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Biosafety Manual

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Biosafety Manual Biosafety Manual 2408 Wanda Daley Drive Ames, Iowa 50011-3602 (515) 294-5359 | www.ehs.iastate.edu Copyright © Reviewed 2021 Biosafety Manual 2 Biosafety Manual Directory of Service and Emergency Providers Services Environmental Health and Safety 2408 Wanda Daley Drive | (515) 294-5359 Iowa State University Occupational Medicine Department G11 Technical and Administrative Services Facility (TASF), 2408 Pammel Drive | (515) 294-2056 McFarland Clinic PC, Occupational Medicine 1018 Duff Avenue | (515) 239-4496 Thielen Student Health Center 2647 Union Drive | (515) 294-5801 Emergency Emergency - Ambulance, Fire, Police 911 Department of Public Safety / Iowa State University Police Armory, 2519 Osborn Drive | (515) 294-4428 Mary Greeley Medical Center 1111 Duff Avenue | (515) 239-2011 3 Biosafety Manual Table of Contents Directory of Service and Emergency Providers 3 A. Introduction 7 Definition of Biohazardous Materials 7 Purpose 7 Responsibilities 8 Iowa State University (ISU) 8 Environmental Health and Safety (EH&S) 8 Supervisors 8 Personnel 8 Institutional Biosafety Committee (IBC) 8 B. Recombinant or Synthetic Nucleic Acid Molecules, Human, Animal, and Plant Pathogens, Biological Toxins: Institutional Biosafety Committee (IBC) 10 C. Medical Survelliance 12 Workplace Exposure Assessment 12 Exposure Monitoring 12 Vaccinations and Testing 13 Exposure to Biohazardous Materials 13 Work-Related Injuries, Illnesses and Exposures 14 Reporting 14 D. Biosafety Practices and Procedures 16 Work Practices (First Line Of Defense) 16 Laboratory Biosafety Level Criteria 16 Biosafety Level 1 (BSL–1) Minimum Criteria 18 Biosafety Level 2 (BSL–2) Minimum Criteria 19 Biosafety Level 3 (BSL–3) Minimum Criteria 20 Biosafety Level 4 (BSL–4) 21 Laboratory Decommissioning 22 Training and Education 22 4 Biosafety Manual Signs and Labeling 23 Security 23 Personal Protective Equipment (PPE) 24 Laboratory Practice and Technique 26 Pipetting 27 Centrifugation 28 Using Needles, Syringes, and Other Sharps 28 Blending, Grinding, Sonicating, Lyophilizing, and Freezing 29 Open Flames 29 Flow Cytometry 30 Evaluating Laboratory Safety 30 Animal Handling 31 Animals on Campus 31 Animals in the Field 32 Arthropod Research 32 Arthropod Containment Levels 33 Cell and Tissue Culture 34 Safety Equipment (Primary Containment) 35 Biosafety Cabinets (BSC) 35 What is a Biosafety Cabinet? 35 When Must I Use a BSC? 36 Open Flames in a BSC 36 Decontamination and Ultraviolet Lights in a BSC 36 Annual Certification Testing 37 Moving or Repairs 37 Purchasing and Installing a New BSC 37 Facility Design (Secondary Containment) 38 E. Disposal and Disinfection of Biohazardous Materials 39 University Policies 39 Supplies 39 5 Biosafety Manual What If I Do Not Have Waste Handling Facilities? 39 Autoclaves 39 Elements Required for Effective Autoclave Use 39 Autoclave Safety 41 Pressure Vessel Monitoring 41 Chemical Disinfectants 42 Choosing a Chemical Disinfectant 42 Types of Chemical Disinfectants 43 Inactivation, Verification, and Biocontainment of Infectious Agents and Toxins 46 Prion Inactivation and Biocontainment Procedures 46 USDA Recommendations for Inactivation of Prions Affecting Livestock 46 BMBL Recommendations for Inactivation of Prions Affecting Humans 46 Precautions in Using NaOH or Sodium Hypochlorite Solutions in Autoclaves 47 Biocontainment and Working Procedures 47 F. Biohazard Spill Clean-up 48 Biohazard Spill Kit 48 Biohazard Spill Response Procedure 49 G. Transporting and Shipping Biohazardous Materials 51 On-Campus Transport of Biohazardous Materials 51 Off-Campus Transport of Biohazardous Materials by Commercial Carriers 51 Permit Requirements 52 Animals, Plants, Introduction of Genetically Modified Organisms 52 Human Pathogens or Biological Toxins 52 CDC Importation Permits for Etiologic Agents 52 Select Agents and Toxins 53 Packaging and Paperwork Requirements 54 Off-Campus Transport of Biohazardous Materials by Non-Commercial Routes 55 H. Biological Material Inventory and Biohazardous Materials Security 57 Bioinventory 57 Biosecurity 57 Non-discrimination6 Statement 58 Biosafety Manual A. Introduction Definition of Biohazardous Materials Biohazardous materials are those materials of biological origin that could potentially cause harm to humans, domestic, or wild animals, or plants. Examples include recombinant or synthetic nucleic acid molecules, transgenic animals or plants, human, animal, or plant pathogens, biological toxins (such as tetanus toxin), human blood, and certain human body fluids, and human or primate cell cultures. Purpose The purpose of the Iowa State University (ISU) Biosafety Program is to assist in protecting faculty, staff, and students; minimize exposure to biohazardous materials, prevent the release of biohazardous materials that may harm humans, animals, plants or the environment, and protect the integrity of experimental materials. To better fulfill these goals, biosafety staff members serve on the Institutional Biosafety Committee (IBC) and the Institutional Animal Care and Use Committee (IACUC), manage the Bloodborne Pathogen Exposure Control Plan, and conduct exposure assessments for the Occupational Medicine (Occ Med) program. Environmental Health and Safety (EH&S) biosafety staff also: • coordinate the certification of biosafety cabinets, • advise faculty, staff, and students who work with biohazardous materials about applicable regulatory guidelines, • assist researchers in determining appropriate practices and facilities for biocontainment and proper biohazardous waste disposal methods, • oversee proper disposal of biohazardous waste, • provide assistance with obtaining regulatory permits and shipping biohazardous materials, and • oversee the Select Agents and Toxins program. The Biosafety Manual outlines appropriate practices, university policies, and regulatory requirements for working safely with biohazardous materials. For a comprehensive overview of the core requirements that must be followed in all laboratories at ISU, please see the Laboratory Safety Manual. 7 Biosafety Manual Responsibilities Iowa State University (ISU) The president of Iowa State University is ultimately responsible for all environmental, health and safety issues. This responsibility is exercised through the normal lines of authority within the university by delegating the charge for ensuring safe work practices and adherence to established policies and guidelines to the senior vice president and provost, deans, directors, department chairs, principal investigators, supervisors, and, ultimately, each employee. Environmental Health and Safety (EH&S) EH&S is responsible for the development and oversight of proper management practices for all biohazardous materials at Iowa State University, including developing and implementing policies for ISU. EH&S is also responsible for ensuring that affected departments are aware of the university policies and regulatory guidelines regarding the proper use of biohazardous materials. Supervisors Principal Investigators (PIs), instructors, and supervisors are primarily responsible for ensuring that the policies and guidelines established in this manual are strictly followed by all personnel under their jurisdiction, including collaborating researchers. Personnel Individuals who work with biohazardous materials have a responsibility to follow the guidelines presented in this manual and to consult with their supervisors regarding the safe handling and proper disposal of specific biohazardous materials used in their work area. Individuals who are pregnant, immunocompromised, or have other health conditions are advised to consult the safety data sheets (SDS) for all hazardous chemicals, radioactive materials, and pathogenic organisms in their workplace environment in order to determine if any risks exist. They should also consult with their supervisor, Occupational Medicine, or their physician of choice concerning potential risks and how to manage those risks. Institutional Biosafety Committee (IBC) The IBC is appointed by the Office of the Vice President of Research and serves as the review committee in all matters involving recombinant or synthetic nucleic acid molecules studies, as required by the National Institutes of Health’s (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid 8 Biosafety Manual Molecules (NIH Guidelines). The IBC is responsible for reviewing the biological safety and public health programs at ISU, including: • any use of human, animal, or plant pathogens or biological toxins, • administration of experimental biological products (vaccines, sera, etc.) to animals, and • field releases of plant pests or genetically engineered organisms. The IBC also makes policy recommendations to the Office of the Vice President for Research to ensure compliance with federal, state and local regulations and guidelines. The IBC has the authority to require operational changes to ensure compliance with required conditions. 9 Biosafety Manual B. Recombinant or Synthetic Nucleic Acid Molecules, Human, Animal, and Plant Pathogens, Biological Toxins: Institutional Biosafety Committee (IBC) The Institutional Biosafety Committee (IBC) must approve any teaching or research project that involves: • Recombinant or synthetic nucleic acid molecules, including transgenic animals or plants. • Human, animal, or plant pathogens (such as bacteria, viruses, fungi, prions, or parasites). • Toxins of biological origin (such as tetanus toxin or aflatoxin). • Administration of experimental biological products
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