Availability of an Environmental Assessment for Field Testing West Nile Virus Vaccine, Live Flavivirus Chimera, 69307-69308 [E5-6293]
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Federal Register / Vol. 70, No. 219 / Tuesday, November 15, 2005 / Notices
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
November 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E5–6297 Filed 11–14–05; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. 05–083–1]
Availability of an Environmental
Assessment for Field Testing West
Nile Virus Vaccine, Live Flavivirus
Chimera
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
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 West Nile Virus Vaccine,
Live Flavivirus Chimera for use in
horses. 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
VerDate Aug<31>2005
15:50 Nov 14, 2005
Jkt 208001
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 December
15, 2005.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov and, in the
‘‘Search for Open Regulations’’ box,
select ‘‘Animal and Plant Health
Inspection Service’’ from the agency
drop-down menu, then click on
‘‘Submit.’’ In the Docket ID column,
select APHIS–2005–0105 to submit or
view public comments and to view
supporting and related materials
available electronically. After the close
of the comment period, the docket can
be viewed using the ‘‘Advanced Search’’
function in Regulations.gov.
• Postal Mail/Commercial Delivery:
Please send four copies of your
comment (an original and three copies)
to Docket No. 05–083–1, Regulatory
Analysis and Development, PPD,
APHIS, Station 3C71, 4700 River Road
Unit 118, Riverdale, MD 20737–1238.
Please state that your comment refers to
Docket No. 05–083–1.
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, Chief Staff Officer,
Operational Support Section, Center for
Veterinary Biologics, Policy, Evaluation,
and Licensing, VS, APHIS, 4700 River
Road Unit 148, Riverdale, MD 20737–
1231; (301) 734–8245.
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
PO 00000
Frm 00002
Fmt 4703
Sfmt 4703
69307
business information removed), contact
Dr. Patricia L. Foley, Risk Manager,
Center for Veterinary Biologics, Policy,
Evaluation, and Licensing VS, APHIS,
510 South 17th Street, Suite 104, Ames,
IA 50010; phone (515) 232–5785, fax
(515) 232–7120.
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: West Nile Virus Vaccine,
Live Flavivirus Chimera.
Field Test Locations: Tennessee,
Kansas, Missouri, Florida, Texas,
Oklahoma, Kentucky, California, New
Jersey, Wisconsin, and Montana.
The above-mentioned product is a
live chimeric virus consisting of the
attenuated human vaccine strain of
Yellow Fever Virus (strain 17 D) with its
structural premembrane (prM) and
envelope (E) genes replaced by the prM
and E genes of West Nile virus. The
vaccine is for use in horses as an aid in
the prevention of viremia and clinical
signs caused by West Nile 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 provision
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
E:\FR\FM\15NON1.SGM
15NON1
69308
Federal Register / Vol. 70, No. 219 / Tuesday, November 15, 2005 / Notices
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
November 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E5–6293 Filed 11–14–05; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Forest Service
Natapoc Ridge Forest Restoration
Project, Okanogan-Wenatchee National
Forests, Chelan County, WA
Forest Service, USDA.
Notice of intent to prepare an
environmental impact statement.
AGENCY:
ACTION:
SUMMARY: The Forest Service, USDA,
will prepare an environmental impact
statement (EIS) on a site-specific
proposal to improve forest health and
sustainability on National Forest lands
in the Natapoc Mountain area of the
Wenatchee River Ranger District,
Okanogan-Wenatchee National Forests.
The proposal will include a variety of
vegetative treatments and road
management actions, as further
described in the SUPPLEMENTARY
INFORMATION section below.
Approximately 4,588 acres would be
treated in the proposed project area.
The analysis area is located within the
Wenatchee River watershed near Plain,
Washington, approximately 12 miles
north of the city of Leavenworth. It is
generally bounded by U.S. Highway 2
VerDate Aug<31>2005
15:50 Nov 14, 2005
Jkt 208001
and State Highway 207 to the west, and
the Wenatchee River to the north, east
and west, and includes parts of the
following townships: T27N, R17E;
T26N, R17E; and T25N, R17E.,
Williamette Meridian.
The proposal is designed to meet the
following needs: (1) Promote the
restoration of forest structure,
composition, and age class distribution,
to a more sustainable condition; (2)
reduce the risks from wildfire, insects,
and disease to late-successional habitat
in the Deadhorse Late Successional
Reserve and Natapoc Managed Late
Successional Area; and (3) reduce
hazardous fuels within the wildlandurban interface, particularly in areas
adjacent to private property. The
direction in the Wenatchee National
Forest Land and Resource Management
Plan (1990), as amended by the
Northwest Forest Plan (1994; 2004),
provides the overall guidance for
management of this area.
Activities would be implemented
between 2006 and approximately 2016
by a combination of private contracting,
Forest Service personnel, cooperative
agreements, and volunteers.
DATES: Comments concerning the scope
of the analysis must be received by
December 14, 2005.
ADDRESSES: Submit written comments
to James L. Boynton, Forest Supervisor,
c/o Vaughan Marable, District Ranger,
Wenatchee River Ranger District, 600
Sherbourne, Leavenworth, Washington
98826, Attn: Natapoc Ridge Forest
Restoration Project. Comments may be
mailed electronically to
comments_wenatchee_river@fs.fed.us.
See the SUPPLEMENTARY INFORMATION
section below for file formats and other
information about electronic filing of
comments.
FOR FURTHER INFORMATION CONTACT:
Steve Willet, Natapoc Project Leader,
USDA Forest Service, Wenatchee River
Ranger District, 600 Sherbourne,
Leavenworth, Washington 98826; phone
509–548–6977, Ext. 288.
SUPPLEMENTARY INFORMATION:
Purpose and Need for Action
The purpose and need for action in
the project area is to promote the
restoration of forest structure,
composition, and age class distribution,
to a more sustainable condition. Fire
exclusion and timber harvest over the
last 100 years have dramatically
changed these forest components. Stand
densities and fuel accumulations are
abnormally high and at risk of
uncharacteristic stand replacement
wildfire. Fire exclusion and past timber
harvest have also altered forest
PO 00000
Frm 00003
Fmt 4703
Sfmt 4703
composition by increasing the fire
intolerant species while decreasing the
fire tolerant species. The number of host
trees susceptible to disease or insect
attack has increased. The proposed
action is needed to reduce the risk of
large scale, uncharacteristic wildfire and
improve forest health.
In dry forest types within the project
area, the objective is to promote open
stands of large ponderosa pine and
Douglas-fir. In mesic forest types of the
project area, the objective is to promote
a mosiac of diverse stand structures,
spatially isolating crown-fire prone
stands. Within the Deadhorse Late
Successional Reserve and Natapoc
Managed Late Successional Area, the
purpose and need is to reduce the risk
to late-successional habitat from
wildfire, insects and disease. The
Natapoc Ridge Forest Restoration
Project would also reduce hazardous
fuels within the wildland-urban
interface, especially in areas adjacent to
private property, to provide access and
increase safety for firefighters and the
public.
The Forest Service has successfully
implemented similar restoration
projects in the Fish Lake and Natapoc
Ridge area since the early 1990s. This
proposal is a continuation of those
efforts.
Proposed Action
The proposed Natapoc Ridge Forest
Restoration Project would include the
following activities:
—Commercial thinning of overstocked
stands to improve tree vigor, reduce
ladder and crown fuels, and favor the
retention of large healthy Douglas-fir
and ponderosa pine. Various
combinations of underburning, hand
piling/pile burning, and top/limb
yarding would be used to reduce both
activity and existing fuels.
—Non-commercial thinning and some
pruning of small trees to improve
vigor, reduce ladder and crown fuels,
and favor desired species. Treatment
areas would mostly occur in 15+ year
old plantations.
—Regeneration harvest of selected
stands that are currently unstable due
to insect and disease infestations.
Usually, all but 5 to 10 large, healthy
trees would be cut in these areas.
Areas would be replanted with
desired tree species.
—Ladder and surface fuel reduction
through pruning or cutting of low
hanging limbs and small trees up to
6 to 7 inches in diameter in order to
reduce potential surface fire intensity
and to prevent tree torching.
E:\FR\FM\15NON1.SGM
15NON1
]]>Agencies
[Federal Register Volume 70, Number 219 (Tuesday, November 15, 2005)]
[Notices]
[Pages 69307-69308]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-6293]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 05-083-1]
Availability of an Environmental Assessment for Field Testing
West Nile Virus Vaccine, Live Flavivirus Chimera
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 West Nile Virus Vaccine, Live Flavivirus
Chimera for use in horses. 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
December 15, 2005.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://
www.regulations.gov and, in the ``Search for Open Regulations'' box,
select ``Animal and Plant Health Inspection Service'' from the agency
drop-down menu, then click on ``Submit.'' In the Docket ID column,
select APHIS-2005-0105 to submit or view public comments and to view
supporting and related materials available electronically. After the
close of the comment period, the docket can be viewed using the
``Advanced Search'' function in Regulations.gov.
Postal Mail/Commercial Delivery: Please send four copies
of your comment (an original and three copies) to Docket No. 05-083-1,
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your
comment refers to Docket No. 05-083-1.
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, Chief Staff
Officer, Operational Support Section, Center for Veterinary Biologics,
Policy, Evaluation, and Licensing, VS, APHIS, 4700 River Road Unit 148,
Riverdale, MD 20737-1231; (301) 734-8245.
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, 510 South 17th
Street, Suite 104, Ames, IA 50010; phone (515) 232-5785, fax (515) 232-
7120.
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: West Nile Virus Vaccine, Live Flavivirus Chimera.
Field Test Locations: Tennessee, Kansas, Missouri, Florida, Texas,
Oklahoma, Kentucky, California, New Jersey, Wisconsin, and Montana.
The above-mentioned product is a live chimeric virus consisting of
the attenuated human vaccine strain of Yellow Fever Virus (strain 17 D)
with its structural premembrane (prM) and envelope (E) genes replaced
by the prM and E genes of West Nile virus. The vaccine is for use in
horses as an aid in the prevention of viremia and clinical signs caused
by West Nile 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 provision 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
[[Page 69308]]
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 November 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E5-6293 Filed 11-14-05; 8:45 am]
BILLING CODE 3410-34-P
