Availability of an Environmental Assessment for Field Testing Feline Leukemia Vaccine, Live Canarypox Vector, 3075-3076 [2011-980]
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3075
Notices
Federal Register
Vol. 76, No. 12
Wednesday, January 19, 2011
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–2010–0061]
Notice of Decision to Allow Interstate
Movement of Guavas From Hawaii Into
the Continental United States
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
We are advising the public of
our decision to begin allowing the
interstate movement into the
continental United States of fresh guava
fruit from Hawaii. Based on the findings
of a pest risk analysis, which we made
available to the public for review and
comment through a previous notice, we
believe 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
interstate movement of guavas from
Hawaii.
SUMMARY:
Effective Date: January 19, 2011.
FOR FURTHER INFORMATION CONTACT: Mr.
David Lamb, Import Specialist, PPQ,
APHIS, 4700 River Road Unit 133,
Riverdale, MD 20737–1236; (301) 734–
0627.
SUPPLEMENTARY INFORMATION:
DATES:
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Background
Under the regulations in ‘‘Subpart—
Regulated Articles From Hawaii and the
Territories’’ (7 CFR 318.13–1 through
318.13–26, referred to below as the
regulations), the Animal and Plant
Health Inspection Service (APHIS) of
the U.S. Department of Agriculture
prohibits or restricts the interstate
movement of fruits and vegetables into
the United States from Hawaii, Puerto
Rico, the U.S. Virgin Islands, Guam, and
the Commonwealth of the Northern
Mariana Islands to prevent plant pests
VerDate Mar<15>2010
17:04 Jan 18, 2011
Jkt 223001
and noxious weeds from being
introduced into and spread within the
continental United States. (The
continental United States is defined in
§ 318.13–2 of the regulations as the 48
contiguous States, Alaska, and the
District of Columbia.)
Section 318.13–4 contains a
performance-based process for
approving the interstate movement of
commodities that, based on the findings
of a pest risk analysis, can be safely
imported subject to one or more of the
designated phytosanitary measures
listed in paragraph (b) of that section.
Under that process, APHIS publishes a
notice in the Federal Register
announcing the availability of the pest
risk analysis that evaluates the risks
associated with the interstate movement
of a particular fruit or vegetable.
Following the close of the 60-day
comment period, APHIS may begin
allowing the interstate movement of the
fruit or vegetable subject to the
identified designated measures if: (1) No
comments were received on the pest
risk analysis; (2) the comments on the
pest risk analysis revealed that no
changes to the pest risk analysis were
necessary; or (3) changes to the pest risk
analysis were made in response to
public comments, but the changes did
not affect the overall conclusions of the
analysis and the Administrator’s
determination of risk.
In accordance with that process, we
published a notice 1 in the Federal
Register on August 25, 2010 (75 FR
52304–52305, Docket No. APHIS–2010–
0061), in which we announced the
availability, for review and comment, of
a pest risk analysis that evaluates the
risks associated with the interstate
movement of guavas (Psidium guajava
L.) from Hawaii into the continental
United States. We solicited comments
on the notice for 60 days ending on
October 25, 2010. We received one
comment by that date, from a State
department of agriculture. The
commented supported the action
described in the notice. Therefore, in
accordance with the regulations in
§ 318.13–4, we are announcing our
decision to begin allowing the interstate
movement of guavas from Hawaii into
1 To view the notice, the pest risk analysis, and
the comment we received, go to https://
www.regulations.gov/fdmspublic/component/
main?main=DocketDetail&d=APHIS–2010–0061.
PO 00000
Frm 00001
Fmt 4703
Sfmt 4703
the continental United States subject to
the following phytosanitary measures:
• The guavas must be irradiated in
accordance with 7 CFR part 305 with a
minimum absorbed dose of 400 Gy.
• The guavas must be inspected by an
inspector in Hawaii and found free of
Eutetranychus orientalis and
Oligonychus biharensis.
• The guavas may be moved in as
commercial consignments only.
These conditions will be listed in the
Hawaii Fruits and Vegetables Manual
(available at https://www.aphis.usda.gov/
import_export/plants/manuals/ports/
downloads/hawaii.pdf). In addition to
those specific measures, guavas from
Hawaii will be subject to the general
requirements listed in § 318.13–3 that
are applicable to the interstate
movement of all fruits and vegetables
from Hawaii.
Authority: 7 U.S.C. 7701–7772 and 7781–
7786; 7 CFR 2.22, 2.80, and 371.3.
Done in Washington, DC, this 12th day of
January 2011.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2011–985 Filed 1–18–11; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2010–0126]
Availability of an Environmental
Assessment for Field Testing Feline
Leukemia Vaccine, Live Canarypox
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 Feline Leukemia Vaccine,
Live Canarypox 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
SUMMARY:
E:\FR\FM\19JAN1.SGM
19JAN1
mstockstill on DSKH9S0YB1PROD with NOTICES
3076
Federal Register / Vol. 76, No. 12 / Wednesday, January 19, 2011 / Notices
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 February
18, 2011.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/fdmspublic/
component/
main?main=DocketDetail&d=APHIS–
2010–0126 to submit or view comments
and to view supporting and related
materials available electronically.
• Postal Mail/Commercial Delivery:
Please send one copy of your comment
to Docket No. APHIS–2010–0126,
Regulatory Analysis and Development,
PPD, APHIS, Station 3A–03.8, 4700
River Road, Unit 118, Riverdale, MD
20737–1238. Please state that your
comment refers to Docket No. APHIS–
2010–0126.
Reading Room: You may read any
comments that we receive on this
docket in our reading room. The reading
room 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) 690–2817 before
coming.
Other Information: Additional
information about APHIS and its
programs is available on the Internet at
https://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Dr.
Albert P. Morgan, Section Leader,
Operational Support Section, Center for
Veterinary Biologics, Policy, Evaluation,
and Licensing, VS, APHIS, 4700 River
Road, Unit 148, Riverdale, MD 20737–
1231; phone (301) 734–8245, fax (301)
734–4314.
For information regarding the
environmental assessment or the risk
VerDate Mar<15>2010
17:04 Jan 18, 2011
Jkt 223001
analysis, or to request a copy of the
environmental assessment (as well as
the risk analysis with confidential
business information removed), 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.), 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, a risk analysis
was prepared 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) 1 concerning the field
testing of the following unlicensed
veterinary biological product:
Requester: Merial, Inc.
Product: Feline Leukemia Vaccine,
Live Canarypox Vector.
Field Test Locations: Alabama,
California, Florida, Georgia, Missouri,
and Tennessee.
The above-mentioned product
consists of a live recombinant
canarypox vector expressing certain
feline leukemia virus proteins. The
vaccine is for use in healthy cats at 8
weeks of age or older as an aid in the
prevention of disease due to feline
leukemia virus.
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).
1 The risk analysis (with confidential business
information removed) and the EA may be viewed
on Regulations.gov (see ADDRESSES above for a link
to Regulations.gov).
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Frm 00002
Fmt 4703
Sfmt 4703
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.
Done in Washington, DC, this 12th day of
January 2011.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2011–980 Filed 1–18–11; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2010–0115]
Availability of an Environmental
Assessment for a Biological Control
Agent for Air Potato
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice of availability and
request for comments.
AGENCY:
We are advising the public
that the Animal and Plant Health
Inspection Service has prepared an
environmental assessment (EA) relative
to the control of air potato (Dioscorea
bulbifera). The EA considers the effects
of, and alternatives to, the release of an
insect, Lilioceris cheni, into the
continental United States for use as a
biological control agent to reduce the
severity of air potato infestations. We
are making the EA available to the
public for review and comment.
SUMMARY:
E:\FR\FM\19JAN1.SGM
19JAN1
Agencies
[Federal Register Volume 76, Number 12 (Wednesday, January 19, 2011)]
[Notices]
[Pages 3075-3076]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-980]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2010-0126]
Availability of an Environmental Assessment for Field Testing
Feline Leukemia Vaccine, Live Canarypox 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 Feline Leukemia Vaccine, Live Canarypox
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
[[Page 3076]]
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
February 18, 2011.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2010-0126 to submit or view comments and
to view supporting and related materials available electronically.
Postal Mail/Commercial Delivery: Please send one copy of
your comment to Docket No. APHIS-2010-0126, Regulatory Analysis and
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118,
Riverdale, MD 20737-1238. Please state that your comment refers to
Docket No. APHIS-2010-0126.
Reading Room: You may read any comments that we receive on this
docket in our reading room. The reading room 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) 690-2817 before coming.
Other Information: Additional information about APHIS and its
programs is available on the Internet at https://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Section Leader,
Operational Support Section, Center for Veterinary Biologics, Policy,
Evaluation, and Licensing, VS, APHIS, 4700 River Road, Unit 148,
Riverdale, MD 20737-1231; phone (301) 734-8245, 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 removed),
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.), 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,
a risk analysis was prepared 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) \1\ concerning the field testing of the following
unlicensed veterinary biological product:
---------------------------------------------------------------------------
\1\ The risk analysis (with confidential business information
removed) and the EA may be viewed on Regulations.gov (see ADDRESSES
above for a link to Regulations.gov).
---------------------------------------------------------------------------
Requester: Merial, Inc.
Product: Feline Leukemia Vaccine, Live Canarypox Vector.
Field Test Locations: Alabama, California, Florida, Georgia,
Missouri, and Tennessee.
The above-mentioned product consists of a live recombinant
canarypox vector expressing certain feline leukemia virus proteins. The
vaccine is for use in healthy cats at 8 weeks of age or older as an aid
in the prevention of disease due to feline leukemia virus.
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 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.
Done in Washington, DC, this 12th day of January 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-980 Filed 1-18-11; 8:45 am]
BILLING CODE 3410-34-P