[Federal Register Volume 62, Number 68 (Wednesday, April 9, 1997)]
[Notices]
[Pages 17143-17144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-9066]
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Notices
Federal Register
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This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.
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Federal Register / Vol. 62, No. 68 / Wednesday, April 9, 1997 /
Notices
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 96-079-2]
Dekalb Genetics Corp.; Availability of Determination of
Nonregulated Status for Genetically Engineered Corn
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
Dekalb Genetics Corporation's corn line designated as DBT418 that has
been genetically engineered for lepidopteran insect resistance is no
longer considered a regulated article under our regulations governing
the introduction of certain genetically engineered organisms. Our
determination is based on our evaluation of data submitted by the
Dekalb Genetics Corporation in its petition for a determination of
nonregulated status, an analysis of other scientific data, and our
review of comments received from the public in response to a previous
notice announcing our receipt of the Dekalb Genetics Corporation's
petition. This notice also announces the availability of our written
determination document and its associated environmental assessment and
finding of no significant impact.
EFFECTIVE DATE: March 28, 1997.
ADDRESSES: The determination, an environmental assessment and finding
of no significant impact, the petition, and all written comments
received regarding 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. Subhash Gupta, Biotechnologist,
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 October 17, 1996, the Animal and Plant Health Inspection Service
(APHIS) received a petition (APHIS Petition No. 96-291-01p) from the
Dekalb Genetics Corporation (Dekalb) of Mystic, CT, seeking a
determination that a corn line designated as DBT418 that has been
genetically engineered for lepidopteran insect resistance does not
present a plant pest risk and, therefore, is not a regulated article
under APHIS' regulations in 7 CFR part 340.
On November 27, 1996, APHIS published a notice in the Federal
Register (61 FR 60257-60258, Docket No. 96-079-1) announcing that the
Dekalb 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 corn line and food products derived from it. In the notice,
APHIS solicited written comments from the public as to whether this
corn line posed a plant pest risk. The comments were to have been
received by APHIS on or before January 27, 1997. During the designated
60-day comment period, APHIS received one comment on the subject
petition from a university. The comment was favorable to the petition.
Analysis
Corn line DBT418 has been genetically engineered to express a
CryIA(c) insect control protein derived from the common soil bacterium
Bacillus thuringiensis subsp. kurstaki (Bt). The petitioner states that
the Bt delta-endotoxin protein is effective in controlling the European
corn borer throughout the growing season. The subject corn line also
expresses the bar gene derived from Streptomyces hygroscopicus that
encodes the enzyme phosphinothricin-N-acetyltransferase (PAT), which,
when introduced into the plant cell, confers tolerance to the herbicide
glufosinate. The microprojectile bombardment method was used to
transfer the added genes into the parental corn line, and their
expression is controlled in part by gene sequences from the plant
pathogens Agrobacterium tumefaciens and cauliflower mosaic virus
(CaMV).
The subject corn line has been considered a regulated article under
APHIS' regulations in 7 CFR part 340 because it contains gene sequences
derived from plant pathogens. However, evaluation of field data reports
from field tests of the corn line conducted under APHIS notifications
since 1993 indicates that there were no deleterious effects on plants,
nontarget organisms, or the environment as a result of the
environmental release of corn line DBT418.
Determination
Based on its analysis of the data submitted by Dekalb and a review
of other scientific data, comment received, and field tests of the
subject corn line, APHIS has determined that corn line DBT418: (1)
Exhibits no plant pathogenic properties; (2) is no more likely to
become a weed than insect resistant corn lines developed by traditional
breeding techniques; (3) is unlikely to increase the weediness
potential for any other cultivated or wild species with which it 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 corn or other
crops when cultivated. Therefore, APHIS has concluded that the subject
corn line and any progeny derived from hybrid crosses with other
nontransformed corn varieties will be as safe to grow as corn in
traditional breeding programs that are not subject to regulation under
7 CFR part 340.
The effect of this determination is that Dekalb's corn line DBT418
is no longer considered a regulated article 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
[[Page 17144]]
movement of the subject corn line or its progeny. However, importation
of corn line DBT418 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 Dekalb's corn line DBT418 and lines developed from
it 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 3rd day of April 1997.
Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-9066 Filed 4-8-97; 8:45 am]
BILLING CODE 3410-34-P
