[Federal Register Volume 60, Number 121 (Friday, June 23, 1995)] [Notices] [Pages 32650-32651] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 95-15379] ======================================================================== Notices Federal Register ________________________________________________________________________ This section of the FEDERAL REGISTER contains documents other than rules or proposed rules that are applicable to the public. Notices of hearings and investigations, committee meetings, agency decisions and rulings, delegations of authority, filing of petitions and applications and agency statements of organization and functions are examples of documents appearing in this section. ======================================================================== Federal Register / Vol. 60, No. 121 / Friday, June 23, 1995 / Notices [[Page 32650]] DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. 95-016-2] Availability of Determination of Nonregulated Status for Genetically Engineered Tomato Lines AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: We are advising the public of our determination that tomato lines developed by Zeneca Plant Science and Petoseed Company, Inc., designated as B, Da, and F that have been genetically engineered for suppressed polygalacturonase enzyme activity 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 Zeneca Plant Science and Petoseed Company, Inc., in their 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 Zeneca Plant Science and Petoseed, Inc., 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: June 6, 1995. 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, except holidays. Persons wishing to inspect those documents are asked to call in advance of visiting at (202) 690-2817. FOR FURTHER INFORMATION CONTACT: Dr. Subhash Gupta, Biotechnologist, Biotechnology Permits, BBEP, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1237; (301) 734-7612. To obtain a copy of the determination or the environmental assessment and finding of no significant impact, contact Ms. Kay Peterson at (301) 734-7612. SUPPLEMENTARY INFORMATION: Background On February 7, 1995, the Animal and Plant Health Inspection Service (APHIS) received a petition (APHIS Petition No. 94-290-01p) from Zeneca Plant Science of Wilmington, DE, and Petoseed Company, Inc., of Woodland, CA, (Zeneca/Petoseed) seeking a determination that tomato lines designated as B, Da, and F that have been genetically engineered for suppressed polygalacturonase (PG) enzyme activity do not present a plant pest risk and, therefore, are not regulated articles under APHIS' regulations in 7 CFR part 340. On March 17, 1995, APHIS published a notice in the Federal Register (60 FR 14413-14414, Docket No. 95-016-1) announcing receipt of the Zeneca/Petoseed petition and announcing that the petition was available for public review. The notice also discussed the role of APHIS and the Food and Drug Administration in regulating the subject tomato lines and food products derived from them. In the notice, APHIS solicited written comments from the public as to whether the subject tomato lines posed a plant pest risk. The comments were to have been received by APHIS on or before May 16, 1995. APHIS received five comments on the Zeneca/Petoseed petition, from a food company, a seed company, and State departments of agriculture. All the commenters supported the Zeneca/Petoseed petition for nonregulated status for the subject tomato lines. Analysis Zeneca/Petoseed's tomato lines B, Da, and F have been developed from an unmodified proprietary inbred tomato line coded as T7, that has been genetically engineered to contain a fragment of the tomato PG gene in the sense or antisense orientation. Inhibition of the PG enzyme resulting from the transcription of the PG gene fragment results in an increased thickness of the tomato, which is a desired characteristic in processing tomatoes. The subject tomato lines also contain the bacterial neomycin phosphotransferase (nptII) gene that is used as a selectable marker. Tomato lines B, Da, and F were transformed through the use of disarmed vectors from a common soil-borne bacterium, the plant pathogen Agrobacterium tumafaciens. The subject tomato lines have been considered regulated articles under APHIS' regulations in 7 CFR part 340 because they contain certain gene sequences derived from plant-pathogenic sources. However, evaluation of field data reports from field tests of the subject tomato lines conducted under APHIS permits or notifications since 1991 indicate that there were no deleterious effects on plants, nontarget organisms, or the environment as a result of the subject tomato plants' release into the environment. Determination Based on its analysis of the data submitted by Zeneca/Petoseed and a review of other scientific data, comments received from the public, and field tests of the subject tomato lines, APHIS has determined that tomato lines B, Da, and F: (1) Exhibit no plant pathogenic properties; (2) are no more likely to become a weed than tomatoes with suppressed PG activity developed by traditional breeding techniques; (3) are unlikely to increase the weediness potential of any other cultivated plant or wild species with which they can interbreed; (4) are unlikely to harm other organisms, such as bees, which are beneficial to agriculture; and (5) should not cause damage to processed agricultural commodities. The effect of this determination is that tomato lines designated as B, Da, and F are no longer considered regulated articles under APHIS' regulations in 7 CFR part 340. Therefore, the permit and notification requirements pertaining to regulated articles under those regulations no longer apply to the field testing, importation, or interstate movement of the subject tomato lines or their progeny. However, the importation of the subject tomato lines or seeds capable of propagation is still subject to [[Page 32651]] 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) (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 subject tomato lines 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 15th day of June 1995. Lonnie J. King, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 95-15379 Filed 6-22-95; 8:45 am] BILLING CODE 3410-34-P