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
Other stakeholders involved (Laboratory Staff,
Management, Engineers, Health & Safety, etc)
Risk mitigation
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
Depends on transformation and gene(s) affected
Original organism and source of genes considered first
Reassessment of risk required with alteration of:
Pathogenicity/virulence
Pharmacological activity (resistance)
Genes related to hazardous properties
Production of toxins, oncogenes
Survivability outside containment zone
Ability to replicate
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
Gene recipient and gene donor
Replication competency
Potential pathogenic factors of genetic info
Possible novel hazards
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
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
Schedule 1 and Part I of Schedule 5
Considerations
Toxicity (lethal dose and/or effective dose)
Risk and routes of exposure
Concentration and amount used
Rate of action
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)
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
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
Can cause disease in exposed humans/animals
Disease unlikely or not serious
Low community risk
Low transmission potential
Effective treatment available
Regulated containment and handling
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
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
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):
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
Gowning/degowning procedures
Immunization
Respirator fit testing
All personnel trained/equipped with PPE
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
HEPA filtration on all exhaust air
Negative pressure air handling with alarms
Separate gowning areas
Full decontamination possible
Air handling, ceilings, etc
Additional commissioning and certification
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
Serious/lethal disease on infection
Effective treatment unavailable
Airborne transmission
Further engineering controls (addition to CL3)
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
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?