Availability of an Environmental Assessment for Field Testing of a Yersinia Pestis Vaccine, Live Raccoon Poxvirus Vector, 23207-23208 [2013-09144]

Download as PDF sroberts on DSK5SPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 75 / Thursday, April 18, 2013 / Notices The CNAFR will operate under the provisions of the FACA and report to the Secretary of Agriculture. The purpose of the CNAFR is (1) to advise the Secretary of Agriculture on issues related to the participation of Native American farmers and ranchers in USDA farm loan programs; (2) to transmit recommendations concerning any changes to FSA regulations or internal guidance or other measures that would eliminate barriers to program participation for Native American farmers and ranchers; (3) to examine methods of maximizing the number of new farming and ranching opportunities created through the farm loan program through enhanced extension and financial literacy services; (4) to examine methods of encouraging intergovernmental cooperation to mitigate the effects of land tenure and probate issues on the delivery of USDA farm loan programs; (5) to evaluate other methods of creating new farming or ranching opportunities for Native American producers; and (6) to address other related issues as deemed appropriate. The Secretary of Agriculture selected a diverse group of members representing a broad spectrum of persons interested in providing solutions to the challenges of the aforementioned purposes. Equal opportunity practices were considered in all appointments to the CNAFR in accordance with USDA policies. The Secretary selected the members in May 2012. Interested persons may present views, orally or in writing, on issues relating to agenda topics before the CNAFR. Written submissions may be submitted to the contact person on or before April 26, 2013. Oral presentations from the public will be scheduled between approximately 4:00 p.m. to 5:00 p.m. on May 3, 2013. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the issue they wish to present and the names and addresses of proposed participants by April 26, 2013. All oral presentations will be given three (3) to five (5) minutes depending on the number of participants. OTR will also make all agenda topics available to the public via the OTR Web site: https://www.usda.gov/tribalrelations no later than 10 business days before the meeting and at the meeting. In addition, the minutes from the meeting will be posted on the OTR Web site. OTR welcomes the attendance of the public at the CNAFR meetings and will make every effort to accommodate persons with physical disabilities or special VerDate Mar<15>2010 18:54 Apr 17, 2013 Jkt 229001 needs. If you require special accommodations due to a disability, please contact John Lowery, at least 10 business days in advance of the meeting. Dated: April 4, 2013. Max Finberg, Acting Director, Office of Tribal Relations. [FR Doc. 2013–09051 Filed 4–17–13; 8:45 am] BILLING CODE 3410–05–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2013–0020] Availability of an Environmental Assessment for Field Testing of a Yersinia Pestis Vaccine, Live Raccoon Poxvirus Vector Animal and Plant Health Inspection Service, USDA. ACTION: Notice of availability. 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 Yersinia Pestis Vaccine, Live Raccoon Poxvirus Vector. The environmental assessment, which is based on a risk analysis prepared to assess the risks associated with the field testing of this vaccine and related information, examines the potential effects that field testing this veterinary vaccine could have on the quality of the human environment. Based on the risk analysis and other relevant data, 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 May 20, 2013. SUMMARY: PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 23207 You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/ #!documentDetail;D=APHIS-2013-00200001. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2013–0020, Regulatory Analysis and Development, PPD, APHIS, Station 3A–03.8, 4700 River Road Unit 118, Riverdale, MD 20737–1238. Supporting documents and any comments we receive on this docket may be viewed at https:// www.regulations.gov/ #!docketDetail;D=APHIS-2013-0020 or in our reading room, which 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) 7997039 before coming. FOR FURTHER INFORMATION CONTACT: Dr. Donna Malloy, Operational Support Section, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, VS, APHIS, 4700 River Road Unit 148, Riverdale, MD 20737–1231; phone (301) 851–3426, 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, APHIS considers the potential effects of this product on the safety of animals, public health, and the environment. Using the ADDRESSES: E:\FR\FM\18APN1.SGM 18APN1 sroberts on DSK5SPTVN1PROD with NOTICES 23208 Federal Register / Vol. 78, No. 75 / Thursday, April 18, 2013 / Notices risk analysis and other relevant data, APHIS has prepared an environmental assessment (EA) concerning the field testing of the following unlicensed veterinary biological product: Requester: U.S. Geological Survey, National Wildlife Health Center. Product: Yersinia Pestis Vaccine, Live Raccoon Poxvirus Vector. Possible Field Test Locations: Arizona, Colorado, Montana, New Mexico, South Dakota, Texas, Utah, and Wyoming. The above-mentioned product consists of a live recombinant raccoon poxvirus vector expressing two Yersinia pestis proteins. The vaccine is for the oral vaccination of certain wildlife species, specifically free-ranging prairie dogs, as an aid in the prevention and control of sylvatic plague. 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. VerDate Mar<15>2010 18:54 Apr 17, 2013 Jkt 229001 Done in Washington, DC, this 15th day of April 2013. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2013–09144 Filed 4–17–13; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 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) 799–7039 before coming. FOR FURTHER INFORMATION CONTACT: Mr. ` Tony Roman, Import Specialist, PPQ, APHIS, 4700 River Road Unit 156, Riverdale, MD 20737; (301) 851–2242. SUPPLEMENTARY INFORMATION: [Docket No. APHIS–2012–0053] Background Importation of Fresh Oranges and Tangerines From Egypt Into the United States Under the regulations in ‘‘Subpart– Fruits and Vegetables’’ (7 CFR 319.56– 1 through 319.56–58), the Animal and Plant Health Inspection Service (APHIS) prohibits or restricts the importation of fruits and vegetables into the United States from certain parts of the world to prevent the introduction and dissemination of plant pests that are new to or not widely distributed within the United States. Section 319.56–4 contains a performance-based process for approving the importation 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. Oranges (Citrus sinensis) from Egypt were approved to be imported into the United States in 1969, subject to cold treatment for Mediterranean fruit fly (Ceratitis capitata); however, imports of oranges from Egypt were suspended in July 2002 due to the establishment of peach fruit fly (Bactrocera zonata), which is also a pest of citrus in Egypt. Currently, the importation of fresh oranges and tangerines (Citris reticulata) from Egypt is not authorized. We received a request from the national plant protection organization (NPPO) of Egypt to consider the use of cold treatment to mitigate for peach fruit fly in oranges and tangerines (including mandarins and clementines) based on new treatment data the NPPO developed. We determined that cold treatment can be effective for this pest. Because of the time that had passed since importation of oranges from Egypt was suspended, APHIS prepared a pest list to identify pests of quarantine significance that could follow the pathway of importation of oranges and tangerines from Egypt. Based on the pest list, we then completed a commodity import evaluation document (CIED) to identify phytosanitary measures that could be applied to mitigate the risks of introducing or disseminating the identified pests via the importation of Animal and Plant Health Inspection Service, USDA. ACTION: Notice of availability. AGENCY: We are advising the public that we have prepared a pest list associated with oranges and tangerines from Egypt that identifies pests of concern. Subsequently, we prepared a commodity import evaluation document to determine the risk posed by peach fruit fly in oranges and tangerines from Egypt. Based on that evaluation, we have concluded that the application of one or more designated phytosanitary measures will be sufficient to mitigate the pest risk. In addition, we are advising the public that we have prepared a treatment evaluation document that describes a new treatment schedule that can be used to neutralize peach fruit fly and Mediterranean fruit fly in oranges and tangerines. We are making the pest list, commodity import evaluation document, and treatment evaluation document available to the public for review and comment. DATES: We will consider all comments that we receive on or before June 17, 2013. SUMMARY: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/ #!documentDetail;D=APHIS-2012-00530001. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2012–0053, Regulatory Analysis and Development, PPD, APHIS, Station 3A–03.8, 4700 River Road Unit 118, Riverdale, MD 20737–1238. Supporting documents and any comments we receive on this docket may be viewed at https:// www.regulations.gov/ #!docketDetail;D=APHIS–2012–0053 or in our reading room, which is located in ADDRESSES: PO 00000 Frm 00005 Fmt 4703 Sfmt 4703 E:\FR\FM\18APN1.SGM 18APN1

Agencies

[Federal Register Volume 78, Number 75 (Thursday, April 18, 2013)]
[Notices]
[Pages 23207-23208]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09144]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2013-0020]


Availability of an Environmental Assessment for Field Testing of 
a Yersinia Pestis Vaccine, Live Raccoon Poxvirus Vector

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of availability.

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

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 Yersinia Pestis Vaccine, Live Raccoon 
Poxvirus Vector. The environmental assessment, which is based on a risk 
analysis prepared to assess the risks associated with the field testing 
of this vaccine and related information, examines the potential effects 
that field testing this veterinary vaccine could have on the quality of 
the human environment. Based on the risk analysis and other relevant 
data, 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 May 
20, 2013.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov/#!documentDetail;D=APHIS-2013-0020-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2013-0020, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at https://www.regulations.gov/#!docketDetail;D=APHIS-2013-
0020 or in our reading room, which 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) 7997039 before coming.

FOR FURTHER INFORMATION CONTACT: Dr. Donna Malloy, Operational Support 
Section, Center for Veterinary Biologics, Policy, Evaluation, and 
Licensing, VS, APHIS, 4700 River Road Unit 148, Riverdale, MD 20737-
1231; phone (301) 851-3426, 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, 
APHIS considers the potential effects of this product on the safety of 
animals, public health, and the environment. Using the

[[Page 23208]]

risk analysis and other relevant data, APHIS has prepared an 
environmental assessment (EA) concerning the field testing of the 
following unlicensed veterinary biological product:
    Requester: U.S. Geological Survey, National Wildlife Health Center.
    Product: Yersinia Pestis Vaccine, Live Raccoon Poxvirus Vector.
    Possible Field Test Locations: Arizona, Colorado, Montana, New 
Mexico, South Dakota, Texas, Utah, and Wyoming.
    The above-mentioned product consists of a live recombinant raccoon 
poxvirus vector expressing two Yersinia pestis proteins. The vaccine is 
for the oral vaccination of certain wildlife species, specifically 
free-ranging prairie dogs, as an aid in the prevention and control of 
sylvatic plague.
    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 15th day of April 2013.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2013-09144 Filed 4-17-13; 8:45 am]
BILLING CODE 3410-34-P
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