Regulatory Framework for Safety in Pakistan PAKISTAN NUCLEAR

Regulatory Framework for Safety in Pakistan PAKISTAN NUCLEAR REGULATORY AUTHORITY

Contents • PNRA regulatory framework • Process for the development of PNRA Regulations • Process for the development of PNRA Regulatory Guides 2

Establishment of PNRA • Government of Pakistan Established Pakistan Nuclear Regulatory Authority (PNRA) as an independent regulatory authority to regulate nuclear safety and radiation protection in the country and extent of civil liability for nuclear damage resulting from any nuclear incident • January 22, 2001 – Promulgation of Pakistan Nuclear Regulatory Authority Ordinance, 2001 3

PNRA Regulatory Framework Ordinance Regulations Regulatory Guides Codes and Standards • Issued by the Government of Pakistan • Presents basic objectives, concepts and principles of nuclear and radiation safety and protection for the regulation of nuclear energy • Issued by PNRA • Specify the basic requirements that must be fulfilled to ensure safety • Based on IAEA and USNRC standards • Issued by PNRA, of a non-mandatory nature • Recommendations and explanations for meeting safety requirements • Issued by national and international organizations e. g. IEEE, ASME etc. • Recommend standard set of criteria or acceptance 4 values

Powers for Development of Regulations • The Authority shall devise, adopt, make and enforce such rules, regulations, orders or codes of practice for nuclear safety and radiation protection as may, in its opinion be necessary. (Section 16(2)(a) of PNRA Ordinance) • The Authority may by notification in the official gazette, make regulations, not inconsistent with this Ordinance and the rules, for carrying out the purposes of this Ordinance. (Section 56 of PNRA Ordinance) 5

PNRA Organogram 6

Process for Regulations Development (1/7) • The regulations undergo 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 regulations, depicted in the flow chart, takes around 3 years. 7

Process for Regulations Development(2/7) Step-1 (Approval of Document Preparation Profile - DPP) • Any PNRA Directorate may identify the need for the development of Regulations and may submit Document Preparation Profile (DPP). • Following are the basis for development of new regulations or revision of existing regulations: - National Obligations (PNRA Ordinance) International Obligations (international conventions) IAEA safety and security standards Feedback of regulatory experiences Regulations of other Member States • PPD reviews the DPP and shares it with DGs for review/approval 8

Process for Regulations Development(3/7) Step-2 (Preparation of Draft - 1) • After the approval of DPP, originating Directorate is requested to prepare the regulations within 3 months time which is Draft – 1. Step-3 (Review by PPD) • PPD reviews Draft - 1 to check the correctness of the text and its legality under the existing regulatory framework. • As a result of this review, Draft - 2 is prepared. 9

Process for Regulations Development(4/7) Step-4 (Review by technical directorates) • Draft – 2 is circulated among all technical Directorates for review for a period of 2 months. • PPD compiles input/comments of the Directorates and discusses these with the commenting Directorate and prepares a joint position. • PPD incorporates those comments on which consensus is developed and Draft – 3 is formulated. 10

Process for Regulations Development (5/7) Step-5 (Review by Taskforce) • PPD constitutes a task force for clause-by-clause review of Draft - 3. The task force normally comprises of the following personnel: - Representatives of PPD - Representatives of originating Directorate - Two to three relevant technical personnel as subject specialists • The comments offered by the task force are incorporated into Draft - 3 thereby resulting in Draft - 4. 11

Process for Regulations Development (6/7) Step-6 (Review by Director Generals) • Draft - 4 is circulated among all the DGs for comments. • PPD incorporates comments of DGs in consultation with the originating Directorate, resulting in Draft - 5. Step-7 (Review by Stakeholders) • Draft - 5 is then shared with the relevant licensees for review and also placed on PNRA web page (www. pnra. org) for information and review of all stakeholders. • Comments received from the licensees and other stakeholders are incorporated after discussion with the licensees resulting in Draft - 6. 12

Process for Regulations Development (7/7) Step-8 (Review by Part Time Members of the Authority) • Draft - 6 is circulated amongst part time Members of the Authority. • PPD evaluates and incorporates the comments of part time members and Draft – 7 is prepared. Step-9 (Approval by Authority) • Draft - 7 is sent to Secretary of the Authority for presenting it in the forthcoming Authority’s meeting for final approval. Step-10 (Gazette Notification) • After approval of Draft - 7 of the Regulations by the Authority, PPD processes for notification in the Official Gazette of Pakistan 13

Adoption of Regulations • The following procedure is followed for adoption of Regulations: i. Request is initiated by a Director through the concerned DG to adopt any international or IAEA Safety Requirement. ii. It is review by PPD iii. Review by other relevant Directorates • Process for approval is initiated from Step – 4 • PNRA has adopted IAEA Regulations on Transport of Radioactive Material (TSR-1, 2006) and promulgated it as PAK/916 14

Revision of Regulations • Regulations are reviewed by the relevant Directorate after completion of five years of their promulgation or earlier (in case) and revised, if required, in the light of: o Licensing experience o Feedback from stakeholders, and o Development in international standards and practices • The originating Directorate prepares DPP for revision of the Regulations • The Regulations are revised and gazette notified by following the Steps 1 -10 described previously. 15

Amendment in Regulations • Amendment in the regulations means adding, deleting, substituting a clause, or more (such as adding an appendix or annexure) in such a way that the main structure/format of the regulations remain unchanged (with only minor modifications) • It may have the following bases: − Regulatory experience − Licensee’s feedback − Current international practices • The amendment may be requested by any Directorate. PPD seeks approval for proposed amendment. Rest of the procedure is similar as described in Steps 4 -10 16

Repeal of Regulations • Repeal is to revoke or withdraw a previously existing statute by the enactment of a new law • This is generally done when the Regulations or a part of Regulations (section, sub-section, clause or an appendix) is no longer effective, or it is shown to have adverse consequences 17

PNRA Regulations (1/2) Administrative Regulations on Licensing Fee by PNRA (PAK/900) Regulations on Transaction of Business of PNRA (PAK/901) Regulations for Licensing of Nuclear Safety Class Equipment & Components Manufacturers (PAK/907) Regulations for Licensing of Radiation Facilities other than Nuclear Installations (PAK/908) Regulations for Licensing of Nuclear Installations (PAK/909) PNRA Enforcement Regulations (PAK/950) 18

PNRA Regulations (2/2) 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 or Radiological Emergency (PAK/914 ) Regulations on Radioactive Waste Management (PAK/915) Regulations for the Safe Transport of Radioactive Material (PAK/916) Regulations on Safety of Nuclear Research Reactor(s) Operation (PAK/923) Regulations on Physical Protection of Nuclear Material and Nuclear Installations (PAK/925) Regulations for Decommissioning of Facilities using Radioactive Material (PAK/930) 19

Regulatory Guides • PNRA Regulatory Guides play a significant role in the implementation of regulatory requirements set forth under PNRA regulations • Regulatory Guides are non-mandatory and are placed in the lowest tier of PNRA’s regulatory framework • These are developed following a similar but simplified process as compared to the development of regulations 22

Process Flow - Development of Regulatory Guides 23

Current Regulatory Guides of PNRA Title No Probabilistic Safety Assessment of Nuclear Power Plants (Level-1) PNRA-RG-11. 01 Quality Assurance in Nuclear Medicine PNRA-RG-904. 01 Guidance for the Users of I- 131 in Nuclear Medicine Centres PNRA-RG-904. 02 Radiation Safety in Industrial Radiography PNRA-RG-904. 03 Protection of Patients in Diagnostic Radiology PNRA-RG-904. 05 Format and Contents of Application for Design Modification/Change Approvals for Nuclear Power Plants PNRA-RG-913. 02 Format and Contents of Applications for Modifications in Technical Specifications and OPP of NPPs PNRA-RG-913. 03 Dosage and Distribution of Potassium Iodide Tablets (a thyroid blocking agent) In Radiation Emergencies PNRA-RG-914. 01 Preparation of Radiation Emergency Plans of Radiation Facilities and Activities PNRA-RG-914. 02 Transportation of Radioactive Material by Road in Pakistan PNRA-RG-916. 01 Registration/Licensing and Issuance of NOC to the Exporter(s) of Radiopharmaceuticals PAK/9801 24

Future Development Plan (1/2) Following new regulations are under development: • Regulations for the Safe Management of Spent Nuclear Fuel – (PAK/918) • Regulations on Leadership and Management for Safety – (PAK/921) • Regulations on Physical Protection of Nuclear Materials and Nuclear Installations - (PAK/925) • Regulations on Security of Sealed Radioactive Sources - (PAK/926) • Pakistan Nuclear Regulatory Authority Dispute Resolution Regulations – (PAK/949) • Regulations on the Safety of Nuclear Fuel Cycle Facilities - (PAK/9 xx)

Future Development Plan (2/2) • Following new regulatory guides are under development: • RG on Format and Contents of Radiation Protection Program (PNRA-RG 904. 06) • RG on Radiation Protection and Safety in Radiotherapy (PNRA-RG-904. 07) • RG on Format and Contents of Physical Protection Program of Nuclear Installation(s) (PNRA-RG-909. 02) • RG on Format and Contents of Environmental Monitoring Program of Nuclear Installation(s) (PNRA-RG-909. 03) • RG on Format and Contents of Radioactive Waste Management Program of Nuclear Medicine Centers (PNRA-RG-915. 01) • RG on Format and Contents of Radioactive Waste Management Program of Nuclear Installation(s) (PNRA-RG-915. 02) • Revision of a number of Regulations and Regulatory Guides is in progress

THANKS 27