[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 
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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.

[[Page 69611]]

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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