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Proceedings of the Third International

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Annals of the ICRP

Editor-in-Chief
C.H. CLEMENT
Associate Editor
N. HAMADA
PUBLISHED FOR
The International Commission on Radiological Protection
by
CONTENTS
EDITORIAL
ICRP 2015 – The Third International Symposium on the

System of Radiological Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
C. Clement
ADVANCING TOGETHER AFTER 87 YEARS
The future of ICRP: towards a centenary and beyond . . . . . . . . . . . . . . . . . . . . . . 5

C. Cousins
Overview of ICRP Committee 1: radiation effects . . . . . . . . . . . . . . . . . . . . . . . . . . 9
W.F. Morgan
Overview of ICRP Committee 2: doses from radiation exposure . . . . . . . . . . . 17
J.D. Harrison and F. Paquet
Overview of ICRP Committee 3: protection in medicine . . . . . . . . . . . . . . . . . . . 25
E. Vañó, D.L. Miller and M.M. Rehani
Overview of ICRP Committee 4: application of the Commission’s
recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
D.A. Cool
Overview of ICRP Committee 5: protection of the environment . . . . . . . . . . . 41
C-M. Larsson
EXPLORING EXISTING EXPOSURE SITUATIONS
Understanding existing exposure situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

J-F. Lecomte
Cosmic radiation in aviation: radiological protection of Air France
aircraft crew . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
G. Desmaris
Measuring, discussing, and living together: lessons from 4 years
in Suetsugi . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
R. Ando
Contaminated sites from the past: experience of the US Environmental
Protection Agency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
M.A. Boyd
Protection of the environment in existing exposure situations . . . . . . . . . . . . . . 91
D. Copplestone, C-M. Larsson, P. Strand and M.K. Sneve
RADIOLOGICAL PROTECTION IN MEDICINE TODAY
Eight decades of ICRP recommendations in medicine: a perspective . . . . . . 106

P. Ortiz López
Current status of medical radiation exposure in Korea – recent efforts
to develop a radiation exposure control system focussed on justification
and optimisation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
K.-H. Do and S.E. Jung
Current global and Korean issues in radiation safety of nuclear
medicine procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
H.C. Song
Radiological protection in ion beam radiotherapy: practical guidance
for clinical use of new technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
Y. Yonekura, H. Tsujii, J.W. Hopewell, P.O. López, J-M. Cosset,
H. Paganetti, A. Montelius, D. Schardt, B. Jones and T. Nakamura
Internet-based ICRP resource for healthcare providers on the risks
and benefits of medical imaging that uses ionising radiation . . . . . . . . . . . . . . 148
S. Demeter, K.E. Applegate and M. Perez
THE SCIENCE BEHIND RADIATION DOSES
ICRP dose coefficients: computational development and current status. . . . 156

W.E. Bolch, N. Petoussi-Henss, F. Paquet and J. Harrison
Operational quantities and new approach by ICRU . . . . . . . . . . . . . . . . . . . . . . 178
A. Endo
The reference phantoms: voxel vs polygon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188
C.H. Kim, Y.S. Yeom, T.T. Nguyen, Z.J. Wang, H.S. Kim, M.C. Han,
J.K. Lee, M. Zankl, N. Petoussi-Henss, W.E. Bolch, C. Lee
and B.S. Chung
Assessment and interpretation of internal doses: uncertainty and
variability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
F. Paquet, M.R. Bailey, R.W. Leggett and J.D. Harrison
Use of effective dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215
J.D. Harrison, M. Balonov, C.J. Martin, P.O. Lopez, H.-G. Menzel,
J.R. Simmonds, R. Smith-Bindman and R. Wakeford
Dosimetry for animals and plants: contending with biota diversity . . . . . . . . 225
A. Ulanovsky
NEW DEVELOPMENTS IN UNDERSTANDING RADIATION EFFECTS
ICRP Publication 131: Stem cell biology with respect to carcinogenesis

aspects of radiological protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239
J.H. Hendry, O. Niwa, M.H. Barcellos-Hoff, R.K. Globus, J.D. Harrison,
M.T. Martin, T.M. Seed, J.W. Shay, M.D. Story, K. Suzuki
and S. Yamashita
Radiation-related risks of non-cancer outcomes in the atomic
bomb survivors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253
K. Ozasa, I. Takahashi and E.J. Grant
Dose-rate effects in radiation biology and radiation protection. . . . . . . . . . . . 262
W. Rühm, T.V. Azizova, S.D. Bouffler, M.P. Little, R.E. Shore, L. Walsh
and G.E. Woloschak
Evidence for variation in human radiosensitivity and its potential
impact on radiological protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 280
S.D. Bouffler
Analysis of individual differences in radiosensitivity using genome
editing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 290
S. Matsuura, E. Royba, S.N. Akutsu, H. Yanagihara, H. Ochiai, Y. Kudo,
S. Tashiro and T. Miyamoto
ETHICS IN RADIOLOGICAL PROTECTION
Ethical foundations of the radiological protection system . . . . . . . . . . . . . . . . . 297

K.W. Cho
Focal role of tolerability and reasonableness in the radiological
protection system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 309
T. Schneider, J. Lochard and L. Vaillant
Ethics of radiological risk governance: justice of justification as a central
concern. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 322
G. Meskens
Ethical foundations of environmental radiological protection . . . . . . . . . . . . . 345
D.H. Oughton
Are the core values of the radiological protection system shared across
cultures? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 358
F. Zölzer
Editorial
ICRP 2015 – THE THIRD INTERNATIONAL SYMPOSIUM ON THE
SYSTEM OF RADIOLOGICAL PROTECTION
The mission of the International Commission on Radiological Protection (ICRP) is

to advance radiological protection for the public benefit, covering all exposures of
people and the environment to ionising radiation. The ICRP Code of Ethics stresses
the importance of fulfilling this mission independently, impartially, transparently,
and with accountability.
Biennial symposia are now a regular part of the ICRP calendar. The subject of this
proceedings issue is the third such symposium, ICRP 2015, held in Seoul, Korea on
20–22 October 2015. Similar symposia were held in 2011 in Bethesda, MD, USA, and
in 2013 in Abu Dhabi, United Arab Emirates (UAE). It has been announced that
ICRP 2017 will be held in Paris, France on 10–12 October 2017, and preliminary
plans are already underway for ICRP 2019 and ICRP 2021.
Although ICRP must maintain independence to undertake its mission effectively, it is

also essential to remain closely connected to the radiological protection community,
and the much broader community served by our recommendations. It is not enough
that our members are part of this community; this should also be the case for ICRP
as an organisation. The symposia are a way to stay connected – to share our recent,
ongoing, and future work; and to hear directly from the community about what is
useful, what is not, and what may be needed in the future. In part, it is about being
transparent. Moreover, it is about working together to make radiological protection
the best it can be for everyone’s benefit.
As at the previous two symposia, ICRP 2015 began with an introductory session.
‘Advancing together after 87 years’ was dedicated to presenting ICRP and outlining
our programme of work. Five topical sessions followed to round out the 3 days.
‘Exploring existing exposure situations’ presented the wide variety of circumstances

that fall within this exposure situation, including exposures to cosmic radiation,
living in a contaminated area while dealing with post-accident recovery, and the
problem of sites contaminated by past practices. One highlight of the session was
the presentation given by Ryoko Ando on ‘Measuring, discussing, and living
together: what we learned from 4 years in Suetsugi’, during which she described
the lines drawn by radiological protection criteria that have defined the lives of
those in her community since the Fukushima Daiichi accident in March 2011.
1
ICRP 2015 Proceedings
The fact that an entire session was dedicated to radiological protection in medicine is
hardly surprising as this is such a large and important part of the work of ICRP.
‘Radiological protection in medicine today’ began with a review of eight decades of
experience, continued with a discussion of current issues in Korea and worldwide,
and examined the state of the art with a review of recently released ICRP recom-
mendations on radiological protection in ion beam radiotherapy, and web-based
resources that provide information on radiation risks and benefits to healthcare
providers.
‘The science behind radiation doses’ gave those present a peek into the work of ICRP
Committee 2 and the related work of Committee 5, particularly in terms of looking
at the major task of developing dose coefficients. In addition, information was pro-
vided on a new approach being considered for operational quantities by our sister
organisation, the International Commission on Radiation Units and Measurements,
and on ICRP’s effort to provide additional guidance on the use of effective dose.
Some of the very latest scientific findings, and the potential implications for the
system of radiological protection, were presented in ‘New developments in under-
standing radiation effects’, looking at stem cell biology, dose-rate effects, variations
in human radiosensitivity, and risks of non-cancer effects. This included a first look
at ICRP’s effort to review current knowledge on the risk of exposure at low doses
and low dose rates, and a glimpse at some of the findings in an as-yet-unpublished
study of non-cancer effects in the Life Span Study (LSS) cohort. We look forward to
reading the published work from the Radiation Effects Research Foundation to see
what results might be extracted from the invaluable but complex LSS data.
The final session of the symposium was on ‘Ethics in radiological protection’, the
subject of an ICRP Task Group, and a topic that has engaged many in the radio-
logical protection profession since ICRP began to review it in earnest in 2012. This
ICRP effort, and this symposium session, focussed on the ethical values inherent in
the system of radiological protection.
The papers in this proceedings issue are the work of the individual authors. They are
not recommendations of ICRP and do not necessarily represent the views of ICRP.
However, they offer a good representation of the programme of ICRP 2015.
Remarkably, these proceedings include a paper on every single presentation made
during the symposium.
Each symposium builds on the last in important ways. ICRP 2015 was the first where
presentation materials were released almost immediately after they were presented. It
was the first for which videos of the presentations were made available, released
within weeks. It was the first time that the proceedings papers were made available
through the ICRP website in advance of publishing the proceedings. To make life
easy for the online set, we have gathered all of these together in one place, along with
2
abstracts, lists of attendees and supporters, and summaries of the ICRP Main
Commission and Committee meetings held in conjunction with the symposium. To
see for yourself, navigate to www.icrp.org and select ‘ICRP symposia’ from the main
menu.
This time, we even managed to improve the past by applying some of the successes of
ICRP 2015 to the previous symposium. All ICRP 2013 proceedings papers are now
available individually through the ICRP website, and video presentations should be
available by the time these proceedings are published.
Each symposium is a major undertaking for ICRP and, as with any large project,
there are many to thank. A debt of gratitude is owed to all session co-chairs, pre-
senters, and authors for making ICRP 2015 a great success. Thank you as well to
those who worked behind the scenes, particularly: ICRP Executive Assistant Lynn
Lemaire; ICRP Assistant Scientific Secretary Nobuyuki Hamada; ICRP Interns
Audrie Ismail, Chantal Yacoub, Yuto Moriwake, Nguyen Tat Thanh, and Tiffany
Lo; and of course all the members of our host organisation, the Korean Association
for Radiation Protection, who worked tirelessly to make everything run smoothly.
Special thanks also goes to the members of the ICRP 2015 Symposium Editorial
Board, which I had the pleasure to Chair: Kunwoo Cho, Nobuyuki Hamada, Sisko
Saloma, and Michiya Sasaki. You can see their work supporting that of the authors
on every page of these proceedings.
ICRP 2015 would not have been possible without the many organisations providing
support specifically for this event, and all the organisations who have provided
support to ICRP over the years:
Federal Authority for Nuclear Regulation, UAE; Federal Ministry for the Environment,
Nature Conservation, Building, and Nuclear Safety, Germany (special thanks for sup-
porting open access of these proceedings); Korea Institute of Nuclear Safety; Nippon
Foundation, Japan; Nuclear Regulatory Commission and Environmental Protection
Agency, USA.
Australian Radiation Protection and Nuclear Safety Agency; Canadian Nuclear Safety
Commission; Danish Health and Medicines Authority; European Commission; Finnish
Radiation and Nuclear Safety Authority; Health Canada; Icelandic Radiation Safety
Authority; Institute of Radiation Protection and Nuclear Safety, France; International
Atomic Energy Agency; International Radiation Protection Association; International
Society of Radiology; Korea Atomic Energy Research Institute; Korea Hydro and
Nuclear Power Co., Ltd; Ministry of the Environment, Sweden; Norwegian Radiation
Protection Authority; Nuclear Energy Agency; Organization for Economic
Cooperation and Development; Spanish Nuclear Safety Council.
3
Cameco Corporation, Canada; Chinese Society of Radiation Protection; Japan NUS

Co., Ltd; Japan Radioisotope Association; Southern Urals Biophysical Institute, Russia.
Abu Dhabi Health Authority, UAE; Boo Kyung Scientific Medical Co., Ltd, Korea;
Department of Energy, USA; Dongsuh Companies Inc., Korea; Doosan Heavy
Industries & Construction, Korea; Electricité de France; Emirates Nuclear Energy
Corporation, UAE; French Nuclear Safety Authority; Hanil Nuclear Co., Ltd, Korea;
HDX Corporation, Korea; Korea Electric Power Corporation Engineering & Construction
Company Inc.; Korea Inspection & Engineering Co., Ltd; Korea Nuclear International
Cooperation Foundation; Korea Radioactive Waste Agency; Korean Radiation Safety
Foundation; Kwangwon Trading, Korea; Landauer Europe; National Council on
Radiation Protection and Measurements, USA; National Radioactive Waste
Management Agency, France; New Korea Industrial Co., Ltd; Nuclear Energy
Institute, USA; Nuclear Safety and Security Commission, Korea; Public Health
England, UK; Samyoung Unitech Co., Ltd, Korea; Sang Chung International Co., Ltd,
Korea; Shin Jin Medics Inc., Korea; Sunkwang T&S Co., Ltd, Korea; Union Defence
Force, UAE.
Most importantly, thank you to everyone who attended ICRP 2015. Your positive
feedback inspires us to maintain our high standards and to keep improving. Ninety-
one percent of respondents to the post-symposium survey were very satisfied or
extremely satisfied overall, and 94% recommended attendance at ICRP 2017, the
Fourth International Symposium on the System of Radiological Protection, to be
held in Paris, France on 10–12 October 2017. I look forward to seeing you there!
CHRISTOPHER CLEMENT
ICRP SCIENTIFIC SECRETARY
EDITOR-IN-CHIEF
4
The future of ICRP: towards a centenary
and beyond
C. Cousins
Department of Radiology, Box 218, Addenbrooke’s Hospital NHS Trust, Hills Road,
Cambridge CB2 0QQ, UK; e-mail: claire.cousins@addenbrookes.nhs.uk
Abstract–The International Commission on Radiological Protection (ICRP) has been in exist-

ence for 87 y, since its establishment in 1928. It remains a leading authority in radiological
protection, and its role is to provide recommendations and guidance on all aspects of protection
against ionising radiation. The published recommendations of ICRP form the basis of radiation
safety standards worldwide. Modernisation of the organisation in recent years has led to new
initiatives and changes. These have included writing a strategic plan and code of ethics for the
first time. Elections for committee membership have been through open nominations, a process
which will shortly be repeated for the membership in the next term, commencing on 1 July 2017.
Biennial symposia started in 2011, and the success of the first two symposia has secured this
venture as a regular part of the ICRP calendar. ICRP has also revised its method of working with
other organisations by establishing ‘special liaison organisation’ status. This has improved col-
laboration with the ever-expanding number of organisations working in radiological protection,
with whom it is important that ICRP has essential links. ICRP is also looking to review its legal
basis and governing documents in the future, in order to ensure that best practices are being
followed as ICRP evolves. In addition, the strategic plan will be reviewed and updated regularly.
Other ways of working with organisations will be considered to further strengthen engagement
with the wider radiological protection community. ICRP aims to make its publications available
at low or no cost, and to produce both a plain language overview of the system of radiological
protection and a summary of the recommendations. These activities will require additional
financial resources, and ICRP has embarked on a fundraising campaign to support such efforts.
ICRP can be proud of its history of maintaining its independence and preserving the wide
respect earned over many years. Despite long traditions, ICRP has evolved and will continue
to do so to perform as a more modern organisation as it heads towards a centenary and beyond.
Keywords: ICRP; Radiological protection; Recommendations
5
1. INTRODUCTION
The International Commission on Radiological Protection (ICRP) was estab-
lished 87 y ago in 1928 and, hence, is approaching its centenary. The organisation
remains a leading authority in radiological protection, and continues to provide
recommendations and guidance on all aspects of protection against ionising radi-
ation by studying the progression of scientific knowledge, by assessing incidents that
occur involving radiation, and by making balanced judgements.
For many years, the recommendations of ICRP have formed the basis of radi-
ation safety standards worldwide. The objective of the work of ICRP is to contribute
to an appropriate level of protection against the detrimental effects of ionising radi-
ation exposure without unduly limiting the benefits associated with its use, and this
fundamental aim has not changed.
ICRP is a fully independent, not-for-profit organisation that is registered with the
UK Charity Commission. Excluding the salaried Secretariat, the work of ICRP is
performed by members who are experts in the field of radiological protection, and
give their time and efforts voluntarily for the success of ICRP.
2. RECENT EVOLUTION
ICRP has undergone several changes, mainly operational, in the last 5 y.
A strategic plan was developed extending to the end of the term of membership in
2017, and many of the initiatives included in this have been achieved. A code of
ethics has been written for the first time in the history of ICRP.
The process of election to ICRP Committees has been restructured with a call for
open nominations. In 2013, over 200 nominations were received and many new
members were recruited. It is anticipated that the same process will be repeated
for membership selection for the next term, commencing 1 July 2017.
The strategic plan of 2011 included the establishment of biennial symposia, and
the success of the first two symposia, held in the USA and Abu Dhabi, has secured
the venture as a regular event in the ICRP calendar. These are aimed at presenting
the work of ICRP to a wider global audience, and to promote discussion of topical
and challenging issues in radiological protection. The Fourth International
Symposium on the System of Radiological Protection is already being planned, to
be held in Paris in October 2017.
ICRP has revised its method of working with other organisations involved in
radiological protection. The number of such organisations has continued to
expand, and ICRP felt that it was important to give the opportunity of liaison
to a wider field. Hence, ‘special liaison’ status is granted to organisations whose
work is relevant to ICRP’s mandate; at present, this includes 18 organisations main-
taining formal relations with ICRP. Dedicated sessions are arranged at each ICRP
6
symposium to discuss specific and timely topics with representatives of these organ-
isations. In addition, opportunities are provided for representatives of these organ-
isations to meet with members of the ICRP Main Commission to discuss progress in
areas of cooperation and mutual interest. Representatives from these organisations
may be invited to provide expertise in specific ICRP Committee sessions, and may
also be invited to participate as members of ICRP task groups where their expertise
is considered contributory to the objectives of the group.
3. THE FUTURE
In order to maintain its position in the field of radiological protection, ICRP
recognises the need to review its practices and embrace change where relevant.
In a modern technological society, an organisation requires a prominent profile,
and its voice needs to be heard.
ICRP will be considering different ways of working with other organisations to
strengthen engagement with the wider radiological protection community. ICRP
publications are often complex technical documents, and part of ‘wider engagement’
is to produce a plain language overview of the system of radiological protection and
a summary of recommendations. The last fundamental recommendations of ICRP,
Publication 103, were published nearly a decade ago in 2007 (ICRP, 2007), and were
obviously in development for many years prior to this. In the near future, ICRP will
be reviewing and, where necessary, updating the system of radiological protection to
ensure that it remains appropriate for the protection of society at large. It is hoped
that ICRP will be able to make some of its publications available at either low or no
cost in the near future.
At a time of global financial austerity, many of ICRP’s proposed activities require
additional financial resources; as such, ICRP has embarked on a fundraising cam-
paign to support these efforts. This is already showing some success, which will have
a definite benefit for the operation of ICRP. The governing documents, structure,
and legal basis of ICRP are to be reviewed to ensure that best practices are being
followed as ICRP continues to evolve. The strategic plan is in the process of being
updated, and this will continue on a regular basis.
4. CONCLUSION
Since its establishment, ICRP has a long history and long traditions, but has
evolved over the years, particularly more recently, to embrace the challenges
facing radiological protection in the 21st century. ICRP can be proud of its history
of maintaining its independence and preserving the wide respect it has earned over
many years. However, in current society, there is no room for complacency, and
changes often have to be made to remain relevant and ensure survival. ICRP wishes
7
to listen and learn from others so that it continues to make sensible and appropriate
decisions. ICRP has commenced the process of evolution, and will continue to do so,
in order to perform as a more modern organisation as it heads towards its centenary
and beyond.
REFERENCE
ICRP, 2007. The 2007 Recommendations of the International Commission on Radiological
Protection. ICRP Publication 103. Ann. ICRP 37(2–4).
8
Overview of ICRP Committee 1:
radiation effects
W.F. Morgan
Pacific Northwest National Laboratory, Richland, WA 99352, USA
Abstract–Committee 1 of the International Commission on Radiological Protection (ICRP)

addresses issues pertinent to tissue reactions, risks of cancer and heritable diseases, radiation
dose responses, effects of dose rate, and radiation quality. In addition, it reviews data on the
effects of radiation on the embryo/fetus, genetic factors in radiation response, and uncertain-
ties in providing judgements on radiation-induced health effects. Committee 1 advises the
Main Commission on the biological basis of radiation-induced health effects, and how epi-
demiological, experimental, and theoretical data can be combined to make quantitative judge-
ments on health risks to humans. The emphasis is on low radiation doses, in the form of
detriment-adjusted nominal risk coefficients, where there are considerable uncertainties in
terms of the biology and the epidemiology. Furthermore, Committee 1 reviews data from
radiation epidemiology studies and publications on the molecular and cellular effects of ionis-
ing radiation relevant to updating the basis of the 2007 Recommendations published in ICRP
Publication 103. This paper will provide an overview of the activities of Committee 1, the
updated work of the Task Groups and Working Parties, and the future activities being
pursued.
Keywords: Low dose radiation; Tissue reactions; Stochastic effects; Committee 1; Nominal
risk coefficients
1. INTRODUCTION
Committee 1 of the International Commission on Radiological Protection (ICRP)
addresses issues pertinent to tissue reactions, risks of cancer and heritable diseases,
radiation dose responses, effects of dose rate, and radiation quality. In addition, it
This paper does not necessarily reflect the views of the International Commission on Radiological
Protection. The author passed away on 13 November 2015.
9
reviews data on the effects of radiation on the embryo/fetus, genetic factors in radi-
ation response, and uncertainties in providing judgements on radiation-induced
health effects. Committee 1 advises the Main Commission on the biological basis
of radiation-induced health effects and how epidemiological, experimental, and the-
oretical data can be combined to make quantitative judgements on human health
risks. The emphasis is on low radiation doses (<100 mGy), in the form of detriment-
adjusted nominal risk coefficients, where the long-term risk of ionising radiation is
too small to be convincingly demonstrated epidemiologically, or does not exist.
Committee 1 reviews data from radiation epidemiology studies and from publica-
tions on the molecular and cellular effects of ionising radiations relevant to updating
the basis for the 2007 Recommendations in Publication 103 (ICRP, 2007). This work
is undertaken through several Task Groups described below. Committee 1 members
have expertise in epidemiology, physics, statistics, medical sciences, animal sciences,
molecular and cellular biology, biophysics, genetics, and omics technologies, and
many serve on other relevant radiation-related committees including the United
Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR),
the US National Council on Radiation Protection and Measurements (NCRP),
and a host of low-dose radiation research programmes worldwide.
Fig. 1 shows the members of Committee 1 at the 2014 meeting in Beijing, China.
This meeting was hosted by Committee 1 member Quanfu Sun, and former
Committee 1 member Ping-Kun Zhou. Since this meeting, the Vice Chair of
Committee 1 Alice Sigurdson has retired, and Simon Bouffler took over as Vice
Chair at the meeting in Seoul, South Korea in 2015. Andrez Wojcik (Stockholm,
Sweden) has joined Committee 1 and brings much-needed expertise to the commit-
tee. A summary of the discussions at the Beijing meeting is presented in the minutes
available on the ICRP Committee 1 website (http://www.icrp.org/mem-
bers_file.asp?id¼7). Discussions included overviews on current activities and pro-
jected future plans of the Radiation Effects Research Foundation (RERF);
International Agency for Research on Cancer (IARC); Electric Power Research
Institute (EPRI); Central Research Institute of Electric Power Industry (CRIEPI);
UNSCEAR; NCRP; Southern Urals Biophysics Institute (SUBI); various European
Union programmes including SOLO, SOUL, Low Dose Research Towards
Multidisciplinary Integration, Epidemiology and Radiation Biology,
PROCARDIO, CARDIORISK, Multidisciplinary European Low Dose Initiative
(MELODI), and Open Project for European Radiation Research Area
(OPERRA); and the US Department of Energy’s Low Dose Radiation Research
Program. An update on Fukushima included discussion of thyroid ultrasound exam-
ination in children, and the psychological/social impacts of the mental health survey
were also presented to Committee 1.
In addition to being aware of, and able to speak about, recent publications and
issues in their own area of expertise, Committee 1 members are expected to be aware
of publications synthesised by various bodies (e.g. UNSCEAR and NCRP), as well
as advances in high-profile research programmes [e.g. the European Union’s research
programmes (MELODI and OPERRA) and the host of innovative programmes that
10
Fig. 1. Committee 1 participants at the 2014 meeting in Beijing, China. Back row left to right:
Quanfu Sun (China), William F. Morgan (USA; Committee 1 Chair), Michael Hauptmann
(Netherlands), Dan Stram (USA), Simon Bouffler (UK), Dominique Laurier (France),
Wolfgang Dörr (Austria; Task Group 92 Chair), Nobuhiko Ban (Japan, Working Party on
Detriment Chair), Sisko Salomaa (Finland), Alice Sigurdson (USA, Committee 1 Vice Chair),
Anna Merkulova (interpreter for T. Azizova). Front row left to right: Nobuyuki Hamada
(Canada, Assistant Scientific Secretary), Ranajit Chakraborty (USA), Margot Tirmarche
(France; Task Group 64 Chair), Richard Wakeford (UK), Preetha Rajaraman (India),
Tamara Azizova (Russia), Werner Rühm (Germany; Committee 1 Secretary; Task Group
91 Chair).
have been, or are, supported by these over-site groups; RERF, which studies radi-
ation effects in the atomic bomb survivors from Hiroshima and Nagasaki; SUBI; and
the US Department of Energy’s Low Dose Radiation Research Program]. A useful
example of how this works is the recent report on human radiosensitivity published
by researchers at Public Health England in the UK and presented to Committee 1 by
Simon Bouffler (http://www.hpa.org.uk/Publications/Radiation/DocumentsOf
TheHPA/RCE21HumanRadiosensitivity/).
Individual radiosensitivity is a key issue. As scientific advances in omics technol-
ogies (transcriptomics, genomics, proteomics, metabolomics, lipidomics etc.) and
personalised medicine move forward at a rapid pace, it is conceivable that we may
be able to predict an individual’s sensitivity, or resistance, to ionising radiation in the
future. The fiscal, legal, and ethical implications for medicine, employment etc. are
enormous, and will affect radiological protection either directly or indirectly in the
future.
ICRP is fortunate to have world-class experts from many of these organisations
and/or committees represented on Committee 1. In addition to monitoring publica-
tions from these various organisations and/or committees, Committee 1 considers
11
the use of biologically based dose–response models for assessing the effects of low-
dose ionising radiation exposures. In addition, Committee 1 monitors epidemio-
logical data, non-cancer (cataracts, cardiovascular, cerebrovascular and central ner-
vous system) and potential hereditary effects, advances in radiation-induced DNA
damage recognition, DNA repair, and the potential impact of epigenetic effects.
Committee 1 makes a judgement call given the facts and data available regarding
whether or not a block of research warrants a specific Task Group. An overview of
the ‘statement of task’ is presented by the Committee Chairs to the Main
Commission, and a decision is made regarding the need for establishment of a
Task Group. The Task Group will consider the evidence in detail and make recom-
mendations based on scientific principles, philosophy, and policy. Any document
prepared by a Task Group must be approved by the sponsoring Committee and
the Main Commission, and be sent out for public consultation. As many Task Group
members have ‘day jobs’ and Task Group membership is voluntary, this can be a
complicated and protracted experience.
2. COMMITTEE 1 TASK GROUPS AND WORKING PARTIES

Currently, there are two Task Groups and one Working Party under the auspices
of Committee 1. Significantly, the report of Task Group 75 has been completed and
published as Publication 131 (ICRP, 2015).
2.1. Task Group 75: Stem cell biology with respect to carcinogenesis aspects of
radiological protection
Task Group 75 reviewed stem cell/progenitor cell biology and radiobiology with
reference to mechanisms of radiation carcinogenesis. The goal was to:
. consider the tissue weighting factors and previous ICRP reports for specific
tissues;
. compare the response of stem and associated cells in different tissues in terms of
respective risks of cancer, and elucidate the likely stem cell role; and
. use current knowledge of stem cell responses and carcinogenic risks from homo-
geneous acute irradiations to project stochastic risks for short-range radiation and
chronic irradiation scenarios.
Publication 131 (ICRP, 2015) highlights the need for detailed insights into
fundamental biological processes, particularly in stem cells, to inform judgements
on risk extrapolation and risk estimation for radiological protection. ICRP acknow-
ledges the sterling leadership of the Chair, O. Niwa, and his hardworking committee:
M.H. Barcellos-Hoff, R.K. Globus, J.D. Harrison, J.H. Hendry, P. Jacob, M.T.
Martin, T.M. Seed, J.W. Shay, M.D. Story, K. Suzuki, and S. Yamashita, plus
the numerous consultants, readers, and reviewers who all had a significant impact
on this report.
12
2.2. Task Group 64: Cancer risk from alpha emitters

Task Group 64 produced Publication 115, entitled ‘Lung cancer risk from radon
and progeny, and statement on radon’ (ICRP, 2010), and is now extending this to
consider cancer risks from other alpha emitters including plutonium, uranium, thor-
otrast, and radium. This is a joint effort by Committees 1 and 2, and will use the
recently published risk coefficients of lung cancer for a life-long risk calculation in
order to compare risk from these alpha emitters with that from radon and also from
external exposure(s). Selection of the appropriate model systems, accounting for
differences between males and females, as well as smokers and non-smokers, is
also being undertaken. The specific topics being addressed are as follows.
. Tissue that is not subject to mechanical transport or absorption into blood. This
leads to longer retention in the lung than considered initially, and will likely
change the estimate of dose to the lung regions in different proportions for plu-
tonium nitrate or oxide inhaled by smokers and non-smokers.
. Uranium exposures: Task Group 64 will consider data from the CURE project,
looking at a relationship between an observed excess of lung cancer or other
pathologies and related organ dose.
. Comparison with external gamma exposures: estimation of the risk of lung cancer
related to external radiation can be obtained from several populations with dif-
ferent ‘profiles’ of exposure, including the atomic bomb survivor studies and the
nuclear workers studies (IARC study), for comparison of the risk of lung cancer
induced by alpha emitters (radon decay products, plutonium) with that observed
after external exposure.
2.3. Task Group 91: Radiation risk inference at low-dose and low-dose-rate
exposures for radiological protection purposes. Use of dose and dose-rate
effectiveness factors
Task Group 91 met in Kyoto, Japan in 2015 (Rühm et al., 2015), and is making
significant progress. The detriment-adjusted nominal risk coefficients recommended
by ICRP have largely been based on data obtained from the atomic bomb survivors
in Japan. As their exposure was a single acute exposure, and because it was thought
that the most plausible biological model for the dose–response relationship should be
linear quadratic (which implies a larger slope at high doses than at low doses), many
international and national relevant bodies have used a dose and dose-rate effective-
ness factor (DDREF) for estimates of these coefficients at low doses. A value of 2 has
been used by ICRP for low-dose and low-dose-rate exposures. With more epidemio-
logical information becoming available, and with modern techniques of Bayesian
analysis, UNSCEAR has recently re-evaluated all the available information and has
estimated risk coefficients that are similar to the ICRP estimates using high doses and
a DDREF value of 2. However, the Biological Effects of Ionizing Radiation (BEIR)
VII Committee (NAS, 2005), also using a Bayesian approach, recommended a
13
DDREF of 1.5. Task Group 91 will review the available information on the estima-
tion of risk coefficients and recommend:
. whether it is desirable to continue to estimate risk at low doses by assessing the

slope of the dose response at high doses and then applying a DDREF reduction
factor. The alternative is to adopt the UNSCEAR approach of inferring the risk
coefficients at low doses by using all available information and techniques of
Bayesian analysis for estimating the best expert judgement; and
. whether such coefficients are applicable to acute, protracted, and prolonged
exposure to ionizing radiation need a particular correction.
In the first phase, the work focussed on reviewing the literature on DDREF;
relevant molecular, cellular, and animal data; and data from exposed human
cohorts. Based on the collected material, Committee 1 decided during its 2014 meet-
ing that the Task Group should:
. go beyond the BEIR VII analysis of animal data and include additional data that
were not available for BEIR VII;
. perform a meta-analysis of total solid cancer data from epidemiological cohorts
and comparison with the Life Span Study (LSS) data (it was recognised that this
would be a considerable amount of work);
. perform a meta-analysis on selected cancer sites (again, it was recognised that this
would be a considerable amount of work; recent discussions among the Task
Group led to the decision to postpone this action until total solid cancers were
analysed successfully); and
. perform an analysis of dose–response curves (linear vs linear-quadratic) in the
LSS and decide whether or not the UNSCEAR approach not to use a DDREF is
justified.
2.4. Working Party on Circulatory Disease Detriment

The Working Party on Circulatory Disease Detriment is closely related to Task
Group 91, and the goal is to make a ‘what-if’ calculation of circulatory disease
detriment. After discussing assumptions and conditions for the calculation, it was
agreed that work would be continued as follows:
. detriment should be calculated separately for heart disease and stroke;

. the Japanese atomic bomb survivor study and the most recent meta-analysis by
Little et al. (2012) are likely candidates of epidemiological studies on which the
calculation is based;
. while there is no evidence of dose-rate effect, calculation could be conducted with
and without a DDREF; and
. the first step should be focussed on nominal risk estimates, and then adjustment
for severity will be considered.
14
Currently, efforts are being made to collect detailed information from the atomic
bomb survivor study, and baseline incidence data from different reference popula-
tions. A summary of mechanistic considerations is also being prepared to provide a
rationale for assumptions in the calculation.
3. FUTURE ACTIVITIES TO BE MONITORED BY COMMITTEE 1
. Radiation sensitivity and individual susceptibility. Committee 1 will continue to

evaluate studies indicating the presence of certain gene variants that may increase
the risk of cancer (e.g. BRCA1, BRCA2), and make the genome unstable.
. Sequencing and omics technologies related to individual radiosensitivity.
Screening recommendations for individuals with known genetic alterations (e.g.
BRCA or ATM carriers).
. High background radiation areas. There has been progress in describing the inci-
dence of cancer in a cohort study in Kerala, India as well as a cohort mortality
study in Yangjiang, China. In Yangjiang, both cataract and Down’s syndrome
were reported, and ongoing studies in Kerala and Yangjiang involve cerebrovas-
cular disease and thyroid nodules, as well as the incidence of cancer. Committee 1
will continue to follow these studies.
. Computer tomography in children, acknowledging the considerable shortcomings
associated with such studies.
. Impact of epigenetics on radiological protection.
. European Radiation Dosimetry Group (EURADOS) strategic research agenda
that identifies five challenges (www.eurados.org):
towards updated dose concepts and quantities;
towards improved radiation risk estimates deduced from epidemiological
cohorts;
towards an efficient dose assessment in case of radiological emergencies;
towards integrated personalised dosimetry in medical applications; and
towards improved radiation protection of workers and the public.
. Transfer of risk. Variations in background cancer incidence rates are important
and are a problem for the transfer of risk. This is compounded by the lack of
cancer registries in some parts of the world (e.g. Africa). Committee 1 will con-
tinue to follow the efforts of the World Health Organization.
. Education and communication. As evidenced by the Fukushima accident, there is
a need for a clear, consistent strategy for educating and communicating with
regulators, clean-up personnel, and the general public. Committee 1 acknowledges
the excellent work of Committee 4 in this regard, and proposes more interactions
with Committee 4 to communicate an effective ICRP message in the future.
REFERENCES
15
ICRP, 2010. Lung cancer risk from radon and progeny, and statement on radon. ICRP
Publication 115. Ann. ICRP 40(1).
ICRP, 2015. Stem cell biology with respect to carcinogenesis aspects of radiological protec-
tion. ICRP Publication 131. Ann. ICRP 44(3/4).
Little, M.P., Azizova, T.V., Bazyka, D., et al., 2012: Systematic review and meta-analysis of
circulatory disease from exposure to low-level ionizing radiation and estimates of potential
population mortality risks. Env. Health Persp. 120, 1503–1511.
NAS, 2005. National Academy of Science, National Research Council, Committee to Assess
Health Risks from Exposure to Low Levels of Ionizing Radiation: BEIR VII Phase 2.
National Academies Press, Washington, DC.
Rühm, W., Woloschak, G.E., Shore, R.E., et al., 2015. Dose and dose-rate effects of ionizing
radiation: a discussion in the light of radiological protection. Radiat. Environ. Biophys. 54,
379–401.
16
Overview of ICRP Committee 2: doses from
radiation exposure
J.D. Harrisona, F. Paquetb
a
Oxford Brookes University, Faculty of Health and Life Sciences, Oxford OX3 0BP, UK;
e-mail: john.harrison@phe.gov.uk
b
Direction de la Strategie, IRSN, France
Abstract–The focus of the work of Committee 2 of the International Commission on

Radiological Protection (ICRP) is the computation of dose coefficients compliant with
Publication 103. A set of reference computational phantoms is being developed, based on
medical imaging data, and used for radiation transport calculations. Biokinetic models used
to describe the behaviour of radionuclides in body tissues are being updated, also leading to
changes in organ doses and effective dose coefficients. Dose coefficients for external radiation
exposure of adults calculated using the new reference phantoms were issued as Publication 116,
jointly with the International Commission on Radiation Units and Measurements.
Forthcoming reports will provide internal dose coefficients for radionuclide inhalation and
ingestion by workers, and associated bioassay data. Work is in progress to revise internal dose
coefficients for members of the public, and, for the first time, to provide reference values for
external exposures of the public. Committee 2 is also working with Committee 3 on dose
coefficients for radiopharmaceuticals, and leading a cross-Committee initiative to give advice
on the use of effective dose.
Keywords: Reference phantoms; Equivalent dose; Effective dose; Dose coefficients
1. INTRODUCTION
The remit of the International Commission on Radiological Protection (ICRP)
Committee 2 is: the development of dose coefficients for the assessment of internal
and external radiation exposure; the development of reference biokinetic and
Protection.
17
dosimetric models; and the development of reference data for workers and members
of the public (www.ICRP.org). The current membership (2013–2017) is John
Harrison (Chair), François Paquet (Vice-Chair), Wes Bolch (Secretary), Mike
Bailey, Vladimir Berkovski, Luiz Bertelli, Doug Chambers, Marina Degteva,
Akira Endo, John Hunt, Chan Hyeong Kim, Rich Leggett, Jizeng Ma, Dietmar
Nosske, Nina Petoussi-Henss, and Frank Wissmann.
Currently, Committee 2 has five Task Groups that are responsible for the pro-
duction of reports: (1) computational phantoms and radiation transport; (2) internal
dose coefficients; (3) age-dependent dose conversion coefficients for external expos-
ures to environmental sources; (4) the use of effective dose as a risk-related dosimet-
ric quantity; and (5) radiopharmaceuticals.
Committee 2 works closely with the International Commission on Radiation Units
and Measurements (ICRU); the Chairman of ICRU, Hans-Georg Menzel, is a
member of the ICRP Main Commission. Joint work with ICRU is in progress to
update the operational quantities used in the measurement of external radiation
exposures. Committee members also support the work of the other ICRP
Committees, currently providing members for Task Groups of Committees 1, 3 and 5.
Revisions of ICRP recommendations invariably require recalculation of dose
coefficients because changes are made to the radiation weighting factors and tissue
weighting factors used in the calculation of equivalent and effective dose. In addition,
improvements to the models used to calculate doses also lead to revised values. Work
is currently in progress to provide replacement dose coefficients based on the 2007
Recommendations (ICRP, 2007), in which a number of important methodological
improvements will be incorporated. The following Chapters will provide short sum-
maries of the work programmes of each Task Group.
2. COMPUTATIONAL PHANTOMS AND RADIATION TRANSPORT

The remit of Task Group 96 is to develop reference anatomical phantoms and
associated radiation transport calculations for use in the revision of dose coefficients
as defined in Publication 103 (ICRP, 2007) for both external and internal sources.
This Task Group is chaired by Wes Bolch (USA) and includes other members of
Committee 2: John Hunt (Brazil), Chan-Hyeong Kim (South Korea), Akira Endo
(Japan), and Nina Petoussi-Henss (Germany). Additional full members are Maria
Zankl (Germany) and Choonsik Lee (USA); and the corresponding members are
Derek Jokisch (USA), Kwang Pyo Kim (South Korea), Helmut Schlattl (Germany),
and Junli Li (China).
Publication 110 (ICRP, 2009), a joint report with ICRU, provided reference phan-
toms for the adult male and female derived from imaging data for individuals,
replacing the use of stylised hermaphrodite phantoms as developed by the Medical
Internal Radiation Dose Committee of the Society of Nuclear Medicine (e.g. Cristy,
1980; Cristy and Eckerman, 1987). In future calculations, equivalent dose will be
calculated separately for males and females, and averaged in the calculation of
effective dose (ICRP, 2007).
18
Reference phantoms are being developed for newborns; children aged 1, 5, 10, and
15 years; and the fetus and pregnant female at various gestational ages. These dosi-
metric models, and those for adults provided in Publication 110 (ICRP, 2009), are
being used to provide reference radiation transport data in the form of specific
absorbed fractions (SAFs) for radiations emitted from radionuclides retained in
body organs and tissues. SAFs represent the deposition of energy in all important
organs/tissues (target regions) following emissions from radionuclides retained in
body organs and tissues (source regions). These data are used in the calculation of
dose coefficients for the inhalation and ingestion of radionuclides by workers and
members of the public, and also in calculations of doses from radiopharmaceuticals.
The calculation of SAFs involves radiation transport of photons, electrons, and
neutrons for an extensive set of source/target organ pairs. Additional work has
focussed on microcomputed-tomography-based models of electron and a particle
dosimetry of skeletal tissues, and revisions to electron and a particle dosimetry in
the Human Respiratory Tract Model (ICRP, 1994a) and the Human Alimentary
Tract Model (ICRP, 2006). The report providing radiation transport calculations for
adult phantoms (adult SAFs) completed public consultation in October 2015.
3. INTERNAL DOSE COEFFICIENTS

The remit of Task Group 95 is to provide revised dose coefficients and associated
data for intakes of radionuclides for workers and members of the public. This Task
Group is chaired by François Paquet (France) and includes other members of
Committee 2: Michael Bailey (UK), Vladmir Berkovski (Ukraine), and Rich
Leggett (USA). Additional full members are Eric Blanchardon (France), Tim Fell
(UK), and George Etherington (UK); and the corresponding members are Eric
Ansoborlo (France), Luiz Bertelli (USA), Estelle Davesne (France), Demetrio
Gregoratto (UK), Augusto Guissani (Germany), James Marsh (UK), Dunstana
Melo (USA), Dietmar Nosske (Germany), Matthew Puncher (UK), Genadij Ratia
(Ukraine), and Tracy Smith (UK).
Work is in progress to replace the Publication 30 series and Publication 68 (ICRP,
1979, 1980, 1981, 1988, 1994b) that give biokinetic data and dose coefficients for
occupational intakes of radionuclides by inhalation and ingestion, and Publications
54 and 78 (ICRP, 1989, 1997) that give information for bioassay interpretation, with
a single series of reports on occupational intakes of radionuclides (OIR series). Work
is also in progress to replace all currently available dose coefficients for ingestion and
inhalation of radionuclides by members of the public.
OIR Part 1 is now available as Publication 130 (ICRP, 2015b), providing a
description of biokinetic and dosimetric methodology, including a summary of the
Human Alimentary Tract Model (ICRP, 2006), a detailed description of changes to
the Human Respiratory Tract Model (ICRP, 1994a), and an outline of approaches
taken to the development of systemic models for elements. The use of bioassay data
is also discussed. Subsequent parts will consist of element sections describing ele-
ment-specific biokinetic models, and providing dose coefficients and bioassay data.
19
Detailed supporting data will be provided electronically, including organ doses and
additional bioassay data. The elements and radioisotopes to be included in OIR
Parts 2–5 are listed by Harrison (2015). Dose coefficients will be given for different
exposure conditions, including ranges of inhaled particle sizes, and different chemical
forms where information is available, with the advice that site-specific dose coeffi-
cients may be calculated in situations where more specific data are available, and
estimated doses warrant more detailed consideration.
Dose coefficients for inhalation and ingestion of radioisotopes of radon, including
inhalation of Rn-222 and its radioactive progeny, will be included in OIR Part 3.
Dose coefficients for inhaled Rn-222 and its progeny have previously been derived by
epidemiological comparison using the Publication 65 dose conversion convention
(ICRP, 1993; Harrison and Marsh, 2012). Inhalation of Rn-222 represents a special
case because there is good and consistent information on risks of radon-induced lung
cancer derived from epidemiological studies of underground miners and from resi-
dential pooled analyses (ICRP, 2010a). Using the Publication 115 (ICRP, 2010a)
nominal risk coefficient of 5 104 per working level month (WLM), and the
Publication 103 (ICRP, 2007) detriment values, gives dose conversion convention
values of 12 mSv effective dose WLM1 for adults and 9 mSv WLM1 for a popu-
lation of all ages (Marsh et al., 2010). Dosimetric data to be published in OIR Part 3
will include values of approximately 11 mSv effective dose WLM1 for mines and
20 mSv WLM1 for indoor workplaces. However, using a more realistic breathing
rate for sedentary occupations such as office workers gives a value of approximately
14 mSv WLM1 (Harrison and Marsh, 2012). For dwellings, the dose coefficient was
calculated to be 13 mSv WLM1.
4. DOSE COEFFICIENTS FOR EXTERNAL ENVIRONMENTAL

EXPOSURES
The remit of Task Group 90 is to calculate dose coefficients for members of the
public, including adults and children of different ages, for exposures to external
sources of radiation. This Task Group is chaired by Nina Petoussi-Henss
(Committee 2, Germany). The full members are Akira Endo (Committee 2, Japan),
Wes Bolch (Committee 2, USA), Keith Eckerman (Committee 2 Emeritus, USA), and
Helmut Schlattl (Germany); and the corresponding members are Daiki Satoh (Japan),
Michael Bellamy (USA), Nolan Hertel (USA), John Hunt (Brazil), Jan Jansen (UK),
Choonsik Lee (USA), Kimiaki Saito (Japan), and Song Jae Yoo (Korea).
The work to provide dose coefficients for members of the public follows on from
the completion of Publication 116 (ICRP, 2010b), a joint report with ICRU, provid-
ing conversion coefficients for organ and effective doses for external exposures in
occupational settings. Calculations were performed using the Publication 110 (ICRP,
2009) phantoms and in accordance with the 2007 Recommendations (ICRP, 2007).
The radiations considered were external beams of mono-energetic photons, electrons
and positrons, neutrons, protons, pions (negative/positive), muons (negative/posi-
tive), and helium ions. The organ dose conversion coefficients tabulated in the report
20
represent ICRP/ICRU recommended values. Comparisons of the protection quan-

tities, equivalent and effective dose, with corresponding operational quantities show
the latter to provide conservative estimates of dose in the majority of cases. Annexes
and a CD provide detailed supporting information, including equivalent dose coef-
ficients for the lens of the eye and the skin.
Assessment of external exposures of members of the public, including infants and
children, is particularly important in the context of accidental releases from nuclear
installations. Calculation of dose coefficients for external environmental exposures
requires the evaluation of the environmental fields. Work to calculate fields for
contaminated soil, water, and air considering different radiation types is nearing
completion. Organ and effective doses will be calculated using the adult and paedi-
atric reference phantoms being developed by Task Group 96 on computational
phantoms and radiation transport. Dose coefficients will be reported for several
radionuclides, both in terms of environmental radionuclide concentration and
measured ambient dose equivalent.
5. USE OF EFFECTIVE DOSE

Task Group 79 on the use of effective dose, led by Committee 2, also has mem-
bers from Committees 1, 3, and 4. Its remit is to provide advice on the use of effective
dose, including medical applications. This Task Group is chaired by John Harrison
(UK). The full members are Richard Wakeford (Committee 1, UK), Pedro Ortiz López
(Committee 3, Spain), Colin Martin (Committee 3, UK), Hans-Georg Menzel (Main
Commission, Switzerland), Jane Simmonds (ex-Committee 4, UK), and Rebecca
Smith-Bindman (USA); and the corresponding members are Wes Bolch (USA),
John Cooper (UK), and Christian Streffer (Main Commission Emeritus, Germany).
Experience has shown that ‘effective dose’, which has been defined and introduced
by ICRP for risk management purposes (i.e. for risk limitation and optimisation), is
widely used in radiological protection and related fields beyond its original purpose,
and is used incorrectly in some cases. Useful guidance on the use of the quantity is
provided in Annex B to the 2007 Recommendations (ICRP, 2007). Further guidance
is being formulated with an important focus on medical exposures (Balonov and
Shrimpton, 2012; Harrison and Ortiz López, 2015). Task Group proposals are dis-
cussed by Harrison et al. (2016).
6. RADIOPHARMACEUTICALS
The remit of Task Group 36 (joint Committees 2 and 3 Task Group) is to develop
dose coefficients for administered radiopharmaceuticals. This Task Group is chaired
jointly by Dietmar Nosske (Committee 2, Germany) and Sören Mattsson
(Committee 3 Emeritus, Sweden). The full members are Lennart Johansson
(Sweden), Keon Kang (Committee 3, South Korea), Sigrid Leide-Svegborn
(Sweden), and Michael Stabin (USA); and the corresponding members are Martin
Andersson (Sweden), Wes Bolch (Committee 2, USA), Augusto Giussani
21
(Germany), Julian Liniecki (Poland), Katrine Åhlström Riklund (Committee 3,

Sweden), and Marie Sydoff (Sweden).
Publication 128 (ICRP, 2015a) from the Task Group provided a compilation of
Publication 60 (ICRP, 1991)-based dose coefficients for radiopharmaceuticals con-
sidered in Publications 53, 80 and 106 (ICRP, 1987, 1998, 2008). This report also
includes new information for Rb-82-chloride, (I-123, I-124, I-125, I-131)-iodide,
and I-123-labelled 2-carbomethoxy 3-(4-iodophenyl)-N-(3-fluoropropyl) nortropane.
The main future work for the Task Group is to update Publication 128 by values
calculated using the new ICRP adult and paediatric reference voxel phantoms, and
Publication 103 (ICRP, 2007) methodology, as well as to develop biokinetic and
dosimetric models for new substances, and to identify older substances where
improvement models are needed. Biokinetic models for C-11-PIB, C-11-choline,
and Ga-68-HA-DOTA-TATE are in an advanced stage of development, and new
models for F-18-Flutemetamol, F-18-Florbetapir, F-18-Florbetaben (BAY94-9172;
Neuraceq), F-18-FMISO, and other Ga-68-DOTA-peptides (-TOC, -NOC, -TATE,
-NOT) are also being considered.
7. DISCUSSION
The replacement of all reference dose coefficients with values compliant with
Publication 103 (ICRP, 2007) is a substantial scientific effort that will be completed
over the next few years. At the request of the International Atomic Energy Agency
and the European Commission, a compilation of dose coefficients has been provided
as Publication 119 (ICRP, 2012), based on the 1990 Recommendations in Publication
60 (ICRP, 1991). These values are referred to in the International and European
Basic Safety Standards for use while new values based on the 2007
Recommendations are being calculated (EC, 2014; IAEA, 2014). Similarly,
Publication 128 (ICRP, 2015a) provides a compilation of dose coefficients for admi-
nistered radiopharmaceuticals based on Publication 60.
As presaged in the ICRP Statement on Radon (ICRP, 2010a), for the first time,
Committee 2 will provide dose coefficients for radon and its radioisotopes calculated
using biokinetic and dosimetric models. However, as discussed in Chapter 3, inhal-
ation of Rn-222 and its progeny represents a special case because effective dose coef-
ficients can also be derived by epidemiological comparison, as done in Publication 65
(ICRP, 1993). Taking into account the epidemiology and dosimetric calculations, the
Commission will recommend the use of a single dose conversion coefficient of
12 mSv WLM1, equivalent to 3.4 mSv mJ1 h m3, for the calculation of doses fol-
lowing inhalation of radon and its progeny in workplaces (OIR Part 3). This reference
dose coefficient is considered to be applicable to the majority of circumstances with no
adjustment for aerosol characteristics. However, in cases where aerosol characteristics
are significantly different from typical conditions, where sufficient, reliable aerosol
data are available and estimated doses warrant more detailed consideration. It will
be possible to calculate site-specific dose coefficients using the biokinetic and dosimet-
ric data to be provided in OIR Part 3 and the accompanying electronic annexes.
22
In terms of measurement of Rn-222 gas exposure, the reference effective dose coef-
ficient of 12 mSv WLM1 (3.4 mSv mJ1 h m3) corresponds to 7.5 106 mSv Bq1 h
m3, assuming an equilibrium factor, F, of 0.4 between radon and its short-lived
progeny (Harrison and Marsh, 2012). With an occupancy of 2000 h y1 for a
worker (ICRP, 1993, 2010a) and F ¼ 0.4, the effective dose corresponding to annual
exposure at the upper reference level of 300 Bq m3 recommended in Publication 126
(ICRP, 2014) is 4.5 mSv. For the reference residential occupancy of 7000 h y1, the
corresponding value of effective dose is 15.8 mSv.
The dosimetric methodology employed by Committee 2 aims to make best use of
developing scientific approaches. As part of these continuing efforts, a working
group has been set up, led by Chan Hyeong Kim, to develop polygon mesh (PM)
phantoms to overcome some difficulties in the application of voxel phantoms (Kim
et al., 2016). Proper segmentation of smaller tissues such as the lens of the eye, the
skin, the walls of some organs, and skeletal tissues is not possible using voxel phan-
toms with resolution of the order of millimetres. Currently, separate stylised models
are being used to represent these tissues. The first objective of the working group is to
convert the Publication 110 (ICRP, 2009) phantoms to a high-quality PM format,
including all source and target regions, including thin tissue layer targets (10–300 mm)
in the alimentary and respiratory tracts. Such phantoms will be used in future ICRP
calculations.
REFERENCES
Balonov, M.I., Shrimpton, P.C., 2012. Effective dose and risk from medical x-ray procedures.
Ann. ICRP 41(3/4), 129–141.
Cristy, M., 1980. Mathematical Phantoms Representing Children of Various Ages for Use in
Estimates of Internal Dose. ORNL Report TM-367. Oak Ridge National Laboratory, Oak
Ridge, TN.
Cristy, M., Eckerman, K.F., 1987. Specific Absorbed Fractions of Energy at Various Ages
from Internal Photon Sources. ORNL/TM-8381/V1-7. Oak Ridge National Laboratory,
Oak Ridge, TN.
EC, 2014. Council Directive 2013/59/EURATOM of 5 December 2013. Off. J. Eur. Union 57,
L13.
Harrison, J.D., Marsh, J.W., 2012. Effective dose from inhaled radon and its progeny. Ann.
ICRP 41(3/4), 378–386.
Harrison, J.D., 2015. Overview of ICRP Committee 2 ‘doses from radiation exposure’. Ann.
ICRP 44(1S), 15–23.
Harrison, J.D., Ortiz López, P.O., 2015. Use of effective dose in medicine. Ann. ICRP 44(1S),
221–228.
Harrison, J.D., Balonov, M., Martin, C.J., et al., 2016. Use of effective dose. Ann. ICRP
45(1S), 215–224.
IAEA, 2014. Radiation Protection and Safety of Radiation Sources: International Basic
Safety Standards. Series No. GSR Part 3. International Atomic Energy Agency, Vienna.
ICRP, 1979. Limits for intakes of radionuclides by workers. ICRP Publication 30 (Part 1).
Ann. ICRP 2(3/4).
23
Ann. ICRP 4(3/4).
Ann. ICRP 6(2/3).
ICRP, 1987. Radiation dose to patients from radiopharmaceuticals. ICRP Publication 53.
Ann. ICRP 18(1–4).
ICRP, 1988. Limits for intakes of radionuclides by workers: an addendum. ICRP Publication
30 (Part 4). Ann. ICRP 19(4).
ICRP, 1989. Individual monitoring for intakes of radionuclides by workers. ICRP Publication
54. Ann. ICRP 19(1–3).
ICRP, 1991. 1990 Recommendations of the International Commission on Radiological
ICRP, 1993. Protection against radon-222 at home and at work. ICRP Publication 65. Ann.
ICRP 23(2).
ICRP, 1994a. Human Respiratory Tract Model for radiological protection. ICRP Publication
66. Ann. ICRP 24(1–3).
ICRP, 1994b. Dose coefficients for intake of radionuclides by workers. ICRP Publication 68.
Ann. ICRP 24(4).
ICRP, 1997. Individual monitoring for internal exposures of workers. ICRP Publication 78.
Ann. ICRP 27(2–4).
ICRP, 1998. Radiation dose to patients from radiopharmaceuticals (Addendum 2 to ICRP
Publication 53). ICRP Publication 80. Ann. ICRP 28(3).
ICRP, 2006. Human Alimentary Tract Model for radiological protection. ICRP Publication
100. Ann. ICRP 36(1/2).
ICRP, 2008. Radiation dose to patients from radiopharmaceuticals – Addendum 3 to ICRP
Publication 53. ICRP Publication 106. Ann. ICRP 38(1/2).
ICRP, 2009. Adult reference computational phantoms. ICRP Publication 110. Ann. ICRP
39(2).
ICRP, 2010a. Lung cancer risk from radon and progeny and statement on radon. ICRP
ICRP, 2010b. Conversion coefficients for radiological protection quantities for external radi-
ation exposures. ICRP Publication 116. Ann. ICRP 40(2–5).
ICRP, 2012. Compendium of dose coefficients based on ICRP Publication 60. ICRP
Publication 119. Ann. ICRP 41(S).
ICRP, 2014. Radiological protection against radon exposure. ICRP Publication 126. Ann.
ICRP 43(3).
ICRP, 2015a. Radiation dose to patients from radiopharmaceuticals: a compendium of cur-
rent information related to frequently used substances. ICRP Publication 128. Ann. ICRP
44(2S).
ICRP, 2015b. Occupational intakes of radionuclides. Part 1. ICRP Publication 130. Ann.
ICRP 44(2).
Kim, K.H., Yeom, Y.S., Nguyen, T.T., et al., 2016. The reference phantoms: voxel vs polygon.
Ann. ICRP 45(1S), 188–201.
Marsh, J.W., Harrison, J., Tirmarche, M., et al., 2010. Dose conversion factors for radon:
recent developments. Health Phys. 99, 511–516.
24
Overview of ICRP Committee 3: protection
in medicine
E. Vañóa, D.L. Millerb, M.M. Rehanic
a
Radiology Department, Complutense University, Madrid, 28040 Spain;
e-mail: eliseov@med.ucm.es
b
Center for Devices and Radiological Health, Food and Drug Administration, USA
c
Massachusetts General Hospital, Harvard Medical School, USA
Abstract–Committee 3 of the International Commission on Radiological Protection (ICRP)

develops recommendations and guidance for protection of patients, staff, and the public
against radiation exposure when ionising radiation is used for medical diagnosis, therapy,
or biomedical research. This paper presents a summary of the work that Committee 3 has
accomplished over the past few years, and also describes its current work. The most recent
reports published by the Commission that relate to radiological protection in medicine are
‘Radiological protection in cone beam computed tomography’ (Publication 129), ‘Radiation
dose to patients from radiopharmaceuticals: a compendium of current information related to
frequently used substances’ (Publication 128, in cooperation with Committee 2), ‘Radiological
protection in ion beam radiotherapy’ (Publication 127), ‘Radiological protection in paediatric
diagnostic and interventional radiology’ (Publication 121), ‘Radiological protection in cardi-
ology’ (Publication 120), and ‘Radiological protection in fluoroscopically guided procedures
outside the imaging department’ (Publication 117). A new report on diagnostic reference
levels in medical imaging will provide specific advice for interventional radiology, digital ima-
ging, computed tomography, nuclear medicine, paediatrics, and hybrid (multi-modality) ima-
ging procedures, and is expected to be published in 2016. Committee 3 is also working on
guidance for occupational radiological protection in brachytherapy, and on guidance on occu-
pational protection issues in interventional procedures, paying particular attention to the 2011
Commission’s recommendations on the occupational dose limit for the lens of the eye
(Publication 118). Other reports in preparation deal with justification, radiological protection
in therapy with radiopharmaceuticals, radiological protection in medicine as related to individ-
ual radiosusceptibility, appropriate use of effective dose (in cooperation with other Committees),
and guidance for healthcare practitioners on radiological and patient protection. Committee
Protection.
25
3 has also suggested specific priorities for research on radiological protection in medicine to the
Commission.
Keywords: Medicine; Diagnostic; Interventional; Nuclear medicine; Radiation therapy
1. MANDATE OF COMMITTEE 3 ‘PROTECTION IN MEDICINE’

develops recommendations and guidance for protection of patients, staff, and the
public against radiation exposure when ionising radiation is used for medical diag-
nosis, therapy, or biomedical research.
For the 2013–2017 term, Committee 3 is composed of 16 members with expertise
in different areas of radiological protection in medicine: medical physics; nuclear
medicine; radiology (including several subspecialties within radiology); and radiation
oncology. They are: Eliseo Vañó (Chair); Donald Miller (Vice Chair); Madan
Rehani (Secretary); Katrine Åhlström-Riklund; Kimberly Applegate; Michel
Bourguignon; Lawrence Dauer; Sandor Demeter; Keon Kang; Pek-Lan Khong;
Reinhard Loose; Pedro Ortiz López; Colin Martin; Pierre Scalliet; Yoshiharu
Yonekura; and Baorong Yue.
The membership of Committee 3 demonstrates a wide geographical distribution.
Members are from 12 different countries (http://www.icrp.org/icrp_group.asp?id¼9).
Committee 3 currently has two emeritus members, Sören Mattsson and Marvin
Rosenstein, who contribute actively to the ongoing reports. A public summary of
the annual meetings is available on the ICRP website (http://www.icrp.org/
icrp_group.asp?id¼9).
ICRP maintains formal relations with other organisations with an interest in
radiological protection through specific agreements, or by granting special liaison
status to organisations whose work is relevant to the ICRP mandate. Representatives
from the World Health Organization (WHO) (Marı́a Pérez) and from the
International Atomic Energy Agency (IAEA) (Ola Holmberg) attend the annual
meetings of Committee 3.
International organisations and stakeholders are encouraged to propose topics
of interest for new reports. In addition, a new mechanism, introduced at the
second ICRP symposium, provides opportunities for symposium participants to
provide input on suggested topics to the Commission’s Committees. The members
of each Committee review the proposals relevant to their Committee’s area
of responsibility, and evaluate the need to produce reports on specific topics.
Each Committee forwards its recommendations to the Commission of
ICRP. The work suggested by the Committees is subject to approval by the
Commission.
This paper presents a summary of the work that Committee 3 has accomplished
over the past few years, and also describes its current work.
26
2. THE MOST RECENT REPORTS

The reports led by Committee 3 over the last 5 y are as follows.
. Publication 113. Education and training in radiological protection for diagnostic

and interventional procedures. Approved by the Commission in October 2010 but
dated 2009 for editorial reasons (ICRP, 2009).
The need for education and training of medical staff (including medical students)
and other healthcare professionals in the principles of radiological protection is
more compelling today than in the past. This report expands previous basic ICRP
recommendations with regard to various categories of medical practitioners and
other healthcare professionals who perform, provide support for, or refer patients
for diagnostic and interventional procedures that utilise ionising radiation, or
nuclear medicine therapy. It provides guidance regarding the necessary radio-
logical protection education and training for use by: (a) regulators, health autho-
rities, medical institutions, and professional bodies with responsibility for
radiological protection in medicine; (b) the industry that produces and markets
the equipment used in these procedures; and (c) universities and other academic
institutions responsible for the education of professionals involved in the use of
ionising radiation in health care. Advice is also provided on the accreditation and
certification of the recommended education and training. In the context of this
report, the term ‘accreditation’ means that an organisation has been approved by
an authorised body to provide education or training on the radiological protec-
tion aspects. The term ‘certification’ means that an individual medical or clinical
professional has successfully completed the education or training provided by an
accredited organisation.
. Publication 117. Radiological protection in fluoroscopically guided procedures
performed outside the imaging department. Approved by the Commission in
October 2011, but dated 2010 for editorial reasons (ICRP, 2010).
An increasing number of medical specialists use fluoroscopy outside imaging
departments, but there has been a general neglect of radiological protection cover-
age of fluoroscopy used outside imaging departments. Lack of radiological pro-
tection training of those working with fluoroscopy outside imaging departments
can increase radiation risk to workers and patients. Procedures such as endovas-
cular aneurysm repair, renal angioplasty, iliac angioplasty, ureteric stent place-
ment, therapeutic endoscopic retrograde cholangiopancreatography, and bile duct
stenting and drainage have the potential to impart skin doses exceeding 1 Gy.
Although tissue reactions among patients and workers from fluoroscopy proced-
ures have, to date, only been reported in interventional radiology and cardiology,
the volume of fluoroscopy use outside imaging departments creates potential for
such injuries. Specific aspects of protection are included for vascular surgery,
urology, orthopaedic surgery, obstetrics and gynaecology, gastroenterology and
the hepatobiliary system, and anaesthesia and pain management. Information on
radiation dose levels to patients and workers, and recommendations for dose
27
management are presented for each speciality. Radiological protection for preg-
nant patients and pregnant workers is also covered. Specific needs for the target
groups in terms of orientation of training, competency of those who conduct and
assess specialists, and guidelines on the curriculum are also provided. The report
emphasises that patient dose monitoring is essential whenever fluoroscopy is used.
. Publication 120. Radiological protection in cardiology. Approved by the
Commission in October 2011, but dated 2013 for editorial reasons (ICRP, 2013a).
Cardiac nuclear medicine, cardiac computed tomography (CT), interventional
cardiology procedures, and electrophysiology procedures are increasing in
number and account for an important share of patient radiation exposure in
medicine. Complex percutaneous coronary interventions and cardiac electrophysi-
ology procedures are associated with high radiation doses. These procedures can
result in patient skin doses that are high enough to cause radiation injury and
increased risk of cancer. Treatment of congenital heart disease in children is of
particular concern. Additionally, staff in cardiac catheterisation laboratories may
receive high doses of radiation if radiological protection tools are not used prop-
erly. This report provides guidance to assist the cardiologist with justification of
procedures and optimisation of protection in cardiac CT studies, cardiac nuclear
medicine studies, and fluoroscopically guided cardiac interventions. It includes
discussions of the biological effects of radiation, principles of radiological protec-
tion, protection of staff during fluoroscopically guided interventions, radiological
protection training, and establishment of a quality assurance programme for car-
diac imaging and intervention. As tissue injury, principally skin injury, is a risk for
fluoroscopically guided interventions, particular attention is devoted to clinical
examples of radiation-related skin injuries from cardiac interventions, methods to
reduce patient radiation dose, training recommendations, and quality assurance
programmes for interventional fluoroscopy.
. Publication 121. Radiological protection in paediatric diagnostic and interven-
tional radiology. Approved by the Commission in October 2011, but dated
2013 for editorial reasons (ICRP, 2013b).
Paediatric patients have a higher average risk of developing cancer than adults
who receive the same radiation dose. The longer life expectancy in children allows
more time for any harmful effects of radiation to manifest, and some developing
organs and tissues are more sensitive to the effects of radiation. This report aims
to provide guiding principles of radiological protection for referring clinicians and
clinical staff performing diagnostic imaging and interventional procedures for
paediatric patients. It begins with a brief description of the basic concepts of
radiological protection, followed by the general aspects of radiological protection,
including principles of justification and optimisation. Guidelines and suggestions
for radiological protection in specific modalities – radiography and fluoroscopy,
interventional radiology, and CT – are subsequently covered in depth. The report
concludes with a summary and recommendations. The importance of rigorous
justification of radiological procedures is emphasised for every procedure invol-
ving ionising radiation, and the use of imaging modalities that are non-ionising
28
should always be considered. Special consideration should be given to the avail-

ability of dose reduction measures when purchasing new imaging equipment for
paediatric use. Major paediatric interventional procedures should be performed
by experienced paediatric interventional operators, and a second, specific level of
training in radiological protection is desirable for these individuals (in some
countries, this is mandatory). For CT, dose reduction should be optimised by
adjusting scan parameters according to the patient’s weight or age. This report
will assist institutions in encouraging the standardisation of procedures, and may
help to increase awareness and ultimately improve practices for the benefit of
patients.
. Publication 127. Radiological protection in ion beam radiotherapy. Approved by
the Commission in October 2014 (ICRP, 2014).
The goal of external beam radiotherapy is to provide precise dose localisation in
the treatment volume of the target with minimal damage to the surrounding
normal tissue. Ion beams, such as protons and carbon ions, provide excellent
dose distributions due primarily to their finite range, allowing a significant reduc-
tion of undesired exposure of normal tissue. Careful treatment planning is
required for the given type and localisation of the tumour to be treated in
order to maximise treatment efficiency and minimise the dose to normal tissue.
Radiation exposure in ‘out of field’ volumes arises from secondary neutrons and
photons, particle fragments, and photons from activated materials. These
unavoidable doses should be considered from the standpoint of radiological pro-
tection of the patient. Radiological protection of medical staff at ion beam radio-
therapy facilities requires special attention. Appropriate management and control
are required for the therapeutic equipment and the air in the treatment room that
can be activated by the particle beam. Ion beam radiotherapy requires a more
complex treatment system than conventional radiotherapy, and appropriate train-
ing of staff and suitable quality assurance programmes are recommended to avoid
possible accidental exposure of patients, to minimise unnecessary doses to normal
tissue, and to minimise radiation exposure of staff.
. Publication 128 (in cooperation with Committee 2). Radiation dose to patients from
radiopharmaceuticals: a compendium of current information related to frequently
used substances. Approved by the Commission in July 2014 (ICRP, 2015a).
This report is a compilation and ‘transition’ report to facilitate the work of users of
ICRP reports on radiopharmaceuticals until the new dose coefficients for the
International Commission on Radiation Units and Measurements (ICRU)/ICRP
reference computational phantoms for adults and children of various ages become
available. The report compiles current ICRP information relating to radiation dose
to patients, including biokinetic models, biokinetic data, dose coefficients for organ
and tissue absorbed doses, and effective dose for major radiopharmaceuticals based
on the radiological protection guidance given in previous ICRP reports. This report
also includes new information for 82Rb-chloride, iodide (123I, 124I, 125I, and 131I)
and 123I-labelled 2ß-carbomethoxy 3ß-(4-iodophenyl)-N-(3-fluoropropyl) nortro-
pane. The data presented in this report are intended for diagnostic nuclear medicine
29
and not for therapeutic applications. The report also includes annexes on special
biokinetic and dosimetric models, and recommendations on breast-feeding
interruptions.
. Publication 129. Radiological protection in cone beam computed tomography.
Approved by the Commission in January 2015 (ICRP, 2015b).
The objective of this report is to provide guidance on radiological protection in
the new technology of cone beam computed tomography (CBCT). The new appli-
cations of CBCT and the associated radiological protection issues are substan-
tially different from those of conventional CT. The perception that CBCT
involves lower doses was only true in initial applications. CBCT is now used
widely by specialists who have little or no training in radiological protection.
This report provides recommendations on radiation dose management directed
at different stakeholders, and covers principles of radiological protection, training,
and quality assurance aspects. Advice on appropriate use of CBCT needs to
be made widely available. Advice on optimisation of protection when using
CBCT equipment needs to be strengthened, particularly with respect to the use
of newer features of the equipment. Manufacturers should standardise radiation
dose displays on CBCT equipment to assist users in optimisation of protec-
tion and comparisons of performance. Additional challenges to radiological
protection are introduced when CBCT-capable equipment is used for both
fluoroscopy and CBCT during the same procedure. Standardised methods need
to be established for tracking and reporting of patient radiation doses from
these procedures.
3. WORK IN PROGRESS
Committee 3 is currently working on the following reports.
. Task Group 89. Occupational radiological protection in brachytherapy (Chair: L.

Dauer)
Task Group 89 is developing a report related specifically to radiological protection
of staff in brachytherapy. Publications 97, 98 and 105 (ICRP, 2005a,b, 2007) have
addressed radiological protection principles for patients, but there is a need for rele-
vant and practical recommendations for radiological protection of staff in brachy-
therapy. The target audience is clinicians, staff, medical physicists, radiological
protection officers, and regulatory authorities. It is expected that this report will
assist in partially implementing several of the IAEA Bonn call-for-action.
. Task Group 36. Radiation dose to patients from radiopharmaceuticals [Chairs: D.
Nosske (Committee 2) and S. Mattsson (Committee 3 emeritus)]
This is a standing Task Group of Committees 3 and 2. Task Group 36 has
prepared a one-volume compendium published as Publication 128 (ICRP,
2015a) on radiation dose to patients from radiopharmaceuticals. It includes
data compiled mainly from previous ICRP reports, with new information for
30
several radionuclides. Work with the models for certain radiopharmaceuticals is

ongoing, including biokinetic models for 11C-PIB Compound B and 11C-choline.
There is also an analysis of published data on the results of ongoing clinical
studies for the Alzheimer markers 18F-Flutemetamol and 18F-Florbetapir, for
which the development of biokinetic models is planned.
. Task Group 101. Radiological protection in therapy with radiopharmaceuticals
[Chair: Y. Yonekura. Honory Co-Chair: S. Mattsson (Committee 3 emeritus)]
Radionuclide therapy is used increasingly for the treatment of various types of
tumours by introduction of novel radionuclides, compounds, tracer molecules,
and application techniques. The objective is to explore a framework for dosimetry
and radiological protection aspects in these novel treatment approaches, and to
identify those situations with unique aspects that should be considered. It is
expected to include aspects of individual dosimetry and radiobiology of a
emitters.
. Working Party on diagnostic reference levels in medical imaging (Chair: E. Vañó)
This report was posted on the ICRP website for public consultation in January
2016. Previous recommendations have been taken into account (ICRP, 2001a).
Appropriate contact with the Consortium preparing the European guidelines on
paediatric diagnostic reference levels (DRLs) has been maintained to avoid dis-
crepancies between the two reports. The report contains chapters on methods for
surveys to establish DRLs; radiography and diagnostic fluoroscopy; interven-
tional procedures; digital radiography, CT, nuclear medicine, and hybrid
(multi-modality) imaging procedures; paediatrics; and application of DRLs in
clinical practice. The report contains main points at the beginning of each chapter,
and concludes with a summary of the Commission’s recommendations.
. Working Party on occupational protection issues in interventional fluoroscopi-
cally-guided and CT-guided procedures (Chair: P. Ortiz López)
The preliminary draft includes chapters on trends in the use of interventional
procedures, an overview of exposures and reported tissue reactions, application
of the principles of radiological protection to occupational exposures in interven-
tions, staff protection, dose constraints and investigation levels for occupational
protection (body, eye, and hands), protection of pregnant workers, exposure
monitoring, protective methods and devices, and the hospital radiological protec-
tion programme. A first complete draft of the whole document was analysed
during the 2015 annual meeting of Committee 3.
. Working Party on justification (general issues) (Chair: K. Åhlström-Riklund)
Several organisations have produced, or are preparing, documents in the same
field. The ICRP justification report is expected to have content not published
elsewhere, and not to be a repetition of material already published on issues
related to justification.
. Working Party on radiological protection in medicine related to individual radio-
susceptibility (in cooperation with Committee 1) (Chair: M. Bourguignon)
The Working Party discussed clarification of the concepts of radiosensitivity and
radioesthesia. Radiosensitivity is expressed at high doses as early and late tissue
31
reactions after radiotherapy that occur without any error in the delivery of the
therapeutic dose. It is due to cell death and tissue responses. Radioesthesia is
expressed at low doses as the development of stochastic effects (cancer) after:
(a) multiple medical imaging examinations that result in a cumulative dose; or
(b) after radiotherapy, in areas of normal tissue that receive scatter from the
treatment beam. It is a result of survival of cells with altered DNA due to genetic
disorders or instabilities that contribute to the alteration of the DNA damage
response. It is considered that: (a) many tests are available in research laboratories
to evaluate both radiosensitivity and radioesthesia; and (b) the two concepts
should be addressed in subgroups of the populations concerned. The issue of
ethics for medical exposures should also be addressed. Genetic mapping in medi-
cine for individualised treatment is pending. An initial draft document was dis-
cussed during the annual meeting of Committee 3 in Seoul in October 2015.
. Working Party on radiation and patient protection: a guide for healthcare prac-
titioners (Chair: S. Demeter)
This is an update of the ICRP web-based educational document entitled
‘Radiation and your patient: a guide for medical practitioners’ (2001b) (free
access: http://www.icrp.org/docs/Rad_for_GP_for_web.pdf). Substantial material
on radiological protection already exists, published by reputable organisations
such as WHO, IAEA, and the National Council on Radiation Protection and
Measurements, the goal is to create concise short educational pieces that highlight
and reflect what ICRP contributes to the issue. A final draft will be discussed at
the October 2015 annual meeting of Committee 3.
4. OTHER ACTIVITIES
. Educational slides. Several collections of educational slides corresponding to the

most recent reports of Committee 3 have been completed and are available for
free download (http://www.icrp.org/page.asp?id¼35). These educational slide sets
are for:
– Publication 113 (Education and training in radiological protection);
– Publication 117 (Fluoroscopically guided procedures);
– Publication 120 (Radiological protection in cardiology); and
– Publication 121 (Radiological protection in paediatrics).
. Future topics under consideration. During the annual meetings of Committee 3,
proposals for new topics to be considered by the Committee as future work are
discussed. The list of topics under consideration contains the following items:
– framework for optimisation for individual patients;
– dose quantities and units for imaging equipment (in cooperation with ICRU); and
– patient eye dose in CT in light of the new threshold for the lens of the eye
(ICRP, 2012).
32
. Suggestions on research priorities. Topics considered as priorities for research are

also discussed by Committee 3 during its annual meetings. The most recent topics
suggested to the Commission are:
– approaches to improve protection methods and occupational dose assessment
in interventional fluoroscopy and nuclear medicine procedures;
– patient dosimetry and protection in high-dose procedures (interventional and
CT);
– dosimetric data to help in the assessment of cardiovascular, pulmonary fibrosis,
and cerebrovascular effects in radiotherapy and high-dose imaging procedures;
– development and validation of newer methods to improve image quality while
reducing patient doses, including criteria for acceptable levels of image quality
for clinical CT and digital imaging;
– patient risk assessment and risk communication; and
– x-ray energy at 30 kV vs 120 kV for mammography vs CT (suggested to
Committee 1).
REFERENCES
ICRP, 2001a. Reference levels in medical imaging: review and additional advice. ICRP
Supporting Guidance 2. Ann. ICRP 31(4).
ICRP, 2001b. Radiation and your patient: a guide for medical practitioners. ICRP Supporting
Guidance 2. Ann. ICRP 31(4).
ICRP, 2005a. Prevention of high-dose-rate brachytherapy accidents. ICRP Publication 97.
Ann. ICRP 35(2).
ICRP, 2005b. Radiation safety aspects of brachytherapy for prostate cancer using perman-
ently implanted sources. ICRP Publication 98. Ann. ICRP 35(3).
ICRP, 2007. Radiological protection in medicine. ICRP Publication 105. Ann. ICRP 37(6).
ICRP, 2009. Education and training in radiological protection for diagnostic and interven-
tional procedures. ICRP Publication 113. Ann. ICRP 39(5).
ICRP, 2010. Radiological protection in fluoroscopically guided procedures performed outside
the imaging department. ICRP Publication 117. Ann. ICRP 40(6).
ICRP, 2012. ICRP statement on tissue reactions and early and late effects of radiation in
normal tissues and organs – threshold doses for tissue reactions in a radiation protection
context. ICRP Publication 118. Ann. ICRP 41(1/2).
ICRP, 2013a. Radiological protection in cardiology. ICRP Publication 120. Ann. ICRP 42(1).
ICRP, 2013b. Radiological protection in paediatric diagnostic and interventional radiology.
ICRP Publication 121. Ann. ICRP 42(2).
ICRP, 2014. Radiological protection in ion beam radiotherapy. ICRP Publication 127. Ann.
ICRP 43(4).
ICRP, 2015a. Radiation dose to patients from radiopharmaceuticals: a compendium of cur-
44(2S).
ICRP, 2015b. Radiological protection in cone beam computed tomography. ICRP
33
Overview of ICRP Committee 4: application of
the Commission’s recommendations
D.A. Cool
Electric Power Research Institute, 1300 West WT Harris Blvd, Charlotte,
NC 28262, USA; e-mail: dcool@epri.com
Abstract–Committee 4 develops principles and recommendations on radiological protection

of people in all exposure situations. The committee meeting in 2014 was hosted by GE
Healthcare in Arlington Heights, IL, USA on 27 July–1 August 2014. The programme of
work of Committee 4 encompasses several broad areas, including a series of reports covering
various aspects of existing exposure situations, leading the efforts of the International
Commission on Radiological Protection (ICRP) to update and elaborate recommendations
in light of the accident at Fukushima Daiichi nuclear power plant for emergencies and living in
contaminated areas, elaborating the underpinnings of the system of radiological protection,
and developing focussed reports on specific topic areas in consultation with ICRP’s special
liaison organisations. Committee 4 has six active Task Groups working on naturally occurring
radioactive material; cosmic radiation in aviation; updates of ICRP Publications 109 and 111;
ethics of radiological protection; surface and near-surface disposal of solid radioactive waste;
and exposures resulting from contaminated sites from past industrial, military, and nuclear
activities. In addition, there is a Working Party on tolerability of risk, and ongoing work with
the various special liaison organisations of ICRP.
Keywords: Existing exposure; Emergency exposure; Ethics; Practical applications
Protection. The views and thoughts in this paper are the author’s personal opinions, and are not intended
to represent those of the Electric Power Research Institute.
34
1. INTRODUCTION
is dedicated to developing principles and recommendations on radiological protec-
tion of people in all exposure situations. Committee 4 works closely with other
Committees, and the Main Commission, to elaborate the practical application of
the Commission’s recommendations, and provide information on how the system of
radiological protection can be applied in the various exposure situations.
Committee 4 includes 17 members from 14 different countries, with a wide variety
of research, academic, industrial, and regulatory perspectives. The most recent meet-
ing was hosted by GE Healthcare in Arlington Heights, IL, USA on 27 July–1
August 2014.
The programme of work encompasses several broad areas, including a series of
reports covering various aspects of existing exposure situations, leading the efforts of
ICRP to update and elaborate recommendations in light of the accident at
Fukushima Daiichi nuclear power plant for emergencies and living in contaminated
areas, elaborating the underpinnings of the system of radiological protection, and
developing focussed reports on specific topic areas in consultation with ICRP’s spe-
cial liaison organisations. The following sections will describe the current pro-
gramme, accomplishments, and anticipated work. Other sessions in this
symposium will touch specifically on several of Committee 4’s areas of work.
1.1. System of radiological protection

The objective of the work of ICRP is to contribute to an appropriate level of
protection against the detrimental effects of ionising radiation exposure without
unduly limiting the benefits associated with the use of radiation. This is accomplished
through recommendations intended to prevent serious detrimental tissue reactions,
and to minimise, to the extent reasonable, the probability of stochastic effects,
including cancer and heritable effects. Current work within the Commission is look-
ing at non-cancer effects, where the mechanisms may challenge the previously rather
simple separation of effects into two categories.
The foundations of the recommendations come from scientific information,
experience, and social and ethical values. There will be a session within this sympo-
sium that is devoted to the ethical principles and values that support the recommen-
dations, and how clarifying and eliciting these values can assist in decision making
and in interactions with stakeholders.
The ICRP system of radiological protection is a fundamental framework for
dealing with any exposure situation in a systematic and coherent manner. The com-
ponents of the system are illustrated in Fig. 1.
At the centre, the system of radiological protection relies on the three principles of
justification, optimisation, and limitation. These principles are applied in the various
exposure situations, shown in the upper left, of planned, existing, and emergency
exposure situations. There are now four categories of exposure, namely
35
Fig. 1. System of radiological protection, illustrating the interrelationships of the principles of

protection, the exposure situations, the categories of exposure, the dose criteria, and the
requisites for implementation of the system.
occupational, public, medical (associated with medical diagnosis and treatment), and
environmental (associated with protection of the environment). The dose criteria
serve as boundaries within which the optimisation process takes place, and serve
to reduce inequities of exposure. Finally, there are several requisites that must be in
place in order for the system to be implemented effectively. These include the need
for assessment of the exposures, provision of information in a clear and transparent
manner, accountability for safety, and involvement of the relevant stakeholders.
Radiological protection is achieved in any exposure situation by the application of
optimisation. Fundamentally, this means reducing exposures to as low as reasonably
achievable, economic and societal factors being taken into account. This is illustrated
in Fig. 2, where the process of optimisation is shown stylistically to move the dose
distribution towards lower levels of dose, and reduce (preferentially eliminate) indi-
viduals who would be receiving an exposure greater than the selected dose criteria.
The name used for the individual dose criteria, shown in Fig. 1, has presented
some questions, particularly in existing exposure situations. Dose limits, in the
formal, individual related sense used by the Commission in planned exposure situ-
ations, are said not to apply in existing exposure situations. The Commission rec-
ognises, however, that national regulatory bodies prefer to have legally defined
criteria with which to judge the adherence of a particular activity as being within
the standards. If a particular existing exposure has been well characterised, it may be
convenient for national authorities to apply the term ‘limit’ in such a legal context,
36
Fig. 2. Optimisation of protection, showing the movement of the dose distribution towards
lower levels of exposure, with a focus upon doses that may exceed a specified individual dose
criteria.
particularly for occupational exposure. The session of this symposium dealing with
existing exposure situations will elaborate further on this topic.
2. PROGRAMME OF WORK
2.1. Existing exposure situations
Following ICRP’s 2007 Recommendations (Publication 103; ICRP, 2007),
Committee 4 has embarked on a set of related efforts to elaborate the application
of the system of radiological protection in existing exposure situations. The system of
radiological protection was developed principally within the context of planned
exposures, and the translation of the system for existing exposures requires a clear
understanding of the situation, the opportunities for providing for protection, and
the objectives to be achieved.
Within the system of radiological protection, the starting point for any consider-
ation of radiological protection is an assessment of the exposures that may be occur-
ring. Unlike a planned exposure situation in which the conditions can be predicted in
advance, in existing exposure situations – in which the exposures are already occur-
ring – the first requisite is to assess the situation, the pathways and magnitudes of
exposure, and the status of any radiological protection that may be in place. For
example, many industries using ores and other materials may have naturally occur-
ring radioactive material (NORM) present, which may, or may not, have been
recognised previously. Likewise, for radon in dwellings and workplaces, an
37
assessment of the radon levels is essential before consideration can be given to the
need for action.
The most recent publication in this area was Publication 126 (ICRP, 2014b).
Committee 4 has six active Task Groups. Task Group 76 on application of the
Commission’s recommendations to NORM will be presenting draft material at the
Committee 4 meeting in Seoul, South Korea. NORM industries have a great diver-
sity of applications and possibilities of exposure; in most cases, considerations of
radiological protection have not, traditionally, been part of the safety concerns.
Nevertheless, there is potential for relatively significant exposures, depending on
the NORM being processed and the conditions of work.
Public consultation is ongoing for the draft report of Task Group 83 on radio-
logical protection from cosmic radiation in aviation. In this report, the Commission
provides updated guidance on the radiological protection from cosmic radiation in
aviation, taking into account the current ICRP system of radiological protection, the
latest available data on exposures in aviation, and the experience gained worldwide
in their management. The report describes the origins of cosmic radiation, how it
exposes passengers and aircraft crew, the basic radiological protection principles that
apply to this existing exposure situation, and the available protective actions. For
implementation of the optimisation principle, the Commission recommends a graded
approach proportionate with the level of exposure that may be received by individ-
uals. This can be accomplished in a relatively straightforward manner based on time
spent in flight. The objective is to keep the exposure of the most exposed individuals
to reasonable levels. The Commission also recommends that information should be
disseminated to raise awareness about cosmic radiation, and to support informed
decisions among concerned stakeholders. The draft will be reviewed based on the
comments received, and a final version will be moved forward to approval and
publication by the Commission.
Task Group 98 on application of the Commission’s recommendations to expos-
ures resulting from contaminated sites was initiated in 2014. Several teleconferences
have already been held to begin the development of a report.
2.2. Response to Fukushima

Closely related to the work on existing exposure situations is the work of Task
Group 93, updating Publications 109 and 111 (ICRP, 2009a,b). Publications 109 and
111 were published just before the events at Fukushima Daiichi nuclear power plant,
and application in the emergency, and in the time that has since passed, has raised a
number of questions that the Commission intends to address. These questions include
justification for and optimisation of emergency decisions, characterisation of the
radiological situation, protection of emergency and recovery responders, decontam-
ination and waste management strategies, withdrawal of emergency protective
actions, protection of pregnant women and children, information sharing with stake-
holders, and emergency and recovery preparedness. Thus, the work of Task Group 93
is to prepare additional material in light of the lessons from Fukushima, and recent
38
international developments concerning the protection of people in emergency expos-

ure situations, and people living in long-term contaminated areas after a nuclear
accident or a radiation emergency. Task Group 93 has benefited greatly from the
continuing set of dialogue meetings in Fukushima, initiated by the Commission in
November 2011. Committee 4 expects to have extended discussions on draft material
at the Committee 4 meeting in Seoul, South Korea.
2.3. Foundations of radiological protection

The Commission, through Committee 4’s Task Group 94, is currently examining
the ethical foundations for the system of radiological protection. The report is
expected to elaborate on the underpinnings of the system of protection, and is
intended to improve our understanding and use of the system, and assist in develop-
ing decision approaches and communications. Task Group 94 has benefited from a
series of workshops organised in cooperation with the International Radiation
Protection Association (IRPA), beginning in 2013, and continuing in 2014 and
2015. The current plan is to have a report for preliminary consultation during the
time of the 14th Congress of IRPA in South Africa in May 2016. A separate session
of this symposium is devoted entirely to this subject.
Committee 4 is also examining the tolerability of risk through a Working Party of
individuals. The issues of tolerability are, in a number of respects, related to the
ethical considerations being developed by Task Group 94, and are highly dependent
upon the prevailing circumstances of the exposure. A situation that would not be
tolerable in normally well-controlled circumstances may be tolerated for a short
period of time in circumstances of danger. This can be seen in a person’s reaction
to, for example, a significant weather event. Once the event is over, the desire is
always to attempt to return to a state of normalcy, preferably as close to the previous
condition as possible. Such a return to normal may take a considerable period of
time, as was seen in the wake of Hurricane Katrina which devastated the city of New
Orleans, LA, USA, where reconstruction and rehabilitation of areas have taken a
number of years.
2.4. Topical reports

With this term of the Commission, Committee 4 has initiated a series of reports
that are focussed on specific topics where elaboration of the Commission’s recom-
mendations would prove useful. Committee 4 specifically requested the organisations
that have a formal relationship with ICRP to suggest topics where such reports would
be useful. In retrospect, the first of the series could be considered as Publication 122
(ICRP, 2013). This report was developed in close collaboration with the Nuclear
Energy Agency (NEA) of the Organization for Economic Cooperation and
Development (OECD) and groups within the waste community, among others. The
second in the series was Publication 125 (ICRP, 2014a), which addressed the unique
challenges of use of ionising radiation in security screening settings.
39
The series continues with the work of Task Group 97 on application of the
Commission’s recommendations for surface and near-surface disposal of solid radio-
active waste. This Task Group was initiated in late 2014 following the request of
NEA for a follow-up to Publication 122 (ICRP, 2013) for the area of surface dis-
posal. Committee 4 is also considering the possibility of a document dealing with the
application of the Commission’s recommendations for uses of mobile high-activity
sources. Committee 4 welcomes further suggestions for topics that may be useful to
particular groups.
2.5. Support to other Committees

Committee 4 works to support other Committees with application perspectives
during the development of reports. At present, Committee 4 has members that are
part of Task Groups of each of the other Committees, including support for con-
siderations of effective dose (Task Group 79), occupational radiological protection in
brachytherapy (Task Group 89), radiation risk inference at low dose and lose dose
rate (Task Group 91), and terms and definitions (Task Group 92). During the meet-
ing in Seoul, South Korea, proposals for joint work with Committee 5 will be under
discussion, together with discussions on the concept of detriment.
3. CONCLUSIONS
Committee 4 has an active ongoing programme with four major areas of work, six
current Task Groups, several Working Parties, and support for a number of additional
Task Groups of other Committees. During the meeting in Seoul, South Korea,
Committee 4 will be considering several additional proposals for work, as well as
critical review of documents in preparation. The year 2016 should see completion of
the work on radiological protection from cosmic radiation in aviation, and the public
consultation for the work on ethics of radiation protection. Committee 4 is looking
ahead to issues to be clarified and elaborated for the system of radiological protection.
REFERENCES
ICRP, 2009a. Application of the Commission’s recommendations for the protection of people
in emergency exposure situations. ICRP Publication 109. Ann. ICRP 39(1).
ICRP, 2009b. Application of the Commission’s recommendations to the protection of people
living in long-term contaminated areas after a nuclear accident or a radiation emergency.
ICRP, 2013. Radiological protection in geological disposal of long-lived solid radioactive
waste. ICRP Publication 122. Ann. ICRP 42(3).
ICRP, 2014a. Radiological protection in security screening. ICRP Publication 125. Ann.
ICRP 43(2).
ICRP, 2014b. Radiological protection against radon exposure. ICRP Publication 126. Ann.
ICRP 43(3).
40
Overview of ICRP Committee 5: protection
of the environment
C-M. Larsson
Australian Radiation Protection and Nuclear Safety Agency, PO Box 655, Miranda, NSW
2228, Australia; e-mail: carl-magnus.larsson@arpansa.gov.au
Abstract–Protection of the environment is integral to the system of radiological protection, as

outlined in the 2007 Recommendations of the International Commission on Radiological
Protection (ICRP, Publication 103). The Commission’s activities in this area are mainly pur-
sued by Committee 5 and its associated Task Groups. Publication 91 broadly outlines the
approach to radiological protection of the environment, and its alignment with approaches to
environmental protection from hazardous substances in general. Publications 108 and 114
provide the cornerstones of the environmental protection system and relevant databases.
Publication 124 considers its application in planned, existing, and emergency exposure situ-
ations. The system centres on 12 Reference Animals and Plants (RAPs) with broad relevance
for environmental protection based on their ubiquity and significance as well as other criteria,
as described in Publication 108. The databases comprise general biology of the RAPs, transfer
parameters, dose conversion coefficients, and effects data. Derived Consideration Reference
Levels (DCRLs) were established for each RAP; a DCRL represents a band of dose rates that
might result in some deleterious effects in individuals of that type of RAP. Newly established
Task Group 99 will compile the RAP-specific reference information into monographs, with
the view of updating information and improving the applicability of the system in different
exposure situations. For certain scenarios, more precise and ecosystem-specific protection
benchmarks may be justified, which would have to be informed by consideration of represen-
tative organisms (i.e. representative of a particular ecosystem and relevant to the specific
scenario; Publication 124). Committee 5 will explore this further, making use of a limited
number of case studies.
Keywords: Dose conversion coefficients; Environmental protection; Radiation effects;

Reference Animals and Plants; Transfer factors
Protection.
41
1. INTRODUCTION
is concerned with radiological protection of the environment. It aims to ensure that
the development and application of approaches to environmental protection are
compatible with those for radiological protection of people, and with those for pro-
tection of the environment from other hazardous substances. This paper sets out to
review recent activities of Committee 5 and its associated Task Groups, the plan for
future activities, and how they contribute to a consolidated and increasingly user-
friendly system for radiological protection of the environment (the ICRP system for
environmental protection will, for convenience, be herein referred to as the ICRP
environmental protection system).
Chapter 2 briefly outlines the major elements of the ICRP environmental protec-
tion system and its application; readers interested in further details regarding the
origin and evolution of the ICRP environmental protection system can refer to art-
icles published in connection with the First and Second ICRP International
Symposia on the System of Radiological Protection (e.g. Pentreath, 2012a;
Larsson et al., 2015; Pentreath et al., 2015).
Chapter 3 outlines the Committee’s current programme of work, as well as new
information to date.
2. ELEMENTS OF THE ICRP ENVIRONMENTAL PROTECTION SYSTEM

2.1 Assessment and management of an exposure scenario
The ICRP environmental protection system is outlined in Publications 91, 108,
114 and 124 (ICRP, 2003, 2008b, 2009, 2014). In addition, it is outlined briefly
in Publication 103 (ICRP, 2007), which also states the objectives of the ICRP
environmental protection system: ‘The Commission’s aim is now that of preventing
and reducing the frequency of deleterious radiation effects to a level where they
would have negligible impact on the maintenance of biological diversity, the conser-
vation of species, or the health and status of natural habitats, communities and
ecosystems.’
The system requires understanding of the exposure scenario (such scenarios can
occur within the general framework of planned, existing, and emergency exposure
situations). In the ICRP environmental protection system, this understanding is
facilitated by modelling the scenario on certain organisms in the environment for
which relevant databases have been generated [‘Reference Animals and Plants’
(RAPs)]; identification of dose-rate ranges where some deleterious effects may be
expected in RAPs that could warrant consideration of protective measures [Derived
Consideration Reference Levels (DCRLs)]; and an approach to the application of
the environmental protection system in different exposure situations. Essentially, the
components needed for assessing an exposure scenario (illustrated by the arrow
pointing towards the right in Fig. 1) and for managing the exposure scenario for
42
Fig. 1. Elements of the International Commission on Radiological Protection environmental

protection system that enable assessment of the consequences of a specific exposure scenario
(arrow going to the right), and the management of the exposure scenario based on a system for
protection (arrow going to the left), in planned, emergency, or existing exposure situations.
DCC, dose conversion coefficient; Ext/Int, external/internal; RAP, Reference Animal and
Plant; RBE, relative biological effectiveness.
the purpose of environmental protection (the arrow pointing towards the left
in Fig. 1) are the same as those used in the radiological protection of people.
Indeed, the systems for protection of people and for protection of the environment
can be used in an integrated manner – when warranted – to protect people and the
environment. While protection of people is the primary concern in most situations,
certain scenarios may benefit from an integrated approach; other situations may
require decisions based solely on environmental considerations (Copplestone,
2012; Pentreath, 2012b; ICRP, 2014; Pentreath et al., 2015; Copplestone et al., 2016).
2.2 Application in different exposure situations

Publication 124 (ICRP, 2014) outlines the approaches recommended by ICRP
when applying the environmental protection system in planned, existing, and emer-
gency exposure situations. The benchmark that informs decision making is the
DCRL, given as bands of absorbed dose rate. It is important to draw attention to
the following terms:
. consideration (i.e. DCRLs should not be viewed as ‘limits’ or ‘constraints’, but

ranges of absorbed dose rates to any RAP where it may be reasonable for an
assessor or regulator to pause and consider whether environmental effects of radi-
ation are likely, and/or whether the exposure scenario needs to be managed); and
43
Fig. 2. Use of Derived Consideration Reference Levels (DCRLs) to guide decisions to manage
exposures in planned exposure situations (left) and in existing exposure situations (right). For
explanations, see Publication 124 (ICRP, 2014). RAP, Reference Animal and Plant.
. reference (i.e. DCRLs are akin to reference levels that guide optimisation of pro-
tection of people, and that are used in existing and emergency exposure
situations).
The recommended application of DCRLs in different exposure situations was

outlined in Publication 124 (ICRP, 2014), and is illustrated in Fig. 2 for planned
and existing exposure situations.
The aim in planned exposure situations would be to use the lower end of the
DCRL for the relevant RAP as a reference point for the sum of exposures from all
sources (left part of Fig. 2). In most situations, there will be a dominant source of
exposure. The RAPs and DCRLs that may have to be considered may be very few.
However, other situations can be foreseen or come to light (see Section 3.4 for
further discussions of circumstances where a simple RAP-based approach may not
always suffice).
For existing exposure situations, ICRP recommends that the aim should be
to bring exposures to within the DCRL (right part of Fig. 2). While this may not
be achievable when considering costs and other ramifications of activities aimed at
environmental restoration (including unwanted indirect environmental effects), the
DCRL may still inform assessments as well as long-term management decisions.
Early protective actions in emergency exposure situations will, in their entirety, be
directed towards the protection of people. This will remain as one primary consid-
eration and also in the long term, but so will environmental management.
Restoration work may commence even during an emergency, and the preferable
environmental management option, even if the main purpose is the protection of
people, may have to be identified, with due consideration given to long-term aims for
environmental protection. In order to inform this decision-making process, it may be
helpful to consider the likely evolution of environmental exposures over time in
relation to relevant DCRLs, as outlined in Fig. 3.
44
Fig. 3. Use of Derived Consideration Reference Levels (DCRLs) to inform decisions on

management options during and following an emergency. For explanations, see Publication
124 (ICRP, 2014).
3. CONSOLIDATION OF THE ICRP ENVIRONMENTAL

PROTECTION SYSTEM
While it is clear that the ICRP environmental protection system is robust and has
stood the test when ‘road-tested’ in various situations, further work is underway to
consolidate the system and strengthen its scientific basis. A number of elements of
the system have already been the subject of further work; these relate mainly to
exposure and include:
. dosimetry for RAPs;

. the extent to which radiation quality and relative biological effectiveness (RBE)
are matters that need to be taken into consideration (e.g. by applying ‘weighting’
factors that would be akin to weighting factors used in radiological protection of
people); and
. the extent to which internal distribution of specific and dose-dominant radio-
nuclides may affect assessment results and protection approaches.
In addition, Committee 5 is gathering and updating data [e.g. with observations

following the 2011 earthquake, tsunami, and nuclear accident in Japan; and drawing
45
on ongoing programmes such as the International Atomic Energy Agency (IAEA)

Modelling and Data for Radiological Impact Assessments project (https://
gnssn.iaea.org/RTWS/modaria/SitePages/Home.aspx)] and guidance for the best
use of RAPs in support of application of the ICRP environmental protection
system in planned, emergency, and existing exposure situations. This Chapter
reviews the results to date and plans for the future.
3.1 Dosimetry: Task Group 74

The basics of estimation of absorbed doses to RAPs were outlined in Publication
108 (ICRP, 2008b). The models pragmatically assume simple body shapes with uni-
form composition and density, homogeneous internal radionuclide distribution, and
a limited set of idealised external radiation sources for aquatic and terrestrial animals
and plants, and truncate the radioactive decay chains. In order to refine the
approach, ICRP established Task Group 74, and the draft report will be subjected
to public consultation in 2016. Significant methodological changes since Publication
108 (ICRP, 2008b) include: transition to the radionuclide database of Publication 107
(ICRP, 2008a); implementation of a new approach for external exposure of terres-
trial animals with extended sets of radiation sources in soil and air; range of organ-
isms and their locations; assessment-specific consideration of contribution of
radioactive progeny to the dose coefficients of parent nuclides; and use of generalised
allometric relationships to estimate biokinetic or metabolic parameters. The dose
conversion coefficients (DCCs) have been revised.
Comparisons of DCCs suggest that RAP- and exposure-scenario-dependent vari-
ations in DCCs are generally small and can be scaled to suit the assessment or
management purpose (a calculator is being developed to support the estimation of
fit-for-purpose DCCs for different scenarios). The refined dosimetric approach is
further discussed in Ulanovsky (2016).
3.2 RBE and weighting for radiation quality: Task Group 72

Task Group 72 is concerned with data for RBE for the endpoints that are rele-
vant to the ICRP environmental protection system. Specific consideration has been
given to exposure to low-energy b radiation from tritium, and a radiation. The Task
Group will propose, if possible, helpful factors akin to the radiation weighting fac-
tors used for radiological protection of people (i.e. underpinning the use of the radio-
logical protection quantity, equivalent dose). Task Group 72 has
essentially completed its task; the plan is to start public consultation in 2016 [see
Higley et al. (2012)].
Not unexpectedly, data for relevant endpoints and for several RAPs are scarce. In
addition, most data are obtained at exposure levels that are one to several orders of
magnitude higher than the DCRL for the corresponding RAP. For tritium, and
excluding strictly stochastic endpoints, relevant RBEs range from approximately 1
to about 4. For a radiation, values range from just above 1 to close to 40.
The derivation of a ‘weighting factor’ (a term other than ‘weighting factor’ may be
preferable to avoid confusion with weighting factors for stochastic effects used in
46
radiological protection of people1) to be applied across exposure scenarios and RAPs

on the basis of the existing database should be made with caution. Without pre-
empting the finalisation work done by Task Group 72, it can be suggested that for
deterministic endpoints following exposure to a radiation, a value in the range of
5–10 could be considered appropriate. This is in agreement with the recommendation
by the United Nations Scientific Committee on the Effects of Atomic Radiation
(UNSCEAR) in its 2008 report (UNSCEAR, 2011) of a ‘nominal (generic) value
of 10 to reflect the RBE for internally deposited a emitters’, which was also used in
UNSCEAR’s assessments of levels of exposures and effects in the environment fol-
lowing the 2011 nuclear accident in Japan (UNSCEAR, 2014).
UNSCEAR (2011) noted that the most appropriate factor to reflect the RBE of
low-energy b radiation remains an open question. The pragmatic approach taken in
radiological protection of people is to use the same weighting factor for low-energy b
radiation (including from tritium) as for other b radiation, as well as g radiation
(i.e. a value of 1). Optimisation efforts based on dose constraints (as in planned
exposure situations) would eliminate any considerable influence of potential under-
estimates of the RBE for low-energy b radiation on the protection of people (Cox
et al., 2008). This remains a valid approach; however, optimisation in the ICRP
environmental protection system is based on DCRLs that are dose bands where
some effects may be expected to occur. Under such situations, it might be appropri-
ate to consider whether tritium is a significant source of exposure, and make use of
the full dataset in the assessment and/or management decisions when circumstances
justify doing so.
3.3 Monographs: Task Group 99

The outcomes of Task Groups 72 and 74 will contribute to the consolidation of
the ICRP environmental protection system; they will strengthen the basis for the
system but not cause fundamental changes. Their finalisation will give Committee 5
an opportunity to focus on other elements of the environmental protection system
(cf. Fig. 1) where data are scarce and where further work may strengthen its scientific
basis. This work is being carried out by the recently established Task Group 99 on
RAPs monographs.
The objective of Task Group 99 is to gather and update basic data and guidance
for the best use of RAPs in support of the application of the ICRP environmental
protection system in planned, emergency, and existing exposure situations. The
reports (intended to cover a number of RAPs in each volume of a series of perhaps
three reports) will contain generic background text outlining the methodology for
collating and analysing information, followed by separate treatment of: biology/
ecology; transfer; dosimetry (outside of what has been accomplished by Task
Groups 72 and 74); and biological effects. One of the primary objectives of this
exercise is to underpin the chosen DCRLs; while the confidence in the DCRLs is
1
For example, Pentreath (1999) suggested ‘dose equivalent for fauna and flora’, and Trivedi and Gentner
(2000) suggested ‘ecodosimetry weighting factor’ specifically for deterministic effects.
47
generally high, new and expanded data need to be considered and the appropriate-
ness of the DCRLs needs to be reassessed.
As reviewed in Section 3.1, the dosimetry database is robust for simplified geo-
metries and for a range of exposure scenarios, and assumes internal exposure from
homogenously distributed radionuclides. The validity of the simplified geometries for
internal dose assessment can be tested by mapping organ distribution and other
tissue characteristics (such as density), and assumes preferential partitioning of inter-
nal radionuclides to any particular organ. This approach has been put in practice,
including the use of voxel phantoms to represent RAPs (Higley et al., 2015).
Fig. 4 provides one example that illustrates the consequences of assuming that all
radionuclides are partitioned to one specific organ, for the exposure of that organ
and other organs, in relation to what the dose would have been if the particular
radionuclide had been distributed uniformly. Other and more complex examples are
described by Higley et al. (2015). The specific example of Fig. 4 illustrates that organ
dose estimates may be affected by an order of magnitude by introducing assumptions
of preferential distribution of radionuclides to particular organs. A challenge for
Fig. 4. Left: Voxel phantom of a crab (one of the set of 12 Reference Animals and Plants)
used for mapping organ distribution (courtesy of Kathryn A. Higley, Oregon State University,
Corvallis, OR, USA. Right: Dose to source and target organs, assuming 100% partitioning of
activity to the source organ and expressed as a ratio to dose if uniform distribution was
assumed. From Higley et al. (2015).
48
Task Group 99 is to analyse the radionuclide/organ/RAP combinations for which

such considerations become important, and to what extent this affects the assessment
and/or the ways in which exposure scenarios should be managed.
Of relevance to Task Group 99 are the studies of effects, or lack thereof, of
radiation exposures in the environment on animals and plants following the earth-
quake, tsunami, and nuclear accident in Japan in 2011. These studies expand the very
significant body of data that exists already, which includes data from experimental
irradiation under field and laboratory conditions, and observations after accidents
and in natural environments with chronically elevated radiation levels [reviewed, for
example, by UNSCEAR (2011)]. It is outside the scope of this paper to carry out a
fulsome review of the new information following the nuclear accident in Japan, but
such reviews have been published recently (UNSCEAR, 2014, 2015; IAEA, 2015).
Data from UNSCEAR (2014) for levels of exposure in Okuma Town (close to the
reactors of the Fukushima Daiichi nuclear power plant) in June 2011 (i.e. approxi-
mately 3 months after the stricken reactors started to release very significant amounts
of radioactivity into the atmosphere and the sea) are given in Table 1. For four RAPs
Table 1. Reference Animals and Plants (RAPs), corresponding Derived Consideration

Reference Levels (DCRLs), and ratios between exposure levels in Okuma Town and the
lower end of the DCRL for those RAPs for which data exist. Data from Publication 108
(ICRP, 2008b) and UNSCEAR (2014).
Ratio of estimated
DCRL dose rate to lower
1
Wildlife group Ecosystem RAP mGy day end of DCRL
Large terrestrial T Deer 0.1–1 17.8

mammals
Small terrestrial T Rat 0.1–1 11.5
mammals
Aquatic birds F, M Duck 0.1–1 5.3
Large terrestrial T Pine tree 0.1–1 4.3
plants
Amphibians F, T Frog 1–10 0.45
Pelagic fish F, M Trout 1–10 *
Benthic fish F, M Flatfish 1–10 *
Small terrestrial T Grass 1–10 0.65
plant
Seaweeds M Brown seaweed 1–10 *
Terrestrial insects T Bee 10–100 0.04
Crustacean F, M Crab 10–100 *
Terrestrial annelids T Earthworm 10–100 0.11
T: Terrestrial; F: Freshwater; M: Marine.
*Not determined.
49
(deer, rat, duck, and pine tree), the levels of exposure in June 2011 were above the
lower end of the corresponding DCRL; for deer and rat, the levels of exposure were
also above the higher end of the corresponding DCRL. Based on the totality of
information, UNSCEAR (2014) concluded that population effects of major signifi-
cance were unlikely, but that some more long-term effects in the areas with the
highest deposition densities were possible. The main conclusions were also con-
sidered to be relevant in the light of new information that had been possible to
evaluate up until late 2014 (UNSCEAR, 2015). IAEA (2015) arrived at similar con-
clusions. Notwithstanding these assessments, a number of reports (e.g. Hiyama et al.,
2012; Nohara et al., 2014; Garnier-Laplace et al., 2015a; Watanabe et al., 2015) have
attributed more long-term environmental effects to radiation exposure, although in
some cases, the authors have advised caution when interpreting the data.
The evacuation of people and resulting disturbance to the semi-natural ecosys-
tem is one potential confounding factor when assessing census data (Deryabina
et al., 2015). The observations from Fukushima should be taken seriously,
although their attribution to radiation and the influence of confounding factors
need further evaluation. A further consideration was noting how well data that
have been obtained from laboratory experiments translate into field conditions
(Garnier-Laplace et al., 2015b). Causal relationships and dose dependence should
be firmly established, and then the data can be accommodated within the dataset
that underpins the DCRLs.
3.4 Further development of the system for application in specific exposure scenarios
Work is planned to deliver additional guidance to that given in Publication 124
(ICRP, 2014) on application of the ICRP environmental protection system in differ-
ent exposure situations, including case studies, and with focus on emergency and
existing exposure situations. It is unlikely that planned exposure situations are going
to require much additional guidance and advice in the short term, partly because the
advice was clear in Publication 124 and partly because IAEA is currently finalising
safety guides on environmental impact assessment and control of radioactive dis-
charges. Furthermore, the ongoing update of the IAEA generic models for assessing
the impact of radioactive discharges (IAEA, 2001) is providing examples of planned
exposure situations.
Copplestone et al. (2016) provided examples of case studies and sites available for
studies of environmental protection under emergency and existing exposure situ-
ations. Key messages to date state that such exposure scenarios require site-specific
decisions, and that sometimes both humans and biota need to be considered when
developing the management strategy. However, questions remain, such as how to
handle decisions on the management decisions needed where people are considered
to be protected, but biota may not be. Consideration will also be given to convert the
DCRLs into environmental concentrations and other measures (e.g. ambient dose
equivalent) to aid in communication and understanding for existing and emergency
situations.
50
The case studies will be used to determine how decisions governing optimisation
of protection can be made for exposure scenarios where:
. people need protection (and the consequent impacts on the environment);

. the environment needs protection (and people are protected); and
. people and the environment need protection.
The lessons learned will be explored and extracted to provide generic advice and
guidance for use when undertaking design-based accident/incident scenarios, and for
application in real emergencies and existing situations.
As pointed out by Pentreath (2012b) and Larsson et al. (2015), and elaborated on
in Publication 124 (ICRP, 2014), in situations where there is reason to expect that a
scenario of environmental concern exists or will/can evolve, the aim should be to
make the assessments with real organisms in real environments. A ‘real’ organism
may well be one of the RAPs, and existing databases can be used without further
consideration. In other circumstances, the representative organism may not be well
represented by one of the RAPs, and the differences will need to be assessed. In this
case, the Commission has recognised the need to define representative organisms,
typical for a particular exposure scenario in a particular ecological context, each
characterised by its own:
. biology, such as life span or life cycle;

. dosimetry related to physiology, size, shape, and location; and
. response to radiation.
Both the monograph series of reports and the proposed work to further
develop the application approaches outlined in Publication 124 (ICRP, 2014)
will provide practical recommendations on how to deal with real scenarios of
environmental significance and concern, building on existing databases for the
12 RAPs.
4. ACKNOWLEDGEMENTS
The author wishes to thank and acknowledge all past and present members of
Committee 5 for their contribution to the work of the Committee, and for many
stimulating discussions and laughs during the long and enjoyable meetings. The
current members are: David Copplestone, Jacqueline Garnier-Laplace, Kathryn A.
Higley, Jianguo Li, Almudena Real Gallego, Kazuo Sakai, Per Strand, Alexander
Ulanovsky, and Jordi Vives I Batlle.
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environmental protection criteria. Ann. ICRP 41(3/4), 263–274.
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ment in existing exposure situations. Ann. ICRP 45(1S), 91–105.
Cox, R., Menzel, H-G., Preston, J., 2008. Internal dosimetry and tritium – the ICRP position
(invited editorial). J. Radiol. Prot. 28, 131–135.
Deryabina, T.G., Kuchmel, S.V., Nagorskaya, N.N., et al., 2015. Long-term census data
reveal abundant wildlife populations at Chernobyl. Curr. Biol. 25, R811–R826.
Garnier-Laplace, J., Karine Beaugelin-Seiller, K., Della-Vedova, C., et al., 2015a.
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ledge of dose–effect relationships. Sci. Rep. 5, 16594.
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between environmental exposures to radionuclides and the consequences for wildlife: infer-
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ness and radiation weighting factors in the context of animals and plants. Ann. ICRP 41(3/
4), 233–245.
Higley, K., Ruedig, E., Gomez-Fernandez, M., et al., 2015. Creation and application of
voxelised dosimetric models, and a comparison with the current methodology as used
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44(1S), 47–57.
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materials on the pale grass blue butterfly. Sci. Rep. 4, 4946.
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thoughts and ideas. J. Radiol. Prot. 19, 117–128.
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Ann. ICRP 41(3/4), 45–56.
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Pentreath, J., Larsson, C-M., Copplestone, D., 2015. ICRP’s approach to protection of the
living environment under different exposure situations. Ann. ICRP 44(1S), 288–294.
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Biota. 10th International Conference of the International Radiation Protection
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Japanese fir trees around the Fukushima Daiichi nuclear power plant. Sci. Rep. 5, 13232.
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Report, Volume II, Scientific Annex E. United Nations, New York.
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after the 2011 Great East-Japan Earthquake and Tsunami. UNSCEAR 2013, Volume I,
Scientific Annex A. United Nations, New York.
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ICRP 45(1S), 225–238.
53
Understanding existing exposure situations
J-F. Lecomte
Institut de Radioprotection et de Sûrete´ Nucleáire, BP 17, F92262 Fontenay-aux-Roses
Cedex, France; e-mail: jean-francois.lecomte@irsn.fr
Abstract–International Commission on Radiological Protection (ICRP) Publication 103

removed the distinction between practices and interventions, and introduced three types of
exposure situation: existing, planned, and emergency. It also emphasised the optimisation prin-
ciple in connection with individual dose restrictions for all controllable exposure situations.
Existing exposure situations are those resulting from sources, natural or man-made, that already
exist when a decision on control has to be taken. They have common features to be taken into
account when implementing general recommendations, such as: the source may be difficult to
control; all exposures cannot be anticipated; protective actions can only be implemented after
characterisation of the exposure situation; time may be needed to reduce exposure below the
reference level; levels of exposure are highly dependent on individual behaviour and present a
wide spread of individual dose distribution; exposures at work may be adventitious and not
considered as occupational exposure; there is generally no potential for accident; many stake-
holders have to be involved; and many factors need to be considered. ICRP is currently develop-
ing a series of reports related to the practical implementation of Publication 103 to various
existing exposure situations, including exposure from radon, exposure from cosmic radiation in
aviation, exposure from processes using naturally occurring radioactive material, and exposure
from contaminated sites due to past activities.
Keywords: Radon; Naturally occurring radioactive material; Cosmic radiation; Contaminated

sites; Optimisation
1. INTRODUCTION
1.1. From Publication 60 to Publication 103
The International Commission on Radiological Protection (ICRP) system of
radiological protection was developed gradually over the 20th Century, integrating
Protection.
54
developments in knowledge about the effects of ionising radiation, the evolution

of ethical and social values, and feedback experience from its practical imple-
mentation. Prior to the Second World War, the Commission focussed on the
protection of medical staff. After the War, the main focus was on nuclear energy,
and radiological protection was developed to protect workers inside nuclear instal-
lations and the public outside in normal situations. This resulted in a coherent
and effective system of radiological protection applicable to what were called
‘practices’, where a source is introduced deliberately and the exposure can be fully
anticipated. This system is based on solid concepts, principles, and standards (ICRP,
1977, 1991).
Over the last decades, the radiological protection system has been challenged
profoundly by the occurrence of nuclear accidents, the threat of malevolent events,
rising concerns about natural exposures, and exposure situations inherited from the
past. These considerations were not entirely absent from the system recommended in
Publication 60 (ICRP, 1991). However, this system appeared to be a two-speed pro-
tection system. In the case of practices, exposures should be reduced to a level as low
as reasonably achievable (ALARA) below ceiling dose criteria (dose limits and dose
constraints), which are not expected to be exceeded. In the case of interventions, it
was recommended that action should only be taken when exposures exceed floor
dose criteria (action levels and intervention levels), with high numerical values on
occasion. This issue, among others, led the Commission to move towards Publication
103 (ICRP, 2007).
Two of the significant evolutions of the system of protection in Publication 103
(ICRP, 2007) were as follows.
. Removal of the distinction between practices and interventions. Three types

of exposure situations were introduced (existing, planned, and emergency), with
generalisation of the optimisation principle in connection with individual dose
restrictions (reference levels and dose constraints) to all controllable exposure
situations.
. The need to account for the views and concerns of stakeholders when optimising
protection in the general recommendations.
Both advancements were driven directly by the desire to better address exposure
situations which are outside the box of practices (i.e. existing and emergency expos-
ure situations).
1.2. A new set of reports

ICRP Committee 4 is in the process of developing a set of reports dedicated to
various types of existing exposure situation. Publication 126 (ICRP, 2014b) is the
first report to update the recommendations for radon exposure. The report on
Radiological Protection from Cosmic Radiation in Aviation was approved for pub-
lication in March 2016 (ICRP, 2016). Task Groups are currently working on reports
related to application of the Commission’s recommendations to naturally occurring
55
radioactive material (NORM) and application of the Commission’s recommenda-

tions to exposures resulting from contaminated sites. In parallel, work is also under-
way to provide updates to Publications 109 and 111 (ICRP, 2009a,b) on emergency
exposure situations and living in long-term contaminated areas following a radio-
logical emergency, respectively.
Through the series of new reports, ICRP is developing a method to apply the 2007
Recommendations (ICRP, 2007) to existing exposure situations.
2. OUTLINES OF THE PUBLICATION 103 SYSTEM OF RADIOLOGICAL

PROTECTION
The ICRP system of radiological protection is a fundamental framework for
dealing with any controllable exposure situation in a systematic and coherent
manner. The components of the system are illustrated in Fig. 1.
At the centre, the system of protection relies on the three principles of justifica-
tion, optimisation, and limitation. These principles are applied in planned, existing,
and emergency exposure situations. There are now four categories of exposure,
Fig. 1. System of radiological protection illustrating the interrelationships of the principles of

protection, the exposure situations, the categories of exposure, the dose criteria, and the
requisites for implementation of the system.
56
namely occupational, public, medical (associated with medical diagnosis and treat-
ment), and environmental (associated with protection of the environment). The dose
criteria serve as boundaries within which the optimisation process takes place, and
serve to reduce inequities of exposure. Finally, several requisites must be in place in
order for the system to be implemented effectively. These include the need for assess-
ment of exposures, provision of information in a clear and transparent manner,
accountability for safety, and involvement of the relevant stakeholders.
This paper endeavours to demonstrate the application of the system of radio-
logical protection to existing exposure situations, keeping in mind that the role of
ICRP is to develop principles and recommendations, and not regulation.
3. NOTION OF EXISTING EXPOSURE SITUATIONS

Existing exposure situations are exposures from sources that already exist when
decisions to control them are made. The corresponding source is generally natural,
such as cosmic radiation in aviation and space flights, NORM, or radon. The source
can also be artificial, such as contaminated sites from past activities and contami-
nated areas after a nuclear accident (ICRP, 2007).
An existing exposure situation may result from a planned exposure situation, as a
legacy site, when the exposure results from operations that were not conducted
within the relevant system of protection, or not to the standards considered accept-
able today. It can also result from an emergency exposure situation after the first
phases of the emergency, when the exposure situation is characterised and managed
on a long-term basis. However, neither a planned exposure situation (except on a
very long-term basis) nor an emergency exposure situation is expected to result from
an existing exposure situation (ICRP, 2007).
Existing exposure situations have a number of common features. Exposures often
affect places of living and day-to-day activities. They need to be measured in order
to characterise the exposure situation. Levels of exposure are highly dependent
on individual behaviours. Exposure situations are generally characterised by a
wide spread of individual dose distribution. They do not present a potential for
accident. In many cases, the exposure can be at least partially controlled by exposed
individuals themselves (self-help protection). Many stakeholders are generally
involved to control the situation. However, a lack of radiological protection culture
is often present, which creates difficulties in working with those stakeholders.
The situation may be controversial or sensitive; as such, radiological protection
in this area is closely connected to social, economic, political, or ethical factors,
among others.
Time is also a key factor for each type of exposure situation. While protective
actions can be implemented at any time and are effective immediately in planned
exposure situations, they must be implemented urgently and in a timely manner in
emergency exposure situations to order to be efficient. In existing exposure situations,
protective measures can only be implemented after characterisation of the exposure
situation, and it generally takes time to progressively reduce or maintain exposures in
57
accordance with the ALARA principle. However, regardless of the type of exposure
situation, protective actions can be envisaged and prepared (i.e. planned) in advance.
4. CATEGORIES OF EXPOSURES
Existing exposure situations can lead to public or occupational exposure. One of
the crucial points with existing exposure situations is to determine when workers can
be considered as occupationally exposed. Due to the ubiquity of radiation and to
avoid the need to subject all workers to a regime of radiological protection, the
Commission limits its use of the term ‘occupational exposure’ to radiation exposures
incurred at work as a result of situations that can reasonably be regarded as being the
responsibility of the operating management (ICRP, 2007). In existing exposure situ-
ations, many workers are exposed adventitiously at work and can be managed using
the Commission’s recommendations for members of the public. However, the
employer has primary responsibility for the protection of workers (see ICRP,
2007, Para. 179) and the management of exposures. Once an exposure has been
identified, careful management is needed.
Application of the definition of occupational exposure is a delicate issue for existing
exposure situations because the definition of the Commission has been developed
having in mind the planned exposure situations. The statement that situations ‘can
reasonably be regarded as being the responsibility of the operating management’ may
not be useful as the source is not deliberately introduced or operated, and not neces-
sarily used for its radioactive properties. In many existing exposure situations, the
operating management does not have real responsibility for the source, and has partial
responsibility only for the pathways and exposure of the workers.
In existing exposure situations, there is little potential for high doses, and classi-
fication of areas is often difficult to determine. Thus, the key elements to deal with
exposure at work are the general responsibility of the employer to protect the health
of the workers, the management of the workplace rather than the workers individu-
ally (i.e. like for other risks when workers are not classified as exposed workers), the
resulting level of exposure of the workers, and individual dose distribution.
Many existing exposure situations lead to environmental exposure and may chal-
lenge the protection of the environment. Although the set of dedicated reports
developed by Committee 5 may be applicable, particularly Publication 124 (ICRP,
2014a), no specific recommendations have been set in the reports devoted to existing
5. PRINCIPLES OF PROTECTION
The ICRP system is based on three principles of radiological protection, and the
first two principles are source-related. According to the principle of justiEcation, any
decision that alters the radiation exposure situation should do more good than harm.
The principle of optimisation of protection means that all exposures should be kept
ALARA, taking into account economic and societal factors, with restrictions on
58
individual exposure to limit inequities in dose distribution. The third principle is

individual-related. This is the application of dose limits, which means that the
total dose to any individual from regulated sources in planned exposure situations,
other than medical exposure of patients, should not exceed the appropriate dose
limits recommended by the Commission. Only the justification and optimisation
principles apply to existing exposure situations. However, source-related dose restric-
tions set for implementation of the optimisation principle serve to frame the expos-
ures carefully in a given exposure situation.
In an existing exposure situation, as the source is not introduced deliberately,
application of the justification principle is mainly focussed on control of the situ-
ation. The corresponding actions can be taken on the source (whenever possible), on
the pathways (mainly), and on individuals (in a few cases). The characterisation of
the situation is a prerequisite. Such characterisation is key in determining who is
exposed; where, when, and how they were exposed; and the feature of the individual
dose distribution.
The principle of optimisation of protection, associated with dose restriction (or
criteria), is the key principle. Experience shows that application of this principle is
the most powerful way to reduce doses, regardless of the exposure situation. It
should be implemented including both prevention (i.e. avoid any unnecessary expos-
ure) and mitigation (i.e. reduce existing exposures ALARA). As illustrated in Fig. 2,
the process of optimisation moves the dose distribution towards lower levels of dose,
and reduces (ideally to zero) the number of individuals receiving an exposure greater
Fig. 2. Optimisation of protection, showing the movement of dose distribution towards lower
levels of exposure, with a focus on doses that may exceed a specified individual dose criterion.
59
than the selected dose restriction. This is a gradual process, as illustrated in Fig. 3.
More information about dose restriction in an existing exposure situation is given in
Chapter 6 below.
The optimisation process should be implemented with prevailing circumstances
taken into account. Compared with planned exposure situations, existing exposure
situations have some specificity. All parameters cannot be anticipated with the same
precision. The status of the source, the classification of areas, the range of exposures,
and the distinction between public and occupational exposures often have to be
Fig. 3. Evolution of the distribution of individual doses with time as a result of the optimisa-
tion process.
60
determined and framed on a case-by-case basis. The people concerned, including those
with responsibilities to address the exposure situation, are not always fully trained and
prepared. The optimisation process should be adapted to these specificities and based
on a graded approach, focussing actions on exposures that are the most significant,
and moving the dose distribution towards lower levels of exposure. This approach is
generally more qualitative and less quantitative than in planned exposure situations.
The way to fulfil with the values of prudence and reasonableness needs more pragma-
tism, which does not mean that the control of exposure is less efficient.
Relevant stakeholder involvement is important to consider the concerns and
expectations of these people more effectively. The process of quantification and
comparison of protective actions should be adapted (e.g. by proposing several
options to stakeholders within an in-depth dialogue before selecting the best
option). In a context where exposures may affect day-to-day activities, the involve-
ment of stakeholders is a way to increase understanding, maintain vigilance, and
promote autonomy and accountability of the people concerned.
In some existing exposure situations, protective actions implemented by exposed
individuals themselves with the support of radiological protection professionals
should be considered, as well as protective actions implemented by authorities.
This is called the ‘co-expertise process’. The objective of the co-expertise process is
to raise awareness among exposed individuals, and to develop their knowledge and
skills step by step (i.e. practical radiological protection culture) in order to allow
them to make informed decisions and behave wisely (self-help protection). It is a
matter of dignity and autonomy.
6. DOSE CRITERIA
The dose criteria (or restriction) in an existing exposure situation is called the
‘reference level’; this is defined as the level of individual dose above which it is judged
to be inappropriate to allow exposures to occur, and below which the goal is to
reduce all doses ALARA (ICRP, 2007).
According to Publication 103 (ICRP, 2007), reference levels for existing exposure
situations should be set typically in the 1–20-mSv range of projected dose. The first
step is to characterise the relevant exposure situation in terms of the nature of the
exposure, the benefits from the exposure situation to individuals and society, and the
practicability of reducing or preventing exposures (ICRP, 2007). Past experience with
the management of similar situations is another factor to take into account (ICRP,
2007). If the situation allows, a reference level below the recommended band could
be selected, if such a selection provides the most appropriate boundary for identify-
ing cases of individual exposure that warrant increased attention, and to best guide
the optimisation process.
Although an existing exposure situation could lead to both public and occupa-
tional exposures, the Commission does not suggest the selection of a reference level
for each category of exposure. In several situations, it is impossible or inappropriate
to select different reference levels. However, Publication 103 (ICRP, 2007) states that
61
Table 1. Reference levels for existing exposure situations adopted or proposed to date.
Occupational
Exposure situations exposure Public exposure
Cosmic radiation 5–10 mSv y1 5–10 mSv y1

Radon 10 mSv y1 10 mSv y1
NORM 20 mSv y1* 1–10 mSv y1*
Contaminated sites Not yet defined Not yet defined
Contaminated areas 20 mSv y1* Lower part of 1–20 mSv y1*
Long term ¼ 1 mSv y1*
NORM, naturally occurring radioactive material.
*Not yet approved by Committee 4.
in most existing exposure situations, there is a desire from the exposed individual, as
well as from the authorities, to reduce exposures to levels that are close to or similar
to situations considered as ‘normal’. This applies particularly in situations of expos-
ure from material resulting from human actions (e.g. NORM residues and contam-
ination from accidents).
Table 1 shows the reference levels adopted or proposed to date for various existing
exposure situations. The reference level can be changed during implementation of the
optimisation process in order to continually stimulate the general improvement of
radiological protection.
7. REQUISITES
The basic requisites that apply to all exposure situations and categories of expos-
ure are the provision of information on the exposure situation, and the assessment of
corresponding exposures. These basic requisites are applied differently depending on
the exposure situation and the category of exposure. In Publication 103 (ICRP,
2007), several requisites are mentioned, such as informed consent, education and
training, collective and individual dose monitoring, recording of exposure, special
health surveillance, and classification of areas.
Most of the requisites in the current system of protection were developed in order
to protect workers inside classified areas, members of the public outside classified
areas, and patients exposed to radiation (i.e. in planned exposure situations). They
can be used in existing exposure situations, although in a specific way.
More thoughts have been carried out, however, on the issue of requistes in exist-
ing exposure situations. The reports dedicated to various types of existing exposure
situation have reflected on this issue. Those emerging are the need to characterise
the exposure situation, including assessment of the exposures prospectively (if pos-
sible) and retrospectively; provision of information in a clear and transparent
manner; accountability for safety; and involvement of the relevant stakeholders.
Accountability for protection of the environment should be added in many existing
62
exposure situations. In situations such as living in a contaminated area, the provision

of means to exposed individuals to assess themselves and reduce their dose, as well as
the development of a radiological protection culture, are mentioned in Publication
103 (ICRP, 2007).
The issue of requisites should also be based on current reflections on the ethical
values of the system of radiological protection. For example, information is closely
linked to the question of the right to know, and stakeholder involvement in the
dignity and autonomy of individuals.
For regulatory convenience, however, the national authority may decide to
manage an existing exposure situation in a manner similar to that for a planned
exposure situation when the situation has been well characterised, and it is possible
to use the types of controls that are usually associated with planned exposure
situations.
8. CONCLUSIONS
Through a new series of reports dedicated to existing exposure situations, ICRP is
moving towards recommendations using a coherent, graded approach based on
assessment of the exposure and prevailing circumstances, justification for action,
and optimisation of protection using individual dose criteria to reduce inequities
in exposure, focus actions on exposures that are the most significant, and move
the dose distribution towards lower levels of exposure.
Some issues still need further reflection, such as a way to address the protection of
the environment in the prevailing circumstances or the basis for radiological risk
tolerability in a more appropriate way than the model developed in Publication 60
(ICRP, 1991).
REFERENCES
ICRP, 1977. Recommendations of the International Commission on Radiological Protection.
ICRP, 2009a. Application of the Commission’s recommendations for the protection of people
in emergency exposure situations. ICRP Publication 109. Ann. ICRP 39(1).
ICRP, 2009b. Application of the Commission’s recommendations to the protection of people
ICRP, 2014a. Protection of the environment under different exposure situations. ICRP
ICRP 43(3).
ICRP, 2016. Radiological protection from cosmic radiation in aviation. ICRP Publication
132. Ann. ICRP 45(1).
63
Cosmic radiation in aviation: radiological
protection of Air France aircraft crew
G. Desmaris
Air France, Occupational Health Service IO.ZM, 45 rue de Paris, F 93747 Roissy Charles de
Gaulle Cedex, France; e-mail: desmaris.g@orange.fr
Abstract–Cosmic radiation in aviation has been a concern since the 1960s, and measurements
have been taken for several decades by Air France. Results show that aircraft crew generally
receive 3–4 mSv y 1 for 750 boarding hours. Compliance with the trigger level of 6 mSv y 1 is
achieved by route selection. Work schedules can be developed for pregnant pilots to enable the
dose to the fetus to be kept below 1 mSv. Crew members are informed of their exposition and
the potential health impact. The upcoming International Commission on Radiological
Protection (ICRP) report on cosmic radiation in aviation will provide an updated guidance.
A graded approach proportionate with the time of exposure is recommended to implement the
optimisation principle. The objective is to keep exposures of the most exposed aircraft mem-
bers to reasonable levels. ICRP also recommends that information about cosmic radiation be
disseminated, and that awareness about cosmic radiation be raised in order to favour
informed decision-making by all concerned stakeholders.
Keywords: Cosmic rays; Air crew; Radiological protection
1. HISTORICAL ACCOUNT
1.1. Discovery of cosmic rays
In 1911–1912, Victor Hess measured radiation at altitudes up to 5 km, and found
that the level increased considerably with altitude. In 1913, Werner Kolhorster con-
firmed the outer space origin of radiation, which Andrews Millikan named ‘cosmic
rays’ in 1925. In 1930, Pierre Auger described giant air showers generated by the
original high-energy particles colliding with air molecules of the earth’s atmosphere.
Protection.
64
This natural ionising radiation became a concern for the race to space in the 1960s. It
is said that Colonel David Simons was worried when he saw the hairs on the back of
his hands turning white after his stratospheric balloon flight. Previously, he had sent
mice and guinea pigs into the upper atmosphere in balloon gondolas to determine the
hazards of primary cosmic radiation (Project Manhigh, Holloman Air Force Base).
1.2. Measurement of cosmic rays

Following the measurement of cosmic rays using satellites (Pionneer, Explorer,
and Elektron), the first measurements at civil aviation flight levels were taken in 1969
on board the supersonic prototype Concorde. Subsequently, measurements were
taken in 1976 during commercial flights operated by Air France and British
Airways. Measurements on board subsonic aircrafts such as Boeing 747 were
taken for comparison. Since 1990, extensive campaigns have been undertaken by
several airlines (Lavernhe et al., 1978; Montagne et al., 1993; Bottollier-Depois,
1997). Dose-rate recordings range between 12 and 15 mSv h 1 on supersonic aircraft,
4 and 6 mSv h 1 on long-haul subsonic jet aircraft, and 1 and 3 mSv h 1 on short-haul
subsonic jet aircraft. Most crew members with approximately 750 boarding hours are
expected to receive exposures in excess of 1 mSv y 1.
1.3. Regulation changeover

In the 1990 Recommendations of the International Commission on Radiological
Protection (ICRP), crew members were recognised as ‘occupationally exposed work-
ers’ (ICRP, 1991). This recommendation became a requirement in the European
Council Directive 96/29 Euratom adopted in 1996 (EC, 1996). According to this
directive, which became effective in France in 2000, companies need to take appro-
priate measures to assess the exposure of the concerned air crew, to inform them
about the potential health risks, to reduce doses to the most highly exposed crew
members, and to maintain the exposure of pregnant crew members to less than 1 mSv
during pregnancy.
2. FRENCH SIEVERT SYSTEM

French authorities opted for an operational and automatic system: the SIEVERT
project, an acronym for ‘Système d’Information et d’Evaluation par Vol de
l’Exposition au Rayonnement cosmique dans les Transports aériens’ (i.e. a compu-
terised system for flight assessment of exposure to cosmic radiation in air transport).
It was developed by the Institute for Radiation Protection and Nuclear Safety
(IRSN) on behalf of the French Directorate General for Civil Aviation and several
partners: the Paris-Meudon Observatory, the Institute for Polar Research with its
ground neutron monitors located at the South Pole, and Air France (the main pro-
fessional user). This system was possible because of the uniformity of the radiation
field into the cabin, and the known composition of that field at different altitudes.
The irradiation is of whole-body type.
65
Air space at the heart of SIEVERT is divided into 265,000 cells, each of which is
assigned an effective dose rate. The first model used was CARI 6, followed by
EPCARD3 based on the FLUKA transport code in 2004. These models assess the
intensity of the galactic component that is permanent but modulated by solar activity
over the course of approximately 11-y solar cycles. IRSN validates the maps each
month based on accurate solar activity.
The dose received during a flight is calculated based on the time spent by the
public in each cell. The more detailed the information on the route, the greater the
accuracy of the estimated dose. When the exact route is not known, a standard route
is used in the same way as the assessment of dose to the general public on
SIEVERT’s website (http://www.sievert-system.org).
Every month, approximately 26,000 Air France flights with navigation data are
processed, and the exposures of 19,000 crew members are calculated. Addition of the
doses received during the flights by each crew member enables the estimation of
monthly or annual individual exposures of all crew members.
In the case of a solar proton event (SPE) classified as a ground level enhance-
ment event (GLE), dose rates at flight altitudes can increase, leading to an add-
itional dose that needs to be included in crew dose records according to French
requirements. The semi-empirical model SiGLE of the Paris-Meudon Observatory
enables estimation of these extra doses (Lantos and Fuller, 2003; Lantos et al.,
2003).
A pioneering aspect of the SIEVERT system lies in the fact that it considers both
galactic cosmic radiation and SPEs.
3. AIR FRANCE APPROACH

3.1. Highly exposed crews
Company physicians inform each crew member of their annual effective dose
when they visit the occupational health service (OHS) for their mandatory annual
examination. This transfer of information is also an opportunity to engage in a
dialogue on the topic of cosmic radiation and its potential health effects.
The OHS cannot meet each crew member every month, so a screening system has
been developed to identify the top 50 exposed crew members each month, and the
top 100 exposed crew members over the last 8 months. To optimise protection, Air
France set a reference level of 6 mSv over 12 rolling months. Using a trigger level at
4 mSv, the duty rota of a crew member can be modified if necessary.
It should be noted that despite the high altitude (15–18 km), the crew members of
Concorde were never among the group of highly exposed workers because of the
short flight duration (Paris to New York only took 3.5 h) and the limitation of 300
boarding hours y 1.
Data collected over the first 7 y showed that the average dose of the top 100
exposed crew members presented an ascendant trend. A few individuals stood out,
and they appeared to have accumulated more than 750 boarding hours and worked
on numerous near-polar flights.
66
4
mSv
0
2001 2002 2003 2004 2005 2006
1st Average 100 th
Fig. 1. Highest exposed flight deck crews during the 2001–2006 period.
4
mSv
0
2001 2002 2003 2004 2005 2006
1st Average 100 th
Fig. 2. Highest exposed cabin crews during the 2001–2006 period.
As crew members are paid according to the hours they fly, they may be reluctant
to reduce their flying time. At present, there is no shielding from neutrons or the
artificial electromagnetic field from charged particles on aircraft, and the only way to
reduce the dose is to rely on ‘natural’ protection [i.e. the earth’s magnetic field (lati-
tude) and the earth’s atmosphere (altitude)]. The intensity of the radiation field
increases with altitude, doubling every 1500 m. At the altitudes flown by commercial
jet aircrafts, galactic cosmic radiation is three to five times less intense near the
equator than in polar regions. However, it is difficult to change routes (altitude
67
6
5.5
5.5
5.07 5.09
5 4.91
4.89
Dose (mSv)
4.96 5.07 5 4.68

4.87 4.41 4.48
4.5 4.39 4.77
4.06 4.45
4.25 3.93
4 3.78 3.74
3.99 4.06
3.91
3.5 3.33 3.87
3.43 3.48
3.15
3
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
Fig. 3. Highest effective dose by year. Black line, pilots; grey line, cabin crew.
Fig. 4. Dose distribution for flight deck crew in 2007.
and latitude) because this conflicts with the routes selected to save fuel. Given this
constraint, the OHS and the radiation protection officer strove to make highly
exposed crews aware of cosmic rays so that they would agree to change their favour-
ite stopovers. This approach was successful, and no crew members have exceeded a
dose of 5 mSv y 1 since 2012 (more than 20 crew members exceeded this dose before
the approach was implemented).
The distribution of individual effective doses (Figs. 3 and 4) shows that the peak
corresponding to long-haul flights is centred on 3 mSv y 1. The shape of the graphs
shows that there is potential to reduce the highest doses; in other words, the
68
collective dose can be shared more equitably. This is possible if transequatorial and
near-polar flights are shared equally between all crew members. This type of policy is
easier to implement in major airline companies operating worldwide flights.
The peak for mid-haul flights is centred on 1.5 mSv y 1. The annual average
effective dose taking into account all mid- and long-haul flights is steadily around
2 mSv y 1 (Figs. 5 and 6). It is thus unlikely that a crew member could accumulate an
effective dose in excess of 100 mSv over a 40-y career.
Fig. 5. Dose distribution of cabin crew in 2007.
2.5
2.14 2.2 2.21
2.09 2.03
2
1.92 1.86
2 1.8 1.78
1.5
Dose (mSv)
0.5
0
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
Fig. 6. Annual average exposure (mSv) of flight deck crew working on mid- and long-haul
flights from 2005 to 2014.
69
2.5 2.3
2.12 2.2 2.19 2.13
2.04 2.03 2
1.86 1.82
2
Dose (mSv)
1.5
0.5
0
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
Fig. 7. Annual average exposure (mSv) of cabin crew working on mid- and long-haul flights
from 2005 to 2014.
3.2. Pregnant crew members

The commercial aircraft environment is not considered to be hazardous for
normal gestation, and there is no evidence that long exposure in commercial aircraft
causes significant pregnancy-related problems. Thus, according to aeronautic
European rules, since 7 January 2005, pregnant pilots have been allowed to fly
during the first two trimesters of their pregnancy if they agree and if they are fit to
do so (i.e. after a strict medical and obstetric evaluation).
As far as the fetus is concerned, the policy is to follow the French regulation based
on ICRP recommendations: ‘The working conditions of a pregnant worker, after
declaration of pregnancy, should be such to ensure that the additional dose to the
fetus would not exceed about 1 mSv during the remainder of the pregnancy’ (ICRP,
2000; French Labour Code).
Information provided by the OHS encourages female pilots to declare their preg-
nancy as soon as possible. The monthly medical examination is the opportunity to
discuss a flight schedule that is less intense than usual. Considering 5 mSv h 1 on a
long-haul flight, 1 mSv is equivalent to 200 flying hours. Work schedules can be
developed for pregnant pilots to enable the dose to the fetus to be kept below
1 mSv. For example, six pregnant pilots were allowed to fly in 2010, and the expos-
ures recorded were between 0.1 and 0.5 mSv.
4. DEVELOPMENT OF THE RADIOLOGICAL PROTECTION CULTURE

At the beginning, Air France had to convince the crew representatives and pro-
fessional unions about the validity of its choices in terms of radiological protection,
such as the assessment of exposure by calculation rather than using individual
dosimeters.
The OHS had to define and write the operating procedures for Air France man-
agement, and add a chapter to the health manual for crew members. All concerned
70
personnel were informed by means of flyers and articles on the company’s news
bulletin.
In order to improve the level of knowledge about natural radioactivity, particu-
larly cosmic rays, and the potential impacts on health, short videos were prepared.
An interactive e-learning programme with a quiz was developed recently. All 18,000
crew members employed by Air France take part in this programme every 3 y.
5. SOLAR FLARES
French regulations state that it is mandatory to take exceptional solar activity into
account. After a significant GLE, a specific map is created and validated.
Astrophysicists are asked to assess the impact on the ground and also at flight
levels. It takes approximately 3–4 weeks to complile the dose-rate maps.
In total, 16 GLEs were recorded during Solar Cycle 23 (1996–2008). No signifi-
cant radiation storms have been recorded to date in the current cycle (Solar Cycle
24). On 9 September 2015, the strongest solar flare since 2012 occurred, but this only
had a relatively light repercussion on the earth’s magnetic field.
Since 2000, four eruptions with GLEs have been studied closely for their ionising
effect at commercial flight altitudes. These occurred on 14 July 2000 (GLE59), 15
April 2001 (GLE60), 20 January 2005 (GLE69), and 13 December 2006 (GLE70).
The latter two have been taken into account by the SIEVERT system, which offi-
cially came into use in September 2001. They were of moderate magnitude (S3) with
a maximum peak flux of 0.1 mSv h 1 at 12,000 m. The intensity fell off rapidly. The
duration was relatively short (approximately 1–6 h). Only a few flights were affected
on routes between Europe, Japan, and North America.
Although the exposure due to a GLE appears to be high, it does not modify the
annual exposure of crew members significantly. However, addressing GLEs is
important in order to retain the trust of crew members.
In the future, radiation storms of greater magnitude may be observed, such as
the famous GLE05 on 23 February 1956 (estimated 10 mSv h 1 at an altitude of
12 km).
The case of Concorde was different because of lower protection at a supersonic
cruise altitude of approximately 18 km. Concorde had ionising radiation monitoring
equipment installed permanently in the flight deck. This equipment was mandatory
when flying above 15 km according to European aviation authority regulations
(JAR-OPS 1.680 cosmic radiation detection equipment).
On three occasions, Air France Concordes had to initiate an emergency descent
after a warning alert was triggered at 0.5 mSv h 1. This was the case on 9 January
1997, when an active dosimeter displayed 1 mSv h 1 at 16,000 m and 10 mSv h 1 at
17,600 m. Concorde descended to 16,000 m to continue the flight towards New
York. The total exposure during this flight was four times higher than usual. A
strong sun–earth connection event was observed at that time (SOHO/LASCO,
NASA).
71
6. IRSN–AIR FRANCE PARTNERSHIP FOR SPACEWEATHER RESEARCH

For the last 20 y, IRSN and Air France have established a strong partnership
that has led to the development of the SIEVERT system during the 2000s, and,
more recently, information on the Fukushima accident and its consequences for the
public. Beyond these actions, measurements on board are key elements of this
partnership.
6.1. Terrestrial c-ray flashes

In several recent papers, terrestrial g-ray flashes (TGFs) have been investigated as
a possible source of exposure of crew members. According to these papers, if an
aircraft is located in or near the high-field region during a lightning discharge, doses
could reach the order of 100 mSv. TGFs are directed from clouds to space (Briggs
et al., 2010; Dwyer et al., 2010).
In order to investigate this phenomenon, several long-haul aircraft of the Air
France fleet have been equipped with passive radiophotoluminescent dosimeters
that are able to record very high dose rate events below 1 ms. Data from 1928
radiophotoluminescent dosimeters used on board between 2009 and 2014 were
analysed by IRSN. No trace of a TGF was found. This does not mean that
TGFs do not exist, but indicates that they are quite rare. However, monitoring
of all transient events will continue in the coming years. It should be noted that air
safety procedures require pilots to fly round huge tropical clouds and not to climb
above them.
6.2. Ground level enhancement events

The models used for dosimetry are based on or compared with very few sets of
inflight measurements during GLEs. There is a clear need for additional data to
improve the existing models.
As such, IRSN and Air France have launched a joint programme to monitor the
effect of GLEs on dose rates at flight altitude along the new solar cycle. The objective
is to have at least two measurement devices flying at the same time on different
routes.
The approach lies in selecting small electronic dosimeters with high battery auton-
omy, g and neutron sensitivity and reliability, high data storage, and electromagnetic
compatibility with aircraft instrumentation. Since 2015, five Liulin spectrometers and
25 EPD-N2 have been available. It is therefore possible to cover the main long-haul
flight routes. As these types of dosimeters were not designed for cosmic radiation, a
specific calibration has been established by comparing data from electronic dosim-
eters with reference instrumentation (TEPEC) during long-haul flights (Trompier
et al., 2013).
The Geostationary Operational Environmental Satellite recorded a proton flare
on 7 January 2014, but Liulin monitoring on a Boeing 777 recorded no significant
increase in dose (Table 1).
72
Table 1. Dose comparison.

H*(10) (mSv) H*(10) (mSv)
Flight Date Measured (Liulin) Computed (SIEVERT)
Paris–Beijing 25–26 December 2013 48.6 48.6

Paris–Beijing 7–8 January 2014 49.6 50
7. CONCLUSIONS
The ICRP system of radiological protection is based on three fundamental prin-
ciples: justification, optimisation and dose limitation.
Aviation enables geographic barriers to be crossed and speeds up socio-economic
integration. In a sustainable development process, this human activity seems to be
justified. The Advisory Council for Aeronautical Research in Europe has launched
an ambitious programme to reduce emissions of NOx, CO2 and noise. The business
jet market also continues to grow. According to the International Civil Aviation
Organization, air traffic will double in 15 y.
Although the possibilities for controlling exposures in aircraft are limited, the
implementation of a protective strategy is feasible using a graded approach as
demonstrated by Air France. Individual exposures can be managed in the optimisa-
tion process using a reference level. The objective is to keep exposures of the most
exposed aircraft members to reasonable levels.
As recommended in the forthcoming ICRP report on protection against cosmic
radiation in aviation (ICRP, 2016), Air France is developing a programme to dis-
seminate information and to raise awareness about cosmic radiation among its per-
sonnel to favour informed decision-making by all concerned stakeholders.
ACKNOWLEDGEMENTS
Thanks to full cooperation with IRSN, Air France management and the respective profes-
sional representatives, significant progress having been made over the last decade. The authors
wish to thank Jean-François Bottollier-Depois, François Trompier, Isabelle Clairand, IRSN
Fontenay aux Roses, Nicolas Fuller, Paris Meudon Observatory, Franck Bonnote, Frédéric
Dollet, and Air France Roissy.
REFERENCES
Bottollier-Depois, J.F., 1997. Evaluation de l’exposition au rayonnement cosmique du per-
sonnel Navigant Air France. IPSN Report SDOS/97-01. Fontenay aux Roses.
Briggs, M.S., Fishman, G.J., Connaughton, V., et al., 2010. First results on terrestrial gamma
ray flashes from the Fermi Gamma-ray Burst Monitor. J. Geophys. Res. Space Phys. 115,
A07323.
Dwyer, J.R., Smith, D.M., Uman, M.A., et al., 2010. Estimation of fluence of high-energy
electron bursts produced by thunderclouds and resulting radiation doses received in air-
craft. J. Geophys. Res. 115, DO9206.
73
EC, 1996. Directive 96/29/EURATOM. Off. J. Eur. Commun. 39: L 159.

ICRP, 2000. Pregnancy and medical radiation. ICRP Publication 84. Ann. ICRP 30(1).
ICRP, 2016. Protection against cosmic radiation in aviation. ICRP Publication 132. Ann.
ICRP 45(1).
Lantos, P., Fuller, N., 2003. History of the solar particle event radiation doses on board
aeroplanes using semi-empirical model and Concorde measurements. Radiat. Prot.
Dosim. 104, 199–210.
Lantos, P., Fuller, N., Bottollier-Depois, J.F., 2003. Methods for estimating radiation doses
received by commercial aircrew. Aviat. Space Environ. Med. 74, 746–752.
Lavernhe, J., Lafontaine, E., Laplane, R., 1978. The Concorde and cosmic rays. Aviat. Space
Environ. Med. 49, 419–421.
Montagne, C., Donne, J.P., Pelcot, D., Nguyen, V.D., Bouisset, P., Kerlau, G., 1993. In-flight
radiation measurements aboard French airliners. Radiat. Prot. Dosim. 48, 79–83.
Trompier, F., Bonottte, F., Desmaris, G., Bottolier-Depois, J.F., 2013. Radiation Monitoring
of GLE On Board Commercial Flights. Tenth European Space Weather Week, 18–22
November 2013, Antwerp, Belgium.
74
Measuring, discussing, and living together:
lessons from 4 years in Suetsugi
R. Ando
Ethos in Fukushima, Fukushima, Japan;
e-mail: ethos.fukushima@gmail.com
Abstract–Cooperating with radiological protection experts and taking radiation measure-

ments, the residents of Suetsugi, Iwaki City, Fukushima have been striving to reshape their
lives since the accident at Fukushima Daiichi nuclear power plant. Suetsugi lies within 30 km
of the power plant, so the residents have had serious reservations about continuing their lives
there since the accident. Today, radiation remains a ‘line’ dividing their lives, with any dose
measurements directly affecting their daily decision making. Assisted by medical and scientific
specialists, the residents faced this challenging situation by measuring exposures individually
and then discussing the results among themselves. Since 2012, the residents of Suetsugi have
been using personal dosimeters, made village-wide trips for whole-body counter tests, and
measured food contamination throughout the village. The results have been shared openly
between the residents. Obtaining and discussing their own data were crucial to gain under-
standing of various results and to practice radiological protection in their daily routine. These
4 y of experience in Suetsugi demonstrate cooperation between various stakeholders, which
should be a lesson for the future.
Keywords: Suetsugi; Three lines; 30-km radius; 0.23 mSv h 1; ND
1. INTRODUCTION
As a resident of Iwaki, a seaside city in Fukushima, Japan, for 13 y, I will discuss
how the ‘lines’ set by the Japanese Government or by scientific measurements have
affected our lives since the accident at Fukushima Daiichi nuclear power plant. Since
Protection.
75
the Great East Japan Earthquake, tsunami, and nuclear plant accident in 2011, three
‘lines’ have emerged that have affected our lives and caused serious disruption. The
first is the geographical ‘line’. The Japanese Government used the radius from the
plant to designate evacuation zones. A 30-km radius ‘line’ became a border for local
residents. The second is the ‘line’ used for decontamination requirement (ambient
dose rate target of 0.23 mSv h 1). The Japanese Government explained that this
ambient dose rate corresponded to an effective dose of 1 mSv y 1. Thus, people
believe that staying in an area with 0.23 mSv h 1 would result in an additional
annual dose of 1 mSv. The third ‘line’ is related to food contamination, ‘not
detected’, or ‘ND.’ Unlike the first two ‘lines’, it was not set by any authority, but
it has been added to the list as people perceive ‘ND’ to be a de-facto ‘standard’.
2. ENFORCED RADIUS ZONE

In reality, numerous ‘lines’ are set by central and local government standards for
no-fly zones, water, school lunches, etc. The three ‘lines’ chosen in this article were
selected as they are believed to have had the most significant impact on the lives of
the local residents.
The first ‘line’ is the 30-km radius from the Fukushima Daiichi nuclear power
plant. At 14:46 on 11 March 2011, a huge earthquake and consequent tsunami
devastated the east coast of Japan. The 15-m-high tsunami disabled the power
supply and cooling of three reactors at Fukushima Daiichi, causing a nuclear acci-
dent. As the situation deteriorated, the Japanese Government ordered nearby resi-
dents to evacuate, and the evacuation zones were expanded with the progress of the
accident. Suetsugi, a district at the northern end of Iwaki City, lies within the 20–30-
km radius zone. On the morning of 13 March 2011, the Mayor of Iwaki City
requested that residents within the 30-km radius zone evacuate voluntarily, prior
to the request from the Government. Two days later, the Government requested all
residents within the 20–30-km radius zone to stay indoors.
The evacuation zones were rearranged by the Government on 22 April 2011. The
areas within the 20-km radius zone were designated as ‘restricted areas’. Although
the 20–30-km radius zone was considered as an ‘evacuation prepared area in case of
emergency’, the northern tip of Iwaki City was not included. However, people had
doubts about the safety of this area. There were many unanswered questions, such as
‘Is it safe to return?’ or ‘Why is this area different?’ My impression is that as the
Japanese Government did not provide information to reassure the residents, the
enforced radius ‘line’ remained in the residents’ minds and became a psychological
barrier.
3. AMBIENT DOSE RATE

The second ‘line’ is the ambient dose rate of 0.23 mSv h 1 and the annual radiation
dose of 1 mSv. In August 2012, the Ministry of Environment introduced these values
in the so-called ‘Act on Special Measures’. This aims to reduce the additional
76
exposure dose of 1 mSv y 1 as the ‘long-term goal’ of decontamination for intensive

contamination survey areas. Below, I will explain how the Ministry of Environment
determined 0.23 mSv h 1, using information from their website.
Of the natural radiation dose that existed prior to the accident, annual terrestrial
dose from the ground was 0.37 mSv y 1. This terrestrial dose, when divided by
24 h 365 days, yields 0.04 mSv h 1.
The Ministry assumed the hourly additional exposure dose to be 0.19 mSv h 1. This
dose corresponds to the annual target additional exposure dose of 1 mSv. To come up
with this figure, the Ministry assumed that an average person spent 8 h outdoors and
16 h indoors in a wooden house with a shielding effect of 0.4. It would take 0.19 mSv h 1
of additional dose for the person to reach the exposure level of 1 mSv y 1. The natural
radiation dose of 0.04 mSv h 1 and target dose of 0.19 mSv h 1 are added to obtain
0.23 mSv h 1. This is the ambient dose that is supposed to correspond to additional
exposure to 1 mSv, and hence the target for decontamination.
I believe that the decontamination standard sounds rather weak, based on arbi-
trary assumptions. However, the Ministry of Environment uses the value as the
standard for decontamination to this day. Initially, the purpose of 0.23 mSv h 1
was to set a standard for decontamination. In other words, the figure was not
intended to signify health risk (i.e. whether it was safe or dangerous to one’s
health). However, the residents took a different view.
Many people believed that any place with an ambient dose higher than
0.23 mSv h 1 that required decontamination must be ‘dangerous’. For example,
some decided not to return until the ambient dose rate around their homes was
less than 0.23 mSv h 1 due to health concerns. Others decided not to go near any
forests or hills where the ambient dose rate was higher. Many people started restrict-
ing their lives based on this figure. The 1 mSv of additional exposure became a
signifier of risk for many people. Any exposure greater than 1 mSv was viewed as
‘dangerous to health’. I lost count of how many times people told me, ‘If you have
been exposed to more than 1 mSv, you will develop cancer in the future, although the
Government says that there is no immediate effect’.
The decontamination standard formed a ‘line’ that had severe impacts on the living
space of the residents. The ‘line’ marked off a zone to be avoided. Without any orders
from the Government, people started limiting their actions and lifestyle choices. Many
people started avoiding places they used to visit daily, such as their fields. At the same
time, huge mistrust and complaints grew against the Government, which had forced this
inconvenience and seemed to be doing nothing to remedy the situation. I believe that
such mistrust and complaints still have a strong hold on the residents.
4. ‘LINE’ OF ‘NOT DETECTED’

The third ‘line’ that affected the lives of residents of Suetsugi is ‘ND’ or ‘not
detected’. Initially, ‘not detected’ simply meant the minimum threshold specification
in a measurement. However, it started to carry a different meaning. People started to
view ‘ND’ as ‘safe’. In my view, the root cause of this confusion is in the change
77
made to the standards of radionuclides in food after the accident. Immediately after
the accident, on 17 March 2011, the Ministry of Health, Labour and Welfare
(MHLW) issued a notice specifying provisional standard values for radiation
levels in food. In essence, it was designed to limit the annual maximum permissible
dose from radioactive caesium in foods at 5 mSv. It set the ‘provisional regulation
value’ of 200 Bq kg 1 for water and 500 Bq kg 1 for most other food products. There
was strong opposition to this standard, claiming that it allowed too much contam-
ination. The MHLW consequently issued ‘New Standard Limits for Radionuclides
in Foods’ on 1 April 2012, 1 y after the accident.
The new standard lowered the annual maximum permissible dose from radio-
active caesium in foods to 1 mSv, with a ‘standard limit’ for most food of
100 Bq kg 1. On the surface, the new standard lowered the limit, so it should have
satisfied people. However, many people became more confused and doubtful. The
opinion I have heard most often is, ‘The limit has become more strict in such a short
time. The first standard must have been wrong; they were labelling something dan-
gerous as safe’. Although there is less vocal discontent about the standards, the
change actually reinforced mistrust against the standards set by the Government.
As a result, the number of people who do not believe such standards seems to have
increased. Lowering the limit did not remove people’s concerns. Thus, people who
did not trust the standard limits set by the Government sought safety in ‘ND’,
whatever that meant.
5. EFFECT OF THE ‘LINES’ ON THE LIVES OF RESIDENTS

OF SUETSUGI
In addition to the three ‘lines’ discussed above, many ‘lines’ drawn after the
accident, including those enforced by government authorities, made our lives uncom-
fortable. These ‘lines’ were engraved in our minds and became internal norms. Thus,
we voluntarily restricted our activities, and became increasingly bound by these
‘lines’. We reached a point where we could not trust the standards for radiation
set by the Government. As a result, we started seeking the minimum, believing
that ‘the lower, the safer’. At the same time, in various situations in our daily
lives, we had to decide whether our choice was ‘safe or dangerous’. Before the
Fukushima Daiichi accident, we never had to think about whether a certain place
was safe, or if a particular herb was contaminated. Now, we had to pause, think, and
make a decision.
Below, I will explain the activities in Suetsugi district to resolve such situations.
Suetsugi is a small community of 118 households and 386 residents, as of April 2014.
It is approximately 27 km from the Fukushima Daiichi nuclear power plant.
Residents of Suetsugi were requested to evacuate on 12 March 2011, and the district
was subject to an evacuation order until 22 April 2011. Most residents experienced
evacuation at least once; some families moved multiple times to find a place to stay,
while other families had to split apart. As described above, little explanation was
given to the residents when the evacuation order was lifted. This is an important
78
point. Suetsugi lay within the 30-km radius, in an area that was deemed to be ‘high
risk’. However, the residents did not receive any information to prove that it was safe
to return and continue living in their homes.
Given this situation, some residents of Suetsugi started to act for themselves. They
measured the ambient dose rate and took soil samples in various places in Suetsugi to
measure the level of radiation and create a contamination status map. Between
Autumn 2011 and Spring 2012, they measured the entire district, gathering more
than 1000 soil samples. Suetsugi is the only district, I believe, that took measure-
ments to such an extent without any external organisational support. This effort built
a base among the residents of Suetsugi to remind them that the ‘line’ drawn using the
distance from Fukushima Daiichi did not matter. It was important to measure the
actual condition and make a judgement based on the measurement, rather than some
value given by the Government.
5.1. Measuring external exposure in Suetsugi

The next step was measuring external exposure. Fig. 1 shows the readings of indi-
vidual dosimeters of residents of Suetsugi. The red horizontal line represents the daily
dose rate corresponding to an additional exposure of 1 mSv y 1, and the green hori-
zontal line represents estimated background radiation prior to the accident.
Some residents started taking measurements on their own in July 2012, and
this has since become a community-wide initiative. Upon request, the district dis-
tributes ‘D-shuttle’ dosimeters (Chiyoda Technology Corp., Tokyo, Japan) to the
residents. Thirty dosimeters were available in April 2014, increasing to 100 dosim-
eters in February 2015. Fig. 1 gives an overall picture of the external exposure of all
residents, as well as an individual’s level in comparison with others in the group.
Also, one can pinpoint where and how the exceptional readings came from.
Fig. 1. Number of days vs accumulated dose per person in Suetsugi. Data measured with
D-shuttle dosimeters for 14 individuals.
79
Fig. 2 shows the distribution of estimated annual exposure of the residents of

Suetsugi. Dr Makoto Miyazaki of Fukushima Medical University, who has sup-
ported our efforts since the beginning, prepared both Figs. 1 and 2. The dotted
line in Fig. 2 shows the additional annual exposure to 1 mSv. Clearly, the exposure
of most residents falls below this line, with the highest number of residents receiving
exposure of 0.4–0.6 mSv y 1. This assured the residents of the exposure level as a
community.
5.2. Measuring food contamination

Since March 2015, the residents of Suetsugi have been able to measure food
contamination at their community centre. Each Tuesday, any resident can walk in
and have their sample measured.
Fig. 3 is based on findings from 3 March 2015. In cities, people buy food in
supermarkets, but in Suetsugi, people grow rice and vegetables. Home-grown vege-
tables and home-prepared pickles are their pride and joy. Before the accident, mush-
rooms and mountain herbs were delicacies to be cherished and shared. Thus,
measuring food to be sure of its safety has been essential for the residents to
Fig. 2. Distribution of annual external exposure in local residents.
80
regain their lifestyle. The opportunity for people to gather and talk freely has also
played a key role for exchanging and sharing information.
6. MEASURING RADIATION LEVELS IN COMMUNITIES

The Polimaster PM1406 (Polimaster Pacific, Tokyo, Japan) is used by the resi-
dents to measure food contamination. The focus of the PM1406 is to determine
whether the contamination of a sample is higher than 100 Bq kg 1. This level is
currently used as the standard limit for most food products in Japan. Thus, the
PM1406 is not convenient for measuring the exact Bq kg 1 value below 100.
When we measure food contamination in Suetsugi, the results are given as either
‘over standard’ or ‘below standard’. Before starting out, the relevant information for
measuring foodstuff was discussed. In my view, the ‘standard’ is the value that has
meaning in our society. In addition, we need to be realistic. This is food to be eaten at
home. Staple food such as rice is consumed in kilogrammes, but this is not true for
foods such as pickled plums. The residents are mainly interested in whether some-
thing is really ‘out of norm’ and should be given up. In any case, residents are
advised to visit the food measurement centre run by Iwaki City, which is approxi-
mately a 10-min drive away, to obtain more detailed results.
Ultimately, we cannot measure everything that comes into our bodies. Therefore,
in addition to measuring food contamination, it is important to confirm the total
amount of radioactive substance in our bodies from ingestion using the whole-body
counter (WBC) test. WBC tests have been conducted in Suetsugi since June 2013,
when 124 residents took the first test. After taking a WBC test, Dr Miyazaki
explained the results to the residents at the community centre. The results were the
same as those for other districts in Fukushima Prefecture. Most residents were ‘ND’
Fig. 3. Distribution of residents consuming local food since the accident at Fukushima
Daiichi nuclear power plant.
81
(i.e. below 300 Bq body 1, the detection limit for the WBC test). The residents com-
pleted a survey before the test. Fig. 3 shows the results from the survey, with the
question, ‘Have you been eating local foodstuff since the accident?’ Forty percent of
residents answered ‘Yes, I have eaten local food’, 32% answered ‘No, I have not
eaten local food’, and the rest (shown as ‘Blank’) did not give an answer.
When Dr Miyazaki explained Fig. 3 to the residents, this had a powerful impact.
As most residents had the same results for the WBC test, they could see that the
results were not affected by their response to the question. In other words, avoiding
local food did not affect the level of internal exposure. A resident told me that, before
the test results came back, she could not be confident about whether her eating habits
were safe. After the WBC test, she was able to start regaining confidence about her
cooking and eating style. Knowing the results for the entire Suetsugi community,
rather than just knowing your own result, was significant in rethinking one’s eating
habits and WBC results.
7. CONTINUED EFFORTS AFTER FUKUSHIMA

To summarise, by creating the contamination map, the residents started thinking
about risk based on actual data, rather than the 30-km radius ‘line’ that was drawn
automatically. Also, by measuring external exposure and getting a real estimate of
their actual exposure, they learned to be free of the spell of ‘0.23 mSv h 1’. What
mattered for the health of the community was the exposure level of people, not the
ambient dose rate of a certain place. Finally, by taking WBC tests and measuring
actual foodstuffs used for cooking, they began to rethink the meaning of ‘ND’.
Instead of having the mentality that ‘anything that is not ‘‘ND’’ is dangerous’,
people were able to use actual values to make a judgement.
With relation to the ‘lines’, our efforts can be described this way. First, the local
residents measure radiation in their living space as well as in their bodies, and discuss
their results and views. Measuring and discussing is the starting point to find a grip
on the ‘lines’ that have been imprinted on to our lives since the accident. In turn, the
people start to relativise these ‘lines’. In other words, the ‘lines’ are no longer invis-
ible, untouchable chains binding their lives. They become one of the many conven-
tions and rules in everyday life. Finally, by measuring and discussing, the residents
start to question the meaning of the ‘lines’; ‘Why they are necessary?’, ‘What benefit
do they bring to one‘s life?’, etc. Through this step, they restore confidence in stand-
ards as well as in the society in general that created these standards.
However, the situation has been simplified for the purpose of explanation. In
reality, the progress is not one way, and things are often murky. In essence, we
have been asking the meaning of the ‘lines’ that divided our lives through measuring
and discussing. ‘What is the meaning of this line to the way I live?’ is the question.
Sharing data within the community allowed us to ask the question not just for
ourselves, but for all of us together, and for our society.
Finally, I would like to highlight a problem. Some ‘lines’ cannot be resolved by the
‘measure and discuss’ approach. These are related to the Government’s actions.
82
Specifically, the ‘lines’ related to evacuation and compensation cannot be resolved by

independent measurement by the residents, because the measured results are not used
as the basis for administrative actions. Another problem is that the ‘measure and
discuss’ approach has been effective for the members of the community in Suetsugi,
but has limits in affecting the thinking of people outside the community. For exam-
ple, even if we explain the results of our measurements to someone in Tokyo, Japan
who believes that ‘Suetsugi is not safe to live because it is in the 30-km zone’, we may
not be able to change their mind. Our efforts to change ‘lines’ by measuring and
discussing do not necessarily work outside the community.
8. CONCLUSIONS: LESSONS LEARNED

What are the lessons learned from these ‘lines’? Each time when a ‘line’ is drawn, it
has huge impacts on people’s lives. A ‘line’ has the power to tear apart someone’s life
or the fabric of a community. However, the Japanese Government believes that it is
its mission to draw ‘lines’ by its orders and standards. Often, the Government does
not consider the full extent of the social impact and the effect on individual lives. I
have worked with the people of Suetsugi for 4 y since the accident at Fukushima
Daiichi nuclear power plant, and I feel that I have been cleaning up the problems
created by the ‘lines’ that were drawn, without much thought, by the Government,
rather than the direct effects of the accident.
I hope that no one feels this way in the future. To that end, I urge people in
responsible positions to think about the ‘lines’ before any similar accident happens
again. I would like them to think about the necessary and appropriate ‘lines’ drawn
in society, and how to draw a ‘line’ that will minimise the negative impact on people’s
lives.
Once there is an accident, governments have to draw ‘lines’ based on ‘standards’
for radiological protection. However, these ‘lines’ directly affect people s lives. ‘Lines’
are no longer just science, and they are social; ‘lines’ affect people’s livelihood and
dignity. Stakeholders have the final word of whether or not a line is appropriate.
Thus, stakeholder involvement is essential to draw ‘appropriate lines’.
83
Contaminated sites from the past: experience
of the US Environmental Protection Agency
M.A. Boyd
Radiation Protection Division, Office of Radiation and Indoor Air, US Environmental
Protection Agency, 1200 Pennsylvania Ave. NW (M/C 6608T), Washington, DC 20460,
USA; e-mail: boyd.mike@epa.gov
Abstract–The purpose of this paper is to provide an overview of the experience of the US

Environmental Protection Agency (EPA) in cleaning up radioactively contaminated sites. In
the USA, EPA regulates the radiological clean-up of uranium mill tailings sites, some
Department of Energy legacy sites within the US nuclear weapons complex, and Superfund
National Priorities List sites. The approach to site remediation decisions, including the deter-
mination of clean-up levels, varies according to the enabling legislation granting EPA these
authorities. Past practices that gave rise to many of the existing exposure situations at legacy
sites were permissible before the advent of environmental clean-up legislation. The Uranium
Mill Tailings Radiation Control Act of 1978 authorised EPA to set applicable radioactivity
concentration standards for soil clean-up at inactive uranium mill sites and vicinity properties.
For the other categories of sites mentioned above, remediation goals are typically based on not
exceeding a target excess cancer risk range established under the Comprehensive
Environmental Response, Compensation, and Liability Act (also known as ‘Superfund’).
EPA’s regulations for cleaning up various contaminated sites in existing exposure situations
often result in residual doses that are typical of optimised doses in planned exposure situa-
tions. Although the clean-up levels selected may differ from those adopted in other countries,
recommendations from the International Commission on Radiological Protection are
reflected in the exposure assessment methodologies used in their establishment.
Keywords: Legacy sites; Radioactive contamination; Uranium Mill Tailings Radiation

Control Act of 1978; Superfund
Protection. The views and thoughts in this paper are the author’s personal opinions, and are not intended
to represent those of the US Environmental Protection Agency.
84
1. RADIOACTIVELY CONTAMINATED SITES IN THE USA

The types of radioactively contaminated sites in the USA can be categorised
chronologically to some extent. The oldest sites are those where naturally occurring
radioactive material (NORM) was present before the existence of radioactivity was
discovered. Even today, these areas of elevated natural background radiation are
seldom subject to remediation, except where programmes exist to test for indoor
radon, and fix houses found to have high concentrations of radon decay products.
Other than these undisturbed NORM sites, some of the oldest contaminated sites in
the USA arose from processing radium following its discovery. Radium contamin-
ation resulted not only from careless practices that were designed to extract radium,
but also from the mining of vanadium and other rare earth elements which left high
concentrations of radium behind as a mining byproduct.
The discovery of nuclear fission and the development of nuclear weapons as well
as nuclear power gave rise to contaminated sites dating from the mid-20th Century.
This era produced sites associated with the exploration, mining, and milling of uran-
ium and thorium ore; the building and testing of nuclear weapons; and the improper
disposal or release of radioactive waste containing fission products, activation prod-
ucts, and transuranic isotopes. Additional sources of contaminated sites arose from
medical, industrial, research, and other uses of radioactive material during the time
when disposal often simply meant burial on site without regard for groundwater
contamination or off-site migration. These various types of contaminated sites, and
the experience of the Environmental Protection Agency (EPA) in the assessment and
remediation of these sites are discussed in the following Sections.
1.1. Radium sites

Following the discovery of radium in 1898, scientists and amateur enthusi-
asts became fascinated with its properties, including radioluminescence which
caused watch dials to glow in the dark. In the USA, many small companies began
producing a variety of products containing radium salts. In addition to the well-
known radium dial industry, some companies produced health and beauty prod-
ucts that claimed almost magical benefits from ingestion or topical application of
radium compounds. For every legitimate use of radium, there were many others that
would prove its uselessness, and often found it to be life threatening. As the evidence
for the harmful effects of radiation became better understood, many of these com-
panies either went out of business or ceased the manufacturing of radioactive
products.
Other legacy radium sites resulted from the mining of rare earth elements such as
vanadium. The extraction processes for these commercially valuable non-radioactive
minerals sometimes left behind high concentrations of radium as a mining bypro-
duct. The fate of these contaminated properties depended on whether or not actions
were taken at the time to document the presence of radium and clean it up. Even
when attempts were made to clean up the radium, residual concentrations were often
left behind which were later found to be unacceptably high by today’s standards.
In some cases, sites were remediated several times over the course of decades.
85
Today, radium sites in the USA are often cleaned up under EPA’s Superfund
Program, as described in Section 2.2.
1.2. Sites contaminated from atomic energy and weapons development programmes
Many of the contaminated legacy sites in the USA are associated with the devel-
opment of nuclear weapons and commercial atomic energy dating from the 1950s.
The Manhattan Engineer District (MED) and the Atomic Energy Commission
(AEC) promoted research and development activities in these areas, many of
which were highly classified at the time. Uranium exploration and mining became
a priority as the need for sources of fissile uranium-235 increased. In addition to
uranium, there was also some interest in mining for thorium-232 to supply the thor-
ium fuel cycle. Although the thorium fuel cycle has its proponents, uranium-235 is
still the principal fissile radionuclide used in commercial nuclear fuel in the USA. As
a result, uranium-contaminated sites represent the largest share of contaminated
legacy sites in the USA.
When EPA was formed in 1970, the authority for setting standards for radio-
activity in the general environment was transferred from AEC to EPA. In 1974, AEC
was abolished, and its authority to regulate the uranium fuel cycle and the possession
of radioactive material was transferred to the US Nuclear Regulatory Commission.
Many of AEC’s remaining functions were transferred to the Energy Research and
Development Administration, which later became part of the US Department of
Energy (DOE). DOE has responsibility for managing most of the legacy sites from
the AEC and MED era. Following clean-up, many sites will require long-term insti-
tutional controls and ongoing site management activities. Some sites have been
remediated completely, but in 2001, DOE listed 129 contaminated sites that require
long-term stewardship (Wells and Spitz, 2003).
In 1974, the Formerly Utilized Sites Remedial Action Program (FUSRAP) started
to address sites with contamination resulting from US atomic energy and nuclear
weapons programmes from the 1940s to 1960s. These sites were contaminated with
low levels of uranium, thorium and radium, and their respective decay products.
The clean-up responsibility for the FUSRAP sites was transferred from DOE to the
US Army Corps of Engineering in 1998. These sites are being cleaned up using the
Comprehensive Environmental Response, Compensation, and Liability Act
(CERCLA) process described in Section 2.2. Following clean-up, FUSRAP sites
were transferred to DOE’s Legacy Management Program.
1.3. Legacy uranium milling sites

After uranium ore is mined, the next step in the fuel cycle involves extracting the
uranium from the ore. According to EPA (1982), between 1948 and 1978, approxi-
mately 145 million metric tons of ore were processed to recover about 150 metric
tons of yellowcake (U3O8). The quantity of mill tailings left behind after processing
was essentially unchanged from the original quantity of ore. A typical inactive mill
tailings site from 1978 included a tailings pile covering approximately 20 hectares.
The mill tailings piles consisted of sandy material that was deposited in slurries,
86
and contained the residual radioactivity from the uranium ore and other hazardous
constituents (EPA, 1982).
Since 1978, DOE has managed the remediation of 22 designated inactive uranium
mill tailings sites. To date, this has resulted in the creation of 19 disposal cells that
contain encapsulated uranium mill tailings and related contaminated material. Over
30 million cubic metres of radioactively contaminated mill tailings are now disposed
into these engineered disposal cells (DOE, 2015).
2. US LAWS FOR MANAGING CONTAMINATED SITES

2.1. Uranium Mill Tailings Radiation Control Act
By 1978, the US Congress recognised that the mill tailings from both inactive and
operating uranium mill tailings sites posed a hazard to the public from residual
radioactivity and other toxic constituents present in the tailings. The Uranium
Mill Tailings Radiation Control Act (UMTRCA) of 1978 was passed to address
clean-up of these sites (UMTRCA, 1978). UMTRCA gave EPA the authority to
set standards for the management of the tailings piles, and for the clean-up of
contaminated land and buildings.
For contaminated land, EPA set a general clean-up standard for radium-226 of
185 Bq kg 1 in the top 15 cm of soil and 555 Bq kg 1 below 15 cm. EPA provided
additional standards that require radon-222 emanation from tailings piles to remain
below 0.74 Bq m 2 s 1 (EPA, 1983).
2.2. Comprehensive Environmental Response, Compensation, and Liability Act

CERCLA was passed in 1980 to address the problem of abandoned or poorly
controlled sites containing hazardous waste, including radioactivity (CERCLA,
1980). It also provides for the management of accidental spills and other emergency
releases of pollutants into the environment. CERCLA is commonly referred to as the
‘Superfund Program’, in part because it provides a mechanism for covering the cost
for cleaning up a site. The basic principle of the Superfund Program is that those
responsible for contaminating a site should pay for its remediation. The Superfund
funding mechanism allows the achievement of stringent risk reduction goals.
Except for uranium mill tailings sites, most EPA radiation site clean-ups are
performed using the process described in the National Contingency Plan, which is
the set of EPA regulations that implement the Superfund Program (EPA, 1990). For
clean-up under the Superfund Program, a site must first be listed on the National
Priorities List (NPL). NPL listings are determined by a hazard ranking system score
that considers all onsite contaminants except for natural background radiation.
The CERCLA clean-up process begins with a preliminary site assessment and site
investigation (EPA, 2016). Data collected during this phase support the determin-
ation of the site’s hazard ranking score. If the score reaches a higher limit, the site is
put on the NPL for eventual remediation under the Superfund Program (EPA, 2011).
The next steps are remedial investigation and a feasibility study, which include
more complete site characterisation and baseline risk assessment (EPA, 2016).
87
This phase produces a set of options for cleaning up the site, taking into consider-
ation the risk reduction associated with each option. Finally, a remedy is selected and
made official through a record of decision. The final steps include clean-up activities,
post-clean-up reviews, and eventual removal of the site from the NPL (EPA, 1990).
For all carcinogens present at a site, both radiological and chemical, the target
residual risk goal is 10 4–10 6 excess cancers for an average member of the US
population (EPA, 1990). The upper end of this risk range equates to no more than
approximately one lifetime excess radiogenic cancer being expected among 10,000
individuals exposed at the final clean-up level. Assuming an exposure duration for
any particular site of 25–30 y, this results in a clean-up goal of approximately 100–
150 mSv y 1 to a reasonably maximally exposed individual at a site containing radio-
nuclides alone.
Publication 103 recommends public dose reference levels for existing site clean-ups
in the range of 1–20 mSv y 1, with optimisation below the reference level (ICRP,
2007). CERCLA-based regulations in the USA result in radiation site clean-up goals
that yield public doses which are typically 10–100 times lower than this range [i.e. on
the lower end of the International Commission on Radiological Protection’s (ICRP)
recommended dose constraints range for planned exposures]. Clean-up goals are
generally determined for unrestricted future use of the site. However, when unre-
stricted future use is not achievable, risk objectives may be met by limiting future use
of the site to commercial or industrial activities, or other restricted access uses (e.g. a
park or game reserve).
3. EXAMPLES OF CONTAMINATED SITE CLEAN-UPS IN THE USA

3.1. Lansdowne, Pennsylvania site (legacy radium site)
From 1924 to 1944, a physics professor at the University of Pennsylvania enriched
radium ore in his home. In 1964, the Pennsylvania Department of Health performed
a partial clean-up of the property. Pennsylvania informed EPA of the site in 1983,
and it was listed on the NPL in 1985. As there were no surviving responsible parties,
clean-up of the site was funded federally under the Superfund Program. EPA
assessed the threat from radium and radon in the original house and in vicinity
properties. The remedial action resulted in the removal of 1300 metric tons of con-
taminated building rubble and 3700 metric tons of contaminated soil. The site was
removed from the NPL in 1991.
3.2. Montclair/West Orange, New Jersey site (legacy radium site)

This site includes 469 residential properties and 10 municipal properties, covering
a total area of approximately 50 hectares that has been remediated under EPA’s
Superfund Program. The site was contaminated from nearby radium-processing
facilities that operated in the early 1900s. The State of New Jersey discovered high
indoor radon and g levels in 1983, and the site was listed on the NPL in 1985. It has
been estimated that 170,000 m3 of radium-contaminated soil was spread across the
site over time. The site remedy involved excavation and off-site disposal of all
88
radium-contaminated soil, followed by restoration of the properties, which required

some residents to be temporarily relocated. Clean-up began in 1990, was completed
in 2004, and the site was removed from the NPL in 2015.
3.3. Niagara Falls Storage Site (FUSRAP)

The Niagara Falls Storage Site was used by MED and AEC from 1947 to 1952 to
store residues from processing uranium ore. The site is 77 hectares on federal land.
Radioactive waste is impounded in a 4-hectare interim waste-containment structure
containing 184,000 m3 of soil contaminated with uranium-238, thorium-230, cae-
sium-137 and radium-226. The site also includes approximately 3000 m3 of legacy
Belgian Congo ore containing radium-226 with an average concentration of
19 MBq kg 1. The US Army Corps of Engineers is in charge of ongoing site man-
agement and clean-up activities at this site. The site clean-up is following a CERCLA
process.
4. SUMMARY
There is general consistency in contaminated site clean-ups in the USA because
EPA regulations issued under CERCLA (1980) and UMTRCA (1978) have guided
the remediation of most legacy radiation sites since the 1980s. Clean-up of various
contaminated sites in existing exposure situations in the USA often results in residual
doses to the public well below Publication 103 (ICRP, 2007) reference levels for
existing exposure situations. However, EPA’s management of contaminated sites
makes use of the ICRP process of optimisation to determine clean-up goals. Also,
the Superfund risk assessment methodology for determining risk-based clean-up
goals relies on ICRP biokinetic and dosimetric models for the assessment of organ
doses following radionuclide intakes and exposures.
REFERENCES
CERCLA, 1980. Comprehensive Environmental Response, Compensation, and Liability Act
of 1980. 42 USC 103. US Government Printing Office, Washington, DC.
DOE, 2015. Site Management Guide (Blue Book), Update 17, January 2015. US Department
of Energy, Office of Legacy Management, Washington, DC. Available at: http://energy.-
gov/lm/downloads/site-management-guide (last accessed 11 March 2016).
EPA, 1982. Final Environmental Impact Statement for Remedial Action Standards for
Inactive Uranium Processing Sites. 40 CFR 192. Vol. 1. EPA 520/4/82/013-1. US
Government Printing Office, Washington, DC.
EPA, 1983. US Code of Federal Regulations, Title 40, Part 192, Health and Environmental
Protection Standards for Uranium and Thorium Mill Tailings. US Government Printing
Office, Washington, DC.
EPA, 1990. US Code of Federal Regulations, Title 40, Part 300, National Oil and Hazardous
Substances Pollution Contingency Plan. US Government Printing Office, Washington,
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90
Protection of the environment in existing
exposure situations
D. Copplestonea, C-M. Larssonb, P. Strandc, M.K. Snevec
a
Biological and Environmental Sciences, School of Natural Sciences, University of Stirling,
Stirling FK9 4LA, UK; e-mail: david.copplestone@stir.ac.uk
b
Australian Radiation Protection and Nuclear Safety Agency, Australia
c
Norwegian Radiation Protection Authority/Centre for Environmental Radioactivity, Norway
Abstract–The International Commission on Radiological Protection (ICRP) described its

approach to the protection of the environment and how it should be applied in Publication
124. The report expanded on the Commission’s objectives for environmental protection, and
how the Derived Consideration Reference Levels (DCRLs) apply within different exposure situ-
ations. DCRLs relate radiation effects to doses over and above their normal local background
radiation levels, and consider different potential pathways of exposure for animals and plants.
This paper will describe how the DCRLs may be used within existing exposure situations to better
understand the potential impacts on animals and plants. In these circumstances, the Commission
recommends that the aim be to reduce exposures to levels that are within the DCRL bands (or
even below, depending upon the potential cost/benefits), but with full consideration of the radio-
logical and non-radiological consequences of doing so. Using examples, this paper will demon-
strate how this may be achieved in practice, bearing in mind the potential exposure of humans,
animals and plants during and following any remediation attempted.
Keywords: Existing exposure situations; Derived Consideration Reference Levels;

Environmental protection; Radiological protection
1. INTRODUCTION
The International Commission on Radiological Protection (ICRP) recommenda-
tions on the framework for radiological protection recognise three exposure
Protection.
91
situations, and apply the fundamental principles of justification and optimisation of

protection (ICRP, 2007). The three exposure situations are as follows.
. Planned exposure situations – exposure situations resulting from the operation of

deliberately introduced sources. Planned exposure situations may give rise to
exposures that are anticipated to occur (normal exposures) and exposures that
are not anticipated to occur (potential exposures).
. Emergency exposure situations – exposure situations resulting from a loss of
control of a planned source, or from any unexpected situation (such as a malevo-
lent event), that requires urgent action in order to avoid or reduce undesirable
exposures.
. Existing exposure situations – exposure situations resulting from sources that
already exist when a decision to control them is taken.
These recommendations have been followed substantially in the International

Basic Safety Standards by the International Atomic Energy Agency (IAEA, 2014).
This includes recognition of the same three exposure situations, although with some
differences in definitions and descriptions. In particular, an existing exposure situ-
ation is defined in ICRP (2007) as a situation ‘. . . that already exists when a decision
on control has to be taken’. In IAEA (2014), an existing exposure situation is defined
as a situation ‘that already exists when a decision on the need for control needs to be
taken’. It is further noted that ‘Existing exposure situations include situations of
exposure to natural background radiation.’ Furthermore, they include situations
of exposure due to residual radioactive material that derives from past practices
that ‘were not subject to regulatory control or that remain after an emergency expos-
ure situation’. The latter circumstances are commonly referred to as ‘legacies’
(IAEA, 2002).
In Paragraph 1.21, IAEA (2014) states that ‘The descriptions of the three types of
exposure situation are not always sufficient to determine unequivocally which type of
exposure situation applies for particular circumstances. For instance, the transitions
from an emergency exposure situation to an existing exposure situation may occur
progressively over time; and some exposures due to natural sources may have some
characteristics of both planned exposure situations and existing exposure situations.’
In Publication 124, ICRP (2014) described its objectives in relation to protection
of the environment through the protection of animals and plants (wildlife) using the
Derived Consideration Reference Levels (DCRLs), which were first described in
Publication 108 (ICRP, 2008). The DCRLs relate radiation effects on a selected set
of 12 Reference Animals and Plants (RAPs) to different potential pathways of expos-
ure over and above the normal background natural radiation levels. Publication 124
goes on to explain how the DCRLs may be used in the three different types of
exposure situations to which its recommendations apply, while considering the key
principles that are relevant to protection of the environment. Importantly, the
approach described indicates the appropriate level of effort relevant to different
92
Fig. 1. Relationship between Derived Consideration Reference Levels (DCRLs) and ambition
to reduce exposures in existing exposure situations (ICRP, 2014). RAPs, Reference Animals
and Plants.
For existing exposure situations, ICRP (2014) recommends that the aim be to
reduce exposures to levels that are within the DCRL bands for the relevant popu-
lations (Fig. 1), with full consideration of the radiological and non-radiological con-
sequences of doing so. If dose rates are within the bands, ICRP believes that
consideration should be given to reduce exposures, provided that the costs and
benefits are such that further efforts are warranted.
Below, examples of recent assessments and decisions on how to control existing
exposure situations are used to explore the ICRP approach for environmental pro-
tection to be applied. Consideration is given to how the knowledge of whether the
dose rates for wildlife are above, or in the relevant DCRL band can be used to help
with decision making, and what controls (if any) should be applied for both human
and environmental radiological protection.
2. EXISTING EXPOSURE SITUATIONS

As a result of evolving standards and/or because new information can come to
light about past activities, new forms of legacy sites continue to be recognised,
including sites associated with processing and the use of naturally occurring
radioactive material (NORM). According to the above definitions, these can be
considered as existing exposure situations, but noting the comments in Gonzalez
et al. (2013), the level of contamination has to be sufficient to be of safety or pro-
tection significance, and thereby warrant regulatory attention before the question of
exposure situation arises. However, there are issues here that this cannot be known
until the circumstances have been investigated. At this stage, the completion of an
investigation is therefore a matter of urgency. The circumstances will require deci-
sions to be made on the need for control regarding the implementation of the
93
investigation, and any interim safety and protection measures. Practically speaking,
these decisions need to be made to address the possible health and protection issues,
and to address the wider concerns of those affected. The nature of the decisions may
be complicated by the existence of other contaminants and hazards falling within the
responsibility of other regulators, as discussed in König et al. (2014).
Regulating the path from legacy recognition, through recovery to release from
regulatory control, is discussed further in Sneve and Smith (2014) where account was
taken for the nature of different types of legacy, and the corresponding nature of the
different types of exposure that may occur. The following major groups of legacies
have been identified in the past:
. sites affected by major accidents and incidents;

. inadequate storage and disposal sites and facilities;
. NORM and uranium mining and milling facilities;
. nuclear technology and development centres; and
. former nuclear peaceful and weapons testing sites.
These groupings cover the range of legacies identified in IAEA (2002), and may be
readily associated with existing exposure situations once the end of any emergency
situation has been recognised. The important distinguishing features from a radio-
logical protection and regulatory perspective are as follows.
. The radionuclides involved in all cases are relatively long-lived; otherwise, there is
no continuing issue to address. Some legacies are manageable within a socially
acceptable timeframe without need for off-site disposal, while others require con-
sideration of disposal off-site.
. Some legacies involve large areas and volumes of material contaminated at levels
that attract regulatory attention, while others are small.
. Large legacies are not usually very radiologically hazardous to individuals,
but have the potential to affect numerous people; however, small
legacies may present a serious hazard if associated with high levels of activity,
although in that case, only a small number of people may be affected. When
considering environmental protection, similar issues may arise with respect to
the wildlife.
. Some legacies predominantly involve radioactivity at the surface, which is rela-
tively easy to measure, but others are the opposite, or involve radionuclides which
are not easy to detect.
. Some legacies involve many different radionuclides with different radioactive,
chemical, and physical properties; others, in contrast, may only have one or a
few radionuclides, which are then easier to analyse.
. Some legacies involve physical and chemical hazards, while others only present a
radiological hazard.
. Some legacies have a linked social or political legacy, which can complicate any
decision-making processes.
94
This background underpins and informs the following assessments of impacts on

the environment at legacy sites, and the interpretation of the results in a regulatory
context.
3. CASE STUDY 1: WASTE STORAGE SITE REMEDIATION

Andreeva Bay is a site for the temporary storage (STS) of spent nuclear fuel and
radioactive waste. Despite its current use, it is a major nuclear legacy site, which is
also being remediated in the north-west of Russia (Shandala et al., 2008). As part of
a regulatory cooperation programme between the Federal Medical and Biological
Agency of Russia and the Norwegian Radiation Protection Authority, a project has
been set up to investigate the possible impact of radioactive contamination on rep-
resentative animals and plants in the STS area. The objective was to determine
whether the criteria, based primarily on the protection of humans, set out in
Shandala et al. (2008) for the range of proposed remediation options would be suf-
ficient to meet protection objectives for the environment as represented by ICRP’s
DCRLs.
To facilitate the assessment, the dose rates to representative species of animal and
plants were determined. The representative species were identified in line with the
recommendations made in ICRP (2014), and are a set of locally relevant species of
fauna and flora including:
. ‘motley grass’;
. squat birch (Betula humilis);
. earthworm (Lumbricidae spp.);
. moor frog (Rana arvaiis); and
. Norwegian lemming (Lemmus lemmus).
These are typical of the region, live directly at the industrial site, and are readily
categorised within the RAP scheme.
Monitoring of the radiation situation at the STS has shown a general decreasing
trend with time, although radiation dose rates may rise from time to time due to in-
building remediation work, which involves changes in shielding arrangements. The
contamination levels are dominated by Sr-90 and Cs-137, and the levels vary signifi-
cantly across the site (Shandala and Kiselev, 2014).
Table 1 presents the extant regulatory dose constraints for people for each remedi-
ation option proposed, taken from Shandala et al. (2008), together with concentra-
tions of Sr-90 and Cs-137 in soil that correspond to the dose constraints applied. It is
recognised that reference levels could be considered in this context, but given that the
context involves rehabilitation of the previously occupied land as described in
Chapter 1, it could also be considered as a planned situation. In any case, the
then-extant Russian requirements were set out in terms of constraints. Note that
the option of conservation implies continued exclusion of the public from all of the
STS area; conversion implies that the public are allowed access to the site supervision
95
Table 1. Regulatory dose constraints applied in Russia and corresponding radionuclide activ-
ities in soil.
Dose constraint Corresponding radionuclide
applied to residual activities in soil (Bq kg 1)
Remediation contamination
option Exposed group (mSv y 1) Cs-137 Sr-90
Conversion Personnel 3 8.17E+04 5.75E+06

Group A (HPA)
Personnel 1 2.32E+04 1.63E+06
Group B (CA)
Public (SA) 0.1 5.26E+02 3.70E+04
Conservation Personnel 2 4.63E+04 3.26E+06
(industrial areas)
Liquidation Public (industrial 1 5.26E+03 3.70E+05
areas)
Public (SA) 0.1 5.26E+02 3.70E+04
CA, controlled area; HPA, health protection area; SA, supervision area.
area surrounding the main industrial areas of the site, which are designated the
‘controlled area’ and the ‘health protection area’. The conversion factor from dose
constraint to soil concentration is different for the various exposed groups because of
the difference in exposure modes.
The ERICA assessment tool (Brown et al., 2008) was used to convert the activity
concentrations in soil shown in Table 1 into wildlife dose rates. These are presented
in Table 2, alongside the corresponding DCRLs. In some cases, the dose rates cor-
responding to the dose constraints exceed the DCRLs. In addition, actual measure-
ments in limited areas of the site suggest that the DCRLs are exceeded locally,
although it should also be noted that the contamination is patchy. Bearing this in
mind, further site investigations and research are in progress. This work is designed,
as part of a wider programme, to support regulatory development in the Russian
Federation, and to give explicit recognition of the need to demonstrate protection of
the environment. Additional information on the assessment and continuing work is
available in Filonova (2015).
Despite the continuing investigations, it should be noted that the populations of
potentially affected wildlife are limited to those living on the STS. These on-site
populations are substantially more adversely affected by the building and construc-
tion work that is ongoing at the site. If there was an overriding interest in protecting
these populations of fauna and flora, this impact would be of substantially greater
significance. However, it should be noted that the same wildlife species live in exten-
sive areas adjacent to the site that are neither materially affected by contamination
nor the industrial works, so the impact on the population as a whole is significantly
limited. Consequently, the provisional conclusions are that the current protection
96
Table 2. Assessed wildlife dose rates for the different remediation options compared with the
relevant Derived Consideration Reference Levels (DCRLs).
Dose rate
Remediation Representative maxima DCRL
option Site organisms (mGy d 1) (mGy d 1)
Conversion STS industrial Moor frog 67.2 10–100

area Motley grass 14.6 1–10
Lemming 148.9 0.1–10
Earthworm 0.6 10–100
Birch 43.9 1–10
STS supervision Moor frog 0.4 1–10
Lemming 1.0 0.1–1
Birch 0.3 1–10
Conservation STS industrial Moor frog 38.1 10–100
Lemming 84.4 0.1–1
Birch 24.9 1–10
Liquidation STS industrial Moor frog 4.3 10–100
Lemming 9.6 0.1–1
Birch 2.8 1–10
STS supervision Moor frog 0.4 10–100
Lemming 1.0 0.1–1
Birch 0.3 1–10
STS, site for the temporary storage of spent nuclear fuel and radioactive waste.
measures taken at this site and within the existing remediation criteria are sufficient
to meet protection objectives for the environment as represented by ICRP’s DCRLs
given the wider population. It is important to remember that if these species were
localised to the STS, the situation could be different.
Several factors should also be considered more widely when interpreting the above
results in the context of existing exposure situations. Firstly, the regulatory dose
constraints were set at a time when there were no Russian documents to regulate
issues of remediation of radioactively contaminated areas relating to existing
97
exposure situations (Shandala et al., 2008); it should be noted that all the constraints
are within respective dose limits. Secondly, the exposures to the fauna and flora at
the site are likely to continue for long periods of time, covering the life span of
several, or more, generations of the relevant species, and we are still learning
about the consequences of long-term transgenerational exposures of wildlife. This
would be typical for many legacy situations as discussed above, including residual
materials arising from inadequate disposal facilities licensed prior to the application
of modern standards; for example, in accordance with standards in IAEA (2014) and
more specific guidance and recommendations on solid waste disposal (IAEA, 2011;
ICRP, 2013), but which precede IAEA (2014). Furthermore, given the variation of
contamination across the site, the potential long timeframe for contamination to be
present, and the presence of similar populations of the same species in areas adjacent
to the site, it is appropriate to consider relevant temporal and spatial averaging to be
adopted in determining the dose rate for comparison with the DCRLs, as discussed
in BIOPROTA (2015). Here, a critical review has been made of international pro-
grammes and associated literature, which has allowed the rationale for addressing
spatial and temporal scales within both human and wildlife dose assessments to be
evaluated. A key issue arising from this review is to have a clear idea of the popu-
lations of species of interest; otherwise, the appropriate spatial averaging cannot be
made, leading to possible over- or under-estimation of the possible impacts.
4. CASE STUDY 2: CONSEQUENCES OF PAST RELEASES

OF RADIOACTIVITY
As part of radioecological and other research to support regulatory supervision of
remediation of areas affected by historic releases of radionuclides from the Mayak
Production Association (PA) nuclear complex, investigations have been carried out
on the status of fish species in the Techa River (Pryakhin et al., 2014).
Within the period from 1949 to 1956, industrial low-level radioactive waste was
released into the Techa River and associated wetland in Chelyabinsk Oblast, Russia.
Over the whole period, 7.6E7 m3 of effluents were discharged with total activity of
approximately 1.1E17 Bq. Fish represent one of the groups of aquatic animals that
are most sensitive to the impact of a wide range of adverse environmental factors,
including radioactive contamination. Between 2011 and 2013, research was con-
ducted into the status of the fish species of the Techa River due to long-term expos-
ure to radionuclides. Sampling was performed twice per year (in May during
spawning and in August during feeding) at three sampling stations with different
levels of radioactive contamination: in the upper reaches (RT1), middle reaches
(RT2), and low reaches (RT3) of the river. At each station, samples of water,
bottom sediments, zooplankton, zoobenthos, algae, and fish (roach, perch and
pike) were collected. Cs-137, Sr-90 and H-3 were determined in all samples. The
following parameters were measured in each fish specimen: weight and size of the
body, age, sex, fin colour, sperm motility during spawning, and morphometric par-
ameters. Haematologic, cytogenetic, and cytologic investigations of the studied fish
98
Fig. 2. Location of sampling stations in the Techa River and the Miass River.
specimens were also conducted. In spring, sperm samples were taken from male fish
at RT1 and in Miass River as a control for the determination of sperm motility
(Fig. 2).
The ERICA assessment tool (Brown et al., 2008) was used to calculate the
absorbed dose rate in the fish, assuming equilibrium distribution of radionuclides
in the organisms and in the surrounding media.
Radiation exposure, with a dose rate up to 220 mGy d 1 for fish in the spawning
period, was correlated with a dose-dependent reduction in the number of cells in
peripheral blood (URCRM, 2014). Such changes were most pronounced in pike
and roach. Other biological effects observed that could be associated with radiation
exposure were: decreased sperm cell motility; changes in fin colouration;
increases in the frequency of trypanosome invasion, which can indicate a
decrease in the immunological reactivity of the fish; and changes in the body
shape of perch.
Those fish species for which radiation-induced effects occurred within the con-
taminated waterways were identified as representative species for the purposes of the
assessment. The representative species for evaluation of cytogenetic effects and cel-
lular DNA damage is roach, the representative species for registration of radiation-
induced reduction in the number of cells in peripheral blood are pike and roach, and
the representative species for evaluation of radiation-induced physiological changes
manifested as change of fin colouration is perch.
99
The average concentration of Cs-137 in the studied fish species in the location of
settlements on the Techa River does not exceed the standard values according to
SanPiN 2.3.2.1078-01, the current Russian regulatory standard. The content of Sr-90
throughout the studied area of the Techa River exceeds the maximum permissible
standard values of the radionuclide content in fish. Consequently, for radiological
protection of people, fishing is banned. However, it is possible to develop regulatory
measures on the basis of SanPiN 2.6.1.2523-09 (NRB-99/2009) to avoid exceeding
the limit of the annual intakes of Sr-90 from fish, based on the selection of species
with low radionuclide content (such as pike) and limitations on the capture/con-
sumption of fish.
The research outputs, linked to an understanding of the ecosystem of the Techa
River, the location and network of control stations, observation periods, and the
critical parameters analysed, allow the determination of reference levels of radiation
exposure for protection of fish. The results of such studies can serve as a basis for the
development of regulatory measures for radiological protection of natural eco-
systems, and it is notable that, for the fish species considered, the dose rates at
which effects were seen are below the corresponding DCRLs (1–10 mGy d 1).
Consequently, it is necessary to consider the natural and/or confounding factors
that may modify the effect of radiation, such as spawning and fish trypanosome
invasion in fish.
Case Study 2 shows that appropriate research and site investigation can improve
understanding of the possible effects of radionuclide release on wildlife. This, in turn,
supports regulatory control, and also contributes to overall optimisation of the
future management of the existing exposure situation in the area. However, while
the critical factor appears to be the protection of people based on dose limits and
constraints (or reference levels set at the same values), there are situations where the
wildlife species may be impacted, as with Case Study 1. That said, in this example,
the practical implementation of regulations relies on a distinction between existing
and planned exposure situations, which is complicated in this case because some of
the environmental radioactivity is the result of planned and authorised releases, and
these continue as a result of continuing operations at Mayak PA nuclear complex.
5. CASE STUDY 3: MANAGEMENT OF LEGACY RADIOACTIVE WASTE

In Australia, the Little Forest Legacy Site (LFLS), formerly known as the ‘Little
Forest Burial Ground’, was originally categorised as a nuclear waste disposal facility.
The LFLS contains low-level radioactive waste and other waste buried in trenches
during the 1960s when Australia was exploring nuclear energy. The site is currently
fenced and controlled for access, and is used for research purposes into, for example,
mitigation of radioactive materials in the environment. In the short term, it is
believed that the current state of the facility will fulfil the fundamental safety object-
ive to protect people and the environment. However, in the longer term, there is a
need to bring this legacy site under more formal control and to codify strong man-
agement systems, in line with international best practice. To that end, the site has
100
recently been subject to a facility licence application. Assessments of the potential

impacts on people and wildlife have been used in the licence determination process.
These assessments have applied the ICRP recommendations and the International
Basic Safety Standards requirements for existing exposure situations.
The key findings in these assessments (using monitoring data) were that the expos-
ure of people was well below the 1 mSv dose limit for members of the public, and
therefore it was unnecessary to set reference values for this existing exposure situ-
ation. This may, however, be reconsidered based on a review of options for the final
management of both the waste and the site. There were indications that the wildlife
(particularly amphibians living in a nearby creek where the leachate from the
trenches may be going, and acacia trees whose roots may grow into the trenches)
could lead to potential dose exposures with potential biological effects. For the bulk
of the wildlife species assessed, the dose rates predicted were below the relevant
DCRLs. However, for the acacia tree and the frog larvae, they were around the
relevant DCRL. In both cases, the assessment scenarios are considered to be worst
case, the number of individuals potentially impacted was small, and the potential
impacts on populations in the area are unlikely to be significant.
In this particular case, it is not possible from the assessments conducted to explore
direct comparisons between people and wildlife exposures, partly because few
humans use this area and those who do are working there. This results in an existing
exposure situation where the exposure to wildlife, while currently not a concern from
the viewpoint of environmental protection, may be a relevant component of strate-
gies for long-term management.
6. LESSONS LEARNED
IAEA (2002) concluded that future international efforts are necessary on the issue
of environmental restoration in order to resolve policy issues, such as those relating
to criteria for the restoration of areas affected by radioactive residues. In addition, it
was said that, in the case of the restoration of residual contamination resulting from
unplanned events such as nuclear and radiation accidents, and from poorly con-
trolled past practices, it was becoming evident that international guidance on the
subject provided by ICRP and IAEA is controversial. The controversy was said to
have arisen because of the difficulty, in some cases, of distinguishing between prac-
tices and intervention situations (from which the current ICRP system of exposure
situations evolved), and because decisions on restoration are strongly influenced by
other factors such as public opinion, and legal and political constraints.
At a more recent meeting on decommissioning and remediation after a nuclear
accident (IAEA, 2013), it was recommended, concerning the application of reference
levels and standards, that further international technical and practical guidance
should be developed to support the existing international standards.
Since these views were made, ICRP has produced a number of reports on how
environmental protection can be addressed, including derivation of the DCRLs and,
in Publication 124 (ICRP, 2014), how these DCRLs may be applied to the three
101
potential exposure situations. However, the advice on both existing and emergency
exposure situations remains limited.
ICRP (2014) says that existing and emergency exposure situations need to be
examined on a case-by-case basis. In both situations, DCRLs can be used as tools
to inform decisions with regard to consequence management alternatives. DCRLs
have been identified as dose-rate bands within which, if experienced or expected, one
should stop and consider further what best to do in the context of justification and
optimisation decisions.
Optimisation and selection of preferred alternatives largely depend upon local
societal and economic factors, and have thus far focussed on the aspects affecting
people. DCRLs are an effective tool for determining whether impacts on wildlife
should be a factor within such an analysis: for example, if assessment results indicate
dose rates within or above the range of DCRLs, as shown in the case studies
presented. However, there are still key issues that need to be considered. For exam-
ple, a key issue is the ability to define and justify the wildlife population(s) of interest.
Without this definition, the relevant environmental concentrations of radionuclides
cannot be determined, so no appropriate comparison with DCRLs can be made.
This means, by definition, considering whether the individuals in the contaminated
area are sufficient to be classed as a viable population, and whether there are indi-
viduals of the same species that are not impacted by radioactivity that could main-
tain a viable population.
Additionally, the selection of a population of interest, and how much it is worth
protecting, is a value judgement. Such a judgement could be supported by a
comprehensive understanding of present and likely future distributions of radio-
nuclides in relevant environmental media, and how these may expose the wildlife
of interest. The assessment of future radionuclide behaviour is particularly relevant
to the typical long-lived radionuclides related to the existing exposure situations at
legacy sites. In the case of existing exposure situations at legacy sites, the timescale
for the assessment can be several decades or even longer, which requires assumptions
to be made about the future nature of the ecosystem (e.g. allowing for environmental
changes including changes induced by human activity). Similar technical assessment
issues arise in the context of safety assessments for solid radioactive waste disposal,
although, in this case, the exposures are considered as a subset of planned exposures
(ICRP, 2007). Assessments of the impacts on wildlife which address temporal and
spatial averaging on long timescales have been considered in BIOPROTA (2015) for
waste disposal facilities, and will have application when considering long-term
aspects of existing exposure situations.
The sites and surrounding areas that present existing exposure situations due to
past accidents and/or lack of regulatory control may also be contaminated as a result
of planned activities due to ongoing operations at the site. This occurs in areas
affected by releases from the Mayak PA nuclear complex. This complicates the
application of the advice in ICRP (2014), as the advice to apply recommendations
for existing situations is supposed to apply simultaneously in an area where there is
102
also planned exposure. For example, the contamination does not indicate whether
the current exposure is due to planned discharges or some previous accident.
Existing exposure situations typically arise at legacy sites where there are other
pollution hazards, or, as in the case of NORM legacies, the uranium simultaneously
presents a notable chemical hazard as well as a radiological hazard (Thorne and
Wilson, 2015). Herein, the most recent information available on the chemical toxicity
and biokinetics of uranium could be used to propose new standards for limiting
intakes of the element to people. The approach adopted by Thorne and Wilson
(2015) allows coherent standards to be set for ingestion and inhalation of different
chemical forms of the element by various age groups of humans. The same approach
might also be applied to address assessment of the impacts on wildlife coherently,
and thus allow the consideration of both chemical and radiological aspects.
It may be noted that no existing exposure situation concept is applied in the case
of regulation of chemical contamination, although decisions on their resolution may
take the existing circumstances into account.
For perspective, it might be noted that coherent regulation of multiple or mixed
hazards has been recognised as a challenge for a long time. A joint document issued
by Nordic regulatory authorities over 20 y ago noted that ‘Threshold levels exist for
the detrimental effects of some chemicals, but for others, the only prudent approach
is the use of a non-threshold hypothesis, as is also the case with ionising radiation.
Universally applicable hazard coefficients for both radioactive and non-radioactive
wastes would be very valuable. Further exchange of information between the fields of
nuclear and non-radioactive waste management would be desirable to harmonize
safety principles and management practices.’ Such objectives have now presented
significant challenges, such as limited information on the genotoxic properties of
various substances to allow such hazard indices to be defined for each substance.
There is also the issue of the impact of multiple stressors, as illustrated in Aleström
(2013).
This highlights that the radiological impact on wildlife at sites classified as existing
exposure situations is just one of the many aspects that should be considered when
decided on the appropriate level of control to apply. For example, the following
aspects could all be considered (this list is not exhaustive):
. the spatial distribution of the radioactive materials;

. any temporal issues relating to the radionuclides of potential interest at a given
site;
. the presence of chemical hazards sitting alongside radiological hazards;
. the need for comparatively long-term assessments;
. sometimes, it is more likely that wildlife is the receptor of interest than people;
. the justification of any changes in terms of benefits to both people and wildlife;
and
. consideration of the consequences and impacts from understanding the current
situation, and the potential consequences of controls put into place.
103
Overall, when considering how to manage existing exposure situations effectively,

it is necessary to consider the benefits of control for people, which should (in terms of
a radiological perspective) also benefit any wildlife present in the area affected.
However, some management options (particularly with respect to cost and expedi-
ency) may actually lead to significant environmental damage (e.g. digging up and
removing contaminated top soil which may contain a seed bank, or by using
chemicals to clean the soil). Wherever possible, consideration of the aspects of envir-
onmental protection in the optimisation and decision-making process should allow
us to ‘do more good than harm’ for both people and wildlife.
7. CONCLUSIONS
The results and discussion in this paper are hopefully a useful contribution to
those needing to consider how to assess existing exposure situations, and to the work
of ICRP Task Groups for preparing further guidance on the application of ICRP
recommendations to the management of contaminated sites [e.g. Task Group 98 on
sites contaminated due to past industrial, military, and nuclear activities (excluding
accidents); and Task Group 93 on territories contaminated following nuclear or
radiological accidents]. Challenges that still need to be addressed include the
following.
. Explanation about why an existing exposure situation has to be controlled differ-

ently for past activities (Task Group 98) and accidents (Task Group 93), or the
development of guidance that applies to all existing exposure situations, irrespect-
ive of the cause.
. How to compare the radiological significance of radiation doses to different wild-
life (including people) in different times and places. This will be necessary to use
assessment results and DCRLs effectively within an optimisation programme.
. What to do if your assessments suggest impacts above the DCRLs but there is no
significant impact on people.
. Development of clear and coherent international guidance on addressing multiple
hazards typically present in existing exposure situations.
. Explanation of the guidance developed to a wide range of different stakeholders.
REFERENCES
Aleström, P., 2013. Presentation to a Centre for Environmental Radioactivity (CERAD)
epigenetics workshop held at the Norwegian Radiation Protection Authority, 19 August
2013, Østerås, Norway. Available at: http://cerad.nmbu.no (accessed 3 March 2016).
BIOPROTA, 2015. Scales for Post-closure Assessment Scenarios (SPACE). Addressing
Spatial and Temporal Scales for People and Wildlife in Long-term Safety Assessments.
Report of a project organized within the BIOPROTA International Forum. Available at:
www.bioprota.org (accessed September 2015).
Brown, J.E., Alfonso, B., Avila, R., et al., 2008. The ERICA tool. J. Environ. Radioact. 99,
1371–1383.
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Filonova, A., 2015. Progress with the Environment Project at Andreeva Bay. Report of the
17th BIOPROTA workshop, 18–19 May 2015, Madrid, Spain.
Gonzalez, A.J., Akashi, M., Boice Jr J.D., et al., 2013. Radiological protection issues arising
during and after the Fukushima nuclear reactor accident. J. Radiol. Prot. 33, 497–571.
IAEA, 2002. Radiation Legacy of the 20th Century: Environmental Restoration. IAEA
TECDOC 1280. International Atomic Energy Agency, Vienna.
IAEA, 2011. Disposal of Radioactive Waste. Specific Safety Requirements No. SSR-5.
International Atomic Energy Agency, Vienna.
IAEA, 2013. Report of an International Expert Meeting on Decommissioning and
Remediation after a Nuclear Accident. International Atomic Energy Agency, Vienna.
Safety Standards. IAEA Safety Standards Series GSR Part 3. International Atomic
Energy Agency, Vienna.
ICRP, 2008. Environmental protection – the concept and use of Reference Animals and
König, C., Drögemüller, C., Riebe, B., Walther, C., 2014. Remediation of TENORM residues:
risk communication in practice. J. Radiol. Prot. 34, 575–593.
Pryakhin, E., Rudolfsen, G., Teien, H.C., Tryapitsina, G., Akleyev, A., 2014.
Characterization of the Current Status of Ichthyofauna in the Techa River. Proceedings
of International Conference on Radioecology and Environmental Radioactivity, 7–12
September 2014, Barcelona, Spain.
Shandala, N., Kiselev, S., 2014. Regulatory Supervision and Assessment of the Radiation
Situation in Areas of Former Military Technical Bases. Presentation to Workshop on
Radioecology and Assessment Research in Support of Regulatory Supervision of
Protection of the Environment and Human Health at Legacy Sites, 6 September 2015,
Held in Association with the International Conference on Radioecology and
Environmental Radioactivity, 7–12 September 2014, Barcelona, Spain.
Shandala, N.K., Sneve, M.K., Titov, A.V., et al., 2008. Radiological criteria for remediation
of sites for spent fuel and radioactive waste storage in the Russian Northwest. J. Radiol.
Prot. 28, 453–466.
Sneve, M.K., Smith, G.M., 2014. Regulating the path from legacy recognition, through recov-
ery to release from regulatory control. Radiat. Prot. Dosim. 164, 30–33.
Thorne, M., Wilson, J., 2015. Generally applicable limits on intakes of uranium based on its
chemical toxicity and the radiological significance of intakes at those limits. J. Radiol. Prot.
35, 743–762.
URCRM, 2014. The Characterization of the Current Status of Ichthyofauna in the Techa
River. Project Report from the Urals Research Centre for Radiation Medicine to the
Norwegian Radiation Protection Authority. Project Reference: L 14–11/18 NRPA, Oslo.
105
Eight decades of ICRP recommendations in
medicine: a perspective
P. Ortiz López
Pazmanitengasse, 19-2A, 1020 Vienna, Austria; e-mail: portizlopez@gmail.com
Abstract–Medicine has been intimately associated with ionising radiation since the discovery
of x rays in 1895; the first adverse effects of radiation were observed in persons working in
research and on medical staff using x rays. Consequently, in 1925, the first International
Congress of Radiology considered the need for a protection committee, which was established
at its second congress in Stockholm in 1928 and is known today as the International
Commission on Radiological Protection (ICRP). The first ICRP recommendations in 1928
were devoted to the protection of medical staff in the use of x rays for diagnosis and radio-
therapy, and radium for radiotherapy. Later, ICRP devoted increased attention to the protec-
tion of patients, starting in 1970 with Publication 16 on protection of the patient in x-ray
diagnosis, followed by three reports on the broad areas of radiation medicine: diagnostic
radiology, radiation therapy, and nuclear medicine. A major change was made at the end of
the 20th Century with the introduction of a series of short reports, focussed on specific problems
and addressing specific medical practices. Since then, as many as 20 reports have been pub-
lished on issues such as prevention of accidental exposure in radiotherapy, avoidance of radi-
ation injuries from interventional procedures, managing radiation dose in digital radiology and
computed tomography, protection in paediatric radiology, and many others.
Keywords: Radiation injuries; Accidental exposure; Protection in medicine
1. DISCOVERY OF RADIATION AND THE APPEARANCE OF

RADIATION INJURIES
Just a few months after the discovery of x rays in November 1895 (Röntgen,
1895), x-ray dermatitis was observed in the USA. Similar observations soon occurred
Protection.
106
in several other countries, including the UK and Germany (Lindell, 1996; Clarke and
Valentin, 2005). In 1896, the identification of radioactivity (Becquerel, 1896) and the
subsequent discovery of radium (Curie, 1898) took place, which led to many further
cases of radiation damage. However, these unwanted effects suggested the idea of
inflicting damage at will on selected tissues, paving the way for radiation therapy
(Lindell, 1996). The first proven cures of patients with cancer were in Sweden in 1899
(Mould, 1993).
X rays were used by military field hospitals as early as 1897. The number of x-ray
injuries escalated during the First World War when primitive mobile x-ray equip-
ment was used in the field. In the following 10 y, many papers were published on
tissue damage caused by radiation.
However, during the first two decades following the discovery of x rays and
radium, lack of knowledge about the risks caused numerous injuries, and early radi-
ologists often used their own hands to focus the beam of their x-ray machines. In
addition to tissue reactions, skin cancer as a result of such exposure was described
within 6 y of the discovery of x rays (Frieben, 1902).
The deleterious effects on hands and skin could be gruesome (as evidenced by the
amputated hand of the German radiologist Paul Krause at the Deutsches
Röntgenmuseum in Remscheid). Unfortunately, it soon turned out that effects
could be lethal, and the well-known monument to ‘x-ray and radium martyrs’ in
Hamburg, erected in 1936 by the German Röntgen Society, carries the names of
several hundred medical workers of many nationalities who died from radiation
damage (Molineus et al., 1992).
In the early 1920s, radiological protection regulations were prepared in several
countries, but it was not until 1925 that the first International Congress of Radiology
(ICR) took place and considered the establishment of international protection
recommendations.
2. THE FIRST 30 YEARS FOCUSSED ON PROTECTION IN MEDICINE

BUT EXCLUDING PATIENTS
When the first ICR was held in London in 1925, the most pressing issue was that
of quantifying radiation, and the International Commission on Radiation Units and
Measurements was created, although it was then named the ‘International X-ray
Unit Committee’. The growing concerns about the effects of ionising radiation
being observed in the medical community were discussed, and the need for an inter-
national radiological protection committee was recognised. The second ICR was
held in Stockholm in 1928, where what is now ICRP was established under the
name of the ‘International X-ray and Radium Protection Committee’ (IXRPC).
Rolf Sievert, at 32 y of age, became the first Chair of the Committee (Lindell,
1996; Clarke and Valentin, 2005).
The parent organisation was and still is the International Society of Radiology,
although the field of work of ICRP has widened from protection in medical
107
radiology to embrace all aspects of protection against ionising radiation. IXRPC was
renamed in 1950, taking its current name. Its recommendations form the basis for
more detailed codes and regulations issued by other international organisations, and
regional and national authorities.
2.1. The early series of recommendations

The first report was issued in 1928 and focussed on the protection of professionals
working in x-ray diagnostic and radiation therapy, including protection from x rays,
radium salt, and emanations from the radium sources. The recommendations were
based on time (limitation of working hours and vacations), distance, and shielding,
with one section devoted to electrical safety which was a critical issue at the time. The
subsequent series of recommendations incorporated protection from external x-ray
beam orthovoltage therapy up to 200 kV and ‘telecurie therapy’. These recommen-
dations were published as papers in various scientific journals in the fields of medi-
cine and physics (Lindell, 1996).
2.2. Start of the current series of publications and widening the scope of
In 1959, ICRP started its own series of reports with Publication 1 (ICRP, 1959).
Medical exposure was recognised under the categories of exposure, but the report
stated that ‘No recommendations are given with regard to the dose to the individual
from medical exposure.’ The report further stated that ‘It is expected that improve-
ments in equipment and techniques may considerably reduce individual exposures,
but the ever-expanding use of x rays may well increase the world population dose.’
This statement is still valid today. It is interesting to note that, referring to occupa-
tional protection, Publication 1 (ICRP, 1959) stated that with ‘present maximum
permissible exposure levels, no special treatment of radiation workers with respect
to working hours and length of vacation is needed’. This represents a significant
change with respect to the initial recommendations.
The widening of the scope of work was stated in 1950 in the following way:
‘Although the primary responsibility of the Commission has been to the radiological
profession, it has had to widen its scope and has accordingly been active not only
during the last two ICR but also in the intervening period.’ The widening of the
scope of the recommendations implied the recognition that the first 22 y of existence
of ICRP (1928–1950) had been focussed on radiological protection in medicine,
namely occupational and public protection.
2.3. Start of patient protection

The protection of patients remained excluded from the scope of ICRP until
Publication 9 (ICRP, 1966), which, citing the 1962 and 1964 United Nations
Scientific Committee on the Effects of Atomic Radiation reports, recognised
that measures can be taken to reduce medical exposure without loss of medically
important information. Soon after this statement, the first Task Group charged
explicitly with patient protection in x-ray diagnosis was established, which produced
108
Publication 16 (ICRP, 1970). This report addressed the following topics, with rec-
ommendations that are still applicable today: properties of the radiation beam; size
and position of x-ray beam; shielding; antiscatter grids; sensitivity of the recording
system; processing control and recording of radiation exposure; and reduction
in number of retakes. The report also included the following statement: ‘The estab-
lishment of efficient measures for patient protection will in no way impede the con-
tinuing development of radiological diagnosis. It may be stated that, without
exception, such measures contribute to the highest standards of clinical radio-
logical practice.’ The current principles of radiological protection were
established in Publication 26 (ICRP, 1977): justification of practices, optimisation
of protection, and dose limitation to individuals. Dose limitation is not applicable to
patients.
2.4. Renaming Committee 3 as ‘Protection in medicine’

In 1977, the Commission renamed Committee 3 to become ‘Protection in medi-
cine’. This decision reflected a significant re-orientation of priorities, explicitly
including patient protection: ‘The Commission considers that its relationship to
the ICR and its traditional contacts with the medical profession warrant the estab-
lishment of a committee specifically concerned with radiological protection in medi-
cine. Matters requiring particular attention by the Committee include protection of
the patient in radiodiagnosis and radiotherapy and protection in nuclear medicine.’
The Chairpersons of Committee 3 have been: 1977–1985, Charles B. Meinhold,
USA; 1985–1993, Julian Liniecki, Poland; 1993–1996, Henri Jammet, France;
1996–2005, Fred J. Mettler, USA; 2005–2009, Claire Cousins, UK; and 2009 to
date, Eliseo Vañó, Spain.
Once the protection of patients was explicitly part of the mission of Committee 3,
a number of reports were devoted to it in the main areas of medical uses of radiation,
namely protection of the patient in diagnostic radiology (ICRP, 1982), in radiation
therapy (ICRP, 1985), and in nuclear medicine (ICRP, 1987). In addition, atten-
tion continued to be paid to occupational protection in medicine, as shown in
Publication 57 on radiological protection of the worker in medicine and dentistry
(ICRP, 1990).
2.5. Concise reports on particular issues for specific audiences

In 1997, under the chairmanship of Fred Mettler, Committee 3 recognised that
ICRP reports were only known to regulators and radiological protection specialists
in hospitals, and were hardly known to, or used by, the medical community. This
realisation led to the decision to publish concise reports, addressing particular needs
demanded by specific audiences within the medical community, worded in plain
language understandable to these audiences but still consistent with ICRP termin-
ology. The first documents addressed pregnancy and the use of radiation in medicine
(ICRP, 2000a), avoidance of radiation injuries in interventional procedures (ICRP,
2001a), prevention of accidental exposure in radiotherapy (ICRP 2000b), radio-
logical protection in computed tomography (ICRP, 2000c), reference levels in
109
medical imaging (ICRP, 2001b), and a guide for medical practitioners called
‘Radiation and your patient’ (ICRP, 2001c).
This initial set of concise reports was soon followed by others that also focussed
on specific topics such as protection in digital radiology (ICRP, 2004a), release of
patients after therapy with unsealed radionuclides (ICRP, 2004b), prevention of
high-dose-rate brachytherapy accidents (ICRP, 2005a), protection in brachytherapy
for prostate cancer with permanent implants (ICRP, 2005b), managing dose in multi-
detector computed tomography (ICRP, 2007a), prevention of accidental exposure
with new external beam radiation therapy (ICRP, 2009a), education and training in
radiological protection for diagnostic and interventional procedures (ICRP, 2009b),
protection in fluoroscopically guided procedures outside the imaging department
(ICRP, 2010), protection in cardiology (ICRP, 2013a), protection in paediatric diag-
nostic and interventional radiology (ICRP, 2013b), protection in ion beam radio-
therapy (ICRP, 2014), and protection in cone beam computed tomography (ICRP,
2015a).
Some of these reports are accompanied by slide presentations, freely available
from the ICRP website, for use by teachers in radiological protection, and some
reports have been translated by professional associations into other languages, such
as Chinese, French, Japanese and Spanish.
In addition, a more comprehensive report on radiological protection in medicine
(ICRP, 2007b) in the traditional style was issued upon publication of the 2007 ICRP
Recommendations (ICRP, 2007c), and the series of radiation doses to patients from
radiopharmaceuticals has continued (ICRP, 2008, 2015b).
3. CURRENT WORK
Committee 3 is currently working on the following drafts: occupational radio-
logical protection in brachytherapy; framework for justification in medical uses of
ionising radiation; radiological protection in therapy with radiopharmaceuticals;
occupational protection issues in radiation imaging guided interventions; diagnostic
reference levels for diagnostic and interventional imaging; radiological protection in
medicine related to individual radiosensitivity to ionising radiations; and radiation
and your patient: a guide for medical practitioners.
4. CONCLUSIONS
Since its creation in 1928, ICRP has been intimately related to protection in
medicine. It was born at ICR, in response to growing concerns about the effects
of ionising radiation being observed in the medical community. During the first 22 y,
its recommendations were devoted to protection of radiological professionals. In
1950, ICRP widened its scope to embrace other areas of protection, but in 1977,
the Commission undertook a significant re-orientation of priorities, assigning
Committee 3 the task to focus on radiological protection in medicine, including
patients. Since then, a number of comprehensive reports have been devoted to
110
patient protection in radiology, nuclear medicine, and radiotherapy, and many con-
cise reports have addressed particular concerns of specific audiences within the med-
ical community.
REFERENCES
Becquerel, H., 1896. Emission des radiations nouvelles par l’uranium metallique. C. R. Acad.
Sci. Paris 122, 1086.
Clarke, R.H., Valentin, J., 2005. A history of the International Commission on Radiological
Protection. Health Phys. 88, 407–422.
Curie, M., 1898. Rayons emis par les composes de l’uranium et du thorium. C. R. Acad. Sci.
Paris 126, 1101.
Frieben, A., 1902. Demonstration eines Cancroid des rechten Handrückes, das sich nach
langdauernder Einwirkung von Röntgenstrahlen entwickelt hat. Fortschr. Röntgenstr. 6,
106–111.
ICRP Publication 1. Pergamon Press, Oxford.
ICRP, 1970. Protection of the patient in x-ray diagnosis. A report prepared by a task group of
lCRP Committee 3. ICRP Publication 16. Pergamon Press, Oxford.
ICRP, 1982. Protection of the patient in diagnostic radiology. ICRP Publication 34. Ann.
ICRP 9(2/3).
ICRP, 1985. Protection of the patient in radiation therapy. ICRP Publication 44. Ann. ICRP
15(2).
ICRP, 1987. Protection of the patient in nuclear medicine (and statement from the 1987 Como
meeting of ICRP). ICRP Publication 52. Ann. ICRP 17(4).
ICRP, 1990. Radiological protection of the worker in medicine and dentistry. ICRP
ICRP, 2000a. Pregnancy and medical radiation. ICRP Publication 84. Ann. ICRP 30(1).
ICRP, 2000b. Prevention of accidental exposures to patients undergoing radiation therapy.
ICRP, 2000c. Managing patient dose in computed tomography. ICRP Publication 87. Ann.
ICRP 30(4).
ICRP, 2001a. Avoidance of radiation injuries from medical interventional procedures. ICRP
ICRP, 2001b. Diagnostic reference levels in diagnostic imaging: a review and additional
advice. ICRP Supporting Guidance 2. Ann. ICRP 31(4).
ICRP, 2001c. Radiation and your patient: a guide for medical practitioners. ICRP Supporting
ICRP, 2004a. Managing patient dose in digital radiology. ICRP Publication 93. Ann. ICRP
34(1).
ICRP, 2004b. Release of patients after therapy with unsealed radionuclides. ICRP Publication
94. Ann. ICRP 34(2).
ICRP, 2005a. Prevention of high-dose-rate brachytherapy accidents. ICRP Publication 97.
Ann. ICRP 35(2).
111
ICRP, 2005b. Radiation safety aspects of brachytherapy for prostate cancer using perman-
ently implanted sources. ICRP Publication 98. Ann. ICRP 35(3).
ICRP, 2007a. Managing patient dose in multi-detector computed tomography. ICRP
ICRP, 2007b. Radiological protection in medicine. ICRP Publication 105. Ann. ICRP 37(6).
ICRP, 2007c. The 2007 Recommendations of the International Commission on Radiological
ICRP, 2008. Radiation dose to patients from radiopharmaceuticals – Addendum 3 to ICRP
Publication 53. ICRP Publication 106. Ann. ICRP 38(1/2).
ICRP, 2009a. Preventing accidental exposures from new external beam radiation therapy
technologies. ICRP Publication 112. Ann. ICRP 39(4).
ICRP, 2009b. Education and training in radiological protection for diagnostic and interven-
tional procedures. ICRP Publication 113. Ann. ICRP 39(5).
ICRP, 2010. Radiological protection in fluoroscopically guided procedures outside the ima-
ging department. ICRP Publication 117. Ann. ICRP 40(6).
ICRP, 2013a. Radiological protection in cardiology. ICRP Publication 120. Ann. ICRP 42(1).
ICRP, 2013b. Radiological protection in paediatric diagnostic and interventional radiology.
ICRP 43(4).
ICRP, 2015a. Radiological protection in cone beam computed tomography (CBCT). ICRP
ICRP, 2015b. Radiation dose to patients from radiopharmaceuticals: a compendium of cur-
44(2S).
Lindell, B., 1996. The history of radiation protection. Radiat. Prot. Dosim. 68, 83–95.
Molineus, W., Holthusen, H., Meyer, H., 1992. Ehrenbuch der Radiologen aller Nationen,
third ed, Blackwell Wissenschaft, Berlin, Germany.
Mould, R.F., 1993. A century of X rays and radioactivity in medicine: with emphasis on
photographs of the early years. Inst. of Physics Publ., Bristol, PA, USA.
Röntgen, W.C., 1895. Über eine neue Art von Strahlen. Sitzungsberichte Phys. Mediz. Ges.
Würzburg 9, 132.
112
Current status of medical radiation exposure in
Korea – recent efforts to develop a radiation
exposure control system focussed on
justification and optimisation
K-H. Doa, S.E. Jungb
a
Department of Radiology and Research Institute of Radiology, Asan Medical Centre,
University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 138-736,
Korea; e-mail: dokh@amc.seoul.kr
b
Department of Radiology, College of Medicine, The Catholic University of Korea, Korea
Abstract–Radiation exposure from diagnostic medical imaging has increased in Korea.

Radiological societies play a key role in radiation safety issues in Korea, including guidelines,
accreditation, advocacy, scientific activity, and education. Any medical radiation exposure
must be justified, and examinations using ionising radiation must be optimised. Education of
referring physicians and radiologists is also important for justification. Medical physicists and
radiographers have an important role to play in quality management and optimisation.
Regulations are essential to control medical radiation exposure. Therefore, national organisa-
tions have made a significant effort to regulate and monitor medical radiation exposure using
guidelines, accreditation, and even the law. Medical radiation exposure must be controlled, and
this could be achieved by continuous interest from health professionals and organisations.
Keywords: Medical exposure; Radiological protection; Healthcare
1. INTRODUCTION
1.1. Healthcare system in Korea
Korea has a public healthcare insurance system with mandatory registration of all
healthcare providers and residents providing universal coverage. The public health
Protection.
113
Fig. 1. Overview of healthcare system in Korea. IHA, individual health assessment.
system mainly relies on privately owned hospitals and is very extensive, covering a
large range of medical situations. Nearly all aspects of the healthcare system are
regulated by the Korean Government (Chun et al., 2009). Step-by-step expansion of
coverage, coupled with demand for a higher quantity and quality of healthcare, have
increased investment and resources, and placed heavy financial pressures on the
system. Hospitals develop services that are not covered by national health insurance
(NHI) in order to increase revenue. Medical services not covered by NHI are also
regulated by the Korean Government (Fig. 1).
1.2. Current status of radiation exposure in Korea

Korea has two separate control systems for medical radiation exposure. Firstly,
diagnostic radiation control falls under the Medical Services Act, under the respon-
sibility of the Ministry of Health and Welfare (MOHW). Secondly, therapeutic radi-
ation and nuclear medicine control falls under the Nuclear Safety Act, under the
responsibility of the Nuclear Safety and Security Commission (Table 1).
There are two components to the rules under the Medical Services Act: (1) safety
control of diagnostic x-ray-generating equipment, and management of equipment
and radiological protection facilities, regulated by the Korean Centre for Disease
Control; and (2) installation and operation of quality assurance systems for
computed tomography (CT), magnetic resonance imaging (MRI), and mammog-
raphy. These cover the management of equipment, occupational exposure, and
radiological protection facilities, but the current regulation is not focussed on patient
safety.
114
Table 1. Medical radiation exposure control system in Korea.

Diagnostic radiation Therapeutic radiation
equipment equipment
Act Medical Services Act Nuclear Safety Act

Responsible ministry Ministry of Health and Welfare Nuclear Safety and Security
Commission
Given the size of the population of South Korea, the country has many items of
medical imaging equipment, which is indicative of the high number of imaging pro-
cedures being undertaken. The number of imaging procedures performed in Korea is
comparable, or even higher, compared with the numbers of imaging procedures
performed in Organization for Economic Cooperation and Development (OECD)
countries. Korea has a very high rate of medical imaging equipment adoption. In
2011, Korea ranked fifth and sixth in the world in terms of the number of MRI and
CT units per million population, respectively. However, the number of MRI and CT
examinations per 1000 population in Korea seems to be relatively low (OECD,
2013). This is because examinations that are privately funded are not included, yet
these represent the majority of examinations in Korea. As these privately funded
examinations are highly commercial, quality control is very important in order to
prevent abuse.
The annual number of diagnostic radiological examinations in Korea increased
rapidly from 2006 to 2011; the total number of diagnostic radiological examinations
and CT scans increased by an average of 8% and 14% y1, respectively. The annual
per-caput effective dose in the Korean population increased by 10% from 2007 to
2011. In 2011, the estimated annual per-caput effective dose was 1.4 mSv. The data in
this study are probably underestimated because the main data source was NHI data,
and did not include out-of-pocket procedures, such as voluntary health screening
programmes (Kim, 2013).
Professional organisations are actively collaborating with many national agencies
regarding quality and safety. In Korea, national agencies interested in medical radi-
ation exposure include the MOHW; the Ministry of Science, ICT, and Future
Planning; and the Ministry of Food and Drug Safety. The National Evidence-
based Healthcare Collaborating Agency (NECA) and the Health Insurance
Review and Assessment Service (HIRA) exist under MOHW. NECA and HIRA
are creating guidelines together with the Korean Society of Radiology (KSR).
2. RADIATION EXPOSURE CONTROL SYSTEM FOR IMAGING STUDIES

2.1. Efforts for justification
Any medical radiation exposure must be justified, and examinations using ionising
radiation must be optimised. The first principle is justification of medical exposures.
Justification goes beyond optimisation, where awareness, appropriateness, and audit
115
are used for the implementation of justification. Practically, knowledgeable and

effective communication with patients (informed consent) and with healthcare pro-
fessionals (education and training) is needed for awareness. It is vital to raise aware-
ness about safety among health professionals. Communication with patients includes
the provision of information about risks and benefits, and gaining informed consent.
Appropriate criteria and referral guidelines can be used by physicians to make deci-
sions regarding justification. Lastly, the importance of clinical audits to improve
justification is emphasised. The adoption of clinical audits is encouraged through
payment systems, accreditation programmes, etc.
There are three stages of radiation exposure control for imaging studies. The first
stage is equipment control. In Korea, there are strict regulations regarding radio-
logical protection of patients, implemented as the Radiation Protection Act of the
Ministry of Food and Drug Safety in 1995 and the accreditation programme in 2004.
The second stage is imaging quality control. In Korea, an accreditation programme
exists for phantom test and clinical imaging evaluation; the Medical Act for CT,
MRI, and mammography. This accreditation programme is similar to the
Mammography Quality Standards Act of the USA.
As of January 2015, Korea has not organised guidelines comparable to the appro-
priateness criteria of the USA, or iRefer of the UK. Currently, KSR is actively
developing clinical diagnostic imaging guidelines adapted from other guidelines.
Over the last 2 or 3 y, several guidelines have been published using government
funding, and several more guidelines are currently in development. Since 2011,
KSR has published many guidelines for radiological imaging and quality manage-
ment, and contrast management. In 2016, work commenced on the development of
comprehensive clinical imaging guidelines. This is a collaborative project between
KSR and NECA.
KSR is fully aware of the importance of justification of these studies, and has
made many contributions to the project (Table 2). KSR has played a significant role
in improving healthcare in Korea. KSR largely consists of regional societies, a
board of directors, and subspecialty societies. Many committees focus on quality
and safety (e.g. health policy and practice, health insurance, radiation safety,
accreditation, and clinical practice guidelines). KSR has recently created a subcom-
mittee called the ‘Radiology Advocacy Network of Korea for Quality and Safety’
(RANK-QS). This started as a voluntary organisation (Korean Advocacy Group for
Radiation Protection and Quality Management) in 2013. Currently, the subcommit-
tee hold monthly meetings and an annual symposium for radiation safety, contrast
media, quality management for imaging facilities and radiologists, clinical imaging
guidelines, etc.
2.2. Efforts for optimisation

The as low as reasonably achievable (ALARA) principle is a basic philosophy for
the optimisation of radiological protection and safety. First, appropriate equipment,
software, technique, and parameters must be used for radiological protection.
Dosimetry must be performed and documented to determine typical doses to patients
116
Table 2. Major efforts for quality and safety made by the Korean Society of Radiology
(KSR).
2004 Establishment of Korean Institute for Accreditation of Medical Imaging
(CT, MRI, and mammography)
2005 Certification for diagnostic imaging centre of excellence by KSR
2008 Assessment and education for national health screening (mammography
boot camp, e-learning programme for mammography interpretation)
2008 Set national diagnostic reference level with Korean CDC (mammography,
CT, x rays, paediatrics, dental x rays, and fluoroscopic examinations)
2012 2012 KSR Committee for Clinical Guidelines ! development of compre-
hensive clinical imaging guidelines (referral guidelines)
2013 Korean Advocacy Group of Radiation Protection and Quality ! 2015
Radiology Advocacy Network of Korea for Quality and Safety
CDC, Centre for Disease Control and Prevention. CT, computed tomography. MRI, magnetic resonance
imaging.
for common procedures for diagnostic radiological procedures. Diagnostic reference

levels (DRLs) are used to review whether the optimisation is adequate, or if correct-
ive action is required if the typical doses/activities exceed or fall below the DRL.
Quality assurance programmes, including standard operating procedures, equipment
quality control and clinical audits, must be established (IAEA, 2014).
After the separation of pharmacy distribution from medical practice in 2000 in order
to reduce medical fees, the rate of self-referral increased. Self-referral in diagnostic
imaging inevitably leads to overuse. If untrained physicians operate radiological equip-
ment or try to interpret images, the number of poor-quality examinations will increase.
On 19 January 2001, the National Assembly of Korea approved various acts, including
quality management for specific medical equipment. By this law, quality management
of specific medical equipment such as CT, MRI and mammography was launched by
MOHW. In collaboration with MOHW, KSR developed guidelines and standards of
quality management for mammography, CT and MRI equipment. KSR established
the Korean Institute for Accreditation of Medical Imaging (KIAMI) as a relevant
professional foundation, and MOHW authorised KIAMI to serve as an organisation
for quality inspection. All CT, MRI and mammography equipment must have quality
control tests mandated by the Medical Service Act Article 38 [installation and oper-
ation of special medical equipment (Do et al., 2007)].
In 2005, 3773 units of medical equipment underwent quality inspection, and 7%
failed to meet the required standard. Given that the failure rate was much higher in
the pilot study performed before inauguration of quality management, this result
shows that the quality of medical imaging performed at certified units is improving,
and public health in Korea has benefited from these improvements (Fig. 2).
The National Institute of Food and Safety Evaluation is executing a national
survey on radiation doses in Korea. A Korean database of patient radiation expos-
ure in radiological examinations has been established for CT, fluoroscopy,
117
25
20.5
20
17
Poor equipment(%)
15
11.5
10 10.5
8
6.6 6.5
5 4.6
4.1 3.9
3.6 3.1 3.1 2.9
2.5
3 1.9 2.7 2.7
3 2
2 0.5 1.5
1.1 0.9 0.9
0 0 0 0.8
2004 2005 2006 2007 2008 2009 2010 2011 2013 2014
MRI 0 0 2.5 2 1.1 0.5 0.9 0.8 0.9 1.5
CT 10.5 20.5 17 8 3.6 3.1 1.9 2 3.9 2.7
Mammo 6.6 11.5 6.5 4.6 3 3 4.1 3.1 2.7 2.9
Fig. 2. Failure rates for equipment on quality control tests. CT, computed tomography.
Mammo, mammography. MRI, magnetic resonance imaging.
angiography, mammography and radiography. DRLs were published for chest pos-
tero-anterior scanning and mammography in 2008, for CT scanning in 2009, for
paediatric chest radiography in 2010, for general radiography in 2012, and for
dental imaging in 2013. Korean DRLs of these examinations are summarised in
Table 3.
3. ISSUES AND CHALLENGES

The first issue and challenge concern diagnostic radiation dose measurement.
Dosimetry will have to contribute fundamentally to patient protection, and a clear
purpose is required. CT dose index volume and dose length product would be
required in the case of CT performance monitoring, and effective dose would be
needed for risk assessment purposes. Secondly, there is a need to determine whether
it is necessary to measure the radiation dose for every diagnostic radiological exam-
ination, or only for relatively high-dose examinations. In some state governments in
the USA, dose reporting is required for CT and fluoroscopy. Finally, there is a need
to determine the level of enforcement.
Regarding the direction for diagnostic radiation control, there is an issue regard-
ing personal dose tracking in Korea. Some groups believe that it must be necessary
for reducing radiation dose. Other groups including radiology professionals do not
agree with that idea because it is not applicable for justification and optimisation.
Procedure tracking could be a substitute for personal dose tracking. However, there
118
Table 3. Diagnostic reference levels in Korea.

X ray
Examination ESD Examination ESD Examination ESD

type (mGy) type (mGy) type (mGy)
Head (AP) 2.7 Neck (AP) 1.98 Clavicle (AP) 1.92

Head (LAT) 3.11 Neck (LAT) 0.97 Shoulder (AP) 1.84
Chest (PA) 0.58 T-spine (AP) 4.09 Forearm (AP) 0.6
Chest (AP) 1.75 T-spine (LAT) 9.22 Elbow (AP) 0.35
Chest (LAT) 3.08 L-spine (AP) 4.74 Wrist (AP) 0.27
Abdomen (AP) 3.9 L-spine (LAT) 12.17 Hip joint (AP) 3.68
Pelvis (AP) 3.94 L-spine (OBL) 6.7 Knee (AP) 0.6
Ankle (AP) 0.39
Fluoroscopy
DAP DAP
Examination type (mGy cm2) Examination type (mGy cm2)
Barium enema 46.4 Intravenous pyelogram 13.1

Upper gastrointestinal series 29.3 Endoscopic retrograde 56.9
cholangiopancreatography
Swallowing study 9.1 Hysterosalpingogram 17.4
Small bowel series 33.8
Intervention
ESD DAP Time

Examination type (mGy) (mGy cm2) (min) Number
Transcatheter arterial chemoembolisation 511.75 209.94 16.61 4.51

Arteriovenous fistula 31.77 27.69 18.76 3.62
Percutaneous transhepatic biliary drainage 58.6 18.45 4.21 0
Cerebral angiography 404.85 226.03 9.31 7.3
Guglielmi detachable coil embolisation 2264 51.1 6.57
Computed tomography Dental x ray
CTDIvol DLP Entrance DAP

(mGy) (mGy cm) dose (mGy) (mGy cm2)
Head 60 1000 Intra-oral 3.07 87.4

Chest 20 700 Panorama 110.9
Abdomen 15 550 Cephalo 161.1
Mammography
Average glandular dose 1.36 mGy
AP, antero-posterior. CTDIvol, computed tomography dose index volume. DAP, dose-area product. DLP,
dose length product. ESD, entrance skin dose. LAT, lateral. OBL, oblique. PA, postero-anterior.
119
are several issues to consider, such as legal problems with the protection of personal
information. HIRA had tried to establish a sharing system for imaging information.
There is a need for practical implementation of justification for each diagnostic
procedure. The first step affecting patient dose is the clinical decision to expose a
patient to radiation, and this is the scope of justification. Education of referring
physicians and radiologists is also important for justification.
Although medical radiation is clearly beneficial, there are potential risks, and it is
necessary to distinguish between real risks and calculated/theoretical risks.
Physicians should work with patient advocacy organisations to communicate the
potential radiation risks and health benefits of imaging procedures more effectively
(Amis et al., 2007). The dose equivalent should be expressed as the equivalent
number of chest radiographs, and the risk of cancers should be expressed as the
number of additional cases in the exposed population (BEIR VII, 2006). Patients
must be protected from unnecessary and unintended radiation exposure.
Understanding, communication, and cooperation of relevant stakeholders will be
needed for patient protection. Medical physicists and radiographers play an import-
ant role in quality management and optimisation.
4. CONCLUSIONS
Radiation exposure from diagnostic medical imaging has increased in Korea.
Each stakeholder plays a unique and complementary role for each patient-centred
care system regarding radiological safety. Radiological societies play a key role in
radiation safety issues in Korea, including guidelines, accreditation, advocacy, sci-
entific activity, and education. Regulations are essential to control medical radiation
exposure. Therefore, national organisations have made a significant effort to regulate
and monitor medical radiation exposure using guidelines, accreditation, and even the
law.
REFERENCES
Amis, E.S. Jr., Butler, P.F., Applegate, K.E., et al., American College of Radiology, 2007.
American College of Radiology white paper on radiation dose in medicine. J. Am. Coll.
Radiol. 4, 272–284.
BEIR VII, 2006. Health Risks from Exposure to Low Levels of Ionizing Radiation.
Washington, DC: The National Academies Press. Available at: http://www.nap.edu/cata-
log/11340/health-risks-from-exposure-to-low-levels-of-ionizing-radiation (last accessed 12
April 2016).
Chun, C.B., Kim, S.Y., Lee, J.Y., et al., 2009. Republic of Korea: Health system review.
Health Syst. Transit. 11, 1–184.
Do, K-H., Na, D.G., Lim, T-H., 2007. Accreditation of Medical Imaging in Korea. University
of Ulsan College of Medicine, Seoul. Available at: https://healthmanagement.org/c/
imaging/issuearticle/accreditation-of-medical-imaging-in-korea (last accessed 12 April
2016).
120
Safety Standards. IAEA Safety Standards Series GSR Part 3. International Atomic
Kim, K.P., 2013. Radiation Exposure of Korean Population from Medical Diagnostic
Examinations. Ministry of Food and Drug Safety, Seoul.
OECD, 2013. Health at a Glance 2013: OECD Indicators. OECD Publishing, Paris. Available
at: http://dx.doi.org/10.1787/health_glance-2013-en (last accessed 12 April 2016).
121
Current global and Korean issues in radiation
safety of nuclear medicine procedures
H.C. Song
Medical Radiation Safety Research Centre, Department of Nuclear Medicine, Chonnam
National University Hospital, 42 Jebongro, Dong-gu, Gwangju, 61469, Republic of Korea;
e-mail: songhc@jnu.ac.kr
Abstract–In recent years, the management of patient doses in medical imaging has evolved as
concern about radiation exposure has increased. Efforts and techniques to reduce radiation
doses are focussed not only on the basis of patient safety, but also on the fundamentals of
justification and optimisation in cooperation with international organisations such as the
International Commission on Radiological Protection, the International Atomic Energy
Agency, and the World Health Organization. The Image Gently campaign in children and
Image Wisely campaign in adults to lower radiation doses have been initiated in the USA. The
European Association of Nuclear Medicine paediatric dosage card, North American consen-
sus guidelines, and Nuclear Medicine Global Initiative have recommended the activities of
radiopharmaceuticals that should be administered in children. Diagnostic reference levels
(DRLs), developed predominantly in Europe, may be an important tool to manage patient
doses. In Korea, overexposure to radiation, even from the use of medical imaging, has become
a public issue, particularly since the accident at the Fukushima nuclear power plant. As a
result, the Korean Nuclear Safety and Security Commission revised the technical standards for
radiation safety management in medical fields. In parallel, DRLs for nuclear medicine pro-
cedures have been collected on a nationwide scale. Notice of total effective dose from positron
emission tomography-computed tomography for cancer screening has been mandatory since
mid-November 2014.
Keywords: Medical radiation; Radiation safety; Nuclear medicine procedures; Justification;

Optimisation
Protection.
122
1. INTRODUCTION
Medical radiation exposure is almost always voluntary and is generally accepted
to have more benefits than risks. As such, the use of medical imaging procedures
continues to increase. The use of radiation for medical exposure of patients accounts
for >95% of man-made radiation exposure, and is only exceeded worldwide by
natural background radiation as a source of exposure (UNSCEAR, 2000). In a
preliminary analysis for 2006 in the USA, the contribution of medical radiation
exposure of patients was considered to be similar in magnitude to natural back-
ground radiation as a source of exposure of the population. Compared with 1982
and 2006, the per-capita dose has increased almost six-fold (from 0.54 to approxi-
mately 3.0 mSv), and the collective dose has increased more than seven-fold (from
124,000 to approximately 900,000 man-Sv). The largest contributions and exposure
increases have come primarily from computed tomography (CT) scanning and
nuclear medicine (Mettler et al., 2008).
Radiation detriments, including the results of a recent article on cancer risks related
to low-dose ionising radiation from medical imaging (Eisenberg et al., 2011) and
the incidence of CT radiation overexposure to patients, have increased fear of over-
exposure to radiation from CT scans (Zarembo, 2009). In Korea, overexposure to
radiation, even from medical imaging, has become a public issue, particularly since the
accident at the Fukushima nuclear power plant in Japan. Issues on reducing radiation
exposure during medical procedures continue to raise concerns about radiation risk
among the general public and scientific community.
Fortunately, large-scale campaigns such as Image Gently (http://www.image
gently.org), Image Wisely (http://www.imagewisely.org/), and Choosing Wisely
(http://www.choosingwisely.org/) advocate the reduction of ionising imaging expos-
ure in children, unnecessary imaging in adults, and avoidance of inappropriate ima-
ging procedures. In addition, efforts have been made to optimise dose and improve
technology in cooperation with international organisations such as the International
Commission on Radiological Protection (ICRP), the International Atomic Energy
Agency (IAEA), and the World Health Organization (WHO) to reduce the exposure
of patients to ionising radiation during medical imaging procedures. The purpose of
this paper is to review current global and Korean issues in radiation safety of nuclear
medicine procedures, with emphasis on radiation exposure from nuclear medicine
examinations.
2. MEDICAL RADIATION EXPOSURE FROM NUCLEAR MEDICINE

PROCEDURES
The United Nations Scientific Committee on the Effects of Atomic Radiation
(UNSCEAR) 2008 Report (UNSCEAR, 2008) estimated that 32.7 million global
diagnostic nuclear medicine examinations are performed annually, which represents
an increase of 0.2 million examinations y1 or <1% since the 1991–1996 survey. The
24% of the global population living in healthcare level I countries receive
123
approximately 90% of all nuclear medicine examinations. The annual frequency of

diagnostic nuclear medicine examinations per 1000 population in healthcare level I
countries has increased from 11 in 1970–1979 to 19 in 2008. Comparative values for
healthcare level II countries also exhibit an increase, from 0.9 per 1000 to 1.1 per
1000 in 1997–2007. Over the same period, the annual collective effective dose to the
world’s population due to diagnostic nuclear medicine examinations rose from
150,000 to 202,000 man-Sv, representing an increase of 52,000 man-Sv or approxi-
mately 35%. Nuclear medicine represents approximately 6% of the collective dose
from the diagnostic use of radiation. The increase in the global collective effective
dose from diagnostic nuclear medicine examinations results from two factors.
Firstly, the average effective dose per procedure has increased from 4.6 mSv
(UNSCEAR, 2000) to the present estimate of 6.0 mSv, an increase of nearly one-
third in the average effective dose per procedure. Secondly, there has been an increase
in the annual number of diagnostic nuclear medicine examinations performed among
the world’s population.
The National Council on Radiation Protection and Measurements (NCRP)
Report 160 (Bolus, 2013) stated that the average exposure of the general US popu-
lation to ionising radiation increased from 3.6 mSv in the 1980s to 6.2 mSv in 2006.
In the 1980s, medical procedures accounted for 15% of all exposures, whereas they
accounted for 48% in 2006. The increase was led primarily by increased use of CT
imaging, followed by nuclear cardiology procedures. When comparing data from
1972 and 2006, the report revealed that there were 15.7 nuclear medicine examin-
ations or visits per 1000 people in 1972, compared with 60.3 million in 2006, repre-
senting an increase of approximately 284%. The annual number of nuclear medicine
procedures over that time increased from approximately 3.3 million to 18.1 million,
or approximately 448%. As far as effective dose estimates for nuclear medicine
procedures are concerned, NCRP Report 160 indicated that nuclear cardiology per-
fusion Tc-99 m sestamibi/Tl-201 studies resulted in an effective dose per procedure of
17.7 mSv. The total collective effective dose for all nuclear medicine procedures in
2005 (the year analysed by the NCRP Report 160 Committee) was approximately
220,500 man-Sv. Nuclear cardiology procedures accounted for 85.2% of this total
[187,915 man-Sv for cardiac procedures (187,915/220,500 man-Sv 100% ¼ 85.2%)].
Bone scans came in second at 9.3%. In another study, the proportion of overall
effective dose from nuclear medicine imaging procedures was found to be approxi-
mately one-quarter (24.8%) of that of procedures making the largest contributions
to radiation exposure in the study population (Fazel et al., 2009). Myocardial per-
fusion imaging alone accounted for over 22% of the total effective dose, while CT
scans of the abdomen, pelvis, and chest accounted for approximately 38%. Bone
scans accounted for 1.4%, thyroid uptake scans accounted for 0.7%, and cardiac
resting ventriculography accounted for 0.6%.
In 2007, the average effective dose to the Korean population was 3.7 mSv y1.
Dominant contributions (80.3%) were from natural sources. Almost all of the
remaining dose (19.7%) was due to medical exposure (KINS, 2007). The annual
collective dose was 27,440 man-Sv [diagnostic radiology: 22,880 man-Sv (83.4%);
124
nuclear medicine: 4560 man-Sv], which can be reduced to the annual per-capita
effective dose of 0.58 mSv by dividing by the Korean population of 47.7 million.
In 2002, the collective effective dose from nuclear medicine was 4560 man-Sv, and the
per-capita dose was 0.096 mSv. In terms of the contribution of nuclear medicine to
the collective dose, myocardial single photon emission CT scans accounted for
2600 man-Sv (58.6%), bone scans accounted for 1060 man-Sv (23.8%), and thyroid
scans accounted for 274 man-Sv (6.1%) (Kwon et al., 2005).
In 2013, according to national statistical data for diagnostic radiation exposure
in Korea collected from four public institutes and government agencies between
2006 and 2013, the annual frequency of diagnostic medical examinations was 231
million, demonstrating rapid growth of 54.4% compared with 150 million in 2006
(Lee et al., 2015). The average collective effective dose and per-capita effective dose
in 2013 were 78,730 man-Sv and 1.54 mSv, respectively, which are 81.5% and
73.9% increases over those in 2006, respectively. The frequencies of CT and
nuclear medicine examinations increased significantly by 120.7% and 90.4%,
respectively, and the annual per-capita effective doses were increased significantly
by 118.8% and 103%, respectively, in 2013. In terms of the distribution of annual
frequency of all types, positron emission tomography (PET)-CT had the highest
average annual increase in rate (49.4%); frequency of PET-CT increased by
815.2% between 2006 and 2013 in accordance with the increased PET-CT pene-
tration rate of 228.6% over the same period. Reimbursement seems to be one of
the most important factors affecting the increased frequency of PET-CT. Korea
began reimbursement by public insurance systems in June 2006, at a cost of
approximately 710,000 KRW (US$ 764) (Kim et al., 2012). The Korean population
is ageing rapidly with the progress of medical technology, and use of examinations
demanding high radiation exposure, such as CT and nuclear medicine examin-
ations, has increased rapidly.
3. IMPLEMENTATION OF THE NEW INTERNATIONAL STANDARDS

FOR RADIOLOGICAL PROTECTION
The international standards for radiological protection were developed from
widely accepted radiological protection and safety principles, such as those published
in ICRP reports and IAEA safety series. ICRP revised the fundamental recommen-
dations about protection against ionising radiation in 2007 (ICRP, 2007a).
Subsequently, IAEA revised its International European Basic Safety Standards
(BSS) to take into account the changes in the ICRP 2007 Recommendations.
‘General Safety Requirements Part 3 – Radiological Protection and Safety of
Radiation Sources: International Basic Safety Standards’ was approved by the
IAEA Board of Governors at its meeting in 2011, and was issued as General
Safety Requirements Part 3 in 2014 (IAEA, 2014).
The recently published Council Directive 2013/59/European Atomic Energy
Community (Euratom) (new BSS) was adopted on 5 December 2013. The new
European BSS incorporate the ICRP 2007 Recommendations, and harmonise the
125
European Union (EU) regime with the BSS of IAEA. The new European BSS repeal
previous European legislation on which the national systems for radiological pro-
tection in medicine of the 28 EU Member States are based, including the 96/29/
Euratom BSS and the 97/43/Euratom Medical Exposure Directives. While most of
the elements of the previous legislation have been kept, there are several legal
changes that will have important effects on regulation and practice in the field all
over Europe. These include, among others: (1) strengthening implementation of the
justification principle and expanding it to medically exposed asymptomatic individ-
uals; (2) more attention to interventional radiology; (3) new requirements for dose
recording and reporting; (4) increased role of the medical physics expert in imaging;
(5) new set of requirements for preventing and following up on accidents; and (6)
new set of requirements for procedures where radiological equipment is used for
people for non-medical purposes (non-medical imaging exposure). The EU
Member States have to enforce the new EU BSS before January 2018 and bring
into force the laws, regulations, and administrative provisions necessary to comply.
The European Commission has certain legal obligations and powers to verify the
compliance of national measures with the EU laws and, wherever necessary, issue
recommendations to, or open infringement cases against, national governments
(Simeonov, 2015).
As soon as the revision of the BSS was completed, the Korean Government
implemented the changes in the BSS and ICRP 2007 Recommendations into its
national radiological protection laws and regulations (Cho and Kim, 2009). The
Korean Nuclear Safety and Security Commission (NSSC) revised ‘Regulations on
Technical Standards for Radiation Safety Control, etc’. in mid-December 2013
(NSSC, 2014). Section 3, entitled ‘Medical safety control in these new regulations’,
has been changed completely, as follows: (1) defining medical exposure as exposure
of patients resulting from their treatment and diagnosis, and of biomedical research
volunteers and carers and comforters, and of the embryo or fetus and infant being
breast fed; (2) implementation of the justification principle and optimisation of
protection and safety; (3) preventing and following up on unintended and acciden-
tal medical exposures; (4) safety control of patients released after radionuclide
therapy; and (5) radiological protection for pregnant or breast-feeding female
patients. The Korean NSSC decided to revise ‘Technical Standards for
Radiation Safety Management in Medical Fields’ in accordance with the revised
regulations (NSSC, 2015). This notice was issued by the Korean Government in the
first quarter of 2015.
4. JUSTIFICATION
ICRP recommendations for radiological protection and safety in medicine are
given in Publication 105 (ICRP, 2007b), which explains that the principle of justifi-
cation applies at three levels in medicine, as described below. At the first level, the
proper use of radiation in medicine is accepted as doing more good than harm to
society. At the second level, a specified procedure is justified for a group of patients
126
showing relevant symptoms, or for a group of individuals at risk for a clinical con-
dition that can be detected and treated. At the third level, the application of a
specified procedure to an individual patient is justified if that particular application
is judged to do more good than harm to the individual patient. Hence, all individual
medical exposures should be justified in advance, taking into account the specific
objectives of the exposure and the characteristics of the individual involved. In the
International BSS for protection against ionising radiation and for the safety of
radiation sources (IAEA, 2014), medical exposures should be justified by weighing
the diagnostic or therapeutic benefits that they are expected to yield against the
radiation detriment that they might cause, with account taken of the benefits and
risks of available alternative techniques that do not involve medical exposure. The
justification of medical exposure for an individual patient should be carried out by
means of consultation between the radiological medical practitioner and the referring
medical practitioner, as appropriate, with account taken, particularly for patients
who are pregnant, breast feeding, or paediatric, of: (1) the appropriateness of the
request; (2) the urgency of the radiological procedure; (3) the characteristics of the
medical exposure; (4) the characteristics of the individual patient; and (5) relevant
information from the patient’s previous radiological procedures.
Relevant national or international referral guidelines should be taken into account
for justification of the medical exposure of an individual patient in a radiological
procedure. Imaging referral guidelines provide physicians with information regard-
ing procedures that are most likely to yield the most informative results, and whether
another modality is equally or more effective, and therefore more appropriate.
Examples of referral guidelines include the American College of Radiology (ACR)
Appropriateness Criteria (ACR, 2014) and ‘iRefer: Making the Best Use of Clinical
Radiology’ (RCR, 2012).
A number of international, regional, and national initiatives are being conducted
to increase appropriateness, reduce unnecessary radiation exposures, and thus pre-
vent unnecessary radiation risks. Activities enhancing implementation of justification
include the Working Party on Justification of Medical Imaging composed of mem-
bers of ICRP Committee 3 and external experts (ICRP, 2014), Global Initiative on
Radiation Safety in Health Care Settings of WHO (WHO, 2008), the framework of
the IAEA International Action Plan for Radiological Protection of Patients (IAEA,
2002), large-scale campaigns pursued intensively by professional societies such as
Image Gently and Eurosafe (http://www.eurosafeimaging.org), and numerous
national initiatives on this topic (Perez, 2015).
In the International BSS, justification for radiological procedures to be performed
as part of a health screening programme for asymptomatic populations should be
carried out by the health authority in conjunction with appropriate professional
bodies. The individual should be informed of the expected benefits, risks, and limi-
tations of the procedure. In Korea, the standard notice for individuals and recom-
mendations for medical institutions regarding the use of PET-CT for voluntary
cancer screening of asymptomatic individuals was made and released by the
127
Korean Medical Association in collaboration with the Ministry of Health and

Welfare, the Korean Society of Nuclear Medicine (KSNM), the Korean Hospital
Association, and the Korean Consumer Agency in 2014. Therefore, there has been a
requirement to notify patients of the total effective radiation dose received from F-18
fluorodeoxyglucose PET-CT for cancer screening, with average annual natural radi-
ation dose (3 mSv), since mid-November 2014 in Korea.
5. OPTIMISATION
The basic aim of the optimisation of protection is to adjust the protection meas-
ures for a source of radiation in such a way that the net benefit is maximised. In the
case of exposure from diagnostic and interventional medical procedures, the object-
ive of diagnostic reference levels (DRLs) is the optimisation of protection. The con-
cept of DRLs was introduced in Publication 60 (ICRP, 1990) as a form of
investigation level used to identify situations where optimisation of protection may
be required in the medical exposure of patients, and the use of DRLs was recom-
mended in Publication 73 (ICRP, 1996) with further information in Supporting
Guidance 2 (ICRP, 2001). Publications 103 and 105 (ICRP, 2007a,b) summarised
previous definitions and recommendations about DRLs. The objective of DRLs is to
help avoid radiation dose to the patient that does not contribute to the clinical
purpose of a medical imaging task.
The International BSS (IAEA, 2014) state that registrants, licensees, and radio-
logical medical practitioners should ensure that protection and safety are optimised
for each medical exposure. For diagnostic radiological procedures and image-guided
interventional procedures, the radiological medical practitioner, in cooperation with
the medical radiation technologist and the medical physicist, and, if appropriate, the
radiopharmacist or radiochemist, should ensure that the following are used: (1)
appropriate medical radiological equipment and software, and, for nuclear medicine,
appropriate radiopharmaceuticals; and (2) appropriate techniques and parameters to
deliver medical exposure of the patient that is the minimum necessary to fulfil the
clinical purpose of the radiological procedure, taking into account relevant norms of
acceptable image quality established by relevant professional bodies, and relevant
DRLs established in accordance with paragraphs 3.148 and 3.169 in the standards.
The particular aspects of medical exposures are considered in the optimisation pro-
cess for paediatric patients subject to medical exposure.
As described above, a number of international, regional, and national initiatives
are also being conducted to optimise radiation exposures in medical imaging pro-
cedures. Activities enhancing implementation of optimisation include the Working
Party on DRL Optimisation of Medical Imaging composed of members of ICRP
Committee 3 (ICRP, 2014); the WHO Global Initiative on Radiation Safety in
Health Care Settings (WHO, 2008); the framework of the IAEA International
Action Plan for Radiological Protection of Patients (IAEA, 2002); the Bonn Call
for Action (IAEA, 2012); multi-society campaigns pursued by professional societies
128
such as Image Gently, Image Wisely, and Choosing Wisely; and several initiatives on
paediatric radiopharmaceutical administered doses (Fahey et al., 2015).
In Korea, DRLs for nuclear medicine procedures were adopted from data of
patient activities administered for each diagnostic nuclear imaging examination, col-
lected using the web-based online database of KSNM (http://www.ksnm.or.kr/stats/)
in 2014. In the first nationwide survey, DRLs were established for 41 examinations of
diagnostic nuclear medicine procedures in 155 hospitals by KSNM and the Medical
Radiation Safety Research Center (http://www.mrsrc.kr) designated by the Korean
NSSC.
6. INTERNATIONAL ACTIVITIES ON RADIOLOGICAL

PROTECTION OF PATIENTS
6.1. ICRP
ICRP (1996) published Publication 73, entitled ‘Radiological protection and safety
in medicine’, to expand on the application in medicine of the Commission’s 1990
Recommendations (ICRP, 1990). Publication 105, entitled ‘Radiological protection
in medicine’ (ICRP, 2007b), was published in 2008 to augment Publication 73 and
underpin the Commission’s 2007 Recommendations (ICRP, 2007a) with regard to
the medical exposure of patients, including their comforters and carers, and volun-
teers in biomedical research. ICRP continues to work on radiological protection in
medicine. Current work topics in progress include: occupational radiological protec-
tion in brachytherapy; justification in medical uses of ionising radiation including
imaging of asymptomatic individuals; radiological protection in therapy with radio-
pharmaceuticals; occupational protection issues in interventional procedures (fluor-
oscopically guided); and DRLs for diagnostic and interventional imaging. At the
time of writing (September 2015), the draft on ‘DRLs in medical imaging’ by
Committee 3 is in progress (Vañó et al., 2015).
6.2. IAEA
6.2.1. International Action Plan for the Radiological Protection of Patients
In 2002, IAEA launched the International Action Plan for the Radiological
Protection of Patients (IAEA, 2002). The fourth meeting of the Steering Panel
was held in 2010, and the plan was met with remarkable success. Some of the
main items and recommendations included in the summary report of that meeting
were: (1) authenticated information to IAEA for inclusion on the Radiological
Protection of Patients (RPOP) website; (2) promotion of educational reporting
systems (on radiation incidents); (3) introduction of radiological protection into
medical and paramedical curricula; (4) urgent international agreement on staffing
needs in radiation medicine; (5) improvement in the availability of dose data in
digital imaging; (6) including patient dose data in the clinical history of patients;
(7) appropriate follow-up and lessons learned from incidents and accidents in
radiation medicine; and (8) promotion of the use of evidence-based referral
guidelines.
129
6.2.2. Radiological Protection of Patients website

The RPOP website (https://rpop.iaea.org) has been a significant instrument of
IAEA to communicate information to help health professionals achieve safer use
of radiation in medicine for the benefit of patients, along with information to
patients and the public on the benefits and risks of ionising radiation in medical
applications. This website was launched in September 2006 and has grown to be the
main website worldwide in the area of medical radiological protection (Rehani,
2013). The website provides extensive material on radiological protection in the
use of radiology, nuclear medicine, radiotherapy, interventional fluoroscopy, inter-
ventional cardiology, other specialities, and imaging modalities including PET-CT
scanning. Radiological protection of patients in nuclear medicine, covering diagnos-
tic nuclear medicine, therapeutic nuclear medicine, and biomedical research, is
included on the RPOP website. This website also contains training materials on
radiological protection in nuclear medicine and radiological protection in PET-
CT. Pregnant women form a specific group for radiological protection purposes,
and they are dealt with separately.
6.2.3. Bonn Call for Action

IAEA held the International Conference on Radiological Protection in Medicine:
Setting the Scene for the Next Decade in Bonn, Germany in December 2012, with the
specific purpose of identifying and addressing issues arising in radiological protection
in medicine. The conference was co-sponsored by WHO, hosted by the Government
of Germany through the Federal Ministry for the Environment, Nature
Conservation, and Nuclear Safety, and attended by 536 participants and observers
from 77 countries and 16 organisations. An important outcome of the conference
was the identification of responsibilities and a proposal for priorities for stakeholders
regarding radiological protection in medicine for the next decade. This specific out-
come is known as the ‘Bonn Call for Action’ (IAEA, 2012). The aims of the Bonn
Call for Action are to: (1) strengthen the radiological protection of patients and
health workers overall; (2) attain the highest benefit with the least possible risk to
all patients by the safe and appropriate use of ionising radiation in medicine; (3) aid
the full integration of radiological protection into healthcare systems; (4) help
improve the benefit–risk dialogue with patients and the public; and (5) enhance
the safety and quality of radiological procedures in medicine. In March 2015, the
US Food and Drug Administration released an update on its efforts in response to
the Bonn Call for Action, with a list of 10 priorities for radiological protection
(FDA, 2015). The 10 calls for action were: (1) enhance implementation of the prin-
ciple of justification; (2) enhance implementation of the principle of optimisation of
protection and safety; (3) strengthen the manufacturers’ role in contributing to the
overall safety regime; (4) strengthen radiological protection education and training
of health professionals; (5) shape and promote a strategic research agenda for radio-
logical protection in medicine; (6) increase availability of improved global informa-
tion on medical exposure and occupational exposure in medicine; (7) improve
prevention of medical radiation incidents and accidents; (8) strengthen radiation
130
safety culture in health care; (9) foster an improved radiation benefit–risk dialogue;
and (10) strengthen the implementation of safety requirements globally.
6.3. WHO
6.3.1. Global Initiative on Radiation Safety in Health Care Settings
WHO has launched the Global Initiative on Radiation Safety in Health Care
Settings to mobilise the health sector in the safe use of radiation in medicine
(WHO, 2008). This initiative brings together key stakeholders (e.g. health authori-
ties, international organisations, professional and scientific societies) in concerted
action. The initiative seeks to complement the International Action Plan for the
Radiological Protection of Patients established by IAEA in 2002. The provision of
policy guidance to health authorities and the development of practical tools for users
of radiation in the medical field will enhance protection of patients and healthcare
workers.
The wide use of radiation in medicine calls for a public health approach to con-
trolling and minimising health risks, while maximising the benefits. WHO is giving
special consideration to the evaluation of possible health hazards related to the use of
radiation. Using scientific evidence, WHO aims to raise awareness by promoting
radiation safety in medicine, particularly in terms of preventing unnecessary medical
radiation exposure. The main objective of this initiative is to support Member States
in the implementation of radiation safety standards in healthcare facilities.
6.4. Multi-society campaigns

6.4.1. Image Gently
Initiated by a group of concerned paediatric radiologists in 2006, Image Gently is
an educational, awareness, and advocacy campaign of the Alliance for Radiation
Safety in Pediatric Imaging, a coalition of healthcare and regulatory organisations
dedicated to providing safe, high-quality paediatric imaging worldwide. The primary
objective of the Alliance is to raise awareness in the imaging community of the need
to adjust the radiation dose when imaging children. The ultimate goal of the Alliance
is to change clinical practice to reduce radiation exposure. Image Gently is directed
and run by volunteers, with small financial contributions from the four founding
organisations [American Association of Physicists in Medicine (AAPM), ACR,
American Society of Radiologic Technologists (ASRT), and Society for Pediatric
Radiology (SPR)]. Composed of more than 60 healthcare organisations and agen-
cies, Image Gently attempts to include all stakeholders involved in paediatric ima-
ging, including parents and families. Stakeholders include more than 700,000
radiologists, technologists, medical physicists, and paediatricians. The Alliance’s
website contains brochures with information for parents and paediatric protocols
for CT, interventional radiology, and nuclear medicine (Applegate and Cost, 2013).
Image Gently and the Society of Nuclear Medicine and Molecular Imaging
(SNMMI, 2014) created the ‘Go with the Guidelines’ awareness campaign to encour-
age community hospitals, academic hospitals, and clinics to observe standardised
guidelines on radiopharmaceutical dose for paediatric patients.
131
6.4.2. Image Wisely

In 2010, AAPM, ACR, ASRT, and the Radiological Society of North America
formed a partnership to address concerns about the surge of public exposure to
ionising radiation from medical imaging. The result was creation of the Image
Wisely campaign, with the objective of lowering the amount of radiation used in
medically necessary imaging studies and eliminating unnecessary procedures. To
date, more than 19,000 health professionals, 30 medical organisations, and more
than 300 medical facilities have taken the Image Wisely pledge to optimise the use
of radiation in imaging patients. The Image Wisely campaign initially addressed
issues involving dose optimisation in the field of CT by launching a website
(http://www.imagewisely.org) that provided information for imaging professionals
(including physicians, physicists, and technologists), referring physicians, and
patients. In its second phase, Image Wisely collaborated with the American
Society of Nuclear Cardiology, SNMMI, and SNMMI–Technologist Section to
develop content with respect to dose optimisation in nuclear medicine.
Information was generated in the fields of general nuclear medicine, nuclear car-
diology, PET-CT, and nuclear medicine physics. As a result, Image Wisely
launched its nuclear medicine page in 2012. Campaigns such as Image Wisely
and its counterpart in paediatric imaging, Image Gently, not only provide valuable
information to its readers regarding dose optimisation in medical imaging, but also
raise awareness of its importance among the medical community (Brink and Amis,
2010).
6.4.3. Choosing Wisely

In 2012, the American Board of Internal Medicine (ABIM) Foundation launched
the Choosing Wisely campaign with the goal of advancing a national dialogue on
avoiding wasteful or unnecessary medical tests, treatments, and procedures.
Choosing Wisely centres around conversations between providers and patients
informed by the evidence-based recommendations of ‘Things Providers and
Patients Should Question’. More than 70 specialty society partners have released
recommendations with the intention of facilitating wise decisions about the most
appropriate care based on a patient’s individual situation. This campaign helps pro-
viders and patients to engage in conversations to reduce overuse of tests and pro-
cedures including nuclear medicine.
On 21 February 2013, SNMMI released a list of ‘Five Things Physicians and
Patients Should Question’ in nuclear medicine and molecular imaging as part of
the Choosing Wisely campaign, led by the ABIM Foundation. SNMMI’s list identi-
fied the following five recommendations: (1) do not use PET-CT for cancer screening
in healthy individuals; (2) do not perform routine annual stress testing after coronary
artery revascularisation; (3) do not use nuclear medicine thyroid scans to evaluate
thyroid nodules in patients with normal thyroid gland function; (4) avoid using a CT
angiogram to diagnose pulmonary embolism in young women with a normal chest
radiograph, and consider a radionuclide lung study ‘[(ventilation/perfusion) V/Q
study]’ instead; and (5) do not use PET imaging in the evaluation of patients with
132
dementia unless the patient has been assessed by a specialist in this field
(SNMMI, 2013).
6.4.4. Image Green in Korea

There are many concerns about radiation exposure in Korea after the accident at
the Fukushima nuclear power plant in 2011 in Japan. In addition, the mass media
have created an air of anxiety that jumps on the population’s fear instead of taking a
scientific approach. The Korean Alliance for Radiation Safety and Culture in
Medicine (KARSM) was founded in September 2011 by eight medical-radiation-
related societies (Korean Society of Radiology, KSNM, Korean Society for
Radiation Oncology, Korean Association of Radiation Protection, Korean Society
of Medical Physics, Korean Society of Radiological Science, Korean Academy of
Oral and Maxillofacial Radiology, Korean Radiological Technologists Association)
with the aim of promoting, educating, and campaigning about medical radiation
safety, so called ‘Image Green’. The activities of KARSM focussed on spreading a
culture of medical radiation safety from 2011 to 2012 (http://www.imagegreen.org)
(Sung and Shin, 2013; Yoon et al., 2013).
6.5. International guidelines for paediatric radiopharmaceutical administered doses

Dose reduction in paediatric imaging has been a work in progress for nearly a
decade. In 2006, the European Association of Nuclear Medicine (EANM) published
a new version of their paediatric dosage card for 39 radiopharmaceuticals (Lassmann
et al., 2007). In 2008, an amendment with respect to the use of F-18 fluorodeoxyglu-
cose was introduced (Lassmann et al., 2008). Following four consensus workshops
conducted in partnership with SNMMI, SPR, and ACR, the 2010 North American
Consensus Guidelines for Pediatric Administered Radiopharmaceuticals were devel-
oped in 2011 (Gelfand et al., 2011). During the 2012 and 2013 EANM annual
congresses, a working group including members of both EANM and SNMMI met
to study the possibility of harmonising the guidelines published by the two societies.
Although paediatric radiopharmaceutical doses in the North American consensus
guidelines differ from those on the EANM paediatric dosage card in several import-
ant respects, these meetings have culminated in the development of a set of inter-
national guidelines, also referred to as ‘Paediatric Radiopharmaceutical
Administration: Harmonization Guidelines’. Twelve radiopharmaceuticals are
included in the new guidelines, and others will soon be incorporated. A modified
version of the new EANM dosage card incorporating the suggested changes was
released in 2014 (Lassmann et al., 2014).
The Nuclear Medicine Global Initiative (NMGI) was formed at an EANM meet-
ing in Milan, Italy in October 2012, and consists of 13 international organisations
with direct involvement in nuclear medicine. The underlying objectives of NMGI are
to promote human health by advancing the field of nuclear medicine and molecular
imaging, encourage global collaboration in education, and harmonise procedure
guidelines and other policies that ultimately lead to improvements in quality and
safety in the field throughout the world. For its first project, NMGI decided to
133
consider the issues involved in the standardisation of administered activities in paedi-

atric nuclear medicine. A report published in early 2015 provides a review of the
value of paediatric nuclear medicine, current understanding of the carcinogenic risk
of radiation as it pertains to the administration of radiopharmaceuticals in children,
and the application of dosimetric models in children. A forthcoming (Part 2) report
will discuss current standards for administered activities in children and adolescents
that have been developed by various organisations, and an evaluation of the current
practice of paediatric nuclear medicine specifically with regard to administered activ-
ities, as determined by an international survey of nuclear medicine clinics and cen-
tres. Lastly, the Part 2 report will recommend a path forwards towards global
standardisation of the administration of radiopharmaceuticals in children (Fahey
et al., 2015).
7. CONCLUSIONS
This paper has here reviewed chronological changes in medical radiation expos-
ure, including nuclear medicine; the implementation status of new international
standards for radiological protection (ICRP, 2007a; IAEA, 2014) in the EU and
Korea; the principles of justification and optimisation; and international activities
on radiological protection of patients from ionising radiation. This includes the work
of ICRP Committee 3 on preparing ‘DRLs in medical imaging’; IAEA engagement
in several activities including the International Action Plan for the Radiological
Protection of Patients; the RPOP website; the Bonn Call for Action; the WHO
Global Initiative on Radiation Safety in Health Care Settings; multi-society cam-
paigns including Image Gently, Image Wisely, and Choosing Wisely; and various
ongoing activities that provide international guidelines for paediatric radiopharma-
ceutical administered doses such as the EANM paediatric dosage card and the
Nuclear Medicine Global Initiative. In conclusion, in the coming years, numerous
efforts will have to be made in these areas to justify and optimise medical procedures
using radiation. A greater effort should be made to educate and assure patients, their
families, and colleagues that the risks of overexposure of ionising radiation have
been taken into account and are well balanced by the benefits in order to avoid
deterring patients from life-saving procedures.
ACKNOWLEDGEMENTS
This work was supported by the Nuclear Safety Research Program through the Korean
Radiation Safety Foundation and the Korean NSSC (Grant No. 1305033).
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137
Radiological protection in ion beam
radiotherapy: practical guidance for clinical use
of new technology
Y. Yonekuraa, H. Tsujiia, J.W. Hopewellb, P. Ortiz Lópezc,
J-M. Cossetd, H. Paganettie, A. Monteliusf, D. Schardtg, B. Jonesh,
T. Nakamurai
a
National Institute of Radiological Sciences, Anagawa 4-9-1, Inage-ku, Chiba 263-8555,
Japan; e-mail: yonekura@nirs.go.jp
b
Green Templeton College, University of Oxford, UK
c
IAEA, Austria
d
Institut Curie, France
e
Massachusetts General Hospital, USA
f
Uppsala University Hospital, Sweden
g
GSI, Germany
h
Gray Institute for Radiation Oncology and Biology, University of Oxford, UK
i
Professor Emeritus of Tohoku University, Japan
Abstract–Recently introduced technologies in radiotherapy have significantly improved the

clinical outcome for patients. Ion beam radiotherapy, involving proton and carbon ion beams,
provides excellent dose distributions in targeted tumours, with reduced doses to the surround-
ing normal tissues. However, careful treatment planning is required in order to maximise the
treatment efficiency and minimise the dose to normal tissues. Radiation exposure from sec-
ondary neutrons and photons, particle fragments, and photons from activated materials
should also be considered for radiological protection of the patient and medical staff.
Appropriate maintenance is needed for the equipment and air in the treatment room, which
may be activated by the particle beam and its secondary radiation. This new treatment
requires complex procedures and careful adjustment of parameters for each patient.
Therefore, education and training for the personnel involved in the procedure are essential
for both effective treatment and patient protection. The International Commission on
Radiological Protection (ICRP) has provided recommendations for radiological protection
Protection.
138
in ion beam radiotherapy in Publication 127. Medical staff should be aware of the possible
risks resulting from inappropriate use and control of the equipment. They should also consider
the necessary procedures for patient protection when new technologies are introduced into
clinical practice.
Keywords: Ion beam radiotherapy; Radiological protection; External radiotherapy
1. INTRODUCTION
Remarkable progress has been made in the application of radiotherapy over the
last half-century. Recently introduced radiotherapy techniques can improve the dose
conformation to the target tumour with better sparing of normal tissues. However,
complicated treatment systems require careful handling of the equipment and basic
knowledge of radiological protection. Thus, education and training specific to new
treatment methods are essential for safe and efficient use of the clinical application.
The International Commission on Radiological Protection (ICRP) has published
recommendations for radiological protection in radiotherapy, including Publication
86 (ICRP, 2000) for prevention of accidental exposure of radiotherapy, and
Publication 112 (ICRP, 2009) with particular emphasis on new technologies in exter-
nal beam radiotherapy.
Ion beam radiotherapy can theoretically provide excellent dose distribution due
to the advantage of enhanced energy deposition at a certain depth in the body
(Tobias et al., 1956). New treatment systems of ion beam radiotherapy permit further
improvements in dose distribution with the advancement of treatment planning
systems. Publication 127 (ICRP, 2014) was prepared to provide recommendations
specific to this new radiotherapy modality. This paper briefly reviews the concept and
procedures of radiological protection, and provides practical guidance for healthcare
professionals involved in ion beam radiotherapy.
2. ION BEAM RADIOTHERAPY

Ion beams provide superior dose distributions due to their finite range in tissue,
resulting in a significant reduction in radiation exposure to surrounding normal
tissues. Ion beam radiotherapy is characterised by production of the maximum ion-
isation density at a certain depth in tissue, depending on the energy of the ion beams
delivered, referred to as a ‘Bragg peak’. This provides improved dose conformation
to the treatment volume, with better sparing of the surrounding normal tissue
structures.
2.1. Patient selection

Ion beams are considered to have the optimum properties for dose localisation.
The selection of patients suitable for ion beam radiotherapy is the first step in the
treatment. Benefits of ion beam therapy can be achieved in patients with solid
139
cancers with defined borders. Further, this treatment can be considered to be ideal
for inoperable tumours.
Proton beam radiotherapy may offer clinical advantages compared with conven-
tional photon radiotherapy for many cancers, mainly as a result of a more favourable
distribution of radiation dose (Lundkvist et al., 2005). Carbon ion therapy has the
advantage of high-linear-energy-transfer (LET) radiation for the treatment of various
tumours which are resistant to conventional photon radiotherapy or chemotherapy
(Chauvel, 1995). The benefits of carbon ion radiotherapy have been shown for non-
squamous cell tumour types, including sarcoma, malignant melanoma, adenocarcin-
oma, adenoid cystic carcinoma, and chordoma (Tsujii and Kamada, 2012).
However, the advantage is more difficult to utilise in patients with cancer of the
digestive tract, such as stomach and colon cancer, due to unexpected motions of the
organ wall during the treatment process, and possible perforation of the wall by any
severe damage caused by the treatment. Although ion beam radiotherapy has not yet
demonstrated a substantial improvement in long-term survival for most patients
(Soarers et al., 2005), it can provide similar outcomes as surgical resection with
better quality of life.
2.2. Delivery of ion beams

An ion beam delivery system consists of an accelerator, a beam transport system,
and an irradiation system. A high-energy ion beam is delivered through a beam
transport system to an irradiation system. The original narrow beam extracted
from the accelerator is not ready for use in treatment, except when using a beam
scanning method. The irradiation system broadens the narrow beam for the specific
target volume. This method is called the ‘broad beam method’ and is classified as the
‘passive method’. Alternatively, ‘beam scanning’ is a method to achieve a highly
conformal field by three-dimensional scanning of the original beam, extracted
from the accelerator, within the target tumour volume. The broad beam method
has the advantage of providing uniform beam distribution in the target volume,
while the beam scanning method requires precise control of beam delivery,
but can theoretically achieve more conformal dose distributions, particularly for
complex-shaped targets. Furthermore, scanning allows the delivery of intensity-
modulated particle fields.
2.3. Physical and biological characteristics

Ion beams are characterised by conformal dose concentration in tissue and
enhanced biological effects. The clinical advantage results from a steeply rising
absorbed dose, or Bragg peak at a certain depth, depending on the energy of the
ion beams. Therefore, a superior dose concentration can be achieved by targeting the
tumour within the Bragg peak. This advantage is similar for both proton and carbon
ion beams.
The absorbed dose in Gy is the primary quantity to determine the biological and
clinical effectiveness of any radiation beam, but radiation quality of an ion beam also
affects the outcome. The most commonly used quantity for specifying radiation
140
quality is the LET (ICRU, 1970). Values of relative biological effectiveness (RBE)
are defined as the ratio of a dose of a low-LET reference radiation to a dose of the
radiation considered that gives an identical biological effect. Proton beams in current
clinical use have been conventionally considered as low-LET radiation, and thus the
RBE values used are close to that of high-energy x rays. However, this simplistic view
has recently been questioned as protons in the region of the distal Bragg peak can
have RBE values as high as fast neutrons, and late-reacting normal tissues may be
more sensitive to subtle increases in LET and thus RBE (Dasu and Toma-Dasu,
2013; Paganetti, 2014; Jones, 2015; Tommasino and Durante, 2015). Carbon ions, on
the other hand, have higher RBE values than protons, and these increase with depth
and have their maximum values near the depth where the Bragg peak occurs. RBE-
weighted absorbed physical doses, Gy(RBE), can be used for clinical purposes when
considering the biological effect of ion beams (ICRU, 2007; Wambersie et al., 2011;
Bentzen et al., 2012).
2.4. Procedures of treatment

2.4.1. Diagnostic imaging
The accurate delineation of the tumour boundary is the first step of this treatment.
Diagnostic imaging, such as x-ray computed tomography (CT), magnetic resonance
imaging (MRI), and positron emission tomography (PET), is indispensable for reli-
able treatment planning. Combined imaging devices, such as PET-CT or PET-MRI,
have also become available to provide valuable diagnostic information for treatment
planning. The excellent outcomes of ion beam radiotherapy, which have been proven
in recent papers, are partly due to advances in diagnostic imaging.
2.4.2. Treatment planning

Treatment planning is based on calculation of the ion beam doses delivered to the
tumour and surrounding tissues, considering the physical and biological character-
istics of ion beams. Careful treatment planning is expected for optimising the dose to
the tumour, with minimum dose and thus effects in surrounding healthy tissues.
Treatment planning for ion beam radiotherapy usually starts from CT scans,
which should be taken under the same conditions as the real treatment. The patient
is immobilised on the treatment couch under the same breathing condition as for
treatment.
The clinical target volume and organs at risk (OARs) are first defined on the
planning CT images, followed by determination of the planning target volume,
which allows for physiological changes between the planning CT and treatment,
including organ motion and daily variations in set-up positions (ICRU, 1993,
1999). Unlike in conventional therapy, ion beam radiotherapy also requires the con-
sideration of range uncertainties (Rietzel et al., 2007; Paganetti, 2012).
2.4.3. Immobilisation and irradiation

After treatment planning, the procedures of ion beam radiotherapy include
patient immobilisation, patient positioning, and beam delivery for irradiation.
141
It is essential to manage the entire process with extreme care in order to achieve the
planned dose to the tumour, and also to avoid accidental overexposure and unneces-
sary damage in the surrounding tissues.
During the treatment process, the patient is immobilised and positioned for treat-
ment, and the ion beams are delivered for a period of seconds or minutes depending
on the intensity of the beams. The conditions of beam delivery, the patient, and
devices are monitored constantly, and the beam is stopped when the prescribed
dose has been administered.
In spite of careful handling and monitoring, the movement of organs in the body
cannot be avoided, which may cause inaccuracy in the dose calculation and unex-
pected doses to tissues, particularly due to changes in the beam range and thus the
position of the Bragg peak. Therefore, these factors should always be considered in
treatment planning.
2.4.4. Respiratory motion

The motion of organs always degrades the precision in dose delivery. Respiratory
breathing is the most common cause of organ motion, with significant movement in
both the thoracic and abdominal regions. However, this problem can be solved in
two ways: by breath holding during irradiation; or by gating of the irradiation
delivery over the respiratory cycle.
Respiratory gating of radiation exposures has been proposed and used in con-
ventional external beam radiotherapy. Breathing motion can be detected and moni-
tored with an infra-red light spot and a position-sensitive charge-coupled device
camera, which provides a respiration waveform signal as used for gating delivery of
ion beams in certain phases of the respiratory cycle. Fluoroscopic imaging can also
be used for this purpose. As the movement of organs is usually more stable at the
end of expiration, gating for beam extraction is usually set to this phase of
respiration.
3. RADIOLOGICAL PROTECTION
3.1. Medical exposure
3.1.1. Therapeutic dose
Treatment planning in ion beam radiotherapy can theoretically provide a curative
radiation dose to be delivered to the target volume. Obviously, the therapeutic dose
delivered to the target tumour could cause serious damage if normal tissues are
included; however, the definitive determination of the tumour boundary is not
always easy in a clinical setting, and irradiation to the marginal zones should
always be considered. Treatment planning should optimise that situation, providing
sufficient dose to the tumour while avoiding potential serious tissue damage in crit-
ical organs, similar to other general radiotherapy methods. The treatment planning
method for proton radiotherapy, as described in ICRU Report 78 (ICRU, 2007), is
essentially the same for carbon ion radiotherapy, except for the consideration of
RBE variations in carbon ion therapy.
142
3.1.2. Dose in out-of-field volumes

Doses in out-of-field volumes can be estimated in the treatment planning of ion
beams, but additional dose also arises from secondary neutrons and photons, par-
ticle fragments, and photons from activated materials. These undesired but unavoid-
able doses should be considered for the purpose of radiological protection.
Secondary neutrons are the main factor to contribute to dose in the areas distant
from the treatment volume. The use of the pencil beam scanning method can reduce
this type of radiation exposure significantly.
Studies comparing conventional photon radiotherapy, intensity-modulated radio-
therapy (IMRT), and proton radiotherapy showed that both IMRT and proton
radiotherapy have a similar ability to improve the dose distribution in the target
volume, but proton radiotherapy provides a more favourable dose distribution in the
out-of-field volumes (Palm and Johansson, 2007). Carbon ion radiotherapy can
reduce the maximum dose to OARs due to its lower scattering power.
3.1.3. Medical exposure from imaging

Imaging procedures involved in ion beam radiotherapy include x-ray CT for
treatment planning, radiographic and fluoroscopic procedures for treatment rehear-
sal, and patient set-up verification at the beginning of each dose fraction. Although
these imaging procedures provide significant information for ion beam radiotherapy,
they also result in additional radiation doses to the patient. Typical doses delivered
from various imaging procedures during ion beam radiotherapy and after treatment
could sometimes reach 100 mGy. This will vary according to the treatment fraction-
ation schedule and frequency of x-ray imaging.
3.1.4. Risk of second cancer after radiotherapy

The expanding use of radiotherapy and significant improvement in long-term
patient survival have resulted in the need to monitor and evaluate patients for pos-
sible risks of second cancers (NCRP, 2011). The risk of second cancer for a patient
depends on the volume of the high-dose region in the irradiation field and the low-
dose region outside that field. Proton and carbon ion radiotherapy achieves the best
dose distribution for the target volume, as mentioned above, and obviously results in
not only reducing side effects in OARs but also minimising the risk of second cancer
within or near the irradiation field. The risk of second cancer in the low-dose region
remains a controversial issue, as the exposure is considerably lower than that close to
the treatment target volume, but it may not be negligible for risk assessment, espe-
cially in younger patients. Previous studies have suggested that proton radiotherapy,
particularly using the scanning method, can reduce the incidence of second cancer
compared with IMRT or conventional photon radiotherapy (Newhauser and
Durante, 2011; Moteabbed et al., 2014).
3.1.5. Protection of family members

High-energy ion beams, such as protons or carbon ions, induce nuclear reactions
in a patient’s body, resulting in the activation of nuclei. The major radionuclides
143
induced are short-lived positron-emitting radionuclides, such as C-11, N-13 and

O-15. This requires the assessment of radiation exposure to people who stay close
to the patient after ion beam radiotherapy, such as working staff, comforters and
carers, and family members. However, radiation exposure of family members
and caretakers due to this activation is quite small, and no specific protection pro-
cedures are required (Tsujii et al., 2009).
3.2. Occupational exposure

In ion beam radiotherapy, interactions with atomic nuclei also result in activa-
tion of the air of the treatment room, the patient’s body, and the beam line devices.
The sources for occupational exposures of radiation workers in the facilities are
these activated materials, and the activity is highest just after irradiation of the
patient as the physical half-lives of the induced radioactivity are relatively short,
and the radioactivity decreases steadily according to the half-lives of these
radionuclides.
Medical staff may have to enter the treatment room just after ion beam radio-
therapy, where the activated air and equipment may cause radiation dose to the staff.
The activation doses in proton radiotherapy are higher than those in carbon ion
radiotherapy because the fluence of protons delivered to patients is generally higher
than that for carbon ions. For both protons and carbon ions, the activation doses
can be lower with the pencil beam scanning method than the broad beam method.
Doses to workers, estimated in typical clinical settings, concluded that the current
regulations for photon radiotherapy are also applicable to ion beam radiotherapy
(Tsujii et al., 2009; ICRP, 2014).
3.3. Management of radiation safety

Appropriate handling and management are required for accelerators when
radiation safety standards for high-energy particle accelerator facilities are
applied. ICRP provided the scope of radiological protection control measures
in Publication 104 (ICRP, 2007). International Safety Standards for Protection
against Ionizing Radiation and for the Safety of Radiation Sources (IAEA,
1996) can be used for proper management. These recommendations and stand-
ards are also used for the prevention of accidental exposure. Lessons learned
from previous accidental exposures in radiotherapy are provided in Publications
86 and 112 (ICRP, 2000, 2009), and IAEA (2000). In addition to the gen-
eral requirement for radiological protection, specific issues associated
with high-energy ion beams should also be addressed by the management of
facilities.
Appropriate management of therapy equipment is needed due to activation
during the treatment process. It should also be considered that air in the treatment
room is activated. Management should always conform with the criteria of the
regulatory agency. The current regulations for occupational exposures in photon
radiotherapy are also applicable to ion beam radiotherapy with protons or
carbon ions.
144
4. PREVENTING ACCIDENTAL EXPOSURE

Recently introduced methods in radiotherapy provide highly conformal dose dis-
tribution, but even subtle errors during the treatment process would easily bring
severe consequences. In order to avoid accidental exposures, prospective, structured,
and systematic approaches to identify the system’s weaknesses are needed (ICRP,
2009). For this purpose, dissemination of the knowledge and lessons learned from
accidental exposures is important in preventing re-occurrence of accidents. As ion
beam radiotherapy has only been applied in a limited number of patients, the lessons
learned from previous accidental exposures from conventional external beam radio-
therapy are also helpful in preventing accidents in ion beam radiotherapy
(ICRP, 2014).
The greatest advantage of ion beams for radiotherapy is dose localisation char-
acterised by the Bragg peak, which enables excellent dose distribution to the target
volume with adjacent OARs receiving the lowest dose possible. However, substantial
concerns still exist due to uncertainties in the beam parameters, as target positioning
is more critical in ion beam radiotherapy (ICRP, 2009). At present, because the
lessons learned from published events are not yet available, prospective approaches
to identify potential risks should be considered carefully for comprehensive quality
assurance (QA). This can detect systematic errors, and decrease the frequency and
severity of random errors (ICRP, 2000; Cantone et al., 2013).
5. RECOMMENDATIONS
Ion beam radiotherapy provides excellent dose distribution to the target tumour,
and proper patient selection should be the first step for justification of the treatment
to provide optimal benefit to the patient (ICRP, 2014). Careful treatment planning is
required for optimisation to provide the maximum efficiency of treatment, and min-
imum dose to normal tissues. Proton and carbon ion therapies are more conformal
than conventional therapy, which makes them more prone to the dosimetric effects
of uncertainties.
An ion beam delivery system consists of an accelerator, a high-energy beam trans-
porter, and an irradiation system. When ion beams pass through or hit these beam
line structures, secondary neutrons and photons can be produced, as well as particle
fragments and photons from the activated materials. Doses in out-of-field volumes
arise from secondary neutrons and photons, particle fragments, and photons from
activated materials.
Appropriate management is required for the equipment and air in the treatment
room. The current regulations for occupational exposures in photon radiotherapy
are also applicable to ion beam radiotherapy with protons or carbon ions. After
treatment with ion beam radiotherapy, the patient is a radioactive source. However,
radiation exposure of family members or the public is small, and no specific care is
required.
145
Ion beam radiotherapy requires a much more complicated treatment system

than conventional radiotherapy. As such, extensive training of staff and an ade-
quate QA programme are recommended to avoid possible accidental exposure of
the patient.
Incorporating lessons learned from past accidental exposures into current training
is crucial to prevent re-occurrence. A number of lessons learned in photon radio-
therapy may also be applicable to ion beam radiotherapy. This retrospective
approach should be complemented with prospective methods for identification of
system weaknesses and their prevention in ion beam radiotherapy.
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Internet-based ICRP resource for healthcare
providers on the risks and benefits of medical
imaging that uses ionising radiation
S. Demetera, K.E. Applegateb, M. Perezc
a
Department of Radiology, University of Manitoba, Section of Nuclear Medicine,
Health Sciences Centre, 820 Sherbrook Street, Winnipeg, Manitoba, R3A 1R9, Canada;
e-mail: sdemeter@hsc.mb.ca
b
Department of Radiology and Imaging Sciences, Emory University School of Medicine, USA
c
Department of Public Health, Environmental and Social Determinants of Health, Cluster of
Family, Women’s and Children’s Health, World Health Organization, Switzerland
Abstract–The purpose of the International Commission on Radiological Protection (ICRP)

Committee 3 Working Party was to update the 2001 web-based module ‘Radiation and your
patient: a guide for medical practitioners’ from ICRP. The key elements of this task were: to
clearly identify the target audience (such as healthcare providers with an emphasis on primary
care); to review other reputable sources of information; and to succinctly publish the contri-
bution made by ICRP to the various topics. A ‘question-and-answer’ format addressing prac-
tical topics was adopted. These topics included benefits and risks of imaging using ionising
radiation in common medical situations, as well as pertaining to specific populations such as
pregnant, breast-feeding, and paediatric patients. In general, the benefits of medical imaging
and related procedures far outweigh the potential risks associated with ionising radiation
exposure. However, it is still important to ensure that the examinations are clinically justified,
that the procedure is optimised to deliver the lowest dose commensurate with the medical
purpose, and that consideration is given to diagnostic reference levels for particular classes of
examinations.
Keywords: Internet; Health education; Radiological protection; Health literacy; Medical

imaging
Protection.
148
1. INTRODUCTION
We live in a time where tremendous amounts of internet-based, or web-based,
information are accessible on almost every conceivable topic, with varying degrees
of source credibility. It is encouraging to note that there are numerous credible
sources of information on radiological protection in medical settings. The purpose
of the International Commission on Radiological Protection (ICRP) Committee 3
Working Party was to update an internet-based ICRP module entitled ‘Radiation
and your patient: a guide for medical practitioners’ (ICRP, 2001), first published in
English in 2001 and subsequently translated into Spanish. In an environment with
many sources of similar information, it is important to ensure that ICRP’s web-
based resource is not superlative. To this end, the updated report will focus on
ICRP’s contribution to radiological protection in medical settings, and directed
interested readers to further resources from both ICRP and other organisations
working on radiological protection. Primary healthcare providers represent the
target audience. The language level for the report is therefore provided in a way
that can be shared with patients and their caretakers if desired. A pragmatic
‘question-and-answer’ format was chosen to allow the document to be searched
easily for specific areas of interest, and to facilitate rapid answers to questions
raised by busy providers. One further goal is to provide the information as open
source to a worldwide audience.
2. METHODS
The original ICRP web-based report (ICRP, 2001) was reviewed, and a set of key
questions were drafted and agreed upon through an iterative review process amongst
members of ICRP Committee 3. Existing credible web-based and peer-reviewed
sources of information were also reviewed, and a selection of these is provided in
Table 1.
In addition, there are a number of credible websites specifically related to the
appropriate use of ionising radiation imaging and dose reduction in patients
(Table 2).
3. RESULTS
A list of commonly encountered radiological protection topics was compiled,
and topics were described in a ‘question-and-answer’ format. These topics are not
intended to be the final set, as the web-based resource can be modified and
expanded at any time. The following is a brief description and summary of the
key topics addressed in the report. Each of these topics is discussed in more detail
in the web report. The main differences between this internet-based resource and
the former are a shorter more focussed question-and-answer format, updated ICRP
references, and an expanded audience of primary healthcare providers beyond
physicians.
149
Table 1. Relevant web-based sources of information on radiological protection in medical

settings.
Organisation or institute (key role) Website (accessed 22 July 2015)
International Commission on http://www.icrp.org/

Radiological Protection (guidance
and policy)
Health Physics Society (resource) http://hps.org/
Health Safety Executive (regulatory http://www.hse.gov.uk/radiation/ionising/index.htm
oversight)
International Atomic Energy Agency https://www.iaea.org/
(regulatory oversight)
National Council on Radiation http://www.ncrp.com/
Protection and Measurements
(guidance and policy)
United Nations Scientific Committee http://www.unscear.org/
on the Effects of Atomic Radiation
World Health Organization http://www.who.int/ionizing_radiation/en/
Table 2. Relevant patient radiation dose reduction and imaging education websites.
Organisation or institute Website (accessed 22 July 2015)
Image Gently – the Alliance for http://www.imagegently.org/Home.aspx

Radiation Safety in Paediatric
Imaging
Image Wisely – Radiation Safety in http://www.imagewisely.org/About-Us
Adult Medical Imaging
Eurosafe Imaging – European http://www.eurosafeimaging.org/
Society of Radiology
Radiology Information for Patients – http://www.radiologyinfo.org
Radiological Society of North
America and American College of
Radiology
3.1. What is the International System of Radiological Protection?

‘Since 1928, ICRP has developed, maintained, and elaborated the international
system of radiological protection used worldwide as the common basis for radio-
logical protection standards, legislation, guidelines, programmes, and practice’
(www.icrp.org).
‘The International System of Radiological Protection has been developed by
ICRP based on (i) the current understanding of the science of radiation exposures
150
and effects and (ii) value judgements. These value judgements take into account
societal expectations, ethics, and experience gained in application of the system’
(ICRP, 2007).
The international system of radiological protection is anchored by three key
principles: justification, optimisation of protection, and the application of dose
limits.
3.1.1. Justification
Justification means that any decision that alters the radiation exposure situation
should do more good than harm (www.icrp.org).
In medicine, this means that a healthcare provider must only recommend an
examination or procedure that uses ionising radiation when the potential benefit is
greater than the radiation risk. ICRP, most recently in Publication 103 (ICRP,
2007), recommends justification of medical exposures at three levels: (1) use of
radiation in medicine should do more good than harm; (2) a given type of pro-
cedure is justified for a particular clinical indication as it will improve the diagnosis
or treatment of patients; and (3) a medical examination for an individual patient
will do more good than harm by contributing to the management of the patient’s
treatment.
3.1.2. Optimisation
Optimisation means that all exposures should be kept as low as reasonably achiev-
able (i.e. the ALARA principle), while taking into account economic and societal
factors, with restrictions on individual exposure to limit inequities in dose distribu-
tion (www.icrp.org).
In medicine, the principle of optimisation is best described as managing the radi-
ation dose to the patient to be commensurate with the medical purpose. The goal is
to use the appropriate dose to obtain the desired image or desired therapy. This
process should ensure that procedure protocols are designed to use the best test and
technique, based on the patient’s age, size, sex, and test availability, to address the
clinical questions being posed.
Examples of optimisation include, but are not limited to:
. reducing fluoroscopy time, such as by using pulsed fluoroscopy and limiting

‘beam-on’ time;
. proper shielding of staff (e.g. lead aprons, eye protection, and shielded con-
trol rooms) and patients (e.g. thyroid, breast, or gonadal shielding, when
appropriate);
. optimisation of clinical protocols to achieve adequate image quality at the lowest
exposure necessary. This involves ensuring that appropriate techniques are used,
that the collimation/field of view is optimised, and that repeat imaging is mini-
mized; and
. exploiting advances in technology such as automatic tube current modulation and
iterative reconstruction algorithms for computed tomography (CT).
151
3.1.3. Dose limits

Except for existing (e.g. background) and emergency situations, dose limits apply
to workers and the public, but not to patients undergoing radiological or nuclear
medicine diagnostic or interventional procedures. However, diagnostic reference
levels (DRLs) can be used in medical imaging to help achieve good image quality
while keeping doses ALARA. DRLs are derived via national-, regional-, or local-
modality- and procedure-specific radiation dose surveys. ICRP does not specify spe-
cific DRLs, leaving this decision to the involved ‘authorised bodies’.
‘Diagnostic reference levels are already being used in medical diagnosis (i.e.,
planned exposure situations) to indicate whether, in routine conditions, the levels
of patient dose or administered activity from a specified imaging procedure are
unusually high or low for that procedure.’ (ICRP, 2007)
3.2. What is ionising radiation?

Ionising radiation deposits energy in tissues and can damage DNA either directly
or indirectly. Health effects of ionising radiation can be divided into threshold-
related tissue reactions (e.g. hair loss, skin erythema, and cataracts) and stochastic
effects (e.g. cancer or hereditary effects) with no threshold.
3.3. How is ionising radiation dose measured?

Radiation dose refers to the deposition of energy in tissues related to exposure to
either external or internal ionising radiation sources. The Système International unit
for radiation dose is the Gray (Gy; J kg 1). The sievert (Sv; J kg 1) is used for
equivalent dose (when radiation weighting factor is applied) and for effective dose
(when radiation weighting and tissue weighting factors are applied).
3.4. How much ‘natural’ radiation are we exposed to?

Natural, or background, radiation originates from terrestrial (i.e. the earth) and
cosmic (i.e. outer space) sources (UNSCEAR, 2008). Natural radiation levels vary
somewhat depending on geology and altitude above sea level. The average back-
ground radiation dose is approximately 3 mSv. Radon gas emitted from the ground
is the largest contributor to natural background radiation dose, and radon is felt to
be the most significant contributor to the incidence of lung cancer in non-smokers.
This compares with a per-capita medical radiation dose (i.e. x rays and nuclear
medicine) in the USA of 0.2 mSv in the early 1980s, increasing by a factor of 7 to
3.0 mSv in 2006 (NCRP, 2009). A medical dose survey conducted between 2007 and
2010 in European Union countries reported a lower per-capita dose of approxi-
mately 1.1 mSv (EC, 2014).
3.5. What are the benefits and risks of diagnostic imaging and interventional
procedures?
Modern diagnostic imaging and image-guided interventional procedures are inte-
gral for a good quality healthcare system. The relatively small risks of ionising
radiation need to be put into the context of significant benefits to patient care related
152
to justified diagnostic or interventional procedures with appropriate protocols. One

of the most important concerns in long complex interventional procedures is to avoid
the risk of radiation-induced skin burns. The theoretical risks of low-dose medical
radiation, such as cancer or adverse hereditary effects, also need to be acknowledged
and managed through the aforementioned principles of justification and optimisa-
tion. Table 2 provides credible sources of information on dose reduction strategies
for medical imaging.
3.6. What are the risks of ionising radiation in pregnancy?

In general, the benefits of justified ionising radiation diagnostic procedures with
appropriate protocols outweigh the risks to the mother or the fetus (Russel et al.,
1997; McCollough, 2007; ICRP, 2015). Ionising radiation interventional procedures
require expert consultation and consideration. There needs to be a standardised
protocol to screen for pregnancy in female patients of reproductive capacity. In
some instances (e.g. high-dose procedures or therapies), laboratory confirmation
such as a negative serum or urine human chorionic gonadotropin b result may be
required.
3.7. What are the risks of ionising radiation to babies during breast feeding?
In nuclear medicine, some radiopharmaceuticals are excreted into breast milk. As
a result, in addition to the mother herself, her breast milk can be a source of radi-
ation to the baby. Depending on the specific radiopharmaceutical administered,
guidelines range from no interruption, to interruption for a prescribed period of
time, to total cessation of breast feeding (Stabin and Breitz, 2000; ICRP, 2004). If
a nuclear medicine examination is necessary while the patient is breast feeding, con-
sultation with a nuclear medicine specialist is advised.
3.8. What are the risks of ionising radiation to children?

With radiation exposure from imaging increasing due to a rapid rise in use, it is
important to consider the unique situation of children. Depending on their age,
organ, and tumour type, children are reported to be, on average, two to three times
more sensitive to radiation than adults, and the younger the infant or child, the
more radiosensitive they are at high doses. A recent report by the United Nations
Scientific Committee on the Effects of Atomic Radiation (UNSCEAR, 2013) found
that 35% of cancers are associated with increased sensitivity in children compared
with adults, with approximately one-third of other cancers not showing different
sensitivity from adults, and the final third of cancers showing inconclusive infor-
mation. In addition, children have a longer lifetime during which cancer may
develop from exposure to radiation. For these reasons, a more cautious approach
tends to be adopted towards the use of ionising radiation imaging in children than
in adults.
The following are a few simple things that can be done to reduce childhood
radiation exposure when using ionising radiation imaging tests (e.g. CT scans):
(1) consider the patient’s age and size, and choose the level of radiation exposure
153
accordingly; (2) most information can be gained from a single study, so do not repeat
studies unnecessarily; and (3) only image the indicated area.
4. DISCUSSION
In the field of radiation safety, there is very little published literature on the utility
of web-based resources. Busby (2002) published a broad set of web-based resources
on ‘radiation’ which included basic and applied science, health effects, regulators,
and related organisations. The target audience was the general public, health pro-
fessionals, policy makers, and scientists.
However, the internet is an ubiquitous source of information that individuals,
professionals or otherwise, access to become better informed. The goal is to ensure
that such individuals become ‘well’ informed rather than just ‘web’ informed. For
example, internet-based information can be seen as a resource and tool to address
radiation risk knowledge gaps between healthcare providers and their patients
(Thornton et al., 2015).
This is reiterated in Jardine et al. (2003) on the essential role of communication in
human health risk management.
5. CONCLUSIONS
In an era of information overload, it is important for web-based resources to
remain timely, relevant, and pitched at the appropriate level for the target audience.
The updated ICRP web-based report on radiological protection in medical settings
will achieve this for healthcare professionals.
REFERENCES
Busby, B., 2002. Radiation information and resources on-line. Toxicology 173, 167–178.
EC, 2014. Medical Radiation Exposure of the European Population. Radiation Protection No
180. European Commission, Luxembourg City.
ICRP, 2001. Radiation and your patient – a guide for medical practioners. ICRP Supporting
ICRP, 2004. Doses to infants from ingestion of radionuclides in mothers’ milk. ICRP
Publication 95. Ann. ICRP 34(3/4).
ICRP, 2015. Radiation dose to patients from radiopharmaceuticals: a compendium of current
information related to frequently used substances. ICRP Publication 128. Ann. ICRP
44(2S).
Jardine, C., Hrudey, S., Shortreed, J., et al., 2003. Risk management frameworks for human
health and environmental risks. J. Toxicol. Environ. Health B Crit. Rev. 6, 569–720.
McCollough, C.H., Schueler, B.A., Atwell, T.D., et al., 2007. Radiation exposure and preg-
nancy: when should we be concerned? Radiographics 27, 917–918.
NCRP, 2009. Ionizing Radiation Exposure of the Population of the United States. Report No.
160. National Council on Radiation Protection and Measurements, Washington, DC.
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Russel, J.R., Stabin, M.G., Richard, B.S., Watson, E., 1997. Radiation absorbed dose to the
embryo/fetus from radiopharmaceuticals. Health Phys. 73, 756–769.
Stabin, M.G., Breitz, H.B., 2000. Breast milk excretion of radiopharmaceuticals: mechanisms,
findings, and radiation dosimetry. J. Nucl. Med. 41, 863–873.
Thornton, R.H., Dauer, L.T., Shuk, E., et al., 2015. Patient perspectives and preferences for
communication of medical imaging risks in a cancer care setting. Radiology 275, 545–552.
UNSCEAR, 2008. Sources of Ionizing Radiation. United Nations Scientific Committee on the
Effects of Atomic Radiation 2008 Report to the General Assembly, with Scientific
Annexes, Vol. I. United Nations, New York.
UNSCEAR, 2013. Sources, Effects, and Risks of Ionizing Radiation. United Nations
Scientific Committee on the Effects of Atomic Radiation 2013 Report to General
Assembly. Vol. II, Scientific Annex B: Effects of Radiation Exposure of Children.
United Nations, New York.
155
ICRP dose coefficients: computational
development and current status
W.E. Bolcha, N. Petoussi-Henssb, F. Paquetc, J. Harrisond
a
University of Florida, Gainesville, FL 32611-6131 USA; e-mail: wbolch@ufl.edu
b
Helmholtz Zentrum München, German Research Centre for Environmental Health, Germany
c
IRSN, Direction de la Strate´gie, France
d
Oxford Brookes University, Faculty of Health and Life Sciences, UK
Abstract–Major current efforts within Committee 2 of the International Commission on

Radiological Protection (ICRP) involve the development of dose coefficients for inhalation
and ingestion of radionuclides, and those for exposure to environmental radiation fields.
These efforts build upon changes in radiation and tissue weighting factors (Publication 103),
radionuclide decay schemes (Publication 107), computational phantoms of the adult reference
male and female (Publication 110), external dose coefficients for adult reference workers for
idealised radiation fields (Publication 116), models of radionuclide intake (Publications 66, 100
and 130), and models of radionuclide systemic biokinetics (Publication 130). This paper will
review the overall computational framework for both internal and external dose coefficients.
For internal exposures, the work entails assessment of organ self-dose and cross-dose from
monoenergetic particle emissions (specific absorbed fraction), absorbed dose per nuclear
transformation (S value), time-integrated activity of the radionuclide in source tissues (inhal-
ation, ingestion, and systemic biokinetic models), and their numerical combination to yield the
organ equivalent dose or effective dose per activity inhaled or ingested. Various challenges are
reviewed that were not included in the development of Publication 30 dose coefficients, which
were based upon much more simplified biokinetic models and computational phantoms. For
external exposures, the computations entail the characterisation of environmental radio-
nuclide distributions, the transport of radiation particles through that environment, and the
tracking of energy deposition to the organs of the exposed individual. Progress towards the
development of dose coefficients to members of the general public (adolescents, children,
infants and fetuses) are also reviewed.
Keywords: Dose coefficients; Internal dosimetry; External dosimetry
Protection.
156
1. INTRODUCTION
A central responsibility of Committee 2 of the International Commission on
Radiological Protection (ICRP) is the development of reference dose coefficients for
radiation exposure of workers (irradiation scenarios under occupational settings) and
members of the general public (irradiation scenarios under environmental settings).
Members of Committee 2 also work in concert with members of Committee 3 regard-
ing dose coefficients for medical exposures, particularly for radiopharmaceuticals
administered either for diagnostic imaging or therapeutic treatment. Dose coefficients
are broadly defined as a quantity that, when multiplied by a measurement of either
radionuclide intake, air kerma, particle fluence, or environmental radioactivity con-
centration, will yield an organ equivalent dose or the effective dose to the exposed
individual. They may be specific to monoenergetic radiation fields, radiation fields
composed of a spectrum of energies, or radiation emissions specific to a given radio-
nuclide or a mixture of radionuclides. For workers, equivalent dose coefficients are
defined for the reference adult male and reference adult female, and these are sex-
averaged in the calculation of effective dose. For members of the general public, dose
coefficients may be defined for infants, children, and adolescents of various defined
reference ages. They may also be defined for pregnant females, where the organs of
interest are those in the developing fetus.
For internal exposures to adult workers, a dose coefficient is defined as either the
committed equivalent dose in organ or tissue T per inhalation or ingestion activity
intake, hT(50), or the committed effective dose per intake, e(50), where 50 is the dose-
commitment period in years over which the dose is calculated. In some cases, the
term ‘dose per intake coefficient’ is used. Internal dose coefficients require the devel-
opment and subsequent implementation of three general types of component models,
as demonstrated graphically in Fig. 1.
The first is a model of radionuclide intake (ingestion, inhalation, or possibly
wound absorption), its subsequent uptake to blood as well as various ‘source’
organs, its release back to blood, and ultimately its excretion from the body
(Fig. 1A). Both physical decay within the body and the ingrowth of radioactive
progeny are considered. The second is a component model of radionuclide nuclear
transformation, including full accounting of the types of radiation particles emitted,
their energies or energy spectra, and their relative emission frequencies (Fig. 1B).
Finally, a component model of the internal anatomy of the exposed individual is
employed, along with radiation transport computation, to follow all radiation par-
ticles from their sites of emission in the various source organs to their sites of energy
deposition within various target organs for which a dose estimate is sought (Fig. 1C).
It is noted that source organs are, by definition, also target organs. Other target
organs are those tissues within the ranges of the emitted radiation particles, including
secondary processes such as bremsstrahlung x-ray emission. The quantity sought in
these simulations is the specific absorbed fraction (SAF), defined as the fraction of
emitted particle energy in the source organ that is deposited per unit mass in the
target organ. Over many decades, ICRP has further refined these different classes of
component models, applying new scientific data and computational techniques as
157
Fig. 1. Three major models needed to calculate internal radiation dose by radionuclides fol-
lowing inhalation, ingestion, or wound entry. These include: (A) a model of radionuclide
biokinetic behaviour within the body tissues; (B) the energies and yields of all radiations
emitted by the radionuclide in the source organs; and (C) anatomical models of the exposed
individual allowing assessment of both self-dose and cross-dose to target organs of interest in
158
Fig. 2. Two exposure scenarios considered for calculation of external dose coefficients in
radiological protection: (A) idealised uniform radiation fields of relevance to occupational
exposures; and (B) radiation fields from radionuclides in contaminated air, water, or soil.
AP, antero-posterior; PA, postero-anterior; LLAT, left lateral; RLAT, right lateral; ROT,
rotational; ISO, isotropic.
they become available. In many cases, specific models are developed within
Committee 2 and its various Task Groups as part of their overall mission to develop
the next generation of reference dose coefficients.
For external exposures, the dose coefficient relates a dose quantity – either the
organ equivalent dose or effective dose – to a calculated or measured quantity such
as air kerma, particle fluence, or radioactivity concentration. As illustrated in Fig. 2,
there are two broad classes of external exposures. The first, shown in Fig. 2A, are
exposures to broad fields of radiation particles that, in an idealised sense, reflect
exposures in occupational irradiation settings. Dose coefficients may thus be assigned
based upon particle type, particle energy, and irradiation geometry. For example,
antero-posterior irradiation infers that the radiation particles impinge on the worker
from his or her front (anterior) surface. Right lateral irradiation infers that the
radiation particle field impinges on the worker from his or her right body side.
The second class of external dose coefficients, illustrated in Fig. 2B, relates the
organ or effective dose rate to either a measurement of air kerma 1 m above the
ground, or to radioactivity concentration in either contaminated air, water, or soil.
The latter can be further defined as a function of soil depth, thus allowing the user to
apply measurements of depth-dependent radionuclide soil activity to the dose assess-
ment. ICRP has recently refined its values of reference dose coefficient for idealised
occupational radiation fields (ICRP, 2010). New efforts are underway to define, for
the very first time, reference dose coefficients for environmental exposures.
2. COMPUTATIONAL FRAMEWORK FOR INTERNAL

DOSE COEFFICIENTS
In prospective radiological protection, internal dose coefficients are defined for either
inhalation or ingestion of radionuclides. Models do exist that allow for the consideration
of entry of radionuclides into the body via wound absorption, but this pathway is
159
considered strictly in the context of accidental dose reconstruction. Models for radio-
nuclide airway deposition, particle airway clearance, and blood absorption are con-
tained in the ICRP Human Respiratory Tract Model given in Publication 66 (ICRP,
1994), with updates provided in Publication 130 (ICRP, 2015). Models for radionuclide
ingestion and gastrointestinal tract translocation are contained in the ICRP Human
Alimentary Tract Model given in Publication 100 (ICRP, 2006). Both models provide a
way of simulating the entry of radionuclides into the blood of the circulatory system,
after which one must invoke a model for systemic biokinetics.
The compartment models of the respiratory and alimentary tract coupled with
those of the systemic biokinetics define a system of first-order differential equations.
The solution to the set of equations is the time-dependent distribution of the radio-
nuclide and its radioactive progeny, if any, in mathematical compartments that are
associated with anatomical regions in the body. Let Ai,j (t) represent the activity of
radionuclide i in compartment j at time t. The rate of change in the activity of
member i of the decay chain, i ¼ 1, 2,. . ., N with i ¼ 1 being the parent nuclide, in
compartment j, can be written as:
2 3
XM 6 X 7 X
dAi,j ðtÞ 6 M 7 i1
¼ 6
Ai,k i,k,j Ai,j 6 P7
i,j,k þ i 7 þ Ak,j k,i Pi ð1Þ
dt 4k ¼ 1 5 k¼1
k¼1
k 6¼ j k 6¼ j
where:
M is the number of compartments describing the kinetic model;

i,j,k is the fractional transfer rate of chain member i from compartment j (donor
compartment) to compartment k (receiving compartment) in the biokinetic model;
Pi is the physical decay constant of chain member i; and
k,i is the fraction of the decays of chain member k forming chain member i.
Given the initial conditions specified for the compartments, Ai,j (0), Eq. (1) defines the
dynamic behaviour of the radionuclide and its progeny within the human body. The first
term on the right-hand side of Eq. (1) represents the rate of flow of chain member i into
compartment j from all donor compartments. The second term represents the rate of
removal of member i from compartment j by transfer to receiving compartment k and
by physical decay. The third term addresses the ingrowth of member i within compart-
ment j due to the presence of its precursor k in the compartment.
The system of N M ordinary first-order differential equations must be
solved using suitable numerical methods. The system is generally solved for the
initial conditions that Ai,j ð0Þ ¼ 0 for all compartments, with the exception of com-
partments of intake where non-zero initial conditions are only applied to the parent
nuclide (i.e. i ¼ 1).
160
To calculate the numerical values of the dose coefficients, it is necessary to associate

the biokinetic compartments of Eq. (1) with anatomical regions in the body; so-called
source regions indexed by rS . The source regions may or may not be a living tissue. For
example, the contents of the alimentary tract are not living tissues, and may consist of
more than one kinetic compartment. The number of nuclear transformations of chain
member i occurring in source region rS , A~ i ðrS Þ (units of Bq s), is given by:
XZ
A~ i ðrS , Þ ¼ Ai,j ðtÞdt ð2Þ
j 0
where is the commitment period (taken to be 50 y for workers). The summation in

Eq. (2) is over all kinetic compartments j associated with source region rS , and the
quantity Ai,j ðtÞ is obtained by solving Eq. (1). The number of nuclear transformations
per activity intake in the source region rS , denoted as a~ i ðrS , Þ (s), is given by:
A~ i ðrS , Þ
a~i ðrS , Þ ¼ P ð3Þ
j A1,j ð0Þ
where the summation in the denominator is over the compartment contents at t ¼ 0.

In the case of inhalation of particulate and gaseous matter, the denominator includes
the exhaled activity as only a fraction of the activity intake that is deposited in the
compartments of the Human Respiratory Tract Model.
The committed equivalent dose coefficient in target region rT of the reference adult
male, hM ðrT , Þ, and reference adult female, hF ðrT , Þ, for integration time is given by:
XX
hM ð r T , Þ ¼ a~ i ðrS , ÞSM
w ðrT rS Þi ð4Þ
i rS
XX
hF ðrT , Þ ¼ a~i ðrS , ÞSFw ðrT rS Þ i ð5Þ
i rS
where the S coefficients, SM w ðrT rS Þi and SFw ðrT rS Þi , are the radiation weighted
equivalent doses in target region rT per nuclear transformation of chain member i in
source region rS [Sv (Bq s)1] for the male and female worker, respectively. Note that
the outer summation extends over the parent nuclide and its progeny. The radiation-
weighted S coefficient [Sv (Bq-s)1] for a radionuclide is calculated as:
X X
Sw ðrT rS Þ ¼ wR ER,i YR,i f rT rS , ER,i ð6Þ
R i
where:
ER,i is the energy of the ith radiation of type R emitted in nuclear transformations of
the radionuclide;
YR,i is the yield of the ith radiation of type R per nuclear transformation [(Bq s)1];
wR is the radiation weighting factor for radiation type R; and
161

f rT rS , ER,i is the SAF, defined as the fraction of energy ER,i of radiation type R
emitted within the source tissue rS that is absorbed per mass in the target tissue
rT (kg1).
A number of tissues used to compute the effective dose are considered to be

represented by a single target region, rT . In cases where more than one tissue
region defines the target tissue, fractional weighting of the equivalent dose must be
made. The committed equivalent dose coefficients for tissue T in the reference adult
male, hM F
T ð Þ, and reference adult female, hT ð Þ, are thus given as:
X
hM
T ðÞ ¼ f ðrT , TÞhM ðrT , Þ ð7Þ
rT
X
hFT ðÞ ¼ f ðrT , TÞhF ðrT , Þ ð8Þ
rT
where the target region fractional weights f ðrT , TÞ are the proportions of the equiva-
lent dose in tissue T associated with target region rT . For the respiratory tract tissues,
values of f ðrT , TÞ are taken as the risk apportionment factors outlined in Publication
66 (ICRP, 1994). For the colon and lymphatic nodes, they are based on fraction
target masses in different anatomical regions of the Reference Person.
The committed effective dose coefficient, eð Þ, is then:
X M
hT ðÞ þ hFT ðÞ
eð Þ ¼ wT ð9Þ
T
2
where wT is the tissue weighting factor for target tissue T, and hM

T ðÞ and
hFT ðÞ are the corresponding committed equivalent dose coefficients for
these same tissues in the reference adult male and reference adult female,
respectively.
3. MODELS FOR RADIONUCLIDE BIOKINETIC DISTRIBUTION

Following intake by either inhalation or ingestion, a fraction of the radionuclide
enters the blood and body fluids of the body. The subsequent fate of the radio-
nuclide in the body is computationally handled by a systemic biokinetic model.
Models are specific to individual elements and apply to all their radioisotopes. In
its first comprehensive report of reference dose coefficients for internal exposure,
ICRP employed systemic biokinetic models in Publication 30 (ICRP, 1980) as
shown generically in Fig. 3. Radioactivity in the ‘transfer compartment’ is trans-
ferred exponentially to one or more compartments of the body tissues. As the radio-
nuclide is then released from the source tissues, it is assumed to be eliminated directly
from the body in excreta (urine or faeces). Individual source organs may be
162
Fig. 3. General structure of biokinetic models of radionuclides in Publication 30 (ICRP, 1980).
represented as either one, two or three compartments, each with their own fractional
uptake from blood and biological half-time.
As an example, the element caesium in Publication 30 (ICRP, 1980) is assumed
to have only one source tissue – the total body. However, that one source
tissue is partitioned in the systemic biokinetic model for caesium into two source
compartments – one with an uptake fraction of 0.1 that clears rapidly from the
body, and the other with an uptake fraction of 0.9 that clears more slowly from
the body:
f1 ¼ 0:1 and f2 ¼ 0:9 ð10Þ
For the radionuclide Cs-137, the effective rate constants for these two source com-
partments (given as the sums of their biological and the physical rate constants) are thus:
ln2 ln2 y
eff1 ¼ B1 þ P ¼ þ
2d 30y 365d
ln2 ln2 y
eff2 ¼ B2 þ P ¼ þ ð11Þ
110d 30y 365d
The activity of Cs-137 as a function of time post-intake is then taken in

Publication 30 (ICRP, 1980) to be given as:

ATB ðtÞ ¼ f1 Ablood ð0Þ exp eff1 t þ f2 Ablood ð0Þ exp eff2 t ð12Þ
This functional form of the time-dependent organ activity is referred to as a

retention equation, and requires the specification of the number of component com-
partments of the source organ; for each component compartment, the fraction of
163
blood uptake and biological half-time must be specified. The time-integrated activity
is then given as the following in this two-compartment total-body systemic model of
Cs-137:
Z ¼50y
A~ TB ¼ ATB ðtÞdt ð13Þ
0
f1 Ablood ð0Þ f2 Ablood ð0Þ

A~ TB ¼ 1 exp eff1 þ 1 exp eff2 ð14Þ
eff1 eff2
While considered, at the time of publication, to be sufficient for the vast majority of
radionuclides of interest to radiological protection, the use of retention equations in
Publication 30 (ICRP, 1980) has several significant limitations. First, one assumes
immediate translocation of activity from blood to the source organs, and thus no
accounting is made for nuclear transformations occurring in blood prior to organ
uptake. As a result, one cannot include a ‘blood source’ in the dose assessment; a
severe limitation for many shorter-lived radionuclides of interest to both environmen-
tal and radiopharmaceutical dosimetry. Second, one assumes that following radio-
nuclide organ metabolism, the activity is excreted immediately from the body. In
reality, the activity re-enters blood, after which only a fraction is processed in either
the colon for faecal excretion or in the kidneys for urinary excretion. For radionuclides
of shorter biological organ elimination, this recycling phase of radionuclide biodistri-
bution is absent and cannot be incorporated into the dose assessment.
Beginning in the early 1990s, Committee 2 and its Task Groups began to adopt
more physiologically realistic models of radionuclide systemic biokinetics that per-
mitted explicit consideration of the initial distribution of the radionuclide in the
circulatory system, and its subsequent re-entry to blood following organ elimination.
This approach employs the construction of a biokinetic compartmental model of
radionuclide distribution in the body.
Fig. 4 shows the current ICRP systemic model for caesium and its various radio-
isotopes. The various labelled compartments thus represent ‘pools’ of the element
within the body, with the connecting arrows representing transfer coefficients defin-
ing the fraction of the source compartment that is transferred to the receiving com-
partment per unit time. Caesium in the blood is thus shown to localise to bone, liver,
the alimentary tract contents, and various soft tissues of the body; the latter are
modelled by three separate compartments with differing transfer rates. Caesium in
the blood is further localised in the kidney tissues as well as processed to urine; it is
stored temporarily in the urinary bladder, and then excreted. This and other models
of the various elements are thus based upon combinations of measured data (animal
or human) and fundamental knowledge of organ/tissue physiology and elemental
metabolism. The use of compartmental systemic models developed by ICRP has a
wide range of applications beyond radiological protection, including human toxicol-
ogy, industrial hygiene, and pharmacodynamics.
164
Fig. 4. Example structure of the physiologically realistic biokinetic models used presently by
the International Commission on Radiological Protection. This particular example shows that
for systemic distribution of caesium in the adult worker.
4. MODELS OF RADIONUCLIDE DECAY AND RADIATION EMISSION

The major component model needed for the calculation of a dose coefficient is
that for the nuclear transformation of the radionuclide. By definition, a nuclear
transformation is a process by which the ratio of neutrons to protons (N/P) in the
nucleus is altered in a manner that ensures a more stable balance of attractive and
repulsive nuclear forces. Four main modes of nuclear transformation are a particle
emission (N/P ratio increases), b particle emission (N/P ratio decreases), positron
emission (N/P ratio increases), and orbital electron capture (N/P ratio increases).
Each of these forms of nuclear transformation has various major associated radi-
ations, including g-ray and conversion electron emissions (both forms of release of
excess nuclear binding energy), and characteristic x-ray and Auger electron emis-
sions (both forms of release of excess electronic binding energy). Models of nuclear
transformation entail detailed accounting of the energies, energy spectra, and
percentage yield relative to all nuclear transformations that are energetically
possible.
The first major compilation of radionuclide decay schemes was released by
ICRP in Publication 38 (ICRP, 1983); this included energies and yields of both
primary and associated radiations emitted from 820 different radionuclides. Data
were restricted to radionuclides with physical half-lives exceeding 10 min. The
report provided abbreviated tables of decay data along with a schematic diagram
165
of the decay scheme for each radionuclide. These data were used in the computa-
tion of dose coefficients in the Publication 30 series (ICRP, 1979a,b, 1980, 1981a,b,
1982a,b).
In 2008, ICRP released its second extensive compilation of radionuclide decay
data in Publication 107 (ICRP, 2008). This report covered some 1252 radionuclides
and included all nuclides with a physical half-life of >1 min for which the
nuclear structure information was judged sufficient for a meaningful assessment of
emissions. Data were provided in Publication 107 for 922 radionuclides with a half-
life of >10 min and for 330 radionuclides with a half-life of <10 min. This report
departed from the formation of Publication 38 (ICRP, 1983) in that it included the
decay data in electronic form as a CD with associated software with rapid look-up
capability software.
5. ANATOMICAL MODELS FOR REFERENCE ADULTS

The third and final component model needed for the computation of reference
dose coefficients is a three-dimensional (3D) model of the exposed person, with def-
initions of both internal organ anatomy and outer body surfaces. Until very recently,
ICRP relied heavily on the use of so-called stylised or mathematical models of organ
anatomy, such as those from Oak Ridge National Laboratory (ORNL). A graphical
representation of the ORNL adult model is shown in Fig. 5. Body and organ surfaces
are defined using geometrical 3D surface equations such as spheres, cones, ellipsoids,
and toroids. These models are generally hermaphrodites with both male and female
sex organs included.
Following issuance of the 2007 Recommendations (ICRP, 2007), the Commission
released new computational phantoms of ICRP reference adult male and reference
adult female in Publication 110 (ICRP, 2009). These reference computational phan-
toms are digital 3D representations of human anatomy and are based on human
computed tomographic data. They are consistent with the information given
in Publication 89 (ICRP, 2002) on the reference anatomical parameters for
both male and female adults. The reference computational phantoms (or models)
were constructed by modifying the voxel models (Zankl and Wittmann, 2001; Zankl
et al., 2005) of two individuals (Golem and Laura) whose body height and mass
closely resembled the reference data. The organ masses of both phantoms were
adjusted to ICRP data with high precision, without altering their realistic anatomy
significantly. The phantoms contain all target regions relevant to the assessment of
human exposure to ionising radiation for radiological protection purposes (ICRP,
2007).
Each phantom is represented in the form of a 3D array of cuboid voxels.
Each voxel is a volume element, and the voxels are arranged in columns,
rows, and slices. Each entry in the array identifies the organ or tissue to
which the corresponding voxel belongs. The male reference computational phantom
consists of approximately 1.95 million tissue voxels (excluding voxels representing
the surrounding vacuum), each with a slice thickness (corresponding to the voxel
166
Fig. 5. Stylised anatomical model of the hermaphrodite adult used in previous reports of the
International Commission on Radiological Protection.
height) of 8.0 mm and an in-plane resolution (i.e. voxel width and depth) of
2.137 mm, corresponding to a voxel volume of 36.54 mm3. The number of slices is
220, resulting in a body height of 1.76 m; the body mass is 73 kg. The female refer-
ence computational phantom consists of approximately 3.89 million tissue
voxels, each with a slice thickness of 4.84 mm and an in-plane resolution of
1.775 mm, corresponding to a voxel volume of 15.25 mm3. The number of slices
is 346, and the body height is 1.63 m; the body mass is 60 kg. The number of indi-
vidually segmented structures is 136 in each phantom, to which 53 different tissue
compositions have been assigned. The various tissue compositions reflect both the
elemental composition of the tissue parenchyma (ICRU, 1992) and each organ’s
blood content (ICRP, 2002) (i.e. organ composition inclusive of blood). Fig. 6
shows frontal (coronal) views of the male (left) and female (right) computational
phantom.
Following the release of Publication 130 (ICRP, 2015), the Commission will issue an
entirely new generation of inhalation and ingestion dose coefficients to replace those
previously contained in Publication 30 (ICRP, 1980) and subsequent reports. As part
167
Fig. 6. Publication 110 (ICRP, 2009) reference computational phantoms of the adult male and
female.
of this effort, new SAF and radionuclide S values are computed and utilised in the
computation of the Occupational Intakes of Radionuclides series based upon
Publication 110 (ICRP, 2009) reference adult phantoms. Example values of photon
and electron SAFs are shown in Fig. 7 for both the reference adult male and reference
adult female. In each case, the radiation source is the kidneys, and the target organ is
the adrenal glands. An entirely new feature of these data is the explicit treatment of
electron transport as shown in Fig. 7B. Prior computations of ICRP dose coefficients
assumed full absorption of electron and b-particle kinetic energy in the source organ,
in which case the SAF value (adrenals kidneys) would be zero. As shown in Fig. 7B,
however, SAF values (adrenals kidneys) at electron energies of several hundred keV
are comparable in magnitude to those for photon emissions in the adult kidneys.
6. ANATOMICAL MODELS FOR MEMBERS OF THE GENERAL PUBLIC

Following the Chernobyl nuclear reactor accident in April 1986, it became abun-
dantly apparent that dose coefficients to members of the general public – including
168
Fig. 7. Values of specific absorbed fractions for (A) photon sources and (B) electron sources
localised in the kidneys of Publication 110 (ICRP, 2009) reference phantoms. The target organ
in each case is the adrenal glands.
169
infants, children, and adolescents – were needed for radiological protection guidance
in both post-accident dose assessment and environmental clean-up standards.
Consequently, ICRP embarked on a series of reports for which age-dependent bio-
kinetic models and anatomical phantoms were employed. Age-specific dose coeffi-
cients for both radionuclide ingestion and inhalation were published in Publications
56, 67, 71 and 72 (ICRP, 1990, 1993, 1995, 1996). Similarly, dose coefficients needed
for reporting organ and effective dose to the developing embryo and fetus were the
focus of Publications 88 and 95 (ICRP, 2001, 2004). In these report series, SAF
values for photons were computed using the ORNL series of paediatric and pregnant
female stylised phantoms (Stabin et al., 1995; Eckerman et al., 1996).
As a major update to these series of reports on public exposures, Committee 2 has
recently developed a new generation of reference voxel phantoms of ICRP paediatric
reference individuals to include newborn, and 1, 5, 10, and 15-y-old males and females.
The basis for this new series of reference phantoms is the University of Florida/
National Cancer Institute series of anatomical models shown in Fig. 8 and docu-
mented in Lee et al. (2010). These phantoms include all the major tissues and
Fig. 8. Future basis of new International Commission on Radiological Protection reference

computational phantoms of children and adolescents.
170
Fig. 9. Future basis of new International Commission on Radiological Protection reference

computational phantoms of the adult pregnant female (8–38 weeks post-conception).
organs included in Publication 110 (ICRP, 2009) adult reference phantoms. For the
updates to Publications 88 and 95 (ICRP, 2001, 2004), a new series of reference com-
putational phantoms of the adult pregnant female have been adopted by ICRP as
shown in Fig. 9. These particular anatomical models were constructed for use in
assessment of in-utero organ doses for the offspring of nuclear facility workers at
the Russian Mayak plant, and people living along the nearby Techa River
(Maynard et al., 2011, 2015a,b). They include explicit models of all fetal organ struc-
tures, including gestation-period-specific ossification centres of the fetal skeleton.
7. COMPUTATION OF EXTERNAL DOSE COEFFICIENTS

As noted previously, ICRP has issued Publication 116 (ICRP, 2010), a compre-
hensive report on dose coefficients for idealised external fields of ionising radiation of
relevance to occupational exposures. In this report, Committee 2 performed exten-
sive Monte Carlo radiation transport simulations using Publication 110 (ICRP, 2009)
adult reference phantoms, and considered monoenergetic fields of external photons,
electrons, neutrons, protons, muons, pions, and helium ions. Values of effective dose,
normalised to particle fluence incident to the exposed phantoms along six differ-
ent irradiation geometries, are shown in Fig. 10A and 10B, respectively, for mono-
energetic photons and neutrons. The report also compared these new external dose
coefficients with the operational quantities of ambient, directional, and personal dose
equivalent, reviewing their ability to assess the effective dose conservatively by radi-
ation particle, energy, and irradiation geometry. Dose coefficients for both effective
dose and sex-specific organ equivalent dose are provided in electronic formats that
accompany Publication 116.
Following the nuclear accident in Fukushima, Japan, ICRP embarked on a major
effort to produce reference dose coefficients for environmental radionuclide expos-
ures using both Publication 110 (ICRP, 2009) adult reference phantoms, and the
171
Fig. 10. Examples of effective dose coefficients for exposures to uniform fields of external
monoenergetic: (A) photons and (B) neutrons.
172
Fig. 11. Graphical depiction of the cylindrical coupling surface used for assessment of dose
coefficients for environmental exposures.
newly established ICRP paediatric reference phantoms of Fig. 8. This work is pres-
ently ongoing within Committee 2 and Task Group 90. As shown in Fig. 11, the
computations are performed in two stages. First, environmental sources of external
photons and electrons are simulated in the environment, and transported to a cylin-
drical coupling surface. At the cylindrical surface, the energies and angles (polar and
azimuthal) are scored for a second series of transport calculations in which different
computational phantoms (e.g. 1-y-old male or 15-y-old female) are inserted. In this
fashion, environmental transport from modeled contaminated air or soil only needs
to be performed once for each particle type and energy. Integration of the mono-
energetic dose coefficients over the full emission spectrum of a radionuclide of inter-
est thus yields the radionuclide-specific dose coefficient at a unit environmental
concentration. For contaminated soil, the calculations are performed as a function
of soil depth, after which one may consider differing soil concentration profiles as
either measured or assumed. Example dose coefficients for soil contaminated with
Cs-134 and Cs-137 are given in Fig. 12A and 12B, respectively (Satoh et al., 2015). In
each case, values of the ambient dose equivalent are shown to conservatively estimate
the effective dose rate per soil activity concentration, as a function of depth, and even
for the most highly exposed individual (i.e. reference newborn).
8. SUMMARY AND FUTURE DEVELOPMENTS

This paper has reviewed the computational framework for computing dose
coefficients for both internal and external radiation fields as needed for both
173
Fig. 12. Examples of effective dose coefficients for exposure to soil contaminated with:
(A) Cs-134 or (B) Cs-137 as a function of soil depth.
174
retrospective dose assessment and prospective planning for radiological protection.

Three component models are needed to compute the dose coefficient. These are:
(1) biokinetic models of radionuclide intake and systemic distribution; (2) models
of radionuclide decay modes, particles, energies, and yields; and (3) anatomical
models of the exposed individual, where they could be adult workers or members
of the general public. While no further development of radionuclide decay data is
envisioned within Committee 2 beyond those reported in Publication 107 (ICRP,
2008), further and ongoing work is being performed with respect to systemic bioki-
netic models and anatomical phantoms. Improved models will be applied to derive
dose coefficients for workers, and dependent on the availability of informative data,
age-dependent parameter values will be applied in the application of these models to
specify dose coefficients for children. For pregnant females, Publication 88 (ICRP,
2001) provided detailed compartmental models for some elements that considered
placental transfer and intrafetal radionuclide organ distribution explicitly. When
human and/or animal data were limited, Committee 2 resorted to the use of ratios
of organ activity concentrations in the fetus to that in the maternal organ. It is
anticipated that newer data will permit Committee 2 to include more physiologically
realistic maternal and fetal biokinetic models, and move further away from reliance
on organ concentration ratios.
ICRP will issue new reports on reference paediatric and pregnant female phan-
toms. As with the adult reference phantoms of Publication 110 (ICRP, 2009), these
reference anatomical models will be in the form of voxelised phantoms. While pro-
viding more anatomically realistic representations of internal anatomy than the older
stylised phantoms, voxel phantoms have their limitations, especially with respect to
small tissue structures (e.g. lens of the eye) and very thin tissue layers (e.g. stomach
wall mucosa and stem cell epithelium). Committee 2 has thus employed more organ-
specific stylised models in its work on internal photon, electron, and a particle SAFs
that replace those computed directly in the computational reference voxel phantoms.
Another example of this is the use of stylised models of the eye and skin as given in
the annexes to Publication 116 (ICRP, 2010).
These issues have arisen due to two specific limitations in radiation transport
computation. First, smaller structures in voxel phantoms can only be modelled by
decreasing voxel resolution at the expense of total matrix size of the phantom.
Second, radiation transport codes could only be utilised as their geometric input
mathematical expressions (as in stylised phantoms) or cuboidal arrays (as in voxel
phantoms). Newer generations of the Monte Carlo radiation transport codes, how-
ever, permit the input of computation phantoms assembled as polygon meshes,
where organ surfaces and outer body contours are modelled using triangular
arrays of vertices. As such, the very small structures that were crudely modelled in
voxel phantoms, or left out altogether, can now be included in the structure of the
reference phantom. These polygon mesh phantoms can thus include all the necessary
source and target tissues defined by ICRP, thereby completely obviating the need for
supplemental stylised models (e.g. respiratory airways, alimentary tract organ walls
and stem cell layers, lens of the eye, and skin epithelial layers). This work of
175
converting the voxelised phantoms of Publication 110 (ICRP, 2009) to polygon mesh
models of the reference adults is an ongoing task for Committee 2 (Nguyen et al.,
2015; Kim et al., 2016).
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177
Operational quantities and new approach
by ICRU
A. Endo on behalf of ICRU Report Committee 26 on Operational
Radiation Protection Quantities for External Radiation
Japan Atomic Energy Agency, Tokai-mura, Ibaraki 319-1195, Japan;
e-mail: endo.akira3@jaea.go.jp
Abstract–The protection quantities, equivalent dose in a tissue or organ and effective dose,
were developed by the International Commission on Radiological Protection (ICRP) to allow
quantification of the extent of exposure of the human body to ionising radiation. These quan-
tities are used for the implementation of limitation and optimisation principles. Body-related
protection quantities are not measurable in practice. Therefore, the International Commission
on Radiation Units and Measurements (ICRU) developed a set of operational dose quantities for
use in radiation measurements for external exposure that can assess the protection quantities. The
current ICRU operational quantities were defined more than 30 y ago. ICRU Report Committee
26 examined the rationale for the operational quantities, taking account of changes in the defin-
itions of the protection quantities in ICRP’s 2007 Recommendations. The considerations included
the range of types and energies of particles contributing to exposure of workers and members of
the public. ICRU Report Committee 26 investigated a set of alternative definitions for the oper-
ational quantities. The major change to the currently favoured set of quantities is redefinition of
the operational quantities, from being based on doses at specific points in the ICRU sphere and
soft tissue, to being based on particle fluence and conversion coefficients for effective dose and
absorbed dose to the lens of the eye and local skin.
Keywords: Operational quantities; Protection quantities; Individual monitoring; ICRU; ICRP
1. INTRODUCTION
Radiological protection requires quantification of the extent of exposure of the
human body to ionising radiation. To this end, the International Commission on
Protection.
178
Radiological Protection (ICRP) developed the protection quantities, equivalent dose

in a tissue or organ and effective dose (ICRP, 1977, 1991, 2007). The protection
quantities are used for the implementation of limitation and optimisation principles.
Human-body-related protection quantities are not measurable in practice; there-
fore, they cannot be used directly as quantities in radiation monitoring.
The International Commission on Radiation Units and Measurements (ICRU) devel-
oped a set of operational quantities for use in radiation measurements for external
exposure to assess the protection quantities. The operational quantities in current use
were defined in the 1980s (ICRU, 1985, 1988), which have been introduced into prac-
tice in many countries under radiological protection directives and regulations over
the past 30 y. Nevertheless, the existing system has some limitations and needs further
improvement to consider changes in the fields of application of the protection quan-
tities and operational quantities (ICRP, 2007, 2010; ICRU, 2010).
ICRU established Report Committee 26 in 2010 to discuss the above-mentioned
issues and propose an alternative system of operational quantities for external radi-
ations. The Committee comprises co-chairs, David Bartlett and Nolan Hertel; mem-
bers, Jean-Marc Bordy, Günther Dietze (deceased), Akira Endo, Gianfranco
Gualdrini, and Maurizio Pelliccioni; consultants, Peter Ambrosi, Rolf Behrens,
Jean-François Bottollier-Depois, Paolo Ferrari, Thomas Otto, Bernd Siebert,
and Ken Veinot; and ICRU sponsors, David Burns, Elena Fantuzzi, Hans Georg
Menzel, and Steve Seltzer. This paper presents an overview of ICRU Report
Committee 26’s discussion on the definitions, deficiencies, and limitations of the
current system, and its proposals for an alternative system of operational quantities.
2. GENERAL CONSIDERATION OF THE CURRENT SYSTEM

2.1. System of protection quantities and operational quantities
Fig. 1 shows the relationship between the protection quantities and operational
quantities for use in radiological protection (ICRP, 1996; ICRU, 1998). The protec-
tion quantities and operational quantities are related to basic physical quantities
which are generally used in radiation metrology and radiation dosimetry, and are
obtained through primary standards at national standards laboratories. Reference
conversion coefficients from the physical radiation field quantities, fluence and air
kinetic energy per unit mass (kerma), to the protection and operational quantities are
calculated using the definitions of the quantities. For the operational quantities,
conversion coefficients are used for the calibration of radiological protection
dosimeters.
2.1.1. Protection quantities developed by ICRP

The protection quantities have been used to quantify the extent of exposure of
the human body to ionising radiation from both whole- and partial-body
irradiation (ICRP, 2007). The main uses of the protection quantities are the opti-
misation of protection and setting of control criteria: limits, constraints, and refer-
ence levels.
179
Fig. 1. Relationship between the protection quantities and operational quantities for use in
The protection quantities are defined based on the mean absorbed dose, DT, R , in
the volume of a specified tissue or organ, T, due to radiation of type R. The equiva-
lent dose in a tissue or organ, HT , is then defined as follows:
X
HT ¼ wR DT, R
R
where wR is the radiation weighting factor for radiation R. The wR values are
chosen to account for the relative effectiveness of different radiation types for
stochastic effects.
The effective dose, E, is defined as:
X X X
E¼ wT HT ¼ wT wR DT, R
T T R
P
where wT is the tissue weighting factor for tissue T, and wT ¼ 1. The wT values are
chosen to represent the contributions of individual tissues and organs to the overall
radiation detriment due to stochastic effects. The unit of equivalent dose and effect-
ive dose is J kg1, and its special name is sievert (Sv).
2.1.2. Operational quantities developed by ICRU

The operational quantities aim to provide a reasonable estimate of the values of
the protection quantities relevant to exposure of humans to external radiation under
most irradiation conditions (ICRU, 1985, 1988, 1993).
180
The operational quantities are defined using the quantity dose equivalent, H
(ICRU, 1985). H is the product of Q and D at a point in tissue; thus, H ¼ QD,
where D is the absorbed dose and Q is the quality factor at that point. Q is defined as
a function of unrestricted linear energy transfer, L1 (often denoted as L or LET), of
charged particles in water (ICRP, 1996).
For area monitoring, two quantities, namely, the ambient dose equivalent, H ðd Þ,
and the directional dose equivalent, H0 ðd, XÞ, are used to link external radiations to the
effective dose and to the equivalent dose to the lens of the eye and local skin. H ðd Þ, at
a point in a radiation field, is the dose equivalent that would be produced by the
corresponding expanded and aligned field in the ICRU sphere at a depth, d, on the
radius opposing the direction of the aligned field. H0 ðd, XÞ, at a point in a radiation
field, is the dose equivalent that would be produced by the corresponding expanded
field at a depth, d, in the ICRU sphere, and on a radius in a specified direction, X.
For individual monitoring, the personal dose equivalent, Hp ðd Þ, is used. Hp ðd Þ is
the dose equivalent in soft tissue at an appropriate depth, d, below a specified point
on the body. The specified point is usually given by the position where the individ-
ual’s dosimeter is worn.
The recommended values of d are chosen for the assessment of various doses:
d ¼ 10 mm for effective dose, d ¼ 3 mm for dose to the lens of the eye, and
d ¼ 0.07 mm for dose to the skin and to the hands and feet. The unit of ambient dose
equivalent, directional dose equivalent, and personal dose equivalent is J kg1 or Sv.
2.2. Limitations of the operational quantities

The operational quantities in current use for external exposure were defined in the
1980s and have since been introduced successfully into legal metrology worldwide.
Nevertheless, the existing system has some limitations.
. The definition of the operational quantities is based on the dose equivalent in

ICRU 4-element tissue. The ICRU 4-element tissue has a density of 1 g cm3, and
a composition by mass of 76.2% oxygen, 11.1% carbon, 10.1% hydrogen, and
2.6% nitrogen. There is the fundamental problem that such tissue cannot be
fabricated, and there are problems with a few aspects of strict metrology.
. The dose equivalent is defined as the product of Q and D at a point in tissue. This
specific definition can never be realised experimentally and can, hence, only be
calculated based on knowledge of the radiation field of secondary charged par-
ticles at the point of interest.
. The values of conversion coefficients for the operational quantities given in
Publication 74 (ICRP, 1996) and ICRU Report 57 (ICRU, 1998) were calculated
in some cases using the kerma approximation method for energies where this
approximation is not appropriate.
. The particle types and energy ranges of radiation fields used in medical diagnosis,
therapy, and scientific research have been extended. There is the inclusion of natural
sources of radiation in ICRP recommendations (ICRP, 1991); aircraft crew are one
of the most highly exposed occupational groups, and the radiation field at flight
181
Fig. 2. Comparison of conversion coefficients for effective dose in various photon incident
directions (ICRP, 2010) and for H*(10). Note that the values for H*(10) are calculated with
full transport of secondary particles in the ICRU sphere. AP, antero-posterior; PA, postero-
anterior; LLAT, left lateral; RLAT, right lateral; ROT, rotational; ISO, isotropic.
altitudes includes a large component of high-energy particles from cosmic radiation.

To comply with the demands, conversion coefficients of the protection quantities
were extended up to 10 GeV in Publication 116 (ICRP, 2010). The operational
quantities are not always close estimates of the protection quantities in higher-
energy fields, and the effective dose is underestimated, as shown in Fig. 2.
. Based on recent epidemiological studies, ICRP has recommended lowering the
occupational equivalent dose limit to the lens of the eye (ICRP, 2012). There is
now strong interest in better modelling of the lens of the eye (Behrens and Dietze,
2011) for the assessment of dose to the lens of the eye and in terms of determining
the operational quantity, Hp ð3Þ.
3. NEW APPROACH BY ICRU

ICRU Report Committee 26 examined the rationale for the operational quan-
tities considering updated definitions of the protection quantities by ICRP (2007,
2010), and investigated a set of alternative definitions for the operational
quantities.
The operational quantities aim to provide reasonable estimates for the values of
the protection quantities. Therefore, as a favoured approach, ICRU Report
Committee 26 proposes to define the operational quantities based on the protection
quantities. The approach is justified because the reference values of the conversion
coefficients for the protection quantities (ICRP, 2010) are available. This concept
can help avoid the use of different phantoms and different weighting factors for
radiation quality between the protection quantities and the operational quantities,
and simplifies the system of radiation monitoring and dose assessment.
182
Equivalent dose to the lens of the eye and local skin has been used to specify limits
to prevent tissue reactions. The equivalent dose is the product of absorbed dose and
wR , which is only defined for stochastic effects. Therefore, the operational quantities
for the lens of the eye and local skin could be set more appropriately in terms of
absorbed dose.
The propositions for area monitoring and individual monitoring are described
below.
3.1. Area monitoring

The ambient dose equivalent, H , at a point in a radiation field is the product of
the particle fluence, ðEÞ, at that point and a conversion coefficient relating the
particle fluence to the maximum value of the effective dose, Emax , that would be
produced by that field, calculated for whole-body exposure of the ICRP reference
phantoms (ICRP, 2009) for parallel and isotropic beams incident in antero-posterior,
postero-anterior, left lateral, right lateral, rotational, and isotropic irradiation geo-
metries for that energy, E (ICRP, 2010). H is given by:
Z
H ¼ hEmax ðEÞ ðEÞdE
where the fluence value is that for the particle at the point of interest and:
hEmax ðEÞ ¼ Emax ðEÞ= ðEÞ:
Fig. 3 shows Emax for photons and neutrons, as a function of energy, evaluated
from the conversion coefficients for effective dose presented in Publication 116
(ICRP, 2010). H ð10Þ is also indicated for comparison.
The measurement of H generally requires that the radiation field be uniform over
the dimensions of the instrument, and that the instrument has an isotropic response.
The directional absorbed dose to the lens of the eye, D0lens ðXÞ, at a point in a
radiation field in a specified direction, X, is the product of the particle fluence,
ðE, XÞ, at that point and a conversion coefficient relating the particle fluence to
the value of the directional absorbed dose to the lens of the eye, D0lens ðE, XÞ, that
would be produced by that field calculated for whole-body exposure of the stylised
phantom incorporating the detailed eye model (Behrens and Dietze, 2011) for par-
allel beams incident in direction X for that energy, E. D0lens ðXÞ is given by:
Z
D0lens ðXÞ ¼ d 0 lens ðE, XÞ ðE, XÞdE
0
dlens ðE, XÞ ¼ D0lens ðE, XÞ=ðE, XÞ:
183
Fig. 3. Emax evaluated using conversion coefficients of effective dose (ICRP, 2010) for pho-
tons and neutrons.
Similarly, the directional absorbed dose to the local skin, D0local skin ðXÞ, is defined
using a conversion coefficient relating the particle fluence to the value of the direc-
tional absorbed dose to the local skin, D0local skin ðE, XÞ, that would be produced by
that field calculated for exposure of ICRU tissue covered with skin layer for parallel
beams incident in direction X for that energy, E. D0local skin ðXÞ is given by:
Z
Dlocal skin ðXÞ ¼ d 0 local skin ðE, XÞ ðE, XÞdE
0
d0local skin ðE, XÞ ¼ D0local skin ðE, XÞ=ðE, XÞ:
184
The measurement of D0lens ðXÞ and D0local skin ðXÞ generally requires that the radi-
ation field be uniform over the dimensions of the instrument, and that the instrument
has the appropriate response as a function of direction. Any statement of direc-
tional dose should include a specification of the direction, X. In radiological protec-
tion practice, X is often not specified, and the maximum value of D0lens ðXÞ or
D0local skin ðXÞ at the point of interest is of importance. This may then be written as
D0lens or D0local skin .
3.2. Individual monitoring

The operational quantities for individual monitoring are defined in terms of effect-
ive dose and absorbed dose to the lens of the eye and local skin. The personal dose
equivalent to estimate the effective dose, Hp , is defined as:
Z
Hp ¼ hE ðEÞ ðEÞdE
where hE ðEÞ is the effective dose conversion coefficient calculated using the ICRP
reference phantoms.
Personal absorbed doses for estimating absorbed doses to the lens of the eye,
Dp, lens , and local skin, Dp, local skin , are defined as:
Z
Dp, lens ¼ dlens ðEÞ ðEÞdE
and:
Z
Dp, local skin ¼ dlocal skin ðEÞ ðEÞdE
where dlens ðEÞ and dlocal skin ðEÞ are the absorbed dose conversion coefficients calcu-
lated using the eye model (Behrens and Dietze, 2011) and ICRU tissue covered with
skin layer, respectively.
Individual monitoring is performed with personal dosimeters worn on the body:
therefore, hE ðEÞ, dlens ðEÞ, and dlocal skin ðEÞ are required for various incident angles.
3.3. Summary of proposition

Table 1 summarises the proposition of the operational quantities for different
external-exposure monitoring tasks.
4. IMPACT OF CHANGES
It is necessary to look at the impact of the changes and to consider the conse-
quences for radiological protection practice, including calibration procedures and
dosimeter design.
185
Table 1. Proposed scheme of the operational quantities used for dose monitoring of external
exposure.
Operational dose quantities for:
Task
control of Area monitoring Individual monitoring
*
Effective dose Ambient dose equivalent, H Personal dose equivalent, Hp
Absorbed dose to Directional absorbed dose, Personal absorbed dose, Dp,lens
the lens of the eye D0lens(X)
Absorbed dose Directional absorbed dose, Personal absorbed dose,
0
to local skin Dlocal skin(X) Dp,local skin
The values of the operational quantities should be traceable to a national or

international standard. The calibration coefficient of an instrument is based on
using the reference value of a fundamental radiation quantity, which can be well
realised by a standard (e.g. fluence at the reference point) and applying reference
conversion coefficients relating these quantities to the operational quantities.
Introduction of the proposed system requires a revision of conversion coefficients,
and it is planned to include these conversion coefficients in the forthcoming ICRU/
ICRP report on the operational quantities. Calibration phantoms for personal dos-
imeters remain unchanged, and there are a few minor changes to be made to the
dosimetry of the International Organisation for Standardisation reference fields and
calibration procedures. Therefore, the impact of adopting the proposed system on
routine measurement practice is not significant as a whole.
Major changes by ICRP to the values of conversion coefficients of the protection
quantities might cause reconsideration of the proposed system of the operational
quantities. However, such changes are likely to occur very infrequently as they are
the result of significant shifts in understanding of the relationships between exposure
to radiation and its effects.
5. CONCLUSIONS
This paper reviewed discussion in ICRU Report Committee 26 on the operational
quantities for protection against external radiations, and investigated the limitations
of the current system. The Committee proposed new operational quantities for exter-
nal exposures by considering changes in the definitions of the protection quantities,
as well as changes in the fields of application of the protection quantities and oper-
ational quantities. A favoured set of operational quantities was defined using the
values of conversion coefficients from particle fluence to effective dose and absorbed
dose to the lens of the eye and local skin. This approach is now considered acceptable
because ICRP has defined the reference values of dose conversion coefficients using
the reference phantoms that are globally recognised. The new operational quantities
provide reasonable estimates of the protection quantities, even at higher energies and
for avoiding tissue reactions. The use of the proposed concept simplifies the systems
186
of protection and operational quantities, and assists in the comprehension of radio-

logical protection quantities by users.
REFERENCES
Behrens, R., Dietze, G., 2011. Dose conversion coefficients for photon exposure of the human
eye lens. Phys. Med. Biol. 56, 415–437.
ICRP, 1977. Recommendations of the ICRP. ICRP Publication 26. Ann. ICRP 1(3).
ICRP, 1996. Conversion coefficients for use in radiological protection against external radi-
ation. ICRP Publication 74. Ann. ICRP 26(3/4).
39(2).
ICRP, 2012. ICRP statement on tissue reactions/early and late effects of radiation in normal
tissues and organs – threshold doses for tissue reactions in a radiation protection context.
ICRP Publication 118. Ann. ICRP 41(1/2).
ICRU, 1985. Determination of Dose Equivalents Resulting from External Radiation Sources.
Bethesda, MD.
ICRU, 1988. Determination of Dose Equivalents from External Radiation Sources – Part II.
Bethesda, MD.
ICRU, 1993. Quantities and Units in Radiation Protection Dosimetry. ICRU Report 51.
ICRU, 1998. Conversion Coefficients for Use in Radiological Protection Against External
Radiation. ICRU Report 57. International Commission on Radiation Units and
Measurements, Bethesda, MD.
ICRU, 2010. Reference data for the validation of doses from cosmic-radiation exposure of
aircraft crew. ICRU Report 84. J. ICRU 10(2).
187
The reference phantoms: voxel vs polygon
C.H. Kima, Y.S. Yeoma, T.T. Nguyena, Z.J. Wanga, H.S. Kima,
M.C. Hana, J.K. Leea, M. Zanklb, N. Petoussi-Henssb, W.E. Bolchc,
C. Leed, B.S. Chunge
a
Department of Nuclear Engineering, Hanyang University, 133-791, 222 Wangsimni-ro,
Seongdong-gu, Seoul, Republic of Korea; e-mail: chkim@hanyang.ac.kr
b
Helmholtz Zentrum München Deutsches Forschungszentrum für Gesundheit und Umwelt
(GmbH), Germany
c
University of Florida, USA
d
National Cancer Institute, USA
e
Ajou University School of Medicine, Republic of Korea
Abstract–The International Commission on Radiological Protection (ICRP) reference male

and female adult phantoms, described in Publication 110, are voxel phantoms based on whole-
body computed tomography scans of a male and a female patient, respectively. The voxel in-
plane resolution and the slice thickness, of the order of a few millimetres, are insufficient for
proper segmentation of smaller tissues such as the lens of the eye, the skin, and the walls of
some organs. The calculated doses for these tissues therefore present some limitations, par-
ticularly for weakly penetrating radiation. Similarly, the Publication 110 phantoms cannot
represent 8–40-mm-thick target regions in respiratory or alimentary tract organs. Separate
stylised models have been used to represent these tissues for calculation of the ICRP reference
dose coefficients (DCs). ICRP Committee 2 recently initiated a research project, the ultimate
goal of which is to convert the Publication 110 phantoms to a high-quality polygon-mesh (PM)
format, including all source and target regions, even those of the 8–40-mm-thick alimentary
and respiratory tract organs. It is expected that the converted phantoms would lead to the
same or very similar DCs as the Publication 110 reference phantoms for penetrating radiation
and, at the same time, provide more accurate DCs for weakly penetrating radiation and small
tissues. Additionally, the reference phantoms in the PM format would be easily deformable
and, as such, could serve as a starting point to create phantoms of various postures for use, for
example, in accidental dose calculations. This paper will discuss the current progress of the
phantom conversion project and its significance for ICRP DC calculations.
Protection.
188
Keywords: Reference phantom; Voxel; Polygon mesh; Effective dose
1. INTRODUCTION
The International Commission on Radiological Protection (ICRP) adult male and
female reference phantoms, which were adopted by ICRP in its 2007
Recommendations (ICRP, 2007), are now used for organ and effective dose calcu-
lations by ICRP (2010) and researchers. These phantoms (ICRP, 2009) were devel-
oped using whole-body computed tomography data of a male and a female patient,
and are consistent with the data given in Publication 89 (ICRP, 2002) on the refer-
ence anatomical and physiological parameters for male and female. Compared with
stylised phantoms, these phantoms are anatomically more realistic; they have, how-
ever, some limitations in representing organs and tissues that are complex or very
thin. This is mainly due to the fact that these phantoms are defined by cuboid-shaped
voxels, the resolution of which is not adequate for all purposes. The voxel sizes of the
male and female phantoms are 2.137 mm 2.137 mm 8 mm, and 1.775 mm
1.775 mm 4.8 mm, respectively (ICRP, 2009). With these large voxels, complex
or thin organs or tissues cannot be modelled or defined properly, causing limitations
in dose calculation, especially for weakly penetrating radiations.
The skin of the Publication 110 (ICRP, 2009) reference phantoms, for example, is
represented by one layer of voxels and has many holes; this is anatomically incorrect,
incurring significant error in dose calculation for charged particles. In addition, the
shallow depth (50–100 mm) at which the cells at risk are located cannot be realised by
the given voxel dimensions. Hollow organs such as the stomach, urinary bladder,
and gall bladder also have many holes. Moreover, the target layers of the respiratory
and alimentary tract organs, which are very thin tissues (i.e. 8–40 mm), cannot be
modelled in the Publication 110 reference phantoms, again due to the limitations of
the voxel resolution. For all abovementioned regions, separate calculations of spe-
cific absorbed fraction (SAF) were performed using stylised phantoms (ICRP, 1994,
2006). Furthermore, the lens of the eye could not be represented properly in the
Publication 110 phantoms. Therefore, for calculating the lens dose coefficients (DCs)
for some geometries and energies of external beams of photons and electrons, add-
itional calculations were performed using a stylised phantom (ICRP, 2010).
Concerning the skeletal tissues, there are a few further minor problems. For instance,
some spongiosa is not covered by cortical bone, part of the cartilage is included
in the spongiosa, and the sacrum of the female phantom does not have any cortical
bone.
These problems were discussed at the ICRP Committee 2 meeting in 2013, and the
decision was made to initiate a research project to convert the Publication 110 ref-
erence phantoms to a high-quality polygon-mesh (PM) format. Prior to that meeting,
a preliminary study had confirmed the feasibility of the conversion (Yeom et al.,
2013). For the conversion project, a working group was established at Hanyang
University in Seoul, Korea in December 2013, and necessary research funding was
189
secured from the Nuclear Safety and Security Commission through the Korea
Foundation of Nuclear Safety in December 2014. The objective of the research
project, as noted above, was to produce exact replicas of the current Publication
110 reference phantoms in high-quality PM format to address the aforementioned
problems. This paper will seek to discuss the current progress of the phantom con-
version project and its significance in ICRP DC calculations.
2. MATERIALS AND METHODS

2.1. Construction of simple organs
To construct PM models of simple organs, the voxel models of the Publication 110
reference phantoms were converted directly to the PM format. For this, two con-
version procedures were developed: one for very simple organs and the other for
more complex organs. For very simple organs, the voxel model is first used to gen-
erate a PM model using a three-dimensional surface rendering method. Next, the
number of polygons in the PM model is increased to facilitate the smoothing and
refinement processes. After completion of the smoothing and refinement processes,
the number of facets is reduced to a proper number. The number of facets for an
organ model is selected rather arbitrarily, considering the shape of the organ model;
that is, for high efficiency in computer simulations, the minimum necessary number
of facets to keep the shape of the organ is used. Finally, the shape of the constructed
organ model is finely adjusted to the voxel model according to the acceptance criteria
used here for organ adjustment.
Two acceptance criteria were developed and applied to the adjustment process.
The first criterion was the Dice index (DI), which is simply the volume overlap
fraction of two different models (Dice, 1945). For confirmation of successful adjust-
ment, the DI should be greater than 97% of the maximally achievable volume over-
lap fraction (MAVOF) for a given organ. Note that the MAVOF exists for a given
organ due to the fundamental difference in the geometry format (i.e. voxel vs PM).
The second criterion was the centroid distance (CD), which is the distance between
the centroids of the voxel model and the PM model. For confirmation of successful
adjustment, the CD should be less than 0.5 mm.
The conversion process for more complex organs is similar to the process for very
simple organs. The only difference is that, during the conversion process, the PM
model is converted to the Non-Uniform Rational B-Spline (NURBS) format. The
NURBS surface is subsequently converted back to the PM format and subjected to
the adjustment process.
2.2. Construction of the skeletal system

The same methods to produce the PM models of simple bones (humeri, ulnae,
clavicles, femora, tibiae, mandible, pelvis, scapulae, sacrum, sternum, cranium, and
ribs) were used for simple organs. The cranium was complicated, so a more elaborate
adjustment process was involved. Each of the 24 ribs was converted and adjusted
individually.
190
Production of a high-quality spine model by the direct conversion methods

proved difficult. Therefore, in this case, a pre-existing high-quality PM spine
model (Shin et al., 2012) was adopted and adjusted to the voxel spine model, moni-
toring both the DI and the CD. The same method was used for the hands and the
feet.
The Publication 110 female phantom has toe-standing feet, while the male phan-
tom has normal-standing feet; therefore, the feet of the female phantom were mod-
ified to the normal-standing form. The cartilage that had been included incorrectly in
spongiosa was extracted and included in the residual tissue. Although this is still not
anatomically correct, this approach is believed to be more appropriate, considering
that cartilage is not a target tissue, and that the composition and mass density of the
cartilage are very close to those of the residual tissue. The costal cartilage and inter-
vertebral discs were modelled following the method used during the construction of
the University of Florida/National Cancer Institute (UF/NCI) phantoms (Lee et al.,
2010). Cortical bone was added to the sacrum of the female phantom. The male
sacrum of the original voxel model did not have the dorsal sacral foramina, and holes
were therefore added to the PM model.
2.3. Construction of complex organs

Phantom construction of complex organs such as the eyes, lymphatic nodes, small
intestine, muscle, lungs, and blood vessels is very challenging and time consuming,
and proper construction methods are still in development. Similarly, the definition of
target layers in the alimentary and respiratory tract organs is also challenging.
Therefore, target layers were classified here as complex organs.
The detailed model of the eye developed by Behrens et al. (2009), which was
adopted for calculations of DC for external beams (ICRP, 2010), has been success-
fully reproduced and incorporated in the PM phantoms. First, a NURBS-surface-
based eye model was produced from the geometrical information of the detailed
model of the eye (Behrens et al., 2009) using Rhinoceros software (Robert McNeel
& Associates, Seattle, WA, USA). The NURBS model produced was subsequently
converted to the PM format. Defects in the eye model were repaired by means of
several refinement functions of Rapidform software (INUS Technology Inc., Seoul,
Korea). The detailed procedure can be found in Nguyen et al. (2015).
The lymphatic nodes of the Publication 110 reference phantoms could not be
converted directly to the PM format due to their complexity and distribution
throughout the body. A dedicated computer programme was developed to model
them in the PM phantoms, following the method used for the UF/NCI phantoms
(Lee et al., 2009). The developed programme will be used to generate the lymphatic
nodes after the construction of muscles is completed.
Construction of the model of the small intestine is also very challenging, again due
to the complexity of the structures. A dedicated procedure and computer programme
have been developed to generate the model of the small intestine in the PM phan-
toms. First, a surface frame that entirely encloses the original voxel model of the
small intestine is constructed with the a-shape algorithm (Edelsbrunner et al., 1983).
191
Next, a C++ programme developed here is used to automatically generate a small

intestine passage line using the Monte Carlo approach. Along with the passage line, a
model of the small intestine is generated in the PM format. Finally, the surface is
copied for use as the interior surface, which is then reduced to match the reference
volumes of the wall and contents, as these are given in Publication 89 (ICRP, 2002).
The aforementioned procedure is repeated 1000 times, randomly producing 1000
different models of the small intestine, and the best model is selected considering
both geometric and dosimetric similarity. This method has been applied to produce
the model of the small intestine for the male phantom (Yeom et al., 2015). The same
method will be used for the female phantom.
2.4. Calculation of DCs

Dose calculations have been performed using the preliminary versions of the
phantoms in order to test the proposed approach for the skeletal system and some
complex organs. The DCs of the PM phantoms and the Publication 110 phantoms
were calculated using GEometry ANd Tracking 4 (Geant4) Version 10.01
(Agostinelli et al., 2003). The physics library used in Geant4 was the
G4EmLivermorePhysics, which includes the Evaluated Photons Data Library
(Cullen et al., 1997), the Evaluated Electrons Data Library (Perkins et al., 1991),
and the Evaluated Atomic Data Library (Perkins et al., 1997). The secondary pro-
duction cut value of 0.1 mm was applied for both photons and electrons, with some
exceptions where the micron-thick target regions are important in dose calculation.
The relative statistical errors were less than 10%.
3. RESULTS AND DISCUSSION

Fig. 1 shows the preliminary PM versions of the Publication 110 reference phan-
toms. Table 1 provides the numerical data. Although it is not visible in the figures,
several thin target layers of the alimentary tract organs are defined (i.e. oral cavity,
oesophagus, stomach, small intestine, and colon). Note that the phantoms described
here do not present the final versions, but their external shapes will not change
significantly. The lymphatic nodes will be remodelled after construction of the mus-
cles. It can be seen that the male phantom has a model of the small intestine that was
constructed here, whereas the female phantom has a stylised model of the small
intestine.
Fig. 2 shows the deviation of DCs of the PM phantoms from those of the
Publication 110 reference phantoms for external photons and for red bone marrow
(RBM). The RBM DCs were calculated using the mass-weighting approximation,
which was used to calculate the Publication 116 DCs (ICRP, 2010). It can be seen
that the deviation is mostly within 5%. Somewhat larger deviation is observed for
photon energies below 0.03 MeV, which is due to problems with the original voxel
phantoms. In the Publication 110 reference phantoms, some spongiosa bones are not
fully enclosed by the cortical bone, which is anatomically incorrect. The result for
endosteum is not given here, but shows a very similar trend.
192
Fig. 1. Polygon-mesh versions (preliminary) of the Publication 110 (ICRP, 2009) reference
phantoms. Top, male phantom; bottom, female phantom. ET, extrathoracic.
193
Table 1. Numbers of polygon facets and masses of the organs of the polygon-mesh versions (under development) of the Publication 110
reference phantoms (ICRP, 2009). For comparison, the masses of the organs of the reference male and female are also given, as in
Publication 89 (ICRP, 2002).
Male Female
Number Reference Diff. Number of Mass Reference Diff.

Organs of facets Mass (g) value (g) (%) facets (g) value (g) (%)
Adrenals 3200 14.00 14 0.00 3000 13.00 13 0.00

Extrathoracic regions 10,100 39.44 19,000 18.61
Oral mucosa, lips and cheeks 4564 0.02 1720 0.02
Oral mucosa, roof of mouth 580 0.02 728 0.02
Oral mucosa, tongue 4192 0.08 73 0.00 5128 0.06 60 0.00
Tongue, upper part (food region) 1232 21.00 2132 21.00
Tongue, lower part 2096 51.92 2564 38.94
194
Trachea 1600 10.00 10 0.00 1600 8.00 8 0.00
Skeleton 604,900 9349.99 10,450 0.00 865,100 6860.00 7760 0.00
Cartilage, costal 18,300 55.54 13,300 41.39
Cartilage, intervertebral discs 30,000 80.91 26,000 68.41

Cartilage, rest (in residual soft tissue) 963.56 790.20
Brain 10,000 1450.00 1450 0.00 10,500 1300.00 1300 0.00
Breasts, adipose tissue 1600 15.00 25 0.00 6800 300.00 500 0.00
Breasts, glandular tissue 1000 10.00 2900 200.00
Gallbladder wall 1100 10.00 10 0.00 1100 8.00 8 0.00
Gallbladder contents 1100 58.00 58 0.00 1100 48.00 48 0.00
Oesophagus wall 3960 39.90 40 0.00 2984 34.90 35 0.00
Oesophagus wall, target layer 2846 0.10 1492 0.10
(continued on next page)
Table 1. (continued)
Male Female

Oesophagus contents 2846 22.65 1492 21.03

Stomach wall 12,060 148.70 150 0.00 7602 138.95 140 0.00
Stomach wall, target layer 4030 1.30 2534 1.05
Stomach contents 4030 250.00 250 0.00 2534 230.00 230 0.00
Small intestine wall 60,000 647.67 650 0.00 32,816 598.01 600 0.00
Small intestine wall, target layer 20,000 2.33 11,036 1.99
Small intestine contents 20,000 350.00 350 0.00 11,036 280.00 280 0.00
Right colon wall 9534 149.50 150 0.00 4904 144.54 145 0.00
Right colon wall, target layer 6748 0.50 2036 0.46
195
Right colon contents 6748 150.00 150 0.00 2036 160.00 160 0.00
Left colon wall 8702 149.60 150 0.00 5368 144.69 145 0.00
Left colon wall, target layer 6000 0.40 2314 0.31
Left colon contents 6000 75.00 75 0.00 2314 80.01 80 0.01

Rectosigmoid wall 6902 69.67 70 0.00 3422 69.67 70 0.00
Rectosigmoid wall, target layer 5060 0.33 1394 0.33
Rectosigmoid contents 5060 75.00 75 0.00 1394 79.99 80 0.01
Heart wall 4000 330.00 330 0.00 6500 250.00 250 0.00
Heart contents (blood) 5000 510.00 510 0.00 5000 370.00 370 0.00
Kidneys 3000 310.00 310 0.00 3300 275.00 275 0.00
Liver 5000 1800.00 1800 0.00 5000 1400.00 1400 0.00
Lungs 13,000 1200.00 1200 0.00 14,000 950.00 950 0.00
(continued on next page)
Table 1. (continued)
Male Female

Lymphatic nodes 65,400 178.37 65,400 142.69

Testes (m)/ovaries (f) 3000 35.00 35 0.00 2000 11.00 11 0.00
Pancreas 2000 140.00 140 0.00 2000 120.00 120 0.00
Pituitary gland 600 0.60 0.6 0.00 620 0.60 0.6 0.00
Prostate (m)/uterus (f) 1000 17.00 17 0.00 2000 80.00 80 0.00
Salivary glands 2500 85.00 85 0.00 8600 70.00 70 0.00
Skin 62,000 3300.00 3300 0.00 65,000 2300.00 2300 0.00
Spinal cord 3000 36.62 1500 18.63
Spleen 1500 150.00 150 0.00 1500 130.00 130 0.00
196
Teeth 4452 50.00 50 0.00 1780 40.00 40 0.00
Thymus 1000 25.00 25 0.00 1700 20.00 20 0.00
Thyroid 1600 20.00 20 0.00 1600 17.00 17 0.00
Tonsils 500 3.00 3 0.00 1600 3.00 3 0.00

Urinary bladder wall 1000 50.00 50 0.00 2400 40.00 40 0.00
Urinary bladder contents 1000 200.00 2400 200.00
Air in the body 1800 0.12 1500 0.05
Lens of the eye 7424 0.456 0.4 14.00 7424 0.456 0.4 14.00
Eyeballs 22,788 14.756 14.6 1.07 22,788 14.756 14.6 1.07
Residual soft tissue 68,000 51,245.50 66,000 42,635.34
Total body 1,166,654 73,000.00 73,000 0.00 1,352,992 60,000.00 60,000 0.00
Fig. 2. Deviation of red bone marrow dose coefficients (DCs) of polygon-mesh (PM) version
phantoms from those of the Publication 110 (ICRP, 2009) reference phantoms. DC
deviation ¼ {DC (PM) – DC (Publication 110)}/DC (Publication 110) 100%. AP, anterior–
posterior; PA, posterior–anterior; LLAT, left lateral; RLAT, right lateral.
Fig. 3 shows the dose results for the small intestine for external photon beams.
Here, the new PM model, which was developed in the current project, was compared
with the previous stylised model. The filled symbols represent the results of the new
PM model, and the open symbols represent those of the previous stylised model
(Yeom et al., 2013). The overall results show that the new model deviates less
from the original voxel model in the Publication 110 male phantom. The deviations
of the new PM model were mostly within 10%.
Fig. 4 shows the electron SAF values of the small intestine calculated by the PM
version of the Publication 110 phantoms developed here and the Publication 100
(ICRP, 2006) stylised phantoms. The SAF values of the PM phantoms and the
stylised phantoms were also calculated using Geant4, but, in this case, the secondary
production cut value was reduced to 1 mm considering the micron-thick target
regions. The data show that the models of the small intestine of the PM phantoms
provide SAF values that are very similar to those of the Publication 100 stylised
197
Fig. 3. Deviation of small intestine dose coefficients (DCs) from those of the Publication 110
(ICRP, 2009) male phantom for the model of the small intestine developed here (filled mar-
kers) and for earlier stylised models of the small intestine (unfilled markers) (Yeom et al.,
2013). DC deviation ¼ {DC (PM) – DC (Publication 110)}/DC (Publication 110) 100%. AP,
anterior–posterior; PA, posterior–anterior; LLAT, left lateral; RLAT, right lateral; SI, small
intestine; UB, urinary bladder.
phantoms. The results for other alimentary tract organs show very similar trends.
These results generally suggest that, in the future, after successful completion of the
PM-based reference phantoms, additional stylised phantoms will not be needed for
SAF calculations for alimentary tract organs as the PM phantoms will suffice in
providing very similar SAF values.
Fig. 5 shows the DCs of the lens of the eye (pGy cm2) calculated for the PM
phantoms for external electron exposures and AP irradiation geometry, along with
the corresponding Publication 116 DCs (ICRP, 2010). The latter were obtained for
electrons from 100 keV to 10 MeV using a stylised eye phantom (Behrens et al.,
2010), and for all other energies using the Publication 110 reference phantoms. In
order to save computation time, it was assumed that only the head of each phantom
is irradiated, and that the contribution of secondary radiations to the dose to the
lens of the eye from the other part of the body is negligible. These results demon-
strate that the new PM phantoms provide dose values very similar to those of
Publication 116, even for those energies for which the stylised model was used.
198
Fig. 4. Specific absorbed fractions (SAFs) for tissues of the small intestine, calculated using
the polygon-mesh (PM) phantoms developed in the present study and the Publication 100
stylised phantoms (ICRP, 2006).
For low-energy electrons (less than 0.7 MeV), the DCs calculated with the current
PM phantoms were higher than the Publication 116 data (maximum difference of
60% at 0.2 MeV). This relatively large difference is caused by the fact that the
Publication 116 data were calculated using the bare-eye model for electron energies
of 10 MeV, and therefore do not properly reflect the dose contribution from the
secondary radiations from the head structure. This result confirms that use of an
additional stylised phantom for dose calculations for the lens of the eye will not be
necessary in the future.
4. CONCLUSIONS
ICRP is currently developing PM versions of the Publication 110 adult reference
phantoms. The final phantoms will include, among the organs and tissues for effect-
ive dose calculation, continuous and fully-enclosed layers for the skin and the walls
of the stomach, gall bladder, and urinary bladder; thin target layers (8–40 mm) of the
respiratory and alimentary tract organs; and detailed and anatomically more accur-
ate models of the skeletal system, lens of the eye, lymphatic nodes, blood vessels,
hands, and feet. It is expected that the developed phantoms would provide dose
199
Fig. 5. Absorbed dose for the lens of the eye per fluence (pGy cm2) for electron exposures in
anterior–posterior (AP) irradiation geometry, as calculated for the present study with the
polygon-mesh phantoms (square) and Publication 116 data (triangle) (ICRP, 2010). The cal-
culated dose values are for the entire lens and present mean values of both eyes and both sexes.
values very similar to those of the current Publication 110 reference phantoms for
highly penetrating radiations, and more accurate or correct dose values for weakly
penetrating radiations (electrons, ions, and low-energy photons <0.03 MeV) and
small tissues. Additionally, the developed phantoms would be deformable, providing
different postures (e.g. walking and sitting) for calculation of DCs in emergency
exposure scenarios, which is planned for the next term of Committee 2 (2017–
2021). The project is expected to provide all-in-one, deformable, high-quality PM
phantoms representing the reference male and female adults for the radiological
protection community.
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Assessment and interpretation of internal doses:
uncertainty and variability
F. Paqueta, M.R. Baileyb, R.W. Leggettc, J.D. Harrisond
a
Institut de Radioprotection et de Sûrete´ Nucleáire, Direction de la Strate´gie,
du de´veloppement et des partenariats, Service des programmes strate´giques, Saint Paul Lez
Durance 13115, France; e-mail: francois.paquet@irsn.fr
b
Retired from Health Protection Agency, UK
c
Oak Ridge National Laboratory, USA
d
Oxford Brookes University, Faculty of Health and Life Sciences, UK
Abstract–Internal doses are calculated on the basis of knowledge of intakes and/or measure-
ments of activity in bioassay samples, typically using reference biokinetic and dosimetric
models recommended by the International Commission on Radiological Protection (ICRP).
These models describe the behaviour of the radionuclides after ingestion, inhalation, and
absorption to the blood, and the absorption of the energy resulting from their nuclear trans-
formations. They are intended to be used mainly for the purpose of radiological protection:
that is, optimisation and demonstration of compliance with dose limits. These models and
parameter values are fixed by convention and are not subject to uncertainty. Over the past few
years, ICRP has devoted a considerable amount of effort to the revision and improvement of
models to make them more physiologically realistic. ICRP models are now sufficiently sophis-
ticated for calculating organ and tissue absorbed doses for scientific purposes, and in many
other areas, including toxicology, pharmacology and medicine. In these specific cases, uncer-
tainties in parameters and variability between individuals need to be taken into account.
Keywords: Internal dosimetry; Biokinetic model; Uncertainty
1. INTRODUCTION
Intakes of radionuclides may occur during routine operations in a range of indus-
trial, medical, educational, and research facilities. They may also occur after an
Protection.
202
incident involving release of radioactive materials followed by inhalation of gases

and particles, or ingestion of contaminated foods.
An adequate assessment of internal exposure resulting from intakes of radio-
nuclides is essential for the optimisation of radiological protection of workers,
for the assessment of the health consequences of releases of radioactivity to the
environment for members of the public, and for the retrospective demonstration
of compliance with regulatory requirements.
Internal and external exposure of workers and members of the public should be
assessed in terms of the protection quantity, effective dose. However, after intake of
radionuclides, doses received by organs and tissues are protracted; therefore, equiva-
lent and effective doses are accumulated over time. The resulting quantities are
referred to as ‘committed doses’. Internal exposure of workers and members of the
public is therefore assessed in terms of committed effective dose.
In internal dosimetry, no operational dose quantities have been defined that pro-
vide a direct assessment of committed effective dose. Different methods are therefore
applied to assess the equivalent or effective dose due to radionuclides in the human
body. They are mainly based on various activity measurements, and the application
of biokinetic and dosimetric models. Biokinetic models for individual elements and
their radioisotopes are used to calculate the total number of transformations (radio-
active decays) occurring within specific tissues, organs, or body regions (source
regions) over a given period of time (usually 50 y for adults, or up to the age of
70 y for children) by determining the time-integrated activity in each source region.
Dosimetric models are used to calculate the deposition of energy in all important
organs/tissues (targets) for transformations occurring in each source region, taking
account of the energies and yields of all emissions (ICRP, 2008). Many biokinetic
and dosimetric models have been produced by the International Commission on
Radiological Protection (ICRP) over time and are described hereafter.
In its 2007 Recommendations, ICRP (2007) introduced important changes that
affect the values calculated per radiation exposure. Publication 103 (ICRP, 2007)
introduced changes to the radiation weighting factors used in the calculation of
equivalent dose to organs and tissues, and changes to the tissue weighting factors
used in the calculation of effective dose. In addition, an important development was
the adoption of reference anatomical computational phantoms (i.e. models of the
human body based on medical imaging data), in place of the composite mathemat-
ical models that have been used for all previous calculations of organ doses. This
process commenced with the adoption of reference adult male and female models
(ICRP, 2009), and will be continued with the adoption of paediatric phantoms.
Publication 103 also clarified the need for separate calculation of equivalent
dose to males and females, and sex-averaging in the calculation of effective dose
(ICRP, 2007). In the revision of dose coefficients, the opportunity has also been
taken to improve calculations by updating radionuclide decay data (ICRP, 2008),
and implementing more sophisticated treatments of radiation transport (ICRP,
2010) using the ICRP reference anatomical phantoms of the human body (ICRP,
2009). These improvements have impacts on dose calculations for external exposures
203
as well as for internal emitters. Work has been conducted by ICRP Committee 2 and
its Task Groups to update the current biokinetic and dosimetric models, and provide
new dose coefficients. The most recent developments are presented here.
2. GENERAL METHODS FOR THE ASSESSMENT OF INTERNAL DOSES

The methods for calculating the committed effective dose after intake of radio-
nuclides are described below (Fig. 1).
By using the reference biokinetic models, the distribution and retention of radio-
nuclides in body organs and tissues of the reference worker or Reference Person1 are
determined as a function of time after intake by inhalation or ingestion. The total
number of nuclear transformations occurring within a 50-y period (or up to the age
of 70 y for children) in each source region is calculated. The dosimetric models based
on the male and female reference computational phantoms and the Monte Carlo
radiation transport codes are used to calculate the sex-specific absorbed dose in each
target organ or tissue resulting from a nuclear transformation in each source region.
The radiation weighting factors are applied to determine sex-specific committed
equivalent doses to each organ or tissue. The sex-specific committed equivalent
doses are sex-averaged, and the tissue weighting factors are then applied to determine
the sex-averaged committed effective dose.
Calculation of doses after internal contamination is a complex procedure. To
simplify the system, ICRP provided dose coefficients (i.e. committed effective dose
and committed equivalent doses to organs or tissues per intake) and bioassay func-
tions (i.e. excretion rates or organ retention per intake). Dose coefficients and bio-
assay functions may be used for both prospective and retrospective assessments of
exposure. Prospective assessments provide estimates of intakes and resulting doses
for workers engaged in specific activities, or for members of the public exposed in
specific circumstances, using information on projected exposures to radionuclides.
These assessments generally make use of default assumptions about exposure con-
ditions and default values for parameters describing material-specific properties,
such as the particle size distribution of an inhaled aerosol or the absorption charac-
teristics of a material after inhalation or ingestion. Retrospective assessments use the
results of individual and workplace monitoring to assess doses in order to maintain
individual dose records and demonstrate compliance with regulatory requirements.
Models describing the deposition of energy from transformations of radionuclides
in the human body were first published in Publication 2 (ICRP, 1959). More recent
reports were published in the 1970s and 1980s, describing the behaviour of
1
The Reference Person is an idealised person for whom the equivalent doses to organs and tissues are
calculated by averaging the corresponding doses of the reference male and female [idealised male or female
with anatomical and physiological characteristics defined by ICRP (2002) for the purpose of radiological
protection]. The reference worker is an adult Reference Person combined with the reference biokinetic and
dosimetric models and their parameter values, as defined in Publication 130 (ICRP, 2015). The structure
and parameter values of biokinetic models of the reference worker are invariant on the sex, age, race, and
other individual-specific characteristics, but based on reference male parameter values where sex-specific
models are available.
204
Quantified intake by
inhalation or ingestion
Biokinetic and
dosimetric models
Mean absorbed dose, DT,R,

in an organ or tissue
Radiation weighting
factors, wR
Equivalent dose, HT,

in an organ or tissue
Tissue weighting
factors, wT
Effective dose, E
Fig. 1. Calculation of absorbed dose and the International Committee on Radiological

Protection’s protection quantities, equivalent and effective dose, for intakes of radionuclides.
Source: Publication 130 (ICRP, 2015).
radionuclides in different parts of the body. Publication 30 (ICRP, 1979, 1980, 1981,
1988a) and its supplements gave dose coefficients and values of annual limits on
intake for workers, for intakes of radionuclides by inhalation and ingestion, referen-
cing the recommendations issued in Publication 26 (ICRP, 1977) and the anatomical
and physiological data in Publication 23 (ICRP, 1975). Publication 68 (ICRP, 1994b)
provided updated dose coefficients for workers following the 1990 Recommendations
in Publication 60 (ICRP, 1991). It applied the Human Respiratory Tract Model
(HRTM) for inhaled radionuclides given in Publication 66 (ICRP, 1994a), the
updated basic anatomical and physiological data for the skeleton given in
Publication 70 (ICRP, 1995b), and revised systemic biokinetic models for selected
isotopes of 31 elements given in Publications 56, 67, 69 and 71 (ICRP, 1990, 1993,
1995a,c). Biokinetic models for other elements were taken from Publication 30, and
modified by addition of explicit excretion pathways to improve dose estimates for the
urinary bladder and colon walls.
A similar approach was taken for calculating doses to members of the public.
Models and dose coefficients after ingestion or inhalation of radionuclides by mem-
bers of the public were published in Publications 56, 67, 69, 71 and 72 (ICRP, 1990,
1993, 1995a,c, 1996). Similarly, models and dose coefficients for the embryo and fetus
from intakes of radionuclides by the mother, and for infants from ingestion of radio-
nuclides in mothers’ milk were published in Publications 88 and 95 (ICRP, 2001,
2004), respectively.
205
Doses from intakes of radionuclides can also be assessed retrospectively from

bioassay measurements (e.g. daily urinary and faecal excretion) or from direct meas-
urements of the radionuclides in the body. Publications 54 and 78 (ICRP, 1988b,
1997) gave guidance on the design of monitoring programmes and the interpretation
of results to estimate doses to workers following radionuclide inhalation or ingestion.
The guidance was supported by numerical data to enable the assessment of intakes
and doses from bioassay data. These data were provided for a number of radio-
nuclides, selected based on those that are most likely to be encountered in the work-
place. Predicted values of the measured quantities for various times after a single
intake or for routine monitoring were given in terms of the activity of the intake
per activity measured. Standard dose coefficients would then be used to calculate
effective dose from the assessed intake.
3. UPDATES IN THE METHODS AND THE MODELS

Publication 103 (ICRP, 2007) introduced changes that affect the calculation of
doses. In addition, numerous advances have been made in physiology, dosimetry,
and monitoring methods over recent years that support a revision of the models
recommended in Publications 30 (doses for workers) and 56 (doses for members of
the public) (ICRP, 1979, 1980, 1981, 1988a, 1990). Updates of the models will be
presented in the ‘Occupational Intakes of Radionuclides (OIR)’ series and the ‘public
exposures’ series, which started being published in ICRP (2015), and are briefly
described hereafter. Emphasis is placed here on updates to the biokinetic models
of the alimentary tract and respiratory tract, and the biokinetic systemic models.
Biokinetic models of the alimentary and respiratory tracts are used to define the
movement of radionuclides within these systems, resulting in absorption to blood
and/or loss from the body. The behaviour of radionuclides absorbed to blood is
described by element-specific systemic models that range in complexity. These
models are intended both for the derivation of dose coefficients and the interpret-
ation of bioassay data. At the end of the section, specific attention is given to a new
development that allows easier assessment of doses directly from bioassay data.
3.1. Human Respiratory Tract Model

The HRTM, described in Publication 66 (ICRP, 1994a), was updated in Part 1 of
the OIR series (ICRP, 2015) to take account of data that have accumulated since
issuance of Publication 66, although the basic features of the model remain
unchanged. Inhaled particles containing radionuclides deposit in the extrathoracic
airways (nose, larynx, etc.), the bronchial and bronchiolar airways of the lung, and
the alveolar-interstitial (AI) region, with deposition in each region dependent mainly
on particle size (ICRP, 1994a, 2002). Removal from the respiratory tract occurs
mainly by dissolution and absorption to blood, and the competing process of trans-
port of particles to the throat followed by their entry into the alimentary tract. The
proportions absorbed to blood or cleared by particle transport depend on the spe-
ciation and the solubility of the material, and on the physical half-life of the
206
radionuclide. The HRTM is also applied to gases and vapours, and in the OIR series
to inhalation of radon and its radioactive progeny.
For absorption to blood, the main changes introduced in the new model are as
follows.
. Redefinition of Type F, M and S absorption default parameter values: larger

rapid dissolution fractions (fr) for Types M and S of 0.2 and 0.01, replacing 0.1
and 0.001, respectively, with lower rapid dissolution rates (sr) of 3 d 1 for Types
M and S, and 30 d 1 for Type F, replacing 100 d 1.
. Material-specific parameter values for fr, sr, and the slow dissolution rate (ss) in
selected cases where sufficient information is available (e.g. forms of uranium and
plutonium).
. Element-specific values of sr and the bound state parameters, fb and sb, where
sufficient information is available.
For clearance by particle transport, the main changes are as follows.
. More realistic clearance from the nasal passage, including transfer from the anter-
ior region to the posterior region, based on recent human experimental studies.
. Revised characteristics of slow particle clearance from the bronchial tree based on
recent human experimental studies. It is now assumed that it only occurs in the
bronchioles, rather than as a particle-size-dependent phenomenon throughout the
bronchial tree.
. Longer retention in the AI region of the lung, with a revised model structure based
on recent data including very-long-term follow-up of groups of workers exposed
to insoluble Co-60 particles and plutonium dioxide.
3.2. Human Alimentary Tract Model

The Publication 30 (ICRP, 1979) model of the gastrointestinal tract has been
replaced by the Human Alimentary Tract Model (HATM) described in Publication
100 (ICRP, 2006). The main features of the HATM are summarised as follows.
. Inclusion of all regions of the alimentary tract: oral cavity, oesophagus, stomach,
small intestine, right colon, left colon, and rectosigmoid (the sigmoid colon and
rectum).
. A default assumption that absorption of an element and its radioisotopes to blood
occurs exclusively in the small intestine (i.e. the total fractional absorption, fA,
equals the fractional absorption from the small intestine, fSI).
. A model structure that allows for absorption in other regions, where information
is available.
. A model structure that allows for retention in the mucosal tissues of the walls of
the regions of the alimentary tract, and on teeth, where information is available.
207
. Explicit specification of the location of target regions for cancer induction within
each region of the alimentary tract.
3.3. Systemic models

A systemic model describes the time-dependent distribution and retention of a
radionuclide in the body after it reaches the systemic circulation, and its excretion
from the body. In contrast to the current and past ICRP biokinetic models describ-
ing the behaviour of radionuclides in the respiratory and alimentary tracts, the ICRP
systemic models have generally been element-specific with regard to model structure
as well as parameter values. A single generic model structure that depicts all poten-
tially important systemic repositories and paths of transfer of all elements of interest
in radiological protection would be too complex to be of much practical use.
However, generic model structures have been used in previous ICRP reports to
address the systemic biokinetics of groups of elements, typically chemical families,
known (or expected) to have qualitatively similar behaviour in the body. For exam-
ple, Publication 20 (ICRP, 1973) introduced a generic model formulation for the
alkaline earth elements calcium, strontium, barium and radium, but provided ele-
ment-specific values for most model parameters. In Parts 1–3 of Publication 30
(ICRP, 1979, 1980, 1981), a model developed for plutonium, including parameter
values as well as model structure, was applied to most actinide elements. The use of
generic systemic model structures was increased in ICRP reports on doses to mem-
bers of the public from intake of radionuclides (ICRP, 1993, 1995a,c), and is further
expanded in new reports because it facilitates the development, description and
application of systemic biokinetic models. An important development is that, as
the availability of data allows, models have been made more physiologically realistic
with regard to the dynamics of organ retention and excretion, so that they are
applicable to the interpretation of bioassay data as well as the calculation of dose
coefficients.
3.4. Interpretation of bioassay data

As described in Chapter 2, doses may be assessed retrospectively by direct meas-
urement of activity in organs, in the body, or by activity measurement in excreta of
biological samples. The system of dose assessment from bioassay data that is gen-
erally applied involves evaluation of the intake of a radionuclide either from direct
measurements (e.g. external monitoring of the whole body or of specific organs and
tissues) or indirect measurements (e.g. of urine, faeces, or environmental samples).
Predicted values of these measured quantities for intake of a radionuclide are rec-
ommended by ICRP, and these values can be used to estimate the intake (ICRP,
1997). The committed effective dose resulting from any intake is then calculated
using the appropriate dose coefficient recommended by ICRP, or determined using
ICRP’s recommended methodology.
In the OIR series, ICRP will also give dose per content functions (calculated from
the dose coefficient divided by the relevant bioassay function). They enable
208
committed doses to be calculated directly from bioassay measurements as a function

of time after intake. The main advantage of this approach is that the user does not
perform the intermediate step of calculating the intake in order to evaluate the dose.
In some cases, the assessed dose is less sensitive to the choice of parameter values
than it is to the assessed intake. However, care is still needed in determining the most
appropriate measurement data and defining the time of the intake.
Effective dose assessed from bioassay measurements is relatively insensitive to the
choice of parameter values when the measured quantity is directly related to an
organ dose that makes a dominant contribution to the effective dose (e.g. in the
case of lung retention measurements after inhalation of an insoluble Co-60 com-
pound, where lung dose dominates the effective dose). However, sensitivity to par-
ameter values may be much higher when the measured quantity is less closely related
to the effective dose, such as when lung dose makes a dominant contribution to
effective dose and urine monitoring is employed. For such a case, the results of
urine monitoring can provide a reliable measure of doses to systemic organs,
but assessed lung dose is sensitive to the choice of absorption parameter values.
An example includes the assessment of effective dose from urine monitoring data
after inhalation of an insoluble uranium compound.
4. UNCERTAINTY AND VARIABILITY IN THE ASSESSMENT

OF EFFECTIVE DOSE
The effective dose calculated for protection purposes is determined from the
equivalent doses to organs and tissues of the human body, which are in turn calcu-
lated from the mean absorbed doses to those organs and tissues. Effective dose
provides a value that takes the given exposure conditions into account, but does
not consider the characteristics of a specific individual. In particular, the tissue
weighting factors that are used to determine effective dose are selected, rounded
values that represent averages over many individuals of different ages and sexes.
The equivalent doses to each organ or tissue of the reference male and the reference
female are averaged, and these averaged doses are both multiplied by the corres-
ponding tissue weighting factor to determine the sex-averaged effective dose for the
Reference Person (ICRP, 2007). It follows that effective dose does not provide an
individual-specific dose, but rather provides a dose for a Reference Person under
given exposure conditions (ICRP, 2007). The reference models and necessary refer-
ence parameter values are established and selected from a range of experimental
investigations and human studies through judgements. For regulatory purposes,
these models and parameter values are fixed by convention and are not subject to
uncertainty.
However, thanks to a considerable amount of effort in the revision and improve-
ment of models to make them more physiologically realistic, the ICRP models are
now sufficiently sophisticated so that they can also be used to calculate organ and
tissue absorbed doses for scientific purposes, and in many other areas, including
209
toxicology, pharmacology and medicine. In these specific cases, uncertainties in par-

ameters and variability between individuals may need to be taken into account.
Reviews of the sources and levels of uncertainties have been published (Leggett
et al., 1998; Harrison et al., 2001; Leggett, 2001; NCRP, 2009). They can be sum-
marised as below.
‘Uncertainty’ here refers to the lack of knowledge of a central value for a popu-
lation, and ‘variability’ refers to the quantitative differences between different mem-
bers of a population. Although uncertainty and variability are distinct concepts, the
variability in biokinetic characteristics within a population is often an important
factor contributing to the uncertainty in a central estimate of a biokinetic quantity.
This is because such variability contributes to the problem of identifying the central
tendency of these characteristics in the population due to the small number of obser-
vations generally available, and because subjects of biokinetic studies are not usually
selected at random. Variability in the biokinetics of radionuclides, pharmaceuticals
or chemicals in human populations appears to result from many different
physiological factors or modulating host factors of an environmental nature, includ-
ing age, sex, pregnancy, lactation, exercise, disease, stress, smoking and diet. Large
interindividual biokinetic variations sometimes persist in the absence of appreciable
environmental differences, and suggest that these variations may be genetically con-
trolled. In real-world situations, genetic and environmental factors may interact
dynamically, producing sizable variations in the behaviour of substances taken
into the human body.
The uncertainty in an internal dose assessment depends on: uncertainties asso-
ciated with measurements used to determine the activity of a radionuclide in vivo or
in a biological sample; uncertainties in the exposure scenario used to interpret the
bioassay results, including factors such as the route of intake, the time pattern of
intake, the specific radionuclide(s) taken into the body, and the chemical and phys-
ical form of the deposited radionuclide(s); and uncertainties in the biokinetic and
dosimetric models used to interpret the bioassay results.
Uncertainties in time and route of intake are important in retrospective dose
assessment using bioassay or body measurement. If an intake is not recognised for
some time after an incident, and if total body retention and urinary and faecal
excretion rates would diminish quickly, the assumed time pattern of intake could
be the dominant uncertainty in the dose estimate. On the other hand, if a worker is
exposed in the vicinity of an immediately recognised accidental release, or if total
body retention and excretion rates are fairly constant, the time pattern of intake may
be a negligible source of uncertainty in the dose estimate.
An additional and important source of uncertainties, for both prospective and
retrospective dose assessment, is linked to the biokinetic models. The confidence that
can be placed in predictions of a biokinetic model for an element or compound
depends not only on uncertainties associated with parameter values of the model,
but also on uncertainties associated with the model structure. Such uncertainties may
arise because the structure provides an oversimplified representation of the known
210
processes, because unknown processes have been omitted from the model, or
because part or all of the model formulation is based on mathematical conveni-
ence rather than consideration of processes. Some combination of these limita-
tions in model structure is virtually associated with all biokinetic models for
radionuclides.
Other sources of uncertainties in biokinetic models are associated with the types of
information used to construct the models for the elements. Available data may be of
different types, including: (i) human data involving quantitative measurements of the
element; (ii) observations of the behaviour of chemically similar elements; (iii) obser-
vations of the behaviour of the element in non-human species; and (iv) observations
of the behaviour of one or more chemically similar elements in non-human species.
Direct information on humans is the preferred type of information on which to base
a biokinetic model. To some degree, this type of direct information is available for
most essential elements, as well as for some important non-essential elements, such as
caesium, lead, radium, uranium, americium and plutonium.
In some cases where information is missing, data on animals and chemical ana-
logues may be used as surrogates, leading to uncertainties in the model parameters.
Interspecies extrapolation of biokinetic data is based on the concept of a general
biological regularity across the different species with regard to cellular structure,
organ structure, and biochemistry. However, despite the broad structural, func-
tional, and biochemical similarities among mammalian species, interspecies extrapo-
lation of biokinetic data has proven to be an uncertain process. Similarities across
species are often more of a qualitative than quantitative nature, in that two species
which handle an internally deposited radionuclide in the same qualitative manner
may exhibit dissimilar kinetics with regards to that substance. Moreover, there are
important differences among the mammalian species, including differences in specia-
lised organs, hepatic bile formation and composition, level of biliary secretion, urine
volume and acidity, amount of fat in the body, magnitude of absorption or secretion
in various regions of the alimentary tract, types of bacteria in the digestive tract, and
microstructure and patterns of bone remodelling.
Similarly, biokinetic models for elements are often constructed partly or wholly
from data for chemically similar elements, on the basis of empirical evidence that
chemical analogues often exhibit close physiological similarities. For example, the
alkaline earth elements calcium, strontium, barium, and radium exhibit many
physiological as well as chemical similarities (ICRP, 1993), and the alkali metals
rubidium and caesium closely follow the movement of their chemical analogue,
potassium. There are, however, counterexamples to the premise that chemical ana-
logues are also physiological analogues. For example, the alkali metals potassium
and sodium share close physical and chemical similarities but exhibit diametrically
opposite behaviours in the body, with potassium being primarily an intracellular
element, and sodium being primarily an extracellular element. Moreover, some of
the chemically similar elements that behave in a qualitatively similar fashion in the
body may exhibit quite different kinetics. For example, caesium follows the behav-
iour of potassium in the body in a qualitative sense, but is distributed somewhat
211
differently from potassium at early times after intake, and exhibits a substantially
longer whole-body retention time.
The level of confidence that can be placed in a model value based on human data
for a chemically similar element depends on the quality and completeness of the data
for the analogue, as well as the expected strength of the analogy for the given situ-
ation. Whatever the quality of the data for the chemical analogue, the confidence
interval should reflect the fact that some confidence in the predictive strength of the
data is lost when the data are extrapolated across elements.
The strength of the chemical analogy for a given element depends largely on the
extent to which the chemically similar elements have also been found to be physio-
logically similar. That is, the analogy would be considered strong for a pair of
elements if a relatively large set of experimental data indicates that these elements
have essentially the same qualitative behaviour in the body, and that their quanti-
tative behaviour is either similar or differs in a predictable fashion. In view of
counterexamples to the premise that chemically similar elements are necessarily
physiologically similar, the chemical analogy does not provide high confidence if
the elements in question have not been compared in animals or humans.
5. CONCLUSIONS
Determination of doses after internal exposure is a complex procedure that
requires the use of models describing the behaviour of the radionuclides and the
deposition of their energy in the tissues. Recent advances have provided models with
increased physiological realism that in turn allows more realistic dosimetry. For
radiological protection purposes (i.e. optimisation and demonstration of compliance
with dose limits), these models are regarded as reference tools that are not subject to
uncertainty. When these models are used in other areas such as toxicology, pharma-
cology, medicine, and dose reconstruction for epidemiological studies, uncertainty
and variability need to be taken into account.
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Use of effective dose
J.D. Harrisona, M. Balonovb, C.J. Martinc, P. Ortiz Lopezd,
H-G. Menzele, J.R. Simmondsf, R. Smith-Bindmang, R. Wakefordh
a
Oxford Brookes University, Faculty of Health and Life Sciences, Oxford OX3 0BP, UK;
e-mail: john.harrison@phe.gov.uk
b
St. Petersburg Institute of Radiation Hygiene, Russia
c
University of Glasgow, UK
d
International Atomic Energy Agency, Austria
e
European Organisation for Nuclear Research, Switzerland
f
Health Protection Agency, UK (retired)
g
University of California, USA
h
University of Manchester, UK
Abstract–International Commission on Radiological Protection (ICRP) Publication 103 pro-

vided a detailed explanation of the purpose and use of effective dose and equivalent dose to
individual organs and tissues. Effective dose has proven to be a valuable and robust quantity
for use in the implementation of protection principles. However, questions have arisen regard-
ing practical applications, and a Task Group has been set up to consider issues of concern.
This paper focusses on two key proposals developed by the Task Group that are under con-
sideration by ICRP: (1) confusion will be avoided if equivalent dose is no longer used as a
protection quantity, but regarded as an intermediate step in the calculation of effective dose. It
would be more appropriate for limits for the avoidance of deterministic effects to the hands
and feet, lens of the eye, and skin, to be set in terms of the quantity, absorbed dose (Gy) rather
than equivalent dose (Sv). (2) Effective dose is in widespread use in medical practice as a
measure of risk, thereby going beyond its intended purpose. While doses incurred at low levels
of exposure may be measured or assessed with reasonable reliability, health effects have not
been demonstrated reliably at such levels but are inferred. However, bearing in mind the
uncertainties associated with risk projection to low doses or low dose rates, it may be con-
sidered reasonable to use effective dose as a rough indicator of possible risk, with the add-
itional consideration of variation in risk with age, sex and population group.
Keywords: Effective dose; Equivalent dose; Absorbed dose; Stochastic risk; Deterministic risk
Protection.
215
1. INTRODUCTION
The concept of effective dose was introduced originally in the 1977
Recommendations of the International Commission on Radiological Protection
(ICRP) for the control of occupational and public exposures to external and internal
sources of radiation, considering moderate and low levels of exposure in relation to
stochastic health effects (ICRP, 1977). While the concept has remained essentially
unchanged through the 1990 Recommendations (ICRP, 1991) to the 2007
Recommendations (ICRP, 2007), its use has been extended to members of the public
of all ages, including in-utero exposures of the embryo and fetus (ICRP, 2001, 2004,
2006). Effective dose is accepted and applied internationally as the central radiological
protection quantity, and has proven to be a valuable and robust quantity for use in the
optimisation of protection and setting of control criteria: limits, constraints, and refer-
ence levels. However, confusion has arisen in its practical application, particularly in the
communication of dose information to non-experts (e.g. Gonzalez et al., 2013). In
addition, effective dose is increasingly used in medical applications, including a prob-
lematic and growing application to the assessment of risks to individuals (Martin, 2007;
Brenner, 2008, 2012; Balonov and Shrimpton, 2012; Harrison and Ortiz-Lopez, 2015).
The calculation of effective dose can be seen as a three-step process, starting
with the determination of mean absorbed doses to organs and tissues, in gray
(Gy; J kg1), with the intermediate stage of converting absorbed doses to equivalent
doses, in sievert (Sv), using radiation weighting factors (wR). The summing of organ/
tissue equivalent doses, each weighted by the appropriate tissue weighting factor
(wT), gives the effective dose, in Sv. Confusion can occur between equivalent dose
(in Sv) and effective dose (also in Sv) when they are not distinguished carefully,
particularly when considering doses from internal emitters that concentrate in spe-
cific organs, such as iodine-131 (Gonzalez et al., 2013). There is also the potential for
confusion between equivalent dose and the operational quantity, dose equivalent
(Sv), used to measure exposures to external sources, and in which monitoring equip-
ment is calibrated (ICRP, 2007).
Effective dose has proven to be a useful tool in controlling exposures received by
patients undergoing medical diagnostic and interventional procedures. However, its
use to provide estimates of risk to individual patients goes beyond its intended use
(ICRP, 2007; Menzel and Harrison, 2012). Brenner (2008, 2012) suggested that
effective dose should be replaced by ‘effective risk’ as a more scientifically based
quantity. This approach ignores the large uncertainties associated with risk inference
at low doses based on epidemiological observations of populations exposed to
higher doses (UNSCEAR, 2012). While doses can be measured or estimated with
reasonable reliability down to very low levels, the inferred risk that may be asso-
ciated with the dose is increasingly uncertain as dose decreases (Dietze et al., 2009;
UNSCEAR, 2012).
An ICRP Task Group is currently preparing a report to provide guidance on the
use of effective dose as a risk-related protection quantity. This paper focusses on
Task Group proposals relating to: (1) discontinuation of the use of equivalent dose
216
as a separate protection quantity; and (2) the use of effective dose as a rough indi-
cator of possible risk from particular medical diagnostic procedures.
2. DOSE QUANTITIES
The procedure for the assessment of effective dose adopted by ICRP is to use
absorbed dose as the fundamental physical quantity; to average it over specified
organs and tissues; to apply suitably chosen wR to take account of differences in
biological effectiveness of different radiations to generate stochastic health effects to
give equivalent dose; and to consider differences in sensitivities of organs and tissues
to radiation-induced stochastic health effects and their contribution to total detri-
ment (ICRP, 1991, 2007). Absorbed doses are calculated for reference persons using
reference phantoms with specified organ and tissues masses (ICRP, 2009). Values of
the equivalent dose to organs and tissues are weighted using wT providing a simpli-
fied representation of relative detriment, and the weighted equivalent doses are then
summed to give the effective dose. This quantity is used to sum exposures to radi-
ation from incorporated radionuclides and to external radiation fields. Exposure
limits, constraints, and reference levels in relation to stochastic health effects are
set in terms of effective dose.
Equivalent dose can be seen as an intermediate step in the calculation of effective
dose. Currently, equivalent dose is only used as a separate quantity in specifying
limits for the avoidance of deterministic effects/tissue reactions in the cases of
irradiation of the hands and feet, lens of the eye, and skin; that is, limits set below
thresholds for the occurrence of damage to organs and tissues (ICRP, 2007).
However, wR values relate specifically to stochastic effects, and available data on
the relative biological effectiveness (RBE) of different radiation types (e.g. a particles
and neutrons, cf. g rays) show that values are generally greater for cancer induction
than for deterministic effects (ICRP, 2003). It is arguably more appropriate, there-
fore, to use absorbed dose to set these deterministic limits, either relying on conser-
vatism in the limits to allow for differences in RBE or using appropriate values of
RBE relating to deterministic effects. In practice, such differences between radiations
may not be of great practical concern in relation to limits for the lens of the eye, skin,
and hands and feet as these are mainly relevant to circumstances of exposure to
penetrating low-linear-energy-transfer (LET) radiations.
Communication difficulties have arisen in situations where equivalent dose (Sv)
and effective dose (Sv) have not been distinguished adequately; for example, in
explaining doses for intakes of iodine-131 for which the equivalent dose to the thy-
roid (wT ¼ 0.04) is more than 20 times greater than the effective dose (Gonzalez et al.,
2013). There is also scope for confusion between equivalent dose and the operational
quantity, dose equivalent (Sv). As effective dose is not a directly measurable quan-
tity, operational quantities for the measurement of external exposures and calibra-
tion of instruments have been defined in terms of dose equivalent (ICRU, 1985, 1988;
ICRP, 2007). Confusion between quantities would be avoided if organ and tissue
doses were referred to in terms of absorbed dose, specifying low- and high-LET
217
components if necessary. For example, an intake of iodine-131 might result in an

effective dose of 10 mSv, with a thyroid dose of 240 mGy (low LET). For ingestion of
plutonium-239 by an adult member of the public, the committed effective dose is
2.5 107 Sv Bq1, dominated (>99.9%) by a particles and contributions of
8.6 108 Gy Bq1 to the liver, 4.1 107 Gy Bq1 to bone surfaces, and
2.0 108 Gy Bq1 to red bone marrow.
It is proposed that consideration should be given to discontinuation of the use of
equivalent dose as a distinct protection quantity, leaving effective dose as the primary
protection quantity relating to stochastic health effects, and dose equivalent as the
operational quantity used in measurements. Deterministic limits would be set in
terms of absorbed dose.
3. DOSES AND RISKS FROM MEDICAL PROCEDURES

The radiation doses received in diagnostic and interventional procedures are rec-
orded in terms of quantities that can be measured for each technique. Suitable
quantities are entrance surface air kinetic energy released per unit mass (kerma)
and kerma-area product for radiography and fluoroscopy, and volume averaged
computed tomography (CT) dose index and dose length product for CT. These
measured quantities provide straightforward methods for assessment, and are used
for comparison of doses for particular types of examination among different health-
care facilities and even different countries. Surveys are made to establish diagnostic
reference levels in terms of these measurable quantities (Martin, 2008, 2011; ICRP,
2016), and dose comparisons are made against them to judge whether protection is
optimised. Measured dose quantities are suitable for making comparisons between
techniques that deliver exposures with similar relative distributions of absorbed dose
inside the body, and should always form the first approach when considering patient
dose. However, as organs and tissues vary in their sensitivity to radiation and asso-
ciated risk of development of cancer, measurable dose quantities are unable to
convey a meaningful comparison of the possible health detriment associated with
techniques that result in different distributions of dose within the body. Effective
dose has provided a valuable tool to fulfil this requirement.
In order to make judgements regarding justification and optimisation of examin-
ations, and for communication with patients, clinicians need language that reflects a
broad perspective of possible risks to health from the procedures being applied.
However, the widespread use of effective dose as a measure of risk goes beyond its
intended applications (ICRP, 2007). Recognising that there is a role for effective dose
in medical practice, it is important that guidance is provided so that uncertainties
associated with inferred risks are appreciated, and distinctions are drawn between
scientific observations, inferred risks at lower doses, and assumptions applied for
protection purposes.
In general, epidemiological data show a linear dose–response relationship between
cancer rates and a briefly received absorbed dose from g rays from a few Gy to
around 100 mGy. The data show age- and sex-related differences in cancer rates
218
Gy1 that also differ between cancer types and populations, depending on the
modelling assumptions applied in transferring risks between populations (ICRP,
2007). Attempts are being made to extend observations to lower levels of exposure,
notably studies on large worker cohorts exposed over a protracted period (Muirhead
et al., 2009; Boice, 2015) and studies of children receiving CT scans (Pearce et al.,
2012; Mathews et al., 2013; Huang et al., 2014). The CT studies reported significant
elevation of cancer rates at doses of a few tens of mSv. However, caution has been
advised in the interpretation of these studies (Boice, 2015). A number of problems
were identified, including lack of information on the reasons for the scans, and lack
of individual dose reconstruction. It is considered that the patients may well have
had underlying conditions that prompted their CT examinations, an example of so-
called ‘reverse causation’ or confounding by indication (UNSCEAR, 2013; Mathews
et al., 2013; Walsh et al., 2014). It is important that future studies are controlled
rigorously to avoid confounding.
Stochastic risks in the range from a few tens of mGy and below are inferred on the
basis of observations applying at higher doses and the application of dose–response
models, including the assumption of a linear-non-threshold (LNT) dose–response
relationship at low doses and dose rates (UNSCEAR, 2013). Unless such models
substantially underestimate risks at low doses, epidemiological studies are unlikely to
be able to demonstrate health effects at the mGy level. While an LNT dose–response
relationship is mechanistically plausible for most cancer types, estimates of risk at
low doses or dose rates are subject to substantial uncertainties that are only partly
quantifiable at present. Other models are being developed that apply more sophis-
ticated mechanistic considerations (Kaiser et al., 2014). The assumption of an LNT
dose–response relationship is explicit in the application of the ICRP protection
system, and implicit in the use of effective dose calculated to reference persons.
Protection is optimised on the assumption that risks are proportional to dose over
a wide range of doses down to fractions of a mSv and even below.
In discussion of the appropriate use of effective dose in medical applications,
Publication 103 (ICRP, 2007) states that: ‘. . . risk assessment for medical diagnosis
and treatment. . . is best evaluated using appropriate risk values for the individual
tissues at risk and for the age and sex distribution of the individuals undergoing the
medical procedures.’ With respect to diagnostic procedures, these are inferred risks
as discussed above, assuming that epidemiological observations of cancer rates Gy1
can be applied, with suitable adjustments, at lower doses.
Wall et al. (2011), and Balonov and Shrimpton (2012) estimated radiation risks
from a range of medical x-ray examinations (radiography, fluoroscopy and CT) as a
function of the age and sex of the patient, applying the risk models of UNSCEAR
(2006) and ICRP (2007). Risk estimates were based on typical organ/tissue doses and
age- and sex-specific risk factors for individual cancer types. Effective dose was also
calculated for each procedure so that values of risk per unit effective dose (Sv) could
be compared. Fig. 1 shows the results presented by Wall et al. (2011), calculated
using risk data for an ICRP Euro-American composite population (Publication 103
analyses use three Euro-American and four Asian populations). While lifetime risks
219
of radiation-induced cancer decrease with patient age for all examinations, the pat-
tern of changes differs markedly between examinations and between sexes, reflecting
differences in the changing radiosensitivity of organs and tissues.
On the basis of the data presented by Wall et al. (2011), and Balonov and
Shrimpton (2012), illustrated in Fig. 1, it can be concluded that risks per unit effect-
ive dose for most examinations may be around twice as great for the 0–9-y age group
than for the 30–39-y age group. For patients in their 60 s, the risk coefficients for
most examinations are approximately half those for patients in their 30 s, falling to
less than one-third for patients in their 70 s, and about one-tenth for those in their
80 s. Risks for the 30–39-y age group are close to the ICRP sex-averaged nominal
detriment-adjusted cancer risk coefficient of 5.5% Sv1.
Typical doses received in medical x-ray examinations range from a few tens of
mSv effective dose for some CT procedures to mSv doses for peripheral x-ray exam-
inations (Mettler et al., 2008; Wall et al., 2011; Smith-Bindman et al., 2015;
Shrimpton et al., 2016). As discussed above, risks associated with such doses are
inferred and uncertain, and this is particularly the case at the very low doses resulting
from peripheral radiographs. Bearing in mind the substantial uncertainties asso-
ciated with projections of low dose risk, it appears questionable whether detailed
calculations of risk using organ/tissue doses and age- and sex-specific risk factors
would generally be justified in evaluating medical procedures. It would appear more
reasonable to use effective dose and nominal risk coefficients as a rough indicator of
possible risk, with the additional consideration of variation in risk with age, sex, and
population group. Balonov and Shrimpton (2012) concluded that although effective
dose was not intended to provide a measure of risk associated with medical x-ray
examinations, simple adjustments to nominal risk coefficients to take account of age
and sex differences might make it a useful instrument when considering the justifi-
cation of examinations.
4. CONCLUSIONS
A cross-Committee Task Group of ICRP is currently developing a report to
provide guidance on the practical applications of effective dose. The report will
cover a range of issues relating the use of effective dose in the control of occupa-
tional, public, and medical exposures. This paper has focussed on two of the central
issues being considered by the Task Group, and summarised proposals developed by
the Task Group. These proposals are under consideration by ICRP Committees and
the Commission.
Confusion can arise in the use of the protection quantities, equivalent and effective
dose (both in Sv), when they are not sufficiently well distinguished, and between
equivalent dose and the operational quantity, dose equivalent (Sv), used in measure-
ments of exposures to external radiation for the assessment of effective dose
(Gonzalez et al., 2013). It is essential to specify which quantity is being used under
particular circumstances. Difficulties would be reduced or avoided if organ and tissue
doses were referred to in terms of mean absorbed dose (Gy), specifying low- and
220
Males
20
18
16
unit effective dose (%/Sv)
Total cancer risk per
14
12
10
0
0 10 20 30 40 50 60 70 80 90 100
Age at exposure (y)
Females
22
20
18
unit effective dose (%/Sv)
Total cancer risk per
16
14
12
10
0
0 10 20 30 40 50 60 70 80 90 100
Age at exposure (y)
Head (AP+PA+Lat)
12 Cervical s pine (AP+Lat)
0
Ches t PA 0 10 0
Thoracic s pine (AP+Lat)
Abdom en AP Pelvis AP
Lum bar s pine (AP+Lat) IVU
Ba s wallow Ba follow
Ba enem a Coronary angiography
Fem oral angiography CT head
CT ches t CT abdom en
CT abdom en + pelvis CT ches t + abdom en + pelvis
Uniform whole body expos ure
Fig. 1. Total lifetime cancer risk per unit effective dose for the International Commission on
Radiological Protection’s Euro-American composite population as a function of age at expos-
ure and sex for a range of x-ray examinations and for uniform whole-body exposure (Wall
et al., 2011). AP, anteroposterior; IVU, intravenous urography; Lat, lateral; PA, postero-
anterior; y, year.
221
high-LET components as necessary. The unit Sv would then apply to the protection
quantity, effective dose, and the corresponding operational quantity, dose equiva-
lent. Limits to prevent deterministic effects to the lens of the eye, skin, and hands and
feet would more appropriately be set in absorbed dose rather than equivalent dose.
The Task Group therefore suggests that consideration should be given to discon-
tinuation of the use of equivalent dose as a separate protection quantity.
Effective dose is a risk-adjusted dosimetric quantity for use in the control of
exposures to all sources of radiation. However, it is also commonly used as a
measure of stochastic risk, particularly in medical applications. While doses can be
measured or assessed with reasonable reliability down to very low levels, the asso-
ciated risk is increasingly uncertain as doses decrease. Risks at doses below around
50–100 mGy are inferred on the basis of epidemiological observations relating to
higher doses, usually assuming a linear dose–response relationship at lower doses or
dose rates. As discussed in Publication 103 (ICRP, 2007), risks associated with med-
ical procedures are best evaluated using appropriate risk values for the individual
tissues at risk, and for the age and sex distribution of the individuals undergoing the
medical procedures. However, the analyses of Wall et al. (2011), and Balonov and
Shrimpton (2012) showed that the use of effective dose and nominal risk coefficients,
rather than best-available data, might underestimate risk for most procedures by
approximately a factor of two for young children, and overestimate risk by a factor
of two for the 60–69-y age group. Thus, effective dose to a reference person might be
used judiciously as a rough indicator of possible risk, with simple adjustments to
take account of age and sex differences, without implying greater knowledge of risks
at low doses than is justified (Harrison and Ortiz-Lopez, 2015). The overriding
consideration in assessing doses received in diagnostic x-ray procedures is arguably
the inference that risks demonstrated at higher doses will apply at lower doses.
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224
Dosimetry for animals and plants: contending
with biota diversity
A. Ulanovsky
Institute for Radiation Protection, Helmholtz Zentrum Munich – German Research Centre for
Environmental Health, Ingolstädter Landstraße 1, D-85764, Neuherberg, Germany;
e-mail: ulanovsky@helmholtz-muenchen.de
Abstract–Diversity of living organisms and their environmental radiation exposure condi-

tions represents a special challenge for non-human dosimetry. In order to contend with such
diversity, the International Commission on Radiological Protection (ICRP) has: (a) set up
points of reference by providing dose conversion coefficients (DCCs) for reference entities
known as ‘Reference Animals and Plants’ (RAPs); and (b) used dosimetric models that prag-
matically assume simple body shapes with uniform composition and density, homogeneous
internal contamination, a limited set of idealised external radiation sources, and truncation of
the radioactive decay chains. This pragmatic methodology has been further developed and
extended systematically. Significant methodological changes include: a new extended
approach for assessing doses of external exposure for terrestrial animals, transition to the
contemporary ICRP radionuclide database, assessment-specific consideration of the contri-
bution of radioactive progeny to dose coefficients of parent nuclides, and the use of general-
ised allometric relationships in the estimation of biokinetic or metabolic parameters. The new
methodological developments resulted in a revision of the DCCs for RAPs. Tables of the dose
coefficients have now been complemented by a web-based software tool, which can be used to
calculate a user-specific DCC for an organism of arbitrary mass and shape, located at user-
defined height above the ground, and for an arbitrary radionuclide and its radioactive
progeny.
Keywords: Non-human biota; Environmental radiation exposure; Dosimetry; Absorbed dose;

Dose conversion coefficients
Protection.
225
1. DOSIMETRY FOR ENVIRONMENTAL RADIOLOGICAL PROTECTION

Activities of the International Commission on Radiological Protection (ICRP)
Committee 5 target topics related to environmental radiological protection, includ-
ing establishment and justification of the environmental radiological protection
system, its criteria, reference levels, and the basics of application practices.
Justification of a methodology for assessing doses of radiation exposure of non-
human biota appears in the list of topics as an important issue. Immense diversity
of non-human life forms, their morphological and biological properties, behaviours,
and life cycles creates a particular challenge for assessment of the environmental risks
of radioactive exposures. Methods for assessing radiation doses are also challenged
by the diversity of biota. This paper focusses on recent improvements in the methods,
endorsed by ICRP, used to derive dose conversion coefficients (DCCs) for non-
human biota, and discusses their application to practices of environmental dose
assessments.
In an attempt to contend with biodiversity in assessment tasks related to dosim-
etry of various organisms, ICRP (2003a, 2008b) created points of reference by estab-
lishing a set of Reference Animals and Plants (RAPs), and by providing DCCs for
these entities exposed to certain basic environmental radiation sources. In addition,
the current approach of ICRP endorses the use of simplified, albeit plausible and
robust, dosimetric models, which have been constructed to adequately reflect the
most essential, from the dosimetric viewpoint, features of an organism or its envir-
onment, and appear to be the only practical means to contend with existing
biodiversity.
Use of simple dosimetric models and approaches targeting absorbed dose aver-
aged in the whole body is also compatible with the considered biological endpoints
for radiological protection of non-human biota, which are defined by ICRP (2014) as
‘. . .those that could lead to changes in population size or structure’. Consequently,
the biological endpoints can be regarded as biased towards early tissue reactions,
which are generally expected at higher dose levels than those relevant to human
radiological protection endpoints.
The current dosimetric approach of ICRP for non-human biota was outlined in
Publication 108 (ICRP, 2008b; Ulanovsky and Pröhl, 2012), and is based on exten-
sive experience accumulated over decades of radioecological and dosimetric studies.
The approach has a strong link to, and stems from, the methodology and data
developed in European-Union-supported projects (Larsson, 2004, 2008). The dosi-
metric data of Publication 108 were prepared using essentially the same methodology
and computational tools as those incorporated in the ERICA assessment tool
(Brown et al., 2008), and the radionuclide emission database of Publication 38
(ICRP, 1983).
Although extensive, the set of published DCCs for non-human biota has often
been regarded as limited because of the restricted set of RAPs, or missing DCCs for
certain radionuclides or particular exposure geometries. These limitations, often
called ‘gaps’, and some internal inconsistencies were present in the dataset of
226
Publication 108 (ICRP, 2008b) (e.g. few available sources for external exposure of
terrestrial biota, or different ranges of accounted body masses of aquatic and terres-
trial animals). Since issuance of Publication 108, new developments have provided
possibilities to close some of these ‘gaps’, and to develop software tools that would
enable one to go beyond the limits inherent in the printed tables of DCCs.
Over recent years, the activities of ICRP Task Group 74 have focussed on incor-
porating the new data and better methods into the current ICRP dosimetry system
for non-human biota in order to update, extend, and harmonise the system, and to
improve its self-consistency. The planned Task Group report is expected to present
results of this activity systematically. The main changes in dosimetry for non-human
biota resulting from this activity are described below.
2. EXTENDING THE ICRP DOSIMETRY SYSTEM FOR

NON-HUMAN BIOTA
The current dosimetric framework for non-human biota appears to be highly
compatible with the previously established framework (ICRP, 2008b; Ulanovsky
and Pröhl, 2012). The existing methodology for assessing dose coefficients of
internal and external exposure of aquatic organisms and internal exposure of
terrestrial organisms uses a uniform isotropic model, and applies rescaling factors
to obtain absorbed fractions for non-spherical bodies (Ulanovsky and Pröhl,
2006).
2.1. Revision and extension of DCCs for external exposure of terrestrial organisms
DCCs for external exposure of terrestrial organisms are based on results obtained
by Monte Carlo simulation of photon radiation transport in terrestrial environments
(Taranenko et al., 2004; Ulanovsky, 2014), so any contributions from a particles and
electrons to the external dose of terrestrial organisms are neglected because of: (a)
their short ranges in dense media; and (b) the fact that radiosensitive tissues of
animals and plants are usually covered by inert layers (e.g. dead skin, fur, feather,
shell or bark) and are beyond the reach of low-penetrating external radiations.
The dose coefficients for external exposure of terrestrial organisms in Publication
108 were based on the data of Taranenko et al. (2004), derived for three radiation
sources in soil and for organisms on the ground surface with body mass ranging from
0.17 g to 550 kg (up to 6.6 kg for burrowing animals). External exposure of flying
organisms (birds and insects) to sources in soil was modelled for organisms with
body mass ranging from 35 g to 2 kg at heights not exceeding 10 m above the ground
surface. The range of accounted body masses for terrestrial organisms was not in
compliance with the accounted range of body masses for internal exposure and
external exposure of aquatic organisms, which ranges from 1 mg to 1000 kg.
Therefore, an obvious extension of the external dosimetry for terrestrial biota
should improve harmonisation of the dosimetric approaches between aquatic and
terrestrial species, and increase a number of radiation sources to address exposure
situations of potential concern.
227
Extension of the dosimetric methods for external exposure of terrestrial organisms

has been completed using the new approach, within which the whole-body doses
arising from external exposure above the ground surface due to various photon
sources in soil or in the ambient air can be estimated for arbitrary heights up to
500 m above the ground surface, and for any organisms with body masses from 1 mg
to 1000 kg. Such flexibility became possible due to factorisation of the external dose
into free-in-air kinetic energy released per unit mass (kerma) spectrum, and the
energy-dependent ratio of whole-body absorbed dose and air kerma [see more details
in Ulanovsky (2014)]. Correspondingly, each physical quantity could be calculated
effectively by the Monte Carlo method using the ‘best available for selected condi-
tion’ technique, resulting in values that were computed accurately and systematically
for the wide range of applicable parameters. Interpolation of the computed quan-
tities allows derivation of dose coefficients for arbitrary masses in the range from
1 mg to 1000 kg, and for heights above the ground from 0.1 m to 500 m.
Due to the complexity and variability of the existing terrestrial life forms, all
possible exposure conditions cannot be addressed. Therefore, generalised represen-
tative cases – as defined by source configuration and energy, contaminated media,
organism sizes, and source/target relative locations – have been selected to model
external exposure DCCs. DCCs for other exposure configurations can be inferred or
deduced using interpolations between the available DCCs, or by superposition of
responses from different basic sources. Currently, the following source-target scen-
arios are considered:
. External exposure of animals and plants on and above the ground surface due to a
planar radionuclide source at a depth of 0.5 g cm2 in soil, which can be regarded
as representative of radioactivity freshly deposited on the ground, accounting for
surface roughness and initial migration.
. External exposure of animals and plants on and above the ground surface due to a
uniformly contaminated volume radionuclide source with a thickness of 10 cm,
which can be treated as representative of an aged contamination of soil following
substantial downward migration and activity redistribution.
. External exposure of animals and plants on and above the ground surface due to
an infinitely deep radioactive source in soil, which can be regarded as a source
representative of naturally occurring radionuclides or anthropogenic contamin-
ation of the environment strongly affected by downward migration, agriculture, or
decontamination practices.
. External exposure of animals and plants located on and above the ground surface
due to immersion in air uniformly contaminated with radioactive materials.
. External exposure of in-soil RAPs that are situated in the middle of a uniformly
contaminated volume radionuclide source with a thickness of 50 cm.
All of the above exposure scenarios, excluding the last scenario for in-soil expos-
ure, have been systematically recalculated or newly calculated in order to allow
interpolations of kerma spectra for source photon energy and height for the given
228
source in soil, and absorbed dose per kerma for body mass and energy of photons
incident on the body surface.
2.2. Effect of radioactive progeny on DCCs

Decay products of many radionuclides are themselves radioactive and may con-
tribute to radiation exposure. Contribution of the radioactive progeny to radiation
exposure of non-human biota is commonly attributed to the parent radionuclide,
subject to various assumptions. The most common is a simple and pragmatic method
when only a part of the full decay chain is taken into account under the assumption
of full equilibrium between the parent radionuclide and its daughter radionuclides.
Criteria for truncation of decay chains are commonly based on the selection of an
upper limit for the half-life of a daughter to be accounted for in the given chain.
Selection of the upper limit varies in the literature, and it can be found as 1 d (Amiro,
1997), 30 d (Jones, 2000; DOE, 2002), 180 d (Yu et al., 1993), and 100 y (Higley et al.,
2003). An approach, adopted in Publication 108, used the value of 10 d as the chain
cut-off criterion, following an approach introduced in the FASSET and ERICA
projects (Larsson, 2004, 2008) and used in the ERICA tool (Brown et al., 2008).
The ERICA tool and the current ICRP approach additionally truncate the chain at a
daughter nuclide if its half-life is longer than that of the parent, because, in such case,
the parent and the daughter would never reach equilibrium and, correspondingly,
equilibrium activity ratios for such nuclides are indefinite.
Truncation of decay chains based on the criteria of maximum allowed half-life of
a daughter is a simple and pragmatic solution when dealing with a limited set of
radionuclides of immediate practical importance for a specific assessment. However,
conditional on the assessment task, the chain truncation criteria may vary and need
to be modified appropriately. Moreover, the development of software tools for DCC
calculation, which use a comprehensive database of radionuclides, also requires the
introduction of a uniform, accurate, and flexible method to account for the effect of
radioactive progeny. Even more important, the method of cutting decay chains and
assigning equilibrium activity ratios to accounted chain members implicitly assumes
a single-thread linear decay chain, so this method may lead to ambiguous results
when applied to complex, branching and merging, decay chains.
A more robust and flexible approach, capable of addressing various exposure
scenarios (emergency, existing, or planned exposure situations), can be formulated
using weighting factors for members of the decay chain based on their time-
integrated activities. If accounting solely for radioactive decay (i.e. implying full
absorption of radioactive substances in the organism in the case of internal exposure,
or no migration of radioactivity deposited in the environment), one can express the
dose as follows:
!
X X q~ j
D ¼ "p q~ p þ "j q~ j ¼ q~ p "p þ "j ð1Þ
j j
q~ p
229
where D is the absorbed dose in Gy, " is the energy emitted per single decay of the
parent (index p) and daughter (index j) nuclides in J, and q~ is the time-integrated
activity concentration in Bq s kg1 of the parent and the daughter, similarly indexed.
As seen from Eq. (1), the effect of radioactive progeny results in an increase of energy
attributed to a single decay of the parent nuclide, and this effect is expressed via the
relative number of radioactive decays of the daughter radionuclides per single decay
of the parent radionuclide.
The implementation of this approach within software tools for DCC calculation
can account for the effect of radioactive progeny for any type of radioactive decay
chain by numerical integration of the differential equations describing the decay
chain. Correspondingly, the integration time can be selected to be pertinent to the
specific assessment task (so called ‘fit-for-purpose’); for example, based on life time
and behaviour of the studied organisms, exposure conditions in their habitats, and
existing temporal changes in radioactive contamination of the environment. An
example of such a coherent approach can be found in Ulanovsky (2014), where
DCCs for external exposure of terrestrial biota are computed for different averaging
times conditional on the environmental source: 15 d for freshly deposited (planar)
source in soil, 1 y for aged (10-cm-thick volume) source in soil, and infinite time
(secular equilibrium ratios) for natural radionuclides uniformly distributed in the
soil depth.
2.3. Transition to the contemporary database of radionuclides

Publication 107 (ICRP, 2008a) replaced Publication 38 (ICRP, 1983) with an
updated and substantially extended database of radiation emitted due to decay of
1252 radioactive isotopes of 97 elements. Therefore, transition to the new radiation
emission database appeared among the priority objectives of the Task Group. The
new ICRP dataset of DCCs for non-human biota has been recalculated completely
using this contemporary radionuclide emission database. The transition to the new
database has also required extension of the set of photon and electron absorbed
fractions up to 10 MeV to address maximum emitted energy for some newly included
radionuclides. As with the previous data from Publication 38, numerical integration
of continuous spectra of b electrons is used in the calculation of DCCs, thus account-
ing for the different range of electrons of various energies in the same emission
spectrum. As a result of the transition, the updated internal DCCs are supplemented
by fractions of dose due to four types of radiation, unlike the three types used in
Publication 108, because of separation of high-linear-energy-transfer (LET) radiation
into two groups: (a) fission fragments and a-recoil nuclei, and (b) a particles (see also
Section 3.2).
2.4. Revised tables of dose coefficients and the software tool

Although the new updated DCC tables for RAPs are prepared for the same list of
radionuclides and for the same decay chain criterion as in Publication 108, they were
recalculated completely using the updated methods, as well as the new radiation
emission dataset from Publication 107 (ICRP, 2008a). Other distinctive features of
230
the new tables are their organisation and layout, which differ substantially from
those used in Publication 108. The present tables are organised on a nuclide basis,
making it easier to reveal interspecies and intersource variability of dose coefficients
for the given radionuclide. In the majority of cases, such variability can be regarded
as low or insignificant, indicating that DCCs are not among the main sources of
uncertainty for an exposure scenario, and that an assessor has to pay attention to
other, probably more significant, sources of uncertainty in the estimated doses.
In Publication 108, DCCs were given for adult forms of RAPs and for RAPs at
various stages of development (eggs, mass, larvae, etc). The new tabulation only
shows DCCs for adult forms of RAPs. The reasons for this decision are two-fold.
First, variability of the dose coefficients for many radionuclides can be regarded as
insignificant and ignored, or can be caught relatively easily by simple interpolation of
the values shown for other RAPs. Second, the special purpose software tool
BiotaDCC can be used to generate DCCs ‘on demand’ by means of a fully flexible
user-friendly interface, accounting for non-standard (user-defined) organisms of
arbitrary shapes and body masses, and under various exposure conditions, including
different methods of accounting for radioactive progeny contribution. The software
tool is planned to complement the printed tables of dose coefficients.
Some radionuclides are known to concentrate in certain organs of an organism
(e.g. iodine isotopes in thyroids, bone-seeking actinides in skeleton, etc.), thus result-
ing in highly inhomogeneous dose distribution within the body. Under such circum-
stances, the average absorbed dose in the whole body may not reflect the actual risk
of radiation exposure (e.g. Gómez-Ros et al., 2008; Caffrey et al., 2015). Still, inter-
nal doses in organs can be evaluated using known radionuclide activity in the organ
and its mass, and simply replacing the body of the whole organism with another
artificial ‘body’ with the size and mass of the organ of interest.
3. ENVIRONMENTAL DOSE ASSESSMENT

3.1. Assessment of internal environmental exposures
Within the current ICRP dosimetric methodology for non-human biota, doses of
internal exposure are expressed as a product of the DCC and of average activity
concentration of a radionuclide in the whole body. If the latter is unknown, it can be
estimated from the known activity concentration in the environment using
concentration ratios (CRs), which are the lumped factors describing transfer of
radionuclides from the environment to the organism. Current estimates of CRs
(ICRP, 2009) bear significant uncertainties because they are defined for chemical
elements for stationary equilibrium conditions, thus ignoring non-stationarity of
intake and retention of radioactivity in the body. Correspondingly, reduction of
the uncertainties related to the lumped CRs has stronger potential to improve
dose estimates than further improving the accuracy of the DCC alone.
Reduction of uncertainty related to transfer of radioactivity from the environment
to the organism can be achieved via the use of radionuclide-specific CRs, which
account for nuclide-specific radioactive decay properties, particularly for those
231
radionuclides with a physical half-life comparable to their biological half-life.

Additionally, allometric relationships can be used to interpolate vital morphological
or biological properties between various types of species to quantify pathway-specific
intake, and to describe retention of radioactivity in the body, thus resulting in more
plausible estimates of CRs derived from simple (e.g. single-compartment) biokinetic
models. As an example of biologically plausible interpolations, generalised allometric
relationships are introduced and shown below for metabolic and inhalation rates of
terrestrial mammals.
Allometric relationships are traditionally expressed (Rubner, 1883; Kleiber, 1947)
as a power function of body mass:
Y ¼ a Mb ð2Þ
where Y represents the approximated property or characteristic, and M is body

mass. The equation can be interpreted as a simple linear response in terms of log-
transformed variables: ln Y ¼ ln a þ b ln M.
Biological data, accumulated and analysed over recent decades (e.g. Marquet
et al., 2005; Nagy, 2005; West and Brown, 2005; White and Seymour, 2005), pro-
vided sufficient information to demonstrate more complex relationships than those
represented by Eq. (2) (e.g. Kolokotrones et al., 2010). Correspondingly, a general-
isation of Eq. (2) can be suggested as follows:

Y ¼ a M b ð3Þ
where the generalised coefficients of the above relationship come from the polyno-
mial regression on log-transformed variables, and appear as follows:
X
K
a ¼ expðÞ and b ¼ 1 þ n ðln MÞn1 ð4Þ
n¼1
Examples are shown in Figs. 1 and 2, where the generalised Eq. (3) is used to
approximate a specific basal metabolic rate of mammals derived from the data of
Jones et al. (2009), and a specific ventilation rate of mammals based on the data of
Bide et al. (2000).
Figs. 1 and 2 show that deviations from the simple power law [Eq. (2)] are sig-
nificant, and the data can be viewed as realisations of random processes with sys-
tematic parts described by the fit (solid lines) and stochastic components, which can
be attributed to interspecies variability and are characterised by a geometric standard
deviation of 1.47 (specific basal metabolic rate, Fig. 1) or 1.55 (specific ventilation
rate, Fig. 2).
Also shown in Figs. 1 and 2 are corresponding age-dependent reference data for
humans (ICRP, 2002a,b), which demonstrate good compliance with other mammals.
The human data appear to show age dependence of basal metabolic and ventilation
232
Fig. 1. Specific basal metabolic rate of mammals derived from the data of Jones et al. (2009)
(dots), fit using generalised allometric Eq. (3), fit and prediction confidence intervals (CI)
(lines), and reference data for humans (ICRP, 2002a).
rates; however, as seen from the figures, this dependence is within uncertainty bands
imposed by interspecies variability and, correspondingly, age effects can be treated as
secondary and statistically insignificant when applied to allometric scaling for ani-
mals of different types.
3.2. Accounting for radiobiological effectiveness of radiation

Radiation effects on biota are known to depend not only on the absorbed dose,
but also on the ‘quality’ of radiation, which in turn depends on the type and energy
of the specific radiation. For example, a particles and other densely ionising radi-
ations, such as heavy ions, are known to cause a stronger radiological effect on living
tissue than that produced by b or g radiation. This is known as the relative biological
effectiveness (RBE) phenomenon, which can be expressed quantitatively via radi-
ation quality factors based on LET in the tissue (ICRP, 2003b, 2007). For the pur-
pose of human radiological protection, the concept of radiation weighting factors,
wR , was introduced and these factors are used in the transition from absorbed to
equivalent dose. In general, radiation weighting factors depend on radiological pro-
tection endpoints, which are known to differ for human and non-human species
233
Fig. 2. Specific ventilation rate of mammals (Bide et al., 2000) (dots), fit using generalised
allometric Eq. (3), fit and prediction confidence intervals (CI) (lines), and reference data for
humans (ICRP, 2002b).
(ICRP, 2007, 2014); thus, discussion on the selection of appropriate radiation

weighting factors for non-human biota is ongoing, and no consensus has been
reached to date. However, based on international experience gained on the issue,
one could expect that different RBE values need to be provided for high-LET radi-
ations (e.g. a particles, a-recoil nuclei, and spontaneous fission fragments) and low-
LET radiations (e.g. photons and electrons). To allow for flexibility of radiation
weighting, the calculated DCCs for internal exposure of non-human biota are com-
plemented by the relative fractions of different types of radiation emissions: (a) f0 for
a-recoil nuclei, spontaneous fission fragments, and neutrons; (b) f1 for a particles; (c)
f2 for b and g radiation with energy <10 keV; and (d) f3 for b and g radiation with
energy >10 keV.
3.3. Uncertainties of external environmental exposures

Similar to internal exposures, in the case of non-human biota exposed to external
radiation sources, uncertainties about DCCs due to interspecies variability can often
234
be regarded as insignificant when compared with the uncertainties resulting from

variability of environmental contamination and ‘source-target’ geometry for the
biota populations of dosimetric interests. Even for aquatic organisms, for which
exposure conditions can be approximated easily by simple exposure geometries
within infinite homogeneous media, variability of radiation source strength in the
environment can result in large variability of external doses among species of the
studied population. For terrestrial organisms, due to diversity of landscapes, vari-
ability of radiation sources and exposure conditions can be much higher, thus
making the external dose assessment for terrestrial species even more complicated.
Doses of external exposure strongly depend on the organism’s life cycle, migration,
and seasonal variations of behaviour. Currently adopted practices make use of a
superposition principle by splitting a complicated external exposure scenario into a
series of simple scenarios and summing their contributions, taking into account the
time quota (occupancy factors) spent by the organism in the various locations.
Dealing with the uncertainties pertinent to external exposure of both aquatic and
terrestrial biota can be achieved using probabilistic models, within which the uncer-
tainties can be quantified and handled. However, use of probabilistic approaches
requires collection of relevant data and statistical modelling. Modern developments
in the field of global positioning system and remote tracking equipment open new
possibilities to test and validate existing dosimetric approaches for free-ranging ani-
mals in highly heterogeneously contaminated environments (e.g. Hinton et al., 2015).
Such studies can provide data to be used as a ‘benchmark’ for testing existing dosi-
metric models and dose assessment techniques; thus, the practical and scientific
importance of such studies cannot be overestimated.
4. CONCLUSIONS
The recent activity of Task Group 74 regarding ‘more realistic dosimetry on non-
human species’ resulted in substantially revised and updated dosimetric methodology
for non-human biota, including tables and software to derive ‘fit-for-purpose’ dose
coefficients for animals and plants, not limited by the ‘family’ of ICRP RAPs alone.
The current dosimetry system for non-human biota was built assuming uniform dis-
tribution of radioactivity in a homogeneous skeleton-less body. Although in many
practically relevant cases, these assumptions are plausible, and corresponding uncer-
tainties in DCCs are much less than those for other parameters important for dose
assessment, there may be situations when the non-uniformity of activity distribution in
the body becomes essential for dose calculation. In such situations, some simple scaling
techniques can still be used, as suggested in Publication 108.
Compared with Publication 108 and the ERICA tool (Brown et al., 2008), the
current methodology for assessment of external exposure DCCs for terrestrial ani-
mals and plants has been systematically expanded and improved, and appears to be
more harmonised and self-consistent. Use of the contemporary radionuclide data-
base puts the new dosimetric methodology in line with other ICRP reports.
235
The new, radionuclide-based layout of the DCC tables facilitates quick interpol-
ation of DCCs between species and sources of exposure. Additionally, ‘fit-for-pur-
pose’ DCCs can be produced using the new software tool, which complements the
report of Task Group 74 and is expected to appear as an open-access web-based
application.
Besides DCCs, there are a number of other open issues that are influential to
plausibility of environmental dose assessments. These issues include: (a) quantifica-
tion of the radionuclide-specific CRs; (b) systematic consideration of uncertainties
caused by variability (either of organisms or environmental contamination and
transfer); (c) introducing and applying techniques of probabilistic modelling and
assessments; (d) studying and accounting for dosimetric effects due to metabolism
and biokinetic; (e) studying the biological effects of radiation on non-human biota in
order to justify radiological protection endpoints and to quantify pertinent radiation
weighting factors; and (f) development of appropriate statistical and information pro-
cessing techniques to allow for effective analysis of large biological and environmen-
tal datasets for highly diverse biota and heterogeneous environments.
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ICRP Publication 131: Stem cell biology
with respect to carcinogenesis aspects of
J.H. Hendrya, O. Niwab, M.H. Barcellos-Hoffc, R.K. Globusd,
J.D. Harrisone, M.T. Martinf, T.M. Seedg, J.W. Shayh, M.D. Storyh,
K. Suzukii, S. Yamashitai
a
Christie Medical Physics and Bioengineering, Christie Hospital NHS Foundation Trust and
University of Manchester, Manchester M20 4BX, UK; e-mail: jhendry2002uk@yahoo.com
b
Fukushima Medical University and Radiation Effects Research Foundation, Japan
c
Radiation Oncology and Cell Biology, New York University School of Medicine, USA
d
Bone and Signaling Laboratory, Space Biosciences Research Branch, NASA Ames
Research Center, USA
e
Centre for Radiation, Chemical and Environmental Hazards, Health Protection Directorate,
Public Health England, UK
f
Laboratoire de Genomique et Radiobiologie de la Kertinopoiese, CEA, France
g
Tech Micro Services Co., USA
h
Radiation Oncology, Simmons Cancer Center, University of Texas, Southwestern
Medical Center, USA
i
Radiation Medical Sciences, Atomic Bomb Disease Institute, Nagasaki University, Japan
Abstract–Current knowledge of stem cell characteristics, maintenance and renewal, evolu-

tion with age, location in ‘niches’, and radiosensitivity to acute and protracted exposures is
reviewed regarding haematopoietic tissue, mammary gland, thyroid, digestive tract, lung,
skin, and bone. The identity of the target cells for carcinogenesis continues to point to the
more primitive and mostly quiescent stem cell population (able to accumulate the protracted
sequence of mutations necessary to result in malignancy), and, in a few tissues, to daughter
progenitor cells. Several biological processes could contribute to the protection of stem cells
from mutation accumulation: (1) accurate DNA repair; (2) rapid induced death of injured
stem cells; (3) retention of the intact parental strand during divisions in some tissues so that
Protection.
239
mutations are passed to the daughter differentiating cells; and (4) stem cell competition,
whereby undamaged stem cells outcompete damaged stem cells for residence in the vital
niche. DNA repair mainly operates within a few days of irradiation, while stem cell repli-
cations and competition require weeks or many months depending on the tissue type. This
foundation is used to provide a biological insight to protection issues including the linear-
non-threshold and relative risk models, differences in cancer risk between tissues, dose-rate
effects, and changes in the risk of radiation carcinogenesis by age at exposure and attained
age.
Keywords: Stem cells; Radiobiology; Mutations; Carcinogenesis; Radiation risk
1. INTRODUCTION
The International Commission on Radiological Protection (ICRP) has reviewed
various aspects of cancer induction from radiation, including skin cancer risk in
Publication 59 (ICRP, 1992), genetic susceptibility to cancer in Publication 79
(ICRP, 1998), biological effects after prenatal irradiation (embryo and fetus) in
Publication 90 (ICRP, 2003), low-dose extrapolation of radiation-related cancer
risk in Publication 99 (ICRP, 2005), and lung cancer risk from radon in
Publication 115 (ICRP, 2010). In these reports, ICRP has made some judgements
and assumptions about the location and radiation response of the target cells respon-
sible for carcinogenesis in various tissues. In most cases, the target cells are con-
sidered to be the tissue stem cells, and, in some cases, their daughter progenitor cells.
Renewal and radiation response of these cells change with age and are governed
largely by exogenous signals from their ‘niche’ residence. The fundamental evidence
for stem cells being target cells has been increasing markedly in recent years. This
evidence contributes to understanding of the biological basis for carcinogenesis, and
helps support modelling of human radiation risk. It was considered that a report on
the subject of target/stem cells would be topical and valuable in order to put all the
target cell evidence for carcinogenic radiation risk in different tissues into a common
framework and perspective for the first time [see Publication 131 (ICRP, 2015) for the
full text].
Seven organ systems with different characteristics were chosen for detailed
review of their stem cell properties and radiation responses. Selection was made
on the basis of importance for radiological protection purposes, and the extent of
available radiobiological knowledge and interest. They comprised haematopoietic
tissues, mammary gland, thyroid, digestive tract, lung, skin, and bone, and
included information on both human and experimental animal systems.
Projections were made of the possible role of various stem cell processes concerning
particular risk issues of continuing importance to ICRP, namely the linear-non-
threshold (LNT) and relative risk (RR) models, dose and dose-rate effectiveness
factor (DDREF), location of target cells, tissue risk factors, and age-dependent
sensitivity to radiation.
240
2. STEM CELL CHARACTERISTICS AND RESPONSE

Stem cells are responsible for the maintenance of tissue function in renewing
tissues. For supplying a large number of a variety of functional cell types, the
tissue cell population has a discrete hierarchical lineage consisting of stem cells,
differentiating progenitor cells, and functional mature cells. In the normal steady
state, asymmetric division of adult tissue stem cells produces both a stem cell and a
progenitor cell. Progenitor cells divide further to increase in number, and they sub-
sequently differentiate into functional cells that are eventually lost from the tissue.
In this general scheme of tissue turnover, stem cells are mainly quiescent, while
progenitor cells divide more rapidly with a limited proliferative capacity. The
number of cell stages in a lineage varies greatly between tissues, from short lineages
in, for example, mammary gland, to long lineages in haematopoiesis and spermato-
genesis, where more diverse and specialised cell functions are required. Stem cells
are defined by their ability to self-renew and to produce progenitor cells of particular
lineages. Isolation and cultivation of stem cells are now greatly facilitated by iden-
tification of various stem-cell-specific markers coupled with flow cytometry, and the
ability of some stem cell types to survive anchorage-independent growth and pro-
liferate under restrictive soluble factor conditions and give rise to discrete spheroidal
groups of descendant cells. Several different subtypes of stem cell have been identi-
fied in particular tissues (e.g. haematopoietic tissue, intestine, skin, and lung) which
is indicative of a hierarchy within the stem cell population. The turnover rate and
the number/location of various cell types in a tissue are believed to be important
determinants of tissue-specific risk of radiation carcinogenesis.
The radiosensitivity of stem cells/progenitor cells regarding cell killing can be
assessed by clonogenic assays in vitro, and also in vivo using transplantation or
in-situ techniques. There are various examples of stem cells being more resistant
than progenitor cells, partly due to quiescence and providing time to undergo
potentially lethal damage repair. Within the stem cell compartment, there are a
few cases where certain stem cell types undergo rapid cell death (apoptosis) with
high sensitivity to radiation (e.g. in small intestine), considered to be a protective
response to delete injured stem cells. DNA repair and damage response play
important roles for tissue stem cells to stay quiescent and preserve genomic sta-
bility. In non-cycling stem cells, the more accurate form of the error-prone non-
homologous end-joining DNA repair pathway is likely the way (in contrast to the
error-free homologous recombination DNA repair in cycling S and G2 phase
cells) that DNA damage is repaired, and hence associated with potentially
lethal damage repair.
Tissue stem cells divide and replenish tissues for the entire life of an individual.
Their division potential is enormous, as shown in studies of bone marrow and intes-
tine. The regulation of proliferation and differentiation of stem cells occurs in the
stem cell ‘niche’ where they reside. Stem cells have limited telomerase activity so that
erosion of telomere ends through rounds of DNA replication is inevitable. One way
to prevent the loss of telomeres is to have efficient repair of DNA damage. Failure to
241
do this results in the loss of stem cells, which necessitates compensatory replication.
Therefore, damage checkpoints and DNA repair are important, and quiescence in
the well-protected microenvironment of the stem cell niche acts to promote the
genomic integrity of the stem cells. Telomere shortening takes place in stem cells
of an ageing body, and is linked to cell senescence.
3. ROLE OF STEM CELLS IN RADIATION CARCINOGENESIS

Cancer in adulthood is envisaged to arise as a result of accumulation of onco-
genic mutations occurring mainly after birth, and during growth and matur-
ational development, whereas some childhood cancers are characterised by
mutations acquired during fetal development or inherited from the parents.
The incidence of cancer in adults, especially solid cancer, exhibits a steady
increase with age. Armitage and Doll (1954) noted that this increase follows
approximately the fifth power of age, and proposed the multistage carcinogenesis
model. This was later supported by the molecular analysis of human colon
cancer, in which the conversion of normal epithelial cells to adenoma and its
progression to carcinoma were shown to be associated with a stepwise acquisition
of mutations of oncogenes and tumour suppressor genes. Acquisition of multiple
mutations by spontaneous processes takes a long time, which may explain why
many adulthood cancers arise late in life. A stem cell origin of cancer is suggested
because stem cells are likely to be the only type of cells that have a sufficiently
long residence time in the body to accumulate multiple mutations and gain malig-
nant phenotypes, while the bodily residence of committed progenitor cells is
somewhat compromised.
Regarding cancer risk in natural (unirradiated) conditions, a strong correlation
has been reported recently between lifetime tissue-specific cancer risk in (American)
populations and the estimated lifetime total number of stem cell divisions in each of a
wide variety of 31 tissues/body sites (i.e. the product of estimates of the stem cell
number and the lifetime number of cell divisions per stem cell in each tissue)
(Tomasetti and Vogelstein, 2015). This study has been discussed variously regarding
data selection, risk differences between populations, and method of analysis (Sills,
2015). Nonetheless, apart from the increasing knowledge of specific gene mutations
associated with increased susceptibility to particular cancers, the number of lifetime
stem cell divisions is the only other biological parameter to date claimed to be
associated with cancer risk in a normal human population. Hence, this study high-
lighted the potential importance of replication-mediated somatic mutation in the
aetiology of spontaneous cancer rather than just the traditionally entertained envir-
onmental and hereditary components.
Another mechanism that has received much attention is the so-called ‘immortal
strand’ hypothesis proposed by Cairns (1975), in which asymmetric segregation of
DNA strands was invoked as minimising DNA replication errors in the tissue stem
cells. Thus, the stem cell retains the template DNA strand after a round of DNA
synthesis, while the progenitor cell inherits the daughter strand with possible errors
242
that are eventually lost by differentiation and maturation as functional cells. There is
evidence in support of this mechanism in small intestinal crypts, mammary epithe-
lium, some muscle satellite cells and progenitor cells, and some central nervous
system cells (Potten and Wilson, 2007). However, the mechanism has been found
not to apply in haematopoietic stem cells (HSCs) (Kiel et al., 2007), and hence does
not apply universally. Also, a genetic sequencing approach has been used to estimate
the mutation accumulation rate in healthy stem cells of human colon, blood, and
head and neck tissues (Tomasetti and Bozic, 2015). Mutations accumulated in those
tissues at rates strikingly similar to those expected without any protection from an
immortal strand mechanism.
Another important feature described recently is the concept of competition
between normal and radiation-injured stem cells for residence in the niche. New
studies suggest that stem cells are competing constantly to occupy the niche, which
serves as a selective process against damaged stem cells. Interestingly, in one cell
type, lymphocytes from in-utero-exposed atomic bomb (A-bomb) survivors and in-
utero-exposed mice largely lacked chromosome aberrations after moderate doses of
radiation, suggesting a possible competition-mediated elimination of aberrant HSCs
(Nakamura, 2005). In contrast, stem cell competition is likely to be less stringent
during childhood, when the stem cell/niche units increase in number to cope with the
increase in tissue volume during childhood growth. Such behaviour of irradiated
stem cells may have relevance to the age-dependent sensitivity to radiation
carcinogenesis.
In addition to these targeted actions, radiation is known to act in a non-targeted
fashion, which includes bystander effects and the induction of genomic instability
(ICRP, 2007). However, the effects are, in most cases, non-linear with dose, thus
making extrapolations uncertain, and there are few studies at the dose levels relevant
for radiological protection. Hence, the present considerations are focussed primarily
on mechanisms of protecting stem cells from mutation accumulation. Also, animal
studies on the adaptation phenomenon, which could reduce the effects of protracted
irradiations, show variations with dose and tissue type, again making difficult any
general identification in a protection system.
4. TARGET CELLS FOR CARCINOGENESIS AMONG TISSUES

4.1. Haematopoietic tissue
Of all leukaemia types, acute myeloid leukaemia (AML) has been studied in
most detail. AML comprises <5% of all childhood leukaemias, but is one of
three radiation-inducible leukaemia subtypes: AML; chronic myeloid leukaemia
(CML); and acute lymphoblastic leukaemia (ALL). Proliferation of haematopoi-
etic malignancy is dependent on the type of tissue niche; HSC-derived leukaemia
cells require a bone marrow microenvironment, and lymphoma cells (progenitor
cell derived) need a lymph node environment. The multistage theory of carcino-
genesis and the importance of the microenvironment in promotional events con-
tinue to suggest that the majority of target cells for leukaemia are likely to be the
243
more slowly renewing primitive cells in the lineage. Indeed, the correlation between
chronic radionuclide (a-particle) doses/location and incidence of AML was closest
for target cells in the central marrow sinusoidal region (Lord et al., 2001), which is
one location of such primitive cells. However, further evidence in mice suggests that
the initial radiation-induced AML stem cell may originate not only from irradiated
HSCs, but also from multipotent and common myeloid progenitor cells (Hirouchi
et al., 2011). In addition, hemizygous deletion of dual-specificity protein phosphat-
ase 2 in chromosome 2 may contribute to the self-renewal potential of radiation-
induced AML stem cells (Hirouchi et al., 2011). Regarding non-targeted effects, a
pertinent example is the use of C57BL/6 and CBA/Ca mice which are resistant or
susceptible, respectively, to both radiation-induced myeloid leukaemia and
chromosomal instability in bone marrow cells, as well as exhibiting differences in
bystander signal generation after higher radiation doses (Zyuzikov et al., 2011).
Over an acute and broad dose range of 1.7 mGy to 3 Gy, bystander effects in the
bone marrow (assessed by p53 pathway signalling 3 h after irradiation) were only
observed after doses >100 mGy, and chromosomal instability at 30 days was only
found after doses 1 Gy. A detailed study of the ‘immortal strand hypothesis’ in
highly purified HSCs revealed that all stem cells segregated their chromosomes
randomly, and division of individual stem cells in culture revealed no asymmetric
segregation of the DNA label. Hence, HSCs did not retain older DNA strands
during division (Kiel et al., 2007). Also, irradiation affects the competition of HSCs
for their residence in the bone marrow niche. When one of two marked bone
marrow cell populations was exposed to 1 Gy and subsequently mixed with the
non-irradiated population prior to grafting into lethally irradiated mice, the latter
population predominated in the reconstituted marrow HSCs (Bondar and
Medzhitov, 2010). Bone marrow cells with higher levels of p53 protein were out-
competed by those from normal wild-type mice, indicating that stem cell competi-
tion for residence in the niche is sensitive to radiation stress, which is sensed by p53.
Within the A-bomb survivor cohort, the risk declined appreciably with increasing
age at the time of exposure (Preston et al., 1994). In the very young (0–9 y), risk
increased steeply during the early years following exposure, whereas in older sur-
vivors, the increase in risk was significantly delayed and more gradual. The repre-
sentative animal model, AML in some strains of mice, does not follow this pattern.
The incidence is low for infant exposure, and becomes high for exposure at
approximately 10 weeks of age or later.
4.2. Mammary gland

Radiation exposure is a well-documented risk factor for breast cancer. The risk
is approximately linear with increasing dose, and inversely related to age at expos-
ure. Exposures after menopausal age appear to carry a reduced excess risk, and
fractionating the dose has minimal influence. A number of studies have been pub-
lished on the effects of dose and dose rate on mammary tumour induction in
rodents (UNSCEAR, 1993). With BALB/c mice, the dose–incidence curve at
high dose rate was linear-quadratic up to approximately 0.25 Gy, and the linear
244
term was similar to that obtained after low-dose-rate (0.07 mGy min 1) exposures.
Dose-fractionation studies showed a significant contribution from the quadratic
component at doses as low as 0.1 Gy fraction 1, and acute daily fractions of
0.01 Gy gave a tumour incidence similar to that observed after low-dose-rate expos-
ure to a total dose of 0.25 Gy in both cases (Ullrich et al., 1987). Low doses of
radiation increased the mammary repopulating activity significantly, and could
thereby increase the number of target cells that could initiate cancer (Nguyen
et al., 2011). Understanding the effects of radiation on mammary stem cells is
likely to help provide additional key insights into physiological and genetic deter-
minants of cancer risk for an extended variety of solid tumour types. Data in the
radiation-chimera mammary model suggest that radiation exposure early in life can
alter heterotypic interactions, set the stage for stem cell expansion, and increase the
risk of developing oestrogen-receptor-negative breast cancer which is observed in
women treated with radiation for childhood cancers (Castiglioni et al., 2007). A
plausible scenario is that radiation elicits a transient change in signalling or a
persistent change in the inflammatory, macrophage, or vasculature compartment
of the gland. This altered microenvironment permanently alters the pool of mam-
mary epithelial stem/progenitor cells. Regarding age-at-exposure effects, the rela-
tively restricted window of carcinogen susceptibility that is evident during or
around puberty in both rodents and humans has been postulated to either contain
the greatest number of target cells or be a critical period of stem cell regulation.
There is a clear hierarchical lineage in mammary epithelium, controlled by many
factors. A cell population in mouse mammary epithelium can be selected which is
highly enriched in multilineage and self-renewal potential. Also, there is evidence
that epithelial label-retaining cells in mouse mammary gland divide asymmetrically
and retain their template DNA strands (Smith, 2005). However, the target cell
origin of radiation-induced breast cancers in terms of stem and progenitor cells
has not been elucidated to date.
4.3. Thyroid
Radiation induces both papillary and follicular carcinomas, but the former type
predominates in humans whereas the latter type predominates in the common rat
model. Although there is evidence for the presence of a stem cell type lineage in
thyroid epithelium, there is no knowledge of whether the different tumour types
originate from the same or different target cells in the lineage. Dose–incidence
relationships for carcinomas (mostly follicular) in 3000 female Long-Evans rats
showed a rising incidence with increasing x-ray dose from 0.8 Gy, flattening off
at the higher doses to 10.6 Gy (Lee et al., 1982). However, adenomas were in the
majority, and these showed a continuously rising dose–incidence curve. Hence, the
curves for the two tumour types appeared to be significantly different in shape. In
addition, concurrent studies with 131I and detailed dosimetry showed a similar
response to the high-dose-rate x-ray results for the carcinomas, but there was a
tendency towards a lower incidence of adenomas at the higher doses of 131I com-
pared with x rays. If the adenoma yields vs dose are interpreted on a
245
linear-quadratic basis, it can be estimated that the linear component (assumed not
modified by dose rate) may be at doses up to approximately 0.8 Gy, and a DDREF
of approximately 2 may apply at approximately 2 Gy. However, for the aggregated
yields of both tumour types, the linear component could be higher and the
DDREF lower, albeit with large uncertainties. The similarity of tumour yields in
rats at low doses of acute x rays and low-dose-rate 131I is compatible with human
data [i.e. the excess relative risk (ERR) for external radiation exposure was com-
patible with the ERR estimates for internal radiation exposure following the
Chernobyl accident].
4.4. Digestive tract

Cancers of the stomach and colon in rodents are only induced by high radiation
doses (e.g. 8 Gy) (Boice and Fry, 1995), and only rarely in the small intestine. A
possible reason invoked for the latter is the radiation-induced apoptosis of mutated
stem cells in the small intestine, which is prevented in the large bowel by expression
of the survival (anti-apoptotic) gene B-cell lymphoma 2 (Merritt et al., 1995).
Nonetheless, the stomach and colon are fairly resistant to cancer induction. Crypt
stem cells are still considered to be the target cells for colonic tumours, and several
types of stem cells have been described. The potential inclusion of some daughter
progenitor cells as target cells is not yet resolved. An interesting recent development
is the finding of rare, slowly cycling, long-lived, and radioresistant telomerase-
positive stem cells (one per 150 crypts) in both small and large intestine, which
can give rise to all differentiated intestinal cell types (Montgomery et al., 2011).
These are likely to be important candidate target cells in the colon in terms of the
multistage model for carcinogenesis. Germline mutation of the adenomatous polyp-
osis coli (APC) gene predisposes both humans and mice to intestinal carcinogenesis.
In humans, inheritance of mutant APC is associated with the cancer predisposing
disorder, familial adenomatous polyposis, and mutation of APC is an early somatic
event in sporadic colon cancer. Individuals carrying germline mutations in the APC
gene develop hundreds to thousands of colorectal adenomatous polyps, some of
which will progress to carcinomas if left untreated. The multiple intestinal neoplasia
(Min) mouse provides a sensitive model for the study of tumourigenesis in irradiated
mice. Min mice are genetically heterozygous for a germline truncating mutation of
the APC gene, and develop multiple intestinal tumours and sporadic colon tumours
in their intestinal tracts within several weeks of birth. Neonates were more radio-
sensitive to tumour induction than young adults. The dose–incidence curve for aden-
omas was linear-quadratic over the range 0–5 Gy x rays, and strikingly, there were
more tumours in the small intestine than in the caecum and colorectum (Ellender
et al., 2011). Tumour incidence was elevated in the caecum after 2 Gy, and in the
colorectum after 1 Gy. In general, adenomas in the small intestine were sessile while
the smaller numbers of adenomas in the large intestine were pedunculated. There was
also an incidence of micro-adenomas in the small intestine, which was greater after
the higher doses in the range used; however, no micro-adenomas were found in the
large intestine.
246
4.5. Lung
From studies of A-bomb survivors and uranium miners, radiation-induced lung
cancers were found to be more likely to be small cell lung carcinomas (SCLCs), and
less likely to be adenocarcinomas (ADCs) (Land et al., 1993). SCLCs do not occur in
mice, and ADCs are the most common type of lung cancer. The induction of ADCs
in female BALB/c mice following acute irradiation was shown to be consistent with a
linear-quadratic model in which the linear term was independent of dose rate by
comparing responses using 0.4 Gy min 1 and 0.06 mGy min 1. Also, the DDREF
was approximately 4.2 at 3 Gy, and approximately 3.2 at 2 Gy. Dose-fractionation
studies predicted that the DDREF would be approximately 1.1 at 0.1 Gy (Ullrich
et al., 1987). In the respiratory tract, the target cells for radiation-associated carcino-
genesis are considered to be basal cells in the trachea and larger bronchi of the
central lung, and Clara variant and type II alveolar cells in the peripheral lung.
An epithelial stem cell niche has been identified in the zone where airways terminate
and form alveoli. The putative mouse bronchoalveolar stem cells at the bronchiolar/
alveolar junction co-express secretoglobin-a1a, type II cell marker surfactant protein
C, and stem cell antigen-1, and are negative for surface markers CD45 and CD31.
Molecular analysis showed that, despite their distinct histopathological phenotypes,
genomic profiles showed near-complete overlap in human ADCs and squamous cell
carcinomas (SCCs), with only one clear SCC-specific amplicon (Tonon et al., 2005).
Hence, the common or different cellular origin of lung cancer types may become
better understood. In addition, there may be influences from the irradiated micro-
environment. For example, migration of mesenchymal stem cells (MSCs) into irra-
diated and stressed regions has been invoked as a potential alternative or
contributory mechanism in carcinogenesis.
4.6. Skin
Human skin cancers induced by ionising radiation are predominantly basal cell
carcinomas (BCCs). The traditional view was that a threshold dose exists for radia-
tion-induced skin cancer in the range of 8–10 Gy, but the A-bomb survivor data
indicated that BCCs can be induced by acute exposure at moderate doses, even as
low as approximately 1 Gy. In mice, radiation readily produces SCCs but no BCCs,
whereas approximately 20% of induced skin tumours in rats are BCCs. The dose–
response curve for total tumours in rats was compatible with a linear-quadratic
model, albeit with a tendency for adnexal (hair follicle and sebaceous) tumours to
be more common. Further, after low doses, adnexal tumours were more common
and occurred earlier after high doses compared with epidermoid tumours. With
repeated weekly doses of 0.75 or 1.5 Gy over a lifetime, more tumours were produced
than expected from single exposure dose responses, suggesting either the number of
events increased per unit dose (i.e. induced sensitisation) or that clonal growth
expanded the number of early transformed cells (Burns and Albert, 1986). The radi-
ation had to penetrate at least 180 mm to induce tumours, and a depth dose of
approximately 300 mm was about optimum irrespective of follicle growth phase
and size, demonstrating that the main target cells were in the stem cell zone of the
247
hair follicle. Also, there was a marked effect of age on the incidence of radiation-
induced cancer. A model for human skin cancer proposed that stem cells were the
likely target cells for BCCs, early progenitor cells for SCCs, and late progenitor cells
for papillomas (Sell, 2004). Stem cells have been found to be more radioresistant
than daughter progenitor cells, both in humans and mice, which may not only favour
tissue maintenance but also influence long-term accumulation of damaged cells.
Molecular characterisation of these different cell populations is continuing, and
the most potent quiescent stem cells appear to possess high levels of the adhesion
molecule integrin b6 and low levels of the transferrin receptor CD71. Quantitative
data of mouse follicle-bulge cell divisions marked with bromodeoxyuridine support
the long-standing infrequent stem cell division model (Waghmare et al., 2008).
However, it was shown that hair follicle stem cells do not retain the older DNA
strands or sort their chromosomes. To date, there are no distinct markers for the
target cells of the different types of skin cancer.
4.7. Bone
Radiation-induced bone sarcoma has been associated with high doses of ionising
radiation from therapeutic or occupation-related exposures. However, the develop-
ment of bone sarcoma following lower doses remains speculative. Analysis of 80,000
individuals in the Life Span Study cohort to assess the development of bone sarcoma
(most commonly osteosarcoma) showed a preferred fit with a dose threshold at
approximately 0.85 Gy (95% confidence interval 0.12–1.85 Gy), and a linear dose–
response association above this threshold (Samartzis et al., 2011). Chadwick et al.
(1995) fitted the radium dial painter data using a two-mutation carcinogenic model
with clonal expansion. The analysis showed that a linear-quadratic dose–effect rela-
tionship can be applied and, because of the very low natural incidence of bone
sarcoma, is consistent with very low absolute risk (AR) at low doses and dose
rates. Much of the experimental work on radiation-induced bone cancers has been
performed using dogs. For the low-linear-energy-transfer b emitter, 90Sr, the dose
response was non-linear with no tumours occurring at doses <18 Gy cumulative
average bone dose. This much higher threshold dose may reflect differences in dos-
imetry, the protraction of the radionuclide dose, and the much shorter life span of
dogs compared with humans. Osteogenic MSCs for the osteoblast lineage reside in
the bone marrow. MSCs are identified as plastic-adherent pluripotent cells, capable
of differentiating into bone, cartilage, and fat cells, and can be isolated from many
different tissues in addition to bone marrow. MSCs express high levels of DNA
damage repair proteins, are relatively radioresistant, and possess robust antioxidant
reactive-oxygen-species scavenging capacity. Exposure to ionising radiation can have
an adverse effect on various key cell functions of cultured MSCs (proliferation, dif-
ferentiation, and senescence) and can also cause loss of bone mass and skeletal
fragility, as well as having a secondary impact on haematopoietic functions, in
both animals and humans. Both primitive HSCs and mesenchymal precursor cells
are possible target cells for radiation-induced bone cancer. Also, these cell types
reside within a low oxygen tension environment in situ, which may help protect
248
cells from radiation damage. The target cells for bone-associated a-emitting radio-
nuclides lie within a few tens of micrometres from the endosteal surface, which is the
range of a particles.
5. CONCLUSIONS
The following conclusions are the main implications of current stem cell know-
ledge for the carcinogenesis aspects in the ICRP system of radiological protection
(ICRP, 2015).
. Target cells for carcinogenesis and their location. Tissue stem cells continue to be
considered primarily as the target cells for carcinogenesis. In haematopoietic
tissue, colonic mucosa, and epidermis, there is some evidence for progenitor
cells also being target cells. The microenvironmental ‘niche’ is an important regu-
lator of stem cell maintenance and a modifier of stem cell response. The locations
of stem cell niches are known in these renewing tissues from animal studies.
. The LNT model and the RR model. A single stem cell origin of radiation-induced
cancer, mutational theory, and the requirement of multiple mutations are consist-
ent with an LNT approach for some tissues and organs. Carcinogenesis depends
primarily on three mechanistic factors: (1) the number and sensitivity of stem cells
to radiation-induced mutation; (2) the retention of mutated stem cells in a tissue;
and (3) the population size of stem cells with a sufficient number of predisposing
mutations. It is postulated here that the ERR function largely reflects cellular
sensitivity to radiation-induced mutation and retention of predisposed stem
cells. In addition to these two factors, the excess absolute risk function reflects
the population size of the predisposed stem cells, thus being more complex but
comprehensive in relation to stem cells and stem cell populations being the targets
for radiation carcinogenesis. Recently, the lifetime number of stem cell divisions
multiplied by the total number of stem cells has been claimed to be an important
factor associated with natural cancer incidence in a wide variety of tissues.
However, this alone cannot explain some features of the natural occurrence of
cancer nor of radiation-induced cancers. Also, for those tissues where population
transfer of risk is based mainly on ERR, the LNT model in combination with the
RR model implies that any risk-reducing health actions that decrease the under-
lying background risk of some cancer types may also be effective in reducing the
risk of radiation-related cancer. To illustrate this point, a reduction in smoking
reduces radon-associated risk of lung cancer, although in this case, a combination
of RR and AR models is used for risk transfer.
. DDREF. The numerical value(s) of DDREF has been under much discussion
recently, and low values suggested in some epidemiological studies vs the higher
values found in other studies and in some animal systems require elucidation.
From the information reviewed in the present report, it is clear that the compo-
nent factors (i.e. dose effectiveness factor and dose-rate effectiveness factor) may
be considered to be conceptually different at the biological level. The former
249
applies for low acute doses, and the latter applies for low protracted doses where
long-term kinetics of target/stem cells in the tissue may modify the dose response.
. Response-modifying mechanisms at low dose rate. There is much evidence for the
presence of genomic instability and bystander effects in cellular and animal sys-
tems after acute doses of >0.5 Gy, but in most cases, the effects are non-linear
with dose, making extrapolations to lower doses uncertain. In a relevant animal
study using doses 100 mGy, and in the A-bomb survivor lymphocytes, genomic
instability effects were absent or small. Also, animal studies on the adaptation
phenomenon show variations with dose, tissue type, and in-vitro and in-vivo
model systems, again making difficult the incorporation of this feature into a
protection framework. Another mechanism is the DNA immortal-strand hypoth-
esis, whereby the parental DNA strand is retained in the stem cells and the muta-
tions are passed to the daughter progenitor cells, so reducing the overall mutation
burden. However, the evidence for this varies between tissue types and techniques.
A further mechanism is where non-injured stem cells outcompete radiation-
damaged stem cells for residence in the stem cell niche, which would reduce the
mutated complement of stem cells. There is some evidence for this in experimental
systems, but the implications for humans are speculative at present.
. Age-dependent sensitivities to radiation carcinogenesis. These can be summarised as
follows: embryo and fetal stages have low to moderate sensitivity, children have
high sensitivity, and adults have low sensitivity. It is possible that stem cells
exposed at the fetal stage of development are less likely to be retained during
neonatal growth, where radiation-damaged stem cells are in strong competition
with non-injured stem cells to settle in the limited number of newly established
stem cell niches. In contrast, high sensitivity in childhood can be understood if
stem cell competition is less stringent, because the stem cell/niche units increase in
number to cope with the increase in tissue volume during childhood growth.
However, true mechanistic insight for the age-dependent pattern of radiation
carcinogenesis is lacking at present.
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Radiation-related risks of non-cancer outcomes
in the atomic bomb survivors
K. Ozasa, I. Takahashi, E.J. Grant
Department of Epidemiology, Radiation Effects Research Foundation, 5-2 Hijiyama-koen,
Minami-ku, Hiroshima, 732-0815, Japan; e-mail: ozasa@rerf.or.jp
Abstract–Risks of non-cancer outcomes after exposure to atomic bomb (A-bomb) radiation

have been evaluated among the Life Span Study (LSS) cohort and its subcohort, the Adult
Health Study (AHS). Information regarding non-cancer outcomes in the LSS is obtained from
death certificates. In the AHS, members undergo clinical examinations biennially to determine
their health status. Many AHS studies have been limited to participants attending the clinic
over a limited period, and therefore have varying degrees of inferential utility; as such, care is
required for comparison with the LSS results. Disease structure of non-cancer diseases in
Japan has changed over the long follow-up period since the end of World War II. The
health status of the A-bomb survivors may be associated with the hardships of living in a
devastated city and impoverished country following the prolonged war effort, in addition to
the direct effects of radiation exposure. Radiation-related risk of cardiovascular disease may
have increased due to radiation-related increased risk of hypertension and other secondary
associations, and the risk of atherosclerotic disorders has also been reported recently. These
results should be interpreted with caution because of changes in disease definitions over the
follow-up period. The radiation-related risk of non-cancer respiratory diseases also appears to
have increased over the follow-up period, but the shapes of the dose–response curves have
shown little consistency.
Keywords: Atomic bomb survivors; Heart disease; Stroke; Japanese population
1. INTRODUCTION
The Life Span Study (LSS) cohort consists of approximately 120,000 atomic
bomb (A-bomb) survivors who were exposed to A-bomb radiation at various
Protection.
253
distances from the hypocentres. The members of its subcohort, the Adult Health
Study (AHS), were selected at random from the LSS members, stratified by dis-
tance from the hypocentres, acute radiation syndrome, and the condition that
they could participate in biennial health examinations at the Atomic Bomb
Casualty Commission and Radiation Effects Research Foundation (RERF) in
Hiroshima and Nagasaki, Japan. The total number of candidates for the AHS
was 24,000 of which approximately 20,600 had at least one examination. All
members of the LSS have been followed up nationally for their vital status and
cause of death since 1950, and the AHS health examination programme was
initiated in 1958 (RERF, 2014). Cause of death, including non-cancer diseases,
is collected for all LSS members via death certificates. The accuracy of non-cancer
death diagnoses based on death certificates is sometimes considered uncertain.
More detailed and precise clinical information is available from the AHS mem-
bers, but the analyses have usually been limited to examinations within specific
periods because the procedures and medical technologies have changed over time.
Therefore, care must be taken when interpreting results from the LSS, and when
comparing the AHS and LSS results.
In addition, disease structure of non-cancer diseases in Japan has changed
over the long follow-up period of the A-bomb survivors. In the devastated
post-war era, infectious and infection-related diseases and cerebral haemor-
rhage were dominant based on poor hygiene and nutrition status. In contrast,
cancers, cerebral infarction, and heart disease have increased with improved
economic conditions and westernisation of the Japanese lifestyle. Therefore, the
overall health status of the A-bomb survivors may be associated with the poor
conditions since the war, changes in disease incidence over time, and pathogenesis
of the diseases, as well as the effects of radiation exposure. In analyses of LSS
mortality, excess relative risk per gray (ERR Gy1) was 0.11 [95% confidence
interval (CI) 0.05–0.17] for circulatory disease and 0.21 (95% CI 0.10–0.33) for
respiratory disease (Ozasa et al., 2012). The findings for these diseases are detailed
below.
Tissue reaction is assumed to be induced by cell loss or injury due to radiation
exposure at relatively high dose levels, typically several gray or higher, with a thresh-
old. It is not certain whether long-term non-cancer effects of radiation exposure at
relatively low dose levels, below a few gray, are induced by typical tissue reactions or
other mechanisms (ICRP, 2007). A concave dose–response curve might indicate a
potential threshold, and a linear dose–response might suggest mechanisms including
stochastic effects. Observations in the A-bomb survivors may provide important
clues.
2. CARDIOVASCULAR DISEASE
2.1. Atomic bomb survivors
In an analysis of deaths over the period 1950–2003 among the LSS cohort, the
estimated radiation-related ERR Gy1 for mortality from all heart disease was 0.14
254
(95% CI 0.06–0.23) with a linear dose–response, and that for stroke was 0.09 (95%
CI 0.01–0.17) on the basis of a linear dose–response, although an indication of
possible upward curvature was suggested. The risks varied by disease subtype
(Fig. 1). Among heart disease, ERR Gy1 was increased significantly for hyperten-
sive heart disease, rheumatic heart disease, and heart failure, but not for ischaemic
heart disease. For stroke, ERR Gy1 was not increased for cerebral infarction,
cerebral haemorrhage, or subarachnoid haemorrhage, but was increased for other
or unspecified types of stroke (Shimizu et al., 2010). Therefore, increased ERR Gy1
was observed for deaths from rather ill-defined diseases.
As information on non-fatal outcomes is available in the AHS, associations
between radiation exposure and incident circulatory diseases were analysed.
Significant quadratic dose–responses were observed between radiation exposure
and incidence of non-fatal myocardial infarction between 1968 and 1998 among
those exposed at less than 40 y of age [relative risk at 1 Gy (RR1 Gy) 1.25], and
the incidence of essential hypertension between 1958 and 1998 was also increased
among all subjects (RR1 Gy 1.03). When using a linear dose–response model, on the
other hand, radiation-related risk was not increased for hypertension, hypertensive
heart disease, ischaemic heart disease, myocardial infarction, vascular occlusion or
stenosis, aortic aneurysm, or stroke (Yamada et al., 2004). In a recent report over the
period 1980–2003 by Takahashi et al. (2012), radiation exposure was significantly
Fig. 1. Excess relative risk (ERR) Gy1 for cardiovascular disease subtypes, Life Span Study,
1950–2003. Upper hierarchical categories are indicated by open diamonds. Bars represent
95% confidence intervals. Data from Shimizu et al. (2010).
255
associated with increased incidence of non-fatal and fatal haemorrhagic stroke in

both sexes, and the effects in women were less apparent until doses exceeded a
threshold at 1.3 Gy. No association was observed between radiation exposure and
ischaemic stroke in either sex.
Kidney disease has been recognised as a risk factor for the development of
circulatory diseases, partly through renal hypertension. A significant quadratic
dose–response between radiation exposure and mortality from possible chronic
renal failure (listed anywhere on the death certificate) was observed in the LSS,
1950–2003 (ERR Gy1 ¼ 0.09) (Adams et al., 2012). The association was similar in
shape to relationships observed for radiation exposure and hypertension in the AHS,
as mentioned above. In a subgroup of Nagasaki AHS members examined in 2004–
2007, a significant association was found between radiation exposure and chronic
kidney disease, consisting of moderate and severe renal dysfunction (odds ratio Gy1
1.29), especially for severe renal dysfunction (odds ratio Gy1 3.19), although the
dose–response was not examined (Sera et al., 2013).
The findings described above may indicate that the shape of the dose–response
curve for cardiovascular disease is non-linear, and is primarily dependent on the
responses at high dose levels (>2 Gy). The associations may be mediated through
hypertension rather than atherosclerosis, although it has been suggested (e.g. in
studies of patients treated with radiotherapy) that atherosclerosis is a possible inter-
mediate cause of radiation effects through endothelial cell injuries or inflammation
(UNSCEAR, 2008). Based on poor hygienic conditions in Japan following World
War II, the authors believe that increased radiation-related risk of rheumatic heart
disease may be associated with increased risk of streptococcal infection among
survivors exposed to high-dose radiation (i.e. proximal survivors). As the radia-
tion-related mortality risk of infectious disease has not increased (Ozasa et al.,
2012), the possible mechanism of increased risk of streptococcal infection among
proximal survivors may not be a true radiation effect, but may be related to poorer
hygienic conditions compared with distal survivors.
2.2. Background in the general population of Japan

The incidence and pathogenesis of circulatory disease have been quite different
between Japan and Western countries. Mortality from heart diseases, primarily
ischaemic heart disease and arteriosclerotic/degenerative heart disease, has been
higher in Western countries and is thought to be primarily due to atherosclerotic
progression (Fig. 2). In Japan, cerebral haemorrhage was the most dominant circu-
latory disease in the past (Fig. 3). During the long period since World War II, which
overlapped with the period of observation of the A-bomb survivors, cerebral haem-
orrhage decreased markedly, while cerebral infarction and heart disease, especially
heart failure, increased until the 1990s.
The most potent risk factor in Japan for stroke, either cerebral haemorrhage or
infarction, is hypertension (Tanizaki et al., 2000; Ueshima, 2007). The Hisayama
study found that the lacular type of cerebral infarction was more common than the
atherosclerotic type in Japan, while the atherosclerotic and cardioembolic types were
256
Fig. 2. Mortality of subtypes of heart disease in Japan and Western countries. Classification
of diseases was changed in 1968 and 1995. Heart failure is included in ‘Other heart disease’.
Data from Health, Labour and Welfare Statistics Association (1960, 1967, 1974, 1984, 1993,
2002), originally cited from the World Health Statistics, World Health Organization.
Fig. 3. Trend of crude mortality rates of circulatory diseases in Japan plotted with 5-y inter-
vals, 1950–2005. Data from Ministry of Health, Labour and Welfare (MHLW, 1952–2006).
more common in Western countries. The lacunar type of cerebral infarction is

based on arteriosclerosis of the cerebral parenchymatous small arteries induced by
hypertension, and the latter two subtypes are based on atherosclerosis of cervical or
intracranial large arteries (Tanizaki et al., 2000). Hypertension is also an important
risk factor for ischaemic heart disease in Japan. Although hypercholesterolaemia can
also be important, its prevalence in Japan is low in older generations (Ueshima,
2007). Therefore, the most influential risk factor for cardiovascular disease among
257
the A-bomb survivors is thought to be hypertension. Thus, although the clinical

manifestations of stroke and heart attack are similar in Western countries and
Japan, the pathogenesis is thought to be different.
The increasing trend of deaths due to heart disease in Japan is primarily due to
increased heart failure rather than increases in atherosclerotic or other specific dis-
eases (Figs. 2 and 3). In 1995, the 10th edition of the International Classification of
Diseases (ICD-10) was introduced, and Japanese medical doctors were instructed to
avoid diagnosing ‘heart failure’ as the underlying cause of death on death certificates.
Soon after that, the mortality rate of ‘heart failure’ dropped, and diagnoses of ‘myo-
cardial infarction’ and ‘cerebral infarction’ increased (Fig. 3 is plotted with 5-y
intervals). Apparent changes are therefore artificial and not natural. As an effective
coroner system with autopsy has not been introduced in most areas of Japan, doctors
may indicate ‘myocardial infarction’ or ‘cerebral infarction’ as the primary cause of
death without specific confirmation for deaths that would probably have been
diagnosed as ‘heart failure’ prior to the new directive in 1995. ‘Heart failure’ is
considered to be a ‘garbage’ category of cause of death that includes various uncer-
tain conditions, including hidden malignancies; this practice may continue today
through inappropriate use of the ‘myocardial infarction’ or ‘cerebral infarction’
categories.
3. RESPIRATORY DISEASE
Radiation-related mortality risk of non-cancer respiratory diseases (NCRDs)
increased by 17% Gy1 (ERR Gy1 0.17, 95% CI 0.08–0.27) with a linear
dose–response between 1950 and 2005. Pneumonia and influenza were the dominant
NCRD subtype (63% of deaths), and ERR Gy1 was 0.20 (95% CI 0.09–0.34). The
ERR Gy1 of other subtypes (i.e. acute respiratory infections, chronic obstructive
pulmonary disease, asthma, or others) was not increased significantly. Period-specific
ERR Gy1 of all NCRDs was 0.11 (95% CI 0.08–0.36), 0.08 (95% CI 0.09–0.29),
and 0.21 (95% CI 0.10–0.34) with a linear dose–response in 1950–1964, 1965–1979,
and 1980–2005, respectively, but a non-linear dose–response was observed over the
period 1950–1964 (Fig. 4). The findings of all NCRDs reflect those of pneumonia
and influenza (Pham et al., 2013). The difference in risk estimates may be associated
with the different pathogenesis of NCRDs between the periods. In the early period,
crude NCRD mortality consisted primarily of acute pneumonia and influenza
involving people of all ages with periodical epidemics (Fig. 5). Bad hygiene, poor
nutrition, and limited availability of medical care were all thought to contribute to
the early high rates of mortality. Chronic obstructive pulmonary disease and asthma
are exacerbated by acute infections, especially in such poor conditions. With the
improvement of conditions in the 1970s, the mortality rate decreased and flattened.
However, mortality increased again in the 1980s because pneumonia occurs fre-
quently in the terminal stage of death in the elderly, such as aspiration pneumonia
and infections in compromised hosts. The increase in crude mortality reflected the
258
Fig. 4. Dose–response of excess relative risk (ERR) for all non-cancer respiratory diseases by
period, Life Span Study, 1950–2005. The closed circles and bars represent point estimates of
ERR and 95% confidence intervals for the dose categories. Solid lines show dose–response
curves based on the linear-quadratic model. Data from Pham et al. (2013).
growing elderly population in Japan, so age-adjusted mortality did not increase after
1980 (data not shown). In Fig. 5, a drop in the mid-1990s was due to the change in
the ICD edition, and a high peak in the late 1990s indicates excess deaths due to an
epidemic of A/H3N2 influenza among elderly people.
In the same way as heart failure for circulatory diseases, pneumonia as the
terminal stage of death among the elderly is thought to include various uncertain
conditions, including hidden malignancies. Evidence of this hypothesis was observed
by results showing that the ERR of radiation for NCRDs decreased after excluding
deaths with coincident cancer, using information from cancer registries and comor-
bidity on death certificates (Pham et al., 2013). The involvement of malignancies in
the increased radiation-related risk of NCRDs may also be indicated by the linear
dose–response in the period 1980–2005.
259
Fig. 5. Trend of crude mortality rates of all non-cancer respiratory diseases in Japan plotted
with 1-y intervals. Data from Ministry of Health, Labour and Welfare (MHLW, 1952–2006).
4. CONCLUSIONS
Increased radiation-related risks for some non-cancer diseases at relatively
high dose levels with non-linear dose–responses have been observed. Those find-
ings were based on mortality data from the LSS cohort, and incidence data
including non-fatal outcomes from the AHS members. As heart failure (and,
possibly, myocardial infarction and cerebral infarction since 1995) and pneumonia
listed on death certificates are thought to include uncertain conditions at death,
including hidden malignancies, the radiation-related risks of mortality/incidence of
non-cancer diseases based on the information on death certificates need to be
interpreted with caution. The AHS has an advantage in that the information
was collected using standardised clinical measurements. In addition, background
rates of non-cancer diseases have varied widely over the long follow-up period of
the A-bomb survivors. Therefore, careful analysis by period, and careful inter-
pretation of the results, are necessary regardless of whether the data were col-
lected in the LSS or the AHS.
ACKNOWLEDGEMENTS
The RERF, Hiroshima and Nagasaki, Japan is a public interest foundation funded by the
Japanese Ministry of Health, Labour and Welfare and the US Department of Energy. This
paper was supported by RERF Research Protocols 1–75 and 2–75. The views of the authors
do not necessarily reflect those of the two governments.
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261
Dose-rate effects in radiation biology and
radiation protection
W. Rühma, T.V. Azizovab, S.D. Boufflerc, M.P. Littled, R.E. Shoree,
L. Walshf, G.E. Woloschakg
a
Helmholtz Centre Munich, German Research Centre for Environmental Health, Department
for Radiation Sciences, Institute of Radiation Protection, Ingolstädter Landstr. 1, 85764
Neuherberg, Germany; e-mail: werner.ruehm@helmholtz-muenchen.de
b
Southern Urals Biophysics Institute, Russian Federation
c
Centre for Radiation, Chemical and Environmental Hazards, Public Health England, UK
d
Radiation Epidemiology Branch, Division of Cancer Epidemiology and Genetics, National
Cancer Institute, USA
e
New York University School of Medicine, USA
f
Federal Office for Radiation Protection, Germany
g
Department of Radiation Oncology, Northwestern University,
Feinberg School of Medicine, USA
Abstract–Quantification of biological effects (cancer, other diseases, and cell damage) asso-
ciated with exposure to ionising radiation has been a major issue for the International
Commission on Radiological Protection (ICRP) since its foundation in 1928. While there is
a wealth of information on the effects on human health for whole-body doses above approxi-
mately 100 mGy, the effects associated with doses below 100 mGy are still being investigated
and debated intensively. The current radiological protection approach, proposed by ICRP for
workers and the public, is largely based on risks obtained from high-dose and high-dose-rate
studies, such as the Japanese Life Span Study on atomic bomb survivors. The risk coefficients
obtained from these studies can be reduced by the dose and dose-rate effectiveness factor
(DDREF) to account for the assumed lower effectiveness of low-dose and low-dose-rate
exposures. The 2007 ICRP Recommendations continue to propose a value of 2 for
DDREF, while other international organisations suggest either application of different
values or abandonment of the factor. This paper summarises the current status of discussions,
and highlights issues that are relevant to reassessing the magnitude and application of
DDREF.
Protection.
262
Keywords: Linear-non-threshold hypothesis; Radiation risk; Dose and dose-rate effectiveness

factor; Low-dose effectiveness factor; Dose-rate effectiveness factor
1. INTRODUCTION
1.1. Setting the scene
The International Commission on Radiological Protection (ICRP) is the leading
organisation for developing recommendations on the protection of workers, the
public, and the environment against exposures to ionising radiation. The radiological
protection framework recommended by ICRP is based on more than a century of
research on the biological effects of ionising radiation, the scientific results of which
are reviewed regularly by major international organisations, such as the United
Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR).
Radiobiological studies at the molecular and cellular levels provide insights into
the damage mechanisms that come into operation when cells or organisms are
exposed to ionising radiation. Such studies have well-defined conditions and can
investigate the influence of numerous parameters (e.g. dose, dose rate, degree of
fractionation, radiation quality, environment, cell type and line, position in the
cell cycle, and repair capacity) on the biological outcome. Indicators of cellular
damage studied include identification of DNA damage [e.g. through detection of
phosphorylated histone H2AX (gH2AX) foci], induction of chromosome aberra-
tions, gene alterations, and cell survival, and may also include non-targeted effects
such as genomic instability, bystander effects and adaptive response. Experimental
studies on animals are another source of information. Animal studies enable direct
investigation of biological effects, again taking into account various parameters such
as dose, dose rate, radiation quality, type of species (such as mice, rats, dogs, and
sometimes incorporating human cell types such as in humanised mice models). The
detrimental outcomes considered may include general effects such as life shortening,
but also more specific outcomes such as cancer incidence or mortality, which are
already close to those relevant for humans after exposure to ionising radiation.
Finally, epidemiological studies on human individuals exposed to ionising radiation
provide an important source of information for radiological protection. For obvious
reasons, these epidemiological studies do not have the advantageous features of the
controlled experimental conditions found in studies on molecules, cells, or animals.
Instead, epidemiological studies must deal with exposure situations as they were in
the past when the exposure happened [e.g. in epidemiological studies on the atomic
bomb (A-bomb) survivors, nuclear workers, uranium miners, the Techa River popu-
lation, Chernobyl clean-up workers, and medical cohorts], or as defined in epidemio-
logical studies due to other reasons (e.g. in studies on computed tomography
exposures of patients where the exposure scenario is controlled but defined by getting
the best image with the lowest dose).
Among the parameters included in the current ICRP system of radiological pro-
tection, the dose and dose-rate effectiveness factor (DDREF) plays an important
263
role. This is because the risks of solid cancer and leukaemia incidence or mortality
obtained from the Life Span Study (LSS) on the A-bomb survivors serve as a major
input for ICRP in defining dose limits, dose constraints, and reference levels for
protection of workers and the public in planned, accidental, and existing exposure
situations. However, the LSS only provides valuable statistically significant results
on radiation-induced solid cancers and leukaemia above whole-body doses of
approximately 100 mGy, from exposures that occurred during a relatively short
time (say seconds up to minutes), therefore involving high dose rates. It was thus
considered that some adjustments to the derived LSS risk coefficients had to be made
in order to make them applicable to the radiological protection setting where lower
doses and dose rates are typical.
1.2. History
The requirement of a dose and dose-rate adjustment was noted in the first report
of UNSCEAR, published in 1958, where it was acknowledged that ‘effects of low
radiation levels must be extrapolated from experience with high doses and dose
rates’, and that ‘among other physical factors, distribution in time governs the effects
of ionising radiation’ (UNSCEAR, 1958). For many years, however, data from the
A-bomb survivors did not show sufficient statistical significance to quantify radia-
tion-induced risk for cancer and leukaemia induction and mortality based on human
data. It was only in 1977 that UNSCEAR first proposed a ‘reduction factor’ to
compare effects from acute exposures to low-linear energy transfer (LET) radiation
with those from fractionated or protracted exposures. The proposed range (2–20 for
this factor) was deduced from animal experiments (UNSCEAR, 1977). Again based
on animal data, the US National Council on Radiation Protection and
Measurements (NCRP, 1980) coined the term ‘dose-rate effectiveness factor’
(DREF) and proposed values between 2 and 10. Finally, in its 1990
Recommendations, ICRP (1991) introduced DDREF and suggested a value of 2
for absorbed doses below 200 mGy, and for higher doses if the dose rate is less
than 6 mGy h1 averaged over a few hours.
For many years, the proposal of a DDREF value of 2 was generally accepted, and
it was re-affirmed in 2007 when ICRP emphasised, in its latest recommendations,
that this value ‘should be retained for radiological protection purposes’ (ICRP,
2007). However, around that time (in 2006), the Committee on the Biological
Effects of Ionizing Radiation (BEIR VII) of the US National Academy of
Sciences (NAS) came to a somewhat lower point estimate of 1.5 based on a com-
bination of information from animal and human data (NAS, 2006). UNSCEAR
(2006) suggested that DDREF should not be used at all, and a linear-quadratic
(LQ) dose–response relationship should be relied upon instead to analyse the data
from the A-bomb survivors. Since then, the trend has continued towards lower
proposed values of DDREF. For example, the World Health Organization
(WHO, 2013) used a value of 1 in its recent report on the health effects after the
Fukushima accident, and the German Commission on Radiological Protection
(SSK, 2014) stated recently that they no longer consider ‘justifications of the use
264
of the DDREF in radiological protection as being sufficient’. A more detailed review

on the historical development of DDREF is given in Rühm et al. (2015).
1.3. Methodological considerations

Although early radiation damage at the DNA level, such as the induction of DNA
double-strand breaks (DSBs) visualised by gH2AX foci, often shows a linear depend-
ence on dose after acute exposure to low-LET radiation, more complex damage such
as chromosome aberrations usually shows an LQ dose–response relationship. The
LQ model includes a term ‘linear in dose’ with a proportional constant , and a term
‘quadratic in dose’ with a proportional constant . Cell survival curves after expos-
ure to low-LET radiation can also be described by LQ models, as well as many
results obtained in animal studies. These observations, together with mechanistic
arguments (theory of dual radiation action), led to the assumption that an LQ
dose–response model can generally be used to describe the induction of complex
biological effects due to acute low-LET ionising radiation. A pure linear extrapola-
tion of experimental observations made at high doses would then result in overesti-
mation of the observed effect at low doses. Accordingly, the ratio of the slope of this
linear extrapolation from dose D to dose zero, and the slope of the LQ dose–response
curve at low doses (dominated by the term) is defined as the low-dose-effectiveness
factor (LDEF):
D þ D2
LDEF ¼ ¼1þ D ð1Þ
D
When a certain dose of low-LET ionising radiation is delivered in a number of

fractions rather than acutely within one short fraction, the exposed cells might be
able to repair the damage if there is sufficient time between two consecutive fractions.
The dose–response of the second fraction may start in a similar way as that of the
first fraction (i.e. with the assumed linear slope in the LQ dose model). In the limit of
chronic exposure (which can be considered as an infinite number of short fractions
with no breaks in between), the resulting dose–response curve is linear with a slope
corresponding to the term in the LQ model. Consequently, the ratio of the slope of
a linear extrapolation from dose D to dose zero using the LQ model for acute
exposure [(D + D2)/D], and the slope of the dose–response curve for chronic
exposure () is defined as DREF. In this limiting case, which implicitly assumes
that the term of the LQ model does not depend on dose rate, DREF converges
towards LDEF.
Based on these and other considerations, ICRP had proposed to combine LDEF
and DREF to one DDREF (see above). It is noted, however, that there are indica-
tions that the term in the LQ model may not necessarily be independent of dose
rate, which would question the approach to use a combined DDREF. It is also noted
that the general use of a simple LQ model can also be questioned. These and other
controversial issues on DDREF were discussed recently at a workshop organised
jointly by ICRP and the Japanese JANUS group to bring together ICRP Task
265
Group 91 members and Japanese experts in the field of radiation research. JANUS is
a consulting company that uses available experience in the fields of energy, the
environment, and social sciences for the benefit of societal development. A summary
of these discussions can be found in Rühm et al. (2015).
2. MOLECULAR AND CELLULAR BIOLOGICAL CONSIDERATIONS

Among radiogenic diseases, cancers and hereditary effects are currently con-
sidered to be of most importance, and are included in the current ICRP approach
to calculation of low-dose radiation detriment. However, in the future, this
approach may have to extend to other conditions, such as circulatory diseases, if
the risk at low dose becomes well established. Current evidence (e.g. UNSCEAR,
2010, 2012) places greatest emphasis on gene mutations and chromosomal aberra-
tions arising from DNA damage as the main mechanism by which radiation expos-
ure contributes to increase the incidence of cancers and hereditary effects. One
prediction, which follows from the proposition that gene and chromosomal muta-
tions are the main contributor to radiation carcinogenesis, is that DNA repair
genes (and, particularly in the case of ionising radiation, DSB repair genes) will
modify radiation cancer risk. There is evidence that genes such as Prkdc and Xrcc2,
involved in the non-homologous end joining and homologous recombination repair
pathways, respectively, modify radiation cancer risk in mouse models, and there is
a degree of tissue specificity (e.g. Degg et al., 2003; Haines et al., 2010, 2015).
Although DNA repair genes have not been commonly identified in screens for
radiation cancer risk modifiers, some repair-related genes have been found to
modify risk in humans, most notably in the case of ATM and radiogenic breast
cancer (e.g. Bernstein et al., 2010). It is appreciated, however, that other modula-
tors may exist that might change the level of disease risk, but that these are not
well defined or understood. It is such mechanistic considerations that are an
important aspect contributing to judgements on the appropriate approach to
low-dose and/or low-dose-rate (LDLDR) risk extrapolation, and therefore consid-
erations of DDREF. A clear understanding of the processes that contribute to
radiogenic cancers and hereditary effects, and their dose/dose-rate responsiveness
over wide ranges is thus important in further development of the concept and use
of DDREF.
The information relevant for risk estimation at doses less than those where direct
human evidence is available comes from studies on induction and repair of DSBs,
gene mutations, chromosomal aberrations, and thresholds for cell-cycle checkpoint
activation and apoptosis. The magnitude of DDREF values derived from chromo-
some aberration studies is not large, generally indicating values of approximately 4.
There are sound data indicating that DNA damage responses and mutational pro-
cesses operate at low doses (down to 20 mGy) and dose rates (down to 1 mGy day1,
equivalent to approximately 0.04 mGy h1) as they do at higher doses and dose rates.
There are, however, pieces of evidence that may indicate that responses over a wide
range of dose are non-linear. For example, some studies have been interpreted to
266
suggest that the formation of protein foci around DSBs may be supralinear at low
doses (e.g. Beels et al., 2009, 2010; Neumaier et al., 2012). Furthermore, several
studies have indicated that DSB repair as monitored by foci of chromatin proteins
is slower or incomplete following low-dose exposures (e.g. Rothkamm and Löbrich,
2003; Grudzenski et al., 2010; Ojima et al., 2011). Some cell-cycle checkpoints have
relatively high thresholds for activation. The G2/M checkpoint, for example, is not
activated at doses below 200 mGy (low-LET exposure), and is estimated to require
the presence of 10–20 DSBs for activation (Löbrich and Jeggo, 2007). At the molecu-
lar level, there has been much interest in patterns of gene expression at high and low
doses and dose rates, and their similarity or difference. While there can be differences
in gene expression following exposure at high and low doses and dose rates (e.g.
Ghandhi et al., 2015), some genes respond over all doses and dose rates, notably p53-
responsive genes (Manning et al., 2013, 2014; Ghandhi et al., 2015). It is therefore
important to develop an understanding of how changes in gene expression relate to
disease, especially as modifications are usually assessed within hours or perhaps a
few days following exposure. While these studies indicate that the magnitude of any
DDREF value is endpoint-dependent, and developing a value for use in general
radiological protection is problematic and highly dependent on judgements on the
processes critical for the development of cancer and mutations following radiation
exposure, one may conclude that cellular data tend to support the application of a
DDREF to estimate risk at low doses.
One critical point is that much time elapses between the induction of gene muta-
tions/chromosomal mutations, alteration of gene expression, etc. and the clinical
presentation of cancer. Many processes are likely to affect and modulate the devel-
opment of disease following the early induction of mutations or other cellular/
molecular alterations. Rarely is it possible to link early post-irradiation events to
disease, although this may be possible in some animal models (e.g. Verbiest et al.,
2015).
Considering the cellular and molecular data relevant to LDLDR risk extrapo-
lation, it is concluded that key challenges remain to identify the biological
mechanisms that lead to disease following radiation exposure, to understand
their dose and dose-rate responsiveness, and to identify the processes that may
modulate the rate and frequency of progression to clinically manifest disease. All
of these factors will be relevant to evaluation of DDREF from a mechanistic
perspective.
3. EVIDENCE FROM ANIMAL STUDIES

When NAS (2006) prepared their BEIR VII report, their analyses of animal data
relied largely on the dataset produced at the Oak Ridge National Laboratory, TN,
USA. However, that type of analysis can now be based on much larger datasets
because databases for irradiated animal data (not used previously by the BEIR VII
267
Committee) have been set up recently in the USA (Wang et al., 2010; Haley et al.,
2011) and Europe (Gerber et al., 1996; Tapio et al., 2008; Birschwilks et al., 2011).
For example, a recent analysis included data from 28,289 mice in 91 treatment
groups from 16 studies (Haley et al., 2015). Inclusion criteria were: external radiation
exposures to low-LET radiation (either x rays or g rays), with a range of dose rates
from 0.001 Gy min1 (and 16.6 mGy fraction1) to 4 Gy min1 (total dose of 1 Gy
fraction1); in all cases, the total dose was no more than 1.5 Gy, and there were at
least three distinct treatment groups per stratum. It should be noted that while these
total dose and dose-rate limits fit the BEIR VII conditions, other agencies have their
own rules for DDREF application [for instance, UNSCEAR (2012) decided that
DDREF was to be entertained only for total doses below 0.1 Gy and dose rates
below 6 mGy h1]. In all cases, digitised data on treatment and life span were con-
firmed by crosschecking with primary literature. In performing this analysis, it
appeared that: (a) protracted exposures induce less risk for life shortening than
acute exposures and to a larger extent than the value of 1.5 estimated by BEIR
VII for DDREF would suggest; and (b) the LQ dose–response model that BEIR
VII used did not fit the observed data. Instead, both acute and protracted exposures
appeared to have approximately linear dose–responses at total doses between 0 and
1.5 Gy, albeit with different slopes [see Haley et al. (2015) for more details].
Next, the animal dataset was altered to include some additional datasets with
exposures as high as 4 Gy that match the highest doses considered in some analyses
of the LSS cohort data (Ozasa et al., 2012). Furthermore, for this work, only those
datasets where both acute and protracted radiation exposures occurred were selected,
or else protracted exposures with different dose rates. Thus, this second analysis
included 11,528 mice in 115 treatment groups from eight studies. Using this dataset
and a linear model that closely mirrors that used to estimate risk from the A-bomb
survivor data, it transpired that: (a) protracted exposures induced approximately
two-fold less risk of life shortening than acute exposures (specifically, DREF was
estimated to be 2.1 with a 95% confidence interval from 1.7 to 2.7); (b) no evidence
was found that DREF limited to a smaller total dose range (e.g. 0–3 Gy) would be
significantly different (exclusion of animals or treatment groups that showed signs of
tissue effects did not lead to significantly different outcomes of this analysis); and
(c) life shortening associated with both acute and protracted exposures shows lin-
ear dose–response relationship, but the slopes of these curves are different.
Nevertheless, it is important to emphasise that although these linear models describe
the data better than the LQ model, they are merely a convenient approximation.
Together, these results demonstrate the need for a systematic analysis of as many
animal datasets as possible, with varying dose ranges and dose-rate ranges, and for
various sets of outcomes. Animals from different species should also be investigated
in such analyses. The described results also demonstrate that the huge set of animal
data that is now available will be a valuable source of information for the current re-
evaluations of DDREF to be applied on human data from acute exposures, such as
those from the A-bomb survivors.
268
4. EVIDENCE FROM EPIDEMIOLOGICAL STUDIES

Epidemiological studies of cancer risk after LDLDR radiation exposures comple-
ment the animal studies that compare effects of radiation exposures at high and low
dose rates. Apart from studies on the A-bomb survivors of Hiroshima and Nagasaki,
Japan, which represent studies on high-dose-rate exposures (Ozasa et al., 2012; Hsu
et al., 2014) (see also Section 4.3), epidemiological studies characterised by exposure
scenarios involving low-dose-rate exposures typical for the cohort of nuclear workers
exposed to chronic radiation have been studied intensively in the past. For example,
a study was performed to combine data on nuclear workers from 15 countries world-
wide (Cardis et al., 2007), while an updated follow-up of nuclear workers from three
countries (USA, UK, and France) was published recently (Richardson et al., 2015;
Hamra et al., 2016). Additionally, the workers exposed at Mayak Production
Association (PA), the first Russian nuclear enterprise, and the population of the
Techa River region, which includes individuals exposed to radiation due to radio-
active releases from Mayak PA in the river, are also an important source of infor-
mation on the influence of radiation dose and dose rate on health effects. Both of
these cohorts have a number of key strengths such as: large size; long follow-up
periods; individual estimates of doses from external and internal exposure; hetero-
geneity by sex, age, and ethnicity; and known vital status and causes of death.
Moreover, for the majority of Mayak PA workers (approximately 95%), complete
information on both incidence and mortality, initial health status, and non-radiation
factors are available. Results of epidemiological studies of these two cohorts per-
formed over recent years provide strong evidence for increased risk of solid cancers
(Schonfeld et al., 2013; Sokolnikov et al., 2015), leukaemia, and non-cancer effects
associated with both external and internal radiation exposures over prolonged per-
iods delivered at low dose rates.
4.1. Major cohorts for epidemiological LDLDR studies

Recently, a number of LDLDR epidemiological studies have provided risk esti-
mates that can potentially be used to estimate DREF by comparing the quantitative
risk estimates from LDLDR studies with matched LSS estimates of risk. Based on
compilations from the literature, DREF is being evaluated from available LDLDR
data for total solid cancer mortality, and for some major cancer subtypes such as
breast, lung, colon, stomach, and liver. More recently, it was decided that, although
the present review focusses on solid cancers, leukaemia will be included in the list of
cancers to be studied in a later phase of the project.
As whole-body irradiation can potentially affect all organs, an analysis of total
solid cancers (hereafter just ‘solid cancers’) provides an integrated estimate of radi-
ation risk. As the total number of solid cancers will be much larger than that for any
individual tumour site, it affords a risk assessment with greater statistical power and
precision than assessments for individual organs.
For each type of cancer, a systematic literature search in PubMed was performed
in August 2015, and supplemental reference ascertainment methods were also used to
269
find primary epidemiological studies with dose–response associations covering the

period January 1980 – June 2015. The new joint analysis of US, French and UK
nuclear workers is also being included in the analysis (Richardson et al., 2015).
Search results were limited to cohort or nested case–control studies on cancer risks
associated with ionising radiation in environmental, occupational, or emergency
situations. The final selection of studies also filtered out overlapping data in indi-
vidual and pooled studies as far as possible, and used the most recent data available
for each study. This comprehensive search for studies that had dose–response ana-
lyses of solid cancers (or of all cancers except leukaemia) was conducted to reduce/
eliminate study selection bias in the risk comparison. Ecological studies (e.g. Tondel
et al., 2011) or reports of only (or mostly) childhood cancers (e.g. Kendall et al.,
2013; Mathews et al., 2013) were not included. For solid cancer mortality, 20 inde-
pendent LDLDR studies with dose–response-based risk estimates have been identi-
fied to date, which represent approximately 960,000 individuals and over 17 million
person-years of follow-up, a collective dose of 36,000 person-Sv, and 33,000 solid
cancer deaths. All except four studies had mean doses below 50 mSv, and most were
worker studies, other than two studies based on environmental exposures
(Yangjiang, China and Techa River; Tao et al., 2012; Schonfeld et al., 2013).
Exposures were to low-LET radiation, except for four studies which had both exter-
nal g exposures and significant high-LET internal exposures [Mayak and Rocky
Flats plutonium workers (Cardis et al., 1995; Sokolnikov et al., 2015), and Port
Hope and German uranium-processing workers (Zablotska et al., 2013; Kreuzer
et al., 2015)], requiring the authors to statistically factor out the internal exposure
contributions to risk. Miner studies were not considered due to the dominance of
exposure to radon progeny and paucity of dose–response data for external exposure.
Of the 20 dose–response-based LDLDR studies, if one examines the 11 studies
that had at least 250 solid cancer deaths, it is notable that nine of these studies had
positive risk coefficients, although only four were statistically significant in the posi-
tive direction; this is not surprising as individual LDLDR studies typically have low
statistical power. It is noted that most of the studies assume a linear dose–response
relationship when risk coefficients were deduced. Meta-analyses of risk coefficients
are underway in the available studies in comparison with the A-bomb LSS risk
coefficients for the subsets of LSS individuals with comparable composition by
sex, age at exposure, and age at observation. The overall results for mortality studies
will be reported, augmented with sensitivity and methodological analyses, and ana-
lyses that include incidence data.
Although an analysis of total solid cancer risk after LDLDR exposures provides a
broad assessment of DREF, it may represent heterogeneous DREFs for various
tumour sites. Radiation effects for tumour sites may differ because of biological
diversity in genetic pathways, epigenetic influences, and tissue and metabolic co-
factors. Various environmental or lifestyle risk factors may modify radiation risk
for certain cancer types but not for others: for example, smoking effects may modify
the radiogenic risk of lung cancer, and reproductive factors may modify the radio-
genic risk of breast cancer. The impact of modifying factors may be dependent on
270
dose. To get an overview of variations in low dose risk, LDLDR studies providing
estimates for breast, lung, colon, stomach, and liver cancers were reviewed. Meta-
analyses will be conducted for these sites to estimate DREFs, and examine the degree
of variation in DREF among tumour sites. LDLDR epidemiological studies have
various limitations as they are all observational and not experimental. For indi-
vidual LDLDR studies, uncertainties and, possibly, bias may be contributed by
factors such as dose uncertainties; incomplete cancer ascertainment; variations in
health surveillance; and lack of information on lifestyle habits, occupational or
socio-economic status, and potential disease risk factors. The meta-analysis esti-
mate of DREF from LDLDR studies is not very precise. It nevertheless provides
the most direct evidence regarding DREF for human radiation exposure, which is
important because DREF represents an average for the human population that is
highly heterogeneous with respect to innate susceptibility and exposure co-factors.
Experimental studies typically do not mimic that heterogeneity. Ultimately, judge-
ments regarding DREF will need to integrate information about associated bio-
logical mechanisms, experimental studies of dose and dose-rate factors in
controlled animal experiments, and epidemiological data.
4.2. Methodology for meta-analyses to deduce DREF values by comparing cancer

risks associated with fractionated and acute doses of ionising radiation
The purpose of the meta-analyses described here is to directly compare cancer
risks associated with ionising radiation from two different non-medical radiation
exposure modalities. The methodology used follows that described in Jacob et al.
(2009). Exposures considered are at low dose rates and low or moderate cumulative
doses (mostly below 100 mGy mean cumulative organ dose) delivered at low dose
rates, or doses covering a wider range than this (under 4 Gy organ dose) but deliv-
ered acutely. Whereas cancer risks associated with low or moderate doses from the
fractionated exposure mode are the most relevant to modern radiological protection,
there are well-established radiation-associated cancer risks for the acute exposure
mode from the LSS on the cohort of the Hiroshima and Nagasaki A-bomb survivors.
In order to quantify the overall differences in all solid cancer and site-specific cancer
risks (lung, breast, stomach, liver, and colon) from these two exposure modalities, a
meta-analysis has been initiated for each type of cancer, mainly considering cancer
mortality and cancer incidence in separate meta-analyses.
For each of the studies in the final selection (Section 4.1), a set of information
related to the radiation risks was extracted, i.e. type of dose reported (e.g. colon dose,
skin dose, etc.), type of risk measure reported [e.g. usually the excess relative risk
(ERR) per unit dose – or some measure that could be converted to ERR], proportion
of males, length of follow-up, age at first exposure, and age at the end of follow-up.
With this information, it was possible to compute ‘matching’ cancer risks in sub-
cohorts of the A-bomb survivors with matching distributions according to sex, age at
exposure, grouping of cancer types, and length of follow-up.
271
The ratio qi of the ERR per unit dose from an individual study i, ri, to the cor-
responding ERR from the A-bomb survivors, rLSSi, was then calculated as qi ¼ ri /
rLSSi, and the combined variance Vi of qi was obtained from error propagation
assuming Gaussian error types. The pooled, inverse-variance weighted mean ratio
Q of the qi study to LSS estimates was then calculated from all individual qi studies
under the basic premise that the average of estimates provided by the pooled studies
is closer to the truth than the estimates provided by any of the individual studies.
Cochran’s Q statistic (and a corresponding p value) method was applied to test for
between-study heterogeneity, and the DerSimonian–Laird method was applied for
pooling heterogeneous groups of studies and for obtaining the overall variance on Q
(DerSimonian and Laird, 1986).
The study is ongoing, and the final results obtained on total solid cancers and site-
specific tumours will be published soon. A similar study is also currently underway
for leukaemia.
4.3. Analysis of dose–response relationship among the A-bomb survivors to

deduce LDEF values
The dose–response for most cancer sites in the LSS cohort is well described by a
linear dose–response (Little and Muirhead, 1996, 1998; UNSCEAR, 2006; Preston
et al., 2007; Ozasa et al., 2012). In the LSS, the major exceptional sites in this respect
are leukaemia and non-melanoma skin cancer (Little and Charles, 1997; Ron et al.,
1998; Preston et al., 2007). When all solid cancers are analysed together, there is no
evidence of significant departure from a linear dose–response in the latest LSS cancer
incidence data, although there are suggestions of modest upward curvature in the
latest LSS mortality data (Preston et al., 2007; Ozasa et al., 2012). The evidence for
breast cancer, where there is reasonable power to study the risks at low doses, sug-
gests that the data are most consistent with linearity (Preston et al., 2002).
Preliminary analysis of the latest version of the solid cancer mortality dataset for
the LSS cohort has been conducted (Ozasa et al., 2012). The organ dose used for all
solid cancers and for the remainder category (all solid cancers excluding breast,
colon, lung, and stomach) was that to the colon, and the appropriate organ dose
was used otherwise. In all cases, a relative biological effectiveness of 10 was assumed
for neutrons, as used by Ozasa et al. (2012). All ‘nominal’ organ doses were calcu-
lated using the latest dosimetry system, the so-called ‘DS02 dosimetry’ (Young and
Kerr, 2005). Individual data were not available, so all analyses used the publicly
available stratified data. The stratification employed is very similar to that used by
Ozasa et al. (2012), and is defined by time since exposure, age at exposure, attained
age, city, sex, ground distance category, and (measurement-error adjusted) dose.
Poisson disease models were used. The models that are used in this paper are func-
tions of the mean organ dose, D, averaged over the survivors in the stratum. A
generalised relative risk model was used for solid cancers, where the expected
number of cancer deaths in stratum i, with city c, sex s, attained age a, age at
272
Table 1. Fit of linear-quadratic model to Japanese Life Span Study solid cancer mortality
data of Ozasa et al. (2012), full dose range.
Linear-quadratic model ERR/Sv (95% confidence interval) p-value (linear-
quadratic
Cancer type Linear term Quadratic/linear term vs linear)
All solid 0.233 (0.121–0.380) 0.105 (0.087–0.544) 0.362

Female breast 1.155 (0.355–2.425) 0.102 (0.256*–0.200) 0.330
Colon 0.055 (0.254*–0.364*) 1.787 (10.536*–14.107*) 0.024
Liver 0.380 (0.066*–0.987) 0.093 (0.462*–0.275*) 0.721
Lung 0.474 (0.155–0.941) 0.099 (0.312–0.376) 0.480
Stomach 0.121 (0.064*–0.374) 0.081 (0.223*–3.957) 0.749
ERR, excess relative risk.
*Wald-based confidence interval.
exposure e, other stratifying variables v (ground distance category, Adult Health

Study status, and calendar time) and DS02 average organ dose D is:

PYi i 1 þ D þ D2 exp D þ 1 ðe 30Þ þ 2 lnða=70Þ þ 3 1sex¼female ð2Þ
where PYi is the number of person-years of follow-up in the stratum. The background
cancer death rate i was assumed to be constant over each stratum defined by groups
of city, sex, categorised attained age, and categorised age at exposure, but was not
otherwise specified parametrically. All doses are adjusted [via regression calibration
(Carroll et al., 2006)] for dose error; the quadratic term in the dose–response was also
corrected (by multiplying by 1.12) to correct for the quadratic calibration approxi-
mation (specifically the discrepancy between E D2 jd and E½Djd2 ). The model par-
ameters were estimated using Poisson maximum-likelihood techniques (McCullagh
and Nelder, 1989). In particular, the background cancer rate parameters were esti-
mated in this way, which is equivalent to the fitting of a conditional binomial model,
conditioned in terms of the numbers of cancer deaths in each stratum defined by city,
sex, categorised attained age, and categorised age at exposure. Only the LQ model is
used here in which and are allowed to vary, and is set to 0.
As can be seen from Table 1, there are generally only modest indications of
curvature for any endpoint for the full dose range. For three endpoints (all solid
cancers, colon cancer, and stomach cancer), there are generally statistically non-
significant (p > 0.05) indications of upward curvature; these are strongest for colon
cancer, for which the upward curvature is statistically significant (p < 0.05), but there
are also numerical instabilities in these non-linear dose–response fits, so perhaps one
should not attach too much weight to these. For the other solid cancer endpoints
(female breast, liver, and lung), there are statistically non-significant (p > 0.05) indi-
cations of downward curvature in the dose–response. As can be seen from Table 2,
273
Table 2. Fit of linear-quadratic model to Japanese Life Span Study solid cancer mortality
data of Ozasa et al. (2012), respective organ dose range < 2 Sv.
Linear-quadratic model ERR/Sv (95% confidence interval) p-value (linear-
quadratic
Cancer type Linear term Quadratic/linear term vs linear)
All solid 0.159 (0.025–0.332) 0.809 (0.080–8.571) 0.017

Female breast 0.584 (0.285–2.150) 0.760 (0.220–3.040*) 0.261
Colon 0.009 (0.083*–0.100*) 2.594 (28.705*–33.893*) 0.237
Liver 0.067 (0.519*–0.825) 4.109 (37.580*–0.736) 0.246
Lung 0.324 (0.034–0.829) 0.330 (0.242–1.553*) 0.430
Stomach 0.207 (0.115*–0.614) 0.251 (0.684*–3.027) 0.483
ERR, excess relative risk.
*Wald-based confidence interval.
there are much stronger indications of upward curvature for most endpoints over the
0–2-Sv dose range. However, for all solid cancers alone, there are statistically sig-
nificant (p 0.05) indications of upward curvature, and for stomach cancer alone,
there is a statistically non-significant (p > 0.4) indication of downward curvature in
the dose–response. These results suggest some dependence of the outcome on the
dose range chosen for the analysis due to the variability in the data, which becomes
obvious in the categorical presentation of the ERR values for solid cancer mortality
(Ozasa et al., 2012). This will also affect LDEF estimates that are based on analyses
of the dose–response relationship.
5. OUTLOOK AND CONCLUSIONS

Since the early times of radiological protection, the problem of how to extrapolate
from high doses and dose rates, where sound data on the health and biological effects
of ionising radiation exist, down to low doses and dose rates which are relevant in
radiological protection of workers and the public, has been a controversial issue. The
current situation, where a number of international bodies such as ICRP,
UNSCEAR, NAS, WHO, and SSK have come to somewhat different conclusions
with regard to the numerical value of DDREF and its application, highlights the
need to revisit the issue.
The deepening in our understanding of the radiobiological mechanisms of radi-
ation action has revealed a number of processes with non-linear dose–response
curves at low doses, and bystander effects where cells are affected although not hit
by any ionising particle, and these complicate the situation. Currently, it is difficult to
judge how these processes contribute to carcinogenesis in humans, which takes place
at a much higher level of organisation than the level of cellular and tissue organisa-
tion involving many unknown parameters, and which continues for many years or
even decades after the initial radiation exposure.
274
In the past, experimental data on animal models from available databases served
as a major input in deriving numerical values for DDREF. Through the current
availability of newer and larger databases and tissue banks, more data are now
available on historical animal experiments than in the past. Task Group 91 recom-
mends that this new infrastructure should be used, with particular emphasis on
investigating low-dose and low-dose-rate effects in animals. Similar evaluation of
data available for different animal species (mice, rats, dogs, etc.) might allow for
the investigation of interspecies variability in low-dose and low-dose-rate effects, thus
helping answer questions related to the extrapolation of results from animal models
to humans.
The continuous follow-up of human cohorts exposed to ionising radiation allows
for continuous improvement in deduction of risk coefficients for the process of
radiation-induced human carcinogenesis, the outcome most closely related to those
endpoints relevant for radiological protection of humans. Task Group 91 plans to
support a meta-analysis of the most recent results of radioepidemiological cohorts,
comparing those exposed to high dose rates (e.g. A-bomb survivors) and low dose
rates (e.g. nuclear workers, medically exposed cohorts, Techa River population,
Chernobyl clean-up workers, and populations living in high background radiation
areas) of ionising radiation.
Some of the available results on radiation-induced biological effects and carcino-
genesis in animals may suggest that dose effects and dose-rate effects should be
treated separately, meaning that values for LDEF and DREF should be deduced
independently before any decision on a combined factor is made. This may imply
that, although ICRP does not recommend the application of a DDREF on leukae-
mia data in its latest recommendations (ICRP, 2007), the proposed new analysis
should also be performed for leukaemia even if the corresponding shape of the
dose–response curve follows an LQ behaviour. This has already been initiated by
Task Group 91, as well as an evaluation of the radiobiological evidence for treating
dose and dose-rate effects separately.
Finally, it is noted that while this paper focusses on DDREF, the overall
radiological protection concept recommended by ICRP includes a number of fur-
ther issues that may need to be revisited; for example, calculation of detriment
as proposed by ICRP in its latest recommendations (ICRP, 2007) includes numer-
ical approaches to quantify the transfer of risk across populations, quality of
life, years of life lost, etc. Additionally, the numerical values recommended
(e.g. radiation and tissue weighting factors), and whether or not one should include
detriment from radiation-induced non-cancer diseases, need to be addressed.
Therefore, these issues should also be revisited in parallel to the current re-analysis
of DDREF.
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Evidence for variation in human radiosensitivity
and its potential impact on radiological
protection
S.D. Bouffler
Radiation Effects Department, Centre for Radiation, Chemical and Environmental Hazards,
Public Health England, Chilton, Didcot, Oxfordshire, OX11 0RQ, UK; e-mail:
simon.bouffler@phe.gov.uk
Abstract–Radiological protection standards generally assume that all members of the popu-
lation are equally sensitive to the adverse health effects associated with radiation exposure,
recognising the age- and sex-related differences in sensitivity to radiation-induced cancer. It
has become very clear over recent years that genetic and lifestyle factors can play important
roles in the susceptibility of individuals to a range of diseases; as such, the same may apply to
radiation-associated diseases. Evidence is accumulating from studies at many levels of
biological organisation – cells, experimental organisms, and humans – that a range of radio-
sensitivity exists between individuals in the population. Consideration of improvements in
radiological protection practices to take account of such differences will require the availabil-
ity of robust and accurate ways to assess the sensitivity of an individual or population sub-
group. In addition, there will need to be careful consideration of the ethical aspects relating to
use of individual sensitivity information. These ethical considerations are very likely to be
exposure context dependent, and require careful risk–benefit balance consideration before
practical application.
Keywords: Ionising radiation; Radiosensitivity; Cancer; Genetics; Radiological protection
Protection.
280
1. INTRODUCTION
Radiological protection aims to ‘manage and control exposures to ionising radi-
ation so that deterministic effects are prevented and the risks of stochastic effects are
reduced to the extent reasonably achievable’ (ICRP, 2007). The risks of stochastic
effects (cancers and hereditary effects) are controlled through the principle of justi-
fication, followed by dose limitation and optimisation below constraints and refer-
ence levels using the concept of effective dose. While effective dose is a risk-adjusted
dosimetric quantity, it does not take account of recognised age- and sex-related
differences in rates of radiation-induced cancer. No account is taken of other factors
that may lead to variation in sensitivity between individuals. If there is substantial
and widespread variation in risk per unit dose between individuals, a more ‘tailored’
system of protection may need to be considered, or a system that serves to protect the
most vulnerable rather than all members of the population based on average sensi-
tivity (Hansson, 2009).
Increasingly sophisticated methods of genetic and epigenetic analysis have been a
significant driver of the identification of genes, variants, or epigenetic states that
impact on an individual’s risk of cancer in general. Methods to analyse chronic
inflammation have also identified potential non-genetic risk modifiers. The genetics
of breast cancer risk are an example, in which breast cancer susceptibility gene 1
(BRCA1) and 2 (BRCA2) variants enhance risk. In the UK, close to 50,000 women
are diagnosed with breast cancer each year, and one in eight women develop breast
cancer in their lifetime (12.5% lifetime risk). Carrying the BRCA1 or BRCA2 variant
can raise the lifetime risk to 45–65% or one in 2.2–1.5 (see http://www.cancerresearch
uk.org/about-cancer/type/breast-cancer/about/risks/definite-breast-cancer-risks). There
is also a growing appreciation of the environmental risk factors for differing cancers,
and, in a few cases, knowledge of interaction between environmental risk factors, not-
ably the interaction between radon gas exposure and tobacco smoke exposure in lung
cancer risk (AGIR, 2009).
People are different in terms of genetic constitution and exposure history, often
referred to as ‘genome’ and ‘exposome’. The extent to which genetic and other
environmental factors interact with ionising radiation to impact individual cancer
risk is not well understood. This paper aims to provide an overview of the evidence
available on variation in radiation sensitivity, and to consider some of the potential
implications for radiological protection. The Advisory Group on Ionising Radiation
2013 report, ‘Human radiosensitivity’ (AGIR, 2013) covers similar ground but in
much greater depth.
2. DEFINITIONS
The term ‘radiation sensitivity’ can relate to deterministic and stochastic end-
points, and some studies may be relevant to both main types of radiation health
effect. It is important to be clear and consistent in definitions and usage. The main
categories can be summarised as follows.
281
. Radiosensitivity relating to deterministic effects – as measured in mean lethal dose

assays for example, and determining normal tissue radiosensitivity following
radiotherapy and associated variations in observed tissue reactions. This category
of radiosensitivity is likely to be relevant to protection of the lens of the eye among
medical radiographers, and in other exposure situations.
. Radiosensitivity relating to stochastic effects, principally susceptibility to radia-
tion-induced cancer – variation between individuals or population subgroups
observed in epidemiological or experimental studies, with established differences
between tissues in their radiosensitivity.
. Cellular radiosensitivity – defined in specific in-vitro or ex-vivo (e.g. lymphocyte)
assays that may relate to either deterministic or stochastic endpoints or both.
When considering radiation sensitivity in a radiological protection context, different

categories are relevant for different situations. Normal tissue radiosensitivity, if severe,
can limit the use of cancer radiotherapy in individuals, and may also be relevant to
circulatory disease risk and cataract risk. Occupational and public protection is gen-
erally concerned with susceptibility to radiation cancer, except in accident situations
where short-term tissue damage may be of concern. Cellular radiosensitivity assays can
be useful for mechanistic investigations and may provide convenient predictive tests.
However, the relationships between measures of radiation sensitivity at different levels
of organisation are far from clear. Ideally when radiation sensitivity is discussed, the
organisational level and specific test employed should be made clear.
3. EVIDENCE
There is substantial evidence for variation in radiation sensitivity at many levels of
organisation, from the whole organisation down to the individual cell level.
3.1. Normal tissue radiosensitivity following radiotherapy

There are many manifestations of clinical morbidity, some early (occurring within
90 days of radiotherapy exposure) and others late (presenting more than 6 months
after radiotherapy), and partly dependent upon the site therapeutically irradiated
(West and Barnett, 2011). A typical range of clinical radiosensitivity is shown in
Fig. 1, which represents the results of a study of >1000 patients with breast cancer
treated with intensity-modulated radiotherapy (Barnett et al., 2012). In reviewing the
factors that affect normal tissue radiosensitivity (AGIR, 2013), it was concluded that
(i) increasing age in adults, (ii) smoking, (iii) diabetes, and (iv) collagen vascular disease
tend to increase clinical radiosensitivity. However, insufficient data are available to
conclude if sex, ethnicity, body mass index, or alcohol consumption have any influ-
ence. There is also evidence that genetic factors influence clinical radiosensitivity, with
heritability estimates generally in the range of 60–80%. Studies that aim to identify
specific genetic risk factors have tended to be inconclusive, as reported associations
have not been replicated in independent studies (Barnett et al., 2012). One more recent
study that included second and third stages of replication in the original report
282
Fig. 1. Example of the range of human clinical radiosensitivity in a sample of 1010 patients
with breast cancer treated with intensity-modulated radiotherapy. The residual score is a
measure of clinical radiosensitivity (toxicity) that standardises several clinical indicators into
a single score having accounted for patient- and treatment-related factors (Barnett et al.,
2012). A score of 0 indicates the expected level of sensitivity, positive scores indicate higher-
than-expected radiosensitivity, and negative scores indicate relative radioresistance. Redrawn
from Barnett et al. (2012).
suggested that a region on Chromosome 2, 2q24.1 including the tetratricopeptide

repeat, ankyrin repeat, and coiled-coil containing 1 (TANC1) gene, is associated
with late clinical radiotherapy toxicity in patients with prostate cancer (Fachal
et al., 2014).
3.2. Radiosensitivity syndromes

A number of rare recessive genetic disorders that have increased cellular radio-
sensitivity and, in some cases, normal tissue radiosensitivity following radiotherapy
have been described. These include the following well-established syndromes: ataxia
telangiectasia, Fanconi anaemia, and Nijmegen breakage syndrome. If these condi-
tions are undetected and the individuals receive radiotherapy, very severe effects may
occur. Some of these disorders are genetically complex, with multiple genes and
mutations leading to a clinically similar phenotype. More recently, further radio-
sensitivity syndromes have been described, such as Cornelia de Lange syndrome,
Warsaw breakage syndrome, and Cernunnos [see AGIR (2013) for further examples
and their genetic basis]. These disorders have been important in helping identify
mechanisms of radiosensitivity. To date, four major groupings have been identified:
(i) those that affect the non-homologous end-joining pathway of DNA double-strand
break repair (e.g. some severe combined immunodeficiencies and Cernunnos); (ii)
those that affect homologous recombination repair of DNA (e.g. Fanconi anaemia
and radiation 51 repair– Rad51 gene syndromes); (iii) those that affect DNA damage
recognition and signalling [e.g. radiosensitivity, immunodeficiency, dysmorphic
283
features, and learning difficulties (RIDDLE) syndrome; and ataxia telangiectasia];

and (iv) those that affect sister chromatid cohesion (e.g. Cornelia de Lange syndrome
and Robert’s syndrome).
While these disorders are genetically recessive, at least in some cases, there is
evidence for radiosensitivity in heterozygous carriers of variants of these genes.
One example is that of modestly increased chromosomal radiosensitivity in
ataxia telangiectasia and Nijmegen breakage syndrome carriers (Neubauer et al.,
2002).
3.3. Predisposition to radiation-associated cancer

A number of paediatric subpopulations have been found to have increased
frequencies of cancers arising in the radiation fields and surrounding ‘penumbra’
of collaterally exposed non-target tissue used for treatment of a primary cancer
(Kleinerman, 2009). These include (i) retinoblastoma cases, where soft tissue sar-
comas are observed within radiation fields; (ii) neurofibromatosis type 1, where
second cancers are associated with primary glioma radiotherapy; (iii) Li-Fraumeni
syndrome, where high frequencies of secondary and tertiary cancers are related to
radiotherapy; and (iv) Gorlin syndrome, where multiple basal cell skin cancers can
occur within radiation fields. There can be similar issues arising due to frequent
diagnostic radiography during treatment. It should also be noted that radiation
may, in some cases, be one amongst multiple environmental contributory risk factors
for cancer, so interactions between these risk factors and genetic risk variants
are possible.
The genetics of radiosensitivity for cancer in adults have been best studied in
breast cancer, where a number of genes encoding proteins involved in aspects of
DNA double-strand break repair and the signalling of repair have been implicated.
While the incidence of the clinically obvious radiosensitivity syndromes, which
frequently present with many obvious features, is low [e.g. one in 300,000 live
births for ataxia telangiectasia in the UK (Woods et al., 1990)], the frequency of
heterozygous carriers of risk variants can be substantial (0.5–1% in this case). It has
been established that ataxia telangiectasia mutated (ATM) heterozygous carriers are
at approximately two-fold higher risk of breast cancer (Renwick et al., 2006; Goldgar
et al., 2011). More recently, it has been found that rare mis-sense variants of
ATM and radiation exposure from breast cancer therapy together confer a greater
risk of contralateral second breast cancer than the sum of the individual effects
(Bernstein et al., 2010). Evidence for other breast cancer susceptibility genes, such
as BRCA1, BRCA2, and checkpoint kinase 2, have been found but are generally
weaker (AGIR, 2013).
At lower levels of exposure in medical diagnostics, it is perhaps unsurprising that
evidence of breast cancer genes affecting radiation cancer susceptibility is less clear.
Despite some indications of increased breast cancer risk in BRCA1/2 carriers sub-
jected to medical diagnostics (Andrieu et al., 2006), overall evidence is mixed and, at
most, potentially indicates that mutation carriers may be at increased risk following
diagnostic exposure (Goldfrank et al., 2006; Narod et al., 2006).
284
3.4. Cellular radiosensitivity

Numerous studies have investigated the range of human cellular radiosensitivity
using several different endpoints; for example, cell survival, chromosome aberration
induction, induction of apoptosis, and cell cycle checkpoint induction. In some cases,
cellular radiosensitivity appears to be associated with increased cancer risk (AGIR,
2013). Studies combining pedigree analysis or twin study designs with cellular radio-
sensitivity assays suggest that on the order of 70% of the observed variation may be
due to genetic factors. One assay deserves particular note: the G2 chromosomal
radiosensitivity assay. This ex-vivo lymphocyte test assesses chromatid aberration
arising in the G2 phase of the cell cycle following radiation exposure. High G2
aberration scores have been observed in several known cancer predisposition syn-
dromes and a high proportion of women with breast cancer [see AGIR (2013) for
further discussion].
3.5. Summary of evidence

There are many lines of evidence for the variation in human radiosensitivity in
terms of tissue reactions (e.g. to radiotherapy) and cancer, certainly following
radiotherapy exposure. In terms of risk to normal tissues during radiotherapy,
other pre-existing conditions or exposures, notably smoking, can affect radiation
risk. This is paralleled by the strong interaction between residential and occupational
radon exposure and smoking (AGIR, 2009). In addition, there is substantial evidence
for genetic variation contributing to radiosensitivity, although identifying all the
genetic influences is challenging.
4. IMPLICATIONS
The growing evidence on variation in human radiosensitivity has potential impli-
cations for many areas of radiological protection. Those highlighted below are
drawn from a more detailed consideration presented by AGIR (2013).
4.1. Medical sector

In radiotherapy, normal tissue damage can limit the ability to control tumour
growth, and regimes are developed to avoid tissue injury in the majority of cases.
There are sometimes options to modify the treatment plan in cases of adverse normal
tissue reaction occurring during therapy. Robust and reliable assays to predict indi-
vidual sensitivity would be beneficial, and could help inform selection of the most
appropriate therapeutic strategy. On the basis of current evidence, patients can be
provided with advice on potentially modifiable risk factors, and this could help
optimise the benefits of therapy.
4.2. Diagnostics
The increasing use of medical diagnostics involving ionising radiation, especially
computed tomography scans, could present problems for highly radiosensitive indi-
viduals in the population, although these are few in number. In some cases,
285
alternative methods can be available, such as in the case of magnetic resonance

imaging as an alternative to x-ray mammography for breast cancer screening.
Again, having assays to accurately determine or predict sensitivity would be benefi-
cial in this respect. There remains, of course, the need to maintain justification of
diagnostic use on the basis of clinical benefit outweighing risk.
4.3. Occupational
Epidemiological studies provide good evidence of females and younger people
being at greater risk of radiation-associated cancer [evidence not discussed in this
paper, but see AGIR (2013)]. As prospective radiological protection aims to protect
the population, it is reasonable to use age- and sex-averaging in defining effective
dose for control of exposures. However, when retrospective assessment of risk in
individuals is being undertaken, these factors should be taken into account.
More specifically, concerns in the occupational sector centre around the ability to
identify those at greater (or even lesser) risk of radiation health effects. The evidence
that ATM carriers can be at increased radiation cancer risk suggests that genetic
testing may become feasible. It is, of course, a highly contentious issue whether
genetic testing is used appropriately in employment selection. Indeed, the
International Labour Organisation strongly discourages the practice, and it is legis-
lated against in many countries. This would not preclude individuals seeking genetic
testing on an individual, private basis to inform their individual employment choices.
4.4. Emergencies
The availability of rapid and reliable tests of radiation exposure is valuable in
emergency situations. The availability of tests that are predictive of tissue injury or
cancer risk on an individual basis could enhance the robustness of immediate and
longer-term clinical decision making in emergencies.
4.5. Public
In provision of public advice on radon risk, inclusion of information on the
role of smoking is clearly relevant. In the UK, Public Health England routinely
provides smoking cessation advice to the public, alongside radon risk and remedi-
ation advice. The ability to determine radiosensitivity by simple tests, obtained
privately by individuals, could be used by members of the public when consider-
ing medical treatment options or in other situations that include exposure to
ionising radiation.
4.6. Ethics
Evolving evidence for variation in human radiosensitivity prompts questions
about the approach to radiological protection. Currently, protection standards
focus on the population rather than the individual. Furthermore, within the popu-
lation, it is a notional average individual that is used in the definition of effective dose
and the control of radiation exposures. Some may argue that the most vulnerable
(i.e. most sensitive) in the population should be protected (Hansson, 2009). However,
286
disproportionate allocation of resources and budgets protecting small high-risk

groups may be seen to lack justice for the wider population.
As reliable routine tests for radiosensitivity are not available at present, the main
focus should be on provision of information about risk and how it may be reduced.
This can be seen to be particularly important where individuals are at liberty to
change their behaviour or lifestyle to reduce their own risk.
5. PREDICTION OF RADIOSENSITIVITY
The preceding section noted that the ability to reliably test for and assess indi-
vidual radiosensitivity could prompt consideration of substantial changes to the
current approaches taken in some areas of radiological protection. The radiation
biology literature has many reports of potential tests for radiosensitivity, but none of
them have entered routine practice.
In the case of normal tissue reaction to radiotherapy, for example, an assay of
apoptosis in blood lymphocytes has been reported to be predictive only for particular
individual biological endpoints (Ozsahin et al., 2005; Azria et al., 2008). In a diag-
nostic setting, it has been claimed that phosphorylated histone H2AX foci levels in
mammary epithelial cells are associated with breast cancer risk (Colin et al., 2011).
As noted, none of these or similar tests has yet reached routine clinical practice.
In addition to cellular assays, genetic testing could play a role, as noted earlier.
Also, tests based on gene expression hold promise. For example, post-irradiation
expression of the cell cycle regulator cyclin-dependent kinase inhibitor 1A was found
to increase much more in a small sample of breast cancer patients with a severe skin
reaction to radiotherapy compared with those with a normal reaction (Badie et al.,
2008), but further validation is needed. More generally useful would be an assay of
radiation cancer risk. The study of Kabacik et al. (2011) suggests that there may be
prospects for such a test. The study used mouse strains modified to carry between
zero and four copies of p53, a key tumour suppressor gene and transcriptional
regulator. In these strains, p53 copy number determines lifetime cancer risk.
A strong linear relationship was found between post-irradiation response of selected
p53 regulated genes and p53 copy number. It was therefore possible to correlate 2-h
post-irradiation cancer risk with lifetime cancer risk with a high degree of statistical
confidence in these specific mouse strains.
6. FUTURE PROSPECTS
It is likely that scientific understanding of human radiosensitivity will improve in
the future, and the long-held hope to develop robust and reliable tests for radio-
sensitivity will be achievable.
In parallel with the accumulation of scientific evidence, other considerations are
necessary before such knowledge is applied in the context of radiological protection.
It needs to be demonstrated that applying knowledge on radiation sensitivity and its
variation will be beneficial in some or all aspects of radiological protection.
287
Any changes would require a robust framework in which to translate and imple-
ment the knowledge. Such a framework is likely to be exposure-situation dependent,
and will need sound justification in scientific evidence and ‘gain’ in terms of radiation
health protection. Finally, acceptance of both the principle and approach will be
needed.
Several needs can be identified before individual human radiosensitivity can be
applied in radiological protection.
. Improved information on the range of human radiosensitivity, particularly in

relation to radiogenic or radiation-associated diseases of concern and at exposure
levels of relevance.
. Robust and reliable predictive assays that are accurate, rapid, and reproducible.
These could be genetic, cellular, or based on gene expression.
. Careful consideration of the benefits of moving to a more individualised
or stratified approach to protection (e.g. considering what could be gained
or lost).
. Development of frameworks in which to implement a stratified or individualised
approach to protection.
. Widespread dialogue with all stakeholder groups to achieve acceptance of any
such change to the approach to protection.
There are therefore challenges to translation of knowledge of human radio-

sensitivity into practical radiological protection. These are both scientific and
ethical/societal, and it will be important that these are considered together if
translation into effective radiological protection practice is to be achieved. Any
move to a more personalised approach to radiological protection is likely to be
more challenging than moves to personalised medicine, and is arguably a more
distant prospect.
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AGIR, 2009. Radon and Public Health. Report of the Independent Advisory Group on
Ionising Radiation. Doc. HPA, RCE–11. Health Protection Agency, Chilton. Available
at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/335102/
RCE-11_for_website.pdf (last accessed 12 April 2016).
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Ionising Radiation. Doc. HPA, RCE–21. Health Protection Agency, Chilton. Available
at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/333058/
RCE-21_v2_for_website.pdf (last accessed 12 April 2016).
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breast cancer among BRCA1/2 mutation cancers in the International BRCA1/2 Carrier
Cohort Study: a report from EMBRACE, GENE PSO, GEO-HEBON and IBCCS
Collaborators Group. J. Clin. Oncol. 24, 3361–3366.
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a scale- and grade-independent measure of late radiotherapy toxicity to facilitate pooling
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Bernstein, J.C., Haile, R.W., Stovall, M., et al., 2010. Radiation exposure, the ATM gene, and
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Colin, C., Devic, C., Noël, A., et al., 2011. DNA double-strand breaks induced by mammo-
graphic screening procedures in human mammary epithelial cells. Int. J. Radiat. Biol. 87,
1103–1112.
Fachal, L., Gómez-Caamaño, A., Barnett, G.C., et al., 2014. A three-stage genome-wide
association study identifies a susceptibility locus for late radiotherapy toxicity at 2q24.1.
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289
Analysis of individual differences
in radiosensitivity using genome editing*
S. Matsuuraa, E. Roybaa, S.N. Akutsua, H. Yanagiharaa,
H. Ochiaib, Y. Kudoc, S. Tashirod, T. Miyamotoa
a
Department of Genetics and Cell Biology, Research Institute for Radiation Biology and
Medicine, Hiroshima University, Hiroshima 734-8553, Japan;
e-mail: shinya@hiroshima-u.ac.jp
b
Department of Mathematical and Life Sciences, Graduate School of Science,
Hiroshima University, Japan
c
Department of Obstetrics and Gynaecology, Graduate School of Biomedical Sciences,
d
Department of Cellular Biology, Research Institute for Radiation Biology and Medicine,
Abstract–Current standards for radiological protection of the public have been uniformly
established. However, individual differences in radiosensitivity are suggested to exist in human
populations, which could be caused by nucleotide variants of DNA repair genes. In order to
verify if such genetic variants are responsible for individual differences in radiosensitivity, they
could be introduced into cultured human cells for evaluation. This strategy would make
it possible to analyse the effect of candidate nucleotide variants on individual radiosensitivity,
independent of the diverse genetic background. However, efficient gene targeting in cultured
human cells is difficult due to the low frequency of homologous recombination (HR) repair.
The development of artificial nucleases has enabled efficient HR-mediated genome editing to
be performed in cultured human cells. A novel genome editing strategy, ‘transcription acti-
vator-like effector nuclease (TALEN)-mediated two-step single base pair editing’, has been
developed, and this was used to introduce a nucleotide variant associated with a chromosomal
instability syndrome bi-allelically into cultured human cells to demonstrate that it is the
causative mutation. It is proposed that this editing technique will be useful to investigate
individual radiosensitivity.
Keywords: Radiosensitivity; Genome editing; Micronucleus assay; Single nucleotide

polymorphism
*
Protection.
290
1. INTRODUCTION
Following the Fukushima Daiichi nuclear power plant accident on 11 March
2011, caused by the Great East Japan Earthquake, social anxiety about the
human health effects of ionising radiation has increased. Current radiological pro-
tection systems are based on the uniform standards established for protection of the
public. However, it has been postulated that individual differences in radiosensitivity
exist within the human population (Scott et al., 1998). Therefore, the next generation
of radiological protection systems should consider the heterogeneity of individual
radiosensitivity.
The cytokinesis-block micronucleus (CBMN) assay has been used previously to
measure cellular radiosensitivity (Fenech, 2007). DNA double-strand breaks (DSBs)
induced by ionising radiation are recognised and rejoined by the DNA repair system.
Therefore, an attenuated DNA repair system results in chromosomal gaps or breaks.
When the cell enters the mitotic phase in the absence of DNA repair, chromosomal
fragments form one or more secondary nuclei [i.e. micronuclei (MN)]. The CBMN
assay has shown that individual differences in radiosensitivity exist, and has identi-
fied mild radiosensitive cases in a small population of patients with breast cancer
(Scott et al., 1998). This individual radiosensitivity may be attributed to single
nucleotide polymorphisms (SNPs) or mutations in DNA repair genes (Iarmarcovai
et al., 2008). To verify this, it would be useful to measure the radiosensitivity of
peripheral blood lymphocytes from individuals carrying candidate SNPs or muta-
tions. However, using this strategy, CBMN assays may be affected by confounding
factors such as smoking (Huang et al., 2009), or influenced by the diverse genetic
backgrounds of the human population. It is therefore necessary to establish an
evaluation system of radiosensitivity in a uniform genetic background with model
human cells. This paper presents a novel genome editing strategy, ‘transcription
activator-like effector nuclease (TALEN)-mediated two-step single base pair editing’,
and it is proposed that this editing technique will be useful to investigate individual
radiosensitivity.
2. CBMN ASSAY USING B-CELL LINES

In order to verify that variants in DNA repair genes are involved in individual
differences in radiosensitivity, radiation-induced MN formation was studied in B-cell
lines from family members with Nijmegen breakage syndrome (NBS). NBS is an
autosomal-recessive disorder characterised by microcephaly, short stature, immuno-
deficiency, and a high incidence of cancer. NBS is caused by germline mutations
in the DSB repair gene, NBS1 (Matsuura et al., 1998). Cultured cells from patients
with NBS show chromosomal instability, increased sensitivity to radiation-induced
cell killing, and abnormal cell-cycle regulation after irradiation (Chrzanowska
et al., 2012).
Epstein-Barr (EB) virus-transformed lymphoblastoid cell lines were collected
from homozygous patients with NBS 7998 and 8026 (NBS1 / ), heterozygous
291
carriers 8000, 8001, 8002, 8004 and 8005 (NBS1+/ ), and a control individual
(NBS1+/+). Radiosensitivity was compared by CBMN assay. Cells (2.5 105
cells ml 1) were irradiated with 1 Gy of g rays, and treated with 3 mg ml 1 cyto-
chalacin-B for 48 h to form binucleated (BN) cells. The cells were grown on slides,
fixed with cold methanol, and nuclei were counterstained with Hoechst33258. The
number of MN in at least 1000 BN cells was counted manually under fluorescence
microscopy. Control cells (NBS1+/+) showed no appreciable increase in MN for-
mation, whereas cells from patients (NBS1 / ) exhibited an increase in MN for-
mation after irradiation (Fig. 1). All cells showed an intermediate response between
the control individual and the patients with NBS. These results suggest that the
heterozygous mutation may underlie the individual differences in radiosensitivity.
This study also found that the proportion of MN formation in cells varied consid-
erably within genotypes, particularly for the NBS1+/ heterozygotes, and possibly
for the patients with NBS to a lesser extent. These results suggest that the
CBMN assay may be affected by the diverse genetic backgrounds of the human
population.
Fig. 1. Radiosensitivity of the Epstein-Barr virus-transformed lymphoblastoid cells estab-

lished from family members with Nijmegen breakage syndrome (NBS). Male patient cell
line 7998 was established from Family Kl in Germany, and heterozygous cell lines 8001 and
8000 were established from his father and mother, respectively. Male patient cell line 8026 was
established from Family W in Germany. Heterozygous cell lines 8005, 8002 and 8004 were
established from the patient’s siblings from Family 1 in the Netherlands (Matsuura et al.,
1998). A founder mutation, 657-661del ACAAA, was detected in all three families (Matsuura
et al., 1998). A control cell line was established from a healthy male individual. Cells from
NBS heterozygous carriers showed intermediate frequency of micronucleus formation between
that of control cells and the cells of patients with NBS. BN, binucleated cells.
292
3. TALEN-MEDIATED TWO-STEP SINGLE BASE PAIR EDITING

Reverse genetics in cultured human cells with a uniform genetic background
could be a direct approach to quantitative measurement of genotype-dependent
radiosensitivity. Targeted gene modification in cultured human cells has been used
previously to investigate gene function. However, this technique proved difficult
due to the extremely low frequency of homologous recombination (HR) in human
cells. Artificial nucleases have been developed recently, including zinc finger nucle-
ases, TALENs, and clustered regulatory interspaced short palindromic repeat/
Cas9-based RNA-guided DNA endonucleases (CRISPR/Cas9). The co-introduction
of artificial nucleases with targeting vectors and subsequent antibiotic selection
enabled efficient HR-mediated genome editing to be performed in mammalian cells
(Soldner et al., 2011; Yusa et al., 2011).
A single base pair editing technique in cultured human cells was developed
recently, and used to identify a causal mutation of a cancer-prone genetic disorder,
premature chromatid separation with mosaic variegated aneuploidy [PCS (MVA)]
syndrome (Ochiai et al., 2014). This is a rare human autosomal-recessive disorder
characterised by constitutional aneuploidy and a high risk of childhood cancer
(Matsuura et al., 2000). Both bi-allelic and mono-allelic mutations of the BUB1B
gene encoding BubR1 have been identified in affected individuals. Mono-allelic
mutations in BUB1B were identified in seven Japanese families with the syndrome
(Matsuura et al., 2006). No second mutation was found in the opposite allele of any
of the families studied, although a conserved BUB1B haplotype within a 200-kb
interval and a reduced transcript were identified. Therefore, the nucleotide sequence
of the 200-kb region was determined in a patient with the syndrome, and 186
known and five unknown SNPs were found. Of these SNPs, only one in an inter-
genic region 44-kb upstream of a BUB1B transcription start site co-segregated with
the disease. This substitution was therefore a strong candidate mutation for the
syndrome. If the nucleotide substitution identified was the disease-causing muta-
tion, its introduction into cultured normal human cells should result in a decrease
of BUB1B transcripts and increased chromosomal instability. To examine this pos-
sibility, a TALEN-mediated two-step single base pair editing strategy was designed
(Fig. 2). The first step included TALEN-mediated targeted integration of a selection
cassette into the SNP flanking region. The targeting vector contained a neomycin-
resistant gene and a herpes simplex virus thymidine kinase (hsvTK) gene, separated
by a 2A peptide sequence, allowing expression of the discrete protein products from
a single open reading frame. The knock-in clones that were positively selected using
neomycin. The second step involved the targeted excision of the selection cassette,
and introduction of the single nucleotide substitution. Single-nucleotide-edited
clones were selected negatively using ganciclovir treatment. This substitution was
introduced bi-allelically into the human colon cancer cell line HCT116. Cell clones
showed reduced BUB1B transcripts and chromosomal instability in the form of
PCS and MVA, which are cellular hallmarks of the syndrome. These results suggest
that the nucleotide substitution identified was the causal mutation of PCS (MVA)
293
Fig. 2. Bi-allelic introduction of single nucleotide substitutions into cultured human cells
using a transcription activator-like effector nuclease (TALEN)-mediated two-step single
base pair editing technique. The first step involved the TALEN-mediated targeted integration
of a selection marker into the single nucleotide polymorphism flanking region. The targeting
vector contained a neomycin-resistant gene and a herpes simplex virus thymidine kinase gene
separated by a 2A peptide. The second step involved the targeted excision of the selection
cassette and introduction of the single nucleotide substitution.
syndrome (Ochiai et al., 2014). The single base pair editing technique was therefore
useful to investigate nucleotide variants of unknown functional relevance (Urnov,
2014).
4. CONCLUSIONS
A number of epidemiological studies have demonstrated an increased risk of
cancer incidence in normal individuals carrying nucleotide variants of DNA repair
genes (Naccarati et al., 2007). This study showed that the radiation-induced MN
formation of NBS heterozygous carriers was intermediate between that of patients
with NBS and a control individual, as reported previously (Stumm et al., 2001;
Neubauer et al., 2002; Dumon-Jones et al., 2003). These results suggest an apparent
294
relationship between heterozygous mutations of familial hyper-radiosensitive dis-

eases, mild radiosensitivity, and cancer incidence. As well as heterozygous mutations,
many SNPs in DNA repair genes associated with risk of cancer have been reported.
However, the functional evaluation of such variants may prove difficult because
their effect sizes may be smaller than those of heterozygous mutations. It is therefore
necessary to establish an evaluation system to compare radiosensitivity using model
human cells with a uniform genetic background. This strategy will be useful to
study the effects of candidate nucleotide variants underlying individual
radiosensitivity.
The single base pair editing technique described here is able to introduce single
nucleotide substitutions anywhere within the genome, without any footprints besides
targeted sites; however, it is labour intensive because it requires multiple sets of
TALENs, two separate targeting constructs, and two rounds of gene targeting.
Recently, oligonucleotides have been used as donor templates to generate novel
allelic variants of endogenous loci in a single step without selection (Chen et al.,
2015). Moreover, the CRISPR/Cas9-based RNA-guided DNA endonuclease is
currently emerging as a simple and efficient artificial nuclease (Cong et al., 2013).
The targeted DNA cleavage by the CRISPR/Cas9 system only requires one short
length (16–20 bases) of gRNA sequence for the recognition of target sequence and
the common Cas9 enzyme, while TALENs require the design and assembly of two
customised nucleases for one target locus. Therefore, it is much easier to engineer the
CRISPR/Cas9 system than TALENs. These editing technologies are facilitating
the future generation of model human cells carrying nucleotide variants of DNA
repair genes for further investigation of radiosensitivity.
REFERENCES
Chen, F., Pruett-Miller, S.M., Davis, G.D., 2015. Gene editing using ssODNs with engineered
endonucleases. Methods Mol. Biol. 1239, 251–265.
Cong, L., Ran, F.A., Cox, D., et al., 2013. Multiplex genome engineering using CRISPR/
Cas systems. Science 339, 819–823.
Chrzanowska, K.H., Gregorek, H., Dembowska-Baginska, B., et al., 2012. Nijmegen break-
age syndrome (NBS). Orphanet J. Rare Dis. 7, 13.
Dumon-Jones, V., Frappart, P.O., Tong, W.M., et al., 2003. Nbn heterozygosity renders mice
susceptible to tumor formation and ionizing radiation-induced tumorigenesis. Cancer Res.
63, 7263–7269.
Fenech, M., 2007. Cytokinesis-block micronucleus cytome assay. Nat. Protoc. 2, 1084–1104.
Huang, P., Huang, B., Weng, H., et al., 2009. Effects of lifestyle on micronuclei frequency in
human lymphocytes in Japanese hard-metal workers. Prev. Med. 48, 383–388.
Iarmarcovai, G., Bonassi, S., Botta, A., et al., 2008. Genetic polymorphisms and micronucleus
formation: a review of literature. Mutat. Res. 658, 215–233.
Matsuura, S., Tauchi, H., Nakamura, A., et al., 1998. Positional cloning of the gene for
Nijmegen breakage syndrome. Nat. Genet. 19, 179–181.
Matsuura, S., Ito, E., Tauchi, H., et al., 2000. Chromosomal instability syndrome of
total premature chromatid separation with mosaic variegated aneuploidy is defective in
mitotic-spindle checkpoint. Am. J. Hum. Genet. 67, 483–486.
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Matsuura, S., Matsumoto, Y., Morishima, K., et al., 2006. Monoallelic BUB1B mutations
and defective motitc-spindle checkpoint in seven families with premature chromatid
separation (PCS) syndrome. Am. J. Med. Genet. A. 140, 358–367.
Naccarati, A., Pardini, B., Hemminki, K., et al., 2007. Sporadic colorectal cancer and indi-
vidual susceptibility: a review of the association studies investigating the role of DNA
repair genetic polymorphisms. Mutat. Res. 635, 118–145.
Neubauer, S., Arutyunyan, R., Stumm, M., et al., 2002. Radiosensitivity of ataxia telangi-
ectasia and Nijmegen breakage syndrome homozygotes and heterozygotes as determined
by three-color FISH chromosome painting. Radiat. Res. 157, 312–321.
Ochiai, H., Miyamoto, T., Kanai, A., et al., 2014. TALEN-mediated single-base-pair editing
identification of an intergenic mutation upstream of BUB1B as causative of PCS (MVA)
syndrome. Proc. Natl. Acad. Sci. USA 111, 1461–1466.
Scott, D., Barber, J.B., Levine, E.L., et al., 1998. Radiation-induced micronucleus induction in
lymphocytes identifies a high frequency of radiosensitive cases among breast cancer
patients: a test for predisposition? Br. J. Cancer 77, 614–620.
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cells differing exclusively at two early onset Parkinson point mutations. Cell 146, 318–331.
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296
Ethical foundations of the radiological
protection system
K.W. Cho
Korea Institute of Nuclear Safety, 62 Gwahak-ro, Yuseong-gu, Daejeon, 305-338,
Republic of Korea; e-mail: kwcho@kins.re.kr
Abstract–The International Commission on Radiological Protection (ICRP) has established

Task Group 94 under Committee 4 to develop a report on the ethical foundations of the
system of radiological protection. The aim of this report is to consolidate the basis of ICRP
recommendations, to improve understanding of the system, and to provide a basis for com-
munication on radiation risk and its perception. Through a series of workshops organised by
the Commission in cooperation with the International Radiation Protection Association and
its associate societies involving radiological protection professionals and specialists of ethics
around the world, Task Group 94 has identified the key ethical and social values underpinning
the system of radiological protection. The purpose of eliciting the ethical principles and values
of the radiological protection system is not only to clarify the rationale for recommendations
made by the Commission, but also to assist in discussions related to its practical implemen-
tation. A clear understanding of the ethical principles will help resolve dilemmas caused by
potential conflicts in actions that might be considered, or decisions that must be made.
Keywords: Ethical values; System of radiological protection; Understanding; Communication
1. INTRODUCTION
Despite long recognition that radiological protection is not only a matter of sci-
ence but also of values, International Commission on Radiological Protection
(ICRP) reports have rarely addressed the ethical foundations of its system of radio-
logical protection explicitly. This does not mean that the Commission is unaware of
the importance of such considerations. Protection recommendations inevitably
Protection.
297
represent an ethical position, irrespective of whether that position is explicit or

implicit. However, the discussion of ethical considerations is not entirely absent
from ICRP reports.
The lessons learned from management of the consequences from Chernobyl, and
more recently from Fukushima, have certainly played a key role in the increase in
recent interest in ethical aspects of radiological protection, and the awareness that
the traditional emphasis on the science of radiation has shown its limits, and there-
fore human and ethical dimensions of the exposure situations are important and
sometimes decisive in the decision-making process.
It is in this context that ICRP initiated a reflection on the ethical foundations of the
radiological protection system in early 2010. After an initial phase during which
Committee 4 reviewed the literature on the subject, Task Group 94 was created in
October 2013 to work on the ethics of radiological protection. The first step of Task
Group 94 was to review the reports of the Commission to identify the ethical values
associated with the system of radiological protection for occupational, public, and med-
ical exposures, and for protection of the environment. A draft report is now in prepar-
ation presenting the ethical and social values structuring the system of radiological
protection, and its implementation for the different types of exposure situations and
categories of exposure. This is the first concerted effort by the Commission to reflect
upon and describe the ethical basis of the system of radiological protection in some detail.
The draft report identifies key components of the ethical theories and principles
prevailing in the fields of safety, health, labour, the environment, and sustainable devel-
opment relevant to the system of radiological protection. In order to involve ethicists,
philosophers, social scientists, and radiological protection professionals from different
regions of the world, a series of six workshops was held by the Commission in collab-
oration with the International Radiation Protection Association to fully examine, dis-
cuss and debate the ethical basis of the current system of radiological protection
[Daejeon (Korea) and Milan (Italy) in 2013; Baltimore (USA) in 2014; Madrid
(Spain), Cambridge, MA (USA), and Fukushima (Japan) in 2015].
This paper summarises the current text of the Task Group 94 draft report: Chapter 2
presents the key steps concerning the scientific, ethical and practical evolutions of the
system of radiological protection since the first ICRP report in 1928; Chapter 3 des-
cribes the core ethical values underpinning the present system (ICRP, 2007a); and
Chapter 4 addresses the key procedural ethical values for implementation of the system.
2. EVOLUTION OF THE SYSTEM OF RADIOLOGICAL PROTECTION:

SCIENCE, ETHICAL VALUES, AND EXPERIENCE
The present system of radiological protection is based on three pillars: the science
of radiation, combining scientific knowledge from different disciplines; a set of values
rooted in ethics and morality; and experience accumulated from the day-to-day
practice of radiological protection professionals. Due to uncertainties concerning
the risk associated with radiation at low doses, this system fundamentally promotes
a prudent approach for protecting people against the detrimental effects of radiation
298
exposure. The following sections describe how the system has evolved progressively
over the 20th Century in relation to historical events associated with the use of x rays
and radioactivity.
2.1. The early days: do no harm

The international system of radiological protection (‘the system’) was ‘born’ in
1928, with the first recommendations of the International X-Ray and Radium
Protection Committee (ICRP, 1928), although some advice had been published
much earlier (Fuchs, 1896). Nearly three decades had passed since the discovery of
x rays (Roentgen, 1895), natural radioactivity (Becquerel, 1896) and radium (Curie,
1898), during which time the use of radiation in medicine had skyrocketed.
The 1928 Recommendations provided advice meant to avoid harmful skin reac-
tions: ‘the dangers of over-exposure . . . can be avoided by the provision of adequate
protection.’ This advice was based on the best scientific knowledge at the time about
the effects of radiation exposure, the experience of nearly 30 y of practice, and the
desire to avoid harm. The relatively simple, implicit ethical value of non-maleficence,
avoidance of doing harm, was sufficient, as it was thought that straightforward pro-
tection measures could keep exposures sufficiently low to avoid harm entirely.
The 1950 Recommendations (ICRP, 1951) saw the first hints of the evolution of
the ethical basis of system beyond the avoidance of doing harm, or at least that the
practicalities of achieving this aim might be less straightforward than previously
thought, recommending that ‘every effort be made to reduce exposures to all types
of ionising radiation to the lowest possible level’.
2.2. A more complex problem: managing risk, a matter of balance

The 1950s saw a growing concern about the effects of radiation exposure not only
to workers and patients, but also to the public. This growing concern, along with the
increasing use of radiation in many fields, the expected increase in the nuclear energy
industry, and emerging evidence of increased leukaemia in radiologists and atomic
bomb survivors, had a profound influence on the system.
In Publication 9 (ICRP, 1966), noting the absence of evidence regarding the existence
of a threshold for this type of effect and in view of the uncertainty concerning the nature
of the dose–effect relationship in the induction of malignancies, the Commission saw
‘. . .no practical alternative, for the purposes of radiological protection, to assuming a
linear relationship between dose and effect, and that doses act cumulatively’.
Cancer and genetic effects, for which it is assumed that there is no absolutely safe
level of exposure (no threshold), presented a much more ethically complex situation
than before. It was no longer enough to avoid doing harm by keeping exposures
sufficiently low; it appeared to be impossible to completely avoid any risk of doing
harm. The problem shifted from avoiding harm to managing the probability of
harm. This was elaborated on in Publication 26 (ICRP, 1977), where the primary
aim of the system was described as ‘protection of individuals, their progeny, and
mankind as a whole while still allowing necessary activities from which radiation
exposure might result’.
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2.3. A broader perspective: protecting the environment per se

The ICRP system also expanded its view from human to non-human species.
Publication 26 (ICRP, 1977) included the first description of extending protection
beyond humans, expanding the scope of the system to include protection of the
environment. However, it did not go much beyond the assertion that ‘if man is
adequately protected then other living things are also likely to be sufficiently pro-
tected’. This statement, although reworded, was repeated in Publication 60 (ICRP,
1991): ‘the standards of environmental control needed to protect man to the degree
currently thought desirable will ensure that other species are not put at risk.’
Protection of the environment was treated more substantially in Publication 91
(ICRP, 2003). This report suggested a framework, based on scientific and ethical-
philosophical principles, by which a policy for the protection of non-human species
could be achieved.
The elaboration of ICRP framework for protection of the environment (ICRP,
2003) was based explicitly on a reflection on ethics. On this occasion, ICRP referred
to sustainable development and human dignity. Procedural ethics was addressed
clearly, and a discussion on tools and guidelines was provided for the implementa-
tion of ethical issues in the ICRP system.
2.4. More than protection from physical harm

The widespread impact of the Chernobyl accident in 1986, increasing awareness
of the legacy of areas contaminated by past activities, the importance of natural
sources of radiation, and concern regarding malevolent acts following the attack
on the World Trade Center in New York City on 11 September 2001 challenged
the ICRP system. Later, the Fukushima accident in 2011 would challenge the system
again in much the same way.
No doubt, the core of the system remained the protection of people and the
environment from physical harm, but these events also highlighted the need to con-
sider some broader societal issues more carefully. Therefore, Publication 103 (ICRP,
2007a) introduced the idea of ‘existing exposure situations’ and ‘emergency exposure
situations’, as distinct from ‘planned exposure situations’, and also emphasised the
importance of ‘the participation of relevant stakeholders rather than radiological
protection specialists alone’.
These ideas were expanded upon shortly thereafter. For example, Publication 111
(ICRP, 2009) introduced the idea of self-help protection, where individuals take
informed actions to improve the radiological situation for themselves, their family,
and their community. This implies a level of autonomy (flowing from the concept of
dignity), relying on information, advice, and support from authorities and other experts.
3. CORE ETHICAL VALUES UNDERPINNING THE SYSTEM

3.1. The system of radiological protection today
The present radiological protection system consists of a set of interdependent
elements interacting to achieve the objectives. The so-called fundamental principles
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of protection (justification, optimisation, and limitation) are central to the system

and apply to the different types of exposure situations (planned, emergency, and
existing) and categories of exposure (occupational, public, and medical exposure
of patients). They are also related to the protection criteria (reference levels, dose
constraints, and dose limits) applied to sources or individuals to restrict exposures,
and also to what is called the basic requisites for practical implementation of the
system (accountability, transparency, and stakeholder involvement) which are
common to all three types of exposure situation.
The following sections present how the values of beneficence/non-maleficence and
prudence are combined with the values of justice and dignity within the system.
3.2. Beneficence and non-maleficence

As far as the protection of human health is concerned, the objective of the
Commission’s recommendations is ‘to manage and control exposures to ionising radi-
ation so that deterministic effects are prevented, and the risks of stochastic effects are
reduced to the extent reasonably achievable’. In the ethical context, the desire to do
good is called ‘beneficence’, and the desire to do no harm is called ‘non-maleficence’.
In its most general meaning, beneficence is the action to promote the well-being of
others. Thus, in a way, beneficence includes non-maleficence, which is the principle
of avoiding harm. ‘Do no harm’ is one of the demands of the Hippocratic Oath. By
developing recommendations seeking to protect people against the harmful effects of
radiation, the Commission undoubtedly contributes to serve the best interests of
individuals and, indirectly, the quality of social life. This is achieved in practice by
ensuring that deterministic effects are avoided and stochastic effects are reduced as
far as achievable given the prevailing circumstances. Non-maleficence is closely
related to prevention, which aims to take measures in order to avoid a situation
from deteriorating. Non-maleficence therefore aims to limit risk by eliminating or
reducing the likelihood of hazards.
Beneficence and non-maleficence may sometimes be separate actions, but may
also be two aspects of one action. The good will to provide benefit does not
always result in good consequences. An action to prevent some harm may cause
other harm. Meanwhile, an action to protect others from harm, even if there is no
intention of providing benefit, may be able to preserve benefit, even well-being of
individuals. It is important to balance actions with intentions of beneficence and
non-maleficence.
3.3. Prudence
The ICRP system of radiological protection of humans is based on a wide spec-
trum of scientific knowledge, ranging from metrology to epidemiology, going
through disciplines as diverse as anatomy, physiology, pathology and radiobiology.
All this knowledge is integrated in a series of models of varying complexity. The use
of models, associated with the lack of precise information on some parameters,
inevitably introduces uncertainties in the estimates, and therefore requires reliance
on value judgements.
301
Despite the ongoing effort undertaken to critically evaluate and reduce these
uncertainties, the Commission is led to use a default option: a series of inferences,
extrapolations and assumptions. One of the key assumptions concerning radiation
risk is the absence of a threshold for stochastic effects adopted in the 1960s to
respond to the uncertainty on the relationship between dose and effect, especially
for low doses.
From an ethical viewpoint, a situation that requires decision making and acting
without the full knowledge of the consequences should be governed by the virtue of
prudence. It is worth noting that the term ‘prudence’ only appeared in the most
recent formulations of the Commission’s recommendations in relation to the
linear-non-threshold (LNT) model: ‘The Commission considers that the continued
application of the LNT model. . .provides a prudent basis for practical purposes
of radiological protection. . .’ or: ‘The LNT model is not universally accepted
as biological truth, but rather, because we do not actually know what level of risk
is associated with very-low-dose exposure, it is considered to be a prudent
judgement for public policy aimed at avoiding unnecessary risk from exposure’
(ICRP, 2007a).
Prudence is essentially a practical virtue of making decisions about what is uncer-
tain. It is the virtue of deliberation and judgement in order to make choices without
full knowledge of the scope and consequences of our actions. It is also the ability to
choose and act on what is in our power to do and not to do. Prudence therefore has a
direct relationship to action and practice. As such, prudence is one of the core values
structuring the radiological protection system.
3.4. Justice
The principle of optimisation of protection requires that all exposures should be
kept as low as reasonably achievable, taking into account economic and societal
factors, using restrictions on individual exposures to reduce inequities in the distri-
bution of exposures among exposed groups. This is the cornerstone of the system. On
one hand, it is a principle of action that allows the practical implementation of
prudence. On the other hand, it allows the introduction of fairness in the distribution
of exposures among people exposed. This dimension of fairness, or equity as desig-
nated by the Commission, refers directly to the ethics of justice.
The principle of limitation of individual exposures requires that all individual
exposures do not exceed the protection criteria recommended by the Commission.
Like the principle of optimisation, it refers directly to the ethical values of prudence,
but mainly to justice by restricting the risk in an equal manner for a given exposure
situation and category of exposure.
It must be emphasised that the Commission never referred to justice explicitly,
neither in its latest recommendations nor in earlier recommendations. However, the
idea of limiting individual exposures in order to correct possible disparities in the
distribution of health damage due to radiation among exposed populations appeared
as early as Publication 26 (ICRP, 1977). In addition, Publication 60 was the first to
use the term ‘inequity’: ‘When the benefits and detriments do not have the same
302
distribution through the population, there is bound to be some inequity. Serious

inequity can be avoided by the attention paid to the protection of individuals’
(ICRP, 1991).
3.5. Dignity
Considering respect for human dignity as a founding value of the radiological
protection system is not obvious a priori. However, on closer examination, it can be
seen as running through the system early on. Dignity is an attribute of the human
condition; the idea that something is due to the human being because she/he is
human. This means that every individual deserves unconditional respect, whatever
her/his age, sex, health, social condition, ethnic origin, and religion.
Personal autonomy is the corollary of human dignity. This is the idea that indi-
viduals have the capacity to act freely and morally. The radiological protection
system respects and promotes the autonomy of people facing radioactivity in their
daily lives, whether at work, as a patient, or simply as citizens confronted with
situations such as radon in their homes (ICRP, 2014b) or radiation from security
screening in airports (ICRP, 2014a).
In radiological protection, the desire to respect dignity was first fostered in the
medical field in relation to protection in biomedical research in the early 1990s
(ICRP, 1992), and later on with the protection of patients (ICRP, 2007b) in connec-
tion with the principle of ‘informed consent’. In parallel, the value of dignity can be
found in relation to protection of the environment (ICRP, 2003), in which the con-
cept of ‘human dignity’ is associated with seeking a fair process of consensus devel-
opment for future generations.
More recently, respecting the dignity of individuals and preserving their auton-
omy have found expression in empathy for people living in post-accident areas or the
legacy sites. It is interesting to note that the promotion of dignity is also closely
related to a set of procedural ethical values – transparency, accountability, and
inclusiveness – which are linked to practical implementation of the system of radio-
logical protection. These aspects are developed in more detail in Chapter 4.
4. ETHICS IN IMPLEMENTATION OF THE RADIOLOGICAL

PROTECTION SYSTEM
For the practical implementation of its recommendations, the Commission sets
out a number of requirements relating to the procedural and organisational aspects
of radiological protection. It gives some indication of the type of infrastructures
and managerial arrangements to ensure efficient implementation of these require-
ments, but does not go into detail. It merely lays down some broad principles,
leaving other international organisations the task of developing them (IAEA,
2014). Three of these requirements deserve to be highlighted because they are
common to all exposure situations: accountability, transparency, and stakeholder
involvement. Ethically, they refer to the ethics of responsibility, procedural justice,
and human dignity, respectively.
303
4.1. Accountability and transparency

Accountability can be defined as the principle that people who are in charge to
make decisions must answer for their actions to all those who are likely to be affected
positively, as well as negatively, by these actions. This definition refers directly to the
ethics of responsibility, which states that everybody has to account for the foresee-
able consequences of her/his actions.
The concept of accountability appeared explicitly in Publication 60 (ICRP, 1991).
It says: ‘The first stage of responsibility is the duty to establish objectives, to provide
the measures needed to achieve those objectives, and to ensure that these measures
are properly carried out. This is essentially a prospective concept. Those bearing
responsibility should then have the authority to commit the resources needed to
meet their responsibilities. There is also a retrospective component of responsibility,
sometimes called accountability, that requires a continuing review of performance to
be made so that failures can be identified and steps taken to prevent recurrence.’ The
Commission also considered the accountability of the present generation towards the
future. This was mentioned explicitly in Publications 77, 81, 91 and 122 (ICRP, 1997,
1998, 2003, 2013) related to waste management and protection of the environment.
Transparency in relation to ethics refers to procedural justice, and concerns the
fairness of the process through which information is intentionally shared between
individuals and/or organisations. Transparency does not simply mean communica-
tion or consultation.
Regarding the radiological protection system, transparency on exposures and
protection actions for the workers has been integrated into ICRP recommendations
since the 1960s: ‘Workers should be suitably informed of the radiation hazard
entailed by their work and of the precautions to be taken’ (ICRP, 1966). Since
then, this requisite has been taken over and expanded in the subsequent recommen-
dations (ICRP, 1991, 2007a). It was not, however, until the 2000s that transparency
became a general principle, applicable not only to information about exposures
and protection actions, but also to the decision-making processes concerning the
choices of protective actions made by policy makers. Moreover, it was generalised
to all categories of exposure: occupational, medical, and members of the public.
Publication 101b (ICRP, 2006) was the first to introduce this, dedicated to the opti-
misation of protection and bearing the evocative subtitle ‘Broadening the process’.
Finally, in its latest recommendations, the Commission emphasised that ‘. . .scien-
tific estimations and value judgements should be made clear whenever possible, so as
to increase the transparency, and thus the understanding of how decisions have been
reached’ (ICRP, 2007a), which shows that recognising the requisite of transparency
should apply wherever value judgements are involved in the radiological protection
system.
4.2. Stakeholder involvement

In recent decades, stakeholder involvement has become an essential part of the
ethical framework in private and public sector organisations. Inclusiveness is one of
the essential procedural values, with transparency and accountability, to make
304
ethical decisions in organisations. This value has recently appeared in the field of
radiological protection, which has long been perceived as rather paternalistic by
some people.
Concretely, engaging stakeholders in radiological protection emerged in the late
1980s and early 1990s in the context of management of exposures in areas contami-
nated by the Chernobyl accident, and sites contaminated by past nuclear activities in
the USA (Beierle and Cayford, 2002; Lochard, 2004). Indeed, citizens found them-
selves involved in situations where they were confronted directly with radioactivity in
everyday life, and this posed new questions to which the system in place at the time
had difficulty in responding.
Stakeholder involvement was first introduced by ICRP in Publication 82: ‘Many
situations of prolonged exposure are integrated into the human habitat and the
Commission anticipates that the decision-making process will include the participa-
tion of relevant stakeholders rather than radiological protection specialists alone’
(ICRP, 1999). This became a requisite in Publication 103 in relation to the principle
of optimisation of protection: ‘It should also be noted that the Commission men-
tions, for the first time, the need to account for the views and concerns of stake-
holders when optimising protection’ (ICRP, 2007a).
Experience from Chernobyl and, more recently, Fukushima demonstrated that
empowerment of affected people helps them to regain confidence, to understand the
situation that they are confronted with, and to make informed decisions to act
accordingly (Lochard, 2013). In other words, engaging stakeholders is a way to
demonstrate respect, and also, in the case of post-accident situations, to help restore
their dignity.
In post-accident situations, it is the responsibility of experts and authorities to
ensure fair support to all different groups of affected individuals. Fairness in this
respect refers to the fundamental values of equity and transparency. This require-
ment to be treated fairly is a key condition for those concerned to enter into a
dialogue with the authorities, and have the objective to restore decent and sustain-
able living conditions. This dialogue with experts allows citizens to better understand
their individual situations, and to empower them to make informed decisions. This
empowerment process relies on the development of ‘a practical radiological protec-
tion culture’ among individuals and communities.
4.3. Reasonableness and tolerability

The problems of deciding which actions are required to ensure that exposures are
kept as low as reasonably achievable given the prevailing circumstances, and which
level of risk can be considered as tolerable for the exposed individuals, are central to
the radiological protection system. Both are consequences of the assumption that
there is no threshold for stochastic effects. Reasonableness is intimately linked to the
optimisation principle and tolerableness to the limitation principle, which together
aim to reflect prudence and justice in protection.
Regarding tolerability, in the 1970s, the Commission relied on the emerging
discipline of risk assessment to try to find a scientific rationality to the question
305
on a ‘non-acceptable risk level’. The Commission developed an approach based

primarily on comparing radiation risk with other similar risks in society to determine
the degree of tolerability of an exposure (or of the associated risk), thus allowing,
depending on the exposure situation, distinction between unacceptable and tolerable
levels of exposure (ICRP, 1991). This conceptual framework, although based on a
rational approach, does not escape the need to use value judgements to make a
decision about the tolerability of the risk. It is interesting to note that ultimately the
Commission defined tolerable exposures as those that are ‘not welcome but can be
reasonably tolerated’, thus making reasonableness a key component of tolerability.
The quest for reasonableness and tolerability are eminently ethical questions.
Decades of efforts to define these two concepts in a variety of recognised fields
have shown that scientific rationality is not sufficient. It is necessary to consider
factors beyond simply the dose, the cost, and risks to balance many societal and
ethical considerations, including common knowledge and the experiences accumu-
lated over time.
In practice, searching for reasonableness and tolerability is a permanent question
that depends on the prevailing circumstances to act wisely based on accumulated
knowledge and experiences [i.e. with the desire to do more good than harm (benefi-
cence/non-maleficence), to avoid unnecessary risk (prudence), to seek for fair distri-
bution of exposures (justice), and to treat people with respect (dignity)].
5. CONCLUSIONS
The ICRP system of radiological protection is based on three pillars: science,
ethics, and experience. As far as ethics is concerned, the system is rooted in
the three major theories of moral philosophy: deontological ethics, utilitarian
ethics, and virtue ethics; and they rely on four core ethical values: beneficence/
non-maleficence, prudence, justice, and dignity. Beneficence and non-maleficence
are directly related to the aim to prevent deterministic effects and to reduce the
risk of stochastic effects. Prudence allows taking account of uncertainties concerning
both the deterministic and stochastic effects of radiation on health. Justice is the way
to ensure social equity and fairness in decisions related to protection. Lastly, dignity
considers the respect that one must have for people. Over the past decade, the system
has also integrated procedural values such as accountability, transparency, and
stakeholder involvement, reflecting the importance of allocating responsibilities to
those involved in the radiological protection process, and to properly inform and
preserve the autonomy and dignity of the individuals potentially or actually exposed
to radiation.
The primary goal and responsibility of the Commission should be to develop the
science of radiological protection for the public benefit. Nevertheless, the
Commission thinks that by eliciting and diffusing the ethical values and related
principles that underpin the radiological protection system, both experts and the
public will undoubtedly gain a clearer view of the societal implications of its recom-
mendations. Just as science, ethics alone is unable to provide a definitive solution to
306
the questions and dilemmas generated by the use or presence of radiation. However,
ethics can certainly provide useful insights into the principles and philosophy of
radiological protection, and thus help the dialogue between experts and citizens.
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Focal role of tolerability and reasonableness
in the radiological protection system
T. Schneider, J. Lochard, L. Vaillant
Nuclear Evaluation Protection Centre, 28 rue de la Redoute, 92260 Fontenay-aux-Roses,
France; e-mail: thierry.schneider@cepn.asso.fr
Abstract–The concepts of tolerability and reasonableness are at the core of the International
Commission on Radiological Protection (ICRP) system of radiological protection.
Tolerability allows the definition of boundaries for implementing ICRP principles, while rea-
sonableness contributes to decisions regarding adequate levels of protection, taking into
account the prevailing circumstances. In the 1970s and 1980s, attempts to find theoretical
foundations in risk comparisons for tolerability and cost–benefit analysis for reasonableness
failed. In practice, the search for a rational basis for these concepts will never end. Making a
wise decision will always remain a matter of judgement and will depend on the circumstances
as well as the current knowledge and past experience. This paper discusses the constituents of
tolerability and reasonableness at the heart of the radiological protection system. It also
emphasises the increasing role of stakeholder engagement in the quest for tolerability and
reasonableness since Publication 103.
Keywords: Ethical values; Tolerability; Reasonableness; Stakeholder engagement
1. INTRODUCTION
Faced with ‘the existing uncertainty as to the dose–effect relationships for somatic
effects’, Publication 1 (ICRP, 1959) recommended ‘that all doses be kept as low as
practicable’, recognising that man could not avoid the use of ionising radiation
completely. Publication 1 concluded that it is necessary to limit doses so that the
risk ‘is not unacceptable to the individual and to the population at large’.
Protection.
309
It took several decades for the International Commission on Radiological

Protection (ICRP) to clarify what was meant by ‘as low as practicable’ and ‘not
unacceptable’, and the criteria on which to base the decisions about these intentions.
It is interesting to note that in its 1966 Recommendations, ICRP adopted the fol-
lowing statement introducing economic and social considerations: ‘As any exposure
may involve some degree of risk, the Commission recommends that any unnecessary
exposure be avoided, and that all doses be kept as low as readily achievable, eco-
nomic and social considerations being taken into account’ (ICRP, 1966).
These recommendations remain the core of the ICRP radiological protection
system today, and lead to a continuous posing of the following guiding questions:
Are individual exposures to radiation considered by society to be tolerable? Are all
exposures maintained as low as reasonably achievable under the prevailing
circumstances?
This paper discusses the main constituents of tolerability and reasonableness, as
well as their historical development in implementation of the radiological protection
system. It also emphasises the increasing role of stakeholder engagement in the quest
for tolerability and reasonableness since Publication 103 (ICRP, 2007).
2. SEARCH FOR TOLERABILITY

2.1. Tolerability and risk comparison
The first attempt from ICRP to address tolerability was made in 1977 in
Publication 26, which introduced a distinction between non-stochastic effects and
stochastic effects: ‘The aim of radiation protection should be to prevent detrimental
non-stochastic effects and to limit the probability of stochastic effects to levels
deemed to be acceptable’ (ICRP, 1977).
For non-stochastic effects, prevention consisted of adopting an exposure limit
below the threshold for occurrence of these effects: ‘The prevention of non-stochastic
effects would be achieved by setting dose-equivalent limits at sufficiently low values
so that no threshold dose would be reached, even following exposure for the whole of
the lifetime or for the total period of working life’ (ICRP, 1977).
For protection against stochastic effects, ICRP referred to the tolerability of
risk, and suggested defining occupational and public dose limits by comparison
with other risks. In this approach, an annual dose criterion (expressed in mSv y 1)
is derived by dividing an annual level of risk considered as tolerable in other
domains (expressed in individual risk of occurrence of fatal effect y 1) by
the radiation risk coefficient (expressed in risk of occurrence of radiation-induced
effects mSv 1).
In 1977, this level of tolerable risk was considered to be in the range of 10 4 y 1
for occupational exposure: ‘The Commission believes that for the foreseeable future
a valid method for judging the acceptability of the level of risk in radiation work is
by comparing this risk with that for other occupations recognized as having high
standards of safety, which are generally considered to be those in which the average
annual mortality due to occupational hazards does not exceed 10 4’ (ICRP, 1977).
310
For defining the annual dose criterion, ICRP introduced considerations on the
distribution of individual occupational exposures: ‘When making comparisons with
other safe occupations, it should be realised that the level of risk representative of a
safe occupation relates to the average risk for all workers in that occupation, the risk
for individual workers varying with their job and being distributed around this
average’ (ICRP, 1977).
This allowed the Commission to assume that: ‘In many cases of occupational
exposure where the Commission’s system of dose limitation has been applied, the
resultant annual average dose equivalent is no greater than one tenth of the annual
limit. Therefore the application of a dose-equivalent limit provides much better
protection for the average worker in the group than that corresponding to the
limit’ (ICRP, 1977).
These considerations led ICRP to adopt an annual dose limit of 50 mSv for
occupational exposure, assuming an average annual exposure of 5 mSv and
corresponding to a risk of 5 10 5 y 1 for fatal cancers and 2 10 5 y 1 for heredi-
tary effects, being in agreement with the tolerable risk level observed in other
occupations.
A similar approach was adopted for defining the annual dose limit for public
exposure. In that case, the Commission referred to risks observed in everyday life
that are considered to be tolerable: ‘From a review of available information related
to risks regularly accepted in everyday life, it can be concluded that the level of
acceptability for fatal risks to the general public is an order of magnitude lower
than for occupational risks. On this basis, a risk in the range of 10 6 to 10 5 y 1
would be likely to be acceptable to any individual member of the public’
(ICRP, 1977).
Based on the radiation detriment of 10 2 Sv 1, the annual radiation criterion
corresponding to an annual risk of 10 5 for an individual member of the public
corresponds broadly to 1 mSv y 1 of lifelong whole-body exposure. As for occupa-
tional exposures, the Commission took the dose distribution into account, and
adopted an annual dose limit of 5 mSv for public exposure, considering that it ‘is
likely to result in average equivalent dose of less than 0.5 mSv’ (ICRP, 1977).
2.2. Model of tolerability of risk

Referring to the work of the Royal Society (1983) and the Health and Safety
Executive (HSE, 1988) of Great Britain, the Commission introduced a conceptual
framework for the tolerability of risk in Publication 60 (ICRP, 1991), enabling deter-
mination of the degree of tolerability of an exposure (or of the associated risk) and
thus, depending on the exposure situation, distinction between unacceptable and
tolerable levels of exposure. This led the Commission to define three levels in this
model of tolerability: ‘. . . The Commission has found it useful to use three words to
indicate the degree of tolerability of an exposure (or risk). They are necessarily
subjective in character and must be interpreted in relation to the type and source
of the exposure under consideration. The first word is ‘unacceptable’, which is used
to indicate that the exposure would, in the Commission’s view, not be acceptable on
311
Fig. 1. The concept of the tolerability of risk in Publication 60 (ICRP, 1991). ALARA, as low
as reasonably achievable.
any reasonable basis in the normal operation of any practice of which the use was a
matter of choice. Such exposures might have to be accepted in abnormal situations,
such as those during accidents. Exposures that are not unacceptable are then sub-
divided into those that are ‘tolerable’, meaning that they are not welcome but can
reasonably be tolerated, and ‘acceptable’, meaning that they can be accepted without
further improvement, i.e. when the protection has been optimised . . .’ (ICRP, 1991).
Fig. 1 presents this model, where the dose limit is the boundary between ‘tolerable
risk’ and ‘unacceptable risk’ (but not the boundary between ‘safe’ and ‘dangerous’).
It is interesting to note that, ultimately, with the introduction of the model of
tolerability, the Commission defined tolerable exposures as those that are ‘not wel-
come but can be reasonably tolerated’, thus linking reasonableness with tolerability. It
is clearly stated that reaching the limit is not the ultimate aim of the protection system.
It is only considered as tolerable, and exposure should be further reduced taking into
account the application of the ‘as low as reasonably achievable’ (ALARA) principle:
‘The dose limit forms only a part of the system of protection aimed at achieving levels
of dose that are as low as reasonably achievable, economic and social factors being
taken into account. It is not to be seen as a target. It represents, in the Commission’s
view, the point at which regular, extended, deliberate, occupational exposure can
reasonably be regarded as only just tolerable’ (ICRP, 1991).
Associated with this model, the Commission also introduced an evolution in the
calculation of the radiation detriment which is no more restricted to the occurrence
of radiation-induced fatal effects, but also considers the reduction of life expectancy,
the incidence of non-fatal cancer, and hereditary effects. In this context, the
approach adopted for selecting the annual dose limit refers to a value that ‘gives
rise to a combination of consequences that is judged to be just short of unacceptable,
i.e. just tolerable . . .’ (ICRP, 1991).
The Commission clearly acknowledged the introduction of value judgements
for selecting the annual dose limit, explaining that it allows a series of
312
‘interrelated factors’, called ‘attributes’, to be considered. The following factors were

considered:
. the lifetime attributable probability of death;

. the time lost if the attributable death occurs;
. the reduction of life expectancy (a combination of the first two attributes);
. the annual distribution of the attributable probability of death; and
. the increase in the age-specific mortality rate, i.e. in the probability of dying in a
year, at any age, conditional on reaching that age.
Based on this approach, lifetime radiation-induced detriments for occupational

exposures were calculated for exposure to 10, 20, 30 and 50 mSv y 1, and compared.
A dose limit of 20 mSv y 1, averaged over 5 y (100 mSv in 5 y, with the provision that
the dose should not exceed 50 mSv in 1 y), was chosen as it gives sufficient protection
and some flexibility for the worker employment while adjusting the exposure over a
period of 5 y.
A different approach was adopted for public exposure, based on comparison of
the variations in doses occurring from natural sources: ‘The approach is to base the
judgement on the variations in the existing level of dose from natural sources. This
natural background may not be harmless, but it makes only a small contribution to
the health detriment which society experiences. It may not be welcome, but the
variations from place to place . . . can hardly be called unacceptable’ (ICRP, 1991).
As the annual effective dose from natural sources (excluding radon) is approxi-
mately 1 mSv, the Commission recommended 1 mSv y 1 as the dose limit for mem-
bers of the public, with some flexibility under special circumstances.
2.3. Exposure situations and attitudes towards risk

One of the major evolutions of ICRP recommendations in Publication 103 (ICRP,
2007) relies on the focus on the three exposure situations (i.e. existing, emergency,
and planned) for implementing the system of radiological protection. The reference
to tolerability is no longer based on quantitative values of risk, but is considered
specifically in each type of exposure situation, taking into account the various char-
acteristics of the situation and not only the risk associated with the exposure.
In terms of risk, ICRP made a general statement to be applied to any exposure
situation and referring to the protection towards health effects: ‘At doses higher than
100 mSv, there is an increased likelihood of deterministic effects and a significant risk
of cancer. For this reason the Commission considers that the maximum value for a
reference level is 100 mSv incurred either acutely or in a year’ (ICRP, 2007).
Instead of adopting a generic level of tolerability, the Commission proposed a
more pragmatic approach, including various components for selecting dose con-
straints or reference levels according to values for each specific exposure situation:
‘For the selection of an appropriate value for the dose constraint or the reference
level, one should consider the relevant exposure situation in terms of the nature of
the exposure, the benefits from the exposure situation to individuals and
313
Fig. 2. A possible adaptation of the tolerability of risk model to Publication 103 (ICRP, 2007)
framework. y, year.
society, . . . and the practicability of reducing or preventing the exposures’ (ICRP,

2007).
For this purpose, the Commission proposed three bands of dose constraints and
reference levels: greater than 20 mSv y 1 to 100 mSv (acute or in 1 y), greater than 1
to 20 mSv y 1, and 1 mSv y 1 or less [Table 5 in Publication 103 (ICRP, 2007)]. There
is no direct reference to tolerability of risk in establishing these bands, but it is
possible to propose an adaptation of the tolerability of risk model to be applied to
the exposure situations as defined in Publication 103 (ICRP, 2007). This proposal is
presented in Fig. 2.
As mentioned above, the reflection on tolerability moved progressively from the
quest for a level of risk considered to be tolerable towards considerations on the tol-
erability of the exposure situations (source-related approach). In this context, there is
no more quest for a ‘universal’ level of risk allowing judgement of the tolerability of the
risk associated with an exposure. Thus, the definition of a dosimetric criterion (refer-
ence level or dose constraint) is linked intrinsically to implementation of the protection
system and the optimisation principle. This criterion depends on the exposure situation
considered, and has to be defined with the involvement of the stakeholders. It is of note,
however, that the Commission maintains the dose limits to be applied for protecting
individuals from all regulated sources in planned exposure situations.
The emphasis on tolerability of the exposure situation, an extension of the model
of tolerability, has been proposed by introducing further considerations on individ-
ual and collective attitudes towards risk (Lochard, 2015). Three main attitudes can
be considered, depending on the level of risk: quietude/peacefulness, vigilance, and
reaction. Some components of each attitude are suggested below.
. Quietude/peacefulness: in everyday life, people forget the risk if they are confident
in the arrangements put in place to control it, and they trust the institutions and
314
people responsible for this control. This is typically the case for public exposures
in planned exposure situations that are completely under control.
. Vigilance: if people are suspicious that something may go wrong, they pay atten-
tion to the situation, and in the proven presence of a risk, they do what is rea-
sonably achievable to maintain or mitigate it to a tolerable level. This is typical of
occupational exposures in planned exposure situations for which workers must
exercise constant vigilance. This is also true, to a lesser extent, for public exposure
in existing exposure situations for which exposures must previously be charac-
terised to be controlled.
. Reaction: when facing an imminent danger or being involved in an emergency,
people act urgently and in a timely manner to protect themselves and their loved
ones, usually demonstrating solidarity with other affected people. This is typically
the case in urgent exposure situations resulting from the loss of control of a
source, such as a nuclear accident, or from any unexpected situation.
This leads to the proposal of the following model (Fig. 3), combining the toler-
ability of risk with attitudes towards risk where the tolerability of risk depends on the
need for action from the involved individuals.
3. SEARCH FOR REASONABLENESS

As mentioned above, in the 1950s, the Commission introduced the search for
reducing exposure as a cornerstone of its recommendations to deal with protection
against stochastic effects: ‘Due to the uncertainty of the dose–effect relationship for
stochastic effects, the use of a limit was no longer a guarantee of the absence of risk’.
This led the Commission to adopt a prudent attitude and to recommend ‘that every
effort be made to reduce exposures to all types of ionising radiation to the lowest
possible level’ (ICRP, 1955). This position facilitated the Commission’s introduction
of the optimisation principle two decades later (ICRP, 2006).
Fig. 3. A proposal to combine the tolerability of risk model and attitudes towards risk to
Publication 103 (ICRP, 2007) framework. y, year.
315
It is interesting to review the evolution of the optimisation principle over the

past decades, highlighting the introduction of economic and societal considerations,
and the place dedicated to reasonableness. As detailed in Publication 101 (ICRP,
2006), the formulation of the optimisation principle evolved as follows:
. to reduce exposures to the lowest possible level (ICRP, 1955);

. to keep exposures as low as practicable (ICRP, 1959);
. to keep exposures as low as readily achievable, economic and social consider-
ations being taken into account (ICRP, 1966);
. to keep exposures as low as reasonably achievable, economic and social consid-
erations being taken into account (ICRP, 1973);
. to keep exposures as low as reasonably achievable, economic and social factors
being taken into account (ICRP, 1977); and
. to keep exposures as low as reasonably achievable, economic and societal factors
being taken into account (ICRP, 2007).
3.1. Introduction of cost–benefit analysis

Publication 22 (ICRP, 1973) was the first report devoted entirely to the elucidation
of the optimisation principle. It introduced the methodology of cost–benefit analysis
as an approach to determine ‘the acceptability of levels of exposure to radiation
proposed for a given activity . . .’. This methodology has played a leading role in
the structuring of the practical implementation of the principle. The main objective
of this methodology is to balance the risk associated with exposure (expressed in
terms of radiation detriment) with the benefit provided by the activities or the situ-
ation for a given group of population: ‘It is then helpful to express the population
dose not only in man-rems, but also in social and economic terms, for example, in
terms of detriment or monetary units, so that the advantage of a reduction in col-
lective dose can be compared directly with the detriment or cost of achieving this
reduction’ (ICRP, 1973).
In addition, in Publication 37, ICRP (1983) introduced further considerations on
social aspects incorporated in monetary terms with the so-called monetary value of
the person-Sv: ‘. . . in some complex situations it may be desirable to add the costs
associated with additional components of detriment to take account of non-objective
features and of non-health detriments’ (ICRP, 1983).
Fig. 4 describes the selection of the optimum level of protection on the basis of the
cost–benefit analysis.
In the 1980s and 1990s, economic developments led the monetary value of the
person-Sv to be defined as the probability of occurrence of a radiation-induced
health effect associated with exposure to ionising radiation, multiplied by the mon-
etary value attributed to that health effect, generally expressed as the number of years
of life lost. Thus, the monetary value corresponds to what the decision-maker is
willing to pay to avoid one unit of collective dose (Schneider et al., 1997).
316
Fig. 4. Cost–benefit analysis for selecting the optimum level of protection.
It has to be acknowledged that this approach has been largely implemented in

decision-making processes for the selection of investments in radiological protection
in the workplace, for which it is generally possible to quantify all the components of
the costs and the benefits. Fig. 5 gives examples of monetary values adopted in the
nuclear industry. Its application was more difficult for evaluation of the benefits and
detriments for public exposures, notably for public exposures associated with the
discharges of nuclear installations, and particularly for exposures of far-future gen-
erations. The weak point here is difficulty in deciding upon the boundaries of the
detriment to be considered.
3.2. From economic rationality to stakeholder involvement

Despite all efforts to anchor the optimisation of protection in the rationality of
classical economics, the process to maintain levels of exposure as low as reasonably
achievable remains essentially a matter of judgement, mixing quantitative and quali-
tative values, and field experience. This led to the successive incorporation into the
optimisation process of components developed in the field of management (ICRP,
1990), and approaches calling on the direct involvement of all parties involved in the
implementation of protection (ICRP, 2006).
317
Fig. 5. Example of monetary values adopted by utilities. Data from ISOE (2012).
In Publication 55 (ICRP, 1990), in order to incorporate the various components

(referred to as ‘attributes’) in the decision-making process and to propose a struc-
tured approach for implementation of the optimisation principle, the Commission
described the steps of the ALARA process and proposed to replace the cost–benefit
analysis by a multi-attribute analysis for complex situations. The Commission also
emphasised the usefulness for ensuring the traceability and transparency of the pro-
cess: ‘A structured approach to optimization of protection is important to ensure
that no important aspects are overlooked and to record the analysis for information
and for assessment by others’ (ICRP, 1990).
From the late 1990s, the search for reasonableness led to the development
of stakeholder involvement approaches for the selection of protective actions
to better cope with the specificities of each exposure situation. For this purpose,
the key challenges are to develop evaluation procedures involving stakeholders,
and also to favour the development of the radiological protection culture for
allowing deliberation on what they consider to be reasonable levels of exposures
given the prevailing circumstances. Such procedures have been implemented suc-
cessfully in the case of post-accident situations or exposure to radon. It should
be stressed that such approaches need to foster the emergence of informed
and advised stakeholders, in order to engage them in dialogue to assess the benefits
and drawbacks of various possible protection options for their own protection and
well-being.
318
Stakeholder involvement was introduced clearly by the Commission in Publication

101 (ICRP, 2006), with the aim of broadening the process of optimisation of radio-
logical protection: ‘The basic definition given in Publication 60 (ICRP, 1991) remains
valid, but the way in which it should be implemented is now viewed as a broader
process reflecting the increasing role of individual equity, safety culture, and stake-
holder involvement in our modern societies . . .’ (ICRP, 2006).
From this perspective, Publication 101 (ICRP, 2006) highlighted the main societal
considerations and values to be addressed in the stakeholder involvement process:
equity; ability to control (measurement, health surveillance, etc.); sustainability;
intergenerational considerations; individual benefit; social benefit; level of informa-
tion/knowledge held by those exposed; and social trust.
3.3. Constituents of reasonableness

In its recommendations, ICRP refers to reasonableness in the sense of discern-
ment, judgement, common sense, and wisdom. It also refers to the faculty of thinking
and allowing the application of judgement to action. The search for reasonableness
requires both understanding of the situation and reference to knowledge and experi-
ence in the assessment of what is considered acceptable in view of individual and
collective values.
The experience of implementation of the ALARA principle shows that the deci-
sion cannot be driven solely by theoretical knowledge, and that it is inseparable from
the establishment of a deliberative process to determine what to do for the protection
of people based on the specificities/characteristics of the situation.
The following paragraphs emphasise some key components of reasonableness in a
broader perspective.
Reasonableness refers to reciprocity in the sense of a situation or a relationship in
which two or more people or groups agree to do something similar for each other.
It relies on the development of a reasoning accessible to others, and the promotion
of fair co-operation. Reasonableness is clearly linked to the ethical values of justice
and equity.
Reasonableness is considered as an expression of wisdom, defined as ‘the quality
of having experience, knowledge, and good judgement’ (Oxford Dictionary). As a
virtue, wisdom is the disposition to behave and act with the highest degree of ade-
quacy under any given circumstances. In its popular sense, wisdom is attributed to a
person who takes reasonable decisions and acts accordingly.
4. CONCLUSIONS
Tolerability allows one to define boundaries for the implementation of ICRP
principles, while reasonableness contributes to finding an adequate level of protec-
tion, taking into account economic and societal aspects given the prevailing circum-
stances. Tolerability is intimately linked with the limitation principle, and
reasonableness is linked with the optimisation principle, which together aim to reflect
the ethical values of prudence and justice in protection (Lochard, 2016).
319
In the 1970s and 1980s, attempts to find rational and objective bases for what is
tolerable, failed to provide clear-cut answers for implementation of the system of
In practice, searching for tolerability and reasonableness are permanent question-
ing processes that depend on the prevailing circumstances in order to act wisely
based on accumulated knowledge and experience (i.e. with the desire to do more
good than harm, to avoid unnecessary risk, to seek fair distribution of exposures,
and to treat people with respect).
These processes can be supported by quantitative methods, but definitely remain
deliberative in nature. It is important to keep in mind that reasonableness and tol-
erability are intrinsically related, as quoted by the International Tribunal of the Law
of the Sea (2003): ‘. . . the very multi-faceted concept of reasonableness should, as
relevant, be patently and fully grounded in such synonymous notions as proportion-
ality, balance, fairness, moderateness, consistency, suitability, tolerableness and
absence of excessiveness’.
REFERENCES
HSE, 1988. The Tolerability of Risks from Nuclear Power Stations. Health and Safety
Executive, Bootle.
Br. J. Radiol. Suppl. 6.
ICRP, 1973. Implications of Commission Recommendations that doses be kept as low as
readily achievable. ICRP Publication 22. Pergamon Press, Oxford.
ICRP, 1983. Cost–benefit analysis in the optimization of radiation protection. ICRP
ICRP, 1990. Optimization and decision making in radiological protection. ICRP Publication
55. Ann. ICRP 20(1).
ICRP, 2006. The optimisation of radiological protection – broadening the process. ICRP
International Tribunal of the Law of the Sea, 2003. Reports of judgments, advisory opinions
and orders. Vol. 4. Kluwer Law International, The Hague.
ISOE, 2012. Man-sievert Monetary Value Survey. ISOE Information Sheet. No. 55.
Information System on Occupational Exposure. Available at: http://www.isoe-networ-
k.net/index.php/component/docman/cat_view/120-etc-information-sheets.html (last
accessed 12 April 2016).
320
Lochard, J., 2015. Application of the Commission’s recommendations: the 2013–2017

Committee 4 programme of work. Ann. ICRP 44(1S), 33–46.
Lochard, J., 2016. First Thomas S. Tenforde Topical Lecture: The ethics of radiological pro-
tection. Health Phys. 110, 201–210.
Royal Society, 1983. Risk Assessment. Report of a Royal Society study. Royal Society,
London.
Schneider, T., Schieber, C., Eeckhoudt, L., Gollier, C., 1997. Economics of radiation protec-
tion: equity considerations. Theory Decis. 43, 241–251.
321
Ethics of radiological risk governance: justice
of justification as a central concern*
G. Meskens
Science and Technology Studies Unit, SCKCEN, B2400 Mol, Belgium and Centre
for Ethics and Value Inquiry, Faculty of Arts and Philosophy, University of Ghent, Belgium;
e-mail: gaston.meskens@sckcen.be
Abstract–Due to the specific character of the radiological risk, judgements on whether the use of
nuclear technology would be justified in society have to consider knowledge-related uncertainties
and value pluralism. The justice of justification not only informs the right of the potentially
affected to participate in decision making, but also implies the responsibility of concerned actors
to give account of the way they rationalise their own position, interests, hopes, hypotheses,
beliefs, and concerns in knowledge generation and decision making. This paper characterises
the evaluation of whether the use of nuclear technology would be justified in society as a ‘complex
social problem’, and reflects on what it would imply to deal with its complexity fairly. Based on
this assessment, the paper proposes ‘reflexivity’ and ‘intellectual solidarity’ as ethical attitudes or
virtues for all concerned actors, to be understood from a specific ‘ethics of care’ perspective
‘bound in complexity’. Consequently, it argues that there is a need for an ‘interactive’ under-
standing of ethics in order to give ethical attitudes or virtues a practical meaning in a socio-
political context, and draws conclusions for the case of radiological risk governance.
Keywords: Ethics; Risk governance; Justification; Complexity
1. INTRODUCTION
What do we talk about when we talk about the risk that comes with the use of
nuclear energy as an energy technology? In the general case of evaluating a practice
or conduct that involves a health risk, we obviously need knowledge about the nature
of cause and effect, and the probability that an adverse effect will occur. However,
Protection.
322
similar to the case of many other risk-inherent technologies with a wider impact on
society (such as the use of fossil fuels, food preservatives, or genetically modified
organisms), assessment of the risk of nuclear energy, in the sense of the evaluation of
its acceptability as a possible threat to our health and the environment, is compli-
cated in two ways. First, there is the fact that, in judging whether the risk is accept-
able in view of the anticipated ‘benefits’, one has to deal with uncertainty due to
incomplete and speculative knowledge. Second, there is the fact that evaluations of
nuclear risk are also made with reference to the existence of alternative energy
technologies, or with reference to more ‘fundamental’ values such as the value of
nature. These will be commented on briefly below1.
In short, the elements of knowledge-related uncertainty, or the ‘epistemic com-
plexity’, to take into account can be summarised as follows.
. The possibility of a nuclear accident [due to technology failure, human error, force
majeure (e.g. the earthquake and tsunami in Fukushima), or a combination of
those factors].
. The lack of ultimate control of the future behaviour or integrity of a nuclear waste
disposal facility.
. Due to the stochastic nature of low dose effects and the fact that health effects
such as leukaemia and solid cancer can also have other causes, the prediction of
radiation health effects at low doses remains a complex endeavour. What is
known of low dose effects can be summarised in three steps:
1. There is evidence of health effects below 100 mSv, which means that it can be
said with certainty that the ‘so-called’ 100-mSv-threshold hypothesis is false.
For an in-depth analysis, see Smeesters (2014).
2. Current understanding of mechanisms and quantitative data on dose and
time–dose relationships supports the linear-non-threshold (LNT) hypothesis
(ICRP, 2005). This insight supports the idea that the LNT hypothesis that
was first introduced based on the precautionary principle is the correct
hypothesis to maintain.
3. Scientific discussions are ongoing with regard to possible concrete health
effects of low doses in concrete situations, such as the scientific discussion
on the INWORKS epidemiological study (e.g. Doss, 2015; Leuraud et al.,
2015; Richardson et al., 2015), and the scientific discussion on the possibility
of thyroid cancer in children in Fukushima (Kageyama, 2015; Tsuda et al.,
2016). While serious scientific discussions are taking place, it has to be
acknowledged that there is no definite scientific conclusion on the actual
manifestation and predictability of these concrete health effects in these con-
crete situations, which does not mean that specific indications, even if they
are preliminary, cannot be used as factors to consider in the evaluation of the
acceptability of the concrete risk.
1
These issues are elaborated on in more detail in Meskens (2013).
323
Of course, assessment of the risk of nuclear energy is not a pure knowledge

problem. Evaluation of whether a nuclear risk would be socially acceptable is also
influenced by ‘external’ value references. These values could serve ‘in favour of’ or
‘against’ nuclear energy, and include:
. the value of nuclear energy as a ‘low-carbon’ energy technology in energy policy

concerned with climate change;
. the fact that nuclear technology can be used to develop nuclear weapons;
. the vulnerability of nuclear installations to terrorist attacks;
. the value of alternative energy technologies (taking into account the benefits and
potential adverse consequences of their use);
. the value of nature (‘one should not mess around with nature’ – an argument that,
in the context of climate change discussions, is now used as well against nuclear
energy as in its favour); and
. more general values such as ‘sustainability’, ‘justice’, ‘precaution’ and ‘freedom’
(the last in the sense of possibility of self-determination in caring for one’s own
health or the environment).
Last but not least, it is known that evaluations of the acceptability of nuclear risk
(taking into account knowledge-related uncertainty and external value references)
are particularly complicated as they now unavoidably take place in a sociopolitical
context that is marked by controversy around the nuclear issue as such. Also, given
that one cannot ‘escape’ history or make abstraction of it, this controversy is trig-
gered by:
. the accidents that happened;

. the link with the military context;
. the ‘democratic deficit’ with respect to the way in which nuclear energy has been
introduced, and power plant and waste disposal siting has been undertaken in the
past (and still undertaken at the present time); and
. the fact that nuclear energy policy is associated with neoliberal global strategies of
profit and power driven by large corporations and their political supporters.
Therefore, taking into account the existence of these external value references and
the context of controversy, one has to accept that even if we would all agree on the
available knowledge to evaluate a nuclear risk, opinions would probably still differ
about its acceptability. In these cases of ‘value pluralism’ or ‘moral pluralism’, sci-
ence may thus inform us (to a certain extent) about the technical and societal aspects
of options, but it cannot always instruct or clarify the choice to make.
The above characterisation of the risk of nuclear energy may support the idea that
there is no overall evidence that would unequivocally lead to consensus on the
unacceptability of the risk of nuclear energy (in view of the potential adverse con-
sequences), nor on its acceptability (in view of its benefit as a low-carbon energy
technology). People may have informed valuable and serene opinions in favour of or
324
against nuclear energy, but none of the two camps can ‘prove’ that the other is
wrong. As a consequence, as with many other practices that come with a collective
health risk, fairness with respect to justifying or rejecting the risk of nuclear energy as
such can only relate to how we make sense of it in knowledge generation and decision
making. This brings us to a reflection on the idea of ‘fair risk governance’ and how to
understand it from the perspective of ethics.
2. ETHICS, FAIRNESS, AND TRUST: THE IDEA

OF FAIR RISK GOVERNANCE
What do we talk about when we talk about ethics? Ethics is about being
concerned with questions of right and wrong, but there are different ‘levels’ of
thinking about these questions. Philosophy identifies ‘meta-ethics’ as that discipline
or perspective that deals with concepts of right and wrong (What is rightness? What
is goodness?). Next to that, philosophers speak of ‘normative ethics’ as the discipline
or perspective that considers the criteria that can be used to evaluate a specific
practice or conduct. In that sense, normative ethics thus refers to ‘what ought to
be’ in the absence of ‘evidence’ that would facilitate straightforward judgement,
consensus, and consequent action. That absence of evidence can relate to the know-
ledge as well as to the values we may want to use to evaluate a specific practice or
conduct.
Chapter 1 indicated which factors of uncertainty must be taken into account in
assessment of the risk of nuclear energy, but also which external value references may
be taken into account in that evaluation. Similar to the case of nuclear energy, one
may understand that the evaluation of other risky practices may also be influenced
by moral pluralism, in the sense that judging whether a practice would eventually be
acceptable can also be done with reference to ‘external’ values. If we thus consider
that an evaluation of the acceptability of a risk-inherent practice in general depends
on knowledge-based opinions and values-based opinions, we can then construct a
simple picture of four distinct cases as presented in Table 1. The table may be over-
simplified in the sense that one cannot always ‘separate’ knowledge from values (in
risk evaluation, specific knowledge may influence the importance of specific values,
and vice versa as the way it is used in evaluation), but it can be used as a meaningful
tool to determine key concepts of fairness of risk assessment and governance, and to
understand differences between risky practices in that respect.
The context of this text does not allow broad elaboration on Table 1, but it shows
primarily that the risks of bungee jumping, mobile phones, or nuclear energy are
incomparable, as the evaluation of their acceptability depends in different ways on
knowledge and values.
The bungee jumper will not ask to see the test procedures of the rope before
making a jump. In general, the jumper trusts that these ropes will be safe, but,
more importantly, he/she makes the decision to jump on a voluntary basis.
Despite the fact that more than one million people die each year in car accidents
325
Table 1. Justifying risk – mapping the field.

Values-based assessment
Risk-inherent practice Dissent Consent

acceptable? ‘moral pluralism’ ‘shared values’
Knowledge- Uncertainty Governance by deliberation Governance by pacification

based (incomplete and Examples Examples
assessment speculative Nuclear energy Medical applications of radioactivity
knowledge) (Fossil fuels) Mobile phones
Fairness Smoking
Caring for ‘intellectual solidarity’ Fairness
in dealing with incomplete Caring for ‘intellectual solidarity’
and speculative knowledge in dealing with incomplete
and moral pluralism and speculative knowledge
# #
Key concepts Key concepts
Precaution Precaution
Informed consent Informed consent
Transparency Transparency
Confrontation of rationales Confrontation of rationales
Accountability to next generations
Consent Governance by negotiation Governance by ‘simple’ regulation
(consensus on Examples Examples
‘evidence’) (Fossil fuels) Traffic
Fairness Bungee jumping
Caring for ‘intellectual solidarity’ Fairness
in dealing with moral pluralism Caring for ‘intellectual solidarity’
# in our behaviour
Key concepts towards each other
Precaution #
Informed consent Key concepts
Confrontation of rationales Precaution
Accountability to next Informed consent
generations Fair play
Adapted from Hisschemöller and Hoppe (1995).
globally,2 no reasonable person is advocating a global car ban. Similar to bungee

jumping, the key concepts of fairness related to taking the risk are precaution,
informed consent, and fair play. In the case of driving a car, precaution not only
refers to protection measures such as air bags, but also to the value of driving
responsibly. In that case, fair play refers to the idea that one can only hope that
other drivers also drive responsibly.
Evaluation of the risk that comes with smoking or the use of mobile phones is
what one could call a ‘semi-structured’ or ‘moderately structured’ problem
(Hisschemöller and Hoppe, 1995) that can be handled on the basis of ‘pacification’.
2
The World Health Organization Global Status Report on Road Safety 2013 indicates that, worldwide,
the total number of road traffic deaths remains unacceptably high at 1.24 million y1 (WHO, 2015a).
326
The reason is that, despite uncertainties that complicate the assessment of those
specific risks,3 people agree to take or allow them on the basis of ‘shared values’.
Shared values are thus about those situations wherein relevant but incommensurable
values may still exist, but in which we also have the feeling that we all accept or allow a
specific ‘risky’ practice in light of a ‘higher’ shared value. This shared value can be a
shared practical benefit (such as in the case of mobile phones), but also a specific
freedom of choice ‘to hurt yourself’ in view of a personal benefit, taking into account
that this behaviour should not harm others (such as in the case of smoking). With
reference to Table 1, one could say that fairness is thus the way we care for ‘intellec-
tual solidarity’ in dealing with incomplete and speculative knowledge, and the key
concepts of fairness in this sense are precaution, informed consent, transparency (with
respect to what we know and do not know, and with respect to how we construct our
knowledge), and our joint preparedness to give account of the rationales we use to
defend our interests (‘stakes’). Due to the uncertainties that complicate the assessment,
protection measures are essentially inspired on and supported by the precautionary
principle. In the case of mobile phones, this principle translates as the recommenda-
tion to use them in a ‘moderate way’ and the recommendation to limit the use by
children. For smoking, it translates as anti-smoking campaigns towards (potential)
smokers (with special attention to young people), and as measures to protect those
‘passively involved’ (the passive smoker). Given the awareness of the addictive char-
acter of smoking, additional measures are gradually adopted to ‘assist’ smokers who
want to quit. In a similar sense, evaluating the risk coming with the use of radiation in
a medical context can also be called ‘governance by pacification’. The value of
informed consent remains central and also applies to the close relations of the patient
(family members), but essentially all agree that the patient takes the risk of a delayed
cancer (due to diagnosis or therapy) in light of a ‘higher’ benefit (information about a
health condition or the hope that the actual cancer will be cured, respectively).
In contrast to complex problems that are handled on the basis of ‘pacification’,
justifying or rejecting nuclear energy seems to be an unstructured problem that will
always need deliberation. Not only do we need to deliberate the available knowledge
and its interpretation, but deliberation will also need to take into account the various
‘external’ values that people find relevant to judge this case, and the arguments that
they construct on the basis of these values. Therefore, the fairness of evaluation
relates to ‘intellectual solidarity’ in dealing with incomplete and speculative
3
With regard to mobile phone use, the World Health Organization (WHO, 2014) states that ‘The elec-
tromagnetic fields produced by mobile phones are classified by the International Agency for Research on
Cancer as possibly carcinogenic to humans’. With respect to smoking, of course there is the known
relation with lung cancer, but the lack of evidence concerns the delayed effect and, especially, the fact
that there is contingency in play (there is no evidence, to date, to explain why some individuals appear to
be more susceptible than others). In addition, while WHO (2015b) clearly states that tobacco kills up to
half of its users, these statistics are not seen to ‘happen’ in our near social environment. To put it more
provocatively, our shared values support the idea that we should protect non-smokers from smokers, but
also the idea that we still live in a free and democratic society where people have ‘the right’ to smoke
themselves to death. It is true that the addictive character of smoking is influencing ‘the freedom of
choice’, but addicted smokers can always decide for themselves to seek medical and social assistance in
their attempt to quit smoking.
327
knowledge, but also in dealing with moral pluralism. The key criteria are again pre-
caution, informed consent, transparency, and (the preparedness for a) confrontation
of rationales, now completed with a sense of accountability towards those who cannot
be involved in the evaluation (next generations). In comparison with nuclear energy,
the evaluation of the risk that comes with the use of fossil fuels is a complex problem
that, in principle, can be treated on the basis of ‘consent on causality’. The
Intergovernmental Panel on Climate Change (2014) states in its Fifth Assessment
Report that ‘. . . human influence on the climate system is clear. . . and that. . . warming
of the climate system is unequivocal, and since the 1950s, many of the observed
changes are unprecedented over decades to millennia. The atmosphere and ocean
have warmed, the amounts of snow and ice have diminished, and sea level has
risen. . .’. Despite this evidence of a ‘slowly emerging adverse effect’, the assessment
of whether concrete draughts or storms can be contributed to human-induced climate
change, or what the concrete effect of specific mitigation or adaptation policies would
be remains troubled by knowledge-related uncertainty. Therefore, the use of fossil
fuels is a complex problem that requires ‘deliberation’, and the key concepts of fairness
remain the same as for the evaluation of nuclear energy: precaution, informed consent,
transparency, confrontation of rationales, and accountability to next generations.
The discussion of Table 1 allows three reflections related to ethics, fairness, and
trust to be made in relation to risk governance. Obviously, these reflections are based
on the author’s specific understanding of risk assessment in relation to fairness, and
are therefore presented as a list of ideas that are open to discussion.
I. The assessment of what is an acceptable health risk for society is not a matter
of science; it is a matter of justice.
I.a. Health risk is not a mathematical formula: it is a potential harm that you
cannot completely know and cannot fully control, but that you eventually
want to face in light of a specific benefit. People will accept a risk that they
cannot completely know and that they cannot fully control simply when
they trust that its justification is marked by fairness. Fairness relates pri-
marily to the value of precaution, but also to the possibility of self-deter-
mination (‘informed consent’).
I.b. Despite the differences between the cases discussed, they can all be char-
acterised in relation to one idea with respect to self-determination: the idea
that ‘connecting’ risk and fairness is about finding ground between ensuring
people the right to be protected on one hand, and the right to be responsible
themselves on the other hand. The right to be responsible leans thereby on
the prime criterion of the right to have information about the risk and the
possibility of self-determination based on that information, but one has to
consider that, in a society of capable citizens, self-determination with
respect to risk taking can have two opposing meanings: it can translate
as the right to co-decide in the case of a collective health risk (as in the
case of nuclear energy), but also as the freedom to hurt yourself in the case
of an individual health risk (as in the case of smoking or bungee jumping).
328
I.c. For any health risk that comes with technological, industrial, or medical
practices and that has a wider impact on society, ‘the right to be responsible’
equals ‘the right to co-decide’. Enabling this right is a corollary of justice.
II. Societal trust in the assessment of what is an (un)acceptable collective health

risk for society should be generated ‘by method instead of proof’.
II.a. With respect to nuclear energy, no scientific or political authority can deter-
mine alone whether the risk would be an acceptable collective health risk
for society. Good science and engineering, open and transparent commu-
nication, and the ‘promises’ of a responsible safety and security culture
would be necessary conditions, but they can never generate societal trust
in themselves. The reason is that there will always be essential factors
beyond full control: nature, time, human error, misuse of technology, etc.
II.b. The fact that people take specific risks in a voluntary way and often based
on limited information may not be used as an argument to impose risks on
them that might be characterised as ‘comparable’ or even less dangerous.
That principle counts to the extreme. For example:
– the fact that the risk of developing cancer from smoking may be ‘higher’
than that from low-level radiation may not be used as an excuse to impose a
radiation risk on people; and
– the fact that a nuclear worker may voluntarily accept an accumulated
occupational dose of 20 mSv y1 may not be used as an argument to justify
a citizen’s dose of 1 mSv y1 originating from a nuclear technology appli-
cation without asking for his/her informed consent.
II.c. Fair risk governance is risk governance of which the method of knowledge
generation and decision making is trusted as fair by society. When the
method is trusted as fair, that risk governance also has the potential to
be effective, as the decision making will also be trusted as fair by those who
would have preferred another outcome.
III. Dealing with the complexity of risk assessment and justification in a fair way
requires new governance methods.
III.a. Is fair risk governance with respect to collective health risks as characterised
above possible today? In other words, do the methods we use to produce
policy supportive knowledge and to make political decisions have the poten-
tial to enable ‘the right to co-decide’ (as a principle of justice) and to generate
trust by their method instead of by their potential or promised outcome? The
short answer is no. Meskens (2015a) argued in depth why and how the ‘gov-
ernance methods’ we use today to make sense of the complexity of assess-
ment and justification of typical collective health risks remain to be driven by
the doctrine of scientific truth and the strategies of political ‘positionism’ and
economic profit. As the context of this text does not allow deeper reflection
on this general argument, the following reflections are restricted to the case
of nuclear energy in the context of energy governance.
329
III.b. For the case of nuclear energy in particular, Meskens (2013) argued that,
because of the doctrinal working of science and the strategies of political
‘positionism’ and economic profit, the issue of nuclear energy is now
locked in a comfort of polarisation that does not only play in public dis-
course but that is deeply rooted in the working of science, politics, and the
market. As a result, in sharp contrast with the way that fossil fuel energy
technologies are now subject of global negotiations driven by the doom of
climate change, nuclear energy technology remains to ‘escape’ a deliberate
justification approach as an energy technology on a transnational level.
III.c. The question of whether one is ‘in favour of’ or ‘against’ nuclear energy
remains meaningless if not integrated in a consensus framework for energy
governance as such. In principle, that consensus framework is possible, as
it would follow three policy principles with which most people would easily
agree. These principles are (in this specific order):
1. the policy principle to minimise energy consumption (or thus to maximise
energy savings) through democratic deliberation on its practical
implementation;
2. the policy principle to maximise renewables through democratic deliberation
on its practical implementation; and
3. the policy principle to organise a fair debate on how to produce what cannot
be done yet with (1) and (2), and ‘confront’ fossil fuels and nuclear energy,
being the two ‘nasty’ risk-inherent energy technologies, with each other.
Democracy in this sense implies that a society would need to be able to
decide on how to produce ‘the rest’ of its energy required for the future:
with nuclear energy, with fossil fuels, or with a combination of both. In line
with the reasoning above, a fair method of decision making would, in this
context, be a method that would be sensed as fair because of its method by all
concerned, regardless of whether the decision making would result in the
acceptance or the rejection of the use of nuclear energy or fossil fuels. The
fact that we are in a historically evolved situation where nuclear energy and
fossil fuels are present while there have never been real democratic debates on
their introduction cannot be used as an excuse not to organise this type of
debate now. While it is true that, in terms of their adverse effects, nuclear
energy and fossil fuels are ‘incomparable’, that additional complexity would
not prevent a democratic society from making informed and deliberate deci-
sions on them.
Although we do not live in a world where politics, science, and the market
would be prepared to engage in deliberation that would put policy principles (1)
and (2) upfront, and that would take principle (3) seriously, we have the capacity to
put that deliberation into practice. Justice with regard to how a specific collective
health risk, such as the risk of nuclear energy or fossil fuels, is evaluated in society
remains the central ethical principle, and that ethical principle translates in practice
as the need for transdisciplinarity and civil society’s participation in scientific debate,
330
and the need for participation of the potentially affected in democratic decision
making.
3. THE BIGGER PICTURE: THE IDEA OF DEALING FAIRLY WITH

COMPLEXITY
3.1. A neutral characterisation of complexity (of complex social problems)
It has now become trivial to say that we live in a complex world. Industrialisation,
technological advancement, population growth, and globalisation have brought ‘new
challenges’, and the global political agenda is now set by issues that burden both our
natural environment and human well-being. Sketching what goes wrong in our world
today, the picture does not look very bright: structural poverty; expanding industri-
alisation and urbanisation, and consequent environmental degradation; spill of pre-
cious resources, water, food, and products; adverse manifestations of technological
risk; economic exploitation; anticipated overpopulation; and derailed financial mar-
kets. All of this adds up to old and new forms of social, political, and religious
oppression and conflict, and makes the world a difficult place to live for many
people. The stakes are high and the need to take action is manifest.
What do we mean when we say that we live in a complex world? Whether we
speak of clearly observable unacceptable situations (e.g. extreme poverty), perceived
worrisome situations or evolutions (e.g. climate change or population growth), or
practices or proposed policy measures with a potential controversial character (e.g.
the use of nuclear energy, genetically modified organisms, or a tax on wealth), the
idea is that we can characterise them all as ‘complex social problems’ with the same
set of characteristics. If science has a role to play in making sense of these problems,
it will typically face the fact that it has to deal with factual uncertainties and
unknowns, which implies that its challenge in a sociopolitical context is not the
production of ‘credible proofs’, but rather the construction of credible hypotheses.
Besides, we know that our judgements on situations, evolutions, practices, and pro-
posed policy measures not only rely on available knowledge about them, but that
they are first and foremost influenced by how we value them in relation to things we
find important (nature, freedom, equality, protection, etc.). Taking that into account,
a specific characterisation of complexity of complex social problems is proposed that,
the author believes, will support the insight that fair and effective governance is
initially not a matter of proper organisation, but essentially that of a fair dealing
with its complexity. The complexity of a complex social problem, such as combating
climate change, the provision of affordable access to healthy food for all, or evalu-
ation of the possible use of nuclear energy, may in this sense be described with seven
characteristics (Table 2).
This text does not want to propose a manual, procedure, or instrument to solve
complex social problems. Rather, the characterisation of complexity is meant as an
incentive and a basis for ethical thinking, as it opens the possibility to reflect on what
it would imply to ‘deal fairly with the complexity’ of those specific social problems,
and of the organisation of our society accordingly. The possibility of doing so is in
331
Table 2. Seven characteristics of a complex social problem.

1. Diversified impact
– Individuals and/or groups are affected by the problem in diverse ways (benefit vs adverse consequence,
diverse ‘degrees’ of benefits or adverse consequences).
– The impact can be economic or related to physical or psychic health, or individual or collective social well-
being.
– The character and degree of impact may evolve or vary in a contingent way in time.
– The impact may also manifest later in time (with the possibility that it manifests after or during several
generations).
2. Interdependence
– The problem is caused and/or influenced by multiple factors (social, economic, technical, natural) and relates
itself to other problems.
– Interdependence can change in time.
– The context of concern becomes global.
3. The need for a coherent approach (organisational complexity)
Due to diversified impact and interdependence, problems need to be tackled ‘together’ in a coherent, system-
atic, and ‘holistic’ approach. This approach needs to take into account the following four additional charac-
teristics of complexity.
4. Relative responsibilities
Due to diversified impact, interdependence, and the organisational complexity, responsibility cannot be
assigned to one specific actor. Responsibilities are relative in two ways:
– (1) mutual: the possibility for one actor to take responsibility can depend on whether another actor takes
responsibility; and
– (2) collective: our collective responsibility is relative in the sense that it will need to be ‘handed over’ to a next
‘collective’ (a new government, next generations).
5. Knowledge-related uncertainty (knowledge problem)
Analysis of the problem is complicated by uncertainty due to speculative, incomplete, or contradictory know-
ledge, with respect to the character and evolution of impact and interdependence, and with respect to the
effects of the coherent and holistic approach.
6. Value pluralism (evaluation problem)
Evaluation of diversified impact, interdependence, and organisational complexity, and of subsequent relative
responsibilities is complicated due to:
– the knowledge problem;
– the existence of different visions based on different specific values and general world views;
– the existence of different interests of concerned actors;
– the fact that it is therefore impossible to determine in consensus what would be the ‘real’ problem or the ‘root’
of the problem; and
– the fact that ‘meta-values’, such as ‘equality’, ‘freedom’, and ‘sustainability’, cannot be translated unambigu-
ously into practical responsibilities or actions.
7. Relative authorities (authority problem)
The authority of actors who evaluate and judge the problem, and rationalise their interests and responsibilities
related to it in a future-oriented perspective is relative in two ways.
– The ‘individual’ authority of concerned actors is relative in the sense that, due to the knowledge and evalu-
ation problem, authority cannot be ‘demonstrated’ or ‘enforced’ purely on the basis of knowledge or judge-
ment. As a consequence, that authority needs to lean on ‘external’ references (the mandate of the elected
politician, the diplomas and experience of the scientific expert, the commercial success of the entrepreneur, the
social status of the spiritual leader, the appeal to justice of the activist, etc.).
– The ‘collective’ authority of concerned actors who operate within the traditional governing modes of politics,
science, and the market is relative, as these governing modes cannot rely on an objective ‘authority of
method’: the systems of representative democracy (through party politics and elections) and the market
both lean on the principle of competition, while science is faced with the fact that it needs to deal with
future-oriented hypotheses.
– As such, concerned actors have the opportunity to reject or question the relevance and credibility of the
judgement of other actors, and consequently to question the legitimacy of their authority.
332
the fact that the characterisation of complexity in the form of the seven proposed
characteristics can be called a ‘neutral’ characterisation, in the sense that it does not
specify wrongdoers and victims as such (which, of course, does not mean there
cannot be any). Representing the complexity as a complexity of interpretation
enables the responsibility to be described ‘in the face of that complexity’ as a joint
responsibility that is, as such, not divisive, which means that, in principle, it provides
the possibility of rapprochement.
This joint responsibility ‘in the face of complexity’ has, at the same time, a binding
and a liberating character for all concerned. Regarding the binding character,
although nobody is blamed or suspected of reckless behaviour or of escaping respon-
sibility, one could say that the characterisation of complexity is imperative for all
concerned. First of all, any reflection on what it would imply to deal fairly with the
complexity of the problem at stake would imply the need for each concerned actor to
transcend the usual thinking in terms of their own interests, and the preparedness to
become ‘confronted’ with the way he/she rationalises their own interests within the
bigger picture. At the same time, due to the knowledge and evaluation problem,
every concerned actor would need to acknowledge his/her specific ‘authority prob-
lem’ in making sense of the complexity of that problem, taking into account that not
only the way he/she rationalises the problem as such, but also the way he/she ration-
alises his/her own interests, the interests of others, and the general interest in relation
to that problem is simply relative. That relativity is reciprocal, in the sense that
nobody can claim higher authority based on a deeper understanding of the problem
that would lead to a view on the ‘solution’ that all others concerned would simply
need to accept. This reasoning provides us with the possibility to argue that joint
responsibility is not only binding but also liberating: as the authority of all concerned
actors is relative in relation to the authority of others, it implies that all actors have
the right to participate in making sense of the problem, and the right to co-decide on
possible solutions to that problem.
The context of this text does not allow deeper reflection on the character of
complexity as described above, and on how it can be ‘translated’ into characteristics
of concrete complex social problems such as those referred to above. More important
here is the focus on an ethical framework that would follow from the general and
neutral characterisation of complexity of complex social problems, and on how that
framework can inspire the new governance methods that would, as emphasised pre-
viously, enable ‘confrontation of rationales’ and ‘the right to co-decide’ in particular.
3.2. Ethics of care for our modern co-existence

As said before, ethics is about judging on ‘what ought to be’ in the absence of
evidence that would facilitate straightforward judgement, consensus, and consequent
action. However, absence of evidence does, of course, not exclude the possibility of
some type of normative reference to assist that judgement. Throughout history,
philosophers have tried to formulate specific rationales to defend possible references,
and one can distinguish four categories of normative ethical theories in Western
philosophy in that sense. Since their emergence at various moments in history, all
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Table 3. Four types of normative reference in Western philosophy normative ethical theories.
Western philosophy normative ethical theories Danger/problem
Theories that seek reference in ‘universally Danger: risk of overlooking the

applicable principles’ particulars of specific situations
‘(Kantian) deontology, consequentialism
(utilitarianism)’
Theories that seek reference in evaluating Danger: risk of self-protective
particular situations relativism (cultural, social,
‘particularism’ political)
Theories that seek reference in virtues (‘being good’) Problem: virtues do not always
‘virtue ethics (Aristoteles)’ translate unambiguously into
concrete action
Theories that seek reference in care for human Problem: works for close
relationships relations with known people;
‘ethics of care’ unclear how it could work for
distant relations with strangers
theories have been subject to academic critique with respect to their attempt to
‘universalise’ their approach. The theories and their critiques are summarised in
Table 3.
Table 3 can now be used as a backdrop for the formulation of a specific virtue
ethics and ethics of care theory that could guide evaluation and action ‘in face of
complexity’ in the context of complex social problems, as characterised above. The
idea is that these theories would not face the traditional problems formulated above,
as they do not aim to instruct concrete practical action of concerned actors, but
rather inspire specific modes of reflective and deliberative interaction among them.
The two theory proposals will be discussed briefly below.
3.2.1. Reflexivity and intellectual solidarity as ethical attitudes or virtues

Recalling the previous considerations on what it would imply to ‘deal fairly’ with
the complexity of complex social problems, we could say that the joint responsibility
of all concerned can be rephrased as the joint preparedness to adopt a specific
responsible attitude or to foster a specific virtue ‘in face of complexity’. That respon-
sible attitude or virtue is identical for all concerned actors (be it the scientist, the
politician, the engineer, the manager, the entrepreneur, the expert4, the civil society
representative, the activist, or the citizen), and can be described in a three-fold
manner.
4
In the context of this text, ‘expert’ denotes any person with a special expertise compared with others
involved. This could be a scientist in an advisory role towards a political authority, or someone who works
for a nuclear regulatory commission, but also a medical doctor in relation to a patient.
334
1. The preparedness to acknowledge the complexity of complex social problems

and the organisation of our society as a whole.
2. (Following 1) The preparedness to acknowledge the imperative character of that
complexity, or thus to acknowledge the own authority problem (in addition to
the knowledge and evaluation problem) in making sense of that complexity;
that preparedness can be reformulated for each concerned actor as the pre-
paredness to see ‘the bigger picture and oneself in it’, each with his/her specific
interests, hopes, hypotheses, beliefs, and concerns.
3. (Following 2) The preparedness to seek rapprochement with other concerned
actors, and this through specific advanced formal interaction methods in
research, politics, and education that would enable sense to be made of that
complexity.
The three-fold preparedness suggested here can be considered as a ‘concession’ to

the complexity as sketched above, and it may be clear that, with these reflections, we
now enter the area of ethics. A first simple but powerful insight in that sense is the
idea that if nobody has the authority to make sense of a specific problem and of
consequent solutions, then concerned actors have nothing other than each other as
equal references in deliberating that problem. In his book ‘The Ethical Project’, the
philosopher Philip Kitcher makes a similar reflection by saying that ‘there are no
ethical experts’ and that, therefore, authority can only be the authority of the con-
versation among the concerned actors (Kitcher, 2014). From the perspective of nor-
mative ethics, we can now (in a metaphorical way) interpret the idea of responsibility
towards complexity as if that complexity puts an ‘ethical demand’ on every con-
cerned actor, in the sense of an appeal to adopt a reflexive attitude in face of that
complexity. That reflexive attitude would not only concern the way each actor
rationalises the problem as such, but also the way he/she rationalises his/her own
interests, the interests of others, and the general interest in relation to that problem.
The responsible attitude considered here can thus be described as a reflexive atti-
tude in face of complexity, and, as a concession towards that complexity, that atti-
tude can now also be called an ‘ethical attitude’ or virtue. However, given that the
responsibility as suggested above would also imply rapprochement among concerned
actors, one can understand that, in practice, this ethical attitude needs to be adopted
in public, and that one needs specific formal interaction methods to make that pos-
sible. The joint preparedness for ‘public reflexivity’ of all concerned actors would
enable a dialogue that, unavoidably, will also have a confrontational character, as
every actor would need to be prepared to give account of his/her interests, hopes,
hypotheses, beliefs, and concerns with respect to the problem at stake. That joint
preparedness can be described as a form of ‘intellectual solidarity’ as, in arguing
about observable unacceptable situations (e.g. extreme poverty), perceived worri-
some situations or evolutions (e.g. climate change or population growth), or prac-
tices or proposed policy measures with a potential controversial character (e.g. the
use of nuclear energy, genetically modified organisms, or a tax on wealth), concerned
actors would need to be prepared to reflect openly towards each other and towards
335
‘the outside world’ about the way they not only rationalise the problem as such, but
also their own interests, the interests of others, and the general interest in relation to
that problem. Similar to understanding reflexivity as an ethical attitude or virtue, one
can understand the sense of intellectual solidarity as an ethical attitude or virtue, and
one could say that the second should and could be ‘stimulated’ by the first. In other
words, a sense of intellectual solidarity implies reflexivity as an ethical attitude with
respect to the own position, interests, hopes, hypotheses, beliefs, and concerns, and
this in any formal role or social position (as scientist, politician, engineer, manager,
entrepreneur, expert, civil society representative, activist, citizen, etc.). It is important
to emphasise that intellectual solidarity is not some high-brow elite form of intellec-
tual cooperation. It simply denotes our joint preparedness to accept the complexity
of co-existence in general and of specific complex social problems in particular, and
the fact that no one has a privileged position to make sense of it all. Intellectual
solidarity, as an ethical commitment, is the joint preparedness to accept that we have
no reference other than each other.
3.2.2. An ethics of care, ‘bound in complexity’

Section 3.2.1 elaborated on the meaning of reflexivity and (a sense of) intellectual
solidarity as ethical attitudes or virtues, and on the need to adopt these attitudes or
to foster these virtues because of complexity. In addition to that, it is possible to
develop an ethical theory on how to deal fairly with the complexity of complex social
problems based on the simple insight that we are all bound in that complexity. The
idea that ‘we are all in it together’ informs the view that we should care for our
relations with each other, in the sense that we need each other to make sense of
complex social problems such as climate change, and to tackle them.
In short, the characterisation of complexity as sketched above enables a formu-
lation of an ethics of care that could work for our distant relationships with stran-
gers. The basic idea is that the ‘fact of complexity’ brings along three new
characteristics of modern co-existence that can be named ‘connectedness’, ‘vulner-
ability’, and ‘sense of engagement’. Their meaning in relation to the complexity of
complex social problems can be summarised as follows:
. Connectedness. We are connected with each other ‘in complexity’. We cannot any
longer escape or avoid it. Fair dealing with each other implies fair dealing with the
complexity that binds us.
. Vulnerability. In complexity, we became intellectually dependent on each other
while we face our own and each other’s ‘authority problem’. We should care for
the vulnerability of the ignorant and the confused, but also for that of ‘mandated
authority’ (such as that of ‘the scientific expert’, ‘the teacher’ or ‘the elected pol-
itical representative’). Last but not least, we should care for the vulnerability of
those who cannot be involved in joint reflection and deliberation at all. Obviously,
without wanting to make evaluative comparisons between them, these can be
identified as the next generations, but also as those among us who are
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Table 4. Intellectual solidarity as an ethical attitude or virtue in an ethics of care framework.

Connectedness, vulnerability, and a sense of engagement inspire
‘intellectual solidarity as a joint ethical commitment’, in the sense of:
Connectedness The joint preparedness to enable and participate in intellectual

confrontation with respect to the ratios we use:
– to defend our interests, hopes, hypotheses, beliefs, and concerns
– to relativise our uncertainties and doubts
The joint preparedness to recognise that the practical limitations to
participation in deliberation cannot be used to question the prin-
ciple of participation as such
Vulnerability The joint preparedness to acknowledge each other’s authority
problem and the vulnerability of those who cannot participate
(Sense of) Engagement The joint preparedness to enable and support ‘intellectual emanci-
pation’ of others with the aim of providing every human being with
the possibility of developing ‘reflexivity as an intellectual skill’, or
thus to develop a (self-)critical sense and to be a (self-)critical actor
in society
intellectually incapable to join (animals, children, and humans with serious mental
disabilities).
. (Sense of) Engagement. Our experiences now extend from the local to the global.
As intelligent reflective beings, becoming involved in deliberating issues of general
societal concern became a new source of meaning and moral motivation for each
one of us.
We can now connect this ethics of care perspective with the idea of reflexivity, and
intellectual solidarity as ethical attitudes or virtues, as elaborated above.
Connectedness, vulnerability, and a sense of engagement, identified as new charac-
teristics of co-existence, imply the need to be intellectually solidary with each other in
the way we make sense of complexity for social organisation. This can be represented
as having a sense for interaction modes that are either ‘confronting’ or ‘enabling’
(Table 4).
3.3. Enabling virtues: intellectual solidarity in democracy, science, and education

Moving now from normative ethical thinking to applied ethical thinking, the
advanced formal interaction modes to enable reflexivity and a sense of intellectual
solidarity referred to above can be given a name and a practical meaning. Taking
into account the knowledge problem and the evaluation problem as the central
characteristics of the complexity of complex social problems, reflexivity and intellec-
tual solidarity as public ethical attitudes or virtues would need to inspire the method
used to generate knowledge about these problems, and the method used to negotiate
and make decisions related to them accordingly. So the question becomes, in what
way could these virtues inspire the practice of research and decision making?
337
With the presentation of virtue ethics as one of the four traditional theories of
ethics (of Western philosophy), it was noted that the problem with virtue ethics as a
theory of normative reference is that virtues not always translate unambiguously into
concrete action. First of all, virtues such as being ‘good’, ‘honest’, or ‘prudent’
obviously need to be considered in a practical context or situation in order to under-
stand their practical meaning. However, even then, different virtues can come into
conflict with each other, or acting from the perspective of one virtue can be compli-
cated because of the existence of conflicting values to take into account. To give one
example, what would it imply for a medical expert to be ‘prudent’ in advice with
respect to mammography campaigns? Would it mean intensifying them in order to
detect more breast cancers, or restricting them in order to limit the possibility of
false-positive results and the risk of radiation?
In the same perspective, it is true that neither reflexivity nor (a sense of) intellec-
tual solidarity can unambiguously inspire concrete action of concerned actors, but
they can inspire interaction methods to enable and enforce them as virtues in the
interest of meaningful dialogue. The following reasoning may clarify this. The pre-
vious section stated that a sense of intellectual solidarity implies reflexivity as an
ethical attitude with respect to the own position, interests, hopes, hypotheses, beliefs,
and concerns, and this in any formal role or social position (as scientist, engineer,
politician, manager, medical doctor, citizen, civil society representative, activist,
etc.). However, one may understand that the ability to adopt this attitude requires
reflexivity as an ‘intellectual skill’, seeing the bigger picture and yourself in it (with
your interests, hopes, hypotheses, beliefs, and concerns). The important thing is that
reflexivity as an intellectual skill may benefit from solitary reflection, but it cannot be
‘instructed’ or ‘thought’. Neither can it be ‘enforced’ or ‘stretched’ in the same way as
one can do with transparency in a negotiation or deliberation setting. For all of us,
reflexivity as an intellectual skill essentially emerges as an ethical experience in inter-
action with others. That interaction may be informal, but it may be clear that the
meaningful and ‘logical’ interactions in this sense are to be organised in the formal
practices of scientific research, political deliberation, and education. In the interest of
keeping this text concise, a brief comment on how this can be understood is given
below.
. As the challenge of science in making sense of complex social problems is no

longer the production of credible proof but the construction of credible hypoth-
eses, reflexivity and intellectual solidarity as ethical attitudes inspire the need to
engage in advanced methods that are self-critical and open to visions from outside
the traditional disciplines of science. In other words, knowledge to advise policy
would need to be generated in a ‘transdisciplinary’ and ‘inclusive’ way, or thus as
a joint exercise of problem definition and problem solving with input from the
natural and social sciences, and the humanities as well as from citizens and
informed civil society.
. An advanced method of political negotiation and decision making inspired by the
ethical attitudes of reflexivity and intellectual solidarity would be a form of
338
‘deliberative democracy’ that sees deliberation as a collective self-critical reflection

and learning process among all concerned, rather than as a competition between
conflicting views driven by self-interest. Political deliberation liberated from the
confinement of political parties and nation states, and enriched with opinions
from civil society and citizens, and with well-considered and (self-)critical scientific
advice would have the potential to be fair in the way it would enforce actors to
give account of how they rationalise their interests from strategic positions,
but also in the way it would enable actors to do so from vulnerable positions.
It would be effective as it would have the potential to generate societal trust based
on its method instead of on promised outcomes. While the utopian picture
sketched here would imply a total political reform on all levels, intellectual soli-
darity can already open up old political methods for the good of society. At both
local and global levels, politicians could organise public participation and delib-
eration around concrete issues, and engage in taking the outcome of that delib-
eration seriously.
. Last but not least, there is the need for a new vision on education. Fair dealing
with complex social problems needs an education that cares for ‘critical-intellec-
tual capacity building’. It would be naı̈ve to think that scientists, politicians,
engineers, entrepreneurs, managers, experts, activists, or citizens will adopt the
ethical attitudes of reflexivity and intellectual solidarity simply on request. The
preparedness of someone to be reflexive about his/her own position and related
interests, hopes, hypotheses, beliefs, and concerns can be called ‘moral responsi-
bility’, but it essentially leans on the capability to do so. Insight into the com-
plexity of our co-existence in general and into our complex social problems in
particular, and an understanding of the ethical consequences for politics, science,
and the market, need to be stimulated and fostered in basic and higher education.
Education should move beyond the 19th Century disciplinary approaches and
cultural and religious comfort zones, and should become pluralist, critical, and
reflexive in itself. Instead of educating young people to function optimally in the
strategic political, cultural, and economic orders of today, they should be given
the possibility to develop as a cosmopolitan citizen with a (self-)critical mind and
a sense for ethics in general and for intellectual solidarity in particular.
An ethics of care perspective on our modern co-existence ‘bound in complexity’

provides a powerful reference to defend the value of (and the need for) these
advanced interaction methods. Recognising the meaningful relations between the
advanced approaches to education, research, and decision making presented
above, together they not only enable and stimulate reflexivity and intellectual soli-
darity based on their discursive potential, but also provide the possibility to generate
societal trust with their working. That societal trust considered here is not the trust
that the outcome of deliberation will be the ‘correct one’, but that its method has the
potential to be judged as fair by everyone in consensus, given the complexity of the
problem.
339
So what is the real problem with living in a complex world? Whether we speak of
clearly observable unacceptable situations (such as extreme poverty), perceived wor-
risome situations or evolutions (such as climate change or population growth), or
practices or proposed policy measures with a potential controversial character (such
as the use of nuclear energy, genetically modified organisms, or a tax on wealth), we
can say that our social challenges have become more complex. The real trouble with
these challenges is not their complexity as such, but the traditional governance
methods we use to make sense of them in politics, science, and the market.
Inherited from modernity, the idea is that these methods are no longer able to
‘grasp’ the complexity of these social problems. Meskens (2015a) argues in depth
about why and how these traditional governance methods are not inspired by reflex-
ivity as an ethical attitude and intellectual solidarity as an ethical commitment,
driven as they still are by the doctrine of scientific truth and the strategies of political
‘positionism’ and economic profit. On the other hand, it may be clear that we do not
need deep utopian reform of our society to make research transdisciplinary and
inclusive, and to make education pluralist, critical, and reflexive. Even in the old
modes of political conflict, steered and limited by party politics and nation state
sovereignty, it is possible in principle to organise public and civil society participa-
tion in deliberation around concrete issues, and to take the outcome of that delib-
eration seriously. So, although we do not live in a society inspired by intellectual
solidarity, we have the capacity to foster it and to put it in practice.
4. CONSEQUENCES FOR RADIOLOGICAL RISK GOVERNANCE

In light of the previous reflections, we can now characterise the evaluation of the
eventual use of nuclear technology in society as a complex social problem that
requires fair dealing with its complexity, in the energy application context as well
as in the medical application context. As a conclusion to this text, we may now
formulate a set of considerations on how all this applies to radiological risk
governance.
4.1. Importance of considering different neutral application contexts

Although Chapter 1 indicated a difference between the energy and medical appli-
cation context in terms of fairness with respect to dealing with knowledge-related
uncertainty (due to incomplete and speculative knowledge) and value pluralism, one
could call the problem a complex problem in both cases because its complexity
follows the seven characteristics proposed above, and a complex social problem
because it concerns the whole ‘range’ of relevant social actors in that application
context.
It is true that, from a societal perspective, one could call the nuclear energy
problem ‘more complex’ than the use of nuclear technology in the medical context,
but the essential message here is that a comparison between both technology appli-
cations is meaningless in terms of fairness of justification. One has to acknowledge
that ethics for the medical and nuclear energy application contexts lean on the same
340
principles, but also that they mean different things in practice when it comes to
ensuring participation and informed consent of potentially affected persons.
Therefore, in any discourse related to risk justification, a joint preparedness to evalu-
ate the eventual use of nuclear technology in its neutral application context (being
the energy or medical context) is a principle of intellectual solidarity in itself.
From a different perspective, one can say that assessment of the justice of justi-
fication of a radiological risk is meaningless in the absence of a context of applica-
tion. Consequently, in terms of applied ethics, it is rather meaningless to speak of
‘radiological protection’, ‘radiological risk management’, or ‘radiological risk gov-
ernance’ without specifying a specific nuclear technology, or without specifying the
societal context of the nuclear technology application. Even more, it becomes mean-
ingless to speak of ‘risk management’ or ‘risk governance’ as such, as, within these
distinct application contexts, the radiological risk becomes a concern if and only if
those involved jointly agree to consider the eventual use of the nuclear technology in
function of ‘the higher good’ (the eventual use of nuclear energy in energy govern-
ance, the eventual use of nuclear technology in health care).
4.2. Enabling virtues in radiological risk governance

Reflections on ethics in relation to radiological protection5 to date have largely
focussed on virtue ethics. They logically and reasonably follow from the question of
what it would imply to be ‘responsible’ or ‘good’ as a scientist, manager, policy
advisor, medical doctor, or regulator. The considerations made in this paper may
now support the argument that ethical thinking in relation to radiological risk gov-
ernance in general, and with respect to consequences for the radiological protection
system in particular, requires broader reflection than traditional virtue ethics alone,
and that it should be completed with ethical reflection with regard to the potential-
ities and ‘hindrances’ that characterise the systems in which these mandatories are
formed and meant to operate. Looking at how politics, science, the market, and
education function today, one could wonder how, in the broader societal context,
virtues identified as relevant for radiological protection (beneficence, non-malefi-
cence, prudence, justice, dignity, honesty, truthfulness, empathy, etc.) can ever
‘work’ in a world still ruled by the doctrine of scientific truth and the strategies of
political positionism and economic profit. It seems as if those virtues always need to
‘resist’ the methods driven by these doctrines and strategies, and need to ‘work’
against them. This is particularly the case for policy advice. Advice on a controver-
sial health issue formulated by an advisory council may be serene and deliberate, but
today one has to accept that it becomes nothing more than an element to be taken
into account (or not) in national party politics or in negotiations between nation
states. Another example is the working of science in post-accident conditions.
Scientific discussions such as those on possible health effects in Fukushima would
benefit from a serene atmosphere, wherein not only scientists but also citizens,
5
Such as those undertaken in the context of the ICRP Initiative on the Ethics of Radiological Protection
(see http://www.icrp.org/page.asp?id¼191).
341
activists, politicians, and representatives from the nuclear industry would be able to
speak openly about uncertainties, interests, and concerns. However, we do not need
deep analysis to conclude that the atmosphere in and around Fukushima today is
rather one of distrust instead of serenity [see the author’s thoughts on post-accident
social justice in Fukushima in Meskens (2015b)].
Therefore, fair radiological risk governance also requires advanced governance
methods for science, political decision making, and education in order to ‘enable’
these virtues to work to their full potential. An ethics of care for our modern co-
existence does not only support these advanced governance methods, but also gives
new meanings to the ethical values underpinning the system of radiological protec-
tion. For every professional concerned with radiological protection, be it the scien-
tist, the engineer, the medical doctor, the manager, or the policy advisor, the virtues
of beneficence, non-maleficence, prudence, justice, dignity, honesty, truthfulness, and
empathy receive an enriched ‘interactive’ ethical meaning when understood as
grounded in care for human relationships ‘bound in complexity’. The reason is
that acting according to these virtues always ‘starts’ with a motivation for rapproche-
ment towards other concerned actors.
4.3. Justice of justification as a central concern

An ethics of care for our modern co-existence ‘bound in complexity’ supports the
value of the principles of fairness in risk governance that were put forward in
Chapter 1, as it provides a powerful reference to defend the principles of precaution,
informed consent of the potentially affected, and accountability towards next gen-
erations against the doctrine of scientific truth and the strategies of political position-
ism and economic profit. However, the ethics of care perspective also supports the
idea that the principles of precaution and informed consent should not be ‘balanced’
as trade-offs. In simple terms, precautionary measures would need to be agreed upon
with the involvement of all concerned actors. As a consequence, the idea of fair risk
governance, as elaborated on in Chapter 1, integrated in the broader ethical vision of
what it implies to deal fairly with the complexity of that risk governance, supports
the argument that the justice of justification, ensured by the possibility of self-deter-
mination of the potentially affected (ensuring their ‘right to be responsible’), should
be the central concern of risk governance and of related systems of protection. In the
complex cases of nuclear technology applications, a risk cannot be justified through
one-directional ‘convincing explanation’, but only through mutual agreement among
concerned actors. An acceptable nuclear risk is a risk that is eventually justified
relying on the formal possibility of deliberation among informed concerned actors
(responsible and affected). Obviously, that mutual agreement, as the outcome of a
justification exercise, can either be to reject or to accept the use of a nuclear tech-
nology. Therefore, intellectual solidarity as an ethical commitment among all con-
cerned should ‘start’ with the joint preparedness to see justification as a mutual
agreement ‘in the face of complexity’.
Seen from a different perspective, ethics in relation to the radiological protection
system is also about considering and recognising the limits of the radiological
342
protection system when it comes to providing a rationale for societal justification of a

radiation risk. In other words, we cannot question the ethical dimensions of the
radiological protection system without questioning the ethical dimensions of the
‘bigger’ systems in which the radiological protection system operates, and on
which it depends. Given that the radiological protection system, in its concern for
providing guidance for decision making, relies on science but also and essentially
wants to consider human and societal values, the bigger systems that need to be
questioned in terms of their ethics are those of knowledge production (research,
advice) and decision making, but also that of education. For risks that manifest in
an occupational context, the system of decision making is the management system.
For risks that manifest on a societal level, the system of decision making is the system
of democracy.
This last reflection introduces the need to raise awareness about the possibilities and
limits of radiological protection and nuclear safety culture in this sense. In light of the
previous, we can state that fostering a responsible radiological protection and nuclear
safety culture is a necessary but insufficient condition for the societal justification of
(the risk of) nuclear technology applications. Many scientists and policy makers still
claim that a nuclear risk is justified when there is a responsible regime of protection put
in place. Based on the ethical considerations above, we can conclude that it is actually
the other way round: responsible protection needs to be put in place once all involved
actors would eventually have jointly justified the use of nuclear technology.
Therefore, even when considering ethical dimensions, the radiological protection
system cannot and should not be stretched to provide the full rationale for societal
justification, but it can and should refer to critical considerations on how our formal
methods of knowledge generation and decision making should foster autonomy and
involvement of the potentially affected, and promote vigilance and fairness in jus-
tifying radiation risks. In its recommendations, the International Commission on
Radiological Protection (ICRP) could highlight the importance of the advanced
methods for science, politics, and education presented in Section 3.3 as a way to
ensure fairness in justifying radiation risks, taking into account the different appli-
cation contexts. In addition, given the central role of science in radiological protec-
tion, ICRP could actively promote a more ‘responsible’ conception of science, being
a transdisciplinary and inclusive science, not only to advise politics in judgements on
justification, but also to support radiological protection policies in both occupational
and post-accident conditions. That science would, in principle, be able to inform
policy in a more reflexive and thus deliberate way, while simultaneously being more
resilient itself against strategic interpretation of its produced knowledge and hypoth-
eses from politics, civil society, and the market.
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Ethical foundations of environmental
D.H. Oughton
Centre for Environmental Radioactivity (CERAD), Norwegian University of Life Sciences,
P.O. Box 5003, N-1432 Aas, Norway; e-mail: deborah.oughton@nmbu.no
Abstract–Assessing the potential ecological impact of ionising radiation raises a number of

ethical questions. These include fundamental questions such as what exactly constitutes harm-
ing the environment, and how the environment should be valued, as well as links to political
protection principles such as sustainability and biodiversity. Starting from developments
within ecological risk assessment, this paper summarises some of the ethical issues concerning
the protection of the environment from radiation. Chapter 2 gives a brief overview of different
philosophical and cultural world views on valuing the environment in a context of radiation
risk. Chapter 3 addresses some recent challenges to proposed environmental protection frame-
works, including practical applications following the Chernobyl and Fukushima accidents,
and some scientific developments such as the ecosystem approach. Finally, Chapter 4 offers
some recommendations on how ethical evaluation can help produce a more robust and trans-
parent approach to the protection of the environment. In conclusion, there is a need for a
holistic evaluation of the environmental impacts of ionising radiation that not only considers
the direct consequences on the health of humans and non-human species, but also the more
complex social, ethical, and economic consequences of both human and non-human
exposures.
Keywords: Ethics; Environmental protection; Anthropocentric; Biocentric; Ecocentric
1. INTRODUCTION
There is growing consensus that radiation risk management needs to address the
question of effects on the environment (Pentreath, 1998, 1999; IUR, 2002; IAEA,
Protection.
345
2002; ICRP, 2003, 2007). Prior to this, radiological protection was almost exclusively
concerned with humans, under the assumption that limits on exposure of humans
will usually entail sufficient protection to the environment (ICRP, 1991, Para. 16).
Challenges to this approach included the fact that it was not in line with the assess-
ment and management of other environmental stressors, and that there were a
number of cases (e.g. marine or geological disposal) where wildlife and ecosystems
could be exposed to high levels of radiation even when human doses were low. Thus,
a requirement to address the impacts on non-human organisms explicitly is now part
of international radiological protection recommendations and standards (ICRP,
2007; IAEA, 2011), as well as national strategy in a number of countries
(Copplestone et al., 2009).
However, consideration of the impacts of ionising radiation on the environment
raises a number of ethical challenges. For example, while most scientists would agree
that radiation can cause various types of change in ecosystems, from genetic muta-
tions to ecosystem level changes, the degree to which this change represents harm can
be a matter of debate. Could one posit that the environment is damaged in some way
by the mere presence of man-made radionuclides? Should genetic changes be seen as
a beneficial adaptation of organisms to stress, or biomarkers that warn of potential
damage? How should one address the indirect effects on either humans or
ecosystems?
Many of the international organisations involved in the development of tools and
frameworks for assessing environmental risks have recognised that producing a prac-
tical and coherent system of radiological protection for wildlife raises a number of
philosophical and ethical questions. The International Atomic Energy Agency
(IAEA, 2002) produced a report on ‘Ethical Considerations in Protecting the
Environment from the Effects of Ionizing Radiation’, which addressed the cultural,
scientific, and social influences on environmental world views, as well as internation-
ally recognised agreements, such as protection of sustainability and biodiversity.
These aspects have also been addressed in the International Union of
Radioecology (IUR, 2002, 2012) and the International Commission on
Radiological Protection (ICRP, 2003) reports on environmental protection.
Common to all approaches is the recognition of diversity in ethical and cultural
views on valuing the environment, and acknowledgement that this diversity should
be respected in the environmental protection frameworks.
This paper reviews and summarises some of the main ethical issues concerning the
protection of the environment from radiation, and looks at more recent develop-
ments in radiation risk assessment on environmental protection1. Chapter 2 gives a
short overview of the different philosophical world views on valuing the environment
in a context of radiation risk. This is followed by Chapter 3, an evaluation of some of
the more recent challenges to the proposed environmental protection frameworks,
including practical applications following the Chernobyl and Fukushima accidents.
Finally, Chapter 4 offers some recommendations about how ethical evaluation can
1
Part of this paper is a summary of work published in Oughton (2003, 2013).
346
help produce a robust and transparent approach to the protection of the

environment from ionising radiation.
2. PHILOSOPHICAL WORLD VIEWS

Environmental ethicists have been debating the matter of why one attaches value
to the environment for a number of decades (Rolston, 1988; Sterba, 1994). Central
philosophical issues include the question of moral standing, and whether the envir-
onment has intrinsic or inherent value (i.e. value in itself) or extrinsic or instrumental
value (i.e. value because of human interest). Although environmental ethics is a
relatively young field within philosophy, a number of distinct views on this question
have emerged. In contemporary environmental philosophy, the most fundamental
source of divergence arises between the anthropocentric view and the non-anthro-
pocentric view.
2.1. Anthropocentism
An anthropocentric ethic (literally human-centred) alleges that only humans have
moral standing, and that environmental degradation only matters as long as it influ-
ences human interests (Norton, 1988; Bookchin, 1993). In defence of anthropocen-
trism, both scientists and philosophers have argued that human interests can provide
a powerful set of motives for protecting nature (Sober, 1986). Understanding the
economic and social impacts of environmental damage on humans can provide a
strong incentive to protect the ecosystem.
Anthropocentrics would be concerned about impacts of radiation on animals and
plants (and even soil and water, should that impact the human use of the resources),
but they would not consider these entities to have moral standing or value in them-
selves, only by virtue of the consequences to humans. Nevertheless, despite the
fact that anthropocentists may agree that humans have a responsibility not to
damage the environment, they can still disagree on what measures are needed to
correct human behaviour, and when intervention will be necessary to protect the
environment.
ICRP (1977) stated that ‘if man is protected, other living species are also likely to
be sufficiently protected’. This is widely perceived to be an anthropocentric approach
to environmental protection, and understandable when combined with the strong
historical human focus on radiological protection. Exposure experiments on animals
were performed largely to provide information on human effects; the majority of
studies on environmental transfer concentrated on those food chains with humans at
the top. However, whilst the statement is clearly an anthropocentric approach to risk
assessment, it does not necessarily mean that radiological protection does not value
the environment per se.
2.2. Biocentrism
Proponents of biocentrism (literally ‘life-centred’) assert that individual life forms
other than humans can have moral standing, and should be respected for what they
347
are, not only because they affect the interests of humans. Different biocentric views
exist regarding which criterion forms the basis for moral standing, and what
hierarchy (if any) exists between different species. However, all views derive moral
value from some biological characteristic of individual members of species, such as
sentience, the ability to feel pleasure or pain (Singer, 1991), self-consciousness
(Regan, 1980), inherent worth, or a ‘good of their own’ of all living things
(Goodpaster, 1978; Taylor, 1986).
As biocentrism focusses on individuals rather than the diversity of species, these
various outlooks have also been described as an ‘individualistic’ environmental ethic
(Sagoff, 1984; Rolston, 1991). In practical policy making, biocentric outlooks have
had the greatest influence in issues of animal welfare and the use of animals in
research (Sagoff, 1984). The ICRP Reference Animals and Plants (RAPs) approach
is consistent with a biocentric methodology for assessing radiation effects on indi-
vidual non-human species. As discussed below, this does not necessarily make it a
biocentric value basis for protecting those individuals. The idea of including impacts
on animals in radiological protection optimisation is also compatible with a broadly
sentience-based, utilitarian approach. In this case, optimisation would include both
the direct impacts of radiation on non-humans, as well as the more general (and
often more damaging) consequences for the environment of reducing doses to
humans [see Oughton et al. (2004) for examples of side-effects of accident remedi-
ation on the environmental and animal welfare]. Nevertheless, optimisation in radio-
logical protection rarely considers exactly why one is bothered about environmental
impacts, and there can, of course, still be disagreements on which species and which
effects matter. For example, Singer’s (1991) criterion of sentience only encompasses
vertebrates, whereas Taylor (1986) suggested that all living organisms are equal
moral subjects (egalitarian biocentrism) as each has some goal to its existence.
2.3. Ecocentrism
Supporters of an ecocentric philosophy claim that the diversity of species,
ecosystems, rivers, mountains, and landscapes can have value in themselves, irre-
spective of the consequences on humans or other individuals of non-human species.
All ecocentrics provide particular value to the diversity, dynamics, and interactions
within healthy ecosystems, but differ in their views on the causes of, and proper
solutions to, modern environmental problems. Callicott (1979, 1989) and Næss
(1974) both see the Western, instrumental view of nature as a main source of envir-
onmental problems. Ecofeminists suggest that the problem lies in the history of male
dominance and the sexist oppression of females (Warren, 1990); other problems stem
from the social and economic structure of society (Bookchin, 1993).
Most ecocentrics claim that mankind needs a radical change from an anthropo-
centric attitude of domination and exploitation of natural resources towards a
greater respect for the integrity of nature. In evaluating actions, Callicott defends
the land-ethic maxim of Aldo Leopold (1949), ‘A thing is right when it tends to
preserve the integrity, stability, and beauty of the biotic community; it is wrong when
it tends otherwise.’ The general concern for the biotic and abiotic community as a
348
whole has led this outlook to be classified by many philosophers as a ‘holistic’ ethic
(in contrast to the individualist biocentric view) (Sagoff, 1984). The inclusion of the
abiotic components of the environment in ecocentrism, together with the fact that
most definitions of the environment in international legislation include man, biota,
abiota, and physical surroundings, raises the issue of how to deal with the abiota (i.e.
soil, rocks, water) in environmental protection. Although many environmental
standards are based on concentrations in media, these usually reflect their value as
habitats.
In radiological protection, the ecocentric view has been linked to the ecosystem
approach of environmental assessment and management (IUR, 2012), and is some-
times presented as an alternative to the RAPs approach by ICRP (2008). One of the
criticisms of the RAPs approach is that the 12 selected species do not permit an
ecosystem level assessment. To do this, one needs a broader range of ecologically
relevant species covering producers, predators, and decomposers, as well as insights
into the differences in sensitivity of species (Brechignac et al., 2011; Bradshaw et al.,
2014); variability in sensitivity is a driving factor for ecosystem change as some
species can prosper by the impacts on others. This does not mean that the ICRP
approach is not capable of providing relevant information; it is simply not sufficient
in addressing the ecosystem level impacts. As mentioned above, the method of per-
forming an environmental impact assessment should not be taken as the same as
ascribing moral value to those entities. As discussed below, many ecosystem service
approaches to environmental protection are blatantly anthropocentric in both their
approach and underlying value system.
2.4. Common ethical principles

Despite the apparent diversity of these three theories, it is important to realise that
although they may disagree quite strongly over exactly why certain factors are rele-
vant to ethics, there can still be room for consensus on some common features. For
evaluation of any actions involving radiation exposure of humans, animals, or
plants, each of the above theories would find it morally relevant to ask: (1) who
and what are being affected; (2) what is the relative size of the benefits and harms
arising from the exposure; (3) what is the distribution of the risks and benefits; and
(4) what alternative courses of action are available? With respect to protection of the
environment and non-human species, all theories can defend the principle that radio-
logical protection should not be limited to humans. As regulations already exist for
the protection of the environment from other contaminants, and all other things are
equal, there is no ethically relevant reason why effects caused by radiation exposure
should be treated differently. This was one of the driving forces for expanding the
system of protection from humans to other species.
3. ENVIRONMENTAL PROTECTION PRINCIPLES

Both IAEA and ICRP have identified a number of primary environmental pro-
tection principles that are supported by the different philosophical world views and
349
have been enshrined in international conventions. These include respect for

sustainable development, environmental justice, human dignity, biodiversity, and
conservation.
Sustainable development relates to the need to recognise the interdependence of
economic development, environmental protection, and social equity, and thus the
obligation to protect and provide for both the human and environmental needs of
present and future generations (WCED, 1997). Internationally, the concept is
linked to the World Commission on Environmental Development, or ‘Brundtland
report’, but also consolidated in the United Nations (UN) ‘Rio’ Declaration of 1992
(UN, 1992).
Environmental justice recognises that inequity can and does arise between the
distribution of what might be termed ‘environmental benefits and harm’, and calls
for a more equitable distribution. As ratified in the Århus Convention, it also relates
to the importance of affected persons having access to information and participation
in decision-making processes in environmental matters (UNECE, 1998).
Environmental justice features in the Rio Declaration (UN, 1992), including the
explicit responsibility to ensure that activities within the national jurisdiction or
control do not cause damage to the environment of other states.
Respect for human dignity is the cornerstone of the Charter of the UN (1945), but
also has relevance to the concept of environmental protection and how it can be
achieved. For example, it recognises the need for the respect of individual human
rights, and for the consequent range of human views on valuing the environment.
Stakeholder engagement is another practice that respects human dignity.
There are many international agreements relating to the conservation of both
species and habitats. They essentially relate to the ‘importance’ or ‘vulnerability’
attached to individual species, or areas where many species live, particularly with
regard to the need for agreement at an international level in order to protect them.
The obligation of maintaining biodiversity also stems from the Rio Declaration
(UN, 1992), and it recognises the need to maintain the biological diversity inherent
within each species, amongst different species, and amongst different types of habi-
tats and ecosystems.
Agreement on principles does not mean that disagreement will not arise over how
those principles might be applied. There can still be different perspectives on which
types of effects matter most: for example, depending on whether harms are evaluated
in terms of sentience, animal rights, consequences for existing humans, or effects on
future generations.
4. ASSESSING ENVIRONMENTAL IMPACTS OF RADIATION

4.1. When does change become damage?
The environmental impacts of both Chernobyl and Fukushima are a matter of
ongoing debate (Smith, 2008; Beresford and Copplestone, 2011), despite an
agreement that radiation exposure can cause changes in biota. It is accepted that
deterministic and stochastic effects in plants, insects, and animals have been seen
350
both in the laboratory and after serious accidents, and that species can show large
variations in radiosensitivity (UNSCEAR, 2008). The Chernobyl accident caused a
number of environmental changes, ranging from reduction in soil invertebrates to
alleged DNA damage and genetic mutations in a number of species (IAEA, 2005;
Møller and Mosseau, 2009; Garnier-Laplace et al., 2013). Damage to pine trees in
the Red Forest resulted in the pine forests being replaced by the more radioresistant
birch (IAEA, 2005). Immediately after the Fukushima accident, questions were
raised about the possible ecosystem effects, and studies claiming impacts on butter-
flies and birds in contaminated areas (Hiyama et al., 2013; Fujita et al., 2015;
Bonisoli-Alquati et al., 2015; Garnier-Laplace et al., 2015), although not without
controversy (UNSCEAR, 2015), were widely reported in both the scientific and
traditional media.
In addition to scientific debate about the cause of such changes, scientists also
disagree over whether or not these changes reflect permanent or serious ecological
damage; after all, the forests grew back, the wildlife returned, and genetic change is
not always a bad thing (Baker et al., 1996). A number of people have suggested that
the ecological benefit of removing humans from the Chernobyl area might outweigh
any radiation detriments (Mycio, 1999). The consequences that are deemed ‘harmful’
may differ with the level of protection awarded to the various components of the
environment (individual, population, species, ecosystem). This, in turn, can depend
on the moral standing of those components.
The regulation on human radiation exposure takes effects on individuals very
seriously. Management of environmental hazards tends to disregard low rates of
stochastic effects, focussing instead on the risk of harm to populations. In this
respect, most environmental risk managers make a clear moral distinction between
human and non-human species; individual humans matter, whereas individual ani-
mals tend not to matter. The types of radiation exposure that result in observable
(and probably, therefore, unacceptable) damage on a population level are thought to
be far higher than the mGy levels at which intervention to protect humans takes
place. While this might be true for mortality, it need not be the case for other bio-
logical endpoints such as reproductive ability and genetic effects. In some cases, such
as for endangered species, effects on the individual are deemed to matter, even if not
quite as much as for individual humans. Of course, the variety of non-anthropo-
centric views may offer quite different interpretations and explanations on this last
point. Some may be offended by the mere presence of man-made radionuclides in the
environment, irrespective of any discernible effect on humans or biota.
4.2. Ecosystem approach and ecosystem services

The interrelationship between the environment, economy, and society is grounded
in the principle of sustainable development, and a central component of an ecosys-
tem approach to environmental protection (Costanza et al., 1997; Millennium
Ecosystem Assessment, 2005). This approach focusses on the ecosystem, rather
than single species, and the sustainable use of resources. It stresses the inherent
dynamic interactions between system components (including humans), potential
351
feedback loops, indirect effects, and resilience. The concepts of ecosystem services
and ecological economics are aimed predominantly at the ultimate benefits of eco-
systems for humans, either financially or otherwise, while the ecosystem approach is
arguably less human-centred. Nevertheless, all approaches share a fundamental rec-
ognition of the integration and interdependency of humans and the environment.
This type of holistic analysis is also in line with ecosystem approaches to environ-
mental impact assessment, as proposed by IUR (2012) and other environmentalists
(Suter and Bartell, 1993) as a possible way of reconciling anthropocentric and non-
anthropocentric world views in practice. Assessment of ecosystem services is an
increasingly recognised approach to document the consequences of ecosystem changes,
especially with reference to economic and societal values (Millenium Ecosystem
Assessment, 2005). However, the approach is not without controversy, particularly
with respect to monetary valuation and the practical implementation of the approach
(Spash, 2008; Kapustka and McCormick, 2015). Some ecologists have suggested that
the root of the problem is capitalism itself, and, in turn, the reduction of all societal
values to profits and losses. In a market economy, nothing can be sacred, since to be
sacred means to be ‘non-exchangeable’ (Kovel, 1993; Spash, 2008).
An analysis of the economic consequences of the Japan tsunami and Fukushima
accident on fishing industries highlights some of the challenges and controversies in
such assessments. Direct economic costs include damage to the fishing industry infra-
structure and the loss of seafood and marine product sales. However, the ecological
economist Shunsuke Managi pointed out that as Japanese fishing industries were
heavily subsided, the Japanese Government is actually saving money through fishing
restrictions (Pacchioli, 2013). Managi also noted that some might see the opportunities
to rebuild and rejuvenate the fishing industry (Pacchioli, 2013). While there may be
concerns about the potential impact of the ionising radiation on marine species, there
are also ecological benefits from banning or restricting fishing over large areas. Note
that none of the above points should be seen as reasons to ‘justify’ the accident; they
illustrate the complexities in performing ecosystem service assessments, and stress that
different parts of the community can be impacted in different ways (Oughton, 2011;
Oughton and Howard, 2012). The accident and contamination caused immense soci-
etal hardships on the lives of those affected, including complex demographic changes
in the predominately young, and people moving out of contaminated areas and not
continuing in family businesses (IAEA, 2015).
Recognising some of the more fundamental concerns that ecocentrics have about
the links between ecological damage and monetary valuation of natural resources is
perhaps the most important recommendation, such that damage is not only assessed
in terms of instrumental value. Assessors should also respect the idea of intrinsic
value of plants, animals, and the environment.
5. CONCLUSIONS
Supporters of both anthropocentric and non-anthropocentric ethics can agree
that harms to non-human populations should be avoided. They may disagree on
352
the level of population change that can be accepted, and which populations should
be considered as the most important to protect. Anthropocentrics and ecocentrics
may focus on endangered species or habitats, and biocentrics may focus on certain
individuals as having value in themselves. Both anthropocentrics and ecocentrics
may find it necessary to address changes in the abiotic environment, such as
increased concentrations of radionuclides in soil, water, and air. Anthropocentrics
support that such views may arise from aesthetics or a wish to ‘preserve’ ‘pristine’
environments such as the Arctic; ecocentric support may arise from consideration of
the inherent value of all components of the ecosystem. Although population effects
can be an appropriate focus for environmental protection from ionising radiation,
this is unlikely to be at the exclusion of effects on individuals, ecosystems, or even the
abiotic environment itself. There are likely to be cases where consideration of indi-
vidual impacts (e.g. endangered species) or pristine environments would be
appropriate.
The variety of cultural and religious beliefs about the way that humans perceive
nature, and the differences in opinion on what has moral standing and why can have
a strong influence on the question of what is ecological harm, and what is meant by
it. Environmental policy needs to be able to acknowledge, respect, and protect this
diversity in beliefs. It would be naive to expect radiological protection practitioners
to resolve such fundamental problems within environmental philosophy, yet it is
important that any framework developed should be sufficiently flexible to
incorporate both anthropocentric and ecocentric values. To be successful, and
broadly justifiable in practice, environmental policy needs to consider both
issues (Rolston, 1991).
Ethics should be seen as a tool rather than a burden in policy making. As there are
no easy answers to the challenges highlighted above, any system of environmental
protection should be sufficiently flexible to allow such conflicts to be addressed.
Ethical evaluation can be valuable both in identifying controversies, in forcing deci-
sion makers to address the issues, and in clarifying the premises upon which decisions
are being made. Showing that decision makers are aware of, and have considered,
such conflicts is an important step in making ethical issues transparent in policy
making. Ethical evaluations also encourage attempts to find alternative solutions
in order to mitigate or avoid the ethical insult, and help document the assumptions
and reasons behind eventual disputes. For instance, it is helpful to know whether
experts disagree on ways of managing radiation risks due to a matter of fact (e.g.
they might disagree about the environmental consequences or the probable cost of
remediation) or a matter of ethics (e.g. they may disagree about the relative import-
ance of human interests against those of non-human species).
Regarding radiological protection, most people would agree that harms caused by
radiation exposure of non-human species should carry weight in optimisation and
justification because the species has value in itself, and/or because of the potential
consequences for future human generations. In this respect, protecting the environ-
ment from radiation will need to be put into context with the risks from other
environmental contaminants and detriments. Unless there are clear and morally
353
relevant grounds, radiation damage should not be treated differently from other
hazards. The significant progress made in developing frameworks and tools
for assessment of the effects of ionising radiation over the past two decades
(e.g. ICRP, ERICA) means that decision makers have a much more robust scientific
basis for comparison of the ecological impacts of radiation with other environmental
stressors.
To conclude, there is a need for a holistic evaluation of the environmental impacts
of ionising radiation that not only considers the direct consequences on the health of
humans and non-human species, but also the more complex, social, ethical, and
economic consequences of both human and non-human exposures. Ethical risk
evaluation for both humans and the environment extends the issue of whether a
risk is acceptable, into dimensions that go beyond its probability of harm; ethical
risk management asks questions other than those connected simply to radiation dose
and its economic costs.
ACKNOWLEDGEMENTS
The author would like to thank the reviewers for their insightful comments on the text. This
work was partly supported by the Research Council of Norway through its centres of excel-
lence funding scheme (Project Number 223268/F50).
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357
Are the core values of the radiological
protection system shared across cultures?
F. Zölzer
Department of Radiology, Toxicology, and Civil Protection, Faculty of Health and Social
Studies, University of South Bohemia, Emy Destinove´ 46, 37005 Česke´ Budeˇjovice,
Czech Republic; e-mail: zoelzer@zsf.jcu.cz
Abstract–In spite of ongoing globalisation in many fields, the ethics of radiological protection
have long been discussed almost exclusively in terms of ‘Western’ moral philosophy concepts
such as utilitarianism or deontology. A cross-cultural discourse in this field is only just begin-
ning. In ‘Principles of Biomedical Ethics’, Beauchamp and Childress suggested that there
exists a ‘common morality’ which is ‘not relative to cultures or individuals, because it tran-
scends both’. They proposed four cross-culturally valid principles for decision making in
medicine: respect for autonomy, non-maleficence, beneficence, and justice. A similar approach
is being developed by the International Commission on Radiological Protection Task Group
94 on the ethics of radiological protection. Here, the core values are: human dignity, benefi-
cence/non-maleficence, prudence, and justice. Other values could be added, such as consider-
ation for the interests of society as a whole or the interests of future generations, or procedural
values such as transparency and accountability; this paper will include a brief discussion on
how they relate to the four basic principles. The main question to be addressed here, however,
is whether the proposed core values are indeed part of a ‘common morality’. This, as it will be
argued, cannot be decided by a global opinion poll, but has to be based on an analysis of the
written and oral traditions that have provided ethical orientation throughout history, and are
still considered seminal by the majority of people. It turns out that there are indeed many
commonalities across cultures, and that the concept of globally shared core values for the
radiological protection system is not hopelessly idealistic.
Keywords: Globalisation; Biomedical ethics; Core values; Procedural values; Balancing

principles
Protection. This research was supported by the Czech Ministry of Interior (VG20132015122).
358
1. GLOBAL ETHICAL BASIS FOR RADIOLOGICAL PROTECTION

1.1. Ethical basis of radiological protection as seen until now
The 2007 Recommendations of the International Commission on
Radiological Protection (ICRP, 2007) obviously presuppose certain elements of
ethics, but these are not always made explicit (Clarke and Valentin, 2009).
Individual authors, including members of the Commission (Clarke, 2003; Streffer
et al., 2005; González, 2011), have identified arguments from utilitarian, deonto-
logical, and other types of ethics.
Thus, for instance, the principle of justification (‘any decision that alters the radi-
ation exposure situation should do more good than harm’) calls for a weighing of
positive and negative consequences of radiation exposures, and is therefore often
thought to be based on utilitarian thinking. However, alternative interpretations
have been offered, ranging from Aristotelianism (Hansson, 2007) to
Machiavellianism (González, 2011). Without going into any detail, this fact alone
shows that the ethical basis of the first principle is not unambiguous.
Somewhat less controversial is the assignment of the principle of optimisation
(‘the likelihood of exposure, the number of people exposed, and the magnitude of
their individual doses shall be kept as low as reasonably achievable, taking into
account economic and societal factors’). As it aims to minimise risk, while leaving
room for other aspects of human well-being, it is generally considered to be utilitar-
ian in nature. Whereas the justification principle is only looking for a net positive
outcome, this second principle is to ensure the widest possible margin between cost
and benefit. ICRP (1973) has even explicitly recommended cost–benefit analysis as a
tool for optimisation.
In contrast, the principle of dose limitation (‘the total dose to any individ-
ual from regulated sources in planned exposure situations . . . should not
exceed the limits specified’) stems from the consideration that doing
good to some people cannot justify doing harm to others. It is not accept-
able, for instance, to expose one individual to a relatively high risk in
order to save many individuals from a relatively low risk, even if this would lead
to a reduction in the collective risk. In the third principle, a deontological argument
is at work, where the emphasis is on the rights of individuals rather than on overall
usefulness.
The problem with all this is that in moral philosophy, utilitarian and deonto-
logical theories are considered to be mutually exclusive because they have different
priorities. For the utilitarian, all that counts is the ‘greatest happiness for the greatest
number’ (Bentham, 1776), whereas the deontologist will insist that you should ‘treat
humanity, whether in your own person or in the person of any other, never merely as
a means to an end’ (Kant, 1795). It is not clear how a combination of these two is
supposed to work, as there are many situations where one would be completely
incompatible with the other. The current philosophical foundation of radiological
protection is therefore rather problematic (Shrader-Frechette and Persson, 1997;
Persson and Shrader-Frechette, 2001; Gardiner, 2008).
359
1.2. Global perspective of ethics

Beyond the role of utilitarian and deontological arguments in the evolution of the
ICRP recommendations, the question can be raised regarding whether it is at all
appropriate in a globalising world to base the recommendations of an international
advisory body mainly on ethical theories developed in Europe during the era of
enlightenment. Less than 30% of the world’s population is living in Europe and
the Americas, but over 50% in Asia and another 20% in Africa and the Middle
East. Is it reasonable to expect the majority of mankind to adopt principles of
radiological protection developed in a context largely alien to them?
It is true that population numbers do not reflect the relative use of radioactive
materials or radiation around the globe, but this situation is gradually changing.
According to the World Nuclear Association (WNA, 2015), there are currently 436
nuclear power reactors in operation, and only 120 of them (28%) are in Asia, Africa,
and the Middle East. However, of the 67 reactors worldwide under construction and
the 166 reactors planned, 43 and 104 (64% and 63%, respectively) will be operating
outside Europe and the Americas. As for medical radiology, a statistical survey for
2011 showed that, on average, 131 computer tomography examinations were per-
formed per 1000 inhabitants of the Organisation for Economic Co-operation and
Development countries. Figures close to this average were reported for Israel
(n ¼ 127), Korea (n ¼ 119), and Turkey (n ¼ 112) (Statista, 2015). These examples
indicate that radiological procedures with relatively high exposures are not restricted
to countries with a ‘Western’ tradition of thought, and countries in Asia, Africa, and
the Middle East are catching up.
Global approaches to questions of values and norms are becoming more and
more common. A first milestone in this development was certainly the ‘Universal
Declaration of Human Rights’ (United Nations General Assembly, 1948). In the
second half of the 20th Century and especially around the turn to the 21st Century,
a number of other international statements on human rights followed, such as the
‘Declaration of the Rights of the Child’ (United Nations General Assembly, 1959),
the ‘Declaration on Human Environment’ (United Nations Conference on the
Human Environment, 1972), the ‘Declaration on Environment and Development’
(United Nations Conference on Environment and Development, 1992), the
‘Universal Declaration on the Human Genome and Human Rights’ (UNESCO,
1997), and the ‘Universal Declaration on Bioethics and Human Rights’
(UNESCO, 2005).
Of course, the idea of human rights (i.e. inalienable rights that belong to every
human being) goes further back in the history of philosophy. Usually, the Stoic
school of philosophy (3rd–6th Century B.C.) is considered to be the first to have
developed the thought. Bartolomé de las Casas (early 16th Century) was nevertheless
still ahead of his time when he advocated the universality of human rights, stating
that ‘all peoples of the world are humans . . . The entire human race is one’ (Carozza,
2003). The idea gained prominence in the era of enlightenment, mainly with John
Locke (1689) arguing that ‘by nature’ human beings have a right to ‘life, liberty, and
property’. Immanuel Kant (1795) emphasised the interconnectedness of human
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rights and human dignity, and their fundamental importance for the international
context, as ‘the community of nations of the earth has now gone so far that a vio-
lation of right on one place of the earth is felt in all’.
With the rise of globalisation over the last few decades, philosophers have
addressed the need for, and possibility of, global ethics from various points of
departure. A few examples may suffice here. Habermas (1998) spoke of a ‘post-
national constellation’ in which we find ourselves, and claims that ‘world citizen-
ship . . . is already taking shape today in worldwide political communications’.
Interested in human flourishing and its global dimension, Sen (2009) wrote exten-
sively about the ‘idea of justice’, which he shows to be central to various cultures
around the world, past and present. One of his close associates, Nussbaum (2004)
identified a number of ‘core capabilities’ to which all individuals in all societies
should be entitled, thus constituting the base of her account of ‘global justice’.
Appiah (2006) explored the reasonability of cosmopolitanism, which he defined as
‘universality plus difference’. While emphasising ‘respect for diversity of culture’, he
suggested that there is also ‘universal truth, though we are less certain that we have it
all already’. Bok (1995) suggested that ‘certain basic values [are] necessary to col-
lective survival’ and therefore constitute a ‘minimalist set of such values [which] can
be recognised across societal and other boundaries’. That does not preclude the
existence of ‘maximalist’ values, usually more culture-specific, nor the possibility
that they can ‘enrich’ the debate, but there is a ‘need to pursue the enquiry about
which basic values can be shared across cultural boundaries’.
One area in which cross-culturally shared ethical principles, values, and norms are
actively discussed is interfaith dialogue. One outcome of such activities was the
‘Declaration towards a Global Ethic’ signed at the Parliament of the World’s
Religions 1993 in Chicago by the representatives of more than 40 different religious
traditions. It proceeded from the assumption that ‘there already exist ancient guide-
lines for human behaviour which are found in the teachings of the religions of the
world and which are the condition for a sustainable world order’ (Küng and
Kuschel, 1993). Interfaith declarations on more specific topics such as business
ethics and environmental ethics have followed (Webley, 1996; Orth, 2002).
1.3. Biomedical ethics as a model

The most widely applied framework of biomedical ethics is probably the frame-
work developed by Beauchamp and Childress (1979) which, although not originally
conceived as a cross-cultural type of ethics, turned out to be compatible with such an
approach. It is based not on one overall conceptual framework (as is the case with
utilitarianism or deontology), but on four somewhat less general principles (respect
for autonomy, non-maleficence, beneficence, and justice). In the more recent editions
of their book, the authors assumed that these principles are rooted in ‘common
morality’, which is ‘not relative to cultures or individuals, because it transcends
both’ (Beauchamp and Childress, 2013).
Beauchamp and Childress are not really interested in the question of where and
how ‘common morality’ can be found. When they introduced the term, they just
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claimed that ‘all morally serious persons’ (Beauchamp and Childress, 1994) or, in the
current edition, ‘all persons committed to morality’ (Beauchamp and Childress,
2013), would agree with their four principles. The present author does not find
this convincing. More effort is needed to show that these principles have cross-
cultural validity, or to find others that are more widely acceptable.
The possibility exists, of course, that empirical research could be used to test the
assumption that the underlying principles are right, but the author is not convinced
that anthropological or cultural studies alone would be meaningful. A universal
‘opinion poll’, which would find out what people around the globe are thinking
about the pertinent questions, would just reflect current dispositions and would be
very much subject to fluctuations. Something with greater long-term validity is
needed.
Orientation has been provided throughout the ages by the religious and philo-
sophical traditions of the different cultures. Although ‘Western’ society is largely
secularised, and fundamentalism, fanaticism, and extremism have brought religion
into discredit, the fact that these traditions continue to be of great influence for
people not versed in ‘Western’ secular philosophy cannot be ignored. Even in the
‘West’, the importance of Christianity is probably still much greater than the number
of people attending Sunday church services would suggest. The views of Europeans
and Americans have been shaped at least as much by Christian values passed on
from generation to generation for centuries, as by the philosophical traditions of the
enlightenment era. An analysis of ‘common morality’ cannot therefore pretend that
religion has no role to play in the 21st Century.
The author’s suggestion then is that the most important documents for establish-
ing a ‘common morality’ are the sacred scriptures of the world’s great religions, such
as the Vedas and the Bhagavadgita for the Hindus, the Sermons of Buddha for the
Buddhists, the Torah for the Jews, the Gospels for the Christians, the Quran for the
Muslims, the Writings of Bahá’u’lláh for the Bahá’ı́s, and so on. They provide a
framework of orientation for the believers (even though there may be some disagree-
ment regarding their exact meaning), because they are considered to be divinely
inspired. A non-believer will, of course, have some difficulty with this notion, but
may at least appreciate that these scriptures reflect values deeply rooted in the vari-
ous cultures. Another category of useful documents for this purpose is those pro-
duced by way of intra- and interreligious dialogue, because they already reflect a
certain cross-cultural agreement.
There are also relevant cultural expressions outside the context of (organised)
religion. Thus, oral traditions in the form of proverbs, stories, legends, and myths,
especially those of indigenous people who have no written records, should not be
ignored. In addition, secular texts of various types that have had a formative influ-
ence over the centuries should be considered. The Hippocratic Oath comes to mind,
or the works of certain philosophers of ancient Greece and China (even if Confucius’
writings are perhaps more appropriately classified as sacred scripture). In addition to
these time-honoured traditions, some modern documents such as the abovemen-
tioned ‘Universal Declaration of Human Rights’ or the ‘Universal Declaration on
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Bioethics and Human Rights’ have been suggested to already constitute ‘common
heritage of humankind’ (ten Have and Gordijn, 2013).
The author has previously attempted to show that the four principles of biomed-
ical ethics are rooted in the written and oral traditions of mankind (Zölzer, 2013).
This paper will seek to do the same for the four core values suggested by ICRP Task
Group 94 as a basis for the ethics of radiological protection. The Task Group did
discuss whether or not it should proceed from the Beauchamp and Childress set of
principles, recognised as they are in medical ethics and other contexts, but decided to
take a somewhat different approach. It tried to identify the core values that have
permeated the system of radiological protection from its beginning. These are simi-
lar, but not identical, to the principles suggested by Beauchamp and Childress. In the
current draft statement of the Task Group, ‘respect for autonomy’ is replaced by the
more comprehensive idea of ‘human dignity’, ‘non-maleficence’ and ‘beneficence’ are
presented as two aspects of one single concept, ‘prudence’ is added to the list, and
only ‘justice’ is left unchanged. This paper will not discuss the advantages and dis-
advantages of this deviation from the established theory of principlism, but will be
restricted to discussing the extent to which the four core values, as well as the related
procedural values, are known and respected in different cultural contexts around the
world.
2. THE FOUR CORE VALUES

2.1. Beneficence and non-maleficence
‘To abstain from doing harm’ is one of the central features of the Hippocratic
Oath (Edelstein, 1943), which was later adopted by Jewish, Christian, and Muslim
physicians (Pelligrino, 2008). The principle is also mentioned, albeit indirectly, in
similar texts from ancient China (Tsai, 1999). Of course, it has always been under-
stood that pain sometimes has to be inflicted to achieve healing, and thus non-
maleficence has to be balanced with beneficence. To work ‘for the good of the
patient’ is also part of the Hippocratic Oath, and it features quite prominently in
the mentioned Chinese medical texts.
More generally (i.e. outside the context of medicine), both beneficence and non-
maleficence can be seen as core principles in any system of religious ethics. A central
concept of both Hinduism and Buddhism is ahimsa, which means kindness and non-
violence to all living beings. The Bhagavad Gita praises the ‘gift which is made to one
from whom no return is expected’, whereas the Dhammapada states that ‘A man is
not great because he is a warrior or kills other men, but because he hurts not any
living being’. Both the Torah and the Gospel express the same thought in a different
way by exhorting everybody to ‘love your neighbour as yourself’. More concretely,
the Talmud observes that ‘to save one life is tantamount to saving a whole world’,
while the Apostle Paul suggests that ‘whenever we have the opportunity, let’s prac-
tice doing good to everyone’. The Quran asserts that ‘Whoever rallies to a good
cause shall have a share in its blessings; and whoever rallies to an evil cause shall be
answerable for his part in it’. Nevertheless, Islamic jurisprudence has the guideline
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that ‘if a less substantial instance of harm and an outweighing benefit are in conflict,
the harm is forgiven for the sake of the benefit’ (Zölzer, 2013).
In the context of radiological protection, beneficence and non-maleficence
together would certainly support the principle of justification, which calls for nothing
else than that the former should outweigh the latter. When it comes to the principle
of optimisation, the matter may be a bit more complicated, as the wording in the
ICRP recommendations suggests ‘taking into account economic and societal fac-
tors’. The interest of the general public, the ‘common good’, is certainly one factor
that none of the traditions would recommend neglecting, but economic consider-
ations are not usually on the agenda of sacred scriptures. Their emphasis is on the
human being, especially his or her spiritual and physical health. However, economic
factors cannot be neglected altogether. Resources are limited, and it is simply not
possible to invest unlimited money into better living conditions – or better radio-
logical protection, for that matter – when that would mean that other aspects
of the common good would not receive attention, or even basic needs would not
be satisfied. Therefore, this question becomes a question of justice, which will be
discussed below.
2.2. Prudence
In recent decades, there has been much discussion about the ‘precautionary prin-
ciple’, especially in the context of environmental issues. For instance, the United
Nations Conference on Environment and Development in Rio de Janeiro in 1992,
also called the ‘Earth Summit’, proposed that ‘where there are threats of serious or
irreversible damage, lack of full scientific certainty shall not be used as a reason for
postponing cost-effective measures to prevent environmental degradation’ (United
Nations Conference on Environment and Development, 1992). Another important
version is the one drawn up by a group of scientists from different disciplines gath-
ered at the Wingspread Conference in 1998: ‘when an activity raises threats of harm
to human health or the environment, precautionary measures should be taken even if
some cause and effect relationships are not fully established scientifically’
(Wingspread Conference, 1998).
Of course, the principle in its modern form cannot be expected to appear in the
written and oral traditions of different cultures. Exhortations to prudence, however,
are ubiquitous, and they are generally interpreted, by people referring to these trad-
itions for orientation, as suggesting a precautionary approach. Thus, in the
Mahabharata, Krishna advises to ‘act like a person in fear before the cause of fear
actually presents itself’, whereas Shotoku Taishi, the first Buddhist regent of Japan,
puts it this way: ‘when big things are at stake, the danger of the error is great.
Therefore, many should discuss and clarify the matter together, so the correct way
may be found.’ Confucius simply says that ‘the cautious seldom err’. The Proverbs
include the statement: ‘those who are prudent see danger and take refuge, but the
naı̈ve continue on and suffer the consequences’, and Muhammad reportedly coun-
selled one of his followers who complained that God had let his camel escape: ‘tie up
your camel first, then put your trust in God.’ For an explicit reference to the
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precautionary principle, the statement of a representative of the Australian

Aboriginals and Torres Strait Islanders is given as an example: ‘over the past
60,000 years we, the indigenous people of the world, have successfully managed
our natural environment to provide for our cultural and physical needs. We have
no need to study the non-indigenous concepts of the precautionary principle (and
others). For us, they are already incorporated within our traditions’ (Zölzer, 2013).
Prudence as a core value of the system of radiological protection is most obvious
when it comes to the optimisation principle. To keep exposures ‘as low as reasonably
achievable’ means to be cautious about possible risks, but it also means to balance
possible radiation risks with risks – and benefits – of a different nature, economic or
societal. It therefore seems appropriate that Task Group 94 suggests ‘prudence’
rather than ‘precaution’ as the key term, because it includes awareness of risks as
well as consideration of the common good, or the interest of the general public as
mentioned above.
In its latest recommendations, ICRP upholds the linear-non-threshold (LNT)
model and says that although there are no data to support or reject it in the very
low dose range, it ‘remains a prudent basis for radiological protection’ (ICRP, 2007).
However, the Commission suggests that ‘the aggregation of very low individual
doses over extended time periods is inappropriate, and in particular, the calculation
of the number of cancer deaths based on collective effective doses from trivial indi-
vidual doses should be avoided’ (ICRP, 2007). This is justified by saying that ‘the
assumptions implicit in the calculation of collective effective dose . . . conceal large
biological and statistical uncertainties’ (ICRP, 2007). In the author’s opinion, there is
an element of inconsistency here, as the calculation of collective dose presupposes the
very LNT model that is otherwise considered applicable even in the absence of direct
evidence. While it is possible that reasons to disregard ‘trivial doses’ may exist in
certain situations, the author does not believe that it is possible to forgo ethically
sound arguments if these reasons are to prevail over established principles. In the
particular case here, the fact that the Commission’s recommendation is based on
‘uncertainties’ cuts across its own statement that the application of the LNT model is
‘commensurate with the precautionary principle’ (ICRP, 2007).
2.3. Justice
The ‘Golden Rule’ is one of the most common ethical guidelines around the
world. It is found in every single tradition one may choose to look at, and even its
wording is strikingly uniform. A few examples must suffice: ‘one should never do that
to another which one regards as injurious to one’s own self’ (Hindu); ‘Hurt not
others in ways that you yourself would find hurtful’ (Buddhist); ‘Never impose on
others what you would not choose for yourself’ (Confucian); ‘That which is hateful
to you, do not do to your fellow. That is the whole Torah; the rest is the explanation;
go and learn’ (Jewish); ‘Therefore whatever you want people to do for you, do the
same for them, because this summarises the Law and the Prophets’ (Christian);
‘None of you [truly] believes until he wishes for his brother what he wishes for
himself’ (Muslim); and ‘If thine eyes be turned towards justice, choose thou for
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thy neighbour that which thou choosest for thyself’ (Bahá’ı́). Due to its general
acceptance, this rule is also foundational to the abovementioned ‘Declaration
Toward a Global Ethic’ of the Parliament of the World’s Religions (Küng and
Kuschel, 1993). It is obvious, at least from some of the versions quoted here, that
the Golden Rule can also serve as support for the principles of non-maleficence and
beneficence. However, the author believes that its greatest importance is for the idea
of justice. It asks everyone to consider the interests of the other as if they were on his
or her own, and thus demands reciprocity (Zölzer, 2013).
Justice, as such, is verifiably an element of ‘common morality’. The Bhagavad
Gita contains the promise that ‘he who is equal-minded among friends, companions
and foes . . . among saints and sinners, he excels’. In the Sermons of Buddha, a similar
statement is found: ‘he, whose intentions are righteousness and justice, will meet with
no failure.’ The Psalms observe that ‘he loves righteousness and justice; the world is
filled with the gracious love of the Lord’, whereas in the introduction to the Proverbs,
the reader is assured that here he will acquire ‘the discipline that produces wise
behaviour, righteousness, justice, and upright living’. Muhammad advises his fol-
lowers to be ‘ever steadfast in upholding equity . . ., even though it be against your
own selves or your parents and kinsfolk’. Finally, Bahá’u’lláh writes that ‘No light
can compare with the light of justice. The establishment of order in the world and the
tranquillity of the nations depend upon it’ (Zölzer, 2013).
A look at secular philosophy will be instructive here, as justice has not only been
of prime importance since Antiquity, but has also been studied systematically early
on (Johnston, 2011). Aristotle, for instance, distinguished between different forms of
justice, and his analysis has exerted decisive influence on later thought. The form
talked about here, and which is certainly also implied by the sacred scriptures quoted
above, is ‘distributive justice’. It concerns the allocation of goods and burdens, of
rights and duties in a society. However, even this one form can be viewed from
different perspectives. Which allocation of goods and burdens is just? An egalitarian
one, one that considers merits, one that considers needs, or one that respects histor-
ical developments? All this is not clear at the outset, and needs to be made the subject
not only of philosophical debate, but also of cross-cultural discourse.
For radiological protection, the principle of justice would seem to be the mainstay
of the dose limitation principle because it exhorts to a just allocation of burdens.
However, as will be argued in the section on beneficence and non-maleficence, its
reach is certainly beyond that, and it also has implications for the optimisation
principle. It is needed to better explicate exactly how ‘economic and societal factors’
should be ‘taken into account’ when determining what is ‘as low as reasonably
achievable’.
2.4. Human dignity

The last core value to be discussed here is perhaps not what one would first think
of when it comes to radiological protection. However, it is probably true to say that
very few people would deny its applicability to just about any area of human activity.
It is expressed in different ways around the world, but the basic idea is virtually
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ubiquitous – that of a dignity pertaining equally to all humans. In the Bhagavad

Gita, Krishna says, ‘I am the same to all beings . . . In a Brahma . . . and an outcast,
the wise see the same thing’. Similar statements are reported of Buddha and
Confucius. In the Bible, the prophet Malachi asks, ‘Do we not have one father?
Has not one God created us?’ The concept is also clearly expressed in the Quranic
verse: ‘We have conferred dignity on the children of Adam . . . and favoured them far
above most of Our creation.’ In Bahá’u’lláh’s writings, one finds ‘know ye not why
we created you all from the same dust? That no one should exalt himself over the
other’ (Zölzer, 2013).
These are just short glimpses from different religious sources, but the broad agree-
ment on the notion that all human beings share the same dignity is also reflected in
the ‘Declaration Toward a Global Ethic’ of the Parliament of World’s Religions in
1993 (Küng and Kuschel, 1993). It says that ‘every human being without distinction
of age, sex, race, skin colour, physical or mental ability, language, religion, political
view, or national or social origin possesses an inalienable and untouchable dignity,
and everyone, the individual as well as the state, is therefore obliged to honour this
dignity and protect it’ (Küng and Kuschel, 1993).
Moreover, human dignity has been invoked by secular philosophers for centuries.
This strand of thought begins with Stoicism, continues through the Renaissance, and
leads up to Enlightenment (Kretzmer and Klein, 2002). In our time, together with the
abovementioned religious traditions, it has played a very prominent role in the
drawing up of the ‘Universal Declaration of Human Rights’ of 1948 (United
Nations General Assembly, 1948) and the ‘Universal Declaration of Bioethics and
Human Rights’ of 2005 (UNESCO, 2005).
There is no space here for detailed discussion of the importance of respect for
‘human dignity’ with regard to radiological protection. It is clear, however, that the
third principle of radiological protection, the principle of dose limitation, partly rests
on this foundation. To expose somebody to high doses in order to spare others is
using him or her merely as a means to an end, and that is – with or without explicit
reference to deontological ethics – not in compliance with human dignity.
The Beauchamp and Childress principle of ‘respect for autonomy’ can be seen as a
concretisation or application of the idea of ‘human dignity’. It has been criticised as
being ‘more or less ethno-ethics of American society’ (Fox, 1990), but of little rele-
vance elsewhere in the world. In particular, some authors claim that people of Asian
background would generally not agree with it, or at least define it differently from
Beauchamp and Childress (Fan, 1997; Fagan, 2004; Kimura, 2014). The role of this
principle is to ensure that the patient is the main decision maker in his or her own
case. An important corollary therefore is the concept of ‘an informed consent’, which
means that neither therapy nor research can be performed without the agreement of
a competent patient. This understanding of ‘autonomy’ is certainly common in the
‘West’, but not so much in other parts of the world. There is at least anecdotal
evidence that decision making is not primarily a matter for the individual patient,
but very much a matter for the patient’s family in Latin America, Muslim countries,
Africa, China, and South East Asia (Justo and Villareal, 2003). There seems to be
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some support for such an attitude in the written and oral traditions of these areas, so
it is indeed questionable whether autonomy in the individualistic sense of
Beauchamp and Childress is justifiable as a cross-cultural principle. Task Group
94 has not included it in its set of core values. It did, however, propose procedural
values that are similar to those demanded by respect for autonomy.
3. PROCEDURAL VALUES
3.1. Transparency
Honesty, sincerity, truthfulness, and trustworthiness are unquestionably virtues
that have their place in any religious and philosophical tradition. The Mahabharata
states, ‘it is always proper to speak the truth’ (Shanti Parva 329:13), and Buddha
describes his true follower as a ‘straightforward person . . . open and honest’
(Dhammapada 9). Confucius states, ‘Every day I examine myself . . . In intercourse
with my friends, have I always been true to my word?’ (Analects 1:4). Similarly, in
the Book of Job, the main character declares, ‘My lips will not speak falsehood, and
my tongue will not utter deceit’ (Job 27:4). The Gospel of Matthew contains the
following exhortation: ‘But let your communication be, Yea, yea; Nay, nay: for
whatsoever is more than these cometh of evil’ (Matthew 5:37). The same terseness
is found in the Quran: ‘Have fear of God, and be among the truthful’ (9:119).
Finally, the Bahá’ı́ writings contain this observation: ‘Truthfulness is the foundation
of all human virtues. Without truthfulness, progress and success are impossible for
any soul’ (Advent of Divine Justice).
3.2. Accountability
Given the emphasis placed by all religions and philosophies of the world on
proper behaviour, it would be difficult to find any source not referring to the
actor’s responsibility for what he or she did or did not do. From Mahatma
Gandhi, to quote a modern representative of Hinduism, came the statement, ‘it is
wrong and immoral to seek to escape the consequences of one’s acts’ (The Diary of
Mahadev Desai), and Buddha says, ‘Don’t look at others’ wrongs, done or undone.
See what you, yourself, have done or not’ (Dhammapada 50). Confucius expresses it
in much the same way: ‘The noble person places demands upon himself, the petty
person blames others’ (Analects 15:20). The prophet Jeremiah warns that God will
‘give every man according to his ways, according to the fruit of his deeds’ (Jeremiah
17:10). Similarly, the Apostle Paul emphasises responsibility to a higher authority:
‘So then each of us will give an account of himself to God’ (Romans 14:12). Finally,
an oral tradition of Muhammad contains this statement: ‘Each of you is a guardian
and is responsible for those whom he is in charge of’ (Al-Bukhari).
3.3. Inclusiveness
Inclusiveness would seem to be the first choice for the main procedural value
behind the much-discussed concept of stakeholder involvement. It must be admitted
that participatory approaches to decision making have historically played a minor
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role. However, it is certainly possible to point to traditions that consider it highly

desirable to solve questions of general interest by way of consultation, including one
of the oldest sacred scriptures, the Rigveda: ‘Meet together, speak together, let your
minds be of one accord . . . May your counsel be common, your assembly common,
common the mind, and the thoughts of these united’ (10:191); and one of the newest,
the Tablets of Bahá’u’lláh: ‘Take ye counsel together in all matters, inasmuch as
consultation is the lamp of guidance which leadeth the way, and is the bestower of
understanding’ (11:16). It is well known that the primitive Christian and Muslim
communities provided space for open consultation, an ideal which was soon lost
from both religions’ mainstream, and has only been revived, to some extent, more
recently. A relevant statement of Shotoku Taishi, the first Buddhist ruler of Japan,
has already been quoted above: ‘When big things are at stake . . . many should discuss
and clarify the matter together, so the correct way may be found.’ Sen (2006), in
‘Identity and Violence’, presents evidence that the democratic ideas of classical
Greece for centuries found no echo anywhere in Europe, while the form of govern-
ment in some Asian city-states at the same time can be described as democratic. All
this must be considered anecdotal evidence, but it shows that it may be worthwhile
looking for participatory approaches in different traditions. At least it demonstrates
that the value of inclusiveness is not an invention of modern times, and is compatible
with traditions.
3.4. Empathy
Although it has not played a significant role in ICRP reports to date, the author
suggests that empathy should be included as a fourth procedural value, which is of
importance for the implementation of radiological protection and has indeed gained
in importance over the last decades, especially with the experience from Chernobyl
and Fukushima. The term goes back to the 19th Century and, as such, cannot be
expected to be found in much older written and oral traditions. Compassion, loving
kindness, and a caring attitude, however, are mentioned everywhere. In the
Bhagavad Gita, Krishna says, ‘who is incapable of hatred toward any being, who
is kind and compassionate, free of selfishness . . . such a devotee of Mine is My
beloved’ (12:13–14). Buddha praises ‘loving kindness and compassion’ as two of
the most important attitudes that the believer should cultivate (Metta Sutta).
‘Care for all others’ (Analects 12:22) is central to Confucius’ teachings. The
Talmud contains this statement: ‘Loving kindness is greater than laws; and the
charities of life are more than all ceremonies.’ One of the epistles ascribed to the
Apostle Peter is the exhortation: ‘Be of one mind, sympathetic, loving toward one
another, compassionate, humble’ (1. Peter 3:8). An Islamic oral tradition relates that
Muhammad said to his followers: ‘You won’t be true believers unless you have
compassion, and I am not referring to the mercy that one of you would have towards
his companion or close friend but I am referring to mercy or compassion to all’ (Al
Taberani). Finally, an American Indian Proverb recommends, ‘Never criticise a man
until you’ve walked a mile in his moccasins’.
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4. IMPORTANCE OF BALANCING
From the foregoing, it seems clear that the system of principles developed by
ICRP is indeed based on values that are shared across cultures. They can be
traced back to the religious and philosophical traditions that have provided moral
guidance for people around the world over the centuries. That is not to say that
secular ethics is wrong and useless, but just that a degree of worldwide consensus
already exists and is reflected in those traditions. It is also apparent that the values
discussed above are similar, if not identical, to the four principles of biomedical
ethics suggested by Beauchamp and Childress, which the authors consider to be
rooted in ‘common morality’. Cross-cultural validity can be demonstrated both for
the core values of the radiological protection system (beneficence/non-maleficence,
prudence, justice, human dignity) and for the procedural values which are to guide its
implementation (transparency, accountability, inclusiveness, empathy). Whether
radiological protection in practice has always, and everywhere, reflected these
values is a different question, but there is certainly a growing awareness of their
importance.
In conclusion, one aspect needs to be emphasised. The values discussed above,
similar to the principles of biomedical ethics, have only ‘prima facie’ validity, which
means that they apply as long as there is no conflict between them. If there is, they
need ‘balancing’ (i.e. their relative importance must be weighed). This is where cul-
tural specificity can play a role. Beneficence and human dignity, to give just one
example, are held in high esteem everywhere around the world, but it is not possible
to implement both of them to the same extent in every situation. If such a conflict
arises, not everybody everywhere may give the same answer to the question which of
the two is to prevail. Should one ignore a patient’s reluctance to having another x-ray
examination and impose it on him or her anyway because this will allow a better
assessment of therapy options? The answer to this question may be different in
Korea, the USA, and the Czech Republic. Some degree of plurality is certainly
acceptable, or even desirable, but there is a need for awareness of the differences,
and discussion about whether they should be retained or if a common approach
should be developed. Making the core values of radiological protection and the
related procedural values explicit, and assessing their cross-cultural validity, will
help in this endeavour.
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Annals o f the ICRP

Annals of the ICRP

Annals of the ICRP

Proceedings of the Third International

Proceedings of the Third International

The International Commission on Radiological Protection

ICRP 2015 – The Third International Symposium on the

ADVANCING TOGETHER AFTER 87 YEARS

The future of ICRP: towards a centenary and beyond . . . . . . . . . . . . . . . . . . . . . . 5

EXPLORING EXISTING EXPOSURE SITUATIONS

Understanding existing exposure situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

RADIOLOGICAL PROTECTION IN MEDICINE TODAY

Eight decades of ICRP recommendations in medicine: a perspective . . . . . . 106

THE SCIENCE BEHIND RADIATION DOSES

ICRP dose coeﬃcients: computational development and current status. . . . 156

NEW DEVELOPMENTS IN UNDERSTANDING RADIATION EFFECTS

ICRP Publication 131: Stem cell biology with respect to carcinogenesis

ETHICS IN RADIOLOGICAL PROTECTION

Ethical foundations of the radiological protection system . . . . . . . . . . . . . . . . . 297

The mission of the International Commission on Radiological Protection (ICRP) is

Although ICRP must maintain independence to undertake its mission eﬀectively, it is

‘Exploring existing exposure situations’ presented the wide variety of circumstances

Cameco Corporation, Canada; Chinese Society of Radiation Protection; Japan NUS

Abstract–The International Commission on Radiological Protection (ICRP) has been in exist-

Keywords: ICRP; Radiological protection; Recommendations

Abstract–Committee 1 of the International Commission on Radiological Protection (ICRP)

2. COMMITTEE 1 TASK GROUPS AND WORKING PARTIES

2.2. Task Group 64: Cancer risk from alpha emitters

. whether it is desirable to continue to estimate risk at low doses by assessing the

2.4. Working Party on Circulatory Disease Detriment

. detriment should be calculated separately for heart disease and stroke;

3. FUTURE ACTIVITIES TO BE MONITORED BY COMMITTEE 1

. Radiation sensitivity and individual susceptibility. Committee 1 will continue to

Abstract–The focus of the work of Committee 2 of the International Commission on

Keywords: Reference phantoms; Equivalent dose; Effective dose; Dose coefficients

2. COMPUTATIONAL PHANTOMS AND RADIATION TRANSPORT

3. INTERNAL DOSE COEFFICIENTS

4. DOSE COEFFICIENTS FOR EXTERNAL ENVIRONMENTAL

represent ICRP/ICRU recommended values. Comparisons of the protection quan-

5. USE OF EFFECTIVE DOSE

(Germany), Julian Liniecki (Poland), Katrine Åhlström Riklund (Committee 3,

Abstract–Committee 3 of the International Commission on Radiological Protection (ICRP)

Keywords: Medicine; Diagnostic; Interventional; Nuclear medicine; Radiation therapy

1. MANDATE OF COMMITTEE 3 ‘PROTECTION IN MEDICINE’

2. THE MOST RECENT REPORTS

. Publication 113. Education and training in radiological protection for diagnostic

should always be considered. Special consideration should be given to the avail-

. Task Group 89. Occupational radiological protection in brachytherapy (Chair: L.

several radionuclides. Work with the models for certain radiopharmaceuticals is

. Educational slides. Several collections of educational slides corresponding to the

. Suggestions on research priorities. Topics considered as priorities for research are

Abstract–Committee 4 develops principles and recommendations on radiological protection

Keywords: Existing exposure; Emergency exposure; Ethics; Practical applications

1.1. System of radiological protection

Fig. 1. System of radiological protection, illustrating the interrelationships of the principles of

2.2. Response to Fukushima

international developments concerning the protection of people in emergency expos-

2.3. Foundations of radiological protection

2.4. Topical reports

2.5. Support to other Committees

Abstract–Protection of the environment is integral to the system of radiological protection, as

Keywords: Dose conversion coefficients; Environmental protection; Radiation effects;

2. ELEMENTS OF THE ICRP ENVIRONMENTAL PROTECTION SYSTEM