MODULE #1 FUNDAMENTAL PRINCIPLES OF BIOSAFETY AND BIOCONTAINMENT PROJECTS JEFFREY R. ZYNDA, ASSOC. AIA | SCIENCE PRACTICE LEADER & ASSOCIATE PRINCIPAL, PAYETTE 290 Congress Street, Fifth Floor, Boston, MA 02210 (T) 617-895-1236 (F) 617-895-1002 [email protected] MODULE 1 | AGENDA • Levels of Containment • Regulatory Requirements • Biological Risk Assessment • Primary vs. Secondary Containment • Project Team / Management • Project Planning OVERVIEW | WHY? 90 mph, 12’-0” dispersion, ~ 5,000 droplets, ~ 10,000 bacteria = 1 sneeze 1 MODULE 1 | REGULATORY BODIES MODULE 1 | REGULATIONS AND STANDARDS Standards, Regulations and nearly so… Biosafety in Microbiological and Biomedical Laboratories – 5th ed. (NIH/CDC 2009) Joint Centers for Disease Control / National Institutes of Health (CDC/NIH) Publication Laboratory Biosafety Manual – 3rd ed. – World Health Organization (WHO: 2004) Adopted by Many EU Countries Laboratory Biosafety Guidelines – 3rd ed. – Public Health Agency Canada (PHAC) 2 MODULE 1 | REGULATIONS AND STANDARDS Standards, Regulations and nearly so… USDA Agricultural Research Service (ARS) – 242.1 – Facilities Design Standards ABSL-3 (Ag) Requirements National Institutes of Health (NIH) – Design Requirements Manual Applies to Intra/Extramural NIH Funded Construction Projects MODULE 1 | REGULATIONS AND STANDARDS Standards, Regulations and nearly so… American National Standard Z9.14 - Testing and Performance Verification Methodologies for Ventilation Systems for Biological Safety Level 3 (BSL- 3) and Animal Biosafety Level 3 (ABSL-3) Facilities 3 MODULE 1 | SELECT AGENTS Standards, Regulations and nearly so… Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Subtitle A of Public Law 107–188 (42 U.S.C. 262a) (the Bioterrorism Preparedness Act): “Individuals possessing, using, or transferring agents or toxins deemed a severe threat to public, animal or plant health, or to animal or plant products notify either the Secretary of the Department of Health and Human Services (HHS) or the Secretary of the Department of Agriculture (USDA). In accordance with the Act, implementing regulations detailing the requirements for possession, use, and transfer for select agents and toxins were published by HHS: 7 CFR part 331 9 CFR part 121 42 CFR part 73 www.selectagents.gov This legislation effectively makes the BMBL 5th ed. law by reference MODULE 1 | REGULATIONS AND STANDARDS Standards, Regulations and nearly so… 7 USC 2131-2159 The AWA requires that minimum standards of care and treatment be provided for certain animals bred for commercial sale, used in research, transported commercially, or exhibited to the public. ETS 123 (Amended ETS 170) 1986 – “European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes” – Directive 8869 / 10 – NHP Use CCAC – Canadian Council on Animal Care Standards Guide to the Care and use of Experimental Animals Guidelines on Laboratory Animal Facilities Guidelines on the Care and Use of Farm Animals Guidelines on the Care and Use of Fish in Research 4 MODULE 1 | REGULATIONS AND STANDARDS Standards, Regulations and nearly so… The Guide for the Care and Use of Laboratory Animals 8th Ed. (ILAR 2010) Primary Containment for Biohazards: Installation and Use of Biosafety Cabinets 3rd ed. (CDC/NIH: 2009) Arthropod Containment Guideline ver 3.1 (The American Committee of Medical Entomology of the American Society of Tropical Medicine and Hygiene) MODULE 1 | LEVELS OF (BIO)CONTAINMENT Biosafety Level One (BSL-1) Agents not know to consistently cause diseases in healthy adults Biosafety Level Two (BSL-2) Agents associated with human disease; routes of transmission include percutaneous injury, ingestion, mucous membrane exposure Biosafety Level Three (BSL-3) Indigenous or exotic agents that may cause serious or potentially lethal disease through the inhalation route of exposure Biosafety Level Four (BSL-4) Dangerous / exotic agents which pose high risk of life threatening disease; aerosol-transmitted laboratory infections have occurred or related agents with unknown risk of transmission. 5 MODULE 1 | LEVELS OF (BIO)CONTAINMENT Biosafety Level One (BSL-1) Agents not known to consistently cause diseases in healthy adults Biosafety Level Two (BSL-2) Agents associated with human disease; routes of transmission include percutaneous injury, ingestion, mucous membrane exposure Biosafety Level Three (BSL-3) Indigenous or exotic agents that may cause serious or potentially lethal disease through the inhalation route of exposure Biosafety Level Four (BSL-4) Dangerous / exotic agents which pose high risk of life threatening disease; aerosol-transmitted laboratory infections have occurred or related agents with unknown risk of transmission. MODULE 1 | LEVEL THREE AGENTS Bacteria Risk B Anthracis Group 1 Brucellosis Botulinium F. Tularensis Risk Y. P e s t i s Group 2 Viral Lethal Human Disease H2N1 Risk H5N1 Preventatives may be Available Group 3 West Nile New Castle High Individual Risk BSE Low Community Risk Risk Group 4 Other Fungal Parasitic Prious 6 MODULE 1 | PRIMARY VS. SECONDARY CONTAINMENT Primary Barriers vs. Secondary Barriers MODULE 1 | PRIMARY VS. SECONDARY CONTAINMENT Laboratory is SECONDARY 7 MODULE 1 | BSL-2 Primary Containment – Class I or II BSC BSC Located Away from Doors and Airflow Disruptions Self-Closing and Locking Door Sink for Hand- Washing; Eyewash Station Autoclave Available in facility Reference: BMBL 5th ed. Section V – Laboratory Biosafety Level Criteria MODULE 1 | BSL-3 LABORATORY BSL-2 Secondary Barrier Primary Requirements, Plus: Containment – Class II or III BSC Required Validated Access to Lab Decontamination through Two Self- Means in Lab Closing and Locking Doors Access to Lab Visual Directional through Two Self- Airflow Indicator Closing Doors Surfaces must be Easily Cleaned and Inward Directional Decontaminated Airflow! Handwashing Sink in Each Zone Reference: BMBL 5th ed. Section V – Laboratory Biosafety Level Criteria 8 MODULE 1 | POSSIBLE BSL-3 ENHANCEMENTS BSL-3 Secondary Barrier Requirements, Plus: HEPA Exhaust Filtration; Based on Risk Assessment Liquid Effluent Decontamination; Based on Risk Assessment Reference: BMBL 5th ed. Appendix D MODULE 1 | BSL-3 POSSIBLE ENHANCEMENTS Personnel Shower-Out; Based on Risk Assessment HEPA Exhaust Filtration; Based on Risk Assessment Liquid Effluent Decontamination; Based on Risk Assessment Reference: BMBL 5th ed. Appendix D 9 MODULE 1 | ABSL-3 BSC for Manipulation of Infectious Material Required Ventilation Provided in Accordance with “The Guide” Visual Directional Airflow Indicator Autoclave “Convenient” to Animal Rooms Reference: BMBL 5th ed. Section V – Vertebrate Animal Biosafety Level Criteria for Vivarium Research Facilities MODULE 1 | ABSL-3 POSSIBLE ENHANCEMENTS Personnel Shower-Out; Based on Risk Assessment HEPA Exhaust Filtration; Based on Risk Assessment Reference: BMBL 5th ed. Appendix D 10 MODULE 1 | ABSL-3 (Ag) Supply Side HEPA Filtration Required Tandem HEPA Exhaust Filtration in Series Required Shower-Out Required; May be Required to be Contiguous with Lab Liquid Effluent Decontamination Required Reference: ARS 242.1-M Chapter 9 – Biohazard Containment Design MODULE 1 | ABSL-3 (Ag) Supply Side HEPA Filtration Required Tandem HEPA Exhaust Filtration in Series Required Room is Primary Containment – Pressure Decay Tested Envelope Air Pressure Resistant Doors on Primary Containment Liquid Effluent Room(s) Decontamination Required Reference: ARS 242.1-M Chapter 9 – Biohazard Containment Design 11 BSL-4 Lab & Animal BSL-4 Lab & BSL-3 AG Lab & Animal (A)BSL-3 BSL-3 (Enhanced) BSL-3 Laboratory BSL-2 Laboratory MODULE 1 MODULE 1 | MODULE 1 Required by BMBL 5 Required by BMBL By Risk Assessment Assessment Risk By Recommended | BIO-RISK ASSESSM BIO-RISK | BIOSAFETY LEVEL RE LEVEL BIOSAFETY th ed. Directional Airflow ENT Double Door Entry QUIREMENT MATRIX QUIREMENT Class I,II BSC` Class III BSC Autoclave Available Pass-through Autoclave Seamless Floors Constructed for Decon Monolithic Ceilings HEPA Filtered Exhaust HEPA Filtered Supply Supply/Exhaust Interlock Redundant Supply Fans Redundant Exhaust Fans Personnel Shower Airlock Entry Pressure Differential HEPA Plumbing Vents Effluent Decontamination Pressure Decay Testing Breathing Air System 12 MODULE 1 | BIO-RISK ASSESSMENT Risk Criteria 1. Infectivity 2. Severity of Disease 3. Transmissibility 4. Nature of Work being Conducted Based on the methodology followed by Public Health Agency Canada and Canadian Food Inspection Agency • PSDS (Pathogen Safety Data Sheets) MODULE 1 | BIO-RISK ASSESSMENT Risk Criteria 1. Infectivity 2. Severity of Disease 3. Transmissibility 4. Nature of Work being Conducted Based on the methodology followed by Public Health Agency Canada and Canadian Food Inspection Agency • PSDS (Pathogen Safety Data Sheets) 13 MODULE 1 | BIO-RISK ASSESSMENT Assessment Process • Agent Characteristics • Personnel • Nature of Experiment • Nature of Environment • Equipment (or Process) MODULE 1 | BIO-RISK ASSESSMENT Agent Characteristics • Pathgenicity / Virulence • Transmissibility • Edemicity • Recombinants • Infectious Dose • Environmental Stability • Economic Considerations (Impact) • Availability of Prophylaxis • Mode of Transmission • Host Range •Vectors 14 MODULE 1 | BIO-RISK ASSESSMENT Personnel: • Level of Training and Experience • Competency Level and Demonstration of Diligence • Use of Personal Protective Equipment • Allergies • Availability of Prophylaxis and First Aid MODULE 1 | BIO-RISK