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Biosecurity Laws

Biosecurity Laws. The Biological Weapons Anti-Terrorism Act of 1989 (Public Law 101-298) The Chemical and Biological Weapons Control and Warfare Elimination Act of 1991 (Public Law 102-182, Title III).

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Biosecurity Laws

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  1. Biosecurity Laws • The Biological Weapons Anti-Terrorism Act of 1989 (Public Law 101-298) • The Chemical and Biological Weapons Control and Warfare Elimination Act of 1991 (Public Law 102-182, Title III). • The Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA PATRIOT ACT) of 2001 (Public Law 107-56). • The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-188) and The Agricultural Bioterrorism Protection Act of 2002 (Public Law 107-188, Title II, Subtitle B).

  2. Implementing Regulations • Interstate shipments of etiological agents (42 CFR 72) Shipping and handling requirements for Select Agents and many other microorganisms and toxins . • Select Agents and Toxins (42 CFR 73). Required risk assessments, access control, and emergency response plans. • Safe and secure transport of hazardous materials (49 CFR 171, 49 CFR 172) Requirements for safe and secure transport of hazardous materials, requirements for security assessments of personnel handling shipments.

  3. Biosafety Guidelines • ``Biosafety in Microbiological and Biomedical Laboratories (CDC Guidelines) • The Occupational Safety and Health Administration (OSHA) regulations in 29 CFR parts 1910.1200 and 1910.1450. • The ``NIH Guidelines for Research Involving Recombinant DNA Molecules,'' (NIH Guidelines).

  4. US Select Agent Rule (2005)source: Sandi National Labs “Introduction to Laboratory Biosecurity” • Facility registration if it possesses one of 81 Select Agents • •Facility must designate a Responsible Official • •Background checks for individuals with access to Select Agents • •Access controls for areas and containers that contain Select Agents • •Detailed inventory requirements for Select Agents • •Security, safety, and emergency response plans • •Safety and security training • •Regulation of transfers of Select Agents • •Extensive documentation and recordkeeping • •Safety and security inspections

  5. Biosafety terms • Dangerous pathogen and toxin (DPT)- term used in public laws, see Select agents and or toxins • Etiological agent (42 CFR 72): a viable microorganism or its toxin which causes, or may cause, human disease. • Overlap select agent and/or toxin (42 CFR 73): a biological agent or toxin listed in § 73.4 and 9 CFR part 121.4. • Select agent and/or toxin (42 CFR§73): unless otherwise specified, all of the biologicalagents or toxins listed in §§ 73.3 and 73.4.

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