Biological Risk Assessment

MODULE OBJECTIVES
• Using lectures and group exercises, develop capabilities for conducting
and challenging biological risk assessment

• Learning objectives
• Understand the importance, purpose and rationale of biological risk assessment
• Understand the methodology of biological risk assessment
• Be able to conduct a basic risk assessment of biological activities
• Be able to evaluate, challenge and discuss the results of a biorisk assessment
 WHY A BIOLOGICAL RISK
• Biological activities are diverse ASSESSMENT?
• Use of a variety of biological agents and materials (incl. GMOs)
• Various disciplines of the life science sector (microbiology, molecular biology…)
• Various types of activities (diagnostic, R&D, production..)
• Multiple (and complex) laboratory activities and protocols
• Variety of infrastructure and equipment
• Diversity of contexts and operational means…

• The nature and level of risk may differ considerably

? • The protective measures need to be adapted to the activity

and to the nature and level of risk
 DIVERSITY OF BIOLOGICAL AGENTS

• Huge diversity in types of organisms (bacteria, virus, fungi…) and morphology

but also in characteristics such as

• Biological mechanisms
• Survival strategies and transmission modes
• Host ranges and environmental preferences
• Resistance mechanisms and sensibility to physical and chemical agents…
DIVERSITY AND COMPLEXITY OF BIOLOGICAL
ACTIVITIES
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 DIVERSITY OF BIOLOGICAL
ACTIVITIES

μl to ml scale

50 too 5000 l scale

 WHY A BIOLOGICAL RISK
ASSESSMENT?
• To define preventive measures that are adapted to the nature and level of risk
• For management purposes, for the sound allocation of resources to preventive measures – this
is even more critical in limited resource settings ! –

☛ Biological risk assessment is

• A risk and also resource management tool
• The cornerstone and a basic requirement of biorisk management
• Also a basic legal requirement in countries that have biosafety regulations
 RISK-BASED RISK CONTROL MEASURES

• All these control measures (work practices, protective barriers…) may be suitable provided
they are adapted to the activity and the nature and level of risk
• Note that they have very different logistic constraints and costs
 WHEN DO WE NEED A BIOLOGICAL
RISK ASSESSMENT?
• Prior to launching new biological activities
• To decide whether or not the risk can be controlled effectively
(= to decide whether the risk is acceptable or not)
• To define and implement the needed control measures

• What are the possible outcomes of such a biological risk assessment?

 GENERAL RISK ASSESSMENT STRATEGY

Describe the
Describe activity
activity

Define control
Identify risks
measures
NO

Determine if risks Characterise risks

YES are acceptable

Modified from ’Laboratory biosafety

Implement defined control measures and conduct activities and biosecurity risk assessment
technical guidance’, Sandia 2014
 GENERAL RISK ASSESSMENT
STRATEGY
Describe work activities

Identify hazards

Determine risks

Decide whether or not If yes Proceed with work

risk is acceptable and monitor controls

If no Prepare risk control

action plan

Revise or Implement control

close project measures

Review adequacy of plan

Modified from ’Laboratory biorisk management’, CWA 15793: 2011

 OTHER SITUATIONS REQUIRING A BIORISK
ASSESSMENT
• During activities
• In case of changes of biological materials, protocols, equipment…
• If unexpected situations present (emergencies, need for special maintenance…)
• In case relevant new information become available
• To check the appropriateness of the control measures in place
• Regularly, as part of a continuous improvement program
• Prior to designing and building a new facility
• To define the needed containment and associated protective measures
• To plan for the required technical, organisational and financial means
• Possibly to obtain the required permits
 BIOLOGICAL RISK OR BIORISK –
DEFINITIONS
• Biological risk (or ’’biorisk’’)
• Probability of occurrence of damage, injury, loss or any other negative consequence that is caused
by biological agents or materials*
• Combination of the probability of occurrence (’’likelihood’’) of harm and
the severity of that harm (’’consequences’’), where the source of harm is a biological agent or
toxin**

* Modified from a general definition of risk / ** CWA 15793: 2011

⚙ Biological toxins are chemical substances of biological origin; they are not biological agents, do not
correspond to the definition of biological materials, require chemical safety control measures, and are
therefore usually not considered in biosafety. However, biological toxins, due to the “Biological Weapon and
Toxins Convention”, are considered in biosecurity, and thus in biorisk management.
 BIORISK ASSESSMENT –
DEFINITIONS
• Biorisk assessment =
• Evaluation of the likelihood that biological agents or materials
involved in a given activity or process will generate negative effects
on the personnel, the community or the environment,
and of the severity of those effects,
in order to establish appropriate control measures*
• Process of evaluating the risk arising from a biological hazard,
taking into account the adequacy of any existing control measures,
and deciding whether the risk is acceptable or not**

* Based on a general definition of risk assessment and the definition of biosafety / ** CWA 15793: 2011

⚙ Biorisk assessment covers both biosafety and biosecurity aspects

 HAZARD VS RISK
• Hazard = Intrinsic ability to cause adverse effects (harm)
(’’a hazardous substance’’)
• Risk = Likelihood that adverse effects (harm) will occur
(’’the risk(s) of a given situation or activity’’)
 BIOLOGICAL HAZARD VS
BIOLOGICAL RISK
• Biological hazard
• Intrinsic ability or potential of a biological agent to cause harm
• Also the source of harm itself (= the biological agent)
• Relates to the intrinsic characteristics of the agents
• Independent from the environment or conditions of use
• Biological risk
• Likelihood that a biological agent will cause harm under certain circumstances
• Combination of the probability of occurrence and the severity of harm
• Relates to the environment and conditions of use (including control measures)

⚙ While generally clearly distinguished in the other fields of safety, “hazard” and “risk” are generally confused
in biosafety (including in major reference documents)
 DIFFICULTIES OF RISK
ASSESSMENT – IN GENERAL
• Evaluation of the occurrence of a potential event and its impact
• Relevant trustable data possibly incomplete or not available
• No universal methodology
• Translation of multiple non-structured data into some structured information
• Requirement of specialised technical experience and expertise
• Cultural and/or personal differences in perception and acceptance of risks
• Balance between technical expertise and some personal judgement…
CULTURAL PERCEPTION AND
ACCEPTANCE OF RISKS
 DIFFICULTIES OF BIOLOGICAL
RISK ASSESSMENT
• Difficulties of any risk assessment
+
• Diversity of biological agents and materials
• Diversity and complexity of the activities
• Quasi-absence of quantitative data
• Biosafety traditionally away from general safety
• Some confuse terminology used, esp. in biosafety
• Who should ideally carry out biological risk assessment?
 WHO SHOULD CARRY OUT THE RISK
ASSESSMENT?
• The people who know the best the hazard and the activities
• The scientist in charge of the lab
• The lab or maintenance technicians who carry out the activities
• Any person who would have useful knowledge or expertise
(esp. for specific activities, e.g. process engineers for complex systems)
• The biosafety officer?

• Since in most situations no one knows all the aspects to consider,

biological risk assessment should normally be the result of some team work
• Due to differences in perception, results of risk assessment should be challenged
• Due to responsibility issues, results of risk assessment should also be approved
by an authority
WHAT SHOULD BE THE ROLE OF THE BIOSAFETY OFFICER
IN BIOLOGICAL RISK ASSESSMENT?

• Ideally, the person in charge of biosafety in the institution should be

• A facilitator – to make sure that the RA process is well managed
• An advisor – especially with respect to control measures
• A challenger – to ensure all relevant aspects are considered
• Part of the committee that would validate the results
• The biosafety officer should normally not be the author of the risk assessment,
and if so, be sure he/she gathers all the required scientific and technical expertise
 Any questions?

THANK YOU FOR YOUR PARTICIPATION

Acknowledgement : Philippe Stroot – Xibios Biosafety Consulting