Availability of an Environmental Assessment for Field Testing of Bursal Disease-Infectious Laryngotracheitis-Marek's Disease Vaccine, Serotype 3, Live Marek's Disease Vector, 52901-52902 [2022-18727]
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52901
Notices
Federal Register
Vol. 87, No. 167
Tuesday, August 30, 2022
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
statements of organization and functions are
examples of documents appearing in this
section.
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 LaryngotracheitisMarek’s Disease Vaccine, Serotype 3,
Live Marek’s Disease Vector
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice of availability.
AGENCY:
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
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SUMMARY:
VerDate Sep<11>2014
17:24 Aug 29, 2022
Jkt 256001
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: barbara.j.sheppard@
usda.gov.
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:
matthew.m.erdman@usda.gov.
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
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Frm 00001
Fmt 4703
Sfmt 4703
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 19day-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
E:\FR\FM\30AUN1.SGM
30AUN1
52902
Federal Register / Vol. 87, No. 167 / Tuesday, August 30, 2022 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
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
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17:24 Aug 29, 2022
Jkt 256001
DEPARTMENT OF AGRICULTURE
Farm Service Agency
[Docket ID FSA–2022–0010]
Request for Applications for Heirs’
Property Relending Program
Farm Service Agency, USDA.
Notice and request for
applications.
AGENCY:
ACTION:
The Farm Service Agency
(FSA) is announcing the opportunity for
interested eligible entities, including
cooperatives, credit unions, and
nonprofit organizations certified to
operate as a lender, to apply for loans
under the Heirs’ Property Relending
Program (HPRP). Approved entities will
serve as intermediaries who will relend
HPRP funds for projects that assist heirs
with undivided ownership interests to
resolve ownership and succession
issues on farmland that has multiple
owners (commonly referred to as ‘‘Heirs’
property’’).
DATES: The application period will open
on August 30, 2022 and will continue
indefinitely until a closing date is
announced in a notice in the Federal
Register.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Raenata Walker; telephone: (202) 720–
4671; email: sm.fpac.fsa.wdc.hprp@
usda.gov. Persons with disabilities or
who require alternative means for
communication should contact the
USDA Target Center at (202) 720–2600
(voice).
SUPPLEMENTARY INFORMATION:
Background
HPRP was authorized by section 5104
of the Agricultural Improvement Act of
2018 (2018 Farm Bill, Pub. L. 115–334),
codified in 7 U.S.C. 1936c. HPRP
provides loans to eligible entities to
relend with the purpose of assisting
heirs with undivided ownership
interests to resolve ownership and
succession issues on farms that are
owned in common by multiple heirs.
HPRP loan funds may be used to
purchase and consolidate fractional
interests held by other heirs in jointly
owned property, and to pay for costs
and fees associated with developing and
implementing a succession plan (for
example, closing costs, appraisals, title
searches, surveys, mediation, and legal
services). During the initial application
period announced in the HPRP final
rule published in the Federal Register
on August 9, 2021 (86 FR 43381–43397),
FSA implemented a 60-day application
period due to concerns around the
availability of funds. After completing
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Fmt 4703
Sfmt 4703
the initial controlled rollout of HPRP,
FSA has expanded funding for HPRP
and is announcing the reopening of the
application period for eligible entities to
apply for HPRP without a closing date
at this time. In the event that
applications are expected to exceed
available funding, a closing date for
applications will be announced and
priority will be given to applicants in
accordance with 7 U.S.C. 1936c(d). Any
such closing date will be announced in
the Federal Register as specified in 7
CFR part 769 subpart B. Additional
information on HPRP can be found on
FSA’s Farmers.gov website at
www.farmers.gov/working-with-us/
heirs-property-eligibility/relending, and
in 7 CFR part 769 subpart B.
Application and Submission
Information
Eligible lenders can obtain
applications and submission
information at FSA’s Farmers.gov
website at www.farmers.gov/workingwith-us/heirs-property-eligibility/
relending.
Application Review Information
FSA will process and approve
applications in accordance with the
regulations in 7 CFR part 769 subpart B.
USDA Non-Discrimination Policy
In accordance with Federal civil
rights law and U.S. Department of
Agriculture (USDA) civil rights
regulations and policies, USDA, its
Agencies, offices, and employees, and
institutions participating in or
administering USDA programs are
prohibited from discriminating based on
race, color, national origin, religion, sex,
gender identity (including gender
expression), sexual orientation,
disability, age, marital status, family or
parental status, income derived from a
public assistance program, political
beliefs, or reprisal or retaliation for prior
civil rights activity, in any program or
activity conducted or funded by USDA
(not all bases apply to all programs).
Remedies and complaint filing
deadlines vary by program or incident.
Persons with disabilities who require
alternative means of communication for
program information (for example,
braille, large print, audiotape, American
Sign Language, etc.) should contact the
responsible Agency or USDA Target
Center at (202) 720–2600 or 844–433–
2774 (toll-free nationwide).
Additionally, program information may
be made available in languages other
than English.
To file a program discrimination
complaint, complete the USDA Program
Discrimination Complaint Form, AD–
E:\FR\FM\30AUN1.SGM
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]]>Agencies
[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]
========================================================================
Notices
Federal Register
________________________________________________________________________
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
statements of organization and functions are examples of documents
appearing in this section.
========================================================================
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.
-----------------------------------------------------------------------
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
