overview of risk analysis -...
TRANSCRIPT
Overview of Risk Analysis
Hajime TOYOFUKU, DVM., PhD
Professor,
Joint Faculty of Veterinary Medicine
Yamaguchi University, Japan
FAO Workshop
Bangkok, Jan 2017
Contents
Risk analysis process and principles in
Codex
Role of Scientific expert bodies
Steps of risk assessment (Hazard
identification, Hazard characterization,
Exposure assessment, and Risk
Characterization)
C O D E X A L I M E N T A R I U S
Working Principles
for Risk Analysis for
Application in the
Framework of the
Codex Alimentarius
FAO/WHO Conference:
Recommendation to Codex
on use of science
1991 1995
FAO/WHO
Expert Cons.
on Risk
Analysis (RA)
FAO/WHO
Expert Cons.
on Risk
Management
(RM)
FAO/WHO
Expert Cons.
on Risk
Communication
1997 1998 20031999
WTO SPS
Agreement
Adoption of statements of
principles on use of
science and food safety
risk assessment and risk
analysis terminology and
guidelines
2000
Codex and Risk Analysis
Statements of
Principle
Relating to the
Role of Food
Safety Risk
Assessment
Definitions of Risk Analysis Terms Related to Food Safety
Codex Procedural Manual
SPS agreement Article 5
Assessment of risk and determination of
Appropriate level of protection
Member shall ensure that the sanitary measures
are based on risk assessment, as appropriate to
the circumstances, of the risk to human life or
health, taking into account risk assessment
technique developed by the relevant
International organizations.
Conclusion
International standards have to be developed
according to the risk analysis principles
C O D E X A L I M E N T A R I U S
Codex Strategic Framework 2003-2007
Objective 2: Promoting widest and
consistent application of scientific
principles and risk analysis
2003
Risk
Assessment
Policy for the
setting of MRLs
of Veterinary
Drugs in Foods
Risk Analysis
Principles applied
by CCPR
Risk Analysis
Principles
applied by
CCFA and
CCCF
Exposure
Assessment of
Contaminants and
Toxins in Foods
2004 2005 20072006 2008
Strategic Plan 2008-2013
Goal 2: Promoting widest and consistent
application of scientific principles and risk
analysis
Risk Analysis
Principles applied
by CCRVDF
Codex and Risk Analysis
Codex Procedural Manual
C O D E X A L I M E N T A R I U S
2008
Encourage countries to
channel their requests for
scientific advice to FAO /
WHO through the CAC
(CAC, CCEXEC, all
subsidiary bodies)
Enhance communication among
relevant Codex subsidiary
bodies and the FAI/WHO
scientific expert bodies
(CCFA, CCCF, CCPR,
CCRVDF, CCFH, CCNFSDU)
Encourage FAO/WHO to
provide training and capacity
building on risk analysis for
food safety
(CAC, CCEXEC, FAO/WHO
Coordinating Committees
and Codex members)
Strategic Plan 2008-2013
Goal 2: Promoting widest and consistent
application of scientific principles and risk
analysis
Codex and Risk Analysis
2013
ongoing - continuing
C O D E X A L I M E N T A R I U S
2009
Review the consistency of risk
analysis principles elaborated
by the relevant Codex
Committees
(by 2011 – CCGP)
Review the set of criteria
recommended to FAO and
WHO for prioritization of
requests from Codex for
scientific advice
(by 2009 – CCEXEC)
Review risk analysis
principles developed by
relevant Codex Committees
(by 2013 – CAC, CCEXEC,
CCFA, CCCF, CCPR,
CCRVDF, CCFH,
CCNFSDU)
Strategic Plan 2008-2013
Goal 2: Promoting widest and consistent
application of scientific principles and risk
analysis
Codex and Risk Analysis
2011 2013
Codex and risk analysis Codex introduced risk analysis
In 1990, series of FAO/WHO expert meetings were held on the application of risk analysis in food safety:
1995 Risk analysis
1997 Risk management
1998 Risk Communication
Based on the outcomes of these EMs, Working Principles for Food Safety Risk Analysis for application in Codex were established. Further, Codex subsidiary committees developed Risk Analysis Principles applied.
- Working Principles for Risk Analysis for Application in the Framework of the Codex Alimentarius
- Working Principles for Risk Analysis for Application for national governments
Risk Analysis
RISK ANALYSIS FRAMEWORK
(Adapted from Benford, 2001)
RISK ASSESSMENT HAZARD IDENTIFICATION HAZARD
CHARACTERIZATION
EXPOSURE ASSESSMENT
RISK CHARACTERIZATION
RISK MANAGEMENT
EVALUATON OF CONTROL OPTIONS
SELECTION AND
IMPLEMENTATION OF SELECTED OPTION
RISK COMMUNICATION INTERACTIVE
EXCHANGES OF OPINION AND INFORMATION REGARDING RISKS
H.Toyofuku
Risk Analysis
Risk Assessment Risk Management
Risk Commmunicatin
Scientific Based Policy Based
interactive process of
exchange of information and
opinion on risk
WHO + FAO CodexJECFA,JMPR
JEMRA
JEMNU
Ad hoc
Who is the advice for?
International risk manager
CODEX
International risk assessment
bodies
JECFA, JEMRA, JMPR etc.
Member Countries
WTO Agreements
Scientific
advice
Standards,
guidelines,
related texts
Requests for
advice, risk
assessment
Needs,
feasibility,
inputs,
etc.
FAO/WHO Scientific Advice programme
Must be authoritative and must be trusted.
Active support to ensure engagement of developing countries
Transparent and reliable
Has to be looked after (maintenance ?)
Development of scientific advice
Soundness - experts and process
Responsibility - accountability
Objectivity - neutrality
Fairness – respect of all views
Transparency – comprehensive and understandable process
Inclusiveness - minority scientific opinion and balance of skills and expertise
CODEX ALIMENTARIUS COMMISSION
CODEX Committees
JEMRAJoint Expert Meeting
on Microbiological Risk Assessment
Ad Hoc Expert
Meetings
JECFAJoint Expert
Committee on Food Additives
JEMNUJoint Expert
Meeting on Nutrition
International Risk Assessment Bodies
JMPRJoint Meeting on Pesticide
Residues
http://www.fao.org/food/food-safety-
quality/scientific-advice/en/
http://www.who.int/foodsafety/en/
http://www.who.int/nutrition/en/
International Food Standards
THE SCIENTIFIC BASIS OF CODEX
FAO/WHO Expert bodies
JECFA: Joint FAO/WHO Expert Committee on Food Additives
since 1956: 2600 food additives, 40 contaminants, 90 veterinary drugs
JMPR: Joint FAO/WHO Meeting on Pesticide residues
since 1963: 240 pesticides, several thousand MRLs in food
JEMRA: Joint FAO/WHO Expert meeting on Microbiological Risk Assessment
since 2000: Salmonella, Campylobacter, Listeria, Vibrio, Enterobacter, virus,
parasite
JEMNU
Joint Expert Meeting on Nutrition. 2010.
Ad-hoc Expert Consultations: Histamine, Marine biotoxins, Methyl mercury
e.g. Risk-Benefit of Fish, AMR, Nanotechnology, Melamine
• Data sponsors, providers (for JEFCA and JMPR industry data is critical)
• Development of capacities to generate data, develop expertise, use the scientific information
• Global pool of experts –national authorities, institutions, professional organizations
• Codex committees –definition of priorities
Secretariat –the face of the programme –
very small
Definition of TORs for work, Calls for data,
experts, approaches and
methodology
Working groups, expert
committees and meetings
Publications and
communications
Interface between risk assessment , standard setting and practical implementation
Technical
guidance for the
development of
shellfish
sanitation
programmes
Contents
Risk analysis process and principle in
Codex
Role of Scientific experts bodies
Steps of risk assessment
Hazard identification,
Hazard characterization,
Exposure assessment, and
Risk Characterization
H.Toyofuku
Risk Assessment components
Risk Assessment Hazard Identification
Adverse effects
Exposure AssessmentPopulation and/or consumer exposure
Hazard CharacterisationDose-response relationship
Risk CharacterisationProbability of an adverse health effect
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0.0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
0 1 2 3 4 5 6 7 8 9 10
Log Dose
Att
ac
k R
ate
1 2
3 4
5 7
11 12
13 21
19 20
22 24
24 25
30 31
32 34
Otbrk-BP
Dose-response curve for Salmonella based on outbreak
data
(Salmonella FAO/WHO risk assessment)
H.Toyofuku
Ad
verse effects
Irreversible effect
dosage
Lethal dosage
Dose
Reversible
Effect dose
‘( )
Actual use level
Relationship between Dose and Response
( )‘( )
H.Toyofuku
JEMRA Salmonella in broiler
Farm to table model steps
Production
Consumption
Preparation
Transport &
Processing
Retail &
storage
Estimate of
exposure
P
P
P
P
N
N
N
N
P - prevalence
N - concentration
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Farm to Folk Approach (food chain)
PF
CF
Prev of
contamination
Prob of
infection
Farm
Harvest
Processing
・manufacturing
Retail Home,
Restaurant
s
Risk
PP
CP
PR
CR
Prevalence
Concentration
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Questions from risk managers
• How likely the adverse health
effects?
• How serious the adverse health
effects?
• Who are high risk population?
• Which factors influence the
results?
Advice to find effective
interventions
Risk Assessment components
Hazard Identification
Exposure Assessment
Hazard Characterization
Risk Characterization
H.Toyofuku
Chemical risk assessmentStep 1: Establishment of Health Based Guidance Values (HBGV)
Acute risk: an Acute Reference Dose (ARfD) should be established
ARfD – estimate of the amount of a substance in food and/or drinking water, expressed on a body-weight basis, that can be ingested in a period of 24h or less without appreciable risk to the consumer on the basis of all known facts at the time of evaluation. (JMPR 2002)
Chronic risk: an Acceptable Daily Intake (ADI) should be established.
ADI – estimate of the amount of a substance in food or drinking water, expressed on a body-weight basis, that can be ingested daily over a lifetime without appreciable risk (standard human 60kg). (WHO 1987)
H.Toyofuku
Chemical risk assessment 2Step 2: Exposure assessment
• Various exposure scenarios should be estimated as a function of results from step 1 S1 (acute toxicity) Maximum exposure over 1 day i.e. a
high portion of a food containing the chemical at high residue concentration.
S2 (chronic toxicity) Average and high dietary exposure on a lifetime basis for a diet containing the chemical at median residue concentration
Step 3: Risk characterization
– When the exposure is > ARfD or > ADI : adjust MRL or no MRLs recommended
– When the exposure is < ARfD or < ADI : MRLs recommended
Challenges
Complexity vs. Resources - Often the key factor in
choosing an approach
C O D E X A L I M E N T A R I U S
Example 1: Residues of Vet drugs in food
CCRVDF
JECFA ADI MRL&
•Residue data when Good
Veterinary Practice is
applied
•Exposure assessment
• Toxicological data derived
from animal study or other
studies
Adapted by
member
countries
CAC
C O D E X A L I M E N T A R I U S
Example 2: GMOs
Approval on non-approval by
National Food Safety
Management Authority
National
Safety
Assessment
Body
Safe Non safeor
• Codex Principles on
Risk Analysis
• Codex Guidelines on
Food Safety Assessments
C O D E X A L I M E N T A R I U S
Codex and risk analysis
Vet drug
residue
Pesticide
residue
Food
Additives
Contaminant
s &natural
toxins
GMO
Risk
assessorJECFA (FAO
and WHO)
JMPR (FAO
and WHO)
JECFA
(FAO and
WHO)
JECFA (FAO
and WHO)governments
Risk
assessment
policy
establishment
Codex
(CCRVDF)
Codex
(CCPR)
Codex
(CCFA)
Codex
(CCCF)
Codex(&
governments
)
Standard
setting
Codex
(CCRVDF
and CAC)
Codex
(CCPR and
CAC)
Codex
(CCFA and
CAC)
Codex
(CCCF and
CAC)
governments
administratio
ngovernments governments governments governments governments
C O D E X A L I M E N T A R I U S
Codex and Risk Analysis
- Challenges -
• Priority setting in each Codex Committees
• Funds for FAO/WHO expert meetings
• Data generation in developing countries
• Training for experts in developing countries
• Divergent risk assessment policy
– E.g. qualitative vs quantitative
• Divergent risk management approach
– e.g. Application of Precaution
Thank you for your attention.