Revision and consolidation of Euratom Basic Safety Standards

1. 1 Revision and consolidation of Euratom Basic Safety Standards European Commission DG Energy D4: Radiation Protection Augustin Janssens

2. 2 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

3. 3 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.pdf http://ec.europa.eu/energy/nuclear/radiation_protection/doc/art31/2010_02_24_opinion_on_bss.pdf

4. 4 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 Recast

5. 5 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

6. 6 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�

7. 7 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

8. 8 ICRP Publication 103 Scope: (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�

9. 9 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

10. 10 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

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13. 13 Options for structure:

14. 14 Table of contents of revised EU-BSS

15. 15 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)

16. 16 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

17. 17 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

18. 18 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

19. 19 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 System of protectionDose limits

20. 20 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

21. 21 Existing exposure situations Radon (workplace, dwellings) Building materials Living in contaminated territory

22. 22 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

23. 23 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

24. 24 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

25. 25 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

26. 26  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

27. 27 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

28. 28 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

29. 29 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)

30. 30 Building Materials

31. 31 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

32. 32 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

33. 33 Planned exposure situations Justification and regulatory control Graded approach Categories of exposure

34. 34 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

35. 35 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

36. 36 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)

37. 37 Justification and regulatory control of planned exposure situations Proportionality Effectiveness of regulatory control

38. 38 Justification and regulatory control of planned exposure situations Proportionality Effectiveness of regulatory control

39. 39 Regulatory Control - Graded Approach

40. 40 Regulatory Control - Graded Approach

41. 41 Regulatory Control - Graded Approach

42. 42 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

43. 43 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

44. 44 NORM residuesClearance criteria

45. 45 Categories of exposure Occupational Medical Public Environment

46. 46 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

47. 47 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

48. 48 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

49. 49 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

50. 50 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?)

51. 51 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

52. 52 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

53. 53 Emergency exposure situations Emergency workers Emergency planning and response protection of the environment public information

54. 54 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

55. 55 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)

56. 56 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

57. 57 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

58. 58 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

59. 59 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

60. 60 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

61. 61 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

62. 62 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?)