Animal and Plant Health Inspection Service December 2007 – Federal Register Recent Federal Regulation Documents

We are amending the Virus-Serum-Toxin Act regulations for certain live bacterial and viral vaccines by removing the requirement to retest the Master Seeds for immunogenicity 3 years after the initial qualifying immunogenicity test. In addition, we are amending the requirement concerning mouse safety tests prescribed for a biological product recommended for animals other than poultry. These changes update the standard requirements by eliminating unnecessary testing of Master Seed bacteria and viruses and other forms of bulk or completed biological product.

We are advising the public that we are making available for review and comment a Business Plan to Advance Animal Disease Traceability. The Business Plan details recommended strategies and actions to enable existing State and Federal regulated and voluntary animal health programs, industry-administered management and marketing programs, and various animal identification methods to work in harmony with the National Animal Identification System.

We are amending the regulations to increase the user fees for the veterinary diagnostic services to reflect changes in our operating costs and expenses. We are also setting rates for multiple fiscal years. These actions are necessary to ensure that we recover the actual costs of providing these services. We are also providing for a reasonable balance, or reserve, in the veterinary diagnostics user fee account. The Food, Agriculture, and Conservation Act of 1990, as amended, authorizes us to set and collect these user fees.

We are amending our Agricultural Quarantine and Inspection Services user fee regulations to update an address that appears in several places. We are also making several nonsubstantive changes to the Veterinary Services user fee regulations to correct errors and to clarify the services covered by certain existing user fees. These changes, which do not affect any existing fees, are necessary to ensure that the user fee regulations are up to date and to ensure their clarity.

We are advising the public that the Animal and Plant Health Inspection Service has received a petition from the Monsanto Company seeking a determination of nonregulated status for insect-resistant corn derived from a transformation event designated as MON 89034. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. In accordance with those regulations, we are soliciting comments on whether this genetically engineered corn is or could be a plant pest. We are also making available for public comment a draft environmental assessment for the proposed determination of nonregulated status.

We are issuing this notice to inform producers and users of veterinary biological products, and other interested individuals, that we will be holding our 14th public meeting to discuss regulatory and policy issues related to the manufacture, distribution, and use of veterinary biological products. We are planning the meeting agenda and are requesting suggestions for topics of general interest to producers and other interested individuals.

We are correcting an error in the cold treatment regulations that resulted from the publication of an interim rule on July 2, 2007, that was effective on August 31, 2007, and the publication of a separate final rule on July 18, 2007, that was effective on August 17, 2007. Because the July 18 final rule reorganized the cold treatment regulations, changes we made in the July 2 interim rule inadvertently removed provisions relating to places for cold treatment and ports of entry from the regulations when the interim rule became effective on August 31, 2007. This correction amends the regulations by reinstating those provisions.

We are amending the Mediterranean fruit fly regulations by adding portions of Santa Clara and Solano Counties, CA, to the list of quarantined areas and restricting the interstate movement of regulated articles from those areas. We are also amending the definitions of the terms core area and day degrees and adding blueberries (Vaccinium spp.) to the list of articles regulated for Mediterranean fruit fly. These actions are necessary to prevent the artificial spread of Mediterranean fruit fly to noninfested areas of the United States and to update the regulations to reflect current science and practices.

We are advising the public that we have prepared a finding of no significant impact relative to a new Federal order that restricts the interstate movement of regulated articles from areas quarantined for citrus greening disease and the Asian citrus psyllid. The finding of no significant impact is based on an environmental assessment that we prepared to document our review and analysis of the potential environmental impacts associated with the implementation of the new Federal order. In a notice published in the Federal Register on November 2, 2007, we made the environmental assessment available to the public for review and comment, but noted that we may have to begin an expanded citrus greening regulatory program in Florida immediately and issue a finding of no significant impact for the environmental assessment before the comment period on the environmental assessment concludes.