[Federal Register Volume 65, Number 116 (Thursday, June 15, 2000)]
[Notices]
[Pages 37516-37517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-15152]



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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 99-036-2]


Monsanto Co.; Extension 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 decision to extend to one 
additional potato line our determination that certain potato lines 
developed by 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 decision is based on our 
evaluation of data submitted by Monsanto Company in its request for an 
extension of a determination of nonregulated status, an analysis of 
other scientific data, and comments received from the public in 
response to a previous notice. This notice also announces the 
availability of our finding of no significant impact.

EFFECTIVE DATE: July 17, 2000.

ADDRESSES: The extension request, an environmental assessment and 
finding of no significant impact, and all comments received may be read 
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. To be sure someone is there to help you, 
please call (202) 690-2817 before coming.

FOR FURTHER INFORMATION CONTACT: Dr. James White, Biotechnology 
Assessments Section, Permits and Risk Assessments, PPQ, APHIS, Suite 
5B05, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-
5940. To obtain a copy of the extension request or the environmental 
assessment and finding of no significant impact, contact Ms. Kay 
Peterson at (301) 734-4885; e-mail: [email protected].

SUPPLEMENTARY INFORMATION: The regulations in 7 CFR part 340, 
``Introduction of Organisms and Products Altered or Produced Through 
Genetic Engineering Which Are Plant
    Pests or Which There is Reason to Believe Are Plant Pests,'' 
regulate, among other things, the introduction (importation, interstate 
movement, or release into the environment) of organisms and products 
altered or produced through genetic engineering that are plant pests or 
that there is reason to believe are plant pests. Such genetically 
engineered organisms and products are considered ``regulated 
articles.''
    The regulations in Sec. 340.6(a) provide that any person may submit 
a petition to the Animal and Plant Health Inspection Service (APHIS) 
seeking a determination that an article should not be regulated under 7 
CFR part 340. Further, the regulations in Sec. 340.6(e)(2) provide that 
a person may request that APHIS extend a determination of nonregulated 
status to other organisms. Such a request must include information to 
establish the similarity of the antecedent organism and the regulated 
article in question.

Background

    On June 22, 1999, APHIS received a request for an extension of a 
determination of nonregulated status (APHIS No. 99-173-01p) from 
Monsanto Company (Monsanto) of St. Louis, MO, for a Russet Burbank 
potato line designated as NewLeaf Plus line RBMT22-82 
(RBMT22-82), which has been genetically engineered for resistance to 
the Colorado potato beetle (CPB) and potato leaf roll virus (PLRV). 
Monsanto requested an extension of a determination of nonregulated 
status issued previously for NewLeaf Plus Russet Burbank 
potato lines RBMT21-129 and RBMT21-350, APHIS petition number 97-204-
01p (63 FR 69610-69611, December 17, 1998, Docket No. 97-094-2). Based 
on the similarity of RBMT22-82 to RBMT21-129, the antecedent organism, 
Monsanto requested a determination that CPB-and PLRV-resistant potato 
line RBMT22-82 does not present a plant pest risk and, therefore, is 
not a regulated article under APHIS' regulations in 7 CFR part 340.
    On March 6, 2000, APHIS published a notice in the Federal Register 
(65 FR 11758-11759, Docket No. 99-036-1) announcing that an 
environmental assessment for Monsanto's extension request had been 
prepared and was available for public comment. During the designated 
30-day public comment period, APHIS received 10 comments from the 
following sources: State potato commissions, a potato growers 
association, an organic consumers association, the U.S. Department of 
Agriculture's Agricultural Research Service, a State university, a 
State university agricultural experiment station, plant virologists, a 
farmer, and a private individual. Six of the comments were in favor of 
the extension request, and four were in opposition. A majority of the 
commenters expressing support for deregulating potato line RBMT22-82 
stressed its effectiveness in resisting the damage caused by CPB and 
PLRV and the associated benefits of reduced pesticide use. Several 
commenters in opposition to deregulation of the subject potato line 
expressed concern that insufficient safety testing had been done on 
such issues as genetic drift, the development of insect resistance, 
effects on beneficial organisms, and the potential for the development 
of novel plant viruses through expression of parts of viruses from a 
transgene. APHIS identified and addressed these issues in the 
environmental assessment prepared for line RBMT22-82 and in the 
environmental assessment and determination prepared for the antecedent 
organism. In consideration of the comments submitted to us, we have 
included a response to comments as an attachment to our finding of no 
significant impact (FONSI) for the environmental assessment. The 
environmental assessment and the FONSI, including the attachment, are 
available from the person listed under FOR FURTHER INFORMATION CONTACT. 


Analysis

    Like the antecedent organism, potato line RBMT22-82 contains the 
cry3A gene derived from Bacillus thuringiensis subsp. tenebrionis (Btt) 
and the orf1/orf2 gene derived from PLRV. The cry3A gene encodes an 
insecticidal protein that is effective against CPB and the orf1/orf2 
gene imparts resistance to PLRV. Potato line RBMT22-82 also contains 
the CP4 EPSPS selectable marker gene, while the antecedent organism 
contained the nptII selectable marker gene. The subject potato line and 
the antecedent organism were developed through use of the Agrobacterium 
tumefaciens transformation system, and expression of the added genes in 
RBMT22-82 and the antecedent organism is controlled in part by gene 
sequences derived from the plant pathogens figwort mosaic virus and A. 
tumefaciens.
    Potato line RBMT22-82 and the antecedent organism were genetically 
engineered using the same transformation method and with the same genes 
that make the plants insect and virus resistant. Accordingly, we have 
determined that RBMT22-82 is similar to the antecedent organism RBMT21-
129 in APHIS petition 97-204-01p and, therefore, should no longer be 
regulated under the regulations in 7 CFR part 340.

[[Page 37517]]

    The subject potato line has been considered a regulated article 
under APHIS' regulations in 7 CFR part 340 because it contains gene 
sequences derived from plant pathogens. However, evaluation of field 
data reports from field tests of RBMT22-82, 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 its environmental release.

Determination

    Based on an analysis of the data submitted by Monsanto, a review of 
other scientific data, and field tests of the subject potato line, 
APHIS has determined that Russet Burbank potato line RBMT22-82: (1) 
Exhibits no plant pathogenic properties; (2) is no more likely to 
become a weed than similar pest-resistant potatoes developed by 
traditional breeding techniques; (3) is unlikely to increase the 
weediness potential for any other cultivated or wild species with which 
it 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 potato 
line RBMT22-82 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.
    Because APHIS has determined that potato line RBMT22-82 does not 
present a plant pest risk based on its similarity to the antecedent 
organism, Monsanto's potato line RBMT22-82 will no longer be considered 
a regulated article 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 line or its progeny. However, 
importation of potato line RBMT22-82 and 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) was 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 potato line RBMT22-82 and lines developed 
from it 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 9th day of June 2000.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 00-15152 Filed 6-14-00; 8:45 am]
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