Availability of an Environmental Assessment for Field Testing of a Bursal Disease-Marek's Disease Vaccine, Serotype 3, Live Marek's Disease Vector, 37045 [2017-16673]
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Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Notices
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2017–0030]
Availability of an Environmental
Assessment for Field Testing of a
Bursal Disease-Marek’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 purposes of
field testing, and then to field test, an
unlicensed Bursal Disease-Marek’s
Disease Vaccine, Serotype 3, Live
Marek’s Disease Vector. Based on the
environmental assessment, risk analysis,
and other relevant data, 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. We
are making the documents available to
the public for review and comment.
DATES: We will consider all comments
that we receive on or before September
7, 2017.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
http://www.regulations.gov/
#!docketDetail;D=APHIS-2017-0030.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2017–0030, 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-2017-0030 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: Dr.
Donna Malloy, Operational Support
Section, Center for Veterinary Biologics,
Policy, Evaluation, and Licensing, VS,
APHIS, 4700 River Road Unit 148,
Riverdale, MD 20737–1231; (301) 851–
3426, fax (301) 734–4314.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
21:16 Aug 07, 2017
Jkt 241001
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 redacted), contact
Dr. Patricia L. Foley, Risk Manager,
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.), the Animal and Plant Health
Inspection Service (APHIS) is
authorized to promulgate regulations
designed to ensure that veterinary
biological products are pure, safe,
potent, and efficacious before a
veterinary biological product license
may be issued. Veterinary biological
products include viruses, serums,
toxins, and analogous products of
natural or synthetic origin, such as
vaccines, antitoxins, or the immunizing
components of microorganisms
intended for the diagnosis, treatment, or
prevention of diseases in domestic
animals.
APHIS issues licenses to qualified
establishments that produce veterinary
biological products and issues permits
to importers of such products. APHIS
also enforces requirements concerning
production, packaging, labeling, and
shipping of these products and sets
standards for the testing of these
products. Regulations concerning
veterinary biological products are
contained in 9 CFR parts 101 to 124.
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 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
considers the potential effects of this
product on the safety of animals, public
health, and the environment. Based
upon a risk analysis and other relevant
data, APHIS has prepared an
environmental assessment (EA)
concerning the field testing of the
following unlicensed veterinary
biological product:
Requester: Zoetis Inc.
Product: Bursal Disease-Marek’s
Disease Vaccine, Serotype 3, Live
Marek’s Disease Vector.
Possible Field Test Locations:
Alabama, Delaware, Georgia, Iowa, and
North Carolina.
PO 00000
Frm 00006
Fmt 4703
Sfmt 9990
37045
The above-mentioned product is a
live Marek’s Disease serotype 3 vaccine
virus containing a gene from the
infectious bursal disease virus. The
attenuated vaccine is intended for use in
healthy 18-day-old or older chicken
embryos by the in ovo route or day-old
chicks by subcutaneous inoculation, as
an aid in the prevention of Marek’s
disease and infectious bursal disease.
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).
We are publishing this notice to
inform the public that we will accept
written comments regarding the EA
from interested or affected persons for a
period of 30 days from the date of this
notice. 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 associated
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
satisfactory 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.
Done in Washington, DC, this 2nd day of
August 2017.
Michael C. Gregoire,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2017–16673 Filed 8–7–17; 8:45 am]
BILLING CODE 3410–34–P
E:\FR\FM\08AUN1.SGM
08AUN1
Agencies
[Federal Register Volume 82, Number 151 (Tuesday, August 8, 2017)]
[Notices]
[Page 37045]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16673]
[[Page 37045]]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2017-0030]
Availability of an Environmental Assessment for Field Testing of
a Bursal Disease-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 purposes of field testing, and then to
field test, an unlicensed Bursal Disease-Marek's Disease Vaccine,
Serotype 3, Live Marek's Disease Vector. Based on the environmental
assessment, risk analysis, and other relevant data, 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. We are making the documents available to the public for
review and comment.
DATES: We will consider all comments that we receive on or before
September 7, 2017.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0030.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2017-0030, 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-2017-
0030 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: Dr. Donna Malloy, Operational Support
Section, Center for Veterinary Biologics, Policy, Evaluation, and
Licensing, VS, APHIS, 4700 River Road Unit 148, Riverdale, MD 20737-
1231; (301) 851-3426, fax (301) 734-4314.
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 redacted),
contact Dr. Patricia L. Foley, Risk Manager, 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.), the Animal and Plant Health Inspection Service (APHIS) is
authorized to promulgate regulations designed to ensure that veterinary
biological products are pure, safe, potent, and efficacious before a
veterinary biological product license may be issued. Veterinary
biological products include viruses, serums, toxins, and analogous
products of natural or synthetic origin, such as vaccines, antitoxins,
or the immunizing components of microorganisms intended for the
diagnosis, treatment, or prevention of diseases in domestic animals.
APHIS issues licenses to qualified establishments that produce
veterinary biological products and issues permits to importers of such
products. APHIS also enforces requirements concerning production,
packaging, labeling, and shipping of these products and sets standards
for the testing of these products. Regulations concerning veterinary
biological products are contained in 9 CFR parts 101 to 124.
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 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 considers the potential effects of this product on the safety of
animals, public health, and the environment. Based upon a risk analysis
and other relevant data, APHIS has prepared an environmental assessment
(EA) concerning the field testing of the following unlicensed
veterinary biological product:
Requester: Zoetis Inc.
Product: Bursal Disease-Marek's Disease Vaccine, Serotype 3, Live
Marek's Disease Vector.
Possible Field Test Locations: Alabama, Delaware, Georgia, Iowa,
and North Carolina.
The above-mentioned product is a live Marek's Disease serotype 3
vaccine virus containing a gene from the infectious bursal disease
virus. The attenuated vaccine is intended for use in healthy 18-day-old
or older chicken embryos by the in ovo route or day-old chicks by
subcutaneous inoculation, as an aid in the prevention of Marek's
disease and infectious bursal disease.
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).
We are publishing this notice to inform the public that we will
accept written comments regarding the EA from interested or affected
persons for a period of 30 days from the date of this notice. 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 associated 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 satisfactory 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.
Done in Washington, DC, this 2nd day of August 2017.
Michael C. Gregoire,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2017-16673 Filed 8-7-17; 8:45 am]
BILLING CODE 3410-34-P