[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]
BILLING CODE 3410-34-P