FAO/WHO guide for application of risk analysis principles to food safety emergencies Food Recall and Traceability (February 2013, Thailand)
• Preparedness • Preliminary risk management • Risk assessment • Risk management • Risk communication • Recovery
• National Food Safety Emergency Response Plan – overarching set of arrangements – FAO/WHO framework for developing national food safety emergency response plans (FAO/WHO, 2010) • “Food safety risk analysis: a guide for national food safety authorities ” (FAO/WHO, 2006
Preparedness • Reduces the number of decisions during an emergency • Reduces confusion (and disagreement) • Agreed structures, roles and responsibilities • Legislative authority and limitations understood • Templates, decision trees and other tools increase efficiency
Process for Incident Response CNP notifies CEO & Deputy CEO Incident Notification CEO appoints NFIC Procedure INP01 Deputy CEO appoints FSANZ IC, RAC, CC, Sec Procedure INP02 Processes and CNP convenes Prepare Draft Determine FIG meeting Emergency Risk incident scope Profile Procedure RAP01, procedures RAP03 Notify Int’l Agencies & Collect Intel. Procedure ICP12 Draft Risk Assessment prepared National Teleconference Procedure RAP02, Procedures ICP01, ICP02, RAP06 ICP04, Affected Agencies identified Incident objective identified Final Risk Actions assigned Industry Assessment Engagement Procedures RAP03, RAP05, RAP06 Affected Agencies determine appropriate response and report S/T implement back to PAs agreed actions Procedure ICP14 Stand down and national debrief Procedures ICP06, ICP11, ICP12
Preliminary Risk Management Verification and validation • Commence investigations (epi, food safety) to establish – Whether food is potentially contaminated with a food hazard – Whether severe illness or death is involved – Whether the event appears to be localized or widespread – Whether the source of the hazard has been identified
Preliminary Risk Management continued • Commence investigations (epi, food safety) to establish – The involvement of a particular food source – The likely scope of distribution of the product (e.g. local, regional, national, international) – Whether action is required – and whether emergency response procedures need to be activated
Crisis
After activating the Emergency Response Plan • Risk managers should – Set the objectives for the emergency response – Identify data required – Evaluate any other relevant factors – Consider need to include other relevant agencies/ministries in MACG – Determine which stakeholders may need to be notified (e.g. senior officials, other agencies, affected private-sector establishments)
Preliminary Risk Management continued • Formulate risk assessment questions – Targeted questions should be presented to risk assessors in a standard format – Clearly defined questions based on currently available evidence should be included – Templates may be helpful
Risk assessment • Screen incoming and other available data and information rapidly • Decide on the appropriate methodological approach and the scope of the risk assessment • Does a risk assessment need to be conducted? – are there food safety standards already in place? – Is there sufficient data to conduct an RA? • Could existing risk assessments be used to feed into the current risk assessment?
Risk assessments continued • Time and information constraints – Usually insufficient time and data to conduct full risk assessments – However, emergency risk assessments need to be robust enough to stand up to scrutiny (and challenge) – For example, Eyjafjallajökull volcanic eruption – used data from previous eruptions
Risk assessment • In an emergency situation frequent, urgent communication between risk managers and risk assessors may be required • Peer review of the risk assessment should be considered – especially where data is limited • Use of existing tools can help – existing national or international consumption data sets, expert networks, international reference values, advice from international counterparts
Risk assessment • Hazard identification – Where insufficient data is available, or hazard is not fully identified, there may be insufficient time to generate new data • Surrogate data may be useful (eg unknown serotype non 0157 e. coli , 0157:H7 data could be used) – Testing methodology • Where no validated method is available in-house, review literature to identify suitable method or seek advice from the international community – or develop a method.
Risk assessment • Hazard Characterisation – Existing data from tox studies, guideline values, dose-response models etc can be used – Where dose-response information is not available, a conservative approach should be taken and the whole population should be considered sensitive
Risk assessment • Exposure assessment – Existing national consumption data preferred – alternatives include • Household food expenditure surveys • Models • Other national datasets • International data (eg WHO GEMS) – *It is important to identify and document assumptions used in dietary exposure assessment modelling
17 Inputs into Dietary Exposure Assessment National nutrition Consumer research data surveys (Australia and Market share data NZ) = ∑ Dietary Food consumption x Food chemical Exposure to food concentration chemicals Other data identifying consumption patterns 17
Risk assessment Risk characterisation • During an emergency, often qualitative or semi- quantitative because of constraints on time and information • Decision trees can be very helpful in quantifying level of risk – and in communicating levels of risk
Principles of risk characterisation An estimation, including attendant uncertainties, of the probability of occurrence and severity of an adverse effect(s) in a given population under defined exposure conditions. In other words . . . what is the likely human health risk ? Aim of the risk characterisation: To integrate information from the hazard assessment and dietary exposure assessment into advice suitable for use in risk management. Hazard assessment Risk Advice to risk managers management Exposure assessment
Templates Procedure XXXXXXXXXX Draft Emergency Risk Profile Number P0XXX FOOD INCIDENT NOTIFICATION Incident No: Version Number 1 [INSERT NUMBER] Release Date July 2011 DRAFT EMERGENCY RISK PROFILE Incident No: [NAME OF INCIDENT] (Interim and incomplete in nature) Time/Date Incident 1. Who [Insert Number] Location/Jurisdiction: [Name from Job Card] Notified: [NAME OF INCIDENT] Imported food (if yes, list country) [INSERT DATE] 2. Why Time/Date Meeting: Present: Describe the issue: This procedure ensures that [XXX is done/prepared – consistent – timing – circulation – Version: recorded – in accordance with the National Food Incident Response Protocol. 3. How [highlight time imperative actions] Relevant Food Standards Code limit (if applicable): Information and background available: 1) XXXXXXXXXXXXXXXXXXXX [action word] Xxxxxxxxxxxxxx Food(s) affected: [Provide details on the description and quantity of product, including Brand name, Lot [action word] xxxxxxxx. Information sought: identification, type and size of package, identification of premises where last packed or 2) XXXXXXXXXXXXXX processed. Use- by, ‘packed - on’ or ‘Best before’ date where relevant] [action word] Xxxxxxxxxx Are there other foods/routes of exposure that should be considered? Hazard ID Distribution of the food: [action word] xxxxxxxx What is it xxxxxx Interstate NSW VIC WA 3) XXXXXXXXXXXXXXXXXXX: [action word] xxxxxxxxxxx QLD SA TAS [action word] xxxxxxxxx ACT NT 4) XXXXXXXXXXXXX Hazard Characterisation [action word] xxxx What could it do to us Exported New Zealand [action word] xxxx Other (list countries) 4. Forms and templates Other information provided by Notifying Agency/Company: [Template title & link] [Does it have acute/chronic effect?Does it affect sub-populations?Can it be treated?What is the outcome of the exposure?What is the severity of the outcome, is it reversible?How is 5. References the hazard transmitted to humans?What is the likelihood of exposure?] Exposure assessment [is there a recall in progress? if so what is the recall number? has any action been taken as How likely is it to be eaten National Food Incident Response Protocol (current version available at yet? what action is proposed (e.g. teleconference etc)? when will the next communications ........)FSANZ’s Incident Response Protocol (current version available at ........) be?] Action required on notification: Risk Assessment [State whether the notification is for information only or if jurisdictions are expected to How sick will it make us respond with their opinion or acceptance of proposed teleconference etc] Contact person(s) for further information: [Full contact details including name, address, telephone, fax number and email address of persons or organisations who can supply further information.]
Risk assessment • Important to document and explain limitations and uncertainties • Need to revise risk assessment as new data becomes available • MACG needs to consider revised risk assessment – and risk management or communication implications
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