[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: mkpeterson@aphis.usda.gov.
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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