Federal Oversight of High-containment Biolaboratories PDF Download

Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher:
ISBN:
Category : Biological laboratories
Languages : en
Pages : 72

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Author: U.s. Government Accountability Office
Publisher: Createspace Independent Publishing Platform
ISBN: 9781973911203
Category :
Languages : en
Pages : 92

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" 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. "

Author: Frank Gottron
Publisher: BiblioGov
ISBN: 9781294247487
Category :
Languages : en
Pages : 36

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Oversight of High-Containment Biological Laboratories: Issues for Congress Congressional Research Service Summary 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 ...

Author: Ann Wright
Publisher: DIANE Publishing
ISBN: 1437922724
Category : Science
Languages : en
Pages : 104

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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.

Author: Marcia Crosse
Publisher:
ISBN: 9781457873232
Category :
Languages : en
Pages : 92

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Book Description
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.

Author: United States. Government Accountability Office
Publisher:
ISBN:
Category : Laboratories
Languages : en
Pages : 97

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Book Description
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. GAO was asked to determine (1) to what extent, and in what areas, the number of high-containment laboratories has increased in the United States, (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. To carry out its work, GAO surveyed and interviewed federal agency officials, (including relevant intelligence community officials), consulted with experts in microbiology, reviewed literature, conducted site visits, and analyzed incidents at high-containment laboratories. GAO is recommending that (1) the National Security Advisor name an entity charged with government wide strategic evaluation of high containment laboratories and (2) the Secretaries of Health and Human Services and Agriculture address specific oversight issues regarding high-containment laboratories.

Author: United States Government Accountability Office
Publisher: Createspace Independent Publishing Platform
ISBN: 9781984167101
Category :
Languages : en
Pages : 104

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High-Containment Laboratories: National Strategy for Oversight Is Needed

Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 0

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Since 2001, the Department of Defense (DOD), the Department of Homeland Security (DHS), the Department of Health and Human Services (HHS), and the Department of Agriculture (USDA) have increased or are in the process of increasing their laboratory capacity for the study of dangerous pathogens. [...] The HHS OIG has levied a total of $1,887,000 in fines on 12 organizations for failure to comply with the Select Agent regulations.16 Biosafety and Laboratory Best Practices Scientists studying dangerous pathogens generally acknowledge the risk of contracting the disease under study and the potential of accidentally releasing a pathogen into the environment. [...] The most commonly referenced guidelines are disseminated by HHS in the publication Biosafety in Microbiological and Biomedical Laboratories (BMBL).17 Biosafety Levels The Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) have established four main levels of biosafety (BSL-1 to BSL-4) to guide laboratory researchers in the safe handling of biological agent [...] The DHS announced its decision to site the NBAF in Kansas.48 Department of Health and Human Services The Department of Health and Human Services (HHS) currently maintains BSL-4 laboratories at the National Institutes of Health (NIH) in Bethesda, MD, and at the Centers for Disease Control and Prevention in Atlanta, GA.49 Additionally it has invested in construction of two BSL-4 National Biocontainm [...] Sufficiency of Current Oversight and Enforcement The growth of BSL-3 and BSL-4 laboratories has raised concerns about the potential for pathogen release into local communities, as well as biological weapon proliferation, either through the transfer of pathogens or the transfer of technical knowledge through training and employment of foreign scientists in such venues.68 Events, such as laboratory.

Author: Frank Gottron
Publisher: DIANE Publishing
ISBN: 1437919375
Category : Science
Languages : en
Pages : 33

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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

Author: United States. Congress. House. Committee on Energy and Commerce
Publisher:
ISBN:
Category :
Languages : en
Pages : 12

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There is still no one agency or group that knows the nation's need for all U.S. high- containment laboratories, including the research priorities and the capacity, number and location, to address priorities. This deficiency may be more critical today than 3 years ago because current budget constraints make prioritization essential. Since the publication of our report in 2009, the number of high-containment laboratories has increased. Although modern high-containment technologies (for example, high-efficiency particulate air [HEPA] filtration) in conjunction with laboratory design have been effective in reducing the level of risk, there is nevertheless some degree of risk associated with design, construction, operations, and maintenance of high-containment laboratories. This was realized following a Centers for Disease Control and Prevention (CDC) power failure incident in Atlanta, Georgia, where no biological agent was released but that showed the difficulties in maintaining biological containment, and a leaky pipe incident in Pirbright, United Kingdom, that failed to maintain biological containment. Increasing the number of laboratories also increases the aggregate national risk. GAO found a continued lack of national standards for the design, construction, commissioning, and operation of high-containment laboratories. These laboratories are expensive to build, operate, and maintain. As we noted in our 2009 report, in the absence of national standards, it is likely that there may be variations resulting from local requirements, but without an underpinning set of standards to ensure safe operations. In the absence of some fundamental criteria, each laboratory can be designed, constructed, and maintained according to local requirements. This will make it difficult to be able to assess and guarantee safety, as we noted in our 2009 report. For example, while investigating a power outage incident in its recently constructed BSL-4 laboratory, the CDC later determined that, some time earlier, a critical grounding cable buried in the ground outside the building had been cut by construction workers digging at an adjacent site. The cutting of the grounding cable, which had hitherto gone unnoticed by CDC facility managers, compromised the electrical system of the facility that housed the BSL-4 laboratory. Given that grounding cables were cut, it is apparent that the building's integrity as it related to adjacent construction was not adequately supervised. CDC officials stated in 2009 that standard procedures under local building codes did not require monitoring of the integrity of the new BSL-4 facility's electrical grounding. This incident highlighted the risks inherent in relying on local building codes to ensure the safety of high-containment laboratories, as there are no building codes and testing procedures specifically for those laboratories. High-containment laboratories, biosafety level (BSL)-3 and BSL-4 laboratories, are used to (1) develop medical and veterinary countermeasures against biological agents and (2) research the risks these agents pose to human health, animal health, the food supply, and the U.S. economy. In 2009 GAO reported on the expansion of these laboratories, which began in the 1990s and accelerated after the 2001 anthrax attack. GAO found that although this expansion was occurring, no single federal agency was responsible for assessing overall laboratory needs. Instead, departments and agencies only assessed laboratory needs that were within the scope of their respective missions. GAO therefore determined that a national strategy for oversight, including periodic assessments of the nation's need for these laboratories, was called for. GAO also found that the absence of national standards for laboratory design, construction, commissioning, operations, and maintenance raised concerns and increased the risk of laboratory accidents. GAO's 2009 report made two recommendations to the National Security Advisor, located in the Executive Office of the President (EOP), to address these weaknesses. Specifically, GAO recommended that the National Security Advisor identify a single entity, charged with periodic government-wide strategic evaluation of high-containment laboratories, that will (1) determine (a) the number, location, and mission of the laboratories needed to effectively meet national goals to counter biothreats; (b) the existing capacity within the United States; (c) the aggregate risks associated with the laboratories' expansion; and (d) the type of oversight needed and (2) develop, in consultation with the scientific community, national standards for the design, construction, commissioning, and operation of high-containment laboratories, specifically including provisions for long-term maintenance. This report addresses the following questions: 1. What actions have been taken to implement the recommendations made in our 2009 report? 2. To what extent is action still needed concerning (1) an assessment of the nation's need for high-containment laboratories, including their numbers, functions, and research priorities and (2) the development of any national standards for designing, constructing, commissioning, maintaining, and operating high-containment laboratories? GAO recommends that the Office of Science and Technology Policy (OSTP) ensure that periodic assessments of national biodefense research and development needs are conducted. These assessments would include whether appropriate resources, in particular, high containment laboratories, exist to meet those needs. GAO also recommends that the OSTP examine the need to establish national standards relating to designing, constructing, commissioning, maintaining, and operating high-containment laboratories.