ASN Report 2020

In 2020, operation of the 7 cyclotrons (including 1 on standby) of CIS bio international was transferred to the Cyclopharma Laboratories, which were already operating 9 (including 3 in standby status). These 16 cyclotrons are now managed by a single organisation named Curium PET France, with 5 of them being used for joint production and research, while 7 are used only for the production of radiopharmaceuticals. A slowdown in the production of cyclotrons, particularly that of fluorine-18, was observed in the first half of 2020 on account of the health crisis, which has led to a reduction in medical imaging examination demands. The assessment of radiation protection in the area of cyclotrons ASN has exercised its oversight role in this area since early 2010; each new facility or any major modification to an existing facility undergoes a comprehensive examination by ASN. The main radiation protection issues on these facilities must be considered as of the design stage. Application of the relevant standards, in particular standard NF M 62-105 “Industrial accelerators: installations”, ISO 106482 “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 effluent discharge limits specified in their license. The discharge levels depend on the frequency and types of production involved. Systems for filtering and trapping the gaseous effluents are installed in the production enclosures and in the facilities’ ventilation systems in order to minimise the activity discharged at the stack outlet. Some licensees have also installed – as close as possible to the shielded enclosures – systems for collecting and storing the gases to let them decay before being discharged, bringing a substantial reduction in the activities discharged into the environment. Consequently, the discharged activity levels and the short half- life of the radionuclides discharged in gaseous effluents mean there is no significant impact on the public or the environment. ASN, jointly with the IRSN, is continuing a study they began in 2016 on the gaseous discharges into the environment from these facilities. The conclusions of the first step, which involved both the IRSN and the licensees, served to establish in 2018 general principles on managing gaseous effluent discharges, the key points of which will be taken up in a draft regulatory text. Alongside this, new assessments of the impacts of discharges from the facilities situated near residential areas have been carried out, using for some facilities modelling tools that are better suited to near-field studies. This work will continue in the coming years. ASN performs about ten inspections at facilities of this type each year (five in 2020). Aspects related to radiation protection, user safety and the correct operation of cyclotrons and production platforms receive particular attention during the inspections. The scope of the inspections performed includes occupational radiation protection, the management of internal events, monitoring and maintenance of the production equipment, inspection of the surveillance and control systems and the gaseous discharge results. These facilities have a satisfactory radiation protection organisation and good knowledge of the regulations. National action plans have been put into place by the licensees and are monitored by ASN in order to ensure continuous improvement of radiation protection and safety in these facilities. 4. The remote inspections were conducted on suppliers who did not hold physical stocks of sources. Fourteen ESRs were reported by the cyclotron licensees in 2020. None of these events led to significant exposure of workers or the public. Most of these events (eight) concerned deliveries of products that had not been ordered by the customer (nuclear medicine department), often due to late cancellations or modifications of medical imaging examinations during the health crisis, which the licensee’s planning & scheduling department was unable to process in time. These departments have adjusted their organisation to permit better management of last-minute information concerning orders. 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 the IRSN, to draw up a draft regulatory text on the technical design and operating rules applicable to companies producing radionuclides using a cyclotron. This draft text was made available for consultation by the stakeholders in 2016. A revised version was produced in 2018, taking account of the observations received and including additional chapters on the control and monitoring of gaseous effluent discharges. This second version of this draft underwent a new consultation by the stakeholders in 2019. Preparation of this draft text will continue in 2021, taking into account the discussions held with the DGT in 2019 and information provided by the IRSN in 2020 in order to establish a single regulatory baselinefor the entire sector of activity concerned. The main conclusions of this regulatory work are already being used when examining license applications in order to include appropriate individual licence conditions. 4.3  The other suppliers of sources Evaluation of radiation protection 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 applications submitted by these suppliers for the sources they intend to distribute in France. In 2020, cyclotrons excluded, 22 inspections were carried out (of which 5 were done remotely (4) at manufacturers/suppliers of sealed or unsealed sources, at companies involved in the dismantling and reconditioning of ICSDs, companies recovering lightning conductors and companies manufacturing and installing X‑ray generators – although these devices are not yet subject to a distribution license, their utilisation is regulated, including the commissioning and maintenance operations carried out by the companies that sell them). As a complement to what was done until now, five of the 22 inspections focused on priority themes other than the supply of sources (seeking out cases of fraud, security of sources, maintenance/expert assessment of devices containing sealed radioactive sources). Lastly, some of these inspections (three) focused on foreign companies distributing ionising radiation sources in France. These inspections have covered about a quarter of the suppliers with safety-significant business on the basis of specific inspec­ tion indicators, more specifically linked to the suppliers’ responsibilities in the tracking and recovery of disused sealed sources from the users in order to dispose of them as appro­ priate for the radiation risks they present for people and the environment. 262 ASN Report on the state of nuclear safety and radiation protection in France in 2020 08 – SOURCES OF IONISING RADIATION AND THEIR INDUSTRIAL, VETERINARY AND RESEARCH APPLICATIONS