Biosecurity Laws

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 CFR73) unless
  otherwise specified, all of the biologicalagents
  or toxins listed in 73.3 and 73.4.