Practical Considerations for Navigating Withdrawal from the Federal Select Agent Program.

Introduction: Clear guidance is provided by the Federal Select Agent Program (FSAP) to assist registered entities in nearly all facets of compliance with the Federal select agent regulations (7 CFR Part 331; 9 CFR Part 121; 42 CFR Part 73). If a registered entity chooses to discontinue its registration, detailed instructions for registration withdrawal are deeply embedded within a document entitled "eFSAP Form 1 Amendment Instructions," which is found on the FSAP website within the electronic Federal Select Agent Program (eFSAP) Resource Center. Methods: Using the information found within the eFSAP Form 1 Amendment Instructions, as well as extensive written and verbal guidance provided by the lead assigned entity point of contact at the FSAP, we completed the FSAP withdrawal process during a 12-month period between 2022 and 2023. Discussion: This commentary shares our recent professional experiences navigating the FSAP withdrawal process at the University of Texas Health Science Center at Houston (UTHealth Houston). Successes, challenges, and lessons learned are shared so that others planning or considering withdrawing may benefit from our experience. Conclusion: The resources provided for withdrawal within the eFSAP Form 1 Amendment Instructions are relatively basic, and additional details are not currently found in other FSAP guidance documents. Therefore, direct communication and support from the FSAP to the entity Responsible Officials are imperative to ensure a safe, secure, and compliant withdrawal.

Characterization of Work Settings in Which Biosafety Professionals Conduct Operations: Results from the First Survey of the Biosafety Analytics Initiative Survey Series.

Introduction: With the endorsement and support of the ABSA International Council and the Prevention, Preparedness and Response (P2R) Academy of The University of Texas Health Science Center at Houston (UTHealth) School of Public Health, a survey to characterize the work settings in which biosafety professionals operate was conducted. The survey was the first of a planned series of 10 solicitations in support of an overarching "Biosafety Analytics Initiative," the goal of which is to identify commonalities, trends, possible benchmarking opportunities, and professional training needs. Methods: The survey was developed, tested, and then distributed electronically for a 3-week period between May 29 and June 19, 2019. Results: A total of 228 ABSA International members completed responses (15.6% of total membership). The results of the survey indicate that 59.7% of the total membership respondents conduct operations in the public or private academic setting, but when separated by domestic vs international respondents, 38% of the international respondents operate in government (nonacademic) settings. The bulk of biosafety activities were reported as providing support to BSL-1 and BSL-2 laboratories, with more than 90% of respondents indicating that they support work with risk group 1 and 2 organisms. Approximately 60% of the biosafety programs responding reported being organizationally aligned within institutional Environmental Health & Safety programs. Conclusion: The results of this survey serve as a foundation for current and future ABSA International priorities regarding professional development, recruitment, and training opportunities.