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

2. Augustin Janssens EC DG ENER D4 2 Overview Revision and consolidation of BSS Exposure situations System of Protection Existing exposure situations –Radon (workplace, dwellings)Radon (workplace, dwellings) –Building materialsBuilding materials –Living in contaminated territoryLiving in contaminated territory Planned exposure situations –Justification and regulatory controlJustification and regulatory control –Graded approachGraded approach –Categories of exposureCategories of exposure Emergency exposure situations –Emergency workersEmergency workers –Emergency planning and responseEmergency planning and response public information Institutional infrastructure Recast Directives Transposition in national law

3. Augustin Janssens EC DG ENER D4 3 Revision and consolidation BSS 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. Augustin Janssens EC DG ENER D4 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. Augustin Janssens EC DG ENER D4 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 http://ec.europa.eu/energy/nuclear/radiation_ protection/article_31_en.htm

6. Augustin Janssens EC DG ENER D4 6 RECAST Better 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. Augustin Janssens EC DG ENER D4 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. Augustin Janssens EC DG ENER D4 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. Augustin Janssens EC DG ENER D4 9 Exposure situations Euratom 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. Augustin Janssens EC DG ENER D4 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

11. Augustin Janssens EC DG ENER D4 11

12. Augustin Janssens EC DG ENER D4 12 Radiation Sources Radioactive Material including Radioactive Substances Radiation Generators Radioactive WasteNaturally occurring radioactive material Radioactive Sources Sealed Sources High activity Sealed Sources Orphan Sources Management of radiation sources depends on the type of exposure situation

13. Augustin Janssens EC DG ENER D4 13 Options for structure: PLANNED EXPOSURE SITUATIONS EMERGENCY EXPOSURE SITUATIONS EXISTING EXPOSURE SITUATIONS Occupational exposure Public exposure Medical exposure OCCUPATIONAL EXPOSURE PUBLIC EXPOSUREMEDICAL EXPOSURE Planned exposure situations Emergency exposure situations Existing exposure situations

14. Augustin Janssens EC DG ENER D4 14 Table of contents of revised EU-BSS Preamble Chapter I Subject Matter and Scope Chapter II Definitions Chapter III System of Protection Chapter IV Requirements for Education, Training and Information Chapter V Justification and Regulatory Control of practices Chapter VI Protection of Workers, Apprentices and Students Chapter VII Protection of Patients and other Individuals submitted to Medical Exposure Chapter VIII Protection of Members of the Public Chapter IX Protection of the Environment Chapter X Requirements for Regulatory Control Chapter XI Final provisions

15. Augustin Janssens EC DG ENER D4 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. Augustin Janssens EC DG ENER D4 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. Augustin Janssens EC DG ENER D4 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... 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

18. Augustin Janssens EC DG ENER D4 18 System of protection Dose 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

19. Augustin Janssens EC DG ENER D4 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 Public exposure System of protection Dose limits

20. Augustin Janssens EC DG ENER D4 20 Effective dose Sum of external and internal exposures –Committed effective dose Reference to definitions of ICRU and ICRP –H p (d) (personal dose equivalent at depth d) –w R and w T (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. Augustin Janssens EC DG ENER D4 21 Existing exposure situations Radon (workplace, dwellings) Building materials Living in contaminated territory

22. Augustin Janssens EC DG ENER D4 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/m 3 Design level for construction of new buildings –200 Bq/m 3

23. Augustin Janssens EC DG ENER D4 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. Augustin Janssens EC DG ENER D4 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. Augustin Janssens EC DG ENER D4 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 Plan i ndicative list of issues in Annex XVI

26. Augustin Janssens EC DG ENER D4 26 Chapter VI Protection of workers Radon in workplaces Establishment of national reference level, –not exceeding 1000 Bq/m 3 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. Augustin Janssens EC DG ENER D4 27 Member States shall establish national reference levels for indoor annual average radon concentrations, not exceeding: –200 Bq/m 3 for new dwellings and new buildings with public access –300 Bq/m 3 for existing dwellings –300 Bq/m 3 for existing buildings with public access In specific cases, allowing for occupancy time, a higher reference level with a maximum of 1000 Bq/m 3 Chapter VIII Protection of the public Radon in dwellings

28. Augustin Janssens EC DG ENER D4 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. Augustin Janssens EC DG ENER D4 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. Augustin Janssens EC DG ENER D4 30 Building Materials

31. Augustin Janssens EC DG ENER D4 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 Annexes Existing exposure situations

32. Augustin Janssens EC DG ENER D4 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. Augustin Janssens EC DG ENER D4 33 Planned exposure situations Justification and regulatory control Graded approach Categories of exposure

34. Augustin Janssens EC DG ENER D4 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 Non-medical exposure of humans

35. Augustin Janssens EC DG ENER D4 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 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 of cargo-screening - Other legal or security purposes

36. Augustin Janssens EC DG ENER D4 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) New type of apparatus or products

37. Augustin Janssens EC DG ENER D4 37 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,

38. Augustin Janssens EC DG ENER D4 38 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

39. Augustin Janssens EC DG ENER D4 39 Regulatory Control - Graded Approach Outside Scope of EU-BSS Generic (explicit) Exemption Specific Exemption Registration Licensing Notification Authorization

40. Augustin Janssens EC DG ENER D4 40 Regulatory Control - Graded Approach Outside Scope of EU-BSS Generic (explicit) Exemption Specific Exemption Registration Licensing Notification 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 airborne or liquid effluent to the environment -.....

41. Augustin Janssens EC DG ENER D4 41 Regulatory Control - Graded Approach Outside Scope of EU-BSS Generic (explicit) Exemption Specific Exemption Registration Licensing Notification Authorization Registration (or licensing): -Administration of radioactive substances to persons -Industrial radiography, accelerators -Radiations generators or radioactive sources for medical exposures -Worker exposure liable to exceed 1 mSv/y -.....

42. Augustin Janssens EC DG ENER D4 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 and clearance levels in revised EU-BSS However, RS-G-1.7 does not apply to natural occurring radionuclides in two cases: –Residues into building materials –Specific risk of groundwater contamination Exemption and clearance

43. Augustin Janssens EC DG ENER D4 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 and clearance levels in revised EU-BSS However, RS-G-1.7 does not apply to natural occurring radionuclides in two cases: –Residues into building materials –Specific risk of groundwater contamination Exemption and clearance

44. Augustin Janssens EC DG ENER D4 44 NORM residues Clearance criteria drinking water standards TID : 0.1 mSv lower activity concen- trations NORM materials Regulated NORM INDUSTRY <300µSv Exempted industry <1Bq/g practices involving artificial radionuclides Nuclear fuel cycle <10µSv specific clearance levels

45. Augustin Janssens EC DG ENER D4 45 Categories of exposure Occupational Medical Public Environment

46. Augustin Janssens EC DG ENER D4 46 Protection of workers Air 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. Augustin Janssens EC DG ENER D4 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. Augustin Janssens EC DG ENER D4 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. Augustin Janssens EC DG ENER D4 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. Augustin Janssens EC DG ENER D4 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. Augustin Janssens EC DG ENER D4 51 Protection of the Environment Chapter 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. Augustin Janssens EC DG ENER D4 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. Augustin Janssens EC DG ENER D4 53 Emergency exposure situations Emergency workers Emergency planning and response –protection of the environment –public information

54. Augustin Janssens EC DG ENER D4 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. Augustin Janssens EC DG ENER D4 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. Augustin Janssens EC DG ENER D4 56 Annexes Emergency 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. Augustin Janssens EC DG ENER D4 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. Augustin Janssens EC DG ENER D4 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 field of medical exposure

59. Augustin Janssens EC DG ENER D4 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. Augustin Janssens EC DG ENER D4 60 RECAST Better 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. Augustin Janssens EC DG ENER D4 61 RECAST Better 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. Augustin Janssens EC DG ENER D4 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?)