[Federal Register Volume 84, Number 149 (Friday, August 2, 2019)]
[Notices]
[Pages 37826-37827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16580]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2019-0043]


Availability of an Environmental Assessment for Field Testing of 
a Pseudogymnoascus destructans Vaccine, Live Raccoon Poxvirus Vector 
(RCN-CAL/SP)

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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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 Pseudogymnoascus destructans Vaccine, Live 
Raccoon Poxvirus Vector (RCN-CAL/SP). 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 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 3, 2019.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2019-0043.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2019-0043, 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 http://www.regulations.gov/#!docketDetail;D=APHIS-2019-
0043 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 (202) 7997039 before coming.

FOR FURTHER INFORMATION 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 
50010; phone (515) 337-6100; fax (515) 337-6120.
    For information regarding the environmental assessment or the risk 
analysis, or to request a copy of the environmental assessment (as well 
as the risk analysis with confidential business information removed), 
contact 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: 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: U.S. Geological Survey, National Wildlife Health Center.
    Product: Pseudogymnoascus destructans Vaccine, Live Raccoon 
Poxvirus Vector (RCN-CAL/SP).
    Possible Field Test Locations: Colorado, Iowa, Minnesota, Nebraska, 
Oklahoma, Texas, or Wisconsin, among others.
    The above-mentioned product consists of a live recombinant raccoon 
poxvirus vector expressing two Pseudogymnoascus destructans proteins. 
The vaccine is for the oral vaccination of bats as an aid in the 
prevention and control of White-Nose Syndrome.
    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

[[Page 37827]]

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 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 30th day of July 2019.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2019-16580 Filed 8-1-19; 8:45 am]
 BILLING CODE 3410-34-P