Daily Rules, Proposed Rules, and Notices of the Federal Government
You may request a copy of the environmental assessment (as well as the risk analysis with confidential business information removed) by writing to Dr. Michel Y. Carr, USDA, APHIS, VS, CVB-LPD, 510 South 17th Street, Suite 104, Ames, IA 50010, or by calling (515) 232-5785. Please refer to the docket number, date, and complete title of this notice when requesting copies.
APHIS documents published in the
Under the Virus-Serum-Toxin Act (21 U.S.C. 151
To determine whether to authorize shipment and grant approval for the field testing of the unlicensed product 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 an environmental assessment (EA) concerning the field testing of the following unlicensed veterinary biological product:
The above mentioned product is a combination Bursal Disease-Marek's Disease Vaccine prepared using serotypes 2 and 3 Marek's disease virus. Serotype 3 Marek's disease virus has been genetically modified to express bursal disease virus antigens. The vaccine is for use in chickens as an aid in the prevention of disease caused by bursal disease virus, and serotypes 2 and 3 Marek's disease virus.
The EA has been prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321
Unless substantial issues with adverse environmental impacts are raised in response to this notice, APHIS intends to issue a final EA and finding of no significant impact (FONSI) and authorize shipment of the above product for the initiation of field tests following the close of the comment period for this notice.
Because the issues raised by field testing and by issuance of a license are identical, APHIS has concluded that the EA that is generated for field testing would also be applicable to the proposed licensing action. Provided that the field test data support the conclusions of the original EA and the issuance of a FONSI, APHIS does not intend to issue a separate EA and FONSI to support the issuance of the product license, and would determine that an environmental impact statement need not be prepared. APHIS intends to issue a veterinary biological product license for this vaccine following completion of the field test provided no adverse impacts on the human environment are identified and provided the product meets all other requirements for licensing.
21 U.S.C. 151-159.