Risk

Outline

Conduct of the process

Hazard Assessment
Exposure Assessment
Dose-Response Assessment
Characterization
Risk Management Considerations

Conduct of the process

Appropriate
incorporation of
stakeholders to ensure
fairness (risk governance)
[When] should
precautionary principle
be invoked?
The Presidential/Congressional
Commission on Risk Assessment
and Risk Management
Final Report
Volume 1
1997

Process
Need firm delineation of baseline from
which risk (and benefits) are being
assessed?
o From the pause?
o From status quo ante?

Hazard
Assessment/Scoping (1)
Seemed to be focus of attention
Move beyond occupational to public health risks
Need to regard influenza, SARS, MERS differently
o To what degree is absence of evidence informative?

GOF not a good term though unclear of a preferred

alternative
Should focus be where more than one of the properties
of transmissibility, pathogenicity, evasion of
countermeasures is being addressed?
Is it possible to triage:
o Situations of minor concern
o Situations of major concern (which maybe should be avoided)
o The broad middle where a case by case or class by class examination is
appropriate

Hazard
Assessment/Scoping (2)
Need to assess for global context
Do BSL/ABSL lab safety records provide an
appropriate basis or are there systematic
differences needing to be incorporated into a RA?
Finer gradations of lab capabilities than existing
BSL/ABSL framework?
Incorporation of deliberate and inadvertent
misuse?
o What is relevance of information from the bioterrorism arena?

Incorporation of information misuse?

Exposure Assessment
P(dose|incident)

Dose Response
Assessment
P(illness|dose)

Risk Characterization
Jump right to case
estimation in general
population
o Are there too many lumped
parameters here?
o Need to consider other
factors?

http://www.phac-aspc.gc.ca/cpip-pclcpi/annf/v2-eng.php

Special considerations
in emerging entrants
[Host & environmental
factors]
[Uncertainty]

Risk Management
To what degree can deliberate biological
modifications reduce/obviate risk?
Balance against risks from not doing proposed work
(preparedness, response, training)
A RA can inform decisions but is not determinative
per se. Acceptable risk is trans-scientific
For individual high risk experiments, can a
standardized template be devised?
Independence of oversight processes at individual
institutions is this a problem and are changes in
framework needed?