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BASIC IRRS TRAINING Lecture 16

BASIC IRRS TRAINING Lecture 16. Reviewing Additional Areas (IRRS Module 11). 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

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BASIC IRRS TRAINING Lecture 16

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  1. BASIC IRRS TRAININGLecture16 Reviewing Additional Areas (IRRS Module 11)

  2. 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 Areas

  3. 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 Areas

  4. 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) MedicalExposure • Know the main contentofthe 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 Areas

  5. 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 Areas

  6. Occupational radiation protection Basic IRRS Training - Module 16 - Additional Areas

  7. 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 focus on • IRRS process addresses the general requirements in the IRRS core modules and specific requirements in additional modules • “Occupational Radiation Protection” Basic IRRS Training - Module 16 - Additional Areas

  8. Occupational Radiation Protection 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. 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 Basic IRRS Training - Module 16 - Additional Areas 8

  9. Legal and regulatoryframework 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 Basic IRRS Training - Module 16 - Additional Areas 9

  10. General responsibilities of registrants, licensees and employers GSR Part 3 (Interim) Requirement 21 • Responsibility for the protection of workersagainstoccupationalexposureshallbeassigned to registrants, licensees and employers of workers. • Employers, registrants and licenseesshallberequired to ensurethat : • occupational protection and safetyisoptimized to ensurethatexposurebekept as low as reasonablyachievable ; • occupationalexposureiscontrolledsothat the relevant dose limits for occupationalexposure are not exceeded. Basic IRRS Training - Module 16 - Additional Areas 10

  11. Cooperationbetweenemployers 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 Basic IRRS Training - Module 16 - Additional Areas 11

  12. General Responsibilities of workers Recommendation of Experienced Reviewers : The responsibilities of workers for ensuring protection and safety must be a clear regulatory requirement 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 Basic IRRS Training - Module 16 - Additional Areas 12

  13. 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. Basic IRRS Training - Module 16 - Additional Areas 13

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

  15. 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. Basic IRRS Training - Module 16 - Additional Areas 15

  16. Medical exposure Basic IRRS Training - Module 16 - Additional Areas

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

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

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

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

  21. 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 Basic IRRS Training - Module 16 - Additional Areas

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

  23. RS-G-1.5: Safety GuideRadiological 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 Basic IRRS Training - Module 16 - Additional Areas

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

  25. 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 Basic IRRS Training - Module 16 - Additional Areas

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

  27. Interfering Modules Radiation Sources 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 Basic IRRS Training - Module 16 - Additional Areas

  28. Example of a reviewer’s list Basic IRRS Training - Module 16 - Additional Areas

  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. 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? Basic IRRS Training - Module 16 - Additional Areas

  31. For medical exposure … that the provision and implementation of - justification (referalcriteria, responsibilities, …) and - optimisation(DRLs, calibration, QA, …) … … ensure the radiation protection of the patient Basic IRRS Training - Module 16 - Additional Areas

  32. 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. Basic IRRS Training - Module 16 - Additional Areas

  33. ……….and Get ideas for your country! Basic IRRS Training - Module 16 - Additional Areas In general: • Understand the system, the players and their roles • Thinkbroadlyand be open to particularities and peculiarities! • Don’t use as basis of the appraisal,the practice in your country • Considerthe justification provided • Take into account arguments regarding the formulation of observations • Shareyourexperience – yourexpertiseisvaluable ……

  34. Reviewing transport of radioactive material Basic IRRS Training - Module 16 - Additional Areas

  35. 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 Areas

  36. 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 Areas

  37. 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: • containment of the radioactive contents • control of external radiation levels • prevention of criticality • prevention of damage caused by heat Basic IRRS Training - Module 16 - Additional Areas

  38. 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 Areas

  39. 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 Areas

  40. 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 Areas

  41. 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 Areas

  42. 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 Areas

  43. 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 Areas

  44. 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. Enforcementactions and investigation of incidents 5. Emergency planning and exercises 6. Audits of management system Design assessment Witnessing testing 9. Witnessing manufacture Basic IRRS Training - Module 16 - Additional Areas

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

  46. Recommendation of Experienced ReviewersGive particular attention to: Basic IRRS Training - Module 16 - Additional Areas 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

  47. 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 Areas

  48. THANK YOU FOR YOUR ATTENTION 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 Photo: V. Friedrich Basic IRRS Training - Module 16 - Additional Areas

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