[Federal Register Volume 62, Number 109 (Friday, June 6, 1997)]
[Notices]
[Pages 31062-31063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14876]
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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. 62, No. 109 / Friday, June 6, 1997 /
Notices
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 96-095-2]
Monsanto Co.; 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
Monsanto Company's corn line designated as MON 802, which has been
genetically engineered for insect resistance and glyphosate herbicide
tolerance, 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 Monsanto Company 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 27, 1997.
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
requested to call before visiting on (202) 690-2817 to facilitate entry
into the reading room.
FOR FURTHER INFORMATION CONTACT: Dr. James Lackey, BSS, PPQ, APHIS,
4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-8713. 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 November 12, 1996, the Animal and Plant Health Inspection
Service (APHIS) received a petition (APHIS Petition No. 96-317-01p)
from the Monsanto Company (Monsanto) of St. Louis, MO, seeking a
determination that a corn line designated as MON 802, which has been
genetically engineered for insect resistance and glyphosate herbicide
tolerance, does not present a plant pest risk and, therefore, is not a
regulated article under APHIS' regulations in 7 CFR part 340.
On December 18, 1996, APHIS published a notice in the Federal
Register (61 FR 66650-66651, Docket No. 96-095-1) announcing that the
Monsanto 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 February 18, 1997. APHIS received no
comments on the subject petition during the designated 60-day comment
period.
Analysis
Corn line MON 802 has been genetically engineered to express a
CryIA(b) insect control protein derived from the common soil bacterium
Bacillus thuringiensis subsp. kurstaki (Bt). The petitioner stated that
the Bt delta-endotoxin protein is effective in protecting the subject
corn line from damage caused by the European corn borer throughout the
growing season. The subject corn line also expresses the CP4 EPSPS
protein isolated from Agrobacterium sp. strain CP4 and the GOX protein
cloned from Achromobacter sp. strain LBAA, which, when introduced into
the plant cell, confer tolerance to the herbicide glyphosate. The
particle acceleration method was used to transfer the added genes into
the parental corn line, and their expression is controlled in part by
the intron from the corn hsp70 gene and by gene sequences from the
plant pathogens Agrobacterium tumefaciens and cauliflower mosaic virus.
The nptII selectable marker gene is present in the subject corn line
under the control of a bacterial promoter, but is not expressed in the
plant.
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 MON 802.
Determination
Based on its analysis of the data submitted by Monsanto, a review
of other scientific data, and field tests of the subject corn line,
APHIS has determined that corn line MON 802: (1) Exhibits no plant
pathogenic properties; (2) is no more likely to become a weed than 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 Monsanto's corn line MON
802 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 movement of the subject corn
line or its progeny. However, importation of corn line MON 802 or seeds
capable of
[[Page 31063]]
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 Monsanto's corn line MON 802 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 30th day of May 1997.
Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-14876 Filed 6-5-97; 8:45 am]
BILLING CODE 3410-34-P
