DIE AKADEMIE FRESENIUS Where Experts Meet!

Highlights

Regulatory Developments and socio-political context• UpdatefromtheEuropeanCommission’s

DGSANTE:CriteriaforEDidentificationunderEURegulationsonplantprotectionproductsandonbiocidalproducts

• UpdateontheongoingactivitiesintheECETOCtaskforceonendocrinedisruption

• ANSES:Past,presentandfutureEDsunderREACH–InfluenceofthecriteriaontheFrenchstrategy

• AcriticalviewofthecommonperceptionofEDsinasocietalcontext

Developments outside of Europe• TheUSEnvironmentalProtectionAgency

onextrapolationofmammalian-basedToxCastassayresultstonon-mammalianspeciestoevaluateendocrinedisruption

Test Methods • EUCommissionDGENV:Activitiesunder

theEUstrategyforED–towardsbetteridentificationofendocrinedisruptors

• OECDguidancedocument150revision

Methods and Epidemiology

• UpdatefromtheEUJointResearchCentre:TheEUstrategyforED–towardsbetteridentificationofendocrinedisruptors–addressingthegaps

• Reviewofnon-monotonicdoseresponsesofsubstancesforhumanriskAssessment

The Experts

Bernhard Allner Gobio-InstituteforEcologyofWaters&AppliedBiology| Jürgen Arning GermanFederalEnvironmentAgency(UBA) | Patience BrowneOrganisationforEconomicCo-operationandDevelopment(OECD)| Laura Fabrizi EuropeanCommission| Richard Green DowAgroSciences/ECETOCEDTaskForce | Henrik Holbech SyddanskUniversitetOdense/ECHAEDExpertGroup| Peter Korytar EuropeanCommission | Carlie A. LaLone EnvironmentalProtectionAgency|Gregory Lemkine LaboratoireWatch-frog| Cécile Michel FrenchAgencyforFood,EnvironmentalandOccupatio-nalHealthandSafety(ANSES) | Sharon Munn EuropeanCommissionJointResearchCentre | Jenny Odum RegulatoryScienceAssociatesLtd.(RSC)| Camila Queiroz Moreira NationalHealthSurveillanceAgency (ANVISA) | Christophe Rousselle FrenchAgencyforFood,EnvironmentalandOccupa-tionalHealthandSafety(ANSES)| Michael Warhurst ChemTrust|Lennart WeltjeBASF| James Wheeler DowAgroSciences | David Zaruk OdiseeUniversityCollege

29 and 30 November 2017 in Cologne/Germany

Endocrine Disruptors8th International Fresenius Conference

Wednesday,29November2017

8.30 Registration and coffee

9.00 Welcome address by Akademie Fresenius and introduction by the Chair

Lennart Weltje, BASF,Germany

Regulatory Developments in the EU9.10 Criteria for ED identification under EU Regu-lations on plant protection products and on biocidal products: an update

Laura Fabrizi,EuropeanCommission,DGSANTE,Belgium

9.40 Past, present and future EDs under REACH: Influence of the criteria on the French strategy

Cécile Michel, FrenchAgencyforFood,EnvironmentalandOccupationalHealthandSafety(ANSES),France

10.10 Panel discussion 10.40 Coffee break

11.10 Industry perspective: Update on the ongoing activities in the ECETOC task force on endocrine disruption• ECETOCviewondraftEFSA/ECHAguidanceonidenti-

ficationofendocrinedisruptors• OverviewofproposedECETOCapproachforidentifi-

cationofendocrinedisruptors• ECETOCviewonrecentthyroid-relatedactivities

intheEU

Alex Charlton, Syngenta/ECETOCEDTaskForce,UnitedKingdom

11.40 EU action on endocrine disruptors: some progress, many concerns• WhyEUactiononEDCsisneeded• TheEU’sprogresssofar–EDCregulationthrough

REACH,andtheprocessofsettingcriteriatoidentifyEDCs

• FutureprospectsforeffectiveidentificationandcontrolofEDCsinEurope

Michael Warhurst, ChemTrust,UnitedKingdom

12.10 Ongoing activities within the ECHA ED Expert Group• MandateoftheECHAEDEG• Workingprocedures• Specialissues

Jürgen Arning, FederalEnvironmentAgency(UBA),Germany

12.40 Panel discussion13.10 Lunch

Developments Outside Europe14.40 Extrapolation of mammalian-based ToxCast assay results to non-mammalian species to evaluate endocrine disruption• UseofUSEPAToxCastdataforscreeningpotential

endocrinedisruptingchemicals• Challengeofextrapolatingmammalian-baseddatato

non-mammalianspecies• EvaluationoftheToxCastAssaymoleculartargets• Identificationofspeciessimilaritiesanddifferences

basedonsuchdata• Identificationofremainingrequirements

Carlie A. LaLone, EnvironmentalProtectionAgency,USA

15.10 Brazilian perspective: Current activities concer-ning Human Health and Endocrine Disruptors

Camila Queiroz Moreira, NationalHealthSurveillanceAgency(ANVISA),Brazil

Test Methods15.40 Activities under the EU strategy for EDs: towards better identification of endocrine disruptors – focus for the future• Gapsintestmethods• Approachtoaddressgaps• FactorsforprioritisingfurtherTGdevelopment

Peter Korytar, EuropeanCommissionDGENV,Belgium

16.10 OECD guidance document 150 revision• ExpansionofstandardisedassaysforEDs• Useofcross-speciesdata• Experiencesafter5yearsofusingGD150

Jenny Odum, RegulatoryScienceAssociatesLtd.(RSC),UnitedKingdom

16.40 Evaluating chemicals for endocrine disruption at OECD• Adiscussionofnewmethodsforendocrinescreening

andtesting• Validationandharmonisationofalternativemethods

forevaluatingendocrineactivechemicalsatOECD

Patience Browne, OrganisationforEconomicCo-operationandDevelopment(OECD),France

Get-Together on Tuesday, 28 November 2017WillyouarriveonTuesday?Cometothehotelbarat8p.m.andmeetotherparticipantsandexpertsinarelaxedatmosphere.

The Programme

17.10 Panel discussion17.50 End of first day

19.00 Departure time for the evening event

Thursday,30November2017

9.00 Welcome address by the Chair Henrik Holbech, SyddanskUniversitetOdense/ECHAEDExpertGroup,Denmark

Methods and Endpoints for Measuring Endocrine Activity9.10 Activities under the EU strategy for EDs: towards better identification of endocrine disruptors – addressing the gaps• RecommendationsfromrecentECfundedworkshops

regarding• Thyroiddisruption• Retinoidsignallingpathway• Temporalaspects• Otheraspects

Sharon Munn, EuropeanCommissionJointResearchCentre,Italy

9.40 Alternative methods as internationally agreed protocols for detecting endocrine disruptors in Europe• Alternativesforreplacinglaboratoryanimals• Biologicalequivalenceconcentrationsand

physiologicalthresholds• Endocrinepotentialdiffersfromadverseeffect

Gregory Lemkine, LaboratoireWatchFrog,France

10.10 Kinetic determination of vitellogenin induction in the epidermis of cyprinid and perciform fishes: Evaluation of sensitive enzyme-linked immunosorbent assays (ELISA)• ProofofconceptforVTGidentificationandquantifica-

tion• AdvantagesofkineticVTGmeasurementsintermsof

animalprotectioninfieldmonitoringstudies,compre-hensivedatasetsforchemicalregistrationproceduresandlaboratoryhandlingofVTGsamples

Bernhard Allner, Gobio-InstituteforEcologyofWaters&AppliedBiology,Germany

10.40 Panel discussion11.10 Coffee break

11.40 Differentiating endocrine and non-endocrine toxicities• Hazardbasedregulationmeansitisimportanttodis-

tinguishendocrinemechanismsfromothertoxicities• Overviewofhowendpointsmaybeaffectedbyendo-

crineandnon-endocrinetoxicities• Recommendationsonhowtobetterincorporatethese

considerationsintestingandassessment

James Wheeler, DowAgroSciences,UnitedKingdom

12.10 Review of non-monotonic dose responses of substances for human risk assessment

Christophe Rousselle,FrenchAgencyforFood,EnvironmentalandOccupationalHealthandSafety(ANSES),France

12.40 A critical view of the common perception and ongoing debate about EDs

David Zaruk, OdiseeUniversityCollege,Belgium

13.10 Final Remarks and discussion13.40 Lunch and end of the conference

Informationavailableonlineat: www.akademie-fresenius.com/2457

Attheendofthefirstconferenceday,AkademieFreseniusinvitesyoutoaleisurelyeveninginCologne.AfterashortvisittothelocalChristmasmarket,wewillhavedinneratatraditionalbrewpubwithlocalbeer.Don‘tmissoutonthisopportunity!

Bernhard Allner hasbeentheTechnicalDirectoroftheGobioInstitutefortheEcologyofWaters&AppliedBiologysince2002.Heisresponsibleforbiologicaltestmethod

basedmonitoringinthefieldofmunicipalandindustrialwatermanage-ment.HeisamemberoftheISOstandardisationpanelsforEDandgenotoxicitytestingmethods.

Jürgen Arning holdsaPhDinBiochemi-stryandworksasaRegulatoryScientistattheGermanFederalEnvironmentAgency.Hismaintaskscomprisetheidentificationand

evaluationofendocrinedisruptorsintheenvironmentundertheREACHframework.Additionally,heisinvolvedininitiatingriskmanagementmeasuresforenvironmentalEDandinaccompanyingscientificresearchprojects.Since2015hehasbeenamemberoftheECHAEndocrineDisruptorsExpertGroup.

Patience Browne iscurrentlyanAdministratorintheOECD’sTestGuidelinesProgramme.PreviouslyshewasaSeniorScientistintheUSEPA’sEndocrineDisruptor

ScreeningProgramme.PatiencebeganhercareerasafieldbiologiststudyingmarinemammalsinAlaskaandhasworkedinbothhumanhealthandwildlifescience.

Laura Fabrizi worksasaPolicyOfficerattheEuropeanCommis-sion,DGforHealthandFoodSafety(DGSANTE),UnitPesticidesandBiocides.Shehasbeenworkingfor15

yearsasaResearcherintoxicologyandfoodchemistry.LaurahasbeeninvolvedintheworkfordevelopingcriteriatoidentifyendocrinedisruptorsinDGSANCO/DGSANTEsince2010.

Richard Green currentlyworksasaToxicologistforDowAgroSciencesandisanactivememberofanumberofEDexpertgroups,includingthoseoftheEuropeanCentre

forEcotoxicologyandToxicologyofChemicals(ECETOC)andtheEuropeanCropProtectionAssociation(ECPA).HeisalsoinvolvedinredraftingOECDGuidanceDocument150.

Henrik Holbech holdsaPhDinEcotoxicologyandcurrentlyworksasAssociateProfessoratDepartmentofBiology,UniversityofSouthern

The ExpertsDenmark.HehasbeeninvolvedinthedevelopmentofOECDTestGuidelinesforendocrinedisruptersinaquaticvertebratesandinvertebratesformorethan15years.HenrikwasselectedbytheDanishEPAtorepresentDenmarkintheOECDVMG-EcoandECHAEDexpertgroup.

Peter Korytar holdsaPhDinAnalyticalChemistryfromtheFreeUniversityofAmster-dam.BeforejoiningtheEuropeanCommissionin2008,heworkedatWageningenIMARESas

aResearcher.AtDGEnvironment,UnitSustainableChemicals,heisaLeaderoftheteaminchargeofpolicydevelop-mentareassuchasEDs,chemicalmixtures,non-toxicenvironmentstrategyandpharmaceuticalsintheenvironment.

Carlie A. LaLone isaBioinformaticistattheMid-ContinentalEcologyDivision,intheOfficeofResearchandDevelopmentwiththeU.S.EnvironmentalProtectionAgency.

From2010-2015shewasapostdoctoralBiologistfortheUSEPAandtheUniversityofMinnesota.Sheservesasataskleadforresearchaimedatdefiningthetaxonomicrelevanceofadverseoutcomepathway(AOP)knowledgetosupportregulatorytoxicology.

Gregory Lemkine istheFounderandChiefExecutiveOfficerofLaboratoireWatchFrog.Hehasathoroughunderstan-dingofthetechnical,scientificsideandthe

marketingofbiotechnologiesandcompletedatraining/actioncycleofHECschoolofmanagement.HealsoholdsaPhDinPhysiologywithaspecificinterestontheroleofhormonestodetermineneuralstemcells.

Cécile Michel isaRegulatoryToxicolo-gistatANSES.Afterworkingforthepharmaceuticalindustry,CécilehasbeenworkingatANSESfor9years.Sheisa

memberoftheEDexpertgroupofECHA.

Sharon MunnisaProjectManagerattheEuropeanCommission,intheDGJointResearchCentre.Herbackgroundisinhumantoxicologyandriskassessment.Sheisworkingin

supportoftheCommunityStrategyforEndocrineDisruptorsfocusingonimprovedapproachesforthedetectionofendocrinedisruptingsubstances.

Jenny Odum isanIndependentConsultantToxicologistwithabroadrangeofexperience.SheisanexpertintheEDfieldandamemberofOECDgroupsontestingfor

endocrinedisruptionandthedevelop-mentoftestguidelines.

Christophe Rousselle isaToxicologistandcurrentlytheManageroftheChemicalRiskAssess-mentUnitattheFrenchAgencyforFood,Occupationaland

EnvironmentalHealth.

Michael Warhurst hasbeentheExecutiveDirectorofCHEMTrustsince2014.AtCHEMTrust,aUKregisteredcharity,heworksatEU,UKandinternationallevelsto

preventman-chemicalsfromcausinglongtermdamagetowildlifeorhumans,byensuringthatchemicalswhichcausesuchharmaresubstitutedwithsaferalternatives.

Lennart Weltje holdsaPhDinEcotoxico-logyandEnvironmentalChemistryandcurrentlyworksasaSeniorEcotoxicologistatBASFconductingriskassessmentsforPPPs

andbiocides.HisformerstationsincludetheDutchNationalInstituteforPublicHealthandtheEnvironment(RIVM).

James WheelerworksasanEcotoxicolo-gistforDowAgroSci-encesbasedintheUK.Hisworkfocusesonenvironmentalriskassessmentandecotoxicologytesting

withaparticularinterestinfishendocrinetestmethods.

David Zaruk isanEnvironmental-healthRiskGovernanceAnalystandaProfessoratOdiseeUniversityCollegeandUniversitéSaint-LouisinBrussels.Hesitsonvarious

researchethicspanelsandfrequentlyservesasachair,expert,rapporteur,ethicsadviserorevaluatorforEuropean-fundedresearchprojects.Davidworked12yearsinchemicalsissuemanagementforSolvay,CeficandBurson-Marstelle.

Who do you meet?Groups that should take part:

Professionalsworkinginthefieldsof

• Toxicologyandecotoxicology

• Researchanddevelopment

• Registration,regulatoryaffairs

• Chemicalriskassessment

• Legalandgeneralcounselling

Sectors taking part:

• Chemical/biocide/agrochemical/pharmaceutical/cosmeticindustries

• Researchinstitutes

• Regulatoryauthorities

• Environmentalandhealthriskconsultants

• Testinglaboratoriesandcontractresearchorganisations(CROs)

• NGOs

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