Title: Food safety risk management: Principles and practice
1Food safety risk management Principles and
practice
- Steve HathawayNew Zealand Food Safety Authority
2Imported food
3Domestic food
Domestic food production
4Exported food
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8What is safe food?
- Codex all conditions and measures applied
during the production process that are necessary
to achieve safety and suitability
9What is safe food?
10What is suitable food?
11Risk analysis
- An outcome-based approach to food safety
- Anchors the concept of safe food
12Positioning risk analysis in food control
- GHP in the 1980s
- HACCP in the early 1990s
- Influence of WTO SPS Agreement in mid-1990s
- Risk analysis in the late 1990s
- Structural change in Competent Authorities in the
2000s - New - source attribution and setting risk-based
public health goals
13Keeping the questions simple
- What can go wrong?
- How likely is it to go wrong?
- How serious would it be if it went wrong?
- What can be done to reduce the likelihood and/or
seriousness of it going wrong?
14Keeping the response simple
- Manage the risks rather than manage the
hazards - Hazard - an agent with the potential to cause
harm - Risk - adverse health effect on the consumer
15Hazard-based regulatory activities
- Decisions, standards and actions that are based
on objective and verifiable information on
relevant hazards - Aimed at eliminating/reducing exposure to
hazards, with the expectation that there will be
a reduction in risk - Will continue to be an essential output of
Competent Authorities
16Risk-based regulatory activities
- Decisions, standards and actions that are based
on specific knowledge of risks - Aimed at achieving an established level of health
protection and should be able to be validated in
these terms - Should be an increasing output of Competent
Authorities
17Taking a lead from WTO
- Applying science and risk assessment to the
extent possible - Risk management decisions should be based on
robust science and in proportion to the likely
benefits in terms of public health - Standards should ensure fair practices in the
trade in food
18Risk analysis
19Operationalising risk analysis
- Principles of risk analysis now well embedded in
national legislation - Operationalisation not as well advanced
- Application of a Risk Management Framework (RMF)
provides a systematic and consistent process for
food control - Codex guidelines provide a good reference
20Risk Management Framework
21Risk profiling Scientific evaluation Risk
assessment
Scientific evaluation Decision support tools
Database design Scientific evaluation
Pre-eminent role of science
Validation Verification
22Risk Management Framework (1)
23Scientific evaluation
- Risk profiles
- Empirical scientific evaluation
- Safety evaluation (chemical hazards)
- Risk assessment
- Food source attribution
- Ranking tools
24Risk profiles commissioned by NZFSA
- Campylobacter
- Poultry
- Offals
- Red meat
- Listeria monocytogenes
- RTE Meats
- Ice cream
- Soft Cheese
- Low Moisture Cheese
- RTE Salads
- STEC
- Red meat
- UCFM
- Leafy vegetables
- Raw milk
- Vibrio parahaemolyticus
- Seafood
- Toxoplasma gondii
- Red meat
- Yersinia enterocolitica
- Pork
- Clostridium
- botulinum
- Seafood
- Honey
- Mycobacterium bovis
- Milk
- Red meat
25Scientific evaluation
- Many risk management decisions will continue to
rely on scientific evaluation rather than risk
assessment - The norm in emergency or precautionary situations
- Supported by applied research on hazard control,
exposure assessments, monitoring and surveillance
registers - Recent NZ examples STEC/VTEC E.coli in UCFMs,
hazard database for animal feeds, A1 and A2
beta-casein in milk, tutin toxin in honey, Total
Diet Survey -
26Risk assessment
- Uses whole of food chain and dose/response to
estimate risk (population basis or edible portion
basis) - Stochastic modelling uses probability
distributions to describe variability,
uncertainty - Primary value - demonstrate impact of different
interventions throughout the food chain on the
risk estimate - Chemical hazards - safety evaluation?
27NZFSA examples
- Campylobacter in broiler chickens (domestic)
- Cysticercus bovis in beef (export)
- Salmonella in broiler chicken (import)
- S. Brandenberg in sheep meat (domestic and
export) - Pasteurisation of milk (domestic)
- Cheeses made from unpasteurised milk (domestic
and import) - Mercury in fish (import, domestic and export)
28Process flow diagram
29Taenia saginata exposure pathways in beef
produced in New Zealand
30Taenia saginata Risk estimates
- Mean number of infections in export and domestic
markets is 0.5 and 1.1 per year respectively - Probability of infection per edible portion of
meat is 4.910-10 and 510-9 respectively
31S. Brandenburg Pattern 14 in humans in NZ
32Risk analysis at peak of epidemic
- Foodborne risks to human health estimated at 6
-10 cases per year - Validation
- - 0 foodborne cases based on case control study
- - 0 foodborne cases on regional trace-back
investigations - - 500 notified human cases (all routes)
- No changes made to process control or inspection
33Havelaar et al Campylobacter in poultry
34Pasteurisation Modelling the food chain
Consump- tion
Primary production
Product processing
Retail sale
Consumer handling
35Pasteurisation primary production
Milking
- Probability that milk is contaminated
- Probable concentration of hazard
Onfarm storage
- Given that a hazard is present,
- probable growth or inactivation
- Probable concentration of hazard
Transport to the factory
- Given that a hazard is present,
- probable growth or inactivation
- Probable concentration of hazard
- Probability that milk is contaminated at the end
of Primary Production - Probable concentration of hazard in milk at the
end of Primary Production
36Raw milk survey Total E. coli and S. aureus
37Raw milk survey - pathogens
38Pasteurisation product processing
Factory storage
- Given that a hazard is present,
- probable growth or inactivation
- Probable concentration of hazard
Heat treatment
- Given that a hazard is present,
- probable growth or inactivation
- Probable concentration of hazard
- Probability that milk is contaminated at the end
of Product Processing (milk) - Probable concentration of hazard in milk at the
end of Product Processing (milk)
39Screening pathogenic groups at 60 - 62.5 C for
60 sec
40Pasteurisation Product processing (cheese)
Factory storage
- Given that a hazard is present,
- probable growth or inactivation
- Probable concentration of hazard
- Given that a hazard is present,
- probable growth or inactivation
- during each step of manufacture
- Probable concentration of hazard
- during each step of manufacture
Cheese manufacture
- Probability that cheese is
- contaminated at the end of
- Product Processing (cheese)
- Probable concentration of hazard in
- cheese at the end of Product
- Processing (cheese)
41Pasteurisation Risk assessment outputs
- Estimate of risk using a standard process
- Product categorisation based on risk assessment
outputs - Category 1 currently permitted for sale
- Category 2 sale permitted
- Category 3 sale not permitted
- Practical tool for risk managers at premises
level Food Control Plans
42Epidemiological approach
Risk assessment
Exposure
Illness
Food chain
Epidemiology / food source
attribution
43Food source attribution
- Risk assessment usually provides information on a
single hazard/food combination - Proportion of foodborne disease attributable to
all hazard/food combinations? - Analytical epidemiology
- Simulation modelling
- Molecular epidemiology (subtyping / source
tracking) - Cannot determine the relative impact of specific
control measures cf. risk assessment
44Human campylobacteriosis
45Human campylobacteriosis Manawatu
water
sheep
chicken
wild bird
cattle
46Salmonella attribution in NZ (1)
47Salmonella attribution in NZ (2)
48Risk Management Framework (2)
49Availability of control measures
- GHP-based measures traditional, prescriptive,
vary markedly between countries - Hazard-based measures measurable at a step,
less prescriptive, vary between countries - Risk-based measures outcome focused, flexible,
international compatibility, opportunity for
equivalence
50Decisions on control measures
- Need to anchor concept of safe and suitable
- Risk management decisions on all aspects of food
control should be proportional to the likely
reduction in foodborne risks to the consumer - Decisions on control measures have a significant
impact on costs to industry and government - Take suitability (consumer acceptability) and
consumer perceptions into account
51Risk management of Taenia saginata
- Mean number of infections in export and domestic
markets is 0.5 and 1.1 per year respectively /
probability of infection per edible portion of
meat is 4.910-10 and 510-9 respectively - Equivalence case presented to US and EU
- Significantly reduced meat inspection and less
cross-contamination - HACCP active surveillance and suspect list
52Level of consumer protection soft cheese
- Probability of occurrence of severe listeriosis
per consumed portion of cheese (concentration and
portion size) - Probability of occurrence of severe listeriosis
per person per year (concentration, portion size
and number of portions) - Tolerable number of severe listeriosis cases per
year (average risk per person per year)
Maximum frequency And concentration
Maximum frequency And concentration
Maximum frequency And distribution
of concentration
53Risk management of chemical hazards
Microbial hazard/food combination
Chemical hazard/food combination
LOP predetermined
Risk assessment
Risk assessment
LOP arrived at
Choice of risk-based control measuresChoice of
risk-based control measures
Implementation)
54Havelaar et al Campylobacter in poultry
55Integrated decision making
- Increasing need for an integrated approach e.g.
health impacts, economic impacts, lifestyle
impacts and consumer perceptions - Need risk-based knowledge on all significant
hazard pathways - Quantify disease burden e.g. DALYs and
intervention costs at levels of consumer,
industry and government - Multi-objective trade-off analysis needed
56Risk Management Framework (3)
57Implementation of measures
- Validation - gaining evidence that a control
measure is capable of controlling a hazard to a
specified outcome hazard-based (step) or
risk-based - Verification - activities that determine if a
control measure is or has been operating as
intended - Provides maximum flexibility while ensuring
required outcomes are met - Validation, verification and monitoring are
inter-related activities that assure regulatory
performance
58Validation
Production step
Process step
Process step
Consumer
- Options for control measures
- based on GHP
- - based on hazards
-
- - based on risks
No validation Step validation
HACCP
Chain validation
ALOP
Risk model
59Verification
- Activities that determine if a control measure is
or has been operating as intended - Occurs after implementation of control measures
- Regulatory responses to non-compliance at a
premises level should take into account the
characteristics of the test system, the likely
risks to human health and overall compliance
60Performance-based verification (1)
61Performance-based verification (2)
62Data systems NZFSA VAOnLine
Web based reports and files available world-wide
with password access National planning tool and
data repository system Procedures storage
system Regulatory model includes third party
verifiers
63Microbiological targets as risk-based tools
- Performance objective (Codex) The maximum
frequency and/or concentration of a hazard in a
food at a specified step in the food chain .
that provides or contributes to . ALOP - Derive risk-based performance criteria, process
criteria, product criteria, microbiological
criteria - Valuable implementation and equivalence tools but
derivation methods still controversial
64HACCP as an implementation tool
- CCP A step at which control can be applied and
is essential to prevent or eliminate a food
safety hazard or reduce it to an acceptable
level - Decisions usually based on ALARA principles i.e.
hazard-based control measures, and not on ALOP - Critical limits can only be validated at that
step - HACCP plans are usually premises-specific and
therefore not directly comparable between
premises / food chains / countries
65Risk Management Framework (4)
66Monitoring
- Different systems for different purposes
- Premises or whole country basis
- Compliance-based e.g. hazard levels associated
with non- compliance with a MRL - Exposure based e.g. total diet surveys
- Risk-based e.g. Codex performance targets
- Include foodborne disease surveillance
- Include regulatory performance goals
67One example NZFSA NMD
- National Microbiological Database for all red
meat species, poultry and ostriches - Indicators and pathogens
- Monthly reporting of data from all premises
- Premises and national performance targets (80th
percentile based) - Ranking of premises on a quarterly basis
(indicator organisms)
68Industry performance Bovine NMD
69Regulatory performance
Intermediate outcomes
Outcomes
Activities/ outputs
Standards Implementation Compliance
Level of hazard control
Level of consumer protection
70NZFSA public health goals Microbes
- As-low-as-reasonably-achievable (ALARA) rather
than appropriate level of protection (ALOP)
approach - - 50 reduction in foodborne campylobacteriosis
after 5 years - - 30 reduction in foodborne salmonellosis after
five years - - no increase in foodborne listeriosis after
five years - Requires a risk-based approach to food control if
goals are to be realised
71Regulatory performance
72NZFSA public health goals Chemicals
- Hazard-based!
- 70 of school-age children achieve ideal range
for dietary intake of iodine over five year
period - Agricultural compounds measured in the
five-yearly TDS do not exceed 10 of the ADI - Exposure to the dithiocarbamate group of
fungicides, as measured in the TDS, will not
exceed 20 of the ADI - Dietary intake of mercury for women 25-years and
older remains below 20 of the PTWI
73Performance goal dietary intake of iodine
74International standards
Codex Alimentarius Commission
75A Codex opinion
- Codex does not set public health goals,
implement standards or monitor their performance
and is likely that Codex standards will
increasingly be enabling in nature, with
specific risk-based control measures being the
domain of national governments
76Replication of measures A failure of the risk
analysis paradigm?
Kiwifruit
77BSE as a global issue
Measures not commensurate with risk and driven by
perceived need to eliminate the hazard
Number of Variant-CJD-cases
UK 157 cases, France 13, Ireland 3, 1 each Italy
, Canada , USA , Japan , Saudi-Arabia ,
Netherlands, Spain, Portugal
78Replication of BSE measures
Cost effectiveness (?)
79Equivalence
- Key provision of the WTO SPS Agreement
- Mutual recognition and comparability are
needed as screening processes, taking advantage
of experience, knowledge, trust and confidence - Additional criteria are needed to establish
comparability e.g. risk profiles (NZ/EU
Equivalency Agreement) - Objective basis of comparison in terms of risks
to human health is final arbiter of equivalence
80Summary (1) Benefits of a RMF process
- Continual improvements in public health
- Ranking of risks and proportional regulatory
responses - Cost-effective and efficient food control
- Consistency and transparency of decisions
- Stakeholder participation
- Industry innovation and flexibility (equivalence)
- Compatibility with international standards
81Summary (2)
- A risk-based approach to food safety brings
multiple advantages but the benefits can only be
fully realised with application of a RMF - The science that provides essential inputs to a
RMF should be fit-for-purpose - Translating risk management principles into
practice at the national level remains a
significant challenge
82Thank you