ASN Report 2017

97 ASN report on the state of nuclear safety and radiation protection in France in 2017 Chapter 03  - Regulations brachytherapy, and for the use of particle accelerators in external radiotherapy and computed tomography devices. Licensing of non-medical activities ASN is responsible for issuing licenses for industrial and research applications. In these fields, this concerns: ཛྷ ཛྷ the manufacture, possession and utilisation, distribution of radionuclides, products or devices containing them, devices emitting ionising radiation, the use of accelerators of all types of particles; ཛྷ ཛྷ the import and export of radionuclides, products or devices containing them. The licence exemption criteria are given in the appendix to the Public Health Code (Tables 1 and 2, appendix 13-8). They will be updated by decree. 2.1.2 The new registration system The new Article L. 1333-7 of the Public Health Code introduces a simplified licensing system known as “Registration”. This system can be utilised for nuclear activities representing serious risks or detrimental effects for the interests mentioned in Article L. 1333-7, when these risks and detrimental effects can, in principle and in the light of the characteristics of these activities and the conditions of their implementation, be prevented by compliance with the general prescriptions. Utilisation of this new system requires relevant regulations and, for the activities concerned, the drafting of general requirements. Medical computed tomography and the use of certain categories of radioactive sources with moderate activity (currently subject to licensing) will henceforth require registration, as will fluoroscopy-guided interventional practices with radiation protection implications (currently require notification). 2.1.3 The notification system and its update The list of activities requiring notification was updated in 2009 by ASN resolution 2009-DC-0146 of 16th July 2009, supplemented by ASN resolution 2009-DC-0162 of 20th October 2009. In the same way as medical radiology, radiology in a veterinary practice is among the activities subject to notification. The resolution of 16th July 2009 was modified in 2015 by a resolution of 10th November 2015 in order more specifically to add X-ray generators used for irradiation of blood products. ASN acknowledges receipt of the notification filed by the natural or artificial person responsible for the nuclear activity. A new notification is mandatory if significant changes are made (change or addition of a device, transfer or substantial modification of the premises, or change in the party responsible for the nuclear activity). This list of activities requiring notification will be updated and broadened in 2018. It will be extended to activities with risks or detrimental effects that are moderate, or which could be prevented by compliance with the general requirements, without it being necessary to examine a licensing or registration application file. This change should enable ASN to focus its monitoring actions primarily on activities with the highest radiation protection risks. This system will henceforth be extended to the use of certain categories of radioactive sources with limited activity, such as lead detection in paint (currently requiring licensing) and electrical devices generating ionising radiation offering high levels of operating safety (baggage inspection systems). 2.1.4 Licensing the suppliers of ionising radiation sources ASN resolution 2008-DC-0109 of 19th August 2008 concerns the licensing system for the distribution, import and/or export of radionuclides and products or devices containing them. This resolution covers the products intended for industrial and research purposes, but also health products: drugs containing radionuclides (radiopharmaceuticals, precursors and generators), medical devices (telegammatherapy devices, brachytherapy sources and associated projectors, blood product irradiators, etc.) and in vitro diagnostic medical devices (for radioimmunoassay). ASN resolution 2008-DC-0108 of 19th August 2008 concerns the license to possess and use a particle accelerator (cyclotron) and the manufacture of radiopharmaceuticals containing a positron emitter. 2.1.5 Approval of radiation protection technical supervision organisations Technical supervision of the radiation protection organisation, including supervision of the management of radioactive sources and any associated waste, is entrusted to approved organisations (Article R. 1333-172 of the Public Health Code). The procedures for approval of these organisations are set by ASN resolution 2010-DC-0191 of 22nd July 2010. These approvals are issued by ASN. The list of approved organisations is available on the ASN website ( www.asn.fr ). The nature and frequency of the radiation protection technical checks are defined in the ASN resolution mentioned in point 1.2.1. This resolution will soon be repealed and replaced by an order. 2.1.6 The rules for the design of facilities ASN technical decisions, subject to approval by the Ministers responsible for Radiation Protection, may be adopted to determine the design and operating rules for facilities in which sources of ionising radiation are used. With regard to the design of installations in which electrical devices are used for the production and utilisation of X-rays, for medical, veterinary, industrial and research purposes, ASN takes account of the lessons learned from the difficulty with implementing resolution 2013-DC-0349 of 4th June 2013. In 2017, it published a new resolution (ASN resolution 2017-DC-0591 of 13th June 2017) setting out the minimum technical design rules applicable to premises in which X-ray generators are used and repealed the previous resolution. The minimum technical rules for design, operation and maintenance to be met by in vivo nuclear medicine facilities were defined by the resolution of 23rd October 2014. The new rules replacing the rules which existed since 1981, mainly concern the ventilation of the laboratory in which the