resolution 2022-DC-0747, for which the situation can be improved. These regulations are still poorly understood, which means that the inspectors also have an informative role. In 2024, 72% of the inspected sites have systems for recording and analysing adverse events and ESRs, compared with 61% in 2023. This restores the level of conformity observed in 2022 (76%) and curbs the drop observed since 2021. In 2024, ASN registered 28 ESRs concerning research activities (see Graph 12), all rated level 0 on the INES scale. The majority of the reported ESRs concern the discovery of sources (68 %). These chance discoveries of “forgotten” sources are often made during tidying-up operations. In the majority of cases these are remnants from past nuclear activities, sometimes out of regulatory control, sometimes having undergone formal cessation but with shortcomings or omissions regarding the scope of the verifications before stopping the activity. In some cases the cessation request is made after a change of personnel with a view to settling liabilities, but without the full knowledge of the history of the activity in question. Lastly, the failure to take measures to effectively eliminate sources on cessation of the activity or irregular or incomplete source inventories are also contributing factors. The other ESRs are one-off events and concern the reception or possession of radioactive sources with higher-than-authorised activity, the incorrect use of a device emitting X-rays during a maintenance operation, the mixing of radioactive effluents with rainwater having infiltrated into the tank retention pit, and three cases of surface contamination of equipment or in unexpected locations. With regard to worker exposure, no cases of personnel contamination were reported to ASN in 2024. ASN reactivated its collaboration with the General Inspectorate for Education, Sport and Research (IGESR) in 2023. The IGESR is the competent body for labour inspection in the public research sector. The agreement signed in 2014, has been updated and is currently being signed. It provides for mutual exchanges of information intended to improve the efficiency and complementarity of the inspections. Annual meetings are also organised between ASN and IGESR. 4 Manufacturers and distributors of radioactive sources and their oversight by ASN 4.1 The issues and challenges The aim of ASN oversight of the suppliers of radioactive sources or devices containing them is to ensure the radiation protection of the future users. It is based on the technical examination of the devices and sources with respect to operating safety and radiation protection conditions during future utilisation and maintenance. It also allows the tracking of source transfers and the recovery and disposal of disused or end-of-life sources. Source suppliers also play a teaching role with respect to users. At present, only the suppliers of sealed radioactive sources (or devices containing them) and of unsealed radioactive sources are regulated in France (see point 2.3.1). ASN lists some 100 suppliers with safety-significant business, including 38 low and medium-energy cyclotrons on 33 sites which are currently licensed under the Public Health Code. Among these 38 cyclotrons, 34 are in operation and produce radionuclides. Cyclotrons are used to produce positron-emitting radionuclides in unsealed sources (primarily fluorine-18). These radionuclides are used either for medical applications, especially in vivo diagnosis, or in clinical trial protocols (human subject research), or for research activities. Cyclotrons apart, the company Orano Med is currently setting up a production site for lead-212-based radiopharmaceutical drugs in the north of France. This site will produce and supply, for the European market, these radiopharmaceutical drugs which are intended for alphatherapy (see chapter 7), initially for clinical trials. The manufacturing process is to be carried out in shielded enclosures. Acceptance of the facilities and the first tests related to radioactive source production process are scheduled during the first half of 2025. 4.2 Cyclotrons Operation As at 31 December 2024, one cyclotron was on standby, three shut down and 34 in service. Among the 34 cyclotrons in routine operation, 27 are used to produce radiopharmaceuticals intended for in vivo diagnosis, sometimes with medical or non-medical research as an additional end-purpose, six produce radionuclides for medical or non-medical research purposes, and one produces radionuclides exclusively for non-medical research. The cyclotron of the university hospital (CHU) of Martinique started functioning in early 2024 to produce fluorine-18 and carbon-11 for performing in vivo diagnostics and participating in clinical trials. It may subsequently also produce oxygen-15, copper-64, gallium-68 and zirconium-89 for the same purposes. Two new licenses for cyclotrons producing radiopharmaceutical drugs in the Paris region were issued by ASN in 2024: one cyclotron was on standby and has been put back into service, while the other is a new machine installed on a site that already had two cyclotrons. In addition to this, a new cyclotron facility for producing radiopharmaceutical drugs has been built in the suburbs of Rennes. It is intended to replace the cyclotron installed within the university hospital of Rennes. ASN issued a license to perform the various equipment qualification tests in 2024. Completion of this test phase and acceptance of the facility are expected during the first half of 2025; the production activity should begin after this. Lastly, a new project to install a cyclotron in the Toulouse “Cancéropôle” (cancer centre) is expected in 2025. Preliminary discussions on this project were held with ASN in 2024 and the future licensee plans submitting its license application in the first quarter of 2025. Evaluation of radiation protection in facilities using cyclotrons ASN has been exercising its oversight in this area since early 2010. Each new facility or any major modification of an existing facility undergoes an extensive examination by ASN. The main radiation protection issues concerning these facilities must be considered as of the design stage. Application of the industrial standards, particularly standard NF M 62‑105 “Industrial accelerators: installations”, ISO 10648‑2 “Containment enclosures” and ISO 17873 “Ventilation systems for nuclear installations”, guarantees safe utilisation of the equipment and brings a significant reduction in risks. Facilities that have a cyclotron used to produce radionuclides and products containing radionuclides are subject to gaseous ASN Report on the state of nuclear safety and radiation protection in France in 2024 271 11 12 13 14 15 AP 10 09 Sources of ionising radiation and their industrial, veterinary and research applications 08 01 02 03 04 05 06 07
RkJQdWJsaXNoZXIy NjQ0NzU=