1. IAEA International Atomic Energy Agency

2. IAEA Outline of the presentation Learning objectives Occupational Radiation Protection Basis of the review Requirements by GSR Part 3 (Interim Edition) Advice from experienced reviewers Medical Exposure Review methods Basis of the review Interface with other IRRS modules Advice from experienced reviewers Examples Transport Particularities of transport safety International and European context Relevant Safety Standards Terminology Focus and topics in IRRS Recommendations of experienced reviewers Basic IRRS Training - Module 16 - Additional Areas2

3. IAEA Learning objectives After finishing this lecture the trainee will: Understand the contents to be reviewed within the scope of IRRS Module 11 (Additional Areas) Occupational Radiation Protection. Understand that occupational radiation protection is a fundamental requirement. Understand that the regulatory body, registrants, licensees, employers and workers have responsibilities for occupational radiation protection. Basic IRRS Training - Module 16 - Additional Areas3

4. IAEA Learning objectives After finishing this lecture the trainee will: Understand the contents to be reviewed in the scope of the IRRS Module 11 (Additional Areas) Medical Exposure Know the main content of the IAEA Safety Standards relevant to the review of this module Become aware of other modules with possible interaction Be informed of lessons-learned in the review of this module during previous missions Basic IRRS Training - Module 16 - Additional Areas4

5. IAEA Learning objectives After finishing this lecture the trainee will: get an understanding of the contents to be reviewed in the scope of IRRS Facilities and Activities understand the particularities of transport safety Basic IRRS Training - Module 16 - Additional Areas5

6. IAEA OCCUPATIONAL RADIATION PROTECTION Basic IRRS Training - Module 16 - Additional Areas6

7. IAEA Basic IRRS Training - Module 16 - Additional Areas7 Basis of the review GSR Part 3 Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards INTERIM EDITION (2011) summarizes the requirements on radiation protection and safety of radiation sources “Occupational Radiation Protection” focus on IRRS process addresses the general requirements in the IRRS core modules and specific requirements in additional modules

8. IAEA Occupational Radiation Protection GSR Part 3 (Interim) Requirements 19 to 26 Legal and regulatory framework General responsibilities of registrants, licensees and employers General responsibilites of workers Requirements for radiation protection programmes Monitoring programmes and technical services 8 Recommendation of Experienced Reviewers : Give particular attention to : GRS Part 3 (Interim) requirements as the basis of the review, rather than your own national regulatory requirements. Basic IRRS Training - Module 16 - Additional Areas8

9. IAEA Legal and regulatory framework GSR Part 3 (Interim) Requirements 19 and 20 A legislative and regulatory framework is established to provide for Occupational Radiation Protection. The regulations specify dose limits for the occupational exposure of any worker, consistent with the requirements of GSR Part 3 (Interim). The regulatory framework requires that the regulatory body establishes and enforces requirements for the monitoring and recording of occupational exposures 9Basic IRRS Training - Module 16 - Additional Areas9

10. IAEA General responsibilities of registrants, licensees and employers GSR Part 3 (Interim) Requirement 21 Responsibility for the protection of workers against occupational exposure shall be assigned to registrants, licensees and employers of workers. Employers, registrants and licensees shall be required to ensure that : occupational protection and safety is optimized to ensure that exposure be kept as low as reasonably achievable ; occupational exposure is controlled so that the relevant dose limits for occupational exposure are not exceeded. 10Basic IRRS Training - Module 16 - Additional Areas10

11. IAEA Cooperation between employers and registrants and licensees GSR Part 3 (Interim) Requirement 23 Employers and registrants and licensees shall cooperate to the extent necessary for compliance by all responsible parties, with the requirements for protection and safety 11Basic IRRS Training - Module 16 - Additional Areas11

12. IAEA General Responsibilities of workers GSR Part 3 (Interim) Requirement 22 Workers shall fulfil their obligations and carry out their duties, following any applicable rules and procedures for protection and safety specified by the employer, registrant or licensee 12 Recommendation of Experienced Reviewers : The responsibilities of workers for ensuring protection and safety must be a clear regulatory requirement Basic IRRS Training - Module 16 - Additional Areas12

13. IAEA Radiation protection programmes (1/2) GSR Part 3 (Interim) Requirement 24 Employers, registrants and licensees shall establish and maintain organizational, procedural and technical arrangements for : the designation of controlled areas and supervised areas, local rules and procedures, the monitoring of the workplace. 13Basic IRRS Training - Module 16 - Additional Areas13

14. IAEA Radiation protection programmes (2/2) GSR Part 3 (Interim) Requirements 25, 26 Employers, registrants and licensees shall be responsible for making arrangements for: assessment of occupational exposures, recording of occupational exposures, workers’ health surveillance Employers, registrants and licensees shall provide workers with adequate information, instruction and training for protection and safety. 14Basic IRRS Training - Module 16 - Additional Areas14

15. IAEA Monitoring programmes and technical services GSR Part 3 (Interim) Requirement 25 Authorization or approval of service providers for individual monitoring, calibration and dose record keeping services should be provided by a competent authority. 15Basic IRRS Training - Module 16 - Additional Areas15

16. IAEA MEDICAL EXPOSURE Basic IRRS Training - Module 16 - Additional Areas16

17. IAEA Review Methods Review of the Advance Reference Material (SARIS self-assessment, legislation, regulations, summaries, other documents) Interviews with personnel and other stakeholders On-site visits: Direct observation of regulatory body procedures during inspections Interaction with other reviewers 17Basic IRRS Training - Module 16 - Additional Areas

18. IAEA IAEA Safety Standards 18 Safety Fundamentals Safety Requirements Safety Guides Basic IRRS Training - Module 16 - Additional Areas

19. IAEA Basis of the review GSR Part 3 Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards INTERIM EDITION (2011) 19 summarizes the requirements on radiation protection and safety of radiation sources “Medical Exposure” Basic IRRS Training - Module 16 - Additional Areas focus on IRRS process addresses the general requirements in the IRRS core modules and specific requirements in additional modules

20. IAEA GSR Part 3: Requirements 20Basic IRRS Training - Module 16 - Additional Areas Requirements are addressed to the Government, the Regulatory Body, the registrants and licensees Requirements in respect of medical exposure in planned exposure situations apply to all medical exposures, including intended, unintended and accidental exposures

21. IAEA GSR Part 3: Requirements 34-42 Definition of Dose Reference Levels (DRLs), Dose Constraints, criteria, guidelines, … Education and training of the personnel involved Justification Measures for optimization of protection and safety Arrangements for pregnant and breast feeding women Criteria for the release of patients following radionuclide therapy Minimization of accidental and unintended medical exposures Reviews and records 21Basic IRRS Training - Module 16 - Additional Areas

22. IAEA Basis of the review RS-G-1.5 Radiological Protection for Medical Exposure to Ionizing Radiation (2002) 22 Basic IRRS Training - Module 16 - Additional Areas Guidance on how the requirements may be fulfilled Addressed to the Government, the Regulatory Body, the registrants and licensees

23. IAEA RS-G-1.5: Safety Guide Radiological Protection for Medical Exposure to Ionizing Radiation 1. Regulatory programme for radiological protection for medical exposure Regulatory control Responsibilities of: registrants and licensees, medical practitioners, qualified experts, manufacturers, suppliers, etc Optimization Education &Training 23Basic IRRS Training - Module 16 - Additional Areas

24. IAEA 2. Specific aspects of radiological protection for medical exposure in: diagnostic and interventional radiology nuclear medicine radiation therapy 24 Justification, optimization, guidance levels, dose constraints, training, accidental exposures, … Basic IRRS Training - Module 16 - Additional Areas RS-G-1.5: Safety Guide Radiological Protection for Medical Exposure to Ionizing Radiation

25. IAEA Interface with other IRRS Modules Review of this module has interfaces with other IRRS modules the review should be strongly focused on the specific provisions coordination and cooperation are necessary to avoid overlaps and ensure effective information exchange amongst reviewers 25Basic IRRS Training - Module 16 - Additional Areas

26. IAEA Interference with other IRRS modules 26Basic IRRS Training - Module 16 - Additional Areas Medical exposure

27. IAEA Interfering Modules Module 1: Responsibilities and functions of the Government Module 3: Responsibilities and functions of the Regulatory Body Module 5: Authorization Module 6: Review and Assessment Module 7: Inspection Module 8: Enforcement Module 9: Regulations and Guides 27 Radiation Sources Basic IRRS Training - Module 16 - Additional Areas

28. IAEA Example of a reviewer’s list 28 RequirementLegal Provision ReferenceTo whom addressed ImplementationCompliance with standards Remarks Justification Generic justification Justification for individual patient National referral guidelines Health screening programme Volunteers for research ……… etc. Basic IRRS Training - Module 16 - Additional Areas

29. IAEA Recommendation of Experienced Reviewers Give particular attention to: 29 The Safety Guide RS-G-1.5 refers to the IAEA BSS, Safety Series 115, 1996 BSS 115 has been replaced by GSR Part 3, Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards INTERIM EDITION (2011) Differences in the basic requirement, glossary, … Basic IRRS Training - Module 16 - Additional Areas

30. IAEA Recommendation of Experienced Reviewers Give particular attention to: For each GSR Part 3 (medical exposure) requirement: Does the RB have regulatory responsibility for that requirement? If yes, is legislation in place and is it consistent with GSR Part 3 and RS-G-1.5? If no, who is responsible for that requirement and how is coordination ensured? In case of overlaps, how is coordination managed and how are the final regulatory decisions made? Are guidelines in place? Implementation? 30Basic IRRS Training - Module 16 - Additional Areas

31. IAEA Recommendation of Experienced Reviewers Give particular attention to: 31 For medical exposure … that the provision and implementation of - justification (referal criteria, responsibilities, …) and - optimisation (DRLs, calibration, QA, …) … … ensure the radiation protection of the patient Basic IRRS Training - Module 16 - Additional Areas

32. IAEA Recommendation of Experienced Reviewers Give particular attention to: Remember the “graded approach”. Don’t forget the module is “medical exposure” - don’t confuse it with other modules (i.e. inspection, authorization etc.). When reviewing the provisions for safety, don’t mix the roles of the regulatory body and the licensee (i.e. the medical physicist). During the site visit (observation of inspection): the reviewers observe the inspectors not the licensee. 32Basic IRRS Training - Module 16 - Additional Areas

33. IAEA Recommendation of Experienced Reviewers Give particular attention to: In general: Understand the system, the players and their roles Think broadly and be open to particularities and peculiarities! Don’t use as basis of the appraisal, the practice in your country Consider the justification provided Take into account arguments regarding the formulation of observations Share your experience – your expertise is valuable …… 33Basic IRRS Training - Module 16 - Additional Areas ……….and Get ideas for your country!

34. IAEA REVIEWING TRANSPORT OF RADIOACTIVE MATERIAL Basic IRRS Training - Module 16 - Additional Areas34

35. IAEA Outline - transport Particularities of transport safety International context Relevant Safety Standards Terminology Focus and topics in IRRS review of transport Recommendations of experienced reviewers Summary Basic IRRS Training - Module 16 - Additional Areas35

36. IAEA Particularities of Transport Safety (1) Prescriptive transport regulations Specific terminology IAEA Transport Regulations apply to all modes on land, water or in the air IAEA Transport Regulations are incorporated in international modal regulations for the carriage of dangerous goods (radioactive material is class 7) IAEA Transport Regulations are revised every two years Basic IRRS Training - Module 16 - Additional Areas36

37. IAEA Particularities of Transport Safety (2) The objective of the Transport Regulations is to ensure safety and to protect persons, property (*) and the environment from the effects of radiation in the transport of radioactive material (*) photographic film for instance The protection is achieved by requiring: o containment of the radioactive contents o control of external radiation levels o prevention of criticality o prevention of damage caused by heat Basic IRRS Training - Module 16 - Additional Areas37

38. IAEA International Context (1) Global Conventions and Regulations ICAO Technical Instructions for the safe transport of dangerous goods by air ( annex 18 to the Convention on International Civil Aviation) International Maritime Dangerous Goods Code [chapter VII of the International Convention for the Safety of life at Sea (SOLAS-convention)] Basic IRRS Training - Module 16 - Additional Areas38

39. IAEA International Context (2) Regional Conventions and Regulations European Agreement concerning the international carriage of dangerous goods by road (ADR) Regulations concerning the international carriage of dangerous goods by rail (RID) European Agreement concerning the international carriage of dangerous goods by inland waterway (ADN) They are revised every two years. Basic IRRS Training - Module 16 - Additional Areas39

40. IAEA Relevant IAEA Safety Standards (1) TS-R-1, Regulations for the Safe Transport of Radioactive Material (2009 edition) [SSR-6, the 2012 edition of the regulations, is not yet incorporated in the modal regulations] Safety Guides TS-G-1.1 (Rev. 1), Advisory Material for the IAEA Regulations for the Safe Transport of Radioactive Material TS-G-1.2, Planning and Preparing for Emergency response to Transport Accidents Involving Radioactive Material Basic IRRS Training - Module 16 - Additional Areas40

41. IAEA Relevant IAEA Safety Standards (2) TS-G-1.3, Radiation Protection Programmes for the Transport of Radioactive Material TS-G-1.4, The Management System for the Safe Transport of Radioactive Material TS-G-1.5, Compliance Assurance for the Safe Transport of Radioactive Material TS-G-1.6, Schedules of provisions of the IAEA Regulations for the Safe Transport of Radioactive Material Basic IRRS Training - Module 16 - Additional Areas41

42. IAEA Terminology Transport comprises all operations and conditions associated with, and involved in the movement of radioactive material; these include: the design, manufacture, maintenance and repair of packaging the preparation, consigning, loading, carriage (including in- transit storage), unloading and receipt at the final destination of loads of radioactive material and packages Package the packaging and its contents prepared for transport Basic IRRS Training - Module 16 - Additional Areas42

43. IAEA Focus of Module 11 The focus of module 11 is on the compliance assurance programme and its implementation. Para. 307 of TS-R-1 The competent authority is responsible for assuring compliance with these Regulations. Means to discharge this responsibility include the establishment and execution of a programme for monitoring the design, manufacture, testing, inspection and maintenance of packaging, special form radioactive material and low dispersible radioactive material, and the preparation, documentation, handling and stowage of packages by consignors and carriers, to provide evidence that the provisions of these Regulations are being met in practice. The compliance assurance programme encompasses all the regulatory functions and should be integrated in the management system of the regulatory body. Basic IRRS Training - Module 16 - Additional Areas43

44. IAEA Topics addressed in the review (1) 1.Regulatory review and maintenance of effective legal framework 2.International/Interdepartmental liaison/Cooperation 3.Monitoring and inspections of transport operations 4.Enforcement actions and investigation of incidents 5.Emergency planning and exercises 6.Audits of management system 7. Design assessment 8. Witnessing testing 9.Witnessing manufacture Basic IRRS Training - Module 16 - Additional Areas44

45. IAEA Topics addressed in the review (2) 10.Examination of maintenance and servicing agreements 11.Issuing of approvals 12.Training and distribution of information Basic IRRS Training - Module 16 - Additional Areas45

46. IAEA Check the following points and key elements therein: authorization covers all types of approval according to the Transport Regulations and the corresponding review and assessment activities verification of an appropriate compliance assurance programme radiation protection programmes for transport activities Basic IRRS Training - Module 16 - Additional Areas Recommendation of Experienced Reviewers Give particular attention to: 46

47. IAEA Summary - transport Focus on the compliance assurance programme does it cover all transport modes? does it cover all elements of transport? (see definition) does it address all the regulatory functions (authorization and licensing, inspection and enforcement, review and assessment, development of regulations and guides)? is a graded approach applied? how are interfaces with other regulations and other authorities managed? Basic IRRS Training - Module 16 - Additional Areas47

48. IAEA THANK YOU FOR YOUR ATTENTION 48 Photo: V. Friedrich Basic IRRS Training - Module 16 - Additional Areas This activity is conducted by the IAEA, with funding by the European Union. The views expressed in this presentation do not necessarily reflect the views of the European Commission