2 // Ensuring that regulation is proportionate to the implications ASN aims to organise its regulatory work in a way that is proportionate to the implications of the activities. It follows a continuous improvement approach to its regulation and oversight practices, in order to consolidate the effectiveness and quality of its actions. ASN uses Operating Experience Feedback (OEF) from more than forty years of nuclear activity oversight and the exchange of best practices with its foreign counterparts. The licensee is the key player in the regulation of its activities. ASN regulates nuclear activities by various means: ∙ inspection, generally on the site, or in an inspected department, or at carriers of radioactive substances. It consists in performing spot checks on the conformity of a given situation with regulatory or technical baseline requirements but may also include an assessment of the licensee’s practices by comparison with current best practices; ∙ authorisation, following analysis of the applicant’s demonstration that its activities are satisfactorily managed in terms of radiation protection and safety; ∙ OEF, more specifically through analysis of significant events; ∙ approval of entities and laboratories taking part in radioactivity measurements and radiation protection inspections, as well as qualification of pressure equipment monitoring organisations; ∙ presence in the field, also frequently outside actual inspections; ∙ dialogue with the professional organisations (trades unions, professional orders, learned societies, etc.). The performance of certain inspections by organisations and laboratories offering the necessary guarantees, as validated by ASN approval or qualification, contributes to the oversight of nuclear activities. 2.1 Oversight by ASN The licensee is required to provide ASN with the information it needs to meet its regulatory responsibilities. The volume and quality of this information should enable ASN to analyse the technical demonstrations presented by the licensee and target the inspections. It should also allow identification and monitoring of the important events marking the operation of a nuclear activity. Regulation and monitoring of Basic Nuclear Installations Nuclear safety is the set of technical provisions and organisational measures related to the design, construction, operation, shutdown and decommissioning of BNIs, as well as the transport of radioactive substances, which are adopted with a view to preventing accidents or limiting their effects. This notion includes the measures taken to optimise waste and effluent management. The safety of nuclear installations is based on the implementation of the following principles, defined by the International Atomic Energy Agency (IAEA) in its fundamental safety principles for nuclear installations (Safety series No. 110) and then to a large extent incorporated into the European Directive on Nuclear Safety of 8 July 2014, which modifies that of 2009: ∙ responsibility for nuclear safety lies primarily with the licensee; ∙ the organisation responsible for regulation and oversight is independent of the organisation responsible for promoting or using nuclear power. It must have responsibility for licensing, inspection and formal notice, and must have the authority, expertise and resources necessary for performance of the responsibilities entrusted to it. No other responsibility shall compromise or conflict with its responsibility for safety. In France, the Environment Code defines ASN as the organisation meeting these criteria, except for Defence-related nuclear facilities and activities, which are regulated by the provisions of the Defence Code. Ordinance 2016-128 of 10 February 2016 implementing the Energy Transition for Green Growth Act 2015-992 of 17 August 2015 (TECV Act) expanded the scope of ASN regulation to the suppliers, contractors and subcontractors of licensees, including for activities performed outside BNIs. In its regulatory duties, ASN is required to look at the equipment and hardware in the installations, the individuals in charge of operating it, the working methods and the organisation, from the start of the design process up to decommissioning. It reviews the steps taken concerning nuclear safety and the monitoring and limitation of the doses received by the individuals working in the facilities, and the waste management, effluents discharge monitoring and environmental protection procedures. Regulatory oversight of pressure equipment Numerous systems in nuclear facilities contain or convey pressurised fluids. In this respect, they are subject to the regulations applicable to pressure equipment, which include NPE. The Environment Code states that ASN is the administrative Authority with competence for issuing individual resolutions and checking the in-service monitoring of the pressure equipment installed within the perimeter of a BNI. The operation of pressure equipment is subject to regulatory oversight in particular covering in-service monitoring programmes, non-destructive testing, maintenance works, processing of anomalies affecting these systems and periodic requalifications. ASN also assesses the compliance of the most important new NPE with the requirements of the regulations. It approves and monitors the organisations responsible for assessing the conformity of the other NPE. Regulation and monitoring of the transport of radioactive substances Transport comprises all operations and conditions associated with movements of radioactive substances, such as packaging design, manufacture, maintenance and repair, as well as the preparation, shipment, loading, carriage, including storage in transit, unloading and receipt at the final destination of the radioactive substance consignments and packages. Regulation and monitoring of activities comprising a risk of exposure to ionising radiation In France, ASN is in charge of drafting and monitoring technical regulations concerning radiation protection. The scope of ASN’s regulatory role in radiation protection covers all the activities that use ionising radiation. ASN exercises this duty, where applicable, jointly with other State services such as the Labour Inspectorate, the Inspectorate for Installations Classified for Protection of the Environment (ICPEs), the departments of the Ministry of Health and the French National Agency for Medicines and Health Products Safety (ANSM). This action directly concerns either the users of ionising radiation sources, or organisations approved to carry out technical checks and inspections on these users. ASN Report on the state of nuclear safety and radiation protection in France in 2021 145 03 – REGULATION OF NUCLEAR ACTIVITIES AND EXPOSURE TO IONISING RADIATION 08 07 13 04 10 06 12 14 03 09 05 11 02 01 AP
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