[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
appearing in this section.
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Federal Register / Vol. 63, No. 103 / Friday, May 29, 1998 /
Notices
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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:
mkpeterson@aphis.usda.gov.
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
