Environmental Health and Safety BIOLOGICAL SAFETY GUIDE Version 2.1 – Revised April 2017 Biological Safety Office Environmental Health and Safety Division 1405 Goss Lane Augusta, GA 30901 706-721-2663 [email protected] TABLE OF CONTENTS Introduction ................................................................................................................................. ..4 Chapter 1 – Roles and Responsibilities ...................................................................................... 5 Chapter 2 – Biosafety Requirements .......................................................................... …………..8 Obtaining Approval for the Use of Biological Materials ............................................................. 8 Communication/Coordination with Other Compliance Offices ................................................ 10 Renewal of Biological Registration Information ....................................................................... 11 Amendments to BSPs/CBSPs ................................................................................................. 11 Laboratory record Keeping ...................................................................................................... 12 Chapter 3 – Opening, Closing and Moving a Laboratory ........................................................ 13 Chapter 4 – Risk Assessment .................................................................................................... 15 Pathogens ............................................................................................................................... 15 Procedures which may be associated with additional risk of exposure .................................. 18 Personnel (experience of staff) ............................................................................................... 18 Chapter 5 - Risk Management and Biosafety Levels ............................................................... 19 Biosafety Levels at Augusta University ................................................................................... 19 General Laboratory Safety Procedures ................................................................................... 19 Tissue, Cell and Microbiological Culture Practices ................................................................ 21 Vacuum Packed Tubes/Vials .................................................................................................. 23 Transport of Biological Material on Campus ........................................................................... 23 Laboratory Equipment/Personal Protective Equipment .......................................................... 24 Chapter 6 – Occupational Health ............................................................................................... 32 Requirement for Occupational Health Services ...................................................................... 32 Tuberculosis (TB) Screening ................................................................................................... 32 Immunizations ......................................................................................................................... 32 Respiratory Protection ............................................................................................................. 33 Medical Restrictions ................................................................................................................ 33 Pregnancy ............................................................................................................................... 33 Work with Animals ................................................................................................................... 34 Latex Gloves and Related Allergies ........................................................................................ 35 Antibiotic Allergies ................................................................................................................... 35 Chapter 7 – Accidents, Exposures, Spill Response ................................................................. 36 Chapter 8 – Decontamination of Biologicals ............................................................................ 40 Autoclave Use and Maintenance ............................................................................................. 40 Chemical Decontaminants ...................................................................................................... 41 Deactivation of Biological Toxins ............................................................................................. 43 Deactivation of Prions ............................................................................................................. 46 Chapter 9 – Biological Waste Management .............................................................................. 48 Definition of Biomedical Waste ................................................................................................ 48 Solid Biomedical Waste (including sharps) ............................................................................. 48 Pathological Waste .................................................................................................................. 51 Liquid Biological Wastes ......................................................................................................... 51 Chemotherapy Wastes ............................................................................................................ 52 Mixed Wastes .......................................................................................................................... 52 Requisition for New or Additional Biohazardous Waste Containers ....................................... 53 Requisition for Biohazardous Waste Pickup ........................................................................... 53 Chapter 10 – Placard Signs and Labels .................................................................................... 54 2 Chapter 11 – Teaching Laboratories .......................................................................................... 56 Registration of Biological Materials ......................................................................................... 56 Occupational Health Requirements ......................................................................................... 56 Minimum Apparel Requirements ............................................................................................. 56 Personal Protective Equipment Requirements ....................................................................... 56 Laboratory Facility Requirements ............................................................................................ 56 Laboratory Equipment Requirements...................................................................................... 57 Standard Laboratory Practices ................................................................................................ 57 Transportation of Biological Materials ..................................................................................... 57 Training Requirements ............................................................................................................ 57 Decontamination ...................................................................................................................... 58 Waste Disposal ........................................................................................................................ 58 Spills .................................................................................................................................... 59 Accidents/Incidents.................................................................................................................. 60 Appendices ................................................................................................................................... 61 Appendix A – Bloodborne Pathogen Exposure Control Plan .................................................. 61 Appendix B – Tuberculosis Exposure Control Plan ................................................................ 66 Appendix C – Human Gene Transfer Clinical Trials ............................................................... 67 Appendix D – Guide to Shipping Biological Substances & Support Materials ........................ 68 3 INTRODUCTION Purpose This Biosafety Guide has been developed by the Division of Environmental Health and Safety (EH&S) Biosafety Office and the Institutional Biosafety Committee (IBC) at Augusta University. This Guide is part of the Augusta University Biosafety Program instituted to accomplish the following goals: • Protect personnel from exposures to biological agents; • Prevent environmental contamination; • Provide an environment for high quality research while maintaining a safe work place; • Comply with applicable federal, state and local regulations and guidelines, and; • Create a secure laboratory environment to prevent unauthorized utilization of a biological agent. Scope The Biosafety Guide and Biosafety Program is applicable to all personnel who are engaged in research or instructional activities where biological materials are used or the potential for exposure to biological materials exists. This guide focuses on Biosafety Levels (BSL) 1 and 2. No work which will require BSL3 or BSL4 containment shall be conducted at Augusta University. Accessibility • The Biosafety