SnowBall archive 8.96-97


GE - GMO potatoes deregulated by USDA

[Federal Register: December 17, 1998
(Volume 63, Number 242)]     [Notices]
[Page 69610-69611]
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
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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:
    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.
    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.
    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.
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
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
    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]
The above information was sent to you by:
Jack L. Cooper
Food Industry Environmental Network (FIEN)
33 Falling Creek Court; Silver Spring, Maryland 20904
Phone: 301/384-8287 --- Fax: 301/384-8340 ---
World Wide Web Site: <>