[Federal Register Volume 61, Number 15 (Tuesday, January 23, 1996)]
[Notices]
[Pages 1744-1745]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-872]
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DEPARTMENT OF AGRICULTURE
[Docket No. 95-059-2]
Dekalb Genetics Corporation; Availability of Determination of
Nonregulated Status for Corn Line Genetically Engineered for
Glufosinate Herbicide Tolerance
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public of our determination that a corn
line developed by the Dekalb Genetics Corporation designated as B16
that has been genetically engineered for tolerance to the herbicide
glufosinate 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: December 19, 1995.
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. Keith Reding, Biotechnologist,
Biotechnology Permits, BBEP, APHIS, 4700 River Road, Unit 147,
Riverdale, MD 20737-1237; (301) 734-7612. To obtain a copy of the
determination or the environmental assessment and finding of no
significant impact, contact Ms. Kay Peterson at (301) 734-7612.
SUPPLEMENTARY INFORMATION:
Background
On May 25, 1995, the Animal and Plant Health Inspection Service
(APHIS) received a petition (APHIS Petition No. 95-145-01p) from the
Dekalb Genetics Corporation (Dekalb) of Mystic, CT, seeking a
determination that a corn line designated as B16 that has been
genetically engineered for tolerance to the herbicide glufosinate does
not present a plant pest risk and, therefore, is not a regulated
article under APHIS' regulations in 7 CFR part 340.
On August 1, 1995, APHIS published a notice in the Federal Register
(60 FR 39146-39147, Docket No. 95-059-1) 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 the subject
corn line posed a plant pest risk. The comments were to have been
received by APHIS on or before October 2, 1995.
APHIS received a total of six comments on the subject petition from
universities, State departments of agriculture, and an agency of the
U.S. government. None of the commenters expressed opposition to the
subject petition.
Analysis
Corn line B16 has been genetically engineered with a modified
version of the bar gene from Streptomyces hygroscopicus that encodes a
phosphinothricin acetyltransferase (PAT) enzyme. When introduced into
the plant cell, the PAT enzyme can inactivate glufosinate herbicides.
The bar gene was introduced into the subject corn line by
microprojectile bombardment, and its expression is under the control of
the 35S promoter derived from the plant pathogen cauliflower mosaic
virus and the Tr7 terminator from Agrobacterium tumefaciens.
Corn line B16 has been considered a regulated article under APHIS'
regulations in 7 CFR part 340 because it contains regulatory gene
sequences derived from the plant pathogens mentioned above. However,
evaluation of field data reports from field tests of the subject corn
line conducted under APHIS permits or notifications since 1991
indicates that there were no deleterious effects on plants, nontarget
organisms, or the environment as a result of the subject corn plants'
release into the environment.
Determination
Based on its analysis of the data submitted by Dekalb and a review
of other scientific data, comments received, and field tests of the
subject corn line, APHIS has determined that corn line B16: (1)
Exhibits no plant pathogenic properties; (2) is no more likely to
become a weed than corn 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
harm other organisms, including agriculturally beneficial organisms and
threatened and endangered species; and (5) should not cause damage to
raw or processed agricultural commodities. Therefore, APHIS has
concluded that corn line B16 and any progeny derived from hybrid
crosses with other nontransformed corn varieties will be just as safe
to grow as traditionally bred corn lines that are not regulated under 7
CFR part 340.
The effect of this determination is that a corn line designated as
B16 is no
[[Page 1745]]
longer considered a regulated article under APHIS' regulations in 7 CFR
part 340. Therefore, the notification requirements pertaining to
regulated articles under those regulations no longer apply to the field
testing, importation, or interstate movement of corn line B16 or its
progeny. However, the importation of the subject corn line or seeds
capable of propagation is 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 (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; 60 FR 6000-6005, February 1, 1995). Based
on that EA, APHIS has reached a finding of no significant impact
(FONSI) with regard to its determination that corn line B16 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 17th day of January 1996.
Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-872 Filed 1-22-96; 8:45 am]
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