Proposed Rules. Notice

Agency: Animal and Plant Health Inspection Service, USDA
Action: Notice
Citation: 65 FR (No. 112) · FR Doc. 00-14615 · Docket No. 00-046-1

Summary

We are advising the public that the Animal and Plant Health Inspection Service has prepared a draft environmental assessment concerning authorization to ship to Kenya for the purpose of field testing, and then to field test in Kenya, an unlicensed, genetically engineered, vaccinia-vectored rinderpest vaccine for use in cattle. The environmental assessment, which is based on a risk analysis prepared to assess the risks associated with the field testing of this vaccine, examines the potential effects that field testing this veterinary vaccine could have on the quality of the human environment. Based on the risk analysis, we have reached a preliminary determination that field testing this veterinary vaccine will not have a significant impact on the quality of the human environment. We intend to authorize shipment of this vaccine for field testing following the close of the comment period for this notice unless new substantial issues bearing on the effects of this action are brought to our attention.

Dates

We invite you to comment on this docket. We will consider all comments that we receive by July 10, 2000.

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 have a reasonable expectation of efficacy before a field trial may be authorized. The purpose of a field trial is to gather additional information concerning the safety and efficacy of a vaccine when used under field conditions that are similar to those in the area(s) where the vaccine will be distributed and used. Prior to conducting a field test on an experimental vaccine, an applicant must obtain approval from the Animal and Plant Health Inspection Service (APHIS), as well as obtain APHIS' authorization to ship the product for field testing. To determine whether to authorize shipment and grant approval for the field testing of the unlicensed vaccine referenced in this notice, APHIS conducted a risk analysis to assess the potential effects of this product on the safety of animals, public health, and the environment. Based on the risk analysis, APHIS has prepared a draft environmental assessment (EA) concerning the field testing of the following unlicensed veterinary biological product: Requester: Dr. Tilahun Yilma, Director, International Laboratory of Molecular Biology for Tropical Disease Agents, School of Veterinary Medicine, University of California, Davis. Product: A live, genetically engineered, vaccinia-vectored rinderpest vaccine. Field test location: Kikuyu, Kenya. The above-mentioned vaccine is for use as an aid in the prevention of rinderpest in cattle. The vaccine was constructed with the Wyeth vaccine strain of the vaccinia virus and further attenuated by insertional inactivation of the thymidine kinase and hemagglutinin genes of the vaccinia virus. The draft EA has been prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (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 issue a final EA and finding of no significant impact and authorize shipment of the above product for the initiation of field tests following the close of the comment period for this notice. Authority: 21 U.S.C. 151-159. Done in Washington, DC, this 5th day of June 2000. Bobby R. Acord, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 00-14615 Filed 6-8-00; 8:45 am]