[Federal Register Volume 63, Number 103 (Friday, May 29, 1998)]
[Notices]
[Pages 29369-29370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14260]


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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 
 and investigations, committee meetings, agency decisions and rulings, 
 delegations of authority, filing of petitions and applications and agency 
 statements of organization and functions are examples of documents 
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  Federal Register / Vol. 63, No. 103 / Friday, May 29, 1998 / 
Notices  

[[Page 29369]]


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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'

[[Page 29370]]

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