Regulatory Body MODIFIED Day 8 – Lecture 3

Objectives To understand the essential functions and responsibilities of the Regulatory Body. MODIFIED

Contents responsibilities; interaction and cooperation; independence; functions; regulatory Program; technical services and expert assistance. MODIFIED

Regulatory Body The legislation should specify: the establishment and funding of an effectively independent Regulatory Body for the control of radiation safety; the Regulatory Body ’s responsibilities and functions; provisions for authority, power, high level of technical competence and human and financial resources. MODIFIED

Division of responsibilities A single Regulatory Body responsible for all aspects of radiation safety is most desirable. However, regulatory functions and responsibilities sometimes are divided among several government authorities, e.g: Transport; Environment; Public health and safety; Occupational safety. MODIFIED

Division of responsibilities (cont) Where responsibilities are divided, legislation should establish clear lines of authority and responsibility so that: gaps in protection and safety are prevented; overlapping of authority is minimized; conflicting requirements from separate authorities are prevented; the users of sources understand which of their activities are subject to various authorities.

Division of responsibilities (cont) Relevant Regulatory Bodies should establish a system of liaison and working procedures to ensure coordination and cooperation including, where appropriate, the development of Memoranda of Understanding (MoU) between government agencies. MODIFIED

Interaction with other national bodies The Regulatory Body must co-operate with other relevant authorities, advise and provide them with information on safety matters. MODIFIED

Regulatory Body Regulatory Body Consumer Protection Agency Customs Authority Defence Forces Regulatory Body Educational Authorities Emergency Coordination Authority Environmental Protection Authority MODIFIED Fire Services Food / Agriculture Authority Health Ministry Local Government Authorities

Regulatory Body Regulatory Body Mining / Minerals regulation National Standards Authority Oil / Gas - exploration & regulation Regulatory Body Police Services Power generation Professional & Registration Bodies MODIFIED Sewerage Authority Transport Regulation Water Supply Authority

MODIFIED

Cooperation on international level The Regulatory Body also should have arrangements on an international level. Bilateral agreements Multilateral agreements MODIFIED

Independence of the Regulatory Body Is established by Government through legislation. Is effectively independent in its decision making The Regulatory Body’s shall have sufficient authority, staffing and financial resources. There is clear functional separation of the Regulatory Body’s functions from those of other government agencies or other organizations having responsibility for development and promotion of regulated practices. MODIFIED

Independence of the Regulatory Body (cont) There needs to be clear separation of the Regulatory Body from practices and others subject to regulation (i.e. from licensees, manufacturers, etc.) Avoidance of engagement in activities with regulated operators which could endanger the Authority’s independence. For example: consultant services; any financial agreements or support. MODIFIED

from those subject to Regulation: Independence of the Regulatory Body (cont) from those subject to Regulation: Licensees Health services Regulatory Body Manufacturers MODIFIED Laboratory services Training services Waste facilities Others

Independence of the Regulatory Body (cont) If the Regulatory Body has functions such as: testing and quality control measurements; initiating safety related research and development; providing personnel monitoring services, care must be taken to ensure that all conflicts with the main regulatory functions are avoided and that the prime responsibility of the radiation user for safety is not diminished. MODIFIED

Empowering the Regulatory Body The Regulatory Body shall be empowered to: develop safety principles and criteria; establish regulations and issue guidance documents and advice; require operators to conduct safety assessments; require necessary information from the operator; issue, amend, suspend or revoke authorizations; MODIFIED

Empowering the Regulatory Body (cont) The Regulatory Body shall be empowered to: enter a site or facility at any time to carry out inspections; inspect relevant facilities and documents; enforce the regulatory requirements; communicate directly with government authorities; MODIFIED

Empowering the Regulatory Body (cont) The Regulatory Body shall be empowered to: obtain necessary documents from other organizations; independently communicate to the public its regulatory requirements, decisions and opinions, and their basis. MODIFIED

Empowering the Regulatory Body (cont) The Regulatory Body shall be empowered to: inform other government bodies, national and international organizations, and the public, on incidents, accidents and other safety related abnormal occurrences; liase and coordinate with other government or non-government authorities having competence in health and safety, environmental protection, security and transport; liase with Regulatory Bodies of other countries and with international organizations to promote cooperation. MODIFIED

The Regulatory Program shall include: preparing regulations for radiation protection and safety; implementing procedures for notification, authorization, review and assessment, inspection and enforcement; providing for exemptions; performing inspections and other compliance monitoring; taking enforcement actions in the event of violations of requirements; investigating accidents and managing emergencies; disseminating information on protection and safety; establishing, implementing and assessing and improving a management system. MODIFIED

Internal Procedures The Regulatory Body shall establish procedures: for receiving and assessing notifications and applications for registration or licence; for creating or modifying conditions of an authorization or of a class of authorizations; for providing guidance to the radiation users; for review and assess relevant information for safety; to ensure that appropriate explanations are provided to applicants for the rejection of authorizations; MODIFIED

Internal Procedures (cont) The Regulatory Body shall establish procedures: to prepare, conduct and follow up inspections; to enforce regulatory requirements; for communication with, and the provision of, information to other governmental bodies, international organizations and the public; to ensure that user experience (incidents, accidents, etc.) is appropriately analysed and that any lessons to be learned are disseminated; to ensure that records relating to the safety of facilities and radiation practices are retained and retrievable; MODIFIED

Internal Procedures (cont) The Regulatory Body shall establish procedures to: ensure that its regulatory criteria are adequate and valid, and that international standards are taken into account; establish, and inform the operator of, any requirements for regular safety reassessments or periodic reviews; ensure government is kept informed of important radiation safety issues; verify the qualifications, training and experience of personnel responsible for the safe operation of the facility or practice. MODIFIED

Technical Services Technical services include: dosimetry services laboratory services calibration services waste management medical services training services expert assistance

Technical Services (cont) Essential technical services (for both radiation users and the Regulatory Body) should be available within the State. External technical services may be used but require Regulatory Body approval. MODIFIED

Expert Assistance Consultants Consultants should be effectively independent of the operator. The use of consultants shall not relieve the Regulatory Body of any of its responsibilities. The Regulatory Body’s responsibility for making decisions and recommendations shall not be delegated. MODIFIED

Expert Assistance (cont) Advisory Bodies Advisory bodies may be formally appointed by Government or the Regulatory Body. Advisory bodies are established either on a temporary or permanent basis to give independent expert opinion or advice (e.g. on technical or ethical issues). Advice offered shall not relieve the Regulatory Body’s responsibility for making decisions. MODIFIED Advisory bodies to the Regulatory Body should have an adequate number of member so that a range of views can be presented. Nominations for membership should be called from relevant professional bodies.

Regulatory Body Personnel and Training In order to properly fulfil its statutory obligations the Regulatory Body requires an appropriate number of personnel: who are appropriately qualified; and who have received appropriate training. MODIFIED

References Governmental, Legal and Regulatory Framework for Safety. General Safety Requirements Part 1 (IAEA Safety Standard Series No. GSR Part 1). Vienna 2010. Handbook on Nuclear Law: Volume 1 & 2 (2010). MODIFIED

Exercise A Regulatory Body is established by legislation to control radiation safety. As there are no such services available in the country, the Regulatory Body is also running a national dosimetry service and a national waste repository. What administrative and other measures should be considered to ensure the effective independence of regulatory actions (e.g. decisions, inspections, enforcement)? MODIFIED Example of measures to ensure independence: Responsibilities and functions of separate departments/sections within the Regulatory Body are clearly defined in legislation and/or in internal guidance. Funding for regulatory operations is provided through the State budget, and it is not depending on fees for technical services. Same persons are not involved both in regulatory activities and in service functions. Advice of independent consultants is used. Independence of regulatory processes is periodically reviewed by assessors from other organizations and by internal audits.