Optimizing the Nation's Investment in Academic Research A New Regulatory Framework for the 21st Century (2016) / Chapter Skim
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11 Research with Select Agents and Toxins
11 Research with Select Agents and Toxins
Pages 177-186
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From page 177... ...
"to promulgate regulations to establish and maintain a list of biological agents that have the potential to pose a severe threat to public health and safety. This list subsequently became known as the Select Agents and Toxins List." 55 Currently, there are 65 agents and toxins on the Select Agents and Toxins List: 34 are HHS BSATs (biological select agents and toxins)
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From page 178... ...
18 states that "whoever knowingly possesses any biological agent, toxin, or delivery system of a type or quantity that, under the circumstances, is not reasonably justified by prophylactic, protective, bona fide research, or other peaceful purpose, shall be fined under this title, imprisoned not more than 10 years, or both." 62 Under this statute, the terms biological agent and toxin did not include those in their naturally occurring environment so long as the agent or toxin had not been cultivated, collected, or otherwise extracted from its natural source. 63 The regulation of BSATs was also affected by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which directed the HHS secretary to, among other things, establish and maintain the Select Agents and Toxins List and provide safeguards and security requirements for possessing, using, and transferring the materials on the list.
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From page 179... ...
66 Research of dual-use concern may subsequently become the subject of tight regulatory control; however, as current regulations focus on select agents, the committee has elected to focus its attention on select agent regulations. Nature of Concern Select agent regulations have created a burdensome regulatory framework for individuals working with a very specific list of microbial agents and toxins.
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From page 180... ...
70 As a result, many irreplaceable samples were lost in the destruction of these collections. New clinical isolates of microbes on the Select Agents and Toxins List are routinely destroyed by clinical microbiology laboratories that lack the resources to transfer such materials in compliance with select agent regulations.
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From page 181... ...
In October 2015, the FTAC issued a report, Recommendations on the Select Agent Regulations Based on Broad Stakeholder Engagement, which offers suggestions for improving the regulatory process and addressing perceived gaps in the select agent regulations in the future. 76 Regarding inventory requirements, the FTAC recommended "retaining requirements to maintain inventories of samples containing biological select agents and toxins, while ensuring that BSAT institutions are not requested to characterize biological agents quantitatively." 77 The FTAC also recommended the "development of lence in Biodefense and Emerging Infectious Diseases," available at: http://www.niaid.
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From page 182... ...
80 HHS is also considering whether to amend the select agents list by removing Brucella melitensis. 81 In addition, the agencies are proposing several amendments to the select agent regulations, including "the addition of provisions to address the inactivation of select agents, provisions addressing biocontainment and biosafety, and clarification of regulatory language concerning security, training, incident response, and records." 82 According to the agen mends that accountability in the SAR be maintained at the level of identifiable physical items, such as vials or plates, and not extended to quantitative measurements of size, volume, mass, or concentration of biological agents (other than needed to describe them quantitatively)
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From page 183... ...
The rulemaking would codify existing policy that all individuals who have re ceived FSAP approval to have access to select agents and toxins will be required to have training that addresses the particular needs of the individual and the risks posed by the select agent or toxin, regardless of whether they routinely access se lect agents or toxins.
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From page 184... ...
Hence, within select agent regulations, there is a tremendous focus on the tracking of individual vials. Select agents, however, are often living, self-replicating microbes that can be removed from a vial without obviously affecting the volume of material in a vial.
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From page 185... ...
Institutions engaged in research on select agents and toxins may be subject to multiple inspections by multiple agencies. The time, effort, and cost of reconciling inconsistent inspection results and complying with different standards and interpretations of select agent regulations are a source of significant burden.
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