Differences and similarities between HACCP and Risk Analysis

1. Differences and similaritiesbetween HACCP and Risk Analysis Mike van Schothorst

2. Terminology

3. ALOP FSO Communication Risk Hazard MRA HACCP MRM Safety Hazard Analysis / Risk Analysis

4. Hazard • A biological, chemical or physical • agent in, or condition of, food • with the potential • to cause an adverse health effect • Codex Alimentarius, 1997

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

6. 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

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

8. Risk Analysis and HACCP Government identification Industry Assessment F a c t o r y HACCP M a r k e t RISK quantification decision Management control review

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

10. The HACCP system compared with Risk Analysis

11. Codex HACCP Guidelines • 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

12. 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

13. (1) Assemble HACCP team • Obtain top management commitment • Appoint a leader and a secretary • Assure participation of experts in QA, microbiology, chemistry, food technology • Assure co-operation of other experts • Define scope of the study • Set priorities

14. Assemble Risk Assessment team • 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

15. (2) Describe product • Formulation and composition • Raw materials & ingredients • Parameters influencing safety • Processing • Packaging • Distribution

16. Products to analysed • 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

17. (3) Identify intended use • Food service establishments • Caterers • Hospitals • General population • Specific groups of the population • Preparation practices • Exportation

18. 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

19. (4) Construct flow diagram • Cover all steps which might have an influence on the safety of the product • Include important data such as time & temperature • Indicate hygiene level of areas and barriers • Indicate personnel movements etc. Raw materials Mixing Heating Filling

20. Perform aProduct / Pathogen / Pathway( PPP ) analysis • 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

21. (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

22. PPP confirmation • 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

23. (6) List all hazardsassociated with each step,conduct a Hazard Analysis,consider any measuresto control identified hazards Determine which potential hazards are significant and should be controled

24. Hazard identification • 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

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

26. Hazard Determination Questions to be answered for each potential hazard for each step Presence of agent in raw material probable ? Presence of agent in line or environment probable ? NO NO No hazard* YES YES Unaccept. survival, persistence or increase at this step probable ? Unaccept. contamination at this step probable ? YES NO NO No hazard* YES YES** Reduction, if any, at a further step adequate? NO HAZARD * Not a hazard to be controlled at this step ** Reduction step becomes thus a CCP

27. Acceptable levels ( 1 ) • 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

28. 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” • Performance Objectives are “benchmarks” • set by authorities

29. 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 Q2: Persistent during processing Q3: Recontamination Q4: Increase during shelf-life Q5: Reduction during preparation CCP     

30. 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

31. Assessment of probability • Possible • Probable • Likely • Reasonably expected to occur These are semi - quantitative expressions of probability , based on analytical data or expert knowledge

32. 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

33. MRA components • Hazard identification which pathogen will be assessed • Hazard characterization what are the effects and what influences the effects • Exposure assessment how often and how many will be ingested • Risk characterization what is the chance that the effects will happen MRA

34. MRA Hazardcharacterization curve ofListeria monocytogenes Log No of cases per 100,000 worst - case scenario Buchanan e.a. 1997 Log No of ingested L.m., all servings contaminated

35. MRA Probabilistic calculation of exposure

36. MRA Outcomes of MRAs • the chance for a person of falling ill by consuming a food • 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

37. 7) Determine Control Measures • Determine wheremeasures must be taken (CCPs) • Determine how and to which extent they are to be controlled at these CCPs • Establish the critical limits and monitoring procedures

38. MRM components • Preliminary MRM activities which pathogen / food will be assessed and why • Evaluation of MRM options selection of control measures • Implementation of MRM decisions communicate with stakeholders and follow-up • Monitoring and Review collect epidemiological and other data, revise decisions if appropriate MRM

39. Control measures • 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

40. 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)” The PO may be the outcome of MRM evaluation

41. MRM 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

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 • Assessment of effectiveness of measures taken • Review risk management and / or assessment • as necessary (new option, new information)

43. An example of differencesand 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

44. HACCP PPP of L. monocytogenes (paté 1) GHP and HACCP assure safety of specific product safe level Log. Lm./g Recontamination Growth

45. MRA PPP of L. monocytogenes (paté 2) A “generic product” under general conditions in a country Log. Lm./g Input for MRA Change conditions ? Recontamination Growth

46. Risk estimates of listeriosis per 100 Mio inhabitants of the USA which level acceptable ? level of L. monocytogenes

47. Risk Acceptability concept Severity • Intolerable • region As low as reasonably achievable ALARA region Acceptable region At which levels are these lines set ?

48. When is acceptable becoming unacceptable ?