1. Relevance of Risk Analysis/Assessment to International Trade and the Precautionary Principle Tom Kasari, DVM, MVSc Diplomate, American College Veterinary Preventive Medicine (Epidemiology) Diplomate, American College Veterinary Internal Medicine Presented by: Stan Bruntz, DVM MPH USDA-APHIS-VS Center for Epidemiology and Animal Health Fort Collins, Colorado

2. Agenda Review relevance of risk analysis/assessment to international trade and the Precautionary Principle Review risk analysis process and its component risk assessment procedure Review quantitative versus qualitative risk assessment methodologies

3. Relevance of Risk Analysis/Assessment to International Trade As per WTO (1995) Multilateral Trade Agreements, the Agreement on the Application of Sanitary and Phytosanitary Measures (the “SPS Agreement”) sets out for member countries the basic rules for food safety and animal and plant health requirements

4. 159 out of 196 Countries in the World are WTO Members As of March 2013 Map source: www.wto.org/english/thewto_e/countries_e/org6_map_e.htm

5. WTO Article 5.1: “Members shall ensure that their sanitary or phytosanitary measures are based on an assessment, as appropriate to the circumstances, of the risks to human, animal or plant life or health, taking into account risk assessment techniques developed by the relevant international organizations” Relevance of Risk Analysis/Assessment to International Trade (WTO SPS Agreement) Source: http://www.wto.org/english/thewto_e/coher_e/wto_oie_e.htm

6. WTO Article 5.1: “Members shall ensure that their sanitary or phytosanitary measures are based on an assessment, as appropriate to the circumstances, of the risks to human, animal or plant life or health, taking into account risk assessment techniques developed by the relevant international organizations” Relevant international organization for animal health: World Organization for Animal Health (aka Office International des Epizooties or OIE) Relevance of Risk Analysis/Assessment to International Trade (WTO SPS Agreement) Source: http://www.wto.org/english/thewto_e/coher_e/wto_oie_e.htm

7. Relevance of Risk Analysis/Assessment to International Trade (WTO SPS Agreement) WTO SPS Measures Article 5.1 is basis for using OIE guidelines for risk analysis (& component risk assessment) process – OIE Terrestrial Animal Health Code (2013)– Vol I: Section 2; Chapter 2.1. Import Risk Analysis

8. Relevance of Risk Analysis/Assessment to International Trade (WTO SPS Agreement) Besides assessment of risk, other key concepts contained in the SPS Agreement: – Harmonization – Equivalence – Regionalization & compartmentalization – Transparency – Notification

9. Relevance of Risk Analysis/Assessment to International Trade (WTO SPS Agreement) Governments encouraged to “harmonize” their animal health standards based on international standards, guidelines, and recommendations developed in other international organizations (i.e. OIE)

10. Relevance of Risk Analysis/Assessment to International Trade (WTO SPS Agreement) Governments encouraged to “harmonize” their animal health standards based on international standards, guidelines, and recommendations developed in other international organizations (i.e. OIE) Harmonization means the establishment, recognition and application of common sanitary and phytosanitary measures

11. Relevance of Risk Analysis/Assessment to International Trade (WTO SPS Agreement) National standards do not violate the SPS Agreement simply by differing from international norms (non-harmonized) – Requirements can be stricter – Justify on basis of analysis of scientific evidence and the risks involved

12. Equivalence Trading partners recognition that significantly different animal health and production systems can provide equivalent animal and human health protection for the purpose of international trade – Infrastructure – Surveillance policies and/or operating procedures – Laboratory systems – Border security – Internal movement controls

13. Regionalization (Zoning) Region/Zone means a clearly defined geographical area (country, part of a country, parts of several countries, several countries) containing an animal subpopulation with a distinct health status with respect to a specific disease for which required surveillance, control and biosecurity measures have been applied for the purpose of international trade. subpopulationdiseaseinternational trade

14. Compartmentalization Compartment – means one or more establishments under a common biosecurity management system containing an animal subpopulation with a distinct health status with respect to a specific disease or specific diseases for which required surveillance, control and biosecurity measures have been applied for the purpose of international trade.establishmentssubpopulation diseasediseases international trade

15. Definition Recognition of animal populations of different health status – Zoning/regionalization Geographical basis – Compartmentalization Management and biosecurity

16. Zones and compartments Both concepts are similar The difference is the responsibility of the application of biosecurity measures – Disease-free zones  Official sector – Compartments  Private sector Need for close supervision and accreditation by the official veterinary service

17. Interstate Trade State’s swine industry Regionalization = establishing and maintaining a disease free status for a subpopulation of animals based on a geographical basis Interstate Trade Regionalization

19. State’s swine industry Compartmentalization = establishing and maintaining a disease free status for a subpopulation of animals based on management systems related to management and biosecurity Interstate Trade Compartmentalization

20. Relevance of Risk Analysis/Assessment to International Trade (WTO SPS Agreement) Risk analysis and regionalization or compartmentalization depend on the data generated by a soundly designed comprehensive surveillance system – Epidemiology is a key element in providing the scientific basis to satisfy international trade requirements

21. Relevance of Risk Analysis/Assessment to International Trade (WTO SPS Agreement) Risk analysis and regionalization depend on the data generated by a soundly designed comprehensive surveillance system “Harmonization”, “equivalence” “transparency”, and “notification” are the basis for mutual trust between veterinary services of trading partners

22. Relevance of Risk Analysis/Assessment to International Trade (WTO SPS Agreement) and Precautionary Principle Precautionary principle: If an action or policy has a suspected risk of causing harm to the public or to the environment, in the absence of scientific consensus that the action or policy is harmful, the burden of proof that it is not harmful falls on those taking an action.

23. Relevance of Risk Analysis/Assessment to International Trade (WTO SPS Agreement) and Precautionary Principle Precautionary Principle tempered by risk assessment requirement of WTO trading partners when it comes to matters of potential onerous animal health regulations “If in doubt, keep it out” zero-risk approach to mitigating animal health-related trade issues is unacceptable

24. Relevance of Risk Analysis/Assessment to International Trade (WTO SPS Agreement) and Precautionary Principle Relevance of Precautionary Principle to (WTO) Article 5.1: “…even if a (WTO) Member follows a precautionary (principle) approach, its SPS measures need to be ‘based on’ (i.e., ‘sufficiently warranted’ or ‘reasonably supported’ by) a risk assessment. Or, to put it another way, such an approach needs to be applied in a manner consistent with the requirements of (WTO) Article 5.1.” Source: http://www.wto.org/english/res_e/booksp_e/analytic_index_e/sps_02_e.htm

25. Validity Criteria for Sanitary and Phytosanitary Measures in International Trade Source: Zepeda C., et al. 2001. Preventive Veterinary Medicine 48: 261-271.

26. Risk Analysis/Assessment

27. Review Concepts What is risk? What is risk analysis? What is risk assessment? Risk analysis and assessment processes

28. What is Risk? The likelihood of the occurrence and the likely magnitude of consequences (biologic & economic) of an adverse event or effect to animal or human health Source: OIE Terrestrial Animal health Code 2011 (glossary)

29. Elements of Risk Probability (likelihood or chance) of an adverse event (the hazard) Consequences (or impact) – Biologic – Economic Uncertainty Ability to manage

30. Critical Questions That Should Shape Any Animal Health-Based Risk Analysis What can go wrong? How likely is the event(s) to occur? If the event(s) happen, what is/are the consequence(s) and extent of damage?

31. What is Risk Analysis? Organized way to answer those three questions…… as well as incorporate: What can be done to change (mitigate) the risk? Whom do we need to inform? What/how do we need to communicate?

32. What Is Risk Analysis? Hazard Identification Risk Assessment Risk Management Risk Communication Source: OIE Terrestrial Animal Health Code (2013)– Vol I: Section 2; Chapter 2.1. http://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_1.2.1.htm What can go wrong? How likely is the event to occur? If the event happens, what are the biologic and economic consequences? What can be done to change (mitigate) the risk? What must be done to implement mitigation(s)? Whom do we inform? What/how do we need to communicate information?

33. Risk Analysis does NOT: Establish the “acceptable risk” level Describe with certainty when/if an agent will be introduced or the consequences Determine policy Provide the ONLY input into decision making 33

34. What is Risk Assessment? Evaluation of the likelihood of entry, establishment, and spread of a disease and the associated potential biological and economic consequences to animal and/or public health Hazard Identification Risk Assessment Risk Management Risk Communication

35. Risk Assessment Consists of: – Entry (release) assessment – Exposure assessment – Consequence assessment Biologic Economic – Risk estimation Source: OIE Terrestrial Animal Health Code (2013)– Vol I: Section 2; Chapter 2.1. http://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_1.2.1.htm

36. Entry (Release) Assessment Describes the biological pathway(s) necessary for an importation activity to 'release' (introduce) a pathogen into a particular environment – Pathways analysis Estimates the probability of that complete process occurring, qualitatively (in words) or quantitatively (as a numerical estimate)

37. Pathways Analysis Definition Systematic assessment of the pathways along which a foreign animal disease agent might enter the US and establish an outbreak of disease in animals and/or man

38. Pathways Analysis Systematic assessment of the pathways along which a foreign animal disease might enter the US and establish an outbreak of disease in animals and/or man Also applicable for delineating the pathways along which a domestic disease agent might spread from a state/province or region to new state(s)/province(s) or region(s)

39. Pathways Analysis Its Uses Risk assessment Targeted surveillance planning Emergency preparedness and response

40. Pathways Analysis Steps Step 1: Establish an understanding of host, agent, and environmental interactions for the disease in question based on scientific literature, expert opinion, personal experience or other sources of information.

41. Pathways Analysis Steps Establish an understanding of host, agent, and environmental interactions for the disease in question based on scientific literature, expert opinion, personal experience or other sources of information. Step 2: Develop a list of potential pathways for entry of the disease agent into a susceptible livestock and/or human population

43. Pathways Analysis Steps Establish an understanding of host, agent, and environmental interactions for the disease in question based on scientific literature, expert opinion, personal experience or other sources of information. Develop a list of potential pathways for entry of the disease agent into a susceptible livestock and/or human population Step 3: Evaluate the feasibility of each pathway

44. Pathways Analysis Steps Establish an understanding of host, agent, and environmental interactions for the disease in question based on scientific literature, expert opinion, personal experience or other sources of information. Develop a list of potential pathways for entry of the disease agent into a susceptible livestock and/or human population Evaluate the feasibility of each pathway Step 4: Identify the populations at-risk for each feasible pathway that the disease agent follows to enter the country (or state/province or region)

45. Gaps in knowledge reduces the certainty of the confidence to place on feasibilty of some pathways

46. Exposure assessment describes the biological pathway(s) necessary for exposure of animals and humans in the importing country (or state) to the hazards released from a given risk sourceimporting countryhazardsrisk Estimate the probability of the exposure(s) occurring, either qualitatively (in words) or quantitatively (as a numerical estimate) – animal and/or people

47. Consequence assessment Describes the relationship between specified exposures to a biological agent and the consequences of those exposures – Direct consequences animal infection, disease, and production losses public health consequences. – Indirect consequences surveillance and control costs compensation costs potential trade losses adverse consequences to the environment

48. Risk estimation Integration of the results from: – Release assessment – Exposure assessment – Consequence assessment

49. Quantitative Versus Qualitative Risk Assessment

50. ‘zero’ risk does not exist 50

51. Types of risk assessment Quantitative Qualitative

52. Quantitative Risk Assessment an assessment where the outputs of risk are expressed numerically – Objective in nature – This number can represent the probability of an event occurring during a specific time frame Disease “X” will enter The Bahamas one out of every 10,000 shipments of product “a”

53. Quantitative studies Advantages More profound Notion of the probability of occurrence of an adverse event Informed decison- making Disadvantages Require time Require good quality data Not possible to apply in all circumstances

54. RISK Herd infected? Detected at inspection? animal infected? Survives processing? Susceptible species exposed? yes no NO RISK Scenario Tree

55. Uncertainty There are no exact values for each parameter It is necessary to produce an estimate that incorporates uncertainty and variability Use of simulation programs

56. Results Not a point estimate but a range of probabilities The result reflects variability and uncertainty 56

57. Qualitative Risk Assessment Not always possible to quantify risks because there simply may not be enough data to make reliable calculations An assessment where the outputs for the likelihood of the outcome or the magnitude of the consequences are expressed in qualitative terms such as ‘high’, ‘medium’, ‘low’ or ‘negligible’ – Subjective in nature

58. Qualitative studies Advantages Faster Applicable to a broader scope of circumstances Disadvantages Less profound Do not provide a numerical probability of occurrence of an adverse event Less precise decision-making

59. Risk Analysis Process Hazard Identification Risk Assessment Risk Management Risk Communication Source: OIE Terrestrial Animal Health Code (2013)– Vol I: Section 2; Chapter 2.1. http://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_1.2.1.htm

60. Questions?