Regulatory Control Training Workshop

Regulatory Control Training Workshop
Module 4 “Development of NPP Safety Regulations in Pakistan” Application Set Regulatory Control Training Workshop DISCLAIMER This example was prepared by (individual or organization) for this IAEA workshop. The information contained in this example is based on publicly available information and/or personal knowledge; therefore, it does not necessarily represent the institutional position of the organization referred to in the example.

CONTENTS PNRA regulatory approach
Development process of PNRA regulations and regulatory guides PNRA regulations and Regulatory Guides Applicability and use of IAEA safety standards and standards from other countries Prioritization for development of safety regulations Involvement of interested parties Use of external technical support WS|M4|Application Set

PNRA REGULATORY APPROACH
WS|M4|Application Set

PNRA REGULATORY APPROACH
Following its establishment in 2001, as an independent regulatory body, PNRA developed its regulatory framework by adapting/adopting the IAEA safety standards as national regulations. PNRA linked regulations to IAEA safety guides and USNRC regulatory guides which further link down to industrial codes and standards with specific acceptance criteria. PNRA offers full flexibility to the licensee to meet the objectives specified in PNRA regulations. The licensee defines a list of codes and standards which is agreed upon by PNRA and become basis for a specific authorization. PNRA regulations are on the whole performance based but also include some prescriptive requirements based on NRC regulations and regulatory guides. WS 3 | T1 | Application PNRA, USNRC, STUK | Rev. 0

MODEL OF PNRA REGULATORY FRAMEWORK
LAW Ordinance In the form of Regulations Regulatory Guides Industrial Codes and Standards RCC ASME IEEE Connected to Administrative Technical Administrative Regulations defines regulatory processes i.e. Licensing process, review and Assessment process, enforcement etc. Technical Regulations covers technical aspects i.e. Design requirements, operating requirements, QA requirements, Siting details, etc. Needs to be approved by PNRA WS 3 | T1 | Application PNRA, USNRC, STUK | Rev. 0

WS 3 | T1 | Application PNRA, USNRC, STUK | Rev. 0
SPECIFIC EXAMPLE PNRA regulations PAK/911 require the licensee to perform probabilistic safety analysis of the plant in order meet the following safety targets: CDF shall be less than 10-5 per reactor year, Frequency for radioactivity release shall be less than 10-6 per reactor year. Although PNRA provides specific acceptance criteria in terms PSA targets/goals, licensee has the flexibility to adopt any methodology to conduct the PSA to meet these goals. The licensee proposed methodology of conducting full power PSA as per recommendations of IAEA SG 50-P-4 which was excepted and applied during the licensing process. In this way PNRA approach provided performance objective as well as prescriptive detail. The regulatory approach is, therefore, mixed i.e. largely performance based complemented by prescriptive approach. WS 3 | T1 | Application PNRA, USNRC, STUK | Rev. 0

DEVELOPMENT PROCESS OF PNRA REGULATIONS AND REGULATORY GUIDES

PNRA REGULATORY PYRAMID
DEVELOPMENT PROCESS OF PNRA REGULATIONS PNRA REGULATORY PYRAMID The pyramid depicts the regulatory framework of PNRA. At the highest level is the PNRA Ordinance. Second tier in the regulatory pyramid are PNRA Regulations. Compliance with the PNRA Regulations is mandatory for the licensees. Third level consists of regulatory guides, which are non-mandatory and provide acceptable methods for meeting the requirements of regulations. WS|M4|Application Set

Each set of regulations undergoes extensive internal review at different levels within the organization and the opinions of all stakeholders, including licensees, the government, and the general public, is actively sought and incorporated. The entire process of developing a regulation, depicted in the flow chart below takes around 3 years. WS|M4|Application Set

Step-1 (Development of a Document Preparation profile (DPP)) Any of the Directorates of PNRA may identify the need for the development of Regulations with the submission of a Document Preparation Profile (DPP). The need for development of new regulations or revision of existing regulations may arise from any of the following: Obligations of the PNRA Ordinance. Obligations of international conventions. Feedback of regulatory/licensing experience. International practice and experience. DPP is reviewed by Policy and Procedures Directorate (PPD) of PNRA and sent for obtaining approval of Director Generals of PNRA. WS|M4|Application Set

Step-2 (Preparation of Draft-1) After the approval of DPP, PPD requests the originating Directorate to submit draft-1 of the Regulations within a period of three months. Step-3 (Review by PPD) PPD reviews Draft-1 to check the correctness of the technical information and its legality under the existing regulatory framework on the basis of the relevant documents PPD generates Draft-2 of the Regulations on the basis of its in consultation with the originating Directorate. Step-4 (Internal Review within PNRA) Draft-2 is reviewed by all technical Directorates within PNRA. Finalized comments are incorporated by PPD to generate Draft-3 of Regulations. WS|M4|Application Set

Step-5 (Review by Taskforce) Internal Task force is formulated for detailed clause-by-clause review of Draft-3. The taskforce generally comprises of the following personnel: Representatives of PPD, Representatives of originating Directorate. Two to three relevant technical professionals as subject specialists. The comments offered by the task force are incorporated by PPD resulting in Draft-4. WS|M4|Application Set

Step-6 (Review by All Director Generals) Draft-4 is circulated among all DGs for comments. Comments by the DGs are incorporated by PPD in consultation with the originating Directorate resulting in Draft-5. Step-7 (Review by Stakeholders) Draft-5 is sent to the relevant licensees and placed on the web page for information of all the stakeholders. The comments received from the licensees and other stakeholders are incorporated after conducting meetings with the licensees resulting in Draft-6. WS|M4|Application Set

Step-8 (Review by Authority part time Members) Draft-6 is circulated among part time Members of the Authority. The comments offered by part time members are evaluated by PPD and incorporated to formulate Draft-7. Step-9 (Approval by Authority) Draft-7 is sent to the Secretary of Authority for presenting it in the Authority’s meeting for final approval. Step-10 (Gazette Notification) After approval of Draft-7 of the Regulations by the Authority, PPD carries out the process of its notification in the official gazette of Pakistan WS|M4|Application Set

The regulatory guides are developed with the view to facilitate the licensee in understanding the requirements of national regulations and provide guidance for their implementation that is non-mandatory. The following guides have been developed by PNRA. Format and Contents of Application for Modifications in Technical Specifications and Operating Policies and Principles of NPP. Format and Content of Application for Design Modification in a NPP. Probabilistic Safety Assessment of Nuclear Power Plant-Level 1. Dosage and Distribution of Potassium Iodide Tablets (A Thyroid Blocking Agent) In Radiation Emergencies. Transport of Radioactive Material by road in Pakistan. Guidance for the Users of I-131 in Nuclear Medicine Centers WS|M4|Application Set

PNRA REGULATIONS ISSUED
Administrative Regulations on Licensing Fee (PAK/900) Regulations on Transaction of Business of the Authority (PAK/901) Regulations for Licensing of NPP Equipment Manufacturers (PAK/907) Regulations for the Licensing of Radiation Facilities (PAK/908) Regulations for Licensing of Nuclear Installations (PAK/909) PNRA Enforcement Regulations (PAK/950)

PNRA REGULATIONS ISSUED
Technical Regulations on Radiation Protection (PAK/904) Regulations on the Safety in NPP Site Evaluation (PAK/910) Regulations for the Safety of NPP Design (PAK/911) Regulations on the Safety of NPP Quality Assurance (PAK/912) Regulations on the Safety of NPP Operation (PAK/913) Regulations on Management of a Nuclear Emergency (PAK/914) Regulations on Radioactive Waste Management (PAK/915) Regulations for the Safe Transport of Radioactive Material (PAK/916)

PNRA REGULATIONS UNDER DEVELOPMENT OR REVISION
Regulations on Physical Protection of Nuclear Material and Nuclear Installations (PAK/925) Regulations for Decommissioning of Facilities using Radioactive Material (PAK/930) Revision of Regulations on Manufacturers of Safety Class Equipment and Transport Packages (PAK/907) Revision of Safety of Nuclear Power Plant Operation (PAK/913) Revision of Safety of Nuclear Power Plant Design (PAK/911) WS M4 | Application Set

DEVELOPMENT OF REGULATORY GUIDES
The regulatory guides are developed with the view to facilitate the licensee in understanding the requirements of national regulations and provide guidance for their implementation that is non-mandatory. The following guides have been developed by PNRA. Format and Contents of Application for Modifications in Technical Specifications and Operating Policies and Principles of NPP. Format and Content of Application for Design Modification in a NPP. Probabilistic Safety Assessment of Nuclear Power Plant-Level 1. Dosage and Distribution of Potassium Iodide Tablets (A Thyroid Blocking Agent) In Radiation Emergencies. Transport of Radioactive Material by road in Pakistan. Guidance for the Users of I-131 in Nuclear Medicine Centers WS | M4 | Application Set |

APPLICABILITY AND USE OF IAEA SAFETY STANDARDS AND STANDARDS OF OTHER STATES INCLUDING VENDOR

APPLICABILITY AND USE OF IAEA SAFETY STANDARDS
PNRA since its inception gained tremendous benefit from the use of IAEA safety standards. Owing to goal based and objective oriented approach of IAEA Safety Standards these provide flexibility in application PNRA adopted the IAEA fundamental safety principles PNRA regulations and regulatory guides are generally based on the IAEA safety standards. The following material show specific examples in different technical areas related to adoption and adaption of IAEA Safety Standards PNRA since its inception has gained tremendous benefit from the use and application of IAEA safety standards in fulfilling its responsibilities of licensing and regulating nuclear and radiation facilities and activities. PNRA adopted the IAEA fundamental safety principles and PNRA regulations and regulatory guides are generally based on the IAEA safety standards. The following material summarize the use and application of IAEA safety standards in different areas: WS 3 | T 7 | Application PNRA | Rev. 0

Nuclear Safety PNRA regulations for the safety of nuclear power plants design (PAK/911) are based on IAEA safety requirements NS-R-1 (2000) with some additional requirements. Currently PAK/911 is undergoing revision process mainly on the basis of IAEA SSR 2/1 “Safety of Nuclear Power Plants: Design”, 2012 and lessons learned from Fukushima accident. Regulations for Safety of NPP operation (PAK/913) are based on IAEA safety requirements NS-R-2 (2000) with some additional requirements. Planned revision is in progress mainly on the basis of IAEA SSR 2/2 “Safety of Nuclear Power Plants: Operation”, 2011 and Fukushima experience. Regulations on the Safety of Nuclear Installations- Site Evaluation (PAK/910) is mainly based on IAEA NS-R-3 (2003) with some additional requirements.

Nuclear Safety Regulations on the Safety of Nuclear Installations- Site Evaluation (PAK/910) is mainly based on IAEA NS-R-3 (2003) with some additional requirements. These requirements are from USNRC regulations related to criteria for determination of exclusion area, low population zone and population centred distances. Quality Assurance regulations (PAK/912) are also based upon IAEA 50-C-Q (1996). Regulations on “Safety of Nuclear Research Reactor Operation (PAK/923)”, are based on IAEA NS-R-4 with the additional requirements on criteria for the licensing of reactor operating personnel.

Radiation Safety and Emergency Preparedness PNRA regulations on Radiation Protection (PAK/904) are mainly based upon IAEA Safety Series No. 115, Basic Safety Standards (BSS) of 1996 With the revision of BSS, PNRA is evaluating the new requirements (GSR Part-3) and is evaluating the experience of its implementation worldwide PNRA regulations for Management of a Nuclear or Radiological Emergency (PAK/914), published in 2008, were mainly based on IAEA GS-R-2 The implementation of these requirements is regularly verified by PNRA before and after commencement of operation of facilities. Pakistan has categorized facilities/activities in five hazard categories according to IAEA recommendations and emergency preparedness arrangements are made on the basis of assessment of hazards. The regulatory guides (e.g. GS-G-2.1, 50-SG-06, 50-SG-G6 etc.) are used for evaluation of emergency preparedness and response arrangements at facilities. Radiation Safety and Emergency Preparedness: PNRA regulations on Radiation Protection (PAK/904) are mainly based upon IAEA Safety Series No. 115, Basic Safety Standards (BSS) of 1996. As BSS has been revised, and an interim version entitled “Radiation Protection and Safety of Radiation Sources“ GSR Part-3 was published in 2011, PNRA is evaluating the experience of new requirements worldwide and later will amend the regulations accordingly. PNRA regulations for Management of a Nuclear or Radiological Emergency (PAK/914), published in 2008, were mainly based on IAEA GS-R-2, “Preparedness and Response for a Nuclear or Radiological Emergency”. The implementation of these requirements is regularly verified by PNRA before and after commencement of operation of facilities. Pakistan has categorized facilities/activities in five hazard categories according to IAEA recommendations and emergency preparedness arrangements are made on the basis of assessment of hazards. The regulatory guides (e.g. GS-G-2.1, 50-SG-06, 50-SG-G6 etc.) are used for evaluation of emergency preparedness and response arrangements at facilities.

Radioactive Waste, Transport Safety and Decommissioning PNRA regulations on Radioactive Waste Management (PAK/915) are mainly based on WS-R-2. Under these regulations, PNRA is also developing a regulatory guide for the management of Radioactive Waste from Medicine, Industry, Agriculture, Research and education on the basis of WS-G-2.7. PNRA adopted TS-R-1 (2003 edition) as national regulations for ensuring safe transport of radioactive material in Pakistan. The regulations on decommissioning under development are generally based on WS-R-5. PNRA regulations on Radioactive Waste Management (PAK/915) are mainly based on WS-R-2. Under these regulations, PNRA is also developing a regulatory guide for the management of Radioactive Waste from Medicine, Industry, Agriculture, Research and education on the basis of WS-G-2.7. PNRA adopted TS-R-1 (2003 edition) as national regulations for ensuring safe transport of radioactive material in Pakistan. The regulations on decommissioning under development are generally based on WS-R-5.

Physical Protection and Nuclear Security PNRA is developing regulations entitled “Physical Protection of Nuclear Material and Nuclear Facilities” which are mainly based upon the latest revision of INFCIRC/225. In future, PNRA is planning to develop guidance documents using IAEA nuclear security implementing guides. Implementation of Management System at PNRA Integrated Management system mainly based on IAEA GS-R-3 is being implemented in the organization In this regard, a management system manual has been established on the basis of GS-R-3 and the IAEA safety guide GS-G-3.1 “Application of the Management System for Facilities and Activities”. PNRA is developing regulations entitled “Physical Protection of Nuclear Material and Nuclear Facilities” which are mainly based upon the latest revision of INFCIRC/225. In future, PNRA is planning to develop guidance documents using IAEA nuclear security implementing guides. PNRA is in the process of implementing an integrated management system in the organization which will be mainly based on IAEA GS-R-3. In this regard, a management system manual has been developed and approved using GS-R-3 and the IAEA safety guide GS-G-3.1 “Application of the Management System for Facilities and Activities”.

In exercise of the powers conferred by section 16(2)(a) of the PNRA Ordinance, PNRA may adopt such Regulations for nuclear safety and radiation protection as, in its opinion, may be necessary. So far PNRA has adopted the IAEA regulations on transport of radioactive material (TSR-1, 2006) WS|M4|Application Set

APPLICABILITY OF STANDARDS OF OTHER STATE’S INCLUDING VENDOR
Design and safety criteria are mainly based on USNRC10 CFR 50, RGs and industrial standards such as ASME, IEEE etc. Safety analysis reports (SARs) are submitted by the licensee according to NRC Regulatory Guide 1.70 and reviewed by using the NUREG-0800 (SRP). However, the design and safety analysis reports were ensured to fulfil the Intent of IAEA Safety Standards In case of the use of Chinese industrial standards the applicant had to demonstrate its equivalence with relevant US standard In establishing design requirements, PNRA adopted IAEA NS-R-1 of complemented by some requirements from 10CFR 50 of NRC. Since the Chinese regulatory body (NNSA) also adopted IAEA safety standards, the vendor country had no real difficulty in getting authorization of the design During the licensing process, the safety analysis reports were developed by the licensee according to NRC Regulatory Guide 1.70 for format and content and reviewed primarily by using the NUREG-0800. However, during the review process, it was ensured that the intent of applicable IAEA Safety Standards was fulfilled by the design and the safety analysis reports. The industrial standards used were mostly of US origin but Chinese standards were also used. Wherever, Chinese standards were used, applicant demonstrated the equivalence with US industrial standards such as ASME as required by PNRA regulations. Prior to the Contract made with China for Chashma unit 2, PNRA developed the detailed technical regulations in the area of design of nuclear power plants. In establishing these PNRA adopted IAEA safety standards on Safety of Nuclear Power Plant; Design NS-R-1 of 2000 complemented by some requirements from 10CFR 50 of NRC. Since the Chinese regulatory body (NNSA) had also adopted IAEA safety standards in their national regulatory framework, the vendor country had no real difficulty in getting authorization of the design from PNRA.

PRIORITIZATION FOR DEVELOPMENT OF SAFETY REGULATIONS

Following the establishment of PNRA, the first task was to develop requirements for granting different authorizations to C-2 during its licensing process. Priority was assigned on need basis during the contract negotiations of C-2 and the regulations for the licensing of nuclear power plants were issued in 2001. Afterwards, detail technical requirements for C-2 design were required and consequently the regulations for the safety of NPP design (PAK/911) were issued. These regulations was issued based on the IAEA safety standard on design (NS-R-1), the licensing experience of C-1 and NRC regulations PNRA developed its third regulations on nuclear power plant Quality Assurance- PAK/912 on need basis for the review of the application for the construction license of C-2 based on IAEA 50-C-QA. WS|M4|Application Set

The regulatory review of the application for the construction licence of C-2 was reviewed against PNRA regulations on Safety of NPP Design (PAK/911) and regulations on Safety of NPP Quality Assurance (PAK/912) along with applicable USNRC regulations/guides and IAEA safety standards. Format and Content of safety analysis report was agreed to be followed as per the USNRC regulatory guide RG 1.70. PNRA uses standard review plan (SRP) of USNRC to review the safety analysis reports. Most of the following regulations were also issued on need basis e.g. the regulations on licensing fee (PAK/900), regulations for licensing of NPP safety class equipment manufacturing (PAK/907) and Enforcement Regulations. WS|M4|Application Set

INVOLVEMENT OF EXTERNAL STAKEHOLDERS IN DEVELOPMENT PROCESS OF SAFETY REGULATIONS

INVOLVEMENT OF INTERESTED PARTIES IN DEVELOPING SAFETY REGULATIONS
PNRA gives prime importance to involve all the stakeholders in the development process of safety regulations During the development process, the draft regulations are sent to the relevant licensees and other interested parties for comments The draft is also placed on website for information of general public for a period of four months Comments received are evaluated and discussed with stakeholders by organizing meetings with stakeholders for acquiring consensus Comments received from the public are also evaluated and incorporated as far as practicable The finalized draft is then sent to the part time external Members of the authority for review which represent different fields and are also represented by the licensee PNRA gives prime importance to involve all the stakeholders in the development process of its safety regulations. During the development process, when the internal review is completed and the draft regulations are finalized and approved by the senior management of PNRA the draft is sent to the relevant licensees and a copy is sent to all interested stakeholders. The same draft is also placed on the web ( for information of all the stakeholders including the general public for a period of four months PNRA evaluates all comments and prepare PNRA’s position on all the comments. Meetings with licensee and other interested parties are organized to discuss and finalized positions on their comments. The comments received from public are also evaluated and incorporated as far as practicable and the regulation is revised accordingly The draft finalized after comments from the stakeholders is sent to part time Members of the authority for review. At this stage as well the view of the interested parties is obtained as the part time Members of the Authority are from different fields and also represented by the licensee.

USE OF EXTERNAL TECHNICAL SUPPORT FOR DEVELOPMENT OF SAFETY REGULATIONS

USE OF EXTERNAL TECHNICAL SUPPORT IN DEVELOPING SAFETY REGULATIONS
Most of regulations of PNRA are generally based on IAEA safety standards, The process for development of safety regulations have not been so stringent. As such, the involvement of External Technical support in drafting or review of safety regulations was not considered. However, the regulations were reviewed by TSO formed within PNRA which is functionally and financially independent. In some cases, the TSO was requested to conduct independent analysis of certain safety criteria before their inclusion or adaptation in safety regulations. Through establishment of internal TSO PNRA achieved the objective of self reliance and independent capability in different technical areas The process ensured obtaining an independent input throughout the development process of safety regulations Since most of the regulations issued by PNRA, during the past decade, are generally based on IAEA safety standards, therefore; the process for development of safety regulations have not been so stringent. As such, the involvement of External Technical support Services (ETS) in the process for development of safety regulations was not considered. PNRA involved its internal TSO in conducting review of various drafts during different stages of development of safety regulations and implementing guides. In some cases, CNS is requested to conduct independent analysis of certain safety criteria before their inclusion or adaptation in safety regulations. As the self-reliance and independent capability has been developed at CNS, it can be said that PNRA ensured obtaining an independent input throughout the development process of safety regulations

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