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Biosafety vs. Biosecurity: What is the Difference?
Some controversy exists over whether the terms biosafety and biosecurity are synonyms. For example, the Federation of American Societies for Experimental Biology and the Association of Medical Colleges in May 2009 issued a joint statement saying, “The news media and policymakers often use the terms biosafety and biosecurity interchangeably, when distinct differences from a policy and regulatory point of view may exist.” As a result, say the two organizations, the distinction between biosafety and biosecurity needs clarification, while at the same time recognizing the opportunities to harmonize these interrelated concepts. (1) The Sunshine Project declares that the terms biosafety and biosecurity “lack consistent usage.” Indeed, “confusion about meanings of biosafety and biosecurity in English deepens in translation. The logical translation of biosecurity into Spanish, French, and other Romance languages is the same word as that used for biosafety (bioseguiridad in Spanish, biosecuirite in French). Translators at the United Nations Food and Agriculture Organization were unable to come up with a word for biosecurity in Chinese…We submit that there is little need, conceptually, to differentiate between biosafety and biosecurity...” (2) The Centers for Disease Control and Prevention (CDC) notes, “Biosafety and biosecurity are related, but not identical concepts.” (3) What is the current state of art in understanding these two arcane concepts?
The term biosafety is older than the term biosecurity—1984 vs. 2007, respectively (?). Biosafety, according to the CDC, is the “discipline addressing the safe handling and containment of infectious microorganisms and hazardous biological materials.” The CDC continues, “The principles of biosafety were first introduced in 1984 in the first edition of Biosafety in Microbiological and Biomedical Laboratories and have carried through to the most current fifth edition [2007]. These principles are containment and risk assessment. The fundamentals of containment include the microbiological practices, safety equipment, and facility safeguards that protect laboratory workers, the environment, and the public from exposure to infectious microorganisms that are handled and stored in the laboratory. Risk assessment is the process that enables the appropriate selection of microbiological practices, safety equipment, and facility safeguards that can prevent laboratory-associated infections.” (3) The SEMP Dictionary definition of biosafety (from 2003) is the “application of knowledge, techniques and equipment to prevent personal and environmental exposure to potentially infectious agents or biohazards. Biosafety defines the containment conditions under which laboratory workers can safety manipulate infectious agents. The objective of containment is to confine biohazards and to reduce the potential exposure of the laboratory worker, people outside of the laboratory, and the environment to potentially infectious agents.” (4)
Today, the meaning of biosafety, according to the 2003 SEMP Dictionary sense (not the already updated 2007 CDC sense), seems to be shifting toward the following definition: the “application of knowledge, techniques and equipment to prevent personal…exposure to potentially infectious agents or biohazards. Biosafety defines the containment conditions under which laboratory workers can safety manipulate infectious agents. The objective of containment is to confine biohazards and to reduce the potential exposure of the laboratory worker…to potentially infectious agents.” In other words, the community and environmental aspects of the meaning of biosafety seem to have gone elsewhere, i.e., to the term biosecurity (more below). Indeed, an important difference between the meanings of biosafety and biosecurity is that biosafety containment measures required for a given microorganism are based on the inherent capability of the given microorganism to cause disease in humans, animals and plants. By contrast, biosecurity containment measures required for a given microorganism are based on the inherent capability of the given microorganism to be used as a bioweapon against humans, animals and plants. (2) One can readily see that biological agents most useful to terrorists might also be the most likely to cause disease in humans, animals, and plants. Why would a terrorist use a microorganism that is benign to humans, animals and plants if he wanted to kill? In the biosafety risk classification system, microorganisms are assigned to one of four groups that correspond with four biosafety risk levels—Biosafety Risk Group 1, which corresponds with Biosafety Level 1 (BSL-1); Biosafety Risk Group 2 with Biosafety Level 2 (BSL-2); Biosafety Risk Group 3 with Biosafety Risk Level 3 (BSL-3); and Biosafety Risk Group 4 with Biosafety Risk Level 4 (BSL-4). The assignment of microorganisms to one of the four risk levels and groups is performed by the CDC to denote the level of danger associated with handling particular biological agents and the proper procedures for working with them. The CDC definition for each biosafety risk group follows (3):
A summary of biosafety information for individual biological agents is available in the book/manual titled Biosafety in Microbiological and Biomedical Laboratories, created by the Public Health Service at CDC, published, and made available online by the CDC (Fifth Edition, 2007). (3) An example of the type and format of information made available by CDC in Biosafety in Microbiological and Biomedical Laboratories for the anthrax organism follows: ******************************************************************************Agent: Bacillus anthracis Bacillus anthracis, a gram-positive, non-hemolytic, and non-motile bacillus, is the etiologic agent of anthrax, an acute bacterial disease of mammals, including humans.Like all members of the genus Bacillus, under adverse conditions B. anthracis has the ability to produce spores that allow the organism to persist for long periods of time until the return of more favorable conditions. Reports of suspected anthrax outbreaks date back to as early as 1250 BC. The study of anthrax and B. anthracis in the 1800s contributed greatly to our general understanding of infectious diseases. Much of Koch’s postulates were derived from work on identifying the etiologic agent of anthrax. Louis Pasteur developed the first attenuated live vaccine for anthrax. Most mammals are susceptible to anthrax; it mostly affects herbivores that ingest spores from contaminated soil and, to a lesser extent, carnivores that scavenge on the carcasses of diseased animals. Anthrax still occurs frequently in parts of central Asia and Africa. In the United States, it occurs sporadically in animals in parts of the West, Midwest and Southwest. The infectious dose varies greatly from species to species and also is route-dependent. The inhalation anthrax infectious dose (ID) for humans primarily has been extrapolated from inhalation challenges of nonhuman primates (NHP) or studies done in contaminated mills. Estimates vary greatly but the lethal dose50 (LD) is likely within the range of 2,500-55,000 spores. It is believed that very few spores (10 or less) are required for cutaneous anthrax. OCCUPATIONAL INFECTIONS Occupational infections are possible when in contact with contaminated animals, animal products or pure cultures of B. anthracis, and may include ranchers, veterinarians and laboratory workers. Numerous cases of laboratory-associated anthrax (primarily cutaneous) have been reported. Recent cases include suspected cutaneous anthrax in a laboratory worker in Texas and a cutaneous case in a North Dakota male who disposed of five cows that died of anthrax. Agent Summary Statements- Bacterial Agents NATURAL MODES OF INFECTION The clinical forms of anthrax in humans that result from different routes of infection are 1) cutaneous (via broken skin), 2) gastrointestinal (via ingestion), and 3) inhalation anthrax. Cutaneous anthrax is the most common and readily treatable form of the disease. Inhalation anthrax used to be known as “Woolsorter disease” due to its prevalence in textile mill workers handling wool and other contaminated animal products. While naturally occurring disease is no longer a significant public health problem in the United States, anthrax has become a bioterrorism concern. In 2001, 22 people were diagnosed with anthrax acquired from spores sent through the mail, including 11 cases of inhalation anthrax with five deaths and 11 cutaneous cases. LABORATORY SAFETY B. anthracis may be present in blood, skin lesion exudates, cerebrospinal fluid, pleural fluid, sputum, and rarely, in urine and feces. The primary hazards to laboratory personnel are; direct and indirect contact of broken skin with cultures and contaminated laboratory surfaces, accidental parenteral inoculation and rarely, exposure to infectious aerosols. Efforts should be made to avoid production of aerosols by working with infectious organisms in a BSC [Biosafety Cabinet]. In addition, all centrifugation should be done using aerosol-tight rotors that are opened within the BSC after each run. Containment Recommendations BSL-2 practices, containment equipment, and facilities are recommended for activities using clinical materials and diagnostic quantities of infectious cultures. ABSL-2 practices, containment equipment and facilities are recommended for studies utilizing experimentally infected laboratory rodents. BSL-3 practices, containment equipment, and facilities are recommended for work involving production quantities or high concentrations of cultures, screening environmental samples (especially powders) from anthrax-contaminated locations, and for activities with a high potential for aerosol production. Workers who frequently centrifuge B. anthracis suspensions should use autoclavable aerosol-tight rotors. In addition, regular routine swabbing specimens for culture should be routinely obtained inside the rotor and rotor lid and, if contaminated, rotors should be autoclaved before re-use. SPECIAL ISSUES Vaccines A licensed vaccine for anthrax is available. Guidelines for its use in occupational settings are available from the ACIP.8,9 Worker vaccination is recommended for activities that present an increased risk for repeated exposures to B. anthracis spores including: 1) work involving production quantities with a high potential for aerosol production; 2) handling environmental specimens, especially powders associated with anthrax investigations; 3) performing confirmatory testing for B.anthracis, with purified cultures; 4) making repeated entries into known B. anthracis spore-contaminated areas after a terrorist attack; 5) work in other settings in which repeated exposure to aerosolized B. anthracis spores might occur. Vaccination is not recommended for workers involved in routine processing of clinical specimens or environmental swabs in general diagnostic laboratories. Select Agent B. anthracis is a Select Agent requiring registration with CDC and/or USDA for possession, use, storage and/or transfer. See Appendix F for additional information. Transfer of Agent Importation of this agent may require CDC and/or USDA importation permits. Domestic transport of this agent may require a permit from USDA/APHIS/VS. A Department of Commerce permit may be required for the export of this agent to another country. See Appendix C for additional information. ****************************************************************************** In summary, biosafety deals with the protection of workers from exposures to infectious materials. (6) The term biosecurity is newer than the term biosafety (ca. 2007 vs. 1984). Indeed, the term is used for the first time in the fifth edition (2007) of CDC’s Biosafety in Microbiological and Biomedical Laboratories. In fact, the fifth edition devotes an entire section to biosecurity (Section VI). The term biosecurity is still struggling to find itself in a definition acceptable to most informed people. The CDC’s Biosafety in Microbiological and Biomedical Laboratories does not define biosecurity, instead noting its objective: “The objective of biosecurity is to prevent loss, theft or misuse of microorganisms, biological materials, and research-related information. This is accomplished by limiting access to facilities, research materials and information.” (3) There is not yet a final SEMP definition for biosecurity. However, one under consideration is: the “application of knowledge, techniques and equipment to prevent or mitigate community and environmental exposure to potentially infectious agents or biohazards resulting from loss, theft or misuse of microorganisms, biological materials, and research-related information. This is accomplished by limiting access to facilities, research materials and information.” (7) Recall that the goal of biosafety is to protect individual laboratory workers from exposure to the microorganisms they handle. By contrast, the goal of biosecurity is to “protect dangerous biological materials from inadvertent or deliberate release to the community or environment.” (2) In other words, inherent to the concept of biosafety is protecting the individual handling the agent, whereas inherent to the concept of biosecurity is protecting populations of humans, animals and plants, as well as the environment. Biosecurity differs from biosafety not only because of its focus on populations and the environment, rather than on individuals. Biosecurity differs from biosafety because its risk classification system is based on the inherent capability of a microorganism to be used as a weapon against humans, animals, plants, and the environment, rather than (as with biosafety) to cause disease in humans, animals, and plants. The biosecurity risk classification system originated in the wake of the Oklahoma City bombing of the Alfred E. Murrah Building in April 1995, according to the National Select Agent Registry of the CDC. (8) Further history of the program, as per the CDC, is as follows: Congress passed the Antiterrorism and Effective Death Penalty Act of 1996 in October 1996. The provisions of this act were implemented by 42 CFR 72.6. HHS delegated authority for operating the Laboratory Registration and Select Agent Tracking Program to CDC. After the terrorist events of September and October 2001, Congress passed the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act Of 2001 (USA PATRIOT Act The most current “Select Agent” list is available online and is reproduced below (most recent update is November 17, 2008) (9) ****************************************************************************
To clarify the distinction between the two terms biosafety and biosecurity in a practical situation, consider the laboratory worker who inhales aerosolized anthrax organisms during handling the microorganisms in the laboratory. In the biosecurity risk classification framework, the anthrax microorganism makes the list as a bioweapon because it has a high likelihood of being used as a bioweapon. In the biosafety risk classification framework, however, the anthrax microorganism is normally classified at a risk level of biosafety 2, except when it is in pure cultures or is aerosolized; in the latter situation, it is assigned to a risk level of biosafety 3. Uncontained aerosolization of anthrax organisms should never happen when effective biosafety systems are in place. However, the occurrence of aerosolization of anthrax is a breach of biosafety containment systems, not biosecurity containment systems, because there is no increased risk for disease to anyone other than the laboratory worker. (1) This is true, because anthrax is not considered contagious between humans. In other words, a laboratory worker infected with anthrax in the laboratory cannot—theoretically—pass it on to other people, for example, to coworkers in the laboratory cafeteria, to passengers on a train on the way home from work, or to family members at home. Now consider the laboratory worker who inhales aerosolized Ebola virus. In the biosecurity risk classification system, Ebola virus makes the list, because, from the perspective of a terrorist, it qualifies as a highly desirable bioweapon. In the biosafety risk classification system, Ebola is classified at a risk level of biosafety 4, because laboratory workers exposed to it are contagious to others and no preventive vaccine or curative therapy currently exists.
Does the possibility exist for an agent on the biosecurity “Select Agent” list to fail to be on the biosafety risk lists (groups 1-4)? The answer is no, because the “Select Agent” list is a subset of the biosafety risk list. Many regulations exist for select agents, as described elsewhere. (10) One biosafety and biosecurity expert, Dr. Tara O’Toole, noted, “You may know that during the H1N1 outbreak, Mexico initially sent samples to Canada, not to the CDC, because of the difficulty of transporting these legitimate research samples into the United States due to the select agent rule. I do worry about that. I think that biology is critical for biodefense but also for economics. That is my concern.” (11) On May 13, 2009, a Winnipeg researcher named Konan Michel Yao tried to smuggle 22 vials of Ebola material into the United States at the Manitoba-North Dakota border. “U.S. customs officers allegedly found the vials wrapped in aluminum foil inside a glove and packaged in a plastic bag, along with electrical wires. In his affidavit, the 42-year-old researcher said he was hired by the Public Health Agency of Canada to work as a PhD fellow at the Winnipeg facility. Yao told officers he was working on a vaccine for the Ebola virus and HIV. Yao told officers he was taking the vials to his new job with the National Institutes of Health at the Biodefense Research Laboratory in Bethesda, Md., because he didn't want to start from scratch in his research. Dr. Frank Plummer, the scientific director of the Winnipeg lab, said the genetic material taken was not the full Ebola virus and does not pose a risk to the public. Plummer said theft has never happened at the lab before. Researchers are reminded they cannot take any lab property without permission, and they sign documents asserting that they know the rules, he said. The lab is now reviewing its biosecurity protocol.” (12)
There are several distinctions that exist between the terms biosafety and biosecurity. First, the list of biosafety microorganisms is very long (potentially, the set of all microorganisms causing, and not known to cause, disease), while the list of biosecurity agents (Select Agents) is much shorter (the set of microorganisms likely to be used as bioweapons). Second, the list of biosecurity agents is a subset of the list of biosafety agents. Third, “while the majority of measures [to improve safety and security] under both concepts are more or less the same, the biosecurity concept focuses primarily on the prevention of access to sensitive materials by theft, diversion or intentional release. For this reason biosecurity concepts usually include additional measures to harden and safeguard facilities containing sensitive biological materials with a bioweapons potential.” (2) In addition, the biosecurity concept makes transporting Select Agents more difficult, even by reputed scientists rushing to identify an emerging virus and decode its genome. Biosafety and biosecurity are distinct concepts. Each has arisen to articulate a novel human experience. Language is speciating. Notes:
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(PDF format)). This was followed in June 2002, by passage of 
(PDF format). The provisions of this Act were implemented by 42 CFR 73, Possession, Use and Transfer of Select Agents; Interim Final Rule. The IFR was published in the 
(PDF format) on December 13, 2002. The IFR underwent a staged implementation, beginning February 7, 2003. Public comment was invited on the IFR between December 13, 2002 and February 11, 2003, for consideration in promulgating the Final Rule. The IFR was amended in November 2003 to provide for provisional entity registrations to prevent disruption or termination of ongoing research and educational projects by entities and individuals needing access to select agents and toxins. The U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) published final rules for the possession, use, and transfer of select agents and toxins (
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