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

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

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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]

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