Transcript Chapter 4

Biorisk
An Engineering Safety Module
Prepared by Valentin Malenkov
Reviewed by Prof. Marc Aucoin
Sponsored by: MINERVA
(www.safetymanagementeducation.com/)
and MITACS
Chapter 4: Risk Assessments, Risk
Groups, and Containment Levels
(CLs)
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Course Outline
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Chapter 1: Introduction to Biorisk
Chapter 2: Microorganisms, Pathogens, and
Toxins
Chapter 3: Regulation of Biohazardous
Materials and Risk Management Systems
Chapter 4: Risk Assessments, Risk
Groups, and Containment Levels
Chapter 5:Biohazardous Material
Containment
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Learning Objectives
1. Understand the purpose and steps
involved in different types of risk
assessments
2. Learn the factors which dictate the
Risk Group of a micro-organism
3. Understand how Risk Group relates to
CL required for it
4. Summarize the characteristics of
facilities at each CL
5. Introduce PPE and protocols required
at each Containment Level
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Chapter 4: Risk Assessments, Risk Groups, and CLs
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Risk Assessments
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Risk Assessment Goal/Purpose
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“Risk Assessments are the basis of all of the
components of a biosafety program;...”
Canadian Biosafety Standards and Guidelines, pg 136
 Extent dependant on scope
 “Overarching”
 Multiple organisms, protocols, laboratories
 Involves most facility staff
 “Local”
 Laboratory/protocol-specific
 Less involved, more specific
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Risk Assessment Goal/Purpose (cont’d)
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 Determine requirements for biosafety
 Equipment, containment, SOPs
 BSO-driven
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Other stakeholders involved (Laboratory Staff,
Management, Engineers, Health & Safety, etc)
 Risk mitigation
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Elimination/substitution
Engineering Controls
Administrative controls
PPE
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Pathogen Risk Assessments
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 One for every pathogen used
 Conducted before it is brought in
 Determines Risk Group
 Required by law based on main host/target
(CBSG)
 Covers all aspects of use
 Storage, containment, handling PPE
 SOPs for entire lifecycle
 Pathogen Safety Data Sheet (PSDS)
created
 Pathogenicity, route of infection, infectious
dose, survival in the environment
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Genetically Modified Organisms
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 Risk can increase or decrease
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Depends on transformation and gene(s) affected
Original organism and source of genes considered first
 Reassessment of risk required with alteration of:
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Pathogenicity/virulence
Pharmacological activity (resistance)
Genes related to hazardous properties
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Production of toxins, oncogenes
Survivability outside containment zone
Ability to replicate
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Attenuation
Change in host range
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Genetically Modified Organisms
 Factors to consider in GMO risk
assessments
 Containment level of organisms
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Gene recipient and gene donor
 Replication competency
 Potential pathogenic factors of genetic info
 Possible novel hazards
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Behaviour of donor genetic info in recipient
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Viral Vectors
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 Engineered viruses
 Can create GMOs
 Transient or permanent gene modification
 Considerations similar to GMO
 “Safety features” included in design
 Reduced risk
 Replication deficiency
 Additional risk from retroviral vectors
 Modify host DNA permanently
 Potential for oncogenesis (mutation causing
cancer)
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Synthetic Biology
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 Genes/sequences created synthetically
 Not found in nature
 More novel approach
 Risk difficult to assess
 Effects not always predictable
 Careful assessment and testing required
 Interaction with existing genes/gene
products
 Unexpected risks
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Infectious RNA
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 RNA infection causing production of whole
virus
 Positive-sense RNA required
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Can be translated into protein
 Ex: Polio, West Nile, Dengue Viruses
 Reduced routes of infection
 Not found in nature
 No natural delivery methods
 Can carry increased risks
 RNA more stable than proteins
 Unaffected by virus-targeting antibodies
 Increased host range
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Toxin Risk Assessment
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 Not infectious material or toxic chemical
 Separate risk assessment required
 Common regulated toxins listed in HPTA
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Schedule 1 and Part I of Schedule 5
 Considerations
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Toxicity (lethal dose and/or effective dose)
Risk and routes of exposure
Concentration and amount used
Rate of action
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Neurotoxins effective in minutes/hours
Cytotoxins effective in hours/days
 Availability of treatment
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Biosecurity Risk Assessment
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 Can be incorporated into overarching
Biological Risk Assessment
 Preliminary for biosecurity plan
 Steps to the assessment:
1. Identify and prioritize assets
2. Define threats
3. Determine risks and mitigation strategies
 Covers information as well as biological
materials
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Chapter 4: Risk Assessments, Risk Groups, and CLs
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Microorganism Risk Groups
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Pathogen Risk Groups
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 Applied to pathogens based on risk
assessment
 Applies to microorganisms, nucleic acid, or
protein
 Risk dictated by circumstances (can change)
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Strain virulence
Genetic modification
Inactivation
 Apply higher group when in doubt
 Dictate level of regulation and containment
 Pathogens listed by risk group
 Schedules 2-4 of Human Pathogens and Toxins
Act (HPTA)
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Risk Group 1
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 Low individual and community risk
 Incapable/unlikely to cause disease in
humans
 May cause opportunistic infections
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Immunocompromised individuals
 No special regulation of containment
 Good micro-biological practises
recommended
 Not listed in HPTA
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Risk Group 2
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 Moderate individual risk
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Can cause disease in exposed humans/animals
Disease unlikely or not serious
 Low community risk
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Low transmission potential
Effective treatment available
 Regulated containment and handling
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Applies to all higher Risk Groups as well
 Ex: Avian Influenza, Cowpox Virus, Hepatitis A
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Risk Group 3
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 High individual risk
 Cause serious disease on exposure
 Low community risk
 Low human transmission risk
 Low to high livestock/poultry risk
 Effective treatment available
 Highly regulated containment/handling
 Ex: Chlamydia, Influenza A H2N2,
Rabies
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Risk Group 4
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 High individual risk, high community risk
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Lack of effective treatment
High risk of human transmission
Low to high risk of livestock transmission
Usually causes deadly disease
 Highly regulated containment and
handling
 Many prohibited except by special permits
 All listed pathogens are viruses
 Ex: Ebola, Herpes B Virus, Marburg Virus
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Chapter 4: Risk Assessments, Risk Groups, and CLs
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Facility Containment Levels
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Facility Containment Levels (CLs)
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 Set minimum containment
requirements
 Physical containment and practises
 Determined alongside Risk Groups in
risk assessment
 Usually same levels
 More based on usage/protocols
 Can change with modification/mitigation
 Inactivation
 Non-infectious strains
 Vaccination
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Factors Affecting CLs
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 Aerosol generation
 Liquid particulate transmission
 Pipetting, centrifugation, mixing, etc.
 Quantity of material
 Scale of work conducted
 State of storage/use
 Concentration of material
 Risk increases with concentration
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Factors Affecting CLs (cont’d)
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 Type of work (usage)
 In vitro vs in vivo
 Protocols heightening risk
 Use of sharps/needles
 Dangerous animals used
 Animal shedding of pathogen
 Replication of pathogen in live animals
 Increased threat of containment breech
 Pathogen in waste and bodily fluid
 Animal containment breech (escape or loss)
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Containment Regulations
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 Regulations for CL2 and above
 PHAC and CFIA regulations
 Specific requirements in CBSG
 Requirements in Chapter 3 (all levels)
 Representative diagrams in Appendix A
 Administrative Requirements
 Biosafety Management, Medical
Surveillance, and Training Programs
 Decontamination and waste management
 Emergency response plan
 Certification and Performance testing
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Containment Regulations (cont’d)
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 Physical requirements
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Structure and location
Containment barriers
Access
Surface finishes and casework
Air handling
Essential equipment
Effluent treatment
 Certification standards must be met
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Containment Level 1
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 Sets baseline for biological safety
 Basic laboratory containment
 Higher levels add to CL1 requirements
 Unregulated Risk Group 1 Pathogens
only
 Low risks for any kind of infection/disease
 Standards not listed in CBSG
 Requirements set by risk assessment and
policy
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Containment Level 1 (cont’d)
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 Recommended elements (CBSG):
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Good microbiology practises
Cleanable and functional space
Proper cleaning/decontamination
Good hygienic practises
 Required hand washing, no food or drink,
no makeup application
 Appropriate PPE available and used
 Gloves, lab coats, closed foot-wear
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Containment Level 2
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 Pathogens of Risk Group 2 or less
handled
 No mitigating circumstances
 animal shedding, high volumes
 Airborne transmission not likely
 Assumes immuno-competent personnel
 Standards mitigating personal risk
 Low risk to general population
 Aerosol generation
 Biological safety cabinets
 Respirators in high-risk work
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Containment Level 3
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 Pathogens of Risk Group 3 or less handled
 Airborne transmission likely
 Serious/lethal disease if infected
 Increased threat with animal work and
aerosols
 Higher standards for personal protection
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Gowning/degowning procedures
Immunization
Respirator fit testing
All personnel trained/equipped with PPE
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Janitorial staff, engineering, etc
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Containment Level 3 (cont’d)
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 Additional facility design and engineering
controls
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HEPA filtration on all exhaust air
Negative pressure air handling with alarms
Separate gowning areas
Full decontamination possible
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Air handling, ceilings, etc
 Additional commissioning and certification
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Full commissioning/inspection before starting
Annual re-certification
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Containment Level 4
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 Pathogens of Risk Group 4 can be handled
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Serious/lethal disease on infection
Effective treatment unavailable
Airborne transmission
 Further engineering controls (addition to CL3)
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Two-stage HEPA filters on exhaust air
Structurally indep. labs
Additional access control
Containment zone storage for pathogens
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Chapter 4: Risk Assessments, Risk Groups, and CLs
Containment Level 4 (cont’d)
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 Extensive PPE requirements
 Positive pressure suits required
 Decontamination prior to de-gowning
 Emergency response considerations
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Positive pressure suit dysfunction
Emergency services access/PPE
 Federally controlled research facilities
 Only 1 facility in Canada
 Highest possible security
Biorisk
An Engineering Safety Module
Prepared by Valentin Malenkov
Reviewed by Prof. Marc Aucoin
Sponsored by: MINERVA
(www.safetymanagementeducation.com/)
and MITACS
Chapter 4: Quiz
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Chapter 4: Risk Assessments, Risk Groups, and CLs
True or False: Risk Assessments are something the BSO conducts on their
own, and other personnel must follow.
A facility rated for CL2 work is in operation and a new research project calls
for a new Risk Group 2 pathogen to be brought in. Is a local or overarching
risk assessment at the facility required based on the situation described.
Explain why.
A facility rated for CL1 work is in operation and a new research project calls
for a new Risk Group 2 pathogen to be brought in. Is a local or overarching
risk assessment at the facility required based on the situation described.
Explain why.
A pathogen is being removed from storage which you’re never worked with.
Where can you find information to work with it safely?
An infectious material is being assessed and found to be infective only by
direct contact. Unfortunately, it also bypasses viral antibodies making it more
dangerous to work with. What is this material?
A risk assessment for a new pathogen. This pathogen is genetically
engineered and is being used to deliver genes into host cells. It has been
designed to not replicate in regular animal cells. What type of pathogen is
this?
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Chapter 4: Risk Assessments, Risk Groups, and CLs
You are interested in research involving a particular human pathogen.
Where is the first place to look to determine its Risk Group?
A human pathogen causes severe illness and is transmitted only by the
fecal-oral route. What is its most likely Risk Group?
What are the five factors affecting the required CL at a facility which
were listed?
True or False: The CL will always match up with the highest Risk Group
which is present at the facility.
A facility is equipped with a few Biosafety Cabinets in which aerosolproducing work is done. However, no biosafety officer is assigned and
no pathogens are of Risk Group above 1. What CL is the facility?
At which CL does the facility house pathogens dangerous to the general
population?