Table Of ContentWissenschaftsethikund 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
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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
