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 places additional responsibilities on universities for safeguarding biological agents used in research

H.R was preceded by the USA 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

Select Agents certain viruses, bacteria, toxins and other biological agents examples 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 Iran Iraq Syria Libya Cuba North Korea Sudan

Public Health Security and Bioterrorism Preparedness Act of 2002 H.R enacted June 12, 2002

H.R 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 notification rules mid July notify HHS/USDA mid September of Select Agents interim final rulesmid 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 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, 2002 Proposed 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, 2002 Proposed rulemaking CDC put their draft notification form out for comment includes a list of USDA high consequence livestock pathogens and toxins

UK must-do items by 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