Environmental statements; availability, etc.: Nonregulated status determinations Monsanto Co.; genetically engineered potatoes,
FR, March 09, 1999 › Notices › Animal and Plant Health Inspection Service
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Federal Register: March 9, 1999 (Volume 64, Number 45)NoticesPage 11434-11435From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr09mr99-29
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
Docket No. 98-067-2Monsanto 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.
SUMMARY: We are advising the public of our determination that certain potato lines developed by Monsanto Company, which have been genetically engineered for resistance to the Colorado potato beetle and potato virus Y, 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 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: February 25, 1999.
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,
[Page 11435]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. David Heron, Biotechnology and Biological Analysis, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-5141. 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: Kay.Peterson@usda.gov.
SUPPLEMENTARY INFORMATION:
Background
On December 5, 1997, the Animal and Plant Health Inspection Service (APHIS) received a petition (APHIS Petition No. 97-339-01p) from Monsanto Company (Monsanto) of St. Louis, MO, seeking a determination that four NewLeaf<SUP></SUP> Y potato lines, which have been genetically engineered for resistance to the Colorado potato beetle (CPB) and potato virus Y (PVY) 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 one of the four NewLeaf<SUP></SUP> Y potato lines, Hilite line HLMT15-46, be withdrawn from consideration in the subject petition.
On July 20, 1998, APHIS published a notice in the Federal Register (63 FR 38805-38806, Docket No. 98-067-1) 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 September 18, 1998. During the designated 60-day comment period, APHIS received 6 comments from potato growers and State and national trade associations. All of the comments were in support of the subject petition.
The subject three NewLeaf<SUP></SUP> Y potato lines include one line of Russet Burbank (RBMT15-101) and two lines of Shepody (SEMT15-02 and SEMT15-15). These three potato lines have been genetically engineered to contain the cry3A gene derived from Bacillus thuringiensis subsp. tenebrionis (BTT), which encodes a protein that is insecticidal to CPB, and the PVY coat protein gene (PVYcp), which imparts resistance to PVY. In addition to the cry3A gene and the PVYcp gene, the subject potato lines contain and express the nptII gene, which is used as a selectable marker in the early stages of plant selection. While the two Shepody lines (SEMT15-02 and SEMT15-15) also contain the aad marker gene, tests indicate that this gene is not expressed in the potato plants. 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.
Russet Burbank potato line RBMT15-101 and Shepody potato lines SEMT15-02 and SEMT15-15 have been considered regulated articles under APHIS' regulations in 7 CFR part 340 because they contain gene sequences derived from plant pathogens. These potato lines have been evaluated in field trials conducted since 1993 under APHIS notifications. In reviewing the notifications, APHIS determined that these field trials, which were conducted under reproductive and physical containment, would not present a risk of plant pest introduction or dissemination.
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 line RBMT15-101 and Shepody potato lines SEMT15-02 and SEMT15-15: (1) Exhibit no plant pathogenic properties and will not pose an increased plant pest risk from the appearance of new plant viruses; (2) are no more likely to become weeds than pest-resistant potato lines developed by traditional plant breeding; (3) are unlikely to increase the weediness potential for any other cultivated or wild species with which they can interbreed; (4) will not harm threatened or endangered species or other organisms, such as bees, that are beneficial to agriculture; and (5) will not cause damage to raw or processed agricultural commodities. Therefore, APHIS has concluded that the subject 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 line RBMT15-101 and Shepody potato lines SEMT15-02 and SEMT15-15 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 Russet Burbank potato line RBMT15-101 and Shepody potato lines SEMT15-02 and SEMT15-15 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), 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 Russet Burbank potato line RBMT15-101 and Shepody potato lines SEMT15-02 and SEMT15-15 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 3rd day of March, 1999. Joan M. Arnoldi, Acting Administrator, Animal and Plant Health Inspection Service.
FR Doc. 99-5780Filed3-8-99; 8:45 amBILLING CODE 3410-34-P
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