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Presentation 1.8: Development, management & implementation

Presentation 1.8: Development, management & implementation of regulations – personal experience. Stavroula Vogiatzi Medical Physicist M.Sc. Licensing & Inspection Department Greek Atomic Energy Commission (EEAE). www.eeae.gr.

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Presentation 1.8: Development, management & implementation

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  1. Presentation 1.8: Development, management & implementation of regulations – personal experience Stavroula Vogiatzi Medical Physicist M.Sc. Licensing & Inspection Department Greek Atomic Energy Commission (EEAE) www.eeae.gr IAEA Regional Workshop - School for Drafting Regulations, 03 - 14 November 2014, Vienna, Austria

  2. Contents • Description of regulatory regime • Process to establish regulations • Role of government, licensees, public & other stakeholders • Lessons learned from process (what would we do differently?) • Future plans for revisions to regulations IAEA Regional Workshop - School for Drafting Regulations, 03 - 14 November 2014, Vienna, Austria

  3. Contents • Description of regulatory regime • Process to establish regulations • Role of government, licensees, public & other stakeholders • Lessons learned from process (what would we do differently?) • Future plans for revisions to regulations IAEA Regional Workshop - School for Drafting Regulations, 03 - 14 November 2014, Vienna, Austria

  4. Hierarchy of the Greek legislation system International conventions, at the moment of their ratification, form an integral part of domestic Greek law & prevail over any other provision to the contrary, provided they constitute a later law, with the exception of the provisions of the Constitution. European Union regulations have universal validity in all MS; they are binding & directly effective in each MS. The incorporation of Directives is made by virtue of a law, Presidential Decree or Ministerial Decision. IAEA Regional Workshop - School for Drafting Regulations, 03 - 14 November 2014, Vienna, Austria

  5. The national radiation protection & nuclear safety system in Greece • gradually established in the decades of 1970 & 1980, through the following 3 instruments: • Government Gazette, Act No. 854, March 10, 1971, “On the terms regarding the establishment and operation of nuclear facilities” • Government Gazette, Legislative Decree 181, Folio No: 347, First issue, November 20, 1974, “Protection against ionizing radiation” • Government Gazette, Law No. 1733, Folio No: 171, First issue, September 22, 1987, “Transfer of Technology, inventions, technological innovation and establishment of the Greek Atomic Energy Commission” IAEA Regional Workshop - School for Drafting Regulations, 03 - 14 November 2014, Vienna, Austria

  6. The national radiation protection & nuclear safety system in Greece • 3 legal acts are acknowledged as the foundations of the national radiation protection & • nuclear safety system - subsequent legislation has been issued by virtue of these Laws & of • their rules of application: • Government Gazette, Presidential Decree No. 610, Folio No. 130, First Issue, August 23, • 1978, issued by virtue of Act No.854, defining the “conditions and procedures for • licensing of the nuclear installation of the Public Power Corporation”. • This Decree has never been activated, since the national strategy on energy supply does • not include the use of nuclear energy. • Government Gazette, Presidential Decree No. 404, Folio No. 173, First Issue, October 5, • 1993, describes the organizational structure of EEAE and has been issued by virtue of • Law 1514/87 defining the national research framework. • Government Gazette, Presidential Decree No. 83, Folio No. 147, First Issue, September 3, 2010, concerns the supervision and control of shipments of radioactive waste and spent fuel (in application of EC Directive 2006/117 EURATOM) has been issued in virtue of Law No. 1733. IAEA Regional Workshop - School for Drafting Regulations, 03 - 14 November 2014, Vienna, Austria

  7. The national radiation protection & nuclear safety system in Greece • A series of Ministerial Decisions have been rendered, regulating specific fields and • transposing EC EURATOM Directives (97/43, 96/29) into the national legislation: • Government Gazette, Joint Ministerial Decision No. 1014 (FOR) 94, Second Issue, Folio No. 216, March 6, 2001 “Approval of Radiation Protection Regulations” • Apply to all practices which involve danger from ionizing radiation arising from natural or artificial sources or/and from natural isotopes • Government Gazette, Ministerial Decree 2739/94, Folio No.165, Second issue, March 15, 1994“Regulation for public information in the event of a radiological emergency” • Government Gazette, Ministerial Decision No. 9087(FOR)1004, Folio No: 849, Second issue, September 13, 1996“Operational protection of outside workers exposed to the risk of ionizing radiation during their activities in controlled areas”, transposing the Council Directive 90/641/EURATOM. • Ministerial Decision No. 10828/(EFA)1897, Folio No. 859, Second Issue, 2006“Control of high-activity sealed radioactive sources and orphan sources”, transposing Council Directive 2003/122/EURATOM. IAEA Regional Workshop - School for Drafting Regulations, 03 - 14 November 2014, Vienna, Austria

  8. Contents • Description of regulatory regime • Process to establish regulations • Role of government, licensees, public & other stakeholders • Lessons learned from process (what would we do differently?) • Future plans for revisions to regulations IAEA Regional Workshop - School for Drafting Regulations, 03 - 14 November 2014, Vienna, Austria

  9. EEAE – responsibilities – regulatory activities • Law 1733/1987 • re-established EEAE as a decentralized civil service & Competent Authority for • radiation protection, nuclear safety & nuclear technology in the country (firstly established in 1954 under Law 2750/26.02.1954) • was amended in 1997 (Law 2496, 87/A/16.05.1997), so as to include non-ionizing radiation in EEAE activities. • EEAE’s primary mission is the protection of the public, the workers and the environment from ionizing and artificially produced non-ionizing radiation. • EEAE’s participation in the “General Civil Protection Plan” entails responsibilities for the prevention, preparedness and response to radiological emergencies. • EEAE participates in the “National Emergency Plan for Nuclear, Radiological, Biological and Chemical Threats” (CBRN). IAEA Regional Workshop - School for Drafting Regulations, 03 - 14 November 2014, Vienna, Austria

  10. EEAE – responsibilities – regulatory activities • Law 1733/1987 • ……EEAE shall also propose to competent bodies and elaborate radiation protection regulations as well as on the taking of preventive measures or of corrective actions in case the said guidelines and regulations have been infringed. • ……EEAE shall issue safety guidelines and shall prepare regulations for the operation of facilities and machinery that emit ionizing radiation. • Such guidelines and regulations shall be approved and enter into force under a decision of the Minister of Industry, Energy and Technology and any other competent Minister, as appropriate, and shall be published in the Government Gazette. • …….EEAE issues safety instructions for the securing, disposal, transport and storage of radioactive materials and makes proposals to competent ministers, as appropriate, for the rendering of ministerial decisions to govern the related control procedures and the observance thereof. IAEA Regional Workshop - School for Drafting Regulations, 03 - 14 November 2014, Vienna, Austria

  11. EEAE – responsibilities – regulatory activities • Government Gazette, Joint Ministerial Decision No.A2st/oik.2236, Second Issue, • Folio No. 422, May 10, 1978 “Radiation Protection Regulations” • Government Gazette, Joint Ministerial Decision No. 14632 (FOR) 1416, Second Issue, Folio No. 539, July 19, 1991 “Approval of Radiation Protection Regulations” • Government Gazette, Joint Ministerial Decision No. 1014 (FOR) 94, Second Issue, Folio No. 216, March 6, 2001 “Approval of Radiation Protection Regulations” • Furthermore , • EEAE has issued Circulars/Decisions providing details & guidance for issues related to radiation protection & safety, e.g. patients excreta release (IAEA 100), • clearance levels of NORM (RP122), • Diagnostic Reference Levels (DRL), • QA/QC protocols e.t.c. IAEA Regional Workshop - School for Drafting Regulations, 03 - 14 November 2014, Vienna, Austria

  12. Contents • Description of regulatory regime • Process to establish regulations • Role of government, licensees, public & other stakeholders • Lessons learned from process (what would we do differently?) • Future plans for revisions to regulations IAEA Regional Workshop - School for Drafting Regulations, 03 - 14 November 2014, Vienna, Austria

  13. Role of government, licensees, public & other stakeholders Government Gazette, Joint Ministerial Decision No. 1014 (FOR) 94, Second Issue, Folio No. 216, March 6, 2001 “Approval of Radiation Protection Regulations” Drafting Committee: & Subcommittees: EEAE EEAE (Greek Atomic Energy Commission) HAMP (Hellenic Association of Medical Physicists) HRC (Hellenic Radiological Society) HSNM(Hellenic Society of Nuclear Medicine) Association of radiographers/technologists In order to be approved & enter into force, Draft Radiation Protection Regulations were forwarded toMinister of Development & other competent Minister, as appropriate, i.e. Minister of Health, Minister of Labour, Minister of Environment, Minister of Finance. IAEA Regional Workshop - School for Drafting Regulations, 03 - 14 November 2014, Vienna, Austria

  14. Contents • Description of regulatory regime • Process to establish regulations • Role of government, licensees, public & other stakeholders • Lessons learned from process (what would we do differently?) • Future plans for revisions to regulations IAEA Regional Workshop - School for Drafting Regulations, 03 - 14 November 2014, Vienna, Austria

  15. The existing legislation General Observations • Voluminous text • Ambiguities • Exhaustive details • No flexibility for new technologies • More coherence needed in the use of terms • Persons or entities with responsibilities for safety are not always explicitly defined Missing • Consolidated statement setting out the national policy and strategy for safety in a single document • Explicit assignment of the prime responsibility for safety • Conferring legal authority to EEAE for enforcement (weak) • Transitional provisions • Graded approach IAEA Regional Workshop - School for Drafting Regulations, 03 - 14 November 2014, Vienna, Austria

  16. Identified needs • To document the national policy and strategy in a single official document • To adopt of a more flexible hierarchy of safety regulations • To obtain the flexibility of a risk-based regulatory framework - graded approach to safety • To strengthen EEAE’s powers of enforcement • To explicitly assign in the legal and regulatory framework, the prime responsibility for safety • To assure senior management commitment & to actively involve all staff in the development & implementation of an integrated management system • To revise the licensing approach in order to include conditions, limits & controls on licenses • To improve the safety culture in the country • To improve reporting of accidents/incidents IAEA Regional Workshop - School for Drafting Regulations, 03 - 14 November 2014, Vienna, Austria

  17. Identified needs To establish safety requirements for decommissioning of facilities & pre-disposal management of radioactive waste To consider the establishment & operation of a disposal facility To define the national strategy for radon & complete the radon mapping of the country To increase the timely & effective exchange of information & coordination of regulatory functions between authorities with assigned competence To develop & strengthen the capacity for review & approval of transport packages & material designs To enhance the use of e-tools for communication with the stakeholders IAEA Regional Workshop - School for Drafting Regulations, 03 - 14 November 2014, Vienna, Austria

  18. Contents • Description of regulatory regime • Process to establish regulations • Role of government, licensees, public & other stakeholders • Lessons learned from process (what would we do differently?) • Future plans for revisions to regulations IAEA Regional Workshop - School for Drafting Regulations, 03 - 14 November 2014, Vienna, Austria

  19. Basis for the regulatory framework revision Radiological Safety • International Basic Safety Standards (ΙΑΕΑ GSR1-4, 7) • New EC Directive (recast of 5 Directives) • Recommendations of the IRRS Mission in Greece • Operational experience from the implementation of the current regulatory framework • Policy, Strategy, Goals of EEAE IAEA Regional Workshop - School for Drafting Regulations, 03 - 14 November 2014, Vienna, Austria

  20. Also … • Council Directive 20014/87/Euratom of 8 July 2014 amending Directive 2009/71/Euratom establishing a Community framework for the nuclear safety of nuclear installations • Council Directive 2011/70/Euratom of 19 July 2011 establishing a Community framework for the responsible and safe management of spent fuel and radioactive waste • Council Directive 2013/51/Euratom of 22 October 2013 laying down requirements for the protection of the health of the general public with regard to radioactive substances in water intended for human consumption IAEA Regional Workshop - School for Drafting Regulations, 03 - 14 November 2014, Vienna, Austria

  21. Graded approach in the regulatory framework revision Issuing of legislative acts (based on the graded approach): • Update of the Law 181/1974 (mainly on enforcement) • Transposition of the new EC Directive in the national legislation in the form of Presidential Decree: • Issue of Ministerial Decrees (national policy and strategy, procedures and requirements for licensing, …) • EEAE decisions describing the technical requirements • EEAE decisions with guidelines and explanatory circulars IAEA Regional Workshop - School for Drafting Regulations, 03 - 14 November 2014, Vienna, Austria

  22. The roadmap • In parallel: • Continuous information • Participation in EC and HERCA activities • Awareness of the stakeholders and the Government IAEA Regional Workshop - School for Drafting Regulations, 03 - 14 November 2014, Vienna, Austria

  23. Cooperation and Transparency: our perspective • Trust among the public, the key stakeholders, the regulatory bodies & authorities, local authorities & political leaders • We aim at high quality decisions, which requires: • Clarity of all issues • Broad perspectives • Many angles to the issue • Challenging of arguments • Model: “For decision makers, stakeholders involvement is a way to create clarity for the sake of high quality decisions.” IAEA Regional Workshop - School for Drafting Regulations, 03 - 14 November 2014, Vienna, Austria

  24. Thank you for your attention! Questions? Greek Atomic Energy Commission P.O Box 60092 Agia Paraskevi, 15310, Athens T: ++302106506700, F: ++302106506748, E: info@eeae.gr, www.eeae.gr facebook.com/eeaegr twitter.com/eeaegr IAEA Regional Workshop - School for Drafting Regulations, 03 - 14 November 2014, Vienna, Austria

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