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

H.Toyofuku

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

H.Toyofuku

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

H.Toyofuku

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.