[Federal Register Volume 79, Number 23 (Tuesday, February 4, 2014)]
[Notices]
[Pages 6531-6532]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02273]


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 Notices
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
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  Federal Register / Vol. 79, No. 23 / Tuesday, February 4, 2014 / 
Notices  

[[Page 6531]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2013-0102]


Availability of an Environmental Assessment for Field Testing a 
Porcine Reproductive and Respiratory Syndrome Vaccine, Respiratory 
Form, Modified Live Virus

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 Porcine Reproductive and Respiratory Syndrome 
Vaccine, Respiratory Form, Modified Live Virus. 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 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 March 
6, 2014.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2013-0102-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2013-0102, 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 http://www.regulations.gov/#!docketDetail;D=APHIS-2013-
0102 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) 799-7039 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 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: ProtaTek International, Inc.
    Product: Porcine Reproductive and Respiratory Syndrome Vaccine, 
Respiratory Form, Modified Live Virus.
    Possible Field Test Locations: Iowa, North Carolina, and Texas.
    The above-mentioned product is a live chimeric virus constructed 
from an infectious clone and a field isolate of porcine reproductive 
and respiratory syndrome virus to produce an attenuated vaccine. The 
vaccine is intended for use in swine, 3 weeks of age or older, as an 
aid in the reduction of lung lesions caused by porcine reproductive and 
respiratory syndrome 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

[[Page 6532]]

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 29th day of January 2014.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-02273 Filed 2-3-14; 8:45 am]
BILLING CODE 3410-34-P