1. 1 REGULATORY ASPECTS OF NPP SAFETY International Conference on Strengthening of Nuclear Safety in Eastern Europe Vienna, June 1999 Ján Š t u l l e r, Petr B r a n d e j s, Alexander M i a s n i k o v, Miroslav Š v á b State Office for Nuclear Safety Czech Republic

2. 2 TOPICS TO BE COVERED Nuclear Regulations Duties of the SÚJB Rights of the SÚJB Material and Human Resources of the SÚJB SÚJB Inspection activities Licensing of Temelín NPP Upgrades and Backfittings Regulatory Position and Practices Concerning Review Activities Conclusions

3. 3 NUCLEAR REGULATIONS (1) (History ) Supervision over industrial utilization of nuclear energy launched by the amendment to the Law No.50/1976 Coll., on Land Planning and Construction Regulations (the Construction Act) Construction Act of 1976 established for the first time that construction of a nuclear installation should require special approvals of the Regulatory Body ( ČSKAE ) in 3 stages based on 3 types of Safety Analysis Reports : Siting (Initial ) SAR, Preliminary SAR, Pre-operational SAR

4. 4 NUCLEAR REGULATIONS (2) (History) Specific regulations issued: Decree No. 2/1978 Coll. of the ČSKAE, on NPP Design Decree No. 4/1979 Coll. of the ČSKAE, on the General Criteria for Nuclear Safety Assurance in the Process of Nuclear Power Installations Sitting Decree No. 5/1979 Coll. of the ČSKAE, on Quality Assurance of Selected Items in Nuclear Power Installations from the Viewpoint of Nuclear Safety Decree No. 6/1979 Coll. of the ČSKAE, on Nuclear Safety Assurance in the Process of Nuclear Power Installation Commissioning and Operation

5. 5 NUCLEAR REGULATIONS (3) (History) Other nuclear safety related regulations: Nuclear Safety Assurance for Nuclear Research Installations Nuclear Safety Assurance in Radioactive Waste Management Physical Protection of Nuclear Nuclear Installations Verification of Special Professional Competence of Selected Personnel at Nuclear Installations ( Control Room Operators ) Quality Assurance of Selected Items with Regard to Nuclear Safety of Nuclear Installations (new )

6. 6 NUCLEAR REGULATIONS (4) (History) First nuclear safety specific Act: The Act No. 28/1984 Coll., on State Supervision of Nuclear Safety at Nuclear Installations was issued in 1984. This Act established the body which exercised the state supervision over nuclear safety independently on manufacturers and operators of nuclear installations. The Act established for the first time that the responsibility for nuclear safety lied with the Investor, or when in operation the Operator ( Responsible Organization ) of the nuclear installation.

7. 7 NUCLEAR REGULATIONS (5) (Current status )

8. 8 NUCLEAR REGULATIONS (6) (Current status) SELECTED LAWS RELATED TO THE SUJB ACTIVITIES: 1. No.18/1997 on Peaceful Utilization of Nuclear Energy and Ionizing Radiation, 2. No.2/1969 on the Duties of Ministries and Other Central Authorities, 3. No.71/1967 on Administrative Proceedings, 4. No.50/1976 on Land Planning and Construction Regulations (the Construction Act), 5. No.552/1991 on State Inspection and Monitoring, 6. No.111/1994 on Road Transport.

9. 9 NUCLEAR REGULATIONS (7) (Current status) January 1997 - new Act No. 18/1997 Coll., on Peaceful Utilization of Nuclear Energy and Ionizing Radiation ( Atomic Act ) The Act entrusted execution of the state administration and state supervision over peaceful utilization of nuclear energy and ionizing radiation to the SÚJB and newly established the province of its authority.The Act was developed with the objective to re-codify peaceful utilization of nuclear energy and ionizing radiation and to cover more adequately such issues as radioactive waste management, liability for nuclear damage and emergency planning.

10. 10 NUCLEAR REGULATIONS (8) (Current status) Examples of issues determined by the Atomic Act: - condition of peaceful use of nuclear energy and ionising radiation, conditions of performance of activities related to nuclear energy utilization and activities resulting in radiation exposures, - requirements for ensuring civil liability in case of a nuclear damage, - conditions for ensuring safe disposal of radioactive waste, - requirements related to the state administration and supervision over nuclear energy utilization, over activities resulting in radiation exposure and over nuclear items

11. 11 NUCLEAR REGULATIONS (9) (Current status) - The Atomic Act transferred into the Czech legal system the Vienna Convention on Civil liability for Nuclear Damage and Joint Protocol related to the Application of the Vienna and Paris Conventions, to which the Czech Republic had acceded. The gap in the legal system, which had been discouraging foreign organizations to be active on the market within the Czech nuclear program, was adequately closed. - The Atomic Act authorizes the SÚJB to issue Act related regulations.

12. 12 NUCLEAR REGULATIONS (10) (Current status) Examples of Atomic Act related regulations: - Transportation and Shipment of Specified Nuclear Materials and Specified Radionuclide Sources, - Physical Protection of Nuclear Materials and Nuclear Facilities and their Classification, - Radiation Protection Requirements, - Quality Assurance, - Criteria for Siting of Nuclear Facilities, - Nuclear Safety and Radiation Protection Assurance during Commissioning and Operation of nuclear Facilities, - Nuclear Safety Assurance in the Process of Nuclear Installations Designing, Licensing and Construction

13. 13 DUTIES OF SÚJB (1) Examples of duties and responsibilities of the SÚJB: - to carry out State supervision over nuclear safety, nuclear items, physical protection, radiation protection and emergency preparedness on the premises of nuclear installations or workplaces with an ionizing radiation source, - to issue licenses to perform practices governed by the Act and to issue type-approvals for packaging assemblies for transport and storage of nuclear materials and radionuclide source

14. 14 DUTIES OF SÚJB (2) - to monitor, assess and regulate the radiation exposure of individuals (professionals and public), - to issue authorizations for selected personnel to perform safety related activities, - to approve documentation, programmes, Limits and Conditions, concepts of physical protection, emergency rules and on-site emergency plans and their modifications,

15. 15 DUTIES OF SÚJB (3) - to establish emergency planning zones and to define areas of workplace with an ionizing radiation source (“controlled areas”), - to carry out the State system of accounting and control of nuclear materials, - to approve the classification of nuclear installations or their components and nuclear materials into appropriate physical protection categories, - to inspect the adherence to the Atomic Act,

16. 16 DUTIES OF SÚJB (4) - to monitor results in safety related R&D area and follow modern trends of practices, and in this respect to coordinate research activities, - to provide information to municipalities and District Authorities concerning radioactive waste management within their territory of administration, - to provide the public with adequate information concerning the results of SUJB activities, unless they are subject to the State, professional or commercial secrecy, and once a year to publish a report on SUJB activities and submit it to the Government of the Czech Republic and to the public

17. 17 RIGHTS OF SÚJB (1) For the execution of the State supervision over peaceful utilization of nuclear energy and ionizing radiation the Atomic Act gives the right to the SÚJB to perform inspection activities. The Atomic Act, together with the Act on State Inspection and Monitoring, provides sufficient instruments to the SUJB to supervise and enforce the fulfillment of all relevant requirements for nuclear safety and radiation protection.

18. 18 RIGHTS OF SÚJB (2) Examples of inspection instruments : inspection instruments include among others the right to: - enter at any time facilities, installations, operation areas, territories and other workplaces of inspected persons where activities related to nuclear energy utilization or practices resulting in exposure are being carried out, - check the compliance with requirements and conditions relate to nuclear safety, radiation protection, PP or SGs and make measurements or take samples at the premises of inspected persons,

19. 19 RIGHTS OF SÚJB (3) ( inspections instruments ) - demand evidence of fulfillment of all safety relevant obligations, - verify professional competence and special professional competence, - participate in investigations of events important for nuclear safety, radiation protection, physical protection and emergency preparedness, including unauthorized handling of nuclear items or ionizing radiation sources,

20. 20 RIGHTS OF SÚJB (4) Examples of enforcement instruments: enforcement instruments include the rights of any inspector to: - require the inspected person to undertake remedial measures within a set of time, - bind the inspected person to perform technical inspections, review or tests necessary for verification of nuclear safety, - withdraw the special professional competence authorization ( control room staff licencies ), - propose a penalty ( fine ) be imposed

21. 21 RIGHTS OF SÚJB (5) Examples of Penalties (Fines) For a violance of a legal obligation determined in the Atomic Act, the SÚJB imposes penalties, up to the amount of: - CZK 100 million to those who violate the prohibition of nuclear energy utilization for other than peaceful purposes, - CZK 10 million to a licensee, violating the prohibition of an import of radioactive wastes, - CZK 200 thousands to employees of an inspected person for a distortion or hiding facts important for the inspection performance.

22. 22 RIGHTS OF SÚJB (6) ( Enforcement instruments ) - The SÚJB is authorized in case there is a danger of delay or a occurrence of undesirable situations with an impact on nuclear safety, radiation protection, physical protection or emergency preparedness, to issue a provisional measure imposing on the inspected person the obligation to reduce the power output or suspend operation of the nuclear installation, to prohibit the handling of nuclear items, ionizing radiation sources or radioactive waste, or to impose on the inspected person the obligation to suffer that this handling is performed by another person on the expenses of the inspected person.

23. 23 MATERIAL AND HUMAN RESOURCES OF THE SÚJB - 1998 staff : 149 (2/3 are nuclear and rad.protection inspectors) budget : 180 million Czech Crowns (6 million US $) National Radiation Protection Institute Independent Advisory groups of experts for: - nuclear safety - radiation protection * Activity of Advisory groups is not regulated by the law, they undoubtedly became a significant advisory body for important issues of nuclear safety and radiation protection.

24. 24 MATERIAL AND HUMAN RESOURCES (cont.)

25. 25 SUJB - 1999 ORGANISATIONAL STRUCTURE 31 48 70 4 3 2 1 129

26. 26 SUJB - 1999 ORGANISATIONAL STRUCTURE (cont.)

27. 27 SUJB - 1999 ORGANISATIONAL STRUCTURE (cont.)

28. 28 SUJB - 1999 ORGANISATIONAL STRUCTURE (cont.)

29. 29 SÚJB INSPECTION ACTIVITIES (1) Three different types of inspection activities: - routine inspections - planned specialized inspections - ad-hoc inspections as a response to certain inadvertent situations Routine inspections cover at nuclear power plant all regular activities of the licensee especially with respect to the observance of Limits and Conditions. These inspections are planned and carried out as regular daily observations by SÚJB site inspectors. These inspection activities are documented monthly in protocols.

30. 30 SÚJB INSPECTION ACTIVITIES (2) Planned specialized inspections - performed in accordance with SÚJB inspection plan (prepared for 6 month period) - inspection plan is based on: - results of inspections performed during past period - operational schedule of Dukovany NPP - results of independent safety review - conclusions of the SÚJB evaluation effort - Usually carried by a team, composed of inspectors from the headquarters in Prague together with site inspectors of corresponding NPP.

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32. 32 SUJB INSPECTION ACTIVITIES (3) Ad-hoc inspections carried out to examine events and failures having impact on nuclear safety, as well as to clarify serious findings of the routine or planned inspections. Ad-hoc inspections are carried out by site inspectors or by inspectors from the headquarters in Prague as needed. Inspection outputs are: - inspection protocols - inspection reports

33. 33 SUJB INSPECTION ACTIVITIES (4) - Inspection Protocol every inspection has to be documented by a protocol, which is an official document prepared by inspector and signed by both sides - representatives of inspected organization and attending inspectors. The protocol describes inspection in details (subject, programme, findings, required relevant remedies) and reflects results of observation - Inspection Report inspection report is an internal document of the SÚJB which provides additional detailed comments and explanations related to findings written down in protocol

34. 34 SÚJB INSPECTION ACTIVITIES (5) SÚJB inspection evaluation process: There are two general levels of evaluation of inspection activities : - Inspection Evaluation Board (Committee) level - SUJB Board of Managers level Inspection Evaluation Board - Board is group of SÚJB managers and specialist established to review and assess inspection activities - Board has regular meetings once a month - Board determines: - necessity of immediate SUJB actions - changes in the Inspection plan - classification of particular inspection into Functional Areas

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36. 36 LICENSING OF TEMELÍN NPP UPGRADES AND BACKFITTINGS (1) Safety Analysis Reports related to the original design of Temelín NPP were prepared by the licensee and evaluated by the ČSKAE in 80-ties. Decision on Temelín NPP design modifications made in early 90-ties Amendments of the original PSAR and relevant Topical Reports have been generated by the licensee ( format and contents as specified in the US NRC R.G.1.70) since 1993 SÚJB safety evaluation process based on US NRC practice ( US NRC Standard Review Plan - NUREG-800 )

37. 37 LICENSING OF TEMELÍN NPP UPGRADES AND BACKFITTINGS (2) SÚJB licensing team was established and formalized ( SÚJB staff experts, headed by a project manager) at the very beginning of the evaluation process. The team has been supported by experts from external research institutes, universities and technical - engineering organizations. Since the very beginning of the NPP Temelín design modification project, regular and effective communication has been establish between SÚJB and licensee.

38. 38 LICENSING OF TEMELÍN NPP UPGRADES AND BACKFITTINGS (3) SÚJB has continuously been kept informed on the concept of design modifications (related Topical Reports submited, presentations given by suppliers followed by informal discussions on technical and regulatory aspects of the presented information). Topical Reports are not official licensing submittals, but are expected to become reference documents to FSAR. Drafts of relevant chapters of SAR have been submitted to SÚJB. SÚJB Requests for Additional information have been communicated to the designer via the licensee.

39. 39 LICENSING OF TEMELÍN NPP UPGRADES AND BACKFITTINGS (4) „Licensing database“ has been developed by the SÚJB staff (US NRC assistance program): - to specify and record all licensing issues - to record SÚJB evaluation of individual licensing issues - to keep track of the licensee‘s response to individual SUJB requests - to get quickly a precise picture of the actual status of the process - to use database information in decision making with respect to resources allocation, planning future activities, etc.

40. 40 REGULATORY POSITION AND PRACTICES CONCERNING REVIEW ACTIVITIES (1) Czech law and regulations must be unconditionally met Quality of safety related items has to be demonstrated (licensee must among others demonstrate the compatibility of components taking into account existing original materials, functionality of subsystems, synergy of all systems, etc...) SÚJB requested the deliverables to be licensable in the country of origin ( compliance with the country of origin regulatory requirements should be showen )

41. 41 REGULATORY POSITION AND PRACTICES CONCERNING REVIEW ACTIVITIES (2) The possibility to adopt any set of industrial standards which would assure the fulfillment of legal requirements to protect public health and safety and regulatory detailed requirements (related for-example to the design) is opened by Czech legislative. SÚJB is engaged in activities related to the verification of the adequacy of codes used to perform calculations to assess properties of nuclear facilities.

42. 42 CONCLUSIONS The Czech regulatory activities are fully and adequately covered by legal instruments. The Czech nuclear safety and radiation protection legal framework and regulatory activities are fully in compliance with internationally recognized good practice and recommendations.