Biological Safety Guide Biological Safety Office Environmental Health & Safety Division 1405 Goss Lane, CI 1001 Augusta, Georgia 30912 Revised: February 2014 STATEMENT OF AUTHORITY Upon publication of these procedures, the Institutional Biosafety Committee (IBC) of the Georgia Regents University, is hereby authorized to act as agent for the Georgia Regents University in matters of review, control, and mediation arising from the use or proposed use of biological materials, including recombinant DNA, at the Georgia Regents University. A statement of composition of the Institutional Biosafety Committee and a delineation of authority is included in the following pages of this text. Furthermore, it is hereby declared that the Biological Safety Office of the Georgia Regents University derives its authority directly from the Office of the President of the Georgia Regents University in all matters involving biological safety and/or violations of accepted rules of practice as described herein. The Biosafety Officer is hereby granted the authority to immediately suspend a project which is found to be a threat to health, property, or the environment. ____________________________________ __________________ James J. Rush, Jr, Esq Date Chief Integrity Officer Georgia Regents University Georgia Regents University Biosafety Guide-January 2012 Statement of Authority TABLE OF CONTENTS List of Abbreviations .............................................................................. viii Forward .................................................................................................. x 1 Introduction ......................................................................................... 1.1 1.1 Emergency Phone Numbers and Office of Environmental Health and Safety Contacts ................... 1.1 1.2 Responsibilities ................................................................................................................................. 1-2 1.2.1 Department Chairperson and/or Center/Institute Director .............................................. 1-2 1.2.2 Principal Investigators, Clinical Directors and/or Instructional Course Directors .......... 1-2 1.2.3 Research and GRU Clinical Personnel ........................................................................... 1-5 1.2.4 Division of Environmental Health and Safety Biological Safety Office and Biosafety Officer ............................................................................................................................ 1-5 1.2.5 GRU Institutional Biosafety Committee......................................................................... 1-7 1.2.6 The Georgia Regents University (GRU) ........................................................................ 1-8 1.2.6.1 Other Offices at GRU .................................................................................. 1-9 1.2.6.1.1 Facilities Operation & Maiantenance ....................................... 1-9 1.2.6.1.2 The Institutional Animal Care and Use Committee (IACUC) and Division of Laboratory Animal Services (DLAS) ............. 1-9 1.2.6.1.3 The Institutional Review Boards (IRBs) and the GRU Office of Human Research Compliance (OHRP)................................ 1-10 1.2.6.1.4 Division of Sponsored Projects Administration (DSPA) ......... 1-11 1.2.6.1.5 Office of Institutional Audits and Compliance (OIAC) and the Compliance Oversight Council (COC) .................................... 1-11 1.2.6.1.6 Office of Technology Transfer and Economic Development (OTTED).................................................................................. 1-12 2 Biosafety Requirements ...................................................................... 2-1 2.1 Registration for the Use of Biological Materials ............................................................................... 2-1 2.1.1 Annual Affirmation of Biosafety Protocol Information ............................................... 2-2 2.1.2 Ammendments to Biosafety Protocols ....................................................................... 2-3 2.1.2.1 Adding New Personnel to or Removal of Personnel from a Biosafety Protocol ................................................................................................... 2-3 2.1.2.2 Amendments for New or Modified Biological Agents or Operations to a Biosafety Protocol ................................................................................... 2-4 2.1.2.3 Modifying the Locations or Equipment on a Biosafety Protocol ............. 2-4 2.1.2.4 Documenting New or Additional Project Titles Associated with a Biosafety Protocol (or Multiple Biosafety Protocols) .............................. 2-5 2.2 Training Requirements .................................................................................................................... 2-6 2.3 Laboratory Establishment, Close-outs and Moves ........................................................................ 2-8 2.3.1 Incoming New Faculty to GRU ................................................................................... 2-8 2.3.2 Laboratory Close-outs ................................................................................................. 2-9 2.3.3 Laboratory Moves ....................................................................................................... 2-10 2.4 Laboratory Record-keeping ............................................................................................................ 2-11 2.5 Paperwork Flow .............................................................................................................................. 2-11 2.5.1 IBC Review/Approval Process for Biosafety Protocols (BSPs) and Amendments ..... 2-12 2.5.2 Verification that IBC has Received and approved Experiments, Agents, and Uses that were Proposed in a Particular Sponsored Project, Clinical Protocol and/or Animal Use Protocol to Other GRU Compliance Offices. ............................................................. 2-14 Georgia Regents University Biosafety Guide January 2012 i 2.6 Biological Materials and Applications Which Must Be Documented on Biosafety Protocols ........ 2-17 2.6.1 Recombinant DNA Experiments ................................................................................. 2-17 2.6.1.1 Definition of Recombinant DNA ............................................................ 2-17 2.6.1.2 Definition of Exempt vs. Non-Exempt Recombinant DNA .................... 2-18 2.6.1.3 Recombinant DNA Registration Requirements ....................................... 2-21 2.6.1.4 Human Gene Transfer/Therapy (HGT) ................................................... 2-21 2.6.2 Human, Animal and/or Agricultural Pathogens and/or Toxins (or Materials Potentially Contaminated with these Pathogens or Toxins) ........................................ 2-22 2.6.2.1 Toxins of Biological Origin ..................................................................... 2-23 2.6.2.2 Select Agents and Toxins ........................................................................ 2-23 2.6.2.2.1 Exclusions from Select Agents and Toxins Regulations .......... 2-26 2.6.2.2.2 Exemptions from Select Agents and Toxins Regulations for Clinical/Diagnostic Laboratories ............................................. 2-27 2.6.2.2.3 Criteria for Handling Select Agent or Toxins Contaminated Specimens for Diagnosis or Verification under the SAT Exemption Clause .................................................................... 2-28 2.6.3 Human Blood, Body Fluids, Cells, Tissues and Other Potentially Infectious Material ....................................................................................................................... 2-29 2.6.3.1 Cultures of Cell Lines of Human and/or Primate Origin ......................... 2-31 2.6.3.1.1 Human Embryonic Stem (hES) Cells and Embryonic Germ Cell Lines ................................................................................ 2-32 2.6.4 Animals and the Use of Biological Materials in Animals ........................................... 2-33 2.6.5 Insects/Arthropods ...................................................................................................... 2-34 2.7 Experiments Prohibited at GRU ..................................................................................................... 2-34 3 Risk Assessment .................................................................................. 3-1 3.1 Risk Assessment and Management Table ......................................................................................... 3-2 3.2 Considerations in a Risk Assessement .............................................................................................. 3-3 3.2.1 Risk Groups: Hazardous Characteristics of a Biological Agent .................................... 3-3 3.2.2 Routes of Exposure ........................................................................................................ 3-4 3.2.3 Operations with may be associated with additional risk of exposure ............................. 3-7 3.2.3.1 Zoonotic Disease Risks/Animal Research Risks ........................................ 3-7 3.2.3.1.1 Non-Human Primates ................................................................ 3-7 3.2.3.1.1.1 Cercopithecine Herpes Virus (CHV-1); Herpes B virus .................................................................. 3-8 3.2.3.1.1.2 Other Viral Infections associated with NHPs ........ 3-9 3.2.3.1.1.3 Gastrointestinal Diseases associated with