1. Cait Maloney Vienna, xx / xx / xx
RER/9/111: Establishing a Sustainable National Regulatory Infrastructure for Nuclear and Radiation Safety TCEU School of Drafting Regulations November Presentation #1.6 and 1.7 role of regulations, regulatory concepts
Cait Maloney
Vienna, xx / xx / xx

2. Objectives and concepts
To understand various elements of regulatory framework
To introduce concepts of:
prescriptive vs performance-based
graded approach
exemption
clearance
optimization

3. Hierarchical structure
A national legal system should include, as appropriate
statutes or laws
decrees
regulations, ordinances
decisions
codes of practice
safety guides, standards, etc.

4. Hierarchical structure (2)
Acts/Laws have very strong authority (courts) but are difficult to amend quickly. They should empower regulatory authority and establish fundamental principles and concepts.
Regulations have strong authority (regulatory penalties) but can usually be amended relatively quickly.
Guidance has weak authority but can be adapted very quickly.

5. Hierarchical structure (3)

6. Hierarchical structure (4)
Principal requirements
Legislation
Detailed requirements
Regulations
Practice specific requirements or guidance
Codes of practice

7. Examples of types of regulation
General:
establishment of regulatory body
administrative processes
cost recovery
fines

8. Examples of types of regulation (2)
Program element specific:
radiation protection
environmental protection
transport
radioactive waste
security
apply to more than one practice

9. Regulatory approach Performance-based regulations
“what must be achieved”
set out general requirements
Prescriptive regulations
“how to comply with requirements”
set out detailed requirements

10. Performance-based regulations
Examples:
The licensee shall .. ensure the presence of a sufficient number of qualified workers to carry on the licensed activity safely and in accordance with the Act, the regulations made under the Act and the licence.
The licensee shall plan and manage work practices so that occupational and public radiation doses are kept as low as reasonably achievable and shall achieve this through the use of suitable workplace and individual monitoring using recognized measurement techniques.

11. Performance-based regulations (2)
Define what has to be achieved – not how to achieve it
Put responsibility on licensee/user to justify methodology and prove compliance

12. Performance-based regulations (3)
Advantages:
focus on objectives: what must be achieved in terms of protection/safety
applicable to a range of practices
flexible – can be adapted to evolving circumstances
reinforce licensee’s responsibility for safety

13. Performance-based regulations (4)
Disadvantages:
must be interpreted for each licensee or practice – room for misunderstanding
requires higher level of expertise for licensee and regulatory staff
not “black or white”

14. Prescriptive regulations
Examples:
A person shall not use a radiation source for industrial radiographic purposes unless that person is certified as an industrial radiographer by the regulatory body.
No person shall use a package of a certified design unless they have received confirmation from the regulatory body that the proposed use of the package has been registered by the regulatory body.

15. Prescriptive regulations (2)
Every protected area shall be enclosed by a barrier that is located at its perimeter.
The barrier shall be designed and constructed to inhibit any unauthorized entry into the protected area
(It) must be one or a combination of the following structures: (a) a fence at least 2.4 m in height constructed of wire chain links made of wire not smaller than gauge number 11, having openings whose sides do not exceed 6 cm in length, and topped with at least three strands of barbed wire or barbed tape installed parallel to the fence on brackets angled outward; (b) a wall at least 2.4 m in height, including any wall that forms part of a building, constructed of steel, wood, concrete, masonry or other substantial material or ……………..

16. Prescriptive regulations (3)
define exactly how to achieve compliance
may define protocols (e.g. how to conduct workplace monitoring)
may define what type of instruments shall be used
may define forms to be used (e.g. what type of records should be maintained)
may be specific to certain types of practices

17. Prescriptive regulations (4)
Advantages:
easy to determine when requirements are met
easy for licensee to comply
reduce time and skills necessary to conduct a licensing review or an inspection
enable authorization and inspection process to focus on simple verification of compliance

18. Prescriptive regulations (5)
Disadvantages:
can drive a “compliance culture” not a “safety culture”
does not reinforce licensee’s responsibility for safety
require practice specific knowledge and experience
need to be regularly amended to keep pace with changes in technology

19. Hierarchical structure (4)
Principal requirements
Legislation
Detailed requirements
Regulations
Practice specific requirements or guidance
Codes of practice

20. Codes of Practice Typically developed for specific practices, such as:
industrial radiography
diagnostic radiology
research use of radionuclides
fixed and portable gauges

21. Codes of Practice (2)
are usually developed and issued by the Regulatory Authority or expert body
give practice-specific advice on how to achieve regulatory requirements
are not necessarily legally binding – unless linked to authorization

22. Regulatory concepts Graded approach
Regulatory requirements and effort must be based on radiation risk posed by the practice.

23. Graded approach (2) dental X-ray unit nuclear medicine facility
industrial radiography
nuclear power plant

24. Graded approach (3) Covers all aspects of regulatory requirements:
safety assessment
regulatory review
frequency and depth of compliance activities
worker training, protective equipment
environmental protection program
public communications

25. Regulatory concepts: Exemption
“Exemption: the determination by a regulatory body that a source or practice need not be subject to some or all aspects of regulatory control on the basis that the exposure and potential exposure… are too small to warrant the application of those aspects….”
(radioactive material does not enter regulatory control)

26. Regulatory concepts: Exemption (2)
Exemption from regulation:
Practices or sources should not come under regulatory control if:
radiation risks are sufficiently low
regulatory control would not yield worthwhile reduction of risk.
(see GSR part 3 Schedule 1 for full explanation)

27. Regulatory concepts: Clearance
“Clearance: the removal of regulatory control by the regulatory body from radioactive material or radioactive objects within notified or authorized practices”.
(radiation source permitted to leave regulatory control)

28. Regulatory concepts: Clearance (2)
Clearance from regulation:
Practices or sources may leave regulatory control if:
radiation risks are sufficiently low
regulatory control would not yield worthwhile reduction of risk.
(see GSR part 3 Schedule 1 for full explanation)

29. Rgulatory concepts: Optimization
“Optimization of protection and safety: the process of determining what level of protection and safety would result in the magnitude of individual doses, the number of individuals subject to exposure and the likelihood of exposure being ALARA”.
i.e. balance cost and dose reduction (below regulatory limits).

30. References / Further Reading
GSR Part 1 Requirements 26, 29, 32
GSR Part 3 Requirements 3,4,5,6,8,11,21, Schedule 1
TECDOC-1067 “Organization and implementation of a national regulatory infrastructure governing protection against ionizing radiation and the safety of radiation sources”