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A Review of H.R. 3448: Public Health Security and Bioterrorism Preparedness Act of 2002 Harry Enoch, Ph.D. Director of Environmental, Health & Safety University of Kentucky July 17, 2002. restricts access to dangerous biological agents that could be used by terrorists or criminals
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A Review of H.R. 3448: Public Health Security and Bioterrorism Preparedness Act of 2002Harry Enoch, Ph.D.Director of Environmental, Health & SafetyUniversity of KentuckyJuly 17, 2002
restricts access to dangerous biological agents that could be used by terrorists or criminals • places additional responsibilities on universities for safeguarding biological agents used in research
H.R. 3448 was preceded by theUSA Patriot Act of 2001 • “If you can’t legally buy a gun, it shouldn’t be legal for you to obtain or possess anthrax.” • made possession of “Select Agents” by “restricted persons” a criminal offense
SelectAgentscertain viruses, bacteria, toxinsand other biological agentsexamples • Ebola and smallpox virus • Anthrax and plague bacteria • Aflatoxin and botulinum toxin
restricted person • convicted or under indictment for a crime • fugitive from justice • unlawful user of controlled substance • illegal alien • mental defective or has been committed • dishonorable discharge • alien from terrorist country
Attorney General’s list of terrorist countries IranIraqSyriaLibyaCubaNorth KoreaSudan
Public Health Security and Bioterrorism Preparedness Act of 2002H.R. 3448enacted June 12, 2002
H.R. 3448 • HHS to regulate possession, use and transfer of Select Agents • HHS to issue rules for safety and security of Select Agents • institutions must register all individuals with access to Select Agents--access is defined very broadly
Dates in H.R. 3448 • notification rules mid July • notify HHS/USDA mid September of Select Agents • interim final rules mid December on registration • final rules effective mid February 2003
Penalties for possessing or transferring listed agents illegally • up to 5 years in prison • up to $250,000 fine for individuals • up to $500,000 fine for institutions
Limited exemptions for • clinical and diagnostic labs • commercial products (licensed, registered, or approved) • products approved for clinical trials • public health emergencies
H.R. 3448 • restricts possession to “legitimate needs” • Justice Department to do background checks on registered individuals • those on initial registration can continue to work until notified otherwise • those who register later cannot work until approved
USDA provisions • must develop a comparable list of agents affecting plant and animal toxicity, production, or marketability • develop controls similar to HHS • cooperate with HHS on co-listed agents
Federal Register notice, July 2, 2002Proposed rulemaking • CDC to receive notifications for HHS • institutions to designate a Responsible Facility Official (RFO) • RFO to collect data and submit forms • facility is a single geographic site
Federal Register notice, July 12, 2002Proposed rulemaking • CDC put their draft notification form out for comment • includes a list of USDA high consequence livestock pathogens and toxins
UK must-do itemsby mid September 2002 • educate the UK community of the law’s requirements and penalties • appoint an RFO • inventory select agents in UK possession • collect data on individuals and agents • submit notification to CDC
in the near future • register with CDC/USDA all agents and individuals with access to agents • limit access to listed agents • notify CDC of releases, losses or theft • comply with safety requirements training safeguard and security measures facilities