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. For the actual entry into effect of this new system, ASN has developed an on-line registration service on its website, allowing application files to be submitted on line, and widely disseminated information to the professionals. 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 devices emitting X-rays. This work will continue in 2023. ASN will continue, 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. Lastly, ASN aims to finalise the draft resolution regulating the design and operations of the facilities using a cyclotron. 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. Publication of the above-mentioned Decree brought into effect the first provisions in this respect in mid-2018: those responsible for nuclear activities 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 to protect sources against malicious acts 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 (just like the cyber security associated with it, from the moment it concerns information necessary for the protection of sources) 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 responsible for the nuclear activity. This person must be assigned the necessary resources and have the requisite skills (assisted if necessary by a person trained in this areas) 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 2019 amended. As information is planned to be shared, 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 must have been put in place, both within facilities and at worksites (utilisation, possession) and for road transport operations. 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 will reach “cruising speed” as of 2023. Likewise, when examining the nuclear activity licensing applications, ASN ensures that the necessary organisation and material provisions have been put in place. The required content of the application files has therefore also evolved in recent years to include protection of radioactive sources. The application forms have been revised accordingly. ASN has moreover continued the actions initiated to train its personnel in this new duty and has made in-house aids available (inspection guide, license application examination matrices, question-and-answer sheets, networks of regional correspondents). To conclude, a number of tangible effects of the Order of 29 November 2019 amended can already be perceived: reduction in the stock of sealed radioactive sources held by the licensees, significant rise in groupings of industrial radiography agencies or equipping of vehicles in 2022. ASN has already started identifying potential changes to the Order that might prove useful; it would be more a question of providing clarifications and relaxing certain provisions than of adding requirements. A proposal to this effect will be made to the Minister responsible for the energy transition in 2023. The year shall be used to continue, through the inspections, the information and awareness-raising actions, particular with regard to the “cyber” risks and risks related to transport operations. 264 ASN Report on the state of nuclear safety and radiation protection in France in 2022 • 08 • Sources of ionising radiation and their industrial, veterinary and research applications 08
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