[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
Federal Register
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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
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
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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]
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