Impacts of Pending Biosafety and Biosecurity Legislation on EHS Departments and Professionals: What’s in the Pipeline?

Ryan Burnette, PhD


Recent, high-profile incidents regarding faults in biosafety and biosecurity programs at academic and government institutions have resulted in an increase in public scrutiny, and a subsequent rise in proposed legislation aimed at more stringent oversight of high-containment labs and operations.  While these legislative proposals will certainly undergo modifications in the coming months, it is clear that the risk and consequences for noncompliance will be more severe in the near future.  Indeed, every laboratory conducting high-containment research is now but one dropped vial away from significant potential adverse media attention, investigation, suspension of research, exposure to potential debarment from research funding, and various civil and criminal penalties, as well as damage to institutional reputation, diversion from research progress, and departure of research leaders.  Additional potential damage includes possible loss of community support, endowment, and especially in the case of for-profit enterprises, shareholder and other litigation.  In this environment, it is essential that every research laboratory conducting this type of research operate at the highest possible levels of documented excellence in research.  Activities at the Federal level have revealed that academic, private and research institutes need to fully embrace the fact that more oversight is pending.  EHS departments need to be proactively thinking and fortifying their biosafety and biosecurity programs via safe and compliant facilities, standard operating procedures (SOP), active institutional biosafety committees (IBC), bio-emergency preparedness, risk assessments and training programs.   


This session will disseminate the major points of this proposed legislative action and provide insight for how to prepare.  It is crucial to understand the major points of this legislation and learn how to navigate the future challenges of meeting these new compliance issues.  In addition, this presentation will highlight the newest activities surrounding the creation of an industry self-regulated biosafety accreditation process through various stakeholders and bodies of expertise.