1. 1.6. Notification and Authorization. Graded Approach
“School for Drafting Regulations on Radiation Safety, IAEA - Module 1 Regulatory framework for safety, authorization and inspection
October 2012
LECTURE 3-1
The International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources (BSS) recognize two main situations where radioactive material is used – practices and interventions. Practices involve use of ionizing radiation within an authorized activity and in compliance with the requirements of BSS. Interventions could result from past practices and accidents, such as discontinued mining and milling operations, weapon tests, accidents lending to disposal of airborne contamination, inadequate management of radioactive materials and past radioactive waste disposal practices. Sites contaminated as a result of past practices and accidents, vary widely in terms of type of contamination level of contamination, size of contaminated areas and spatial distribution of contamination in the affected areas (soil, groundwater, etc.). 1 Practice is any human activity that introduces additional sources of exposure or exposure pathways or extends exposure to additional people or modifies the network of exposure pathways from existing sources, so as to increase the exposure or the likelihood of exposure of people or the number of people exposed
2 Intervention is defined as any action intended to reduce or avert exposure or the likelihood of exposure to sources which are not part of a controlled practice or which are out of control as consequence of an accident.

2. Objective
To provide understanding of the authorisation process and the regulations and procedures for its implementation.
Notification & Authorization. Graded Approach

3. Contents Exemption Notification Authorization Graded approach

4. Exemption. GSR Part3 Exemption
The government or the regulatory body shall determine
which practices
or which sources within practices are to be exempted
from some or all of the requirements of these Standards, including the requirements for notification, registration or licensing,
Basis for this determination - the criteria for exemption or any exemption levels specified by the regulatory body
CRITERIA AND LEVELS - GSR PART 3
Notification & Authorization. Graded Approach

5. Regulated facilities and activities
Exemption
Exempted facilities and activities
Regulated facilities and activities
Exempted
Exempted
Notification & Authorization. Graded Approach

6. Regulated facilities and activities
Clearance
Radioactive discharges
Regulated facilities and activities
Cage
Radioactive decay storage or radioactive waste disposal
Radioactive material clearance
Notification & Authorization. Graded Approach

7. Notification and Authorization. GSR Part3
The regulatory body shall establish a regulatory system for protection and safety that includes:
(a) Notification and authorization; …
Notification & Authorization. Graded Approach

8. Notification and Authorization. GSR Part3
Any person or organization intending to operate a facility or to conduct an activity shall submit to the regulatory body, as appropriate, a notification or an application for authorization.
NOTIFICATION = APPLICATION
NOTIFICATION = LIST OF INTENT
NOTIFICATION = …
Notification & Authorization. Graded Approach

9. Notification and Authorization.
Requirements for notification
Clear identification of the person making the notification;
Clear specification of the practice;
Clear specification of the source(s) to be used in the practice:
form of radioactive source(s), radionuclide(s), identification number, location, activity
X ray equipment - manufacturer, model, serial number, location and power
Notification & Authorization. Graded Approach

10. Notification and Authorization. GSR Part3
Are there any cases when notification is sufficient for regulatory body?
When is notification alone enough?
Notification & Authorization. Graded Approach

11. Notification and Authorization. GSR Part3
When Is notification alone enough?
Example of graded approach
Notification alone is sufficient provided that
the exposures expected are unlikely to exceed a small fraction, as specified by the regulatory body, of the relevant limits,
the likelihood and magnitude of potential exposures and any other potential detrimental consequences are negligible.
Notification & Authorization. Graded Approach

12. Notification and Authorization. GSR Part3
When Is notification alone enough?
Example:
5 category gas chromatography detector source, 5 mCi Ni-63
5 category Gd-153 PET calibration sources, less than 1 mCi
(shown in a carrying case)
Notification & Authorization. Graded Approach

13. Notification and Authorization.
Plans for the facility
or activity
Proceed
Yes
Exempted ? No No
Notification
Proceed
Yes
Is notification enough? No
Notification & Authorization. Graded Approach

14. Notification and Authorization. GSR Part3
Authorization: registration or licensing
Any person or organization intending to carry out any of the actions specified in … shall, unless notification alone is sufficient, apply to the regulatory body for authorization, which shall take the form of either registration or licensing.
Notification & Authorization. Graded Approach

15. Notification and Authorization. GSR Part3
Authorization: registration or licensing
Any person or organization applying for authorization:
Shall submit to the regulatory body the relevant information necessary to support the application;
Shall refrain from carrying out any of the actions specified in … until the registration or license has been granted;
Shall assess the nature, likelihood and magnitude of the expected exposures due to the source and shall take all necessary measures for protection and safety;
Notification & Authorization. Graded Approach

16. Notification and Authorization. GSR Part3
Authorization: registration or licensing (cont’d)
Any person or organization applying for authorization:
Shall, if there is a possibility for an exposure to be greater than a level as specified by the regulatory body, have a safety assessment made and submitted to the regulatory body as part of the application;
Shall, as required by the regulatory body, have an appropriate prospective assessment made for radiological environmental impacts, commensurate with the radiation risks associated with the facility or activity.
Notification & Authorization. Graded Approach

17. Notification and Authorization. GSR Part 1
Authorization of facilities and activities by the regulatory body
The regulatory body shall issue guidance on the format and content of the documents to be submitted by the applicant in support of an application for an authorization...
Notification & Authorization. Graded Approach

18. Notification and Authorization. GSR Part 1
Requirement 23: Authorization of facilities and activities by the regulatory body
Any subsequent amendment, renewal, suspension or revocation of the authorization for a facility or an activity shall be undertaken in accordance with a clearly specified and established procedure, and shall make provision for the timely submission of applications for the renewal or amendment of the authorization
Notification & Authorization. Graded Approach

19. Notification and Authorization. Exercise – 10 minutes
1. What provisions in the law, which regulations, guides and procedures are needed to provide for notification and authorization?
HELP: Use as a reference GSR Part 3 requirements para 3.7,3.8,3.9,3.10 and GSR Part 1 requirements 23, 24.
2. Prepare the list of regulations, guides and procedures and discuss with your neighbor or trainer
Notification & Authorization. Graded Approach

20. Notification and Authorization. GSR Part3
Exemption criteria and levels
Procedure for decision making for exemption from some or all of the requirements
Regulation for the notification and authorization procedure (including subsequent amendment, renewal, suspension or revocation of the authorization)
Guidance for the format and content (including application form) documents to be submitted by the applicant in support of an application for an authorization
Guidance to assess the nature, likelihood and magnitude of the expected exposures due to the source
Requirements for protection and safety for certain activities and facilities
Guidance for the safety assessment (if there is a possibility for an exposure to be greater than a level as specified by the regulatory body)
Guidance for appropriate prospective assessment made for radiological environmental impacts (commensurate with the radiation risks associated with the facility or activity) …
+ GRADED APPROACH
Notification & Authorization. Graded Approach

21. Authorization Proceed Is notification enough?
Yes
Is notification enough? No
Apply for the authorization
Authorized
to work after registration
Yes
Is registration enough? No
Apply for license
Authorized to work after license is granted
Notification & Authorization. Graded Approach

22. GRADED APPROACH Authorization Allowed to work Is notification enough?
Yes
Is notification enough? No
GRADED APPROACH
Apply for the authorization
Allowed
to work after registration
Yes
Is registration enough? No
Apply for license
Allowed to work after license is granted
Notification & Authorization. Graded Approach

23. Graded approach. GSR Part3
The regulatory body shall adopt a graded approach to the implementation of the system of protection and safety, such that the application of regulatory requirements is commensurate with the radiation risks associated with the exposure situation.
Notification & Authorization. Graded Approach

24. Graded approach. GSR Part3
Example of the requirement for graded approach
The application of the requirements for protection and safety in planned exposure situations shall be commensurate with
the characteristics of the practice or the source within a practice,
with the magnitude and likelihood of the exposures.
Notification & Authorization. Graded Approach

25. Graded approach. GSR Part3
Example of the requirement for graded approach
The application of the regulatory requirements of these Standards shall:
conform to any requirements specified by the regulatory body, in accordance with a graded approach;
however, not all the requirements of these Standards are relevant for every practice or source, nor for all the actions specified in para. 3.5.
Notification & Authorization. Graded Approach

26. Graded approach. Radiological risk
8/27/2018
Graded approach. Radiological risk
Radiological risk can be assessed by different tools.
Example 1 - the Risk Analysis Matrix
Likelihood
Consequence
Negligible
Minor
Moderate
Major
Extreme
Almost certain M VH E
Likely H
Possible L
Unlikely
Rare
Integrated Risk Management Analysis Matrix
High and Extreme risks and low risks are relatively easy to deal with
It is the moderate risks that take a great deal of regulatory effort
Notification & Authorization. Graded Approach
IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources
Introduction to the Graded Approach 26

27. Graded approach. Radiological risk
Radiological risk can be assessed by different tools.
Example 2 – another possibility to apply the graded approach is based on categorization of sources and practices according to the associated risk
Image from
Notification & Authorization. Graded Approach
IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources

28. Categorizes Radioactive Sources According to Risk (1category)
8/27/2018
Categorizes Radioactive Sources According to Risk (1category)
Sealed sources are used in a variety of medical and industrial devices.
These photographs show irradiator and teletherapy machine
Notification & Authorization. Graded Approach
IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources
ERCRS Module 3.2 Graded Approach to Authorization Review and Assessment 28

29. Categorizes Radioactive Sources According to Risk (2 category)
8/27/2018
Categorizes Radioactive Sources According to Risk (2 category)
Sealed sources are used in a variety of medical and industrial devices.
These photographs show:
an industrial radiography exposure device which uses a radioactive iridium-192 source to make an “X-ray” image of a weld – a Category Two source
Brahy therapy machine which uses a radioactive iridium-192
Notification & Authorization. Graded Approach
IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources
ERCRS Module 3.2 Graded Approach to Authorization Review and Assessment 29

30. Categorizes Radioactive Sources According to Risk (3 category)
8/27/2018
Categorizes Radioactive Sources According to Risk (3 category)
Sealed sources are used in a variety of medical and industrial devices.
These photographs show:
a fixed density gauge – this one rather dirty – which uses a radioactive Cesium-137 source to measure the density of the contents of a pipe. Thousands of such fixed gauges are installed in factories and mines and mills
Well logging equipment
Notification & Authorization. Graded Approach
IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources
ERCRS Module 3.2 Graded Approach to Authorization Review and Assessment 30

31. Categorizes Radioactive Sources According to Risk (4 category)
8/27/2018
Categorizes Radioactive Sources According to Risk (4 category)
Sealed sources are used in a variety of medical and industrial devices.
These photographs show:
portable moisture-density gauge which uses radioactive Cesium and Americium sources to measure the compaction and moisture content of road beds and asphalt – a Category Four source,
Density gauge
Notification & Authorization. Graded Approach
IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources
ERCRS Module 3.2 Graded Approach to Authorization Review and Assessment 31

32. Source Category Risk Descriptions
8/27/2018
Source Category Risk Descriptions
Source Category
Source Description
Possible Health Effects 1
Extremely dangerous to the person
Permanent injury to fatal in a few minutes to an hour 2
Very dangerous to the person
Permanent injury to fatal in a hours to days 3
Dangerous to the person
Permanent injury, but unlikely to be fatal in a period of days to weeks 4
Unlikely to be dangerous to the person
Temporary injury possible in many weeks of exposure 5
Most unlikely to be dangerous to the person
No one
could be permanently injured by this source.
REFERENCE: Categorization of Radiation Sources RS-G-1.9, Pages 32 & 33
Notification & Authorization. Graded Approach
IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources
ERCRS Module 3.2 Graded Approach to Authorization Review and Assessment 32

33. Graded approach. Radiological risk
8/27/2018
Graded approach. Radiological risk
Example 3. National risk-informed
classification of radiation practices
See earlier lecture for the method of relative risk ranking of radiation practices
Industrial radiography and therapeutic nuclear medicine at the top of the chart;
teaching and storage of radiation sources at the bottom of the chart
Notification & Authorization. Graded Approach
IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources
ERCRS Module 3.2 Graded Approach to Authorization Review and Assessment 33

34. Graded approach. Application for authorization
Graded approach is a basic tool to optimize regulatory resources
Notification & Authorization. Graded Approach

35. Graded approach. Application for authorization
At the early stage of regulatory system development, when resources are minimum – notification is broadly applied with the condition when the application for the authorization should be provided to the regulatory authority
Notification & Authorization. Graded Approach

36. Graded approach. Application for authorization
Different authorization procedures for different facilities and activities
Registration or licensing?
No answer in GSR Part 3 requirements
No clear difference in the “Definitions”
(registration - a form of authorization for practices of low or moderate risks whereby the person or organization responsible for the practice has, as appropriate, prepared and submitted a safety assessment of the facilities and equipment to the regulatory body. The practice or use is authorized with conditions or limitations as appropriate)
Notification & Authorization. Graded Approach

37. Graded approach. Application for authorization
Registration or licensing?
Advice in GSR Part 3 footnote for typical practices that are amenable to registration:
Practice complexity
safety
operating procedures
safety training
problems with safety
largely ensured by the design of the facilities and equipment
simple to follow
requirements are minimal
there is a history of only few problems
in operations
Notification & Authorization. Graded Approach

38. Graded approach. Application for authorization
Type of Control
Risk level
Practice Complexity
Notification, or Authorization by Registration
Low
Simple
Authorization
by Licensing
High
Complex
Notification & Authorization. Graded Approach

39. Graded Levels of Authorization
8/27/2018
Graded Levels of Authorization
Authorization by:
Registration.
Licensing
Modern tendency - registration and licensing are similar procedures that even can have the same name, but the graded approach is applied
Regulatory
Effort
Increases
Requirements for the safety assessment and licensing conditions become more severe
For those sources and practices requiring authorization, there are graded levels of authorization
From the IAEA Safety Glossary:
Notification: A document submitted to the regulatory body by a legal person to notify an intention to carry out a practice or other use of a source.
Registration: A form of authorization whereby the legal person for the practice has, as appropriate, prepared and submitted a safety assessment of the facilities and equipment to the regulatory body and the practice or use is authorized with conditions or limitations as appropriate that are typically less severe than those for licensing.
Licensing: The issuance of a legal document by the regulatory body granting authorization to perform specified activities related to a facility or activity
Notification & Authorization. Graded Approach
IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources
ERCRS Module 3.2 Graded Approach to Authorization Review and Assessment 39

40. Graded Levels of Authorization
8/27/2018
Graded Levels of Authorization
Licensing can be graded to provide additional safety information to the Regulatory Body about a proposed action:
Licensing of facility’s life cycle stages is used where each stage can be started after regulatory review proved safe completion of the previous stage and licensee demonstrated safety of the next stage (e.g. radiotherapy department construction and operation).
Regulatory
Effort
Increases
Requirements for the safety assessment and licensing conditions become more severe
Full set of stages: site selection, construction, commissioning, operation, decommissioning (closure)
Notification & Authorization. Graded Approach
IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources
ERCRS Module 3.2 Graded Approach to Authorization Review and Assessment 40

41. Graded Levels of Authorization
8/27/2018
Graded Levels of Authorization
Regulatory body shall have the power to include specification of the conditions necessary for safety into the license (some countries have general law prohibition to do this)
Licensing conditions are graded according to the specific practice
Licensing conditions provide additional safety requirements for concrete licensee
Regulatory
Effort
Increases
licensing conditions become more detailed and severe
Full set of stages: site selection, construction, commissioning, operation, decommissioning (closure)
Notification & Authorization. Graded Approach
IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources
ERCRS Module 3.2 Graded Approach to Authorization Review and Assessment 41

42. Graded Levels of Authorization
8/27/2018
Graded Levels of Authorization
Licensing can be graded to provide additional safety information to the Regulatory Body about a proposed action:
Licensing with condition:
List of certain operations that are important for the safety
requirement to obtain special permissions to start operations from this list
Regulatory
Effort
Increases
Requirements for the safety assessment and licensing conditions become more severe
Full set of stages: site selection, construction, commissioning, operation, decommissioning (closure)
Notification & Authorization. Graded Approach
IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources
ERCRS Module 3.2 Graded Approach to Authorization Review and Assessment 42

43. Graded Levels of Authorization
The extent of information required by the RB in an application
The limits, conditions and controls imposed on the authorization by the RB
Should be in accordance with a graded approach.
GSR Part 1 – Paragraph 4.33“… the applicant shall … submit a safety assessment, which shall be reviewed and assessed by the regulatory body …. The extent of the regulatory control applied shall be commensurate with the radiation risks … in accordance with a graded approach.”
Notification & Authorization. Graded Approach
IAEA Training Course on Effective and Sustainable Regulatory Control of Radiation Sources

44. Graded approach
Graded approach is used not only for authorization but for all regulatory processes: different regulatory procedures for different facilities and activities
Notification & Authorization. Graded Approach

45. Graded approach
Graded approach is used for establishing regulatory requirements
1 way - specific for the facility and activity set of requirements that is chosen from the full set of requirements
Example: generators use – no radioactive waste management program, no assessment for environment impact is required
Example: 3 category radioactive sources use - no safety assessment could be required
2 way - specific requirements are applicable
Example: Individual exposure monitoring program requirements strongly vary depending from on activities and facilities
Notification & Authorization. Graded Approach

46. Additional Information IAEA-TECDOC-1525
IAEA-TECDOC-1525 Notification and Authorization for the Use of Radiation Sources (Supplement to IAEA Safety Standards Series No. GS-G-1.5)
Notification & Authorization. Graded Approach

47. Additional Information IAEA-TECDOC-1525
Notification & Authorization. Graded Approach

48. Additional Information IAEA-TECDOC-1525
Notification & Authorization. Graded Approach

49. Additional Information IAEA-TECDOC-1525
GUIDELINESS FOR APPLICANTS ON AUTHORIZATION
GUIDELINES FOR REVIEW AND ASSESSMENT OF APPLICATIONS FOR AUTHORIZATION for
diagnostic radiology & dental practices
nuclear medicine
radiotherapy
industrial radiography
Irradiators
gauges for well logging
Notification & Authorization. Graded Approach

50. Further Reading and References
Governmental, Legal and Regulatory Framework for Safety, No. GSR Part 1, General Safety Requirements Part 1, (2010)
Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards, INTERIM EDITION, No. GSR Part 3 (Interim), General Safety Requirements Part 3, (2011)
Regulatory Control of Radiation Sources Safety Guide, IAEA, Safety Standards Series No GS-G-1.5, IAEA, 2005
Safety of Radiation Generators and Sealed Radioactive Sources Safety Guide, IAEA Safety Standards Series No RS-G-1.10, 2006
Categorization of Radioactive Sources Safety Guide, IAEA Safety Standards Series No RS-G-1.9, IAEA, 2005
Notification and Authorization for the Use of Radiation Sources (Supplement to IAEA Safety Standards Series No. GS-G-1.5), IAEA-TECDOC Series No 1525, 2007
Notification & Authorization. Graded Approach

51. Questions?
Notification & Authorization. Graded Approach