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

2. Content of the Presentation
Occupational Radiation Protection
Basis of the review
Requirements by GSR Part 3
Advice from experienced reviewers
Medical Exposure
Review methods
Interface with other IRRS modules
Examples
Transport
Particularities of transport safety
International 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 this lecture the trainee will:
understand the scope of the IRRS review of the regulatory oversight of Occupational Radiation Protection in accordance with Module 11 (Additional Areas);
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 this lecture the trainee will:
understand the scope of the IRRS review of the regulatory oversight of Medical Exposure in accordance with Module 11 (Additional Areas);
know the main content of the IAEA Safety Standards relevant to the review of this Medical Exposure;
be aware of other modules with possible crossovers or shared issues;
be informed of lessons-learned from previous missions with regard to the review of Medical Exposure.
Basic IRRS Training - Module 16 - Additional Areas

5. Learning objectives After this lecture the trainee will:
understand the scope of the IRRS review of the regulatory oversight of the transport of radioactive materials in accordance with Module 11 (Additional Areas);
know the main content of the IAEA and other international Safety Standards relevant to the review of transport;
be informed of lessons-learned from previous missions with regard to the review of Transport.
Basic IRRS Training - Module 16 - Additional Areas

6. Learning objectives
After this lecture the trainee will better understand:
the scope of the IRRS review of occupational radiation protection in all regulated facilities and activities;
The scope of the IRRS review of medical exposure;
understand the particularities of transport safety.
Basic IRRS Training - Module 16 - Additional Areas

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

8. “Occupational Radiation Protection”
Basis of the review
GSR Part 3
Radiation Protection and
Safety of Radiation Sources:
International Basic Safety Standards
(2014)
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

9. Occupational Radiation Protection
GSR Part 3 Requirements 19 to 28
Legal and regulatory framework
General responsibilities of registrants, licensees and employers
General responsibilities of workers
Requirements for radiation protection programmes
Monitoring programmes and technical services
Basic IRRS Training - Module 16 - Additional Areas 9

10. Recommendation of Experienced Reviewers : Give particular attention to :
GSR Part 3 Requirements.
In most instances, the requirements set out in GSR Part-3 provide the basis for recommendations and suggestions relating to occupational radiation protection.
Avoid the temptation to apply your own national regulatory requirements.
Basic IRRS Training - Module 16 - Additional Areas 10

11. Legal and regulatory framework
GSR Part 3 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.
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 11

12. General responsibilities of registrants, licensees and employers
GSR Part 3 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.
Basic IRRS Training - Module 16 - Additional Areas 12

13. Cooperation between employers and registrants and licensees
GSR Part 3 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 13

14. General Responsibilities of workers
GSR Part 3 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 14

15. Recommendation of Experienced Reviewers : Give particular attention to :
As set out in GSR Part 3 Requirement 22, the responsibilities of workers for ensuring their own protection and safety and the protection and safety of others must be a clear regulatory requirement, understood, accepted and implemented as appropriate by employers and workers alike.
Basic IRRS Training - Module 16 - Additional Areas 15

16. Radiation Protection Programmes
GSR Part 3 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 16

17. Radiation Protection Programmes
GSR Part 3 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.
Basic IRRS Training - Module 16 - Additional Areas 17

18. Monitoring programmes and technical services
GSR Part 3 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 18

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

20. 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
Basic IRRS Training - Module 16 - Additional Areas

21. IAEA Safety Standards Safety Fundamentals Safety Requirements
To give the three types of IAEA documents (fundamentals/requirements/guides) and more precisely the ones concerning the specific module. Repeat the differences regarding the binding aspect.
Safety Requirements
Safety Guides
Basic IRRS Training - Module 16 - Additional Areas

22. Basis of the review GSR Part 3 “Medical Exposure”
Radiation Protection and
Safety of Radiation Sources:
International Basic Safety Standards
(2014)
summarizes the requirements on radiation protection and safety of radiation sources
The review of the module Medical exposure is based on the requirements included in the part “Medical Exposure” of the GSR Part 3. The general requirements of the GSR Part 3 concern the core modules or other additional modules.
focus on
IRRS process addresses the general requirements in the IRRS core modules and specific requirements in additional modules
“Medical Exposure”
Basic IRRS Training - Module 16 - Additional Areas 22

23. 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
A very general statement regarding the part Medical exposure of the GSR Part 3
Basic IRRS Training - Module 16 - Additional Areas

24. 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
the list of the requirements
Basic IRRS Training - Module 16 - Additional Areas

25. Basis of the review
RS-G-1.5 Radiological Protection for Medical Exposure to Ionizing Radiation (2002)
Guidance on how the requirements may be fulfilled
Addressed to
the Government, the Regulatory Body,
the registrants and licensees
The safety guide relevant for this module is the whole document RS-G-1.5 It is a guidance!
Basic IRRS Training - Module 16 - Additional Areas 25

26. 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
The first part of the safety guide that gives the four major issues of the regulatory programme
Basic IRRS Training - Module 16 - Additional Areas

27. accidental exposures, …
RS-G-1.5: Safety Guide Radiological Protection for Medical Exposure to Ionizing Radiation
2. Specific aspects of radiological protection for medical exposure in:
diagnostic and interventional radiology
nuclear medicine
radiation therapy
Justification,
optimization,
guidance levels,
dose constraints,
training,
accidental exposures, …
Provides the specific aspects in the three fields of the medical uses of radiation: diagnosis (and interventional), nuclear medicine and radiotherapy. The issues in the cycle apply (mostly) to all of them.
Basic IRRS Training - Module 16 - Additional Areas

28. 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 relating to medical exposure
Good coordination and cooperation between review team members is essential to avoid overlaps and ensure effective information exchange among reviewers
Basic IRRS Training - Module 16 - Additional Areas

29. Potential crossover with other IRRS modules
The modules that interfere with the Medical Exposure
Medical exposure
Basic IRRS Training - Module 16 - Additional Areas

30. Potential Cross-over 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
Radiation Sources
Practically it is the same with the previous slide. You can chose the one you prefer.
Basic IRRS Training - Module 16 - Additional Areas

31. Example of a reviewer list
Requirement
Legal Provision
Reference
To whom addressed
Implementation
Compliance 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

32. Basic IRRS Training - Module 16 - Additional Areas
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 (2014)
Differences in the
basic requirement, glossary, …
This is an important remark.
Basic IRRS Training - Module 16 - Additional Areas

33. Basic IRRS Training - Module 16 - Additional Areas
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

34. Basic IRRS Training - Module 16 - Additional Areas
For medical exposure
… that the provision and implementation of
- justification (referral criteria, responsibilities, …) and
- optimisation (DRLs, calibration, QA, …) …
Without underestimating the other requirements, the issue of justification and optimisation are the most important in the medical exposure.
… ensure the radiation protection of the patient
Basic IRRS Training - Module 16 - Additional Areas

35. Basic IRRS Training - Module 16 - Additional Areas
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.
The site visit in this module is an inspection in a hospital/laboratory. The reviewer observes the RB’s inspector and interviews the licensee but doesn’t inspect the licensee.
Basic IRRS Training - Module 16 - Additional Areas

36. Basic IRRS Training - Module 16 - Additional Areas
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 ……
……….and
Get ideas for your country!
Basic IRRS Training - Module 16 - Additional Areas

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

38. 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

39. 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
Modal regulations comprise generic provisions and several class specific provisions.
Interfaces with authorities competent for transport of dangerous goods in general and for transport of other classes will have to be managed.
Basic IRRS Training - Module 16 - Additional Areas

40. 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

41. 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)]
ICAO = International Civil Aviation Organization
All European Union Member States are contracting parties to these conventions.
Basic IRRS Training - Module 16 - Additional Areas

42. 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.
Only the conventions applicable in Europe are listed. There are also regional conventions in other continents.
It must be noted that ADR, RID and AND, as well as the ICAO Technical Instructions and the IMDG Code, are revised every two years. That’s why the IAEA Transport Regulations are revised every two years.
They are applicable in the European Union.
Basic IRRS Training - Module 16 - Additional Areas

43. 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
TS-G-1.1 (rev. 1) is to be replaced by SSG-26 (advisory material for the 2012 edition).
Basic IRRS Training - Module 16 - Additional Areas

44. 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
In the context of an IRRS, the most important standards are TS-R-1 (to be replaced later by SSR-6) and TS-G-1.5.
Basic IRRS Training - Module 16 - Additional Areas

45. Terminology Transport Package
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

46. Focus of transport review
The focus of reviewing transport 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.
The term ‘competent authority’ is replaced by ‘regulatory body’ in SSR-6.
Reviewers should be familiar with the Transport Regulations and the safety guide on compliance assurance.
Basic IRRS Training - Module 16 - Additional Areas

47. 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
Design assessment
Witnessing testing
9. Witnessing manufacture
Basic IRRS Training - Module 16 - Additional Areas

48. 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 Areas

49. Check the following points and key elements therein:
Recommendation of Experienced Reviewers Give particular attention to:
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

50. Summary (1)
GSR Part-3 is the prime reference for the regulatory aspects of both occupational radiation protection and medical exposure.
Every regulated facility or activity is subject to regulatory oversight of the implementation of an occupational radiation protection programme.
Employers, employees, registrants and licensees are all variously responsible for applying the requirements for occupational radiation protection.
Requirements in respect of medical exposure in planned exposure situations apply to all medical exposures, including intended, unintended and accidental exposures.
Basic IRRS Training - Module 16 - Additional Areas

51. Summary (2)
The applicable IAEA requirements and guidance are addressed to government, the regulatory body, registrants and licensees as appropriate.
IRRS review of Module 11 ‘additional’ areas should avoid duplicating the approach and consequent findings for Modules 1 through 9.
Observations arising from review of Module 11 more closely associated with Modules 1 through 10 should be integrated into the appropriate chapters of the IRRS report, working closely with the relevant Module lead reviewers.
Basic IRRS Training - Module 16 - Additional Areas

52. Summary (3) Focus on the compliance assurance programme of transport
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

53. 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

54. Discussion Points
Occupational radiation protection is not facility-specific. How should IRRS reviewers ensure it is effectively in place in all regulated facilities?
Medical exposure is a matter for doctors, who know best.
Frequency of review/revision of the IAEA Transport Regulations is higher than for other safety standards: advantages? inconveniences?
Basic IRRS Training - Module 16 - Additional Areas