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1Augustin Janssens EC DG ENER D4
Revision and consolidation of Euratom Basic Safety Standards
European Commission
DG Energy
D4: Radiation ProtectionAugustin Janssens
2Augustin Janssens EC DG ENER D4
Overview• Revision and consolidation of BSS• Exposure situations• System of Protection• Existing exposure situations
– Radon (workplace, dwellings)– Building materials– Living in contaminated territory
• Planned exposure situations– Justification and regulatory control– Graded approach– Categories of exposure
• Emergency exposure situations– Emergency workers– Emergency planning and response
• public information
• Institutional infrastructure• Recast Directives• Transposition in national law
3Augustin Janssens EC DG ENER D4
Revision and consolidationBSS DIRECTIVE
• Article 31 Group of Experts since 2005• Topical issues
– natural radiation sources– exemption, clearance, graded approach
• WP “Recast”– First consolidated draft text: meeting in June 2009 – Final text for Article 31 Experts in November 2009
• Approval of draft text and related Opinion – on 23-24.2. 2010
• Impact Assessment Report• Inter-Service consultation• Translation• Commission proposal to be adopted in September 2011
http://ec.europa.eu/energy/nuclear/radiation_protection/doc/art31/2010_02_24_draft_euratom_basic_safety_standards_directive.pdfhttp://ec.europa.eu/energy/nuclear/radiation_protection/doc/art31/2010_02_24_opinion_on_bss.pdf
5Augustin Janssens EC DG ENER D4
Preparing revised and consolidated EU-BSS
• Commission Radiation Protection Unit in Luxembourg
• Article 31 Expert Group– WP BSS– WP Exemption and Clearance– WP Natural Sources– WP Graded Approach– WP MED– WP Recast
http://ec.europa.eu/energy/nuclear/radiation_protection/article_31_en.htm
6Augustin Janssens EC DG ENER D4
RECASTBetter legislation - simplification
• Directives: – Basic Safety Standards (workers, general public): 1996– Patients/Medical Exposure Directive: 1997– Informing the public on measures in the event of a radiological
emergency: 1989– Outside Workers: 1990– High Activity Sealed Sources (HASS): 2003– (Radon Recommendation 90/143/Euratom)
• Recast:– In principle no discussion of unmodified text– In practice: too many changes with cross-cutting impact– Hence: “consolidation”
7Augustin Janssens EC DG ENER D4
Revision of EU-BSS
• Consolidation of current Directives
• Allow for ICRP/IAEA– Exposure situations
• rather than processes: practices/interventions
– Incorporate natural radiation sources
• strengthen the requirements
– Protection of the environment
8Augustin Janssens EC DG ENER D4
ICRP Publication 103Scope:
(176) … applied to all sources and all exposed individuals, in the following three exposure situations:
– planned: … involving the planned operation of sources (practices in operation)– existing: … that already exists when a decision on control has to be taken, including natural
background radiation …– emergency exposure situations
Principle of Justification:(206) … introduction of new activities where radiological protection is planned in advance and the necessary actions can be taken on the source(207) … where exposures can be controlled mainly by action to modify the pathways of exposure and not by action on the source
Problems:• “planned” associated with the applicable regime of regulatory control
– notification, registration and licensing of practices– any (industrial) activity for which an undertaking has legal responsibility for its conduct and
for the resulting exposure should be managed in the same way as practices• “existing” has been confounded with “practices that already exist”
9Augustin Janssens EC DG ENER D4
Exposure situationsEuratom approach
• Planned: new source or new pathway of exposure resulting from the activity
• industries processing naturally occurring radioactive materials (NORM)
• operation of aircraft
• Existing: resulting from features of the location (not the type of activity)
• indoor Radon (ingress from soil) • commodities managed together with the exposure situation:
– building materials (gamma exposure, radon exhalation)– foodstuffs (post-accidental situation)
• Emergency: urgent situation• which can be planned or prepared for
10Augustin Janssens EC DG ENER D4
Definitions
• Practice: any type of activity that involves the operation or introduction of radiation sources or which alters exposure pathways and is managed as a planned exposure situation
• Undertaking: a natural or legal person which has legal responsibility for carrying out a practice or who has legal responsibility for a radiation source– including the owner or holder of a source who does not conduct
related activities
• Occupational exposure: exposure of workers incurred in the course of their work – responsibility of the employer for (outside) workers and for
exposure to radon at work
12Augustin Janssens EC DG ENER D4
Radiation Sources
Radioactive Material including
Radioactive Substances
Radiation Generators
Radioactive Waste Naturally occurring radioactive material
Radioactive Sources
Sealed Sources
High activity Sealed Sources
Orphan SourcesManagement of ra
diation sources
depends on the type of
exposure situatio
n
13Augustin Janssens EC DG ENER D4
Options for structure:PLANNED EXPOSURE
SITUATIONSEMERGENCY EXPOSURE
SITUATIONSEXISTING EXPOSURE
SITUATIONS
Occupational exposure Occupational exposure Occupational exposure
Public exposure Public exposure Public exposure
Medical exposure
OCCUPATIONAL EXPOSURE
PUBLIC EXPOSURE MEDICAL EXPOSURE
Planned exposure situations Planned exposure situations Planned exposure situations
Emergency exposure situations
Emergency exposure situations
Existing exposure situations Existing exposure situations
14Augustin Janssens EC DG ENER D4
Table of contents of revised EU-BSS
PreambleChapter I Subject Matter and ScopeChapter II DefinitionsChapter III System of ProtectionChapter IV Requirements for Education, Training and InformationChapter V Justification and Regulatory Control of practicesChapter VI Protection of Workers, Apprentices and StudentsChapter VII Protection of Patients and other Individuals
submitted to Medical ExposureChapter VIII Protection of Members of the PublicChapter IX Protection of the EnvironmentChapter X Requirements for Regulatory ControlChapter XI Final provisions
15Augustin Janssens EC DG ENER D4
System of Protection Principles
• Justification of practices• Optimisation of protection
– constraints in planned exposure situations– reference levels in existing or emergency
situations– For medical exposure of patients: DRL’s
• Dose limits– effective dose (stochastic effects)– organ dose (tissue effects)
16Augustin Janssens EC DG ENER D4
Reference levels• Bands of reference levels for public exposure and
corresponding societal criteria• RL in the range 20 mSv – 100 mSv for emergency
exposure situations– below 20 mSv if no disproportionate detriment or
excessive cost of countermeasures
• RL in the range 1 to 20 mSv per year for existing exposure situations– indoor radon exposure– long-term post-accidental management
• RL below 1 mSv for specific pathways of exposure
17Augustin Janssens EC DG ENER D4
• Dose constraint– Prospective upper bound on individual dose– As an operational tool in cooperation between
employer (Outside Worker) and undertaking– For public exposure, to ensure compliance
with the dose limit
System of protection Optimisation
... where appropriate dose constraints may apply to organ doses (in terms of equivalent doses), as a precautionary measure to allow for uncertainties on health detriment below the threshold for deterministic effects
18Augustin Janssens EC DG ENER D4
System of protectionDose limits
• Age limit for exposed workers (>18 y)
• Effective dose limit– 20 mSv in any single year– 5-years averaging may be authorised for certain
situations specified in national legislation
• Equivalent dose limit for the lens of the eye– Same as effective dose limit
Occupational exposure
19Augustin Janssens EC DG ENER D4
• Effective dose limit– 1 mSv in any single year
• Equivalent dose limit for the lens of the eye– 15 mSv in any single year– 31-Expert Group June 2011: Keep provisionally
mainly for reasons of consistency with the Int.-BSS
Public exposure
System of protectionDose limits
20Augustin Janssens EC DG ENER D4
Effective dose
• Sum of external and internal exposures– Committed effective dose
• Reference to definitions of ICRU and ICRP– Hp(d) (personal dose equivalent at depth d)
– wR and wT (organ and tissue weighting factors)
• Dose coefficients per unit intake– Inhalation, ingestion, workers, public (diff. ages)– Forthcoming consolidated publication by ICRP
• Under contract with EC: free public web access• IAEA: tables to be appended in CD Rom to printed version
21Augustin Janssens EC DG ENER D4
Existing exposure situations
• Radon (workplace, dwellings)
• Building materials
• Living in contaminated territory
22Augustin Janssens EC DG ENER D4
EC Recommendation on indoor exposure to radon (90/143/Euratom)
• Establish a system for reducing any exposure to indoor radon concentrations.
• Apply principle of optimisation.• Decisions should be made on annually-averaged
radon measurements • Develop criteria for identifying regions, sites and
building characteristics likely to cause high indoor radon levels
• Reference level for existing buildings– 400 Bq/m3
• Design level for construction of new buildings– 200 Bq/m3
23Augustin Janssens EC DG ENER D4
Natural Radiation Sources in present BSS Directive 96/29/Euratom
• Exposure to radon in dwellings is not included in the scope
• Radon in workplaces– Addressed in Title VII (Natural Radiation Sources)
• Identification of “work activities” of concern
– Large flexibility for Member States on measures taken
• No specific requirements on building materials
24Augustin Janssens EC DG ENER D4
New BSS: Radon action plan
• ”Member States shall establish an action plan to manage long term risks from radon exposures in dwellings, buildings with public access and workplaces for any source of radon ingress, whether from soil, building materials and water.”– Take into account issues specified in Annex XVI
25Augustin Janssens EC DG ENER D4
• Assign responsibilities, allocate resources for measurements and remedial actions
• Criteria for delineation of radon prone areas• Criteria for identification of buildings of concern• Criteria for accreditation of measurement and
remediation services• Strategy for increasing public awareness in relation to
smoking• Long term goals for reducing lung cancer
Radon Action Planindicative list of issues in Annex XVI
26Augustin Janssens EC DG ENER D4
Chapter VI Protection of workers Radon in workplaces
• Establishment of national reference level, – not exceeding 1000 Bq/m3
• Measurements necessary in – workplaces located at ground floor or at basement
level in radon prone areas – specific types of workplaces identified in action
plan• Principle of optimisation
– Reduce radon concentrations or exposures• If levels stay above reference level despite actions
– Manage as a planned exposure situation– Dose limit and requirements for occupational
exposure apply
27Augustin Janssens EC DG ENER D4
Member States shall establish national reference levels for indoor annual average radon concentrations, not exceeding: – 200 Bq/m3 for new dwellings and new buildings
with public access– 300 Bq/m3 for existing dwellings– 300 Bq/m3 for existing buildings with public access
• In specific cases, allowing for occupancy time, a higher reference level with a maximum of 1000 Bq/m3
Chapter VIII Protection of the public Radon in dwellings
28Augustin Janssens EC DG ENER D4
Chapter VIII Protection of the public Radon in dwellings
Member States shall:• identify dwellings above reference level and
encourage remedial action• ensure measurements in buildings with public
access in radon prone areas• establish building codes to prevent radon
ingress from soil and building materials• provide information (local and national) on
radon situation, risks and means for reducing radon concentrations
29Augustin Janssens EC DG ENER D4
Building materials
• Reference level of 1 mSv per year– for indoor external exposure from building materials
• in excess of the background outdoor external exposure
• Below 1 mSv/y the material is exempted and free on the market in EU– above 1 mSv/y the national authority may consider appropriate
control measures• Information about the materials relevant for compliance
with building codes should be available before their placing on the market– activity concentration index– two categories (reflecting whether the material is used in bulk or
superficial quantities)– CEN/TC standards (construction products)
30Augustin Janssens EC DG ENER D4
Building MaterialsIndustries processing residues and by-
products
Determine concentrations in listed types of building materials
Determine activity index I
Types of building materials identified by Regulatory Authority
Compliance with building codes
Classification of the materials
A BExempted
Types of building materials authorised by Regulatory
Authority
Architects
> Reference Level (1 mSv)
31Augustin Janssens EC DG ENER D4
• VII: gives definition and use of the activity concentration index for the gamma radiation emitted by building materials
• IX: indicative list of types of building materials considered for control measures with regard to their emitted gamma radiation
• XVI: indicative list of items to be covered in the national action plans for radon in dwellings and workplaces
AnnexesExisting exposure situations
32Augustin Janssens EC DG ENER D4
Contaminated areas• Delineation of affected regions• Consideration of the
– need and extent of protective measures– need to prevent or control access
• or impose restrictions on living conditions
• Assessment of exposures– means available to individuals for controlling their exposure
• In consultation with stakeholders:– Allow habitation and resumption of social and economic activities– Ongoing control of exposures– Establish living conditions that can be considered as normal,
including:• Reference level consistent with day-to-day life• Infrastructure to support self-help protective measures
– Information, advice, monitoring
33Augustin Janssens EC DG ENER D4
Planned exposure situations
• Justification and regulatory control
• Graded approach
• Categories of exposure
35Augustin Janssens EC DG ENER D4
Justification and regulatory control of planned exposure situations
• Identification of practices (two types)
• Justification:– 3 levels (type A)– 2 levels (type B)
• Authorisation, optimisation, dose constraints
• Informed consent (except law enforcement)– Routine security screening: alternative methods
Non-medical exposure of humans
Type A(Medical staff and equipment)
- Employment purposes
- Immigration purposes
- Insurance purposes
- Physical development and age
- Concealed object within the body
Type B
- Concealed objects on or attached to the body
- Concealed humans as part ofcargo-screening
- Other legal or security purposes
36Augustin Janssens EC DG ENER D4
Justification and regulatory control of planned exposure situations
• Relevant information to competent authorities (Annex)
• Justification (Annex)
– Type approval / Consumer products
• Information of the competent authorities of other Member States
• European and international standards (IAEA/EU/NEA working group)
New type of apparatus or products
37Augustin Janssens EC DG ENER D4
Justification and regulatory control of planned exposure situations
• Proportionality
• Effectiveness of regulatory control
Graded approach
Member States shall require any notified practice to be subject to regulatory control commensurate with the magnitude and likelihood of exposures resulting from the practice,
38Augustin Janssens EC DG ENER D4
Justification and regulatory control of planned exposure situations
• Proportionality
• Effectiveness of regulatory control
Graded approach
Member States shall require any notified practice to be subject to regulatory control commensurate with the magnitude and likelihood of exposures resulting from the practice,
and commensurate with the extent by which regulatory control may have an impact on reducing such exposures or improving the safety of the installations
40Augustin Janssens EC DG ENER D4
Regulatory Control - Graded Approach
Outside Scope of EU-BSS
Generic (explicit) Exemption
Specific Exemption
Registration
Licensing
Noti
fica
tion Authorization
Licensing:
- Nuclear fuel cycle
- Production of consumer goods
- High-activity sealed sources
- Worker exposure liable to exceed 6 mSv/y
- Discharge of significant amounts of airborneor liquid effluent to the environment
- .....
41Augustin Janssens EC DG ENER D4
Regulatory Control - Graded Approach
Outside Scope of EU-BSS
Generic (explicit) Exemption
Specific Exemption
Registration
Licensing
Noti
fica
tion Authorization
Registration (or licensing):
- Administration of radioactive substances topersons
- Industrial radiography, accelerators
- Radiations generators or radioactive sourcesfor medical exposures
- Worker exposure liable to exceed 1 mSv/y
- .....
43Augustin Janssens EC DG ENER D4
Release from regulatory control
• No general clearance levels in 1996 EU-BSS(Recommendations in RP 122)
• IAEA RS-G-1.7• Comparative Study
– IAEA levels used as both exemption andclearance levels in revised EU-BSS
• However, RS-G-1.7 does not apply to naturaloccurring radionuclides in two cases:
– Residues into building materials– Specific risk of groundwater contamination
Exemption and clearance
44Augustin Janssens EC DG ENER D4
NORM residuesClearance criteria
drinking water standardsTID : 0.1 mSv
lower activity concen-trations
NORM materials
Regulated NORM INDUSTRY
< 300 µSv
Exempted industry
<1 Bq/g
practices involving artificial radionuclides
Nuclear fuel cycle
< 10 µSv
specific clearance
levels
45Augustin Janssens EC DG ENER D4
Categories of exposure
• Occupational
• Medical
• Public
• Environment
46Augustin Janssens EC DG ENER D4
Protection of workersAir and space crew
• Exposure of air crew– Requirements maintained– Regarded as planned exposure situation
• Exposure of space-crew– Included in scope of EU-BSS– Special authorised exposure
47Augustin Janssens EC DG ENER D4
Protection of patients (Chapter VII)
• MED requirements essentially all maintained• New emphasis on
– Justification, e.g. for asymptomatic individuals– Information provided for patients– Diagnostic reference levels for Interventional
radiology procedures– Dose recording and reporting
• Dose indicating devices or features• Radiation dose in the report on the examination
48Augustin Janssens EC DG ENER D4
Protection of patients (Chapter VII)
• New features– Detailed consideration of accidental or unintended exposures– The role of the quality assurance programme, including risk
analysis in radiotherapy, to avoid incidents – Strengthened involvement of the Medical Physics Expert in
radiological imaging examinations
49Augustin Janssens EC DG ENER D4
Protection of members of the public
• Consumer goods (Chapter V)• Radioactive airborne or liquid effluent (Chapter
VIII)– Discharge authorisations shall
• Take account of the results of optimisation• Reflect good practice• Allow margin for operational flexibility
– Realistic assessment of doses• Representative person• Environmental monitoring• Record keeping• Information available to stakeholders
50Augustin Janssens EC DG ENER D4
Protection of the Environment
• This Directive applies to the protection of the environment as a pathway from radiation sources to the exposure of man, complemented where appropriate with specific consideration of the exposure of biota in the environment as a whole.
• ICRP Publication 103– change in the paradigm– Publication 108: the concept and use of
reference animals and plants– principles of protection (2012?)
51Augustin Janssens EC DG ENER D4
Protection of the EnvironmentChapter IX
• National legal framework– provision for protection of non-human species– environmental criteria
• populations of vulnerable or representative species• significance as part of the ecosystem
– identify practices for which regulatory control is warranted
• Authorised limits of discharges– generic screening assessment
• Technical measures to mitigate the environmental consequences of accidents
• Specific environmental monitoring
52Augustin Janssens EC DG ENER D4
ICRP Guidance on the Protection of the Environment
• Publication 103 (2007): need for a scientific framework• Publication 108 (2008): “The concept and use of Reference Animals and
Plants”– Including an assessment methodology and – Derived Concentration Reference Levels (DCRL)
• Publication 1xx (2012): “The approach to protection of the environment under different exposure situations”
– Environmental Reference Levels for planned exposure situations• ERL < lower bound of DCRL• Starting point of optimisation of environmental exposures• No dose limits, compliance based solely on concentrations of radionuclides in the
environment (or rate of discharge)– Emergency exposure situations
• Severe effects: one or more orders of magnitude > DCRL• Limited options for mitigation• Impact on siting
– Existing exposure situations• DCRL starting point of optimisation of environmental exposures
53Augustin Janssens EC DG ENER D4
Emergency exposure situations
• Emergency workers
• Emergency planning and response– protection of the environment– public information
54Augustin Janssens EC DG ENER D4
Chapter VI: Emergency workers• Responsibility:
– Article 30.1(b): the (emergency response) organisation responsible for the protection of emergency workers
• Article 52: Emergency occupational exposure– Ensure that no emergency worker undertakes actions resulting in
doses in excess of 50 mSv• except in specific cases identified in the national emergency plan
– appropriate reference level above 50 mSv• In exceptional circumstances, …, a reference level above 100 mSv
may be set– Emergency workers liable to exceed 50 mSv are
• volunteers• clearly and comprehensively informed, in advance, of the associated
health risks and protection measures– In the event of an emergency exposure:
• radiological monitoring and medical surveillance• individual dose assessment as appropriate to the circumstances
55Augustin Janssens EC DG ENER D4
Emergency planning and response• More comprehensive system:
– threat analysis– overall emergency management system– emergency response plans for identified threats
• reference levels– pre-planned strategies for the management of
each postulated event
• Compulsory cooperation between Member States– Member States shall (instead of …shall seek to)
56Augustin Janssens EC DG ENER D4
AnnexesEmergency exposure situations
• IX.A: Elements to be included in an emergency management system
• IX.B: Elements to be included in an emergency response plan
• X.A: Prior information to the population likely to be affected by a radiological emergency
• X.B: Information to be provided to the affected population in case of a radiological emergency
57Augustin Janssens EC DG ENER D4
Institutional infrastructure• Competent authority
– Communication to the Commission– Publication by the Commission
• Recognition of services and experts– Occupational health services– Dosimetry services– Radiation protection experts– Medical physics experts
– Specify the recognition requirements and communicate these to the Commission
• Radiation protection officer– Tasks within undertakings, necessary means, reporting directly to the
undertaking
58Augustin Janssens EC DG ENER D4
Education, training and information
• Information and training of exposed workers, apprentices and students
• Information and training of workers potentially exposed to orphan sources
• Information and training of emergency workers
• Education, information and training in the fieldof medical exposure
59Augustin Janssens EC DG ENER D4
Enforcement and Inspection
• Systematic inspection programme
• Findings available to the public
• Information to relevant parties of lessons learned from inspection and from incidents and accidents
60Augustin Janssens EC DG ENER D4
RECASTBetter legislation - simplification
• Basic Safety Standards (workers, general public): 1996– Natural radiation sources– Emergency exposure situations– Non-medical imaging– Graded approach to regulatory control– Protection of the environment
• Patients/Medical Exposure Directive: 1997• Informing the public on measures in the event of
a radiological emergency: 1989• Outside Workers: 1990• High Activity Sealed Sources (HASS): 2003
61Augustin Janssens EC DG ENER D4
RECASTBetter legislation - simplification
• Basic Safety Standards (workers, general public): 1996• Patients/Medical Exposure Directive: 1997
– Strengthened requirements• Informing the public on measures in the event of a
radiological emergency: 1989– In Annex
• Outside Workers: 1990– Responsibility of employer– Radiation Passbook and Dose Registry
• High Activity Sealed Sources (HASS): 2003– Annexes– Definition in Code of Conduct– Orphan sources, metal scrap
62Augustin Janssens EC DG ENER D4
Transposition
• This Directive establishes the basic safety standards for the protection of the health of workers, general public, patients and other individuals subject to medical exposure against the dangers arising from ionising radiation for the purpose of their uniform implementation by Member States.
• Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 00.00.0000 at the latest. (2y?)
– The provisions laid down in Chapter X with regard to the protection of the environment shall be transposed by 00.00.0000. (4 y?)