In July 2010, Executive Order 13546 “Optimizing the Security of Biological Select Agents and Toxins (BSAT),” created and tasked the Federal Experts Security Advisory Panel (FESAP) to address policy issues relevant to the security of biological select agents and toxins.
The duties of the FESAP are solely advisory and shall extend only to the submission of advice or recommendations.
In 2014, a series of incidents involving BSAT raised serious safety and security policy issues. The White House National Security Council (NSC) staff tasked the FESAP, in September 2014, to 1) identify needs and gaps and make recommendations to optimize biosafety, biosecurity, oversight, and inventory management and control for BSAT; 2) identify actions and any regulatory changes to improve biosafety and biosecurity; and 3) identify an approach to determine the appropriate number of high-containment U.S. laboratories required to possess, use, or transfer BSAT
In response to these taskings, the FESAP delivered the December 2014 Report of the Federal Experts Security Advisory Panel. Among its other recommendations, Part IV of the report addresses the “Identification of an Approach to Determine the Appropriate Number of High-Containment U.S. Laboratories Required to Possess, Use, or Transfer BSAT”. The three-phase approach described in Part IV includes:
An intended outcome of Phase I is a ‘best practices checklist’ to be used as a guideline by departments and agencies when considering the construction of high or maximum containment laboratories (HCL). The best practices checklist will help ensure that departments and agencies have considered the different potential options to address their containment research needs and could potentially enable a reduction in the time and cost for planning; design; the release of the request for funding; the award; and the construction of HCL.
The checklist should help departments and agencies in operationalizing generalized principles, foster the use of standard methodologies, and assist in developing templates that could be applied to guide assessments of current and projected needs for HCL space, as well as mechanisms to efficiently meet those needs.
This Best Practices Checklist is advisory in nature; it is intended to assist departments and agencies in determining and evaluating all possible options and variables when considering their HCL needs. This guidance is not exclusive and does not replace existing policy or regulations. Departments and agencies will still be required to abide by all applicable acquisition, procurement, and contracting regulations, policy, and guidelines.
This checklist is intended to be applied only to HCL supported by federal funding within the United States. For federally supported laboratories outside the United States, see the Department of State’s “Guiding Principles and Assessment Process Related to the Provision of Biocontainment Facilities to Foreign Countries.”
Departments and agencies who are considering their current and projected needs for HCL space should adhere to the following general principles:
The following checklist contains questions that departments and agencies should consider in operationalizing the general principles listed above. These questions may not have simple ‘yes’ or ‘no’ answers; departments and agencies should develop detailed responses for each.
This checklist is not intended to serve as a series of boxes that must be checked. Rather, it is intended to provide a comprehensive set of questions that department and agencies should consider throughout their planning process. It is intended as tool to help departments and agencies ensure that they are evaluating all possible options and variables when considering their HCL needs.