Review of Restricted Experiment Requests, Division of Select Agents and Toxins, US Centers for Disease Control and Prevention, 2014-2021.

The US Centers for Disease Control and Prevention Division of Select Agents and Toxins (DSAT) regulates laboratories that possess, use, or transfer select agents and toxins within United States as part of the Federal Select Agent Program. DSAT also mitigates biosafety risks through the review of "restricted experiments," which under the select agent regulations are experiments that pose heightened biosafety risks. In a previous study, we evaluated restricted experimental requests submitted to DSAT for review between 2006 and 2013. The purpose of this study is to provide an updated analysis of requests to conduct potential restricted experiments submitted to DSAT between 2014 and 2021. This article describes the trends and characteristics of the data associated with restricted experimental requests involving select agents and toxins that have an impact on public health and safety (US Department of Health and Human Services agents only) or both public health and safety and animal health or products (overlap agents). From January 2014 to December 2021, DSAT received 113 requests to conduct potential restricted experiments; however, 82% (n=93) of those requests were determined not to meet the regulatory definition of a restricted experiment. Of the 20 requests that met the definition of a restricted experiment, 8 were denied because the experiments had the potential to compromise disease control in humans. DSAT continues to encourage entities to practice due diligence and request a review of research that could potentially meet the regulatory definition of a restricted experiment out of an abundance of caution to protect public health and safety and prevent any potential compliance action.

Review of Requests to Exclude Attenuated Strains of Select Agents and Modified Select Toxins, Division of Select Agents and Toxins, Centers for Disease Control and Prevention, 2003-2017.

The Centers for Disease Control and Prevention's Division of Select Agents and Toxins (DSAT) regulates the possession, use, and transfer of select agents and toxins throughout the United States as part of the Federal Select Agent Program. The Department of Health and Human Services (HHS) select agent regulations also include criteria for the exclusion of select agents and toxins from the requirements of the regulations (42 CFR § 73.3 and 73.4). An entity may request the exclusion of an attenuated strain of a select agent or a select toxin modified to be less potent or toxic. The Intragovernmental Select Agents and Toxins Technical Advisory Committee (ISATTAC) reviews the exclusion request by conducting a risk assessment to determine whether the attenuated strain or modified toxin has the potential to pose a severe risk to public health and safety. In this study, DSAT analyzed the number and types of exclusion requests reviewed by the ISATTAC from January 2003 through December 2017. As of December 2017, DSAT has excluded 50 strains of biological agents and 10 modified toxins from the select agent regulations. The select agent regulations provision for the exclusion of attenuated select agents or modified toxins that no longer have the potential to pose a severe threat to public health and safety is an important mechanism for reducing the regulatory burden on entities that do not need to work with the fully virulent or toxic forms of the agent or toxin. This provision may have the added benefit of encouraging entities to consider working with variants of select agents or toxins that are of less risk than the fully virulent or toxic forms in their research studies and as a positive control.