Animal and Plant Health Inspection Service March 2018 – Federal Register Recent Federal Regulation Documents

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 to prevent the introduction of gypsy moth from Canada into noninfested areas of the United States.

We are advising the public that we are making available for review and comment a revised version of the Chronic Wasting Disease (CWD) Herd Certification Program Standards. The CWD Program Standards provide guidance on how to meet CWD Herd Certification Program and interstate movement requirements. We are taking this action to address concerns of State and industry participants about the existing standards.

We are proposing to amend the regulations to allow the importation of fresh pummelo fruit from Thailand into the continental United States. As a condition of entry, fresh pummelo fruit from Thailand would be subject to a systems approach that would include irradiation treatment, packinghouse processing requirements, and port of entry inspection. The fruit would also be required to be imported in commercial consignments and be accompanied by a phytosanitary certificate issued by the national plant protection organization of Thailand. This action would allow for the importation of fresh pummelo fruit from Thailand while continuing to provide protection against the introduction of plant pests into the continental United States.

We are restructuring the regulations governing the importation of plants for planting. In the new structure, restrictions on the importation of specific types of plants for planting will no longer be found in the regulations, but instead will be found in the Plants for Planting Manual. We will make changes to the restrictions in the manual after taking public comment through notices published in the Federal Register. As part of this restructuring, we are grouping together restrictions in the plants for planting regulations that apply to the importation of most or all plants for planting, and we are adding general requirements for the development of integrated pest risk management measures that we may use to mitigate the risk associated with the importation of a specific type of plants for planting. We are also amending our foreign quarantine regulations to remove various provisions regarding the importation of specific types of plants for planting that are not currently subject to the general plants for planting regulations; these provisions will also be found in the Plants for Planting Manual. This action does not make any major changes to the restrictions that currently apply to the importation of plants for planting. These changes will make restrictions on the importation of specific types of plants for planting easier for readers to find and less cumbersome for us to change.

We are amending the regulations governing the importation of plants for planting by authorizing the importation of Campanula spp. plants for planting from Denmark in approved growing media into the United States, subject to a systems approach. The systems approach will include measures that are currently specified in the regulations as generally applicable to all plants for planting authorized importation into the United States in approved growing media. This action will allow for the importation of Campanula spp. plants for planting from Denmark in approved growing media, while providing protection against the introduction of plant pests.

We are amending the regulations to clarify that the expiration date of a serial or subserial of a veterinary biologic should be computed from the date of the initiation of the first potency test. We are also requiring the expiration dating period (stability) of a product to be confirmed by conducting a real-time stability study with a stability-indicating assay, stability monitoring of products after licensing, and specifying a single standard for determining the expiration date for veterinary biologics