[Federal Register Volume 87, Number 167 (Tuesday, August 30, 2022)]
[Notices]
[Pages 52901-52902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18727]


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 Notices
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
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  Federal Register / Vol. 87, No. 167 / Tuesday, August 30, 2022 / 
Notices  

[[Page 52901]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2022-0029]


Availability of an Environmental Assessment for Field Testing of 
Bursal Disease-Infectious Laryngotracheitis-Marek's Disease Vaccine, 
Serotype 3, Live Marek's Disease Vector

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-Infectious Laryngotracheitis-
Marek's Disease Vaccine, Serotype 3, Live Marek's Disease Vector. The 
environmental assessment, which is based on a risk analysis prepared to 
assess the risks associated with the field testing of this vaccine, 
examines the potential effects that field testing this veterinary 
vaccine could have on the quality of the human environment. Based on 
the risk analysis, 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, and that an 
environmental impact statement need not be prepared. We are making the 
environmental assessment and risk analysis available for public review 
and comment. We intend to authorize shipment of this vaccine for field 
testing following the close of the comment period for this notice 
unless new substantial issues bearing on the effects of this action are 
brought to our attention. We also intend to issue a U.S. Veterinary 
Biological Product license for this vaccine, provided the field test 
data support the conclusions of the environmental assessment and the 
issuance of a finding of no significant impact and the product meets 
all other requirements for licensing.

DATES: We will consider all comments that we receive on or before 
September 29, 2022.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov. 
Enter APHIS-2022-0029 in the Search Field. Select the Documents tab, 
then select the Comment button in the list of documents.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2022-0029, 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 on this docket may 
be viewed at www.regulations.gov or in our reading room, which is 
located in Room 1620 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 (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 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; email: [email protected].
    The alternative contact is Dr. Matthew Erdman, Science Advisor, 
Diagnostics and Biologics, Associate Deputy Administrator's Office, VS, 
APHIS, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010; phone: (515) 
337-6100; email: [email protected].

SUPPLEMENTARY INFORMATION: Under the Virus-Serum-Toxin Act (21 U.S.C. 
151 et seq.), a veterinary biological product must be shown to be pure, 
safe, potent, and efficacious before a veterinary biological product 
license may be issued. 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 the Animal and Plant Health Inspection Service 
(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 the unlicensed product referenced in this notice, 
APHIS conducted a risk analysis to assess the potential effects of this 
product on the safety of animals, public health, and the environment. 
Based on the risk analysis, APHIS has prepared an environmental 
assessment (EA) concerning the field testing of the following 
unlicensed veterinary biological product:
    Requester: Intervet Inc.
    Product: Bursal Disease-Infectious Laryngotracheitis-Marek's 
Disease Vaccine, Serotype 3, Live Marek's Disease Vector.
    Possible Field Test Locations: Arkansas, Georgia, and South 
Carolina, among others.
    The vaccine has been shown to be effective for the vaccination of 
18- to 19-day-old embryonated chicken eggs (E18) or healthy 1-day-old 
chickens against Marek's disease, infectious bursal disease, and 
infectious laryngotracheitis. This vaccine consists of a live Marek's 
Disease, Serotype 3, Turkey Herpesvirus (HVT) vector expressing 
proteins encoded by genes from an Infectious Bursal Disease Virus 
(IBDV) and an Infectious Laryngotracheitis Virus (ILTV). In the 
proposed study, the vaccine will be administered in ovo at E18 or older 
or subcutaneously at 1-day-old.
    APHIS' review and analysis of the potential environmental impacts 
associated with the proposed field tests are documented in detail in an 
EA titled ``Environmental Assessment for Field Testing of a Bursal 
Disease--Infectious Laryngotracheitis-Marek's Disease Vaccine, Serotype 
3, Live Marek's Disease Vector.'' We are making this EA and the risk 
analysis with confidential business information removed 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 and the risk analysis may be viewed on the Regulations.gov 
website

[[Page 52902]]

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 product license, and APHIS 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 24th day of August 2022 .
Anthony Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2022-18727 Filed 8-29-22; 8:45 am]
BILLING CODE 3410-34-P