Transcript Public Health Security and Bioterrorism Preparedness Act

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. 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
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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. 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
of Select Agents
• interim final rules
on registration
mid September
• final rules effective
mid February 2003
mid December
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 items
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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