COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document COUNCIL DIRECTIVE laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation /* SWD/2012/0137 final - NLE 2011/0254 */
COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document COUNCIL DIRECTIVE laying down basic safety standards
for protection against the dangers arising from exposure to ionising radiation Main abbreviations Table of contents Measurement units Terminology This
working document is intended for use by European Commission staff and is for
information only. It does not represent an official position of the Commission
on this issue, nor does it anticipate such a position. MAIN
ABREVIATIONS ALARA
– As Low As Reasonably Achievable Article
31 Group of Experts - the Group of Experts, established under Article 31 of the
Euratom Treaty BSS –
Basic Safety Standards DG –
Directorate General of the European Commission ESOREX
– European Study on Occupational Radiation Exposures EAEC
– European Atomic Energy Community, grounded through the Euratom Treaty EU –
European Union Euratom
- European Atomic Energy Community FAO –
Food and Agricultural Organisation HASS
– High-Activity Sealed Sources HERCA
- Heads of European Radiological protection Competent
Authorities (EU, Switzerland, Norway, Iceland) IAEA
– International Atomic Energy Agency ICRP
– International Commission on Radiological Protection ILO –
International Labour Organisation IRPA – International
Radiation Protection Association NEA
(OECD) – Nuclear Energy Agency to the Organisation
for Economic Co-operation and Development NORM
- Naturally
Occurring Radioactive Material PAHO
- Pan American Health Organization UNSCEAR
– United Nations Scientific Committee on the Effects of Atomic Radiation WHO – World Health Organisation TABLE OF CONTENTS COMMISSION STAFF WORKING PAPER IMPACT
ASSESSMENT Error! Bookmark not defined. 1........... Section 1: Procedural issues and
consultation of interested parties.................................. 10 1.1........ Organisation and timing................................................................................................. 10 1.2........ Information sources...................................................................................................... 11 1.2.1..... Projects, studies, networks,
conferences....................................................................... 12 1.2.2..... Public consultation........................................................................................................ 12 1.2.3..... Recommendations of the
International Commission on Radiological Protection (ICRP)... 12 1.2.4..... Cooperation at international level................................................................................... 12 2........... Section 2: Problem definition......................................................................................... 14 2.1........ Context of the initiative.................................................................................................. 14 2.1.1..... Introduction.................................................................................................................. 14 2.1.2..... Affected population and current
levels of exposure........................................................ 15 2.1.3..... Community radiation protection
legislation..................................................................... 16 2.1.4..... International context...................................................................................................... 17 2.2........ Underlying problems..................................................................................................... 18 2.2.1..... Health protection of workers and
the public does not respond to latest scientific progress 18 2.2.2..... Insufficient protection of workers
in NORM industries and in specific professional groups such as Outside Workers
and interventional radiologists......................................................................... 19 2.2.3..... Health protection of patients and
the public does not respond to latest advances in technologies 20 2.2.4..... Insufficient health protection of
the public from natural radiation sources......................... 21 2.2.5..... The risk of ionising radiation for
non-humans species, or the environment as a whole, is not explicitly addressed,
contrary to international recommendations..................................................................... 22 2.2.6..... Complexity of the current legal
framework for radiation protection................................. 22 2.2.7..... Opinion of the Article 31 Group of
Experts................................................................... 22 2.3........ Baseline Scenario......................................................................................................... 23 2.4........ Community right to act.................................................................................................. 24 3........... Section 3: Objectives.................................................................................................... 25 4........... Section 4: Policy options............................................................................................... 25 4.1........ Option 1: Maintaining the status
quo of existing legislation.............................................. 28 4.2........ Option 2: Revision of Basic
Safety Standards and Medical Directive.............................. 28 4.3........ Option 3: Revision and
consolidation of Basic Safety Standards and Medical Directive, and integration
of the Outside Workers Directive, the Public Information Directive and the High
Activity Sealed Sources Directive 30 4.4........ Option 4: Revision of BSS
broadening the scope to natural radiation sources................. 31 4.5........ Option 5: Revision of BSS
broadening the scope to the protection of non-human species 32 4.6........ Option 6: Revision and
consolidation of BSS and Medical Directive and integration of the other three
Directives, and broadening the scope both for the natural radiation sources and
protection of non-human species 32 5........... Section 5: Analysis of impacts....................................................................................... 32 5.1........ Analysis of the impact of Option
1................................................................................. 33 5.2........ Impact analysis of Option 2........................................................................................... 33 5.2.1..... Health and Social impacts............................................................................................. 33 5.2.2..... Environmental impact.................................................................................................... 34 5.2.3..... Economic impact.......................................................................................................... 34 5.2.4..... Coherence and clarity of
legislation................................................................................ 35 5.3........ Impact Analysis of Option 3.......................................................................................... 36 5.3.1..... Health and social impact............................................................................................... 36 5.3.2..... Environmental impact.................................................................................................... 37 5.3.3..... Economic impact.......................................................................................................... 37 5.3.4..... Coherence and clarity of
legislation................................................................................ 37 5.4........ Impact Analysis of Option 4.......................................................................................... 37 5.4.1..... Health and social impact............................................................................................... 37 5.4.2..... Environmental Impact................................................................................................... 37 5.4.3..... Economic impact.......................................................................................................... 37 5.4.4..... Coherence and clarity of
legislation................................................................................ 38 5.5........ Impact analysis of Option 5........................................................................................... 38 5.5.1..... Health and social impact............................................................................................... 38 5.5.2..... Environmental Impact................................................................................................... 38 5.5.3..... Economic impact.......................................................................................................... 38 5.5.4..... Coherence and clarity of
legislation................................................................................ 39 5.6........ Impact analysis of Option 6........................................................................................... 39 5.6.1..... Health and social impact............................................................................................... 39 5.6.2..... Environmental Impact................................................................................................... 39 5.6.3..... Economic impact.......................................................................................................... 39 5.6.4..... Coherence and clarity of
legislation................................................................................ 40 6........... Section 6: Comparing the options.................................................................................. 40 6.1........ Effectiveness................................................................................................................. 40 6.2........ Efficiency...................................................................................................................... 40 6.3........ Coherence.................................................................................................................... 43 6.4........ Conclusion................................................................................................................... 43 7........... Section 7: Monitoring and
evaluation............................................................................. 43 7.1........ Indicators for the implementation
of the new regulatory approach to the management of exposures due to natural
radiation sources:.......................................................................................................... 43 7.2........ Indicators for the success of the
comprehensive approach to the occupational exposure and the proposed recast of
Outside Workers Directive and BSS Directive 96/29:.................................................... 44 7.3........ Indicator for the level of
harmonisation of the authorisation regime.................................. 44 7.4........ Indicators for the improvement of
radiation protection in medicine:................................. 44 7.5........ Indicators for the implementation
of the regulatory approach to non-medical imaging exposure (NMIE) would be:.................................................................................................................................... 45 7.6........ The Euratom Treaty offers in
addition general monitoring tools for the implementation of the Basic Safety
Standards:.................................................................................................................... 45 LIST
OF ANNEXES Annex
I Organisations in Radiation Protection Annex
II (A) Summaries of the scientific publications, projects and studies Annex
II (B) Summaries of the Reports Published in the Euratom Radiation Protection
Series Annex
III (A) Statute and Work of the Group of Experts referred to in Article 31 of
the Euratom Treaty (Article 31 Group of Experts) Annex
III (B). Main Points from the Opinion of Article 31 Group of Experts on the
Revised Basic Safety Standards for the protection of the health of workers and
the general public against the dangers arising from ionising radiation Annex
IV Summary of the Commission Services' public consultation regarding natural
radiation sources in new Euratom BSS Annex
V Legislation enacted under Articles 30 and 31 from Euratom Treaty Annex
VI Estimated contributions to public exposure from different sources (in mSv) Annex
VII Evolution of the medical diagnostic exposure in France between 2002 and
2007 Annex
VIII. (A) Naturally occurring radioactive material and building material Annex
VIII. (B) Types of operation identified, on the basis of worker dose, as likely
to require regulatory control Annex
VIII. (C) Documents examined for the impact assessment regarding NORM Annex
VIII.(D) Worldwide trends in number of monitored workers and in collective
effective doses and effective doses to monitored workers (UNSCEAR Report 2008) Annex
VIII.(E) Exposure to ionising radiation for workers in NORM industries (case
study) Annex
IX.A. Annual Averaged Indoor Radon Concentration Annex
IX.B. Radon in Dwellings Annex
X.A. Graded Approach to Regulatory Control Annex
X.B. Total expected mass of building rubble and steel scrap Annex
XI: Table summarising possible solutions for each identified problem area (the
numbers refer to the subsections in section 2 where the issues are explained) Annex
XII: Working document: Comparison International and Euratom Basic Safety
Standards MEASUREMENT UNITS mSv (millisievert) - The dose received by
an individual is expressed with a special unit Sv (sievert) which
physically expresses the absorbed radiation energy per unit mass in a given
tissue, but actually is modified so as to express the health detriment by
weighing different organs or tissues as well as radiation types; 1 Sv = 1000 mSv Bq (becquerel) The unit for the activity
of radioactive decay, corresponding to one disintegration per second. TERMINOLOGY[1] ALARA
– see
Principle of optimisation Artificial source of ionising radiation -
Ionising
radiation emitted by radiation generators (e.g. X-ray machine) or by
radionuclides that are man-made (e.g. by irradiation of stable nuclides or as a
result of fission of uranium in a nuclear reactor). Clearance level - Level of activity
concentration in materials (e.g. from a decommissioned reactor) that may be
released from regulatory control for free circulation on the market (for reuse
or recycling) or for conventional waste disposal. Dose limit - Limit of annual exposure for an
individual (worker or member of the public) that is not allowed to be exceeded. Dose constraint - Restriction on the exposure to
an individual from a single source, lower than the dose limit. Dose constraint
is used as a starting point for the optimisation of protection; a dose
constraint should not be planned to be exceeded, but if it is exceeded, this
does not constitute a legal infringement in the same way as a dose limit. Emergency exposure situation - An exposure situation
resulting for instance from a nuclear accident and that needs to be managed as
a matter of urgency. The possible occurrence of such an event and its
management has to be envisaged already during normal operation of the
installation. Existing exposure situation - An exposure situation that
already exists at the time it is discovered so that it cannot be planned for in
advance. All natural radiation sources are managed as an existing exposure
situation if they are not affected significantly by human activities. Exemption level - Level of activity or activity
concentration of radioactive materials used in a practice, above which this
practice needs to be notified to the competent authority. Exposed worker - A worker who may be exposed to
ionising radiation as a result of working in a regulated practice. Ionising radiation - High energy electromagnetic
radiation, or particles, capable of producing ions while passing through
matter. Medical exposure - The deliberated exposure of an
individual for the purpose of medical diagnosis or treatment. Medico-legal exposure - The deliberate exposure of an
individual for insurance or legal purposes without a medical indication. Natural sources of ionising radiation - Ionising radiation from cosmic
or terrestrial origin. The latter includes long-lived radionuclides present in
the earth's crust since the beginning of time. Occupational exposure - Exposure of a worker that is
the legal responsibility of his employer. Outside worker - An exposed worker whose
occupational exposure arises in different undertakings, other than the one of
his employer. Planned exposure situation - An exposure situation that
results from a planned activity or from the planned introduction of a radiation
source. Principle of justification - This principle requires that
all planned activities involving ionising radiation result in a net benefit to
individuals and to society, outweighing the health detriment of radiation
exposure. Principle of optimisation - This principle requires that
all exposures be subject to radiation protection in such a way that they are As
Low As Reasonably Achievable ("ALARA"), allowing for medical,
economic and social considerations. Public exposure - Exposure of a member of the
public which does not qualify as an occupational or medical exposure. Reference level - Restriction on the exposure to
an individual similar to a dose constraint but for application in an emergency
or existing exposure situation. The difference is that in such situations the
prevailing exposure may happen to exceed the reference level, hence
optimisation of protection should focus on reducing such exposures down to
below the reference level in the first place. 1. Section
1: Procedural issues and consultation of interested parties Identification:
Lead DG - Directorate-General for Energy Agenda planning2008/ENER/002 1.1. Organisation
and timing In 2005, the Group of Experts referred to
in Article 31 of the Euratom Treaty[2]
(the Article 31 Group of Experts) started discussions on a possible revision of
the Euratom Basic Safety Standards, established according to Article 30 of the
Euratom Treaty. The Article 31 Group of Experts set up several topical working
groups to analyse the need for revision (Annex III). In order to support the
review and revision of existing requirements, the European Commission launched
several studies and established networks for discussion of particular
challenges. In addition, in 2009 a public consultation was carried out on the
specific topic of natural radiation sources. For the purpose of the current Impact
Assessment, a Steering Group was set up, composed of representatives of the
interested services – Secretariat General, DG External relations, DG
Employment, Social Affairs and Equal Opportunities, DG Information Society and
Media, DG Freedom, Justice and Security, DG Joint Research Centre, DG Research,
DG Health and Consumers, DG Energy. The group had two meetings and finalised
its work in October 2010. The Impact Assessment Board assessed the
draft Impact Assessment Report submitted in November 2010 and February 2011 and
issued opinions on 17 December 2010 and 22 March 2011. In the light of the
opinions DG ENER revised the Impact Assessment Report in several areas. In
particular, the problem definition was improved by clarifying the problems and
their scale (See Section 2, Sub-section 2.1). The main problems focus on
insufficient protection (2.2.1-4), the complexity of the legislation (2.2.5)
and risk perception associated with the protection of the environment (2.2.6).
The report now highlights the data presented in the annexes on the number of
radiologists, medical procedures resulting in high doses, number of employees
in NORM industries receiving doses higher than the public etc. The status and
nature of Recommendations of the International Commission on Radiological
Protection (ICRP) and International Basic Safety Standards are now explained
better in Section 2 to provide better relation with the specific objective to
ensure coherence with international standards and recommendations. A new
paragraph is introduced in Section 2.2.4 to explain why the current legislation
on exposure to natural radiation sources does not address all health issues
adequately and how the options will allow to achieve a substantial reduction of
exposure to indoor radon beyond the impact of the current Commission
Recommendation 90/143. The presentation of the objectives in Section 3 is
improved thus ensuring a better link between the problems and the objectives.
An additional objective was added in line with the problem definition and the
broader range of options. The rationale for choosing policy options is
explained both in relation to topical issues and with response to possible
legal (simplification) instruments (Section 4). Following the recommendation of
the Board, the range of options is expanded to include different options for the
scope of the legislation (See Section 4, subsection 4.5) and envisages
non-legislative measures as part of Option 3. The proposal within Option 2 to
establish a harmonised annual dose limit of effective dose to exposed workers
is now better explained. In Section 5 the impact analysis now benefits from
better identification of the industries and workers concerned and the cost for
the business and administration. In addition, analysis on stakeholders'
concerns on dose constraints, clearance levels and the requirements on the
protection of the environment is introduced in Section 5. The potential
enforcement costs for the competent authorities is presented as a general
assumption since not enough information is available on the institutional,
decision making and enforcement systems in the Member States. However, since
none of the Options will result in establishment of new administrations or
require major restructuring it is expected that the enforcement costs will be
relatively low. For instance, the establishment of national dose registries is
not a new requirement; the costs for establishment of registries are already
incurred and the administrative costs for adjusting the existing records should
not be significant. In Section 6 the effectiveness, efficiency and coherence of
the options are assessed and additional comparison tables are included to match
the underlying analysis. The impact analysis of some of the aspects of the
options is improved and the available data is better used. The observations of the Impact Assessment
Board concerning lack of justification for the proposed legislative measure in
Options 5 and 6 for protection of non-human species are correct. Indeed for now
there are no agreed criteria for protection of the non-human species. However,
the principle for protection can already be introduced in the scope of
legislative measure. Since action on this issue is recommended by ICRP and is
consistent with the draft international standards, and in the light of the
simplification effort, these options are legitimate. The Board has also underlined the
importance of the timing of this initiative –with regard to the nuclear crisis
in Japan following the earthquake and tsunami of 11 March 2011. In this respect
it has to be noted that all the options envisaged in the Impact Assessment
propose further development of the existing requirements on emergency
management systems, emergency preparedness and international co-operation.
Options 3 and 6 offer comprehensive framework which includes also the requirements
for information of the public, now established in separate piece of
legislation. Options 3 and 6 introduce more challenging requirements on
emergency preparedness and response compared to current Directive
96/29/Euratom. While the establishment of dose reference levels for the
introduction of countermeasures is still a national responsibility, the
Directive for the first time gives indication of the range of doses within
which such a reference level should be chosen, in general 20-100 mSv. In addition,
Options 2, 3 and 6 require that Member States cooperate in the establishment of
cross-border emergency plans. These options will considerably contribute to the
harmonisation of emergency plans and of national responses to emergencies. 1.2. Information
sources This
impact assessment is based on a wide range of information sources: –
European Commission initiatives - projects,
studies, networks, conferences, workshops, public consultation and other fora; –
public consultation on a "Proposal for new
requirements on natural radiation sources in the Basic Safety Standards
Directive"; –
recommendations of the International Commission
on Radiological Protection (ICRP); –
cooperation at international level. 1.2.1. Projects,
studies, networks, conferences In order to assess the implementation of
current EU legislation and to identify problem areas, the Commission (DG ENER)
initiated and supported several projects and studies on specific radiation
protection issues, the result of which were published in the Radiation Protection
Series of the European Commission[3].
The projects, studies and conferences identify challenges with the
implementation of the current radiation protection legislation and problem
areas which are not sufficiently covered by the current system of protection.
Possible solutions are proposed. Summaries of the results are given in Annex
II. 1.2.2. Public
consultation The Commission launched in 2009 a topical
consultation on a "Proposal for new requirements on natural radiation
sources in the Basic Safety Standards Directive". The Working Party Natural
Sources of the Article 31 Group of Experts offered a comprehensive approach to
the regulation of NORM industries, radon and building materials. This document
was published on the Commission website and was also highlighted on the EANNORM
website[4].
The consultation period was 02/02/2009 - 20/04/2009. A summary of the consultation (Annex IV),
and of how the different opinions had been taken care of, was published on the
EANNORM website in April 2010. The summary was also presented to the
Article 31 Group of Experts in June 2009 and the comments were further
discussed and treated by Working Parties of the Group of Experts. 1.2.3. Recommendations
of the International Commission on Radiological Protection (ICRP) The International Commission on
Radiological Protection (ICRP) plays a key role in updating scientific
knowledge on radiation risks and setting standards in radiological protection.
The new ICRP Recommendations for a System of Radiological Protection were adopted
in 2007 (ICRP Publication 103, see Annex II.1). While ICRP Publication 103 does
not change the dose limits for occupational exposure and for public exposure,
the methodology for calculating the doses has changed. ICRP also calls for a
system of protection of non-human species. The
key role that ICRP plays in setting standards in radiological protection
accelerated the process of revision of the Euratom BSS and IAEA BSS (see also
section 2.1.4). The Article 31 Group of Experts
recommended to the Commission that the revision of the BSS should incorporate
both the philosophy and the technical aspects of the new ICRP Recommendations. 1.2.4. Cooperation
at international level The revision of the Euratom Basic Safety
Standards has benefited from continuous interaction with two organisations
representing major stakeholders, namely the Heads of
European Radiological protection Competent Authorities (HERCA), the
International Radiation Protection Association (IRPA) and European Atomic Forum
(FORATOM): –
HERCA: The outline of the revision of the BSS
was presented to HERCA at meetings in December 2008 and 2009 as well as in June
2010. The response of the radiation protection authorities' representatives was
positive and HERCA did not raise any important issue calling for changes in the
approach. –
IRPA: Presentations on the ongoing revision of
the Euratom BSS have been made at the International IRPA Congress (Buenos Aires
2008) and at European Congresses organised by IRPA (Brasov, 2006, Helsinki
2010) as well as at annual meetings of the European IRPA societies. The
European IRPA branch has set up a working party to collect input from their
societies on the ongoing revision of the international and the Euratom BSS. –
FORATOM has set up special expert groups to
follow the process of revision of Euratom Basic Safety Standards. The
Commission services were in constant interaction with FORATOM and their
concerns were thoroughly discussed. More information on the role of these
stakeholder groups is provided in Annex I. The European Commission has also
cooperated closely with the IAEA and other international organisations on the
revision of the International Basic Safety Standards. The
International Basic Safety Standards reflect
an international consensus on what constitutes a high level of safety for
protecting people and the environment from harmful effects of ionising
radiation. They are approved by IAEA Board of Governors and are of
non-binding nature. The main document in radiation protection is Safety
Standards N° 115 "International
Basic Safety Standards for Protection against Ionising Radiation and for the
Safety of Radiation Sources", IAEA, 1996. In 2006, IAEA
together with other international organisations (FAO, ILO, the NEA/OECD, PAHO and WHO) undertook the revision of
Safety Standards N° 115. This ongoing activity is also driven by the new ICRP
Recommendations 103, published in 2007. The relationship between Euratom and
international standards is discussed in further detail in section 2.1.4. 2. Section
2: Problem definition 2.1. Context
of the initiative 2.1.1. Introduction For as long as they have been on the
planet, human beings have been exposed to ionising radiation from natural
sources, and since the last century also to man-made (artificial) sources.
There are two main contributors to natural radiation exposure – cosmic
radiation and radionuclides present in the earth's crust. The artificial
sources of radiation are used in various areas of life – in electricity
generation and other industrial sectors, in medicine, education and research.
The exposure to ionising radiation, both from natural and artificial sources,
is liable to affect the health and life of humans as well as non-human species.
Ionising radiation causes damage to
living tissue. The resulting health detriment relates either to cell killing,
with clinically observable health consequence at high doses, or cell mutation
and corresponding late effects (cancer, genetic deficiencies). The late effects
are assumed to have no threshold in terms of dose, the probability of
occurrence being proportional to the accumulated dose to an individual. The
harmful effects of ionising radiation are known for nearly a century. The need
for protection was recognised at the time of the conclusion of the Treaty
establishing the European Atomic Energy Community (Euratom Treaty). Since 1958,
when the Euratom Community (EAEC) was established, ionising radiation is used
more and more in other sectors of life than the nuclear industry, e.g. in
medical applications for diagnosis and therapy, in industrial applications, and
in research. Chapter III, Health and Safety, of the
Euratom Treaty, entrusts the Community with the responsibility for the
establishment of uniform basic safety standards for the health protection of
workers and the general public against the dangers arising from ionising
radiation (Article 30 – 33). Chapter III further includes requirements in
primary legislation on the control of levels of radioactivity in the
environment (Articles 35 – 39). Article 31 of the Euratom
Treaty also lays down the procedure for the establishment of these Standards,
in particular that the Commission shall seek the opinion of a Group of Experts
("Article 31 Group of Experts"). The International Commission on
Radiological Protection (ICRP), since its creation in 1927, has always played a
key role in updating scientific knowledge on radiation risks and setting
standards in radiological protection. The Community legislation has always
followed the recommendations of the ICRP. This worldwide recognised and
respected scientific organisation has recently issued new guidance on the
system of protection (ICRP Publication 103, 2007). ICRP sheds new light on the
coherent application of the principles throughout any exposure situation and
irrespective whether the source of radiation is man-made or natural. Apart from accident situations, doses are
so low that direct health effects are not observed. The absence of a dose
threshold for low-dose cancer causation however calls for a special protection
regime based on the three fundamental principles of justification of
practices or activities, optimisation of protection and limitation
of exposures. The most recent update of scientific data on radiation effects
(undertaken by ICRP, see Section 1.3.1 and Annex II.A. point 1) did not result
in the dose limits being revised. ICRP calls however for more efficient
application of the concept of optimisation of protection (doses shall be As Low
As Reasonably Achievable (ALARA)) by the introduction of constraints and
reference levels. The principle of justification also remains important,
in particular in medical applications. 2.1.2. Affected
population and current levels of exposure The population that needs to be protected
against the dangers arising from ionising radiation includes workers, members
of the public as well as patients in medical applications of ionising
radiation. Correspondingly, radiation protection relates to occupational
exposure, public exposure and medical exposure. Radiation
protection is also concerned with the protection of the environment, including
non-human species, against ionising radiation. The number of exposed workers in the EU
is approximately 1 million[5]
including around 170 000 working in nuclear industry, 680 000 in medicine, 110
000 in industry, 60 000 in education and 27 000 employed in workplaces with
enhanced exposure to natural radionuclides[6].
Most of the exposed workers are employed by the undertakings conducting
practices with ionising radiation. However, there is an important fraction of
workers working for employers providing services to different undertakings, in
particular itinerant workers doing for instance maintenance work in different
nuclear facilities ("Outside Workers"). These workers in general
receive much higher accumulated annual doses than workers permanently employed
in the nuclear industry, and therefore merit special attention. An important
fraction of workers in industries processing Naturally Occurring Radioactive
Materials (NORM) (e.g. in mines, phosphate ore processing, ceramic industries)
receive doses above the dose limit for members of the public. In 2004, the
number of workers in NORM industries in the EU which are currently regulated as
exposed workers was 27 000[7].
Studies estimate the actual number of exposed workers in EU NORM industries to
be around 85 000 (2004). While there is some information on this category of
exposed workers, the absence of a regulatory framework in some Member States
does not allow giving a precise picture. The world-wide average radiation exposure
of an individual member of the public accounts to 3.0 mSv/year and is dominated
by exposure to natural radiation sources and medical applications (see Annex
VI, Figure IV). Artificial radioactivity in the environment contributes only
little to this average radiation exposure. The assessment of the exposure of the
population to levels of radioactivity in the environment does not allow for a
possible detriment to non-human species and the environment itself. The
radiation protection experts are convinced that in any known current situation
(except the area in proximity to the site of Chernobyl) there is no observable
detriment to non-human species. The assumption that there is no effect at all
is currently not based on well defined criteria and a proper scientific
assessment however. Radon, a natural radioactive noble gas
entering buildings from the soil below and exhaled from some building
materials, is a major contributor to population exposure. Radon concentrations
are also highly variable from one building to another. While the extent of the
radon issue is defined by regional geological features rather than by State
boundaries, the affected regions extend all over Europe. Recent epidemiological
studies[8]
have confirmed the causation of lung cancer by exposure to radon, and the World
Health Organisation (WHO) now ranks indoor radon as a major health issue.
Another type of indoor exposure is due to radioactivity in building materials.
There are currently no agreed criteria for the use of building materials in new
construction, neither for natural stones nor for the recycling of residues from
NORM industries into building materials. As regards the exposure of patients, the
world trend presented by UNSCEAR[9]
is that between 1997 and 2007 the radiation exposure of the population due to
medical diagnostic examinations increased by approximately 70%. This trend is
the strongest in countries with a high level of healthcare, all EU Member
States falling under this category, where the exposure from medical uses is on
average now equal to about 80% of that from natural sources. This trend is
caused mostly by the rapid increase in the use of new, high-dose, X-ray
procedures and in particular computed tomography (CT) scanning. According to
the UNSCEAR 2008 report: "for several countries, this has resulted, for
the first time in history, in a situation where the annual collective and per
caput doses of ionising radiation due to diagnostic radiology exceeded those
from the previously largest source (natural background radiation)." 2.1.3. Community
radiation protection legislation Following the entry into force of the
Euratom Treaty, a comprehensive set of legislation establishing basic safety
standards has been enacted on the basis of Article 31 of the Treaty (see Annex
V). The main pillar of that legislation is Council Directive 96/29/Euratom laying
down basic safety standards for the protection of the health of workers and the
general public against the dangers arising from ionising radiation (Euratom BSS
Directive). The BSS Directives have been regularly
updated in 1962, 1966, 1976, 1980, 1984 and 1996[10], taking
account of advances in scientific knowledge on the effects of ionising
radiation in line with the recommendations of ICRP and on the basis of operational
experience. Medical exposures have been included in specific legislation since
1984[11].
Specific problem areas are covered in three "associated directives" –
High activity sealed sources (HASS) Directive[12],
Outside Workers Directive[13]
and Public Information Directive[14]. In 2005 the European Commission published
"A strategy for the simplification of the regulatory environment: the
better regulation initiative" (COM/2005/535 final) as a response to the
European Parliament’s and Council’s requests to simplify EU-legislation and
enhance its quality. This action is undertaken in the context of the Lisbon
strategy for achieving growth and jobs in Europe. This initiative is the basis
for attempting the consolidation of all above legislation. 2.1.4. International
context The current Euratom BSS Directive
followed the recommendations of ICRP from 1990. The Directive was transposed
and implemented in the Member States as of 13 May 2000. Since 2000, radiation protection science,
in an international context, has evolved, and ICRP issued new international
recommendations (ICRP Publication 103, 2007) and new scientific findings (e. g.
sensitivity of the lens of the eye) are published. ICRP has always been recognised to give
state-of-the-art guidance on the methodology for dose assessment, on dose
limits, and on the overall radiation protection philosophy. While for this
reason the Euratom legislation has always, since 1959, closely followed ICRP,
there is no legal obligation to do so. The ICRP makes recommendations, which
are followed world-wide on a voluntary basis. ICRP issues no regulatory
requirements, but its guidance is also incorporated in the International Basic
Safety Standards. The organisations sponsoring the International Basic Safety
Standards now also pursue a major revision of these standards, led by the IAEA
and along the recommendations of ICRP. The EAEC Community has been invited to
also sponsor the international Basic Safety Standards. This possible
co-sponsorship has been an opportunity for the Commission to be involved very
actively in the revision of the international standards as well, in order to
pursue the best possible coherence to the two documents. The international
standards are now close to final drafting (draft 4.0 was endorsed by IAEA's
Committees in December 2010). The text is close to the draft Euratom Directive
proposed by the Article 31 Experts in February 2010, but there are important
differences. A detailed comparison with draft 3.0 of IAEA was made in June 2010
(see Annex XII). There are two main reasons why referring
to or incorporating the International BSS in Community legislation is not
feasible. On the one hand, the Euratom Community is bound by the Treaty to
establish uniform basic safety standards. Incorporating the International BSS
in a community act is difficult. The language of the International BSS does not
correspond to EU legal drafting rules. The international requirements are also
sometimes far too detailed and go beyond the idea of "basic"
standards in the Euratom Treaty. The requirements of the Euratom BSS need to
allow for EC internal market rules. On the other hand, the International BSS
allow for the fact that States in the whole world, with different level of
development of regulatory and technological infrastructure, must be able to
comply with the requirements. The Community legislation is more ambitious. Hence, relying only on the
International Basic Safety Standards to ensure further development of good
practice in radiation protection would be contrary to the high standard
currently achieved in Community legislation. The Euratom standards are binding
to EU Member States, whereas the International Basic Safety Standards are not
(or only in specific contexts). If the binding Euratom Basic Safety Standards
were left unmodified, Member States would be frustrated in their desire to
adjust their legislation to the new recommendations of ICRP. In addition,
problems resulting from different requirements, especially numerical criteria,
between the International and Euratom Basic Safety Standards could become
increasingly important. To avoid such inconsistencies, all Community
legislation under Chapter III of the Euratom Treaty would in fact need to be
withdrawn, which is obviously not acceptable. It should be borne in mind that
ever since the first Euratom Basic Safety Standards (1959) and International
BSS (1962) Europe has been very much in advance of the rest of the world. 2.2. Underlying
problems The current system to protect workers,
the public, patients and the environment from the effects of ionising radiation
does not respond any longer to the latest scientific findings and new societal
and technological developments. Figure 1 summarises the problem definition. Figure
1: Graphical
presentation of the problem definition 1. Health protection of workers and the public does not respond to latest scientific progress. Members States may respond with varying national regulations || || 2. Insufficient protection of workers in NORM industries and in specific professional groups such as Outside Workers and interventional radiologists || || 3. Health protection of patients and the public does not respond to latest advances in technologies || || 4. Insufficient health protection of the public from natural radiation sources || || 5. Risk of ionising radiation for non-humans species or the environment as a whole is not explicitly addressed, contrary to international recommendations || || 6.Complexity of the current legal framework for radiation protection || ↑ || || ↑ || || ↑ || || ↑ || || ↑ || || ↑ || Current system to protect workers, the public, patients and the environment from the effects of ionising radiation does not respond to latest scientific findings and new societal and technological developments || ↑ || || ↑ || || ↑ || || ↑ || || ↑ New international recommendations (ICRP Publication 103). Recent scientific findings (e.g. sensitivity of the lens of the eye; radon in dwellings) || || Operational experience with the implementation of current Euratom radiation protection regulation in EU Member States since 1996 || || Significant exposures from natural radiation sources, e.g. radon in dwellings, NORM industries, building material || || Advances in technologies, techniques and professions. || || European Commission initiative “A Strategy for the simplification of the regulatory environment: the better regulation initiative” (COM/2005/535) 2.2.1. Health
protection of workers and the public does not respond to latest scientific
progress The current Radiation Protection
legislation reflects the status of radiation protection in the 90ies, in
particular the basic safety standards laid down in Directive 96/29/Euratom.
These standards have, since 1959, been regularly updated in the light of
developments in scientific knowledge of radiation effects and the corresponding
changes in the overall protection philosophy. ICRP, which recommendations have
over more than 50 years been the basis of the Community legislation, has issued
new recommendations in 2007 (ICRP Publication 103). ICRP plays a key role in updating
scientific knowledge on radiation risks and accordingly defining the dose
limits, as well as the methodology for the assessment of the dose. ICRP
introduces a modified methodology to calculate doses based on latest knowledge
on radiation risks. Doses calculated according to the new methodology will be
different from doses calculated according to the methodology given in the
current BSS Directive, which will impair the control of compliance with the
dose limits, especially for workers. Different calculation methods will also
lead to a gap between Euratom and international standards. In the EU, this will
concern the assessment of exposure of more than 1 million exposed workers. ICRP is also publishing new scientific
data providing evidence for a higher radiosensitivity of the lens of the eye.
Maintaining current organ dose limits for the lens of the eye would result in a
high incidence of radiation induced cataract in specific professions such as
interventional radiologists, as can be observed already now. 2.2.2. Insufficient
protection of workers in NORM industries and in specific professional groups
such as Outside Workers and interventional radiologists Industries processing natural occurring
radioactive material extracted from the earth's crust (NORM industries)
accumulate and concentrate natural radiation sources resulting in enhanced
radiation exposures of workers and, if material is released to the environment,
of the public. Either the industries use the material (e.g. production of
thorium compounds) or they are involved in the extraction itself (e.g. mining
of ores). The BSS Directive introduced already in 1996 requirements on work
activities involving natural radiation sources. The requirements offered
maximum flexibility to Member States to decide for instance which NORM
industries were of concern, and on the required level of protection for
workers. This has been cause of very different levels of achievement in
controlling NORM industries and in protecting workers in these industries. This
situation is not compatible with the Community’s role in setting uniform
standards for the protection of workers and the public. The available data
demonstrates that the workers in NORM industries may receive doses higher than
the limit for the public. In France 17% of the monitored workers in NORM
industries received effective doses above the 1mSv annual limit for the members
of the public (See Annex VIII(E)). NORM industries which may lead to
considerable exposures of workers are listed in Annex VIII.B. Although no exact
data on the size of these industries are available, the dimension of the issue
can be estimated through the following examples: 381 enterprises in the EU
extract crude petroleum and natural gas, 293 enterprises produce lead, zinc and
tin and the number of enterprises mining iron ores is estimated to 40[15]. Data on the
number of exposed workers in NORM industries are also scarce. In 2004, the
number of workers in NORM industries in the EU which are currently regulated as
exposed workers was 27 000[16].
Studies estimate the actual number of exposed workers in EU NORM industries to
be around 85 000 (2004). There are professional groups specialised
in specific tasks involving high radiation exposures, and receiving the highest
doses among exposed workers in Europe. These specialised workers are mostly in
the category "Outside Workers", as not being employed by the
undertaking in which they operate, but providing services in different
installations. It is important that this category of workers receives adequate
protection and that their doses are properly recorded. Increasing
specialisation of skilled workers in the nuclear industry also calls for an
enhanced mobility of these workers, crossing borders within the EU and beyond.
Variations in the interpretation of current requirements have led to different
national implementations, e.g. of the dose limit for occupational exposure and
the requirements on individual radiation passbooks, creating obstacles for the
mobility of these specialists. The regulation of the protection of Outside
Workers is currently split between BSS Directive 96/29/Euratom and Outside
Workers Directive 90/641/Euratom. This situation is an obstacle to a
comprehensive set of requirements for overall worker protection, in particular
with regard to the responsibilities of the undertaking and the employer for the
protection of Outside Workers. The number of Outside Workers in Europe that
would benefit from better protection amounts to approximately 100 000[17]. Technological developments in medical
applications of ionising radiation, in particular the minimally invasive
interventional radiology procedures, result in an increasing number of
interventions performed by a single radiologist in a high radiation
environment, leading to substantial doses to the body and in particular to the
lens of the eye. The epidemiological studies in this respect were discussed in
2006 in the framework of the EU scientific seminar "New Insights in
Radiation Risk and Basic Safety Standards" (Annex II.B. Radiation
Protection № 145) and are more recently summarised in a review by the
Article 31 Group of Experts Working Party on Research Implications on Health
and Safety Standards[18].
Health protection of individuals from this professional group needs
improvement, not only for the lens of the eye. This group of professionals is
estimated to amount in Europe to approximately 12 000. 2.2.3. Health
protection of patients and the public does not respond to latest advances in
technologies In the medical area, important
technological and scientific developments, e.g. in X-ray computed tomography
imaging (CT), in minimally invasive interventional radiology procedures and in
nuclear medicine, have also caused a notable increase in the exposure of
patients. As an example in France the number of performed medical procedures in
the period 2002-2007 has increased by only 2%. However, the annual dose per
capita from these procedures increased by 57% in 5 years (see Annex VII). While
high dose CT procedures are generally for the benefit to the diagnosis of the
patient, recent years have indicated that too many examinations are carried out
although the CT procedure would not be necessary for the diagnosis. The IAEA[19] estimates
that in economically advanced countries more than 20% of the radiological
examinations may not be justified; in special cases this can be as high as 45%,
and even up to 75% for specific techniques. With the ever-growing use of
radiological imaging there is a corresponding increase in non-justified
exposures. An issue of particular concern is the rapidly growing use of
high-dose procedures (e.g. CT) on children, where the higher sensitivity to
radiation and the longer available time to develop the disease may lead to an
observable increase in cancer rates in a few decades. A further problem
resulting from the new technologies is an increase in the reported cases of
unintended high exposures in radiotherapy and in interventional radiology,
sometimes with severe individual consequences. These issues have been
highlighted in a recent Communication of the Commission to the Council[20]. Advances in
imaging technology using ionising radiation have similarly benefited its
non-medical applications, where new issues, not foreseen a decade ago, emerged.
Security screening with X-rays, e.g. of passengers in airports, normally
involves very low individual screening doses. However, in the case of routine
screening the frequency of exposure and the number of exposed individuals may
quickly become significant thus requiring specific justification and regulatory
response to ensure adequate protection of the public[21]. 2.2.4. Insufficient
health protection of the public from natural radiation sources Radon is a radioactive gas that emanates
from rocks and soils and tends to concentrate in enclosed spaces such as
underground mines and houses. Studies on indoor radon and lung cancer provide
strong evidence that radon causes a substantial number of lung cancers in the
population; the proportion of lung cancers attributable to radon ranges from 3%
- 14%. It is after smoking the second known cause of lung cancer. Exposure to
radon in dwellings was addressed in 1990 in a Commission Recommendation[22]. The, now
confirmed, causation of lung cancer by exposure to radon calls for
strengthening radon mitigation policies in Europe through binding requirements,
in line with WHO guidelines[23].
Public health strategies to prevent radon in new buildings through appropriate
building codes and to remediate existing building allow reducing the radon risk
and the number of lung cancers. In Sweden, for example, more than 10% of
dwellings show radon concentrations above 200 Bq/m3, which is
considered a level, new buildings should not exceed, putting a considerable
fraction of the population at enhanced risk of developing lung cancer. The
respective percentage varies between Member States ranging from very low in the
Netherlands, over less than 1% in United Kingdom to 12% in Finland (see also
Annex IX). Even though the extrapolation is difficult, one could say that some
10 million European citizens are concerned by this health issue. The Commission Recommendation of 1990
already raised the issue at an early stage and recommended reference levels
which are still used in most Member States and close to the most recent
international recommendations (even though now WHO and ICRP advocate a maximum
reference level of 300 Bq/m³ rather than 400 Bq/m³ in the Commission
Recommendation). The experience with the Recommendation, in most Member States,
however was that it is not sufficient to establish reference levels; tangible
results can only be achieved through a constant and ambitious programme to make
progress in reducing radon concentrations in existing and new dwellings. The
establishment of such a "Radon Action Plan" should become a mandatory
requirement; in addition the Commission should be kept informed of such plans
and on the identification of radon prone areas. Natural radioactivity in building
materials also contributes to the exposure of the public and can lead to
exposures above the dose limit for members of the public. A coherent and uniform
framework for the protection of the public against building materials with high
levels of radioactivity, either from the recycling of residues from NORM
industries or from other sources, is still missing. To give an indication of
amounts of building materials, the production of granite (crude or roughly
trimmed) in the EU in 2009 was around 4.5 billion kg. The production of
porphyry, basalt, quartzite and other monumental or building stone (crude,
roughly trimmed, cut) in the EU in 2009 was around 15 billion kg[24]. 2.2.5. The
risk of ionising radiation for non-humans species, or the environment as a
whole, is not explicitly addressed, contrary to international recommendations The radiation protection approach
prevailing in 1996 was based only on the health protection of man, without
explicit consideration of a possible detriment to other species. Overall, there
has been a growing concern in society for the protection of the environment,
and the fact that this is not explicitly addressed with regard to ionising
radiation contributes to the lack of acceptance. In 2002, the European
Commission (at the time DG Environment) hosted a main stakeholder conference
(Stakeholder's conference on approaches to environmental radioactivity,
Luxembourg, 2-3 December 2002) concluding on the need for a revision of the BSS
to ensure the protection of the natural environment. While it is generally
believed among radiation protection specialists that the exposure of biota does
not call for additional measures, there are currently neither criteria nor an
agreed methodology for demonstrating compliance with environmental standards.
Such demonstration is warranted by widespread public and political perception
that nuclear industry causes an environmental detriment. In addition, the protection
of the environment against radiation is pursued under a number of international
agreements (for instance under the OSPAR Convention). Also ICRP now advocates
the explicit assessment of the impact of ionising radiation on non-human
species, as part of an overall environmental policy rather than one looking
only into environmental pathways of human exposure and corresponding health
detriment. ICRP has already published a methodology for the assessment of
exposures to biota (ICRP Publication 108). 2.2.6. Complexity
of the current legal framework for radiation protection The analysis of the legislation enacted
under Article 31 of the Euratom Treaty (Annex V) reveals that the Medical
Directive[25],
High activity sealed sources (HASS) Directive[26],
Outside Workers Directive [27]and
Public Information Directive[28]
are closely linked with the BSS Directive 96/29, developing further the
requirements of this Directive or referring to different texts of the BSS
Directive. As these issues have been developed over a long period of time
(1989-2003), the respective legislative acts are not streamlined. They,
therefore, constitute a complex set of legislation, which is cumbersome to read
and apply. This problem was identified in the context of the Commission's
policy of simplification of Community legislation. 2.2.7. Opinion
of the Article 31 Group of Experts Article 31 of the Euratom
Treaty defines a specific procedure for the elaboration of basic safety
standards for the protection of the health of workers and the general public
against the dangers arising from ionising radiation - "the basic safety
standards shall be worked out by the Commission after it has obtained the
opinion of a group of persons appointed by the Scientific and Technical
Committee from among scientific experts, in particular public health experts,
in Member States". Thus, the Group of Experts established in accordance
with Article 31 of the Euratom Treaty is involved in all Euratom initiatives in
the radiation protection field. The Article 31 Group of Experts
has assisted the Commission in analysing the implications of the new ICRP
Publication 103, and has concluded that it justified a comprehensive review of
the Community radiation protection legislation. They eventually recommended to
revise the Euratom Basic Safety Standards and, in the context of the
simplification initiative, other related legislation. The Article 31 Group of
Experts also looked into operational experience and new technical developments
since the adoption of the Basic Safety Standards Directive and the Medical
Exposure Directive. The Experts set up various working parties to resolve
technical issues, to assist the Commission in drafting new or modified
requirements, and to help with the simplification efforts. In February 2010, at the end of their 5
years mandate, the Experts issued an Opinion[29]
on the revision of Directive 96/29/Euratom and the integration of the other
directives (Council Directive 97/43/Euratom, Council Directive 90/641/Euratom,
Council Directive 2003/122/Euratom, Council Directive 89/618/Euratom). The
Opinion is based on the results of the studies and networks commissioned by the
European Commission (see Annex II) and the reports of the Article 31 Group of
Experts Working Parties. The principal observations of the Working Parties, as
reflected in the opinion of the Article 31 Group of Experts, are listed in
Annex III., in particular the concept of a "graded approach" to
regulatory control (see Annex X) which may have a positive economic impact. The
issues addressed by the Experts, other than the core issues discussed in the
previous sections and the abovementioned "graded approach", are not
analysed in further detail in this report. Bearing in mind Article 31 of the Euratom
Treaty, the Commission has an obligation to take the Opinion of the Experts
into account if it proposes new or revised radiation protection legislation. 2.3. Baseline
Scenario All things remaining equal,
i.e. without new or revised Community legislation, the problem areas described
in Section 2.1 will continue to exist and, in the absence of Community
legislation harmonising the national requirements, will show little prospect
for improvement. Indeed, Member States may align with the new ICRP
Recommendations or scientific evidence through their own interpretation or
through the International BSS, as far as some of the changes that are needed
would be made in the international standards. The Euratom Community is obliged
to establish uniform basic safety standards and any abstention from
action will infringe the Treaty. Euratom legislation would loose its status of
being at the top of scientific knowledge and good practice and would no longer
be in line with international recommendations and standards. The problem of incoherence of
Community legislation will aggravate with the introduction of new specific
pieces of legislation that may be proposed in future by EU legislation. While
Member States have so far accommodated these incoherencies in national
legislation, the discrepancies may cause a significant regulatory burden over
the next decades. The exposures in medical
applications will probably further substantially increase over the next decades
(see the world trend between 2000 and 2008 in Annex VI, Figures 3 and 4). In
particular, in the absence of a requirement to report accidental exposures in
radiotherapy or other high-dose medical applications the regulatory authority
will not be in a position to intervene and correct the management or equipment
failures that are the cause of such accidents. The exposures in non-medical
imaging, e.g. for security screening, will also increase substantially over the
next decades, because of the necessity to enhance security measures at airports
and public buildings. The lack of clear radiation protection requirements as
for other public exposure may result in a proliferation of devices for security
screening not only in airports but also in schools, public buildings etc. This
may not only lead to high cumulative exposures to some individuals but also to
a high collective dose in the EU. Without a comprehensive
radiation protection system incorporating both artificial and natural radiation
sources the current lack of balance will continue to prevail, and will
perpetuate the misunderstanding that “artificial” radiation is more harmful
than "natural" radiation. In addition, the absence of
uniform community legislation may result in different regimes of regulatory
control to be imposed by Member States, both with regard to NORM industries and
to the production of building materials, which may affect the functioning of
the internal market. Different levels of protection for workers in NORM
industries and for the public from building materials will continue to exist. In summary, the baseline scenario is
expected to show the following important trends: –
Members States may respond to new developments by
introducing national regulations which will vary within Europe; –
the current set of Euratom legislation would not
be streamlined and simplified; –
the overall exposure of patients will continue
to increase and may give rise in future to an observable health detriment in
some categories of exposed individuals; –
different levels of protection of workers and
the public against natural radiation sources would continue to exist. 2.4. Community
right to act According to
Article 2(b) of the Euratom Treaty "…the Community shall, as provided in
this Treaty …. Establish uniform safety standards to protect the health of
workers and of the general public and ensure that they are applied".
Accordingly, in the Treaty's Preamble, the Member States declare that they are "resolved
to create the conditions necessary for the development of a strong nuclear
industry" and also "anxious to create conditions of safety
necessary to eliminate hazards to the life and health of the public". Community
is mandated to "establish uniform safety standards to protect the
health of workers and of the general public and ensure that they are
applied." Therefore, the competence of the European Atomic Energy
Community to regulate in the field of the health protection against ionising
radiation is explicitly recognised by the Euratom Treaty. According
to the principle of subsidiarity, in areas where the Community has no exclusive
power to act, it should only act "if and in so far as the objectives of
the proposed action cannot be sufficiently achieved by the Member States and
can therefore, by reason of the scale or effects of the proposed action, be
better achieved by the Community". The exclusive nature of the Euratom Community's
legislative powers under Articles 30 and 31 of the Euratom Treaty does not
require, in principle, the application of the principle of subsidiarity. 3. Section
3: Objectives The general objective of this
initiative is to ensure a high level of protection of workers and the general
public, including patients exposed in medical applications of ionising
radiation. This general objective could now be extended to the protection of
the environment as a whole. In the light of the problem
definition in Section 2, Community legislation shall respond to the latest
scientific findings and new societal and technological developments to the
benefit of improved protection of workers, the public, and patients. There is
also a need to ensure coherence of existing Community legislation in this
field. At the same time, the EU should strive to reach coherence with the
international recommendations, and thus create the most advanced and
comprehensive EU legal framework for nuclear safety, security and
non-proliferation. The main objective of this initiative is
translated into four specific objectives: 1. to bring the health
protection of workers, the public and patients in line with latest scientific
data and operational experience, 2. to streamline existing EU
legislation in the field of radiation protection, 3. to ensure coherence with
international standards and recommendations, 4. to cover the whole range
of exposure situations, including exposure to natural radiation sources at
home, as well as the protection of the environment. 4. Section
4: Policy options In the light of the problem definition
and the objectives, credible policy options should be considered in two
different areas: –
Improving the protection in the identified
subject matter areas (2.2.1-2.2.5), –
Reducing the complexity of existing radiation
protection legislation (2.2.6). To align EU radiation protection
legislation to latest scientific progress, implementing ICRP Recommendation 103
(see problem 2.2.1), the dose calculation methodology and the dose limit
for the lens of the eye stipulated in the current Basic Safety Standards need
to be amended. In order to provide a uniform level of protection for Outside
Workers and for workers in NORM industries (see problem 2.2.2), the
requirements in the current Basic Safety Standards on NORM industries need to
be strengthened and an annual dose limit for occupational exposure needs to be
imposed. These amendments can only be achieved through a revision of the Basic
Safety Standards Directive. To respond to the technological progress
in medical imaging procedures and to enhance the protection of patients (see problem
2.2.3), the two requirements on justification and optimisation in the
current Medical Exposure Directive need to be strengthened. Appropriate
protection of the public from non-medical imaging procedures (see problem
2.2.3), such as airport security screening, requires to include specific
requirements in the Basic Safety Standards Directive and to amend the Medical
Directive correspondingly. Improving the protection in the
identified subject matter areas, as discussed above, could be achieved through
the simultaneous amendment of the Directives affected by scientific and
technological progress, the Basic Safety Standards Directive, and the Medical
Exposure Directive, without addressing the complexity of existing radiation
protection legislation. To address the issues identified with regard to radon,
building materials and the protection of non-human species, this option relies
on the development of non-legislative measures, such as guidance and
recommendations. A table supporting this analysis with
more details is provided in Annex XI. With regard to the complexity
of existing radiation protection legislation (see problem 2.2.6),
different methods to achieve simplification have been analysed –
Codification or recast of all Community
legislation; –
Revision of the BSS and integration of the other
Directives into the BSS. It is only possible to codify
or recast legislative acts with the same legal instrument (e.g. Directives with
Directives, Regulations with Regulations). Regulations, Decisions,
Recommendations cannot be part of a recast without changing the binding or
non-binding character of the requirements. As Euratom legislation uses all
legal instruments, codification of all Community legislation (Annex V), is not
possible. Not all Euratom Directives are directly
concerned with radiation protection. Some acts (for instance Directive
2006/117/Euratom) are of administrative nature, others (for instance Directive 2009/71/Euratom)
concern only a certain type of installations or practices. Although overall
they contribute to a better protection of the population their subject matter
is different from the other radiation protection legislation. Thus bringing
them together with acts establishing scientific criteria and general
requirements will not contribute to the simplification and clarity. In addition
since Directive 2009/71/Euratom is not yet transposed in national legislation,
it is not at this stage sensible to consider its inclusion in a recast. Thus we concentrate on the relevant
Directives which are the Basic Safety Standards Directive, the Medical
Directive[30],
the High activity sealed sources (HASS) Directive[31], the Outside
Workers Directive[32]
and the Public Information Directive[33].
A pure codification of these relevant Directives is also not possible, as there
are differences in definitions, scope of application etc. A recast of these
Directives is technically feasible. A recast with minimal changes, while
reducing the number of legal acts, will not satisfy the specific objectives of
the current initiative, and contribute little to the improvement of protection
in the identified subject matter areas, as discussed above. In addition, only a
thoroughly revised structure of the BSS Directive 96/29, gives the requirements
of the other Directives a logical place in the overall architecture. Therefore, the only credible solution
reducing the complexity of radiation protection legislation which is compatible
with the other objectives for amendment of the legislation is the revision of
the Basic Safety Standards Directive and the simultaneous integration of the
Medical Exposure Directive, the Outside Workers Directive, the Public
Information Directive and the High Activity Sealed Sources Directive. The issues raised in 2.2.4 Public
exposure to natural radiation sources and in 2.2.5 Protection of the
environment (non-human species) could be solved either by extending the
scope of the revised Basic Safety Standards Directive, to cover these areas, or
by the development of new Directives exclusively for these purposes, or by
non-legislative measures, such as guidance on national action plans for radon,
or guidance on the protection of the environment (See Annex XI). Binding requirements
on national action plans for radon, however, can only be achieved through
legislative measures. Stand-alone Directives on all three issues would be
contrary to the simplification policy. With regard to building materials a
stand-alone Directive would, in addition, not allow to ensure coherence with
the management of residues from NORM industries. With regard to the protection
of the environment, a stand-alone Directive would not ensure coherence with the
protection of human health from environmental radioactivity. In conclusion, public exposure to natural
radiation sources and the protection of the environment can only be efficiently
addressed through a revision of the Basic Safety Standards Directive. For this
purpose two distinct policy options have been considered, the two aspects being
unrelated to each other. The assessment of these two options does not depend on
whether the revision of the Basic Safety Standards Directive is combined with a
revision of the Medical Directive or with the integration of the four
identified Directives. The comparison is less transparent however if the
amendments to the other four Directives are considered at the same time. For
the sake of completeness a final option is evaluated, which consists of a
combination of the two options broadening the scope together with the
consolidation of all Directives. The combination of the two options should be
considered only if they are both found to be an efficient solution to their
respective problem areas. Similarly, the combination with the consolidation of
all Directives is considered only if this is found to be an efficient solution
to the need for simplification in its own right. Option 1: Maintaining the status quo
of existing legislation, Option 2: Revision of Basic
Safety Standards and Medical Directive, Option 3: Revision and
consolidation of Basic Safety Standards and Medical Directive, and integration
of the Outside Workers Directive, the Public Information Directive and the High
Activity Sealed Sources Directive (non-legislative measures to address natural
radiation issues and the protection of non-human species, see Annex XI), Option 4: Revision of the Basic Safety
Standards Directive and broadening the scope to cover public exposure to
natural radiation, Option 5 Revision of the Basic Safety
Standards Directive and broadening the scope to cover protection of non-human
species, Option 6 Revision and consolidation of
the Basic Safety Standards Directive and Medical Directive, integration of the
Outside Workers Directive, the Public Information Directive and the High
Activity Sealed Sources Directive and broadening the scope to cover public
exposure to natural radiation and protection of non-human species. In summary: № || Options 1 || Status quo 2 || Revision of BSS and Medical Directives 3 || Revision and consolidation of BSS and Medical Directives and integration of three other Directives 4 || Revision of BSS broadening the scope to natural radiation sources 5 || Revision of BSS broadening the scope to the protection of non-human species 6 || Revision and consolidation of BSS and Medical Directive, integration of the other three Directives, and broadening the scope both for the natural radiation sources and protection of non-human species 4.1. Option
1: Maintaining the status quo of existing legislation This policy option entails no action to
be taken. While in 1996, the existing body of Community legislation overall
offered adequate protection to workers, members of the public and patients, it
no longer serves the needs resulting from changes in technology and in society.
There would also be no legislative
response to the many detailed amendments required to improve the issues
described in Section 2.2. With regard to the assessment of the health detriment
this option would not allow for the latest scientific knowledge as provided by
ICRP. 4.2. Option 2:
Revision of Basic Safety Standards and Medical Directive The development in science, as published
in ICRP Recommendation 103, affects the BSS Directive 96/29/Euratom which is
based on the earlier ICRP Recommendation 60 (published in 1990), as well as,
but to a lesser extent, the Medical Directive 97/43/Euratom. Technological and
societal developments also affect both Directives. Option 2 would mean to
undertake the necessary amendments in each of these two Directives separately. The changes in the BSS Directive 96/29
will cover the following issues: 1. Dose calculation
methodology and organ dose limits for the lens of the eye according to latest
scientific publications from ICRP The revision of the BSS will allow
updating the methodology to calculate doses based on latest knowledge on
radiation risks as published by ICRP. This will align the dose calculation
methodology required by the BSS with international standards allowing the
correct assessment of exposure of more than 1 million exposed workers and a
control of compliance with the dose limits. The revision of the BSS will also present
an opportunity to reduce significantly the organ dose limits for the lens of
the eye as a response to latest scientific data providing evidence for a higher
radiosensitivity of the lens of the eye. The reduction of the organ dose limit
for the lens of the eye will ensure a high level of protection for certain
categories of workers, in particular interventional radiologists. 2. Occupational exposure in
NORM-industries Exposures due to natural radiation sources
are already within the scope of Directive 96/29/Euratom (Title VII). The
requirements, however, offer maximum flexibility to Member States to decide
which NORM industries are of concern, and on the required level of protection
for workers. This has been cause of very different levels of achievement in
controlling NORM industries and in protecting workers in these industries.
Therefore, the requirements on natural radiation sources are strengthened. In
addition, importance is given to natural radiation sources in the ICRP
Recommendations. The revision of the Directive allows defining precise criteria
for the identification of industries of concern and applying requirements for
the protection of workers in a similar way, irrespective of whether their
exposure occurs in a NORM industry or for instance in nuclear industry. 3. The dose limits for occupational
exposure Since 1990, it is internationally recognised
and recommended that workers should in average not be exposed to more than 20
mSv/year, allowing for some averaging over time. This recommendation is already
reflected in Directive 96/29/Euratom, where the dose limit for occupational
exposure is set to 100 mSv in a consecutive period of five years, subject to a
maximum annual exposure of 50 mSv. The flexibility in this requirement,
however, has led to different national definitions of the dose limits,
representing an obstacle for outside workers crossing borders. It is now
proposed to set an annual dose limit for occupational exposure to the
internationally recommended value of 20 mSv, without the possibility of averaging
over 5 years, in order to ensure a harmonised dose limit within Europe. Any
deviation from the internationally recommended value of 20 mSv is not an
option. The
changes in the Medical Directive will affect the following areas. 1. Strengthening certain
Medical Directive requirements for protection of patients and other individuals
submitted to medical exposure. The definition of medical exposure needs to be
brought in line with the latest ICRP Recommendations, e.g. to include
"carers and comforters". Requirements on medical exposure procedures
need reinforcement through specifically addressing justification of the
exposure of asymptomatic individuals, provision of appropriate information to
patients enabling their informed consent, considering staff exposure in
justification process, further restricting the use of equipments that do not
provide adequate information about the radiation doses and incorporating the
patient doses in the reports from the examination. Optimisation of
protection shall be strengthened through inclusion of interventional procedures
in the group of procedures for which Diagnostic Reference Levels (DRLs) are
required, requirements for periodic revision of the DRLs and closer involvement
of the Medical Physics Expert in the medical radiological procedures. Unintended
and accidental exposures receive new, comprehensive consideration, including
provisions on risk assessment for radiotherapy and on recording, reporting and
responding to accidents in medical exposure procedures. 2. New approach to
"medico-legal exposures", as defined in the Medical Directive. The conclusions of the International Symposium
on Medico-legal exposures, organised by the Commission in 2002, propose to take
medico-legal procedures out of the definition of medical exposure. Based on the
conclusions of this conference, the Article 31 Group of Experts proposed in
2005 to replace the term "medico-legal procedures" by the concept of
"non-medical imaging exposures" and to change the definition of
medical exposure, to include a reference to the intended benefit to the health
or the well-being of the exposed individual. Requirements for radiation
protection in relation to the new category of non-medical imaging exposure are
developed in the revised Basic Safety Standards Directive, including those for
justification, regulatory control, optimisation of protection, dose constraints
and dose limits. The proposed draft requirements were discussed at the
international meeting organised by the Commission on 8 and 9 October 2009 in
Dublin. The other related Directives -
Outside Workers Directive, Public Information Directive and High
activity sealed sources Directive - will remain unchanged. This results in
a "no change situation" in terms of simplification. 4.3. Option
3: Revision and consolidation of Basic Safety Standards and Medical Directive,
and integration of the Outside Workers Directive, the Public Information
Directive and the High Activity Sealed Sources Directive This option offers the revision of the
Basic Safety Standards Directive by extending the requirements to medical
exposure, public information, outside workers exposure and high-activity sealed
sources. Within this policy option, the BSS Directive 96/29 and the related
legislative acts (Medical Directive 97/43/Euratom, Outside Workers Directive
90/641/Euratom, HASS Directive 2003/122/Euratom, Public Information Directive
89/618/Euratom, Commission Recommendation 90/143/Euratom) will merge and the
requirements of BSS Directive and Medical Directive will at the same time be
upgraded to the latest scientific knowledge and regulatory experience. In
addition to the changes in Directive 96/29/Euratom and Directive 97/43/Euratom
as described in Option 2, Option 3 will offer the following opportunities: 1. Better management of
radiation sources which are not under regulatory control (because the source
has been abandoned, lost, misplaced or stolen) will be achieved through the
incorporation of the corresponding requirements from the HASS Directive into
the emergency preparedness regime, now under Directive 96/29/Euratom. The
definition of high activity sealed sources (HASS) will be aligned to the
definition in the international Code of Conduct (IAEA). 2. The specific requirements
for the protection of the outside workers (Outside Workers Directive) will be
added to the requirements for all exposed workers in Directive 96/29. This will
offer a comprehensive approach to the protection of occupationally exposed
people clearly defining the responsibilities of the undertaking responsible for
the radiation source and the employer of an outside worker. Member States will
be required to establish National Dose Registries which cover all exposed
workers. Radiation passport should also be established for each individual
outside worker. 3. The requirements for informing
the public before and in case of an emergency (Public Information Directive)
are part of the arrangements for the management of emergency exposure
situations and will fit in the requirements for emergencies currently
established in Title IX of Directive 96/29/Euratom. Merging the above mentioned five
Directives should be a major step in terms of the simplification of the acquis
in radiation protection to the benefit of improved protection of outside
workers and the public. For this purpose, the overall Directive must be
substantially re-structured in order to ensure that the simplification also
improves the clarity of the text and better operational implementation of the
radiation protection principles. While the opportunity of merging these
Directives is taken for incorporating further amendments, those are of no
significance in terms of the impact analysis. This option relies on non-legislative
measures for solving the problems described in sections 2.2.4 (protection from
natural radiation sources) and 2.2.5 (the risks of ionising radiation to the
non-human species). As indicated in Annex XI non-legislative measures like
guidance may advise Member States how to establish action plans for reducing
the impact to health of radon. However, there is no binding requirement for the
establishment of such plans, nor tools for the management of radon exposures in
dwellings, buildings with public access and workplaces. In addition Option 3
would result in the need of amending the current Commission Recommendation of
21 February 1990 on the protection of the public against indoor exposure to
radon which is no longer fully in line with international recommendations. 4.4. Option
4: Revision of BSS broadening the scope to natural radiation sources With this option, a comprehensive
approach to the management of exposures due to natural radiation sources will
be incorporated within the overall set of requirements of the Euratom BSS. The
requirements will reflect the distinction between planned and existing exposure
situations, as made in ICRP Publication 103. While occupational exposure
to natural radiation sources (as well as public exposure from residues or
effluents from NORM industries) is already considered in Options 1 to 3, the
exposures to natural radiation sources that will explicitly be incorporated
relate to public exposure in the domestic environment: 1. Indoor exposure to
radon in dwellings. The new requirements build upon
the Commission Recommendation 90/143/Euratom, and require national Action Plans
for indoor Radon to be established. The recent epidemiological demonstration of
lung cancer causation by radon exposure calls for the Commission Recommendation
adopted in 1990 to be upgraded and incorporated in the BSS Directive
96/29/Euratom. Upgrading the Recommendation to binding requirements will on the
one hand enhance uniformity within the EU with respect to the protection of the
public from exposure to radon, on the other hand flexibility needs to be
preserved to adjust national policies to geological features and type of
buildings (see Annex IX.). The new BSS Directive will set the upper boundary
for the reference level for indoor radon, in line with a statement from ICRP in
November 2009. Member States will be required to identify radon prone areas in
order to prevent that new buildings exceed the reference level and to focus
efforts for remedial work in existing dwellings. 2. Building materials
with high concentrations of naturally occurring radionuclides will be required
to be monitored; an index is defined so as to determine which materials are
liable to exceed the reference level. Within this option it is proposed to bring also
building materials with high levels of naturally occurring radionuclides under
regulatory control. At present the regulation of the radiation exposure due to
building materials is established in the Member States based on national
decisions. Some harmonisation was achieved with EU guidance on "Radiological
Protection Principles Concerning the Natural Radioactivity of Building Materials",
published 1999, as N° 112 in the Radiation Protection Series of the European
Commission. A radioactivity index was defined in Annex II of this publication.
This guidance recommended the establishment of dose criterion between 0.3 mSv –
1 mSv per year for introducing regulatory control. On the basis of this
recommendation a uniform reference level will be proposed. 4.5. Option
5: Revision of BSS broadening the scope to the protection of non-human species The subject matter and general purpose of
the BSS Directive 96/29/Euratom is the health protection of the population and
workers against dangers of ionising radiation. This Directive applies to the
protection of the human environment, but only as a pathway from environmental
sources to the exposure of man. In line with the new ICRP Recommendations, it
will be complemented with specific consideration of the exposure of biota in
the environment as a whole. The aim would be to require Member States to
consider suitable protection of non-human species in their radiation protection
legislation. So far no specific environmental impact
assessment was required for the possible detriment to non-human species, under
the assumption that if man was protected (through environmental pathways of
exposure) then also non-human species are protected. While the human health
detriment includes cancer causation as an important risk to an individual
person, such types of effects on biota are in general irrelevant in terms of
their ecological impact. It is expected that ICRP will provide guidance on the
application of a radiation protection system in 2011-2012. Pending such further
guidance it is up to national authorities to translate the new requirement in
reasonable licensing conditions. The requirements for the
protection of the environment would therefore not be very demanding at this
stage. It would still be timely, before adoption of the Directive by the
Council, to include harmonised criteria on the basis of the forthcoming ICRP
recommendations. 4.6. Option
6: Revision and consolidation of BSS and Medical Directive and integration of
the other three Directives, and broadening the scope both for the natural
radiation sources and protection of non-human species This option includes all the
elements of Option 3 (revision of the Basic Safety Standards Directive and
integration of the other four Directives). The revision of the Basic Safety
Standards includes all identified issues, and broadens the scope to include the
whole range of exposure situations, including indoor public exposure to radon
and to building materials, and all categories of human and non-human exposures. 5. Section
5: Analysis of impacts Nuclear energy continues to play an
important role in Europe's energy production, not only in view of the
sustainable and secure supply of energy but also with regard to the policy of
decarbonisation of energy production. Radiation sources have also found uses
outside nuclear energy, especially in medical diagnosis and therapy, but also
in other applications in industry and research. Radiation protection legislation is an
essential condition for the health protection of workers, the public and
patients. In addition to this health perspective, the possible impact of
radiation protection legislation on these important economic sectors to be
sustained or further developed is not within the scope of this analysis. 5.1. Analysis
of the impact of Option 1 Option 1 would not effectively change the
radiation protection requirements at EU level. This option would however have a
negative impact in the light of the changes in technology and society that
emerged since 1996. Further analysis of the possible
evolution of the impact of this option for the different aspects of radiation
protection is presented in Section 2.3. 5.2. Impact
analysis of Option 2 Option 2 envisages an update of BSS
Directive 96/29 and the Medical Directive 97/43. The substantial changes that
result from the latest scientific recommendations of ICRP and from related
studies that have been conducted and operational experience over the past
years, as well as from the working parties of the Article 31 Group of Experts,
have been analysed in terms of their economic impact, the impact on
environmental protection, the social impact in particular for health and safety
at work, and finally in terms of their regulatory benefit or possible burden. 5.2.1. Health
and Social impacts Protection of workers. The social impact of the
revised BSS relates essentially to health and safety at work. The proposed reduction of
current dose limits for the lens of the eye will lead to an improved protection
of workers, in particular certain medical professionals, and will substantially
reduce the risk of developing radiation induced cataract. Within Option 2 industries
processing materials with high levels of naturally occurring radionuclides
(NORM-industries) will be strengthened. Exposures to NORM used or processed in
specific industries are already in the scope of Directive 96/29/Euratom (Title
VII). However, the current requirements are non-specific and unclear leaving it
for Member States to decide on the level of control of the exposures in this
sector. As a consequence there is a lack of a comprehensive picture of actual
doses to workers in NORM industries and there are considerable differences
between Member States regarding the control of occupational exposures,
resulting in different treatment of the workers and to different restrictions
on the management of residues. The integration of NORM industries in the
radiation protection framework will offer equal treatment to workers
occupationally exposed in these industries, and ensure appropriate health
protection for exposed workers. In addition, radiation protection will become
an essential component of overall work hygiene. Due to the fact that according
to the current legislation Member States can choose which radiation protection
measures, if any, apply to workers in the NORM industries, it is estimated that
currently only one third of the workers who may receive considerable radiation
exposures in these industries are considered as exposed workers. Protection of patients. In the medical area, the
proposed changes will lead to improved protection of individual patients and
aim to guarantee good medical practice and further technological development
without undue increases of the population exposure. This will be achieved by
improved implementation of the principle of justification of individual medical
exposures and by strengthening the legal requirements for optimisation of
protection and for prevention of unintended exposures. The corresponding
actions at national level to meet the revised legal requirements should lead to
the integration of radiation protection concerns in the overall public health
policy. The strengthening of the requirements for medical applications of
ionising radiation will thus meet the conclusions laid down in Communication
COM/2010/0423. 5.2.2. Environmental
impact While NORM industries will now be subject
to regulatory control in the same way as other practices, this will most of
times require restrictions on occupational exposures rather than on discharges
of radioactive effluent, which will in general be exempted. The comprehensive
management of residues from NORM industries will however be instrumental in ensuring
that the huge volumes of solid residues will be disposed of so as to preclude
ground water contamination or excessive levels of radioactivity in building
materials in which residues are being recycled. It should be noted that in this
option the regulation of NORM residues still does not fit in an overall
approach to the regulation of building materials. 5.2.3. Economic
impact Functioning of the internal market. With regard to NORM
industries (see 5.2.1), the new Directive shall thus include a clear and well-structured
set of requirements as well as a positive list of which types of industries are
of concern. This will ensure equal treatment of the industries. There is little
information on the actual industries affected by these requirements, which indeed
results from the current lack of reporting in the absence of firm requirements.
Although no exact data on the size of these industries are available, the
dimension of the issue can be estimated through the following examples: 381
enterprises in the EU extract crude petroleum and natural gas, 293 enterprises
produce lead, zinc and tin and the number of enterprises mining iron ores is
estimated to 40[34]. The introduction of an annual dose limit
for occupational exposure, which no longer allows for flexible national
interpretations, will facilitate mobility of workers across borders. The new
Directive will emfasise the role of dose constraints within th eoveral
principle of optimisation. The use of this concept is not new, but it's
prominent role in particular for the protection of workers should allow a
better protection. On the other hand nuclear industry is afraid that this will
prompt the regulatory authorities to intervene directly in the establishment of
dose constraints, which in their view would be counter-productive (See Annex
XIII). This concern is alleviated by clearly stating that dose constraint is
merely an opeartional tool for optimisation, not a limit. The revision of exemption and clearance
values, in the context of the graded approach to regulatory control (Annex X),
is liable to have an economic impact. On the one hand, the lowering of the
exemption levels will have a minor economic impact. The study published by the
Commission in Radiation Protection N° 157 (Annex II.B, p.9) demonstrates inter
alia that these changes will in general not add a burden for the Member
States or the stakeholders, in particular as regards consumer goods in which
radionuclides are incorporated. On the other hand, there is benefit in having
the same values for both exemption and clearance, in terms of simplification
and coherence of the requirements. Using the same values for the two concepts
would also enhance public acceptance and facilitate useful (justified)
application of radioactive substances in consumer goods. The harmonisation of clearance
levels was not achieved in the 1996 Directive and shall be pursued with the new
Directive. The use of clearance levels is important for the dismantling of
decommissioned nuclear installations, which is a very important economic
aspect. Very large volumes of materials with a potential for recycling (e.g.
steel) and with nothing but trace amounts of radioactive substances, below
clearance levels, can be made available so as to save natural resources and
energy. For other materials it allows to avoid the cost of disposal as
radioactive waste (Annex X.B). While difficult to quantify, it is clear that
the economic benefit of the new requirements facilitating the application of
the concept of clearance could be equally important. Nuclear industry prefers
the clearance levels laid down in national legislation following the
publication of default values in Radiation protection 122, Part I. The industry
would also prefer th especific clearance levels for metals, building rubbler
etc. (See Anex XIII) to be attached to the future Directive. This desire was
balanced against international harmonisation and the flexibility for regulators
to use the concept of clearance. The industry concerns will be to some extend
met by emphasising the role of such specific clearance levels. Administrative costs for
companies. Should
the Member States follow the proposed "graded approach" to regulatory
control as described in Annex X.A, then the administrative burden for the
regulated entities will be reduced. It offers more flexibility and in principle
a more efficient use of regulatory resources. At the same time, the industry
will benefit from the regime of specific exemption or from the regime of
registration rather than the full licensing procedure as is the case in most
Member States so far. Administrative costs for
public authorities.
The revision of the BSS along operational experience should not have a major
impact on national legislation The burden of transposition in national law
should be minimal, except for some new features such as the regulation of NORM
industries (for those Member States who do not yet properly regulate these
matters). While the graded approach to
regulatory control in principle should allow saving resources also for the
regulatory authority and thus reduce the regulatory burden, its application
also requires a lot of judgement to be exercised by the competent authorities,
and hence possibly better competencies and qualifications. However, the
estimation of the necessary resources is extremely difficult as far as it
depends on each particular national situation (the structure of the state
administrative organisation, the level of development of regulatory bodies
etc.). Coherence of the Euratom Directives with
the international standards will also have a positive impact on the efficiency
of national regulations. It will avoid that experts in the national competent
authority need to be familiar with two sets of requirements, and they will
benefit from the comprehensive body of guidance and training material provided
by IAEA without being confused by different definitions or a different
regulatory approach. Most important is the harmonisation of values that may
have an impact on trade. Within Option 2 it is proposed
to enhance the graded approach to regulatory control by introducing two levels
of authorisation – registration and licensing. This will align the Euratom BSS
with the International BSS which offers the same concept. This option also
allows maintaining uniformity of exemption values in Euratom and International
BSS as well as the harmonisation of clearance levels (default values). 5.2.4. Coherence
and clarity of legislation The amendment of BSS Directive
96/29 and Medical Directive 97/43 will clarify the requirements, align the definitions
and better describe the concepts of protection of workers (BSS Directive) and
the patients (Medical Directive). 5.3. Impact
Analysis of Option 3 The consolidation of five
Directives in Option 3 offers a significant benefit in terms of simplification.
The simplification of Community legislation should be followed by a similar
effort at national level which, together with a clear allocation of regulatory
responsibilities, should reduce the regulatory burden and make the regulatory
efforts more efficient. The Option 3 adds to Option 2 the
subject matters of the Outside Workers Directive, Public Information Directive,
and the HASS Directive. In fact, BSS Directive 96/29/Euratom and the Medical
Directive will be amended as in Option 2 and merged with the Outside Workers
Directive, Public Information Directive and HASS Directive. The radon and
non-human species issues will be addressed by non-legislative measures. Within this option the economic, social
and environmental impacts concerning the changes in BSS Directive 96/29/Euratom
and Medical Directive would be broadly as described under Option 2. For the
other three directives, even though they are not substantially changed, there
are additional benefits resulting from being merged with the BSS Directive,
which is evaluated as follows: 5.3.1. Health
and social impact Protection of workers. The incorporation of the
Outside Workers Directive should also have a positive health and social impact
through the envisaged clarification of the responsibilities, for the protection
of the outside worker, of the employer and of the undertaking carrying out the
practice. The establishment of national centralised networks for the dose
records and of an individual radiological monitoring document (radiation dose
passport) will represent an important benefit for the health protection of
Outside workers. The combination of the Basic
Safety Standards Directive and the Medical Exposures Directive will have a
positive impact on the health protection of medical professionals, in
particular those receiving high doses in the course of their work, such as
interventional radiologists. Indeed, the medical profession often looks only
into the Medical Directive, and ignores the measures in the BSS Directive for
their own protection. Protection of members of the public: The Public Information
Directive establishes rules for informing the public and emergency workers
about the health protection measures before and in the event of emergency. This
should be part of the emergency arrangements, which are currently established
in Title IX of BSS Directive 96/29/Euratom. The consolidation of the Public
Information Directive within the overall framework of the emergency exposure
situations in the BSS will allow a more coherent application of this Directive
with regard to public exposures. The importance of a clear strategy for
emergency preparedness and for adequate response plans and coordination in view
of cross-border consequences has been dramatically emphasised through the
nuclear accident on 11 March 2011 in the Fukushima NPP in Japan. Guidance on establishment of national
action plans for reducing the risks from indoor radon exposure will again draw
the attention of the Member States to this problem and possible actions for
solving it. However this action will have added value only if Member States
follow the proposed advice, which in the absence of binding requirements is
probably not the case. The impact on protection of patients and
on protection of members of the public, in normal planned situations, does not
change compared to the one associated with Option 2. 5.3.2. Environmental
impact Option
3 will have the same environmental impact as Option 2. 5.3.3. Economic
impact The envisaged improvements in
the field of occupational exposure will have a positive economic impact on
undertakings. The incorporation of the Outside Workers
Directive into the BSS Directive should improve the system for recording the
doses of outside workers thus facilitating their mobility. There is also an
economic benefit: maintenance work in nuclear installations as well as certain
dismantling operations is best carried out by specialised teams operating in
different installations and the above requirements will enhance the mobility of
workers within Member States and across borders. 5.3.4. Coherence
and clarity of legislation Option 3 envisages integration of five
Euratom Directives into one piece of legislation. This will simplify and
clarify the radiation protection requirements. In general the regulatory authorities
will benefit from better structured and understandable Euratom radiation
protection legislation. This should improve the level of correct transposition. The incorporation of the HASS Directive
should be an opportunity for aligning the definition of HASS with the
definition in the Code of Conduct of IAEA, which will now be incorporated in
the IAEA Standards. This would be an important aspect in meeting the objective
of international harmonisation, and avoid national authorities to run two
separate inventories. 5.4. Impact
Analysis of Option 4 Option 4 includes the features of Option
2 with regard to the revision of Basic Safety Standards Directive and the
associated impacts; the additional impact is discussed below. 5.4.1. Health
and social impact Option 4 will have a very
positive impact on the health of the public. The implementation of restrictions
on the level of radon in buildings will considerably reduce the health risks
(lung cancer risk) for the public from this source. International public health
policies (WHO) consider the radon issue to have high priority. In the long run
national action plans for radon mitigation will have a positive impact on lung
cancer incidence, even though smoking is still the main cause of lung cancer.
Radon is the second known cause of lung-cancer and radon-related lung cancer is
one of the most frequent cancers overall. It will therefore be an important
achievement if the new Directive would achieve a substantial, progressive,
reduction of indoor radon concentrations. 5.4.2. Environmental
Impact This Option does not have impact on the
environment. 5.4.3. Economic
impact The introduction of reference
levels for radon in buildings will not have an economic impact as far as the
requirements on indoor exposure to radon in Commission Recommendation
90/143/Euratom are already largely introduced throughout the European Union.
The efficiency of remedial policies will however be enhanced through the
establishment of national action plans. Option 4 offers to establish in the BSS
Directive specific requirements for building materials based on the guidance in
Radiation Protection N° 112. Upgrading this guidance to the level of a binding
requirement is liable to have an impact on the market and on the building
profession. In order to mitigate negative market effects, the Article 31 Group
of Experts recommended setting a single reference level of 1 mSv for building
materials (upper part of the range given in the guidance) and a corresponding
classification system. In this way the fraction of materials that would be
subject to national restrictions will be further limited (first by the list
with specific materials, then by the 1 mSv criterion). It should be underlined
that the need for characterisation of building materials does not imply that
all batches need to be monitored: if there is no important change in the origin
or composition of the material the initial assessment remains valid. Hence the
cost of monitoring should be minimal. The cost of labelling for the building
industry is to the benefit of the consumer. Further harmonisation will be
pursued through the standards of the European Committee for Standardization
(CEN TC 351). The harmonisation of the requirements on building materials will
benefit the producers who now face different national restrictions and will
simplify transboundary movement of building materials within the EU. Further
information on types of material and amounts can be found in Annex VIII.A. 5.4.4. Coherence
and clarity of legislation The incorporation of the
regulation of radon and building materials in the overall radiation protection
framework will lead to more comprehensive radiation protection legislation,
which covers all exposure situations. Radon and building materials
being also covered by the International BSS, Option 4 offers also coherence
with these standards. The chosen reference levels are in line with the latest
scientific data presented by ICRP in November 2009. 5.5. Impact
analysis of Option 5 Option 5 includes the features of Option
2 with regard to the revision of Basic Safety Standards Directive and the
associated impacts; the additional impact is discussed below. 5.5.1. Health
and social impact This Option does not have
specific health and social impact. 5.5.2. Environmental
Impact The actual environmental
impact is probably very small. However, the requirements will allow providing
reassurance that this assumption is actually true. The benefit of the new
provisions on the protection of non-human species is thus more in terms of
demonstration of compliance with overall environmental policies. 5.5.3. Economic
impact The introduction of protection criteria
for non-human species will in general not lead to further restrictions on
discharges of radioactive effluent. If Member States' competent authorities
make full use of the screening tools developed under the research programme,
the explicit inclusion of environmental criteria in the establishment of
discharge authorisations would be very exceptional. The administrative burden
for the industry is therefore expected to be small. The benefit for the
industry, and for society as a whole, would be a better political and public
acceptance if compliance with overall environmental criteria is explicitly
demonstrated. The nuclear industry rased concerns that the inclusion of the
protection of the environment in legal act may lead to a high cost for
demonstrating compliance. However, without such Euratom legal framework it is
up to the competent national authorities to decide on this issue, which may provide
even less stability in the requirements. The industry concerns will be
alleviated if indeed ICRP provides recommendations on the radiation protection
system within the next year or so. 5.5.4. Coherence
and clarity of legislation In view of the fact that
currently there are no agreed environmental criteria, it was considered to
leave this project to be covered later in Community legislation. This would
however be contrary to the simplification policy of the Commission and also
would not ensure a coherent radiation protection system covering humans and non
human species. The Article 31 Experts therefore recommended to include the
requirements already now in the Commission proposal, rather than adding another
piece of legislation a few years later. The incorporation of the protection of
the environment within the scope of the Euratom Basic Safety Standards is
coherent with the revised International Basic Safety Standards. 5.6. Impact
analysis of Option 6 Option 6 includes the features of Option
3 and the associated impacts; the additional impact is discussed below. 5.6.1. Health
and social impact Option 6 will have a very
positive impact on the health of the public. The implementation of restrictions
on the level of radon in buildings will considerably reduce the health risks
(lung cancer risk) for the public from this source. International public health
policies (WHO) consider the radon issue to have high priority. In the long run
national action plans for radon mitigation will have a positive impact on lung
cancer incidence, even though smoking is still the main cause of lung cancer. 5.6.2. Environmental
Impact The actual environmental
impact is probably very small. However, the requirements will allow providing
reassurance that this assumption is actually true. The benefit of the new
provisions on the protection of non-human species is thus more in terms of
demonstration of compliance with overall environmental policies. 5.6.3. Economic
impact Upgrading the guidance on building
materials to the level of a binding requirement is liable to have an impact on
the market and on the building profession. The cost of labelling for the
building industry is to the benefit of the consumer. Further harmonisation will
be pursued through the standards of the European Committee for Standardization
(CEN TC 351). The harmonisation of the requirements on building materials will
benefit the producers who now face different national restrictions and will
simplify transboundary movement of building materials within the EU. The introduction of protection criteria
for non-human species will in general not lead to further restrictions on
discharges of radioactive effluent. If Member States' competent authorities
make full use of the screening tools developed under the research programme,
the explicit inclusion of environmental criteria in the establishment of
discharge authorisations would be very exceptional. The administrative burden
for the industry is therefore expected to be small. The benefit for the
industry, and for society as a whole, would be a better political and public
acceptance if compliance with overall environmental criteria is explicitly
demonstrated. 5.6.4. Coherence
and clarity of legislation This Option covers all exposure
situations and categories of exposure in a coherent framework and adds
significantly to the clarity of all requirements, both existing and new
requirements resulting from the broader scope. This broader scope is fully
coherent with the revised International Basic Safety Standards. 6. Section
6: Comparing the options The different options are analysed in
this section with regard to their effectiveness in achieving the objectives,
their efficiency, including their economic, environmental, health and social
impact as described in Section 5, and in terms of their coherence with overall
Euratom and EC legislation. 6.1. Effectiveness Option 1 does not meet the specific
objectives of this initiative, but it must be emphasised that current Community
legislation still offers in most situations satisfactory protection of workers,
patients and members of the public, which is the general objective of Community
legislation under Chapter III, Health and Safety, of the Euratom Treaty. It is
included as a baseline scenario for the comparison of the other options. Option
2 fully responds to the first objective and improves to some extent the
coherence of Euratom radiation protection legislation and it is also coherent
with corresponding requirements in international standards, thus meeting three
of the specific objectives. Option 3 fully meets the objective of coherence and
clarity, and allows additional specific aspects of operational experience to be
addressed. It also meets the Commission's policy of simplification. Options 4
and 5 both meet the objective of coherence with international recommendations
as well as of covering the whole range of issues in radiation protection. Both
options meet specific aspects of the objective for broadening the scope of
radiation protection legislation. Their combination, in Option 6, together with
undertaking an effort for consolidation similar to Option 3, is most effective
in achieving all objectives. 6.2. Efficiency Option 1 is taken as a
baseline scenario for the comparison of the other options. Hence the benefits
of Options 2 and 3 must be compared to the current situation. The comparison of
the impact of options 2 and 3 demonstrates the efficiency of different sets of
updated operational requirements, respectively in the BSS and Medical Directive
and in the three other Directives, which will be achieved. An overview of the different components
of the assessment is given in table 1. Both positive and negative impacts are
qualified in terms of their relative importance (minor, important, very
important). The overall balance, irrespective of weighing of different aspects
or components of all options, is positive. As it is demonstrated in the
table, all benefits of Option 2 are kept in Option 3, with additional benefits
in particular in terms of the simplification of legislation and it also
enhances some positive aspects of option 2. Option 4 broadens the scope of
current legislation and this may imply a certain administrative cost for the
industry. However the benefit in terms of public health will be very important,
and meet the objectives of WHO in the fight against lung cancer. The similar
benefit in regulating building materials needs to be balanced against the
regulatory burden and the cost of monitoring and labelling for the building
industry. However, it also enhances the efficiency of the control of residues
from NORM industries, envisaged in options 2 and 3. Option 5 also broadens the
scope of current legislation and this may imply a certain administrative and
economic cost. The actual environmental benefit of this option would be small.
Nevertheless, it is expected that this option will significantly contribute to
the understanding and acceptance of radiation detriments. Option 6 adds up the benefits
and detriments of all previous options. The overall benefit is thus maximised. Table 1: Summary of the comparison of options 2
to 6 (See Annex XIII for extended table) Impact || Option 2 || Option 3 || Option 4 || Option 5 || Option 6 || Economic || (+) || (+) || (+) || (+) || (+) || Functioning of the internal market || (+) || (+) || (+) || (+) || (+) || Administrative burden on businesses || (+) || (+) || (+)(-) || (+) (-) || (+)(-) || Regulatory authorities || (-) || (+) || (-) || (-) || (+)(--) || Environment || (+) || (+) || (+) || (++) || (++) || Protection of the environment || (+) || (+) || (+) || (++) || (++) || Social and Health || (+) || (++) || (++) || (+) || (++) Health and safety at work || (+) || (++) || (+) || (+) || (++) Mobility of workers and experts || (+) || (+) || (+) || (+) || (+) Protection of patients || (+) || (+) || || || (+) Protection of the public || (+) || (+) || (++) || (+) || (++) Coherence and clarity of legislation || (+) || (++) || (+) || (+) || (++) International coherence || (+) || (+) || (+) || (+) || (++) Overall impact || + || ++ || ++ || + || +++ 6.3. Coherence The consolidation of five Directives in a
single Basic Safety Standards Directive with a broader scope (Options 4, 5 and
6) is an important development to ensure the overall coherence of the entire
radiation protection legislation with other EU policies. Coherence within
radiation protection legislation is pursued in specific objective 2 and
international coherence in specific objective 3. Where other legislation
currently refers to the Directive 96/29/Euratom (e.g. the Directive on shipment
of radioactive waste) this will be automatically transferred to the new
Directive, with little impact (for instance the definition of radioactive waste
by reference to exemption levels introduced in Options 2 and 3). New
legislation under Chapter III of the Euratom Treaty, the adopted Directive on
nuclear safety of nuclear installations ( Council Directive 2009/71/Euratom)
and the proposed Directive on radioactive waste and spent fuel management
(COM(2010)618 final).), are complementary to the Basic Safety Standards and not
affected by any of the options that have been proposed. Legislation and
policies outside the remit of the Euratom Treaty would be strengthened by the
new Euratom Directive(s): Within the remit of EC legislation, Council Directive
93/42/EEC on medical devices would find a clearer reference to criteria that
should be met through the updated Medical Directive (Options 2, 3 and 6), the
Directive on construction products (Council Directive 89/106/EEC) would find
clear criteria for the characterisation of building materials in Option 4 and
6. The policy to prevent malevolent use of radiation sources will benefit from
strengthened requirements in the HASS Directive under Options 3 and 6; the
overall policy on indoor air quality (including radon) will benefit from the
broadened scope to natural radiation sources in Options 4 and 6, and coherence
with overall environmental policies and legislation on Environmental Impact
Assessment will benefit from the new requirements in Options 5 and 6. Option 6
offers the best possible coherence with all other policies. 6.4. Conclusion Option 6 addresses all
problems identified and meet all of the objectives. Option 3 would still
address the main issues and meet most of the objectives if the burden of
broadening the scope of the legislation would not be warranted. Option 2 is
eligible if the increase in clarity and coherence, in line with the
Commission's policy of simplification of legislation, would appear to be
insufficient to warrant a major simplification of current legislation. The
analysis of the options in terms of efficiency supports the conclusion that
Option 6 should be pursued, as the most effective, efficient and coherent
policy option. 7. Section
7: Monitoring and evaluation Core indicators for the level
of the achievement of the specific objectives are the accuracy of the
transposition and the implementation of the policy in the Member States. The
following indicators can be established for the implementation of the chosen
policy option in the different subject matter areas: 7.1. Indicators
for the implementation of the new regulatory approach to the management of
exposures due to natural radiation sources: –
the identification of radon prone areas in the
Member States and action plans to manage long term exposures to radon; –
the identification of new types of NORM
industries; –
the number of undertakings from the NORM
industry under regulatory regime and the number of exposed workers within this
industry. The monitoring of the
implementation of the policy for the protection from radon exposures can be
done by establishing a reporting obligation for the Member States, to submit to
the European Commission the identified radon prone areas and action plans. Information on the
implementing measures and national practices as well as relevant statistics for
the implementation of the proposed regulatory policy to NORM Industries can be
discussed in the framework of the European ALARA Network for naturally
occurring radioactive materials. This may include information on the number of
undertakings within this industry, submitted to authorisation regime after the
implementation of the revised BSS Directive, the number of exposed workers etc. 7.2. Indicators
for the success of the comprehensive approach to the occupational exposure and
the proposed recast of Outside Workers Directive and BSS Directive 96/29: –
the establishment of national dose registries
for the results of the individual monitoring of exposed workers; – the number of outside workers and their individual doses. The ESOREX project
will be used to monitor the implementation of the proposed comprehensive
approach to the occupational exposures from artificial and natural sources. In
particular, from this network the Commission will receive information on the
number of workers in the radon prone areas, number of exposed workers in the
different industries, doses per industry and per country, number of outside
workers and their doses. 7.3. Indicator
for the level of harmonisation of the authorisation regime Indicator for the level of harmonisation
of the authorisation regime throughout Euratom Community as a result of the
proposed graded approach to the authorisation of practices involving
radioactivity is the ratio of practices in the Member States submitted to
registration and licensing. The main monitoring tool for
this indicator would be the communication of the draft national transposing
measures (Article 33 from Euratom Treaty). The analysis of the transposing
measures will give an overview of the licensed and registered practices in the
Member States and information to what extend Member States have followed the
proposed graded approach to the authorisation regime. The European Commission
may issue recommendations with regard to the transposition of the Basic Safety
Standards Directives (see p.7.6 below). 7.4. Indicators
for the improvement of radiation protection in medicine: –
number of countries using diagnostic reference
levels, referral guidelines and clinical audit; –
number of countries maintaining up-to-date
national records of population doses from medical exposure procedures; –
number of countries introducing reporting
system(s) for unintended and accidental medical exposures; –
doses to population from medical exposure procedures
- to avoid a steep increase, e.g. like in the United States of America in the
past decade[35];
–
number of unjustified medical exposure
procedures, e.g. full-body scanning of asymptomatic individuals – to be reduced
as far as possible; –
optimised medical radiological procedures –
reduced discrepancies in the doses from the same procedure in different
countries or in-between hospitals. The indicators related to
medical exposure will be monitored through dose collection exercises for the
European Union (consecutive Dose Data projects, Dose Data -2 launched in August
2010), through the established European Medical ALARA Network (EMAN) and
through exchange of data on specific topics between the Commission, the Member
States, the IAEA and the WHO. Express ad-hoc data collection will be launched,
when appropriate, using HERCA network. 7.5. Indicators
for the implementation of the regulatory approach to non-medical imaging
exposure (NMIE) would be: –
number of NMIE practices identified in the
Member States; –
number of (formal) justification decisions taken
by national regulations; –
dose constraints and other regulatory
requirements established for the justified practices in the Member States; –
in the case of introduction of routine security
screening of people using ionising radiation – the number of people screened,
the doses to the population from the practice and the availability of non-ionising
alternative to the screened individuals. The indicators related to the
non-medical imaging exposure will be monitored through HERCA, ad-hoc exchange
with the Member States and organisation of periodic meetings, similar to Dublin
2002 and 2009. Further information will be sought from DG MOVE in relation to
security screening at airports. 7.6. The
Euratom Treaty offers in addition general monitoring tools for the
implementation of the Basic Safety Standards: –
According to Article 33 of the Euratom Treaty
the Member States have the obligation to communicate to the Commission the
draft national provisions for transposition of the Community radiation
protection legislation. On the basis of this information the Commission is in a
position to make appropriate recommendations for harmonising the provisions
applicable in this field in the Member States. This monitoring tool will be
used for all areas of the chosen policy. However, it will have a major impact
in areas like the harmonisation of the authorisation regime through the graded
approach to the authorisation. –
Article 35 of the Treaty requires Member States
to carry out continuous monitoring of the level of radioactivity in the air,
water and soil in order to ensure compliance with the basic safety standards.
Member States are obliged to communicate periodically information from this
monitoring to the Commission (Article36 from Euratom Treaty). This allows the
Commission to be informed on the level of radioactivity to which the public is
exposed and respectively the implementation of the BSS. The level of harmonisation between
Euratom BSS and IAEA BSS will be assessed by the services of DG ENER once the
two documents are in their final stage of preparation. This issue is also
subject to continuous interaction between the European Commission and IAEA. A
provisional table of correspondence has been prepared in June 2010, discussed
by the Article 31 Group of Experts and transmitted to IAEA. [1] These definitions are included for clarification and
not for use in a legal context as in current Community legislation. [2] Group of public health experts, appointed by the
Euratom Scientific and Technical Committee, to advice the European Commission
in the establishment of basic safety standards for the protection of the health
of workers and the general public against the dangers arising from ionising
radiation. The current composition of the group includes experts in radiation
protection regulation, scientists in radiobiology and epidemiology, medical
doctors and other radiation protection professionals. [3] Publications in the Radiation Protection Series of
the European Commission can be found on http://ec.europa.eu/energy/nuclear/radiation_protection/publications_en.htm.
[4] The result of the consultation can be found on the
website of the European ALARA network for NORM industries (EANNORM)
webpage under http://www.ean-norm.net/lenya/ean_norm/live/news.html [5] European Study on Occupational Radiation Exposures
(ESOREX), 2004. [6] It should be noted that this figure reflects workers
who are currently being monitored and doses registered. Since the present BSS
Directive leaves to MS to decide whether or not monitoring of workers in these
sectors is relevant, the number of workers could actually be higher. [7] European Study on Occupational Radiation Exposure
(ESOREX), 2004. [8] Darby S et al. (2006). Residential radon and lung
cancer. Scan J Work Environ Health, 32 Suppl 1: 1-83 [9] Sources and Effects of Ionizing Radiation, United
Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR)
report 2008. [10] Council Directive 96/29/Euratom of 13 May 1996 laying
down basic safety standards for the protection of the health of workers and the
general public against the dangers arising from ionising radiation, OJ
L 159, 29.6.1996, p. 1. [11] Currently Council
Directive 97/43/Euratom of 3 September 1997 on health protection of the
individuals against the dangers of ionising radiation in relation to medical
exposure, repealing 84/466/Euratom of 3 September 1984 (Medical Directive); [12] Council
Directive 2003/122/Euratom of 22 December 2003 on the control of
high-activity sources and orphan sources (HASS Directive) [13] Council
Directive 90/641/Euratom of 4December 1990 on the operational
protection of outside workers exposed to the risk of ionizing radiation during
their activities in controlled areas (Outside Workers Directive) [14] Council
Directive 89/618/Euratom of 27 November 1989 on informing the general
public about health protection measures to be applied and steps to be taken in
the event of a radiological emergency (Public Information Directive) [15] EUROSTAT Basic Statistic for 2007 [16] European Study on Occupational Radiation Exposure
(ESOREX), 2004. [17] European Study on Occupational Radiation Exposure
(ESOREX), 2004. [18] See Annex 2 of the Summary Report of the Article 31
Group of Experts meeting, 3–5 November 2009 [19] http://rpop.iaea.org/RPOP/RPoP/Content/PastEvents/justification-medical-exposure.htm [20] The Commission adopted on 6 August 2010 a Communication
(COM/2010/0423) discussing in more detail today's issues in medical uses of
ionising radiation and calling, among others, for enhanced regulatory control
of medical practices and for strengthening certain requirements of the Medical
Exposure Directive. [21] The use of security screening devices in airports has
been addressed in a Communication from the Commission to the Council and the
Parliament, adopted in June 2010 (COM(2010)311, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2010:0311:FIN:EN:PDF [22] Commission Recommendation 90/143/Euratom of 21 February
1990 on the protection of the public against indoor exposure to radon (OJ L-80) [23] WHO Handbook on indoor radon, World Health
Organisation, 2009, ISBN 978 92 4 154767 3 [24] EUROSTAT PRODCOM Database 2009 [25] Council
Directive 97/43/Euratom of 3 September 1997 on health protection of the
individuals against the dangers of ionising radiation in relation to medical
exposure, repealing 84/466/Euratom of 3 September 1984 (Medical Directive); [26] Council
Directive 2003/122/Euratom of 22 December 2003 on the control of high-activity
sources and orphan sources (HASS Directive) [27] Council
Directive 90/641/Euratom of 4December 1990 on the operational
protection of outside workers exposed to the risk of ionizing radiation during
their activities in controlled areas (Outside Workers Directive) [28] Council
Directive 89/618/Euratom of 27 November 1989 on informing the general
public about health protection measures to be applied and steps to be taken in
the event of a radiological emergency (Public Information Directive) [29] http://ec.europa.eu/energy/nuclear/radiation_protection/article_31_en.htm [30] Council
Directive 97/43/Euratom of 3 September 1997 on health protection of the
individuals against the dangers of ionising radiation in relation to medical
exposure, repealing 84/466/Euratom of 3 September 1984 (Medical Directive); [31] Council
Directive 2003/122/Euratom of 22 December 2003 on the control of
high-activity sources and orphan sources (HASS Directive) [32] Council
Directive 90/641/Euratom of 4December 1990 on the operational
protection of outside workers exposed to the risk of ionizing radiation during
their activities in controlled areas (Outside Workers Directive) [33] Council
Directive 89/618/Euratom of 27 November 1989 on informing the general
public about health protection measures to be applied and steps to be taken in
the event of a radiological emergency (Public Information Directive) [34] EUROSTAT Basic Statistic for 2007 [35] http://www.ncrponline.org/Publications/160press.html ANNEX I Organisations
in Radiation Protection Heads of the European Radiation Control Authorities (HERCA) is an informal body of high-level ("heads")
representations of national authorities with competence in radiation
protection. This group was constituted in May 2007 on the initiative of French
Nuclear Safety Authority (ASN) and brings together the heads of European
radiation protection authorities. At their request, five working groups have
been set up to examine a series of themes considered by the authorities as
problematic. Each working group is jointly chaired by representatives of
different national authorities. The first working group, devoted to the
question of “radiological passports”, met in 2008. Two other working groups are
devoted to the themes of “justification” and “new medical techniques”. The Commission was invited to inform on progress with the revision
of the BSS at meetings in December 2008 and 2009 as well as in June 2010. At
the meeting in June 2010 a working document comparing extensively the draft
Euratom BSS with draft 3.0 (January 2010) of the International BSS was
presented by the Commission, and the group further supported the Euratom
approach. International Commission on Radiological Protection (ICRP) is an independent
Registered Charity, established to advance for the public benefit the science
of radiological protection, in particular by providing recommendations and
guidance on all aspects of protection against ionising radiation. ICRP is the
worldwide recognised scientific society in radiation protection. Based on the
latest available scientific information of the biology and physics of radiation
exposure, its recommendations lay out the philosophy and the technical
benchmarks in the radiation protection area. Without being of obligatory
nature, ICRP recommendations are internationally recognised for the development
of radiation protection rules all over the world. A few years ago, ICRP started
to revise their Recommendations for a System of Radiological Protection taking
account of the latest scientific findings. In view of the importance afforded
to ICRP’s recommendations and to ensure that the new recommendations adequately
and appropriately address national issues and concerns, the ICRP has initiated
an open process involving two phases of international public consultation. The
ICRP has received input from a broad spectrum of radiation protection
stakeholders, ranging from government institutions and international
organisations to scientists and non-governmental organisations. The draft
recommendations have been discussed at a large number of international and
national conferences and by many international and national organisations with
an interest in radiological protection. The European Commission, with the
support of the Article 31 Group of Experts, took part in these discussions. International Radiation Protection Association (IRPA)
is an international non-profit organisation that enlists
individuals as members who are also members of an affiliated national or
regional Associate Society. Today, there are 46 associated societies around the
world with membership of nearly all professionals with operational
responsibilities in radiation protection. The primary purpose of IRPA is to
provide a medium whereby those engaged in radiation protection activities in
all countries may communicate more readily with each other and through this
process advance radiation protection in many parts of the world. This includes
relevant aspects of such branches of knowledge as science, medicine,
engineering, technology and law, to provide for the protection of man and his
environment from the hazards caused by radiation, and thereby to facilitate the
safe use of medical, scientific, and industrial radiological practices for the
benefit of mankind. International
Atomic Energy Agency (IAEA) is an independent international organisation,
related to the United Nations system, which seeks to promote the peaceful use
of nuclear energy. The IAEA was established as an autonomous organisation on 29
July 1957 with headquarters in Vienna, Austria. Today, IAEA has 151 member
states. The IAEA serves as an intergovernmental forum for scientific and technical
cooperation in the peaceful use of nuclear technology and nuclear power
worldwide. The programs of the IAEA encourage the development of the peaceful
applications of nuclear technology, provide international safeguards against
misuse of nuclear technology and nuclear materials, and promote nuclear safety
(including radiation protection) and nuclear security standards and their
implementation. A big part of the IAEA´s statutory mandate is the
establishment, and promotion, of advisory international standards and guides. The IAEA safety standards reflect an international
consensus on what constitutes a high level of safety for protecting people and
the environment from harmful effects of ionising radiation. They are issued in
the IAEA Safety Standards Series, and cover nuclear safety, radiation
protection, radioactive waste management, the transport of radioactive
materials, the safety of nuclear fuel cycle facilities and quality assurance.
The main document in radiation protection is Safety Standard 115 "International Basic Safety Standards for Protection
against Ionising Radiation and for the Safety of Radiation Sources",
edition 2003. These Standards, co-sponsored by FAO[1], ILO[2],
OECD/NEA[3], PAHO[4] and WHO[5], are based on assessments
of the biological effects of radiation made by the United Nations Scientific Committee
on the Effects of Atomic Radiation, and on the recommendations of the
International Commission on Radiological Protection and the International
Nuclear Safety Advisory Group. In 2006 IAEA together with the cosponsors
undertook revision of Safety Standard 115. This is ongoing activity also driven
by the new ICRP Recommendations 103, published in 2007. European Atomic Forum (FORATOM)
is a trade association for the nuclear energy industry in Europe. Its main
purpose is to promote the use of nuclear energy in Europe by representing the
interests of this important and multi-faceted industrial sector. The membership
of Foratom is made up of 16 national nuclear associations. Foratom also
represents some of the continent's largest industrial concerns. Nearly 800
firms are represented. United
Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) was established by the General Assembly of the United Nations in
1955. Its mandate in the United Nations system is to assess and report levels
and effects of exposure to ionising radiation. Governments and organisations
throughout the world rely on the Committee's estimates as the scientific basis
for evaluating radiation risk and for establishing protective measures. ANNEX II Projects,
Studies, Scientific Radiation Protection Publications A. Summaries
of the scientific publications, projects and studies 1. Publication 103 of ICRP. After eight years of discussions, involving scientists, regulators,
and users all around the world, the International Commission on Radiological
Protection adopted its new recommendations on 21 March 2007 (published in
December 2007). The new Recommendations (Publication N° 103) have two primary aims: -
to take account of new biological and physical
information and of trends in the setting of radiation safety standards; and -
to consolidate and rationalise the previous
Recommendations (Publication N° 60) and the supplementary
reports, issued since their publication in 1991. The present Recommendations update the radiation and tissue
weighting factors in the quantities equivalent and effective dose and update the
radiation detriment, based on the latest available scientific information of
the biology and physics of radiation exposure. They maintain the Commission’s
three fundamental principles of radiological protection, namely justification,
optimisation, and the application of dose limits, clarifying how they apply to
radiation sources delivering exposure and to individuals receiving exposure. The
Recommendations evolve from the previous process-based protection approach
using practices and interventions by moving to an approach based on the
exposure situation. They recognise planned, emergency, and existing exposure
situations, and apply the fundamental principles of justification and
optimisation of protection to all of these situations. They maintain the Commission’s
current individual dose limits for effective dose and equivalent dose from all
regulated sources in planned exposure situations. They re-enforce the principle
of optimisation of protection, which should be applicable in a similar way to
all exposure situations, subject to the following restrictions on individual
doses and risks; dose and risk constraints for planned exposure situations, and
reference levels for emergency and existing exposure situations. The
Recommendations also include an approach for developing a framework to
demonstrate radiological protection of the environment. 2. European
Study on Occupational Radiation Exposure (ESOREX). The ESOREX was established in 1997 to
collect information on how individual monitoring is structured in MS and how
data are recorded and reported. The project consisted of surveys on radiation
monitoring and exposure of workers for the period from 1995 to 2005. The data
collected have allowed statistical evaluation of occupational radiation
exposure in different work sectors. The analysis of different years allowed the
evaluation of changes and trends after the implementation of the BSS Directive
96/29. The objective of
this European Union survey is to provide the Commission and the national
competent radiation protection authorities with reliable information on how
personal radiation monitoring, reporting and recording of dosimetric results is
structured in European countries. The survey resulted in the following main
conclusions: -
To ensure that outside workers receive the same
level of protection as workers permanently employed by a licensee, it is
imperative that the Outside Workers Directive is coherently incorporated in the
Basic Safety Standards Directive 96/29. Definitions need to be made consistent,
and the responsibilities of an undertaking and of the employer of an outside
worker for the protection of the outside worker need to be clearly defined. -
To allow free movement of outside workers within
Europe it is necessary to establish a harmonised dose limit for occupational
exposure. It is therefore recommended to abandon the current dose limit of 100
mSv averaged over 5 years (with a yearly maximum of 50 mSv) and to introduce a
single year dose limit of 20 mSv. -
The establishment of a national dose registry
allows tracking the doses of exposed workers nationally, in particular the
doses of outside workers. -
The introduction of an individual radiological
monitoring document (Radiation Passbook) for each outside worker shall further
facilitate recording and reporting of individual exposure data. The radiation
passbook of an outside worker should furthermore allow undertakings to be
informed about the dose history of an outside worker and to easily check
compliance with requirements on education and training, medical surveillance
and with dose limits. 3. "European ALARA
Network for naturally occurring radioactive material – NORM" is a forum for communication, knowledge exchange, identification
of problems and discussions about possible solutions on different topics
related to NORM. The European Commission has used the workshops organised by
the European ALARA Network for NORM (EANNORM) and its website for
presenting and discussing different proposals for modifications in the 96/29
Directive with regard to NORM (see public consultation on natural radiation
sources). The main European ALARA Network held in 2005 a workshop (9th
European ALARA Network Workshop), that focused on the control of the
exposure received by workers from natural radiation sources, in particular
workers in the NORM industries and exposure to radon. The Workshop recommended
that national authorities should develop long-term action plans for addressing
occupational radon exposures and that the EC clarifies the Scope of Title VII
of the BSS Directive, in particular to which workplaces it applies. It also
recommended that the regulatory system applied to NORM should focus on
significant risks and a graded approach is necessary. 4. European Platform on Training and
Education in Radiation Protection (EUTERP) was established in 2006
following the results of a survey carried out on behalf of the European
Commission and published as Radiation Protection N° 133.
EUTERP recommends that the status of the "qualified experts" in the
directive is enhanced with particular requirements for their involvement in the
supervision and execution of radiation protection tasks. In addition it is
proposed to establish two levels of expertise - Radiation Protection Expert and
Radiation Protection Officer. These proposals aim to establish harmonised
environment for the recognition of these specialist and to contribute to the
free movement of these experts. These proposals aim to establish harmonised
environment for the recognition of these specialist and to contribute to the
free movement of these experts. 5. International Conference on Modern Radiotherapy: 'Advances and
Challenges in Radiation Protection of the Patients', organised by the French Nuclear Safety
Authority in cooperation with the International Atomic Energy Agency, the World
Health Organization and the European Commission from 2 to 4 December 2009 in
Versailles[6]. During this conference
detailed consideration has been given to the "accidental or unintended
exposures" of patients following the several cases of such accidents that
occurred in recent years (France, Belgium…). 6. International
Conference on Justification of Medical Exposure in Diagnostic Imaging,
organised jointly by the International Atomic Energy Agency and the European
Commission from 2 to 4 September 2009 in Brussels[7].
Despite these initiatives, the approach to and compliance with justification is
weak in diagnostic radiology and nuclear medicine. Work within the EU SENTINEL Project and a
number of IAEA consultations confirm this. It is also probable that there are
significant justification problems in radiological practice in the developing
world. In the West, recent studies indicate that >20% of examinations may
not be appropriate; this can be as high as 45% in special cases, and up to 75%
for specific techniques. This situation should be tackled promptly,
particularly as tools are now available to improve it. The sense of urgency
about the problem is reinforced by newer high dose activities in radiology,
newly available tools for justification and clinical audit, the ongoing
revision of the IAEA Basic Safety Standards (BSS), the recasting of the
European Directives, and the requirement for an effective regulatory approach
in a sensitive area. These developments are happening against a background of
worryingly increasing medical radiation doses, and the American College of Radiology (ACR) white paper noting “The rapid growth of CT and certain nuclear
medicine studies may result in an increased incidence of radiation-related
cancer in the not-too-distant future”. These concerns provide additional
motivation for dealing with justification. Finally there is a need to align
medical justification with contemporary ethical and social thinking. 7. IAEA RS-G-1.7. The objective of this Safety Guide is to provide guidance to
national authorities, including regulatory bodies, and operating organisations
on the application of the concepts of exclusion, exemption and clearance as
established in the BSS. The Safety Guide includes specific values of activity
concentration for both radionuclides of natural origin and those of artificial
origin that may be used for bulk amounts of material for the purpose of
applying exclusion or exemption. It also elaborates on the possible application
of these values to clearance. 8. International Symposium
on Non-Medical Imaging Exposures, organised by
the European Commission on 8 and 9 October 2009 in Dublin. The objective of the
symposium was to collect up-to-date information and exchange experiences on
non-medical/medico-legal exposures, identify the issues of concern and discuss
the ways of addressing them in a revision of the Euratom BSS Directive. The
meeting concluded that it is clear that there is a need to retain the level of
protection and justification that applies to medical exposures, as defined in
the current Medical Exposure Directive. However in doing this it is also
necessary to ensure that the over-arching framework is such that all practices
are regulated and appropriate levels of control are in place. It was clear that
the single most important issue in this area is justification and that this
must be applied for every practice and individual exposure. The conclusions
supported the exclusion of the medico-legal exposures from the legal definition
of medical exposure and grouping them together with other similar cases under
the new term 'non-medical imaging exposures', for which a detailed new approach
should be proposed in the revised BSS Directive. B.
Summaries of the Reports Published in the Euratom Radiation Protection Series 1. Radiation
Protection N° 95 "Reference levels for
workplaces processing materials with enhanced levels of naturally occurring
radionuclides". The purpose of this Guide is to provide advice on work
activities where the processing of NORM is subject to the requirements in Title
VII of the BSS Directive 96/29. Since the existence of the radiation risk is
incidental to the process undertakings are sometimes not aware of the risk.
Therefore, simple means of identifying and categorising such industries are
needed so that managements can decide whether more detailed radiological
assessments are necessary. The report proposes a graded approach to the
regulatory control of workers in NORM industries and suggests dose levels at which
the different levels of regulatory control would apply; below 1 mSv per year no
regulatory control, between 1-6 mSv per year low level of control, between 6-20
mSv per year high level of control and above 20 mSv exposures should not be
accepted. The report also indicates the most significant industries in Europe where processing of NORM can cause increased exposure of workers. 2. Radiation Protection
N° 112 "Radiological protection
principles concerning natural radioactivity of building materials". The
purpose of this publication is to provide guidance for establishing regulatory
control of building materials containing enhanced levels of natural
radioactivity. The report recommends the establishment of a dose criterion for
introducing regulatory control and proposes a methodology for screening
material (using an Activity Index formula) to see if the dose criterion is
complied with. The study which formed the basis for the report, see RP 96
Enhanced radioactivity in building materials, also included information about
national regulation on natural radioactivity in building materials. In 1997
when the RP 96 was published only five Member States had legislation and the
Activity Index formula used to screen material varied between those countries. 3. Radiation Protection N° 122 "Practical use of the
concepts of clearance and exemption". Part I "Guidance
on general clearance levels for practices" offers
default values for any type of material and any pathway of recycling or
disposal (in addition to the specific levels for metals and building rubble,
published earlier). Part II
"Application of the concept of exemption and clearance to natural
radiation sources". The application of the
concepts of exemption and clearance to natural radiation sources is discussed
in this study within the overall context of regulatory control of natural
radiation sources and in particular as laid down in Title VII of the Basic
Safety Standards for work activities. The study discusses how these concepts
can be used and which clearance levels would be appropriate. The main
conclusions were: -
as a result of the large volumes of material
processed and released by NORM industries, the concepts merge and it would be
appropriate to have one single set of values both for exemption and clearance; -
although the basic concept and criteria for
exemption and clearance for NORM work activities are similar to those for
practices, it is not meaningful to define levels on the basis of the individual
dose criterion for practices (10µSv per year); instead a dose increment in the
order of 300 µSv is appropriate. 4. Radiation
Protection N° 130 "Medico-legal exposures,
exposures with ionising radiation without medical indication". Proceedings
of the International Symposium, organised by the Commission in 2002[8].
According to the Medical Exposure Directive, all individual exposures are
supposed to be justified both by the prescriber and by the practitioner, each
with respect to their own expertise and area. In cases where a medical doctor
is asked by an insurance company, judge, employer etc. to provide advice and/or
a conclusion about the physical state of a person, it is likely that X-ray will
be indicated to complete the assessment. However, there are situations where
the medical doctor is effectively directed to use X-rays by an employer, judge
etc. In those cases, the one who orders the X-ray becomes the prescriber. 5. Radiation
Protection
N° 133 "The Status of the Radiation Protection
Expert in the EU Member States and Applicant Countries". This report provides a survey of the present situation of radiation
protection experts (RPEs) in the Member States of the European Union and the
Applicant Countries (at the time of the survey). Based on the conclusions of
the study, some recommendations are made: -
In the context of the single market and the
enlargement process, it is recommended to try to achieve harmonisation in the
qualifications of the so called "qualified expert" often introduced
in national legislations as RPE. This would help promote the achievement of the
aims of the Directive on free movement of workers in the European Union and
should take due note of the Directive on safety at work. -
Definition, tasks and provisions for recognition
of the RPE in the national regulations of EU Member States and Applicant
Countries should be compared in detail, in order to expose the obstacles
preventing a harmonised implementation of the concept of the “Qualified
Expert”. As a means of achieving this goal, it is recommended to establish a
Discussion Platform that could serve as a means for exchange of information on
education, training, recognition and registration of RPEs. This Platform may
provide a vehicle for moving forward to mutual recognition. The topics
mentioned in the recommendations hereunder could be addressed in such a
Discussion Platform (see part A.5.). 6. Radiation
Protection N° 135 "Effluent and dose
control from European Union NORM industries: Assessment of current situation
and proposal from a harmonised Community approach". This report identifies
relevant NORM industries but from the point of view of discharges. Furthermore,
it contains an overview of national regulations in 16 Member States.
relevant to NORM and proposes a set of screening values based on certain dose
criteria for NORM discharges above which a more detailed radiological
assessment would be advised. The overview of the national regulations showed
that at the time of the publication of the report (2003) most Member States had
focused on identification of significant exposures to the workers but that
identification of significant exposure to the public from NORM wastes and
discharges was still in an early stage. Only nine of the countries had or
planned to set up specific discharge controls or assessment procedures for NORM
discharges. 7. Radiation
Protection
N° 154 "European
Guidance on Estimating Population Doses from Medical X-Ray Procedures". DG TREN launched in 2004 a study, called Dose DataMed, to
review the situation in the Member States regarding the doses to the population
from medical exposure procedures. The results for 10 European countries
participating in the study were published in 2008, demonstrating that there are
considerable differences between, and even within, the countries. It was
concluded that there is a need for harmonization of the dose data collection
among the Member States. 8. Radiation
Protection N° 156 "Evaluation of the Implementation of Radiation
Protection Measures for Aircrew". The study
concluded that current requirements in Directive 96/29/Euratom lead to a
satisfactory protection of aircrew against the dangers arising from cosmic
radiation and that there is no area where requirements would be incomplete or
where regulations would clearly be missing. It is, however, recommended to
incorporate the requirements on protection of aircrew coherently in the title
on the protection of workers. These conclusions are made on the base of the
collected data on the implementation of the requirements of the BSS Directive
96/29 in various EU Member States and other countries. 9. Radiation
Protection Publication N° 157 "Comparative Study of EC and IAEA Guidance
on Exemption and Clearance levels". The BSS
Directive 96/29 contains general requirements on disposal, recycling and reuse
of materials used in practices under regulatory control. According to these
requirements material can be released from radiation protection control if they
comply with levels of radioactivity set by national competent authorities
(clearance levels). The aim of the study is to compare the values in EU
Radiation Protection N° 122 and the IAEA document RS-G-1.7 and to
provide a basis for deciding whether the IAEA levels could also be used as
clearance levels and as a substitution of the level, above which the practices
should be notified (exemption levels). After a comprehensive review of the two
documents, it is concluded in the report that the IAEA values can be used as
general clearance levels, replacing the values recommended by the Commission.
It is also justified that the IAEA values can replace the activity
concentration values for the exemption of practices from notification and
authorisation regime. 10. Radiation
Protection Publication N° 166 "Implementation of the Council Directive
90/641/Euratom". According to the final report,
the outside workers in European Countries can be estimated to at least 100 000,
mainly working for the nuclear industry. Almost all the operators who use
outside workers check the medical surveillance and fitness of the outside
workers, provide them with specific training and protective equipment; 75% of
the operators ensure that radiological data of each worker is recorded into a
radiation passport or a network; additionally 50% of the operators set up dose
constraints for outside workers. However, the answers provided by outside
undertakings (the employers of the outside workers) clearly outline that there
is a large variety of situations and there is a need for a harmonisation of
both exposure assessment and medical surveillance. The need for a uniform
European network or radiation passport is particularly highlighted in this
survey. ANNEX III Article
31 Group of Experts – Statute and Opinion on the Revision of BSS A. Statute and Work of the Group of Experts referred to in Article
31 of the Euratom Treaty (Article 31 Group of Experts) Article 31 Group of Experts is
established according to Article 31 from the Euratom Treaty with the task to
advise on the elaboration of uniform basic safety standards as described in
art.30 from the Treaty. The Group consists of scientific experts, in particular
public health experts from Member States, appointed by the Scientific and
Technical Committee, set up in compliance with Article 134 of the Treaty. The
members of the Group are appointed on a personal basis for a term of five
years, renewable. The members of the Group speak on their own behalf and act
independently of all external influence. The Treaty requires the European
Commission to consult this Group when preparing, revising and supplementing the
basic standards for the protection of the health of workers and the general
public against the dangers arising from ionising radiation. When in 2005 the
European Commission undertook the revision of the Basic Safety Standards
Directives, Art.31 Group of Experts was asked to investigate and deliver an
opinion on this issue. This action was triggered by the fact that the
International Commission for Radiological Protection (ICRP) has engaged in a
process of revising and updating their Recommendations for a System of
Radiological Protection which since decades represent the internationally
accepted basis for radiological protection. In this context the revision of the
BSS was considered as the most important activity of the Group of Experts to be
completed before the end of its mandate in May 2010. Therefore, several working
parties (WP) were established to identify the items in the BSS directives that
may need revision and to look into the impact of the possible changes:
WP Basic
Safety Standards - established at the June 2005 meeting of the Article 31
Group of Experts to monitor the development of the ICRP recommendations,
to oversee the work of the topical WPs and ensure that the developments in
these WPs are coherent.
WP Graded
Approach to Regulatory Control – this WP was established with the main
objective to discuss current concepts of regulatory control with a view to
the introduction in BSS of a more elaborated graded approach to regulatory
control.
WP Natural
Sources – established in November 2005 to address questions relating to
natural radiation exposures. The WP Natural Sources' first priority was to
examine how the requirements on natural radiation sources in Title VII of
the present Directive could be strengthened and if it was feasible to
integrate the regulatory control of so-called NORM industries into the
framework of regulatory control for practices. The second task was to look
into the possibility to establish in the BSS Directive requirements
related to exposure to radon, taking into account the Commission
Recommendation 90/143/Euratom on indoor exposure to radon. The third
assignment was to propose a regulatory framework for building materials
containing natural radiation sources. For each of these tasks the WP
produced comprehensive reports, giving background data on international
and Commission standards and guidance, indicating where further guidance
and work is necessary and providing proposals for new or modified
requirements. The reports have been presented to the Article 31 Group of
Experts and agreed upon.
WP Exemption
and Clearance – established in November 2005 with the task to make a
review of the existing sets of values for exemption and clearance in the
directives, recommendations and international guides. On this basis the WP
should advise on possible harmonisation of the values for clearance
(choose one set of values) and on harmonisation of the values for
exemption and clearance. The conclusions of the WP were expressed in a
report submitted to the Article 31 Group of Experts.
WP on the
Recast of Basic Safety Standards – this WP was established in November
2007 to undertake a recast of the BSS directive and four other related
directives. According to the mandate WP Recast should focus combining 5
directives into one peace of legislation - BSS Directive (recast). The WP
should use the outcomes and the proposals of the other working parties and
the results of studies, projects and consultations.
The existing
working parties on "Medical exposures" and "Research and
Implications on the Health and Safety Standards" (RIHSS) were also
involved in the process. WP "Medical exposures" was asked by Article
31 Group of Experts to elaborate on the possible recast of Council Directive
97/43 and BSS Directive and to look into the latest developments in the medical
exposures area. RIHSS looked into the scientific basis of the biological
effects of radiation, as input both to ICRP and to the revision of the BSS. After several
years of discussions and preparation of the possible revision of BSS Directive
and associated directives, Art.31 Group of Experts issued their opinion in February 2010. B. Main
Points from the Opinion of Article 31 Group of Experts on the Revised Basic
Safety Standards for the protection of the health of workers and the general
public against the dangers arising from ionising radiation 1) A graded
approach to the regulatory control of practices needs to be established. It is
proposed that the regulatory regime is built on three steps – notification,
registration, licensing instead the current 2 levels – notification and
authorisation. The Working Party on Graded Approach proposed a list of
practices which can be submitted to simple registration instead of licensing. 2) In order to
ensure equal protection of the workers in different economic sectors it is
proposed to submit the so-called NORM industries[9] to the
regulatory control established for the other practices involving radioactivity. 3) With regard
to the Commission Recommendation 90/143/Euratom on indoor exposure to radon,
which is largely introduced in the Member States, the Working Party on Natural
Sources recommended to introduce requirements on the control of radon in
workplaces, dwellings and public buildings into the revised BSS Directive. 4) A new regulatory framework should be established for building
materials containing naturally occurring radionuclides present in the earth's
crust. Member States shall be required to identify building materials of
concern. The national authorities should set a reference level of 1 mSv per
year for indoor external exposure from building materials. For the identified
types of building materials which are liable to exceed the reference level the
competent authority shall decide on appropriate measures ranging from
registration and general application of relevant building codes, to specific
restrictions on the envisaged use of such materials. 5) A revised BSS
Directive should propose a set of default activity concentration levels for the
clearance of materials from regulated practices involving radiation sources.
The levels chosen should be harmonised with international guidance. Based on
the findings of the "Comparative Study of EC and IAEA Guidance on
Exemption and Clearance levels" (Radiation Protection Series 157) the
Working Party on Exemption and Clearance proposed to establish the same set of
activity concentration levels for the exemption of practices from regulatory
control and for the clearance of materials from regulated practices. Although
this will result in lower thresholds above which regulatory control would
apply, the study concluded that in practical terms this will not impose
additional burden since only a few, if any, practices will be affected. 6) The control
of high activity sealed sources (HASS) and orphan sources, now regulated in
Council Directive 2003/122/Euratom, is part of the regulatory control regime
and covers issues regarding emergency preparedness and response. It is
recommended to incorporate the text of Directive 2003/122 into the revised BSS
Directive to achieve a more coherent and comprehensive regulation for the control
of high activity sealed sources. 7) In view of
the development of techniques involving deliberate exposure of individuals for
security and other legal purposes like security screening, age determination
etc. it is necessary to establish new requirements. The Working Party on
Medical Exposures proposed the concept of a regulatory regime for these
exposures. 8) In view of
new scientific findings regarding enhanced incidence of radiation induced
cataracts it is recommended to lower the current organ dose limits for the lens
of the eye. This has been supported by reports given at the 2006 Scientific
Seminar on New insights in radiation risk and basic safety standards. The
proceedings of the 2006 Scientific Seminar are published in the Radiation
Protection Publication N° 145 "New Insights in
Radiation Risk and Basic Safety Standards". ANNEX IV || EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR ENERGY DIRECTORATE D - Nuclear Energy D.4 - Radiation Protection Luxembourg, 9 April
2010 D4/ÅW D(2010) Summary of the Commission Services' public
consultation regarding natural radiation sources in new Euratom BSS Note to EANNORM Consultation
and response A consultation
document with the Commission Services' considerations regarding natural
radiation sources in the new Euratom Basic Safety Standards Directive (BSS)[10]
was launched on the European Commission's website in February 2009. The end
date was set to 20 April 2009 although comments kept coming until the end of
April. Those have been included as well. In total
forty-seven contributions were received, mostly from industry/industrial
organisations or governmental organisations/authorities (around 15 each). A
substantial amount of contributions came from individuals (10) and from
radiation protection associations or group of experts (5). The contributions
from industry were distributed over the following industrial sectors: - Steel
producers - Zirconium
chemicals producers - Producers of
abrasive products - Building
materials industry - Tiles and
bricks industry - Radon
measurement and remediation companies With regard to
the geographical distribution, comments were received from the following
countries: Germany(13), UK(5), Spain(4), Italy(4), Belgium(3), Ireland(3), the Netherlands(2), Sweden(2) and Finland, Greece, Poland, Austria, Norway, Switzerland, Australia (one each) [11].
A compilation of
the comments received was sent to the WP Recast and WP Natural Sources
(sub-groups of the Article 31 Group of Experts) for further discussion. It
should be noted that the text of the draft BSS has constantly evolved since the
Article 31 Group of Experts meeting in November 2008 when the consultation
document was approved. Some of the problems raised in the comments were already
addressed and solved by the time of the consultation and several issues have
been taken care of in the further drafting process during 2009. In February
2010 the Article 31 Group of Experts finalised the draft Euratom BSS and
adopted an Opinion on the draft. The Opinion of the Article 31 Group of Experts
reflects the broad range of views within the Group of Experts on some issues. Outcome: In
general The consultation
was well received and a large part of the contributors express their
appreciation for being invited to comment on ideas this early in the process of
revising the Directive. In general the contributions endorsed the goal of the
Commission to harmonise, clarify and strengthen the requirements related to
natural sources. The contributors
believe the Commission has chosen the right approach when introducing the
so-called graded approach to regulatory control but would like to have more
information on the regime of notification, registration and licensing. There is
also a high demand for guidance and clarification about the rationale for certain
issues and about how to implement the requirements in practice. The Commission
is planning to further elaborate on principal issues and their implementation
in a guidance document which should be published in connection with the
adoption of the new Directive. Furthermore there is a demand for clear
definitions, e.g. on buildings, dwellings, reuse, recycling, disposal, waste,
constructions, natural radiation source and inert material. This has been taken
care of and the draft BSS now contain the relevant definitions. Outcome:
Specific topics The forty-seven
contributions contained a number of comments, some detailed, some addressing
broader issues. The main concerns are listed below along with comments in
italics about how these concerns have been or will be dealt with. Please note
that the summary is very brief and does not contain the full reasoning behind
neither the comments and concerns nor the outcome shown in italics. NORM Positive list –
Some additional industries are suggested. Two of them have been added: Geothermal energy production, since it has similar radiation
protection issues as other types of fluid extraction, e.g. oil and gas
extraction. Mining of ores other than uranium ore. Although exposure to radon is
normally the main pathway of exposure in underground workplaces, some mines
have problems with high concentrations of Radon-226 in fissure water. –
The positive list is a good thing but after
assessment Member States should have the possibility to remove certain
industries This is not explicitly mentioned in the draft BSS, instead it states
that all industries on the list needs to be taken into account when Member
States make the initial identification of industries which cannot be
disregarded from a radiation protection point of view. Materials of concern –
Need for clarification about pathways when
assessing doses This is an area where the Commission is considering issuing further
guidance although earlier Commission guidance such as RP 122 part II is still
relevant for identifying pathways. Mandatory requirement for notification if the industry is recycling
residues into building material –
Does not fit with graded approach –
Will be difficult to implement and to control –
Would it not be enough if the building material
complies with what is required in the Directive for building materials (index,
reference level, etc)? The mandatory requirement is kept in the draft BSS since recycling
of residues into building materials is one of the pathways that may lead to
doses to the public exceeding 1 mSv/y and it is therefore necessary to have
some form of regulatory control of the industries recycling residues into
building materials. The draft BSS contain an annex with of building materials
of concern, including a list of the types of residues. The annex indicates
which industries would be affected by this requirement. Exemption values –
Why not use RP 122, part II values (e.g. 0.5
kBq/kg instead of 1 kBq/kg)? For the sake of harmonisation with international standards the
values in the IAEA report RS-G-1.7 have been incorporated, in the same way as
for artificial radionuclides. Some of the Article 31 Experts also prefer the RP
122 values and this is reflected in the Opinion. –
Some contributors mention the need for allowing
lower values when drinking water may be affected. This has been introduced in the draft BSS: without explicitly
allowing lower levels, the competent authority may impose restrictions wherever
drinking water or other pathways of exposure may be affected. Graded approach –
How to assess doses to workers? Should
conventional health and safety equipment be taken into account? It has been taken care of by referring to "normal working
conditions", which implies that compulsory health and safety requirements
relevant to the workplace should be taken into account. –
Why notification already when doses to workers
are likely to exceed 1 mSv/y? Some of the German contributors mention that they
have good regulatory experience of setting the level for notification at 6
mSv/y. Why ask for anything more than notification? Licensing or
registration requirements would only lead to an unnecessary administrative
burden. The draft BSS now deal with NORM industries in the same regulatory
framework as for other practices. The graded approach applies to all practices
and the choice of registration or licensing is based on different criteria,
e.g. dose assessment to workers and members of the public. However, for doses
to workers in the range 1-6 mSv/y the requirements for occupational exposure to
NORM are less demanding. Mixing –
Mixing NORM with other material should be
encouraged. Significant amounts of NORM are recycled and end up mixed with
other materials, e.g. in cement and concrete. The term "inert" may
also not be appropriate. The term "inert material" is no longer used and the text
is modified. Radon –
There is a clear demand for technical guidance,
especially with regard to measurement techniques, and for standards and
harmonisation on a European level for this. According to the website of the International Organization of
Standardization (ISO), one of its subcommittees, TC85/SC2, is in the process of
developing several ISO standards for Radon-222. With regard to building
materials, CEN/TC 351 is presently investigating the possibility of setting a
CEN standard for measuring radioactivity concentration (gamma radiation) in
building materials. –
There are worries that the action plan will only
address radon in dwellings and public buildings. Radon in workplaces needs
equal attention. The draft BSS are clear about the fact that the national action plan
must also address radon in workplaces. –
Some contributors question a threshold for
recording doses to workers in NORM industries and question the choice of the
value of 400 Bq/m3. This threshold has been removed. –
Modify so that within radon-prone areas all
workplaces with a high occupancy are requested to be measured. This is reflected in the requirements on the content of the national
action plan. –
Modify so MS have the possibility to choose a
higher reference level for workplaces with a very low occupancy. It should be noted that a reference level is not a limit. For such
workplaces, where radiation protection measures are optimised, the radon
concentrations may very well exceed the reference level. –
Include criteria on level of rooms or workplaces
in addition to requirements for measurements in radon-prone areas (upper floors
excluded?) The requirements for measurements at workplaces have been slightly
modified. For buildings with public access or dwellings setting specific
requirements on types of rooms or workplaces would require a high level of
detail. It would be more suitable to discuss such a complex issue in a guidance
report. Building
materials –
Clarification needed about whether materials
used for infrastructure projects are considered building materials. The draft BSS contain a definition of building materials. –
Some contributors worry about the proposed
requirements causing stigmatization of certain groups of materials, whereas
others are concerned that the flexibility, for instance when setting up the
list of building materials which need to be considered, would lead to problems
in shipping and trading products within EU. These are valid concerns. However, in order to make informed
decisions when constructing buildings, so as to not exceed the appropriate
levels of exposure to workers or members of the public and to fulfil Annex 1 of
the Council Directive related to construction products (89/106/EEC)[12],
the building industry should be made aware of the radioactivity content of the
materials a Member State has deemed to be of concern. The flexibility for
Member States to establish a reference level for building materials has been
removed. –
Some contributors question why the value for
exemption proposed by RP 112 (0.3 mSv/y) is replaced by 1 mSv/y. Based on the prevailing activity concentrations in building material
produced in the European Union the Article 31 Group of Experts decided that a
level of 1 mSv/y would be more appropriate in a Directive, also in order to
avoid problems in trade within the EU. –
Harmonisation or guidance on how to measure
radionuclide concentrations and calculate the index would be beneficial, as
well as on the concept of "superficial material". Some information can be found in earlier Commission guidance, such
as RP 96 and RP 112, but this is an area where the Commission considers issuing
further guidance. ANNEX V Legislation
enacted
under Articles 30 and 31 from Euratom Treaty Council Directive 96/29/Euratom laying down basic safety standards for the protection of the health
of workers and the general public against the dangers arising from ionising
radiation (BSS Directive 96/29) is the main
pillar of the body of secondary legislation on basic safety standards, adopted
pursuant to Article 31 of the Euratom Treaty. The following acts are based on
art.31 from Euratom Treaty: 1. Council Directive 97/43/Euratom of 30
June 1997 on health protection of the individuals against the dangers of
ionising radiation in relation to medical exposure, repealing 84/466/Euratom of
3 September 1984 (Medical Directive); 2. Council Directive 90/641/Euratom of
4December 1990 on the operational protection of outside workers exposed to the
risk of ionising radiation during their activities in controlled areas (Outside
Workers Directive); 3. Council Directive 2003/122/Euratom
of 22 December 2003 on the control of high-activity sources and orphan sources
(HASS Directive); 4. Council Directive 89/618/Euratom of
27 November 1989 on informing the general public about health protection
measures to be applied and steps to be taken in the event of a radiological
emergency (Public Information Directive); 5. Council Decision 87/600/Euratom of 14 December 1987 on Community arrangements for early exchange of
information in the event of a radiological emergency; 6. Council Regulation 87/3954/Euratom of 22 December 1987 laying down maximum
permitted levels of radioactive contamination of foodstuffs and of
feedingstuffs following a nuclear accident or any other case of radiological
emergency and the related legislative acts - Commission Regulation 944/89/Euratom
of 12 April 1989 laying down maximum permitted levels of radioactive
contamination in minor foodstuffs following a nuclear accident or any other
case of radiological emergency, Commission Regulation 770/90/Euratom
of 29 March 1990 laying down maximum permitted levels of radioactive
contamination of feedingstuffs following a nuclear accident or any other case
of radiological emergency[13]; 7. Council Regulation 93/1493 of 8 June
1993 on shipments of radioactive substances between Member States; 8. Commission Recommendation 2001/928/Euratom
of 20 December 2001 on the protection of the public against
exposure to radon in drinking water supplies; 9. Council Directive 2006/117 of 20
November 2006 on the supervision and control of shipments of radioactive waste
and spent fuel; 10. Commission Recommendation 90/143 of
21 February 1990 on the protection of the public against indoor exposure to
radon; 11. Council Directive 2009/71/Euratom of
25 June 2009 establishing a Community framework for the nuclear safety of
nuclear installations. ANNEX VI ESTIMATED
CONTRIBUTIONS TO PUBLIC EXPOSURE FROM DIFFERENT SOURCES (in mSv) (data
published in UNSCEAR Report 2008) Figure I Figure II Figure III Figure IV ANNEX VII EVOLUTION
OF THE MEDICAL DIAGNOSTIC EXPOSURE IN FRANCE between 2002 and 2007[14] || Number of procedures || Number of procedures per capita || Collective effective dose in mSv || Annual dose per capita in mSv 2002 || 73,6 millions || 1,2 || 50 675 472 || 0,83 2007 || 74,6 millions || 1,2 || 82 630 000 || 1,3 The
number of performed medical procedures in the period 2002-2007 has increased by
only 2%. However the annual dose per capita from these procedures increased by
57% for 5 years. This notable increase is due to the increase of number of
procedures in computed tomography and nuclear medicine where the highest dose
in diagnostic medicine is delivered. While for 5 years the number of procedures
in the conventional radiology is stable, in computed tomography and nuclear
medicine significant increase of accordingly 26% and 38% is observed. At the
same time the collective effective dose from conventional radiology decreased,
while the collective effective dose from computed tomography and nuclear
medicine increased by 33 % and in 2007 is 68% from the dose delivered due to
medical diagnostic exposure as a whole. ANNEX VIII (A) NATURALLY
OCCURING RADIOACTIVE MATERIAL A. Naturally
occurring radioactive material and building material The industrial
activities covered by the term "NORM industries" are all related to
material extracted from the earth's crust. Either the industries use the
material (e.g. production of thorium compounds) or they are involved in the
extraction itself (e.g. mining of ores). Table 1 shortlists the types of
operations that are likely to warrant regulatory control with the type of
material involved and range of dose to workers. It is difficult to forecast the
number of enterprises likely to be affected since it depends on the industrial
process in each enterprise and on the content of radioactivity in the material
being processed. As an example the number of enterprises extracting crude
petroleum and natural gas in the EU is 381, the number of enterprises producing
lead, zinc and tin is 293 and the number of enterprises mining iron ores is
estimated to 40[15]. While the
protection of workers in the nuclear industry has been discussed since long,
resulting in international consensus on monitoring and registering of doses to
workers, this is not the case for exposure to workers in NORM industries.
Although many reports were consulted, see Table 2, and the Article 31 Working
Party Natural Radiation Sources experts shared their knowledge on approaches
and situations in their countries, the collection of data for the impact
assessment has been difficult and the data available is often based on
estimations rather than actual monitored doses to workers. Furthermore, the
NORM sector covers a wide range of industrial activities and there is very
little compiled data for the whole sector. The proceedings of the NORM V
conference did however provide a summary of the data presented on doses to
workers and to members of the public. The results are in line with the doses
indicated in Table 1. With regard to estimations of doses from NORM industries
to members of the public, the proceedings conclude that members of the public
in general receive far less than 0.3 mSv per year. Data on the
number of exposed workers are as previously mentioned scarce. The ESOREX
database on occupational exposure does however provide certain information. In
2004 the number of exposed workers in the EU employed in workplaces with
enhanced exposure to natural radionuclides was 27 000[16].
One of the objectives of the SMOPIE project (see Table 2) was to provide
information on the number of industrial workers exposed to NORM. The project
concludes that this information is very scarce but based on the information
received and compiled they estimate the number of potentially exposed workers
in EU NORM industries to be around 85 000 (2004). The project further concluded
that exposure data based on actual workplace monitoring is very scarce. This
lack of data reflects the lack of consistent and harmonised requirements on
monitoring of workers and registration of doses in this industrial sector. Far
more data should become available once the new Directive is implemented. The issue of
natural radionuclides in building materials was discussed by the Art.31 Working
Party Natural Radiation Sources. Based mainly on two reports on activity concentrations
in building materials[17] and one study made on
Italian building materials[18], the group concluded on
a list of materials that Member States should take into account when setting up
national lists of materials that would require regulatory control due to their
content of radioactivity:
Natural
materials such as alum-shale and materials from natural igneous origin
(e.g. granite, basalt and lava)
Materials
incorporating by-products or residues from NORM industries (e.g. fly ash,
phosphogypsum and red mud – a residue from Aluminium production)
The Article 31 Group
of Experts adopted the list with the some additions (e.g. porphyries and
residues from steel production). To give an
indication of amounts, the production of granite (crude or roughly trimmed) in
the EU in 2009 was around 4.5 billion kg. The production of porphyry, basalt,
quartzite and other monumental or building stone (crude, roughly trimmed, cut)
in the EU in 2009 was around 15 billion kg[19]. ANNEX VIII (B) Types of operation
identified, on the basis of worker dose, as likely to require regulatory
controla Type of operation || Description of material involved || Worker dose (mSv/a) Rare earth extraction from monazite || Monazite, Thorium concentrate, Scale, Residue || Average 1 to 8, could approach or exceed dose limit Production of thorium compounds || Thorium concentrate, Thorium compounds || Typically 6 to 15 Manufacture of thorium-containing products || Thorium compounds, Products || <1 to a significant fraction of dose limit Processing of niobium/tantalum ore || Ore, Pyrochlore concentrate, Residue, Slag || Could reach a significant fraction of dose limit Some underground mines and similar workplaces such as water treatment facilities || Ore, Scales from Radium-rich water, Air || <1 to a significant fraction of dose limitb Oil and gas production || Scales during removal from pipes/vessels || <1 to a significant fraction of the dose limit TiO2 pigment production || Scales during removal from pipes/vessels || <1 to 6 Thermal phosphorus production || Fume and precipitator dust || 0.2 to 5 (average: ~1) Fused zirconium production || Fume and precipitator dust || 0.25 to 3 Production of phosphate fertilizers || Dust and scales || Possible to exceed 1 Metal production: smelters || Dust and dust scales || Possible to exceed 1 a Information from IAEA Safety Reports Series No 49, Assessing
the Need for Radiation Protection Measures in Work involving Minerals and Raw
Materials and European Commission Radiation Protection Series No 88. b Measurements in some metal mines indicate an
effective dose from gamma radiation and dust of about 0.5 mSv/a per unit
U-238 activity concentration (in Bq/g) in the ore. The effective dose from
radon is highly variable and difficult to predict, being strongly dependent on
ventilation conditions and other factors. ANNEX VIII (C)
DOCUMENTS EXAMINED
FOR THE IMPACT ASSESSMENT REGARDING NORM
Title || Published || Organisation Approaches for regulating management of large volumes of waste containing natural radionuclides in enhanced concentrations, EUR 16956 || 1996 || European Commission Current practice of dealing with natural radioactivity from oil and gas production in EU Member States, EUR 17621 || 1997 || European Commission Recommendations for the implementation of Title VII of the European Basic Safety Standards Directive (BSS) concerning significant increase in exposure due to natural radiation sources, Radiation Protection Series N° 88 || 1997 || European Commission Establishment of reference levels for regulatory control of workplaces where materials are processed which contain enhanced levels of naturally occurring radionuclides, Radiation Protection Series N° 107 || 1999 || European Commission Radiological impact due to wastes containing radionuclides from use and treatment of water, EUR 19255 || 2000 || European Commission Monitoring and surveillance of residues from mining and milling of Uranium and Thorium, Safety Reports Series N°27 || 2002 || IAEA Radiation Protection and the Management of Radioactive Waste in the Oil and Gas Industry, Safety Reports Series N° 34 || 2003 || IAEA Occupational radiation protection in the mining and processing of raw material, RS-G-1.6 || 2004 || IAEA Strategies and Methods for Optimisation of Protection against Internal Exposure of Workers from Industrial Natural Sources, EC project N° FIGM-CT2001-00176 (SMOPIE-project) || 2004 || NRG, NRPB and CEPN Summary and recommendations from EAN 9th Workshop, "Occupational exposure to natural radiation" || 2005 || European ALARA Network Assessing the need for radiation protection measures in work involving minerals and raw material, Safety Reports Series N° 49 || 2006 || IAEA Radiation protection and NORM residue management in the Zircon and Zirconium industries, Safety Reports Series N° 51 || 2007 || IAEA Naturally Occurring Radioactive Material (NORM V), Proceedings from international symposium in Seville, Spain, 19-22 March 2007 || 2008 || IAEA Sources and effects of ionising radiation, UNSCEAR 2008 || 2010 || United Nations [1] Food and Agriculture Organisation of United Nations [2] International Labour Organisation [3] Organisation for Economic Cooperation and Development, Nuclear
Energy Agency [4] Pan American Health Organisation [5] World Health Organisation [6] main findings from the conference are available on http://www.conference-radiotherapy-asn.com [7] http://rpop.iaea.org/RPOP/RPoP/Content/PastEvents/justification-medical-exposure.htm [8] http://ec.europa.eu/energy/nuclear/radiation_protection/doc/publication/130.pdf [9] Industries involving NORM (Naturally Occurring Radioactive
Materials) [10] The present BSS is the Council Directive 96/29/Euratom of 13 May
1996 laying down basic safety standards for the protection of health of workers
and the general public against dangers arising from ionizing radiation. [11] The sum does not equal forty-seven since some contributions cannot
be associated to a specific country. [12] Council Directive 98/106/EEC, Annex 1, states that "…the
construction work must be designed and built in such a way that it will not be
a threat to the hygiene or health of the occupants or neighbours, in particular
as a result of … the presence of dangerous particles or gases in the air [or]
the emission of dangerous radiation…" [13] These acts are subject to recast - Proposal for a Council
Regulation (EURATOM) laying down maximum permitted levels of radioactive
contamination of foodstuffs and of feedingstuffs following a nuclear accident
or any other case of radiological emergency (Recast) COM/2010/0184 final - CNS 2010/0098 [14] Etard C,
Sinno-Tellier S, Aubert B. Exposition de la population française aux rayonnements
ionisants liée aux actes de diagnostic médical en 2007. Saint-Maurice (Fra) :
Institut de veille sanitaire, juin 2010, 104 p. Disponible sur :
www.invs.sante.fr [15] EUROSTAT Basic Statistic for 2007 [16] ESOREX Database [17] UNSCEAR Report, 1993, and "Extent of Environmental
Contamination by Naturally Occurring Radioactive Material (NORM) and Technical
Options for Mitigation", Technical Reports Series No 419, IAEA, 2003 [18] Radioactivity in Building Materials: Experimental Methods,
Calculations and an Overview of the Italian Situation, Proceedings "Radon
in the Living Environment", Athens, 19-23 April 1999 [19] EUROSTAT PRODCOM Database 2009 ANNEX VIII (D) WORLDWIDE TRENDS IN NUMBER
OF MONITORED WORKERS AND IN COLLECTIVE EFFECTIVE DOSES AND EFFECTIVE DOSES TO
MONITORED WORKERS (UNSCEAR Report 2008) ANNEX VIII (E) EXPOSURE TO IONISING RADIATION FOR
WORKERS IN NORM INDUSTRIES (case study) FRANCE, Bilan 2008 de la surveillance de
travailleurs exposés aux rayonnements ionisants en France (Institute de
Radioprotection et de Sûreté Nucléaire) ANNEX
IX RADON (A)
Annual Averaged Indoor Radon Concentration ANNEX IX (B) Radon in Dwellings || Finland[1] || Sweden[2] || United Kingdom[3] Housing stock || 1 700 000 || 4 500 000 || 27 000 000 Average radon concentrations || 96 || 108 || 20 Estimated number of dwellings at or above 200 Bq/m3 || 200 000 || 450 000 || 100 000 Percentage of dwellings at or above 200 Bq/m3 || 12 || 10 || < 1 ANNEX
X (A) Graded Approach to Regulatory Control The concept of a graded approach to
regulatory control was developed some ten years ago by NEA’s Committee on
Radiation Protection and Public Health (CRPPH). CRPPH advocated that, in
addition to the concept of optimisation of radiation protection, the efficiency
of regulatory control could benefit from a similar approach. Hence regulatory
authorities would concentrate their supervision on those situations which
represent a higher risk of exposure and on those where regulatory intervention
is instrumental in reducing overall exposures. The BSS Directive from 1996
already gives indication that as an exception to the rule MS may specify that
practices shall not require authorisation in cases where "a limited risk
of exposure does not necessitate the examination of individual cases and the
practice is undertaken in accordance with conditions laid down in national
legislation". This opportunity given by the Directive has been used to
little extend, because the requirement is very vague. Given that proper
implementation of the graded approach would reduce the administrative burden to
the businesses, it is important to clarify and enforce the use of this concept.
In this respect it is necessary to
improve the requirements on regulatory control, on the one hand by making the
list of practices submitted to authorisation more precise, and on the other
hand introducing list of practices that can be submitted to lighter regimes
like registration (a two-tier approach replacing the current concept of
"prior authorisation" (Article 4 of the BSS). Article 3 of the BSS
Directive 96/29 requires all practices to report the conduct of a practice
involving ionising radiation or radioactive substances. Practices may be
exempted from the requirement to report if certain values, called exemption
levels, are not exceeded. There are exemption values for the total activity
as well as for activity concentrations. These exemption values are laid down
in the Directive (on the basis of a European study published in our radiation
protection series: RP65) and uniformly transposed in national legislation. The
Euratom values were also incorporated in the International Basic Safety
Standards of 1996. Later, IAEA adopted a Safety Guide (RS-G-1.7) laying down a
different set of radionuclide-specific values (in general lower than those in
RP65). As part of the graded approach it is envisaged to make explicit
provision for exemption of specific practices, for specific radionuclides, as
long as the exemption criteria laid down in the Directive are complied with
(essentially that doses should be lower than 1% of the dose limit). The current
Directive, again, does not rule out this possibility but it is very vague
("MS's may exempt further practices …"). A second important aspect of the “graded
approach” relates to the release of materials arising from within a regulated
practice. In the absence of any criteria all such materials should be regarded
as radioactive waste. Taking into account the huge volume of materials arising
from the dismantling of decommissioned nuclear power plants, this would be at a
tremendous cost and there would be a shortage of disposal sites. Most of this
material has in fact no or very little radioactivity, so it could be cleared
from regulatory control. The concept of "clearance", for materials
with no or very little contamination, for instance steel or building rubble, is
very important in this context. In the current BSS Directive the application of
the concept of clearance was left to national authorities, being merely
required to take Community guidance into account (as was later published in the
Radiation Protection Series). Harmonisation of clearance levels for
materials resulting from dismantling has therefore become a crucial issue, both
within the EU as internationally. In the international guidance (IAEA RS-G_1.7)
and draft new standards it is envisaged to use the same set of values both for
clearance and exemption (with the lower numbers taken from RS-G_1.7). This
approach could be incorporated in the Euratom BSS as well. [1] Recommendations
for radon in dwellings in the Nordic countries, 2009, see Nordic radiation protection
authorities' websites, e.g. www.ssm.se [2] Recommendations for radon in dwellings in
the Nordic countries, 2009 [3] Radon and Public Health, Report prepared by the Subgroup on Radon
Epidemiology of the independent Advisory Group on Ionising Radiation. Advisory
Group to Health and Protection Agency, UK, 2009 (B) TOTAL
EXPECTED MASS OF BUILDING RUBBLE AND STEEL SCRAP Figure I
TOTAL EXPECTED MASS OF BUILDING RUBBLE PER 5a PERIOD FROM ALL PRESENTY EXISTING
NUCLEAR FACILITIES IN EUROPE[1] Figure I To estimate the total concrete masses arising in Europe and the time
of their generation, it is necessary to make generic assumptions. Most of the
rubble is produced from the dismantling of nuclear power plants to green field
conditions. Because the available data about the concrete masses in power
plants is limited, a linear extrapolation of the concrete masses in relation to
the power output for smaller and larger units of each type of plant is assumed.
The estimation of waste masses in Europe takes into account all types of
facilities (nuclear power plants, research reactors and fuel cycle facilities),
the number of plants in various countries, the planned operating time, the time
for the post-operational period and eventually a safe enclosure and the
assumption for the correlation between building masses and electric or thermal
power or capacity, respectively. The results of these estimations are presented
in figure I. The mass as a function of time shows two distinct peaks in the
range between 2020 and 2040 as well as between 2070 and 2090. The first peak is
caused by nuclear power plants that will be dismantled soon after their final
shut-down, the second peak corresponds to those installations for which a safe
enclosure of several decades is foreseen prior to final dismantling. It can be
seen that building rubble will also arise in the time after 2100. This
corresponds to installations mainly in the UK where a long term safe enclosure
with an enclosure period of 130 years is envisaged. It should be noted that this estimation does not include
any new nuclear installations that might be built in the future, any nuclear
installations in countries that might become member states of the European
Union in the future, and any accelerators Figure II
PROJECTED AMOUNT OF CLEARABLE STEEL SCRAP FROM DECOMMISSIONING COMMERCIAL POWER
REACTORS IN THE EU (under the assumption that no new reactors are built)[2] ANNEX XI:
Table 1: Possible
solutions for each identified problem area (the numbers refer to the
subsections in section 2 where the issues are explained) Problem || Solution 1 || Solution 2 || Analysis 2.2.1 Scientific progress (ICRP 103) || Amend methodology for dose calculation in BSS and revise dose limits for the lens of the eye || || As dose calculation methodology and dose limits are explicitly stipulated in the current BSS Directive, there is from a legal point of view only one solution possible. 2.2.2 Insufficient protection of workers || || || - Outside workers || Revise the BSS, impose an annual occupational dose limit and incorporate Outside Workers requirements || Revise BSS and impose an annual occupational dose limit || Both solutions provide uniform level of protection for these workers. Solution 1 would facilitate the clarification of the responsibilities of undertakings and employers. - Workers in NORM industries || Strengthen the requirements on NORM industries in BSS || Establish guidance on NORM industries || Uniform protection of workers can only be achieved with Solution 1. 2.2.3 Health protection of patients and the public due to technical progress || || || - patients || Strengthen requirements on justification and optimisation in MED Directive || Strengthen implementation of current requirements through guidance || Solution 1 and solution 2 should both enhance patient protection, but in certain areas it is expected that only binding legislation is effective. - non-medical imaging exposures || Include specific requirements in the BSS and amend MED correspondingly || Amend MED Directive and issue guidance on non-medical imaging exposures || Solution 1 allows best protection of the public from these exposures. 2.2.4 Public exposure to natural radiation sources –radon and building materials || Legislative measures: 1. Extension of the scope of BSS Directive 2. new Directive(s) on radon and on building materials || Non-legislative measures such as guidance on national action plans for radon, recommendation on building materials || Solution 1.1 provides for best protection from natural radiation and is in line with the simplification objective. 2.2.5 Protection of the environment (non-human species || Legislative measures: 1. Extension of the scope of BSS Directive 2. new Directive on protection of the environment || Non-legislative measures such as guidance on the protection of the environment || Solution 1.1 offers the best coherence with the protection of human health from environmental radioactivity. ANNEX XII Working document: Comparison
International and Euratom Basic Safety Standards This document
was drafted to give a comprehensive though not exhaustive overview of the
differences in approaches and specific requirements in the international
standards (draft 3.0) and the revised and recast Euratom Basic Safety Standards
(version 24.02.2010, on which the Group of Experts had given an Opinion). By and large
this document is meant to be descriptive, and does not give views on the need
for changes in the international standards, except with regard to the overall
approach to natural radiation sources. The Experts have
been invited to discuss this document at their meeting on 3 – 4 June 2010 and
where appropriate make recommendations either to IAEA or to the Commission. The
Commission will forward the recommendations to IAEA and discuss these at the
meeting of the BSS-Secretariat (with IAEA and other co-sponsors) Vienna on 25 June 2010. The Comparison
of the draft Standards has been completed to the extent possible with further
relevant issues, brought forward by the Experts. This update will continue in
order to provide eventually a comprehensive comparison of the different sets of
requirements. 1. Introduction Throughout the
development of the revised international Basic Safety Standards (BSS) and the
revised and recast Euratom Basic Safety Standards there has been good
cooperation in order to ensure their consistency to the largest possible
extent. The Commission has played an active role in the Secretariat of
sponsoring organisations of the international standards. Representatives of EU
Member States have provided comments to the different Committees of IAEA,
especially RASSC. Reports on progress with the international standards have
been presented at each meeting of the Group of Experts by IAEA representatives.
The Group of Experts has so far never formally given its own views on the
international standards. In view of the eventual co-sponsorship of the
standards by the Atomic Energy Community it is now the right time to do so,
since draft 3.0 has been sent to IAEA Member States for comment and it is
envisaged that the final draft will be approved by the Committees by the end of
this year. The Experts invite IAEA to consider these comments together with the
comments and corrections that have been proposed by the Commission before the
deadline for consultation (31.05.2010). 2. General comments To a very large
extent the Euratom and international standards are consistent. There are no
essential points that are in contradiction. Numerical values are all the same,
with the provisional exception of the definition of High Activity Sealed
Sources, pending further consideration of the rationale of the two sets of
values. Nevertheless,
there are notable differences. These results on the one hand from the
constraint to make as little and few changes to the current standards as
necessary. This justification of any changes was an essential component of the
DPP for the revision of Safety Series 115, and in the spirit of the
"recast" of Euratom Directives this applied to the revision of
Council Directive 96/29/Euratom as well. Hence many differences which had
appeared already in 1996 continue to exist. In addition, while both organisations
started from ICRP Publication 103, they have given a slightly different
interpretation to the introduction of planned, existing and emergency exposure
situations in structuring the requirements. This does not matter too much since
the main message of ICRP was that throughout the exposure situations the
principles of radiation protection apply very much in the same way.
Nevertheless, the allocation of responsibilities and the extent of regulatory
control have been addressed in different ways for some situations, especially
for exposure to natural radiation sources. This has also
led the Euratom Basic Safety Standards to choose a different structure. While
initially both standards were developed along a structure reflecting the three
exposure situations, Euratom Standards are now structured along the categories
of exposure, occupational, medical and public, within which the differences in
management along the exposure situations are reflected. This inversion of the
matrix has no implications on content, but makes the comparison of the two
standards more difficult. In order to
preserve consistency with the current standards, and for IAEA also with the
Safety Fundamentals, the requirements use a different set of definitions. The
concept of "facilities and activities" in IAEA is reflected in the
definition of "Undertaking" in Euratom BSS. The latter definition
incorporates better the concept of legal responsibility for the conduct of
activities or the introduction of a radiation source. The term "radiation
source" has a very general meaning in the Euratom Standards (including
"facilities") and is further differentiated between radiation
generators, radioactive sources, natural radiation sources etc.). This allows a
more precise formulation of the requirements where the term "source"
may be cause of confusion. IAEA is invited to consider introduction
of these definitions and explore whether their use would improve clarity of the
text. The terminology
of the Euratom Standards has been adjusted to the international standards on
one important point. The requirements for regulatory control are now structured
along the concepts of notification, registration and licensing (as opposed to
reporting and prior authorisation in Directive 96/29). The graded approach to
regulatory control has been worked out in more detail in the Euratom Standards
however, and the differentiation between registration and licensing is more
explicit. It should be noted that in principle all requirements in the Euratom
BSS apply to Member States or to their competent authorities. It is for
national law to transpose the requirements and for the authorities to impose
them and ensure their enforcement. The international standards differentiate
much more between requirements applying to different responsible parties, e. g.
designers, employers, registrants and licensees, often with much more detail
than in the Euratom Standards. These different
contexts and approaches have led to many small differences in formulation. The
most notable differences with regard to requirements for occupational, public
and medical exposure as well as on the protection of the environment are listed
in a comprehensive albeit not exhaustive way in the next chapter. The more
fundamental differences with regard to the approaches to natural radiation
sources are discussed separately. Finally, there are important differences in
the application of the concepts of exemption and clearance, especially for
naturally occurring radionuclides. With regard to artificial radionuclides,
while both standards have now introduced the values in IAEA RS-G-1.7, the
Euratom Standards give less prominence to the continued use of the old
exemption values for "moderate amounts of material", and address more
explicitly the role of specific clearance levels for specific materials and
pathways of disposal. The Euratom approach allows a better optimisation of the
management of materials arising e.g. from dismantling of nuclear facilities. The
Group of Experts hopes that these differences will be resolved through a
careful redrafting of the international standards. The Group of Experts
also endorses the comments repeatedly made by the Commission, and now
re-introduced with regard to draft 3.0, along the lines of this document. The System of Protection
as laid down respectively in Requirement 1 and Schedule III of the
international BSS and Title III of the Euratom BSS are broadly the same, with
some differences as a result of the different consideration given to planned
and existing exposure situations. It should be noted however that in the
Euratom BSS it is in general no longer foreseen that doses be integrated over
periods longer than 1 year. The dose limits for the lens-of-the-eye are left
open, pending ICRP advice, and dose constraints may apply also to organ doses,
as a matter of precaution. 3. Comparison of the draft standards 3.1. General This chapter
compares specific requirements in the international standards (Draft 3.0) with
those in the Euratom Basic Safety Standards (draft 24.02.2010) with regard to
occupational, public and medical exposures as well as with regard to the
protection of the environment. Draft 3.0, in
contrast to the Euratom BSS, contains more detailed requirements, which are
often addressed directly to the "responsible parties" (government,
regulatory body, licensees and registrants, etc. – defined in Para. 2.40 and
2.41). This approach risks unnecessarily restricting implementation of
radiation protection to what is "prescribed" while:
the level of
detail does not seem to correspond to the importance of the issue,
the
requirements and described responsibilities, however detailed, are not
exhaustive, and
the proposed
rigid distribution of responsibilities does not allow for national
differences and sometimes restricts too much the responsibility of a given
party.
3.2. Occupational exposure 3.2.1. Differences IAEA Paragraphs 3.77: workers exposed to radiation
from sources not required by or directly related to their work shall receive
"the same level of protection" as if they were members of the public.
Euratom: no such requirements,
but for the operational protection of workers specific requirements only apply
to those who are "exposed workers": … who are liable to receive doses
exceeding one or other of the dose levels equal to the dose limits for members
of the public. There was a
similar requirement in Directive 96/29; the new Directive has been drafted so
as to ensure the same level of protection without re-introducing it; the term
"the same level of protection" is indeed ambiguous in legal terms, in
particular for existing and emergency exposure situations where in some
situations (e.g. radon in workplace) it may be understood to mean that the dose
limit for public exposure would apply. IAEA is invited to consider whether
paragraph 3.77 offers any additional protection and otherwise delete it. 3.115: no person under the age of 18
years is allowed to work in a controlled area unless under supervision and then
only for the purpose of training for employment involving exposure to radiation
or for students required to use sources in the course of their studies. Euratom: In the Euratom BSS this is covered
by Article 9: persons under 18 years may not be assigned to any work which
would result in their being exposed workers, and Article 12.2: the limit for
effective dose for apprentices (and students) aged between 16 and 18 years …
shall be 6 mSv per year (as for category B workers). In both cases the exposure of apprentices and students is
restricted, either by their access to controlled areas or by the dose. Schedule III: An
effective dose of 20 mSv per year, averaged over five consecutive years. Euratom: The dose limit for occupational
exposure is now simply 20 mSv per year, without averaging. However, a higher
effective dose may be authorised in a single year, subject to a maximum
effective dose of 50 mSv, … Euratom Articles: Art. 6.2: categorisation of exposed workers
(A or B) with an impact on individual monitoring (Art. 64) and medical surveillance
(Art. 69 – 72) IAEA: the international standards do not
introduce different categories of workers but in 3.99 individual monitoring
shall be undertaken, where appropriate, adequate and feasible, for any worker
who is normally employed in a controlled area or who … may receive significant
occupational exposure. No distinction is made between the health surveillance
of different categories of workers or different conditions of work. Title II: Definitions
of Radiation Protection Expert and Radiation Protection Officer These definitions distinguish
between the responsibilities of experts (give radiation protection
advice) and of officers (designated by the undertaking to oversee the
implementation of the radiation protection arrangements). The capacity to act
as an RPE is recognized by the competent authorities. The RPO shall simply be
"technically competent". The arrangements for the recognition of the
experts (as well as for the medical physics expert) are laid down in Article
16. The responsibilities of the RPE are spelled out in detail in Article 19. IAEA: Qualified expert. In the
international standards this definition relates to the professional
qualifications of an individual. In 2.21 (b) there is formal recognition of
these experts by the relevant authority for taking up certain responsibilities
(footnote 7) The involvement of qualified experts is mentioned in several
paragraphs throughout the text of the international standards. 3.2.2. IAEA requirements with no corresponding
Euratom text Workers 3.79: recording
of any report received from a worker (see 3.82) Req. 22: Compliance
by workers (3.81, 3.82) 3.86 (a): involve
workers in optimization of protection and safety Euratom: it is not appropriate for a Directive to put
requirements on workers. Operational guidance 3.89: delineation
of controlled areas 3.91: delineation
of supervised areas 3.92 – 3.94: local
rules and personal protective equipment Euratom: it is not appropriate for a Directive to go into
so much practical detail. Conditions of service Req. 27: no
substitute for protection and safety 3.113: conditions
of service for pregnant or breastfeeding workers Euratom: these are basic principles of
overall occupational health policy which do not need to be recalled
specifically for work with ionizing radiation. 3.2.3. Euratom
requirements without correspondence in the international standards National dose register Article 67.1 (d)
requires the results of individual monitoring to be submitted to a centralised network.
In 67.2 provisions are made for a future European Radiation Passport for
outside workers. In the
international standards there are requirements for the establishment of
exposure records and for their transmission to workers and other employers registry
(Para. 3.102 – 105), but no central. There is no reference to a radiation
passport. Natural radiation sources The approach to
natural radiation sources in the Euratom standards is quite different from the
international standards (see chapter 4 in this document). With regard to
occupational exposure the most striking features of the Euratom standards are
the following: Article 59.2 (second sentence): Where the effective dose to workers
is less than or equal to 6 mSv per year the competent authorities shall at
least require undertakings to keep exposures under review, taking into account
the potential for protection to be improved or the potential for doses to
increase over time or as a result of changes in the process on work
instructions. This requirement is an important element of a graded approach to
regulatory control, which is missing in the international standards. IAEA is
invited to consider a similar graded approach for the Regulatory Control of
occupational exposure, especially for workers in NORM industries. Article 59.3 specifies the assessment and management of the exposure
of aircrew to cosmic radiation. In addition, since in the Euratom standards the
exposure to aircrew occurs within a planned exposure situation, the
requirements for the protection of pregnant aircrew and the child to be born
(Article 11.1) are fully applicable. In the international standards exposure of aircrew is regarded as an
existing exposure situation, and the detail of its management is left for
Member States to consider. IAEA is invited to apply similar binding
requirements for the protection of aircrew and for the registration of their
exposure as in the Euratom Directive; indeed, the operation of airlines calls
for international harmonisation. 3.3. Public exposure 3.3.1. Differences IAEA addresses
public exposure to consumer products more prominently than in the Euratom
standards. See: 3.117: suppliers
of consumer products 3.124: responsibilities
of suppliers of consumer products Req. 33: consumer
products 3.137: consumer
products shall not be made available to members of the public unless exempted
or authorised for use by members of the public 3.138: responsibility
of the regulatory body 3.139: compliance
with the conditions of authorisation (including optimisation of design) 3.140 - 142: labelling
and information Euratom: 1) does not require labelling and
information (but this could be part of conditions of use); 2) does not put requirements on the suppliers and designers of the
products. On the other hand the Euratom BSS (Art. 53.2 (b)) require licensing
of the deliberate addition of radioactive substances in the production and
manufacture of consumer goods and the import or export of such goods. The
design features and conditions of use will be specified as part of the licence.
The introduction of new types of apparatus or products is subject to
justification, their use as a consumer product shall explicitly be permitted
and a type-approval granted. Hence the Euratom Standards achieve the same objective but put all
responsibility on the licensing authority: the designer or supplier is not
responsible for further uses. There is neither an explicit requirement for
information of the user or distributor, nor for labelling: it is generally
understood that such labelling is contrary to the concept of exempted consumer
good, but it can nevertheless be requested by the licensing authority at the
time of manufacture or import. Once the consumer good is placed on the market
in the EU, no further trade restrictions should apply. However, since national
authorities may conclude differently on the justification or type approval, the
use of a consumer good may be prohibited or subject to notification; in order
to avoid inconsistencies, competent authorities are required to allow for the
information provided by other national authorities. Schedule III
(3b): averaging over five years (maximum 5 mSv) has been deleted in the Euratom
Directive. 3.3.2. IAEA requirements with no corresponding
Euratom text 3.123: Impact
outside the country Euratom Treaty provisions
under Article 37 allow the Commission to assess such impact; however, in the
Joint Convention there is a similar requirement which may be taken up in
legislation on waste management. 3.127: Visitors A Euratom Directive does not
require such detail; in addition the phrase "in cooperation with
employers" makes this difficult to understand. 3.128: External
exposure (details) 3.129: Avoid
spread of contamination (implicit in Euratom) 3.130: Details
of radioactive waste management (might appear in a specific legislation) 3.135: Access to monitoring data is
foreseen in Articles 35 – 36 of the Euratom Treaty. 3.4. Medical exposure 3.4.1. Differences Roles and
responsibilities are
distributed differently in the IAEA and the Euratom drafts:
In draft 3.0
the government (Req. 34, Para.3.145-3.147) and the regulatory
body (Req. 35, Para.3.148, 3.154, 3.163, 3.166, 3.167, etc.) have
specific but quite limited responsibilities with respect to medical
exposure while in the Euratom BSS the majority of the requirements are
addressed to Member States (i.e. government).
In draft 3.0 a
great deal of responsibility is placed on "registrants and
licensees" (Req. 36, Para.3.149-3.152, 3.160, 3.164, etc.), who
shall ensure that "no person receives medical exposure" unless a
series of conditions are fulfilled. In the Euratom BSS the requirements
directly addressed to "undertakings" are limited to issues like
QA and provision of information to patients and there are almost no
prohibitive requirements (with the exception of examinations which
"can not be justified").
Definitions: medical exposure: Draft 3.0 mentions
asymptomatic individuals in paragraph 3.149: ("whether asymptomatic or not
…"). In the Euratom BSS these are grouped with, but are different from,
patients. Draft 3.0 also does not refer to the intended benefit to the health
or the wellbeing of the exposed person, as in the Euratom BSS. IAEA is
invited to give explicit consideration to asymptomatic individuals and to
exposures benefiting to the well-being of the exposed person, in particular to
sharpen the definition of non-medical imaging exposures. In the Euratom Directive (Article 5 (b)) medical exposures shall be
"as low as reasonably achievable, commensurate with the medical
purpose". "ALARA" is here to be distinguished from other
contexts where economic and social considerations need to be taken into
account. The Experts believe that the mere reference to "commensurate
with ..." is not sufficient. optimization of protection and
safety for medical exposure: Draft 3.0 states that
it is "management of the radiation dose to the patient commensurate with
the medical purpose" without any reference to ALARA as is the case in the
Euratom BSS. radiological medical practitioner: Draft 3.0 defines the responsibilities of the radiological
medical practitioner more rigidly, especially for justification of medical
exposure for individual patients (Para. 3.155). This is done in a more indirect
and flexible way in the Euratom BSS by Art. 82.2 requiring that the
exposure is undertaken under the clinical responsibility (including
justification) of a radiological practitioner but allowing Member States to
define the level of involvement of the practitioner and the referrer in
justification process (Art. 82.1). medical physicist: The role of the medical
physicist is more specifically and with more detail defined in Draft 3.0
(Para. 3.152, 3.165, 3.166, 3.168, 3.169, etc.). The IAEA definition of medical
physicist (MP) differs from the Euratom definition of medical physics expert
(MPE) mainly in that the MP is defined by IAEA as "health
professional" (i.e. recognized to practice a profession related to
health). medical radiation technologist: Draft 3.0 defines "medical radiation technologist",
who is included in the list of "other parties who have responsibilities
for protection and safety" (Para. 2.41) and is assigned to a number of
tasks and responsibilities – Para. 3.161-3.163, 3.168, 3.173, etc. The Euratom
BSS have no such definition. There are the
following differences with regard to justification:
Para. 3.149 (a) effectively prohibits self-presentation,
which is not explicitly done in Euratom BSS. The same article requires
information on the clinical context to be provided.
Para. 3.149 (b) puts responsibility for justification on the
radiological practitioner, in consultation with the referring medical
practitioner. The Euratom BSS do not put so much emphasis on the role of
the radiological practitioner.
Para. 3.153 – only alternative techniques that do
not involve medical exposure shall be taken into account, against the
Euratom BSS requirement of taking into account also techniques involving less
exposure (Art. 80.1).
Para. 3.154 – generic justification shall be carried
out by the health authority in conjunction with the appropriate
professional bodies – missing in Euratom BSS.
Para. 3.155 – there is a requirement that the practitioner
shall take into account the appropriateness (missing in Euratom BSS)
and the urgency of the request (required only for pregnant and
breastfeeding women in the Euratom BSS – Art. 87.1).
Para. 3.159 – exposure of volunteers for biomedical
research is not justified if it doesn't comply with the Helsinki
Declaration and the respective guidelines by the CIOMS and the
recommendations of ICRP. No such references in Euratom BSS.
In Article 81 on Justification in the Euratom Directive, the
requirements are to a large extent written in the passive "shall"
style. Para. 3.146 of draft 3.0 stipulates the government shall ensure
that diagnostic reference levels (DRLs) are established
against the weaker Euratom BSS requirements that Member States "promote
the establishment" of DRLs. 3.4.2. IAEA requirements with no corresponding Euratom
text Para. 3.152 (c) requiring that registrants and licensees shall ensure
that sufficient medical and paramedical personnel are available
as specified by the health authority does not have correspondence in Euratom
BSS. Para. 3.147 specifies that dose constraints are
established as a result of consultation between the health authority, relevant
professional bodies and regulatory body, which is not specified in Euratom BSS.
Dose constraints are required only for research volunteers undergoing
diagnostic investigations (in Euratom BSS this applies to all medical exposures
but restricted to cases where there is no direct health benefit to the exposed
person). Para. 3.160 contains design considerations for the
medical radiological equipment and software, which shall comply with the IEC
and the ISO standards or to national standards "adopted by the regulatory
body". This is out of the scope of the Euratom BSS, since design and
pre-marketing phases of medical equipment are regulated under Council Directive
93/42/EEC of 14 June 1993 concerning medical devices[3]. Para. 3.165 – requirements for calibration, missing
in the Euratom BSS. Para. 3.166 – detailed requirements for clinical dosimetry
in relation to a "typical patient". Para. 3.168-170 contains detailed (but not exhaustive and not
specific to the type of the procedure) requirements on quality assurance,
which are absent from the Euratom BSS:
Reference to
"principles established by the WHO, PAHO and relevant professional
bodies".
QA shall
include verification of physical and clinical factors used in patient
diagnosis or treatment, records of procedures and results, periodic checks
of dosimetry and monitoring equipment, QA audits.
Quite a few
paragraphs require records and documentation for instance on personnel
with radiation protection responsibilities (3.148 (c)), on advice by a
medical physicist (3.152 (e)), on delegations of responsibility
(3.152 (f) and 3.181 (a)), on training records (3.181 (b)), on
calibrations and periodic checks of relevant clinical parameters (3.182), on
data allowing dose assessment (3.183). Para. 3.177-179 on unintended and accidental medical
exposures:
3.177 defines
the main causes of unintended and accidental exposures (design flaws and
operational failures of equipment and software and human errors) and puts
the responsibility for reducing the likelihood of these exposures with the
registrants and licensees. This can be too restrictive since design and
software flaws are hard to predict and deal with by the licensees alone.
3.178 defines
a (exhaustive) list of types of unintended and accidental exposures which
should be investigated.
3.4.3. Euratom
requirements without correspondence in the international standards unintended
and accidental medical exposures: the
requirement in Euratom BSS Art. 88 (b) that the QA programme for
radiotherapeutic practices shall include a study of risk of accidental or
unintended exposures is missing in draft 3.0 (see Para. 3.177-179 above). While the
international standards highlight quality assurance and introduce the concept
of "radiological reviews" (Para. 3.180), this does not match the more
powerful Euratom concept of "clinical audit" (Article
83.4). Draft 3.0 does
not contain a requirement for estimating population doses from
medical exposure procedures, as in Euratom BSS (Art. 89). 3.5. Protection of the environment Both standards address the protection of the environment but in
different ways. In principle, the protection of the environment has a prominent
place in draft 3.0. It is part of the objectives of the international standards
and is specifically addressed in one of the Fundamental Safety Principles
referred to in the first chapter of draft 3.0 (Para.1.7 and 1.26). Whenever
draft 3.0 speaks about radiation risks, the risks to ecosystems are included in
this term (footnote 6 and Glossary), for instance when setting up legal
frameworks and regulatory control (Para.2.13 and 2.14), and making arrangements
for the protection of the environment (Para.2.25). However, further on in the
draft 3.0 there are only general requirements with regard to the protection of
the environment for discharge authorisation (Para.3.122 and 3.131), emergency
(Para.3.42, 4.2 and 4.5) and monitoring programmes (Para.2.23), and it is
difficult to detect if these requirements are issued to protect the environment
itself or it they are set to protect the environment as being a resource
to humans (food production, recreation, industrial use). In the first case both
Standards have the same set of requirements but the Euratom BSS is more to the
point consolidating all requirements for the protection of non-human species in
one Title. In the second case the Euratom approach is indeed more elaborate as
it includes a separate Title with clear and well-balanced requirements for the
radiation protection of non-human species while leaving sufficient flexibility
for Member States to adopt these requirements to national situations. 4. Different
approaches with regard to natural radiation sources Both set of
standards have a comprehensive approach towards natural radiation sources. The
Euratom BSS are more explicit when it comes to actual requirements, mainly for
building materials where the international standards basically have only one
specific requirement, but also for NORM industries, aircrew and radon. The main
difference exists however on a philosophical level – whether to classify the
different exposure situations as planned or existing according to ICRP
terminology. 4.1. NORM Although the
Euratom BSS are clearer about which specific requirements concern NORM, these
industries are essentially regulated in the same way in both standards and the
same exemption, clearance or threshold values apply, for the benefit of
international harmonisation. The Euratom BSS have explicitly incorporated NORM
industries in the framework for practices in a planned exposure situation
(Title VI), while the international standards regard them as existing exposure
situations while applying the requirements in Section 3, Planned Exposure
Situations (Para.3.4). Another difference is that the Euratom BSS use the
assessment of doses to workers as a tool for identifying the appropriate level
of regulatory control and measures to be taken for the protection of workers
(above 6 mSv/y then licensing and full range of requirements in Title VII,
between 1-6 mSv/y then registration or licensing and merely requiring
undertakings to regularly review exposures) (Art.53), whereas draft 3.0 leaves
it to the Member State to decide on which requirements in Section 3
Occupational Exposure (Para.3.68-3.115) should apply. The Euratom BSS also
consider doses to members of the public when requiring authorisation for NORM
industries (public exposure ≥0.3 mSv/y) (Art.53.3.(f)), while draft 3.0
gives no indication of such a criterion. The Euratom Directive is much more
clear about which industries may be of concern by introducing a list of
industrial sectors (Annex 8). 4.2. Radon For radon in
dwellings or buildings with public access the approaches are the same in both
standards and they both use 300 Bq/m3 as the upper boundary on the reference
level for existing buildings. Terminology differs slightly where the Euratom
BSS talk about buildings with public access (Art.100) when draft 3.0 uses the
term "other buildings with a high occupancy factor of the public"
(Para.5.19). Draft 3.0 includes kindergartens, schools and hospitals in that
term (footnote 35). The Euratom BSS are more specific about the content of a
national action plan for radon (Annex 13) and specify also which types of
exposure to radon this plan should include - radon exposures in dwellings,
buildings with public access and in workplaces, from all sources of radon: soil,
building materials or water (Art.38.1). The IAEA approach is to demand an
action plan, if appropriate, for public exposure to indoor radon (Requirement
50). Concerning reference levels there are two further differences: Draft 3.0
does not include a requirement for setting reference levels for new buildings
and it does not contain any requirements for setting reference levels for the
"other buildings with high occupancy factors of the public". With regard to
radon in workplaces; the basic requirements are the same as well as the upper
boundary for the reference level (1000 Bq/m3). In reality there are
no major differences between the standards on this point. 4.3. Cosmic radiation While exposure
to aircrew is addressed in both standards, the Euratom BSS offer detailed
requirements such as clarifying what kind of measures to take with regard to
occupational doses depending on the dose to the aircrew (Art.59.3). Draft 3.0
includes a more general requirement on the possible assessment of doses to aircrew
and subsequent requirements for occupational exposure (Para.5.30). With regard
to space crew the Euratom BSS treat this as a specially authorised exposure
where specific requirements apply (Art.77.3) whereas draft 3.0 requires that a
framework for radiation protection applicable to humans in space-based
activities is established, when appropriate (Para.5.31). Another difference is
that the Euratom Directive regards both types of exposure as planned exposure
situations while draft 3.0 regards them as existing exposure situations. 4.4. Building materials With regard to
exposure to building materials both standards address this as an existing
exposure situation. The Euratom BSS are however much more specific in terms of
requirements. While draft 3.0 merely requires that reference levels are set
(Para.5.22) that would generally not exceed around 1 mSv/y, the Euratom BSS
allocate a whole section of the Directive to new requirements for building
materials (Art.101), based on earlier guidelines (RP 112). The aim is to
address exposure from building materials in a clear and comprehensive way and
enable harmonisation between Member States and smoother trans-boundary movement
of these types of material. Another difference is that the Euratom Directive
defines the term building materials, deliberately not using the wider term
construction material, while the draft 3.0 mentions construction materials
without defining the term. 4.5. Exemption and clearance With the
introduction of the IAEA RS-G-1.7 values as exemption and clearance levels in
the Euratom BSS, the two standards have the same set of values for exemption
and clearance. For natural radiation sources the draft 3.0 Schedule I
(Para.I-4) gives Member States a large degree of flexibility by stating that exemption
should be made on a case by case basis and refers to levels commensurate with
natural background levels. On the other hand paragraph 3.4(a) indicates that 1
and 10 Bq/g should be used to detect when an activity should be regulated as a
planned exposure situation. This is confusing. For clearance however, draft 3.0
gives the levels 1 and 10 Bq/g. The Euratom BSS also use those values with the
difference that they should be used as both exemption and clearance for natural
radiation sources. The Euratom approach is more coherent, in particular as it
not only sets general criteria for artificial radionuclides but introduces
exemption and clearance criteria for natural radionuclides as well (in the
order of 0.3 mSv/y or less for members of the public and
1 mSv/y for workers). Furthermore, the Euratom BSS include a comprehensive and
cautious use of the clearance criterion for NORM residues, in particular for
recycling in building materials and in case of ground water contamination. IAEA
is further invited to include relevant isotopes of Uranium and Thorium, Table
I-2, for application to clearance of materials arising from the dismantling of
nuclear installations such as uranium enrichment or fuel fabrication plants (on
the basis of the 10 mSv exemption criterion). Recommendation: It should be made clear in the
international standards what values to use as exemption levels for natural
radionuclides. It would also be beneficial to introduce a dose criterion
for clearance of natural radionuclides, indicating that if drinking water
supplies might be affected this would call for special attention. Basically the
whole Schedule I would need to be rewritten. At least the paragraphs in draft
3.0 Schedule I that cause confusion should be deleted, pending on more thorough
revision:
Schedule I
Para.I-4
This paragraph is still very confusing. The restriction to
"other than incorporated into consumer products…" is redundant with
footnote 42. The intention is probably to provide for exemption of bulk
amounts. There is no need for such exemption since the scope of "planned
exposure situations" is already defined in Para.3.4. A case by case
assessment in relation to doses to individuals (workers?) of about 1 mSv per
year would only apply for the application for instance of requirements for
occupational exposure (after assessment of doses when the concentration exceeds
the levels defined in Para.3.4, so on a retrospective basis, not for
prospective exemption).
Schedule I
Para.I-5 (b)
It is redundant to include the levels defined in Para.3.4 as
clearance levels, since this is the entry point for a planned exposure. In
addition, despite footnote 45 this may still easily be misunderstood as
applying to building materials or to situations where the residues of NORM
industries would contaminate groundwater. There is no clearance criterion (in
dose) for natural radionuclides. The criterion in Para.I-4 is more useful in
the context of clearance (case-by-case assessment on the basis of a dose
criterion which should not exceed 1 mSv per year). However this would
require a full restructuring of the requirements or of Schedule I. 5. Further
issues identified by the Article 31 Experts 5.1. Non-medical human imaging exposure 5.1.1. Differences IAEA Paragraphs 3.61. The government
shall ensure that the measures described in para. 3.16 for the justification of
practices are applied to any imaging procedure that exposes humans to radiation
not intended for diagnostic or therapeutic purposes. The justification process
shall consider, inter alia, (a) Appropriateness of the radiation equipment for the proposed use. (b) The use of alternative techniques that do not utilize ionizing
radiation[4]. (c) The benefits and detriments of implementing the procedure (d) The benefits and detriments of not implementing the procedure. (e) Evaluation of various radiation technologies available,
including the effectiveness and limitations of the procedures. (f) Availability of sufficient resources to safely conduct the
imaging procedure during the intended period of use. (g) The impact of any legal or ethical issues which may be raised by
the use of the technology Euratom: Items (a) and (c) to (g) are not
considered. Item (b), referring to alternative
techniques, differs from EURATOM item (f) of Annex 16 in as far as IAEA
requires the use of alternative techniques that do not utilize ionizing
radiation to be considered as part of the justification whereas EURATOM
requires that alternative techniques which do not involve exposure to ionising
radiation are available where the exposure is routinely carried out for
security purposes. This item (b) is believed to be redundant (it applies to
justification also in other contexts). The Euratom requirement is in
addition to justification. 5.1.2. IAEA requirements with no
corresponding Euratom text IAEA Paragraphs 3.18. Human imaging
using radiation performed for occupational, legal or health insurance purposes,
and undertaken without reference to clinical indication, shall normally be
deemed to be not justified. If, in exceptional circumstances, the justification
of such imaging is to be considered, the requirements of paras 3.60 to 3.64
shall apply. Euratom: no such statement. However, the list of practices in
Annex 16 and the list of the exceptional circumstances mentioned by IAEA (note
19 of para 3.64) are the same. 3.19. Human imaging using radiation for
theft detection purposes shall be deemed to be not justified. Euratom: no such statement 3.66. Registrants and
licensees shall ensure that all persons that are about to be exposed to
radiation for inspection procedures, are informed about the possibility of
choosing an alternative technique that does not use ionizing radiation, where
vailable. Euratom: guarantee that people are informed is not
required 5.1.3. Euratom
requirements without correspondence in the international standards Art. 49.3: Practices
involving the deliberate exposure of humans for non-medical purposes (e) Informed consent
of the individual to be exposed is sought, allowing for cases when the law
enforcement bodies may proceed without consent according to national
legislation. IAEA: informed
consent is not sought (d) Relevant requirements of
Title VIII, including those for equipment, optimisation, responsibilities and
special protection during pregnancy, are met for procedures implemented by
medical staff using medical radiological equipment. IAEA: special
protection during pregnancy is not mentioned 5.2. GENERAL REQUIREMENTS 5.2.1. SCHEDULE III: TABLE III-I. CONVERSION COEFFICIENTS FOR RADON AND THORON
PROGENY Comment: These
coefficients are really obsolete: those for radon are taken from ICRP 65 (1993)
and were criticised in the 2009 ICRP Radon statement (2009), those for thoron
are taken from ICRP 50 (1987) and they were repeatedly declared scientifically
incorrect in international literature. ICRP has announced the publication of
new dose coefficients. Euratom: no mention to
dose conversion coefficients for radon and thoron. Reference in general is made
in article 14 (b) “For internal exposure from a radionuclide or from a
mixture of radionuclides…ingestion and inhalation dose coefficients in the
international basic safety standards published by IAEA shall be used to
estimate the effective doses”. In this way Euratom will also adopt these dose
conversion coefficients IAEA is invited to delete Table III–I pending receipt of new dose
coefficients from ICRP SCHEDULE III: DOSE LIMITS FOR PLANNED EXPOSURE
SITUATIONS For occupational exposure of workers over the age of 18 years, the
dose limits are: … (b) An equivalent dose to the lens of the eye of 150 mSv in a year; Euratom: The Experts asked to
the Commission to establish a lower value, even if ICRP would not do it, in
view of abundant scientific evidence of a higher risk than estimated in the
past. 5.2.2. SCHEDULE IV: CRITERIA
FOR USE IN EMERGENCY PREPAREDNESS AND RESPONSE TABLE IV-1: GENERIC
CRITERIA FOR ACUTE DOSES AT WHICH PROTECTIVE AND OTHER ACTIONS ARE EXPECTED TO
BE UNDERTAKEN UNDER ANY CIRCUMSTANCES TO AVOID OR MINIMIZE SEVERE DETERMINISTIC
HEALTH EFFECTS Euratom: no generic
criteria to prevent severe deterministic effects is made 5.2.3. SCOPE Art.3: Exclusion ("This
Directive shall not apply to …") of radionuclides not usually
contained in the human body… IAEA: Para. 1.31: These Standards shall apply to all situations that are amendable to
control (footnote 3 gives some examples of the opposite). 5.3. Other
Euratom requirements without correspondence in the international standards Metal scrap and orphan
sources: Art. 28.2: Member States shall make arrangements for
the establishment of systems aimed at detecting orphan sources in places
such as large metal scrap yards and major metal scrap recycling installations
... and Art. 29: Metal contamination IAEA: possible melting of a source in metal
foundry is not mentioned. Miscellaneous: Art. 97 and 98, annex 12A and B: information of the public IAEA: information of
the public is not mentioned Art. 48: Prohibition of the
deliberate addition of radioactive substances in the production of foodstuffs,
toys, personal ornaments and cosmetics, and the import or export of such goods. IAEA: such practices
are not prohibited but only "deemed to be unjustified". Art. 82.3: The practitioner
shall ensure that the patient or legal guardian is provided with adequate
information relating to the benefits and risks associated with the radiation
dose from the medical exposure to enable informed consent. IAEA only information
of the patient is required, informed consent is not required. Natural radiation sources (see also section 4): Art. 50: Member States shall
ensure the identification of NORM industries which cannot be disregarded from
the radiation protection point of view, taking the list of industrial sectors
in Annex 8 into account IAEA: No
establishment of a list of NORM industries is required Reading and comparing par. 3.4
and 5.1 (b) it is not clear how agricultural fertilizers and soil amendments should
be considered. A contradiction seems to be present between para 5.22
and 5.23. Drinking water cannot have a reference level of 1 mSv/y, because WHO
recommended a reference level of 0.1 mSv/y, moreover a reference level of 1
mSv/y from each of the cited sources is not acceptable. It is also not clear how building materials should be
managed. ANNEX XIII CONSULTATION
WITH FOREATOM[5] The last draft
version of the Euratom Basic Safety Standards Directive (Council Directive
96/29) was released on 24 February 2010. This draft has taken into account the
ICRP recommendations in Publication 103 by structuring the requirements along
the concepts of planned, existing and emergency exposure situations. ENISS (The
European Nuclear Installations Safety Standards) has in accordance with its
working procedures set up special expert groups on radiation protection and on
exemption and clearance in relation to decommissioning, with the mission to
follow the revision of the Euratom BSS. As the revision process has advanced in
parallel to the revision of the IAEA BSS the same expert groups have worked on
the IAEA draft. ENISS welcome the fact that the fundamental requirements in the
two documents are very close, while the draft Euratom BSS is much more concise,
easier to read and thus should prove easier to be transposed into national
regulations. You will find enclosed the industry detailed comments on the draft
BSS. The members of
the ENISS Radiation Protection Expert Group have welcomed the opportunities
that have been given during the revision process of the Euratom BSS to meet and
discuss with you items of special concern. We would therefore very much
appreciate a new opportunity to meet you again to discuss in detail the new
draft of the BSS. At present, the
Council Directive 96/29 is the basis of all regulations regarding radiation
protection in EU Member States and it has been proven effective and sufficient
since it came into force. From our experience we thus do not see the necessity
of significant changes. This view largely goes in line with ICRP 103,
proclaiming in essence “continuity and stability”. Therefore some proposed
changes in the draft BSS raise our concern and we are not convinced that the
envisaged changes in the radiation protection system will enhance worker or
public safety and health or offer a better protection of environment. Optimisation
and the use of dose constraints Optimisation is
one of the major guiding principles according to the ICRP system of radiation
protection. The radiation protection expert group of ENISS would therefore like
to emphasise its importance for radiation protection in general and in
particular for the continuing trends of decreasing radiation doses in nearly
all industries using ionizing radiation. The concept of dose constraints
already introduced by the ICRP long time ago can be viewed as one of the tools
that could be used in the optimisation process. According to the
ALARA principle, licensees have for decades optimised radiation protection,
starting at the design of the new facility up to the day to day optimisation of
protection, including the wide use of experience feedback. Thus it seems
appropriate to consider the setting of dose constraints for occupational
exposures as a tool used by licensee and employer, under their responsibility,
in the optimization process. In this context, the licensee may use the term
constraint for designing the maximum target dose for an operator doing a
particular task or the target collective dose for a team doing a particular
maintenance task. It could also mean the target dose for workers and
subcontractors during a year, based on the planned activities. The definition
of the dose constraint is therefore not essential for setting an efficient
radiation protection management system resulting in decreasing dose trends.
Consequently having too strict definitions or a dependency of some regulatory
supervision might act contradictory and lead to a change of a system that has
worked very well. Accordingly, ENISS proposes that the general frame of
optimisation should be addressed more clearly in the BSS, along with the
establishment of dose constraints. Radiation
protection officers and experts In the current
draft, the role of the “qualified expert” in the Council Directive 96/29/Euratom
has been split between two functions: the radiation protection expert and the
radiation protection officer. ENISS does not see any reason behind such a
change. In addition, almost all the responsibilities are given to the radiation
protection expert. A better balance must be achieved between the tasks
requiring an expertise and the practical implementation of protection carried
out by the radiation protection officer. In addition the
current version of the BSS gives most of the responsibility for the
occupational exposure to the undertaking. This is a shift from current practice
in many Member States where the responsibility for the protection of workers
lies mainly with the employer. We suggest, whenever possible, to leave the
flexibility and let national regulations assign the responsibilities between
undertaking and the employer. Exemption
and clearance The ENISS
special expert group on exemption and clearance has through a questionnaire
collected data of current practices of clearance in the different EU Member
States using nuclear energy and Switzerland. The responses showed that the
strategies in the respective countries were to large extent based on the
current recommendations of the European Commission. In the Draft EURATOM Basic
Safety Standards Directive the clearance levels endorsed for the sake of
international harmonization are coming from the IAEA recommendations (RS-G-1.7)
and not from the respective EU guidance documents that have been issued on
general clearance levels for any type of material [RP 122 part 1]. The EC
guidance on clearance levels – the general clearance levels (see above) as well
as clearance levels for metals [RP 89], for buildings and building rubble [RP
113] – has received a lot of positive attention internationally and it is
commonly assumed that they are scientifically even better founded than the IAEA
guidance levels. Concomitantly, several European Member States, with large
decommissioning projects ahead, have recently issued new regulations on
clearance based on the current EC guidance. The EU members of ENISS therefore
proposes that the BSS Directive should contain the general clearance levels
from EU recommendation RP 122/1 instead of IAEA exemption levels from RS-G-1.7
and directly incorporate the levels from EU recommendations RP 89 and 113, in
order to harmonise the clearance levels in the EU Member States (see appendix
to the ENISS comments on the draft BSS). Protection
of the environment In the draft
Euratom BSS requirements for the protection of the environment have been laid
down. However, neither the underlying principles for the suggested actions nor
any definitions on the environment are stated. In addition, there are large
numbers of open scientific and technical questions still to be solved in this
field which makes the suggested detailed requirements doubtful. ENISS would be
opposed to enlarge the regulatory and surveillance efforts and waste human and
monetary resources without being sure of improving radiation protection of the
environment. ANNEX XIV Comparison of options 2 to 6 Impact || Option 2 || Option 3 || Option 4 || Option 5 || Option 6 Economic || || || || || Functioning of the internal market || (+) competitiveness of NORM industries due to harmonised regulation || (+) competitiveness of NORM industries due to harmonised regulation || (+) 1. competitiveness of NORM industries due to harmonised regulation 2. harmonised labelling and control of building materials || (+) competitiveness of NORM industries due to harmonised regulation || (+) 1. competitiveness of NORM industries due to harmonised regulation 2. harmonised labelling and control of building materials Administrative burden on businesses || (+) reduction of dismantling costs by better application of the concept of clearance || (+) reduction of dismantling costs by better application of the concept of clearance || (+) reduction of dismantling costs by better application of the concept of clearance (-) cost for monitoring and labelling of building materials || (+) reduction of dismantling costs by better application of the concept of clearance (-) monitoring and assessment of environmental impact || (+) reduction of dismantling costs by better application of the concept of clearance (-) 1. cost for monitoring and labelling of building materials 2. monitoring and assessment of environmental impact Regulatory authorities || (-) transposition into national law || (+) overall coherent set of legislation || (-) New requirements, extended scope || (-) New requirements, extended scope || (+) overall coherent set of legislation (--) New requirements, extended scope Impact || Option 2 || Option 3 || Option 4 || Option 5 || Option 6 Environment || || || || || Protection of the environment || (+) regulating residues and effluents from NORM industries || (+) regulating residues and effluents from NORM industries || (+) regulating residues and effluents from NORM industries || (++) 1. regulating residues and effluents from NORM industries 2. better demonstration and understanding of protection of non-human species || (++) 1. regulating residues and effluents from NORM industries 2. better demonstration and understanding of protection of non-human species Impact || Option 2 || Option 3 || Option 4 || Option 5 || Option 6 Social and Health || || || || || Health and safety at work || (+) 1. Equal treatment of workers in all industrial sectors. 2. Reduction of the dose-limit for the lens of the eye || (++) 1. Equal treatment of workers in all industrial sectors. 2. Reduction of the dose-limit for the lens of the eye 3. Better Protection of Outside Worker through clearer assignment of responsibilities to the undertaking and the employer || (+) 1. Equal treatment of workers in all industrial sectors. 2. Reduction of the dose-limit for the lens of the eye || (+) 1. Equal treatment of workers in all industrial sectors. 2. Reduction of the dose-limit for the lens of the eye || (++) 1. Equal treatment of workers in all industrial sectors. 2. Reduction of the dose-limit for the lens of the eye 3. Better Protection of Outside Worker through clearer assignment of responsibilities to the undertaking and the employer Mobility of workers and experts || (+) Harmonisation of dose limits eases mobility of outside workers || (+) 1. Harmonisation of dose limits eases mobility of outside workers 2. Radiation passport for outside workers || (+) 1. Harmonisation of dose limits eases mobility of outside workers || (+) 1. Harmonisation of dose limits eases mobility of outside workers || (+) 1. Harmonisation of dose limits eases mobility of outside workers 2. Radiation passport for outside workers Protection of patients || (+) Better justification of medical examinations and corresponding reduction in number of exposures || (+) Better justification of medical examinations and corresponding reduction in number of exposures || || || (+) Better justification of medical examinations and corresponding reduction in number of exposures Protection of the public || (+) Regulation of non-medical imaging exposures || (+) Regulation of non-medical imaging exposures Guidance on radon and protection of non-human species || (++) 1. Regulation of non-medical imaging exposures 2. Reduction of lung cancer incidence through binding requirements on radon in dwellings || (+) Regulation of non-medical imaging exposures || (++) 1. Regulation of non-medical imaging exposures 2. Reduction of lung cancer incidence through binding requirements on radon in dwellings Impact || Option 2 || Option 3 || Option 4 || Option 5 || Option 6 Coherence and clarity of legislation || (+) 1. Clearer requirements 2. Graded approach to regulatory control || (++) 1. Clearer requirements 2. Graded approach to regulatory control 3. Simplification and integration of five Euratom Directives || (+) 1. Clearer requirements 2. Graded approach to regulatory control 3. Commission recommendation indoor radon incorporated in Directive || (+) 1. Clearer requirements 2. Graded approach to regulatory control 3. Coherent approach to protection of man and the environment for authorisation of effluent discharges || (++) 1. Clearer requirements 2. Graded approach to regulatory control 3. Simplification and integration of five Euratom Directives 4. Comprehensive framework for all exposure situations 5. Commission recommendation indoor radon incorporated in Directive 6. Coherent approach to protection of man and the environment for authorisation of effluent discharges International coherence || (+) 1. Exemption and clearance levels, 2. Overall approach and definitions 3. Requirements for authorisation of practices || (+) 1. Exemption and clearance levels, 2. Overall approach and definitions 3. Requirements for authorisation of practices 4. Harmonisation of categorisation of sealed sources || (+) 1. Exemption and clearance levels, 2. Overall approach and definitions 3. Requirements for authorisation of practices 4. Protection against indoor radon exposure in the same way as international standards || (+) 1. Exemption and clearance levels, 2. Overall approach and definitions 3. Requirements for authorisation of practices 4. Protection of the environment covered in the same way as in the international standards || (++) 1. Exemption and clearance levels, 2. Overall approach and definitions 3. Requirements for authorisation of practices 4. Harmonisation of categorisation of sealed sources 5.Full range of exposure situations and categories of exposure, including environmental exposures, covered in the same way as in the international standards Overall impact || + || ++ || ++ || + || +++ [1] Radiation Protection Publication 113
"Recommended radiological protection criteria for the clearance of buildings
and building rubble from the dismantling of nuclear installations" [2] Recommended
radiological protection criteria for the recycling of metals from the
dismantling of nuclear installations, Radiation Protection N° 89, 1998 [3] The Directive's main purpose is to ensure
that medical devices placed on the European market do not compromise the safety
and health of patients, users and other individuals. The medical devices must
meet the essential requirements for their design and construction, including
those for justification of the intended use of the equipment on the basis of
risk/benefit weighting and for incorporation of technical features for
radiation protection of patients, users and other individuals. This is ensured,
inter alia, through a system of harmonized standards issued by the European
standardization organizations (CENELEC in this case), pre-market conformity
assessment procedures and appropriate supervision by the competent authorities. [4] Such techniques
may include manual examination, electrical and magnetic source imaging,
ultrasound and sonar, magnetic resonance imaging, microwave imaging, terahertz
imaging, infrared imaging and visible imaging [5] FORATOM ENISS comments dated 19 November
2010