IAEA Safety Standards Regional Training Course “Orphan Source Search Training” TC Regional Project RAS/9/062 and RAS/9/085 Philippine Nuclear Research Institute (PNRI) Quezon City, Philippines 17 - 21 October 2016

IAEA Statute “To establish … standards of safety … and to provide for the application of these standards …”

Why Safety Standards? IAEA Statute (Article III.A.6) “To establish or adopt… [in consultation with…] standards of safety for the protection of health and minimization of danger to life and property” “…and to provide for the application of these standards” The IAEA safety standards are seen as the global reference for nuclear, radiation protection, radioactive waste and transport safety used by Member States to deliver consistent levels of safety for the protection of workers, the public and the environment IAEA Training Course for Regulators on Enforcement Module 1.2

Safety Standards as an Element of the Global Safety Regime Providing for Application of Standards Establishing Safety Standards Conventions & International Instruments Networking Feedback Supporting TC programs Promoting E&T Fostering Information Exchange Rendering Safety Review Services / Appraising Compliance Knowledge Base

History 1958 1961 1962 1974 1996 of Radioactive Material Safe Transport Radiation Protection BSS for of Radioisotopes Safe Handling Programme NUSS Basic Safety Standards 1958 1961 1962 1974 1996 IAEA Training Course for Regulators on Enforcement Module 1.2

History (cont’d) 1996 2003 2004 2006 Unified Safety Fundamentals Commission and Committees Unified Safety Fundamentals Overall Structure Action Plan CSS COMMISSION ON SAFETY STANDARDS NUSSC RASSC WASSC TRANSSC 2003 2004 2006

History (cont’d) Long Term Structure New Format 2008 2010 2011

Legal Status of the IAEA Safety Standards Safety Standards are not binding on Member States, but may be adopted by them. However… Safety Standards are binding for IAEA’s own activities. on States in relation to operations assisted by the IAEA. on States wishing to enter into project agreements IAEA.

Paradigm for developing safety standards 103 The 2007 Recommendations of the International Commission on Radiological Protection The revised BSS will be based on: the scientific evidence analysed by UNSCEAR, the recommendations of ICRP, and the Fundamental Safety Principles. The new Safety Requirements will include all the essential prescriptive criteria for radiation safety that underpin publications in the Safety Standards Series, such as: requirements defining responsibilities for safety; measures for protection of workers, patients and the public; numerical values of dose limits, action levels, exemption levels, etc. These basic requirements apply across the spectrum of circumstances of exposure to radiation, including nuclear power generation, industrial applications of radiation technology, radioactive waste disposal, and transport of radioactive material. Effects of radiation Recommendations for protection 9

Safety Standards Fundamental Safety Objective Safety Guides Safety Fundamentals Safety Requirements “to protect people and the environment from harmful effects of ionizing radiation” Apply to all facilities and activities that give rise to radiation risks

Fundamental Safety Principles (2006) 10 Fundamental safety principles for protecting people against ionizing radiation Basis for all other IAEA Safety Standards

Fundamental Safety Principles Safety Principle 1: Responsibility for safety: The prime responsibility for safety must rest with the person or organization responsible for facilities and activities that give rise to radiation risks. Safety Principle 2: Role of government: An effective legal and governmental framework for safety, including an independent regulatory body, must be established and sustained. Safety Principle 3: Leadership and management for safety: Effective leadership and management for safety must be established and sustained in organizations concerned with, and facilities and activities that give rise to, radiation risks.

Fundamental Safety Principles (cont’d) Safety Principle 4: Justification of facilities and activities: Facilities and activities that give rise to radiation risks must yield an overall benefit. Safety Principle 5: Optimization of protection: Protection must be optimized to provide the highest level of safety that can reasonably be achieved. Safety Principle 6: Limitation of risks to individuals: Measures for controlling radiation risks must ensure that no individual bears an unacceptable risk of harm. Safety Principle 7: Protection of present and future generations: People and the environment, present and future, must be protected against radiation risks.

Fundamental Safety Principles (cont’d) Safety Principle 8: Prevention of accidents: All practical efforts must be made to prevent and mitigate nuclear or radiation accidents. Safety Principle 9: Emergency preparedness and response: Arrangements must be made for emergency preparedness and response for nuclear or radiation incidents. Safety Principle 10: Protective actions to reduce existing or unregulated radiation risks: Protective actions to reduce existing or unregulated radiation risks must be justified and optimized.

Responsibility for safety 4/17/2018 Responsibility for safety The IAEA Fundamental Safety Principles (SF-1) place the prime responsibility for safety on the person or organization responsible for facilities and activities that give rise to radiation risks. It is the role of the regulatory body to set the rules and to assure compliance It is the role of the person or organization responsible for facilities and activities, and all other parties having responsibilities for safety, to follow the rules. SF-1 Fundamental Safety Principles Principle 1: Responsibility for safety “The prime responsibility for safety must rest with the person or organization responsible for facilities and activities that give rise to radiation risks.” This responsibility of the operator is not diminished by the existence of a programme of routine regulatory compliance inspections. BSS: The principal parties shall permit duly authorized representatives of the Regulatory Authority, and of the relevant Sponsoring Organizations when applicable, to inspect their protection and safety records and to carry out appropriate inspections of their authorized activities.” IAEA SS #115 (Basic Safety Standards) GS-R-1: § 5.12. “The regulatory body shall conduct inspections to satisfy itself that the operator is in compliance with the conditions set out, for example, in the authorization. BSS REVISION (DRAFT) 2.39 The person or organization responsible for any facility or activity that gives rise to radiation risks shall have the prime responsibility for protection and safety, which cannot be delegated. 2.40 The principal parties responsible for protection and safety are: (a) Registrants or licensees, or the person or organization responsible for facilities and activities for which notification only is required; (b) Employers, in relation to occupational exposure; (c) Radiological medical practitioners, in relation to medical exposure; (d) Those persons or organizations designated to deal with emergency exposure situations or existing exposure situations. 2.41 Other parties shall have specified responsibilities in relation to protection and safety. These other parties include: (a) Suppliers of sources, providers of equipment and software, and providers of consumer products; (b) Radiation protection officers; (c) Referring medical practitioners; (d) Medical physicists; (e) Medical radiation technologists; (f) Qualified experts or any other party to whom a principal party has assigned specific responsibilities; (g) Workers other than workers listed in (a)–(f); (h) Ethics committees. 3.4 Strategies for Inspections and the Inspection Programme 15

Governmental, Legal and Regulatory Framework for Safety (2010) General Requirements for the national regulatory infrastructure for safety Regulatory framework Establishment of an effectively independent Regulatory Body Core regulatory functions: Authorization, inspection, enforcement

Transport Safety (2012) Transport regulations for all radioactive materials Basis for international transport regulations

Basic Safety Standards (BSS) International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources Safety Standards Series No. 115 (1996): The recommendations contained in ICRP Publication 60 have been incorporated into the BSS (1996). The BSS(1996) has been revised taking into account the new ICRP publication 103 The new BSS is GSR Part 3 (interim, 2011) IAEA Training Course for Regulators on Enforcement Module 1.2 18

Basic Safety Standards (2014) A key Standard since 1960, co-sponsored by several international organizations Comprehensive set of requirements covering all aspects of radiation protection and safety All exposure situations: planned, emergency, and existing situations All categories of exposed people: workers, patients, public Reference document for national radiation safety regulations

Leadership and Management for Safety-2016 Sets requirements for establishing, assessing, sustaining and continuously improving effective leadership and management for safety in organizations concerned with, and facilities and activities that give rise to, radiation risks includes the regulatory body and other competent authorities, and the organization responsible for the facility or for the activity.

Code of Conduct on the Safety and Security of Radioactive Sources (2004) Not a Safety Standard For Governments and Regulatory Bodies Set of objectives and principles for the control of sources Additional Guidance on import/export Topics include: national register of sources, strategies for disused sources, orphan sources…

State Political Commitment to the Code of Conduct In September 2003, GC urged each State to write to the Director General that: it fully supports and endorses the Agency's efforts to enhance the safety and security of radioactive sources; and It is working toward following the guidance contained in the Code and encourages other countries to do the same. (GC47/Res7) As of 27 March 2013, 120 States have written to the Director General Made a commitment IAEA Training Course for Regulators on Enforcement Module 1.2

Basic Principles States should take appropriate measures to ensure that radioactive sources are kept safe and secure throughout their whole life-cycle (recognizing that the prime responsibility is with the authorized user) This requires: Effective national legislation, regulations and a regulatory body paragraphs 7–22 of the Code; and Effective import/export controls paragraphs 23-29 of the Code + supplementary Guidance

SSG-19 National Strategy for Regaining Control Over Orphan Sources and Improving Control Over Vulnerable Sources

RS-G-1.9 Categorization of Radioactive Sources

SSG-17, Orphan Sources and Other Radioactive Material in the Scrap Metal and Recycling Industries (2012) Recommendations on meeting safety requirements in relation to the presence of radioactive material in scrap metal Responsibilities and actions concerning the discovery of radioactive material and regaining control over it Scope is primarily domestic

Summary The IAEA establishes safety standards and guidance about how to implement them The standards evolve through time and are based on international knowledge and experience Some safety standards are or may be made legally binding At the core are the safety fundamentals followed by the general safety requirements Orphan sources are addressed in several IAEA specific safety standards