Karla Petrova Chair Working Party on Graded Approach to Regulatory Control EUROPEAN COMMISSION

| 2 Progress report from the Working Party Graded Approach Objective. Discuss current and future concepts of regulatory control, in particular the possibility of introducing a graded approach. Revise Title III Reporting and Authorisation of Practices and Title VIII Implementation of Radiation Protection for the Population in Normal Circumstances (Council Directive 96/29/Euratom )

| 3 Progress report from the Working Party Graded Approach Further objectives. Discuss also Title I Subject matter and scope. Harmonisation (to the extent possible) with graded approach for NORM. Harmonisation with International BSS

| 4 Progress report from the Working Party Graded Approach General structure of the regulatory framework. Exclusion of certain exposure situations from radiological protection legislation on the basis that they are unamenable to control with regulatory instruments (scope of regulation),. Exemption of certain practices from some regulatory requirements, because regulatory action is unwarranted,. Notification to the competent authority of the intention to use a source or introduce a planned exposure situation,. Registration of planned exposure situations for practices of low or moderate risks, ( partly already in Art.4, §4 g of Dir. 29/1996)in cases where a limited risk of exposure of human beings does not necessitate the examination of individual cases the practice is undertaken in accordance with conditions laid down in national legislation). Licensing.

Generic (explicit) exemption (Art. 3) Outside the Scope of the Directive Regulatory Control of planned exposure situations Revised European Directive Magnitude & likelihood of exposures Notification Specific Exemption Registration Licensing Authorised planned exposure situations

Generic exemption Exclusion – Scope of the Directive Current approaches for Planned exposure situations International BSS European Directive Authorisation Registration Licensing (prior) Authorisation Article 4 § 3 (b) Magnitude & likelihood of exposures Exemption Notification Reporting

| 7 Progress report from the Working Party Graded Approach Definitions. Notification – requirement of submitting a document to the competent authority to notify the intention to carry out a practice within the scope of this Directive.. Registration – a permission granted in a document by the competent authority, or granted by national legislation, to carry out a practice [of low or moderate risk] within the scope of this Directive.. Licence – a permission granted in a document by the competent authority, on application to carry out a practice within the scope of this Directive.

| 8 Progress report from the Working Party Graded Approach Registration vs. License. Registration » applies to types of practices where the risk of exposure to workers and the public is low conditions for the operation of these practices are laid down in national legislation » Regulatory control can be limited regulatory authority may issue a document specifying national regulations which apply for this type of practice. License » applies to practices which are not exempted or cannot be registered, » Site specific license for a given practice stipulating specific requirements for this practice Including for example a discharge authorisation

Flow chart for the regulatory control of planned exposure situations All radioactive sources and radiation generators within the Scope of this Directive? Justified? Excluded Forbidden Exempted from Notification? Generic Exemption Notification to regulatory authority Decision of the regulatory authority Specific Exemption RegistrationLicensing Yes No Yes

| 10 Progress report from the Working Party Graded Approach Registration – Examples. Use of low activity industrial gauges (level of the activity to be defined) » manufactured according to IEC standards/certification needed. Dental X-ray diagnostics » Under certain conditions » Small dental units with CT feature will have to be licensed. Laboratory with low activity unsealed sources » total activity of unsealed sources < 10 times the exemption value. X-ray screening of the baggage of passengers for security purposes

| 11 Progress report from the Working Party Graded Approach Registration or licensing – Examples. Industrial radiography (with X-rays and g-rays). X-ray imaging for security purposes » testing the baggage of passengers » screening of passengers. Production and testing of equipment including radiation sources (x-ray generators). Diagnostic and interventional X-ray radiography. X-ray diagnostics/nuclear diagnostics in veterinary medicine. use of unsealed sources (depending on the activity). use of radiation sources in research applications (depending on the activity). accelerators in industry and research

| 12 Progress report from the Working Party Graded Approach Licensing – Examples. use of high activity industrial gauges » level of the activity to be defined. irradiators in industrial use. irradiators for sterilisation in medical applications. radionuclide production for radiopharmaceuticals. trade in radioactive substances/materials. production of radioactive substances/materials. radiotherapy. nuclear medicine. intermediate storage of radioactive materials. treatment/reprocessing of radioactive materials » including disused/ obsolete sources, NORM waste. radioactive waste storage and disposal. installation, repair and service of radiation sources (maintenance)

| 13 Progress report from the Working Party Graded Approach Licensing – Examples (2). Practices for which prior authorisation was already required in Directive 96/29/Euratom » operation and decommissioning of any facility of the nuclear fuel cycle and exploitation and closure of uranium mining; » the deliberate addition of radioactive substances in the production and manufacture of medicinal products and the import or export of such goods; » the deliberate addition of radioactive substances in the production and manufacture of consumer goods and the import or export of such goods; » the deliberate administration of radioactive substances to persons and, in so far as radiation protection of human beings is concerned, animals for the purpose of medical or veterinary diagnosis, treatment or research;

| 14 Progress report from the Working Party Graded Approach Summary. Graded approach to regulatory control » Notification » Registration » License. Harmonised with » International BSS » Approach for NORM industries. Input to Working Party RECAST » proposed concept acknowledged » draft directive text discussed and further developed

| 15 Progress report from the Working Party Graded Approach Final text – Dir.59/2013 Article 24 Graded approach to regulatory control. 1.Member States shall require practices to be subject to regulatory control for the purpose of radiation protection, by way of notification, authorisation and appropriate inspections, commensurate with the magnitude and likelihood of exposures resulting from the practice, and commensurate with the impact that regulatory control may have in reducing such exposures or improving radiological safety.. 2.Without prejudice to Articles 27 and 28, where appropriate, and in accordance with the general exemption criteria set out in Annex VII, regulatory control may be limited to notification and an appropriate frequency of inspections. For this purpose, Member States may establish general exemptions or allow the competent authority to decide to exempt notified practices from the requirement of authorisation on the basis of the general criteria specified in Annex VII; in the case of moderate amounts of material, as specified by Member States, the activity concentration values laid down in Annex VII, Table B, column 2 may be used for this purpose.. 3.Notified practices which are not exempted from authorisation shall be subject to regulatory control through registration or licensing.

| 16 Progress report from the Working Party Graded Approach Article 25 Notification. 1.Member States shall ensure that notification is required for all justified practices, including those identified according to Article 23. The notification shall be made prior to the practice commencing or, for existing practices, as soon as possible once this requirement is applicable. For practices subject to notification, Member States shall specify the information to be provided in conjunction with the notification. Where an application for an authorisation is submitted, no separate notification is needed.. Practices may be exempted from notification, as specified in Article Member States shall ensure that notification is required for workplaces specified in Article 54(3), and for existing exposure situations that are managed as a planned exposure situation, as specified in Article 100(3).. 3.Notwithstanding the exemption criteria laid down in Article 26, in situations identified by Member States where there is concern that a practice identified in accordance with Article 23 may lead to the presence of naturally ‑ occurring radionuclides in water liable to affect the quality of drinking water supplies or affect any other exposure pathways, so as to be of concern from a radiation protection point of view, the competent authority may require that the practice be subject to notification.

| 17 Progress report from the Working Party Graded Approach Article 27 Registration or licensing. 1.Member States shall require either registration or licensing of the following practices: (a)the operation of radiation generators or accelerators or radioactive sources for medical exposures or for non ‑ medical imaging purposes; (b)the operation of radiation generators or accelerators, except electron microscopes, or radioactive sources for purposes not covered by point (a).. 2.Member States may require registration or licensing for other types of practices.. 3.The regulatory decision to submit types of practices to either registration or licensing may be based on regulatory experience, taking into account the magnitude of expected or potential doses, as well as the complexity of the practice.

| 18 Progress report from the Working Party Graded Approach IAEA GSR Part The government shall promulgate laws and statutes to make provision for an effective governmental, legal and regulatory framework for safety. This framework for safety shall set out the following: The type of authorization that is required for the operation of facilities and for the conduct of activities, in accordance with a graded approach; Footnote: Authorization to operate a facility or to conduct an activity may be granted by the regulatory body or by another governmental body to an operating organization or to a person.. ‘Authorization’ includes approval, written permission, licensing, certification or registration.. See Ref. [2]. Glossary

| 19 Progress report from the Working Party Graded Approach GSR Part 1 - Requirement 26: Graded approach to review and assessment of a facility or an activity. Review and assessment of a facility or an activity shall be commensurate with the radiation risks associated with the facility or activity, in accordance with a graded approach.

| 20 Progress report from the Working Party Graded Approach Requirement 29: Graded approach to inspections of facilities and activities. Inspections of facilities and activities shall be commensurate with the radiation risks associated with the facility or activity, in accordance with a graded approach.

| 21 Progress report from the Working Party Graded Approach GSR Part 3 – IAEA BSS Req.7 / Authorization: registration or licensing 3.8. Any person or organization intending to carry out any of the actions specified in para. 3.5 shall, unless notification alone is sufficient, apply to the regulatory body fo authorization17, whichshall take the form of either registration18 or licensing. Footnote18) Typical practices that are amenable to registration are those for which: (a) safety can largely be ensured by the design of the facilities and equipment; (b) the operating procedures are simple to follow; (c) the safety training requirements are minimal; and (d) there is a history of few problems with safety in operations. Registration is best suited to those practices for which operations do not vary significantly.