5 Conclusion and outlook Implementation of the new regulatory framework applicable to nuclear activities In 2021, reinforcing of the graded approach to oversight, based on a classification of the different categories of nuclear activities involving sources of ionising radiation continued, with the entry into effect of resolutions relative to the registration system and the development of the associated remote registration system for on‑line submission of application files. In 2022, to finalise the overhaul of the systems of the Public Health Code as a whole, ASN began the process to revise the three existing resolutions concerning the content of applications to carry out nuclear activities subject to the licensing system; this update will include, if necessary, the part relating to the supply of electrical devices emitting X‑rays. This work continued in 2023 and should result in 2024 in a first modification of the content of the information required for nuclear activities subject to licensing. ASN is continuing, in collaboration with the DGT, its work on the updating of the regulatory framework concerning the technical design rules and the certification procedures for industrial radiography devices (Article R. 4312‑1‑3 of the Labour Code), ensuring that it ties in properly with the existing European framework. In 2023, ASN also participated in the updating of the part of the Labour Code relative to the protection of workers against the risks arising from ionising radiation (Decree 2023‑489 of 21 June 2023). More specifically, as from 1 January 2025, the utilisation in work zones of industrial radiology devices whose manipulation presents a high risk of exposure to ionising radiation and which contain one or more high‑activity sealed sources, will necessitate at least two CAMARI‑certificated employees of the company possessing the device. In this context, the provisions of the current ASN resolution 2007‑DC‑0074 of 29 November 2007 amended, (which establishes the list of devices or device categories whose operation requires the CAMARI certificate) and those of the Order of 21 December 2007 amended (which defines the conditions of CAMARI training and certification), will be updated by a new order in 2024. ASN will participate in the drafting of this new Order, which will also set the conditions of deployment and utilisation of mobile industrial radiology devices in a work zone. Oversight of the protection of radioactive sources against malicious acts ASN has been designated as the authority to oversee the provisions to protect radioactive sources against malicious acts in the majority of facilities. This essentially concerns activities associated with gamma radiography and brachytherapy. Publication of the Decree of 4 June 2018 enabled the first provisions on the subject to enter into effect: RNAs must more specifically give individual authorisations for access to the most hazardous sources, including for their transport, and for access to sensitive information. These initial provisions have been reinforced with the entry into effect on 1 January 2021 of part of the amended Order of 29 November 2019 which requires company functioning and organization to be adapted to these specific risks. Although these are new regulatory provisions, it is above all an additional risk to be managed and integrated in the corporate culture particularly through measures to raise awareness and inform the personnel, which must be renewed periodically. On this account, the quality management system must include measures to combat malicious acts, and senior management of the companies concerned must henceforth define and formalise a policy of protection against malicious acts implemented by the person RNA. This person must be assigned the necessary resources and have the requisite skills (assisted if necessary by a person trained in this area) and sufficient authority. The measures adopted must also take account of the “cyber” aspect in order to fight against the compromising of sensitive information, a matter provided for explicitly by the Order of 29 November amended. All the company staff and external partners must be made aware of this subject. In order to have appropriate rules, the company’s sensitive information must be clearly identified and framed. On 1 July 2022 the Order entered fully into effect and the technical provisions for the physical protection of sources should have been put in place, both within facilities and at worksites (utilisation, possession) and for road transport operations. Although the situation is not yet fully compliant, the six‑monthly review of the indicators nevertheless shows an improvement trend. Since 2019, the ASN inspections address the protection of sources against malicious acts with greater emphasis. Inspections devoted entirely to this question began in limited numbers in 2021 and reached “cruising speed” as of 2023 with more than 60 inspections. This level of inspection will be maintained in 2024 and 2025. When examining the nuclear activity licensing applications, ASN also ensures that the necessary organisation and material provisions have been put in place. The content of the files to be provided takes this question into account. ASN has moreover continued the training of its personnel and made in‑house aids available to them (inspection guide, license application examination matrices, question‑and‑answer sheets, networks of regional correspondents). To conclude, some effects of the Order of 29 November 2019 amended have been clearly visible for slightly more than a year: reduction in the stock of sealed radioactive sources of certain licensees, grouping of industrial radiography agencies and equipping of vehicles. The year 2024 should witness the continuation of two works in progress: ∙ the modification of the Order of 29 November 2019 amended. Based on what has been learned from past inspections, it is more a question of clarifying or even relaxing certain provisions than adding requirements. Proposals have already been made to the MTE, the text signatory, and the discussions will continue in 2024; ∙ the reflection concerning the protection of unsealed sources. IRSN has been mandated by the MTE to conduct field investigations to assess the general level of protection of unsealed sources. These sources, which are used mainly in the medical or research sectors, very often have a radiological half‑life of a few days at the most. However, some activities use products which no longer really have such reassuring characteristics. The MTE should adopt a position late 2024 on the principle of regulating such sources or not. ASN will participate in each stage of the reflection. 268 ASN Report on the state of nuclear safety and radiation protection in France in 2023 • 08 • Sources of ionising radiation and their industrial, veterinary and research applications
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