Availability of an Environmental Assessment for Field Testing West Nile Virus Vaccine, Live Flavivirus Chimera, 69307-69308 [E5-6293]

Download as PDF 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]


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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
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