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[Federal Register Volume 78, Number 185 (Tuesday, September 24, 2013)]
[Notices]
[Pages 58514-58515]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-23175]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2013-0077]

Availability of an Environmental Assessment for Field Testing of 
a DNA Immunostimulant

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of availability.

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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 DNA Immunostimulant recommended for reduction 
in morbidity and mortality due to Escherichia coli in chickens and 
reduction in bovine respiratory disease due to Mannheimia haemolytica 
in cattle. The environmental assessment, which is based on a risk 
analysis prepared to assess the risks associated with the field testing 
of this veterinary biological product and related information, examines 
the potential effects that field testing this product could have on the 
quality of the human environment. Based on the risk analysis

[[Page 58515]]

and other relevant data, we have reached a preliminary determination 
that field testing this product 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 
product 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 product, 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 
October 24, 2013.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2013-0077-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2013-0077, 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-
0077 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, 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) 851-3426, fax (301) 734-4314; 
email: Donna.L.Malloy@aphis.usda.gov. For information regarding the 
environmental assessment or the risk analysis, or to request a copy of 
the environmental assessment or the risk analysis (with confidential 
business information redacted), contact Dr. Patricia 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 conducted a risk analysis to evaluate 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 product:
    Requester: Bayer HealthCare LLC, Animal Health Division.
    Product: DNA Immunostimulant.
    Possible Field Test Locations: Texas, Mississippi, and Georgia for 
poultry; Nebraska, Indiana, and Missouri for cattle.
    The above mentioned product consists of non-replicating plasmid DNA 
in an immunogenic complex for use as an immunostimulant. This product 
will be recommended for the reduction in morbidity and mortality due to 
Escherichia coli in chickens and reduction in bovine respiratory 
disease due to Mannheimia haemolytica in cattle.
    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 veterinary biological 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 product 
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 19th day of September 2013.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2013-23175 Filed 9-23-13; 8:45 am]
BILLING CODE 3410-34-P
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