[Federal Register Volume 60, Number 52 (Friday, March 17, 1995)] [Notices] [Pages 14413-14414] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 95-6651] ======================================================================== 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. 52 / Friday, March 17, 1995 / Notices [[Page 14413]] DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. 95-016-1] Receipt of Petition for 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 that the Animal and Plant Health Inspection Service has received a petition from Zeneca Plant Science and Petoseed Company, Inc., seeking a determination of nonregulated status for tomato lines designated as B, Da, and F that have been genetically engineered for suppressed polygalacturonase enzyme activity. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. In accordance with those regulations, we are soliciting public comments on whether these tomato lines present a plant pest risk. DATES: Written comments must be received on or before May 16, 1995. ADDRESSES: Please send an original and three copies of your comments to Docket No. 95-016-1, Animal and Plant Health Inspection Service, Policy and Program Development, Regulatory Analysis and Development, 4700 River Road Unit 118, Riverdale, MD 20737-1228. Please state that your comments refer to Docket No. 95-016-01. A copy of the petition and any comments 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 access to that room to inspect the petition or comments are asked to call in advance of visiting at (202) 690-2817. FOR FURTHER INFORMATION CONTACT: Dr. Subhash Gupta, Biotechnologist, Animal and Plant Health Inspection Service, Biotechnology, Biologics, and Environmental Protection, Biotechnology Permits, 4700 River Road Unit 147, Riverdale, MD 20737-1228; (301) 734-7612. To obtain a copy of the petition, contact Ms. Kay Peterson at (301) 734-7612. SUPPLEMENTARY INFORMATION: The regulations in 7 CFR part 340, ``Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,'' regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered organisms and products are considered ``regulated articles.'' The regulations in Sec. 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. Paragraphs (b) and (c) of Sec. 340.6 describe the form that a petition for determination of nonregulated status must take and the information that must be included in the petition. On February 7, 1995, 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) requesting a determination of nonregulated status under 7 CFR part 340 for modified T7 processing tomato inbred lines designated as B, Da, and F that have been genetically engineered for suppressed polygalacturonase (PG) enzyme activity. As described in the petition, tomato lines B, Da, and F have been developed from an unmodified proprietary inbred tomato line coded as T7, genetically engineered to contain a fragment of the tomato PG gene in the sense or antisense orientation. The PG enzyme is responsible for the breakdown of pectin molecules in the cell walls of tomato fruit during ripening. The 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 PG gene fragment in the subject tomato lines is regulated by the 35S promoter from the plant pathogen cauliflower mosaic virus. Tomato lines B, Da, and F were transformed through the use of disarmed vectors from a common soil-borne bacterium, the plant pathogen Agrobacterium tumefaciens. The subject tomato lines also contain the bacterial neomycin phosphotransferase (nptII) gene that is used as a selectable marker. The subject tomato lines are currently considered regulated articles under the regulations in 7 CFR part 340 because they contain gene sequences (vectors, promoters, and terminators) derived from plant pathogens. Tomato lines B, Da, and F were evaluated in field trials conducted under APHIS permits in l991, 1992, and 1993, and under APHIS notifications in 1994. In the process of reviewing the applications for those field trials, APHIS determined that the vectors and other elements were disarmed and that the trials, which were conducted under conditions of reproductive confinement, would not present a risk of plant pest introduction or dissemination. In the Federal Plant Pest Act, as amended (7 U.S.C. 150aa et seq.), ``plant pest'' is defined as ``any living stage of: Any insects, mites, nematodes, slugs, snails, protozoa, or other invertebrate animals, bacteria, fungi, other parasitic plants or reproductive parts thereof, viruses, or any organisms similar to or allied with any of the foregoing, or any infectious substances, which can directly or indirectly injure or cause disease or damage in any plants or parts thereof, or any processed, manufactured or other products of plants.'' APHIS views this definition very broadly. The definition covers direct or indirect injury, disease, or damage not just to agricultural crops, but also to plants in general, for example, native species, as well as to organisms that may be beneficial to plants, for example, honeybees, rhizobia, etc. Food or animal feed uses of the subject tomato lines may be subject to regulation by the Food and Drug Administration (FDA) under the [[Page 14414]] authority of the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 301 et seq.). The FDA published a statement of policy on foods derived from new plant varieties in the Federal Register on May 29, 1992 (57 FR 22984-23005). The FDA statement of policy includes a discussion of the FDA's authority for ensuring food safety under the FFDCA, and provides guidance to industry on the scientific considerations associated with the development of foods derived from new plant varieties, including those plants developed through the techniques of genetic engineering. Zeneca has notified the FDA that it has completed its food safety and nutritional assessment for the subject tomato lines. In accordance with Sec. 340.6(d) of the regulations, we are publishing this notice to inform the public that APHIS will accept written comments regarding the Petition for Determination of Nonregulated Status from any interested person for a period of 60 days from the date of this notice. The petition and any comments received are available for public review, and copies of the petition may be ordered (see the ADDRESSES section of this notice). After the comment period closes, APHIS will review the data submitted by the petitioner, all written comments received during the comment period, and any other relevant information. Based on the available information, APHIS will furnish a response to the petitioners, either approving the petition in whole or in part, or denying the petition. APHIS will then publish a notice in the Federal Register announcing the regulatory status of Zeneca/Petoseed's tomato lines B, Da, and F and the availability of APHIS' written decision. Authority: 7 U.S.C. 150aa-150jj, 151-167, and 1622n; 31 U.S.C. 9701; 7 CFR 2.17, 2.51, and 371.2(c). Done in Washington, DC, this 13th day of March 1995. Terry L. Medley, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 95-6651 Filed 3-16-95; 8:45 am] BILLING CODE 3410-34-P