A Culture of Responsibility: Laboratory Safety at the FDA
By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs, and Segaran Pillai, Ph.D., Designated Agency Safety and Health Official and the Director of the Office of Laboratory Safety
A cornerstone of the U.S. Food and Drug Administration’s scientific work is to ensure that we operate our laboratories in a safe and secure manner. October 2020 is the seventh anniversary of Biosafety & Biosecurity Month, an initiative begun at NIH to raise awareness and improve the effectiveness of biosafety programs nationwide. This year’s theme is The Role of Biosafety and Biosecurity in Mitigating Emerging Risk, and the Association for Biosafety and Biosecurity is focusing activities on identifying best practices and lessons learned from the COVID-19 pandemic.
As a nation, we have made significant changes to minimize the risks of the current international public health crisis, one that has profoundly upended our professional and personal lives. These changes require flexibility, teamwork, and cooperation from all of us. Biosafety and biosecurity professionals at the FDA play a critical role in educating and mitigating the risk associated with SARS- CoV-2, the virus that causes COVID-19, for our staff and research scientists as they work to understand and respond to the unique challenges posed by the pandemic. Our work depends on the collaborative efforts of FDA’s centers, Office of Regulatory Affairs (ORA), Employee Safety and Occupational Health (ESOH), and Office of Laboratory Safety (OLS) to protect FDA staff. Our biosafety and biosecurity professionals are integral to addressing the conditions for FDA staff to return to work safely, including laboratory staff doing SARS-CoV-2 research, given the new challenges and constraints posed by the transmission characteristics of SARS-CoV-2.
As part of these efforts, OLS collaborated with FDA centers and offices to release interim guidelines for FDA staff working directly with the virus, together with a regularly updated SARS-CoV-2 fact sheet to support risk assessments, before initiating any laboratory work. This ensures safe and secure practices. The interim guidelines include:
- Proper use of PPE (personal protective equipment like masks, face shields, gloves, gowns, and shoe covers).
- Engineering controls (biosafety cabinets, secure rooms).
- Administrative controls (risk assessment, pre-work approval from the FDA Institutional Biosafety Committee, participation in medical surveillance, and respiratory protection programs, as appropriate).
- Best practices for decontaminating surfaces and proper procedures for packing and transporting any hazardous biomaterials, including SARS-CoV-2.
OLS also has worked closely with FDA centers and ORA to provide critical infrastructure support for all aspects of research and safety across FDA laboratories. Since its inception, OLS has served as the central point of accountability for lab safety at the FDA, while providing oversight and leadership in environmental management and overseeing occupational safety, and health programs. OLS’s efforts include developing policies, safety manuals, inspection and audit processes, training curricula, and an inventory control and information management system to establish standardized approaches for planning, conducting, and assessing safety across all FDA laboratories and to ensure compliance with applicable regulations.
The FDA is obligated to maintain safe laboratory working environments and ensure that applicable health, safety, and environmental regulations are adhered to. OLS and the FDA ESOH Office are committed to supporting the agency’s mission in providing an effective occupational safety and health program for our laboratory employees. We are driven by a responsibility to comply with safety and health standards issued under Section 6 of the Occupational Safety and Health Act of 1970.
FDA centers and ORA each independently manage their site-specific laboratory safety programs and responsibilities that are unique to their site-specific missions. In addition to these center-and office-specific activities, there are cross-cutting biosafety and biosecurity issues that benefit from a coordinated effort to foster consistency and cross-agency input, and engagement are managed and overseen by OLS. Those include biological, chemical, radiological, laser, and Biological Select Agents and Toxins (BSAT) safety programs.
OLS has established councils, committees, and working-groups to address each of these areas so as to offer an opportunity to collaborate and share best practices and lessons-learned agency-wide. Deliberations and combined judgment of all safety professionals through these groups and committees can be brought to bear on important focus areas and challenges that affect all programs – and ultimately offer a more holistic, realistic, and objective appraisal of initiatives and concerns from all angles.
By continuing to provide resources, tools, and platforms to enhance and facilitate cross-communication and collaboration, OLS strives to support an outstanding Laboratory Safety Program at the FDA. In collaboration with FDA centers and ORA, OLS strives to provide a robust and integrated laboratory science, laboratory security, and agency-wide environmental and occupational safety and health programs. At the same time, as OLS provides this critical support, we embrace a culture of responsibility and safety at the FDA: lab safety is everyone’s responsibility.