Pioneer Hi-Bred International, Inc.; Availability of Determination of Nonregulated Status for Corn Genetically Engineered for Male Sterility and Glufosinate Herbicide Tolerance

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 98-009-2]

Pioneer Hi-Bred International, Inc.; Availability of

Determination of Nonregulated Status for Corn Genetically Engineered

for Male Sterility and 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 the

Pioneer Hi-Bred International, Inc., corn lines designated as 676, 678,

and 680, which have been genetically engineered for male sterility and

tolerance to the herbicide glufosinate as a marker, are no longer

considered regulated articles under our regulations governing the

introduction of certain genetically engineered organisms. Our

determination is based on our evaluation of data submitted by Pioneer

Hi-Bred International, Inc., in its petition for a determination of

nonregulated status and an analysis of other scientific data. This

notice also announces the availability of our written determination

document and its associated environmental assessment and finding of no

significant impact.

EFFECTIVE DATE: May 14, 1998.

ADDRESSES: The determination, an environmental assessment and finding

of no significant impact, and 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 to facilitate entry

into the reading room.

FOR FURTHER INFORMATION CONTACT: Dr. Subhash Gupta, Biotechnology and

Biological Analysis, 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 December 8, 1997, the Animal and Plant Health Inspection Service

(APHIS) received a petition (APHIS Petition No. 97-342-01p) from

Pioneer Hi-Bred International, Inc. (Pioneer), of Johnston, IA, seeking

a determination that corn lines designated as 676, 678, and 680, which

have been genetically engineered for male sterility and tolerance to

the herbicide glufosinate as a marker, do not present a plant pest risk

and, therefore, are not regulated articles under APHIS regulations in 7

CFR part 340.

On February 18, 1998, APHIS published a notice in the Federal

Register (63 FR 8161-8162, Docket No. 98-009-1) announcing that the

Pioneer 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

corn lines 676, 678, and 680 and food products derived from them. In

the notice, APHIS solicited written comments from the public as to

whether these corn lines posed a plant pest risk. The comments were to

have been received by APHIS on or before April 20, 1998. APHIS received

no comments on the subject petition during the designated 60-day

comment period.

Analysis

Corn lines 676, 678, and 680 have been genetically engineered to

contain a dam gene derived from Escherichia coli. The dam gene

expresses a DNA adenine methylase enzyme in specific plant tissue,

which results in the inability of the transformed plants to produce

anthers or pollen. The subject corn lines also contain the pat

selectable marker gene isolated from the bacterium Streptomyces

viridochromogenes. The pat gene encodes a phosphinothricin

acetyltransferase (PAT) enzyme, which, when introduced into a plant

cell, inactivates glufosinate. Linkage of the dam gene, which induces

male sterility, with the pat gene, a glufosinate tolerance gene used as

a marker, enables identification of the male sterile line for the

production of hybrid seed. The subject corn lines were transformed by

the particle gun process, and expression of the introduced genes is

controlled in part by gene sequences derived from the plant pathogen

cauliflower mosaic virus.

Corn lines 676, 678, and 680 have been considered regulated

articles under APHIS regulations in 7 CFR part 340 because they contain

regulatory gene sequences derived from a plant pathogen. However,

evaluation of field data reports from field tests of the subject corn

lines conducted under APHIS notifications since 1995 indicates that

there were no deleterious effects on plants, nontarget organisms, or

the environment as a result of the environmental release of these corn

lines.

Determination

Based on its analysis of the data submitted by Pioneer and a review

of other scientific data and field tests of the subject corn lines,

APHIS has determined that corn lines 676, 678, and 680: (1) Exhibit no

plant pathogenic properties; (2) are no more likely to become a weed

than corn lines developed by traditional breeding techniques; (3) are

unlikely to increase the weediness potential for any other cultivated

or wild species with which they can interbreed; (4) will not cause

damage to raw or processed agricultural commodities; and (5) will not

harm threatened or endangered species or other organisms, such as bees,

that are beneficial to agriculture. Therefore, APHIS has concluded that

corn lines 676, 678, and 680 and any progeny derived from hybrid

crosses with other corn varieties will not exhibit new plant pest

properties, i.e., properties substantially different from any observed

for the subject corn lines already field tested, or those observed for

corn in traditional breeding programs.

The effect of this determination is that Pioneer's corn lines

designated as 676, 678, and 680 are no longer considered regulated

articles under APHIS'

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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 movement of Pioneer's corn

lines 676, 678, or 680 or their progeny. However, the importation of

the subject corn lines 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 (NEPA), as amended (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 Pioneer's corn lines 676, 678, and 680 and lines

developed from them 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 May 1998.

Charles P. Schwalbe,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 98-14260 Filed 5-28-98; 8:45 am]

BILLING CODE 3410-34-P