a review of h.r. 3448: public health security and bioterrorism preparedness act of 2002 harry enoch,...

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 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 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

IranIraq

SyriaLibyaCuba

North KoreaSudan

Public Health Security and Bioterrorism Preparedness

Act of 2002

H.R. 3448

enacted 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, 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 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