The "Public Health Security and Bioterrorism Preparedness and Response Act of 2002" (Public Law 107-188) requires that all persons possessing select biological agents or toxins deemed a threat to public health, animal or plant health, or animal or plant products register with the appropriate federal agency.
On March 18, 2005, final rules were published in the Federal Register by the Departments of Health and Human Services (DHHS)
and Agriculture (USDA)
(.pdf) governing facilities that possess, use or transfer select biological agents or toxins. These rules became effective on April 18, 2005.
If you anticipate using Select Agents, you must contact the University Biosafety Officer (Jacqueline Wagner at 8-1427, firstname.lastname@example.org
) regardless of the planned quantity. You should be aware that if registration is required for your work, the CDC registration process and security risk assessment through the FBI will take an estimated 8 weeks and possibly longer. Furthermore, sources of research funds to cover the costs of facility security improvements associated with compliance will need to be identified.
Anyone contemplating Select Agent use should understand that a decision to do so means accepting a significant level of personal responsibility for meeting all aspects of the requirements mandated by the federal rules. Non-compliance carries with it the potential for significant civil and criminal penalties for violations.