bridging radiation policy and science

BRIDGING

RADIATION

POLICY AND

SCIENCE

BRIDGING

RADIATION

POLICY AND

SCIENCE

An International Conference

Airlie House Conference Center

Warrenton, Virginia

1-5 December 1999

FINAL REPORT

BRIDGING

RADIATION

POLICY AND

SCIENCE

BRIDGING

RADIATION

POLICY AND

SCIENCE

An International Conference

Airlie House Conference Center

Warrenton, Virginia

1-5 December 1999

FINAL REPORT

Prepared By

Kenneth L. Mossman, E. Gail de Planque, MarvinGoldman, Kenneth R. Kase, Sigurdur M. Magnusson, L.

Manning Muntzing, and Genevieve S. Roessler

The authors are solely responsible for the contents of this report except for the

Conclusions and Recommendations that area verbatim transcript of what was agreed

to by attendees on the last day of theconference.

31 January 2000

Published by:Bridging Radiation Policy and Science Conference

1313 Dolley Madison Blvd. Suite 402McLean, VA 22101

Table of Contents

EXECUTIVE SUMMARY

Page 1

PREFACE

Page 3

INTRODUCTION

Page 5

PLENARY SESSION SUMMARIES

Page 7

CONFERENCE CONCLUSIONS AND RECOMMENDATIONS

Page 15

APPENDIX A: LIST OF PARTICIPANTS

Page 17

APPENDIX B: TECHNICAL PROGRAM

Page 23

Bridging Radiation Policy and Science Conference Participants Airlie House, Warrenton, Virginia 1-5 December 1999

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Airlie House Conference CenterWarrenton, Virginia1-5 December 1999

Scientists, engineers, lawyers, social scientists, regula-tors, and policymakers from five continents and 20countries reached consensus on a number of conclu-sions and recommendations regarding low-level ioniz-ing radiation exposures at an international conference,“Bridging Radiation Policy and Science,” at the AirlieCenter in Warrenton, Virginia, 1 – 5 December 1999.The goal of the conference was to develop strategies forformulating national and international policy based oncurrent scientific information in the context of econom-ic, political, and social concerns. Specifically, attendeesexplored how to establish public policies with respect toradiation protection in view of the scientific uncertain-ties of the effects of low-level radiation [<100 mil-lisievert (mSv)]. Conference participants agreed thatscience will not likely answer in the near future funda-mental questions about the shape of the dose-responsecurve and mechanisms of effects of radiation at lowdoses. The conference endorsed the quest for a prudentand coherent radiation policy based on the InternationalAtomic Energy Agency’s (IAEA) “evolving globalframework.”

Conference Conclusions

■ Ionizing radiation is a well-known human carcino-gen. During the past 50 years numerous epidemiological studies of adult human populations exposed to radiation from medical, occupational, or military purposes have been conducted. The lowest dose at which a statistically significant radiation risk has been shown is ~ 100 mSv. This does not imply the existence of a threshold.

■ The effects of low-level radiation below 1 mSv per year above background radiation cannot currently be distinguished from those of everyday natural health hazards.

■ The concept of collective dose is often misapplied, e.g., to estimate health impacts of very low average radiation doses in large populations and/or doses delivered over long time periods. Collective dose can be a useful comparative tool, for instance, in the evaluation of protection options.

■ It is essential to continue to foster international cooperation in radiation safety. In particular, international harmonization of radiation safety policies for radiation sources delivering low radiation doses should be developed.

■ Consistent and coherent radiation policy on a national level is necessary for the effective implementation of radiation safety.

■ Economic, environmental, ethical, psychological, and scientific factors are all essential in the policy and regulatory decision-making process to assure public health and well-being. The way in which these factors are incorporated in nation-specific decision-making processes may vary.

■ Concern over low doses should not deter the public from obtaining benefits of medical procedures.

Conference Recommendations

■ Policy discussions on the regulation of radiation sources delivering low-level radiation should include references to natural background radiation.

■ The conference supports the evolving global framework of the International Atomic Energy Agency (IAEA) for the safe use of radiation.

■ The conference supports further development and evaluation of the ideas associated with the proposal on controllable dose.

■ No radiation dose is below regulatory concern but certain levels should be below regulatory action, and appropriate dose levels should be established.

■ Fundamental questions about the shape of the dose-response curve and mechanisms of effects of radiation at low doses are unlikely to be answered in the near future. Scientific research, including molecular and cellular radiobiology studies, are critical in order to better understand mechanisms of radiogenic effects and provide important informa-tion about the likely shape of the dose-response curve at low doses of radiation, and should be coordinated and continued.

E X E C U T I V E S U M M A RY

Bridging Radiation Policy and Science

■ The conference strongly encourages multinational support and analysis of human data derived from studies such as the Radiation Effects Research Foundation (RERF) Life Span Study, the Russian Mayak and Techa River studies, nuclear workers studies, and studies of populations living in high natural background areas in order to assist in reducing scientific uncertainties in risk and in elucidating mechanisms of radiation health effects. These data offer a unique opportunity to further quantify effects at low doses in human populations.

■ Groups involved in the development of policy and regulations, or making recommendations for such policies and regulations, should operate in an open and transparent manner, and engage in dialogue with stakeholders.

■ There is a pressing need for more effective communication by scientists with the public, politicians, policymakers, regulators, and other interested persons. The science should be clearly articulated, emphasizing what we do and do not know, explaining the limitations in the information and what we are doing about it.

The conference was sponsored by the InternationalNuclear Energy Academy, the International NuclearLaw Association, the International Nuclear SocietiesCouncil, the International Radiation ProtectionAssociation, and the World Federation of NuclearMedicine and Biology. Hans Blix, former DirectorGeneral of the International Atomic Energy Agency,chaired the Sponsors Committee composed of a repre-sentative from each of these organizations.

The conference was organized by E. Gail de Planque,International Nuclear Societies Council; MarvinGoldman, University of California-Davis; Kenneth R.Kase, Stanford Linear Accelerator Center; Kenneth L.Mossman, Arizona State University; L. ManningMuntzing, International Nuclear Law Association; andGenevieve S. Roessler, University of Florida. The pro-gram committee was chaired by Sigurdur M.Magnusson, Icelandic Radiation Protection Institute.

The conference was financially supported by the fol-lowing organizations: American Academy of HealthPhysics, American Nuclear Society, Atomic Energy ofCanada Ltd., British Nuclear Fuels Ltd., CanadianNuclear Society, Cogema, Inc., Electric PowerResearch Institute, Health Physics Society, JapanHealth Research Foundation, Korea Institute of NuclearSafety, Nuclear Energy Institute, Pacific NorthwestNational Laboratory, U.S. Department of Energy, U.S.Environmental Protection Agency, and U.S. NuclearRegulatory Commission.

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Attendees in plenary session. Left to right front row:Genevieve Roessler and Annie Sugier. Left to right backrow: Hans Blix, Manning Muntzing and Gail de Planque

Coffee break. Left to right: Ralph Andersen, William Mills,and Richard Setlow

P R E FA C E

Background

In 1997, a conference titled “Creating a Strategy forScience-Based National Policy: Addressing ConflictingViews on the Health Risks of Low Level IonizingRadiation” was held at the Wingspread ConferenceCenter near Racine, Wisconsin (31 July-3 August1997). Fifty policymakers, regulators and scientistsconvened to discuss science and policy issues regardinglow-level radiation health effects of national (U.S.)interest. A report of the Wingspread Conference waspublished by the Council of Scientific SocietyPresidents.* The emphasis of the conference was onscience issues and scientific uncertainties in policy andregulatory decision-making.

The Airlie Center Conference “Bridging RadiationPolicy and Science” expanded the goals of the success-ful Wingspread Conference in several ways: First, theemphasis of the conference shifted to analysis of prob-lems and their solutions in policymaking and regulato-ry decision-making. Second, economic, ethical, psy-chological, risk, and social factors, in addition to scien-tific uncertainties, were discussed as equal componentsin policymaking and regulatory decision-making.Third, conference discussions on radiation policy andregulations were expanded to include international per-spectives and concerns.

Financial Support

Financial support for the Airlie Center Conference wasreceived from the following organizations. The confer-ence organizers are grateful for their generous support.

American Academy of Health Physics American Nuclear Society Atomic Energy of Canada LimitedBritish Nuclear Fuels Ltd.Canadian Nuclear SocietyCogema, Incorporated Electric Power Research InstituteHealth Physics Society Japan Health Research Foundation Korea Institute of Nuclear Safety Nuclear Energy Institute Pacific Northwest National LaboratoryU.S. Department of EnergyU.S. Environmental Protection AgencyU.S. Nuclear Regulatory Commission

Sponsors

The conference was sponsored by the InternationalNuclear Energy Academy, the International NuclearLaw Association, the International Nuclear SocietiesCouncil, the International Radiation ProtectionAssociation, and the World Federation of NuclearMedicine and Biology. Hans Blix, former DirectorGeneral of the International Atomic Energy Agency,chaired the Sponsors Committee composed of a repre-sentative from each of these organizations.

Conference Organizers

Conference planning and overall direction were provid-ed by the Conference Organizers: E. Gail de Planque,International Nuclear Societies Council; MarvinGoldman, University of California-Davis; Kenneth R.Kase, Stanford Linear Accelerator Center; Kenneth L.Mossman, Arizona State University; L. ManningMuntzing, International Nuclear Law Association; andGenevieve S. Roessler, University of Florida. Theorganizers worked closely with the Program Committeechair in developing the technical program.

* Creating a Strategy for Science-Based National Policy: Addressing Conflicting Views on the Health Risks of Low-Level Ionizing Radiation,Wingspread Conference, Washington, D.C.: Council of Scientific Society Presidents; March 3, 1999.

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Attendees in breakout group discussion. Left to right:Geoffrey Webb, Rick Jones, Ronald Kathren, and KennethMossman

Advisory Committee

Simon Carroll, Greenpeace International (TheNetherlands); Roger Clarke, International Commissionon Radiological Protection (U.K.); Abel Gonzalez,International Atomic Energy Agency (Austria); RonaldKathren, American Academy of Health Physics (U.S.);William Mills, Health Physics Society (U.S.); JerryPuskin, Environmental Protection Agency (U.S.); andSam Thompson, OECD Nuclear Energy Agency(France) served on a committee to advise the confer-ence organizers and the Program Committee.

Program Committee

Sigurdur M. Magnusson, Icelandic Radiation Protec-tion Institute (Iceland) served as chair of the ProgramCommittee. Other members of the committee were:Helen Garnett, Australian Nuclear Science andTechnology Organisation (Australia); George Gray,Harvard University (U.S.); Stanley Hatcher, StanHatcher & Associates (Canada); Jai Ki Lee, HanyangUniversity (Korea); Carmel Mothersill, Dublin Instituteof Technology (Ireland); Shigenobu Nagataki,Radiation Effects Research Foundation (Japan); TaraO´Toole, Johns Hopkins University (U.S.); MauriceTubiana, University of Paris (France); and JackValentin, International Commission on RadiologicalProtection (Sweden).

Conference Coordinators

Administrative services for the conference were provided by Burk & Associates, Incorporated, 1313Dolley Madison Blvd., Suite 402, McLean, VA 22101.Voice: 703.790.1745, fax: 703.790.2672, e-mail:[email protected].

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Coffee break. Left to right: Andre Maisseu, Maurice Tubiana,and Klaus Trott

Overview

Natural and man-made sources of ionizing radiation1

have made and continue to make invaluable contribu-tions to society and to individuals. Radiation is part ofnature. Natural sources of radiation including radon gasfrom the earth’s crust and cosmic radiation from outerspace account for 80-90 percent of the radiation towhich the public is exposed every year. Man-madesources provide hundreds of beneficial uses includingmedical and dental x rays, nuclear medicine pharma-ceuticals, and nuclear power plants. Man-made radia-tion, used primarily in medical diagnosis and therapy,accounts for 10-20 percent of the public’s exposureevery year.

Individual and population exposures to man-made radi-ation sources are controlled so as to minimize potentialdetrimental health effects (primarily cancer) withoutcompromising the beneficial uses of radiation. Theselection of appropriate levels of control of radiationexposures is a complex matter. The issue is especiallyproblematic because cancer occurs at high rates in thegeneral population and it is almost impossible to detectsmall excess cancer risks attributable to low levels ofradiation exposure. Public exposure limits have been setat levels orders of magnitude below exposure levelsknown to cause cancer. Regulations to limit environ-mental and occupational exposures to radiation arebased on the assumption that any dose of radiation, nomatter how small, may cause cancer. While regulatorydecision-making was designed to protect the publichealth, in some ways it has become punitive and bur-densome. The idea that any exposure to radiation maybe harmful has led to public anxiety and to enormouseconomic expenditures that are disproportionate to theactual radiation risks involved. In the United States andsome other countries, regulatory compliance costs aresteadily growing, while desired public health benefitsfrom added regulation are increasingly difficult tomeasure.

Conference Goals

“Bridging Radiation Policy and Science” was an inter-national conference held at the Airlie Center,Warrenton, Va., 1-5 December 1999. The conferencebrought together by invitation 78 engineers, lawyers,policymakers, regulators, scientists, and psychologistsand other social scientists from around the world in anattempt to reach a consensus among people who havetaken different technical, policy and regulatory posi-

tions on the important societal issue of low-level ioniz-ing radiation exposures. A list of participants is provid-ed in Appendix A.

The conference provided a forum for international par-ticipants to share personal and national views on a widevariety of policy, regulatory, scientific, ethical, econom-ic, psychological, science, and policy questions pertain-ing to low-level radiation health effects. The conferencefacilitated a rich international dialogue that promises tobe of great value to policymakers, regulators, and sci-entists interested in developing appropriate public poli-cy with respect to exposure to low-level radiation.

The goal of the conference was to develop strategies forformulating national and international policy based oncurrent scientific information in the context of econom-ic, political, and social concerns. Specifically, the con-ference attendees explored how to establish public poli-cies (legislation, regulation, etc.) with respect to radia-tion protection in view of the scientific uncertainties ofthe effects of low-level radiation [<100 millisieverts(mSv)].

Format of the Conference

Prior to the conference, invited participants wererequested to submit a 1-2 page statement concerningwhat they considered to be the major issues of the con-ference and their expectations regarding the outcome ofthe conference. A conference briefing book containingall statements was distributed to the participants aboutone week prior to the meeting. The briefing book servedtwo purposes: First, it gave each participant an opportu-nity to review issues about which others were con-cerned. Second, the organizers used the briefing book todevelop discussion questions that were critical to theorganization and outcome of breakout sessions.

The conference was organized to promote the exchangeof information and discussion among the participants.This was done through plenary and breakout group ses-sions. The technical program is provided in AppendixB. Facilitators who did not have a professional interestin the subject material led plenum and breakout groupdiscussions. After an opening session to set the confer-ence goals and objectives, a policy session addressedthe challenges in setting policy at the highest level andwhat the policymakers need to know. A sequence of ses-sions examined relevant issues, including scientificuncertainties; economic, political and social factors thatinfluence policy; international organizations and policy;

I N T R O D U C T I O N

1 Ionizing radiation includes x rays and gamma rays. They differ from other types of radiation such as visible light, ultraviolet rays, and ultrasound by their ability to cause ionization of atoms and to break chemical bonds.

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regional and national policy issues; and issues bridgingscience and policy. Each session included keynote pre-sentations providing brief overviews to set the stage andstimulate the discussion in plenum. The goal of the lastplenary session was to finalize conference conclusionsand recommendations. A summary of each session isincluded in this report. Three breakout sessions werescheduled during the conference to explore specificquestions relevant to the goals of the conference. Eachparticipant was assigned to one of four breakout groups.Group assignments were made to balance national andprofessional perspectives in each group. Each groupconsidered the same set of questions. At the end of eachbreakout session, a group reporter summarized discus-sions in a plenary session.

The breakout questions were as follows:

Breakout I: Clarify/define the issues associated withbalancing science and the other factors influencing pol-icy

■ What do policymakers and regulators need to know in order to make decisions?

■ How do risk, economic, social, psychological, political, scientific, and ethical factors influence policy and regulations?

Breakout II: Develop recommendations on the formu-lation of policy and regulations

■ What are the major scientific uncertainties of concern to policymakers and regulators, and is it appropriate to use predictive theories to establish policy and regulations?

■ How can advisory bodies (e.g., ICRP, NCRP) be used appropriately in the policy-making and regulatory process?

■ How can constituency (e.g., public, industry) concerns be more effectively incorporated in the policy-making and regulatory processes?

Breakout III: Develop recommendations on the use ofavailable resources, develop guidance on directions,and continue to develop overall recommendations andconclusions

■ Are current regulations and policies appropriate? If not, what are the alternatives? What are the social and economic costs and benefits of alternatives?

■ Should there be an international agreement to adopt a single coherent and consistent system of regulations and policies?

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Session 1: A Philosophical Overview of Policymaking

The first session of the conference focused on the chal-lenges of setting policy and on what the policymakersneed to know when formulating policy at the highestlevel. The description below reflects not so much asummary as the highlights of each person’s remarks thatindicate the needs of policymakers.

Peter Lyons began the session by reading a statementfrom U.S. Senator Pete Domenici who was not able toattend the session in person and sent his regrets. TheSenator is keenly interested in the accuracy of the lin-ear, non-threshold (LN-T) theory and commented that“If these standards overestimate risks, they force us todivert funds from other, potentially more worthy,national goals.” Further, he was critical of the way theLN-T theory is being used, especially by the U.S.Environmental Protection Agency. He has personallytaken action to influence the creation of an $18 millionresearch fund for the Department of Energy to look intothe effects of low-level radiation. He has also instigat-ed an investigation by the General Accounting Office toassess the cost impact of the application of the LN-Ttheory to projects such as the disposal of high- and low-level waste, nuclear power plant decommissioning, andenvironmental cleanup, as well as to look at variationsof levels of natural background radiation in the U.S. andany correlation with cancer incidence. Finally, he isconsidering having Congress “…mandate that no stan-dards be more stringent than the variation in natural lev-els within the United States for any substance or phe-nomena, unless specific health studies support the needfor a departure.” The Senator’s bottom line is thatresponsible and honest scientific information is neededto guide policy and that standard setters need to bemindful of costs.

Bennett Johnston expressed similar reservations. He isespecially concerned about costs. He gave as an exam-ple the costs for site characterization of YuccaMountain, originally estimated to be $60 million andnow estimated to be $6 billion, all due to what he seesas standards that are unnecessarily stringent and unjus-tified by the scientific evidence. He also expressed con-cern about the extraordinary public fear of radiation andon the other hand, scientists who seem to want to bepoliticians and heroes of the public and the press anddistort science in that attempt. Bennett Johnston’s

bottom line was that scientists and policymakers shouldfollow good solid science.

Andrew Miller described guidelines set up by theBritish government, setting out key principles for thepresentation of scientific information for policymaking.These guidelines address: the ability to identify issuesearly, the need to obtain information from a wide vari-ety of sources, and the need to ensure that the processleading to a balanced view be transparent and consistentacross policy areas. Miller emphasized the need forEuropean Union policy to have a sound scientific basis.He recommended that scientists whose advice is beingsought should help decision makers frame and assesspolicy options. Finally, he stressed the “…need toensure that our citizens are well-informed and are notsimply reliant upon the views of an editor with an ax togrind or of a pressure group.”

Simon Carroll took a fundamental and philosophicalapproach. He stressed the importance of establishingthe principles that should underpin policy and deter-mining how they apply in practice. He stressed theneed to identify what further scientific data needs to becollected to modify current policy or regulation.Carroll raised the question of how reasonable decisionscan be made when there are uncertainties in the scien-tific data on the one hand and disputes on the underpin-ning principles on the other. He stressed the importanceof the “precautionary principle” as a guiding principlein decision-making in this field and emphasized that,while risk assessment was an essential component ofthe application of the precautionary principle, riskassessment should be seen as only one of a number offactors to be taken into account.

Junko Matsubara presented a very useful description ofthe recent accident at Tokai Mura, Japan, together withthe reactions of the experts, regulators, government andthe public. She stressed the need for experts and thepublic to arrive at a proper recognition of risk, cost, andbenefit of nuclear technologies. She gave support to theidea of comparing dose limits with natural backgroundlevels as a way to convey a better sense of level of risk.

KunMo Chung pointed out the great needs of develop-ing countries for nuclear technologies in securing cleanenergy and utilizing radioisotopes for medical, agricul-tural and industrial applications. Because of the uncer-tainties surrounding the LN-T theory, he cautioned that

Plenary Session Summaries

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the scientific community needs to convey flexibility inoptions to the policymakers and regulators. He empha-sized the need for stakeholder participation in policy-making along with the need to inform the public about“…unsubstantiated health effects and the existinguncertainties of scientific conclusions.” He called forinternational collaboration on studies and recommenda-tions and concluded that “We cannot afford public pol-icy based on untested scientific judgment and illogicalassessment of risks.”

In summary, several key consistent messages can bedistilled from Session I:

■ underpinning principles should be established,■ policy should be based on sound science,■ uncertainties should be clearly delineated,■ processes need to be transparent,■ policies need to be consistent (nationally and

internationally),■ stakeholder input is essential,■ citizens need to be accurately informed in language

that is understandable■ relating dose limits to levels of natural background

radiation and/or variations is useful

Session 2: Science Issues

In “The Science Issues” session, formal presentationsand discussions on epidemiological and molecular andcellular radiobiology investigations focused on thenature of scientific uncertainties, current research prob-lems and future needs to clarify mechanisms of radi-ogenic health effects, and reducing uncertainties in low-level radiation risk estimates. In the context of bridgingpolicy and science, this approach was considered to bemore productive than to attempt to resolve the LN-Tdebate, and its related policy and regulatory implica-tions.

Epidemiology

Shigenobu Nagataki provided an overview of theRadiation Effects Research Foundation (RERF) activi-ties, including the current status of the Life Span Study(LSS). This is the major source of data used by the sci-entific community to estimate the magnitude of radia-tion risks at low doses. The LSS was established in1950 and has more than 80,000 subjects. About 75 per-cent of the exposed individuals received radiation dosesless than 100 mSv. The objective of the RERF is to pro-vide long-term follow-up of the large cohort of A-bombsurvivors; to consider all biologically plausible theoriesto describe the shape of the dose-response function; andto consider modifying factors, such as age, that mayaffect the dose-response pattern. Although each scientist

may analyze data according to his/her own ideas,hypotheses, or methodologies, RERF has to considerseriously all suggestions, proposals, and criticisms. Inthis regard, collaborations with RERF are welcomed.Nagataki provided the following summary concerningthe LSS solid cancer data: (1) There is a statistically sig-nificant dose-response over the range of 0-200 mSv; (2)the slope of this response is consistent with, and virtu-ally identical to that for the full dose range; and (3) thebest estimate of a threshold is essentially zero with anupper 95 percent confidence bound of less than 100mSv. The understanding of cancer risks at low doses islimited, and thus a broad scientific approach includingmolecular and cellular radiobiology studies has to beconsidered. New molecular biology studies on the basicmechanisms by which radiation causes its effects can beconducted using the unique collection of tumor tissuesfrom the RERF registries.

Dale Preston and Charles Land discussed some of themajor scientific issues and limitations in radiation epi-demiology based on experiences related to the A-bombsurvivor data. Preston identified some of the limitationsof low-dose epidemiological studies, including the lowpower (chance of detecting an effect when the effect ispresent) of studies in the low-dose range (less than 100mSv), the difficulty and expense in conducting adequatemedical follow-up of subjects, and the appropriatenessof the study population as representative of the generalpopulation. He noted that the relevant hypotheses to beexplored in epidemiological studies are: Does radiationmodify disease risk?, and are the low dose risks consis-tent with linear extrapolation from risks seen at higherdoses (the failure to observe an effect does not neces-sarily equate to no effect)? Preston outlined thestrengths and limitations of several populations thatprovide or may eventually provide useful informationon low-dose risks. These include the pooled analyses ofnuclear worker cohorts, the Mayak and Techa Rivercohorts, Chernobyl liquidators, and the RERF LSScohort. Preston also discussed issues in cellular radiobi-ology, including radiation effects and cells, how suchcell effects determine long-term disease risk, and pro-tective mechanisms, noting that uncertainties aboutrepair, epigenetic effects, adaptive response, etc. pre-clude definitive conclusions in the low-dose range.

Land focused on quantifying the level of statisticaluncertainty in the atomic bomb survivor cohort using,as examples, breast cancer and pancreatic cancer.Another source of uncertainty, translating risk estimatesderived from one population to another population withdifferent demographic characteristics, was also dis-cussed. Land also explored the issue of thresholds.Based on present evidence, it is not possible to postulatewith certainty any threshold below which there is no

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risk. While a threshold cannot be totally ruled out,allowing for that possibility had little effect on theupper confidence or credibility limits for risk at lowdoses. Thus, the uncertain possibility of a low-dosethreshold is unlikely to have any practical influence ona conservative, risk-based radiation protection policy.

Discussions on human health effects focused on theLSS data. Preston indicated that modification ofHiroshima neutron doses, while lowering the LSS-derived risk estimates somewhat, still appear to be con-sistent with low-dose linearity. It was also recognizedthat studies of residential radon exposures and lungcancer risks and various medical studies have also beenconducted and provide important epidemiological evi-dence that complement the LSS data. In addition, alarge body of data derived from laboratory animal stud-ies has been important in identifying various host andenvironmental factors and their relation with radiationas determinants of cancer risk. Studies in animals havealso been important in bridging effects observed at themolecular and cellular level with the appearance ofcancer in the whole organism.

Molecular and Cellular Radiobiology

Carmel Mothersill, Richard Setlow, and Klaus Trottreviewed the current status of molecular and cellularradiobiology, factors that modify risk, what scientificstudies may be useful in clarifying mechanisms ofmolecular and cellular damage, and how uncertaintiesin radiation risk may be reduced.

Mothersill reviewed effects of radiation on cells at lowdose (less than 50 mSv) including genomic instability,persistence of stress response, bystander effects (fieldeffects involving cells not hit by radiation), apoptosis(programmed cell death), proliferation stimuli andinduced repair. Cell damage at low dose appears to besimilar to stress response. Stress response is saturatedat doses less than 10 mSv. The consequences of expo-sure are dictated by the response to the damage ratherthan the damage itself. There are important scientificquestions that are still to be resolved: What are themechanisms and consequences of genomic instabilityand bystander effects? How does a particular celldecide whether to repair radiation damage or induceapoptosis? Since some environmental agents (e.g.some metals) also produce genetic instability, are therecommon mechanisms involved in radiation and chem-ical injury? Understanding the long-term healthimpacts of radiation exposure requires a shift in think-ing away from effects in single cells (such as DNAdouble strand breaks) to field effects and damage incell populations and tissues and organs. Long-termeffects in cells are becoming increasingly important.

Tissue architecture and proliferation kinetics of stemcells and progenitor cells are important in understand-ing long-term disease processes. Mothersill alsostressed that evidence for thresholds for specific mech-anisms did not mean that thresholds exist for diseaserisk.

Setlow discussed factors that modify radiation risk atthe cellular level: DNA repair removes damage beforereplication. Adaptation involves small doses of radia-tion that reduce the effects of subsequent large doses.Apoptosis reduces mutations and possibly cancer byprogrammed cell death of damaged cells. Bystandereffects involve cells damaged by high linear energytransfer (LET) radiation (e.g., alpha particles) that mayresult in mutation and transformation of contiguousneighbors. Genetic instability involves chromosomalchanges and mutations that may appear after a largenumber of cell divisions. Setlow also discussed thenature of DNA damage and its repair. Single strandbreaks and base damage are repaired rapidly and com-pletely. These DNA effects occur very frequently incells but have few, if any, health consequences. Doublestrand breaks occur much less frequently (about 5 per-cent of the single strand break rate); the fact that therepair of such damage is slow and incomplete mayhave significant health consequences. The health con-sequences of multiply damage sites in DNA may besignificant; repair of such damage appears to be ineffi-cient. The kinetics of DNA damage in cells argueagainst the existence of a threshold.

Klaus Trott discussed several scientific issues that needto be addressed for future policy and regulatory deci-sion-making. Low-dose epidemiological investigationsare limited in part because of the non-specificity ofradiogenic cancer and the absence of clearly distin-guishable DNA fingerprints to identify radiogenic dis-ease. The molecular features of the specific mutationsin radiogenic cancer in man (PTC 3 translocations orpoint mutations rather than deletions as was expected)suggest that the critical mutation does not occur as adirect result of radiation interactions with DNA butduring processing and/or repair of the initial lesion.These observations do not support the microdosimetricargument in favor of the LN-T theory.

In the discussion, there was a consensus that no break-through exists that would have permitted a final con-clusion about the shape of the dose-response at lowdoses. There were various questions about technicalissues of particular analyses, but these did not affectthe general conclusion about uncertainty. Some differ-ences of opinion existed about the correct way to han-dle presumed but undetectable small risks—shouldthey be disregarded or not?

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Session 3: Bridging to Application—Factors That Influence Policy

This session summarized a number of factors otherthan science that impact policy and regulation.Presentations focused on risk, economic, social, psy-chological, and ethical factors.

Risk Assessment

George Gray made the case that, because of limitationson resources, comparative risks should be taken intoaccount in setting priorities for resource allocation.This should apply to all societal activities, includingthe regulation of radiation exposure. The principles ofrisk analysis are becoming accepted and used beyondsimple standard-setting to risk management. It allowsquantitative determination of benefit/cost ratios andallows society to expend resources on tackling theworst problems first. Risk analysis has been used tocompare different types of risk and communicate thesecomparisons to the public. This has proved effective inhelping prioritize risk in more than 35 U.S. states,regions, and tribal governments.

In making comparative risk analyses it is important touse the best available information on risks and accountfor uncertainties, rather than conservative values. Thelatter have been justified on the basis that it is better tobe safe than sorry, but conservative input can skew theresults toward unrealistic comparisons. Precautionarynotions do not belong in risk assessment exercises; thisis a social factor that should be applied when the realrisk is known. However, there is still much to be done,and evolution of risk analysis methods and risk charac-terization must continue if this technique is to fulfill itstrue potential in helping to guide policymakers and reg-ulators toward optimal solutions for society.

Economics

Neville Chamberlain examined the economic cost ofregulation. He used several examples to illustrate howmeeting escalating regulatory requirements has drivencosts to unreasonable levels for the benefits obtained.In particular, the collective dose concept has beeninappropriately applied. Multiplication of very smallindividual doses by very large populations is an incor-rect application and abuse of the collective dose con-cept as developed from the LN-T theory. If there is noagreement on a threshold for radiation-induced healthrisks, we must get the near-zero risks in proper per-spective and agree on a cut-off level for regulatory pur-poses and restore a balance to the use of economicresources. The conclusion was that a line has to bedrawn somewhere in the reduction of radiation dose at

ever-increasing costs. Chamberlain argued that theabsence of such a line amounted to economic abuse ofprudence and has resulted in a vacuum that has led todistorted energy policy. Clear guidance from the sci-entific community is needed to counter the trend ofpolitical campaigners and the popular media to useunscientific and emotional information to sway politi-cians and regulators toward requirements that result inunnecessary expenditures to the detriment of society atlarge.

Social Issues

In addressing social issues, Rick Jones proposed thatthe time has come for shared responsibility. We needmore communication and transparency. Current andpast U.S. practice have involved recommendationsfrom national and international bodies using a closedgroup of professionals (where tradeoffs were not trans-parent and uncertainties were not well documented)with the result that policymakers and regulators havewound up defending a system of protection that theypoorly understand. Reactions of the public, laborunions, special interest groups, and the press resulted inthe courts being the final judge and interpreter of radi-ation protection policy.

For the future, it was proposed that we should democ-ratize radiation protection policy by opening the dia-logue and forums to the public, unions, policymakers(politicians), press, and courts and require federalagencies to achieve consensus on radiation protectionrequirements. This would require an advisory commit-tee for all new rulemakings. Shared responsibilitywould require agreement on resolving issues, involvingall parties and would result in final policy which couldbe implemented in an efficient and effective manner,despite the uncertainties of science. This approach hasbeen used effectively in beryllium rulemaking in theU.S. and in resolving the issue of contamination in theMarshall Islands.

Psychological Factors

Lennart Sjöberg traced the historical evolution ofthinking on social issues and pointed out that in the1970s the so-called psychometric model was pub-lished. The cultural theory of risk perception evolvedin parallel. However, neither of these models pass thesystematic empirical tests that have been done. In the1980s, risk communication (essentially “teaching”)was tried, with disappointing results.

In the 1990s, social scientists began to see risk com-munication as a dead end, and “trust” was suggested asthe key factor. It was believed that trust might be


established through transparency of policy and realinfluence on decision-making. But who should beinvolved, since the silent majority were not interestedenough to invest the time needed? Stakeholdersseemed to be the answer to representing the public.However, trust does not seem to be a strong factor inrisk and related attitudes. People do trust the expertsbut do not accept their conclusions, because the publicbelieves that there are unknown effects and factors thatare not understood. Furthermore, stakeholders do notrepresent the public, but their own particular interests.

While experts talk about risks as probabilities, the pub-lic thinks in terms of the severity of consequences, andthis is the key difference in the view points of expertsand the public. We haven’t really understood how todeal with this yet.

Ethical Issues

Deborah Oughten said that ethical values are complexin risk evaluation, particularly when science cannotidentify a safe level of radiation. There is a problemwith risk and benefit being distributed over differentpopulations at different times. However, recommenda-tions are vague as to what ethical values should beincorporated into radiation protection. From an ethicalstandpoint, the following questions might be included:Do the benefits outweigh the costs? Is the distributionof risk and benefit equitable? Have affected peoplebeen involved in the decision-making process? Is therea viable alternative? Does the person have control over(or has the person given consent to) the risk? Has theperson been compensated for the risk?

The justification principle is in line with the ethicalprinciple that one should do more good than harm.However, net benefit is not usually adequate to deem apractice ethically justifiable. Although the ALARAprinciple has been criticized both for putting a price onhuman life and for causing an excessive use of funds,there are strong ethical grounds for retaining someform of optimization in radiation protection policy.However, authorities should guard against pursuingcost-effectiveness without due consideration of otherethical values.

Dose limits are criticized by some people who feel theyare too high and by others who feel they are too low.They usually relate only to humans and not to other

species. Small harms, while never ethically irrelevantin themselves, may be deemed trivial and not worth theinvestment of resources for regulation or control.

Session 4: International Organizationsand Policymaking

This session focused on the role of international organ-izations in the policy-making process. Abel Gonzalezdiscussed IAEA activities in the policy arena. IAEA ispromoting an international radiation safety regime tofoster international consensus on radiation issues andfacilitate the solution of problems faced worldwide inregulation of radiation2. The regime’s key elementsare legally binding international undertakings by states,globally agreed international safety standards, and pro-visions for applications of standards. The scientificpolicy supporting the regime is formulated by theUnited Nations Scientific Committee on the Effects ofAtomic Radiation (UNSCEAR) for the scientific data-base on radiation health effects, and the InternationalCommission on Radiological Protection (ICRP) for theradiation protection recommendations. The regimeserves as a decision-aiding mechanism that should becoupled to societal and other concerns (e.g., stakehold-ers) in the decision-making process.

Roger Clarke discussed ICRP activities. Recommen-dations on radiation safety are the main role of theICRP. Over the past 60 years of its existence, the ICRPhas continually evolved as radiation knowledge devel-oped. Initially, the ICRP focused on prevention ofdeterministic effects, simple severity thresholds, andthe idea that protecting society also protects the indi-vidual. Now, the ICRP is concerned mainly with rec-ommendations related to stochastic effects (e.g., can-cer), dose effects relations and a precautionary as-low-as-reasonably-achievable (ALARA) philosophy andacceptable risks, and a focus on individual risk andaverting individual doses.

Burton Bennett provided an overview of UNSCEARactivities. UNSCEAR, created in 1955 to monitoratmospheric weapons fallout, has served as an interna-tional resource and database for radiation levels world-wide. Its periodic reports to the United NationsGeneral Assembly now include scientific summariesand integration of the world literature on fallout, healtheffects, natural background radiation, adaptiveresponse, and practices involving radiation.

2Under Article III.A.6 of the IAEA Status, the Agency is authorized “to establish or adopt, in consultation and, where appropriate, in collab-oration with the competent organs of the United Nations and with the specialized agencies concerned, standards of safety for protection of health and minimization of danger to life and property.” Details about IAEA safety standards may be found in IAEA (1999) Measures to Strengthen International Co-operation in Nuclear, Radiation and Waste Safety, IAEA General Conference Document GC(43)/INF/8, Vienna:IAEA; and Safety Standards (1998) IAEA Bullentin 40(2).

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Geoffrey Webb discussed the International RadiationProtection Association (IRPA). IRPA is a global asso-ciation of radiation safety and protection societies. Itsponsors international and regional congresses. It pro-motes the role of professionals in development of poli-cies and standards, has developed a code of ethics, andemphasizes rationality and stability in supporting theprofession of health physics.

Patrick Green discussed activities of Friends of theEarth. This organization strives to enhance the societalrole in developing and monitoring radiation policy. Itencourages increased activity by industry in managingits radiation legacy. It fosters increased societal, ethi-cal and political values in the decision process and inpolicy development. Above all, it emphasizes the needfor justification of decisions and actions and opennessand transparency in the “debate.”

Session 5: Regional and NationalPolicies

This session was devoted to discussions concern-ing development of regional and national radiationpolicies. Overviews were provided by John Loy(Australia), Kaare Ulback (European Union/Denmark), Kun-Woo Cho (Korea), and Stephen Page(United States). The following summary emphasizesthe key messages from the session, rather than provid-ing a précis of each speaker’s presentation.

ICRP plays a central role in determining radiation poli-cies among countries represented in thesession.Translation of ICRP recommendations intohighly binding directives differs from one country tothe next, but in all cases takes a long time (five years atleast in Australia). Because of the effort needed totransform ICRP recommendations into regulations(and for other reasons), “stability” in ICRP recommen-dations is desirable.

In the European Union (at the moment 15 memberstates) the Euratom Treaty of 1957 requires uniformbasic safety standards to be set in order to protect work-ers and the public from health risks of exposure to ion-izing radiation. Since 1959 seven revisions of theStandard Directive have been negotiated and put intoforce in Europe. These revisions have been based on thelatest recommendation from ICRP and have supportedthe basic principles of radiation protection (justifica-tion, optimization, dose limitation), and licensing pro-cedures (reporting and prior authorization of practices).The present Standard Directive, adopted on 13 May1996 by the Council of the European Union, is based onthe 1990 recommendations of the ICRP (ICRP

Publication 60) and is to be implemented by the mem-ber states before 13 May 2000. Being minimum direc-tives, the actual incorporation into national legislation isleft to the individual member states. Minor differencesin the detailed regulations among member states may beexpected.

International cooperation in crafting radiation regula-tions is happening and is useful, but difficult. Forinstance, U.S. flexibility is somewhat limited by histor-ical regulatory and legal actions requiring lifetime risks<10-4. It seems most attainable in areas of shared inter-est where there is clear need for harmonized regula-tions, e.g., standards for commodities (contaminatedmetals) and environmental restoration of contaminatedsites (shared problem).

Public confidence in regulations and policies is impor-tant in all countries represented on the panel. It is espe-cially critical in Korea where past mistakes, distrust ofmilitary dictatorship and memories of the atomic bomb-ings create significant fear of radiation and where eco-nomic development is dependent on nuclear power.Public confidence is thought to improve if radiationpolicies and regulations are established in an openatmosphere; there is some evidence of increasingmoves toward more public participation. For example,Australia now includes a representative of the public onits chief authoritative radiation review board.

It is highly important to establish national/regional radi-ation regulations in which the public has confidence.Billions of dollars are being spent on cleanup at U.S.Department of Energy contaminated sites. One must dothis right and apply resources to sites appropriately.There is some urgency, and decisions are being madenow.

Session 6: From Science to Policy and Regulations

This session addressed the reconciliation of science,international recommendations, and governing policyin the formulation of regulations. Overviews were pro-vided by Klaus Becker (Germany), David Michaels(United States), Annie Sugier (France), and TsutomuSugahara (Japan).

The session focused on developing needed regulations.The “givens,” which had already been discussed in themeeting, were the science, with its inherent uncertain-ties, the activities of the various international andnational bodies, and the policies that the various bodieshad developed. Regulations need to reflect these poli-cies.

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Richard Osborne opened the session by reflecting onthe tour that the Conference attendees took to ThomasJefferson’s home, Monticello, the previous day. Henoted that Jefferson would like the goals of ourConference and that it was Jefferson himself who said“Knowledge is happiness.” This session should bringtogether the knowledge that we have; the audienceshould be happy despite the differing opinions. Gettingthis last step right is key, though; regulations are wherethe “rubber meets the road.”

Annie Sugier emphasized that the common theme of thesession was that “Working together is the key.” Shepointed out that this needs to be achieved at the nation-al and the international level and, most important, at thelocal level. There are a number of aspects to this: sharedresponsibility, value judgments, paradoxes, mispercep-tions, non-science issues, and science not being takenfor granted. She stressed the necessity to structure thedebates making a clear distinction between the differentstages of radiological risk management and acknowl-edging the existence at each stage of not only scientificand technical aspects but also judgments by experts thatneed to be explained.

Several speakers pointed out that there is a responsibil-ity for all those who are generating policies and regula-tions to ensure that all who are involved can state theirviews and be comfortable that their voices are heard.The corollary of this is that there is a responsibility ofthose so involved to work toward constructive solu-tions.

There will be value judgments both in setting the poli-cies and in developing the regulations. Much of theconfusion and angst that arises in reactions to regula-tions arises from failure to have made such value judg-ments explicit.

Paradoxes are also commonly a part of the picture.Klaus Becker gave a vivid example of the paradox thatoccurs with radon. It is accepted and even promoted asa health benefit in radon spas while governments try toemphasize the importance of controlling it in the home.These paradoxes will continue to arise because of theapproach that is necessarily taken in selecting for thepurposes of protection a single theory for the relation-ship between radiation exposure and effects on health.He felt that the LN-T theory was not necessarily themost appropriate one.

David Michaels used the example of radioactively con-taminated nickel from DOE in steel that might get intoorthodontic braces as well as other commercially usedproducts. He noted that recycling metals may be theright thing to do, but we need to involve the public inhelping to deal with their issues and concerns.

Tsutomu Sugahara voiced concern that more attentionneeds to be paid to the uncertainties in the science thatunderlie the development of regulations. He notedexamples where biological endpoints that show aresponse to low doses of radiation may, in fact, not becorrelated with cancer causation. He cited the “trans-scientific” nature of the science for risk managementthat is involved here. In these situations, he felt that thestandards to be developed needed to reflect the views ofa large peer community, including the public. Riskassessment was essential, and Sugahara suggested thatthe medical and engineering fields could provide help insolving this particularly difficult risk assessment prob-lem.

Questions and comments dealt with how we can com-pare different kinds of risk so that money is not spent toreduce types of risk that are low. A common theme wasthat unless the people affected are involved in makingthe decisions and value judgments, they are unlikely toaccept the outcome.

Session 7: Problems and Options

This session focused on the main problems in imple-menting present radiation policy and whether (and how)such policy should be changed. Roger Clarke contend-ed that the current international system for radiationprotection, stemming from the ICRP’s 1990 recommen-dations, has a number of problems. In general, it isoverly complex and incoherent. Specific problemsinclude difficulty in classifying certain situations aspractice or intervention, no limits in emergency situa-tions, and misuse of collective dose. He proposed a sim-pler approach based on controllable dose, recognizingthat if the dose to the most exposed is controlled thenthe total risk is acceptable3. His approach would involvean individual dose scale, which would take into accountbackground radiation and provide a basis for policy-making. Criteria could be presented on doses that arefractions or multiples of background and there would bea level (e.g., less than 0.03 mSv) below which dosewould be considered trivial. ALARA would bereplaced with ALARP (i.e., as low as reasonably practi-

3Controllable dose may be defined as the dose or the sum of the doses to an individual from a particular source that can reasonably be controlled by whatever means. Details about the controllable dose concept may be found in: Clarke, R. (1999) Control of low-levelradiation exposure: time for a change? Journal of Radiological Protection 19(2): 107-115.

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cable), and the concept of “justification” would be ele-vated to a higher decision-making level. In addition, itwould no longer be necessary to differentiate betweenoccupational, public and medical exposures. Finally,this approach could be a basis for developing an envi-ronmental radiation protection policy.

Helen Garnett referred to four cases to demonstrate thedeficiencies in the application of the current system,both nationally and internationally. She, too, called fora simpler approach embodying greater harmonizationof standards and their application that would be helpfulto countries where regulatory practices are still evolv-ing as well as to those where they are mature. This sim-pler system should: (a) embody a practical approach todeclassification/exemption of material previously clas-sified as low-level waste where, with further evaluationagainst newer principles/criteria, classification wouldno longer apply, and (b) eliminate the often inappropri-ate automatic application of the collective doseapproach. Such a system should be based on “protec-tion of the most exposed individual” in appropriate cir-cumstances. Like Clarke, she saw a need to move awayfrom the distorted ALARA approach so often usedwhere the interpretation is just as low as achievable, toa more flexible standard taking into account social andeconomic issues. Garnett stressed that the lack of inter-national consensus on science issues leaves open thepossibility that low operational doses can lead to unnec-essary public concern. She sees utility in providing toworkers and the public explanations of dose in terms ofnatural background and airline travel. In this connec-tion, she recommended that policymakers and the pub-lic be informed that 1mSv is a level below which thereis uncertainty about the effects of chronic low doseexposure. Such a level is equivalent to the dose receivedby airline travellers making four round-trip flights peryear between Sydney and London. Decisions need totake into account social, economic, and political factors,although doses at very low levels (e.g., 0.25 mSv) cor-responding to one round-trip flight between Sydney andLondon could be considered trivial.

Maurice Tubiana focused his presentation on the LN-Tapproach of the current system. He stressed that thereis no evidence of carcinogenic effect at doses below 100mSv and that LN-T theory is not compatible with datafrom a number of studies or with the complexity of car-cinogenesis. In addition, he noted that the LN-T theoryactually has demonstrably detrimental effects, havingfueled unnecessary anxiety in the aftermath of theChernobyl accident, leading the public to resist medicaland other useful non-power applications of atomic ener-gy, and necessitating disproportionate expenditureswith respect to very low risks. He called for a clear

statement that the LN-T theory cannot be used to pre-dict the number of cancer risks below 50 mSv. LikeClarke and Garnett, he expressed misgivings about theALARA principle, which he said was misleadingbecause it indicates that even the smallest dose is harm-ful. In this regard, he noted that when all data are con-sidered together (including those corresponding toosteosarcoma induced by radium in the dial paintersand hepatoma in patients having received thorotrast),the only simple dose-effect relationship which fits allthe data is the quadratic one. With this relationship theeffect becomes extremely small when the dose is verylow. Tubiana advocated more research to demonstratewhether the relationship between dose and effect is bet-ter explained by a quadratic relationship rather than theLN-T theory. He called for a more balanced approachto risks from nuclear and other sources and emphasizedthat public health measures should be determined on thebasis of a rational assessment of their cost and benefits.Tubiana said there was a need to base radiological pro-tection on new concepts, as proposed by Clarke andGonzalez, related to doses which require intervention ormonitoring, or are considered negligible.

Nils Diaz pointed out that the scientific debate relativeto radiation protection must be of high quality to be use-ful to policymakers, or it will likely delay policy. In anycase, the nuclear debate, including radiation protectionissues, cannot be carried out only at the scientific level,but must incorporate social, political, and economicissues. Moreover, there is a pressing need to educatethe news media on nuclear/radiological issues, includ-ing the cost to society for radiation remediation, and tohave more stakeholder involvement in a transparentdecision-making process. Diaz saw merit in moving toa system based more on individual than collectivedose/risk and said he would support consideration ofsuch a system once it might become finalized. In anycase, it was necessary to eliminate the application ofcollective dose to very low doses in large populationsand/or doses delivered over long time periods, althoughits use as a performance indicator was justified. He alsostressed that no radiation dose was below regulatoryconcern, although certain levels should be below regu-latory action. He noted that the validity of the LN-T orthreshold theories is not known and therefore it wasnecessary to focus on the relevant application to today’sissues. What is needed is a 10-year hiatus during whichresearch would continue, interim policy would exist,and decision-making could proceed taking into accountdose levels at which there is confidence that healtheffects from radiation are indistinguishable from exist-ing everyday health effects. Finally, he noted the NRCis going through a period of change, which provides anopportunity to consider new approaches.


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The conference conclusions and recommendations werebased on discussions in plenum and responses to break-out group questions. A number of conference conclu-sions and recommendations were suggested.Considering that many recommendations were not fullyconsidered because of the lack of time, the participantsagreed that another conference should be organized tofurther develop these and other recommendations. Thefollowing list reflects these conclusions and recommen-dations that received the broadest support.

Conclusions

■ Ionizing radiation is a well-known human carcinogen. During the past 50 years numerous epidemiological studies of adult human populations exposed to radiation from medical, occupational, or military purposes have been conducted. The lowest dose at which a statistically significant radiation risk has been shown is ~ 100 mSv. This does not imply the existence of a threshold.

■ The effects of low-level radiation below 1 mSv per year above background radiation cannot currently be distinguished from those of everyday natural health hazards.

■ The concept of collective dose is often misapplied, e.g., to estimate health impacts of very low average radiation doses in large populations and/or doses delivered over long time periods. Collective dose can be a useful comparative tool, for instance, in the evaluation of protection options.

■ It is essential to continue to foster international cooperation in radiation safety. In particular, interna-tional harmonization of radiation safety policies for radiation sources delivering low radiation doses should be developed.

■ Consistent and coherent radiation policy on a national level is necessary for the effective implementation of radiation safety.

■ Economic, environmental, ethical, psychological, and scientific factors are all essential in the policy and regulatory decision-making process to assure public health and well-being. The way in which these factors are incorporated in nation-specific decision-making processes may vary.

■ Concern over low doses should not deter the public from obtaining benefits of medical procedures.

Recommendations

Policy and Regulatory Process

■ Policy discussions on the regulation of radiation sources delivering low-level radiation should include references to natural background radiation.

■ The conference supports the evolving global framework of the International Atomic Energy Agency (IAEA) for the safe use of radiation.

■ The conference supports further development and evaluation of the ideas associated with the proposal on controllable dose.

■ No radiation dose is below regulatory concern but certain levels should be below regulatory action, and appropriate dose levels should be established.

Science

■ Fundamental questions about the shape of the dose-response curve and mechanisms of effects of radiation at low doses are unlikely to be answered in the near future. Scientific research, including molecular and cellular radiobiology studies are critical in order to better understand mechanisms of radiogenic effects, and providing important informa-tion about the likely shape of the dose-response curve at low doses of radiation, and should be coordinated and continued.

■ Multinational support and analysis of human data derived from studies such as the Radiation Effects Research Foundation (RERF) Life Span Study, the Russian Mayak and Techa River studies, nuclear workers studies, and studies of populations living in high natural background areas to assist in reducing scientific uncertainties in risk and in elucidating mechanisms of radiation health effects are strongly encouraged. These data offer a unique opportunity to further quantify effects at low doses in human populations.

Conference Conclusions and Recommendations

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Constituent Concerns

■ Groups involved in the development of policy and regulations, or making recommendations for such policies and regulations, should operate in an open and transparent manner, and engage in dialogue with stakeholders.

■ There is a pressing need for more effective communication by scientists with the public, politicians, policymakers, regulators, and other interested persons. The science should be clearly articulated, emphasizing what we do and do not know, explaining the limitations in the information, and what we are doing about it.

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Ralph AndersenSr. Project ManagerNuclear Energy Institute1776 I St., NW, Suite 400Washington, DC 20006USA

Klaus BeckerBoothstr. 27, D-12207Berlin,Germany

Ralph BeedleSr. VP & Chief Nuclear OfficerNuclear Energy Institute1776 I Street, NW, Suite 400Washington, DC 20006USA

Burton BennettSecretaryUNSCEARP.O. Box 500A-1400 ViennaAustria

Hans BlixDirector General EmeritusIAEA1 Runebergsgatan11429 StockholmSweden

Simon CarrollAdvisor, Nuc. & Disarmament AffairsGreenpeace InternationalKeizersgracht 1761016 DW AmsterdamThe Netherlands

Neville ChamberlainINEA2 The Paddock Hinderton RoadNeston, Cheshire CH64 9PHUK

Kun-Woo ChoHead, Radiation Protection Dept.Korea Institute of Nuclear SafetyPO Box 114, YusongTaejon, 305-600The Republic of Korea

KunMo ChungCommissioner, Korean Atomic Energy Commission9430 Meadow Shire LaneGreat Falls, VA 23066USA

Roger ClarkeProf. & Chairman, Intl. Comm. Radiological Prot.National Rad. Protection BoardChilton, DidicotOxfordshire, OXll ORQUK

David CoulstonDirector Environment, Health & SafetyBritish Nuclear Fuels PLCHinton House, RisleyWarrinston, Cheshire, WA3 6ASUK

Gail de PlanquePresidentInternational Nuclear Societies Council11136 Powder Horn DrivePotomac, MD 20854 USA

Nils DiazCommissionerU.S. Nuclear Regulatory Commission11555 Rockville PikeRockville, MD 20852USA

Greta Dicus (unable to attend)CommissionerU.S. Nuclear Regulatory CommissionMS 016-C1Washington, DC 20555USA

A P P E N D I X A

List of Participants

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Jill Fitch Director, Radiation Protection BranchDepartment of Human ServicesPO Box 6, Rundle MallAdelaide, South Australia 5000Australia

Duane FitzgeraldAssistant DirectorU.S. General Accounting Office441 G St. NW, Room 2T23Washington, DC 20548USA

Joseph FitzgeraldDeputy Assistant SecretaryU.S. Department of Energy1000 Independence AvenueEH-1Washington, DC 20545USA

Helen GarnettChief ExecutiveAustralian Nuclear Science and Technology Organisation (ANSTO)Private Mail Bag 1, Menai NSW 2234Australia

Norman GentnerSenior Science AdvisorAtomic Energy of Canada (AECL)Health, Chemistry & Enviromental Div.Chalk River, Ontario K8H 2W8Canada

Marvin GoldmanProfessor EmeritusUniversity of California, Davis1122 Pine LaneDavis, CA 95616USA

Lawrence GoldsteinManager, ToxicologyElectric Power Research Institute3412 Hillview Ave.Palo Alto, CA 94304USA

Abel GonzalezDirector, Division of Radiation

and Waste SafetyIAEAPO Box 100, Wagramerstrasse 5A-1400 ViennaAustria

Patricio GonzalezSecretary General WFNMB.Nuclear Medicine SectionClinical Hospital,University of ChileChile

George GrayHarvard School of Public HealthHarvard Center for Risk Analysis718 Huntington AvenueBoston, MA 02115USA

Patrick GreenSenior CampaignerFriends of the Earth26 Underwood StreetLondon N1 7JQUK

Jean-Claude GuaisVice President, Strategic DevelopmentCogema Inc.7401 Wisconsin AvenueChevy Chase, MD 20814

Robert M. HalliseyChairperson CRCPD205 Capitol AvenueFrankfort, KY 40601USA

Ole HarbitzDirector GeneralNorwegian Radiation Protection Auth.Grini Naeringspark 13PO Box 55N-1361 ØsteråsNorway

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Stan HatcherPresident, Stan Hatcher & Assoc.14423 Winston Churchill Blvd.Terra CottaOntario L0P 1N0Canada

Carolyn HuntoonAssistant Secretary, Office of Environmental Mgmt.U.S. Department of Energy1000 Independence Ave. SW, 5A014Washington D.C. 20585USA

Raymond Johnson Jr.President, Health Physics Society481 N. Fredrick Ave., Suite 302Gaithersburg, MD 20877USA

Bennett JohnstonChief Executive OfficerJohnston & Associates1455 Pennsylvania, NW – Suite 200Washington, DC 20004USA

Cynthia JonesSenior Assistant for MaterialsOffice of Commissioner DicusUS Nuclear Regulatory CommissionMail Stop 016-C1Washington, DC 20555USA

C. Rick JonesDirectorOffice of Worker Protection Program and Hazards ManagementEH-52/270CCU.S. Department of Energy19901 Germantown RoadGermantown, MD 20874-1290USA

Andrew C. KadakPresidentAmerican Nuclear Society555 N. Kensington Ave.LaGrange, Illinois 60526USA

Kenneth KaseAssociate Director, Environment, Safety & HealthStanford Linear Accelerator CenterMenlo Park, CA 94025USA

Ron KathrenAAHP, Past PresidentProfessor EmeritusWashington State University2710 University DriveRichland, WA 99352USA

Martha KrebsDirector, Office of ScienceU.S. Department of Energy1000 Independence Ave. SWWashington, DC 20585

Charles LandChief, Risk Analysis SectionRadiation Epidemiology BranchNCI/NIHEPS 70466120 Executive Blvd., MS 7238Bethesda, MD 20892-7238USA

Jai Ki LeeProfessorDepartment of Nuclear EngineeringHanyang University17 Hangdarng, Sungdong-kuSeoul, 133-791Korea

John LoyChief Executive OfficerARPANSA P.O. Box 655 MIRANDA New South Wales 2228Australia

Peter LyonsScience AdvisorSenator Domenici’s OfficeHart Senate Office Building, Room 3282nd & C Street, NEWashington, DC 20510 USA

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Sigurdur M. MagnússonDirectorIcelandic Radiation Protection InstituteRaudararstigur 10150 ReykjvavikIceland

Andre MaisseuPresidentWorld Council of Nuclear Workers49, rue Lauriston75116 ParisFrance

Frank MarcinowskiActing Director, Radiation Protection Div., ORIAU.S. Environmental Protection Agency401 M Street, SW (6608J)Washington, DC 20460

Junko MatsubaraCommissionerNuclear Safety Commission2-2-1, Kasumigaseki, ChiyodakuTokyo, 100-8966Japan

Charles MeinholdPresidentNCRP7910 Woodmont Avenue, Suite 800Bethesda, MD 20814-3095USA

Richard A. MeserveChairmanU.S. Nuclear Regulatory CommissionMail Stop 0-16C1Washington, DC 20555-0001USA

David MichaelsAssistant Secretary for Environment,

Safety and HealthUS Department of Energy1000 Independence Ave., S.W.Washington, D.C. 20585USA

Andrew MillerMember of ParliamentHouse of CommonsLondon SW1A 0AAUK

William MillsPast PresidentHealth Physics Society2915 Ascott LaneOlney, MD 20832

Kenneth MossmanProfessor and Director Office of Radiation SafetyArizona State UniversityTempe, AZ 85287-3501USA

Carmel MothersillRadiation Science Centre,Dublin Institute of TechnologyKevin Street,Dublin 8Ireland

James MuckerheidePresident Radiation Science & HealthCenter for Nuclear Technology and Society atWorcester Polytechnic Institute793 Great Plain AvenueNeedham, MA 02492USA

Manning MuntzingPresidentInternational Nuclear Law Association8305 Turnberry CourtPotomac, MD 20854USA

Shigenobu NagatakiChairmanRadiation Effects Research Foundation5-2 Hijiyama ParkMinami-kuHiroshima 732-0815Japan

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Hideki OmichiDirectorJapan Atomic Energy Research InstituteWashington Office1825 K Street, NWWashington, DC 20006

Richard V. OsborneBox 11167 Pine Point CloseDeep RiverOntario, K0J 1POCanada

Tara J. O’TooleSenior FellowJohns Hopkins UniversityCenter for Civilian Biodefense Studies 111 Market Place, Suite 850Baltimore, MD 21202-6709

Deborah OughtonProfessorNorwegian Agricultural UniversityNLHPostboks 5026NO 1432 As Norway

Stephen PageOffice DirectorOffice of Radiation and Indoor AirU.S. Environmental Protection Agency401 M. St. SW, 6601JWashington DC 20460USA

Dale PrestonRadiation Effects Research Foundation5-2, Hijiyama Park,Minami-ku, Hiroshima 732-0815Japan

Jerome PuskinDirectorCenter for Science and Risk AssessmentU.S. Environmental Protection Agency401 M St. SW, 6608JWashington, DC 20460USA

Genevieve RoesslerProfessor EmeritaUniversity of FloridaRR1, Box 1394Elysian, MN 56028USA

Randal ScottDirector, Off. Safety, Health & SecurityU.S. Department of EnergyOffice of Environmental Management1000 Independence Avenue, SWWashington, DC 20585

Paul SeligmanDeputy Assistant Secretary for

Health Studies (EH-6-270CC)U.S. Department of Energy19901 Germantown RoadGemantown, MD 20874USA

Richard SetlowSenior BiophysicistBiology DepartmentBrookhaven National LaboratoryUpton, NY 11973USA

Lennart SjöbergStockholm School of EconomicsBox 6501113 83 StockholmSweden

Daniel StromStaff ScientistPacific Northwest National LaboratoryMS K3-56, PO Box 999Richland, WA 99352USA

Tsutomu SugaharaProfessorHealth Research FoundationPasteur Bldg. 5F103-5 Tanaka Monzen-chyoSakyo-ku, Kyoto 606-8225Japan

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Annie SugierDirector of ProtectionInstitut de Protection et de Sureté NucléaireBP 6Fontenay-aux-Roses 92265France

David ThomassenProgram CoordinatorDOE Office of Biological & Environmental Research19901 Germantown RoadGermantown, MD 20874-1290

Sam ThompsonDeputy Director-GeneralOECD Nuclear Energy Agency12 Blvd. Des Iles - Le Seine St-Germain92130 Issy-les-MoulineauxFrance

Klaus TrottProfessorDepartment of Radiation BiologySt. Bartholomew’s Medical CollegeCharterhouse SquareLondon EC1M 6BQUK

Maurice TubianaProfesssorAcademie des Sciences (Paris, F)Centre Antoine BécléreFaculté de Médecine45, rue des Saints-Péres75006 ParisFrance

Kaare UlbakDirector of InstituteNational Institute of Radiation HygieneKnapholm 7DK 2730 HerlevDenmark

Jack ValentinSecretaryInternational Commission on Radiation ProtectionSE-17116 StockholmSweden

Geoffrey WebbInternational Radiation Protection Association“Brunswick”Cornwall GardensBrighton, BNl 6 RJEngland

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Wednesday, 1 DecemberReception and Dinner Introduction of organizers and program committee

Thursday, 2 DecemberOpening of ConferenceChairs: E. Gail de Planque and

Sigurdur M. Magnusson

Introduction of Key SpeakerManning Muntzing

Overview of Goals and Objectives of ConferenceHans Blix, Director General Emeritus IAEA

Session 1 – A Philosophical Overview of Policymaking

This session will focus on the challenges of setting policy and what the policymakers need to know when formulating policy at the highest level.

Peter Lyons, Chief of Staff for Senator Domenici, U.S. Senate

Bennett Johnston, Former U.S. SenatorAndrew Miller, Member of Parliament,

House of Commons, UKSimon Carroll, Advisor, Greenpeace

International, NetherlandsJunko Matsubara, Commissioner, Nuclear

Safety Commission, JapanKunMo Chung, Former Minister for Science

and Technology, Korea

Session 2 – The Science Issues

Chairs: Kenneth L. Mossman and Jack Valentin

This session will focus on the state of the science, themain scientific uncertainties and what studies are need-ed for future policy and regulatory decision-making.

The State of the Science - Setting the Stage.Shigenobu Nagataki, RERF, JapanDale Preston; RERF, Japan

What Are the Main Scientific Uncertainties?How Do They Effect Radiation Policy?

Charles Land, NIH, USACarmel Mothersill, DIT, Ireland

What studies in molecular biology, epidemiology andother science are needed for future policy and regula-tory decision-making?

Richard Setlow, Brookhaven, USAKlaus Trott, St. Bartholomew Hospital, UK

Session 3 – Bridging to Application: Factors That Influence Policy

Chairs: Jill Fitch and Stanley Hatcher

This session will focus on the risk, economic, social,psychological and ethical factors that influence policy.

Risk Issue.George Gray, Harvard University, USA

Economics.Neville Chamberlain, INEA, UK

Social Issues. Rick Jones, DOE, USA

Psychological Issues. Lennart Sjöberg, SSE, Sweden

Ethics.Deborah Oughton, NAU, Norway

Breakout - I

Clarify/define the issues associated with balancing sci-ence and the other factors influencing policy.

Friday, 3 December

Session 4 – International Organizationsand Policymaking

Chairs: Marvin Goldman and Patricio Gonzales

This session will focus on the role of the internationalorganizations in the policymaking process and the challenge to be true to science while providing in a user-friendly way what is needed by the policymakers.

The Role of the UN Family of Organizations. Abel Gonzalez, IAEA

A P P E N D I X B :

Technical Program

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Panel Discussion:Abel Gonzalez, IAEARoger Clarke, ICRPBurton Bennett, UNSCEARGeoffrey Webb, IRPAPatrick Green, Friends of the Earth

Session 5 – Regional and National Policies

Chairs: Tara O´Toole and Jai Ki Lee

This session will focus on the development of regional and national radiation policies.

National and Regional Overviews:Australia - John Loy, ARPANSAEuropean Union/Denmark - Kaare Ulbak,

NIRHKorea - Kun-Woo Cho, KINS USA - Stephen Page, EPA

Panel Discussion:National Representatives Assistant Undersecretary Carolyn Huntoon,

USA - DOE (Environmental Management)

Breakout - II

Develop recommendations on the formulation of policyand regulation, especially with respect to what is needed by policymakers and regulators in terms of scientific guidance. Begin the process of formulatingoverall conclusions and recommendations.

(Following the breakout session, attendees had the after-noon free. A tour was arranged to Monticello, the homeof Thomas Jefferson.)

Saturday, 4 DecemberSession 6 – From Science to Policy andRegulations

Chairs: Genevieve F. Roessler and Richard Osborne

This session will focus on the reconciliation of science,international recommendations, and governing policy informulation of regulations.

Klaus Becker, DIN, GermanyDavid Michaels/Joseph Fitzgerald, DOE, USAAnnie Sugier, IPSN, France Tsutomu Sugahara, HRF, Japan

Session 7 - Problems and Options

Chairs: Manning Muntzing and Sam Thompson

This session will focus on the main problems in imple-menting present policy and if (and how) we need tochange the present policies.

Roger Clarke, ICRP, NRPB, UK Nils Diaz, NRC, USAHelen Garnett, ANSTO, AustraliaMaurice Tubiana, University of Paris, France

Breakout - III

Develop recommendations on if there is a need forchange (especially with respect to unreasonable use ofresources due to present policy) and guidance on directions. Continue to develop overall conclusions andrecommendations.

Session 8 – Summary Sessions

Chairs: Kenneth R. Kase and Ole Harbitz

One chair of each session presents highlights of his session stressing points of consensus as well as those ofno consensus followed by facilitated discussion.

Plenary

Presentation and discussion of conclusions and recom-mendations.

Dinner Speaker

Speaker: Richard Meserve, Chairman, NRC, USA

Sunday, 5 December

Session 9 – Where Do We Go From Here (Pulling It All Together!!)

Chairs: E. Gail de Planque, Sigurdur M. Magnusson, and Kenneth L. Mossman

Plenary

Final review of conclusions and recommendations andconference consensus on conclusions and recommenda-tions

Closing of ConferenceRepresentatives of organizers, program committee, andsponsors committee.

bridging radiation policy and science

Documents