[Federal Register Volume 63, Number 242 (Thursday, December 17, 1998)]
[Notices]
[Pages 69610-69611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33435]
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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. 242 / Thursday, December 17, 1998 /
Notices
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 97-094-2]
Monsanto Co.; Availability of Determination of Nonregulated
Status for Potato Genetically Engineered for Insect and Virus
Resistance
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public of our determination that certain
potato lines developed by the Monsanto Company, which have been
genetically engineered for insect and virus resistance, 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 the
Monsanto Company 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 Monsanto Company'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: December 3, 1998.
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 requested to
call before visiting on (202) 690-2817 to facilitate entry into the
reading room.
FOR FURTHER INFORMATION CONTACT: Dr. James White, Biotechnology and
Biological Analysis, PPQ, APHIS, 4700 River Road Unit 147, Riverdale,
MD 20737-1236; (301) 734-5940. 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 July 23, 1997, the Animal and Plant Health Inspection Service
(APHIS) received a petition (APHIS Petition No. 97-204-01p) from the
Monsanto Company (Monsanto) of St. Louis, MO, seeking a determination
that seven NewLeaf Plus Russet Burbank potato lines, which
have been genetically engineered for resistance to the Colorado potato
beetle (CPB) and potato leaf roll virus (PLRV), do not present a plant
pest risk and, therefore, are not regulated articles under APHIS'
regulations in 7 CFR part 340. Subsequently, Monsanto requested that
all but two (RBMT21-129 and RBMT21-350) of the NewLeaf Plus
Russet Burbank potato lines be withdrawn from consideration in the
subject petition.
On November 20, 1997, APHIS published a notice in the Federal
Register (62 FR 61961-61962, Docket No. 97-094-1) 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 potato lines and food products derived from them. In the
notice, APHIS solicited written comments from the public as to whether
these potato lines posed a plant pest risk. The comments were to have
been received by APHIS on or before January 20, 1998. During the
designated 60-day comment period, APHIS received 14 comments from the
following: Potato farmers and processors; State and national trade
associations; a State congressional delegation; the U.S. Department of
Agriculture's Agricultural Research Service; a research entomologist
from a university agricultural research center; and a European crop
research institute. All of the comments were in support of the subject
petition.
Analysis
Russet Burbank potato lines RBMT21-129 and RBMT21-350 have been
genetically engineered to contain the cryIIIA gene derived from
Bacillus thuringiensis subsp. tenebrionis (Btt), which encodes an
insecticidal protein that is effective against CPB, and the orf1/orf2
gene derived from PLRV, which imparts resistance to PLRV. In addition
to the cryIIIA gene and the orf1/orf2 gene, these potato lines contain
the nptII gene, which encodes the NPTII protein used as a selectable
marker in the initial stages of plant transformation. The subject
potato lines were developed through use of the Agrobacterium
tumefaciens transformation method, and expression of the added genes is
controlled in part by gene sequences derived from the plant pathogens
A. tumefaciens and figwort mosaic virus.
The subject potato lines have been considered regulated articles
under APHIS' regulations in 7 CFR part 340 because they contain gene
sequences derived from plant pathogens. However, evaluation of field
data reports from field tests of these potato lines conducted under
APHIS permits and notifications since 1994 indicates that there were no
deleterious effects on plants, nontarget organisms, or the environment
as a result of the environmental release of the subject potato plants.
Determination
Based on its analysis of the data submitted by Monsanto, a review
of other scientific data and field tests of the subject potato lines,
and an analysis of comments from the public on the subject petition,
APHIS has determined that Russet Burbank potato lines RBMT21-129 and
RBMT21-350:
(1) Exhibit no plant pathogenic properties; (2) are no more likely
to become a weed than pest-resistant potato 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, or have an adverse impact on the ability to
control nontarget insect pests.
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Therefore, APHIS has concluded that the subject Russet Burbank potato
lines and any progeny derived from crosses with other potato varieties
will be as safe to grow as potatoes that are not subject to regulation
under 7 CFR part 340.
The effect of this determination is that Monsanto's Russet Burbank
potato lines RBMT21-129 and RBMT21-350 are no longer considered
regulated articles 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 potato lines or their progeny.
However, importation of the subject potato 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, 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 Russet Burbank potato lines RBMT21-129
and RBMT21-350 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 14th day of December 1998.
Joan M. Arnoldi,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 98-33435 Filed 12-16-98; 8:45 am]
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