Availability of an Environmental Assessment for Field Testing Fowl Laryngotracheitis-Marek's Disease Vaccine, Serotype 3, Live Marek's Disease Vector, 50026-50027 [E6-14040]

Download as PDF 50026 Notices Federal Register Vol. 71, No. 164 Thursday, August 24, 2006 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–2006–0128] Availability of an Environmental Assessment for Field Testing Fowl Laryngotracheitis-Marek’s Disease Vaccine, Serotype 3, Live Marek’s Disease Vector Animal and Plant Health Inspection Service, USDA. ACTION: Notice. rmajette on PROD1PC67 with NOTICES1 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 Fowl LaryngotracheitisMarek’s Disease Vaccine, Serotype 3, Live Marek’s Disease 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. VerDate Aug<31>2005 15:15 Aug 23, 2006 Jkt 208001 We will consider all comments that we receive on or before September 25, 2006. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov and, in the lower ‘‘Search Regulations and Federal Actions’’ 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–2006–0128 to submit or view public comments and to view supporting and related materials available electronically. Information on using Regulations.gov, including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site’s ‘‘User Tips’’ link. • Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. APHIS–2006–0128, 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– 2006–0128. Reading Room: You may read environmental assessment, the risk analysis (with confidential business information removed), and 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 DATES: PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 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: Fowl LaryngotracheitisMarek’s Disease Vaccine, Serotypes 3, Live Marek’s Disease Vector. Field Test Locations: Alabama, Arkansas, Florida, Georgia, Indiana, Iowa, Kentucky, Missouri, Pennsylvania, Tennessee, Texas, and Washington. The above-mentioned product is a live recombinant virus consisting of the avirulent turkey herpesvirus (HVT) vector expressing two genes of infectious laryngotracheitis virus. The vaccine is for use in chickens as an aid in the prevention of disease caused by virulent Marek’s disease virus and infectious laryngotracheitis 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 E:\FR\FM\24AUN1.SGM 24AUN1 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Notices 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 21st day of August 2006. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E6–14040 Filed 8–23–06; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Forest Service Notice of Resource Advisory Committee, Sundance, WY Notice of Resource Advisory Committee, Sundance, Wyoming, USDA Forest Service, USDA. ACTION: Notice of meeting. rmajette on PROD1PC67 with NOTICES1 AGENCY: SUMMARY: Pursuant to the authorities in the Federal Advisory Committee Act (Pub. L. 92–463) and under the Secure Rural Schools and Community SelfDetermination Act of 2000 (Pub. L. 106– 393) the Black Hills National Forests’ Crook County Resource Advisory Committee will meet Monday, September 11th, 2006 in Sundance, Wyoming for a business meeting. The meeting is open to the public. VerDate Aug<31>2005 15:15 Aug 23, 2006 Jkt 208001 The business meeting on September 11 will begin at 6:30 p.m., at the USFS Bearlodge Ranger District office, 121 South 21st Street, Sundance, Wyoming. Agenda topics will include a review of previously funded projects and consideration of FY 2007 project proposals. A public forum will begin at 8 p.m. (MT). FOR FURTHER INFORMATION CONTACT: Steve Kozel, Bearlodge District Ranger and Designated Federal Officer at (307) 283–1361. SUPPLEMENTARY INFORMATION: Dated: August 18, 2006. Steven J. Kozel, District Ranger, Bearlodge Ranger District. [FR Doc. 06–7118 Filed 8–23–06; 8:45 am] BILLING CODE 3410–11–M DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration [I.D. 020306A] Small Takes of Marine Mammals Incidental to Specified Activities; Seismic Surveys in the Beaufort and Chukchi Seas off Alaska National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Notice of Issuance of an Incidental Harassment Authorization. AGENCY: SUMMARY: In accordance with regulations implementing the Marine Mammal Protection Act (MMPA) as amended, notification is hereby given that an Incidental Harassment Authorization (IHA) to take small numbers of marine mammals, by harassment, incidental to conducting a marine geophysical program, including deep seismic surveys, on oil and gas lease blocks located on Outer Continental Shelf (OCS) waters in the mid- and eastern-Beaufort Sea and on pre-lease areas in the Northern Chukchi Sea has been issued to Shell Offshore, Inc. (Shell) and WesternGeco, Inc. DATES: Effective from July 10, 2006 through December 31, 2006. ADDRESSES: The application, a list of references used in this document, and the IHA are available by writing to P. Michael Payne, Chief, Permits, Conservation and Education Division, Office of Protected Resources, National Marine Fisheries Service, 1315 EastWest Highway, Silver Spring, MD 20910–3225, or by telephoning one of the contacts listed here. A copy of the PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 50027 application and/or the research monitoring plan (LGL, 2006) is also available at: https://www.nmfs.noaa.gov/ pr/permits/incidental.htm#iha. Documents cited in this document, that are not available through standard public (inter-library loan) access, may be viewed, by appointment, during regular business hours at this address. A copy of the Minerals Management Service’s (MMS) Programmatic Environmental Assessment (PEA) is available on-line at: https:// www.mms.gov/alaska/ref/pealbe.htm. FOR FURTHER INFORMATION CONTACT: Kenneth Hollingshead or Jolie Harrison, Office of Protected Resources, NMFS, (301) 713–2289. SUPPLEMENTARY INFORMATION: Background Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq.) direct the Secretary of Commerce to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review. An authorization shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses and the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth. NMFS has defined ‘‘negligible impact’’ in 50 CFR 216.103 as ’’...an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.’’ Section 101(a)(5)(D) of the MMPA established an expedited process by which citizens of the United States can apply for an authorization to incidentally take small numbers of marine mammals by harassment. Except with respect to certain activities not pertinent here, the MMPA defines ‘‘harassment’’ as: any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, E:\FR\FM\24AUN1.SGM 24AUN1

Agencies

[Federal Register Volume 71, Number 164 (Thursday, August 24, 2006)]
[Notices]
[Pages 50026-50027]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14040]


========================================================================
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. 71, No. 164 / Thursday, August 24, 2006 / 
Notices

[[Page 50026]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2006-0128]


Availability of an Environmental Assessment for Field Testing 
Fowl Laryngotracheitis-Marek's Disease Vaccine, Serotype 3, Live 
Marek's Disease 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 Fowl Laryngotracheitis-Marek's Disease 
Vaccine, Serotype 3, Live Marek's Disease 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 
September 25, 2006.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://
www.regulations.gov and, in the lower ``Search Regulations and Federal 
Actions'' 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-2006-0128 to submit or view public comments and 
to view supporting and related materials available electronically. 
Information on using Regulations.gov, including instructions for 
accessing documents, submitting comments, and viewing the docket after 
the close of the comment period, is available through the site's ``User 
Tips'' link.
     Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to Docket No. APHIS-
2006-0128, 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-2006-0128.
    Reading Room: You may read environmental assessment, the risk 
analysis (with confidential business information removed), and 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, 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: Fowl Laryngotracheitis-Marek's Disease Vaccine, Serotypes 
3, Live Marek's Disease Vector.
    Field Test Locations: Alabama, Arkansas, Florida, Georgia, Indiana, 
Iowa, Kentucky, Missouri, Pennsylvania, Tennessee, Texas, and 
Washington.
    The above-mentioned product is a live recombinant virus consisting 
of the avirulent turkey herpesvirus (HVT) vector expressing two genes 
of infectious laryngotracheitis virus. The vaccine is for use in 
chickens as an aid in the prevention of disease caused by virulent 
Marek's disease virus and infectious laryngotracheitis 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

[[Page 50027]]

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 21st day of August 2006.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E6-14040 Filed 8-23-06; 8:45 am]
BILLING CODE 3410-34-P
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