DIE AKADEMIE FRESENIUS Where Experts Meet!

Highlights

Cumulative risk assessment, evaluation of mixtures• Assessingchemicalmixtures• DevelopmentoftheEFSAguidanceonrisk

assessmentofcombinedexposuretomultiplechemicals

• AMemberStateperspectiveonmixtureriskassessment

• UpdateontheEuroMixProject• AcuteriskassessmentoftheFrench

consumerusingtheCAG“nervoussystem”• Assessmentofco-formulants• Cumulativeriskassessmentofpesticidesin

theUS

Assessment of metabolites• Groupingmetabolites• Genotoxicityassessmentsonmetabolites

Acute dietary risk assessment – IESTI• ImpactofarevisedIESTIequationonthe

EuropeanMRLsandconsumersafety• TheproposedIESTIrevisionandits

consequencesforCodex• RelevanceofIESTItominorcrops:adevelo-

pingcountryperspective

Establishment of MRLs• Importtolerancesandhazard-basedcutoff

criteria:aMemberState’sview• Riskmanagementviewonhazard-basedcut

offcriteria• MRLs:Implicationsforinternationaltrade

andfoodsecurity

The Experts

Alan R. Boobis ImperialCollegeLondon| Monika Bross BASF| Julie Chao U.S.DepartmentofAgriculture’s(USDA)ForeignAgriculturalService(FAS) | Evisabel Craig U.S.EnvironmentalProtectionAgency(EPA) | Christopher Dobe SyngentaCropProtection | Caroline Harris Exponent| Christer Hogstrand King’sCollegeLondon | Karsten Hohgardt GermanFederalOfficeofConsumerProtectionandFoodSafety(BVL) | Susanne Hougaard Bennekou TheDanishEnvironmentalProtectionAgency(EPA) | Carsten Kneuer GermanFederalInstituteforRiskAssessment(BfR)| Alexandra Mienné FrenchAgencyforFood,EnvironmentalandOccupationalHealthandSafety(ANSES) | Angelo Moretto InternationalCentreforPesticidesandHealthRisksPrevention(ICPS) | Lucy M. Namu KenyaPlantHealthInspectorateService(KEPHIS) | Christian Prohaska AustrianAgencyforHealthandFoodSafety(AGES) | Dieter Schrenk UniversityofKaiserslautern | Trijntje van der Velde-Koerts DutchNationalInstituteforPublicHealthandtheEnvironment(RIVM) | Jacob van Klaveren RIVM | Gaelle Vial FrenchAgencyforFood,EnvironmentalandOccupationalHealthandSafety(ANSES) | Bruce Young BayerCropScience Division

17 and 18 April 2018 in Mainz/Germany

Food Safety and Dietary Risk Assessment

16th International Fresenius Conference

Tuesday,17April2018

8.30 Registration and coffee

9.00 Welcome address by Akademie Fresenius and introduction by the Chair

Dieter Schrenk, UniversityofKaiserslautern,Germany

Cumulative risk assessment, evaluation of mixtures9.10 Assessing chemical mixtures

• Scientificandlegislativeneedtoassesschemicalmixtures

• Differentapproachesusedindifferentregulatorysectorsanddifferentgeographicalregions

• Needforharmonisationwithinandbetweenregions,toensurepublichealthprotectionandequitablearrangementfortrade

• Issuesthatneedtoberesolved

Alan R. Boobis, ImperialCollegeLondon,UK

9.35 Development of the EFSA guidance on risk assessment of combined exposure to multiple chemicals

Christer Hogstrand, King’sCollegeLondon,UK

10.00 A Member State perspective on mixture risk assessment

• Whatdowedonow?• Isthatenough?Whatdoesthedatatellus?• Whatisfurthertheneeded?• Whichtoolsareavailable?• Whatarethechallenges?• Whataretheopportunities?

Susanne Hougaard Bennekou, TheDanishEnvironmentalProtectionAgency(EPA),Denmark

10.25 Panel discussion10.55 Coffee break

11.25 Update on the EuroMix Project

• Integratedteststrategy• Multiplechemicalsandmultipleexposureroutes• EuroMixdataandmodelplatform• Usergroupsandstakeholderinvolvement

Jacob van Klaveren, NationalInstituteforPublicHealthandtheEnvironment(RIVM),TheNetherlands

11.50 Acute risk assessment of the French consumer using the CAG “nervous system”

Alexandra Mienné, FrenchAgencyforFood,EnvironmentalandOccupationalHealthandSafety(ANSES),France

12.15 Assessment of co-formulants

• Sourcesofco-formulantdata• Riskassessmentunderparallellegislation• Co-formulantsnotapprovedforuseinplant

protectionproducts

Christopher Dobe, SyngentaCropProtection,Switzerland

12.40 Panel discussion13.10 Lunch

14.40 Cumulative risk assessment of pesticides in the US

Evisabel Craig, U.S.EnvironmentalProtectionAgency(EPA),USA

15.05 Cumulative risk assessment using the CARES NG model – a case study evaluating mixtures of plant protection products in the US

• Population-andcalendar-basedprobabilisticexposuremodel

• Aggregateandcumulativeexposuremodel• Cloudbasedexposuremodel

Bruce Young,BayerCropScienceDivision,USA

15.30 Panel discussion16.00 Coffee break

Assessment of metabolitesChair

Caroline Harris, Exponent,UK

16.30 Genotoxicity assessments on metabolites

• QSARconsiderations• Testing• Intakeassessmentconsiderations• Criticalissues

Angelo Moretto,InternationalCentreforPesticidesandHealthRisksPrevention(ICPS),Italy

16.55 Questions and answers

17.05 Approaches to grouping of metabolites – an EU-Member State‘s perspective

Carsten Kneuer,FederalInstituteforRiskAssessment(BfR),Germany

Get-Together on Monday, 16 April 2018WillyouarriveonMonday?Cometothehotelbarat8p.m.andmeetotherparticipantsandexpertsinarelaxedatmosphere.

The Programme

17.30 Grouping metabolites – industry perspective

Industry representative(confirmed)

17.55 Panel discussion18.20 End of the first conference day

19.00 Departure time for the evening event

Wednesday,18April2018

8.20 Welcome address by the Chair

Monika Bross, BASF,Germany

Acute dietary risk assessment – IESTI8.30 Impact of a revised IESTI (short-term dietary exposure for pesticide residues) equation on the European MRLs (maximum residue limits) and consumer safety – an update

• OverallimpactonthesettingofEuropeanMRLsandconsumersafety

• Detailedimpactofindividualparametersontheoutputoftheriskassessment

Gaelle Vial, FrenchAgencyforFood,EnvironmentalandOccupationalHealthandSafety(ANSES),France

8.55 The proposed IESTI revision and its consequences for Codex

• Relativechangesinexposureestimatesbetweencurrentandproposedequations

• EffectonexposuredistributionexpressedasapercentageoftheARfD

• EffectonnumberofacceptableCodexMRLs• AchievementsoftheCCPRelectronicworkinggroup

IESTI2017

Trijntje van der Velde-Koerts, DutchNationalInstituteforPublicHealthandtheEnvironment(RIVM), TheNetherlands

9.20 Relevance of IESTI to minor crops: a developing country perspective

Lucy M. Namu, KenyaPlantHealthInspectorateService(KEPHIS),Kenya

9.45 Panel discussion10.25 Coffee break

Establishment of MRLsChair

Caroline Harris, Exponent,UK

10.55 Import tolerances and hazard-based cut off criteria: a Member State’s view

• Consequencesforinternationaltrade• Decisionmakingprocess• ImpactonimplementationofCodexMaximum

ResidueLimitsforPesticides(CXLs)

Christian Prohaska, AustrianAgencyforHealthandFoodSafety(AGES),Austria

11.20 Risk management view on hazard-based cut off criteria

• Achoicebetweendevilandthedeepbluesea

Karsten Hohgardt,FederalOfficeofConsumerProtectionandFoodSafety(BVL),Germany

11.45 MRLs: Implications for international trade and food security

• Theroleoftradeinmeetingglobalfooddemand• Enhancingthegrowertoolbox:Theneedfordiverse

cropprotectiontools• GlobalinitiativestoadvanceworkonMRLs

Julie Chao,U.S.DepartmentofAgriculture’s(USDA)ForeignAgriculturalService(FAS),USA

12.10 Panel discussion 13.10 Lunch and end of the conference

Informationavailableonlineat: www.akademie-fresenius.com/2503

Attheendofthefirstconferenceday,AkademieFreseniusinvitesyoutoaleisurelyeveninginthelocalwinegrowingregion.Enjoyagreatmealwithwinefromtheregionandcontinuetheday’snetworkingactivitiesinarelaxedatmosphere.

Alan R. Boobis isaProfessorofToxicologyatImperialCollegeLondon.HeretiredfromthissubstantivechairinJune2017andisnowemployedparttimeat

theCollege.HehasbeenamemberoftheEFSAPPRandCONTAMPanel.Heservesregularlyasamember/chairoftheJointFAO/WHOMeetingonPesticideResiduesandJointFAO/WHOExpertCommitteeonFoodAdditivesandisChairoftheUKCommitteeonToxicity.

Monika Bross hasbeenworkingatBASFAgriculturalCenterinLimburgerhofformorethan20years.WithinBASFshehasbeeninvolvedinalltypesofresidueandmetabolism

studies,butalsoindietaryexposureassessmentandthepreparationofsubmissiondocumentstoauthorities(EU,US,JMPR).MonikaischairingtheECPAResidueExpertGroupandisamemberofrelatedad-hocteamsondietaryexposureassessmentandcumulativeassessment.

Julie Chao joinedtheUSDAForeignAgriculturalService(FAS)in2016asaSeniorAdvisoroninternationalpesticideregulatorypolicyandtrade.Inherposition,sheworks

closelywiththeU.S.growersandotherinternational,Federal,andStatepartnerstosupportglobalagriculturaltradeandfoodsecurity.PriortojoiningFAS,JulieworkedfortheU.S.EPAasapesticideriskmanager.

Evisabel Craig isaPharmacologistandToxicologistandistheCoordinatorofcumulativeriskassessmentsattheU.S.EPA’sOfficeofPesticideProgrammes.

Christopher Dobe isaChemistandhasbeenwithSyngentaCropProtectionsince2010,andcurrentlyleadstheGlobalRegulatoryChemistrygroup,responsibleforglobalchemicalregistra-tions,includingafocusonco-formulantsustainability.HeistheChairoftheECPAChemicalLegislationExpertGroup,whichhasbeendevelopingtheECPAREACH-INtoolsforco-formulantsexposureassessmentunderREACH.

Caroline Harris istheCentreDirectorforChemicalRegulationandFoodSafetyinExponentInternational’sUKoffice.AftermanyyearsasaRegulatoratCRD,she

continuestobeinvolvedwithMRLs,importtolerancesandpesticideresiduesininternationaltrade.Shealsoremainshighlyactiveinthefieldofconsumerriskassessment.

The ExpertsChrister Hogstrand isaProfessoratthe

Diabetes&NutritionalSciencesDivisionatKing’sCollegeLondon.Besidesthisrole,heisanExpertfortheEFSAandcurrentlyamember

ofitsPanelonContaminantsintheFoodChain.Hehasbeeninvolvedin12EFSAworkinggroupsandispresentlychairingthree,includingtheworkinggrouponChemicalMixtures.

Karsten Hohgardt istheHeadoftheunitresponsibleforriskmanagementinthefieldoftoxicologyandresiduebehaviour.Since2006hehasalsobeenDeputyHeadofthe

PlantProtectionProductsDepartmentatBVL.HismainexperienceliesinMRLsettingandresiduebehaviour.

Susanne Hougaard Bennekou isaSeniorAdvisorinthePesticideDivisionoftheDanishEPA.AsaRegulatoryToxicologistherworkalsoinvolvesriskassessmentof

biocidesandREACHregulatedchemicals.SheisVice-ChairofEFSA’sPPRpanel.Currently,sheisinvolvedindevelopingtheEFSAGuidanceDocumentforHarmonisationofRiskAssessmentMethodologiesforHumanHealthandEcologicalRiskAssessmentofCombinedExposuretoMultipleChemicals.

Carsten Kneuer isaToxicologistandtheHeadoftheUnit„ToxicologyofActiveSubstancesandtheirMetabolites“inthePesticidesSafetyDepartmentoftheBfR.HestartedworkingfortheBfRin2007asaSeniorScientistRiskAssessment.

Alexandra Mienné startedworkingforANSESasaRiskAssessorin2012.Shehasbeeninvolvedinresidueassessmentsincethen,draftingregistrationsreportsandEuropean

monographs.

Angelo Moretto isaProfessorattheUniversityofMilanoandtheDirectoroftheInternationalCentreforPesticidesandHealthRisksPreventionattheUniversityHospital

“LuigiSacco“ofMilan.Hehasbeeninvolvedintheriskassessmentofchemicals,especiallypesticides,formanyyearsandalsoinmanyEFSAprojects,includingthedevelopmentofthedatabaseongenotoxicityofmetabolitesofpesticides.HeisinvolvedintheEuroMixproject.

Lucy M. Namu isChiefAnalyticalChemistattheKenyaPlantHealthInspectorateService.

Christian ProhaskastudiedfoodandbiotechnologyinVienna.Heworkedforpublicbodiesdealingwiththeriskassessmentofplantprotectionproductsbeforehe

gainedapostgraduatedegreeintoxicologyandstartedworkingatAGESin2002.

Dieter Schrenk hasbeenaProfessorforFoodChemistryandEnvironmentalToxicologyattheUniversityofKaisers-lauternsince1996.In2005hetookonthefull

professorshipforFoodChemistryandToxicology.

Trijntje van der Velde-Koerts isaChemistandaScientificEmployeeatRIVMinthefieldofpesticides,biocidesandveterinarymedicines.SheisamemberoftheResidue

ChemistryExpertGroupofOECDandanFAOpanelmemberoftheJMPR.AspartofherworkfortheWHOCollaboratingCentreatRIVM,shepreparestheJMPRmodelsforthepesticideresiduedietaryexposureestimates.

Jacob van Klaveren hasworkedforRIVMasSeniorScientificAdvisorsince2010.HecoordinatestheR&DprogrammeonfoodsafetyforWageningenResearch,theEUfunded

ACROPOLISprojectandtheEFSA-RIVMpartnershiponthefollow-upACROPOLIS.Since2015heiscoordina-tingtheEuroMixproject.

Gaelle Vial startedworkingforANSESin2007andhasbeeninchargeofpesticideriskassessmentforconsumersafety.Sheisinvolvedinactivesubstanceapprobation,

plantprotectionproductsassessmentaswellasinrelationswithlaboratoriesonmonitoringprogrammesandpostregulationriskassessment.

Bruce Young hasbeenworkingatBayerCropScienceDivisionfor27yearsinecologicalandhumanriskassessmentandiscurrentlyresponsibleforassessingaggregate

andcumulativedietaryandresidentialassessments.HeistheTechnicalExpertforboththeCumulativeAggregateRiskEvaluationSystemandtheResidentialExposureJointVenture.

Who do you meet?Groups that should take part:

Managingdirectors,boardsofdirectors,managers,consultantsandscientistsinthefieldsof

• Qualityassurance&control

• Productsafety

• Legal&regulatoryaffairs

• Registrationandauthorisation

• Toxicology

• Riskassessment

• Research&development

Sectors that should take part:

• Foodindustry

• Foodretailing

• Agrochemicalindustry

• Authorities(e.g.agriculturalandfoodinspectionoffices,registrationandcontrolautorities)

• Laboratories

• Researchinstitutes

• Professionalassociations

About

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18and19June2018inMainz

20th International Fresenius AGRO Conference

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