Low Dose Exposures in the Environment: Dose-Effect Relations and Risk Evaluation PDF
Preview Low Dose Exposures in the Environment: Dose-Effect Relations and Risk Evaluation
Wissenschaftsethikund Technikfolgenbeurteilung Band23 SchriftenreihederEuropäischen Akademiezur Erforschung von Folgen wissenschaftlich-technischerEntwicklungen BadNeuenahr-AhrweilerGmbH . herausgegeben von Carl Friedrich Gethmann Springer-Verlag Berlin Heidelberg GmbH c. Streffer .H. Bolt .D. Fellesdal .P. Hall J. G. Hengstler .P. Jakob· D. Oughton K. Prieß .E. Rehbinder .E. Swaton Low Dose Exposures in the Environment Dose-Effect Relations and RiskEvaluation With 68Figures and28Tables , Springer Editoroftheseries ProfessorDr.Dr.h.c.Carl FriedrichGethmann EuropaischeAkademieGmbH WilhelmstraBe 56,53474BadNeuenahr-Ahrweiler,Germany Fortheauthors ProfessorDr.Dr.h.c.ChristianStreffer Aufdem Sutan 12 45239 Essen, Germany Editing FriederikeWutscher EuropaischeAkademieGmbH WilhelmstraJ3e56, 53474 BadNeuenahr-Ahrweiler,Germany BibliographicinformationpublishedbyDieDeutscheBibliothek DieDeutscheBibliohekliststhispublicationintheDeutscheNationalbibliografie;detailedbibliographicdataisavaila bleintheInternetat<http://dnb.ddb.de>. This work issubject to copyright. Allrights are reserved, whetherthe whole orpart of thematerial isconcerned, specificallytherightsoftranslation,reprinting,reuseofillustrations,recitation,broadcasting,reproductiononmicrofilm orioanyotherway,andstorage indatabanks.Duplicationofthispublicationorpartsthereofispermittedonlyunder theprovisionsoftheGermanCopyrightLawofSeptember9,1965,initscurrentversion,andpermissionforusemust alwaysbeobtainedfromSpringer-Verlag.ViolationsareliableforprosecutionundertheGermanCopyrightLaw. springeronlioe.com ISBN 978-3-642-05923-0 ISBN 978-3-662-08422-9 (eBook) DOI 10.1007/978-3-662-08422-9 ©Springer-VerlagBerlinHeidelberg2004 OriginallypublishedbySpringer-VerlagBerlinHeidelbergNewYorkin2004. Softcoverreprintofthehardcover1stedition2004 Theuseofgeneraldescriptivenames,registerednames,trademarks,etc.iothispublicationdoesnotimply,eveninthe absenceofaspecificstatement,that suchnamesare exemptfromtherelevant protective laws andregulationsand thereforefreeforgeneraluse. Productliability:Thepublishercannot guarantee theaccuracyofanyiofonnation about dosage andapplication con tainedinthisbook.Ineveryindividualcasetheusermustchecksuchinformationbyconsultingtherelevantliterature. Typesetting:KellenDruck+VerlagGmbH,Bonn+Berlin Coverdesign:deblik,Berlin Printedonacid-freepaper 62/3020hu- 5432I0- Europäische Akademie zurErforschung vonFolgenwissenschaftlich-technischerEntwicklungen BadNeuenahr-AhrweilerGmbH TheEuropäischeAkademie The Europäische Akademie zur Erforschung von Folgen wissenschaftlich technischerEntwicklungen GmbHisconcerned with the scientific studyofconse quences ofscientific and technological advance for the individual and social life and forthe natural environment.The Europäische Akademie intendsto contribute to a rational way ofsociety of dealing with the consequences of scientific and technological developments. This aim is mainly realised in the development of recommendations for options to act, fromthe point ofview oflong-term societal acceptance.The work oftheEuropäischeAkademie mostly takes place intempor aryinterdisciplinary project groups,whosemembersarerecognisedscientistsfrom European universities. Overarching issues, e.g. from the fields of Technology Assessment or Ethic of Science, are dealt with by the staff of the Europäische Akademie. TheSeries The series "Wissenschaftsethik undTechnikfolgenbeurteilung" (Ethics ofScience andTechnology Assessment)servestopublishtheresults oftheworkofthe Euro päische Akademie. lt is published by the Academy's director. Besides the final results ofthe project groups the series includes volumes on general questions of ethicsofscienceandtechnologyassessmentatweilasothermonographicstudies. Acknowledgement The project Environmental Standards. Low Dose Effect Relations and their Risk Evaluation has been partially supported by the Bundesministerium für Bildung undForschung. Preface The EuropäischeAkademie BadNeuenahr-AhrweilerGmbH isconcernedwiththe scientificstudy oftheconsequencesofscientificandtechnological advance forthe individual, society and the natural environment and, therefore, not least with the study ofconsequences ofrecent developments in life-sciences and medical disci plines. The EuropäischeAkademie intends to contribute to find a rational way for society to deal with the consequences ofscientific progress. This aim is mainly realised byproposingrecommendationsforoptions ofaction with long-term social acceptance. The work ofthe EuropäischeAkademie mostly takes place in tempo rary interdisciplinary project groups, whose members are recognised scientists from European universitiesandother independentinstitutes. In the light of recent discussions on the validity ofscientific assumptions con cerning the extrapolation ofharmful effects into the low-dose range the Europäis cheAkademie set up a project on "Lew-Dose Exposures in the Environmenttheir RiskAssessments and Regulatory Processes" inJanuary 2001. Experts ofradiobi ology,toxicology,medical epidemiology,modelling,jurisprudence,psychology and philosophy fromdifferent European countries wcrebrought together todiscuss cur rent scientific developments in environmental standard setting and risk evaluation ofsubstances and ionising radiation at very low doses in order to ensure rational, efficient,and fairdecisions. Iam glad that bymeans ofthis memorandum, that continues ourwork on envi ronmental standards and after our recommendations with respect to the regulation ofcombined agentswecan nowfocus on theeffects and the regulation ofharmful agents inthevery low-doserange. Ihope this memorandumwill get thecredit that itdeserves.Itshould beable to enhance the awareness that scientists and regulators are faced with various uncer tainties whenharmful and especially genotoxic agents havetobe regulated.Inthis regard,theproject group developedmanyvaluable recommendations. For more than two years, the members of the project-group had made a very challenging and productive effort on an interdisciplinary project. I would like to thank the members oftheproject-group and their chairman, ProfessorDr.Dr.h.c. ChristianStreffer,forthiscommitment. Iamalsograteful toDr.Kathrin Prieß who co-ordinatedtheproject onbehalfoftheEuropäische Akademie. BadNeuenahr-Ahrweiler,December2003 Carl Friedrich Gethmann Foreword Exposurestophysiealandehemiealtoxieagentshaveinereasedwith theriseofthe industrialization and of the density of human populations in wide regions ofthe world.During the lastdeeadeseoneernsofthepublie havebeen voieed that health effeets maybeeaused bythese exposures.Inthe range oflowexposures theinduc tion ofcancer is the most serious concern.In order to limit or optimally to avoid possible health effects environmental standards and regulations are necessary. A complete avoidance ofhealth effects is not possible if a dose response without a threshold dose does exist. The procedure ofdeveloping environmental standards mustbebased onsolid scientificdata.However,exposure limitswillbeusuallyset indoserangeswherenosignificanthealtheffectscanbemeasured.Underthesecir cumstancesextrapolationsareperformed fromhigherdoserangeswithmeasurable data to the lower dose ranges without measurable effects for risk estimates. Such processes bear uncertainties which lead to questions not only within the scientific community but also within the public. For these and other reasons it is generally necessaryalsotoconsiderethical,sociological,economic asweilaslegalaspectsin these processes.An interdisciplinary approach and a broad discussion is wanted. Thisapproach hasbeenpursued inaproject group withscientists from various dis ciplines and various European countries.The regulations for environmental stan dards usually differ for physical agcnts like ionising radiation and carcinogenic chemicals.It has been tried during the discussions ofthe group therefore whether and under which conditions a certain harmonization is possible for these agents withearcinogenieactivities. In January 2001, Professor Per Hall (Department of Medical Epidemiology, Karolinska Institute, Stockholm), Professor Eckard Rehbinder, (Sehool of Law, University of Frankfurt1M),Professor Christian Streffer (Institute for Scicnce and Ethics,University ofEssen)and Dr.Elisabeth Swaton (IAEA,Vienna)met to dis eussaproject oftheEuropäischeAkademie GmbH. Further experts,ProfessorHer mann Bolt (Institute ofOceupartional Health,University ofDortmund), Professor Dagfinn Fellesdal (Department of Philosophy, Oslo University/Stanford Univer sity),ProfessorJan-Georg Hengstler(CenterforToxicology,UniversityofLeipzig), Dr. Peter Jacob (GSF National Research Center for Environment and Health, Neuherberg), and Professor Deborah Oughton (Department of Chemistry and Biotechnology, Agrieultural University of Norway, Aas) subsequently broadened thegroup'sintellectualspectrum.Thegroupagreed tocarry outanexemplarystudy on the effectson human health after exposures to ionising radiation and ehemieal carcinogensinthelowdoserange. Finallytheimpact oftheindividualexpertise for the settingofenvironmental standards weretobe developed inaninterdisciplinary manner. X Foreword The members of the project group prepared draft texts from the perspective of their disciplines.Thedrafts, together with additional expertise givenbyinvitedsei entists served asthebasis forthe interdisciplinarydiscussions ofthegroup inorder towork outacompilation ofgeneral agreement. Inthiscontext, theworking group would like to thank Professor Dietrich Henschler(lnstitute ofToxicology, Univer sity Würzburg) and Professor Wolfgang Lutz (lnstitute of Toxicology,University Würzburg) fortheir valuablecontributionsinthe field oftoxicologyandmodelling ofdoseresponses. The project wasco-ordinatedbyDr.Kathrin Prieß(Europäische Akademie GmbH) whoalso contributedactively tothe project group's workasco author and ascollaboratorinthe final shaping ofthe project,Finally,asaresult of 15 meetings and several years work, the project group approved the texts in the present form. In summer 2002 the work ofthe project group was advanced so that the results werepresented toareviewpanelofexperienced colleaguesforacriticalreview.The project group's midterm meeting took place in September2002 in Bad Neuenahr Ahrweiler.Themeeting alloweddiscussions oftheresults oftheproject group with a broader interdisciplinary expert panel. Reviews were given by Professor Maria Blettner (University of Bielefeld, now University of Mainz), Professor Monika Böhm (University ofMarburg),Professor 1.Philip Day(University ofManchester), Professor Anne Fagot-Largeault (College de France, Paris), Professor Ludwig Feinendegen (Lindau), Professor Bernd Hansjuergens (UFZ Centre for Environ mental Research Leipzig), Professor Bernhard Irrgang (Technical University of Dresden), Professor GeorgF. Kahl(University ofGoettingen),Professor .TosKlein jans (University ofMaastricht), Professor Wolfgang Köck (UFZ Centre for Envi ronmental Research Leipzig), Professor Suresh H. Moolgavkar (Fred Hutchinson Cancer Research Centre, Seattle), Dipl. Päd. Holger Schütz (Research Centre .Tuelich). We are indebted to all the participants for the helpful discussions and advice thatimprovedthemanuscripttoitspresent form. Wealso would like to thank Dr.VesnaProkic (GSF Neuherberg) for collabora tion and Mrs Christa Schotola (GSF Neuherberg) for producing graphs for the chapter on mathematical models. We also appreciated the discussions with Dr. WolfgangHeidenreich(GSF,Neuherberg) ontheTSCE model. Abigthank-you isaddressed toMrsBirgittaJerrestenfromtheKarolinska Insti tuteforassistance atthemeeting inStockholm asweilasstaffmembersoftheNor wegian Academy of Seiences in Oslo at the meeting in Oslo. Our acknowledge ments are alsogratefully addressed toMrs Friederike Wütscher oftheEuropäische Akademie whowasresponsible fortheproofreadingofthe final text,as weilasto Mrs.Margret Pauels of the Europäische Akademie who cared for our meetings in BadNeuenahr-Ahrweiler. The collaboration with all mentioned colleagues and with the Europäische Akademie wasanenjoyable undertaking andpleasure. Essen,December2003 Christian Streffer Table of Contents 1 Introduction . 1 1.1 Background ...... .......... ...... ... ...... . . 1.2 Theproblem. ......................................... 2 1.3 Examp1e- theacrylamidecasc ........................... 3 1.4 Pre1iminaries.... ............ .. ....... .... .... .. ..... .. 4 1.5 References.. .... .... .... .......... ........ ....... .. .. 9 2 EthicalAspectsofRisk............................... 11 2.1 Introduction. .. .... .... .. ........ ..... ..... ..... ..... . 11 2.1.1 Risk. .... .... .... .... .... .. .. .... .......... .... 11 2.2 Rationaldecisionmaking................................ 12 2.2.1 Decisionmakers................................. 15 2.2.2 Alternatives ...... ...... ....... ........ ......... 15 2.2.3 Probabilitiesofconsequences.Theprecautionaryprincip1e 16 2.2.4 Uti1itarianismandconsequentia1ism ................. 18 2.2.5 Va1ues... ...... ..... ......... ...... ..... ....... 20 2.2.6 Time.. .............. ..... ........... ......... 20 2.2.7 Life 21 2.2.8 Health................ .. ....... ...... .......... 22 2.2.9 Environmenta1 va1ues. ............................ 22 2.2.10 Knownindividua1soranonymousones............... 23 2.2.11 Freechoice..................................... 24 2.2.12 Consent ....................................... 24 2.2.13 Distribution ................. ..... ............ .. 25 2.2.14 Compensation .................................. 26 2.2.15 Backgroundexposure ............................ 27 2.2.16 Valueofactions ................................. 27 2.2.17 Comparisonofva1ues.Ultimatejustification .......... 29 2.3 Imp1ementation:ethics,1awandeconomics. ................. 31
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