Nuclear and Treaty Law Section Office of Legal Affairs IAEA Regional Workshop School on Drafting / Reviewing Regulations Radiation Safety stream 16-27 January 2017 Overview of the Legal Framework Abdelmadjid Cherf Senior Legal Officer Nuclear and Treaty Law Section Office of Legal Affairs

Legal Framework for Safety International component National component

Legal Framework for Safety National Legal Hierarchy Constitution Primary Legislation Laws, Acts, Statutes Secondary Legislation Regulations – Decrees, Orders Guidance Documents Drafted by constituent assembly/government and adopted through referendum Prepared by the Government or the Parliament and adopted by the Parliament Prepared by the government or expert bodies such as regulatory body Issued by regulatory body

Legal Framework for Safety National Policy for Safety Drafted by the Parliament or the Government, Should reflect the understanding of the Government of the need to give full consideration to safety when using nuclear technologies, Objective: Establish the appropriate safety infrastructure, Reflects national priorities, Contains background information on the national circumstances, the existing and planned activities, human and financial resources, Takes into account societal aspects, and also the international instruments to which the State is a party, Includes the Fundamental Safety Principles ( prime responsibility for safety, protection of people and the environment, present and future, prevention of accidents, establishment of an independent regulatory body, etc.) It shall be implemented according to a graded approach to ensure that the activities and facilities involving nuclear material and radiation sources receive appropriate attention by the Government or by the regulatory body. Provides for the international cooperation.

Legal Framework for Safety National Strategy for Safety Sets out the mechanisms to implement the National Policy for Safety, Shall establish a comprehensive set of legal, technical and administrative arrangements to ensure that all sources are under control, Shall define the regulatory approach.

Legal Framework for Safety Laws/Acts/Statutes Form of the law: a unified comprehensive law or separate laws. Establish the general framework governing activities involving ionising radiations. Must be adapted to the nature and extent of the facilities and activities to be regulated. Establish the regulatory body with its functions and determine responsibilities. Regulations Provide details and explanations on how the law is implemented. Establish requirements with which all operators must comply. Such regulations shall provide a framework for more detailed conditions and requirements to be incorporated into individual authorizations. Should be closely linked to the law they are implementing and any other relevant laws ( environmental, health, labour, etc.). Should be adapted to the nature and extent of the facilities and activities to be regulated and commensurate to the magnitude and the nature of the risks in the country.. Performance-oriented regulations vs. prescriptive regulations

Legislative Process Drafting Team (legal and technical experts). Clear understanding of relevant issues to be addressed in the law and regulations. Assessment of current and future nuclear applications programs and plans. Assessment of laws and regulatory arrangements. Initial draft. Stakeholder’s input. IAEA review of the draft. First review of initial draft. Further legislative consideration. Adoption and promulgation of final text.

Legal Framework for Safety Necessity to take into account related legislation Health Transport Emergency Preparedness and Response Environmental Protection Import and Export Labour

Elements of a comprehensive nuclear law General Provisions Objective Scope Prohibitions Definitions

Elements of a comprehensive nuclear law The Regulatory Body Establishment of an independent regulatory body Functions of the regulatory body Human and financial resources Advisory bodies Main Regulatory activities Notification Authorisation Inspection Enforcement and appeals against regulatory decisions Penalties

Elements of a comprehensive nuclear law Specific Provisions Radiation protection principles Regulatory Control for Radiation Protection Primary Responsibility and Duties of the Authorized Person Occupational, medical and public exposures Safety and Security of Radioactive Sources Export and Import of Radioactive Sources Recovery of Orphan Sources Mining and milling activities

Elements of a comprehensive nuclear law Specific Provisions Radioactive waste management Decommissioning of facilities Transport of radioactive material Emergency preparedness and response Nuclear Security, physical protection and illicit trafficking Safeguards and Import export controls Sanctions Transitory and final provisions

General Structure of Regulations Title and preamble Determined by the scope and objectives and should reflect the content of the regulations. Date / Reference number Regulations may begin with a recitation of the considerations that have motivated their issuance called “preamble” or “exposé des motifs”. The preamble should reflect the basic content of the regulations and may help in interpreting and implementing them. General provisions - Link with the law that authorizes the regulatory body or the government Minister to issue regulations in a particular field

General Provisions of Safety Regulations Objectives/Purpose of the regulations Establish the requirements for the protection of people and the environment against the harmful effects of ionising radiations, Establish the requirements to achieve and maintain a high level of safety for radiation sources.

General Provisions of Safety Regulations The scope of application Define to what field the regulations apply. It shall specify facilities, activities and materials that are covered by the scope of the regulations and what is excluded from the scope. Identify the persons/entities responsible for applying the regulations. Identify the persons /entities who must comply with the regulations. Exemptions/Clearance.

General Provisions of Safety Regulations Definitions Include definitions of the terms used in the regulations / Ensure consistency of the definitions with relevant laws and international instruments, including standards. Transitional and Final Provisions Validity of existing licences. Timeframe for the application of authorisations. Entry into force The date of entry into force shall be specified. Postponement in complying with specific articles may be granted in certain specific cases.

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