Environmental Assessments; Availability. etc.: Oral Rabies Vaccine Trial Risk Assessment

This Notice document was issued by the Animal and Plant Health Inspection Service (APHIS)

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Animal and Plant Health Inspection Service
[Docket No. APHIS-2011-0089]

Oral Rabies Vaccine Trial; Availability of a Risk Assessment and an Environmental Assessment


Animal and Plant Health Inspection Service, USDA.


Notice of availability and request for comments.


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 West Virginia. The environmental assessment, which is based on a risk analysis prepared to assess the risks associated with an experimental rabies vaccine, analyzes the use of that vaccine in field safety and efficacy trials in 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 and risk assessment available to the public for review and comment.


We will consider all comments that we receive on or before September 7, 2011.


You may submit comments by either of the following methods:

  • Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2011-0089-0001.
  • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2011-0089, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238.

Supporting documents and any comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0089 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 (202) 6902817 before coming. This notice and the proposed 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

Dr. Dennis Slate, Rabies Program Coordinator, Wildlife Services, 59 Chennell Drive, Suite 7, Concord, NH 03301; (603) 223-9623. To obtain copies of the environmental assessment discussed in this notice, contact Beth Kabert, Environmental Coordinator, Wildlife Services, 140-C Locust Grove Rd., Pittstown, NJ 08867; (908) 735-5654, fax (908) 735-0821, or e-mail (beth.e.kabert@aphis.usda.gov). To obtain copies of the risk assessment (also the manufacturer's risk analysis with confidential business information removed), contact Dr. Patricia Foley, Risk Manager, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, 1920 Dayton Avenue, Ames, IA 50010; (515) 337-6100, fax (515) 337-6120, or e-mail (patricia.l.foley@aphis.usda.gov).

Supplementary Information


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 coated sachet baits containing vaccinia-rabies glycoprotein (VRG) 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 efficacy of a new human adenovirus type 5-rabies glycoprotein recombinant vaccine (AdRG1.3) rabies vaccine in an effort to find a rabies vaccine that will be safe and efficacious in a variety of animal species including striped skunks, raccoons, foxes, and coyotes. APHIS' Center for Veterinary Biologics (CVB) has prepared a risk assessment that will allow for experimental use of the AdRG1.3 vaccine.

The proposed field trial would take place within an approximately 559-square-mile area of Greenbrier, Summers, and Monroe Counties, WV, including portions of the USDA Forest Service National Forest System lands, excluding Wilderness Areas. The proposed rabies vaccine field trial is a collaborative effort between APHIS-WS, the Centers for Disease Control and Prevention, the vaccine manufacturer (Artemis Inc.), and the West Virginia Departments of Agriculture, Health and Human Resources, and Natural Resources.

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 West Virginia” (July 2011). 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 (no Federal funding or participation by APHIS-WS). 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 headingDATESat the beginning of this notice.

The EA and the CVB risk assessment may be viewed on the Regulations.gov Web site or in our reading room (seeADDRESSESabove for instructions for accessing Regulations.gov and information on the location and hours of the reading room). You may request paper copies of the EA and risk assessment by calling or writing to the person listed underFOR 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 4th day of August 2011.
Gregory L. Parham,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-20177 Filed 8-5-11; 8:45 am]
Comment Period Closed
Sep 7 2011, at 11:59 PM ET
ID: APHIS-2011-0089-0001
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Document Information

Date Posted: Aug 8, 2011
Federal Register Number: 2011-20177
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Comments Received*
See attached file(s)
Rabies remains a significant threat to human and animal health around the globe, despite ongoing efforts to contain and eliminate it. Currently, wildlife such...
Wild terrestrial carnivores and bats are the only reservoirs of rabies virus in the United States. Controlling rabies in reservoir species protects human and...

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