Whenever it considers it necessary, ASN requests an opinion from its technical support organisations, the most important of which is IRSN. The safety review implies cooperation by numerous specialists, as well as efficient coordination, in order to identify the essential points relating to safety and radiation protection. The IRSN assessment is based on in-depth technical discussions with the licensee teams responsible for designing and operating the installations. It is also based on studies and research and development programmes focused on risk prevention and on improving our knowledge of accidents. For certain dossiers, ASN asks the competent Advisory Committee of Experts (GPE) for its opinion. For other matters, IRSN examines the safety analyses and gives its opinion directly to ASN. ASN procedures for requesting the opinion of a technical support organisation and, where required, of an Advisory Committee, are described in chapter 2. At the design and construction stage, ASN –aided by its technical support organisation– assesses the safety analysis reports describing and justifying the design principles, equipment and system design calculations, utilisation rules and test procedures, and quality organisation provisions implemented by the prime contractor and its suppliers. It also analyses the facility’s environmental impact assessment. ASN regulates and oversees the construction and manufacture of structures and equipment, in particular that of the main primary system and the main secondary systems of Pressurised Water Reactors (PWRs). In accordance with the same principles, it checks the packages intended for the transport of radioactive substances. Once the nuclear facility has been commissioned, following ASN authorisation, all changes to the facility or its operation made by the licensee that could affect security, public health and safety, or the protection of the environment, are reported to ASN or submitted to it for authorisation. Moreover, the licensee must perform periodic safety reviews to update the assessment of the facility, taking into account any changes in techniques and regulations, as well as OEF. The conclusions of these reviews are submitted by the licensee to ASN, which can issue new binding requirements for continued operation. The other files submitted by BNI licensees A large number of files concerns specific topics such as fire protection, fuel management in PWRs, relations with the outside contractors, etc. The licensee therefore also periodically provides activity reports as well as summaries of water intake, liquid and gaseous discharges and waste produced. 3.2.2 Review of the applications required by the Public Health Code ASN is responsible for reviewing applications to possess and use ionising radiation sources in the medical and industrial sectors. ASN also deals with the specified procedures for the acquisition, distribution, import, export, transfer, recovery and disposal of radioactive sources. It in particular relies on the inspection reports from the approved organisations and the reports on the steps taken to remedy nonconformities detected during these inspections. In addition to the verifications carried out under the responsibility of the facilities and the periodic checks required by the regulations, ASN carries out its own checks when examining the applications. 3.3 Lessons learned from significant events 3.3.1 Anomaly detection and analysis approach Background The international Conventions ratified by France (Article 19vi of the Convention on Nuclear Safety of 20 September 1994; Article 9v of the Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management of 5 September 1997) require that BNI licensees implement a reliable system for early detection and notification of any anomalies that may occur, such as equipment failures or errors in the application of operating rules. Ten years previously, the “Quality Order” of 10 August 1984 already required such a system in France. Based on thirty years of experience, ASN felt that it would be useful to transpose this approach, initially limited to nuclear safety, to radiation protection and protection of the environment. ASN thus drafted three guides defining the principles and reiterating the obligations binding on the licensees with regard to notification of incidents and accidents: ∙ The Guide of 21 October 2005 contains the provisions applicable to BNI licensees and to on-site transport managers. It concerns significant events affecting the nuclear safety of BNIs, radioactive material transports taking place inside the perimeter of the BNI or an industrial site and without using the public highway, radiation protection and protection of the environment. ∙ Guide No. 11 of 7 October 2009, updated in July 2015, contains provisions applicable to those in charge of nuclear activities as defined in Article L. 1333-1 of the Public Health Code and to the heads of the facilities in which ionising radiation is used (medical, industrial and research activities using ionising radiation). ∙ Guide No. 31 describes the procedures for notification of radioactive substances transport events (see chapter 9). This guide has been applicable since 1 July 2017. These Guides can be consulted on the ASN website, asn.fr. What is a significant event? Detection of events (deviations, anomalies, incidents, etc.) by those in charge of the activities using ionising radiation, and implementation of corrective measures decided on after analysis, play a fundamental role in accident prevention. For example, the nuclear licensees detect and analyse several hundred anomalies every year, for each EDF reactor. Prioritising the anomalies should enable the most important ones to be addressed first. The regulations have defined a category of anomalies called “significant events”. These are events which are sufficiently important in terms of safety, the environment or radiation protection to justify that ASN be rapidly informed of their occurrence and subsequently receive a fuller analysis. Significant events must be reported to it, as specified in the Order of 7 February 2012 (Article 2.6.4), the Public Health Code (Articles L. 1333-13, R. 1333-21 and R. 1333-22), the Labour Code (Article R. 4451-74) and the regulatory texts applicable to the transport of radioactive substances (for instance, the European Agreement on the International Carriage of Dangerous Goods by Road –ADR). The criteria for notifying the public authorities of events considered to be “significant” take account of the following: ∙ the actual or potential consequences for workers, the general public, patients or the environment, of events which could involve safety or radiation protection; ∙ the main technical, human or organisational causes that led to the occurrence of such an event. ASN Report on the state of nuclear safety and radiation protection in France in 2021 151 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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