[Federal Register Volume 85, Number 38 (Wednesday, February 26, 2020)]
[Notices]
[Pages 11045-11046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03830]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2020-0001]


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.

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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

[[Page 11046]]

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) 
799-7039 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 (515) 337-6100, fax (301) 337-6120.
    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 (515) 337-6100, fax (515) 337-6120.

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.
[FR Doc. 2020-03830 Filed 2-25-20; 8:45 am]
BILLING CODE 3410-34-P