Lars-Erik Holm Vice Chairman

1. NSFS Seminar "Quality in Radiation Protection” Malmö, 4 February 2004ICRP’s 2005 Recommendations on Radiological Protection From a Quality Perspective Lars-Erik Holm Vice Chairman

2. Quality Systems in Radiological Protection Purpose: • to ensure high quality in the performance of tasks; • to support the daily work, thereby helping to solve the tasks efficiently and in the right way – the first time as well as each time thereafter.

3. Quality Systems in Radiological Protection A quality system should contain strategies for Quality Assurance, Quality Control, and Quality Inspection. The system should be designed so that • it is understandable, implemented and applied; • the production meets the needs and expectations of the customers; • society’s needs are met and relevant environmental criteria complied with; • the focus is on preventing problems rather that dealing with problems that have occurred.

4. Value Judgements in Quality Systems • focus on the customer; • committed leadership; • participation and involvement of all employees; • collaboration between different competences; • clear and distinct communication; • good service; • foresight, and planning; • a culture that promotes creativity; and • preparedness for change

5. The Quality System of a Regulator • Similar demands on QA are put on the regulator’s own activities as on those of the operators. • The quality system is an important management and steering tool.

6. Radiological Protection as a Quality SystemStructure of ICRP’s current system • objectives and the scientific basis; • concepts (practice, intervention) to distinguish between different types of situations; • source-related and individual-related assessments; • classification of different types of exposure; • justification of a practice, optimisation of protection and dose limitation; • justification of intervention and optimisation of the type and scale of intervention; • potential exposure and accident prevention; • emergency planning; • quantities and units; and, • implementation of the recommendations by operators and regulators.

7. ICRP RECOMMENDATIONS ICRP’s advice is aimed at regulators and operators. General recommendations appeared in 1991. Additional recommendations have appeared in 9 other publications since then. The system of protection has become too complex. ICRP intends to make it more coherent and simplify its applications.

8. RECOMMENDATIONS SINCE 1990 Are in terms of max. individual dose or risk, from single sources, which restrict the inequity in optimisation, i.e.CONSTRAINTS. CONSTRAINTS ARE ALWAYS NEEDED WHENEVER OPTIMISATION IS SPECIFIED

9. CONSTRAINTS There exist nearly 30 different ‘constraints’ in current ICRP recommendations. They are justified in at least 6 ways. CAN FEWER CONSTRAINTS BE SET AND ON A SIMPLER BASIS?

10. MAJOR CHANGES FROM THE 1990 RECOMMENDATIONS The aim is a single set of recommendations, consolidating the work since 1990. Primary emphasis continues to be on the protection of the individual. A set of fewer constraints to optimisation. Revision of the dosimetric quantities. Inclusion of a framework for protection of the environment.

11. JUSTIFICATION The distribution of responsibilities for justification lies primarily with society at large. Radiological considerations are only one input. The recommendations apply to practices only when they have been declared justified. Justification of medical exposures is included.

12. UNDERLYING POLICIES • The system of protection applies to practices that have been justified. • The recommendations apply to control of sources or to pathways leading to doses in individuals. • Protection concerns - exposure to incremental doses to natural background, and - with risks at levels > a few mSv in a year.

13. DOSIMETRIC QUANTITIES Effective dose is the principal quantity for radiological protection. Radiation-weighted absorbeddose will be used instead of the ‘equivalent dose’ to avoid confusion. Weighting factors, wR and wT, will be revised.

14. RADIATION-WEIGHTING FACTOR, wR

15. THE SYSTEM OF PROTECTION ICRP recommends two standards of protection: • the DOSE LIMIT provides a level of protection for individuals. • the DOSE CONSTRAINT protects all individuals to planned exposures from an identified source. Further measures should be applied to each source, i.e. the OPTIMISATION OF PROTECTION, and ALARA.  

16. INDIVIDUAL DOSE LIMITS OCCUPATIONAL EXPOSURE:20 mSv/ year 100 mSv in 5 years, and max. 50 mSv in any single year. PUBLIC EXPOSURE:1 mSv in a year A higher dose could be allowed in a year, if the 5-year average does not exceed 1 mSv/year.

17. THE 2005 CONSTRAINTS • The starting point can be the annual dose from natural background. • Constraints • can be set using existing numerical values -which achieves continuity. • can be explained in relation to background -which achieves simplicity. • are a necessary, but not sufficient, criterion for protection -which requires optimisation.

18. YEAR 2005 CONSTRAINTSEFFECTIVE DOSE IN A YEAR 200 mSv Life-saving, relocation 20 mSv Occupational, radon, countermeasures 1 mSv Public 0.01 mSv Protection optimised ACTION MANDATORY ACTION UNNECESSARY

19. NATURAL SOURCES Recommendations for radon will continue: A max. level of dose(CONSTRAINT) translated into an activity concentration and followed by optimisation to find a lower action level. This level will be theEXCLUSION LEVEL, and exposures below that level will be excluded from the system of protection.

20. EXPOSURE OF PATIENTS • Dose limitation to the individual patient may reduce the effectiveness of the diagnosis or treatment. • The emphasis is on the justification of the medical procedures. • Optimisation: keep the doses as low as is consistent with the medical objectives. • DIAGNOSTIC REFERENCE LEVELSare indicators of good practice.

21. OPTIMISATION OF PROTECTION • Optimisation • applies to individuals and groups • is restricted by the appropriate constraint • is a frame of mind, ‘Protection Culture’. • ICRP can give guidance, but it is a task for national authorities.

22. ICRP AND THE ENVIRONMENT • ICRP will develop a framework for assessment of radiation effects in non-human species. • The approach is similar to that proposed for the protection of humans. • Reference Animals and Plants. • Derived Consideration Levels.

23. POSSIBLE REFERENCE ANIMALS AND PLANTS Rodent (mouse/rat) Duck Frog Salmonid Flat fish Gastropod mollusc Bee Worm Pine tree Grass Brown algae

24. A COMMON APPROACH Practices Environmental radionuclide concentration(s) Reference Man (look-up tables) Reference Animals and Plants (look-up tables) Levels of Concern, Constraints Derived Consideration Levels for Fauna and Flora Decision-Making with Regard to Public Health and Environment for the Same Environmental Situation

25. PROTECTION OF NON-HUMAN SPECIES • A framework must be practical and simple. • A set of ambient activity concentration levels would be the simplest tool. • In order to transparently demonstrate the derivation of such levels, the use of Reference Animals and Plants would be helpful.

26. EVOLUTION OF RECOMMENDATIONS • 1990 2005 • PracticeRetain • InterventionReplace using constraints • JustificationResponsibilities clarified, patient • exposure added • ConstraintsNumber to be reduced • Optimisation (Formal CBA)Stakeholder involvement • Collective doseDisaggregated - replaced by weighted matrix • LimitsRetain in Basic Safety Standards

27. EVOLUTION OF RECOMMENDATIONS • 1990 2005 • Effective dose Revised wR and wT, simplified basis • Nominal risk coefficientCancer fatality similar, • Hereditary - changed • Definition of ‘individual’New consideration • ExemptionExclusion • Natural SourcesComprehensive, not just Rn-222 • Non-human speciesExplicitly addressed, not assumed

28. CHANGES IN ICRP’S VALUE JUDGEMENTS DAD: decide, announce and defend replaced by MUM: meet, understand and modify. (SON: Stakeholder Opinion Now!)