Viruses, Serums, Toxins, and Analogous Products; Licenses, Inspections, Records, and Reports

We are amending the regulations under the Virus-Serum-Toxin Act to clarify certain provisions concerning licenses, inspections, records, and reports. The effect of the rule is to ensure that licensees are aware of the fact that licenses are issued on the condition that the licensee permit inspection of establishments, products, and records, and that a licensee must have at least one product license in order to maintain a valid establishment license. Failure to permit inspection will make the license subject to suspension or revocation. We are also amending the regulations to specify the types of records and reports that must be available for inspection including records describing product development and preparation and market suspensions and recalls. Finally, we are amending the regulations to require that APHIS receive notification immediately if there are indications which raise questions regarding purity, safety, potency, or efficacy of a product, or if it appears there may be a problem regarding the preparation, testing, or distribution of a product. The rule is necessary to clarify and simplify certain provisions of the regulations and to describe required records with greater specificity.