[Federal Register Volume 62, Number 97 (Tuesday, May 20, 1997)]
[Notices]
[Pages 27581-27582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13116]


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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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