Differences and similarities between HACCP and Risk Analysis Mike van Schothorst

Terminology

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

Hazard A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect Codex Alimentarius, 1997 The word "hazard" has a particular meaning in the HACCP concept. It refers to something which is unacceptable because it may cause harm to the consumer. This “something” can be a biological, chemical or physical agent in a food. It can also be a feature or condition of a food. For instance, if a food permits the growth of a infectious agent (a “pathogen”), and if the food is not refrigerated properly, such a condition is a hazard.

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

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

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

An operational system to select and implement 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

The HACCP system compared with Risk Analysis

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 The Codex guidelines describe how a HACCP study should be performed. These guidelines give a certain universal structure to a study, which will make it more likely to be accepted by other parties (food inspectors and trade partners). The 7 principles may be applied taking specific conditions into account, and not following the guidelines exactly.

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 HACCP system consists of 7 principles. These principles form the minimum requirements in the mandatory application of HACCP system. They are simple, provided that we understand the meanings of the terms. Therefore, we will now review the meanings of the essential terms used in these principles

(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 To perform a HACCP study, a HACCP team has to be assembled. A leader knowledgeable in HACCP should be appointed as well as a secretary. Documenting the HACCP study is a very important aspect of the exercise. Experts in quality assurance, microbiology, chemistry, food technology etc. will be needed in complicated food production or preparation lines. Often, other experts, e.g. on logistics, agricultural practices etc., may be needed to complete the study. To keep the study manageable, it is important to define its scope and set priorities.

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

(2) Describe product Formulation and composition Raw materials & ingredients Parameters influencing safety Processing Packaging Distribution One of the first activities of the study team is to describe the product. Which raw materials and ingredients are used, and who are the suppliers. Which parameters influence safety (pH, Aw, modified atmosphere packaging, storage temperature and time etc.)? What are the processing conditions, temperature treatments etc.? How is the packaging performed, and what are the characteristics of the packaging material? What are the real conditions during distribution, warehousing and sales?

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

(3) Identify intended use Food service establishments Caterers Hospitals General population Specific groups of the population Preparation practices Exportation Next, the intended use of the product has to be defined, because this may influence the level of safety to be assured, or the risks which can be taken. If the product is to be sold to hospitals or groups of the population with high susceptibility to certain microbes, more safety has to be built in and critical limits need to be more strict. The use and preparation practices may also influence the safety of a product. HACCP is successful only if applied from farm to fork. For certain products such as hamburgers, the preparation practices determine the final safety for the consumer. For certain bacteria, such as Salmonella, contamination of the raw material (i.e. meat) at the agricultural level can not be prevented. Thus, if the processing does not include any killing step, the only CCP which can render the product safe is the adequate heat treatment during preparation.

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 Include important data such as time & temperature Indicate hygiene level of areas and barriers Indicate personnel movements etc. Raw materials Mixing Heating To understand how a product is manufactured, and to have a disciplined approach in the study, it is important to construct a flow diagram covering all steps where product safety could be affected. Temperatures in heat treatments should be mentioned as well as time, time and temperature should also be mentioned for holding the product in buffer tanks, holding vats etc. In many food production and preparation establishments, different areas or rooms have different hygiene levels, and barriers, such as walls or air curtains separate them. For instance, most Good Manufacturing Practices require a clear separation between raw materials and prepared foods. For the same reason, it is important to indicate on the diagram the personnel movements. Filling

Perform a Product / 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

(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 Up to this point, the study is a paper exercise. Clearly, what has been put on paper should be confirmed by an on-site inspection. This should check the correctness of the information and ensure that nothing crucial was overlooked. It is important to inspect the site and the practices applied during all hours (night shifts, weekends etc.) of operation, as well as the idle hours. Inspection of the cleaning procedures and validation of their efficacy is very important. Operators often are better informed than Chief Engineers or Production Managers about practices and the problems encountered during the operation, and may have information about problems that were not considered in the study.

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

Determine which potential hazards (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 This activity will be described in detail during the next lecture.

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

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 This overhead gives the Codex definition of Hazard Analysis.

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

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

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

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 

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

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

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 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

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

Probabilistic calculation of exposure MRA Probabilistic calculation of exposure

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 Up to now, not too many countries and organisations have conducted full MRA studies. Little experience has thus been gained yet on articulating risk estimates and interpreting them in risk management decision-making. For most of the MRA studies undertaken, the outcome aimed for was an “absolute” measure of risk, a numerical estimate in it’s own right about the chance of falling ill upon consumption or the number of people falling ill per year in a country. MRAs aiming at “relative” risk estimates, expressing the risk level posed by a particular hazard between products or compared to other products, are few at present but may become frequent [since it may proof to be much more feasible to conduct the in practice as there is less of a need to articulate a explicit risk level]. The risk managers will evaluate the outcome of the MRA, with attendant uncertainties, the intervention options possibly included, the expected impact or effect and recommendations or conclusions Risk managers are ultimately responsible for selecting and implementing appropriate options for control or management of the risk. This may well necessitate careful consideration and weighing of policy alternatives. They often have to weigh different types of risk (biological, chemical, physical) and have to balance that against costs and benefits of interventions. Part of the equation can also be a number of other values and considerations among the various stakeholders that are more societal and less science-based. HACCP in product development uses also different scenarios, but the outcome is a level of safety, not a level of risk

7) Determine Control Measures Determine where measures 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 Up to this point, the study is a paper exercise. Clearly, what has been put on paper should be confirmed by an on-site inspection. This should check the correctness of the information and ensure that nothing crucial was overlooked. It is important to inspect the site and the practices applied during all hours (night shifts, weekends etc.) of operation, as well as the idle hours. Inspection of the cleaning procedures and validation of their efficacy is very important. Operators often are better informed than Chief Engineers or Production Managers about practices and the problems encountered during the operation, and may have information about problems that were not considered in the study.

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

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

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

Performance Objective ( PO ) 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

Monitoring and Review in MRM 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)

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

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

PPP of L. monocytogenes (paté 2) 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

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

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

When is acceptable becoming unacceptable ?