Publication of three decrees reinforcing protection of the public, patients and workers in the field of nuclear activities

Published on 13/06/2018 • 12:22 pm

Information notice

On 05 June 2018, two decrees concerning the protection of workers against the risks arising from ionising radiation and one decree containing various nuclear provisions were published in the Official Gazette. In particular, these decrees transpose the Council Directive 2013/59/Euratom of 5 December 2013 Council directive 2013/59/Euratom of 5th December 2013 setting basic standards for heath protection against the dangers arising from epxosure to ionising radiation. They more specifically modify the regulatory parts of the Labour, Public Health, Environment and Defence Codes[1], and thus supplement the regulatory oversight of certain nuclear activities.

An update of the worker protection system

The provisions of chapter I of title V of book IV of the fourth part of the Labour Code have been entirely revised. Articles R. 4451-1 to R. 4451-135 of the Labour Code, thus modified, update the system of radiation protection for all workers liable to be exposed to ionising radiation during the course of their professional activities. The changes are not limited to the transposition of the new provisions of the directive of 5th December 2013 but also propose a simplification of the existing provisions. More particularly, a grading of requirements more closely matching the risks run by the workers was adopted, along with closer harmonisation between the approach applicable to the “ionising radiation” risk and that adopted for the other occupational risks.

The main changes in these first two decrees concern:

  • Regulatory limits: the limit for exposure of the lens of the eye is reduced to 20 mSv/year (from 150 mSv/year), although with a transitional implementation period of five years. This change reinforces the implementation of the optimisation principle, particularly in the medical sector, for fluoroscopy-guided interventional practices;
  • Risk assessment by the employer, which is a prerequisite for determining the means of prevention (collective and individual protection measures, etc.);
  • The organisation of radiation protection, which is now based on the appointment of a “radiation protection adviser”, who may – as decided by the employer – be either the person competent in radiation protection (PCR) or a certified organisation competent in radiation protection ( (OCR). Over and above the role of providing advice on worker protection, the duties of the PCR and the OCR will be extended to cover questions of protection of the population and the environment; furthermore, at the request of the employer, the PCR or the OCR may carry out internal technical checks which had previously been entrusted to the technical inspection organisations approved by ASN;
  • The external technical verifications which will now be entrusted to accredited organisations.
  • The approval of worker dosimetry organisations, issued by ASN, is superseded by accreditation by the COFRAC. The approvals currently issued by ASN will continue to be valid until 1st July 2020.
  • Monitoring of exposure to radon is extended to all workplaces: in basements and on ground floors, whereas previously, only underground environments were subject to mandatory monitoring. The annual average reference level of radon in the working environment is lowered to 300 becquerels (Bq)/m3 from 400 Bq/m3. In the case of worker exposure exceeding 6 mSv/year, the employer shall set up a radiation protection organisation, “radon” zoning, individual worker dosimetry monitoring and “reinforced” monitoring of worker health by an occupational physician.

Reinforced protection of the population and patients

The decree containing various nuclear provisions entirely modified chapter III of title III of book III of the first part of the Public Health Code (articles R. 1333-1 to 175). It comprises new measures to reinforce the general protection of the population and of persons exposed for medical purposes.

These new provisions do not simply transpose the provisions of the Directive of 5th December 2013, but also create additional tools for reinforcing the effectiveness of the oversight of nuclear activities: the possibility of implementing land use restrictions on sites contaminated by radioactive substances and monitoring the protection of certain sources of ionising radiation (in particular those used in industry) against malicious acts.

The main changes concern:

  • Reinforcing the use of the justification and optimisation principles for the implementation of practices utilising ionising radiation, notably by introducing the notions of “dose constraint” and “reference level”. These values constitute “benchmarks” for the optimisation approach.
  • The administrative procedures concerning the protection of sources against malicious acts (“source security”) are clarified, with the distribution of competences between authorities.
  • The system applicable to small-scale nuclear activities (medical, veterinary, industrial and research applications) is overhauled: 3 administrative systems applicable to nuclear activities are now defined (notification, registration, authorisation), which will allow a graded approach more closely matching the actual implications. This change paves the way for administrative simplification of nuclear activities with only moderate safety implications.
  • The checks carried out by the organisations approved by ASN and performed in accordance with the Public Health Code are maintained, but with a new definition of their scope: apart from verifying compliance with the rules concerning source management and the management of effluents and wastes, these organisations will be tasked with checking the rules put into place for collective protection of workers, maintenance and quality control of medical devices, as well as evaluation of the doses delivered to patients during a medical diagnosis examination.
  • The regulatory system concerning the radiation protection of patients, gradually implemented since 2003 is consolidated, with updates regarding the justification of medical procedures, the training of health professionals in the protection of persons exposed for medical purposes and quality assurance.

 

For exposure to naturally occurring ionising radiation:

  • The annual radon exposure reference level is lowered from 400 Bq/m3 to 300 Bq/m3 in all premises open to the public and the definition of priority zones for radon measurement is revised.
  • The regulatory framework applicable to activities utilising raw materials containing naturally occurring radioactive materials – NORM (substance containing radionuclides which exceed the exemption levels given in appendix 2 of the decree) is updated; most of these activities will be subject to the notification system of installations classified for protection of the environment (ICPE – heading 1716).
  • Finally, new provisions have been introduced to regulate natural radioactivity in construction materials.

The publication of these three decrees thus allows correct transposition into French law of the Euratom directive of 5th December 2013. It supplements the regulatory oversight of certain nuclear activities and paves the way for tangible simplification of activities with lesser safety implications. Most of the provisions will come into force on 1st July 2018.

In the coming months, ASN will continue with detailed, substantive work with the Government and the professionals, for the production of Ministerial orders or of its own resolutions. It has already begun to prepare some of these implementing texts, notably to broaden the list of nuclear activities eligible for simple notification of the administration.

The end of a long regulatory process

After taking part in the preparation of the new directive 2013/59/Euratom, as of 2008, ASN organised a consultation of the stakeholders in 2010 on the basis of the draft directive published by the European Commission (ASN link). Then, between 2011 and 2013, during the European level negotiations, ASN provided the Government with expert advice. As of the publication of the directive at the end of 2013, ASN assisted the Ministries for the Environment, Health and Labour with setting up a transposition committee and organised several working groups to identify and propose the necessary modifications so that this directive could be transposed in full into French law.

In February 2017, ASN also sent the Government three opinions on the draft decrees which had been submitted to it. These opinions were in favour of the draft decree modifying the Labour Code and, with a number of reservations, were in favour of the draft modification of the Public Health Code and the Environment Code. Most of ASN's suggestions were incorporated into the texts finally adopted.

 

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[1] The legislative parts of the codes were modified with the publication of ordinance 2016-128 of 10th February 2016 containing various nuclear provisions.

Date of last update : 26/06/2018