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USDA ANNOUNCES THE AVAILABILITY OF AN ENVIRONMENTAL ASSESSMENT FOR FIELD TESTING RABIES VACCINE

September 17, 2008

The U.S. Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) is advising the public that the Animal and Plant Health Inspection Service has prepared an environmental assessment concerning authorization to ship for the purpose of field testing, and then to field test, an unlicensed Rabies Vaccine, Live Raccoon Poxvirus Vector. 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, and that an environmental impact statement need not be prepared. 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. We also intend 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.

This action is scheduled for publication in Sept. 18 Federal Register.

Consideration will be given to comments received on or before Oct. 20. You may submit comments by either of the following methods:

  • Federal eRulemaking Portal: Go to http://www.regulations.gov/fdmspublic/component/
    main?main=DocketDetail&d=APHIS-2008-0099
    to submit or view comments and to view supporting and related materials available electronically.

  • Postal Mail/Commercial Delivery: Please send two copies of your comment to Docket No. APHIS-2008-0099, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. APHIS-2008-0099.

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Note to Reporters: Public notices and other APHIS information are available on the Internet. Go to the APHIS news release page at http://www.aphis.usda.gov and click on the “Newsroom” button. For additional information about this topic contact Brienne German at (301) 734-7253 or by e-mail at brienne.b.german@aphis.usda.gov.



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