Availability of an Environmental Assessment for Field Testing Escherichia Coli Vaccine, Live Culture, 24498-24499 [05-9281]

Download as PDF 24498 Notices Federal Register Vol. 70, No. 89 Tuesday, May 10, 2005 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. 04–126–2] National Wildlife Services Advisory Committee; Notice of Solicitation for Membership Animal and Plant Health Inspection Service, USDA. ACTION: Notice of solicitation for membership. AGENCY: SUMMARY: The Secretary of Agriculture has renewed the National Wildlife Services Advisory Committee for a 2year period. Through this notice, the Secretary is soliciting nominations for membership on this Committee. DATES: Consideration will be given to nominations received on or before June 24, 2005. ADDRESSES: Nominations should be addressed to the person listed under FOR FURTHER INFORMATION CONTACT. FOR FURTHER INFORMATION CONTACT: Ms. Joanne Garrett, Director, Operational Support Staff, WS, APHIS, 4700 River Road Unit 87, Riverdale, MD 20737– 1234; (301) 734–7921. SUPPLEMENTARY INFORMATION: The National Wildlife Services Advisory Committee (the Committee) advises the Secretary of Agriculture on policies, program issues, and research needed to conduct the Wildlife Services program. The committee also serves as a public forum enabling those affected by the Wildlife Services program to have a voice in the program’s policies. The Committee Chairperson and Vice Chairperson shall be elected by the Committee from among its members. Terms will expire for the current members of the Committee in July 2005. We are soliciting nominations from interested organizations and individuals to replace members on the Committee. An organization may nominate VerDate jul<14>2003 16:17 May 09, 2005 Jkt 205001 individuals from within or outside its membership. The Secretary will select members to obtain the broadest possible representation on the Committee, in accordance with the Federal Advisory Committee Act (5 U.S.C. App. II) and U.S. Department of Agriculture (USDA) Regulation 1041–1. Equal opportunity practices, in line with the USDA policies, will be followed in all appointments to the Committee. To ensure that the recommendations of the Committee have taken into account the needs of the diverse groups served by the Department, membership should include, to the extent practicable, individuals with demonstrated ability to represent minorities, women, and persons with disabilities. Done in Washington, DC, this 5th day of May 2005. W. Ron DeHaven, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 05–9280 Filed 5–9–05; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. 05–034–1] Availability of an Environmental Assessment for Field Testing Escherichia Coli Vaccine, Live Culture Animal and Plant Health Inspection Service, USDA. ACTION: Notice of availability and request for comments. 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 Escherichia Coli Vaccine, Live Culture for use in chickens. 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 PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 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 June 9, 2005. ADDRESSES: You may submit comments by either of the following methods: • EDOCKET: Go to https:// www.epa.gov/feddocket to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once you have entered EDOCKET, click on the ‘‘View Open APHIS Dockets’’ link to locate this document. • Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to: Docket No. 05–034–1, 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. 05–034–1. Reading Room: You may read the environmental assessment, the risk analysis (with confidential business information removed), and any comments that we receive 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: You may view APHIS documents published in the Federal Register and related information on the Internet at https:// www.aphis.usda.gov/ppd/rad/ webrepor.html. FOR FURTHER INFORMATION CONTACT: E:\FR\FM\10MYN1.SGM 10MYN1 Federal Register / Vol. 70, No. 89 / Tuesday, May 10, 2005 / Notices 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; 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: Fort Dodge Animal Health. Product: Escherichia Coli Vaccine, Live Culture. Field Test Locations: Delaware, Maryland, Georgia, Virginia, and Arkansas. The above-mentioned product is a live aroA gene-deleted Escherichia Coli Vaccine. The vaccine is for use in chickens as an aid in the prevention of disease caused by Escherichia coli. 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 VerDate jul<14>2003 16:17 May 09, 2005 Jkt 205001 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 4th day of May 2005. Elizabeth E. Gaston, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 05–9281 Filed 5–9–05; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Forest Service DEPARTMENT OF THE INTERIOR Bureau of Land Management Notice of Intent To Prepare an Environmental Impact Statement for the Sawtooth National Forest, Idaho; Twin Falls BLM District, ID; Bald Mountain Ski Resort Master Development Plan AGENCIES: Forest Service, Agriculture, Lead Agency; Bureau of Land Management, Interior, Cooperating Agency. ACTION: Notice of intent. SUMMARY: Pursuant to the National Environmental Policy Act of 1969 (NEPA) and the Federal Land Policy and Management Act of 1976 (FLPMA), the USDA Forest Service (Lead Agency) and PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 24499 the USDOI Bureau of Land Management (Cooperating Agency) intend to prepare an Environmental Impact Statement (EIS) to analyze and disclose the effects of the updated Bald Mountain Ski Area Master Development Plan (MDP) and 40-year term ski area permit application. Both agencies have authority over the Bald Mountain ski area, which is also known as the Sun Valley Ski Resort. DATES: Written comments concerning the proposed action should be postmarked by June 9, 2005. The draft environmental impact statement is expected to be available for public review and comment in July 2006 and the final environmental impact statement is expected to be available March 2007. ADDRESSES: Written comments should be sent to Kurt Nelson, District Ranger at the Ketchum Ranger Station; P.O. Box 2356, Ketchum, ID 83340. Faxes should be sent to 208–622–3923 and e-mails to: comments-intermtn-sawtoothketchum@fs.fed.us. Comments received on this proposal, including names and addresses, will be considered part of the public record and will be available for public inspection. Individual respondents may request confidentiality. If you wish to withhold your name or street address from public review or from disclosure under the Freedom of Information Act, you must state this prominently at the beginning of your written comment. Such requests will be honored to the extent allowed by law. All submissions from organizations and businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, will be available for public inspection in their entirety. FOR FURTHER INFORMATION CONTACT: Joe Miczulski, Winter Sports Manager at the Ketchum Ranger District; P.O. Box 2356, Ketchum, ID 83340; or phone at (208) 622–5371. SUPPLEMENTARY INFORMATION: Sun Valley Company has requested a new 40-year term ski area permit for the Bald Mountain Ski Resort. The existing ski area permit, which was issued in December 1977, expires December 2007. One requirement for a ski area permit is to have an approved Master Development Plan (MDP), which is prepared by the permit holder and encompasses the entire winter sports resort envisioned for development and authorization by the permit. Upon acceptance by the Authorized Officers, the MDP becomes part of the ski area permit. The EIS will analyze the effects of the proposed action and alternatives. The agencies give notice of the National E:\FR\FM\10MYN1.SGM 10MYN1

Agencies

[Federal Register Volume 70, Number 89 (Tuesday, May 10, 2005)]
[Notices]
[Pages 24498-24499]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9281]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 05-034-1]


Availability of an Environmental Assessment for Field Testing 
Escherichia Coli Vaccine, Live Culture

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of availability and request for comments.

-----------------------------------------------------------------------

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 Escherichia Coli Vaccine, Live Culture for 
use in chickens. 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 June 
9, 2005.

ADDRESSES: You may submit comments by either of the following methods:
     EDOCKET: Go to https://www.epa.gov/feddocket to submit or 
view public comments, access the index listing of the contents of the 
official public docket, and to access those documents in the public 
docket that are available electronically. Once you have entered 
EDOCKET, click on the ``View Open APHIS Dockets'' link to locate this 
document.
     Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to: Docket No. 05-034-1, 
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. 05-034-1.
    Reading Room: You may read the environmental assessment, the risk 
analysis (with confidential business information removed), and any 
comments that we receive 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: You may view APHIS documents published in the 
Federal Register and related information on the Internet at https://
www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT:

[[Page 24499]]

    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; 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: Fort Dodge Animal Health.
    Product: Escherichia Coli Vaccine, Live Culture.
    Field Test Locations: Delaware, Maryland, Georgia, Virginia, and 
Arkansas.
    The above-mentioned product is a live aroA gene-deleted Escherichia 
Coli Vaccine. The vaccine is for use in chickens as an aid in the 
prevention of disease caused by Escherichia coli.
    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 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 4th day of May 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 05-9281 Filed 5-9-05; 8:45 am]
BILLING CODE 3410-34-P
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