Responsible Research with Biological Select Agents and Toxins (2009) / Chapter Skim
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Pages 7-20
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From page 7... ...
Summary INTRODUCTION More than 300 years ago, Antonie van Leeuwenhoek constructed a primi tive microscope and made the first detailed descriptions of microorganisms. More than 200 years ago, Edward Jenner carried out the first experimental vaccination, using cow pox virus to build immunity in humans against the deadly smallpox virus.
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From page 8... ...
The Current Select Agent Program Since the list of select agents and toxins was first introduced in 1997, the U.S. government has created a formal regulatory structure to oversee BSAT research and to decide who could possess microorganisms and toxins that could be used as weapons and how facilities that did possess them would be protected.
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From page 9... ...
The committee was also asked to consider the impact of biosecurity policies and regulations on the ability of the scientific community to conduct BSAT research. 2 GUIDING PRINCIPLES FOR SCIENCE AND SECURITY In considering its task, the committee developed a set of principles that should guide how research with biological select agents and toxins should be viewed and conducted.
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From page 10... ...
And the more one tries to avoid letting a security risk get through the screening, the more one increases the number of innocent individuals who will "fail" the test. The Current Process The current screening process to select individuals to work in facilities conducting BSAT research is based on the search for a set of disqualifying behaviors and activities that automatically and permanently deny a person access.
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From page 11... ...
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. Identifying Potential Threats through Testing Current policy discussions have included questions about whether to require more extensive testing and evalu ation of applicants to work with BSAT materials, perhaps as part of a formal Personnel Reliability Program.
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From page 12... ...
The committee concluded that there is no "silver bullet," that is, no single assessment tool that can offer the prospect of effectively screening out every potential terrorist. Although it can be appropriate for organizations to employ integrity testing and clinical personality assessments as part of screening to serve other purposes, the committee reached the same conclusion concerning polygraph testing as was reached by a 2003 NRC committee that applies even more broadly, namely to its use in security screening: "Polygraph testing yields an unacceptable choice for…employee security screening between too many loyal employees falsely judged deceptive and too many major security threats left undetected.
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From page 13... ...
Managing BSAT Research and the Select Agent Program In addition to issues of personnel reliability, the committee addressed other issues related to physical security and to operation of the Select Agent Program, which led to several additional recommendations.
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From page 14... ...
But because BSAT research is carried out and supported by several federal agencies, the committee believes a more formal structure is needed to engage the community of stakeholders in the continued operation of the program. 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)
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From page 15... ...
Importantly, mechanisms for timely inclusion or removal of an agent or toxin from the list are necessary and should be developed. The BSATAC should advise the Select Agent Program on the implications that stratification of the list of select agents and toxins has on implementation of personnel screening, physical security requirements, and other procedures.
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From page 16... ...
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)
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From page 17... ...
Because each facility is different in design, dif ferent physical security methods are required to address site-specific security requirements. Determination of which physical security measures to include in a plan is made based on "a site-specific risk assessment and must provide graded protection in accordance with the risk of the select agent or toxin, given its intended use." These select agent regulations provide overall guidelines for the content of site-specific security plans; however, they are sufficiently broad to allow for variation in their implementation.
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From page 18... ...
Specifically, the committee encourages coordination and consolidation so that entities with select agent programs sponsored and/or regulated by different federal agencies are not subject to very different and possibly conflicting guidance and regula tions or to duplicative inspections. In addition, it is critical to ensure that the requirements of multiple agencies are not contradictory; otherwise, the result ing confusion and uncertainty results in excess time and cost and increased difficulty of compliance.
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From page 19... ...
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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