[Federal Register Volume 60, Number 15 (Tuesday, January 24, 1995)] [Notices] [Pages 4588-4589] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 95-1622] ======================================================================== 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. 15 / Tuesday, January 24, 1995 / Notices [[Page 4588]] DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. 94-092-2] Availability of Determination of Nonregulated Status for Genetically Engineered Tomato Line AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: We are advising the public of our determination that a DNA Plant Technology Corporation delayed-ripening tomato line, designated as line 1345-4, is no longer considered a regulated article under our regulations governing the introduction of certain genetically engineered organisms. The determination is based on our analysis of a petition submitted by DNA Plant Technology Corporation for a determination of nonregulated status, and our review of scientific data and comments received from the public in response to a previous notice announcing receipt of the DNA Plant Technology Corporation'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: January 17, 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. Ved Malik, Biotechnologist, Biotechnology Permits, BBEP, APHIS, USDA, room 850, Federal Building, 6505 Belcrest Road, Hyattsville, MD 20782, (301) 436-7612. The telephone number for the agency will change when agency offices in Hyattsville, MD, move to Riverdale, MD, during February. Telephone: (301) 436-7612 (Hyattsville); (301) 734-7612 (Riverdale). To obtain a copy of the determination or the environmental assessment and finding of no significant impact, contact Ms. Kay Peterson at (301) 436-7601 (Hyattsville); (301) 734-7601 (Riverdale). SUPPLEMENTARY INFORMATION: Background On August 16, 1994, the Animal and Plant Health Inspection Service (APHIS) received a petition from DNA Plant Technology Corporation (DNAP) of Oakland, CA, seeking a determination that its delayed- ripening tomato line 1345-4 (tomato line 1345-4) and any progeny derived from hybrid crosses between that line and other non-transformed tomato varieties do not present a plant pest risk and, therefore, are not regulated articles under APHIS' regulations in 7 CFR part 340. On September 26, 1994, APHIS published a notice in the Federal Register (59 FR 49055-49056, Docket No. 94-092-1) announcing receipt of the DNAP petition and stating that the petition was available for public review. The notice also discussed the role of APHIS and the Food and Drug Administration in regulating tomato line 1345-4 and food products derived from it. In the notice, APHIS solicited written comments from the public as to whether tomato line 1345-4 posed a plant pest risk. The comments were to have been received by APHIS on or before November 25, 1994. APHIS received seven comments on the DNAP petition submitted by universities, State officials, and a tomato grower. One comment concerned the information provided in the notice of receipt of the petition; the remainder of the comments were in favor of the petition. APHIS has provided a summary of the comments in the determination document, which is available upon request from the individual listed under FOR FURTHER INFORMATION CONTACT. Analysis Tomato line 1345-4, as described by its developer, DNAP, contains a gene that delays ripening. Using TranswitchTM gene suppression technology, DNAP introduced a truncated version of the tomato aminocyclopropane carboxylate (ACC) synthase gene into the tomato genome in the ``sense'' or normal orientation, resulting in tomato plants that exhibit significantly reduced levels of ACC synthase. ACC synthase is the rate-limiting enzyme that coverts s-adenosylmethionine to 1-aminocyclopropane-1-carboxylic acid, the immediate precursor to ethylene. Tomato line 1345-4 contains a gene which is derived from the tomato ACC synthase gene, but which does not encode a functional ACC synthase enzyme. Though the fruit of these plants exhibits delayed- ripening, they ripen as usual when exogenous ethylene is applied. Tomato line 1345-4 has also been transformed with the nptII gene from E. coli that encodes the enzyme neomycin phosphotransferase II and serves as a selectable marker enabling identification of the transformed plant cells. This gene is fused to a nos promoter sequence and octopine synthase termination sequence from A. tumefaciens, a known plant pest. Tomato line 1345-4 has been considered a regulated article under APHIS' regulations in 7 CFR part 340 because the line has been engineered using noncoding regulatory sequences derived from the plant pathogens A. tumefaciens and cauliflower mosaic virus. However, field tests of tomato line 1345-4 have been conducted at tomato growing regions in the United States since 1992 under permits issued by APHIS, and the field reports from those tests indicate that there were no deleterious effects on plants, nontarget organisms, or the environment as a result of this testing. Determination Based on its analysis of data submitted by DNAP, a review of other scientific data and comments received from the public, APHIS has determined that tomato line 1345-4: (1) Exhibits no plant pathogenic properties; (2) is no more likely to become a weed than the nonengineered parental variety; (3) is unlikely to increase the weediness potential of any other cultivated plant or [[Page 4589]] native wild species with which the organism can interbreed; (4) is unlikely to harm other organisms, such as bees, that are beneficial to agriculture; and (5) will not cause damage to processed agricultural commodities. APHIS has also concluded that there is a reasonable certainty that new progeny varieties bred from tomato line 1345-4 will not exhibit new plant pest properties, i.e., properties substantially different from any observed in the field- tested tomato line, or those observed in traditional tomato breeding programs. The effect of this determination is that tomato line 1345-4 and all other lines bred from this line by sexual or asexual reproduction involving Mendelian inheritance, 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 line or its progeny. However, the importation of the tomato line and any nursery stock 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 (NEPA) of 1969 (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 Guidelines Implementing NEPA (44 FR 50381-50384, August 28, 1979, and 44 FR 51272- 51274, August 31, 1979). Based on that EA, APHIS has reached a finding of no significant impact (FONSI) with regard to its determination that the tomato line designated as 1345-4 and other lines bred from the line by sexual or asexual reproduction involving Mendelian inheritance, 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 17th day of January 1995. Lonnie J. King, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 95-1622 Filed 1-23-95; 8:45 am] BILLING CODE 3410-34-M