Chapter 6 - Select Agents/toxins and Principles of laboratory Biosecurity

Select Agents are federally regulated agents that have potential use in biological warfare. Health and
Human Services (HHS) regulates select agents targeting humans, the United States Department of
Agriculture (USDA) regulates select agents targeting animals, and the USDA Plant Protection and
Quarantine (PPQ) regulates select agents targeting plants. Before possessing, using, sending, or
receiving select agents, the institution and Principal Investigator must register with CDC, APHIS, and/or
USDA to receive official authorization for each individual requesting access to select agents.
Requirements include background checks on those authorized to access select agents, security plans and
inventories. Immediately notify EHS if you discover select agents in your laboratory that have not been
registered. View the Select Agent/Toxin List here:
https://www.selectagents.gov/SelectAgentsandToxinsList.html. Anyone desiring to work with these
materials must have security clearance to do so and have special security procedures in place for their
labs. Investigators wishing to work with any of these agents MUST contact Melissa Dooley, the EHS
Director, prior to doing so, and all security clearances and procedures must be in place prior to
requesting the Select Agents (note that requests for Select Agents MUST be placed by the Responsible
Official). Contact Melissa Dooley Phone: 870-972-3644 E-mail: mdooley@astate.edu for assistance
with Select Agent requirements.
The term “biosecurity” has multiple definitions. In the animal industry, the term biosecurity relates to
the protection of an animal colony from microbial contamination. In some countries, the term
biosecurity is used in place of the term biosafety. For the purposes of this section the term “biosecurity”
will refer to the protection of microbial agents from loss, theft, diversion or intentional misuse. This is
consistent with current WHO and American Biological Safety Association (ABSA) usage of this term.
Biosafety and biosecurity programs share common components. Both are based upon risk assessment
and management methodology; personnel expertise and responsibility; control and accountability for
research materials including microorganisms and culture stocks; access control elements; material
transfer documentation; training; emergency planning; and program management. Biosafety and
biosecurity program risk assessments are performed to determine the appropriate levels of controls
within each program. Biosafety looks at appropriate laboratory procedures and practices necessary to
prevent exposures and occupationally-acquired infections, while biosecurity addresses procedures and
practices to ensure that biological materials and relevant sensitive information remain secure.