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Nuclear Safety Regulatory Regime Consolidation

Nuclear Safety Regulatory Regime Consolidation



The Project PHARE RO 01.10.01 has been implemented under the contract N° RO 01.10.01 signed between the CFCU of the Ministry of Finance of
Romania/>/> and APAT on 30.10.2003 and respectively 27.11.2003 with the main objective to strengthen and enhance the effectiveness of the Romanian Nuclear Regulatory Authority (CNCAN) and to improve its competence

The project addressed the areas for which the enhancement has the highest priority in the framework of accession process and for which transfer of Western European methods and practices is deemed to be most appropriate

The project was structured on 12 tasks, including the administrative one, according to the provisions stipulates in ToRs, as listed below:

Task 1: Technical & administrative Co-ordination of the project

/>/>Task 2: Quality Management approach for the Nuclear Regulatory Authority Task 3 Revision of specific procedures for a Technical Support Organization

Task 4: Revision of the Norms on transport of radioactive materials

Task 5: Elaboration of the final version of the Norms for RW Management

Task 6: Revision of the norms on raw material mining and milling

Task 7: Revision of the Norms on Safeguards and on Physical Protection

Task 8: Revision of specific norms in nuclear safety and emergency preparedness

Task 9: Revision of final version of the norms in nuclear safety area

Task 10: Revision of the final version of the specific regulations on radiation safety

Task 11 Revision of the whole package of norms covering Directive 96129uratom

Task 12 Assistance to CNCAN in the management of PHARE Regulatory Assistance Projects

The specific technical and organizational aspects which have been the subject of strengthening of the Romanian Nuclear Regulatory Authority were developed in the. framework of 11 tasks and can be summarized as follows:

  • Significant improvement was achieved with regard to the CNCAN Quality, Management System in terms of structure, content, identification of main and support processes, definition of flowcharts and procedures. Even though the objectives were successfully achieved, the Consortium of Western Regulators' (CWR) considered that the development, implementation and improvement of the CNCAN Quality Management System (QMS) require still plenty of efforts and resources.

  • Assistance and support was required for the elaboration of the specific procedures: for a Technical Support Organisation (TSO). The setting-up of such TSO, as support for CNCAN decisions, was envisaged to increase the technical capability of the nuclear safety authority in
    Romania/>/>. During the first part of the task, CNCAN selected the specific procedures and decided to adopt an integrated structure for its, TSO. His solution was considered as the most adequate taking into account technical and financial aspects, such as the size of the nuclear programme in
    Romania/>/> and the lower cost supposed by the functioning of an integrated structure.

  • Assistance and support was required on relevant regulatory practices an procedures concerning the safe transport of radioactive material with the ultimate' goal to revise ihelVornis on Transport of Radioactive Materials - Authorization Procedures" which apply to shipments of radioactive material on the Romanian territory. The objectives were successfully achieved. However, CWR recommend to give due consideration to the overall regulatory control of radioactive material transport and in the related authorisation/approval process to include. for example in respect to security requirements, emergency response arrangements, third party liability and the reliability and trustworthiness of the transport personnel and organisation involved in the transport of radioactive material.

  • The Consultant was required to participate, together with the CNCAN staff, in the elaboration of the final draft of the set of norms on radioactive waste management, that includes: the classification of the radioactive waste, the principles of the radioactive waste management, the clearance levels of radioactive waste; the radioactive effluents; the authorisation of the pre-treatment, treatment, conditioning, packaging, storage of the radioactive waste. In this context, it was expected for the Consultant to make full use of the EC recommendations on radioactive waste classification, and free release limits for very low level radioactive waste. In order to present to the CWR experts the Romanian situation in the field of the radioactive waste management, CNCAN experts sent to the CWR experts the radioactive waste management strategy in
    Romania/>/>. The strategy was presented together with the Romanian report to the first review meeting of the contracting parties to the Joint Convention on the safety of spent fuel management and on the safety of radioactive waste management that took place in 2003..

  • Assistance was required in the process of reviewing the regulatory framework in the field of raw material mining and milling taking into account the European requirements and practice. It was pointed out by the CWR experts that the related Romanian Norms and regulations appear to be in compliance with the IAEA recommendations and the Directive 96/29 Euratom.

  • Assistance was required also in the process of revision the regulatory legislative framework covering the safeguards and physical protection aspects of nuclear installations. In the course of the task was recognized that the two considered norms do not need a further revision. The norm on safeguards will need in the future only administrative changes in order to become adequate to the new situation that will be created by the
    Romania/>/> accession to the European Union. As far as it concerns the norm on Physical Protection it will be useful in the early future to elaborate guidelines on specific topics related to the application of the norm.

  • The Consultant was required to participate, together with the CNCAN staff, in the elaboration of the final draft of norms covering specific aspects related to nuclear safety and emergency preparedness. The set objectives were met at the end of the task. CNCAN experts made an excellent work in drafting very comprehensive draft regulations in a short time period on topics which are very complex and challenging. The list of the specific norms that to be elaborated under this task was established in the inception meeting, according to those stipulated in the ToRs Thus, three norms out seven of were agreed to be elaborated in this project. . In general, CWR concluded that the requirements level presented in these drafts are relatively detailed and to some degree rather ambitious.

  • Assistance—and -support was- provided- to- elaborate the final- version of the regulations in nuclear safety area. Two norms out of four were selected for revision in the inception meeting. These norms refer to requirements for personnel licensing for nuclear power plant and safety classification of systems, structures and components for nuclear power plant. As regards the classification topic, the final draft presented in the last task meeting was significantly improved. CNCAN clarified that the scope of the norm is to provide safety classification criteria to assure the completeness of the classification also by the point of view of QA graded implementation. As regards personnel licensing, after improvements made by CNCAN, it was concluded that the proposed norm is acceptable to reference western practice (Germany/> and
    Italy/>/>). The norm has been already analysed and accepted by experts from CNCAN, from Nuclear Research Subsidiary of Pitesti and from National Company Nuclearelectrica. After the approval by CNCAN President through Order No. 368/01.11.2004, the norm was published in the Official Law Bulletin No 118/07.02.2005.

  • At present, CNCAN is in process of implementing the acquis communautaire related: to the Council Directives 96/29/EURATOM and 97/43/EURATOM. Assistance was required for revision of the final version of regulations on radiation safety in the, areas of radiotherapy, radio diagnosis, industry and nuclear medicine and the codes' of practice for Dosimetry. After review and assessment of the revised versions of the' specific regulations on diagnostic and interventional radiology, nuclear medicine radiotherapy and industrial radiography, the CWR-experts have found no contradiction with respect to the requirements laid down in the European Directives. 96/29/EURATOM and 97/43/EURATOM.

  • In this task the Consultant was required to assess the concordance between the Council Directive 96/29/Euratom requirements and the provisions of the Romanian, norms (the Fundamental Norms for Radiation Safety and the Norms on Medical Surveillance of Occupational Exposed Workers to the Ionising Radiation) as well as the conformity evaluation of the requirements included in the Norms on Radiation Safety — Authorization Procedures SR-02 with the European appropriate ones. After. review and assessment of the revised versions of the Fundamental Norms on Radiological Safety and the Radiation Safety Norm on Authorisation Proceduresii some aspects consisting in different approaches have been identified and discussed with CWR experts.
  • Assistance was required to improve the CNCAN capability in the field of management of the projects from the PHARE Nuclear Safety Programme. In fact the CNCAN staff (in particular the Program Implementation Unit within CNCAN) was experienced only in the technical assistance projects developed by the International Atomic Energy Agency. The performed workshops succeeded in giving case studies and a comprehensive presentation on rule, requirements and guidelines related to Phare project management and answering to the various specific questions raised by the CNCAN experts. This task succeeded also, in discussions and team work for selection and development of indicators of achievements, in order to allow, evaluation of a PHARE project, identification of possible corrective actions to be undertaken during implementation of a PHARE project, development of a flowchart, covering the project cycle and role of PIU, development of CNCAN internal procedure for managing PHARE Projects.

Beneficiary Organizations Details

- National Commission for Nuclear Activities Control (CNCAN)

Project Aims

The purpose of the project was to improve the efficiency of the Nuclear Safety Regulatory Regime in Romania and to improve safety level of Cerna voda Nuclear Power Plant (particularly as regards design safety, on-site assistance and equipment supplies).

Project Results

The Project had three main components:

  • Component 1: Technical Assistance for elaboration of the working procedures in support of an internal CNCAN guide in the area of Quality Assurance.
  • Component 2: Review and elaboration of new national regulations and norms in the nuclear safety field, according to the European Union requirements.
  • Component 3: Assistance in programme implementation, including, in particular monitoring that time schedules are stringently met.

The budget for this project was: 1 000 000 euro.

Further Project Results

Further information on the project could be sought from the beneficiary organizations. See also attached file.

General Information

Nuclear Safety Regulatory Regime Consolidation
Budget year: 
Types of activities: 
Regulatory Authorities
Duration (months): 
APAT (Agenzia per la protezione dell ambiente e per i servizi tecnici)
Old reference: 
Effective contract date: 
Closure date: