1. Training Course Introduction to the Use of Risk Analysis in Aquaculture

2. Part 9: Pathogen Risk Analysis – Risk Management
“Logical consequences are the scarecrows of fools and the beacons of wise men. “
Thomas Henry Huxley (1825–1895)

3. The Import Risk Analysis Framework
Modified from OIE (2008).

4. 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)
Note that report preparation, implementation and monitoring and review are also part of the risk management process.

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

6. 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

7. 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
In some cases, no risk management actions will make the level of risk acceptable. When this occurs, the proposal has to be rejected.

8. Risk Evaluation
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
In practice the estimated risk is compared to the ALOR.
Photo: Quarantine station in northern Malaysia (photo: R. Arthur)

9. Concept of Appropriate Level of Protection
“A country’s 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)

10. Concept of Appropriate Level of Protection
“Appropriate Level of Protection” is an explicit or implicit statement of a country’s 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 country’s 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)

11. The Other Side of the Coin - 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.

12. Use of ALOR in Risk Evaluation
Estimated Consequences
Estimated Likelihood of Release & Exposure
Negligible
Low
Moderate
High
Catastrophic
Risk
Extreme
Very Low
Likelihood combines the release estimate and the exposure estimate.
The ALOR in this case is Low (or alternately, ALOP is High). Everything in red is unacceptable risk, while everything in green represents acceptable risk. The ALOR is the border between the two colors.
Note that if either the likelihood of release or the likelihood of exposure or the estimated consequences were negligible the risk assessment would have been terminated earlier.

13. ALOP/ALOR – Key Points
ALOP is a societal value judgment that reflects the maximal risk (or expected loss) from a pathogen’s spread &/or establishment that a country considers “acceptable”
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.

14. 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.
ALOP/ALOR thus incorporates both potential benefits to be gained from importations and potential negative consequences that might occur.

15. 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
Note that if the calculation had been done using the tables given in this presentation, the estimated risk would have been “Very Low” and would have been considered acceptable.

16. 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

17. Results of Risk Assessment in the 9 Pathogen Risk Analyses
Risk Analysis
No. Hazards in Preliminary List
No. Hazards Assessed
No. Hazards Requiring Risk Management
Salmonids for human consumption 85 7
7 (8%)
Live ornamental finfish to Australia
104 44
12 (8%)
Juvenile kingfish from Australia to NZ 42 9
4 (9.5%)
Litopenaeus stylirosis from Brunei to Fiji 21 8
8 (38%)
Postlarval Macrobrachium from Fiji to Cook Islands 61 2
2 (3%)
See next slide for summary data.
Modified from Diggles and Arthur DAAVII presentation.

18. No. Hazards in Preliminary List No. Hazards Requiring Risk Management
Risk Assessment in the 9 Pathogen Risk Analyses (continued)
Risk Assessment
No. Hazards in Preliminary List
No. Hazards Assessed
No. Hazards Requiring Risk Management
Ornamental fish &marine invertebrates to NZ
>500 35
13 (2.5%)
Adult Macrobrachium from Hawaii to NZ 76 6
4 (5%)
Menhaden (Brevoortia sp.) from USA to Australia 42 1
1 (2.4%)
Pacific oysters from Tasmania to NSW 18
(includes pests) 13
3 (17%)
Mean for single species RA
(6 studies)
43.3 hazards
6.5
3.6 (8.3%)
Mean for multispecies RA
(3 studies)
230 hazards
26.3
10.6 (4.6%)
Modified from Diggles and Arthur DAAVII presentation.
General experience shows that there will probably be only a few hazards that require management.

19. 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 country’s appropriate level of protection (ALOP).
The management measures selected must be both effective in reducing the risk to an acceptable level, and also able to be implemented.

20. 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.
Efficacy looks at the option’s ability to reduce the overall risk posed by a hazard, through reducing either the likelihood of release or the likelihood of exposure.
Feasibility generally focuses on the technical, operational and economic aspects of implementing a risk management measure.

21. 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 evaluation is an iterative process that can involve many passes through the risk estimation process using different management options, either alone or in combination.
There may be several risk management measures that achieve the same results. In this case, the proponent can be offered a choice of actions.

22. 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 country’s 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
SPF – specific pathogen free. This term is frequently misunderstood. It indicates that the aquatic animals come with a guarantee (based on repeated diagnostics testing of stocks and confinement in a biosecure facility) that they are free of certain pathogens.
Note that:
They still may carry other pathogens, epibionts, etc.
They are not necessarily more resistant to infections that other stocks (however, some stocks are Specific Pathogen Resistant).
Once they leave the SPF production facility, they are not longer SPF – they are now called High Health.
At present SPF stocks only exist for certain species of penaeid shrimp.

23. 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)

24. 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
Photo – Quarantine Notice - Malaysia

25. 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)

26. No. Hazards Requiring Risk Management
Risk Management in the 9 Pathogen Risk Analyses
Risk Analysis
No. Hazards Requiring Risk Management
Recommended Risk
Management Methods
Salmonids for human consumption 7
Pre-export certification; head off, eviscerated, processing at registered premises only
Live ornamental finfish to Australia 12
Pre-export certification;
Post-arrival quarantine with ad hoc disease testing
Juvenile kingfish from Australia to NZ 4
Pre-export conditions & viral testing: post-arrival quarantine &conditions
Litopenaeus stylirosis from Brunei to Fiji 8
Larvae from SPF broodstock,
pre-export conditions &viral testing, post-arrival conditions
Postlarval Macrobrachium from Fiji to Cook Islands 2
Pre-export viral testing, post-arrival conditions
This slide and the following show some of the risk management measures that have been recommended by the 9 pathogen risk analyses. The measures include pre-border measures such as health certification, diagnostics testing and the use of SPF stocks; border measures, such as quarantine and inspection upon arrival; and pre-border activities, such as restrictions on processing and contingency planning.
Modified from Diggles and Arthur DAAVII presentation.

27. No. Hazards Requiring Risk Management
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 13
High-risk hosts prohibited, post-arrival quarantine with targeted passive surveillance
Adult Macrobrachium from Hawaii to NZ 4
Pre-export conditions & viral testing, post-arrival quarantine & conditions
Menhaden (Brevoortia sp.) from USA to Australia 1
Pacific oysters from Tasmania to NSW 3
Pre-shipment viral testing, chlorine bath treatment to remove pests/epibionts
Modified from Diggles and Arthur DAAVII presentation.

28. 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 is a popular approach to dealing with uncertainty in scientific decision-making. Its essence is that where uncertainty exists and serious damage is possible, governments (and private sector) should err on the side of caution.

29. 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 arose not from environmental science or from philosophy of science, but from awareness of past failures in dealing with environmental risks and recognition that a “common sense” approach to dealing with uncertainty was needed.

30. 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.
Paraphrased from GEMSAMP Reports and Studies 76.

31. 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
Photo: Quarantine office, Malaysia

32. 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.
As previously mentioned, the “assumption of innocence” as applied to pathogen risk analysis is in contrast to the “assumption of guilt” that is seen in other risk analysis sectors (i.e.. In these sectors (environmental, genetic, ecological RA, suspicion of potential for negative impacts is sufficient to prohibit an activity until lack of harm is shown). However, it is often impossible to clearly demonstrate “lack of harm”.

33. 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

34. 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.

35. 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

36. 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.

37. 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.

38. 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.

39. 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.
Full documentation will assist with implementation of the selected risk management measures and with monitoring and review.
The growing library of completed risk analyses for aquatic animals is a valuable resource for future risk analyses involving similar commodities.

40. Steps in Preparing a Risk Analysis Report
Describe the preliminary risk analysis objectives & plans
Describe the scale and scope of the risk analysis
Describe the operational context of the project/system to be assessed
Review the risk analysis process & agreed endpoints with a statement of ALOP
Discuss primary data sources & methods used for data collection & analysis
Modified from Hewitt (2009)

41. Steps in Preparing a Risk Analysis Report
Describe the identified hazards with risk profiles (likelihood and consequence assessments) for each hazard; include a summary of uncertainty in each risk profile
Identify risk management options for each risk profile and provide advice on the extent to which the risk is reduced by the management option
Summarize overall risk acceptability
Modified from Hewitt (2009)

42. 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.

43. 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.