Availability of an Environmental Assessment for Field Testing of a Clostridium Perfringens Type A Vaccine, Live Salmonella Vector, 20974-20975 [2020-07914]
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20974
Notices
Federal Register
Vol. 85, No. 73
Wednesday, April 15, 2020
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–2020–0010]
Availability of an Environmental
Assessment for Field Testing of a
Clostridium Perfringens Type A
Vaccine, Live Salmonella Vector
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
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 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.
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:22 Apr 14, 2020
Jkt 250001
We will consider all comments
that we receive on or before May 15,
2020.
DATES:
You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/#!docket
Detail;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 https://
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.
ADDRESSES:
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
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00001
Fmt 4703
Sfmt 4703
(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
E:\FR\FM\15APN1.SGM
15APN1
Federal Register / Vol. 85, No. 73 / Wednesday, April 15, 2020 / Notices
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
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2014–0005]
Decision To Authorize the Importation
of Fresh Citrus From China Into the
Continental United States
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
jbell on DSKJLSW7X2PROD with NOTICES
AGENCY:
We are advising the public of
our decision to authorize the
importation of five species of
commercially produced fresh citrus fruit
(pummelo, Nanfeng honey mandarin,
SUMMARY:
VerDate Sep<11>2014
18:22 Apr 14, 2020
Jkt 250001
ponkan, sweet orange, and Satsuma
mandarin) from China into the
continental United States. Based on the
findings of the pest risk analysis, which
we made available to the public to
review and comment through a previous
notice, we have concluded that the
application of one or more designated
phytosanitary measures will be
sufficient to mitigate the risks of
introducing or disseminating plant pests
or noxious weeds via the importation of
these five species of citrus fruit from
China.
DATES: The articles covered by this
notification may be authorized for
importation after April 15, 2020.
FOR FURTHER INFORMATION CONTACT: Ms.
Claudia Ferguson, Senior Regulatory
Policy Specialist, Regulatory
Coordination and Compliance, PPQ,
APHIS, 4700 River Road, Unit 133,
Riverdale, MD 20737–1236; (301) 851–
2352.
SUPPLEMENTARY INFORMATION: Under the
regulations in ‘‘Subpart L—Fruits and
Vegetables’’ (7 CFR 319.56–1 through
319.56–12, referred to below as the
regulations), the Animal and Plant
Health Inspection Service (APHIS)
prohibits or restricts the importation of
fruits and vegetables into the United
States from certain parts of the world to
prevent plant pests from being
introduced into and spread within the
United States.
Section 319.56–4 of the regulations
contains a notice-based process based
on established performance standards
for authorizing the importation of fruits
and vegetables. The performance
standards, known as designated
phytosanitary measures, are listed in
paragraph (b) of that section. Under the
process, APHIS proposes to authorize
the importation of a fruit or vegetable
into the United States if, based on the
findings of a pest risk analysis, we
determine that the measures can
mitigate the plant pest risk associated
with the importation of that fruit or
vegetable. APHIS then publishes a
notice in the Federal Register
announcing the availability of the pest
risk analysis that evaluates the risks
associated with the importation of that
fruit or vegetable.
In accordance with that process, we
published a notice 1 in the Federal
Register on May 1, 2019 (84 FR 18474–
18475, Docket No. APHIS–2014–0005),
in which we announced the availability,
for review and comment, of a pest risk
assessment (PRA) that evaluated the
1 To view the notice, PRA, RMD, supporting
documents, and the comments that we received, go
to https://www.regulations.gov/#!docketDetail;
D=APHIS-2014-0005.
PO 00000
Frm 00002
Fmt 4703
Sfmt 4703
20975
risks associated with the importation
into the continental United States of five
species of commercially produced citrus
fruit from China into the continental
United States. These citrus fruits were:
Citrus grandis (L.) Osbeck cv.
Guanximiyou, referred to in this
document as pummelo; Citrus kinokuni
Hort. ex Tanaka, referred to in this
document as Nanfeng honey mandarin;
Citrus poonensis Hort. ex Tanaka,
referred to in this document as ponkan;
Citrus sinensis (L.) Osbeck, referred to
in this document as sweet orange; and
Citrus unshiu Marcov., referred to in
this document as Satsuma mandarin.
In the notice, PRA, and RMD
published previously, we referred to
Citrus grandis (L.) Osbeck cv.
Guanximiyou, as pomelo; however, the
preferred spelling of the common name
for this fruit is pummelo. We have
corrected the spelling in this document
and in our revised RMD.
The PRA identified the following 15
quarantine pests as potentially
following the pathway on the
importation of these citrus species from
China into the continental United
States: The mites Brevipalpus junicus
and Tuckerella knorri; the fruit flies
Bactrocera correcta, B. cucurbitae, B.
dorsalis, B. minax, B. occipitalis, B.
pedestris, B. tau, and B. tsuneonis; and
the moths Carposina niponensis, C.
sasakii, Ostrinia furnacalis,
Cryptoblabes gnidiella, and Rosseliella
citrifrugis.
The PRA also identified
Xanthomonas citri, the causal agent of
citrus canker, and Phyllosticta
citricarpa, the causal agent of citrus
black spot, as existing in China. These
pathogens, present in the United States,
are considered quarantine pests since
they have limited distribution and are
under official control in the United
States.
Based on the conclusions of the PRA,
APHIS prepared a risk management
document (RMD) recommending
mitigations for the 15 quarantine pests
and 2 pathogens the PRA had identified
as potentially following the pathway on
the importation of citrus from China
into the continental United States.
We solicited comments on the PRA
and RMD for 60 days ending on July 1,
2019. We received 11 comments by that
date. They were from the national plant
protection organization (NPPO) of
China, the NPPO of Ghana, two State
departments of agriculture, four
organizations representing domestic
citrus producers, a domestic citrus
producer, and private citizens.
The issues raised by the commenters
are addressed below, by topic.
E:\FR\FM\15APN1.SGM
15APN1
]]>Agencies
[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]
========================================================================
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. 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.
-----------------------------------------------------------------------
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 https://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 https://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
