[Federal Register Volume 85, Number 73 (Wednesday, April 15, 2020)]
[Notices]
[Pages 20974-20975]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07914]


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 Notices
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 This section of the FEDERAL REGISTER contains documents other than rules 
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  Federal Register / Vol. 85, No. 73 / Wednesday, April 15, 2020 / 
Notices  

[[Page 20974]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2020-0010]


Availability of an Environmental Assessment for Field Testing of 
a Clostridium Perfringens Type A Vaccine, Live Salmonella Vector

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 Clostridium Perfringens Type A Vaccine, Live 
Salmonella 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 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 May 
15, 2020.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2020-0010.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2020-0010, 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-2020-
0010 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) 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, 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. Matthew 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: Huvepharma, Inc.
    Product: Clostridium Perfringens Type A Vaccine, Live Salmonella 
Vector.
    Possible Field Test Locations: Alabama, Arkansas, Georgia, 
Mississippi, and North Carolina, among others.
    The above-mentioned product consists of a live, recombinant, 
attenuated Salmonella enterica vector containing genes from C. 
perfringens type A. So that the vaccine will be effective against 
necrotic enteritis associated with C. perfringens type A, the chickens 
will be vaccinated twice, once at the hatchery by spray route and 11 
days later in a grow-out house by drinking water application.
    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 
Clostridium Perfringens Type A Vaccine, Live Salmonella Vector.'' 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

[[Page 20975]]

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 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 8th day of April 2020.
Michael Watson,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2020-07914 Filed 4-14-20; 8:45 am]
 BILLING CODE 3410-34-P