2013-13435. Oral Rabies Vaccine Trial; Availability of a Supplemental 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 a supplemental environmental assessment (EA) relative to an oral rabies vaccination field trial in New Hampshire, New York, Ohio, Vermont, and West Virginia. The supplemental EA analyzes expanding the field trial for an experimental oral rabies vaccine for wildlife to additional areas in New York. The proposed field trial is necessary to evaluate whether the wildlife rabies vaccine will produce sufficient levels of population immunity against raccoon rabies. We are making the supplemental EA available to the public for review and comment.

DATES:

We will consider all comments that we receive on or before July 5, 2013.

ADDRESSES:

You may submit comments by either of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov/​#!documentDetail;​D=​APHIS-2013-0046-0001.
• Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2013-0046, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238.

The supplemental environmental assessment and any comments we receive may be viewed at http://www.regulations.gov/​#!docketDetail;​D=​APHIS-2013-0046 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 supplemental 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, Rabies Program Coordinator, Wildlife Services, APHIS, 59 Chennell Drive, Suite 7, Concord, NH 03301; [phone]. To obtain copies of the supplemental environmental assessment, contact Ms. Beth Kabert, Staff Wildlife Biologist, 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.

Currently, APHIS conducts an oral rabies vaccination (ORV) program to control the spread of rabies. The ORV program has utilized a vaccinia-rabies glycoprotein (V-RG) vaccine. APHIS-WS' use of the V-RG vaccine has resulted in several notable accomplishments, including the elimination of canine rabies from sources in Mexico, the successful control of gray fox rabies virus variant in western Texas, and the prevention of any appreciable spread of raccoon rabies in the eastern United States. While the prevention of any appreciable spread of raccoon rabies in the eastern United States represents a major accomplishment in rabies management, the V-RG vaccine has not been effective in eliminating raccoon rabies from high-risk spread corridors. This fact prompted APHIS-WS to evaluate rabies vaccines capable of producing higher levels of population immunity against raccoon rabies to better control the spread of this disease.

In 2011, APHIS-WS initiated a field trial to study the immunogenicity and safety of a promising new wildlife rabies vaccine, human adenovirus type 5 rabies glycoprotein recombinant vaccine in portions of West Virginia, including U.S. Department of Agriculture Forest Service National Forest System lands. The vaccine used in this field trial is an experimental oral rabies vaccine called ONRAB (produced by Artemis Technologies Inc., Guelph, Ontario, Canada).

To further assess the immunogenicity of ONRAB in raccoons and skunks for raccoon rabies virus variant, APHIS-WS determined the need to expand the field trial into portions of New Hampshire, New York, Ohio, Vermont, as well as West Virginia, including National Forest System lands. On July 9, 2012, we published in the Federal Register (77 FR 40322-40323, Docket No. APHIS-2012-0052) a notice ^[1] in which we announced the availability, for public review and comment, of an environmental assessment (EA) that examined the potential environmental impacts associated with the proposed field trial to test the safety and efficacy of the ONRAB vaccine in New Hampshire, New York, Ohio, Vermont, and West Virginia. We announced the availability of our final EA and finding of no significant impact in a notice published in the Federal Register (see footnote 1) on August 16, 2012 (77 FR 49409-49410, Docket No. APHIS-2012-0052). The field trial began in August 2012, taking place within approximately 10,483 square miles in portions of New Hampshire, New York, Ohio, Vermont, and West Virginia, including portions of National Forest System lands, excluding Wilderness Areas. The field trial is a collaborative effort among APHIS-WS; the Centers for Disease Control and Prevention; the vaccine manufacturer; 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.

Given promising immunogenicity levels documented during the field trial of the ONRAB vaccine and the need for further field testing, APHIS is considering expanding the current field trial for the ONRAB vaccine to additional counties in New York. APHIS has prepared a supplemental EA in which we analyze expanding the area of the field trial zone in New York to include Erie, Franklin, Jefferson, Lewis, Niagara, St. Lawrence, and Wyoming Counties. This would add approximately 14 square miles to the field trial, increasing the field trial from approximately 10,483 square miles to approximately 10,697 square miles. The supplemental EA analyzes a number of environmental issues or concerns with the ONRAB vaccine and activities associated with the field trial, such as capture and handling animals for monitoring and surveillance purposes with regard to the proposed action.

We are making the supplemental 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 supplemental 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 3rd day of June 2013.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.

Footnotes

1.  To view the notice, the comments we received, the EA, and the followup finding of no significant impact, go to http://www.regulations.gov/​#!docketDetail;​D=​APHIS-2012-0052.