Animal and Plant Health Inspection Service April 2005 – Federal Register Recent Federal Regulation Documents

We are proposing to amend the Virus-Serum-Toxin Act regulations to require licensees and permittees to confirm the proposed expiration dating period of products by potency testing serials on multiple occasions throughout the proposed dating period, rather than only at release and at the approximate expiration date as is currently required. We would require that those stability test data be submitted to the Animal and Plant Health Inspection Service for review and filing, and that the approval date be specified in a filed Outline of Production. In addition, after a product is licensed and its dating period confirmed, the licensee or permittee would have to submit a plan to monitor the stability of the product and the suitability of its dating period; that plan would have to include regular testing of serials for potency during and at the end of dating. The proposed changes would help clarify the distinction between specifying an expiration date for an individual serial of a product and establishing the appropriate expiration dating period for the product. The effect of these proposed changes would be to establish a single uniform standard for determining expiration dates for veterinary biological products.

We are proposing to amend the regulations governing the importation of plants and plant products to add Christmas cactus, Schlumbergera spp., and Easter cactus, Rhipsalidopsis spp., from the Netherlands and Denmark to the list of plants that may be imported in an approved growing medium subject to specified growing, inspection, and certification requirements. We are taking this action in response to requests from the Netherlands and Denmark and after determining that Christmas cactus and Easter cactus established in growing media can be imported without resulting in the introduction into the United States or the dissemination within the United States of a plant pest or noxious weed. The proposed change would allow Christmas cactus and Easter cactus established in growing media to be imported into the United States from the Netherlands and Denmark under certain conditions.

We are amending the Asian longhorned beetle regulations by removing portions of Cook and DuPage Counties, IL, from the list of quarantined areas and removing restrictions on the interstate movement of regulated articles from those areas. We have determined that the Asian longhorned beetle no longer presents a risk of spread from those areas and that the quarantine and restrictions are no longer necessary.

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with proposed regulations for the payment of compensation in the event of an outbreak of foot-and-mouth disease in the United States.

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with regulations to prevent the interstate spread of plant diseases within the United States.

We are adopting as a final rule, without change, an interim rule that amended the Asian longhorned beetle regulations by adding portions of Middlesex and Union Counties, NJ, to the list of quarantined areas and restricting the interstate movement of regulated articles from those areas. That action was necessary to prevent the artificial spread of the Asian longhorned beetle into noninfested areas of the United States.

We are amending the bovine tuberculosis regulations regarding State and zone classifications by raising the designation of California from modified accredited advanced to accredited-free. We have determined that California meets the criteria for designation as an accredited-free State.

We are advising the public that the Animal and Plant Health Inspection Service will be holding two public scoping forums to promote further public involvement in the development of an environmental impact statement as part of our consideration of a petition received from Monsanto Company and The Scotts Company for a determination of nonregulated status for a glyphosate-tolerant creeping bentgrass (Agrostis stolonifera). The information received in response to this notice, as well as the information received previously, will be considered during development of an environmental impact statement prepared in accordance with the National Environmental Policy Act.

We are proposing to amend the regulations for importing animals and animal products into the United States to apply a uniform set of importation requirements related to classical swine fever (CSF) to a region consisting of all of the 15 Member States of the European Union (EU) that comprised the EU as of April 30, 2004 (the EU-15) and prohibit for a specified period of time the importation of live swine and swine products from any area in the EU-15 that is identified by the veterinary authorities of the region as a restricted zone. We believe these changes are necessary to help prevent the introduction of CSF into the United States while increasing our responsiveness to changes in the CSF situation in the EU.

We are amending the regulations concerning overtime services provided by employees of the Agency's Plant Protection and Quarantine (PPQ) and Veterinary Services (VS) programs by adding or amending commuted traveltime allowances for travel between certain locations in Texas, New Mexico, and Mexico. Commuted traveltime allowances are the periods of time required for PPQ or VS employees to travel from their dispatch points and return there from the places where they perform Sunday, holiday, or other overtime duty. The Government charges a fee for certain overtime services provided by PPQ and VS employees and, under certain circumstances, the fee may include the cost of commuted traveltime. This action is necessary to inform the public of commuted traveltime for these locations.