[Federal Register Volume 61, Number 96 (Thursday, May 16, 1996)]
[Notices]
[Pages 24755-24757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12332]



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DEPARTMENT OF AGRICULTURE
[Docket No. 95-090-2]


Monsanto Company; Availability of Determination of Nonregulated 
Status for Potato Lines Genetically Engineered for Insect 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 that have been 
genetically engineered for resistance to the Colorado potato beetle are 
no longer considered regulated articles under our regulations governing 
the introduction

[[Page 24756]]

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: May 3, 1996.

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 asked to call 
in advance of visiting at (202) 690-2817.

FOR FURTHER INFORMATION CONTACT: Dr. James Lackey, Biotechnology 
Permits, BBEP, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-
1237; (301) 734-7612. To obtain a copy of the determination or the 
environmental assessment and finding of no significant impact, contact 
Ms. Kay Peterson at (301) 734-7612; e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    On December 4, 1995, the Animal and Plant Health Inspection Service 
(APHIS) received a petition (APHIS Petition No. 95-338-01p) from the 
Monsanto Company (Monsanto) of St. Louis, MO, seeking a determination 
that two Superior potato lines (SPBT02-5 and SPBT02-7) that have been 
genetically engineered for resistance to the Colorado potato beetle 
(CPB) do not present a plant pest risk and, therefore, are not 
regulated articles under APHIS' regulations in 7 CFR part 340. On 
December 15, 1995, APHIS received Monsanto's amendment to APHIS 
Petition No. 95-338-01p to include five additional genetically 
engineered, CPB-resistant Atlantic potato lines (ATBT04-6, ATBT04-27, 
ATBT04-30, ATBT04-31, and ATBT04-36).
    On January 22, 1996, APHIS published a notice in the Federal 
Register (61 FR 1557-1558, Docket No. 95-090-1) 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 March 22, 1996. During the 
designated 60-day comment period, APHIS received three comments on the 
subject petition, all of which were from potato growers, and all of 
which were favorable to the petition.

Analysis

    Monsanto's two Superior potato lines and five Atlantic potato lines 
have been genetically engineered to contain the cryIIIA gene from the 
common soil bacterium Bacillus thuringiensis subsp. tenebrionis (Btt), 
which encodes a delta-endotoxin insect control protein that is 
effective against CPB. The subject potato lines also contain the nptII 
gene from the prokaryotic transposon Tn5, which encodes the enzyme 
neomycin phosphotransferase II and is used as a selectable marker for 
transformation. Expression of the added genes is controlled in part by 
35S promoters from the plant pathogen cauliflower mosaic virus and the 
3' region of the nopaline synthase gene from the plant pathogen 
Agrobacterium tumefaciens. The genes used to develop the subject potato 
lines were stably transferred into the genome of potato plants through 
the use of the A. tumefaciens transformation system. The parental 
Superior and Atlantic potato varieties are male fertile, as are the 
subject potato lines.
    The subject Superior and Atlantic potato lines have been considered 
regulated articles under APHIS' regulations in 7 CFR part 340 because 
they contain regulatory gene sequences derived from plant pathogens. 
However, evaluation of field data reports from field tests of the 
subject potato lines conducted under APHIS permits or notifications 
since 1992 indicates that there were no deleterious effects on plants, 
nontarget organisms, or the environment as a result of the release of 
these potato lines into the environment.

Determination

    Based on its analysis of the data submitted by Monsanto and a 
review of other scientific data, comments received, and field tests of 
the subject potato lines, APHIS has determined that these potato lines: 
(1) Exhibit no plant pathogenic properties; (2) are no more likely to 
become weeds than potatoes 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. Therefore, 
APHIS has concluded that the subject Superior and Atlantic potato lines 
and any progeny derived from hybrid crosses with other nontransformed 
potato varieties will be as safe to grow as potatoes in traditional 
breeding programs that are not subject to regulation under 7 CFR part 
340.
    The effect of this determination is that Monsanto's Superior potato 
lines SPBT02-5 and SPBT02-7 and Atlantic potato lines ATBT04-6, ATBT04-
27, ATBT04-30, ATBT04-31, and ATBT04-36 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 (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 Superior potato lines SPBT02-5 and 
SPBT02-7 and Atlantic potato lines ATBT04-6, ATBT04-27, ATBT04-30, 
ATBT04-31, and ATBT04-36, 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.


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    Done in Washington, DC, this 9th day of May 1996.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-12332 Filed 5-15-96; 8:45 am]
BILLING CODE 3410-34-P