[Federal Register Volume 64, Number 45 (Tuesday, March 9, 1999)]
[Notices]
[Pages 11434-11435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5780]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 98-067-2]
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 Monsanto Company, which have been genetically
engineered for resistance to the Colorado potato beetle and potato
virus Y, 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 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: February 25, 1999.
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,
[[Page 11435]]
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. David Heron, Biotechnology and
Biological Analysis, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 147,
Riverdale, MD 20737-1236; (301) 734-5141. 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:
Kay.Peterson@usda.gov.
SUPPLEMENTARY INFORMATION:
Background
On December 5, 1997, the Animal and Plant Health Inspection Service
(APHIS) received a petition (APHIS Petition No. 97-339-01p) from
Monsanto Company (Monsanto) of St. Louis, MO, seeking a determination
that four NewLeaf Y potato lines, which have been
genetically engineered for resistance to the Colorado potato beetle
(CPB) and potato virus Y (PVY) 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 one of the four
NewLeaf Y potato lines, Hilite line HLMT15-46, be withdrawn
from consideration in the subject petition.
On July 20, 1998, APHIS published a notice in the Federal Register
(63 FR 38805-38806, Docket No. 98-067-1) 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 September 18, 1998. During the designated 60-day
comment period, APHIS received 6 comments from potato growers and State
and national trade associations. All of the comments were in support of
the subject petition.
The subject three NewLeaf Y potato lines include one
line of Russet Burbank (RBMT15-101) and two lines of Shepody (SEMT15-02
and SEMT15-15). These three potato lines have been genetically
engineered to contain the cry3A gene derived from Bacillus
thuringiensis subsp. tenebrionis (BTT), which encodes a protein that is
insecticidal to CPB, and the PVY coat protein gene (PVYcp), which
imparts resistance to PVY. In addition to the cry3A gene and the PVYcp
gene, the subject potato lines contain and express the nptII gene,
which is used as a selectable marker in the early stages of plant
selection. While the two Shepody lines (SEMT15-02 and SEMT15-15) also
contain the aad marker gene, tests indicate that this gene is not
expressed in the potato plants. 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.
Russet Burbank potato line RBMT15-101 and Shepody potato lines
SEMT15-02 and SEMT15-15 have been considered regulated articles under
APHIS' regulations in 7 CFR part 340 because they contain gene
sequences derived from plant pathogens. These potato lines have been
evaluated in field trials conducted since 1993 under APHIS
notifications. In reviewing the notifications, APHIS determined that
these field trials, which were conducted under reproductive and
physical containment, would not present a risk of plant pest
introduction or dissemination.
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 line RBMT15-101 and
Shepody potato lines SEMT15-02 and SEMT15-15: (1) Exhibit no plant
pathogenic properties and will not pose an increased plant pest risk
from the appearance of new plant viruses; (2) are no more likely to
become weeds than pest-resistant potato lines developed by traditional
plant breeding; (3) are unlikely to increase the weediness potential
for any other cultivated or wild species with which they can
interbreed; (4) will not harm threatened or endangered species or other
organisms, such as bees, that are beneficial to agriculture; and (5)
will not cause damage to raw or processed agricultural commodities.
Therefore, APHIS has concluded that the subject 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 line RBMT15-101 and Shepody potato lines SEMT15-02 and SEMT15-15
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 Russet Burbank potato line
RBMT15-101 and Shepody potato lines SEMT15-02 and SEMT15-15 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 Monsanto's Russet Burbank potato line RBMT15-101 and
Shepody potato lines SEMT15-02 and SEMT15-15 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 3rd day of March, 1999.
Joan M. Arnoldi,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 99-5780 Filed 3-8-99; 8:45 am]
BILLING CODE 3410-34-P
