module #1 fundamental principles of biosaf ety and ...€¦ · fundamental principles of biosaf ety...

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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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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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



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

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MODULE 1 | SELECT AGENTS


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



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 StandardsGuide to the Care and use of Experimental AnimalsGuidelines on Laboratory Animal FacilitiesGuidelines on the Care and Use of Farm AnimalsGuidelines on the Care and Use of Fish in Research

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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

Risk Group 1

Risk Group 2

Risk Group 3

Risk Group 4

Bacteria

B Anthracis

Brucellosis

Botulinium

F. Tularensis

Y. Pestis

Viral

H2N1

H5N1

West Nile

New Castle

BSE

Lethal Human Disease

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 Hand-Washing; Eyewash Station

Autoclave Available in facility

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

MODULE 1 | BSL-3 LABORATORY

Primary Containment –Class II or III BSC Required

Access to Lab through Two Self-Closing and LockingDoors

Handwashing Sink in Each Zone

Surfaces must be Easily Cleaned and Decontaminated

BSL-2 Secondary Barrier Requirements, Plus:

Visual Directional Airflow Indicator

Validated Decontamination

Means in Lab

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

Inward Directional Airflow!

Access to Lab through Two Self-

Closing Doors

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MODULE 1 | POSSIBLE BSL-3 ENHANCEMENTS

HEPA Exhaust Filtration; Based on Risk Assessment

Liquid Effluent Decontamination; Based on Risk Assessment

Reference: BMBL 5th ed. Appendix D

BSL-3 Secondary Barrier Requirements, Plus:

MODULE 1 | BSL-3 POSSIBLE ENHANCEMENTS

Personnel Shower-Out;

Based on Risk Assessment


Liquid Effluent Decontamination; Based on Risk Assessment


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MODULE 1 | ABSL-3

BSC for Manipulation of

Infectious Material Required

Visual Directional Airflow Indicator

Autoclave “Convenient” to Animal Rooms

Ventilation Provided in Accordance with “The Guide”

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



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MODULE 1 | ABSL-3 (Ag)

Tandem HEPA Exhaust Filtration in Series Required

Liquid Effluent Decontamination

Required

Supply Side HEPA Filtration Required

Shower-Out Required; May be Required to be Contiguous

with Lab

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

MODULE 1 | ABSL-3 (Ag)

Tandem HEPA Exhaust Filtration in Series Required

Liquid Effluent Decontamination

Required

Supply Side HEPA Filtration Required

Room is Primary Containment –

Pressure Decay Tested Envelope

Air Pressure Resistant Doors on

Primary Containment Room(s)

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

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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

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mRequired by BMBL 5th ed.

Recommended

By Risk Assessment

MODULE 1 | BIO-RISK ASSESSMENT

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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)


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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Assessment Process

• Agent Characteristics

• Personnel

• Nature of Experiment

• Nature of Environment

• Equipment (or Process)


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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Personnel:

• Level of Training and Experience

• Competency Level and Demonstration of Diligence

• Use of Personal Protective Equipment

• Allergies

• Availability of Prophylaxis and First Aid


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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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


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

DESIGN TEAM

CONTRACTOR

I. ENGINEERS I. ARCHITECTS

PM

HUSBANDRY VET TECHS MAINTENANCE STAFF

OWNER

PI

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

DESIGN TEAM

CONTRACTOR

I. ENGINEERSI. ARCHITECTS

HUSBANDRY

VET TECHS

MAINTENANCE

STAFF

OWNERPM

PI

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]

Date:

Session:

Presenters:

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module #1 fundamental principles of biosaf ety and ...€¦ · fundamental principles of biosaf ety...

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