Animal and Plant Health Inspection Service 2006 – Federal Register Recent Federal Regulation Documents

The International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH) has developed two draft guidelines titled ``Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports'' and ``Pharmacovigilance of Veterinary Medicinal Products: Data Elements for Submission of Adverse Event Reports.'' These draft guidelines describe, respectively, standardized terminology for the identification of possible adverse events following the use of veterinary medicinal products, and the specific data elements to be used for the submission and exchange of spontaneous adverse event reports between marketing authorization holders (licensees/permittees) and regulatory authorities. Because the draft guidelines apply to pharmacovigilance and adverse event reporting on veterinary vaccines regulated by the Animal and Plant Health Inspection Service under the Virus-Serum-Toxin Act, we are requesting comments on the scope of each guideline and its provisions so that we may include any relevant public input on the drafts in the Agency's comments to the VICH Steering Committee.

We are proposing to amend the regulations regarding tuberculosis in captive cervids by extending, from 2 years to 3, the term for which accredited herd status is valid and increasing by 12 months the interval for conducting the reaccreditation test required to maintain the accredited tuberculosis-free status of cervid herds. We are also proposing to reduce, from three tests to two, the number of consecutive negative official tuberculosis tests required of all eligible captive cervids in a herd before a herd can be eligible for recognition as an accredited herd. These actions would reduce testing costs for herd owners, lessen the potential for animal injury or death during testing, and lower administrative costs for State and Federal regulatory agencies. In addition, we are proposing to amend the regulations by removing references to the blood tuberculosis test for captive cervids, as that test is no longer used in the tuberculosis eradication program for captive cervids. This proposed change would update the regulations so that they refer only to those official tests currently in use.

We are advising the public that the Animal and Plant Health Inspection Service has prepared an environmental assessment for a field trial of genetically engineered strains of a bacterium, Erwinia carotovora, the causal agent of tuber soft rot disease in potato. The bacteria have been genetically engineered to disrupt the disease causing pathway. This field trial will allow researchers to better understand the function of each mutated gene under field conditions. The environmental assessment provides a basis for our conclusion that these field tests will not present a risk of introducing or disseminating a plant pest and will not have a significant impact on the quality of the human environment. Based on its finding of no significant impact, the Animal and Plant Health Inspection Service has determined that an environmental impact statement need not be prepared for these field tests.

We are advising the public of our determination that the Monsanto corn line designated as transformation event MON 88017, which has been genetically engineered for resistance to a corn rootworm complex and for tolerance to the herbicide glyphosate, is no longer considered a regulated article under our regulations governing the introduction of certain genetically engineered organisms. Our determination is based on our evaluation of data submitted by Monsanto in their petition for a determination of nonregulated status, our analysis of other scientific data, and comments received from the public in response to a previous notice announcing the availability of the petition for nonregulated status and an environmental assessment. This notice also announces the availability of our written determination and our finding of no significant impact.