[Federal Register: January 8, 1999 (Volume 64, Number 5)] [Notices] [Page 1177-1178] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr08ja99-37] ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. 98-079-2] Novartis Seeds and Monsanto Co.; Availability of Determination of Nonregulated Status for Sugar Beet Genetically Engineered for Glyphosate Herbicide Tolerance AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: We are advising the public of our determination that the Novartis Seeds and Monsanto Company's sugar beet line designated as GTSB77, which has been genetically engineered for tolerance to the herbicide glyphosate, 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 Novartis Seeds and Monsanto Company in their 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: December 23, 1998. ADDRESSES: The determination, an environmental assessment and finding of no significant impact, the petition, and all written comment received 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, Riverdale, MD 20737-1236; (301) 734-5940. 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 June 22, 1998, the Animal and Plant Health Inspection Service (APHIS) received a petition (APHIS Petition No. 98-173-01p) from Novartis Seeds (Novartis) of Research Triangle Park, NC, and Monsanto Company (Monsanto) of St. Louis, MO, (Novartis/Monsanto) seeking a determination that a sugar beet (Beta vulgaris L.) line designated as GTSB77, which has been genetically engineered for tolerance to the herbicide glyphosate, does not present a plant pest risk and, therefore, is not a regulated article under APHIS' regulations in 7 CFR part 340. On August 20, 1998, APHIS published a notice in the Federal Register (63 FR 44604-44605, Docket No. 98-079-1) announcing that the Novartis/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 sugar beet line and food products derived from it. In the notice, APHIS solicited written comments from the public as to whether this sugar beet line posed a plant pest risk. The comments were to have been received by APHIS on or before October 19, 1998. APHIS received one comment on the subject petition during the designated 60-day comment period. The comment was from an organization representing North American sugar beet processors, and it was in support of the petition. Analysis The GTSB77 sugar beet line has been genetically engineered to express an enolpyruvylshikimate-3-phosphate synthase (EPSPS) enzyme derived from Agrobacterium sp. strain CP4 (CP4 EPSPS), and the b- D-glucuronidase (GUS) protein from Escherichia coli. The CP4 EPSPS enzyme confers tolerance to the herbicide glyphosate, and the GUS protein serves as a marker in the plant transformation process. The subject sugar beet line also expresses a novel protein known as 34550, which [[Page 1178]] has no known biological activity, and was apparently created when a truncated glyphosate oxidoreductase (gox) gene fused to sugar beet DNA. Expression of the added genes is controlled in part by gene sequences derived from the plant pathogens figwort mosaic virus and cauliflower mosaic virus. The Agrobacterium tumefaciens method was used to transfer the added genes into the parental proprietary sugar beet A1012 line. The subject sugar beet 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 this sugar beet line conducted under APHIS permits and notifications since 1996 indicates that there were no deleterious effects on plants, nontarget organisms, or the environment as a result of the environmental release of the GTSB77 sugar beet line. Determination Based on its analysis of the data submitted by Novartis/Monsanto, and a review of other scientific data and field tests of the subject sugar beet, APHIS has determined that sugar beet line GTSB77: (1) Exhibits no plant pathogenic properties; (2) is no more likely to become a weed than herbicide-tolerant sugar beet 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, or have an adverse impact on the ability to control nontarget insect pests. Therefore, APHIS has concluded that the subject sugar beet line and any progeny derived from crosses with other sugar beet varieties will be as safe to grow as sugar beets that are not subject to regulation under 7 CFR part 340. The effect of this determination is that the Novartis/Monsanto GTSB77 sugar beet 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 sugar beet line or its progeny. However, importation of GTSB77 sugar beet 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 the Novartis/Monsanto GTSB77 sugar beet 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 30th day of December 1998. Craig A. Reed, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 99-362 Filed 1-7-99; 8:45 am] BILLING CODE 3410-34-P