Preparedness Preliminary risk management Risk assessment Risk - - PowerPoint PPT Presentation

Food Recall and Traceability (February 2013, Thailand)

FAO/WHO guide for application of risk analysis principles to food safety emergencies

• 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

Incident Notification

Procedure INP01

CNP convenes FIG meeting National Teleconference

Procedures ICP01, ICP02, ICP04,  Affected Agencies identified  Incident objective identified  Actions assigned

CNP notifies CEO & Deputy CEO CEO appoints NFIC Deputy CEO appoints FSANZ IC, RAC, CC, Sec

Procedure INP02

Determine incident scope Affected Agencies determine appropriate response and report back to PAs

Procedure ICP14

Prepare Draft Emergency Risk Profile

Procedure RAP01, RAP03

Notify Int’l Agencies & Collect Intel.

Procedure ICP12

Draft Risk Assessment prepared

Procedure RAP02, RAP06

Industry Engagement S/T implement agreed actions Final Risk Assessment

Procedures RAP03, RAP05, RAP06

Stand down and national debrief

Procedures ICP06, ICP11, ICP12

Processes and procedures

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

Dietary Exposure to food chemicals

= ∑ Food consumption x Food chemical

concentration

Consumer research data National nutrition surveys (Australia and NZ) Market share data

Inputs into Dietary Exposure Assessment

17

Other data identifying consumption patterns

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 Exposure assessment Advice to risk managers Risk management

DRAFT EMERGENCY RISK PROFILE (Interim and incomplete in nature)

Incident No: [Insert Number] [NAME OF INCIDENT] Present: Time/Date Meeting: Version:

Information and background available: Information sought: Are there other foods/routes of exposure that should be considered? Hazard ID What is it Hazard Characterisation What could it do to us Exposure assessment How likely is it to be eaten Risk Assessment How sick will it make us

Draft Emergency Risk Profile

Templates

FOOD INCIDENT NOTIFICATION

Incident No: [INSERT NUMBER]

[NAME OF INCIDENT]

Location/Jurisdiction: Imported food (if yes, list country) Time/Date Incident Notified: [INSERT DATE] Describe the issue: Relevant Food Standards Code limit (if applicable): Food(s) affected: [Provide details on the description and quantity of product, including Brand name, Lot identification, type and size of package, identification of premises where last packed or

• processed. Use-by, ‘packed-on’ or ‘Best before’ date where relevant]

Distribution of the food: Interstate NSW VIC WA QLD SA TAS ACT NT

Exported

New Zealand Other (list countries) Other information provided by Notifying Agency/Company: [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 the hazard transmitted to humans?What is the likelihood of exposure?] [is there a recall in progress? if so what is the recall number? has any action been taken as yet? what action is proposed (e.g. teleconference etc)? when will the next communications be?] Action required on notification: [State whether the notification is for information only or if jurisdictions are expected to 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.]

Procedure XXXXXXXXXX Number P0XXX Version Number 1 Release Date July 2011

• 1. Who

 [Name from Job Card]

• 2. Why

This procedure ensures that [XXX is done/prepared – consistent – timing – circulation – recorded – in accordance with the National Food Incident Response Protocol.

• 3. How [highlight time imperative actions]

1) XXXXXXXXXXXXXXXXXXXX  [action word] Xxxxxxxxxxxxxx  [action word] xxxxxxxx. 2) XXXXXXXXXXXXXX  [action word] Xxxxxxxxxx  [action word] xxxxxxxx  xxxxxx 3) XXXXXXXXXXXXXXXXXXX:  [action word] xxxxxxxxxxx  [action word] xxxxxxxxx 4) XXXXXXXXXXXXX  [action word] xxxx  [action word] xxxx

• 4. Forms and templates

 [Template title & link]

• 5. References



National Food Incident Response Protocol (current version available at ........)FSANZ’s Incident Response Protocol (current version available at ........)

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

Risk management

• Although public health and safety is

paramount, social and economic impacts need to be considered

• Preparation will help with risk management

decisions during an emergency – eg pre- agreed risk management options and decision triggers, templates and decision trees etc

• Documenting risk management decisions is

critical

Risk management

• Identify risk categories and possible risk

management options – A template may be helpful

Draft Risk management matrix for sibutramine in weight loss products

A national risk management decision tree has been developed to provide guidance and a consistent approach to managing the presence of sibutramine (schedule 4 drug, prescription medication) in weight loss products. Please note:

• this risk management matrix is for sibutramine in weight loss beverages only and should not be used for any other products

NO Scenario 1 No further action Has sibutramine been detected in weight loss food product? What level of sibutramine was detected? Unsuitable and Potentially Unsafe Consider on case by case analysis (contains prescription only medicine)

Scenario 2 Risk management: States and Territories to consider the following on a case by case:

• Voluntary withdrawal
• Need for an advisory statement

Unsafe

(likely to cause physical harm in some consumers)

Scenario 3 (Health risk) Risk management: States and Territories to consider the following on a case by case:

• Consumer level recall
• Need for an advisory statement

YES More than 9mg per serve Less than 3mg per serve

FSANZ Responsibility

Less than 9mg but more than 3mg per serve

Jurisdiction responsibility

Could the product reasonably be consumed at 3 or more serves per day NO or unclear YES

Risk management

• Factors to consider in selecting risk

management options – Capacity issues, eg to implement or laboratory capacity issues and ability to obtain assistance from elsewhere – Uncertainty about the nature of the risks – Public expectations and perceptions – Legal considerations

Risk management

• Factors to consider

– Industry considerations, Industry support and cooperation – International considerations, eg actions taken by other countries, trade implications – Other

Risk management

• Implementation

– Capacity – resources and trained personnel – May need to involve agencies/ministries not usually involved in food enforcement – Legal authority – Consultation and coordination with industry – Complex supply chains and traceability

• After the emergency

– Monitoring, evaluation and refinement

Risk communication

• May be very different from usual

communication approaches – Urgent with short timeframes – Communicating complexity and uncertainty – Messages may change as situation unfolds – Public, media or political concern and pressure for action – Demands for frequent updates from different stakeholders

Risk communication

• Communicating with industry

– Will allow faster response and may help with an earlier return to market of recalled products – Important to establish industry/government contact points for use during emergency – Two way communication is important – industry may be a good source of information and may be able to assist in implementing risk management – Think about the supply chain

Risk communication

• Communicating with industry

– Industry needs to be aware of requirements on them and the emergency response rules and guidelines – Industry needs to be advised of investigation approaches, proposed risk management options and legal basis – Important that government and industry communication messages are consistent

Risk communication

• Communicating with the general public

– Early communication is critical even when there is uncertainty – Public trust can be easily damaged – Must be as accurate as possible, timely, consistent, complementary, demonstrate confidence, well targeted and address public concerns – May need to counter inaccurate or misleading statements by others

Risk communication

• Communications to the public need to cover

– What is known about the food safety emergency – The food products involved – What the risks are and whether they are known – What levels of exposure could be harmful – What the public should do if they have consumed or obtained affected products – How to access additional information

Risk communication

• Consider a range of different ways to

communication with the affected public – Traditional media – Social media – Signs in shops – Community organisations – Advertising – Health officers, field officers

Risk communication

• International counterparts
• Importing countries
• International bodies, eg WHO - IHR

requirements, INFOSAN

Conclusion

• Preparedness is the key

– A national food safety emergency response plan – Tools to help with decision making (eg decision trees, templates) – Data and information storage on food hazards and previous risk assessments – Access to expert assistance – Evaluating and refining emergency arrangements after each event