IAEA Safety Publications Related to Regulatory Infrastructure Safety Fundamentals SF 1 Safety Requirements GSR Part 1, GSR Part 3 School of Drafting Regulations, Vienna, November / December 2012 Stephen Evans

Outline Introduction to the IAEA Safety Standards Safety Fundamentals GSR Part 1 Governmental, Legal and Regulatory Framework for Safety GSR Part 3 Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards Draft Model Regulations

IAEA Safety Standards Categories Safety Fundamentals Safety Requirements Safety Guides

IAEA Safety Standards Categories Fundamental safety objectives and principles for protecting people and environment Requirements that must be met to ensure protection of people and the environment – “shall” statements Recommended ways of meeting the requirements

IAEA Safety Standards In 1958, the IAEA published its first Safety Standard Safety Series No. 1, Safe Handling of Radioisotopes Over the years, some 200 publications have been issued in the Safety Series

IAEA Safety Standards In 1996 , the Department of Nuclear Safety established: a new approach to developing Safety Standards Harmonized processes involving: the Commission on Safety Standards (CSS); the four Safety Standards Committees; preparation of an overall structure for the Safety Standards.

Commission & Committees on Safety Standards (CSS) Nuclear Safety Standards Committee (NUSSC) Radiation Safety Standards (RASSC) Waste Safety Standards (WASSC) Transport Safety Standards (TRANSSC)

Commission & Committees The Commission on Safety Standards and the Committees were established with the objective of achieving consensus, quality, coherence and consistency in the development of international standards for safety. IAEA safety standards are developed in close consultation with Member States and with representatives of relevant international organizations. Approval by the Board of Governors is required for Safety Fundamentals and Safety Requirements. The authority to establish Safety Guides has been delegated to the IAEA Director General. Consensus at the highest level The Commission on Safety Standards and the Committees were established with the objective of achieving consensus, quality, coherence and consistency in the development of international standards for safety. The Commission has a special overview role in the preparation and review of the IAEA safety standards. Consensus on what constitutes a high level of safety is reached at the highest level: IAEA safety standards are developed in close consultation with Member States (through their representatives in the Commission and Committees and the 120 day comment period) and with representatives of relevant international organizations. Approval by the Board of Governors is required for Safety Fundamentals and Safety Requirements. The authority to issue Safety Guides has been delegated to the IAEA Director General.

Fundamental Safety Principles Unified 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.” Principle 2: Role of government “An effective legal and governmental framework for safety, including an independent regulatory body, must be established and sustained.”

Fundamental Safety Principles Principle 3: Leadership and management for safety Principle 4: Justification of facilities and activities “Facilities and activities that give rise to radiation risks must yield an overall benefit.” Principle 5: Optimization of Protection “Protection must be optimized to provide the highest level of safety that can reasonably be achieved.”

Fundamental Safety Principles Principle 6: Limits on risks to individuals “Measures for controlling radiation risks must ensure that no individual bears an unacceptable risk of harm.” Principle 7: Protection of present and future generations and the environment Principle 8: Prevention of accidents Principle 9: Emergency preparedness and response Principle 10: Protective actions to reduce existing or unregulated radiation risks

Governmental, Legal & Regulatory Framework for Safety (GSR Part 1) Published in 2010 Applicable to all States, for all types of facilities and activities Three sets of requirements: Responsibilities and functions of the Government The global safety regime Responsibilities and functions of the regulatory body

Governmental, Legal & Regulatory Framework for Safety (GSR Part 1) Responsibilities and functions of the Government Safety policy Safety framework Establishment of an independent regulatory body Emergency preparedness and response Waste management Existing exposure situations

Governmental, Legal & Regulatory Framework for Safety (GSR Part 1) The global safety regime International obligations and cooperation Sharing of operating experience and regulatory experience

Governmental, Legal & Regulatory Framework for Safety (GSR Part 1) Responsibilities and functions of the regulatory body Organization Staffing and Training Management system Authorization Inspection Enforcement Regulations and Guides

International Basic Safety Standards GSR Part 3 Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards Published 2011

Comprehensive character of the BSS Regulatory control of exposure Occupational and public exposure from practices Safety of sources Safety of radioactive waste Medical exposure Existing exposure situations Emergency preparedness Rehabilitation Basis for safe transport The essential protection and safety requirements of the BSS underpin all circumstances of exposure to radiation Many countries have stressed the need to retain the comprehensive character of the BSS. The essential protection and safety requirements, including requirements for regulatory control of sources, justification, optimization, responsibilities of the various parties, numerical values of dose limits, exemption levels, etc, underpin all circumstances of exposure to radiation. This does not mean that a revised BSS will absorb other existing Safety Requirements, such as GS-R-1 and GS-R-2, but that appropriate essential requirements will be included in the revised BSS for completeness, with cross-linkages to the detailed requirements in other documents.

Structure of the BSS – GSR Part 3 Three exposure situations: Planned exposure situations Emergency exposure situations Existing exposure situations Three categories of exposure Occupational Public Medical

Responsibilities in the BSS Responsibilities for implementing requirements assigned, as appropriate, to: Government Regulatory body or other national authority Registrants and licensees Employers Radiological medical practitioners Manufacturers and other suppliers Emergency response organizations

BSS Section 2: General requirements for protection and safety Section 2 contains requirements that are applicable to all three exposures situations (planned, emergency, existing) It establishes the three radiation protection principles Justification Optimization of protection of safety Dose limitation Noting that: Justification and optimization apply to all three exposure situations; Dose limitation only applies to planned exposure situations, excluding medical exposure

BSS Section 2: General requirements for protection and safety Responsibilities of government / regulatory body As in GSR Part 1 Responsibilities of other parties Prime responsibility for safety – registrants & licensees Principal parties: Registrants and licensees, and those responsible for notified practices Employers – occupational exposure Radiological medical practitioners - medical exposure Designated persons or organizations to deal with emergency exposure situations or existing exposure situations

BSS Section 3: Planned Exposure Situations - Scope Practices, including: use of radiation or radioactive material in industry, medicine, etc.; mining and processing of raw materials that leads to exposure due to radioactive materials; generation of nuclear power and other activities in nuclear fuel cycle. Sources within practices, including: facilities that contain radioactive material and radiation generators, e.g.: Medical radiation facilities Irradiation facilities Radioactive waste management facilities Mineral extraction & mineral processing facilities Nuclear installations individual sources of radiation Occupational, medical and public exposure Some natural sources above specified levels

BSS Section 3: Planned Exposure Situations - Generic Requirements Requirements include: Graded approach Notification & Authorization Exemption & Clearance Responsibilities of Registrants & Licensees Justification Optimization of protection and safety Dose limits

BSS Section 3: Planned Exposure Situations - Occupational exposure Requirements include: Responsibilities of regulatory body Monitoring and recording of exposures Responsibilities of employers and licensees Compliance by workers Arrangements for a Radiation Protection Programme Classification of (work) areas Local rules and personal protective equipment Monitoring of the workplace Assessment of occupational exposure Information, instruction and training Conditions of service Special arrangements – pregnant women, breast-feeding women, persons under 18 years of age

BSS Section 3: Planned Exposure Situations - Public exposure Requirements include: Responsibilities of Government and the Regulatory Body Establish and enforce requirements that require protection and safety be optimized and that public exposure is limited Responsibilities of relevant parties specific to public exposure Radioactive waste and discharges Monitoring and reporting Consumer products

BSS Section 3: Planned Exposure Situations - Medical exposure Requirements include: Responsibilities Government Regulatory body Licensees Justification of medical exposures Optimization of protection and safety Pregnant women & breast-feeding women Unintended & accidental medical exposures Reviews and records

BSS Section 4: Emergency Exposure Situations Requirements include that Government ensures: An emergency management system; preparedness and response to an emergency; arrangements for controlling the exposure of emergency workers; arrangements for the transition from an emergency exposure situation to an existing exposure situation

BSS Section 5: Existing Exposure Situations Scope includes: Exposure due to contamination by residual radioactive material, arising from: Past activities that were never regulated A nuclear or radiation emergency, after such has been declared ended Commodities that incorporate radionuclides arising from residual radioactive material Food, water, feed, building materials Exposure to natural sources, including: Radon in dwellings and workplaces Radionuclides of natural origin in commodities Exposure of aircrew and space crew to cosmic radiation

BSS Section 5: Existing Exposure Situations Requirements include: Responsibilities of Government Ensure that existing exposure situations that have been identified are evaluated from a radiation protection view point Specify general principles underlying protection strategies that can be used Assign responsibilities to establish & implement protection strategies Justification for protective actions & optimization of protection and safety Responsibilities for remediation of areas with residual radioactive material Public exposure due to radon indoors Exposure due to radionuclides in commodities Exposure in workplaces

Summary The combination of: the Fundamental Safety Principles, SF-1; Governmental, Legal & Regulatory Framework for Safety, GSR Part 1; and Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards, GSR Part 3 sets the requirements for establishing a national infrastructure for nuclear and radiation safety.

Application of the Safety Standards Notable application by MS: Formally adopted Direct use of Safety Standards Used as reference for review of national standards and as benchmark for harmonization

Current Status of the Safety Standards Since the establishment of the Safety Standards Series: Safety Fundamentals issued in 2006 Safety Requirements established from 1996 to 2010 In total 108 Safety Standards published Updated “Status of Safety Standards” on the web site: http://www-ns.iaea.org/standards/status.pdf Includes hyperlinks to the published Safety Standards in official languages Includes general information and link to the IAEA Safety Glossary

Legal Status of the IAEA Safety Standards Safety Standards are: non binding on Member States but may be adopted by them; binding for the IAEA’s own activities; binding on States in relation to operations assisted by the IAEA or States wishing to enter into project agreements with the IAEA. They are also: a condition for TC cooperation; used in the assessment of compliance with Safety Standards for project approval and source procurement.

Draft Model Regulations MODEL REGULATIONS FOR THE USE OF RADIATION SOURCES AND FOR THE MANAGEMENT OF THE ASSOCIATED RADIOACTIVE WASTE: Provides States with advice on appropriate regulations covering all aspects of the use of radiation sources and the safe management of the associated radioactive waste. Allows States to appraise the adequacy of their existing regulations and regulatory guidance documents. Covers the range of circumstances related to most facilities and activities using radiation sources; Provides guidance on matters to be addressed in national policy, strategy and regulations. Includes examples of texts as reference to assist national authorities, regulatory bodies, technical and legal experts in the development or review of regulations for radiation safety.

Draft Model Regulations MODEL REGULATIONS FOR THE USE OF RADIATION SOURCES AND FOR THE MANAGEMENT OF THE ASSOCIATED RADIOACTIVE WASTE: Supplements Safety Guide GS-G-1.5 in providing practical advice to States on the development of regulations for the safe use and control of radiation sources in medicine, industry, research, agriculture and education. Provides States with model provisions for regulations for the control of radiation sources and safe management of radioactive waste. Compatible with, and supplements, the ‘Handbook of Nuclear Law, Implementing Legislation’. You are encouraged to use these model regulations extensively during the School.

…Thank you for your attention IAEA Headquarters in Vienna, Austria. The IAEA was established in 1957.