Executive Summary

Scientists have been conducting research with the organisms classified as biological select agents and toxins (BSAT) for several hundred years in order to understand the biology of these potentially dangerous pathogens and to develop countermeasures that will diminish the threat they pose. Because of legitimate concerns that BSAT materials might be used in deliberate criminal or terrorist acts, the federal government has instituted policies and procedures governing the security of BSAT laboratories and the reliability of personnel who work with BSAT materials. The committee was asked to consider the appropriate framework for laboratory security and personnel reliability measures that will optimize benefits, minimize risk, and facilitate the productivity of research.1

The committee identified six principles that should guide consideration of BSAT research; these principles also provide the lens through which the committee offers its conclusions and recommendations:

  1. Research on biological select agents and toxins is essential to the national interest.

  2. Research with biological select agents and toxins introduces potential security and safety concerns.

  3. The Select Agent Program should focus on those biological agents and toxins that might be used as biothreat agents.

  4. Policies and practices for work with biological select agents and toxins should promote both science and security.

  5. Not all laboratories and not all agents are the same.

  6. Misuse of biological materials is taboo in every scientific community.

1

See Box 1-2 for the full statement of task.



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Executive Summary Scientists have been conducting research with the organisms classified as biological select agents and toxins (BSAT) for several hundred years in order to understand the biology of these potentially dangerous pathogens and to develop countermeasures that will diminish the threat they pose. Because of legitimate concerns that BSAT materials might be used in deliberate criminal or terrorist acts, the federal government has instituted policies and procedures governing the security of BSAT laboratories and the reliability of personnel who work with BSAT materials. The committee was asked to consider the appropriate framework for laboratory security and personnel reliability measures that will optimize benefits, minimize risk, and facilitate the productivity of research. 1 The committee identified six principles that should guide consideration of BSAT research; these principles also provide the lens through which the com - mittee offers its conclusions and recommendations: 1. Research on biological select agents and toxins is essential to the na - tional interest. 2. Research with biological select agents and toxins introduces potential security and safety concerns. 3. The Select Agent Program should focus on those biological agents and toxins that might be used as biothreat agents. 4. Policies and practices for work with biological select agents and toxins should promote both science and security. 5. Not all laboratories and not all agents are the same. 6. Misuse of biological materials is taboo in every scientific community. 1 See Box 1-2 for the full statement of task. 

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 RESPONSIBLE RESEARCH WITH BIOLOGICAL SELECT AGENTS AND TOXINS Consideration of these principles led the committee to nine recommenda - tions that it believes are essential for keeping BSAT research secure from both internal and external threats. RECOMMENDATIONS Recommendation 1 assigns responsibility for fostering a culture of trust and responsibility to a partnership of laboratory leaders and the Select Agent Program: RECOMMENDATION 1: Laboratory leadership and the Select Agent Program should encourage and support the implementation of programs and practices aimed at fostering a culture of trust and responsibility within BSAT entities. These programs and practices should be designed to mini- mize potential security and safety risks by identifying and responding to potential personnel issues. These programs should have a number of common elements, tailored to reflect the diversity of facilities conducting BSAT research: • Consideration should be given to including discussion of personnel monitoring during (1) the initial training required for all person- nel prior to gaining access to BSAT materials and annual refresher updates and (2) safety inspections to obtain a more complete assess - ment of the laboratory’s ability to provide a safe and secure research environment. • More broadly, personnel with access to select agents and toxins should receive training in scientific ethics and dual-use research. Training should be designed to foster community responsibility and raise awareness of all personnel of available institutional support and medical resources. • Federal agencies overseeing and sponsoring BSAT research and pro - fessional societies should provide educational and training resources to accomplish these goals. Recommendation 2 engages the research community in oversight of the Select Agent Program through formation of an advisory committee: RECOMMENDATION 2: To provide continued engagement of stake- holders in oversight of the Select Agent Program, a Biological Select Agents and Toxins Advisory Committee (BSATAC) should be established. The members, who should be drawn from academic/research institutions and the private sector, should include microbiologists and other infec-

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 SUMMARY tious disease researchers (including select agent researchers), directors of BSAT laboratories, and those with experience in biosecurity, animal care and use, compliance, biosafety, and operations. Representatives from the federal agencies with a responsibility for funding, conducting, or oversee - ing select agent research would serve in an ex officio capacity. Among the responsibilities of this advisory committee should be the following: • Promulgate guidance on the implementation of the Select Agent Program; • Facilitate exchange of information across institutions and sectors; • Promote sharing of successful practices across institutions and sectors; • Provide oversight for evaluation of the Select Agent Program; • Provide advice on composition/stratification of the list of select agents and toxins; • Convene regular meetings of key constituency groups; and • Promote harmonization of regulatory policies and practices. Two recommendations address the composition of the list of select agents and toxins and the implications that the nature of the agents has for accountability: RECOMMENDATION 3: The list of select agents and toxins should be stratified in risk groups according to the potential use of the material as a biothreat agent, with regulatory requirements and procedures calibrated against such stratification. Importantly, mechanisms for timely inclusion or removal of an agent or toxin from the list are necessary and should be developed. RECOMMENDATION 4: Because biological agents have an ability to replicate, accountability is best achieved by controlling access to archived stocks and working materials. Requirements for counting the number of vials or other such measures of the quantity of biological select agents (other than when an agent is transported from one laboratory site to another) should not be employed because they are both unreliable and counter-productive, yielding a false sense of security. A registered entity should record the identity of all biological select agents and toxins within that entity, where such materials are stored, who has access and when that access is available, and the intended use(s) of the materials. There have been extensive discussions about the appropriateness of the current Security Risk Assessment process for screening personnel before they

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 RESPONSIBLE RESEARCH WITH BIOLOGICAL SELECT AGENTS AND TOXINS are permitted to work with BSAT; the committee concluded that this process is adequate for screening, but there should be an opportunity to consider mitigat- ing factors as part of an appeal process: RECOMMENDATION 5: The current Security Risk Assessment screen- ing process should be maintained, but the appeal process should be expanded beyond the simple check for factual errors to include an oppor- tunity to consider the circumstances surrounding otherwise disqualifying factors. Because of confusion within the community about how physical security requirements should be implemented, the committee calls upon the Select Agent Program to provide a minimum set of requirements that would apply across agencies: RECOMMENDATION 6: The Select Agent Program should define minimum cross-agency physical security requirements, which recognize that facilities have unique risk-based security needs and associated design components, to assist facilities in meeting their regulatory obligations. The committee recognizes the importance of data to inform the operation of the Select Agent Program and recommends ongoing independent evaluation of the program: RECOMMENDATION 7: Independent evaluation of the Select Agent Program should be undertaken to assess the relative benefits for achiev - ing security, to consider the consequences of the program (intended and unintended) on the research enterprise, and to provide useful data about the Select Agent Program. Such evaluation, which may be coordinated through the BSAT Advisory Committee, should be provided with dedi- cated funding. Recognizing the critical role that laboratory inspections play in maintaining the efficient and effective operations of select agent research, the committee calls for appropriate knowledge, experience, and training among inspectors: RECOMMENDATION 8: Inspectors of select agent laboratories should have scientific and laboratory knowledge and experience, as well as ap - propriate training in conducting inspections specific to BSAT research. Inspector training and practice should be harmonized across federal, state, local, and other agencies.

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 SUMMARY Finally, the committee concluded that security and compliance costs have been a challenge for the BSAT research community and calls upon federal fund- ing agencies to provide sustained support for these facility costs: RECOMMENDATION 9: Because of considerable security and compli- ance costs associated with research on biological select agents and tox - ins, federal agencies funding BSAT research should establish a separate category of funding to ensure sustained support for facilities where such research is conducted.

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