a review of h.r. 3448: public health security and bioterrorism preparedness act of 2002 harry enoch,...
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![Page 1: 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](https://reader035.vdocuments.site/reader035/viewer/2022072015/56649eda5503460f94be9abd/html5/thumbnails/1.jpg)
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
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• 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
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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
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Select Agents certain viruses, bacteria, toxins
and other biological agents
examples• Ebola and smallpox virus
• Anthrax and plague bacteria
• Aflatoxin and botulinum toxin
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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
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Attorney General’s list of terrorist countries
IranIraq
SyriaLibyaCuba
North KoreaSudan
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Public Health Security and Bioterrorism Preparedness
Act of 2002
H.R. 3448
enacted June 12, 2002
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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
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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
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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
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Limited exemptions for
• clinical and diagnostic labs
• commercial products (licensed, registered, or approved)
• products approved for clinical trials
• public health emergencies
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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
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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
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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
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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
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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
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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