than biosafety.1 As discussed in Chapter 1, biosafety and biosecurity are related and complementary, but there are important distinctions. Biosafety in Microbiological and Biomedical Laboratories (CDC/NIH 2007) defines biosafety programs as those which “reduce or eliminate exposure of individuals and the environment to potentially hazardous biological agents,” whereas the objective of biosecurity is to “prevent loss, theft or misuse of microorganisms, biological materials, and research-related information” (CDC/NIH 2007). Biosafety is reducing the risk that pathogens or toxins will escape containment and cause illness in researchers, clinicians, or the general public. Biosecurity is related to minimizing the possibility that such pathogens will be used for malevolent purposes.2 The BMBL sets standards for how U.S. laboratories conduct research with biological agents and toxins; the Recombinant DNA Advisory Committee (RAC) and Institutional Biosafety Committees (IBCs) provide guidance and oversight focused on biosafety.3 This is a robust and effective system. In fact, if the purpose of the Select Agent Regulations were solely biosafety, it would largely be an unnecessary duplication. However, the primary role of the Select Agent Regulations is to restrict access to agents that may be used as biological weapons by someone with nefarious intent. There is a good deal of overlap between biosafety and biosecurity threats in that the pathogens deemed to pose

1

This section draws on discussion in the 2009 National Research Council report “Responsible Research with Biological Select Agents and Toxins.”

2

The 2009 National Research Council report states:“[i]t should be noted that the use of the term “biosecurity” presents a number of difficulties. At its most basic, the term does not exist in some languages, or is identical with “biosafety”; French, German, Russian, and Chinese are all examples of this immediate practical problem. Even more serious, the term is already used to refer to several other major international issues. For example, to many “biosecurity” refers to the obligations undertaken by states adhering to the Convention on Biodiversity and particularly the Cartagena Protocol on Biosafety, which is intended to protect biological diversity from the potential risks posed by living modified organisms resulting from modern biotechnology. (Further information on the Convention may be found at <http://www.cbd.int/convention/> and on the Protocol at <http://www.cbd.int/biosafety/>.) “Biosecurity” has also been narrowly applied to efforts to increase the security of dangerous pathogens, either in the laboratory or in dedicated collections; guidelines from both the World Health Organization (WHO 2004) and the Organization for Economic Cooperation and Development (OECD 2007) use this more restricted meaning of the term. In an agricultural context, the term refers to efforts to exclude the introduction of plant or animal pathogens. (See NRC 2009a:8-9 for a discussion of this and other issues related to terminology.) Earlier NRC reports (2004ab, 2006, 2009a) confine the use of “biosecurity” to policies and practices to reduce the risk that the knowledge, tools, and techniques resulting from research would be used for malevolent purposes.”

3

The Recombinant DNA Advisory Committee (RAC) assisted the NIH in the development of the NIH Guidelines for Research Involving Recombinant DNA Molecules, which has become the standard of safe scientific practice in the use of recombinant DNA. Institutional Biosafety Committees (IBCs) which are mandated by the NIH Guidelines, are charged with reviewing research involving recombinant DNA, although many IBCs have chosen to review other forms of research that involve potential biohazards—including research involving Biological Select Agent and Toxins (BSATs). Institutions are required to register their IBCs with NIH’s Office of Biotechnology Activities.



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