1. Postgraduate Educational Course in radiation protection and the Safety of Radiation sources
PGEC Part IV The International System of Radiation Protection and the Regulatory Framework
Module IV Safety and Security of Radioactive Sources
11.2 Regulatory Authority Information System
Transport of radioactive sources;
Recovery of orphan sources

2. Overview of Module IV.11
This module will discuss the following aspects:
Introduction & Basic Requirements,
Code of Conduct: Scope and objectives, Legislation and Regulations, Regulatory Body, Import and Export of Radioactive Sources, Role of the IAEA.
Introduction to Regulatory Authority Information System (RAIS), including National inventory of radiation sources
Guidance on transport of radioactive sources; recovery of orphan sources;

3. Regulatory Authority Information System (RAIS)
RAIS is software developed by the IAEA.
Developed to assist Member States in managing their regulatory activities in accordance with IAEA Safety Standards and guidance, including the Code of Conduct on the Safety and Security of Radioactive Sources and supplementary Guidance.
Operation of RAIS depends on:
Notifications
Categorization of Radiation Sources
Inventory of Radiation Sources and Users/Locations

4. Notification - Form Contents of the form
Name and Address of the Legal Person
Name and Address of the Organization
Nature of the Practice in which source is used
(cont.)

5. Notification - Form Identification of each source Date
(a) Radionuclide Activity
Chemical Form
Sealed Source (if yes, Manufacturer/Model)
(b) Radiation Generating Equipment
Manufacturer, Model
Operating Potential
Nature of Equipment in which source is installed
Date
Signature for Legal Person

6. Notification New regulatory authority should (1/3)
prioritize the need for gaining regulatory control over practices in terms of likelihood and magnitude of potential exposures
identify and list likely source users
provide documented requests for notification to all likely source users and request replies
follow up likely source users telephonically or by on-site visits, if there is no response to the request for notification

7. Notification New regulatory authority should (2/3)
follow up on cases where a negative response was provided to the request for notification, but where the regulatory authority has contradictory information or other reasons to believe that the respondent may possess sources
document and log into the inventory all cases where sources (either in use/storage/abandoned) or source users are identified

8. Notification New regulatory authority should (3/3)
periodically update the source inventory with new information
develop and implement a process to check on the accuracy of the notification/inventory system, with an emphasis on sources or practices with higher risks
be able to identify and locate every source (either directly through its own inventory or through licensees/registrants inventories) subject to its regulatory control

9. Categorization of sources
Categorization is relevant to
decisions in bringing sources under control
guide the application of a regulatory infrastructure
prioritize a regulatory authority’s resources and training activities
guide the degree of detail necessary for a safety assessment
serve as a measure of the intensity of effort which should be applied to the safety and security of a particular type of source

10. Categorization of sources
Categorization of Radioactive Sources, Safety Guide RS-G-1.9, IAEA, Vienna (2005)
Safety Guide builds on IAEA-TECDOC 1191, Categorization of Radiation Sources (Dec 2000)
The categorization is based on the concept of dangerous sources which are quantified in terms of D values.
The D value is the radionuclide specific activity of a source which, if not under control, could cause severe deterministic effects.
D values are used as normalizing factors to provide a reference for comparing risks.

11. Categorization of sources
Five categories are introduced
Category Activity ratio (A/D)
1 A/D ≥ 1000
> A/D ≥ 10
> A/D ≥ 1
> A/D ≥ 0.01
> A/D
and A > exempt

12. Category 1 Sources A/D ≥ 1000 Examples
Radioisotope thermoelectric generators (RTGs)
Irradiators
Teletherapy sources
Fixed, multi-beam teletherapy (gamma-knife) sources

13. Category 2 Sources 1000 > A/D ≥ 10
Examples
Industrial gamma radiography sources
High/medium dose rate brachytherapy sources

14. Category 3 Sources 10 > A/D ≥ 1
Examples
Fixed industrial gauges that incorporate high activity sources
Well logging gauges

15. Category 4 Sources 1 > A/D ≥ 0.01
Examples
Low dose rate brachytherapy sources (except eye plagues and permanent implants)
Industrial gauges that do not incorporate high activity sources
Bone densitometers
Static eliminators

16. 0.01 >A/D and A > exempt
Category 5 Sources
0.01 >A/D and A > exempt
Examples
Low dose rate brachytherapy eye plagues and permanent implant sources
X-ray fluorescence (XRF) devices
Electron capture devices
Mossbauer spectrometry sources
Positron emission tomography (PET) sources

17. Regulatory authority Information System (RAIS)
Module 1: Inventory of Radiation Sources and Installations
Lists all radiation sources within an installation, classified by practice
Covers installations having a given type of equipment, for a given practice
Covers multiple radiation sources
Tracks history of a source until returned to the supplier or managed as radioactive waste

18. Regulatory authority Information System (RAIS)
Module 2: Authorization
Tracks the administrative status of an installation, from initial application to its authorization, including pre-operational inspections
Covers authorization related to transfers of radiation sources between authorizations
Allows the regulatory authority to issue authorization documents through RAIS

19. Regulatory authority Information System (RAIS)
Module 3: Inspection and Enforcement
Inspections carried out within specified time periods
Inspections that should be done over a future time period
Assists in monitoring follow-up actions and deadlines
Allows the regulatory authority to issue inspection reports through RAIS

20. Regulatory authority Information System (RAIS)
Module 4: Individual Dose Monitoring
Calculates estimates of the effective dose to workers from measured individual dose records
Lists doses to workers at each installation
Computes total doses for workers employed at more than one installation
Stores the dose histories of workers

21. Regulatory authority Information System (RAIS)
Module 5: Performance Indicators
REGULATORY AUTHORITY INDICATORS
Lists authorizations processed
Displays average time for processing an authorization, classified by practice
Lists inspections, by practice, geographic area or inspector; enforcement actions; ongoing actions/deadlines
LICENSEE INDICATORS
Displays average occupational doses by practice, doses exceeding dose constraints or investigation levels
Stores history of incidents and non-compliance
Stores history of enforcement actions

22. Regulatory authority Information System (RAIS)
Search and reporting capabilities (1/3)
sources report by installation
installation reports by practice
installation report by authorization type
frequency of inspection by category report
report on inspections by practice
inspections made, pending and outstanding
list of inspections by inspector name

23. Regulatory authority Information System (RAIS)
Search and reporting capabilities (2/3)
number of sealed sources by nuclide
total activity of sealed sources by nuclide
number of accelerators by practice
number of authorizations by practice
number of pending authorizations
average time for granting authorizations
the number of enforcement letters by practice/period

24. Regulatory authority Information System (RAIS)
Search and reporting capabilities (3/3)
number of proposals for penalties by practice/period
number of findings by practice
number of monitored workers
maximum accumulated dose by practice
annual effective dose distribution
number of workers

25. Overview of Module IV.11
This module will discuss the following aspects:
Introduction & Basic Requirements,
Code of Conduct: Scope and objectives, Legislation and Regulations, Regulatory Body, Import and Export of Radioactive Sources, Role of the IAEA.
Introduction to Regulatory Authority Information System (RAIS), including National inventory of radiation sources
Guidance on transport of radioactive sources; recovery of orphan sources;

26. Transport of radioactive sources
The next section provides a broad outline of the framework within which radioactive materials must be transported:
Types of transport package
Marking and Labelling
Documentation
Vehicle requirements (road)
Driver training
Note: before undertaking transport operations a specialist should be consulted 7
RADIOACTIVE

27. Dangerous Goods Classification
Class Description
1 Explosives
2 Gases
3 Flammable liquids
4 Flammable solids
5 Oxidising substances
6 Toxic & infectious substances
7 Radioactive materials
8 Corrosive substances
9 Miscellaneous
Regulations allocate Classes to the different types of dangerous goods.
In general safety ensured by:
a. integrity and marking of packaging
b. training of personnel
c. strict rules relating to mixed loads
but specific requirements apply to each class of goods.

28. When is transport required?
Source change or repair
Movement to another company
Transfer of samples (leak tests, etc)
Return of a source to manufacturer or disposal agent
Contaminated objects
Supply of radioactive material
Mobile sources…….
Stress transport is not only relevant when it is your primary job, but can impact on many radiation uses.

29. IAEA Regulations
Regulations for the Safe Transport of Radioactive Material, 2009 Edition Safety Requirements
Regularly updated
Adopted worldwide for all modes of transport – national legislation based on IAEA Regulations

30. Modes of Transport
Mention that each mode regulated by separate authorities, but basic requirements the same.
Recap IAEA TS-R-1 as basis (this previously described in Introduction to Legislation)

31. International Legislation
The International Maritime Dangerous Goods Code
Safe Transport of Dangerous Goods by Air
Council Regulation 1493/93/Euratom - transfrontier shipment of RAM
Council Directive 92/3/Euratom - the supervision and control of shipments of radioactive waste between Member States
ADR / RID “European Agreement Concerning the Transport of Dangerous Goods by Road / Rail”
Mention the significance of ADR, introducing ‘Class7’
Show Maritime and IATA regulations
Expand on briefly movement waste shipment regs and how they impact and are enforced in the UK.

32. Transport regulations define:
Consignor
Carrier
Consignee
Give examples of each category

33. Responsibilities Consignor Carrier Consignee Packing
Marking and labelling
Documentation
Information
Placarding QA
RPP
Carrier
Safety in Carriage
(radiation & fire/accident) QA
RPP
Consignee
RPP
Restriction of exposure following receipt of package
Briefly describe
purpose of RPP
extent / responsibilities for QA checks

34. Arranging a consignment
1. Packaging
2. Marking and Labelling
3. Documentation
4. Vehicle requirements (road)
5. Training
Briefly summarise notifications -
RSA 93 compliance - ensure consignee is registered
Notifications under Shipment of Radioactive Materials Between Member States

35. Package Types Excepted Type A Type B Type C Industrial Describe:
Increasing level of protection offered by each package type (illustrate with slides / props)
Information required to decide which package type is needed
Who may undertake compliance tests on each
Note: special form covered already in Basic Concepts, but recap if necessary
Coverage of A1 / A2 values not require unless specifically asked

36. Excepted packages
for the transport of limited activity/limited hazard materials
activity limits
individual items
total consignment
limits are fractions of the limits for Type A packages
surface dose rate must be < 5 Sv/h

37. Excepted Packages Stout cardboard box often sufficient
Pack item well to prevent movement and absorb liquid
Radiation warning inside package

38. Industrial Packages Industrial Packages: IP-I IP-II IP-III
basic requirements
IP-II
IP-I plus stacking and drop tests
IP-III
equivalent to Type-A package

39. Industrial Packages
Tanks and freight containers may be used as Industrial Packages II or III
provided
Loss of radioactive material or loss of shielding would not occur during normal conditions of transport

40. Industrial package limits
Activity limits for industrial packages depend on:
exclusive use
LSA/SCO category
physical state (solid/liquid/gas)

41. Type A Package More robust than excepted package
Smallest dimension at least 10 cm
Must satisfy specified tests
consignor to demonstrate compliance
Transport of:
Unsealed sources for medicine / research
Nuclear Density Gauges
Other portable gauges

42. Type A Packages Activity limits: Radionuclide specific
Special form material: A1
Non special form material: A2
Radionuclide specific

43. Special Form vs. Other Form
Special Form Radioactive Materials are sealed radioactive sources for which a ‘Special Form Certificate’ is held
All other Radioactive Materials are ‘Other Form’

44. Type A Packages

45. Type B Package
For the transport of large industrial sources / nuclear material
all type A requirements
further specified tests
certificate issued by competent authority (CA)
activity limited by certificate

46. Approval of Shipments For a type B container which:
relies on intermittent venting;
is not designed to withstand -40 to 70 degrees;
contains >3000 A1 or A2, or 1000 TBq; or
contains fissile material with Transport Index, TI >50
shipment requires multilateral approval
Certificate issued by all relevant CAs
Must demonstrate compliance with conditions of Type B certificate

47. Type C For transport of high activity sources by air
specific tests under low pressure conditions
Competent Authority tested

48. Packaging of fissile material
Additional requirements:
competent authority approval
maintain subcriticality throughout journey
consider:
water seepage
loss of efficiency of moderators
re-arrangement within the package
reduced spacing between packages
temperature changes

49. Contamination Control
Packages and vehicles should be checked for contamination if this is likely to arise
Contamination must be below specified limits
Frequency of monitoring depends on likelihood of contamination

50. Transport Index (TI)
Dose rate (Sv/hour) at 1 metre from the surface divided by 10
Used to assess the relative hazard of type A and B packages

51. Vehicle Limits Limits on Transport Index: Dose rate limits
50 TI limit for normal transport
no limit if under exclusive use
Dose rate limits
2 mSv/hour at surface
100 Sv/hour at 2 metres
Criticality Safety Index Limits
50 for normal transport
100 if under exclusive use

52. Exclusive Use The consignor or consignee has direction
throughout the movement:
initial loading
transport / storage in transit
final unloading

53. External marking Excepted packages Type A packages, as above plus:
Details of consignor or consignee
UN number of content
Weight if > 50 kg
Type A packages, as above plus:
‘Type A’
UN number plus Proper Shipping Name
Appropriate label

54. External marking Industrial Packages -as excepted package plus:
IP-I, IP-II or IP-III as appropriate
Appropriate labels

55. External marking Type B package - as excepted package plus
fire proof trefoil symbol
id for package design
package design serial number
appropriate labels
Type B(U) or Type B(M)
Type C Package - as Type B

56. Category I - white
< 5 Sv/hour at surface of package
Module 4

57. Category II - yellow > 5 - 500 Sv/h at surface 10 Sv/h at 1 m
TI between 0 and 1.0
Module 4

58. Category III - yellow > 500 - 2000 Sv/h at surface
> Sv/h at 1 m
TI between 1.0 and 10
Module 4

59. Transport Document Provided by consignor Travels with the package
Contains specified information
Required for all package types
Signed declaration
Copy retained by consignor for 2 years
Regular consignment certificates - incidences where same package and contents are transported on a regular basis by the same consignor

60. Documentation Transport document Emergency provisions Transport
Consignor: Rad-tools
Warrington
Consignee: Rad-tools
Exeter
Class 7
Material: Am-241
Emergency contacts:
Mr I Freely
Transport document
Emergency provisions
Discuss when documentation is required and who is responsible for it.
Expand on contents of transport document, and retention requirements
Do not expand on the content of local rules, registration, contingency plans as these are covered elsewhere in the course.

61. Radiation Protection Programme
A radiation protection programme must be established to restrict radiation exposures during transport & in the event of an accident

62. Quality & Compliance Assurance
A Quality Assurance Programme should demonstrate that the design, manufacture, testing, documentation, carriage, use, maintenance and inspection:
of all special form material,
of all low dispersible radioactive material,
of all packages and packaging, and
for transport and in-transit operations, meet the requirements of the regulations

63. Vehicle Placards & Plates
Radioactive 7

64. Placard

65. Orange Plates Not required for Excepted Packages Front & back
Min 300 x 120 mm

66. Vehicle Placards & Plates

67. Carried in Vehicle Transport documents Statement for carrier
Instructions for loading/unloading & stowage
Emergency provisions
Fire extinguishers may be required by national legislation

68. Driver Training
All individuals involved in any aspect of the transport operation should receive training in radiation protection and the IAEA regulations, commensurate with their responsibilities
Level of training often varies with type and number of packages being carried

69. Overview of Module IV.11
This module will discuss the following aspects:
Introduction & Basic Requirements,
Code of Conduct: Scope and objectives, Legislation and Regulations, Regulatory Body, Import and Export of Radioactive Sources, Role of the IAEA.
Introduction to Regulatory Authority Information System (RAIS), including National inventory of radiation sources
Guidance on transport of radioactive sources; recovery of orphan sources;

70. Orphan Sources
An orphan source is a radioactive source which is not under regulatory control, either because it has never been under regulatory control or because it has been abandoned, lost, misplaced, stolen or otherwise transferred without proper authorization.
A vulnerable source is a radioactive source for which the control is inadequate to provide assurance of long term safety and security, such that it could be relatively easily be acquired by unauthorized persons.

71. Code of Conduct Basic Principle 7 states that
“Every State should, in order to protect individuals, society and the environment, take the appropriate measures necessary to ensure: …. (a) that the radioactive sources within its territory, or under its jurisdiction or control, are safely managed and securely protected during their useful lives and at the end of their useful lives”.

72. Code of Conduct Basic Principle 8 states that
“Every State should have in place an effective national legislative and regulatory system of control over the management and protection of radioactive sources. Such a system should: ….(b) minimize the likelihood of a loss of control; (c) include national strategies for gaining or regaining control over orphan sources”.

73. Recovery of orphan sources
In order to develop a national strategies for gaining or regaining control over orphan sources need to:
Decide on the scope of the strategy;
Gather specific information on all aspects of the past and current degree of regulatory control of radioactive sources;
Identify problems and potential issues (gap analysis).

74. Scope of the strategy
Scope should at least include those sources capable of causing severe deterministic human health effects if not under control.
Such sources are in Categories 1, 2 and 3 according to the Safety Guide on Categorization of Radioactive Sources

75. Gathering specific information

76. Identifying problems
Problems and potential issues should be identified while the data gathering is taking place.
As questions are asked and answered, it will become clear where there are gaps in information or where there are problems
If experts are not available within a State, a peer review mission should be requested in order to obtain assistance

77. Further information
Home page for IAEA Nuclear Safety & Security:
IAEA Safety Requirements BSS GSR Part 3 (Interim) IAEA (2011)
IAEA Safety Requirements: Governmental, Legal and Regulatory Framework for Safety. GSR Part 1 IAEA (2010)
Regulations for the Safe Transport of Radioactive Material, 2009 Edition Safety Requirements, IAEA (2009)
Code of Conduct on the Safety and Security of Radioactive Sources, IAEA, Vienna (2004)
Guidance on the Import and Export of Radioactive Sources IAEA, Vienna (2005)
Security of Radioactive Sources, IAEA Nuclear Security Series No. 11, IAEA, Vienna (2009)
Security in the Transport of Radioactive Material, IAEA Nuclear Security Series No. 9, IAEA, Vienna (2008).
Other publications issued in the IAEA Nuclear Security Series
National Strategy for Regaining Control over Orphan Sources and Improving Control over Vulnerable Sources SSG-19, IAEA (2011)
Security of Radioactive Sources, TECDOC 1355, IAEA (2003)
Categorization of Radioactive Sources, Safety Guide RS-G-1.9, IAEA, Vienna (2005)