Animal and Plant Health Inspection Service January 31, 2007 – Federal Register Recent Federal Regulation Documents
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Viruses, Serums, Toxins, and Analogous Products; Standard Requirements for Live Vaccines
We are proposing to amend 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 proposing to amend the requirement concerning mouse safety tests prescribed for a biological product recommended for animals other than poultry. These proposed changes would update the standard requirements by eliminating unnecessary testing of Master Seed bacteria and viruses and other forms of bulk or completed biological product.
Classical Swine Fever Status of the Mexican State of Nayarit
We are proposing to amend the regulations for importing animals and animal products by adding the Mexican State of Nayarit to the list of regions considered free of classical swine fever (CSF). We are proposing this action at the request of the Mexican Government and the State of Nayarit, and after conducting a risk evaluation that indicates that Nayarit is free of this disease. We are also proposing to add Nayarit to the list of CSF-affected regions whose exports of live swine, pork, and pork products to the United States must meet certain certification requirements to ensure their freedom from CSF. These actions would relieve certain CSF-related restrictions on the importation into the United States of pork, pork products, live swine, and swine semen from Nayarit while continuing to protect against the introduction of this disease into the United States.
Public Meeting; Veterinary Biologics
We are advising producers and users of veterinary biological products, and other interested individuals, that the 14th public meeting on veterinary biologics previously scheduled to be held on March 28 and 29, 2007, is canceled.
Viruses, Serums, Toxins, and Analogous Products; Detection of Avian Lymphoid Leukosis Virus
We are proposing to amend the Virus-Serum-Toxin Act regulations concerning testing for avian lymphoid leukosis in veterinary biologics to specify that the test is for the detection of extraneous replicating avian leukosis virus; require such testing to be conducted using a procedure that will detect extraneous replicating avian leukosis virus and that is acceptable to the Animal and Plant Health Inspection Service; require firms to develop a procedure to test for lymphoid leukosis virus contamination in the case of vaccine virus cytopathic to chick embryo cell cultures; and specify the equivalent inoculum dose of vaccine to be used when testing certain specified chicken vaccines for lymphoid leukosis virus. These proposed changes would update the testing for lymphoid leukosis virus contamination by prescribing a test procedure that increases the probability of detecting atypical lymphoid leukosis viruses such as those recently found in a contaminated vaccine.
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