Federal Select Agent Program:
Update on Community Engagement and Transparency
Following several incidents involving biological select agents and toxins (BSAT) in 2014, the White House issued a memorandum outlining a series of short- and long-term actions to enhance laboratory biosafety and security practices. One long-term charge was to engage stakeholders to determine how the select agent regulations (SAR) impact science, technology, and national security in the United States. In response, the National Science and Technology Council established a Fast Track Action Committee (FTAC).
Following engagement with stakeholders, in October 2015 the Fast Track Action Committee on the Select Agent Regulations released a reportpdf iconexternal icon outlining findings and recommendations focused on ways to improve the regulatory process and address gaps in the SAR. One specific FTAC recommendation, recommendation 11, called for the development of a peer advisory mechanism that would serve as an external group that could share best practices or make recommendations to the Federal Select Agent Program (FSAP). This recommendation captured the need expressed by stakeholders for greater peer-to-peer involvement with FSAP by which stakeholders would be able to engage with FSAP on a routine basis to provide subject matter expertise on the SAR.
Beginning in late 2015 and continuing today, FSAP has implemented – and continues to implement – a number of program changes that address this recommendation. Rather than creating a formal membership-based peer advisory group composed of select individuals, FSAP has taken significant steps to ensure that the regulated community as a whole has the opportunity to provide input into the program on an ongoing basis.
In order to address this recommendation, FSAP actions include:
- FSAP developed a formal process to publicly respond to requests for clarification regarding the SAR (i.e., provide interpretations).
- As appropriate, FSAP now shares draft regulatory policies and interpretations, guidance documents, and intended actions with the regulated community before these efforts are finalized. This allows our stakeholders to provide input into those issues that will affect their work.
- FSAP implemented a formal dispute resolution process, which allows registered entities to dispute specific inspection findings.
- FSAP completed a three-day in-person Responsible Officials (RO) training workshop in December 2016, which included the opportunity for peer-to-peer engagement of the regulated community with FSAP, as well as networking between colleagues. FSAP plans to host this type of in-person workshop again in the future.
- FSAP established an independent forum, through the American Biological Safety Association (ABSA) International, to encourage routine peer-to-peer sharing regarding best practices among those working with select agents and toxins. ABSA International has supported online discussions, an in-person workshop, and webinars, thereby allows the regulated community to share information and best practices with each other independent of FSAP.
- FSAP developed a post-inspection survey that allows registered entities to provide feedback on their inspection experience.
- FSAP continues to create other opportunities to engage with stakeholders through the analysis and reporting of our program’s findings. For example in June 2016, FSAP released the 2015 Annual Report of the Federal Select Agent Program, which summarizes 2015 FSAP data. The data in the report provide insight into work conducted with biological select agents and toxins at laboratories across the nation, as well as the how the program provides regulatory oversight of these labs.
- FSAP will continue to pursue the input of external panels to review our program or to provide expertize on topical issues for the implementation of our program, as needed. For example, an independent external group recently completed a study of risk assessment and risk management in the BSAT setting to provide recommendations for FSAP to move operations further toward risk-based oversight and management.
All of these efforts provide the regulated community a greater ability to influence and provide input on pending policy changes, provide feedback on inspections, and influence future rulemaking by sharing best practices.
These commitments reflect only part of our extensive efforts over the past year to increase the effectiveness of FSAP and strengthen and improve our ability to provide effective oversight of this important work.