1. Regulatory Control Training Workshop Regulatory Cooperation Forum
Legislative and regulatory framework for the for the safe implementation of a Nuclear Power Programme
Regulatory Control Training Workshop
Regulatory Cooperation Forum
Luis Lederman
7-11 November, 2016
IAEA, Vienna

2. In this lecture participants will learn about:
Learning objectives
In this lecture participants will learn about:
The essential elements of a regulatory infrastructure
The related IAEA safety principles and requirements
Establishment of the regulatory body and its functions
Staffing the regulatory body and the use of external technical support
Independence of the regulatory body

3. Considerations to launch a NPP 1/3
By its nature a nuclear power programme involves issues associated with nuclear material, ionizing radiation and the related national and international challenges. This is a major undertaking requiring careful planning, preparation and investment in a sustainable infrastructure that provides legal, regulatory, technological, human and industrial support to ensure that the nuclear material is used exclusively for peaceful purposes and in a safe and secure manner.

4. Considerations to launch a NPP 2/3
Needs include:
comprehensive nuclear legal framework covering safety, security, safeguards, liability and the commercial aspects related to the use of nuclear materials
effective regulatory system
human resources required to effectively supervise and implement the NPP

5. Considerations to launch a NPP 3/3
adequate financial resources for the construction, sustained safe operation and decommissioning of the NPP, as well as radioactive waste management
long term management of nuclear materials
open and transparent communication with the public and the neighbouring States about the considerations behind the introduction of nuclear power.

6. Fundamental Safety Principles
Principle 2: Role of government
An effective legal and governmental framework for safety, including an independent regulatory body, must be established and sustained.
To adopt legislation, regulations, and other standards and measures that are necessary to fulfil all its national responsibilities and international obligations effectively,
To establish an independent regulatory body.
To ensure that arrangements are made for preparing programmes of actions to reduce radiation risks, including actions in emergencies, for monitoring releases of radioactive substances to the environment and for disposing of radioactive waste.
According to our main reference, which is Fundamental Safety Principles document,
Although the prime responsibility rests with the licensee, the government has also a crucial role for safety.
The main role of the government is to establish and maintain an effective legal and governmental framework for safety.
Therefore, the government is responsible
………
And so on.

7. IAEA Safety Requirements
GSR part 1 - Requirement 2
Establishment of a framework for safety
The government shall establish and maintain an appropriate governmental, legal and regulatory framework for safety within which responsibilities are clearly allocated.
The government shall promulgate laws and statutes to make provision for an effective governmental, legal and regulatory framework for safety.
Our second main reference IAEA safety standard on the subject is the GSR Part 1:
It tells us “what should be done for establishment of an effective and adequate governmental, legal and regulatory framework for ensuring safety”.
Req#2 states that
………………
To meet this requirement, the Government shall first promulgate …………..

8. Elements of a national legal framework
Adhering to International Instruments
State’s commitment to safety, security and peaceful use
International cooperation
Enacting the National Nuclear Law
Comprehensive provisions on safety, security, safeguards and nuclear liability
Implementing international obligations
Revising other National Laws
Coherence of national legal framework
Avoiding gaps and overlaps

9. The 3S concept
Safety
Security
Safeguards
Liability

10. International Legal Instruments - Safety

11. International Legal Instruments - Security

12. International Legal Instruments - Safeguards

13. Essential elements 1
The establishment of an effective and independent regulatory body having all relevant legal authorities, responsibilities and resources;
(2) The safety principles for protecting people, society and the environment from radiation risks, both at present and in the future;
GSR Part 1 defines the followings as the essential elements of the regulatory framework.
This framework shall set out or provide:
- Creation and maintenance of a regulatory body with an effective independence and sufficient authorities and resources
………..
…………….
………………..
(3) The types of facilities and activities that are included within the scope of the framework for safety;
(4) The type of authorization that is required for the operation of facilities and for the conduct of activities, and the rationale for the authorization;

14. Essential elements 2
(5) Provision for assigning legal responsibility for safety to the persons or organizations responsible for the facilities and activities,
(6) Provision for the involvement of interested parties and for their input to decision making;
7) Provision for the review and assessment and inspections of facilities and activities;
(8) Provision for appeals against decisions of the regulatory body;
9) Responsibilities and obligations in respect of financial provision for the management of radioactive waste and of spent fuel, and for decommissioning of facilities and termination of activities;
GSR Part 1 defines the followings as the essential elements of the regulatory framework.
This framework shall set out or provide:
- Creation and maintenance of a regulatory body with an effective independence and sufficient authorities and resources
………..
…………….
………………..

15. Essential elements 3
(10) The criteria for release from regulatory control;
(11) The specification of offences and the corresponding penalties;
(12) Provision for acquiring and maintaining the necessary national competence for ensuring safety;
13) Provision for preparedness for, and response to, a nuclear or radiological emergency;
(14) Provisions for the interface with nuclear security;
And so on and so forth.
This is a kind of list of subjects that should be covered in nuclear act and/or relevant nuclear legislation.
The main purpose of the nuclear law is to establish a well functioning regulatory framework in the country.

16. Establishment of the Regulatory Body
GSR Part 1
Requirement 3:
The government, through the legal system,
shall establish and maintain a regulatory
body, and shall confer on it the legal authority and provide it with the competence and the resources necessary to fulfil its statutory obligation for the regulatory control of facilities and activities.
The main and key actor in the regulatory frame work is the regulatory body.
Therefore, GSR Part 1 Requirement#3 states that ………………..

17. Responsibilities of the Regulatory Body
Core Functions
To establish, promote or adopt regulations and guides
To review and assess the operator’s submissions
To issue, amend, suspend or revoke authorization
To perform regulatory inspections
To take enforcement actions if needed
This is the list of main regulatory functions:
………
In addition to that the RB may have another additional duties that will not in conflict with its main duties and will not create problem for its independency in its decision making. Such as

18. Coordination among Regulatory Authorities
Requirement 7
Where several authorities have responsibilities for safety within the regulatory framework for safety, the responsibilities and functions of each authority shall be clearly specified in the relevant legislation.
The government shall ensure that there is appropriate coordination of and liaison between the various authorities concerned in areas
Depending on the legal and the government infrastructure of a country, regulatory functions might be allocated to more than one organizaton; Requirement #7 of GSR Part 1 deals with this issue.
In this case, the responsibilities and functions of each authority shall be clearly specified in the relevant legislation.
This coordination and liaison can be achieved by means of memoranda of understanding, appropriate communication and regular meetings. Such coordination assists in achieving consistency and in enabling authorities to benefit from each other’s experience.
If responsibilities and functions do overlap, this could create conflicts between different authorities and lead to conflicting requirements being placed on authorized parties or on applicants. This, in turn, could undermine the authority of the regulatory bodies and cause confusion on the part of the authorized party or the applicant.

19. Organization of the Regulatory Body
Requirement 16
The regulatory body shall structure its organization and manage its resources so as to discharge its responsibilities and perform its functions effectively; this shall be accomplished in a manner commensurate with the radiation risks associated with facilities and activities.
Requirement #16 of GSR Part 1 talks about Organizational structure of the regulatory body and
allocation of resources. This requirement states that it is the responsibility of the RB to structure its ……..
Also,
according to SSG-16, after the establishment of the regulatory body in Phase 2, “The government ………..

20. Staffing of the Regulatory Body
It may not be possible for an embarking country to have all the competencies in house, which are required for nuclear safety at the beginning of the NP Programme.
A broadly used approach is to outsource some regulatory activities to external bodies or consultants/experts that can provides assistance to the regulatory body.
Outsourced technical support should be independent from the licensee.
On the other hand, It may not be possible, actually not be realistic, for an embarking country to have all the competencies in house which are required for regulatory supervision of an NPP project in the early phases.
Therefore, first, in considering its future tasks and the best use of available resources, the regulatory body will need to define which activities must be retained ‘in-house’ as core activities, and any which it might delegate to out source.
A broadly used approach is to outsource some regulatory activities to external bodies or consultants/experts that can provides assistance to the regulatory body. In this case, Outsourced technical support TSO should be independent from the licensee. 20 20

21. Use of External Support by the Reg.Body
Requirement 20 :
“The regulatory body shall obtain technical or other expert professional advice or services as necessary in support of its regulatory functions, but this shall not relieve the regulatory body of its assigned responsibilities”.
In making decisions, the regulatory body is expected to have the necessary means to assess advice provided by external support.

22. Guidance for the Use of External Support
Adequate contractual arrangements are necessary to specify the role and responsibilities of the provider of external technical support.
An action plan should be developed and implemented in order to have the relevant competencies in order to discharge effectively the regulatory duties in timely manner.
When using TSOs,
…………
……………
But, getting all the competencies this should be a goal in the long-term
Therefore, an action plan should be developed and implemented in order to have most of the relevant competencies in order to discharge effectively the regulatory duties in timely manner. 22

23. Independence of the Regulatory Body 1/3
Principle 2: Role of government
An effective legal and governmental framework for safety, including an independent regulatory body, must be established and sustained.
Our last topic but not least, is the Independence of the Regulatory.
The Fundamental Safety Principle #2 clearly emphasize the establishment of an independent Regulatory Body.

24. Independence of the Regulatory Body 2/3
Requirement 4:
The government shall ensure that the regulatory body is effectively independent in its safety related decision making and that it has functional separation from entities having responsibilities or interests that could unduly influence its decision making.
Similarly, GSR Part 1 Requirement #4 states that “the government shall ensure that the regulatory body is effectively independent in its safety related decision making and that it has functional separation from entities having responsibilities or interests that could unduly influence its decision making.”
Actually, when we talk about the independency of an RB that means we talk about independency in decision making.

25. Independence of the Regulatory Body 3/3
To be effectively independent, the RB shall have:
sufficient legal authority
sufficient staffing and competence
sufficient financial resources for the proper discharge of its assigned responsibilities
In other words,
…………………………………

26. Principle 1: Responsibility for Safety
Outlook
Principle 1: Responsibility for Safety
The prime responsibility for safety must rest with the person or organization responsible for facilities or activities that give rise to radiation risks.
Other groups as designers, manufacturers, employers, contractors , and consignors and carriers, also have legal professional or functional responsibilities with regard to safety.
THE REGULATORY BODY PROVIDES INDEPENDENT OVERSIGHT ON ALL SAFETY MATTERS
In other words,
…………………………………

27. Thank you