Availability of an Environmental Assessment for Field Testing a Swine Influenza Vaccine, H1N1 & H3N2, Modified Live Virus

September 9, 2015 — 

The Animal and Plant Health Inspection Service (APHIS) has prepared an environmental assessment concerning authorization to ship for the purpose of field testing, and then to field test, an unlicensed Swine Influenza Vaccine, H1N1 & H3N2, Modified Live Virus. 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 and other relevant data, APHIS reached a preliminary determination that field testing this veterinary vaccine will not have a significant impact on the quality of the human environment, and that an environmental impact statement need not be prepared. The agency intends 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. APHIS also intends to issue a U.S. Veterinary Biological Product license for this vaccine, provided the field test data support the conclusions of the environmental assessment and the issuance of a finding of no significant impact and the product meets all other requirements for licensing. APHIS will consider all comments received on or before October 5, 2015. [Docket No. APHIS-2015-0054]