There are several basic characteristics of regulatory organizations reflecting the nature of their regulatory activities. The two most relevant characteris­tics, which also distinguish their regulatory functions, are:

• regulatory independence

• interfaces with other regulators and coordination.

4.2.1 Regulatory independence

The fundamental element of a regulatory organization is the establishment of effective regulatory independence. The reason for this independence is to ensure that independent regulatory decisions can be made and regula­tory enforcement actions taken without pressure from outside interests that may conflict with safety. The independence to take regulatory decisions affords credibility to the regulatory body in the view of the general public; the regulatory body must be seen to be independent of the organization that it regulates as well as independent of governmental organizations and industry groups that promote nuclear technologies.

The importance of regulatory independence is affirmed in the Convention on Nuclear Safety. Article 8.2 of the Convention requires: ‘. . . an effective separation between the functions of the regulatory body and those of any other body or organization concerned with the promotion or utilization of nuclear energy’ (IAEA, 1994). However, this condition is necessary but not sufficient to obtain effective independence to regulate safety. There are internationally recognized elements that need to be considered, i. e. political, legislative, financial, competence, public information and international col­laboration elements; these will be discussed in more detail below. A regula­tory body cannot be absolutely independent of other parts of government: it must function within a national system of laws and budgets, just as other governmental bodies and private organizations must do. Nevertheless, for the regulatory body to have credibility and effectiveness, it should have effective independence in order to be able to make the necessary decisions in respect of protection of workers, the public and the environment. INSAG has addressed the importance of independence in regulatory decisions (INSAG, 2003).

1. Political elements. The political system needs to provide clear and effective separation of responsibilities and duties of the regulatory body and those of organizations promoting or developing nuclear technologies. The regulatory body should not be subject to political influence or pressure in taking decisions relating to safety. The regulatory body should, however, be accountable in respect of fulfilling its mission to protect people and the environment from undue radiation hazards. One way of ensuring this accountability is to establish a direct reporting line from the regulatory body to the highest levels of government. Where a regulatory body is part of an agency or organization that has responsibility for exploiting or pro­moting the development of nuclear technologies, there should be channels of reporting to a higher authority that has safety as one of its primary mis­sions and to which the regulatory body is clearly accountable when resolv­ing conflicts of interest that may arise. This accountability should not compromise the independence of the regulatory body in making specific decisions relating to safety with neutrality and objectivity.

2. Legislative elements. The functions and independence of the regulatory body with respect to safety should be defined in the legislative framework of the national regulatory system (i. e. in the laws or decrees relating to nuclear energy). The regulatory body should have the authority to adopt or to develop regulations relating to safety that give effect to laws enacted by the legislature. The regulatory body should also have the authority to take decisions, including decisions on enforcement actions. There should be a formal mechanism for appeal against regulatory decisions, with predefined conditions that must be met for an appeal to be considered.

3. Financial elements. The regulatory body needs adequate financial resources to discharge its assigned responsibilities. While it is recognized that the regulatory body is in principle subject to the same financial controls as the rest of government, the budget of the regulatory body should not be subject to review and approval by government agencies responsible for exploiting or promoting the development of nuclear technologies.

4. Competence elements. The regulatory body needs independent techni­cal expertise in the areas relevant to its responsibilities for safety. The management of the regulatory body should therefore have the responsibil­ity and authority to recruit staff with the skills and technical expertise it considers necessary to carry out the regulatory body’s functions. In addition, the regulatory body should maintain an awareness of developments in safety-related technology. In order to assist it in its decision making on regulatory matters, the regulatory body should have access to external technical expertise and advice that is independent of any funding or support from operators or from the nuclear industry; to obtain this advice the regu­latory body should have the authority to set up and fund independent advisory bodies to provide expert opinion and advice and to award con­tracts for research and development projects. In particular, an IAEA general safety guide (IAEA, 2002), suggests that the regulatory body should be able ‘to obtain such documents and opinions from private or public organiza­tions or persons as may be necessary and appropriate’.

5. Public information elements. One of the responsibilities of the regula­tory body should be to inform the public. An IAEA general safety require­ment (IAEA, 2010a) establishes that ‘The regulatory body shall have the authority to communicate independently its regulatory requirements, deci­sions and opinions and their basis to the public.’ The public will only have confidence in the safe use of nuclear technologies if regulatory processes are conducted and decisions are made openly. The governmental authorities should set up a system to allow independent experts and experts represent­ing major stakeholders (for example, the nuclear industry, the workforce and the public) to provide their views on safety and related issues. The experts’ findings should be made public.

6. International collaboration. The regulatory body needs the authority to liaise with the regulatory bodies of other countries and with international organizations to promote cooperation and the exchange of regulatory information.