[Federal Register Volume 61, Number 19 (Monday, January 29, 1996)]
[Notices]
[Pages 2789-2790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1507]
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Notices
Federal Register
________________________________________________________________________
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. 61, No. 19 / Monday, January 29, 1996 /
Notices
[[Page 2789]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 95-067-2]
Northrup King Co.; Availability of Determination of Nonregulated
Status for Corn Line Genetically Engineered for Insect Resistance
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 Northrup King Company designated as Bt11 that has
been genetically engineered for 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
Northrup King Company 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 Northrup King Company'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: January 18, 1996.
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,
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 July 14, 1995, the Animal and Plant Health Inspection Service
(APHIS) received a petition (APHIS Petition No. 95-195-01p) from the
Northrup King Company (Northrup King) of Golden Valley, MN, seeking a
determination that a corn line designated as Bt11 that has been
genetically engineered for resistance to the European corn borer (ECB)
does not present a plant pest risk and, therefore, is not a regulated
article under APHIS' regulations in 7 CFR part 340.
On September 7, 1995, APHIS published a notice in the Federal
Register (60 FR 46573-46574, Docket No. 95-067-1) announcing that the
Northrup King 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 November 6, 1995.
APHIS received a total of 106 comments on the subject petition
during the designated 60-day comment period from seed companies,
individuals, farmers and farm seed dealers, agricultural products
companies, State departments of agriculture, an agricultural council, a
growers association, and a university. All of the comments were
favorable to the petition.
Analysis
Corn line Bt11 has been genetically engineered to contain the
cryIA(b) gene from Bacillus thuringiensis subsp. kurstaki (Btk), which
expresses a delta-endotoxin insecticidal protein known to be effective
against certain lepidopteran insects, including ECB. Corn line Bt11
also contains the pat gene isolated from Streptomyces viridochromogenes
that encodes a selectable marker, the phosphinothricin-N-
acetyltransferase (PAT) enzyme. When introduced into the plant cell,
the PAT enzyme can inactivate glufosinate herbicides. Expression of the
introduced genes is controlled by the 35S promoter derived from the
plant pathogen cauliflower mosaic virus and a NOS terminator derived
from the nopaline synthase gene of Agrobacterium tumefaciens.
Corn line Bt11 has been considered a regulated article under APHIS'
regulations in 7 CFR part 340 because it contains regulatory gene
sequences derived from plant pathogens. However, evaluation of field
data reports from field tests of the subject corn line conducted under
APHIS permits or notifications since 1992 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 Northrup King and a
review of other scientific data, comments received, and field tests of
the subject corn line, APHIS has determined that corn line Bt11: (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) should not
cause damage to raw or processed agricultural commodities; (5) will not
harm other organisms, including agriculturally beneficial organisms and
threatened and endangered species; and (6) should not reduce the
ability to control insects in corn and other crops. Therefore, APHIS
has concluded that corn line Bt11 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
Bt11 is no longer considered a regulated article
[[Page 2790]]
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 Bt11 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 Bt11 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 22nd day of January 1996.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-1507 Filed 1-26-96; 8:45 am]
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