2017-14921. 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, Ohio, and West Virginia. 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 August 16, 2017.

ADDRESSES:

You may submit comments by either of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov/​#!docketDetail;​D=​APHIS-2017-0046.
• Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2017-0046, 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-2017-0046 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 EA 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], email: [e-mail]. 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:

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-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. 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, and 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 (FONSI) in a notice published in the Federal Register (see footnote 1) on August 16, 2012 (77 FR 49409-49410, Docket No. APHIS-2012-0052).

On July 17, 2015, we published in the Federal Register (80 FR 42467-42469, Docket No. APHIS-2015-0047) a notice ^[2] in which we announced the availability, for public review and comment, of a supplemental EA that examined the potential environmental impacts associated with expanding the field trial to additional areas in Ohio and increasing bait distribution density in portions of West Virginia. We announced the availability of our final EA and FONSI in a notice published in the Federal Register (see footnote 2) on September 17, 2015 (80 FR 55826-55827, Docket No. APHIS-2015-0047).

In 2017, there were two confirmed cases of raccoon variant rabies 8-10 km (5-6 miles) west of the established V-RG ORV zone in Ohio (approximately 20 km [12 miles]) east of the city of Canton, OH). To address this emergency, APHIS-WS proposes to shift the existing ORV zone in Ohio in an effort to contain the outbreak and to secure the zone. ONRAB vaccine-baits will be distributed in this revised portion of the ORV zone.

APHIS-WS is also proposing to add Webster, Braxton, Nicholas, Wyoming, McDowell, Upshur, Barbour, Harrison, Lewis, Tyler, Ritchie, Doddridge, Wetzel, Taylor, Marion, Monongalia, and Preston Counties in West Virginia so that ONRAB vaccine-baits may be applied to the western edge of the ORV zone in West Virginia to provide added confidence in the seroconversion rates based on results from previous field trials. This will provide an opportunity to improve serological sampling spatially throughout the zone as part of an increased monitoring initiative.

Finally, APHIS-WS is proposing to expand the field trial zone in New York into Oswego County. The current ORV ONRAB zone in New York includes Jefferson County, which shares a border with Oswego County. Current ONRAB bait distribution occurs very close to the Oswego County border and including this county will allow APHIS-WS to opportunistically distribute any remaining excess baits while collecting additional serological data to further assess the field trial.

APHIS-WS has prepared a supplemental EA in which we analyze expanding the area of the field trial zone in New York, Ohio, and West Virginia. 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 12th day of July 2017.

Michael C. Gregoire,

Acting Administrator, Animal and Plant Health Inspection Service.

Footnotes

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

2.  To view the notice, the supplemental EA, and the FONSI, go to http://www.regulations.gov/​#!docketDetail;​D=​ APHIS-2015-0047.