Biosafety Manual

53 Biosafety Manual USDA-APHIS-Plant Protection and Quarantine (permits for the import and interstate transport of plant materials, plant pests, plant pathogens, and soils) USDA-APHIS Biotechnology Regulatory Services (permits and notifications for the import and interstate movement of Genetically Modified Plants, Plant Pests, or Plant Pathogens) USDA-APHIS Veterinary Services (permits for the import and interstate transport of pathogens of livestock and poultry, and anything biological derived from or exposed to pathogens of livestock and poultry) Select Agents and Toxins As of February 2003, the CDC and USDA federal regulations regarding Select Agents and Toxins (42 CFR Part 73, 7 CFR Part 331 and 9 CFR Part 121) supersede any previous regulations. Entities that export, import, transport, or possess Select Agents (SAs), which include certain viruses, bacteria, Rickettsia, fungi, and biological toxins, are now required to apply for and receive registration with the appropriate federal agency before possession occurs. Substantial criminal penalties apply to both individuals and organizations that do not comply with the regulatory requirements. Separate paperwork must not only be completed for each laboratory on campus that plans to possess any of the SAs covered by these regulations, but also for each SA used. The paperwork consists of an extensive application packet requiring renewal every three years. Registered laboratories are subject to inspection by outside agencies. The CDC and USDAwebsites and the biosafety officer (515) 294-5359 can help determine whether the SA rules apply to specific projects and whether registration is required. Each individual working with SAs must also obtain clearance to do so, by having a Bioterrorism Security Risk Assessment conducted by the FBI. Additional Resources CDC Select Agent Program USDA Agricultural Select Agent Program

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