Biosecurity - Biosecurity Regulations

Biosecurity Regulations

• US Select Agent Regulations

• 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

• Biological Weapons Convention addresses three relevant issues:

• National Implementing Legislation
• National Pathogen Security (biosecurity)
• International Cooperation
• States Parties agree to pursue national implementation of laboratory and transportation biosecurity (2003)

• UN 1540

• urges States to take preventative measures to mitigate the threat of WMD proliferation by non-state actors
• “Take and enforce effective measures to establish domestic controls to prevent the proliferation of . . . biological weapons . . .; including by establishing appropriate controls over related materials”

• European Commission Green Paper on Bio-Preparedness (November 2007)

• recommends developing European standards on laboratory biosecurity including Physical protection, access controls, accountability of pathogens, and registration of researchers

• Organization for Economic Cooperation and Development

• published “Best Practice Guidelines for Biological Resource Centers” including a section on biosecurity in February 2007

• Kampala Compact (October 2005) and the Nairobi Announcement (July 2007)

• stress importance of implementing laboratory biosafety and biosecurity in Africa