2012-16799. Oral Rabies Vaccine Trial; Availability of an Environmental Assessment

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice of availability and request for comments.

SUMMARY:

We are advising the public that the Animal and Plant Health Inspection Service has prepared an environmental assessment relative to an oral rabies vaccination field trial in New Hampshire, New York, Ohio, Vermont, and West Virginia. The environmental assessment analyzes the use of an experimental rabies vaccine in field safety and immunogenicity trials in portions of New Hampshire, New York, Ohio, Vermont, and West Virginia. The proposed field trial is necessary to evaluate a wildlife rabies vaccine that will produce sufficient levels of population immunity in raccoons and striped skunks. We are making the environmental assessment available to the public for review and comment.

DATES:

We will consider all comments that we receive on or before August 8, 2012.

ADDRESSES:

You may submit comments by either of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov/​#!documentDetail;​D=​APHIS-2012-0052-0001.
• Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2012-0052, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238.

The environmental assessment and any comments we receive may be viewed at http://www.regulations.gov/​#!docketDetail;​D=​APHIS-2012-0052 or in our reading room, which is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call [phone] before coming.

This notice and the environmental assessment are also posted on the APHIS Web site at http://www.aphis.usda.gov/​regulations/​ws/​ws_​nepa_​environmental_​documents.shtml.

FOR FURTHER INFORMATION CONTACT:

Mr. Richard Chipman, Acting Rabies Program Coordinator, Wildlife Services, APHIS, 59 Chennell Drive, Suite 7, Concord, NH 03301; [phone]. To obtain copies of the environmental assessment, contact Ms. Beth Kabert, Environmental Coordinator, Wildlife Services, 140-C Locust Grove Road, Pittstown, NJ 08867; [phone], fax [phone], email: [e-mail].

SUPPLEMENTARY INFORMATION:

Background

The Wildlife Services (WS) program in the Animal and Plant Health Inspection Service (APHIS) cooperates with Federal agencies, State and local governments, and private individuals to research and implement the best methods of managing conflicts between wildlife and human health and safety, agriculture, property, and natural resources. Wildlife-borne diseases that can affect domestic animals and humans are among the types of conflicts that APHIS-WS addresses. Wildlife is the dominant reservoir of rabies in the United States.

One of the activities undertaken by APHIS-WS to address rabies is an Oral Rabies Vaccination (ORV) program involving the distribution of baits containing vaccinia-rabies glycoprotein (V-RG) vaccine to stop the spread of specific raccoon (eastern States), coyote (Texas), and gray fox (Texas, New Mexico, and Arizona) rabies virus variants to new areas. While this vaccine has proven to be orally effective in raccoons, coyotes, and foxes, it does not produce detectable levels of population immunity in striped skunks. Because skunks infected with raccoon rabies likely serve as a source of perpetuating and maintaining this rabies virus variant (i.e., raccoon rabies), they may compromise the effectiveness of our ORV program.

APHIS-WS is the lead agency regarding a proposed action that will test the safety and immunogenicity of a new human adenovirus type 5-rabies glycoprotein recombinant virus (AdRG1.3) rabies vaccine in an effort to find a rabies vaccine that will be safe and immunogenic in a variety of animal species including raccoons, skunks, foxes, and coyotes. The proposed field trial would take place within approximately 10,483 square miles of portions of New Hampshire, New York, Ohio, Vermont, and West Virginia, including portions of the U.S. Department of Agriculture Forest Service National Forest System lands, excluding Wilderness Areas. The proposed field trial is a collaborative effort among APHIS-WS; the Centers for Disease Control and Prevention; the vaccine manufacturer (Artemis Inc.); the appropriate agriculture, health, and wildlife agencies for the states of New Hampshire, New York, Ohio, Vermont, and West Virginia; the Ontario Ministry of Natural Resources; and the Quebec Ministry of Natural Resources and Wildlife.

APHIS' review and analysis of the proposed action are documented in detail in an environmental assessment (EA) titled “Field Trial of an Experimental Rabies Vaccine, Human Adenovirus Type 5 Vector in New Hampshire, New York, Ohio, Vermont, and West Virginia” (May 2012). The EA analyzes a number of environmental issues or concerns with the oral rabies vaccine and activities associated with ORV field trials, such as capture and handling animals for monitoring and surveillance purposes. The EA also analyzes alternatives to the proposed action, including no action (continuation of the current program, which involves field trials in West Virginia only) and no ORV field trials. We are making the 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 heading DATES at the beginning of this notice.

The EA may be viewed on the Regulations.gov Web site or in our reading room (see ADDRESSES above for instructions for accessing Regulations.gov and information on the location and hours of the reading room). In addition, paper copies may be obtained by calling or writing to the individual listed under FOR FURTHER INFORMATION CONTACT.

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 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).

Done in Washington, DC, this 29th day of June 2012.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.