Risk analysis is a process used to evaluate the likelihood and potential consequences of adverse events related to international trade. It involves hazard identification, risk assessment, risk management, and risk communication. While zero risk does not exist, trade still implies some level of risk. Equivalence recognizes that different sanitary or phytosanitary measures may achieve similar levels of protection. Key aspects of equivalence include comparing the effects of mitigation measures and defining appropriate levels of protection based on outputs rather than approaches. Building trust between trading partners through transparency, continuous improvement, and regional coordination can facilitate trade while managing risk.

1. The Role of Risk Analysis in the
Judgement of Equivalence

2. Zero risk and trade
• Zero risk does not exist
• Trade implies risk
• Lack of trade also implies risk
• Unregulated trade

3. Risk analysis
• A process composed of:
– Hazard identification
– Risk assessment
– Risk management
– Risk communication

4. 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

5. Three questions:
• What can go wrong?
• How likely is it?
• If it happens, what is the magnitude
of the consequences?

6. Hazard
• Source for potential damage
• Cause of the adverse event

7. Definition of Risk
Probability of occurrence of an
adverse event
and
the magnitude of consequences

8. Is disease exotic to
importing country?
No
Is disease under
No
official control?
Yes Yes
Are same SPS measures
Requires scientific
required internally?
demonstration
No
Yes
Are countries with equivalent Are SPS measures based on
health status treated equally? international standards (OIE Code) or
on a scientifically valid risk
(non discrimination) assessment?
No
Yes
Invalid SPS
measure
Legitimate SPS
measure

9. Risk assessment
• Release assessment
• Exposure assessment
• Consequence assessment
• Risk estimation

10. Consequence
Release assessment Exposure assessment assessment
Exporting country Importing country

11. Release assessment
• Describes possible pathways for
the introduction of a disease
agent
• Biological factors
• Country factors
• Commodity factors

12. 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

13. Scenario trees
Initial
event yes
Importation of Herd
meat from infected?
country x
No risk
no

14. Scenario trees
yes
Initial yes
Animal
event infected?
Importation of Herd No risk
meat from infected? no
country x
No risk
no

15. Scenario trees
no
yes
Detected during
inspection?
Initial yes
Animal
event infected?
No risk
yes
Importation of Herd No risk
meat from infected? no
country x
No risk
no

16. Scenario trees
yes
Risk
yes Susceptible
species exposed?
no
Agent survives
No risk
process?
no
yes
Detected during
inspection? No risk
Initial yes
no
Animal
event infected?
No risk
yes
Importation of Herd No risk
meat from infected? no
country x
No risk
no

17. Risk management
• Risk evaluation
• Determination of the appropriate level
of protection
• Option evaluation
• Implementation
• Monitoring and review

18. Exposure probability
Insignifi- Extre- Very Low Slight Modera High
cant mely low te
low
High I EL VL L S M H
Release probability
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

19. Consequences
Insignifi- Very Low Modera- High Extreme
cant low te
High I VL L M H E
Moderate I VL L M A E
Release and exposure
Slight I VL L M A E
probability
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

20. Equivalence
• Recognition that different SPS measures may
achieve similar results
• Allows for flexibility in the organization of
veterinary services, surveillance systems, etc.

21. 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

22. 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))

23. Overall probability of detection
1.200
1.000
Country A
0.800
0.600
Country B
0.400
Country C
0.200
0.000
0.91 0.9325 0.955 0.9775 1

24. 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?

25. A shift in approach
NOT
FREE
FREE

26. Alternatives
All depend on
• Country freedom
– Does the country present
negligible risk? • Effective veterinary
• Regionalization services
– Does the geographical area – Veterinary accreditation
present negligible risk? – Para-vets, CAHWs
• Compartmentalization
– Does the management • Producer participation
system present negligible
risk?
• Commodity-based trade
– Does the product present
negligible risk?

27. 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

28. 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

29. 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

30. 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?

31. 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

32. Transparency
• Trust is based on transparency
– Structure of veterinary services
– Surveillance systems
– Disease reporting
– Production systems

33. Building trust
• High-level bilateral visits and negotiations
• Accept limitations and plan for improvements
• Establish mechanisms to reinstate trade
– Commodities
– Compartments?

34. Regional approaches
• Regional problems require regional solutions
– Coordinated efforts across borders
• However, certification is still a national responsibility