IRRS follow-up mission to France - October 2017

17 are important for the protection of health and the environment” regardless of their location and regardless of the party carrying out the activity. As regards medical exposures, Ordinance 2016- 128 and a second Ordinance 2017-45 issued on the 19th January 2017 amended the Public Health Code to give ASN's radiation protection inspectors powers to access documents protected by medical confidentiality. With respect to nuclear installations, ASN's powers of inspection begin when an application for authorization is received. However it also has other means to provide safety opinions that can be exercised in advance of receipt of the application. In particular, ASN can contribute to public debates/consultations with respect to nuclear installations; under Article 6 of the Decree concerning BNIs and the supervision of the transport of radioactive materials with respect to nuclear safety (2007-1557), ASN canprovide its opinion on the safety options proposed by a future operator of a nuclear installation; and ASN can publish a formal notice setting out its views. ASN highlighted several examples where it has provided safety opinions in such a manner. Recommendation 2: The Ministry for the Ecological and Solidary Transition and ASN have further clarified the position with respect to ASN's effective independence and its authority to make independent regulatory judgements and decisions. ASN can take decisions that have legal force without reference to any other entity. Where an ASN resolution impacts multip le installations, it is regarded as a regulation and, as such, it is subject to a so-called homologation process set out in Article L.592-20 of the Environment Code. There are also a small number of instances where an individual resolution of ASN is subject to approval – these are in setting limits on environmental discharges from a facility; in the de-licensing of a basic nuclear installation or in the suspension of operation of a facility. The purpose of this homologation process is to ensure consistency and coherence between the regulatory texts issued by the Government and ASN. Any changes to the original decision proposed by the Ministry must be approved by the ASN Commission. The updated resolution of ASN together with the approval orders are then published in the Official Journal of the French Republic. In practice, the Government has never vetoed a resolution of ASN, but minor changes have been made to the initial wording of ASN resolutions to ensure coherence with the existing body of legislation. Status of the finding in the initial mission Recommendation 1 (R1) is closed as ASN's inspection powers have been strengthened to cover both off-site activities and activities undertaken by providers and sub-contractors. Recommendation 2 (R2) is closed as ASN is effectively independent and is able to make independent regulatory judgements and decisions, free from any undue influence that might compromise safety. 1.4. COMPLIANCEWITH REGULATIONS AND RESPONSIBILITY FOR SAFETY There were no findings in this area in the initial IRRS mission. 1.5. COORDINATION OF AUTHORITIES WITH RESPONSIBILITIES FOR SAFETY WITHIN THE REGULATORY FRAMEWORK There were no findings in this area in the initial IRRS mission.

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