Biosafety Level 2 01Biosafety Level 1 03Biosafety Level 3 Biosafety Level 4

Total Page:16

File Type:pdf, Size:1020Kb

Biosafety Level 2 01Biosafety Level 1 03Biosafety Level 3 Biosafety Level 4 BIOSAFETY 1,2,3,4 Established by the National Institutes of Health (NIH) and Centers for Disease Control (CDC), biosafety levels 1 through 4 represent a collection of laboratory techniques, practices, and equipment used to manage the biohazards posed when working with various infectious agents. Biosafety 01 Level 1 Infectious Agents Strains of viable microorganisms that usually pose a minimal potential threat to laboratory workers and the environment and do not consistently cause disease in healthy adults. • Bacillus suBtilis • Canine Hepatitis • Escherichia coli Practices Standard microbiological practices • Mechanical pipetting • Safe sharps handling • Splash and aerosol avoidance • Decontamination of work surfaces Safety Equipment Facilities Standard personal protective equipment Open benchtop and sink required consisting of gloves, eye protection, and lab coat or gown. Biosafety Level 2 02 Infectious Agents Pathogens that cause only mild disease to humans and for which preventive or therapeutic interventions are available, or are difficult to contract via aerosol in a laboratory setting. • Hepatitis B virus • Lyme disease • Measles • Salmonellae Practices Level 1 PLUS • Limited access • Biohazard warning signs • Additional Sharps precautions • Biosafety manual defining decontamination and medical surveillance policies • Respiratory protection as required Safety Equipment Facilities Level 1 + A physical containment device Level 1 + Autoclave available is required for all manipulation of agents that cause splashes or aerosols of infectious materials. • Class I Biological Safety Cabinet • Class II Biological Safety Cabinet Biosafety 03Level 3 Infectious Agents Indigenous or exotic agents with potential for aerosol transmission, disease may have serious or lethal consequences. These agents typically have high individual risk but low community risk. • anthrax • hantavirus • malaria • Rocky Mountain Spotted Fever • West Nile Virus Practices Level 2 PLUS • Controlled access • Decontamination of waste and clothing • Serum samples of lab personnel Safety Equipment Facilities Level 2 + A physical containment device Level 2 + is required for all open manipulations of • Self-closing, double doors agents. Respiratory protection is required • Physical separation from as needed. access corridors • Class I Biological Safety Cabinet • Negative airflow into laboratory • Class II Biological Safety Cabinet • Exhaust air not recycled Biosafety Level 4 04 Infectious Agents Viruses that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not generally available. These diseases present both high individual and community risk. • Argentine & Bolivian hemorrhagic fevers • Ebola virus • Lassa fever virus • Marburg virus • Variola virus Practices Level 3 PLUS • Clothing change before entering lab • Shower on exit • All material decontaminated on exit from lab Safety Equipment Facilities All procedures are conducted in a Class III • Separate building or isolated zone BSC or in a Class I or II BSC in combination • Dedicated supply/exhaust vacuum with a full body, air-supplied, positive- and decontamination system. pressure personnel suit. • UV light rooms and autonomous detection systems may also be in place to both detect and destroy pathogens. Selecting a Biological Safety Cabinet Biosafety Levels Type of Protection BSC Selection Levels 1 – 3 Personnel Protection Class I, Class II Levels 1 – 3 Personnel and Product Protection Class II Level 4 Personnel Protection (Glove Box Lab) Class III Level 4 Personnel Protection (Suit Lab) Class I, Class II.
Recommended publications
  • 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.
    [Show full text]
  • 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
    [Show full text]
  • 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
    [Show full text]
  • 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.
    [Show full text]
  • 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 .........................................................................................................................
    [Show full text]
  • 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
    [Show full text]
  • 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.
    [Show full text]
  • 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 .
    [Show full text]
  • 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.
    [Show full text]
  • 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.
    [Show full text]
  • Strengthening the Biological and Toxin Weapons Convention (BTWC) Publication Year: 2003 BTWC Briefing Papers: 2Nd Series: No
    Maximizing the Security and Oversight of Pathogenic Microorganisms and Toxins Item Type Briefing Paper Authors Pearson, Graham S. Citation Pearson, G.S. (2003). Maximizing the Security and Oversight of Pathogenic Microorganisms and Toxins. Bradford, Bradford Disarmament Research Centre, Department of Peace Studies, University of Bradford. BTWC Briefing Papers: 2nd Series, No. 6. Rights © 2003 University of Bradford. This work is licensed under a Creative Commons Attribution-Non-Commercial-Share Alike License (http://creativecommons.org/licenses/by-nc-nd/2.0/uk). Download date 02/10/2021 22:06:26 Link to Item http://hdl.handle.net/10454/787 The University of Bradford Institutional Repository This work is made available online in accordance with publisher policies. Please refer to the repository record for this item and our Policy Document available from the repository home page for further information. Author(s): Pearson, G.S. Title: Maximizing the Security and Improving Oversight of Pathogenic Oversight of Pathogenic Microorganisms and Toxins Project: Bradford Project on Strengthening the Biological and Toxin Weapons Convention (BTWC) Publication year: 2003 BTWC Briefing Papers: 2nd Series: No. 5 Series Editor(s): Pearson, G.S. and Dando, M.R. Publisher: University of Bradford (http://www.brad.ac.uk) Publisher’s repository: http://bradscholars.ac.uk:8080/dspace Copyright statement: © 2003 University of Bradford. This work is licensed under a Creative Commons Licence (http://creativecommons.org/licenses/by-nc- nd/2.0/uk/). Strengthening the Biological Weapons Convention Briefing Paper No 5 (Second Series) Maximizing the Security and Improving Oversight of Pathogenic Microorganisms and Toxins July 2003 Series Editors Graham S Pearson and Malcolm R Dando Department of Peace Studies, University of Bradford 1 Strengthening the Biological Weapons Convention Briefing Paper No 5 (Second Series) Maximizing the Security and Improving Oversight of Pathogenic Microorganisms and Toxins Graham S.
    [Show full text]
  • The Basics of Biocontainment
    technology feature The basics of biocontainment Studying potentially dangerous microbes in animal models of the disease they cause takes some extra considerations, as researchers and staf must perform their work under the careful restrictions of diferent biosafety level laboratories. Jim Kling n early 2020, when the first concerns arose about a SARS-CoV-2 pandemic, Iresearchers at biosafety facilities realized they would soon be pivoting to work with the novel coronavirus. Fortunately, many had previous experience to draw on, such as working with influenza virus or other airborne pathogens, or with SARS-CoV-1. That 2002 outbreak resulted in a more severe, though less transmissible, disease than the current virus. Preprints from Chinese and Asian researchers guided early efforts, said Kenneth Palmer, director of the University of Louisville (UoL) Regional Biocontainment Laboratory and the UofL Center for Predictive Medicine for Biodefense and Emerging Infectious Diseases. The team in Kentucky had also established a ferret model during their Keeping microbes, such as SARS-CoV-2, contained is a critical consideration for those studying work with SARS-CoV-1. “We found that dangerous agents in biosafety facilities. Credit: E. Dewalt, Springer Nature our experience with the ferret model of SARS-CoV-1 was very similar to the published experience [with SARS-CoV-2], and the procedures we are using for research are tiered from biosafety level (BSL) 1 to are reserved for agents with a high fatality are very similar between SARS-CoV1 4. BSL-1 can be used for agents that don’t rate, such as Ebola. They require full body and SARS-CoV2, and avian influenza consistently cause disease.
    [Show full text]