[Federal Register Volume 62, Number 75 (Friday, April 18, 1997)] [Notices] [Page 19097] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-10102] ======================================================================== 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. 62, No. 75 / Friday, April 18, 1997 / Notices [[Page 19097]] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. 97-028-1] Availability of an Environmental Assessment and Finding of No Significant Impact 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 prepared an environmental assessment and a finding of no significant impact for the shipment of an unlicensed veterinary biological product for field testing. A risk analysis, which forms the basis for the environmental assessment, has led us to conclude that shipment of the unlicensed veterinary biological product for field testing will not have a significant impact on the quality of the human environment. Based on our finding of no significant impact, we have determined that an environmental impact statement need not be prepared. Therefore, with this notice, we state our intention to authorize shipment of this product for field testing after 14 days from the date of this notice, unless new substantial issues bearing on the effects of the action contemplated here are brought to our attention. Furthermore, with this notice, we also state our intention to issue a veterinary biological product license for this product, provided the field trial data support the conclusions of the original environmental assessment and finding of no significant impact and the product meets all other requirements for licensure. ADDRESSES: Copies of the environmental assessment and finding of no significant impact may be obtained by writing to the person listed under FOR FURTHER INFORMATION CONTACT. When requesting copies, please refer to the docket number of this notice, the product name and code number, and the producer (requester). Copies of the environmental assessment and finding of no significant impact (as well as the risk analysis with confidential business information removed) are also available for public inspection 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 requested to call ahead on (202) 690- 2817 to facilitate entry into the reading room. FOR FURTHER INFORMATION CONTACT: Dr. Jeanette Greenberg, Technical Writer-Editor, Center for Veterinary Biologics-Licensing and Policy Development, VS, APHIS, USDA, 4700 River Road Unit 148, Riverdale, MD 20737-1231; telephone (301) 734-5338; fax (301) 734-8910. SUPPLEMENTARY INFORMATION: Under the Virus-Serum-Toxin Act (21 U.S.C. 151 et seq.), a veterinary biological product must be shown to be pure, safe, potent, and efficacious before a veterinary biological product license may be issued. A field test is generally necessary to satisfy prelicensing requirements for veterinary biological products. In order to ship an unlicensed veterinary biological product for the purpose of conducting a proposed field test, a person must receive authorization from the Animal and Plant Health Inspection Service (APHIS). In determining whether to authorize shipment for field testing of the unlicensed veterinary biological product referenced in this notice, APHIS conducted a risk analysis to assess the potential effect of this product on the safety of animals, the public health, and the environment. Based on the risk analysis, APHIS has prepared an environmental assessment (EA). APHIS has concluded that shipment of the unlicensed veterinary biological product for field testing will not significantly affect the quality of the human environment. Based on this finding of no significant impact (FONSI), we have determined that there is no need to prepare an environmental impact statement. An EA and FONSI have been prepared by APHIS for the shipment of the following unlicensed veterinary biological product for field testing: Requester: Rhone Merieux, Inc. Product: Avian Influenza-Fowl Pox Vaccine, Live Fowl Pox Vector, Code 1061.R0. Field test locations: Delaware, Georgia, Texas. The EA and FONSI have been prepared in accordance with: (1) The National Environmental Policy Act of 1969, as amended (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). Unless substantial environmental issues are raised in response to this notice, APHIS intends to authorize the shipment of the above product and the initiation of the field tests after 14 days from the date of this notice. Because the issues raised by authorization of a field trial and issuance of a license are identical, APHIS has concluded that the EA and FONSI that were generated for the field trial would also be applicable to the proposed licensing action. Furthermore, provided that the field trial data support the conclusions of the original EA and FONSI, APHIS does not intend to issue a separate EA to support the issuance of the product license, and would determine that an environmental impact statement need not be prepared. Therefore, APHIS intends to issue a veterinary biological product license for this product following the completion of the field trial, provided no adverse impacts on the human environment are identified as a result of field testing this product and provided the product meets all other requirements for licensure. Authority: 21 U.S.C. 151-159. Done in Washington, DC, this 15th day of April 1997. Donald W. Luchsinger, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 97-10102 Filed 4-17-97; 8:45 am] BILLING CODE 3410-34-P