Responsible Research with Biological Select Agents and Toxins (2009) / Chapter Skim
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1 Introduction
1 Introduction
Pages 21-36
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From page 21... ...
Enormous advances have resulted in the development of vaccines and other treatments that have greatly diminished the risks posed by infectious disease agents. It is not an exaggeration to attribute increased human lifespan and better human health to the research of legions of microbiologists and other biomedical researchers on the biology of bacteria and viruses and the toxins they produce.
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From page 22... ...
More than 80 of these most dangerous bacteria, viruses, toxins, and fungi have been officially listed as biological select agents and toxins (BSAT) and are subject to special security requirements.1 Whether deliberately deployed as a biological weapon or the result of a natural outbreak, the potential for mass human casualty or potentially cata strophic impact on plants or animals as a direct or indirect result of select agents is omnipresent.
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From page 23... ...
Clearly, there is genuine and legitimate concern that laboratories working with select agents and toxins should receive special security and safety attention that other types of biological research would not require. Even though many of the materials on the select agent list may be found in natural environments, some laboratories maintain purified strains of the most dangerous pathogens.
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From page 24... ...
Nonetheless, denying would-be terrorists ready access to BSAT materials is an important component of national security. SUMMARY OF THE CURRENT SELECT AGENT PROGRAM4 After the anthrax attacks of 2001, the United States expanded the exist ing regulations governing the transfer of BSAT materials among laboratories 4 Throughout this report, the term "Select Agent Program" is used to refer to the National Select Agent Registry Program, which oversees activities related to biological select agents and toxins.
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Chapter 2 describes in greater detail the current policy and regulatory framework governing BSAT research in the United States. The scope of the Select Agent Program is circumscribed by those agents and toxins on the formal select agent list.
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. This Act added requirements for regulations governing possession of select agents, including approval for laboratory personnel by the Attorney General following a background check by the Federal Bureau of Investigation (FBI)
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The BMBL and this report use the term to cover security for both pathogens and for the information that results from research. 9 To that end, some select agent laboratories do not broadcast their location, even if that infor mation is considered public.
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Similar concerns apply to others subject to the select agent regulations, including public health professionals who are essential to the nation's response to biological emergencies. Future discoveries and successful research on select agents specifically -- and in the life sciences more generally -- depend on a healthy, vibrant, and sustainable research environment.
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From page 29... ...
are charged with reviewing re search involving recombinant DNA, although many IBCs have chosen to re view other forms of research that involve potential biohazards -- including some BSAT research. IBCs are required to register with NIH's Office of Biotechnology Activities.
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From page 30... ...
has been adopted nationwide, even without federal legal standing.12 Unlike these models, the oversight and screening structures for the Select Agent Program are considerably more substantial than those applicable to other biological research, especially in the involvement of outside oversight bodies and groups not necessarily composed of scientific peers. Moreover, BSAT research is the only area of biological research that requires verification of personnel beyond assessment of technical competence to carry out the proposed research protocols.
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From page 31... ...
. The release of the report of the Congressionally chartered Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism, chaired by former senators Bob Graham and Jim Talent, drew additional attention to the perceived risks.
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As part of the response to the various calls for increased regulation of high containment laboratories and BSAT research, President George W Bush issued Executive Order (EO)
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From page 33... ...
The committee believes these are essential to the safe conduct of BSAT research, but time did not allow a thorough review and assessment: • Transportation of Select Agents Some have identified transportation of select agents and toxins as the weak link in security procedures. Agents taken from one highly secure facility to another may be at risk for 16 Theterm "dual use" refers to research that, although carried out for beneficial purposes, could yield knowledge, tools, or techniques with the potential to be misused to cause deliberate harm.
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From page 34... ...
The committee's conclusions and recommendations will be designed to inform policy discussions in the United States regarding necessary steps to balance the security risks and benefits of BSAT research and to harmonize policies across the government, including government-funded extramural research. Based on expert knowledge of the current oversight systems for BSAT research, in formation gathered in the course of the study about the specifics of the programs that have been implemented by each of the federal agencies with active BSAT research programs, and information about personnel assurance programs outside the federal government that might offer useful models or practices, the committee should: theft during transportation because security during this process may be minimal.
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From page 35... ...
ORGANIZATION OF THE REPORT After the brief introduction to the issues addressed in the report in this chapter, Chapter 2 contains basic factual material describing the current regu latory environment including the development and operation of current U.S. policies to govern BSAT research, a review of other federal regulations related to BSAT research, and a brief discussion of how BSAT research is regulated in other countries.
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From page 36... ...
6 RESPONSIBLE RESEARCH WITH BIOLOGICAL SELECT AGENTS AND TOXINS committee in selecting those issues it chose to emphasize and in reaching its conclusions and recommendations. Chapters 4 and 5 discuss specific issues and offer the committee's analysis and assessments, including its conclusions and recommendations.
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