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Report of the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight

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Report of the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight July 2009 - 1 - Report of the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight Table of Contents ExecutiveSummary 4 Chapter I Overview and Charge of the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight 13 Chapter II Background 19 Chapter III Current Framework for Federal, State, and Local Biosafety and Biocontainment Oversight 40 Chapter IV Guiding Principles and Objectives for an Optimized Framework of Biosafety and Biocontainment Oversight of Research in High and Maximum Containment Facilities 68 Chapter V Enhanced Framework for Biosafety and Biocontainment Oversight 73 Chapter VI Culture of Accountability and Compliance 87 Chapter VII Training and Competency 94 Chapter VIII Incident-Reporting, Analysis, and Information-Sharing 103 Chapter IX Biosafety and Biocontainment Regulations and Guidelines 109 Chapter X Infrastructure Maintenance and Sharing Best Practices 116 Chapter XI Biosafety and Biocontainment Research Programs 122 Chapter XII Public Communication, Outreach, and Transparency 125 Chapter XIII Summary of Task Force Recommendations for Optimizing Biosafety and Biocontainment Oversight 127 Glossary 129 Abbreviations and Acronyms 140 Appendices 143 - 2 - Appendix A Membership of the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight 144 Appendix B Charge of the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight 155 Appendix C Scope of Federal Biosafety and Biocontainment Oversight 159 Appendix D DOL (BLS) Sample Survey Results—2006: Scientific Research and Development Injury and Illness Data 164 Appendix E Suggested Roles and Responsibilities for Biosafety Professionals and Local Biosafety Review Committees 166 Appendix F Examples of Federal Outreach and Education Activities 170 Appendix G Accreditation of Biosafety Management Programs 176 Appendix H Available Training and Certification Programs 179 Appendix I Proposed Centralized Incident-Reporting, Analysis, and Information-Sharing System 182 Appendix J Facility Review and Inspection 183 - 3 - Report of the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight EXECUTIVE SUMMARY New scientific tools and understanding have created unprecedented opportunities for progress in life sciences research, medicine, and agriculture. Coincident with this era of opportunity have been elevated concerns about emerging infectious diseases, bioterrorism, and criminal acts involving the use of hazardous biological agents, prompting the rapid development of diagnostics, vaccines, and other medical countermeasures. Research on hazardous biological agents that could threaten human health or agriculture has become a national priority, with increased Federal support for programs to promote scientific investigation in academic and commercial settings, as well as in Federal research facilities. Essential to continued progress in these areas of research are the high and maximum containment1 facilities in which to study these agents. Effective biosafety and biocontainment practices and oversight of research activities at individual high and maximum containment facilities are critical components of the research enterprise. The Federal Government is committed to the highest quality design and construction of biocontainment facilities, the rigorous training of personnel who work in these laboratories, and the safe conduct of research and research-related activities that occur within these facilities. However, there are areas of concern, which include lapses in biosafety, lack of timely reporting of incidents, and lack of Federal oversight for research involving pathogens that are neither select agents nor recombinant DNA agents. Press reports, articles in scientific publications, Government Accountability Office reports, a report by the Commission on the Prevention of WMD Proliferation and Terrorism,2 as well as congressional hearings have focused attention on these issues. At the October 4, 2007, House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations hearing entitled “Germs, Viruses, and Secrets: The Silent Proliferation of Bio-Laboratories in the United States,” the Department of Health and Human Services (HHS) announced the formation of the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight (the “Task Force”). Purpose and Scope of the Task Force 1 The term “high and maximum containment” is used in this report to describe biosafety level 3 (BSL-3) and BSL-4 laboratories and equivalent containment facilities, i.e., animal facility/vivarium ABSL-3 and ABSL-4, and biosafety level-3 agriculture (BSL-3-Ag) facilities. “High containment” refers to BSL-3 and equivalent containment facilities, whereas “maximum containment” refers to BSL-4 and equivalent containment facilities. 2 The acronym “WMD” refers to weapons of mass destruction. Certain biological agents are regarded as potential WMD. - 4 - The purpose of the Task Force is to propose options and recommendations to improve biosafety and biocontainment oversight of research and research-related activities at high and maximum containment laboratories in the United States, without hindering the progress of science. The scope of activities considered by the Task Force includes those that occur in all high and maximum containment research laboratories in all sectors (government [Federal, State, Tribal, and municipal], academia, privately funded research institutions, and private industry) utilizing potentially hazardous biological agents. The activities covered include research with disease-causing agents (pathogens) that can infect humans, zoonotic agents that can infect both animals and humans, biologic toxins, and agricultural pathogens and pests. Also included are activities related to research, such as the maintenance of facilities and equipment needed for effective biosafety and biocontainment, incident-reporting, and public outreach and communication efforts. Outside the scope of the Task Force report are non-research activities that take place in diagnostic and treatment (non-research) facilities such as hospitals, clinics, veterinary, and food diagnostic laboratories. Non-research activities in most licensed biomedical production facilities and mobile field analytical laboratories also lie outside the scope of this report because they vary markedly from those of facilities engaged in high and maximum containment research. To generate this report, the Task Force reviewed the current system of biosafety and biocontainment oversight by individual research institutions, a sampling of municipal and State government entities, and Federal agencies.3 The review included oversight entities, processes, and mechanisms; Federal regulations, guidelines, standards, and policies; and mechanisms for coordinating oversight activities. In addition, the Task Force discussed the accountability and compliance of individuals and institutions; training and competency of relevant staff at high and maximum containment research institutions; incident-reporting, analysis, and information-sharing; maintenance of facility infrastructure and equipment; applied biosafety research programs; and public communication, outreach, and transparency. The issues of biosecurity and personnel reliability, although related to laboratory biosafety and biocontainment, are not the focus of this report but are being addressed by a Federal Working Group established by Executive Order 13486, Strengthening Laboratory Biosecurity in the United States. All three issues—biosafety/biocontainment, biosecurity, and personnel reliability—are important and are being explored in detail by the Federal Government. 3 Although the Task Force reviewed oversight at many levels, its emphasis is on Federal and “local” biosafety/biocontainment oversight of research and related activities at high and maximum containment facilities. In this report, the term “local oversight” refers to oversight of the biosafety/biocontainment entities, processes, and mechanisms in place at facilities where high or maximum containment research is conducted. - 5 - Membership of the Task Force The Task Force is co-chaired by HHS and the U.S. Department of Agriculture (USDA), and is comprised of representatives from a broad range of Federal agencies that have responsibility for and oversight of work with hazardous biological agents at high and maximum containment research facilities. In addition to HHS and USDA, the members of the Task Force include representatives from the Departments of Commerce, Defense, Energy, Homeland Security, Labor, State, Transportation, Veterans’ Affairs, as well as the Environmental Protection Agency and National Science Foundation. Importance of Public Involvement Given the importance of laboratory biosafety and biocontainment to many private-sector research activities, as well as to the protection of laboratory workers, public health, agriculture, and the environment, input from key stakeholders in academia, private industry, and professional societies, as well as the public at large, is critical. To that end, the Task Force held a public engagement meeting on December 8−9, 2008. Importance of High and Maximum Containment Research The need for strategies and products to protect public health and agriculture in the event of a natural emergency, man-made biological incident or event, or act of bioterrorism has resulted
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