2020-03830. Availability of an Environmental Assessment for Field Testing of a Vaccine for Use Against Bursal Disease and Marek's Disease

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice of availability.

SUMMARY:

We are advising the public that the Animal and Plant Health Inspection Service has prepared an environmental assessment concerning authorization to ship for the purpose of field testing, and then to field test, an unlicensed Bursal Disease-Marek's Disease Vaccine, Serotype 3, Live Marek's Disease Vector. Based on the environmental assessment, risk analysis, and other relevant data, we have reached a preliminary determination that field testing this veterinary vaccine will not have a significant impact on the quality of the human environment. We are making these documents available to the public for review and comment.

DATES:

We will consider all comments that we receive on or before March 27, 2020.

ADDRESSES:

You may submit comments by either of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov/​#!docketDetail;​D=​APHIS-2020-0001.
• Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2020-0001, 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 may be viewed at http://www.regulations.gov/​#!docketDetail;​D=​APHIS-2020-0001 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.

FOR FURTHER INFORMATION CONTACT:

For information regarding the environmental assessment or the risk analysis, or to request a copy of the environmental assessment or the risk analysis with confidential business information removed, contact Dr. Barbara J. Sheppard, Senior Staff Veterinary Medical Officer, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, VS, APHIS, 1920 Dayton Avenue, Ames, IA; phone [phone], fax [phone].

The alternative contact is Dr. Mathew Erdman, Senior Staff Veterinary Medical Officer, Center for Veterinary Biologics, Policy, Evaluation, and Licensing VS, APHIS, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010; phone [phone], fax [phone].

SUPPLEMENTARY INFORMATION:

Background

Under the Virus-Serum-Toxin Act (21 U.S.C. 151 et seq.), the Animal and Plant Health Inspection Service (APHIS) is authorized to promulgate regulations designed to ensure that veterinary biological products are pure, safe, potent, and efficacious before a veterinary biological product license may be issued. Veterinary biological products include viruses, serums, toxins, and analogous products of natural or synthetic origin, such as vaccines, antitoxins, or the immunizing components of microorganisms intended for the diagnosis, treatment, or prevention of diseases in domestic animals.

APHIS issues licenses to qualified establishments that produce veterinary biological products and issues permits to importers of such products. APHIS also enforces requirements concerning production, packaging, labeling, and shipping of these products and sets standards for the testing of these products. Regulations concerning veterinary biological products are contained in 9 CFR parts 101 to 124.

A field test is generally necessary to satisfy prelicensing requirements for veterinary biological products. Prior to conducting a field test on an unlicensed product, an applicant must obtain approval from APHIS, as well as obtain APHIS' authorization to ship the product for field testing.

To determine whether to authorize shipment and grant approval for the field testing of an unlicensed veterinary biological product, APHIS considers the potential effects of this product on the safety of animals, public health, and the environment. Based upon a risk analysis and other relevant data, APHIS has prepared an environmental assessment (EA) concerning the field testing of the following unlicensed veterinary biological product:

Requester: Zoetis Inc.

Product: Bursal Disease-Marek's Disease Vaccine, Serotype 3, Live Marek's Disease Vector.

Possible Field Test Locations: Alabama, Arkansas, Delaware, Georgia, Maryland, North Carolina, South Carolina, and Virginia, among others.

The above-mentioned vaccine consists of a live Marek's disease, serotype 3, turkey herpesvirus vector containing a gene from an infectious bursal disease virus. The vaccine has been shown to be effective for the vaccination of 18- to 19-day-old embryonated chicken eggs or healthy 1-day-old chickens against infectious bursal disease and Marek's disease.

APHIS' review and analysis of the potential environmental impacts associated with the proposed field tests are documented in detail in an EA entitled “Environmental Assessment For Field Testing of a Bursal Disease—Marek's Disease Vaccine, Serotype 3, Live Marek's Disease Vector” (December 2019). We are making this 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 DATES section 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 a link to Regulations.gov and information on the location and hours of the reading room). You may request paper copies of the EA by calling or writing to the person listed under FOR FURTHER INFORMATION CONTACT. Please refer to the title of the EA when requesting copies.

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).

Unless substantial issues with adverse environmental impacts are raised in response to this notice, APHIS intends to issue a finding of no significant impact (FONSI) based on the EA and authorize shipment of the above product for the initiation of field tests following the close of the comment period for this notice.

Because the issues raised by field testing and by issuance of a license are identical, APHIS has concluded that the EA that is generated for field testing would also be applicable to the proposed licensing action. Provided that the field test data support the conclusions of the original EA and the issuance of a FONSI, APHIS does not intend to issue a separate EA and FONSI to support the issuance of the associated product license, and would determine that an environmental impact statement need not be prepared. APHIS intends to issue a veterinary biological product license for this vaccine following completion of the field test provided no adverse impacts on the human environment are identified and provided the product meets all other requirements for licensing.

Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

Done in Washington, DC, this 21st day of February 2020.

Kevin Shea,

Administrator, Animal and Plant Health Inspection Service.