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 overseeing 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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