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HIGH-CONTAINMENT LABORATORIES: Recent Incidents of Biosafety Lapses
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.
In response to the global spread of emerging infectious diseases and the threat of bioterrorism, high-containment biosafety laboratories (BSL)--specifically biosafety level (BSL)-3 and BSL-4--have been proliferating in the United States. These labs--classified by the type of agents used and the risk posed to personnel, the environment, and the community--often contain the most dangerous infectious disease agents, such as Ebola, smallpox, and avian influenza. This testimony addresses (1) the extent to which there has been a proliferation of BSL-3 and BSL-4 labs, (2) federal agencies' responsibility for tracking this proliferation and determining the associated risks, and (3) the lessons that can be learned from recent incidents at three high-containment biosafety labs. To address these objectives, GAO asked 12 federal agencies involved with high-containment labs about their missions and whether they tracked the number of labs overall. GAO also reviewed documents from these agencies, such as pertinent legislation, regulation, and guidance. Finally, GAO interviewed academic experts in microbiological research ...
In response to the global spread of emerging infectious diseases and the threat of bioterrorism, high-containment biosafety laboratories (BSL)--specifically biosafety level (BSL)-3 and BSL-4--have been proliferating in the United States. These labs--classified by the type of agents used and the risk posed to personnel, the environment, and the community--often contain the most dangerous infectious disease agents, such as Ebola, smallpox, and avian influenza. This testimony addresses (1) the extent to which there has been a proliferation of BSL-3 and BSL-4 labs, (2) federal agencies' responsibility for tracking this proliferation and determining the associated risks, and (3) the lessons that can be learned from recent incidents at three high-containment biosafety labs. To address these objectives, GAO asked 12 federal agencies involved with high-containment labs about their missions and whether they tracked the number of labs overall. GAO also reviewed documents from these agencies, such as pertinent legislation, regulation, and guidance. Finally, GAO interviewed academic experts in microbiological research ...
Stringent protocols and engineering are used to contain the most dangerous pathogens, therefore these facilities are often referred to as high-containment laboratories. High-containment laboratories play a critical role in the biodefense effort, offering the hope of better responses to a biological attack and a better understanding of the bioterrorism threat. However, they could also increase the risk of a biological attack by being a source of materials or training. This book examines the biosafety and biosecurity issues in high-containment laboratories across the United States.
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?
High-Containment Laboratories: Preliminary Observations on Federal Efforts to Address Weaknesses Exposed by Recent Safety Lapses