Lastly, national action plans are put into place by the licensees of the two major French radiopharmaceutical production groups and are monitored annually by ASN to ensure continuous improvement of radiation protection and safety in these facilities. Six ESRs were reported by the cyclotron licensees in 2023. None of these events led to significant exposure of workers or the public. Two events concerning the accidental release of carbon‑11 during a production operation were reported because of leaks on a target in the first case and at a transfer valve seal in the second case. Given the very short half‑life and the one‑off release of the carbon‑11, the impact on the workers, the public or the environment close to each of the sites is negligible. In the second case, because the leak caused the authorised limit for radioactive atmospheric discharges to be exceeded, the event was rated level 1 on the INES scale and published on asn.fr as an incident notice. The other four ESRs concerned exceeding of the dose constraint (set by the company) to the hands of workers on several occasions, the removal of a drum of liquid waste containing fluorine‑18 by a waste removal contractor before the required decay time had elapsed, the loss of the atmospheric discharge monitoring data covering a short period of time and the crushing of a 10 kBq sealed source of caesium‑137 de when conducting quality controls using a new chromatography device. There are disparities in the technical and organisational means implemented by the licensees, depending on the age of the facilities and the type of activities performed (research or industrial production). Experience feedback in this area has led ASN, assisted by IRSN, to draw up a draft resolution on the technical design and operating rules applicable to facilities producing radionuclides using a cyclotron and on the control and monitoring of their gaseous effluent discharges. The draft resolution has already undergone several informal consultations with the stakeholders and discussions with the DGT; its preparation will continue in 2024 in order to create a single regulatory baseline for the whole sector concerned. The main conclusions of this regulatory work are already being used when examining license applications for these facilities in order to include appropriate requirements in the individual licenses. The conclusions resulting from the considerations on the wording of the atmospheric discharge limit values will also be included. 4.3 THE OTHER SUPPLIERS OF SOURCES Evaluation of the radiation protection situation Suppliers of radioactive sources, cyclotrons excluded, propose technical solutions for the industrial, medical and research sectors. Suppliers may be manufacturers of “bare” sources or of devices containing sealed radioactive sources, manufacturers of unsealed sources, or distributors who import sources from other countries. Whatever the case, ASN examines the license application files for the sources these suppliers wish to distribute in France. In 2023, cyclotrons excluded, 35 inspections were carried out at the manufacturers/distributors of radioactive sources or sources emitting ionising radiation, an increase on the preceding year. These inspections were carried out at manufacturers/distributors of sealed and unsealed radioactive sources, companies removing lightning conductors or removing and dismantling ICSDs, and companies manufacturing, installing, or maintaining electrical generators of ionising radiation or particle accelerators (although they are not yet subject to a distribution authorisation, these devices are subject to utilisation regulations, including in particular the commissioning or maintenance operations carried out by the companies that sell them). Several of the inspections concerned priority themes other than those mentioned above; more specifically, five inspections focused on the protection of radioactive sources against malicious acts and two concerned the possession and national use of radioactive sources by the armed forces. Lastly, one inspection concerned a foreign company that distributes radioactive sources in France. These inspections covered about a quarter of the suppliers with safety‑significant business, checking specific inspection indicators, more particularly linked to the suppliers’ responsibilities in the tracking and recovery of disused sealed radioactive sources from the users in order to dispose of them appropriately, taking into account the radiation risks they present for people and the environment. ASN considers the radiation protection situation associated with the radionuclide distribution activity to be satisfactory on the whole. The large majority of licensees meet the main requirements and assume their responsibilities adequately (transfer of documents on delivery, tool for tracking the delivered sources or devices, setting up the source recovery streams, transmission of information to IRSN). Furthermore, there is a distinct improvement in the verifications suppliers must carry out before delivering any sources compared with 2022. These verifications, for which the supplier must take appropriate organisational measures (by computer blocking or verifications during actual preparation of the order), include verification of the existence of an administrative document (license or registration or notification acknowledgement) authorising the customer to hold the sources concerned, verification of the fact that the delivery of the source in itself will not, considering the other sources already delivered by the supplier, result in exceeding of the customer’s license limits, and lastly that the delivery address is consistent with the authorised holding sites. Compliance with the obligation of unconditional recovery of distributed sealed radioactive sources that have expired (ten years counting from the date of the first registration figuring on the supply form) or surplus to requirements, has also improved compared with 2022. These inspections also provided the opportunity to inform the suppliers about the latest regulatory developments, particularly those relative to the new modalities of the radiation protection verifications required under the Public Health Code and those induced by the Defence Code modification which lowers some thresholds of nuclear material quantities, thereby making some suppliers subject to the licensing system under this Code, in addition to their obligations under the Public Health Code. The inspections carried out during 2023 nevertheless also revealed certain points requiring particular attention, particularly as regards tracking of the distribution of particle accelerators and electrical devices emitting ionising radiation. In effect, the tracking tools used by the distributors were judged insufficient on half the inspected sites and inexistent on one site. ESR notifications are significantly lower than in 2022, and no significant event rated level 1 or higher on the INES scale was recorded in 2023. The ESRs notified in 2023 mainly concerned poor management of dosimeters (dosimeter left in the radiography room and in luggage during X‑ray security checks in an airport zone) resulting in incorrect dose recordings, and the discovery of radioactive substances (sources, effluent canisters, traces of contamination in places not provided for in the licenses of the sites concerned. On one licensee’s premises, an irradiator containing high‑activity sealed sources suffered serious damage, necessitating the shutting down one of the irradiation lines pending repair. None of the supplier ESRs notified for 2023 had any significant consequences on the environment or the workers. ASN Report on the state of nuclear safety and radiation protection in France in 2023 267 • 08 • Sources of ionising radiation and their industrial, veterinary and research applications 08 05 15 11 04 14 06 07 13 AP 03 10 02 09 12 01
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