Availability of an Environmental Assessment for Field Testing Feline Leukemia Vaccine, Live Canarypox Vector, 3075-3076 [2011-980]

Download as PDF 3075 Notices Federal Register Vol. 76, No. 12 Wednesday, January 19, 2011 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–2010–0061] Notice of Decision to Allow Interstate Movement of Guavas From Hawaii Into the Continental United States Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: We are advising the public of our decision to begin allowing the interstate movement into the continental United States of fresh guava fruit from Hawaii. Based on the findings of a pest risk analysis, which we made available to the public for review and comment through a previous notice, we believe that the application of one or more designated phytosanitary measures will be sufficient to mitigate the risks of introducing or disseminating plant pests or noxious weeds via the interstate movement of guavas from Hawaii. SUMMARY: Effective Date: January 19, 2011. FOR FURTHER INFORMATION CONTACT: Mr. David Lamb, Import Specialist, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737–1236; (301) 734– 0627. SUPPLEMENTARY INFORMATION: DATES: mstockstill on DSKH9S0YB1PROD with NOTICES Background Under the regulations in ‘‘Subpart— Regulated Articles From Hawaii and the Territories’’ (7 CFR 318.13–1 through 318.13–26, referred to below as the regulations), the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture prohibits or restricts the interstate movement of fruits and vegetables into the United States from Hawaii, Puerto Rico, the U.S. Virgin Islands, Guam, and the Commonwealth of the Northern Mariana Islands to prevent plant pests VerDate Mar<15>2010 17:04 Jan 18, 2011 Jkt 223001 and noxious weeds from being introduced into and spread within the continental United States. (The continental United States is defined in § 318.13–2 of the regulations as the 48 contiguous States, Alaska, and the District of Columbia.) Section 318.13–4 contains a performance-based process for approving the interstate movement 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. Under that process, APHIS publishes a notice in the Federal Register announcing the availability of the pest risk analysis that evaluates the risks associated with the interstate movement of a particular fruit or vegetable. Following the close of the 60-day comment period, APHIS may begin allowing the interstate movement of the fruit or vegetable subject to the identified designated measures if: (1) No comments were received on the pest risk analysis; (2) the comments on the pest risk analysis revealed that no changes to the pest risk analysis were necessary; or (3) changes to the pest risk analysis were made in response to public comments, but the changes did not affect the overall conclusions of the analysis and the Administrator’s determination of risk. In accordance with that process, we published a notice 1 in the Federal Register on August 25, 2010 (75 FR 52304–52305, Docket No. APHIS–2010– 0061), in which we announced the availability, for review and comment, of a pest risk analysis that evaluates the risks associated with the interstate movement of guavas (Psidium guajava L.) from Hawaii into the continental United States. We solicited comments on the notice for 60 days ending on October 25, 2010. We received one comment by that date, from a State department of agriculture. The commented supported the action described in the notice. Therefore, in accordance with the regulations in § 318.13–4, we are announcing our decision to begin allowing the interstate movement of guavas from Hawaii into 1 To view the notice, the pest risk analysis, and the comment we received, go to https:// www.regulations.gov/fdmspublic/component/ main?main=DocketDetail&d=APHIS–2010–0061. PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 the continental United States subject to the following phytosanitary measures: • The guavas must be irradiated in accordance with 7 CFR part 305 with a minimum absorbed dose of 400 Gy. • The guavas must be inspected by an inspector in Hawaii and found free of Eutetranychus orientalis and Oligonychus biharensis. • The guavas may be moved in as commercial consignments only. These conditions will be listed in the Hawaii Fruits and Vegetables Manual (available at https://www.aphis.usda.gov/ import_export/plants/manuals/ports/ downloads/hawaii.pdf). In addition to those specific measures, guavas from Hawaii will be subject to the general requirements listed in § 318.13–3 that are applicable to the interstate movement of all fruits and vegetables from Hawaii. Authority: 7 U.S.C. 7701–7772 and 7781– 7786; 7 CFR 2.22, 2.80, and 371.3. Done in Washington, DC, this 12th day of January 2011. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2011–985 Filed 1–18–11; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2010–0126] Availability of an Environmental Assessment for Field Testing Feline Leukemia Vaccine, Live Canarypox Vector Animal and Plant Health Inspection Service, USDA. ACTION: Notice. 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 Feline Leukemia Vaccine, Live Canarypox 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 SUMMARY: E:\FR\FM\19JAN1.SGM 19JAN1 mstockstill on DSKH9S0YB1PROD with NOTICES 3076 Federal Register / Vol. 76, No. 12 / Wednesday, January 19, 2011 / Notices 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 February 18, 2011. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/fdmspublic/ component/ main?main=DocketDetail&d=APHIS– 2010–0126 to submit or view comments and to view supporting and related materials available electronically. • Postal Mail/Commercial Delivery: Please send one copy of your comment to Docket No. APHIS–2010–0126, 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– 2010–0126. 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, 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 VerDate Mar<15>2010 17:04 Jan 18, 2011 Jkt 223001 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, a risk analysis was prepared 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) 1 concerning the field testing of the following unlicensed veterinary biological product: Requester: Merial, Inc. Product: Feline Leukemia Vaccine, Live Canarypox Vector. Field Test Locations: Alabama, California, Florida, Georgia, Missouri, and Tennessee. The above-mentioned product consists of a live recombinant canarypox vector expressing certain feline leukemia virus proteins. The vaccine is for use in healthy cats at 8 weeks of age or older as an aid in the prevention of disease due to feline leukemia 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 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). 1 The risk analysis (with confidential business information removed) and the EA may be viewed on Regulations.gov (see ADDRESSES above for a link to Regulations.gov). PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 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 12th day of January 2011. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2011–980 Filed 1–18–11; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2010–0115] Availability of an Environmental Assessment for a Biological Control Agent for Air Potato Animal and Plant Health Inspection Service, USDA. ACTION: Notice of availability and request for comments. AGENCY: We are advising the public that the Animal and Plant Health Inspection Service has prepared an environmental assessment (EA) relative to the control of air potato (Dioscorea bulbifera). The EA considers the effects of, and alternatives to, the release of an insect, Lilioceris cheni, into the continental United States for use as a biological control agent to reduce the severity of air potato infestations. We are making the EA available to the public for review and comment. SUMMARY: E:\FR\FM\19JAN1.SGM 19JAN1

Agencies

[Federal Register Volume 76, Number 12 (Wednesday, January 19, 2011)]
[Notices]
[Pages 3075-3076]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-980]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2010-0126]


Availability of an Environmental Assessment for Field Testing 
Feline Leukemia Vaccine, Live Canarypox 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 Feline Leukemia Vaccine, Live Canarypox 
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

[[Page 3076]]

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 
February 18, 2011.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2010-0126 to submit or view comments and 
to view supporting and related materials available electronically.
     Postal Mail/Commercial Delivery: Please send one copy of 
your comment to Docket No. APHIS-2010-0126, 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-2010-0126.
    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, 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, 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, 
a risk analysis was prepared 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) \1\ concerning the field testing of the following 
unlicensed veterinary biological product:
---------------------------------------------------------------------------

    \1\ The risk analysis (with confidential business information 
removed) and the EA may be viewed on Regulations.gov (see ADDRESSES 
above for a link to Regulations.gov).
---------------------------------------------------------------------------

    Requester: Merial, Inc.
    Product: Feline Leukemia Vaccine, Live Canarypox Vector.
    Field Test Locations: Alabama, California, Florida, Georgia, 
Missouri, and Tennessee.
    The above-mentioned product consists of a live recombinant 
canarypox vector expressing certain feline leukemia virus proteins. The 
vaccine is for use in healthy cats at 8 weeks of age or older as an aid 
in the prevention of disease due to feline leukemia 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 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 12th day of January 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-980 Filed 1-18-11; 8:45 am]
BILLING CODE 3410-34-P
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