[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.P[email protected].

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]
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