Oversight Of High Containment Biological Laboratories

The fed. gov¿t. responded to the 9/11 terrorist attacks and the subsequent anthrax attacks with increased focus on and funding for biodefense. High-containment labs. (HCL) play a critical role in the biodefense effort, offering the hope of better responses to an attack and a better understanding of the threat posed by bioterrorism. However, they also could increase the risk of a biological attack by serving as a potential source of materials or training. Policymakers have become increasingly interested in the oversight of these facilities following reports of accidents, regulatory noncompliance, and community resistance. A key task for policymakers is to define their goals for enhancing oversight of HCL. Illustrations

U.S. laboratories working with dangerous biological pathogens (commonly referred to as high-containment laboratories) have proliferated in recent years. As a result, the public is concerned about the oversight of these laboratories. The deliberate or accidental release of biological pathogens can have disastrous consequences. This report determines: (1) to what extent, and in what areas, the number of high-containment laboratories has increased in the U.S.; (2) which federal agency is responsible for tracking this expansion and determining the associated aggregate risks; and (3) lessons learned from highly publicized incidents at these laboratories and actions taken by the regulatory agencies. Charts and tables.

The federal government responded to the September 11, 2001, terrorist attacks and the subsequent anthrax attacks with increased focus on and funding for biodefense. A key consideration in this response was addressing shortages in diagnostic, clinical, and research laboratory capacity. Several departments and agencies have increased or are in the process of increasing their laboratory capacity. High-containment laboratories play a critical role in the biodefense effort, offering the hope of better responses to an attack and a better understanding of the threat posed by bioterrorism. However, they also could increase the risk of a biological attack by serving as a potential source of materials or training. Indeed, the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism recommends tightening government oversight of high-containment laboratories. Policymakers have become increasingly interested in the oversight of these facilities following reports of accidents, regulatory noncompliance, and community resistance. The increase in high-containment laboratory capacity has raised new policy questions and emphasized existing ones. How much laboratory capacity is enough? What is the necessary federal investment? Should laboratories be consolidated or dispersed? What plans exist to coordinate multiple agency efforts to expand high-containment laboratory capacity? Does increasing laboratory capacity increase the risk of accidents and the opportunity for purposeful misuse? What is an acceptable balance between the benefits these laboratories provide and the risks they pose?

Safety lapses at federal high-containment laboratories in 2014 and 2015 raised concerns about federal departments' oversight of these laboratories. Such laboratories work with hazardous biological agents to develop measures to protect public and animal health and the food supply against these agents. This report examines (1) the extent to which federal agencies have comprehensive and up-to-date policies for managing biological agents in these laboratories; (2) how they oversee laboratories; and (3) the extent to which the Departments of Health and Human Services (HHS) and Defense (DOD) have implemented recommendations from laboratory safety reviews. Tables. This is a print on demand report.

" Safety lapses at federal high-containment laboratories in 2014 and 2015 raised concerns about federal departments' oversight of these laboratories. These laboratories work with hazardous biological agents to develop measures to protect public and animal health and the food supply against these agents. GAO was asked to review oversight at federal high-containment laboratories. This report examines (1) the extent to which federal agencies have comprehensive and up-to-date policies for managing biological agents in these laboratories, (2) how they oversee laboratories, and (3) the extent to which HHS and DOD have implemented recommendations from laboratory safety reviews. GAO assessed policies and oversight activities at 8 departments and their 15 component agencies that own and operate high-containment laboratories against federal internal control standards and program management leading practices, reviewed plans for implementing laboratory safety recommendations, and interviewed federal officials. "

During July 10-13, 2011, 68 participants from 32 countries gathered in Istanbul, Turkey for a workshop organized by the United States National Research Council on Anticipating Biosecurity Challenges of the Global Expansion of High-containment Biological Laboratories. The United States Department of State's Biosecurity Engagement Program sponsored the workshop, which was held in partnership with the Turkish Academy of Sciences. The international workshop examined biosafety and biosecurity issues related to the design, construction, maintenance, and operation of high-containment biological laboratories- equivalent to United States Centers for Disease Control and Prevention biological safety level 3 or 4 labs. Although these laboratories are needed to characterize highly dangerous human and animal pathogens, assist in disease surveillance, and produce vaccines, they are complex systems with inherent risks. Biosecurity Challenges of the Global Expansion of High-Containment Biological Laboratories summarizes the workshop discussion, which included the following topics: Technological options to meet diagnostic, research, and other goals; Laboratory construction and commissioning; Operational maintenance to provide sustainable capabilities, safety, and security; and Measures for encouraging a culture of responsible conduct. Workshop attendees described the history and current challenges they face in their individual laboratories. Speakers recounted steps they were taking to improve safety and security, from running training programs to implementing a variety of personnel reliability measures. Many also spoke about physical security, access controls, and monitoring pathogen inventories. Workshop participants also identified tensions in the field and suggested possible areas for action.

High-Containment Laboratories: National Strategy for Oversight Is Needed

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