engineered organisms. Our

determination is based on our evaluation of data submitted by Calgene,

Inc., in its petition for a determination of nonregulated status and an

analysis of other scientific data. This notice also announces the

availability of our written determination document and its associated

environmental assessment and finding of no significant impact.

EFFECTIVE DATE: April 30, 1997.

ADDRESSES: The determination, an environmental assessment and finding

of no significant impact, and the petition 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 to inspect those documents are asked

to call in advance of visiting at (202) 690-2817.

FOR FURTHER INFORMATION CONTACT: Dr. James White, BSS, PPQ, APHIS, 4700

River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-8761. To

obtain a copy of the determination or the environmental assessment and

finding of no significant impact, contact Ms. Kay Peterson at (301)

734-4885; e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

Background

On January 13, 1997, the Animal and Plant Health Inspection Service

(APHIS) received a petition (APHIS Petition No. 97-013-01p) from

Calgene, Inc., (Calgene) of Davis, CA, seeking a determination that

cotton lines designated as BXN with Bt cotton lines derived

from transformation events 31807 and 31808 (events 31807 and 31808),

which have been genetically engineered for bromoxynil herbicide

tolerance and lepidopteran insect pest resistance, do not present a

plant pest risk and, therefore, are not regulated articles under APHIS'

regulations in 7 CFR part 340.

On February 21, 1997, APHIS published a notice in the Federal

Register (62 FR 7996-7997, Docket No. 97-006-1) announcing that the

Calgene petition had been received and was available for public review.

The notice also discussed the role of APHIS, the Environmental

Protection Agency, and the Food and Drug Administration in regulating

the subject cotton lines and food products derived from them. In that

notice, APHIS solicited written comments from the public as to whether

these cotton lines posed a plant pest risk. The comments were to have

been received by APHIS on or before April 22, 1997. During the

designated 60-day comment period, APHIS received no comments on the

subject petition.

Analysis

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 the common soil bacterium Bacillus

thuringiensis subsp. kurstaki HD-73 (Bt). The subject cotton lines also

express the nptII gene, which 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 added

genes is controlled in part by noncoding DNA sequences derived from the

plant pathogens Agrobacterium tumefaciens and cauliflower mosaic virus.

The Agrobacterium transformation method was used to transfer the added

genes into the Coker 130 parental cotton plants.

The subject cotton lines have been considered regulated articles

under APHIS' regulations in 7 CFR part 340 because they contain gene

sequences derived from plant pathogens. However, evaluation of field

data reports from field tests of the cotton lines conducted under APHIS

notifications since 1994 indicates that there were no deleterious

effects on plants, nontarget organisms, or the environment as a result

of the environmental release of events 31807 and 31808.

Determination

Based on its analysis of the data submitted by Calgene and a review

of other scientific data and field tests of the subject cotton plants,

APHIS has determined that events 31807 and 31808: (1) Exhibit no plant

pathogenic properties; (2) are no more likely to become weeds than

cotton lines developed by traditional breeding techniques; (3) are

unlikely to increase the weediness potential for any other cultivated

or wild species with which they can interbreed; (4) will not cause

damage to raw or processed agricultural commodities; (5) will not harm

threatened or endangered species or other organisms, such as bees, that

are beneficial to agriculture; and (6) should not reduce the ability to

control insects in cotton or other crops when cultivated. Therefore,

APHIS has concluded that the subject cotton lines and any progeny

derived from hybrid crosses with other nontransformed cotton varieties

will be as safe to grow as cotton in traditional breeding programs that

are not subject to regulation under 7 CFR part 340.

[[Page 27582]]

The effect of this determination is that Calgene's cotton events

31807 and 31808 are no longer considered regulated articles under

APHIS' regulations in 7 CFR part 340. Therefore, the requirements

pertaining to regulated articles under those regulations no longer

apply to the field testing, importation, or interstate movement of the

subject cotton lines or their progeny. However, importation of cotton

events 31807 and 31808 or seeds capable of propagation are still

subject to the restrictions found in APHIS' foreign quarantine notices

in 7 CFR part 319.

National Environmental Policy Act

An environmental assessment (EA) has been prepared to examine the

potential environmental impacts associated with this determination. The

EA was prepared in accordance with: (1) The National Environmental

Policy Act of 1969, as amended (NEPA)(42 U.S.C. 4321 et seq.); (2)

regulations of the Council on Environmental Quality for implementing

the procedural provisions of NEPA (40 CFR parts 1500-1508); (3) USDA

regulations implementing NEPA (7 CFR part 1b); and (4) APHIS' NEPA

Implementing Procedures (7 CFR part 372). Based on that EA, APHIS has

reached a finding of no significant impact (FONSI) with regard to its

determination that Calgene's cotton events 31807 and 31808 and lines

developed from them are no longer regulated articles under its

regulations in 7 CFR part 340. Copies of the EA and the FONSI are

available upon request from the individual listed under FOR FURTHER

INFORMATION CONTACT.

Done in Washington, DC, this 14th day of May 1997.

Donald W. Luchsinger,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 97-13116 Filed 5-19-97; 8:45 am]

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