Animal and Plant Health Inspection Service March 2016 – Federal Register Recent Federal Regulation Documents

Under the auspices of the National Science and Technology Council, USDA, along with the White House Office of Science and Technology Policy, the Environmental Protection Agency and the Food and Drug Administration (FDA) are holding the third public meeting related to the memorandum entitled, ``Modernizing the Regulatory System for Biotechnology Products,'' issued by the Executive Office of the President in July 2015. The purpose of the third public meeting is to illustrate current Federal roles and responsibilities regarding biotechnology products. The docket, FDA-2015-N-3403, established by FDA prior to the first public meeting, will continue to be used for this interagency effort.

We are proposing to amend the National Poultry Improvement Plan (NPIP, the Plan), its auxiliary provisions, and the indemnity regulations for the control of H5 and H7 low pathogenic avian influenza to clarify participation in the NPIP and amend participation requirements, amend definitions for poultry and breeding stock, amend the approval process for new diagnostic tests, and amend laboratory inspection and testing requirements. These changes would align the regulations with international standards and make them more transparent to Animal and Plant Health Inspection Service stakeholders and the general public. The proposed changes were voted on and approved by the voting delegates at the Plan's 2014 National Plan Conference.

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request approval of a revision to and extension of an information collection associated with regulations for the importation of live poultry, poultry meat, and other poultry products from specified regions.

We are advising the public that the Animal and Plant Health Inspection Service has prepared a record of decision for the programmatic environmental impact statement titled ``Carcass Management During a Mass Animal Health Emergency.''

We are advising the public that we have prepared a pest risk analysis that evaluates the risks associated with importation of fresh pomegranate fruit from Peru into the continental United States. Based on the analysis, we have determined 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 importation of fresh pomegranates from Peru. We are making the pest risk analysis available to the public for review and comment.

We are extending the comment period for our proposed rule that would amend the Animal Welfare Act regulations concerning the humane handling, care, treatment, and transportation of marine mammals in captivity. This action will allow interested persons additional time to prepare and submit comments.

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 Canine Osteosarcoma Vaccine, Live Listeria 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 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.

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request a revision to and extension of approval of an information collection associated with the regulations for the importation of fresh bananas from the Philippines into the continental United States.

We are extending the comment period for our notice of intent to prepare a programmatic environmental impact statement in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered organisms. This action will allow interested persons additional time to prepare and submit comments.

We are giving notice of a meeting of the General Conference Committee of the National Poultry Improvement Plan.