2013-23175. Availability of an Environmental Assessment for Field Testing of a DNA Immunostimulant

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 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 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 [phone], fax [phone]; email: [e-mail]. 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 [phone], fax [phone]

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.