2019-14536. Oral Rabies Vaccine Program; 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 (EA) relative to an oral rabies vaccination (ORV) program in Maine, New Hampshire, New York, Ohio, Tennessee, Texas, Vermont, Virginia, and West Virginia. The EA analyzes the proposed expanded use of ONRAB vaccine-baits throughout the ORV distribution zone in those States in cooperation with the U.S. Forest Service. The proposed expanded ONRAB vaccine distribution is necessary as a higher level of population immunity in raccoons is desired in order to maximize the effectiveness of ORV programs. We are making the EA available to the public for review and comment.

DATES:

We will consider all comments that we receive on or before August 8, 2019.

ADDRESSES:

You may submit comments by either of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov/​#!docketDetail;​D=​APHIS-2019-0034.
• Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2019-0034, 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-2019-0034 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 Animal and Plant Health Inspection Service website 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]; email: [e-mail]. To obtain copies of the supplemental environmental assessment, contact Ms. Beth Kabert, Staff Wildlife Biologist, Wildlife Services, 59 Chennell Drive, Suite 7, Concord, NH 03301; [phone]; fax [phone]; email: [e-mail].

SUPPLEMENTARY INFORMATION:

The Wildlife Services (WS) program in the Animal and Plant Health Inspection Service 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 WS addresses. Wildlife is the dominant reservoir of rabies in the United States.

WS 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. 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 WS to evaluate rabies vaccines capable of producing higher levels of population immunity against raccoon rabies to better control the spread of this disease.

Since 2011, WS has been conducting field trials to study the immunogenicity and safety of an experimental oral rabies vaccine, a human adenovirus type 5 rabies glycoprotein recombinant vaccine called ONRAB (produced by Artemis Technologies Inc., Guelph, Ontario, Canada). The field trials began in portions of West Virginia, including U.S. Department of Agriculture Forest Service National Forest System lands.

Beginning in 2012, WS expanded field trials into portions of New Hampshire, New York, Ohio, Vermont, and new areas of West Virginia, including National Forest System lands, in order to further assess the immunogenicity of ONRAB in raccoons and skunks for raccoon rabies virus variant.

WS is now proposing to further expand ONRAB vaccine distribution to enhance rabies management in the United States to protect human and animal health and reduce social costs. The proposed expanded use of ONRAB is necessary as a higher level of population immunity in raccoons is desired in order to maximize the effectiveness of ORV programs, and the RABORAL V-RG vaccine has not produced sufficient levels of population immunity in skunks (primarily striped skunks) in the wild at the current dose.

WS has prepared an environmental assessment (EA) in which we analyze the proposed expanded use of ONRAB vaccine-baits throughout the ORV distribution zone in Maine, New Hampshire, New York, Ohio, Tennessee, Texas, Vermont, Virginia, and West Virginia in cooperation with the U.S. Forest Service. This EA will supersede the 2012 EA “Field Trial of an Experimental Rabies Vaccine, Human Adenovirus Type 5 Vector in New Hampshire, New York, Ohio, Vermont, and West Virginia” and the subsequent supplemental EAs issued in 2013, 2015, 2017, and 2018.

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 website 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 2nd day of July 2019.

Kevin Shea,

Administrator, Animal and Plant Health Inspection Service.