1. IAEA International Atomic Energy Agency PGEC Part IV The International System of Radiation Protection and the Regulatory Framework Module IV.8 Legal framework for radiation protection and the safe use of radiation sources Postgraduate Educational Course in radiation protection and the Safety of Radiation sources

2. IAEA This module will discuss 1. Legislative framework: Scope of basic legal framework: Statutory base; enabling legislation 2. The Regulatory body : Mandate of regulatory authorities; Responsibilities; organization; adequate resources; Training, qualification of staff; Advisory committees & consultants 3. Safety culture of staff at all levels: priority to safety : policies, procedures; responsibilities; the lines of authority for making decisions; organizational arrangements; communication lines; examples of safety culture Overview of Module IV.8 2 key references

3. IAEA 1. Legislation  Objectives of section 1 - Legislation To discuss the basic legal framework & purpose of legislation To discuss the elements and concepts to be included in legislation To discuss the statutory base & enabling legislation To discuss the IAEA sample legislation

4. IAEA 1. Basic purpose of legislation  Use of radiation can be beneficial  Radiation may be harmful  Protection is needed Workers Members of the public Patients Environment  Protection should permit beneficial uses of radiation

5. IAEA 1. Structure of Legal framework Principle requirements Detailed requirements Practice specific requirements or guidance Legislation Regulations Codes of practice

6. IAEA 1. Elements and concepts of legislation  Enabling legislation Basic legal document enacted by the national legislative body Simple as feasible – need for subsequent amendments should be minimised Consistent with national situation – realistic expectations and effective use of resources more important than “an ideal system”

7. IAEA 1. Elements and concepts of legislation Scope of the legal framework Establishment of regulatory body Allocation of responsibilities Establishment of fundamental protection principles and structures Interagency co-ordination and co-operation Mechanism for appealing (Establishment of services and facilities needed, but not otherwise available)

8. IAEA 1. Scope of the legislation  General definitions, e.g.: All situations involving exposure or the potential for exposure to ionising radiation Exclusions (e.g. K-40 in human body,…) Concept of exemption (specific criteria and values to be defined in regulations)

9. IAEA 1. Establishment of regulatory body  Independence Formal independence from promotional and regulated activities Not always possible, but effective independence desired  Means of funding National fiscal process (state budget) Fees (authorizations, inspections,..)

10. IAEA 1. Establishment of regulatory body  Powers and responsibilities, e.g.: To issue regulations Supervisory and enforcement powers To decide on exclusions and exemptions To decide on detailed conditions for authorization To assist in emergency response

11. IAEA 1. Allocation of responsibilities  Relation to other laws Laws on Nuclear Energy, Safety in Mining, Labour Protection, Environmental Protection, Medical practices, Transport,etc.  Allocation of responsibilities Ministries of Social Affairs and Health, Trade and Industry, Environment, Internal Affairs, etc. 

12. IAEA 1. Establishment of key protection principles and structures 1  Key principles Justification of practices, optimisation of protection, dose limitation  Obligations of the responsible party Prime responsibility of safety  System of authorization and notification  System of protection of workers  1 Not included in the IAEA sample legislation; these are considered in the IAEA sample regulations

13. IAEA 1. Interagency co-ordination and co-operation l Link between Customs Authorities and the Regulatory body l Authorization for the Regulatory body to enter into agreements with other regulatory bodies Prevention of gaps and overlaps in Memorandum of understanding

14. IAEA 1. Appeals Mechanism for appealing against decisions made by the Regulatory body

15. IAEA 1. (Establishment of services and facilities)  Services and facilities essential for radiation safety, i.e.: Personal dosimetry Training services Environmental monitoring Facilities for waste storage and disposal Metrology and calibration services  Note: might be provided through legislation if such services are not otherwise available

16. IAEA 1. IAEA TECDOC 1067 – published 1999 Introduction & explanatory text p 1 – p 25 Sample legislation, p. 27 – p 33 Sample Regulations p34 – p 83 

17. IAEA Objectives of section 2 In relation to regulatory authorities, discuss their Mandate Responsibilities; organization; Adequacy of resources; training, qualification of staff; Advisory committees & consultants 2. The Regulatory body

18. IAEA responsibilities; interaction and co-operation; independence; functions; regulatory program; technical services and expert assistance. Regulatory body:- 2. The Regulatory body

19. IAEA BSS Requirement 2: Establishment of a legal and regulatory framework. The government shall establish and maintain a legal and regulatory framework for protection and safety and shall establish an effectively independent regulatory body with specified responsibilities and functions. National legislation should specify:- the establishment and funding of an effectively independent Regulatory body for the control of radiation safety; the body’s responsibilities and functions; provisions for body, power and resources. 2. The Regulatory body

20. IAEA 2. The Regulatory body BSS Requirement 3: Responsibilities of the regulatory body. The regulatory body shall establish or adopt regulations and guides for protection and safety and shall establish a system to ensure their implementation 20

21. IAEA Regulatory functions and responsibilities are often divided among several government authorities. eg:- transport environment public health and safety occupational safety 2. Division of responsibilities A single Regulatory body responsible for all aspects of radiation safety is desirable but maybe not achievable.

22. IAEA 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. Relevant regulatory authorities should establish a system of liaison and working procedures to ensure co-ordination and co-operation including, where appropriate, the development of Memoranda of Understanding (MoU) 2. Division of responsibilities (cont)

23. IAEA Consumer Protection Agency Regulatory body Defence Forces Educational Authorities Emergency Co-ordination Authority Environmental Protection Authority Fire Services Customs Authority Food / Agriculture Authority Health Ministry Local Government Authorities The Regulatory Authority must co-operate with other relevant authorities, advise and provide them with information on safety matters 2. Interaction with other national bodies

24. IAEA Mining / Minerals regulation Regulatory body Oil / Gas - exploration & regulation Police Services Power generation Professional & Registration Bodies Sewerage Authority National Standards Authority Transport Regulation Water Supply Authority 2. Interaction with other national bodies (cont)

25. IAEA

29.  The Regulatory body also should have arrangements on an international level. Co-operation on international level Bilateral agreements Multilateral agreements

30. IAEA Is established by Government through legislation.  The Body’s functions and responsibilities are kept completely distinct from those of any other party.  There is clear separation of the Body’s functions from those of other government agencies or other organizations having responsibility for development and promotion of regulated practices. Independence of the Regulatory Body

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

32. IAEA from those subject to regulation:- Licensees Regulatory Body Manufacturers Laboratory services Training services Waste facilities Others Health services Independence of the Regulatory Body (cont)

33. IAEA If the Regulatory Body has functions such as:- testing and quality control measurements; initiating safety related research and development; providing personnel monitoring services, Independence of the Regulatory Body (cont) 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.

34. IAEA 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; Empowering the Regulatory Body develop safety principles and criteria; The Regulatory Body shall be empowered to:-

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

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

37. IAEA liase and co-ordinate with other government or non-government authorities having competence in health and safety, environmental protection, security and transport; liase with regulatory authorities of other countries and with international organizations to promote co-operation. 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; Empowering the Regulatory Body (cont)

38. IAEA implementing procedures for notification and authorization; providing for exclusions and 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. The Regulatory Programme shall include:- preparing regulations for radiation protection and safety; Regulatory Programme

39. IAEA for creating or modifying conditions of an authorization or of a class of authorizations; for providing guidance to the radiation users; to ensure that proprietary information is safeguarded; to ensure that appropriate explanations are provided to applicants for the rejection of authorizations; Internal Procedures The Regulatory Body shall establish procedures:- for receiving and assessing notifications and applications for registration or licence;

40. IAEA to ensure that user experience (incidents, accidents, etc.) is appropriately analyzed 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; Internal Procedures (cont) The Regulatory Body shall establish procedures:- for communication with, and the provision of, information to other governmental bodies, international organizations and the public;

41. IAEA 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. 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;

42. IAEA dosimetry services laboratory services calibration services waste management medical services training services expert assistance Technical Services Technical services include:-

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

44. IAEA 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. Expert Assistance Consultants should be effectively independent of the operator. Consultants

45. IAEA 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. Advisory bodies may be formally appointed by Government or the Regulatory Body. Expert Assistance (cont) Advisory Bodies

46. IAEA Regulatory Body Personnel and Training In order to properly fulfil its statutory obligations the Regulatory Body requires an appropriate number of competent personnel; Competence (knowledge, skills and attitudes) is built, in the context of the regulatory framework for safety, by such means as: —Technical training; —Learning through academic institutions and other learning centres; —Research and development work. —On the job training

47. IAEA Safety culture of staff Principle 3: Leadership and management for safety The management system has to ensure the promotion of a safety culture Safety culture includes: Individual and collective commitment to safety on the part of the leadership, the management and personnel at all levels; Accountability of organizations and of individuals at all levels for safety Measures to encourage a questioning and learning attitude and to discourage complacency with regard to safety

48. IAEA Questioning Attitude Rigorous and Prudent Approach Communication Safety + + Individual Characteristics Contributing to Safety Culture Commitment to Safety +

49. IAEA BSS Requirement 5: Management for protection and safety the management system is required to be designed and implemented to enhance protection and safety by, among other things, promoting safety culture 49 Safety culture of staff

50. IAEA Safety culture of staff The principal parties shall promote and maintain a safety culture by: (a) Promoting individual and collective commitment to protection and safety at all levels of the organization; (b) Ensuring a common understanding of the key aspects of safety culture within the organization; (c) Providing the means by which the organization supports individuals and teams in carrying out their tasks safely and successfully, with account taken of the interactions between individuals, technology and the organization; (d) Encouraging the participation of workers and their representatives and other relevant persons in the development and implementation of policies, rules and procedures dealing with protection and safety........

51. IAEA Safety culture of staff (e) Ensuring accountability of the organization and of individuals at all levels for protection and safety; (f) Encouraging open communication with regard to protection and safety within the organization and with relevant parties, as appropriate; (g) Encouraging a questioning and learning attitude and discouraging complacency with regard to protection and safety; (h) Providing means by which the organization continually seeks to develop and strengthen its safety culture.

52. IAEA IAEA Fundamental Safety Principles SF-1 2006 BSS/GSR Part 3 (Interim) http://www-pub.iaea.org/MTCD/Publications/PDF/p1531_startpage.pdf Home page for IAEA Nuclear Safety & Security: http://www- ns.iaea.org/default.asp Governmental, Legal and Regulatory Framework for Safety, IAEA Safety Standards Series No. GSR Part 1, IAEA, Vienna (2010). IAEA TECDOC 1067 http://www-ns.iaea.org/security/legal_instruments_list.asp http://www-ns.iaea.org/security/legal_instruments_list.asp Further information 52