“Logical consequences are the scarecrows of fools and the beacons of wise men. “ Thomas Henry Huxley (1825–1895)

Logical consequences are the scarecrows of fools and the beacons of wise men. Thomas Henry Huxley (18251895)

The Import Risk Analysis Framework

Simplified Hypothetical Risk Analysis Process 9. Conduct Risk Management Risk evaluation (compares risk with ALOR) Option evaluation (if unacceptable risk is found) 10. Internal/External Scientific Reviews/Revisions 11. Revised Risk Analysis to Stakeholders for Final Comment & Revise as Necessary 12. Implement Finalized RA via Policy & Legislation (incl. any risk management measures & monitoring & review)

In Practical Terms: Risk = Commodity x Source x Destination x Volume Live Adult Wild Direct Release Billions Processed SPF Immediate One Product Consumption Animal Higher Lower

Risk Management What can be done to reduce either the likelihood or the consequences of its going wrong? What can we do to reduce the risk to an acceptable level? The process of deciding upon, evaluating & implementing measures to effectively manage risk

Overview of Steps in Risk Management Risk evaluation Determines whether the risk posed by the hazard is acceptable or unacceptable Option evaluation Identifies and evaluates possible actions to reduce the risk Implementation applies the selected action(s) Monitoring & Review auditing to ensure intended results are achieved

Risk Evaluation Appropriate Level of Protection (ALOP) to determine if Compares the estimated risk with the Appropriate Level of Protection (ALOP) to determine if the risk posed by the hazard is acceptable to the importing country

Concept of Appropriate Level of Protection A countrys appropriate level of protection (ALOP) is the level of protection deemed appropriate by the country establishing a sanitary or phytosanitary measure to protect human, animal or plant life or health within its territory (WTO 1994)

Concept of Appropriate Level of Protection Appropriate Level of Protection Appropriate Level of Protection is an explicit or implicit statement of a countrys risk tolerance. Explicit: Clearly stated in a policy &/or legal document. In dealing with risks posed by threats to plant, animal and human health and wellbeing, Australia has a very high level of protection. Implicit: Determined by a risk analysis working group through examination on the countrys past history and performance with regard to trade. Based on examination of its past trading practices with plants, terrestrial animals and aquatic animals, it can be stated that Singapore has a very low level of protection. Compares the estimated risk with the ALOP Determines whether the risk posed by the hazard is negligible or non-negligible The definition of non-negligible & negligible is a political decision - a policy must be determined as to the Acceptable Level of Risk or the (ALOP)

The Other Side of the Coin - Acceptable Level of Risk Acceptable Level of Risk Acceptable Level of Risk is the inverse of ALOP. Very high ALOP = Very low ALOR Because risk analysis calculates the level of risk (not the level of protection needed), ALOR is used in Risk Evaluation.

Use of ALOR in Risk Evaluation NegligibleLowModerateHighCatastrophic HighNegligible Risk Low Risk Moderate Risk High Risk Extreme Risk ModerateNegligible RiskLowRisk Moderate Risk High Risk Extreme Risk LowNegligible Risk Very Low RiskLowRisk Moderate Risk High Risk Very LowNegligible Risk Negligible Risk Very Low RiskLowRisk Moderate Risk Negligible Risk Negligible Risk Negligible Risk Negligible Risk Negligible Risk Estimated Likelihood of Release & Exposure Estimated Consequences

ALOP/ALOR Key Points ALOP is a societal value judgment that reflects the maximal risk (or expected loss) from a pathogens spread &/or establishment that a country considers acceptable risk analysts do not determine ALOP Setting national ALOP is a political decision, thus risk analysts do not determine ALOP, they just use it to determine if the risk is Acceptable or Unacceptable. A risk is acceptable if it is within the ALOP (i.e. equal to or lower than the national ALOR). National ALOP must be consistent across all sectors plants, terrestrial animals and aquatic animals. Most countries do not have an explicitly stated ALOP.

ALOP/ALOR Key Points It setting national ALOP, politicians must weigh many factors, including: the importance its citizens place on protecting national biodiversity and natural ecosystems the availability of species for agriculture & aquaculture development, the need for social and economic development, and past trading practices, including those in the plant and livestock sectors.

Practical Example: Risk Evaluation for WSSV in Giant River Prawn Likelihood of Release Low Likelihood of Exposure Low Likelihood of Release and Exposure Low Estimate of Consequence Moderate Estimate of overall risk Moderate Proposed ALOR for Cook Islands: Very Low Conclusion An unacceptable level of risk exists

Possible Outcomes of Risk Evaluation The Risk is Acceptable If the commodity presents only 1 hazard, then approve. If there are other hazards, then proceed to risk assessment for the next hazard. Risk is Unacceptable Proceed to Option Evaluation

Results of Risk Assessment in the 9 Pathogen Risk Analyses Risk AnalysisNo. Hazards in Preliminary List No. Hazards Assessed No. Hazards Requiring Risk Management Salmonids for human consumption 857 7 (8%) Live ornamental finfish to Australia 10444 12 (8%) Juvenile kingfish from Australia to NZ 429 4 (9.5%) Litopenaeus stylirosis from Brunei to Fiji 218 8 (38%) Postlarval Macrobrachium from Fiji to Cook Islands 612 2 (3%)

Risk Assessment in the 9 Pathogen Risk Analyses (continued) Risk AssessmentNo. Hazards in Preliminary List No. Hazards Assessed No. Hazards Requiring Risk Management Ornamental fish &marine invertebrates to NZ >5003513 (2.5%) Adult Macrobrachium from Hawaii to NZ 7664 (5%) Menhaden (Brevoortia sp.) from USA to Australia 4211 (2.4%) Pacific oysters from Tasmania to NSW 18 (includes pests) 133 (17%) Mean for single species RA (6 studies) 43.3 hazards6.53.6 (8.3%) Mean for multispecies RA (3 studies) 230 hazards26.310.6 (4.6%)

Options Evaluation The process of identifying, evaluating the efficacy and feasibility of, and selecting measures to reduce the risk associated with the importation in line with the importing countrys appropriate level of protection (ALOP).

Options Evaluation The process: Identify possible risk management options Examine the efficacy of each option: Identify the critical points in the release and exposure pathways where the option will reduce the likelihood of a pathways step being completed. Insert new likelihood estimates for these steps. Recalculate release &/or exposure likelihood estimates. Recalculate total risk estimate (the restricted risk) Compare the new estimate with ALOR. If the management measure(s) are effective, then evaluate their feasibility.

Options Evaluation The use of scenario trees allows the risk analyst to evaluate the probable effectiveness of various options and combinations of options to find those that are: Effective in lowering risk to an acceptable level Not excessive (minimum level necessary) Most acceptable to the proponent

Options for Reducing Pathogen Risk for Live Aquatic Animals Improving knowledge of health status Assuring good health by evaluating detailed health history required from the proponent, production facility and/or importing countrys Competent Authority Requiring international health certificate Requiring additional diagnostics testing Requiring alternate sourcing Sourcing from stock with known health history (e.g. SPF) Quarantine (pre-border, border, post-border, including additional diagnostics) Requiring broad spectrum prophylactic treatment/or specific treatment if a treatable pathogen is found

Options for Reducing Pathogen Risk for Live Aquatic Animals Evaluation of competent authority On-site inspections of production facilities to verify biosecurity claims Restrictions on initial use Limited distribution Higher level of containment Contingency planning Control, treat and/or eradicate (stamping out)

Options for Reducing Pathogen Risk for Live Aquatic Animals Risk management measures are usually applied in combination. No risk management measure or combination will reduce risk to zero

Options Evaluation Outcomes: No management possible reject request Acceptable management measures possible Proponent agrees move to implementation Proponent disagrees Proponent proposes alternate risk management measures Revaluation of risk (acceptable approve) Proponent takes no further action (unacceptable no approval)

Risk Analysis No. Hazards Requiring Risk Management Recommended Risk Management Methods Salmonids for human consumption 7Pre-export certification; head off, eviscerated, processing at registered premises only Live ornamental finfish to Australia 12Pre-export certification; Post-arrival quarantine with ad hoc disease testing Juvenile kingfish from Australia to NZ 4Pre-export conditions & viral testing: post-arrival quarantine &conditions Litopenaeus stylirosis from Brunei to Fiji 8Larvae from SPF broodstock, pre-export conditions &viral testing, post-arrival conditions Postlarval Macrobrachium from Fiji to Cook Islands 2Pre-export viral testing, post- arrival conditions Risk Management in the 9 Pathogen Risk Analyses

Risk Management in the 9 Pathogen Risk Analyses (continued) Risk Analysis No. Hazards Requiring Risk Management Recommended Risk Management Methods Ornamental fish & marine invertebrates to NZ 13High-risk hosts prohibited, post-arrival quarantine with targeted passive surveillance Adult Macrobrachium from Hawaii to NZ 4Pre-export conditions & viral testing, post-arrival quarantine & conditions Menhaden (Brevoortia sp.) from USA to Australia 1Pre-export conditions & viral testing, post-arrival quarantine & conditions Pacific oysters from Tasmania to NSW 3Pre-shipment viral testing, chlorine bath treatment to remove pests/epibionts

The Precautionary Principle In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation Principle 15 of the Rio Declaration of the UN Conference on Environment and Development (UNCED)

The Precautionary Principle While the need for precaution is generally accepted and has been included in a number of international agreements, the Precautionary Principle is not enshrined in international law. There have been a wide variety of interpretations. A precautionary approach is one that takes into consideration the precautionary principle.

The Precautionary Principle Most people would agree that the sprit of the principle is: That we should be careful when embarking on something new, That we should be reasonably convinced that no unacceptable harm will come of it, and That we should be particularly careful when there is much uncertainty or ignorance about possible outcomes.

The Precautionary Principle A Precautionary Approach requires that both importing & exporting nations act responsibly & conservatively to avoid the introduction of potential pest species & the spread of serious pathogens

In Pathogen Risk Analysis The burden of proof of harm is placed on the risk analyst. The Precautionary Principle can be applied in cases where sufficient information is lacking to make an accurate assessment of risk. However, steps must be taken to obtain the needed information in a timely manner - the Precautionary Principle cannot be used to avoid making a decision. In any case, the risk management measures chosen must be based on a risk assessment that considers the available scientific evidence and based on a logical rationale.

How is the Precautionary Principle Applied in Pathogen Risk Analysis? Cautious interim measures (temporary restrictions, conditions and bans). Targeted research on key areas where critical information is lacking. By Risk Management

Cautious Interim Measures May provide a mechanism to allow importations to proceed until a full risk analysis can be taken. Activities include: preliminary hazard identification: identification of all possible hazards & screening for those posing potential risk identification of risk management measures (biosecurity measures) that will assure safe importation assuming the worse case (overly stringent measures) implementation of overly stringent measures until a more comprehensive RA can be completed.

Practical Example: Risk Management for Giant River Prawn Option Evaluation Options were not rigorously evaluated to determine their impact on the level of risk. An overly cautious approach was recommended: Risk can be reduced to an acceptable level if: testing of broodstock or PLs themselves for WSSV is done using OIE standards removal of animals from receiving facility requires prior permission of the supervising agency operator keeps detailed records & reports any serious disease outbreak or mortality a contingency plan is developed & in place

Practical Example: Risk Management for Giant River Prawn Key findings: As results for WTD were similar to those for WSSV, the suggested mitigation measures would reduce the risk to within the ALOP. Given the high level of uncertainty, the supervising agency might apply a precautionary approach until the health status of the parent stock is clearly known.

Implementation Implementation is the process of following through with the risk management decision and ensuring that the risk management measures are in place. Implementation is accomplished through: Legislation and regulation Enforcement Implementation is not the responsibility of the Working Group or the Pathogen Risk Analysis Team it may be done by the CA in cooperation with other government agencies (including the exporting country CA) and by the exporter and importer.

Monitoring and Review An on-going process by with the risk management measures are continually audited to ensure that they are achieving the intended results. Standards for auditing must be defined. Responsibilities and mandates for monitoring and review must be established monitoring will most likely be done by the CA and the results may be regularly reviewed by the PRAT. Serious non-compliance with risk management requirements or the outbreak of a serious non-treatable disease will result in revocation of the import permit, destruction of the imported stock and appropriate sanitary measures.

Report Preparation A key product of the risk analysis is a report. Its important that the risk analysis process and its outcomes be fully documented. To ensure the scientific quality of the report and that the conclusions are fully supported, the draft report should be sent to several independent experts for critical review and comment.

Steps in Preparing a Risk Analysis Report 1. Describe the preliminary risk analysis objectives & plans 2. Describe the scale and scope of the risk analysis 3. Describe the operational context of the project/system to be assessed 4. Review the risk analysis process & agreed endpoints with a statement of ALOP 5. Discuss primary data sources & methods used for data collection & analysis

Steps in Preparing a Risk Analysis Report 7. Describe the identified hazards with risk profiles (likelihood and consequence assessments) for each hazard; include a summary of uncertainty in each risk profile 8. Identify risk management options for each risk profile and provide advice on the extent to which the risk is reduced by the management option 9. Summarize overall risk acceptability

Key Points Risk management measures should be required only to the extent needed to reduce risk to an acceptable level. Exporting country can propose alternate mitigation measures having the same results (equivalence) In cases of high uncertainty, the Precautionary Principle can be applied, but only for a period needed to obtain the missing data.

Key Points Risk management measures are often applied in combination. No risk management measure or combination will reduce risk to zero. Sometimes no risk management measures will be identified. In other cases, the measures identified will be unacceptable to the proponents.

Documents

“Logical consequences are the scarecrows of fools and the beacons of wise men. “ Thomas Henry Huxley (1825–1895)