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

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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)

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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 (BSL3) and Animal Biosafety Level 3 (ABSL-3) Facilities

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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

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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.

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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 Group 1

B Anthracis Brucellosis Botulinium F. Tularensis

Risk Group 2

Y. Pestis

Viral

Lethal Human Disease

H2N1

Risk Group 3

H5N1 West Nile New Castle BSE

Risk Group 4

Preventatives may be Available High Individual Risk Low Community Risk

Other Fungal Parasitic Prious

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MODULE 1 | PRIMARY VS. SECONDARY CONTAINMENT

Primary Barriers

vs.

Secondary Barriers

MODULE 1 | PRIMARY VS. SECONDARY CONTAINMENT

Laboratory is SECONDARY

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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 HandWashing; 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 Requirements, Plus:

Validated Decontamination Means in Lab Access to Lab through Two SelfClosing Doors Inward Directional Airflow!

Primary Containment – Class II or III BSC Required Access to Lab through Two SelfClosing and Locking Doors Visual Directional Airflow Indicator Surfaces must be Easily Cleaned and Decontaminated Handwashing Sink in Each Zone

Reference: BMBL 5th ed. Section V – Laboratory Biosafety Level Criteria

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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

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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

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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 Room(s)

Liquid Effluent Decontamination Required

Reference: ARS 242.1-M Chapter 9 – Biohazard Containment Design

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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 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

MODULE 1 | BIOSAFETY LEVEL REQUIREMENT MATRIX

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

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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)

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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

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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

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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

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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?

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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)

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MODULE 1 | TYPICAL APPROACH OWNER

PM

I. ARCHITECTS

I. ENGINEERS

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)

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TEAM | STAKEHOLDER APPROACH PI

I. ARCHITECTS

I. ENGINEERS PM

OWNER

DESIGN TEAM

STAFF CONTRACTOR

MAINTENANCE

HUSBANDRY VET TECHS

MODULE 1 | TEAM

Perseverance with the stakeholder team will ultimately lead to success!

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MODULE 1 | TRADITIONAL LAB PROJECT

MODULE 1 | BIOCONTAINMENT PROJECT

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MODULE 1 | EFFECTIVE IMPACT

MODULE 1 | EFFECTIVE IMPACT

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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

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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]

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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