10th European ALARA Workshop Survey on the implementation of the radiological protection principles of ‘justification’, ‘optimisation’ and ‘limitation of doses’ in national regulations in Europe P. Croüail, F. Drouet 10th European ALARA Workshop Prague, September 12-15, 2006

Ten Years After…It isn’t A Sad Song 1996: EAN Founded by the European Commission 1996: Basic Safety Standards for the Protection of the Health of Workers and the General Public from the Dangers Arising from Ionizing Radiation (EURATOM Directive 96/29) 1997: Measures on health protection of individuals against the dangers of ionising radiation in relation to medical exposure (EURATOM Directive 97/43) First Survey on the implementation of EURATOM/96/29 Directive in 2001 (Results were published in ALARA Newsletter #9) Enlargement of EU (25 countries since 2004) Creations of the “New EAN” and RECAN (2005) And 10 Years After (2006)…the Prague Workshop is a good opportunity to perform a Second Survey on the implementation of both Directives through EAN & RECAN: ~25 answers / 38 countries (First results were published ALARA Newsletter #19) 10th European ALARA Workshop Prague, September 12-15, 2006

Implementation of European Directives 96/29 and 97/43 Questions Asked: Since when have the European Directives 96/29 and 97/43 been implemented? If they are not implemented, is it expected and when? 10th European ALARA Workshop Prague, September 12-15, 2006

Implementation of European Directives 96/29 and 97/43 Summary of Answers: Both Directives are - fully or partially - implemented in all 25 EU-Members Countries (Dates of Implementations in Table 1), Both Directives are already implemented - or ready to be - in the 2 Acceding and 2 (or 3?) Candidate Countries to EU, National Regulations are in compliance with EC Directives in most of the other Countries in Europe. 10th European ALARA Workshop Prague, September 12-15, 2006

Principle of Justification (1) Questions Asked: What is the exact wording of the justification principle in the Law? Which practices are explicitly named as unjustified or forbidden? Which regulatory body(ies) is (are) responsible to determine if a practice is justified or not? 10th European ALARA Workshop Prague, September 12-15, 2006

Principle of Justification (2) Summary of Answers: All countries have introduced the principle in Regulations. Common Definition: Any practice involving exposures to radiation should be adopted unless it produces sufficient benefit to the exposed individuals or the society to offset the detriment it causes, and … any intervention with the purpose to reduce pre-existing doses also should do more good than harm. Small differences in wording, especially in what kind of aspects should balance the health detriment that may be caused by the introduction of a new practice or medical procedures, 10th European ALARA Workshop Prague, September 12-15, 2006

Principle of Justification (3) Summary of Answers (cont’d): Complete lists of unjustified/forbidden practices do not exist, Addition of radioactive substances to foodstuff, personal ornaments, jewellery , toys and cosmetics, is forbidden everywhere (as well as importation/exportation of such goods), Other practices are still mentioned as forbidden in some countries It is generally of the competence of the Ministry of Health and/or the Radiological Protection Authority to declare that a practice is justified or not (sometimes in consultation with an Ethical Committee, or a Council of Experts). 10th European ALARA Workshop Prague, September 12-15, 2006

Principle of Optimisation - ALARA (1) Questions Asked: What is the wording of the optimisation principle in the Law/regulations? Does the national regulation give a description on the practical way to implement the optimisation principle (e.g. need to perform dose prediction and to establish dose objectives, need to perform real-time dose follow-up, need to write feedback experience report, etc)? Does it exist a specific guidance to help operators/end-users in implementing the optimisation principle? 10th European ALARA Workshop Prague, September 12-15, 2006

Principle of Optimisation - ALARA (2) Summary of Answers: Almost all countries have introduced the principle in Law or Regulations. Common Definition: Radiation exposures must be kept as low as reasonably achievable (ALARA), social and economical factors being taken into account. What is necessary to do in order to consider/judge that the optimisation is well implemented has been clarified in the regulations and/or additional guidance Optimization in the medical sector is not always clearly mentioned in Law as a basic principle 10th European ALARA Workshop Prague, September 12-15, 2006

Concept of Dose Constraint (1) Questions Asked: How is the concept of dose constraint mentioned in the Law (if so)? In which domain (e.g. public dose, occupational dose, patient dose, etc) and by whom (regulatory body, operators, etc) are dose constraints implemented in your country? What are the corresponding values and rationales behind these values? What is(are) the real status(es) of dose constraint(s)? What is effectively done - and by whom - if a constraint is exceeded? 10th European ALARA Workshop Prague, September 12-15, 2006

Concept of Dose Constraint (2) Summary of Answers: The fact that “dose constraint” does not mean always the same thing - in function of the context - has led to heterogeneous answers. Huge variety of interpretation and uses of the concept: occupational dose constraint (from 1 to 20 mSv/y, job-related), public dose constraint (from 10 to 300 µSv/y, source-related) dose constraints for people who support or comfort patients. (Examples in Table 2) In an occupational exposure context, it is generally considered that constraints should be defined for the purpose of providing an upper bound on the process of optimisation of protection and should therefore be used prospectively. Thus, this level must be understood as the upper value, which shall not be exceeded in normal circumstances of operation, and below which optimization has to be undertaken. In a public exposure context, the dose constraint is rather expressed as a fraction of the regulatory individual dose limit, and attached to a single source of exposures or pathway (e.g. the releases from a nuclear installation). In that case, it is used to guarantee that an individual who would be exposed to several sources, will always receive a total dose below the individual dose limit. This concept is the most frequently used in Europe but the values vary from 10 µSv/y (Greece) to 300 µSv/y. without any understandable rationale! A third meaning of the “dose constraint” deals with those persons who are not subject to dose limits, e.g. individuals who knowingly and willingly incur an exposure to radiation in the support or comfort of a patient. As they are not health-care employees but could receive doses higher than 1 mSv/y, dose constraints are established for restricting any unnecessary exposure of such people. 10th European ALARA Workshop Prague, September 12-15, 2006

Limitation of exposures (1) Questions Asked: Can you provide us with present regulatory dose limits established to reduce the probability of occurrence of stochastic effects? public dose limits occupational dose limits, interim workers dose limits, pregnant women dose limits, post-accidental intervention dose limits, life dose limit (if any) other dose limit (if any) What are the legal dose limits to prevent public and workers from deterministic health effects? 10th European ALARA Workshop Prague, September 12-15, 2006

Limitation of exposures (2) Summary of Answers: Regulatory individual limits in terms of public and occupational annual effective - or equivalent - doses are likely the same evrywhere in Europe: 1 mSv/year for general members of the public, 20 mSv/year for workers, 6 mSv/year for minor students, and category B workers 1 mSv (to foetus), limits pregnant women exposure 150 mSv/y (lens of the eyes), 500 mSv/y (hands, forearms, feet and ankles, /cm2 of skin) for workers (10x lower for the public, why?) Minor differences in terms of periods of reference (calendar year, 12 rolling months, 5 years) - Is that really understandable? 10th European ALARA Workshop Prague, September 12-15, 2006

Limitation of exposures (3) Summary of Answers (cont’d): additional limits (occupational time, lifetime) in a few countries Dose limits for work in exceptional circumstances (but not post-accidental ones) vary also considerably (but a preliminary authorisation is needed everywhere) (see Table 3) 10th European ALARA Workshop Prague, September 12-15, 2006

(Personal) Conclusion and work for the next 10 years There are a common legal framework and compatible regulations through Europe, Lists of unjustified/forbidden practices should be developed, Procedures and criteria for justifying new practices and, revising regularly the justification of “ancient” practices should be proposed, Small differences between countries in terms of dose limits -especially occupational ones - can be unduly time-consuming, and then should be harmonized in the future, The optimization principle became universal but, the ICRP concept of dose constraint seems still misunderstood; its use should be clarified in function of the context. 10th European ALARA Workshop Prague, September 12-15, 2006

Thank you! I must particularly thank the EAN and RECAN national contact persons from Armenia, Belgium, Croatia, Czech Republic, Denmark, Estonia, France, Georgia, Germany, Greece, Ireland, Italy, Kazakhstan, Latvia, Lithuania, Rep. of Macedonia, Norway, Rep. of Serbia, Slovak Rep., Spain, Sweden, Switzerland, and the United Kingdom,, who kindly have answered to the EAN questionnaire ! And also all the other who will do that soon… ean.forum@lists.eu-alara.net And, 40 years after Ten Years After… thanks to Alvin Lee, Leo Lyons, Ric Lee and Chick Churchill 10th European ALARA Workshop Prague, September 12-15, 2006