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Monsanto Co.; Availability of Environmental Assessment for Extension of Determination of Nonregulated Status for Potato Genetically Engineered for Insect and Virus Resistance

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Animal and Plant Health Inspection Service, USDA.




We are advising the public that an environmental assessment has been prepared for a proposed decision to extend to one additional potato line Start Printed Page 11759our 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.


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


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​ppd/​rad/​webrepor.html.

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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:

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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 § 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 § 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.


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.


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.

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Done in Washington, DC, this 29th day of February 2000.

Bobby R. Acord,

Acting Administrator, Animal and Plant Health Inspection Service.

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[FR Doc. 00-5353 Filed 3-3-00; 8:45 am]