1. Challenges faced by a newly independent regulatory body in maintaining regulatory independence Presented at the 7th Annual Meeting of NERS September 23-24, 2004 IAEA HQ, Vienna - Austria

2.  Regulatory independence is an obligatory requirement for Pakistan as it is entrenched in the Convention on Nuclear Safety to which Pakistan is a signatory. In January 2001 the Government of Pakistan issued an Ordinance creating an independent regulatory body –– the Pakistan Nuclear Regulatory Authority (PNRA) –– reporting directly to the Prime Minister and responsible for matters dealing with protection of the radiation worker, public and environment from the harmful effects of ionizing radiation (for more details please see www.pnra.org ). A little more than 3 years have elapsed since the establishment of the PNRAwww.pnra.org  Some of the challenges faced by PNRA to its regulatory independence are given below. These are further discussed under the format of a mini-brochure printed by the IAEA. REGULATORY INDEPENDENCE

3. The political system shall ensure clear and effective separation of responsibilities (duties) between the regulatory body and organizations responsible for the development of nuclear technologies. In this regard, it is important to distinguish between independence and accountability. The regulatory body should not be subject to political influence or pressure in taking safety decisions. The regulatory body should however be accountable with regard to fulfilling its mission to protect workers, the public and the environment from undue radiation hazards. One way of providing this accountability is by establishing a direct reporting line from the regulatory body to the highest levels of government. In the case where a regulatory body reports to a government agency that has responsibility for exploiting or promoting nuclear technologies, there should be channels of reporting to higher authorities to resolve any conflicts of interest that may arise. This accountability should not interfere with the independence of the regulatory body in making specific safety decisions with neutrality and objectivity. ELEMENTS OF REGULATORY INDEPENDENCE - Political

4. Status and Challenges: Through the promulgation of a statutory Ordinance it has been ensured that clear and effective separation of responsibilities (duties) between the regulatory body and organizations responsible for the development of nuclear technologies has taken place. The regulatory body is not subjected to political influence or pressure in taking specific safety decisions with neutrality and objectivity. The regulatory body is accountable with regard to fulfilling its mission to protect workers, the public and the environment from undue radiation hazards and directly reports to the Prime Minister of Pakistan-the highest level of government. ELEMENTS OF REGULATORY INDEPENDENCE - Political

5. In the legislative framework of a national regulatory system (e.g. atomic laws or decrees) the role, competence and independence of the regulatory body with respect to safety should be defined. The regulatory body shall have the authority to adopt or develop safety regulations that implement laws passed by the legislature. The regulatory body shall also have the authority to take decisions including 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. The regulatory body shall have the responsibility for adopting or developing safety regulations that implement laws passed by the legislature. ELEMENTS OF REGULATORY INDEPENDENCE - Legislative

6. Status and Challenges: The current status is that through the PNRA Ordinance role, competence and independence of the regulatory body with respect to safety has been defined. The regulatory body has the authority to adopt or develop safety regulations that implement the intent of PNRA Ordinance. The regulatory body also has the authority to take decisions including enforcement actions. A formal mechanism has been established for appeal against regulatory decisions through setting up of Tribunals. ELEMENTS OF REGULATORY INDEPENDENCE - Legislative

7. “The regulatory body shall be provided with adequate authority and power, and it shall be ensured that it has adequate staffing and 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 the government agencies responsible for exploiting or promoting nuclear technologies. ELEMENTS OF REGULATORY INDEPENDENCE - Financial

8. Status and Challenges: The current status is that the budget of regulatory body is not subject to review and approval by government agencies responsible for exploiting or promoting nuclear technologies. However, in the past the budget of regulatory authority was lumped together with that of the body responsible for promotion of nuclear energy. This has since been corrected and the budget allocation is now made separately. Similarly, the body responsible for promotion of nuclear energy was appointed the Principal Accounting Officer of the regulatory body. This would have meant placing the regulatory body in the financial control agency responsible for exploiting or promoting nuclear energy. This was also corrected later. ELEMENTS OF REGULATORY INDEPENDENCE - Financial

9. The regulatory body should have independent technical expertise in the areas relevant to its safety mission. The management within the regulatory body should therefore have the responsibility and authority to recruit staff with the skills and technical expertise they consider necessary to carry out the regulatory functions. In addition the regulatory body should maintain awareness of the state of the art in safety technology. In order to have access to outside technical expertise and advice that is independent of operator or industry funding/support to support its regulatory decision-­making, "The regulatory body shall have the authority to obtain such documents and opinions from private or public organizations or persons as may be necessary and appropriate". In particular, the regulatory body shall have the ability to set up and fund independent advisory bodies to provide expert opinion and advice and to award contracts for research and development projects. ELEMENTS OF REGULATORY INDEPENDENCE - Competence

10. Status and Challenges: The regulatory body has independent technical expertise in the areas relevant to its safety mission. It is not dependent on the licensee for manpower or other resources necessary for discharging its regulatory responsibilities. The regulatory body has the responsibility and authority to recruit staff with the skills and technical expertise it considers necessary to carry out the regulatory functions. Since its establishments several professionals have been recruited, trained and absorbed in the PNRA. The regulatory body maintains awareness of the state of the art in safety technology through various means of information and maintains contact with international organisations. The regulatory body has set up two Advisory Committees to provide expert opinion and advice and to award contracts for safety research and development projects.. Difficulties are encountered in out sourcing work as little nuclear expertise exist outside PNRA or the bodies responsible for promotion of nuclear energy. A policy of “Hire and train” is being pursued for maintaining regulatory competence. ELEMENTS OF REGULATORY INDEPENDENCE - Competence

11. One of the responsibilities of the regulatory body is to provide information to the public. "The regulatory body shall have the authority to communicate independently its regulatory requirements, decisions and opinions and their basis to the public." Since the public will only have confidence in the safe use of nuclear technology if the regulatory process and decisions are transparent, government should set up a system to allow independent experts and experts from major stakeholders (for example, the industry and the workforce and the public) to provide their views. The experts' findings should be published. ELEMENTS OF REGULATORY INDEPENDENCE Information to the Public

12. Status and Challenges: The regulatory body provides information to the public through the print and electronic media. It has a public awareness program and issues press releases when necessary to inform the public of its activities. A future activity may be to involve public in addition to other stakeholders in the regulatory process and decisions making. ELEMENTS OF REGULATORY INDEPENDENCE Information to the Public

13. "The regulatory body shall have the authority to liaise with regulatory bodies of other countries and with international organizations to promote co ‑ operation and exchange of regulatory information." ELEMENTS OF REGULATORY INDEPENDENCE – International

14. Status and Challenges: One such case in point was pointed out by the IRRT mission in December 2003 that PNRA has to go through its licensee - the Pakistan Atomic Energy Commission (PAEC) – to communicate PNRA needs to the IAEA. “The PNRA should seek government approval for direct contact and accreditation as a Government of Pakistan contact for liaison with PNRA. It is most unusual and not all in line with accepted international practice, for official and primary contact between a nuclear regulator and the IAEA to be done through a licensee of the regulator” ELEMENTS OF REGULATORY INDEPENDENCE – International

15. Assuring both de jure and de facto regulatory independence  Whereas the PNRA has achieved a full measure of regulatory independence from the promoters of nuclear energy, in practical terms regulatory independence can only be achieved in time when:  technical competence has reached – and is maintained – at a level where effective and efficient regulatory decisions are made  there is a sound base of safety R &D  a regulatory competency education & training framework for all regulatory staff is in position and being implemented  there is a constant in-flow of young professionals  technical support centre(s) and advisory committees are functional, and providing assistance to the regulatory body in the many disciplines and methodologies needed for it to fulfil its functions  International cooperation framework is in position to complement and add to the existing national framework of technical support.  Constant efforts are being made that de jure regulatory independence is not being compromised. This is also reflected in Table in the next overhead

16. Indicators of Regulatory Performance Ensures acceptable level of safety being maintained by licensees Appropriate actions taken to prevent degradation of safety and to promote safety improvements Performs its functions in a timely and cost effective manner Performs its functions in a manner that ensures the confidence of the operating organisation Ensures regulations and procedures in position and understood by licensee Takes appropriate steps for human resource development and has competent and certified regulatory staff Ensures that a well- established quality management system exists Performs its functions in a manner that ensures the confidence of the general public Strives for continuous improvement of its performance Ensures that adequate legal provisions exist for enforcement i.e. dealing with non- compliance or license violations Ensures that adequate resources available for performing its functions and Technical Support Centre(s) available for specialist assistance when required Performs its functions in a manner that ensures the confidence of the government Rating System GREENSatisfactory WHITEMinimally Acceptable YELLOWNeeds Improvement REDUnsatisfactory PINKNot Acceptable