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. Prior to conducting a field test on an unlicensed product, 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 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:

Requester: Huvepharma, Inc.

Product: Clostridium Perfringens Type A Vaccine, Live Salmonella Vector.

Possible Field Test Locations: Alabama, Arkansas, Georgia, Mississippi, and North Carolina, among others.

The above-mentioned product consists of a live, recombinant, attenuated Salmonella enterica vector containing genes from C. perfringens type A. So that the vaccine will be effective against necrotic enteritis associated with C. perfringens type A, the chickens will be vaccinated twice, once at the hatchery by spray route and 11 days later in a grow-out house by drinking water application.

APHIS' review and analysis of the potential environmental impacts associated with the proposed field tests are documented in detail in an EA entitled “Environmental Assessment for Field Testing of a Clostridium Perfringens Type A Vaccine, Live Salmonella Vector.” We are making this EA available to the public for review and comment. We will consider all comments that we receive on or before the date listed under the DATES section at the beginning of this notice.

The EA may be viewed on the Regulations.gov website or in our reading room (see ADDRESSES above for a link to Regulations.gov and information on the location and hours of the reading room). You may request paper copies of the EA by calling or writing to the person listed under FOR FURTHER INFORMATION CONTACT . Please refer to the title of the EA when requesting copies.

The EA has been prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et ( printed page 20975) 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 issues with adverse environmental impacts are raised in response to this notice, APHIS intends to issue a finding of no significant impact (FONSI) based on the EA 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.

(Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4)

85 FR 20974