1. IAEA International Atomic Energy Agency PGEC Part IV The International System of Radiation Protection and the Regulatory Framework Module IV.9. Regulatory System Postgraduate Educational Course in radiation protection and the Safety of Radiation sources

2. IAEA This module will discuss the following aspects: Framework for a Radiation Safety Regulatory Infrastructure; Framework for a Radiation Safety Regulatory Infrastructure; Basic Elements of a Regulatory Program for Radiation Safety; Basic Elements of a Regulatory Program for Radiation Safety; A national strategy for building competence in protection and safety; Overview of Module IV.9 2

3. IAEA Framework for a Radiation Safety Regulatory Infrastructure Legislation, Regulatory Authority, Prime Responsibility for Radiation Safety Basic Element of a Regulatory Program for Radiation Safety Funding, Radiation Safety Regulations, System of authorization (graded approach) licensing, registration, notification, exemption and clearance; control of facilities or/and activities, Inspection, Enforcement Emergency preparedness and response requirements (including response to illicit trafficking and terrorism attacks) Investigation and Follow-up Staffing and Training Information Dissemination and communication with the public Co-ordination and Co-operation between employers (sharing safety information, individual monitoring records, etc.) Technical Services A national strategy for building competence in protection and safety General concept; analysis of training needs; design, development and implementation of a national training programme ; evaluation of the strategy for building competence 3 Detail of Module IV.9

4. IAEA Framework for a Radiation Safety Regulatory Infrastructure 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. 4

5. IAEA Requirement 2: Establishment of a framework for safety The government shall establish and maintain an appropriate governmental, legal and regulatory framework for safety within which responsibilities are clearly allocated. 5 Framework for a Radiation Safety Regulatory Infrastructure

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

7. IAEA Features of Legal Framework  Enabling legislation – high level, simple, flexible Sample legislation given in Tecdoc 1067  Regulations – more detail of what is required performanceprescriptive Important to consider style of regulation - can be performance or prescriptive  Codes of practice – tend to be even more detailed and provide guidance on how to meet requirements 7

8. IAEA Performance regulations Performance regulations:- give general goal setting requirements; specify overall radiation safety requirements and basic operational parameters. Style of Regulation Prescriptive Regulations Prescriptive Regulations:- give detailed requirements; state how to achieve radiation safety. Most regulations contain both types but are predominantly of one type

9. IAEA Regulatory Body Requirement 3: Establishment of a regulatory body The government, through the legal system, shall establish and maintain a regulatory body, and shall confer on it the legal authority and provide it with the competence and the resources necessary to fulfil its statutory obligation for the regulatory control of facilities and activities. 9 Requirement 4: Independence of the regulatory body The government shall ensure that the regulatory body is effectively independent in its safety related decision making and that it has functional separation from entities having responsibilities or interests that could unduly influence its decision making.

10. IAEA Independence of the regulatory body  responsibilities of the Regulatory Body should be kept completely distinct from those of any other party  Important to have clear separation of functions and responsibilities of the Regulatory Body from those of other government departments and agencies having responsibility for development and promotion of regulated practices  Funding of the regulatory body is important 10

11. IAEA Funding of the regulatory body  To be effectively independent, the regulatory body needs not only sufficient authority and staffing but also sufficient financial resources  Funding provision through implementing legislation or the national fiscal process.  If costs are to be recovered by authorization and inspection fees, authority to levy charges should be granted by the legislation.  Where the Regulatory Body levies charges for authorizations, inspections and fines related to enforcement, a direct link between the generated funds and the Regulatory Body budget should be avoided 11

12. IAEA BSS Requirement 3  The regulatory body has to establish requirements for the application of the principles of radiation protection for all exposure situations – this includes establishing or adopting regulations and guides for protection and safety. Regulations provide a framework which operators etc must comply with Guides provide information on how to comply with the regulations 12 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.

13. IAEA  The regulatory system to include: Notification and authorization*; Review and assessment of facilities and activities; Inspection of facilities and activities; Enforcement of regulatory requirements; The regulatory functions relevant to emergency exposure situations and existing exposure situations; Provision of information to, and consultation with, parties affected by its decisions and, as appropriate, the public and other interested parties. * including issuing, amending or revoking authorizations which may be subject to conditions specified by the regulatory body 13 BSS Requirement 3: regulatory system

14. IAEA Requirement 3: Notification and authorization 14 Notify Proposed practice Apply for Authorization Obtain licence Notification only requirement? Suitable for registration? N N Y Y proceed

15. IAEA Examples of practices and devices that should be subject to licensing - Authorization by Licensing industrial radiography; industrial irradiators; high-activity gauges; use of unsealed sources; medical applications; manufacturing of sources; storage of radioactive material or waste and disposal.

16. IAEA Requirement 3: Regulatory Assessment comply  Regulatory review and assessment is carried out to determine whether facilities and activities comply with regulatory requirements and the conditions specified in the authorization. prior to authorization over the lifetime  Such work has to be performed prior to authorization and as appropriate over the lifetime of the facility, or the duration of the activity graded approach  Such work has to be commensurate with the radiation risks associated with the facility or activity i.e. a graded approach 16

17. IAEA  Inspection is needed to ensure that: Facilities, equipment and work performance meet requirements Documents are valid and being complied with Employees (including contractors) are competent Deficiencies are identified and corrected Lessons are learned and disseminated  Routine inspections carried out according to a systematic programme related to hazard potential  Additional inspections may be at short notice, e.g. if there is an abnormal event Requirement 3: Regulatory Inspection

18. IAEA Suggested* Inspection Frequencies Practice Inspection Frequency (years) Dental radiography 5 Nuclear medicine 1-2 Radiotherapy 1 Diagnostic radiology – centres with2-3 complex equipment Diagnostic radiology – centres with3-5 conventional X ray equipment only Industrial radiography 1 Irradiators (i.e. industrial) 1 Irradiators (i.e. research) 3-5 Radiation gauges 3-5 Well logging 1-3 18 * IAEA Inspection of Radiation Sources and Regulatory Enforcement Tecdoc 1526 (2007)

19. IAEA to correct matters  Regulatory body needs to respond to non-compliance to require a registrant, licensee or other responsible party to correct matters 19 Requirement 3: Regulatory Enforcement application of penalties Where appropriate, the application of penalties (prosecution, suspension or cancellation of the authorization, verbal or written warnings, etc.) graded approach Regulatory action to be commensurate with the seriousness of the offence i.e. a graded approach Attribution: Fan Yang

20. IAEA 20 The regulatory body has to: ensure the application of the requirements for education, training, qualification and competence adopt specific acceptance and performance criteria for sources, devices, equipment or facilities that have implications for protection and safety seek continual improvement of its management system Requirement 3: some responsibilities of the regulatory body

21. IAEA The regulatory body has to make provision regarding records which include: 21 Requirement 3: Records registers of sealed sources and radiation generators; Records of doses from occupational exposure; Records relating to the safety of facilities and activities; Records that might be necessary for the shutdown and decommissioning or closure of facilities; Records of events, including non-routine releases of radioactive material to the environment; Inventories of radioactive waste and of spent fuel.

22. IAEA Exemption and clearance BSS Requirement 8: Exemption and clearance  The government or the regulatory body shall determine which practices or sources within practices are to be exempted from some or all of the requirements of the IAEA Standards. The regulatory body shall approve which sources, including materials and objects, within notified practices or authorized practices may be cleared from regulatory control. 22

23. IAEA Exclusion & Exemption 23 Excluded? Notify Exempted? Proposed practice Apply for Authorization Obtain licence Notification only requirement? Suitable for registration? Y Y N N N N Y Y proceed

24. IAEA Emergency preparedness and response 24  Regulatory Bodies should have plans to details their specific role in coordinating and supporting protective actions foreseen in licensee emergency plans

25. IAEA Emergency preparedness and response  Regulatory bodies may provide expert advice to government & licensee both during an emergency & during the follow-up phase  Routine regulatory administration (e.g. issue of prior authorizations) may need to be suspended in favour of a timely emergency response.  When the emergency has been brought under control, and for potentially serious accidents, an independent investigation should be conducted by the Regulatory Body 25

26. IAEA Basic Obligations (BSS Requirement 16): Registrants and licensees shall conduct formal investigations of abnormal conditions investigations Registrants and licensees shall conduct an investigation as specified by the regulatory body in the event that: (a) A quantity or operating parameter relating to protection and safety exceeds an investigation level or is outside the stipulated range of operating conditions; or (b) Any equipment failure, accident, error, mishap or other unusual event or condition occurs that has the potential for causing a quantity to exceed any relevant limit or operating restriction 26

27. IAEA An investigation shall be conducted as soon as possible after the event. investigations (cont) A written report shall be produced on its causes, doses received and actions taken to prevent recurrence. A summary report shall be communicated to the Regulatory Body and to other relevant parties as soon as possible. 27

28. IAEA Basic Obligation (BSS Requirement 41) Unintended and accidental medical exposures Registrants and licensees shall promptly investigate any unintended or accidental medical exposures and, if appropriate, shall implement corrective actions E.g. equipment failure; accident; error; misuse; or other unusual occurrence. investigations (cont) 28

29. IAEA a pharmaceutical other than that prescribed is used; the dose differs substantially from the prescribed value; or treatment leads, or may lead, to undue acute secondary effects inadvertent exposure of the embryo or fetus Accidental Medical Exposures – Licensees or Registrants shall conduct formal investigations if:- Any medical treatment is delivered to either the wrong patient or the wrong tissue; investigations (cont) 29

30. IAEA typical doses or activities exceed, or are substantially below, the relevant diagnostic reference level Requirement 38: Optimization of protection and safety In relation to medical diagnosis, Licensees shall conduct formal investigations if:-  Any diagnostic radiological procedure or image guided interventional procedure in which the wrong individual or the wrong tissue of the patient is subject to exposure;  Any exposure for diagnostic purposes that is substantially greater than was intended ; investigations (cont) 30

31. IAEA For an accidental medical exposure, the licensee has to Accidental Medical Exposures notify the Regulatory Body of any significant unintended or accidental medical exposures without delay calculate or estimate the dose received and the dose distribution within the patient; identify and implement proposed corrective measures; without delay, submit a report of the investigation to the Regulatory Body; Inform the referring medical practitioner and the patient or the patient’s legal authorized representative. investigations (cont) 31

32. IAEA Minor accidents can usually be investigated and corrected by the user with the results reported to the Regulatory Body. Serious accidents should have an independent investigation :- by the Regulatory Body and by other governmental authorities (if appropriate) Investigation and Follow-up Note: Investigation by the Regulatory Body is not a substitute for investigation and report by the user. The user is always obliged to conduct an investigation after accident. investigations (cont) 32

33. IAEA Objectives for an investigation by the Regulatory Body : 1.gather and establish the facts of an incident, 2.identify immediate and underlying causes and the lessons to be learned, 3.prepare recommendations to prevent recurrence, 4.detect non-compliance, 5.Provided evidential basis for appropriate action, including formal enforcement Investigation and Follow-up (cont) investigations (cont) 33

34. IAEA Following an investigation, the Regulatory Body should-: determine corrective and enforcement actions; verify completion of corrective and enforcement actions; disseminate information regarding the causes of the accident, the consequences and the preventative or mitigation actions taken; report the results of the investigation within the State and, if appropriate, internationally. document and file the findings; investigations (cont) 34

35. IAEA The Regulatory Body should have:- Requirement 18 The regulatory body shall employ a sufficient number of qualified and competent staff, commensurate with the nature and the number of facilities and activities to be regulated, to perform its functions and to discharge its responsibilities. A human resources plan Recruitmen t qualification requirements individual training plans (based on analysis of the necessary competence and skills) funding for staff training Staffing and competence of the regulatory body 35

36. IAEA Staffing levels will depend on :- the number, scope and complexity of practices; Staffing Levels for the regulatory body the degree to which standardized sources, facilities and equipment suitable for generic assessment are in use; the nature of the regulations (prescriptive/performance); the extent to which practice specific guidance documents and standard assessment plans are used; the status of the regulatory program i.e. organization, implementation or operational phase. 36

37. IAEA Possible Structure for a Regulatory Body DIRECTOR TECHNICAL SERVICES INSPECTIONSAUTHORIZATIONS ADMINISTRATIVE LEGAL & ENFORCEMENT Could be part of Administrative, or external 37

38. IAEA Budget and staff recruitment; Responsibilities of the Director of the Regulatory Body Regular reviews of the program's effectiveness. e.g. number of applications received and processed; number of notifications; registrations and licences; inspections performed; accident / incident reports and follow-up; etc. Supervise regulation amendments; Dissemination of Information to the public and authorities. 38

39. IAEA maintain the budget; Responsibilities of the Administrative Section prepare job descriptions; administer recruitment and personnel matters; maintain coordinated staffing and training plans; arrange training; perform housekeeping tasks; maintain and co-ordinate emergency response; 39

40. IAEA development of regulations* Responsibilities of the Administrative Section (cont) *could be the responsibility of a separate legal and enforcement section maintain source inventory; prepare policies and procedures*; analyse program data for quality management system; disseminate information. 40

41. IAEA maintain radiation monitoring equipment operate or identify analytical laboratory/equipment Also either the Technical Section or external services need to provide:  personal dosimetry,  environmental monitoring  calibration of monitoring and measuring equipment. Responsibilities of the Technical Section 41

42. IAEA establish safety assessment review procedures; Responsibilities of the Authorization Section establish schedules for submission of applications and safety assessments; review notifications and authorization applications; initiate detailed safety assessments when indicated by inspections. 42

43. IAEA initiate inspections based on requirements of new regulations and in accordance with established inspection priorities and schedules; Responsibilities of the Inspection Section initiate enforcement action as appropriate; investigate the potential for abandoned, orphan sources; follow up on status of potential users that have not submitted appropriate notifications. 43

44. IAEA Authorizations Regulations and codes development Inspections RADIOTHERAPY DIAGNOSTIC X-RAYS INDUSTRIAL Input from Regulatory Staff 44

45. IAEA knowledge of a radiation safety regulatory program (legislation and regulations); knowledge of the safety of radiation practices & sources that are subject to regulatory control; operational and regulatory experience to effectively verify that regulations are being implemented and complied with. Regulatory sections require:- a broad knowledge of radiation protection; Regulatory Body Staff 45

46. IAEA to ensure that the proper skills are acquired and that adequate levels of competence are achieved and maintained; Objectives of a Staff Training Program to ensure that staff are aware of technological developments and new safety principles and concepts. 46

47. IAEA legislation and regulations the authorization process procedures and guidance for authorization assessment procedures and guidance for inspections the enforcement policy emergency response procedures, etc Contents of a Staff Training Program 47

48. IAEA Information Dissemination and communication with public Basic Obligation - BSS Requirement 3: Responsibilities of the regulatory body  ensure that mechanisms are in place for the timely dissemination of information to relevant parties, such as suppliers and users of sources, on lessons learned for protection and safety from regulatory experience and operating experience, and from incidents and accidents and the related findings. The mechanisms established shall, as appropriate, be used to provide relevant information to other relevant organizations at the national and international level.  establish a regulatory system for protection and safety that includes provision of information to, and consultation with, parties affected by its decisions and, as appropriate, the public and other interested parties 48

49. IAEA Requirement 11: Competence for safety  The government shall make provision for building and maintaining the competence of all parties having responsibilities in relation to the safety of facilities and activities. 49 A national strategy for building competence in protection and safety

50. IAEA A national strategy for building competence in protection and safety A national strategy for building competence consists of interrelated phases:  Analysis of training needs;  Design of a national training programme in a realistic time frame;  Development and implementation of a national training programme;  Evaluation of the effectiveness of the national strategy and its individual components. 50

51. IAEA A national strategy for building competence in protection and safety: The Process “What is needed ?” “What is the programme of work that will meet the need ?” “How is the programme of work to be implemented ?” “Is the established programme of work of value ?”

52. IAEA Responsibility for providing training etc  Registrants and licensees are required to provide information, instruction and training for persons working in controlled areas.  Workers are required to accept necessary information, instruction and training  The regulatory body should not be responsible for providing training (except for training its own staff)  The regulatory body may provide guidance in respect of: the types of training required, the course content, the duration and level of training, and the assessment of trainees. 52

53. IAEA Fundamental Safety Principles SF-1 IAEA 2006 IAEA Safety Requirements BSS GSR Part 3 (Interim) IAEA 2011 http://www-pub.iaea.org/MTCD/Publications/PDF/p1531_startpage.pdf IAEA Safety Requirements: Governmental, Legal and Regulatory Framework for Safety. GSR Part 1 IAEA 2010 Home page for IAEA Nuclear Safety & Security: http://www-ns.iaea.org/default.asp IAEA Safety Requirements: The Management System for Facilities and Activities; IAEA Safety Standards Series No. GS-R-3 : IAEA 2006. IAEA, Organization and Implementation of a National Regulatory Infrastructure…, IAEA-TECDOC-1067, Vienna (1999). IAEA, Assessment by Peer Review of…, IAEA-TECDOC-1217 (2001). IAEA Safety Guide: Building Competence in Radiation Protection and the Safe Use of Radiation Sources RS- G-1.4 IAEA 2001 IAEA Inspection of Radiation Sources and Regulatory Enforcement Tecdoc 1526 (2007) IAEA-TECDOC 1191, Categorization of Radiation Sources (Dec 2000) Further information 53