11th CRPA SYMPOSIUM




THE ROMANIAN SOCIETY FOR RADIOLOGICAL PROTECTION AND ITS CONTRIBUTION TO THE TRANSPOSITION OF THE COUNCIL DIRECTIVE 2013/59/EURATOM IN ROMANIA

Constantin MILU, Ph.D.

President, The Romanian Society for Radiological Protection

Bucharest, ROMANIA

e-mail: constantinmilu@upcmail.ro

www.srrp.ro

SUMMARY

The Romanian Society for Radiological Protection (RSRP) is a professional association of the Romanian specialists in the field of radiological protection, an independent, nonprofit and non-governmental organization. The RSRP was founded in May 30, 1990 and it is an Associate Society to International Radiological Protection Association (IRPA) since 1992.

The RSRP has now 78 active members from the whole country. Annually are organized National Conferences with enlarged participations from several professional domains. It can be also remembered the IRPA Regional Congress for Central and Eastern Europe, which was successfully organized by RSRP in 24 - 28 September 2007, in Braov, Romania. 15 colleagues from Croatia attended this Congress ten years ago, including the old friends: Maria Ranogajec-Komor, Saveta Miljanic, Djurdjica Milkovic, Ines Krajcar Bronic, Ivitca Prlic and Marija Suric Mihic.

On 17th of January 2014, it the Official Journal of the European Union was published the Council Directive 2013/59/Euratom of 5 December 2013 laying down the European Basic Safety Standards (EBSS) for protection against the dangers arising from exposure to ionizing radiation, and repealing Directive 89/618/Euratom, 90/641/Euratom, 96/43/Euratom and 2003/122/Euratom 1. In the same year, the International Atomic Energy Agency (IAEA) published the new International Basic Safety Standards 2. Both standards are according to the Recommendations of the International Commission on Radiological Protection (ICRP), published in 2007 as ICRP

Report No.103 3.

As a full member of the European Union (since 2007) and with a technical support from IAEA, Romania starts in 2015 several activities related to the transposition and the practical implementation in the country of the new standard recommendations.

The title and topics of the last three RSRPs National Conferences were dedicated to this purpose: general principles (2014), public exposure and NORM/TENORM (2015) and occupational exposure (2016). 2017 meeting will be dedicated to medical exposure.

MATERIAL AND METHODS

Before any elaboration of a new Romanian radiation protection regulation, according to the new international standards and recommendations, an important task for the Romanian Nuclear Regulatory Authority (CNCAN) was to establish the national approach for this process.

For this purpose, four decisions taken by CNCAN have to be mentioned :

- to follow the transposition of the Directive 2013/59/Euratom and not fully the International Basic Safety Standards;

- to modify the Romanian Basic Law No.111/1996, by including in the all new provisions from Directive;

- to repeal the old Fundamental Norms for Radiological Safety (NFSR, 2000) and to elaborate a new document (according to the Directive 59);

- to keep some specific old "Norms" in term of "Guide", but only after their strong modification, regarding title, purpose, definitions, content, formulations, requirements, etc, in agreement with the Directive and to the new Law and the new NFSR.

In medicine, such old Norms are:

- NSR - 11 Radiological Safety Norms in Diagnostic and Interventional Radiology Practices;

- NSR 12 Radiological Safety Norms in Radiotherapy Practice, and

- NSR 14 Radiological Safety Norms in Nuclear Medicine Practice.

It was very clear from the beginning that before any elaboration of a new Romanian regulation, the following important tasks have pe be performed:

- the identification of the new provisions in the revised Euratom Directive;

- the identification of principal gaps in the current regulation;

- the identification of responsibilities for the different competent authorities involved and of the technical regulatory problems;

- the detection of issues and the identification of good practices;

- the identification of topical issues which require further attention, action and activities.

As an useful practical example, in 2014 the Members of the Group of Experts referred to in Article 31 of the Euratom Treaty and of the Working Party MED have identified a list of new provisions in the Directive 2013/59/Euratom, regarding radiological safety in medicine:

- New set of definitions and concepts.

- Increased role of justification principle and consideration of occupational doses in justification and optimization.

- New requirements in relation to exposure of asymptomatic individuals exposed as part of an approved health screening program.

- Use of diagnostic reference levels (including interventional) and regular review.

- Interventional radiology new defined, reflecting the importance of this modality in relation to staff and patient doses.

- Recognition and involvement of the Medical Physics Expert (MPE) and his new role in the modern imaging.

- Definition and recognition of the Radiation Protection Expert (RPE) and of the Radiation Protection Officer (RPO).

- Dosimetric information in all diagnostic system and transfer to the patient report.

- Dosimetric information mandatory for all interventional and CT procedures.

- Prevention, registry and analysis of all accidental or unintended exposures of patients.

- Population dose evaluation taking into account the age distribution and the gender.

- New dose limit for lens of the eyes.

- Old medico-legal exposures removed from medical chapter and a new set of requirements developed for non-medical imaging exposures.

- New criteria of acceptability for equipment, for clinical use.

- Enlarged practical use of the dose constraint concept.

- Education and training dealt with as part of more general requirements in medicine.

With the aim to support CNCAN in the transposition process, the last three Annual National Conferences of the RSRP were dedicated to the Directive 2013/59/Euratom, for specific subjects:

A- 24 October 2014 - The Council Directive 2013/59/Euratom- General principles;

B- 9 October 2015 - The Council Directive 2013/59/Euratom - Practical and Legislative aspects on optimisation of radiation protection of the population;

C- 14 October 2016 - The Council Directive 2013/59/Euratom on Occupational Radiation Exposure.

The 2017 Conference shall be on Medical Exposure.

SOME MAIN RESULTS AND CONCLUSIONS

A- Regarding the general aspects of the Directive:

1.- The need of a new set of terms and definitions. Some examples:

- Planned Exposure Situation, which has to replace the old term Practice.

- For all specific regulation, the term Guidelines ( or Regulation) instead of Norms, to avoid confusion with the Fundamental Norms, which remain the basic national safety standard for protection against the dangers arising from exposure to ionizing radiation.

- The term SHALL shall be used in all formulations of all requirements, showing a stronger (mandatory) requirement.

- "Emergency Exposure Situation" instead of "Radiological Accident".

- "Unintended Exposure" instead of "Incident".

-"Exposed worker" instead of "Radiation Worker".

- "Referrer" instead of "Prescriber" of a medical exposure,etc.

2. The change of the licence process, which is now a complicated procedure. A new guidelines on authorization procedures need be elaborated soon, applying the new graded approach to regulatory control (notification, registration, licence) and deciding some exception from authorization (for ex., for possession or for renting a medical radiological equipment, a.s.o.).

3. According to the Directive 2013/59/Euratom competent authority means an authority or system of authorities designated by Member States as having legal authority for the purpose of this Directive. CNCAN is indeed the only competent authority for radiation protection in Romania, but the specific responsabilities have to be identified for several "competent authorities" from other fields : medicine, research, nuclear energy, etc.

B. NORM/TENORM

An important statement of the Directive refers to the fact that "protection against the natural sources should be fully integrated within the overall requirements; in particular, industries processing materials containing naturally-occuring radionuclides should be managed within the same regulatory framework as other practices". Countries, as well as Romania, have to decide the national list of such industries, to perform measurements and risc estimates and to decide on the need of a further regulatory control.

C.Occupational radiation exposure.

A real new task for radiation protection, due to a new equivalent dose limit for lens of eyes, e.g. 20 mSv/y, instead of 150 mSv/y.

REFERENCES

1 The Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionizing radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/43/Euratom and 2003/122/Euratom, The Official Journal of the European Union, 17 January 2014.

2 Radiation protection and safety of radiation sources: International basic safety standards, General Safety Requirements Part 3, No. GSR Part 3, STI/PUB/1578, Vienna International Atomic Energy Agency, 2014

3 The International Commission on Radiological Protection (ICRP), International Recommendations of the ICRP, ICRP Report No.103, 2007.