October 14, 2011 - CDC Proposed Rule Changes for Importation of Etiologic Agents

The CDC published a Notice of proposed rulemaking in the October 14 Federal Register to revise regulations that cover the importation of etiological agents, hosts and vectors. The rule proposes changes to the Foreign Quarantine regulations, including section heading, terms and definitions (eg, “host”, “vector”);  a requirement for appropriate biosafety measures as a prerequisite for a permit and a provision for CDC inspection authority to inspect an applicant’s facility for the conduct of research at the biosafety levels 3 and 4 if it has not been inspected by the select agent program; permit exemptions are described for select agents, diagnostic specimens, genomic material, and regulated products.  The importer must be in compliance with all applicable laws concerning the packaging and shipment of infectious substances. Comments are due by December 13.



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