IAEA-NS-IRRS-2008/03 February 2008 ORIGINAL: English INTEGRATED REGULATORY REVIEW SERVICE (IRRS) TO MADAGASCAR Institut National des Sciences et Techniques Nucléaires (INSTN) 25 to 29 February 2008 DEPARTMENT OF NUCLEAR SAFETY AND SECURITY i
INTEGRATED REGULATORY REVIEW SERVICE (IRRS) REPORT TO THE GOVERNMENT OF MADAGASCAR INSTITUT NATIONAL DES SCIENCES ET TECHNIQUES NUCLEAIRES 25 to 29 February 2008 v
REPORT INTEGRATED REGULATORY REVIEW SERVICE (IRRS) Mission date: 25-29 February 2008 Regulatory body: Location: Institut National des Sciences et Techniques Nucléaires (INSTN) Regulated facilities and activities: medical, industrial and research applications Organized by: IAEA IAEA Review Team: Mr Michel SONCK (Team Leader, Belgium) Mr Herve LAMOTTE (Reviewer, France) Mr Hilaire MANSOUX (IAEA/NSRW, Team Coordinator) IAEA-2008 Issue date: 10 2008 The number of recommendations, suggestions and good practices is in no way a measure of the status of the regulatory body. Comparisons of such numbers between IRRS reports from different countries should not be attempted. vi
EXECUTIVE SUMMARY At the request of Director General of the Institut National des Sciences et Techniques Nucléaires (INSTN), an international team of three experts in radiation safety visited INSTN from 25 to 29 February 2008 to conduct an Integrated Regulatory Review Service (IRRS) mission to review Madagascar s regulatory framework and its effectiveness. The purpose of this IRRS mission was to conduct a peer review of Madagascar s regulatory framework for all regulated activities involving radiation sources, facilities and practices, to review its regulatory effectiveness and to exchange information and experience in the areas considered by IRRS. It is expected that the IRRS mission will facilitate regulatory improvements in Madagascar and throughout the world from the knowledge gained and experiences shared by INSTN and the IRRS reviewers. The scope of the mission included all sources, facilities and activities in medical, industrial and research fields, and safety and security of radioactive sources. The significance of the IRRS mission for Madagascar is increased by the on-going transitional situation, pending the creation of the Autorité Nationale de Protection et de Sûreté Nucléaire (ANPSR), established by Law in 1998. Before this Law, INSTN was the Regulatory Body and was fulfilling its regulatory functions. Although the new legislation gives INSTN a clear role of technical support to ANPSR, the Law revokes INSTN as Regulatory Body. However, INSTN, for the sake of continuity of the regulatory control of sources, continues to grant authorizations, waiting for the new regulatory body to take over. The result is that the regulatory infrastructure for the control of radiation sources in Madagascar today is quite ambiguous. There is a legal framework, completely revised 10 years ago, which has never been implemented, mainly because the new Regulatory Body has never been established. There is an institution, INSTN, which is not empowered to be the Regulatory Body but which continues to discharge the regulatory functions for a transition phase that has now lasted for 10 years without a sound legal basis. The IRRS Review Team consisted of senior experts from two Member States Regulatory Bodies and one staff member from the IAEA. The IRRS team carried out the review of Madagascar s regulatory infrastructure in all relevant areas: legislative and governmental responsibilities; responsibilities and functions of the regulatory body; organization of the regulatory body; activities of the regulatory body, including the authorization process, review and assessment, inspection and enforcement and the development of regulations and guides, safety of radioactive sources, the management system and information management. All these issues were evaluated from both perspectives: what ANPSR is responsible for according to the legal framework and what activities INSTN is currently conducting. From a series of interviews and discussions with key personnel at INSTN, review of documentation provided during the course of the mission and two site visits, the team presented its findings based on the IAEA safety standards. Additionally, the IRRS team, together with INSTN, discussed some policy issues relating to the regulation of radiation safety. The results of the discussions will serve as a useful basis for the evolution of future IRRS missions and will assist continuous improvement in the regulation of radiation safety. During the mission, INSTN organized meetings with the Minister and the vice Minister of Health and Family Planning, the Secretary General of the Ministry of Education and Research (supervising 1
Ministry of INSTN) and the Prime Minister and his director of Cabinet, to discuss the peculiar situation of Madagascar. The IRRS Review Team noted the significant effort made by INSTN in the preparation of the mission. The IRRS Review Team made recommendations and suggestions that indicate where improvements are necessary or desirable to further enhance the legal and governmental infrastructure for radiation and safety and improve effectiveness of regulatory controls. Some recommendations are made to the Government of Madagascar, some recommendations are made to the future ANPSR, and finally some recommendations and suggestions are made to INSTN, an organization that is currently trying to fill in the gap of an effective and efficient regulatory body. The IRRS Review Team believes that consideration of the following items should be given high priority because the experts considered that they will contribute significantly to the enhancement of the overall performance of the regulatory system: On an urgent basis the Government of Madagascar should either formally appoint ANPSR, or revise its statute and composition, in order to implement the provisions of the Law and to have an effective and operational Regulatory Body; Madagascar should revise and complement its legal framework for radiation safety and the security of radioactive sources, to ensure that it is consistent with IAEA safety standards, and to fulfil the recent commitment of the State of Madagascar to implement the Code of Conduct on the Safety and security of radioactive sources; The Government of Madagascar should ensure that appropriate resources are allocated for regulatory activities, both at present (INSTN) and for the future (ANPSR and its technical support organizations); INSTN needs to develop formal written procedures for all of the regulatory activities it is still discharging, including authorization and inspection. The IRRS Review Team findings are summarized in Appendix V. 2