Biosafety/Biocontainment Plan Guidance
As used in this document the following terms have the following meanings:
Decontamination – Disinfection or sterilization of articles contaminated with toxins or agents to make the articles safe for use or disposal.
Disinfection – The elimination of nearly all recognized pathogenic microorganisms but not necessarily all microbial forms (e.g., bacterial spores) on inanimate objects.
Risk – The potential for an adverse outcome assessed as a function of threats, vulnerabilities, and consequences associated with an incident, event, or occurrence.
Risk Assessment – The process of evaluating the risk(s) arising from a hazard(s), taking into account the adequacy of any existing controls and deciding whether or not the risk(s) is acceptable.
Select agents and toxins – A subset of biological agents and toxins that the Departments of Health and Human Services (HHS) and Agriculture (USDA) have determined to have the potential to pose a severe threat to public health and safety, to animal or plant health, or to animal or plant products. The current list of select agents and toxins can be found at 42 CFR §§ 73.3external icon, 73.4external icon, 9 CFR §§ 121.3external icon, 121.4external icon, and 7 CFR § 331.3external icon. Also see the current select agents and toxins list.
Sterilization – Any item, device, or solution is considered to be sterile when it is completely free of all living microorganisms and viruses. The definition is categorical and absolute (i.e., an item is either sterile or it is not). A sterilization procedure is one that kills all detectable microorganisms, including high numbers of bacterial endospores.
Tier 1 Select agents and toxins – A subset of select agents and toxins have been designated as Tier 1 because these biological agents and toxins present the greatest risk of deliberate misuse with significant potential for mass casualties or devastating effect to the economy, critical infrastructure, or public confidence, and pose a severe threat to public health and safety: Bacillus anthracis, Bacillus cereus Biovar anthracis, Botulinum neurotoxins, Botulinum neurotoxin producing species of Clostridium, Burkholderia mallei, Burkholderia pseudomallei, Ebola virus, Francisella tularensis, Foot-And-Mouth Disease virus, Marburg virus, Rinderpest virus, Variola major virus (Smallpox virus), Variola minor virus (Alastrim), and Yersinia pestis.