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Biological Agents in the Laboratory
PUBLIC INTEREST REPORT FALL 2011 BACKGROUND BRIEF HISTORY OF BIOSAFETY Within three weeks of the destruction of the World Trade Center towers on September Innovation and development of biosafety 11, 2001, the United States experienced a second assault in the form of anthrax spores in the United States is reflected accurately delivered through the U.S. mail. The event in the history and pre-history of the initiated widespread changes in the scientific American Biological Safety Association enterprise of the United States, in its (ABSA). The first unofficial meeting was federally-based funding priorities and in the held on April 18, 1955 at Camp Detrick regulatory and oversight mechanisms that (now Fort Detrick) and involved strive to keep laboratories and communities members of the military representing safe. Camp Detrick, Pine Bluff Arsenal, Arkansas (PBA), and Dugway Proving “The events of September 11, 2001, and the Grounds, Utah (DPG). In those days, the anthrax attacks in October of that year re- offensive BW program of the United shaped and changed, forever, the way we States was in full swing: the opening manage and conduct work in biological and keynote address was “The Role of Safety clinical laboratories.”1 in the Biological Warfare Effort.” Beginning in 1957, the yearly meetings Biosafety and biosecurity have dominated began to include non-classified sessions to the policy discourse and the two have been broaden the reach of the Association; inexorably intertwined. Biosafety and representatives of the USDA were regular biosecurity are defined by the World Health 2 attendees through this “transition Organization (WHO): Biosafety comprises 4 “the containment principles, technologies period.” There were striking changes in and practices that are implemented to the meetings in 1964-1965: the NIH and prevent unintentional exposure to pathogens CDC joined for the first time, along with and toxins or their accidental release”; a number of other relevant federal biosecurity is defined as “the protection, agencies. -
Animal Biosafety Level
Biological Safety Manual Prepared by: Environmental Health and Safety Office April 2012 Table of Contents Table of Contents .................................................................................................................... ii Tables and Figures ................................................................................................................. vii Acronyms ........................................................................................................................... viii Foreword ............................................................................................................................... x Document History .................................................................................................................... x 1.0 Introduction ........................................................................................................ 1-1 1.1 Biological Material ............................................................................................. 1-1 1.1.1 Biohazardous Material ........................................................................................ 1-1 1.1.2 Nonbiohazardous Material .................................................................................. 1-2 1.2 Regulations, Guidelines, and Permit Requirements ............................................. 1-2 1.3 Roles and Responsibilities ................................................................................... 1-4 1.3.1 Vice President for Research and Economic Development -
Clinical Laboratory Preparedness and Response Guide
TABLE OF CONTENTS Table of Contents ...................................................................................................................................................................................... 2 State Information ....................................................................................................................................................................................... 7 Introduction .............................................................................................................................................................................................. 10 Laboratory Response Network (LRN) .......................................................................................................................................... 15 Other Emergency Preparedness Response Information: .................................................................................................... 19 Radiological Threats ......................................................................................................................................................................... 21 Food Safety Threats .......................................................................................................................................................................... 25 BioWatch Program ............................................................................................................................................................................ 27 Bio Detection Systems -
Responding to the Threat of Agroterrorism: Specific Recommendations for the United States Department of Agriculture
Responding to the Threat of Agroterrorism: Specific Recommendations for the United States Department of Agriculture Anne Kohnen ESDP-2000-04 BCSIA-2000-29 October 2000 CITATION AND REPRODUCTION This document appears as Discussion Paper 2000-29 of the Belfer Center for Science and International Affairs and as contribution ESDP-2000-04 of the Executive Session on Domestic Preparedness, a joint project of the Belfer Center and the Taubman Center for State and Local Government. Comments are welcome and may be directed to the author in care of the Executive Session on Domestic Session. This paper may be cited as Anne Kohnen. “Responding to the Threat of Agroterrorism: Specific Recommendations for the United States Department of Agriculture.” BCSIA Discussion Paper 2000-29, ESDP Discussion Paper ESDP-2000-04, John F. Kennedy School of Government, Harvard University, October 2000. ABOUT THE AUTHOR Anne Kohnen graduated from the Kennedy School of Government, Harvard University, in June 2000, with a Master’s degree in public policy, specializing in science and technology policy. This paper is an extension of her Master’s thesis. ACKNOWLEDGEMENTS The author expresses special thanks go to the following people who contributed to this paper valuable information and expertise. From the USDA: Jerry Alanko, Dr. Bruce Carter, Dr. Tom Gomez, Dr. David Huxsoll, Dr. Steve Knight, Dr. Paul Kohnen, Dr. Marc Mattix, Dr. Norm Steele, Dr. Ian Stewart, Dr. Ty Vannieuwenhoven, Dr. Tom Walton, and Dr. Oliver Williams. From other agencies: Dr. Norm Schaad (USAMRIID), Dr. Tracee Treadwell (CDC). From the Kennedy School of Government: Dr. Richard Falkenrath, Greg Koblentz, Robyn Pangi, and Wendy Volkland. -
Biosafety Level 2 Guide University of Illinois at Urbana-Champaign
Biosafety Level 2 Guide University of Illinois at Urbana-Champaign Table of Contents Introduction .................................................................................................................................................. 2 Risk Assessments .......................................................................................................................................... 2 Routes of Exposure ................................................................................................................................... 3 Risk Groups and Biosafety Levels .............................................................................................................. 4 IBC Registrations ....................................................................................................................................... 5 Laboratory Audits...................................................................................................................................... 5 Risk Assessment Scenarios ........................................................................................................................ 5 Training requirements .................................................................................................................................. 7 Introduction to Biosafety .......................................................................................................................... 7 NIH Guidelines Overview ......................................................................................................................... -
Bioterrorism & Biodefense
Hugh-Jones et al. J Bioterr Biodef 2011, S3 Bioterrorism & Biodefense http://dx.doi.org/10.4172/2157-2526.S3-001 Review Article Open Access The 2001 Attack Anthrax: Key Observations Martin E Hugh-Jones1*, Barbara Hatch Rosenberg2 and Stuart Jacobsen3 1Professor Emeritus, Louisiana State University; Anthrax Moderator, ProMED-mail, USA 2Sloan-Kettering Institute for Cancer Research and State Univ. of NY-Purchase (retired); Scientists Working Group on CBW, Center for Arms Control and Non-Proliferation, USA 3Technical Consultant Silicon Materials, Dallas, TX,USA Abstract Unresolved scientificquestions, remaining ten years after the anthrax attacks, three years after the FBI accused a dead man of perpetrating the 2001 anthrax attacks singlehandedly, and more than a year since they closed the case without further investigation, indictment or trial, are perpetuating serious concerns that the FBI may have accused the wrong person of carrying out the anthrax attacks. The FBI has not produced concrete evidence on key questions: • Where and how were the anthrax spores in the attack letters prepared? There is no material evidence of where the attack anthrax was made, and no direct evidence that any specific individual made the anthrax, or mailed it. On the basis of a number` of assumptions, the FBI has not scrutinized the most likely laboratories. • How and why did the spore powders acquire the high levels of silicon and tin found in them? The FBI has repeatedly insisted that the powders in the letters contained no additives, but they also claim that they have not been able to reproduce the high silicon content in the powders, and there has been little public mention of the extraordinary presence of tin. -
Report of the Federal Experts Security Advisory Panel (FESAP)
Report of the Federal Experts Security Advisory Panel December 2014 - 0 - Report of the Federal Experts Security Advisory Panel Table of Contents Executive Summary 3 Chapter I Federal Experts Security Advisory Panel Overview and Charge to the Panel 10 Chapter II Identification of Needs and Gaps, and Recommendations to Optimize Biosafety, Biosecurity, Oversight, and Inventory Management and Control for Biological Select Agents and Toxins 13 Chapter III Identification of Actions and any Regulatory Changes to Improve Biosafety and Biosecurity 34 Chapter IV Identification of an Approach to Determine the Appropriate Number of High-Containment U.S. Laboratories Required to Possess, Use, or Transfer Biological Select Agents and Toxins 40 Glossary 78 Abbreviations and Acronyms 86 Appendices 90 Appendix A Previous Recommendations of the Federal Experts Security Advisory Panel 91 Appendix B Membership of the Federal Experts Security Advisory Panel 93 Appendix C Identification of Needs/Gaps, and Recommendations to Optimize Biosafety, Biosecurity, Oversight, and Inventory Management/Control 96 Appendix D Regulatory Framework for an Occupational Safety and Health Administration Infectious Diseases Standard 102 - 1 - Appendix E Examples of Assessments of Research and Development Needs 106 Appendix F National Bio and Agro-Defense Facility (NBAF) Program Requirements – Historical Documentation 115 - 2 - Report of the Federal Experts Security Advisory Panel EXECUTIVE SUMMARY On July 2, 2010, President Obama signed Executive Order 13546 “Optimizing the -
Chapter 26 BIOSAFETY Appendix B. Pathogen and Toxin Lists B.1
Chapter 26 BIOSAFETY ____________________ Appendix B. Pathogen and Toxin Lists B.1 Introduction and Scope Pathogens and toxins are discussed in detail in Work Process B.3.d, Pathogenic Agents and Toxins, of this manual. This appendix lists the following biological agents and toxins presented in Work Process B.3.d: Human etiologic agents (pathogens) from Appendix B of the NIH Guidelines Select agents and toxins from the National Select Agent Registry (NSAR) Plant pathogens previously identified by U.S. Department of Agriculture (USDA) These lists are provided for convenience in this manual, but may not reflect the actual regulatory list or applicable agents or materials. Regulatory sources, standards, and Web links noted in this appendix and Work Process B.3.d should be consulted to confirm applicable agents or toxins. B.2 NIH Guidelines Human Etiologic Agents This section provides a list of human pathogens and their Risk Group (RG) 2, RG3, and RG4 designations as excerpted from Appendix B, Classification of Human Etiologic Agents on the Basis of Hazard, of the NIH Guidelines, amendment effective November 6, 2013. B.2.1 Risk Group 1 Agents RG1 agents are not associated with disease in healthy adult humans. Examples of RG1 agents include asporogenic Bacillus subtilis or Bacillus licheniformis (see NIH Guidelines, Appendix C-IV-A, Bacillus subtilis or Bacillus licheniformis Host-Vector Systems, Exceptions); adeno-associated virus (AAV, all serotypes); and recombinant or synthetic AAV constructs, in which the transgene does not encode either a potentially tumorigenic gene product or a toxin molecule and which are produced in the absence of a helper virus. -
Studies of Military R&D and Weapons Development: Offensive/Defense
5. The Question of Offensive/Defensive Distinctions in Biological Weapons Related Research, and the Potential Stimulus to BW Proliferation by Expanded Research Programs The word "research," or any specific reference to "offensive" or "defensive" in a research context, does not appear in Article I of the Biological Weapons Convention. That reads as follows: "Each State Party to the Convention undertakes never in any circumstances to develop, produce, stockpile or otherwise acquire or retain: (1) Microbial or other biological agents, or toxins whatever their origin or method of production, of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes; (2) Weapons, equipment or means of delivery designed to use such agents or toxins for hostile purposes or in armed conflict.,,1 However, the word research did appear in the provisional treaty draft that had been drawn up by the U.K. and that had been presented to the negotiating states on July 10, 1969. That draft required states signing or ratifying the treaty "not to conduct, assist or permit research aimed at production ... " of the agents or weapons forbidden by Article I (1) and (2) above. 2 Even earlier in a working paper on microbiological warfare that the U.K. submitted to the states negotiating in Geneva, the U.K. stated: The Convention would also need to deal with research work. It should impose a ban on research work aimed at production of the kind prohibited above, as regards both microbiological agents and ancillary equipment. It should also provide for the appropriate civil medical or health authorities to have access to all research work which might give rise to allegations that the obligations imposed by the Convention were not being fulfilled. -
Federal Select Agent Program (FSAP) When to Report: Using APHIS/CDC Form 3 (Incident Notification and Reporting) 2018 Responsible Official Workshop
Federal Select Agent Program (FSAP) When to Report: Using APHIS/CDC Form 3 (Incident Notification and Reporting) 2018 Responsible Official Workshop August 16, 2018 Agenda 1. Background/definition 2. What is considered a release? (occupational exposure, outside of the primary barriers of the biocontainment area) 3. Commonly reported release incidents, associated agents 4. Scenarios/examples (consult handout) Applicable Regulations . (a) Upon the discovery of the theft or loss of a select agent or toxin, an individual or entity must immediately notify DSAT or AgSAS and the appropriate Federal, State, or local law enforcement agencies. Thefts or losses must be reported even if the select agent or toxin is subsequently recovered or the responsible parties are identified. (b) Upon discovery of the release of an agent or toxin causing occupational exposure, or release of the select agent or toxin outside of the primary barriers of the biocontainment area, an individual or entity must immediately notify DSAT or AgSAS. *42 CFR §73.19, 7 CFR §331.19, 9 CFR §121.19 Definitions Release . A release of biological select agent and toxin (BSAT) causing occupational exposure, or . A release of BSAT outside of the primary barriers of the biocontainment area Theft/Loss . Theft : Unauthorized removal of BSAT . Loss : Failure to account for BSAT Occupational Exposure . Any reasonably anticipated skin, eye, mucous membrane, parenteral contact, or respiratory aerosol exposure to select agents or toxins that may result from the performance of an employee’s duties. Includes both direct and proximity exposures . Does not need to result in a laboratory-acquired infection (LAI) to be reported Examples of Breaches at Every Biosafety Level (BSL) BSL-2 . -
Dugway Proving Ground
Dugway Proving Ground Mission & Capabilities Overview Approved for Public Release—Distribution Unlimited Agenda Dugway Overview Installation Support Activities WDTC Capabilities Current Initiatives Questions BLUF: Test Tube to Battlefield Dugway Proving Ground is the Nation’s designated Major Range and Test Facility Base for Chemical and Biological Defense Testing and Training Chem Testing Bio Testing Training 3 Approved for Public Release—Distribution Unlimited DPG Mission To safely test our Warfighters’ equipment to the highest standards within cost and schedule. DPG Vision To be recognized as the nation’s premier chemical and biological test center enabling the delivery of reliable defense products to our forces through rigorous developmental and operational testing. 4 Approved for Public Release—Distribution Unlimited Army T&E Organizational Structure Mission: Secretary of Facilitate equipment procurement/ fielding decisions Defense through testing and analysis to ensure our Army’s Warfighters have the right capabilities for success Under Secretary of across the entire spectrum of operations. Director, Operational Defense (Acquisition Test & Evaluation &Technology)/Strategic &Tactical Systems/ Developmental T&E Conduct rapid testing in direct support of the Global War on Terror Warfighter, providing capabilities and limitations analyses of weapon systems to enable Assist Secretary for Undersecretary of Secretary Acquisition, Logistics the Army of the Army and Technology employment decisions for rapid fielding to the Combat Soldier. -
GAO-18-422, BIOLOGICAL SELECT AGENTS and TOXINS: Actions
United States Government Accountability Office Report to Congressional Committees September 2018 BIOLOGICAL SELECT AGENTS AND TOXINS Actions Needed to Improve Management of DOD's Biosafety and Biosecurity Program GAO-18-422 September 2018 BIOLOGICAL SELECT AGENTS AND TOXINS Actions Needed to Improve Management of DOD’s Biosafety and Biosecurity Program Highlights of GAO-18-422, a report to congressional committees Why GAO Did This Study What GAO Found In May 2015, DOD discovered that one The Department of Defense (DOD) has made progress by taking a number of of its laboratories (formerly called the actions to address the 35 recommendations from the Army’s 2015 investigation Life Sciences Division) at Dugway report on the inadvertent shipments of live Bacillus anthracis (anthrax). However, Proving Ground, Utah, had DOD has not yet developed an approach to measure the effectiveness of these inadvertently made 575 shipments of actions. As of March 2018, DOD reports 18 recommendations as having been live Bacillus anthracis—the bacterium implemented and 17 as having actions under way to implement them. These that causes anthrax—to 194 actions are part of a broader effort to improve biosafety, biosecurity, and overall laboratories and contractors worldwide program management. For example, in March 2016, DOD established the from 2004 through 2015. A December Biological Select Agents and Toxins (BSAT) Biorisk Program Office to assist in 2015 investigation by the Army overseeing the BSAT Biosafety and Biosecurity Program and implementation of determined that there was insufficient evidence to establish a single point of the recommendations. Measuring the effectiveness of each implemented failure and made recommendations for recommendation would help better determine if the actions taken are working, if improving safety and security at DOD there are unintended consequences, or if further action is necessary.