1. Differences and similarities between HACCP and Risk Analysis
Mike van Schothorst

2. Terminology

3. Hazard Analysis / Risk Analysis
Communication
ALOP
FSO
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
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.

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. 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

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. 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

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
Apply principles
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.

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
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

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
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.

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
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?

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
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.

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
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

20. 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

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
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.

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. 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.

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
This overhead gives the Codex definition of Hazard Analysis.

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. 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

35. Probabilistic calculation of exposure
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
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

37. 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.

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. 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

42. 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)

43. 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

44. 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

45. 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

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 ?