Diff Sim HA RA 1

Differences and similarities between HACCP and Risk Analysis

Mike van Schothorst

Diff Sim HA RA 2

Terminology

ALOP Risk MRA MRM

Communication

Hazard Analysis / Risk Analysis FSO Hazard HACCP Safety Diff Sim HA RA 3

Hazard

A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect Diff Sim HA RA 4 Codex Alimentarius, 1997

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Risk

A function of the probability of an adverse health effect and the severity of that effect consequential to a hazard in food

Risk Analysis

A regulatory tool to maintain or enhance the supply of safe food, both locally produced and imported, in a certain country It is not only an analysis, it includes also risk management Diff Sim HA RA 6

Science based MRA Risk Analysis Microbiological Risk Assessment MRM Microbiological Risk Management Policy based Risk Communication Interactive exchange of information and opinions concerning risks and control measures Diff Sim HA RA 7

Risk Analysis and HACCP M a r k e t m e t n G o v e r n Assessment R I S K

Management

identification quantification

decision

control review Diff Sim HA RA 8 H A C C P t r y I n d u s

F a c t o r y

Diff Sim HA RA 9 HACCP An operational system to select and implement effective control measures to ensure the safety of a food product Microbiological Risk Assessment ( MRA ) A procedure to provide data that are used in the selection of appropriate risk reduction measures

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The HACCP system

compared with

Risk Analysis

Codex HACCP Guidelines

Diff Sim HA RA 11 1. Assemble HACCP team 2. Describe product 3. Identify intended use 4. Construct flow diagram 5. Confirm on-site flow diagram 6. List all potential hazards, conduct a hazard analysis and consider control measure 7 - 12. Apply principles 2 - 7

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HACCP Principles

1. Conduct a hazard analysis 2. Determine the CCPs 3. Establish critical limit(s) 4. Establish a monitoring system 5. Establish corrective actions 6. Establish verification procedures 7. Establish documentation

(1) Assemble HACCP team



Obtain top management commitment

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Appoint a leader and a secretary

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Assure participation of experts in QA, microbiology, chemistry, food technology

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Assure co-operation of other experts

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Define scope of the study

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Set priorities Diff Sim HA RA 13

Assemble Risk Assessment team

Diff Sim HA RA 14 Same general principles apply, but Risk managers are mainly governmental regulators and scientists, while a HACCP team consists mainly of production people.

The pathogen and food of concern is often already decided upon by the Risk Managers MRA

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(2) Describe product



Formulation and composition Raw materials & ingredients Parameters influencing safety



Processing

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Packaging



Distribution

Products to analysed

Diff Sim HA RA 16 Same general principles apply, but the product is a commodity, not a specific one.

It is a product produced in different manners by different manufacturers, including manufacturers in other countries MRA

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(3) Identify intended use

Food service establishments Caterers Hospitals General population Specific groups of the population Preparation practices Exportation

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Use of Products

Same categories may apply, however, products for export may need to be treated separately because of the differences in use and users MRA

(4) Construct flow diagram



Cover all steps which might have an influence on the safety of the product

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Include important data such as time & temperature

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Indicate hygiene level of areas and barriers



Indicate personnel movements etc.

Diff Sim HA RA 19 Raw materials Mixing Heating Filling

Perform a Product / Pathogen / Pathway ( PPP ) analysis

Diff Sim HA RA 20 The fate of the pathogen of concern from “farm to fork” will be described in detail, data concerning conditions at the various steps need to be collected and treated, growth, survival etc. will be “modelled” MRA

(5) On - Site confirmation of flow diagram



Check correctness of information



Check whether important information was not overlooked



Check during all periods of operation and cleaning, but also during idle hours



Discuss practices with operators Diff Sim HA RA 21

PPP confirmation

Diff Sim HA RA 22 The pathway and its conditions need to be checked, models need to be validated and the outcomes verified as far as possible. Uncertainties need to be identified.

the PPP in risk analysis is less specific as the one used in HACCP MRA

Diff Sim HA RA 23 (6) List all hazards associated with each step, conduct a Hazard Analysis, consider any measures to control identified hazards Determine which potential hazards are significant and should be controled

Hazard identification

Diff Sim HA RA 24 The hazard of concern is identified by MRM.

Important aspects of the ecology and behaviour of the pathogen are collected.

This is particularly difficult when the risk of a “new” pathogen is assessed in HACCP hazard identification means determination which hazards are significant MRA

Perform a Hazard Analysis

Diff Sim HA RA 25 Collect and interpret information on hazards and conditions leading to their presence at unacceptable levels and decide which need to be controlled HA is not RA "the analysis of hazards must be quantitative if it is to be meaningful" ICMSF 1988

Hazard Determination Questions to be answered for each potential hazard for each step Presence of agent in raw material probable ?

NO YES

No hazard*

Presence of agent in line or environment probable ?

NO YES Unaccept. survival, persistence or increase at this step probable ?

NO YES Reduction, if any, at a further step adequate ?

YES Unaccept. contamination at this step probable ?

No hazard*

YES** NO NO HAZARD * Not a hazard to be controlled at this step Diff Sim HA RA 26 ** Reduction step becomes thus a CCP

Acceptable levels

( 1 ) Diff Sim HA RA 27 Not all levels (or sizes) of all agents are harmful to all individuals under all conditions Agents (contaminants) are acceptable as long as their levels remain below a certain maximum

Acceptable levels

( 2 ) Products with a good record of safety are used as a “benchmark” New products, or changed products should be as safe as the “benchmark” Diff Sim HA RA 28 Performance Objectives are “benchmarks” set by authorities

Hazard Analysis of aflatoxin in milk Maximum Level accepted 15 μg / kg Possible Probable Likely No Q1: Presence of hazard at unacceptable levels in raw material CCP Q2: Persistent during processing Q3: Recontamination Q4: Increase during shelf-life Q5: Reduction during preparation

    

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HA of Listeria in hotdogs

Maximum Level accepted <100 / g ? Possible Probable Likely No Q1: Presence of hazard at unacceptable levels in raw meat Q2: Survival during processing



Q3: Recontamination Q4: Increase during shelf-life



Q5: Reduction during preparation

 

or

 

CCP Diff Sim HA RA 30

Assessment of probability

Possible Probable Likely Reasonably expected to occur These are semi - quantitative expressions of probability , based on analytical data or expert knowledge Diff Sim HA RA 31

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Probabilities

Risk assessors use “models” to calculate probabilities of survival, persistence, growth etc.

Models for recontamination are being developed the same models can be and are used in HACCP MRA

MRA components

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Hazard identification which pathogen will be assessed

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Hazard characterization what are the effects and what influences the effects

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Exposure assessment how often and how many will be ingested

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Risk characterization what is the chance that the effects will happen MRA

MRA Hazard characterization curve of Listeria monocytogenes L.m. dose-response Log No of cases per 100,000

worst - case scenario Buchanan e.a.

1997

2 1 0 6 5 4 3 2 3 4 5 6 7 8 9 10 Log No of ingested L.m., all servings contaminated Diff Sim HA RA 34

Diff Sim HA RA 35 Probabilistic calculation of exposure MRA

MRA

Outcomes of MRAs

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the chance for a person of falling ill by consuming a food

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the estimated number of illnesses (e.g. per year in a country) due to consumption of a specific food/pathogen combination



risk estimates for different processing, distribution and consumer use conditions and risk reduction scenarios HACCP in product development uses also different scenarios, but the outcome is a level of safety, not a level of risk Diff Sim HA RA 36

7) Determine Control Measures



Determine (CCPs)

where

measures must be taken



Determine

how and to which extent

they are to be controlled at these CCPs



Establish the critical limits and monitoring procedures Diff Sim HA RA 37

MRM components

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Preliminary MRM activities which pathogen / food will be assessed and why

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Evaluation of MRM options selection of control measures

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Implementation of MRM decisions communicate with stakeholders and follow-up

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Monitoring and Review collect epidemiological and other data, revise decisions if appropriate MRM

Control measures

Diff Sim HA RA 39 Risk managers are responsible for the evaluation and selection of control measures.

Food business operators are responsible for their execution in HACCP both activities are in the same hands MRM

Establish Critical Limits

They must assure that the required level of safety is obtained This level can be the “benchmark” or the “Performance Objective (PO)” Diff Sim HA RA 40 The PO may be the outcome of MRM evaluation

Diff Sim HA RA 41 Performance Objective ( PO ) The maximum frequency and / or concentration of a microbial hazard in a food

at a specified step

in the food chain before time of consumption that still provides or contributes to the achievement of an Food Safety Objective

or Appropriate Level Of Protection, as applicable.

A PO is an acceptable level of a hazard in HACCP terminology MRM

Diff Sim HA RA 42 9) Monitoring in HACCP The act of conducting a planned sequence of observations or measurement of control parameters to assess whether a CCP is under control

Monitoring and Review in MRM

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Assessment of effectiveness of measures taken

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Review risk management and / or assessment as necessary (new option, new information)

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An example of differences and similarities

Product Pathogen Pathway of Listeria monocytogenes in a specific paté produced according to GHP and HACCP and a “generic” paté, as used in Microbiological Risk Assessment

Log.

Lm./g 1 0 -1 -2 -3 Reception PPP of L. monocytogenes (paté 1) GHP and HACCP assure safety of specific product HACCP safe level Heating Packaging Recontamination Growth Diff Sim HA RA 44

MRA PPP of L. monocytogenes (paté 2) A “generic product” under general conditions in a country Log.

Lm./g 4 2 0 -2 -4 Reception Heating Packaging Recontamination Growth Input for MRA

Change conditions ?

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Risk estimates of listeriosis

per 100 Mio inhabitants of the USA which level acceptable ?

3 2 1 0 8 7 6 5 4 1/g Diff Sim HA RA 46 cases of listeriosis 10/g 100/g 1000/g level of L. monocytogenes

Risk Acceptability concept

Severity

Intolerable region ALARA region As low as reasonably achievable Acceptable region At which levels are these lines set ?

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