Northrup King Co.; Availability of Determination of Nonregulated Status for Corn Line Genetically Engineered for Insect Resistance

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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