1. What is the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002?
On June 12, 2002, President Bush signed the, “Public Health Security
and Bioterrorism Preparedness Response Act of 2002” (Public Law
107-188). The law is designed to improve the ability of the United States
to prevent, prepare for, and respond to bioterrorism and other public
health emergencies. Section 202(a) of the Law requires that all persons
possessing biological agents or toxins deemed a threat to public health
to notify the Secretary, Department of Health and Human Services (HHS).
Section 213(b) of Law requires all persons possessing biological agents
or toxins deemed a threat to animal or plant health and to animal or
plant products notify the Secretary, United States Department of Agriculture
(USDA). These regulated toxins and biological agents are called “select
agents.”
2. What is the USA PATRIOT Act and how does it relate to the Bioterrorism
Preparedness and Response Act?
The USA PATRIOT Act is a law signed by President Bush on October 26,
2001, that places restrictions on persons who possess select agents
and provides criminal penalties for possession of such agents that cannot
be justified for specified peaceful purposes. More information on the
PATRIOT Act can be found at: http://www.selectagents.gov/.
3. What is a select agent or toxin?
The list of select agents continues to change. A listing of all select
agents and toxins in the select agent regulation (42 CFR 73) is available
at: http://www.selectagents.gov/agentToxinList.htm.
The select agent list includes “High Consequence Livestock Pathogens
and Toxins” that the US Department of Agriculture (USDA) considers
having the potential to pose a severe threat to animal or plant health,
or to animal or plant products. The plant pathogens listed by USDA have
been deemed a threat to plant health or products. The list also includes
biological agents and toxins deemed by the Department of Health and
Human Services to be a threat to public health.
4. What do I need to do if I want to work with select agents at NC State?
The USA PATRIOT Act requires registration prior to possession of select
agents. Contact the NC State Biosafety Officer (Bruce_Macdonald@ncsu.edu,
515-6858) prior to accepting or procuring select agents. The Biosafety
Officer will assist you with the approval process.
5. How long does it take to receive approval to work with select agents?
The approval process is rigorous and lengthy. Allow at least 3 months
for approval. Application material must be submitted by the University
Biosafety Officer, to the Centers for Disease Control (CDC). The CDC
submits information to the Federal Bureau of Investigation. All users
of select agents will be fingerprinted and the US Attorney General will
conduct a background check. You may not possess select agents until
approval is granted by federal regulators.
6. How do I comply with all of the select agent rules and regulations?
Information to help assure compliance is available at: http://www.selectagents.gov/.
The University Biosafety Officer is also available to provide guidance
and assistance. However, select agent users have a personal responsibility
to comply with all regulatory requirements. Penalties for non-compliance
are both civil and criminal and the federal government has prosecuted
faculty and graduate students who have not complied with applicable
rules.
