[Federal Register Volume 76, Number 152 (Monday, August 8, 2011)]
[Notices]
[Pages 48119-48120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-20177]



[[Page 48119]]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2011-0089]


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

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of availability and request for comments.

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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 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.

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

ADDRESSES: You may submit comments by either of the following methods:
    <bullet> Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2011-0089-0001.
    <bullet> 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 
(<a href="/cdn-cgi/l/email-protection#accec9d8c482c982c7cdcec9ded8eccddcc4c5df82d9dfc8cd82cbc3da"><span class="__cf_email__" data-cfemail="e28087968acc87cc898380879096a283928a8b91cc97918683cc858d94">[email protected]</span></a>). 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 (<a href="/cdn-cgi/l/email-protection#2151405553484248400f4d0f474e4d44586140514948520f545245400f464e57"><span class="__cf_email__" data-cfemail="7e0e1f0a0c171d171f5012501811121b073e1f0e16170d500b0d1a1f50191108">[email protected]</span></a>).

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 
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 heading DATES at 
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 (see ADDRESSES above 
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 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).


[[Page 48120]]


    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]
BILLING CODE 3410-34-P


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