[Federal Register: February 10, 1998 (Volume 63, Number 27)] [Notices] [Page 6703-6704] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr10fe98-52] ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. 97-091-2] AgrEvo USA Co.; Availability of Determination of Nonregulated Status for Canola Genetically Engineered for Glufosinate Herbicide Tolerance AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: We are advising the public of our determination that AgrEvo USA Company's canola designated as Transformation Event T45, which has been genetically engineered for tolerance to the herbicide glufosinate, is no longer considered a regulated article under our regulations governing the introduction of certain genetically engineered organisms. Our determination is based on our evaluation of data submitted by AgrEvo USA Company in its petition for a determination of nonregulated status and an analysis of other scientific data. This notice also announces the availability of our written determination document and its associated environmental assessment and finding of no significant impact. EFFECTIVE DATE: January 29, 1998. ADDRESSES: The determination, an environmental assessment and finding of no significant impact, and 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 to facilitate entry into the reading room. FOR FURTHER INFORMATION CONTACT: Dr. James Lackey, Biotechnology Evaluation, BSS, PPQ, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-6748. 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: mkpeterson@aphis.usda.gov. SUPPLEMENTARY INFORMATION: Background On July 24, 1997, the Animal and Plant Health Inspection Service (APHIS) received a petition (APHIS Petition No. 97-205-01p) from AgrEvo USA Company (AgrEvo) of Wilmington, DE, seeking a determination that canola (Brassica napus L.) designated as Transformation Event T45 (event T45), which has been genetically engineered for tolerance to the herbicide glufosinate, does not present a plant pest risk and, therefore, is not a regulated article under APHIS' regulations in 7 CFR part 340. On September 30, 1997, APHIS published a notice in the Federal Register (62 FR 51081-51082, Docket No. 97-091-1) announcing that the AgrEvo 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 canola and food products derived from it. In the notice, APHIS solicited written comments from the public as to whether this canola posed a plant pest risk. The comments were to have been received by APHIS on [[Page 6704]] or before December 1, 1997. APHIS received no comments on the subject petition during the designated 60-day comment period. Analysis Event T45 canola has been genetically engineered to contain a pat gene derived from Streptomyces viridochromogenes. The pat gene encodes the enzyme phosphinothricin-N-acetyltransferase (PAT), which confers tolerance to the herbicide glufosinate. Expression of the pat gene is controlled by a 35S promoter and terminator derived from the plant pathogen cauliflower mosaic virus. The Agrobacterium tumefaciens method was used to transfer the added genes into the parental cultivar B. napus var. AC EXCEL. The subject canola 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 this canola conducted under APHIS permits since 1996 indicates that there were no deleterious effects on plants, nontarget organisms, or the environment as a result of the environmental release of event T45 canola. Determination Based on its analysis of the data submitted by AgrEvo, and a review of other scientific data and field tests of the subject canola, APHIS has determined that event T45 canola: (1) Exhibits no plant pathogenic properties; (2) is no more likely to become a weed than canola 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 the subject canola and any progeny derived from hybrid crosses with other nontransformed canola varieties will be as safe to grow as canola in traditional breeding programs that are not subject to regulation under 7 CFR part 340. The effect of this determination is that AgrEvo's event T45 canola is no longer 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 subject canola of its progeny. However, importation of the subject canola 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 AgrEvo's event T45 canola 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 4th day of January 1998. Terry L. Medley, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 98-3312 Filed 2-9-98; 8:45 am] BILLING CODE 3410-34-P