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The Role of Risk Analysis in theJudgement of Equivalence
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Zero risk and trade
• Zero risk does not exist
• Trade implies risk
• Lack of trade also implies risk• Unregulated trade
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Risk analysis
• A process composed of:
– Hazard identification
– Risk assessment
– Risk management
– Risk communication
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Definition of Risk Assessment
Evaluation of the likelihood of entry, establishment and spread of a disease and
the associated potential biological and economic consequences and its impact on
public health
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Three questions:
• What can go wrong?
• How likely is it?
• If it happens, what is the magnitude of the consequences?
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Hazard
• Source for potential damage
• Cause of the adverse event
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Probability of occurrence of an adverse event
and
the magnitude of consequences
Definition of Risk
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Is disease exotic to
importing country?
Yes
Requires scientific
demonstration
Legitimate SPS
measure
NoIs disease under
official control?
Yes
Invalid SPS
measure
Are same SPS measures
required internally?
No
Are countries with equivalent
health status treated equally?
(non discrimination)
Are SPS measures based on
international standards (OIE Code) or
on a scientifically valid risk
assessment?
Yes
No
YesNo
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Risk assessment
• Release assessment
• Exposure assessment
• Consequence assessment
• Risk estimation
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Release assessment
Exporting country
Exposure assessment
Importing country
Consequence assessment
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Release assessment
• Describes possible pathways for the introduction of a disease agent• Biological factors
• Country factors
• Commodity factors
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Exposure assessment
• Describes the pathways leading to an outbreak• Volume and use of the commodity
• Density and distribution of susceptible animal populations
• Immunity
• Vectors
• Seasonality
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Scenario trees
Herd infected?
yes
no
No risk
Importation of meat from country x
Initial event
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Scenario trees
Herd infected?
Animal infected?
yes
yes
no
no
No risk
No riskImportation of meat from country x
Initial event
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Scenario trees
Herd infected?
Detected during inspection?
Animal infected?
yes
yes
yes
no
no
no
No risk
No risk
No riskImportation of meat from country x
Initial event
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Scenario trees
Herd infected?
Detected during inspection?
Animal infected?
Agent survives process?
Susceptible species exposed?
yes
yes
yes
yes
Riskyes
no
no
no
no
no
No risk
No risk
No risk
No risk
No riskImportation of meat from country x
Initial event
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Risk management
• Risk evaluation
• Determination of the appropriate level of protection
• Option evaluation
• Implementation
• Monitoring and review
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Exposure probability
Relea
se pro
bab
ility
Insignifi-
cant
Extre-
mely
low
Very
low
Low Slight Modera
te
High
High I EL VL L S M H
Moderate I EL VL L S M M
Slight I I EL VL L S S
Low I I I EL VL L L
Very low I I I I EL VL VL
Extremely low I I I I I EL EL
Insignificant I I I I I I I
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Consequences
Insignifi-
cant
Very
low
Low Modera-
te
High Extreme
Relea
se an
d ex
po
sure
pro
ba
bility
High I VL L M H E
Moderate I VL L M A E
Slight I VL L M A E
Low I I VL L M A
Very low I I I VL L M
Extremely low I I I I VL L
Insignificant I I I I I VL
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Equivalence
• Recognition that different SPS measures may achieve similar results
• Allows for flexibility in the organization of veterinary services, surveillance systems, etc.
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Role of epidemiology in equivalence
• Develop methods to compare the effect of mitigation measures
• Develop criteria to define the appropriate level of protection
• Focus on outputs rather than approaches
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Equivalence of surveillance systems
Surveillance component Sensitivity (SE) of each component
Country A Country B Country C
Passive surveillance 0.6 0.7 0.6
Survey 0.95 0.90 0.73
Slaughter surveillance 0.75 0.75 0.5
Overall system SE 0.995 0.992 0.947
1-((1-SE1)*(1-SE2)*(1-SE3))
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Overall probability of detection
0.000
0.200
0.400
0.600
0.800
1.000
1.200
0.91 0.9325 0.955 0.9775 1
Country A
Country C
Country B
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Disease freedom
• Is disease freedom the only answer?
– Traditionally has been the goal
– May not be achievable in a reasonable time frame
– For some diseases may not be achievable at all
• Are there other options?
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A shift in approach
FREE
NOT
FREE
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Alternatives
• Country freedom– Does the country present
negligible risk?
• Regionalization– Does the geographical area
present negligible risk?
• Compartmentalization– Does the management
system present negligible risk?
• Commodity-based trade– Does the product present
negligible risk?
All depend on
• Effective veterinary services– Veterinary accreditation
– Para-vets, CAHWs
• Producer participation
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Commodity-based trade
• The OIE Code explicitly mentions for each listed disease:
– Commodities for which no measures are required• e.g. milk and BSE
• Hides and skins and RVF
– Commodities for which specific requirements have been established• e.g. beef and Foot-and-Mouth disease
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Commodity-based trade
• Different approaches depending on the presence or absence of the agent in the commodity
• CBT allows to trade from countries or zones where disease is still present
• CBT is NOT a substitute for efficient official veterinary services– Certification processes still required
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Example of layered mitigations in CBT
Country or zone level – Outbreak prediction and surveillance– RVF mitigation program based on risk-based decision
making Herd-level
Surveillance or vaccination
Animal level Ante and post-mortem inspection
Commodity level Maturation Deboning
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Stepwise approach
• How do we improve existing systems?– Are there ecosystems or time periods where the
prevalence of disease is naturally lower?
– Do the existing production systems lend themselves to compartmentalization?
– How can we provide assurances to trading partners that trade is “safe” i.e. with an acceptable level of risk?
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Risk, trust and trade
• Trade is based on trust
• Trust is a very delicate commodity
– It takes a long time to develop
– It takes very little to lose it
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Transparency
• Trust is based on transparency
– Structure of veterinary services
– Surveillance systems
– Disease reporting
– Production systems
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Building trust
• High-level bilateral visits and negotiations
• Accept limitations and plan for improvements
• Establish mechanisms to reinstate trade– Commodities
– Compartments?
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Regional approaches
• Regional problems require regional solutions
– Coordinated efforts across borders
• However, certification is still a national responsibility