[Federal Register Volume 60, Number 119 (Wednesday, June 21, 1995)] [Notices] [Pages 32299-32300] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 95-15112] ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. 95-007-2] Availability of Determination of Nonregulated Status for Genetically Engineered Corn AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: We are advising the public of our determination that Ciba Seeds' corn designated as Event 176 Corn that has been genetically engineered for insect resistance 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 Ciba Seeds in its 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 Ciba Seeds 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: May 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, 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 November 15, 1994, the Animal and Plant Health Inspection Service (APHIS) received a petition (APHIS Petition No. 94-319-01p) from Ciba Seeds of Research Triangle Park, NC, seeking a determination that corn designated as Event 176 Corn that has been genetically engineered for insect resistance does not present a plant pest risk and, therefore, is not a regulated article under APHIS' regulations in 7 CFR part 340. On February 21, 1995, APHIS published a notice in the Federal Register (60 FR 9656-9657, Docket No. 95-007-1) announcing receipt of the Ciba Seeds petition and announcing that the petition 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 corn and food products derived from it. In the notice, APHIS solicited written comments from the public as to whether the subject corn posed a plant pest risk. The comments were to have been received by APHIS on or before April 24, 1995. APHIS received 37 comments on the Ciba Seeds petition. Comments were received from farm-related businesses, universities, national and State associations, farmers cooperatives, farmers, individuals, a cooperative extension research center, and a member of the U.S. House of Representatives. Thirty-five commenters either expressed support for the Event [[Page 32300]] 176 Corn petition for nonregulated status or endorsed the concept of an insect-resistant corn variety without specific reference to the petition. Two of the 37 commenters expressed reservations about a determination in favor of the subject petition based on their concerns about resistance management. APHIS has provided a summary and discussion of the comments in the determination document, which is available upon request from the individual listed under FOR FURTHER INFORMATION CONTACT. Analysis Ciba Seeds' Event 176 Corn has been genetically engineered to express an insect control protein representing a truncated form of the CryIA(b) protein that occurs naturally in Bacillus thuringiensis subsp. kurstaki (Btk), a common gram-positive soil bacterium. Btk proteins are very effective against certain lepidopteran insects, including European corn borer (ECB). Event 176 Corn has been modified to produce the CryIA(b) protein in green tissues and pollen cells. During field tests of Event 176 Corn, ECB infestations were significantly reduced as compared to the nontransgenic control plants. The subject corn has been considered a regulated article under APHIS' regulations in 7 CFR part 340 because it contains certain gene sequences derived from plant-pathogenic sources. However, evaluation of field data reports from field tests of the subject corn conducted since 1992 indicates that there were no deleterious effects on plants, nontarget organisms, or the environment as a result of the subject corn plants' release into the environment. Determination Based on its analysis of the data submitted by Ciba Seeds and a review of other scientific data, comments received from the public, and field tests of the subject corn, APHIS has determined that Event 176 Corn: (1) Exhibits no plant pathogenic properties; (2) is no more likely to become a weed than lepidopteran-insect-resistant corn developed through traditional breeding techniques; (3) is unlikely to increase the weediness potential of any other cultivated plant or native wild species with which it can interbreed; (4) should not cause damage to raw or processed agricultural commodities; (5) is unlikely to harm organisms beneficial to the agricultural ecosystem; and (6) when cultivated, should not reduce the ability to control insects in corn and other crops. APHIS has also concluded that there is a reasonable certainty that new varieties developed from Event 176 Corn will not exhibit new plant pest properties, i.e., properties substantially different from any observed in the field tested Event 176 Corn, or those observed in corn in traditional breeding programs. The effect of this determination is that insect-resistant corn designated as Event 176 Corn is no longer considered a regulated article 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 corn or its progeny. However, the importation of the subject corn or seeds capable of propagation is 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)(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 corn 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 13th day of June 1995. Lonnie J. King, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 95-15112 Filed 6-20-95; 8:45 am] BILLING CODE 3410-34-P