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RISK‐BASED APPROACH FOR FOOD SAFETY:Authorities perspective
Moez SANAA, Agence Nationale de Sécurité Sanitaire, France
Workshop: Food Safety Challenges for Mediterranean Products(Zaragoza, Spain; 10‐11 June 2014)
Foodborne illnesses are prevalent in all parts of the world, and the cost in terms of human life and suffering is enormous.
Contaminated food contributes to 1.5 billion cases of diarrhea in children each year, resulting in more than three million premature deaths, (according to WHO).
Those deaths and illnesses are shared by both developed and developing nations.
Consumer costs include medical, legal, and other expenses, as well as absenteeism at work and school.
Costs to national governments stem from increased medical expenses, outbreak investigations, food recalls, and loss of consumer confidence in the products.
Foodborne diseases lead to increased demands on already overburdened healthcare systems in developing countries.
Food borne disease Burden Food borne disease Burden
Regional diversity: due to differences in income level, diets, local conditions, and government infrastructures.
Changes in animal husbandry
Agricultural practices have contributed to the increased risks associated with fresh fruit and vegetables, such as the use of manure, chemical fertilizers, untreated sewage, or irrigation water containing pathogens.
International trade allows for the rapid transfer of microorganisms from one country to another.
The increased time between processing and consumption of food leads to additional opportunities for contamination and time/temperature abuse, increasing the risk of foodborne illness
New and unfamiliar food borne hazards can more easily reach consumers who have not developed immunities to those pathogens.
Advances in processing, preservation, packaging, shipping, and storage technologies bring new forms of foods to the market, and occasionally new hazards.
The increase in travel: Persons exposed to a food borne illness in one country can expose others to the infection in a location thousands of kms from the original source.
Changes in lifestyle and consumer demands
Current and new challenges to food safetyCurrent and new challenges to food safety
Consumption
Storage
Retail SaleRetail service
Transport
Conditioning
Step 4Step 3Step 2Step 1
Reception
Transport
Harvest
Preparation
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Proce
ssing
Multiple points of food borne Multiple points of food borne hazards introductionhazards introduction
Food and non food sources of Food and non food sources of hazardshazards
Food or food components contamination:
Changes in prevalence and concentration
Adverse health effect
RiskLikelihood and severity of the adverse health effect
Multiple points of intervention
Food Safety relies on adequate control of all Food Safety relies on adequate control of all relevant hazardsrelevant hazards
Best practice systems : GAP‐GMP‐GHP
HACCP systems
Sound product concept
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Permit the achievement of a high level of food safety assurance when they are deployed faithfully and
consistently.
World Trade Organization (WTO, 1995) and SPS World Trade Organization (WTO, 1995) and SPS agreement agreement –– Codex AlimentariusCodex Alimentarius
Risk analysis has become the cornerstone in developing food control measures by linking epidemiological and laboratory findings with modeling procedures to estimate risks and their mitigation…
Risk Analysis ≠ Hazrad Analysis
DIFFERENCE BETWEENDIFFERENCE BETWEENRISK ANALYSIS RISK ANALYSIS AND AND HAZARD ANALYSIS HAZARD ANALYSIS (HACCP)(HACCP)
Hazard analysis – an operational system to select and implement effective control measures to ensure the safety of food product.Usually conducted at the plant/process level.
Risk analysis – a regulatory tool to maintain or enhance the supply of safe food, both locally produced and imported, in a certain country. Include risk assessment that provide information that are used in the selection of appropriate risk reduction measures
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Identification
Quantification
Decision
Control
ReviewReview
Assessment Assessment
ManagementManagement
Hazard or RiskHazard or Risk‐‐based Food Safety Systems?based Food Safety Systems?
Hazard‐BasedThe simple presence of a hazard is reason for considering a food unsafe
Preventing or Eliminating identified hazards
Risk‐BasedConsider the likelihood and the nature of consequences of an exposure to decide if a food is unsafe
Managing hazards based on acceptable levels of risk
While "hazard‐based decision‐making" has been, and often still is, the norm, governments around the world (lead by Codex Alimentarius, FAO, and WHO) are adopting Risk Analysis (RA) as the framework for risk‐based decision‐making.
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In order to understand the nuances of this debate it is necessary to make the technical distinction between the terms ‘risk’ and ‘hazard’.
Hazard ‐ A biological, chemical or physical agentin, or condition of, foodwith the potential to cause an adverse health effect.
Risk ‐ A function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food.
Muddled thinking can lead to believing, mistakenly, that the only way to reduce risk is to reduce or remove the hazard, when we can manage or reduce risk by leaving the hazard unchanged but controlling or reducing its exposure.
Risk Assessment?Risk Assessment?
RA is the qualitative or quantitative characterization or estimation of potential adverse health effects associated with exposure of individuals or populations to hazardshazards
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physical, physical, chemical, or chemical, or microbial microbial agentsagentsNot used in Not used in
isolation, but as isolation, but as a part ofa part ofRisk AnalysisRisk Analysis
Purpose of Risk AssessmentPurpose of Risk Assessment
A scientifically based process consisting of the following steps: (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization
A systematic examination of an issue to help make better risk management decisions
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Risk Based ApproachRisk Based Approach
Directing our resources to where the risk is greatest
Make the most effective use of all our efforts
Cannot be uniformly applied
Each food sector and Food Business Operator faces different risks
Seeks to achieve real outcomes
Reduce food borne illness burden, and subsequent economical and societal consequences
RISKRISK‐‐BASED APPROACH REQUIRESBASED APPROACH REQUIRES
Understanding the risks:National Risk Assessment should provide fundamental background affecting responsibilities and resourcing (Importance of public‐private information sharing) Enables well‐informed judgments
Define risk appetite, with minimum requirementsNo zero tolerance regime
Regulation and supervision must be effective, transparent, and include:Review of FBO’s own risk assessmentsPublication of appropriate guidancetools to identify weaknesses and sanction reckless behavior
Directing our resources to where the risk is greatest
selecting of appropriate risk reduction measures
Risk RankingRisk assessment
Risk Ranking and Risk Based resource allocationRisk Ranking and Risk Based resource allocationEfficient allocation of resources should be based upon assessment of the cost‐effectiveness of alternative risk reduction opportunities
Risk RankingRisk Ranking
Risk ranking is motivated by the hypothesis that
If the relative risks associated to a range of food products can be established, then risk reduction efforts can be directed at the worst ranked food products.
Food products at high risk are likely to have more and larger opportunities for risk reduction than food products at low risk
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In risk assessment In risk assessment
Risk: a function of the probabilityprobability of an adverse health effect and the severityseverity of that effect, consequential to a hazard(s) in food
Probability: diseases frequency (Incidence/Prevalence)
Seriousness of its consequencesHospitalizations
Mortalities
Cost of illness
Combined: e.g. DALY
Disability Adjusted Life YearsDisability Adjusted Life Years
• Risk metrics
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00
Quality Quality of lifeof life
115050 7070 8080
AgeAge
DALYs = years of life lost (YLL) + years lived with disability (YLD)= 10 + (20 x 0.4) = 18 years
0.40.4
Illness Death
Campylobacter Infection OutcomesCampylobacter Infection Outcomesaverage DALYs = 0.02 per caseaverage DALYs = 0.02 per case
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GE: gastroenteritisR: recoveryGBS: Guillain-Barré syndromeIBS: Irritable Bowel SyndromeReA: Reactive Arthritis
Exposure to STEC – O157
Exposure to STEC – O157
Infection(I)
Infection(I)
Non –bloody diarrhea
(W)
Non –bloody diarrhea
(W)
Bloody diarrhea
(B)
Bloody diarrhea
(B)D+HUSD+HUS
Death(M)
Death(M)
Recovery
Dialysis(D)
Dialysis(D)
Kidney transplantation
(TX)
Kidney transplantation
(TX)
Graft rejected(GR)
Graft rejected(GR)
Functioning graft(FG)
Functioning graft(FG)
End‐Stage renal disease
(ESRD)
End‐Stage renal disease
(ESRD)
Havellar et al. 2004 et Tariq et al 2011DAILY/case COI/case
D 0.006 126 €HUS 2.7 25 713 €ESRD 19.33 2 761 310 €Recovery
Risk Ranking using epidemiological surveillance dataRisk Ranking using epidemiological surveillance data
* Havellar et al., 2012** in France 2009‐2012
Hazrads *DALY/1000 **Notified cases/year DALYs/y RankBacillus cereus 2.3 1003 2 9Campylobacter 41 4629 190 4Clostridium perfringens 3.2 1391 4 8Staphylococcus aureus 2.6 1978 5 7Escherichia coli (STEC 143 134 19 6Virus de l’hépatite A 167 1302 217 3Virus de l’hépatite E 460 216 99 5Listeria monocytogenes 1450 304 441 2Salmonella spp . 49 9975 489 1
Top-down (epidemiologic risk assessment)
•Empirical analysis vs. Modeling
Empirical analysis of epidemiological dataUsing statistical methods
Bottom-up approache
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Retail Food X Storage
preparation Exposure Infection Illness
Transfer to ready to eat
foods
Consumption data
Dose Response
Disease burden
DALY template
Risk is assessed trough modeling analysis and simulations
Data to feed risk ranking modelData to feed risk ranking model
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Scientific reports and guidance, FAO, EFSA, FDA, EPA, ….
Dietary monitoring data
Food operators
Directing our resources to where the risk is greatest
selecting of appropriate risk reduction measures
Risk RankingRisk assessment and food safety targets
New Risk MetricsNew Risk MetricsAs part of the Codex Alimentarius Risk Analysis framework several new risk metrics have been designed to link country public health policies with operational control of the market food
New metrics are consistent with to the central principles of the SPS Agreement: harmonization, equivalence, appropriate level of protection (ALOP), risk assessment, regional conditions and transparency
ALOP: is the level of protection deemed appropriate by the WTO member to protect human, animal or plant life or health within its territory.
The ALOP is a broad objective
SPS measures are established to attain that objective
Each WTO member has the right to determine its own ALOP (However, members should consider the objective of minimizing negative trade effects and must avoid arbitrary or unjustifiable distinctions that result in discrimination or a disguised restriction on international trade)
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Stringency that food safety systems should achieveStringency that food safety systems should achieve
ALOP should not be discussed as the acceptable number of human disease cases…
It expresses what can be achieved with an acceptable cost for the society
For example, the level 10‐6 (1 per million) could be :Technologically reachableProhibitively costly that the activity originating the risk turn out to be unsustainable
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MRM metrics definitionsMRM metrics definitions
Food Safety Objective:“The maximum frequency and/or concentration of a hazard in a food at the time of consumptionconsumption that provides or contributes to the appropriate level of protection (ALOP)”
Performance Objective (PO):“The maximum frequency and/or concentration of a hazard in a food at a specified point in the food chain before the time of consumption that provides or contributes to an FSO or ALOP, as applicable”
Performance Criterion (PC):“The effect in frequency and/or concentration of a hazard in a food that must be achieved by the application on one or more control measures to provide or contribute to a PO or FSO” . Examples: reduce the prevalence by 2, reduce the microbial load by 10, 100….
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MRM metrics definitionsMRM metrics definitions
Process Criterion (PrcC):The processing conditions that must be met to achieve the PO/PC/FSO. Example: heat the product at 70°c during 30 seconds
Product Criterion (PrdC):The characteristic(s) of a food that must be maintained or achieved to achieve a PO/PC/FSO. Example: pH < 4
Microbiological Criterion (MC):The level and/or frequency detected by a specified method and sampling plan that achieves the PO/PC
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FSO/PO/MCFSO/PO/MC
Establishing a FSO or a PO is both a scientific and a societal decision• FSO is means of relating stringency of the entire farm‐to‐table system to public health outcomes
• PO is the primary means of articulating the level of stringency to the level of performance at a specified step in the food chain
• MC is a means of verifying that a PO is being achieved
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Consumption
StorageRetailingTransportConditioningStep 4
Step 3
Step 2
Step 1
Reception
Transport
Harvest
PreparationCooking
FSO ALOP
PO1
PO2
PO3
PC
PC
PC
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PrC
PrC
PrC
PCPdC
Food Safety Objective Performance Objective Performance Criterion Process Criterion Product Criterion
Control measures
Control measures
Control measures
Control measures
Microbial Criteria
Goverment and industry reponsabilitiesGoverment and industry reponsabilities
Producing and marketing safe foods are industry responsibility
Government has the role to:Establish the stringency that food safety systems should achieve (ALOP/FSO)Evaluate the equivalence of different approaches to achieving the desired stringencyEnsuring that industry is meeting its responsibilities at the desired level
The degree of “regulatory control” placed on a pathogen‐food pair should be a function of public health risk
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OpportunitiesOpportunities
Risk based concept provides targets for the cost‐effective design of Food safety management systems in individual businesses• Flexibility in combining the relative effects of control measures
• Moving away from reliance on analytical testing (high operational costs) towards reliance on validation (increased cost of product development)
Reduces barriers to international trade• Provide adequate documentation of compliance with ALOPs (or ALOP –derived targets) at different markets
• Provides documentation of equivalence, despite diverging national legislation
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