[Federal Register Volume 60, Number 90 (Wednesday, May 10, 1995)] [Notices] [Pages 24851-24852] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 95-11500] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [OPP-50806A; FRL-4952-8] Issuance of an Experimental Use Permit for a Transgenic Plant Pesticide AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. ----------------------------------------------------------------------- Summary: On April 13, 1995, EPA issued EPA Experimental Use Permit (EUP) to Calgene Inc. to conduct field testing of a transgenic plant pesticide. EPA has determined that this permit may be of regional and national significance. The Agency evaluated the data submitted by Calgene and, based on these data and other available data, could foresee no significant risk to humans or to nontarget organisms from this group of field tests as proposed by Calgene. In accordance with 40 CFR 172.11(a), the Agency is soliciting public comments. DATES: Written comments must be received on or before June 9, 1995. ADDRESSES: Written comments, in triplicate should bear the docket control number OPP-50806A and be submitted to: Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection agency, 401 M St., SW., Washington, DC 20460. In person bring comments to Rm. 1128, Crystal Mall #2, 1921 Jefferson Davis Highway, Crystal City, VA. Comments and data may also be submitted electronically by sending electronic mail (e-mail) to: [email protected]. Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on disks in WordPerfect in 5.1 file format or ASCII file format. All comments and data in electronic form must be identified by the docket number ``OPP-50806A'' No Confidential Business Information (CBI) should be submitted through e-mail. Electronic comments on this document may be filed online at many Federal Depository Libraries. Additional information on electronic submissions can be found in unit III of this document. Information submitted in any comment concerning this notice may be claimed confidential by marking any part or all of that information as ``Confidential Business Information'' (CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the comment that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice to the submitter. Written comments will be available for public inspection in Rm. 1128 at the address given above, from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. FOR FURTHER INFORMATION CONTACT: By mail: Linda A. Hollis, Biopesticides and Pollution Prevention Division (7501W), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460, Office location and telephone number: CS1 5th floor, 2800 Crystal Drive, Crystal City, VA (703-308-8733). SUPPLEMENTARY INFORMATION: I. EUP Program The EUP was issued to Calgene Inc., 1920 5th St., Davis, CA 95616. The permit was assigned EUP number 65247-EUP-1 and issued for 1 year, beginning April 13, 1995 and ending April 15, 1996. Calgene will be testing a transgenic insect resistant cotton plant which expresses a Bacillus thuringiensis subsp. kurstaki (B.t.k.) cryIA(c) segment within the plant cells. Bacillus thuringiensis subsp. kurstaki protein will be present at no more than .001 percent of the total weight of the cottonseed. The cryIA(c) gene of Bacillus thuringiensis is transferred to cotton via the Ti plasmid of Agrobacterium tumefaciens, a vector system which has been used to stably transform many plant pesticides. All transgenic plants to be used in this field trial are upland cotton Gossypium hirsutum. A total of 2,460 pounds of transgenic cottonseed will be planted on 2.0 to 27.0 acre sites for a total of 67 acres transgenic planting. Calgene's test sites are located in the following States: Alabama, Arizona, Arkansas, Georgia, Louisiana, Mississippi, Missouri, North Carolina, South Carolina, Tennessee and Texas. Upon completion of data collection and/or harvest, all cotton plants in the transgenic trial will be destroyed by incorporation into the soil. Seed harvested from the plant breeding nursery and strains test may be retained for use in further research and [[Page 24852]] development and used as future planting seed. No seed may be used for food or feed, and all other plant material must be destroyed. Calgene's EUP program will include the following three experiments designed to evaluate the performance of the expressed proteins against lepidopteran pests: Strains Tests; Breeding Nurseries, and Research Tests. EPA's scientific staff has evaluated the potential for adverse effects on nontarget species and the environment as a result of this EUP. The Agency does not foresee any human health risks or effects resulting from the proposed field tests because there will be minimal human exposure. Further, EPA foresees no significant environmental impact resulting from the testing under this EUP because it is of limited acreage and duration and because minimal offsite movement (approximately three percent or less) of expressed proteins is expected to occur. Yet a potential exists for offspring of commercially grown cotton to become feral (wild), and these wild offspring might have a selective advantage due to the addition of these insect resistance traits in their genetic make-up; however, feral cotton has many additional constraints, such as hardiness, habit, and reproductive limits, which have prevented it from becoming aggressive or weedy despite cotton's long cultivation in the continental United States. Hence, the expression of B.t.k. protein or NPT II marker enzyme genes is expected to neither create nor aggravate any weedy or aggressive characteristics in cotton grown for this EUP. Because the field tests will be conducted in areas of the 11 States where no known populations of endangered lepidopteran species exist, no risk is expected as a result of the proposed field tests. In addition, because of the low exposure due to the limited acreage and duration of the EUP, EPA feels that there will not be a situation warranting a formal review under the Endangered Species Act for any endangered mammals, birds, invertebrates, plants or aquatic species. II. Labeling The labeling states the following: This package contains insect resistant cottonseed expressing a Bacillus thuringiensis subsp. kurstaki (B.t.k.) protein effective in controlling certain lepidopteran insects. For use only at an application site of a cooperator and in accordance with the terms and conditions of the Experimental Use Permit. This labeling must be in the possession of the user at the time of planting. Not for sale to any person other than a participant or cooperator of the EPA approved Experimental Use Permit Program. The contents may only be used according to the approved EUP program. Cooperators must have at least one copy of each applicable protocol prior to initiating any research with the contents. III. Public Comments A record has been established for this document under docket number ``OPP-50806A'' (including comments and data submitted electronically as described below). A public version of this record, including printed, paper versions of electronic comments, which does not include any information claimed as CBI, is available for inspection from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The public record is located in Rm. 1132 of the Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. Electronic comments can be sent directly to EPA at: [email protected] Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. The official record for this document, as well as the public version, as described above will be kept in paper form. Accordingly, EPA will transfer all comments received electronically into printed, paper form as they are received and will place the paper copies in the official record which will also include all comments submitted directly in writing. The official record is the paper record maintained at the address in ``ADDRESSES'' at the beginning of this document. The Agency announced receipt of Calgene's application in the Federal Register of March 1, 1995 (60 FR 11904). A 30-day public comment period was provided. No comments were received. Dated: April 28, 1995. Janet L. Andersen, Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. [FR Doc. 95-11500 Filed 5-9-95; 8:45 am] BILLING CODE 6560-50-F