Biosafety and Biosecurity: Regulatory Impact

Abstract

Biological agents have been documented as instruments of warfare and terror (bioterrorism) to produce fear and harm in vulnerable and susceptible populations for thousands of years. The ultimate goal for those using these agents was to inflict harm upon selected individuals or the general human population as well as upon animals and plants (1, 2). The Federal Bureau of Investigation (FBI) defines terrorism as the “unlawful use of force against persons or property to intimidate or coerce a government, the civilian population, or any segment thereof, in the furtherance of political or social objectives” (3). Basically, bioterrorism is a form of biological warfare. Biological warfare is the intentional use of etiologic agents, such as viruses, bacteria, fungi, or toxins derived from living organisms, to produce death or disease in humans, animals, or plants (4). An etiologic agent is “a viable microorganism or its toxin that causes or may cause human disease, and includes those agents listed in 42 C.F.R. 72.3 of the U.S. Department of Health and Human Services (DHHS) regulations and any material of biologic algorithm that poses a degree of hazard similar to those organisms” (5). A toxin, also included as an etiologic agent, is defined as “toxic material of biologic origin that has been isolated from the parent organism. The toxic material of plants, animals, or microorganisms” (6). Potential agents that could be used in a bioterrorist event include those causing the diseases anthrax (Bacillus anthracis), plague (Yersinia pestis), tularemia (Francisella tularensis), the equine encephalitides (Venezuelan equine encephalitis and eastern equine encephalitis), hemorrhagic fever viruses (arenaviruses, filoviruses, flaviviruses, and bunyaviruses), and variola virus (smallpox). Some of the toxins that could be used in a bioterrorism event include botulinum toxin from Clostridium botulinum; ricin toxin from the castor bean Ricinus communis; the trichothecene mycotoxins from Fusarium, Myrothecium, Trichoderma, Stachybotrys, and other filamentous fungi; staphylococcal enterotoxins from Staphylococcus aureus; and the toxins from marine organisms such as dinoflagellates, shellfish, and blue-green algae. The list of potential etiologic agents is quite extensive (7). However, the list of agents that could cause mass casualties by the aerosol route of exposure is considerably smaller (8–17).