Notice2022-18727
Availability of an Environmental Assessment for Field Testing of Bursal Disease-Infectious Laryngotracheitis-Marek's Disease Vaccine, Serotype 3, Live Marek's Disease Vector
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 30, 2022
Issuing agencies
Agriculture DepartmentAnimal and Plant Health Inspection Service
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 167 (Tuesday, August 30, 2022)</title>
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[Federal Register Volume 87, Number 167 (Tuesday, August 30, 2022)]
[Notices]
[Pages 52901-52902]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-18727]
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Notices
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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:
<bullet> Federal eRulemaking Portal: Go to <a href="http://www.regulations.gov">www.regulations.gov</a>.
Enter APHIS-2022-0029 in the Search Field. Select the Documents tab,
then select the Comment button in the list of documents.
<bullet> 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 <a href="http://www.regulations.gov">www.regulations.gov</a> 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: <a href="/cdn-cgi/l/email-protection#5e3c3f2c3c3f2c3f7034702d363b2e2e3f2c3a1e2b2d3a3f70393128"><span class="__cf_email__" data-cfemail="395b584b5b584b581753174a515c4949584b5d794c4a5d58175e564f">[email protected]</span></a>.
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: <a href="/cdn-cgi/l/email-protection#ff929e8b8b979a88d192d19a8d9b929e91bf8a8c9b9ed1989089"><span class="__cf_email__" data-cfemail="7815190c0c101d0f5615561d0a1c151916380d0b1c19561f170e">[email protected]</span></a>.
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 <a href="http://Regulations.gov">Regulations.gov</a>
website
[[Page 52902]]
or in our reading room (see ADDRESSES above for a link to
<a href="http://Regulations.gov">Regulations.gov</a> 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
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