[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
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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 
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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]
BILLING CODE 3410-34-P