Risk Analysis in the International Setting - Roles and...

___________________________________________________________________________

2009/SOM2/SCSC/WKSP2/005

Risk Analysis in the International Setting - Roles and Responsibilities

Submitted by: World Health Organization

Examination of Hot Issues in Risk Analysis Workshop Singapore

1-2 August 2009

APEC-Meeting Aug09 World Health Organization 1

Risk Analysis in the Risk Analysis in the International SettingInternational Setting

Roles and ResponsabilitiesRoles and Responsabilities

Dr. Angelika TritscherDr. Angelika TritscherWHO Joint Secretary to JECFA and JMPRWHO Joint Secretary to JECFA and JMPRDepartment of Food Safety and Department of Food Safety and ZoonosesZoonoses

World Health OrganizationWorld Health Organizationhttp://http://www.who.intwww.who.int/foodsafety/en//foodsafety/en/http://http://www.who.int/ipcs/food/enwww.who.int/ipcs/food/en//


Risk Analysis ParadigmRisk Analysis Paradigm

Scientific advice and information analysis

Regulationand control

Dialog with all stakeholders

Risk AssessmentRisk Assessment Risk ManagementRisk Management

Risk CommunicationRisk Communication


Joint Expert Committee on Food Additives Joint Expert Committee on Food Additives (JECFA)(JECFA)

Joint Meeting on Pesticide Residues Joint Meeting on Pesticide Residues (JMPR)(JMPR)

Joint Expert Meeting on Microbiological Joint Expert Meeting on Microbiological Risk AssessmentRisk Assessment(JEMRA)(JEMRA)

Ad hoc expert meetingsAd hoc expert meetings(e.g. Melamine expert meeting)(e.g. Melamine expert meeting)

International Risk Assessment BodiesInternational Risk Assessment Bodies


JECFA: the historyJECFA: the history19561956: : 1. JECFA meeting,1. JECFA meeting, procedures for the testing of procedures for the testing of food additivesfood additives1958: Specifications for Identity and Purity of Food Additives1958: Specifications for Identity and Purity of Food Additives19611961: : First ADIFirst ADI for antioxidants and preservativesfor antioxidants and preservatives19671967: First Meeting to deal with : First Meeting to deal with contaminantscontaminants1978: Guide to specifications (revised 1983, 1991)1978: Guide to specifications (revised 1983, 1991)19871987: Principles for the Safety Assessment of Food Additives and : Principles for the Safety Assessment of Food Additives and

Contaminants (Contaminants (EHC 70EHC 70))19871987: First meeting dedicated to : First meeting dedicated to veterinary drug residues veterinary drug residues (individual (individual

compounds evaluated in earlier meetings)compounds evaluated in earlier meetings)1992: Compendium of Food Additive Specifications1992: Compendium of Food Additive Specifications19951995: Start of systematic assessment of : Start of systematic assessment of flavouring agentsflavouring agents2001: First meeting dedicated to 2001: First meeting dedicated to mycotoxinsmycotoxins2005: Contaminants meeting, incl. 2005: Contaminants meeting, incl. genotoxic&carcinogenicgenotoxic&carcinogenic compoundscompounds20062006: 50: 50thth anniversary!!!!anniversary!!!! 2009:2009: 7171stst MeetingMeeting


•• Risk assessment/safety evaluation of:Risk assessment/safety evaluation of:–– Food AdditivesFood Additives–– Processing aids (considered as food additives)Processing aids (considered as food additives)–– Flavouring agents (by groups of related compounds)Flavouring agents (by groups of related compounds)–– ContaminantsContaminants–– Natural toxinsNatural toxins–– Residues of Veterinary Drugs in animal productsResidues of Veterinary Drugs in animal products

•• Specifications and analytical methods, Residue Specifications and analytical methods, Residue definition, MRL proposals definition, MRL proposals (veterinary drugs)

•• Development and improvement of general principlesDevelopment and improvement of general principles

JECFA: Areas of WorkJECFA: Areas of Work


JECFA : JECFA : ProcedureProcedure

CODEX AlimentariusCommission

FAO and WHOMember countries

ISSUES & PRIORITIESThe Joint Secretariat decides

the agenda of JECFA

Call for dataSelection participants & preparation of working papersMeetingReport & Monographs

Secretariat


Who is JECFA?Who is JECFA?

Committee is selected for each meeting:Committee is selected for each meeting:•• Expert RosterExpert Roster

Joint FAO/WHO Secretariat of JECFAJoint FAO/WHO Secretariat of JECFA–– FAO: Dr. Annika Wennberg, AGNSFAO: Dr. Annika Wennberg, AGNS–– WHO: Dr. Angelika Tritscher, Dr. Myoengsin Choi, FOSWHO: Dr. Angelika Tritscher, Dr. Myoengsin Choi, FOS


JECFA OutputJECFA Output

Summary Report:Summary Report:•• Electronic summary containing Electronic summary containing only basic conclusionsonly basic conclusions

Report:Report:•• Concise summary of relevant information for Concise summary of relevant information for

evaluation and conclusion, including intake estimatesevaluation and conclusion, including intake estimates

Monographs:Monographs:•• Detailed description and evaluation of all Detailed description and evaluation of all

available data used in evaluationavailable data used in evaluation(1) Toxicological Monographs(1) Toxicological Monographs(2) Specifications etc.(2) Specifications etc.


JECFA OutputJECFA Output

To date evaluated:To date evaluated:-- Over 1800 additives and flavoursOver 1800 additives and flavours-- Over 40 contaminantsOver 40 contaminants-- Over 95 veterinary drugsOver 95 veterinary drugs

ReRe--evaluations:evaluations:-- Based on request when new data become availableBased on request when new data become available

JECFA at WHO:JECFA at WHO:http://http://www.who.int/ipcs/food/jecfa/enwww.who.int/ipcs/food/jecfa/en//

JECFA at FAO: JECFA at FAO: http://http://www.fao.org/ag/agn/agns/jecfa_index_en.aspwww.fao.org/ag/agn/agns/jecfa_index_en.asp


JECFA: selected highlightsJECFA: selected highlights

•• JECFA 64JECFA 64: Feb 05 : Feb 05 -- ContaminantsContaminants–– AcrylamideAcrylamide–– PAHsPAHs–– PBDEsPBDEs–– Tin Tin -- acute reference dose acute reference dose

•• JECFA 70JECFA 70: Oct 08 : Oct 08 –– Veterinary DrugsVeterinary Drugs–– Several antibioticsSeveral antibiotics–– Important general considerations regarding methods and Important general considerations regarding methods and

procedures procedures –– Decision Tree ApproachDecision Tree Approach•• JECFA 72JECFA 72: Feb 10 : Feb 10 –– ContaminantsContaminants

–– Acrylamide reAcrylamide re--evaluationevaluation–– ArsenicArsenic–– FuranFuran–– PerchloratePerchlorate

genotoxic carcinogens


Risk AssessmentRisk AssessmentJoint Meeting on Pesticide ResiduesJoint Meeting on Pesticide Residues

First JMPR convened in 1963 to perform toxicological assessments of pesticide residues in food. Since 1966 residue evaluations also performed to recommended MRLs for compounds when used in accordance to good agricultural practice.


JMPR: the historyJMPR: the history19611961: Recommendation to DG of FAO and WHO to evaluate : Recommendation to DG of FAO and WHO to evaluate

pesticide residuespesticide residues19631963: : First JMPRFirst JMPR convened to establishconvened to establish ADIsADIs, annual meetings ever , annual meetings ever

sincesince19661966: First meeting to consider both : First meeting to consider both ADIsADIs and and MRLsMRLs19901990: Principles for the Toxicological Assessment of Pesticide : Principles for the Toxicological Assessment of Pesticide

Residues in Food (Residues in Food (EHC 104EHC 104))19951995: Consideration of acute toxicity (: Consideration of acute toxicity (acute reference dose acute reference dose ARfDARfD))in recent years: consideration of other routes of exposure, in recent years: consideration of other routes of exposure,

environmental hazard assessmentenvironmental hazard assessment2001: Recommendation to establish working group to further devel2001: Recommendation to establish working group to further develop op

concepts on acute reference doseconcepts on acute reference dose2005: Guidance document published on the setting of 2005: Guidance document published on the setting of ARfDsARfDs;;

IPCS Cancer Mode of Action Framework adoptedIPCS Cancer Mode of Action Framework adopted2008: 28 pesticides evaluated (6 new, 5 re2008: 28 pesticides evaluated (6 new, 5 re--evaluations)evaluations)


•• Risk assessment/safety evaluation of Risk assessment/safety evaluation of pesticide residues in foodpesticide residues in food–– chronic and acute intake (ADI, chronic and acute intake (ADI, ARfDARfD))

•• Dietary Risk Assessment Dietary Risk Assessment –– longlong--term and shortterm and short--termterm

•• Recommendation of Recommendation of MRLsMRLs•• Development of general principlesDevelopment of general principles

JMPR: Areas of WorkJMPR: Areas of Work


Who is JMPR?Who is JMPR?

Committee is selected for each meeting:Committee is selected for each meeting:•• Expert RosterExpert Roster

Joint FAO/WHO Secretariat of JMPRJoint FAO/WHO Secretariat of JMPR–– FAO: YongZhen Yang, AGPPFAO: YongZhen Yang, AGPP–– WHO: Angelika Tritscher, Myoengsin Choi, FOSWHO: Angelika Tritscher, Myoengsin Choi, FOS


JMPR OutputJMPR Output

Summary Report:Summary Report:•• Electronic summary containing Electronic summary containing only basic conclusionsonly basic conclusions

Report:Report:•• Concise summary of relevant information for Concise summary of relevant information for

evaluation and conclusion, including intake estimatesevaluation and conclusion, including intake estimates

Monographs:Monographs:•• Detailed description and evaluation of all Detailed description and evaluation of all

available data used in evaluationavailable data used in evaluation(1) Toxicological Monographs(1) Toxicological Monographs(2) Residue Monographs ((2) Residue Monographs (MRLsMRLs etc.)etc.)


JMPR OutputJMPR Output

To date evaluated:To date evaluated:-- Over 250 pesticidesOver 250 pesticides

-- plus periodic replus periodic re--evaluationsevaluations

JMPR at WHO:JMPR at WHO:http://http://www.who.int/ipcs/food/jmpr/enwww.who.int/ipcs/food/jmpr/en//JMPR at FAO: JMPR at FAO: http://http://www.fao.org/ag/agp/agpp/Pesticid/Default.htmwww.fao.org/ag/agp/agpp/Pesticid/Default.htm


JMPR: selected highlightsJMPR: selected highlights

•• JMPR 2004JMPR 2004: Sept 04: Sept 04–– worksharingworksharing pilot project pilot project -- trifloxystrobintrifloxystrobin

•• US, EU, Australia, Canada, JapanUS, EU, Australia, Canada, Japan

–– acute Reference Doseacute Reference Dose

•• detailed guidance paper, incl. specific endpoints and experimentdetailed guidance paper, incl. specific endpoints and experimental al design (link to Drinking Water Guidelines and to contaminants)design (link to Drinking Water Guidelines and to contaminants)

•• JMPR 2006JMPR 2006: Oct 06: Oct 06–– worksharingworksharing, further pilot, further pilot

•• JMPR 2008JMPR 2008: Sept 08: Sept 08• Considerations on globally harmonized MRLs through JMPR


Microbiological risk assessment is performed for pathogen/food combinations that are associated with food-borne illness(single pathogen, one product type, whole chain)

Listeria monocytogenes

Salmonella

Campylobacter

Escherichia coli O157Vibrio parahaemolyticus

Microbiological risk assessment


JEMRAJEMRAJoint FAO/WHO Expert Meetings on Joint FAO/WHO Expert Meetings on Microbiological Risk AssessmentMicrobiological Risk Assessment

19991999::•• Codex adopts the Principles and Guidelines for the Codex adopts the Principles and Guidelines for the

conduct of Microbiological Risk Assessment;conduct of Microbiological Risk Assessment;•• Codex Committee on Food Hygiene develops a Codex Committee on Food Hygiene develops a

prioritized list of 21 pathogen/food of concernprioritized list of 21 pathogen/food of concern20002000: : •• At the request of World Health Assembly and Codex At the request of World Health Assembly and Codex

Alimentarius Commission, FAO/WHO convene the Alimentarius Commission, FAO/WHO convene the first first JEMRA meetingJEMRA meeting


JEMRAJEMRA

Experts selected for each meeting:Experts selected for each meeting:•• From roster established for each meeting according to call From roster established for each meeting according to call

for expertsfor experts

Joint FAO/WHO Secretariat of JEMRAJoint FAO/WHO Secretariat of JEMRA–– FAO: Sarah Cahill, Lourdes CostarricaFAO: Sarah Cahill, Lourdes Costarrica–– WHO: Peter K. Ben EmbarekWHO: Peter K. Ben Embarek

JEMRA at JEMRA at WHO:http://www.who.int/foodsafety/micro/jemra/en/index.htmlWHO:http://www.who.int/foodsafety/micro/jemra/en/index.htmlJEMRA at JEMRA at FAO:tp://www.fao.org/es/esn/jemra/index_en.stmFAO:tp://www.fao.org/es/esn/jemra/index_en.stm


JEMRAJEMRA outputoutput

•• SalmonellaSalmonella spp. in broiler chickens and eggs spp. in broiler chickens and eggs (publ. in 2003)(publ. in 2003)

•• ListeriaListeria monocytogenesmonocytogenes in readyin ready--toto--eat foods eat foods (publ. 2004)(publ. 2004)

•• CampylobacterCampylobacter spp. in broiler chickens spp. in broiler chickens (to be publ. in 2006)(to be publ. in 2006)

•• VibrioVibrio spp. in seafood spp. in seafood (to be publ. in 2005 & 2006)(to be publ. in 2005 & 2006)

•• EnterobacterEnterobacter SakazakiiSakazakii in infant formulain infant formula(publ. in 2006)(publ. in 2006)

New / proposedNew / proposed

•• EnterobacterEnterobacter SakazakiiSakazakii in followin follow--up formulaup formula

•• E.coliE.coli O157 H7 O157 H7 in Ground Beef and Fermented Sausagesin Ground Beef and Fermented Sausages

•• Control of microbiological hazards in fresh produceControl of microbiological hazards in fresh produce

•• Viruses in foodViruses in food* Customers for FAO/WHO’s JEMRA: WHO, FAO, and Member States,

CCFH and Codex Member States


Ad hoc expert meetingsAd hoc expert meetings

•• To address urgent and emerging needs for To address urgent and emerging needs for scientific advice in foods safetyscientific advice in foods safety

•• To address issues not covered by existing To address issues not covered by existing expert groupsexpert groups

•• ExamplesExamples–– RiskRisk--benefit of use of active chlorine in food benefit of use of active chlorine in food

production and processingproduction and processing–– Melamine Melamine –– Nanotechnology as related to food and feedNanotechnology as related to food and feed–– RiskRisk--benefit of fish consumptionbenefit of fish consumption


Outcome of expert meetingsOutcome of expert meetings

•• Safety assessment/risk assessmentSafety assessment/risk assessment–– HealthHealth--based guidance values (e.g. ADI)based guidance values (e.g. ADI)

•• Quantitative risk assessment Quantitative risk assessment –– increased cancer risk at defined level of exposure (e.g. increased cancer risk at defined level of exposure (e.g.

aflatoxins) aflatoxins) –– Example for MRAExample for MRA

•• Level of concern: Margin of Exposure Level of concern: Margin of Exposure –– For genotoxic carcinogens (e.g. acrylamide, For genotoxic carcinogens (e.g. acrylamide, PAHsPAHs))

•• Impact of different management actions (impact of Impact of different management actions (impact of different hypothetical different hypothetical MLsMLs for aflatoxins)for aflatoxins)–– E.g. aflatoxins, cadmiumE.g. aflatoxins, cadmium

•• Identification of main foods contributing to exposure Identification of main foods contributing to exposure •• Description of analytical methods, sampling plansDescription of analytical methods, sampling plans


Health Based Guidance ValuesHealth Based Guidance Values(Safety Standard)(Safety Standard)

Guidance values for chronic intake•• ADI ADI acceptable daily intake; applied to substances

'added' to food: additives, pesticide and veterinarydrug residues

•• TDITDI tolerable daily intake; for unavoidable tolerable daily intake; for unavoidable contaminantscontaminants

•• PTWI PTWI provisional tolerable weekly intake; for provisional tolerable weekly intake; for contaminants with cumulative properties (e.g. Heavy contaminants with cumulative properties (e.g. Heavy metals)metals)

Guidance value for acute intake•• ARfDARfD acute reference dose; currently applied to acute reference dose; currently applied to

pesticide and veterinary drug residues, also relevant pesticide and veterinary drug residues, also relevant for some contaminants for some contaminants


HealthHealth--based Guidance Valuesbased Guidance Values

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)

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)

NOTE: assumes threshold for effect

i.e. dose below which no adverse effects occur


Other outcomes of risk assessmentOther outcomes of risk assessment

Margin of exposure approach•• DjhfkdDjhfkd•• lksdfkllksdfklImpact assessment of different hypothetical maximum

limits:•• kdjfldkfjkdjfldkfj


Outcome of international risk Outcome of international risk assessment work feeds directly into assessment work feeds directly into

Codex Standard Setting Process Codex Standard Setting Process

•• JECFA assessments are a prerequisite to include food additives JECFA assessments are a prerequisite to include food additives in thein the "Codex General Standard for Food Additives" (GSFA) "Codex General Standard for Food Additives" (GSFA) –– GSFA sets forth the conditions of useGSFA sets forth the conditions of use

•• JECFA recommendations for Maximum Residue Levels (JECFA recommendations for Maximum Residue Levels (MRLsMRLs) ) form the basis for Codex form the basis for Codex MRLsMRLs on veterinary drug residues in on veterinary drug residues in foodfood

•• JECFA assessments on contaminants form the basis for JECFA assessments on contaminants form the basis for Maximum Maximum LimtsLimts ((MLsMLs) in foods) in foods–– Specific questions, e.g. impact assessments, can guide the risk Specific questions, e.g. impact assessments, can guide the risk

management processmanagement process•• JMPR recommendations for Maximum Residue Levels (JMPR recommendations for Maximum Residue Levels (MRLsMRLs) )

form the basis for Codex form the basis for Codex MRLsMRLs on pesticide residues in on pesticide residues in agricultural commoditiesagricultural commodities


Codex Alimentarius CommissionCodex Alimentarius Commission

The CAC was founded in 1963 by FAO and WHO to develop standards, guidelines und other documents (e.g. ‘Code of Practice’) for foods.

181 Member States, representing 99% of the world's population



““. . . to guide and promote the . . . to guide and promote the elaboration and establishment of elaboration and establishment of

definitions and requirements for foods, to definitions and requirements for foods, to assist in their harmonization and, in assist in their harmonization and, in

doing so, to facilitate international tradedoing so, to facilitate international trade””..

� Consumer Protection

� Fair Trade

http://www.codexalimentarius.net/



Coordinating CommitteesCoordinating Committees(sub) regional, coordination of activites, incl. development of regional standards

Codex CommitteesCodex CommitteesDevelopment of standards for CAC

Commodity Committees (‘vertical committees’)Standards for specific foods and food groups

General Subject Committees (‘horizontal committees’)General standards relevant for all commodities, e.g. limits for pesticide residues by CCPR; limits for additives and contaminants by CCFAC


Codex Alimentarius and WTOCodex Alimentarius and WTO

The The Codex AlimentariusCodex Alimentarius is the collection of is the collection of international scienceinternational science--based food standardsbased food standards

World Food Trade: 300 - 400 Billion US $ annually

World Trade Organisation: World Trade Organisation: Multilateral Agreements on Trade in GoodsMultilateral Agreements on Trade in Goods

WTO SPS and TBT agreementsWTO SPS and TBT agreements


Codex Alimentarius und WTOCodex Alimentarius und WTO

WTOWTO--TBTTBT::'Agreement on Technical Barriers to Trade':'Agreement on Technical Barriers to Trade':Harmonization of technical rules and standards, e.g. packaging aHarmonization of technical rules and standards, e.g. packaging and nd labeling. labeling.

WTOWTO--SPSSPS::'Agreement on the Application of Sanitary and Phytosanitary Meas'Agreement on the Application of Sanitary and Phytosanitary Measures':ures':Acknowledges the right of all countries to take measures to protAcknowledges the right of all countries to take measures to protect their ect their consumersconsumersBUT: only as far as necessary to protect public healthBUT: only as far as necessary to protect public healthAND: AND: scientificallyscientifically justifyablejustifyable

• Importance of international harmonization of standards

• For food safety, Codex Alimentarius is the scientific standard


Risk Analysis InternationallyRisk Analysis Internationally•• Food standards are developed on the basis of Food standards are developed on the basis of

scientific assessments scientific assessments •• Codex Standards are an integral Codex Standards are an integral legallegal part in part in

international food tradeinternational food trade

JECFA JECFA JMPRJMPR

JEMRAJEMRAAd hocAd hoc

CACCACCCFACCCFAC

CCRVDFCCRVDFCCPRCCPRCCFHCCFH

Risk AssessmentRisk AssessmentWHOWHO

&&FAOFAO

Risk ManagementRisk ManagementCACCAC

&&Member StatesMember States

Risk CommunicationRisk Communication

Risk Analysis in the International Setting - Roles and...

Documents

Transcript of Risk Analysis in the International Setting - Roles and...