2. “Science is the knowledge of consequences, and dependence of one fact upon another. “ Thomas Hobbes (1588-1679)

3. Some General Principles The following are some universal principles that to apply to all public- sector risk analyses. 3

4. Risk Analysis should be based on Common Sense 1. The Principle of Common Sense In assessing risks, the use of “common sense” should prevail. In many cases the outcomes are obvious and uncontroversial and a decision can be made without resulting to a full risk analysis, which can be a lengthy and expensive process. 4

5. All Risk Analyses are Done in the Face of Uncertainty 2. The Principle of Uncertainty All risk analyses contain an element of uncertainty. A good risk analysis will seek to reduce uncertainty to the extent possible. 5

6. Due Precaution is Essential 3. The Principle of Precaution If the level of uncertainty is high, the Precautionary Principle can be applied to delay a decision until key information is obtained. However, steps must be taken to obtain the information in a timely manner. 6

7. The Precautionary Principle – Two Ethos Convention on Biological Diversity (CBD) ethos - better to make the mistake of denying entry to a non-pest than to allow entry of a pest, because a decision to admit a species is usually irreversible. World Trade Organization (WTO) ethos - preferable to allow trade unless there is a demonstrable and scientifically valid reason for not doing so. 7

8. Risk Analyses should be Done as Objectively as Possible 4. The Principle of Objectivity Risk analyses should be conducted in the most objective way possible. However, due to uncertainty and human nature, a high degree of subjectivity may be present. The risk analysis should clearly indicate where subjective decisions have been made. 8

9. Transparency of Process is Essential 5. The Principle of Transparenc y Risk analyses conducted by public-sector agencies should be fully transparent, so that all stakeholders can see how decisions were reached. 9

10. Risk Analyses should be Consistent 6. The Principle of Consistency Decisions, particularly those made by government, should be reached via standardized methods and procedures. In theory, two risk analysts independently conducting the same risk analysis should reach roughly similar conclusions. 10

11. Risk Analyses Should be Reviewed by Independent Experts 7. The Principle of Scientific Validation The scientific basis of a risk analysis should be validated by independent expert review. 11

12. Stakeholder Consultation is Essential 8. The Principle of Stakeholder Consultation If the results of a risk analysis is likely to be of interest to, or impact upon others, then stakeholder consultations should be held. 12

13. Risk Management Should be Proportional to the Risk Involved 9. The Principle of Stringency The stringency of the risk management measures to be applied should increase in direct proportion to the risk involved. 13

14. Risk Management Measures Should be the Minimal Needed 10. The Principle of Minimal Risk Management Risk management measures that impinge on others should be applied only to the extent necessary to reduce the risk to an acceptable level. 14

15. Some Actions are Just too Risky 11. The Principle of Unacceptable Risk If the level of risk is unacceptable and no effective or acceptable risk management measures are possible, then the activity should not take place. 15

16. Results are More Important than Means 12. The Principle of Equivalence Risk mitigation measures proposed by trading partners that meet the acceptable level of risk should be accepted by the importing country. 16

17. Countries Retain the Right to Determine their Risk Tolerance 13. The Principle of National Sovereignty It is a country’s right to determine the stringency of disease prevention measures required to protect national human, animal and plant health. None To all or part of OIE standards More stringent than OIE standards (but WTO members must justify additional measures using risk analysis!) 17

18. What is Needed to Implement Risk Analysis? Political will Clear policy (part of a National Strategy) A Risk analysis framework Assignment of responsibilities Development and training of risk analysts Development of the technical components (i.e. sources of necessary information) Practical experiences

19. Risk Analysis and Developing Countries No good reason for importing countries to accept commodities of unknown/uncertain health status Use of quarantine should be rationalized More emphasis on knowledge of stock history, certification & diagnostic testing Possible to develop regional criteria for “approved” low- risk sources for major species traded (penaeid shrimp, seabreams, tilapia, etc.)? Possible to apply risk analysis at various levels (international, domestic, farm)?

20. Characteristics of Risk Analysis that Support Good Governance Consistency of process Transparency of process Emphasis on stakeholder consultation Separation of the objective (scientific fact) from the subjective (opinion) Recognition of the principle of equivalence of risk management measures Emphasis on precautionary approaches

21. Characteristics of Risk Analysis that Support Good Governance Concept of appropriate level of protection (ALOP) (which is the same across all types of commodities) Separation of science-based and political decisions and Concept of unacceptable risk

22. Can Regional Approaches be Applied to Risk Analysis? Regional countries could develop: mutually agreed upon risk analysis methodologies an ALOP that is consistent across all countries well chosen RA working groups comprised of specialist & generalist expertise linkages with international laboratories (OIE & others) shared regional databases Shared contingency plans for shared aquatic systems

23. Constraints to Pathogen Risk Analysis Lack of baseline data for hazard identification Scarce data on pathogen inactivation Uncertainty regarding the ecological & financial consequences of pathogen introduction Inconsistent evaluation of risk Lack of consistency of the appropriate level of protection (ALOP) Regulatory issues, especially in developing countries – (lack of surveillance, lack of competent authority or competent authority lacking expertise and/or diagnostic capacity in aquatic animal health)

24. “Left to themselves, things tend to go from bad to worse.” Corollary to Murphy’s Law

25. What is Your Country’s Current Situation? Do politicians recognize the need for risk analysis? Is current legislation adequate? Are species movements adequately considered? Are formal risk assessment procedures in place? Is implementation effective? Is there emergency preparedness and contingency planning?

26. Thank you!