[Federal Register Volume 62, Number 68 (Wednesday, April 9, 1997)]
[Notices]
[Pages 17143-17144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-9066]


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 Notices
                                                 Federal Register
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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 
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 delegations of authority, filing of petitions and applications and agency 
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  Federal Register / Vol. 62, No. 68 / Wednesday, April 9, 1997 / 
Notices  

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 96-079-2]


Dekalb Genetics Corp.; Availability of Determination of 
Nonregulated Status for Genetically Engineered Corn

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that the 
Dekalb Genetics Corporation's corn line designated as DBT418 that has 
been genetically engineered for lepidopteran 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 
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: March 28, 1997.

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, 
BSS, PPQ, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; 
(301) 734-8761. To obtain a copy of the determination or the 
environmental assessment and finding of no significant impact, contact 
Ms. Kay Peterson at (301) 734-4885; e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    On October 17, 1996, the Animal and Plant Health Inspection Service 
(APHIS) received a petition (APHIS Petition No. 96-291-01p) from the 
Dekalb Genetics Corporation (Dekalb) of Mystic, CT, seeking a 
determination that a corn line designated as DBT418 that has been 
genetically engineered for lepidopteran insect resistance does not 
present a plant pest risk and, therefore, is not a regulated article 
under APHIS' regulations in 7 CFR part 340.
    On November 27, 1996, APHIS published a notice in the Federal 
Register (61 FR 60257-60258, Docket No. 96-079-1) 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 this 
corn line posed a plant pest risk. The comments were to have been 
received by APHIS on or before January 27, 1997. During the designated 
60-day comment period, APHIS received one comment on the subject 
petition from a university. The comment was favorable to the petition.

Analysis

    Corn line DBT418 has been genetically engineered to express a 
CryIA(c) insect control protein derived from the common soil bacterium 
Bacillus thuringiensis subsp. kurstaki (Bt). The petitioner states that 
the Bt delta-endotoxin protein is effective in controlling the European 
corn borer throughout the growing season. The subject corn line also 
expresses the bar gene derived from Streptomyces hygroscopicus that 
encodes the enzyme phosphinothricin-N-acetyltransferase (PAT), which, 
when introduced into the plant cell, confers tolerance to the herbicide 
glufosinate. The microprojectile bombardment method was used to 
transfer the added genes into the parental corn line, and their 
expression is controlled in part by gene sequences from the plant 
pathogens Agrobacterium tumefaciens and cauliflower mosaic virus 
(CaMV).
    The subject corn line has been considered a regulated article under 
APHIS' regulations in 7 CFR part 340 because it contains gene sequences 
derived from plant pathogens. However, evaluation of field data reports 
from field tests of the corn line conducted under APHIS notifications 
since 1993 indicates that there were no deleterious effects on plants, 
nontarget organisms, or the environment as a result of the 
environmental release of corn line DBT418.

Determination

    Based on its analysis of the data submitted by Dekalb and a review 
of other scientific data, comment received, and field tests of the 
subject corn line, APHIS has determined that corn line DBT418: (1) 
Exhibits no plant pathogenic properties; (2) is no more likely to 
become a weed than insect resistant corn lines 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 cause damage to raw or processed agricultural 
commodities; (5) will not harm threatened or endangered species or 
other organisms, such as bees, that are beneficial to agriculture; and 
(6) should not reduce the ability to control insects in corn or other 
crops when cultivated. Therefore, APHIS has concluded that the subject 
corn line and any progeny derived from hybrid crosses with other 
nontransformed corn varieties will be as safe to grow as corn in 
traditional breeding programs that are not subject to regulation under 
7 CFR part 340.
    The effect of this determination is that Dekalb's corn line DBT418 
is no longer considered a regulated article under APHIS' regulations in 
7 CFR part 340. Therefore, the requirements pertaining to regulated 
articles under those regulations no longer apply to the field testing, 
importation, or interstate

[[Page 17144]]

movement of the subject corn line or its progeny. However, importation 
of corn line DBT418 or seeds capable of propagation are 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, as amended (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). Based on that EA, APHIS has 
reached a finding of no significant impact (FONSI) with regard to its 
determination that Dekalb's corn line DBT418 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 3rd day of April 1997.
Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-9066 Filed 4-8-97; 8:45 am]
BILLING CODE 3410-34-P