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 MODULE 1 | BIOSAFETY LEVEL REQUIREMENT MATRIX
Required by BMBL 5th ed. Recommended By Risk Assessment Directional Airflow Double Door Entry Class I,II BSC` Class III BSC Autoclave Available Pass-through Autoclave Seamless Floors Constructed for Decon Monolithic Ceilings Filtered Exhaust HEPA Filtered Supply HEPA Interlock Supply/Exhaust Fans Redundant Supply Fans Redundant Exhaust Personnel Shower Airlock Entry Pressure Differential Vents Plumbing HEPA Decontamination Effluent Testing Decay Pressure Breathing Air System BSL-2 Laboratory BSL-3 Laboratory BSL-3 (Enhanced) (A)BSL-3 BSL-3 AG Lab & Animal BSL-4 Lab & Animal
MODULE 1 | BIO-RISK ASSESSMENT
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 ASSESSMENT
Nature of Experiment
• Aerosol Generating Activities • Potential Self-Inoculation • Concentration of samples • Nature of Sample (Clinical, Pure Culture, Previously Manipulated) • Volume of Pathogen • Animal Use • Cell Line Characteristics • Toxin Production •Vector Use • Contingency Plan (Exposure, Release, Equipment Failure) • Techniques • Decontamination Procedures
15 MODULE 1 | BIO-RISK ASSESSMENT
Nature of Environment
• Level of Containment • Factors Affecting Containment • Impact of External Activities • Biosecurity • Lab Facility Conditions • Availability and Statues of Emergency Support • Housekeeping and Maintenance • Public Access
MODULE 1 | BIO-RISK ASSESSMENT
Equipment
• Maintenance • Periodic Decontamination • Training and Correct Operation • Equipment Specific Hazards • Standard Operating Procedures • Ventilation Considerations • Location within Lab
16 MODULE 1 | TEAM
MODULE 1 | TEAM
Scope of Work?
• Programming? • Design? • Master Planning? • Risk / Hazard Analysis? • Scientific Need Determination? • Equipment Selection, Coordination? • Threat / Risk & Vulnerability, Analysis? • Cost Estimation? • Environmental Impact Analysis? • Regulatory Agency Liaison? • Overall Project Management?
17 MODULE 1 | TEAM
Professional Team:
• Programmer •Architect • Engineers • Mechanical, Electrical, Plumbing, Low-Voltage, Structural • Cost / Quantity Surveyor • Specialty Consultants: • Industrial Hygienists • Vibration / Acoustic • Wind / Wake
MODULE 1 | TEAM
Stakeholders • End-Users: Facility Director(s) Principal Investigator(s) Technicians / Staff Animal Health and Welfare
• Facilities Maintenance • Environmental Health / Safety • First Responders • Security / Law Enforcement • Risk Management • Legal Department • Constructor • Commissioning Agent(s)
18 MODULE 1 | TYPICAL APPROACH
OWNER PM
I. ENGINEERS I. ARCHITECTS
DESIGN TEAM
PI
CONTRACTOR HUSBANDRY VET TECHS MAINTENANCE STAFF
MODULE 1 | TEAM
Stakeholders • End-Users: Facility Director(s) Principal Investigator(s) Technicians / Staff Animal Health and Welfare
• Facilities Maintenance • Environmental Health / Safety • First Responders • Security / Law Enforcement • Risk Management • Legal Department • Constructor • Commissioning Agent(s)
19 TEAM | STAKEHOLDER APPROACH PI
I. ARCHITECTS I. ENGINEERS
PM OWNER DESIGN TEAM
STAFF CONTRACTOR
HUSBANDRY MAINTENANCE
VET TECHS
MODULE 1 | TEAM
Perseverance with the stakeholder team will ultimately lead to success!
20 MODULE 1 | TRADITIONAL LAB PROJECT
MODULE 1 | BIOCONTAINMENT PROJECT
21 MODULE 1 | EFFECTIVE IMPACT
MODULE 1 | EFFECTIVE IMPACT
22 MODULE 1 | PROCESS IMPACT
MODULE 1 | PROCESS IMPACT
Cost Impacts due to Enhanced Effort: Design Fees Typical Micro-Bio Laboratory = 5-7% Biocontainment Laboratory = 10-30% = 100-300% Increased Cost Construction Fees Typical Lab – 1.5-4% Biocontainment – 2-10%
Containment Projects Average 60-75% Increase in Project Time Commitment
23 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]
24 Date: Metrics Tools Session: Resources
Presenters: Innovative Ideas Proofs
Date: Metrics Tools Session: Resources
Presenters: Innovative Ideas Proofs
Date: Metrics Tools Session: Resources
Presenters: Innovative Ideas Proofs
Date: Metrics Tools Session: Resources
Presenters: Innovative Ideas Proofs