[Federal Register: May 27, 1999 (Volume 64, Number 102)] [Notices] [Page 28794-28795] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr27my99-32] ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. 99-002-2] University of Saskatchewan; Availability of Determination of Nonregulated Status for Flax Genetically Engineered for Tolerance to Soil Residues of Sulfonylurea Herbicides AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: We are advising the public of our determination that the University of Saskatchewan's flax line designated as CDC Triffid, which has been genetically engineered for tolerance to soil residues of sulfonylurea herbicides, 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 the University of Saskatchewan in its petition for a determination of nonregulated status and our 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: May 19, 1999. 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 White, Biotechnology and Biological Analysis, PPQ, APHIS, 4700 River Road Unit 147, Suite 5B05, Riverdale, MD 20737-1236; (301) 734- [[Page 28795]] 5940. 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 1, 1998, the Animal and Plant Health Inspection Service (APHIS) received a petition (APHIS Petition No. 98-335-01p) from the Crop Development Centre (CDC) of the University of Saskatchewan (CDC/ Saskatchewan) of Saskatchewan, Saskatoon, Canada, seeking a determination that a flax (Linum usitatissimum L.) line designated as CDC Triffid, which has been genetically engineered for tolerance to residues of sulfonylurea herbicides in soil, does not present a plant pest risk and, therefore, is not a regulated article under APHIS' regulations in 7 CFR part 340. On March 4, 1999, APHIS published a notice in the Federal Register (64 FR 10442-10443, Docket No. 99-002-1) announcing that the CDC/ Saskatchewan 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 flax line and food products derived from it. In the notice, APHIS solicited written comments from the public as to whether the CDC Triffid flax line posed a plant pest risk. The comments were to have been received by APHIS on or before May 3, 1999. APHIS received no comments on the subject petition during the designated 60-day comment period. Analysis The CDC Triffid flax line has been genetically engineered to contain a modified acetolactate synthase (als) gene derived from Arabidopsis thaliana. The als gene encodes a modified acetolactate snythase enzyme that extends to root tissues the reported natural ability of flax to withstand sulfonylurea herbicides. The subject flax line also contains and expresses the nopaline synthase (nos) gene derived from Agrobacterium tumefaciens and the neomycin phosphotransferase-II (nptII) gene derived from Escherichia coli. The nos and nptII genes were used as selectable markers during the plant transformation process. Expression of the added genes is controlled in part by gene sequences from the plant pathogen A. tumefaciens, and the A. tumefaciens method was used to transfer the added genes into the parental Norlin commercial flax variety. The CDC Triffid flax line has been considered a regulated article under APHIS' regulations in 7 CFR part 340 because it contains gene sequences derived from a plant pathogen. However, evaluation of data from field tests and site monitoring conducted in Canada indicates that there were no deleterious effects on plants, nontarget organisms, or the environment as a result of the environmental release of the CDC Triffid flax line. Determination Based on its analysis of the data submitted by CDC/Saskatchewan and a review of other scientific data and field tests of the subject flax line, APHIS has determined that the CDC Triffid flax line: (1) Exhibits no plant pathogenic properties; (2) is no more likely to become a weed than flax varieties developed by traditional plant breeding; (3) is unlikely to increase the weediness potential for any sexually compatible cultivated or wild species; (4) will not harm nontarget organisms, including threatened or endangered species or organisms that are recognized as beneficial to the agricultural ecosystem; and (5) will not cause damage to raw or processed agricultural commodities. Therefore, APHIS has concluded that the subject flax line and any progeny derived from hybrid crosses with other flax varieties will be as safe to grow as flax in traditional breeding programs that is not subject to regulation under 7 CFR part 340. The effect of this determination is that CDC/Saskatchewan's CDC Triffid flax line 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 flax line or its progeny. However, importation of the CDC Triffid flax line 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 CDC/Saskatchewan's CDC Triffid flax line 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 21st day of May 1999. Craig A. Reed, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 99-13515 Filed 5-26-99; 8:45 am] BILLING CODE 3410-34-P