[Federal Register Volume 65, Number 44 (Monday, March 6, 2000)]
[Notices]
[Pages 11758-11759]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5353]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 99-036-1]


Monsanto Co.; Availability of Environmental Assessment for 
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 that an environmental assessment 
has been prepared for a proposed decision to extend to one additional 
potato line

[[Page 11759]]

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. We are making this environmental assessment 
available to the public for review and comment.

DATES: We will consider all comments that we receive by April 5, 2000.

ADDRESSES: Please send your comment and three copies to: Docket No. 99-
036-1, Regulatory Analysis and Development, PPD, APHIS, Suite 3C03, 
4700 River Road Unit 118, Riverdale, MD 20737-1238.
    Please state that your comment refers to Docket No. 99-036-1.
    You may read any comments that we receive on this docket in our 
reading room. The reading room is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue, SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 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.
    APHIS documents published in the Federal Register, and related 
information, including the names of organizations and individuals who 
have commented on APHIS dockets, are available on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: Dr. James White, Biotechnology 
Assessments Section, 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, 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 Russet Burbank line 
RBMT22-82 (RBMT22-82), which has been genetically engineered for 
resistance to the Colorado potato beetle (CPB) and potato leaf roll 
virus (PLRV). The Monsanto request seeks an extension of a 
determination of nonregulated status issued for NewLeaf  Plus 
Russet Burbank potato lines RBMT21-129 and RBMT21-350 in response to 
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 requests 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.

Analysis

    Like the antecedent organism, 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 potato line RBMT22-82 is similar to the antecedent 
organism RBMT21-129 in APHIS petition number 97-204-01p, and we are 
proposing that this line should no longer be regulated under the 
regulations in 7 CFR part 340.
    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.
    Should APHIS approve Monsanto's request for an extension of a 
determination of nonregulated status, potato line RBMT22-82 would 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 would no longer apply to the field 
testing, importation, or interstate movement of the subject potato line 
or its progeny.

National Environmental Policy Act

    An environmental assessment (EA) has been prepared to examine any 
potential environmental impacts associated with this proposed extension 
of a determination of nonregulated status. 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). Copies of Monsanto's extension request and 
the EA are available upon request from the individual listed under FOR 
FURTHER INFORMATION CONTACT.

    Done in Washington, DC, this 29th day of February 2000.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 00-5353 Filed 3-3-00; 8:45 am]
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