International Atomic Energy Agency Establishing the Infrastructure for

International Atomic Energy Agency Establishing the Infrastructure for Radiation Safety Preparatory Actions and Initial Regulatory Activities

The Government is responsible for developing the national regulatory infrastructure for radiation safety The Government should: • Design an integrated roadmap that fits the national circumstances to develop national regulatory infrastructure in line with IAEA safety standards International Atomic Energy Agency

Considerations by the Government in developing notational regulatory infrastructure for radiation safety • national circumstances, • legal system in the State, • governmental structure, • availability of human, technical and financial resources International Atomic Energy Agency

Areas for National Regulatory Infrastructure for the Control of Radiation Sources • Legal framework for safety laws or acts for radiation safety To provide for the legal frame to regulate the use of radiation sources in the country • Regulatory framework for safety regulatory body and regulatory system Established by the Law to ensure the implementation of the provisions of the Law International Atomic Energy Agency

Legal and Regulatory Infrastructure Radiation Safety Law to provide for the legal frame to regulate the use of radiation sources in the country Establishing Independent Regulatory Body Provided with established by the Law to ensure the implementation of the provisions of the Law Resources, Funds, Staff Empowered Licensing Inspection Enforcement Regulations International Atomic Energy Agency

Radiation Safety Law Steps for enacting the Radiation Safety Law: 1. Designate a body to draft the law Committee encompassing legal, political and technical experts in radiation safety 2. Draft the law IAEA standards, international obligations, inputs from interested parties 3. Review of the draft by IAEA to ensure its compliance with IAEA safety standards 4. Finalise the draft law 5. Approval of the law International Atomic Energy Agency

Radiation Safety Law cont. The legislative framework for safety should cover, inter alia, the following: o o o The safety principles for protecting people, society and the environment from radiation risks, both at present and in the future; Provisions for assigning the prime responsibility for safety to the persons or organizations responsible for the facilities and activities, The types of facilities and activities in its scope The establishment of an independent regulatory body; Provisions for the authorization of facilities and activities; International Atomic Energy Agency

Radiation Safety Law cont. o o o Provisions for the inspection of facilities and activities; Provisions for enforcement and for the specifications of offences and the corresponding penalties; The authority and responsibility of the regulatory body for promulgating (or preparing for the enactment of) regulations and preparing guidance for their implementation; Provision for appeals against decisions of the regulatory body; Provisions for communication and consultation of the regulatory body with interested parties and the public International Atomic Energy Agency

Radiation Safety Law cont. The designated body for drafting the Law should ensure that: The draft legislation provides for functional separation of the regulatory body from governmental departments or agencies and other organizations that are charged with the promotion of radiation applications or are responsible for facilities or activities International Atomic Energy Agency

How long it will take for the Country to approve the Law and establish the regulatory body? • Establishment of the legislative framework and regulatory framework for safety will take time depending on the country system in drafting, reviewing and approving and implementing Laws. Meanwhile : • Government should, as far as practicable, ØTake actions to protect public, workers, patients and the environment from harmful effects of ionizing radiation using the existing legislative and governmental framework INITIAL REGULATORY ACTIVITIES WITHIN THE EXISTING LEGISLATIVE FRAMEWORK International Atomic Energy Agency

Initial Regulatory Activities within the existing legal framework The Government: explore and implement possible activities for controlling radiation sources within the existing legal framework • • Some of the actions relating to establishing the national radiation safety infrastructure could be taken by the government within the existing legislative and governmental framework Several governmental agencies as defined in their existing legislative framework are authorised to perform some initial regulatory activities for example : o Customs authorities may have responsibility for controlling the import and export of radiation sources o Ministry of Health may have responsibility for performing some initial regulatory activities relating to the use of ionizing radiation in the medical field International Atomic Energy Agency

Initial Regulatory Activities within the existing legal framework Cont. • should be conducted in parallel with the process of establishing the legislative framework for safety • should not lead to: or - Unnecessary delays in developing the legislative framework - Fragmentation of regulatory control among different bodies International Atomic Energy Agency

Initial Regulatory Activities within the existing legal framework Cont. Who will implement these actions? Government should appoint: Steering Group (SG) • existing organization or • newly established organization or • Committee from representatives of the main interested parties in the State SG should: Collate information on the relevant national legal and administrative instruments International Atomic Energy Agency

Actions to be taken within the existing legal framework Collection of the necessary information on the radiation sources and their users in the State Actions to be taken within the existing legal framework To register import and export of radiation sources and make this information available to other relevant authorities Establish requirements for radiation safety within the existing legal framework Maintain cooperative relationships with the users of ionizing radiation and should promote awareness of measures to enhance safety International Atomic Energy Agency

Action 1 Collection of the necessary information on the radiation sources and their users in the State steering group should: § Conduct survey of radiation sources and facilities in the country § identify possible means for obtaining relevant information about the inventory of radiation sources within the area of competence of each relevant authority ü An important mean is to make arrangements with other authorities and organizations for regular provision of such information. Example: customs authorities to provide information on the import and export of radiation sources regularly International Atomic Energy Agency

Action 1 Cont. Collection of the necessary information on the radiation sources and their users in the State Other sources of information could be Notifications by the suppliers and users of radiation sources: q on a voluntary basis, q when requested or q in response to instructions by the government within the existing legislative framework. Facilitated by q Distribution of questionnaires q media announcements q To perform site visits to facilities where radiation sources are likely to be used in: o medical facilities, o industrial complexes, construction sites, o oil industry facilities, research centres and o universities. IMPORTANT The collected information on radiation sources and their users should be properly managed, kept up-to-date and ultimately transferred to the regulatory body, once it has been established by Law International Atomic Energy Agency

Action 2 ØExamples: To register import and export of radiation sources and make this information available to other relevant authorities Customs, Port Authorities, …. usually have records of the import and export of all goods including records on the import and export of radiation sources ØImport and export data should be made available to the relevant authorities (For Action 1 ) ØFormal arrangements should be in place to facilitate such exchange of information such as: o official correspondence or o memorandum of understanding International Atomic Energy Agency

Action 3 Establish requirements for radiation safety within the existing legal framework Ø Certain authorities may have a mandate within the existing legislative framework to establish and enforce requirements relating to radiation safety in their areas of competence Examples of possible mandates Health Authorities Labour Authorities in establishing radiation safety requirements in the medical field and to inspect medical facilities in establishing radiation safety requirements relating to occupational exposure Environment Authorities Transport Authorities in establishing requirements relating to discharges and other areas of environmental protection in establishing requirements for the safe transport of radioactive material Agencies that have the power to inspect facilities and activities for reasons other than radiation safety may be able to include radiation safety within the scope of their inspection International Atomic Energy Agency

Action 3 Cont. Establish requirements for radiation safety within the existing legal framework The relevant authorities should: o develop the necessary competence for the establishment and enforcement of radiation safety requirements o ensure that the requirements are in compliance with the IAEA safety standards and international arrangements or regulations as applicable Important Consideration should be given to ensuring the smooth transfer of responsibility for enforcing such safety requirements to the regulatory body when it is established and integrated into the radiation safety regulations that will be established International Atomic Energy Agency

Action 4 The relevant authorities should Maintain cooperative relationships with the users of ionizing radiation and should promote awareness of measures to enhance safety Promote awareness of safety within the existing legislative framework Through: Establish with the users (or potential users) of ionizing radiation and other interested parties formal or informal arrangement for: q seminars q conferences q training courses q media q Internet q promoting the exchange of information and experience q providing advice q promoting safety culture q encouraging the implementation of safety measures q strengthening staff training and International Atomic Energy Agency qualifications

REGULATORY FRAMEWORK FOR SAFETY • The establishment of legislative framework for safety marks a significant milestone on the roadmap to the national radiation safety infrastructure. • Once the legislative framework for safety is in place, regulatory responsibilities shall be clearly assigned to the newly established regulatory body. International Atomic Energy Agency

REGULATORY FRAMEWORK FOR SAFETY Cont. Once the legislative framework for safety is in place and the regulatory body has been established, the government should: § Cease those initial regulatory activities § Ensure that the associated responsibilities are transferred to the regulatory body. § Ensure that all relevant information and records relating to the initial regulatory activities are made available to the regulatory body. International Atomic Energy Agency

Regulatory Framework for Safety(Cont. ) set out requirements for the regulation of facilities and activities set out development of the other areas of the national radiation safety infrastructure The newly established regulatory body should apply a graded approach to gradually building the regulatory system prioritize its activities needed International Atomic Energy Agency

Regulatory Framework for Safety (Cont. ) Issues to be considered by newly established regulatory body: ØImplementation of Core Regulatory Functions • • • Notification Authorization Inspection Enforcement Development of regulations and guides ØIts Organizational Structure and Competence ØEstablishment of Safety Related Records ØMeans of Communication and Consultation International Atomic Energy Agency

IAEA Assistance • Sensitisation events • Advise the national authorities • Review the draft law • Train the Steering Group members • Provide some equipment • Send experts • Assist to participate in regional events for experience exchange International Atomic Energy Agency