WorldWideScience

Sample records for regulatory authorities require

  1. Regulatory authority information system RAIS

    International Nuclear Information System (INIS)

    Ortiz, P.; Mrabit, K.; Miaw, S.

    2000-01-01

    In this lecture the principles of the regulatory authority information system (RAIS) are presented. RAIS is a tool currently being developed by the IAEA for the Regulatory Authorities. It is a part of a set of supporting actions designed to assist member states in achieving the objectives of the Model project on radiation and waste safety infrastructure. RAIS is a tool that provides the management of the Regulatory Authority with the key information needed for the planning and implementation of activities and to ensure confidence that resources are optimally used. The RAIS contains five modules: Inventory of installations and radiation sources; Authorization process; Inspection and follow-up actions; Information on personal dosimetry; Assessment of effectiveness by means of performance indicators

  2. Regulatory authority infrastructure for Namibia

    International Nuclear Information System (INIS)

    Shangula, K.

    2001-01-01

    The Republic of Namibia is participating in the International Atomic Energy Agency's Model Project for the Improvement of National Regulatory Authority Infrastructures in Member States. The paper illustrates our experience in solving problems and difficulties confronted in establishing an effective regulatory authority operating within the existing national infrastructure that should be supported by the Government. An effective regulatory authority is seen as part of the wider administrative scope of our Government through ministerial mandates given by the State from time to time, guaranteeing its independence when implementing legal provisions under statutes. Sections of the report illustrate our experience in the following areas: 1. National radiation protection policy 2. Structure of our national regulatory authority 3. Laws and regulations 4. Provisions for notification, authorization and registration 5. In-depth security measures for radiation sources and radioactive material 6. Systems for the inspection of radiation sources, radioactive materials, enforcement of legal provisions 7. Extent of the applications of radiation sources and radioactive materials in the country. The paper provides information regarding existing Government policy on radiation protection; structure and legal aspects of the national regulatory, including statutes and regulations; the extent of application and uses of radiation sources and security of radioactive materials; human resources: strengths and constraints; management practices and financing of regulatory authority; and plans for emergency recovery of orphan sources. National plans for management of disused sources, recovery of orphan sources, abnormal emergencies, communication of information to affected persons on exposure effects, and the safety training of persons using these applications are discussed. the paper provides a summary and some suggestions of the way forward for Namibia. (author)

  3. Management systems for regulatory authorities

    International Nuclear Information System (INIS)

    Mpandanyama, Rujeko Lynette

    2015-02-01

    For a regulatory body to fulfil its statutory obligations, there is need to develop and implement a regulatory management system that has the necessary arrangements for achieving and maintaining high quality performance in regulating the safety of nuclear and radiation facilities under its authority. Hence, the regulatory management system needs to fully integrate the human resources, processes and physical resources of the organization. This study sought to provide an understanding of the concept, principles, policies and fundamentals of management systems as they relate to regulatory systems in the field of radiation protection and to make appropriate recommendations to ensure that an effective management system exists for the control of ionizing radiation and radiation sources and addresses all relevant stakeholders in Zimbabwe. A comparative analysis was done on the current management status and the ideal management system, which led to the identification of the gaps existing. The main key that was found to be of significance was lack of linkages between processes and management tools within the institution. (au)

  4. Improvements related with the safety required by the Argentine Regulatory Authority to the Atucha I Nuclear Central

    International Nuclear Information System (INIS)

    Calvo, J.; Michelin, C.; Navarro, R.; Waldman, R.

    2006-01-01

    The Argentinean Nuclear Regulation Authority (ARN) verified the existence of changes in the state of some internal components of the reactor of the Atucha I Nuclear Power station that, of continuing in the time, it could take to an inconvenient degradation for the safety operation of the installation. In consequence, to the effects of preventing that reach this situation, at the end of 1999, the ARN required to the Responsible Entity for the operation of this power station the implementation of an important improvements program in the internal components of the reactor. Additionally, and based on the results of the Probabilistic Safety analysis, it was added the one mentioned improvements program the implementation of an alternative cooling system of the reactor core denominated Second Drain of Heat, due to it was determined that, for some accidental sequences, their performance would reduce considerably the probability of damage to the core. The concretion of the improvements program implied to the Responsible Entity the realization of an important quantity of engineering studies, tests and specific inspections that allowed to carry out changes on the control bars of the reactor and its guide tubes; the coolant channels; the sensors of neutron flow; and diverse components of the primary and moderator systems. On the other hand also it was implemented the system Second Drain of Heat, what represents a considerable effort to make compatible the instrumentation and control of last generation, with the instrumentation and existent control systems in the power station. Also, it was requested to be carried out an integrity of the pressure recipient for to demonstrate the existence of an acceptable margin for the difference among the acceptable limit temperatures and of ductile/fragile transition of the material for all the possible accidental scenarios during the useful life of the reactor. (Author)

  5. Management of the Regulatory Authority Information

    International Nuclear Information System (INIS)

    Suman, H.

    2003-01-01

    Safe Management of the Regulatory Authority Information is one of the essential elements to ensure the effectiveness of the regulatory program as a whole. This paper briefly describes the information management basis in RNRO, which is in charge of the regulatory authority tasks in Syria. SINA-2, a computational tool prepared in RNRO for managing the information related to the inventory of radiation sources and users, is also introduced

  6. Annual Report 2008. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2009-01-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across four parts and seven annexes the activities developed by the organism during 2008. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the occupational surveillance; the environmental monitoring; improved organizational and budgetary developments. Also, this publication have annexes with the following content: regulatory documents; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.

  7. Annual Report 2007. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2008-01-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across tree parts and seven annexes the activities developed by the organism during 2007. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the occupational surveillance; the environmental monitoring; improved organizational. Also, this publication have annexes with the following content: regulatory documents; inspections to medical, industrial and training installations; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.

  8. Annual Report 2009. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2010-01-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across four parts and seven annexes the activities developed by the organism during 2009. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the environmental monitoring; the occupational surveillance; the training and the public information; improved organizational and budgetary developments. Also, this publication have annexes with the following content: regulatory documents; inspections to medical, industrial and training installations; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.

  9. Annual Report 2010. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2010-01-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across six chapters and seven annexes the activities developed by the organism during 2010. The main topic are: institutional issues; regulatory guides and standards; argentinean nuclear regulatory system; quality assurance of the ARN; the institutional communications; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the safeguards and the physical protection; the environmental control; the institutional relations; the training and the public information. Also, this publication have annexes with the following content: the regulatory framework; regulatory documents; inspections to medical, industrial and training installations; measurement and evaluation of the drinking water of Ezeiza; international expert's report on the application of the international standards of radiological protection of the public in the zone of the Ezeiza Atomic Center; ethical code

  10. Annual Report 2011. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2011-01-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across six chapters and seven annexes the activities developed by the organism during 2011. The main topic are: institutional issues; regulatory guides and standards; argentinean nuclear regulatory system; quality assurance of the ARN; the institutional communications; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the safeguards and the physical protection; the environmental control; the institutional relations; the training and the public information. Also, this publication have annexes with the following content: the regulatory framework; regulatory documents; inspections to medical, industrial and training installations; measurement and evaluation of the drinking water of Ezeiza; international expert's report on the application of the international standards of radiological protection of the public in the zone of the Ezeiza Atomic Center; ethical code

  11. Annual Report 2013. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2010-01-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across seven parts and eight annexes the activities developed by the organism during 2013. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the environmental monitoring; the occupational surveillance; the training and the public information; improved organizational and budgetary developments. Also, this publication has annexes with the following content: regulatory documents; inspections to medical; presentations of publications from ARN staff; measurement and evaluation of the drinking water of Ezeiza; international expert report on the implementation of international standards on radiation protection in the Ezeiza Atomic Center; Code of Ethics of the Nuclear Regulatory Authority.

  12. Views from the japanese regulatory authority

    International Nuclear Information System (INIS)

    Aoyama, S.

    2004-01-01

    The legislation system for regulation of radioisotope in Japan was established in 1957. The system has been revised gradually since its establishment. Major amendments of the law were made in 1988 on the basis of ICRP Publication 26 and in 2000 on the basis of Publication 60. Main principles provided in the publication have been already introduced into the law. However, some concepts proposed in the recommendations are still under discussion. The current status of implementation of the ICRP recommendations in the Japanese regulatory system is summarised. Views from the regulatory authority of Japan on the points to be improved in the current system of radiological protection are presented. (author)

  13. Establishing exemption and clearance criteria by the regulatory authority

    International Nuclear Information System (INIS)

    Salih, A.E.A.

    2012-04-01

    This Project work discusses the relationship between the concepts of exemption and clearance, and their practical use in the overall scheme of regulatory control of practices. It also discusses how exemptions and clearance is established and the scope of its applications for regulatory control. The concept of general clearance levels for any type of material and any possible pathway of disposal is also introduced in this work. Guidance of the Group of Experts establishing scenarios for general clearance, parameter values, and a nuclide-specific list of calculated clearance levels is also presented. Regulatory authorities are required to develop guidance on exemption and clearance levels to assist licensees and registrants to know which practices and sources within practices are exempted from regulatory control and those to be cleared from further controls. Exemption and clearance levels are tools for assisting the Regulatory Authority to optimize the use of resources. (author)

  14. Independent regulatory authorities in European electricity market

    DEFF Research Database (Denmark)

    Olsen, Ole Jess; Larsen, Anders; Sørensen, Eva Moll

    2006-01-01

    Liberalisation of the electricity market has taken place in most European countries within the last decade. It is considered a precondition of successful liberalisation to establish so-called independent regulatory authorities. In this article, we compare the status and practice of them in 16...

  15. Independent regulatory authorities in European electricity markets

    International Nuclear Information System (INIS)

    Larsen, Anders; Pedersen, Lene Holm; Sorensen, Eva Moll; Olsen, Ole Jess

    2006-01-01

    Liberalisation of the electricity market has taken place in most European countries within the last decade. It is considered a precondition of successful liberalisation to establish so-called independent regulatory authorities. In this article, we compare the status and practice of them in 16 European countries, and discuss the relationship between the organisation of the regulation and the market outcome

  16. Technical Memory 2010. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2010-01-01

    The technical memory 2010 of the Nuclear Regulatory Authority of Argentine Republic, compile the papers published in the subject on radiation protection and nuclear safety presented in journals, technical reports, congress or meetings of these subjects by the ARN personnel during 2010. In this edition the documents are presented on: environmental protection; safety transport of radioactive materials; regulations; licensing of medical installations; biological radiation effects; therapeutic uses of ionizing radiation and radioprotection of patients; internal dosimetry; radioactive waste management [es

  17. Nuclear Regulatory Authority Act, 2015 (Act 895)

    International Nuclear Information System (INIS)

    2015-04-01

    An Act to establish a Nuclear Regulatory Authority in Ghana. This Act provides for the regulation and management of activities and practices for the peaceful use of nuclear material or energy, and to provide for the protection of persons and the environment against the harmful effects of radiation; and to ensure the effective implementation of the country’s international obligations and for related matters. This Act replaced the Radiation Protection Instrument, of 1993 (LI 1559).

  18. Technical Memory 2011. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2011-01-01

    The technical memory 2011 of the Nuclear Regulatory Authority of Argentine Republic, compile the papers published in the subject on radiation protection and nuclear safety presented in journals, technical reports, congress or meetings of these subjects by the ARN personnel during 2011. In this edition the documents are presented on: environmental protection; safety transport of radioactive materials; regulations; licensing of medical installations; biological radiation effects; therapeutic uses of ionizing radiation and radioprotection of patients; internal dosimetry; radioactive waste management [es

  19. Cooperation of Ukrainian regulatory authorities in the SIP

    Energy Technology Data Exchange (ETDEWEB)

    Kutina, L.; Bachner, D.; Bykov, V.; Erickson, L.; Kondralyev, S.; Redko, V.; Simonov, I.; Vasilchenko, V. [SSTC NRS, Stusa St. 35-37, 03142, Kyiv (Ukraine)

    2003-07-01

    The State Nuclear Regulatory Committee of Ukraine (SNRCU) supported by the State Scientific and Technical Center (SSTC) and the Licensing consultant (LC - RISKAUDIT/SCIENTECH) coordinates the activities of other regulatory authorities (RA) within the Shelter Implementation Plan (SIP) licensing. A protocol on cooperation and differentiation of competence in the SIP has been agreed between SNRCU and other RA (Ecology, Health, Construction, Occupational safety, Fire). The RA intended to carry out their activities such that SIP be implemented in the most efficient way by: - providing the Chernobyl NPP with a possibility to choose optimal variants for Shelter transformation; - minimizing required regulatory steps for SIP; - reviewing SIP documents at the initial stages of development of SIP designs; - providing consultative support by technical support organizations (TSO) on the SIP designs; - relating regulatory decisions on safety issues to the competence of the inspection at the Chernobyl NPP site. Coordination of regulatory activity and cooperation in safety areas are presented.

  20. Technical Memory 2008. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2011-01-01

    The technical memory 2008 of the Nuclear Regulatory Authority of Argentine Republic, compile the papers published in the subject on radiation protection and nuclear safety, and presented in journals, technical reports, congress or meetings of these specialties by personnel of the mentioned institution during 2008. In this edition the documents are presented on: environmental protection; transport of radioactive materials; regulations; research reactors and nuclear power plants; biological radiation effects; therapeutic uses of ionizing radiation and radioprotection of patients; internal dosimetry; physical dosimetry; knowledge management; radioactive waste management. [es

  1. 76 FR 20759 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-04-13

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate..., 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange.... For more information about the rulebook consolidation process, see Information Notice, March 12, 2008...

  2. 76 FR 40412 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-07-08

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate..., Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission... a more limited application by their terms. For more information about the rulebook consolidation...

  3. 75 FR 60157 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-09-29

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate..., 2010, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange... information about the rulebook consolidation process, see Information Notice, March 12, 2008 (Rulebook...

  4. 75 FR 71164 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-11-22

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate..., 2010, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange.... For more information about the rulebook consolidation process, see Information Notice, March 12, 2008...

  5. 76 FR 12380 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-03-07

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Amendment No. 1..., the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange... information about the rulebook consolidation process, see Information Notice, March 12, 2008 (Rulebook...

  6. 76 FR 66344 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2011-10-26

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... 31, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of... consolidation process, see Information Notice, March 12, 2008 (Rulebook Consolidation Process). For convenience...

  7. 75 FR 17456 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-04-06

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change..., Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission... terms. For more information about the rulebook consolidation process, see Information Notice, March 12...

  8. The regulatory application of authorization in radiological protection

    International Nuclear Information System (INIS)

    Lazo, T.; Frullani, S.

    2004-01-01

    Authorization is the process used by governments and regulatory authorities to decide what regulatory controls or conditions, if any, should be applied to radioactive sources or radiation exposure situations in order to protect the public, workers and the environment appropriately. Over the years, governments and regulatory authorities have used various approaches to the authorization process under differing circumstances. Now, with the new draft recommendations from the International Commission on Radiological Protection (ICRP), there is the prospect of being able to use a single, simple and self-coherent approach for the process of regulatory authorization under all circumstances. Previously, the ICRP recommended the use of various approaches to manage radiological protection situations. For what were called practices, exposures were subject to limits, and optimisation was required below these limits. What were called interventions were subject to intervention levels, above which some action could be considered justified, and which should be optimised based on consideration of how much dose could be averted by the countermeasure considered. Radon in homes was subject to action levels, above which some sort of countermeasure could be recommended. These approaches are all philosophically distinct and logically constructed, but their differences, particularly in the types of numerical criteria used (limits, intervention levels, action levels, etc.) contributed to confusion and misunderstanding. (author)

  9. Services of the Nuclear Regulatory Authority Library

    International Nuclear Information System (INIS)

    Carregado, M.A.; Wallingre, G.V.

    2011-01-01

    Full text; The main of this work is to present the services and activities of the ARN (Autoridad Regulatoria Nuclear) Library to potential users from the biological dosimetry area in the framework of the intercomparison Meeting of the Latin American Biological Dosimetry Network held in Buenos Aires from October 27-30 of 2008. It makes a short chronology of the library; the services offered to each type of users and the tasks related to technical and international cooperation with other organizations such as: the terminology Committee of IRAM (Instituto Argentino de Normalizacion y Certificacion); the input of national literature to the INIS Database of the IAEA; the retrospective digitalisation, indexing and bibliographic description of institutional publications to be submitted to the repository of the Ibero American Forum of Nuclear and Radiation Safety Regulatory Organizations and the participation in nuclear information networks. Finally it shown some relevant data from the internal statistics. (authors)

  10. Authorization basis requirements comparison report

    Energy Technology Data Exchange (ETDEWEB)

    Brantley, W.M.

    1997-08-18

    The TWRS Authorization Basis (AB) consists of a set of documents identified by TWRS management with the concurrence of DOE-RL. Upon implementation of the TWRS Basis for Interim Operation (BIO) and Technical Safety Requirements (TSRs), the AB list will be revised to include the BIO and TSRs. Some documents that currently form part of the AB will be removed from the list. This SD identifies each - requirement from those documents, and recommends a disposition for each to ensure that necessary requirements are retained when the AB is revised to incorporate the BIO and TSRs. This SD also identifies documents that will remain part of the AB after the BIO and TSRs are implemented. This document does not change the AB, but provides guidance for the preparation of change documentation.

  11. Authorization basis requirements comparison report

    International Nuclear Information System (INIS)

    Brantley, W.M.

    1997-01-01

    The TWRS Authorization Basis (AB) consists of a set of documents identified by TWRS management with the concurrence of DOE-RL. Upon implementation of the TWRS Basis for Interim Operation (BIO) and Technical Safety Requirements (TSRs), the AB list will be revised to include the BIO and TSRs. Some documents that currently form part of the AB will be removed from the list. This SD identifies each - requirement from those documents, and recommends a disposition for each to ensure that necessary requirements are retained when the AB is revised to incorporate the BIO and TSRs. This SD also identifies documents that will remain part of the AB after the BIO and TSRs are implemented. This document does not change the AB, but provides guidance for the preparation of change documentation

  12. Regulatory requirements related to maintenance and compliance monitoring

    International Nuclear Information System (INIS)

    Ling, A.K.H.

    1997-01-01

    The maintenance related regulatory requirements are identified in the regulatory documents and licence conditions. Licensee complies with these requirements by operating the nuclear power plant within the safe operating envelope as given in the operating policies and principles and do maintenance according to approved procedures and/or work plans. Safety systems are regularly tested. AECB project officers review and check to ensure that the licensee operates the nuclear power plant in accordance with the regulatory requirements and licence conditions. (author). 6 tabs

  13. Regulatory requirements for radiation protection

    International Nuclear Information System (INIS)

    Mason, E.A.; Cunningham, R.E.; Hard, J.E.; Mattson, R.J.; Smith, R.D.; Peterson, H.T. Jr.

    1977-01-01

    Regulatory requirements for radiation protection have evolved and matured over several decades. Due to the wide adoption of recommendations of the International Commission on Radiation Protection (ICRP), there exists international agreement on the principles to be followed for radiation protection. This foundation will be increasingly important due to the growing need for international agreements and standards for radiation protection and radioactive materials management. During the infancy of the commercial nuclear industry, primary reliance was placed on the protection of the individual, both in the work force and as a member of the public. With the growth of nuclear power in the 1960's and 1970's, environmental impact assessments and expert reviews of bio-effects data have focused attention on statistical risks to large population groups and the use of the collective dose commitment concept to estimate potential effects. The potential release of long-lived radionuclides from the nuclear fuel cycle requires further consideration of radionuclide accumulation in the biosphere and calls for controls conceived and implemented at the international level. The initial development efforts for addressing these concerns already have been instituted by the ICRP and the IAEA. However, formal international agreements and a unified set of international standards may be required to implement the recommendations of these groups. Further international efforts in the field of radiation protection are also called for in developing waste management practices and radioactive effluent control technology, in site selection for fuel reprocessing plants and waste dispersal facilities, and for ensuring safe transport of high-level wastes in various forms. Since the regulation of very low dose rates and doses will be involved, it will be useful to reexamine dose-effect relationships and societal goals for health protection. Improved criteria and methodologies for ''as low as readily

  14. 75 FR 21686 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-04-26

    ... to pay arbitration awards to remain in the securities industry presents regulatory risks and is...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule... Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission (``SEC'' or...

  15. 76 FR 21932 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2011-04-19

    ... statement therein, as follows: I. Introduction On February 4, 2011, the Financial Industry Regulatory...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting Approval of a... Financial Industry Regulatory Authority, Inc. (``FINRA'') to amend Rule 13806 of the Code of Arbitration...

  16. Independent regulatory authorities - a comparative study of European energy regulators

    International Nuclear Information System (INIS)

    Sander Johansen, K.; Holm Pedersen, L.; Moll Soerensen, E.

    2004-04-01

    Independent regulatory authorities are widely recommended as part of the institutional design of liberalised energy markets - not least by the European Commission. This report describes and compares the regulatory authorities for energy in the EU. Arguments for regulatory independence are presented and discussed, and an index is developed to measure the degree of conformance to theories of regulatory independence. It is established that the main pattern of variation is that countries, which formerly had strong state-owned companies, have chosen to create regulatory authorities at state level with many institutional safeguards for independence. (au)

  17. 78 FR 54502 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-09-04

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of a Proposed Rule... Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission (``SEC'' or ``Commission... or manipulative motivation for the trading activity at issue.\\4\\ Specifically, proposed Supplementary...

  18. Nuclear Regulatory Authority of the Slovak Republic. Annual Report 2016

    International Nuclear Information System (INIS)

    2017-01-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2016 is presented. These activities are reported under the headings: Foreword by the Chairperson; (1) Legislative activities; (2) Regulatory Activities; (3) Nuclear safety of nuclear installations; (4) Nuclear Materials; (5) Competence of the building authority; (6) Emergency planning and preparedness; (7) International activities; (8) Public relations; (9) Nuclear Regulatory Authority of the Slovak Republic; (10) Annexes; (11) Abbreviations.

  19. Nuclear Regulatory Authority of the Slovak Republic. Annual Report 2013

    International Nuclear Information System (INIS)

    2014-04-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2013 is presented. These activities are reported under the headings: Foreword by the Chairperson; (1) Legislative activities; (2) Regulatory Activities; (3) Nuclear safety of nuclear power plants; (4) Nuclear Materials in SR; (5) Building Authority; (6) Emergency planning and preparedness; (7) International activities; (8) Public communication; (9) Nuclear Regulatory Authority of the Slovak Republic; (10) Annexes; (11) (12) Abbreviations.

  20. Nuclear Regulatory Authority of the Slovak Republic. Annual Report 2015

    International Nuclear Information System (INIS)

    2016-01-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2015 is presented. These activities are reported under the headings: Foreword by the Chairperson; (1) Legislative activities; (2) Regulatory Activities; (3) Safety of nuclear installations; (4) Nuclear Materials; (5) Competence of the building authority; (6) Emergency planning and preparedness; (7) International activities; (8) Public relations; (9) Nuclear Regulatory Authority of the Slovak Republic; (10) Annexes; (11) Abbreviations.

  1. Grand Gulf-prioritization of regulatory requirements

    International Nuclear Information System (INIS)

    Meisner, M.J.

    1993-01-01

    As cost pressures mount, Grand Gulf nuclear station (GGNS) is relying increasingly on various prioritization approaches to implement, modify, eliminate, or defer regulatory requirements. Regulatory requirements can be prioritized through the use of three measures: (1) safety (or risk) significance; (2) cost; and (3) public policy (or political) significance. This paper summarizes GGNS' efforts to implement solutions to regulatory issues using these three prioritization schemes to preserve a balance between cost and safety benefit

  2. Creating a safety culture in the regulatory authority: The Cuban experience

    International Nuclear Information System (INIS)

    Ferro Fernandez, R.; Guillen Campos, A.

    2002-01-01

    The Cuban regulatory authority has been working during several years for the fostering and development of a high Safety Culture level in nuclear activities in the country. As starting point to achieve this objective the assessment of the Safety Culture level in the regulatory authority performance was considered an important issue. For this purpose a preliminary diagnosis was carried out by means of a national survey that allowed identifying some areas of the regulatory activity that required improvements in order to achieve a higher Safety Culture and to immediately implement appropriate actions. Two of the most important actions undertaken were: the statement of the regulatory authority Safety Policy which governs and determines the performance of this organization and its staff and also the implementation of a new interaction practice at top level between the regulatory authority and the utilities of the nuclear sector through the Annual Regulatory Conference. The present paper summarizes these two introduced practices into the Cuban regulatory activity. (author)

  3. The bibliographical documentation in the Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Carregado, M.A.

    1998-01-01

    Full text: The presentation of the following work serves to display the recourses which the Information Center (I.C.) - Ezeiza Sector of the Nuclear Regulatory Authority of the Argentine Republic possesses. These recourses help the investigation and application of the regulatory subject as well as the scientific technical community, which uses the information about radiation protection and nuclear safety. Periodical publications, reports, books, standards, etc., are specified quantitatively in detail. Mainly, the automated means are emphasized in order to get to safe ways of information. Data bases in CD-ROM are also enumerated. These are now essential in order to track down the expert information on each theme. The most outstanding ones among these data bases are: INIS, Nuclear Science Abstracts, Nuclear Regulatory Library, Medline and Poltox. Some recourses for obtaining important documents are mentioned, e.g.: The British Library, HMSO and NTIS, as well as addresses of institutions, catalogues of publication on Internet, etc., which allow an easy access to the bibliography required. An evaluation of periodical publications by the Information Center is carried out, as well as information about users connected to the request of bibliographical searches and documents. (author) [es

  4. Cooperation between Norwegian and Russian Regulatory Authorities: NRPA and Rostechnadzor

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2011-07-01

    The Norwegian Radiation Protection Authority has been cooperating with the Federal Environmental, Industrial and Nuclear Supervision Service, Rostechnadzor, on the upgrading of the regulatory framework for the safe decommissioning and disposal of Radioisotope Thermoelectric Generators. (Author)

  5. 75 FR 59771 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving the...

    Science.gov (United States)

    2010-09-28

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving the Proposed Rule.... I. Introduction On July 27, 2010, the Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k... pertinent distribution-related information from its members in a timely fashion to facilitate its Regulation...

  6. 75 FR 41254 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-07-15

    ... registered capacity, may work in other investment-related industries, such as financial planning, or may seek...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a Proposed Rule..., 2010, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and...

  7. 77 FR 7218 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2012-02-10

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... thereunder,\\2\\ notice is hereby given that on January 30, 2012, Financial Industry Regulatory Authority, Inc.... For more information about the rulebook consolidation process, see Information Notice, March 12, 2008...

  8. 75 FR 2897 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-01-19

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule... hereby given that on December 23, 2009, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a... consolidation process, see Information Notice, March 12, 2008 (Rulebook Consolidation Process). NASD Rule 2450...

  9. 76 FR 60106 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-09-28

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... 14, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of.... For more information about the rulebook consolidation process, see Information Notice, March 12, 2008...

  10. 75 FR 5157 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-02-01

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... Consolidated FINRA Rulebook January 25, 2010. On December 2, 2009, the Financial Industry Regulatory Authority... later in the rulebook consolidation process. It is therefore ordered, pursuant to Section 19(b)(2) of...

  11. 77 FR 47470 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Science.gov (United States)

    2012-08-08

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Withdrawal of Proposed Rule Change To Adopt FINRA Rule 2231 (Customer Account Statements) in the Consolidated FINRA Rulebook August 2, 2012. On April 22, 2009, the Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a...

  12. 76 FR 21084 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Science.gov (United States)

    2011-04-14

    ... Securities April 8, 2011. I. Introduction On March 3, 2011, the Financial Industry Regulatory Authority, Inc... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-64283; File No. SR-FINRA-2011-012] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer...

  13. 78 FR 62784 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Science.gov (United States)

    2013-10-22

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer... 5210 (Publication of Transactions and Quotations) October 4, 2013. I. Introduction On August 15, 2013, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission...

  14. 76 FR 50796 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-08-16

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Increase the Position Limit for Options on the Standard and Poor's... Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission...

  15. 75 FR 53998 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-09-02

    ... characteristics and risks of security futures. \\6\\ 15 U.S.C. 78o-3(b)(6). B. Self-Regulatory Organization's...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Security Futures Risk Disclosure Statement August 27, 2010...

  16. 75 FR 27606 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-05-17

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate...\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on April 27, 2010, the Financial Industry... restated following the formation of FINRA through the consolidation of NASD and the member regulatory...

  17. Creating a National Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Way, R.

    2010-01-01

    For a number of reasons, countries throughout the world are now considering the development of new nuclear power programs. Whether it is to meet increased power requirements, lack of indigenous resources or environmental concerns, these countries are looking at nuclear power as a solution to their increasing energy needs. Such an undertaking will require a concerted effort by national industrial firms and several branches of government. This paper will look the various phases that encompass the development of a nuclear power program from the perspective of the human resources development. In short it will consider the following issues: Planning a Human Resource Development strategy; Establishing organization, roles and responsibilities; Establishing an Human Resource Development vision, mission, goals and objectives; Collecting and evaluating data for an HRD needs and resource assessment; Conducting a Human Resource Development needs and resource assessment; Determining short-, medium-, and long-term needs; Developing an implementation plan to address education, training, recruitment, retention and knowledge management; Establishing systems that monitor, evaluate and anticipate HRD needs as the nuclear program evolves; Funding and financing short- and long-term Human Resource Development efforts

  18. Risk acceptance criteria of the Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Felizia, Eduardo R.

    2005-01-01

    This report describes some of the regulatory and control functions legally conferred upon the Argentine Nuclear Regulatory Authority concerning radiological risks, as well as a critical analysis of the radiological risk acceptance criteria contained in the Argentine regulatory system. A summary of the application of regulatory standards AR 3.1.3. - 'Radiological criteria related to accidents in nuclear power reactors' and AR 4.1.3. - 'Radiological criteria related to accidents in research reactors' to concrete cases is made, while the favourable and unfavourable aspects of the risk acceptance criteria are discussed. The conclusion is that the Argentine regulatory system contains adequate radiological risk acceptance criteria, that the latter are consistent with the radiological protection principles applicable to man and that, for the moment, there is no need to perform any modifications that would broaden the conceptual framework on which such criteria are based. (author) [es

  19. Regulatory capital requirements and bail in mechanisms

    NARCIS (Netherlands)

    Joosen, B.P.M.; Haentjens, M.; Wessels, B.

    2015-01-01

    With the introduction of the Capital Requirements Regulation (CRR) in the European Union, the qualitative requirements for bank regulatory capital have changed. These changes aim at implementing in Europe the Basel III principles for better bank capital that is able to absorb losses of banks,

  20. Dose constraint for Industrial gammagraphy developed by regulatory authorities

    International Nuclear Information System (INIS)

    Salinas Mariaca, Rodrigo

    2008-01-01

    Aware that the dose limitation established by the Basic Safety Standards, is one of the radiation protection requirements necessary but not sufficient; and also aware that given the characteristics of the different practices and the culture of security already achieved in such practices, the workers occupationally exposed are far below from the respective limits. It becomes imperative to improve and exploit another of the requirements established by the referred standards, which is the Dose Constraint. This job takes as a basis the dose history having in the Bolivian Authority in nuclear issues, referred to the practices related to Nuclear Gauges, Well Logging, Radiotherapy and Industrial Gammagraphy (practices considered dangerous). This analysis is intended to be the pivot for the remainder practices and had as its goal, the establishment of a specific dose constraint value. The dose constraint suggested for every practices studied, were determined considering the percentile 95 and with the logic that if that 95% are able to achieve certain values of effective dose, the other 5% should be able to adapt their working conditions in order to decrease their doses. The spread of this work is intended not only aware, to other regulatory bodies to achieve a symbiosis between the different requirements of the Standard, but basically emphasize the fact that it is not convenient let the requirement of dose constraint exclusively in the hands of the regulated institutions and associated workers; making it, very subjective among those institutions according to their analysis (many times with no statistical support). Furthermore these dose constraint values should be determined previously to a new practice authorization or failing shortly after its implementation. (author)

  1. Authority Defied : Need for Cognitive Closure Influences Regulatory Control When Resisting Authority

    NARCIS (Netherlands)

    Damen, Tom G. E.; van Leeuwen, Matthijs L.; Dijksterhuis, Ap; van Baaren, Rick B.

    The present studies examined whether differences in need for cognitive closure (NCC) were related to differences in regulatory control when confronted with authority. In two studies, levels of regulatory control were measured when participants resisted (Study 1; N = 46) or prepared to resist the

  2. Authority Defied: Need for Cognitive Closure Influences Regulatory Control When Resisting Authority

    NARCIS (Netherlands)

    Damen, T.G.E.; Leeuwen, M.L. van; Dijksterhuis, A.J.; Baaren, R.B. van

    2014-01-01

    The present studies examined whether differences in need for cognitive closure (NCC) were related to differences in regulatory control when confronted with authority. In two studies, levels of regulatory control were measured when participants resisted (Study 1; N = 46) or prepared to resist the

  3. Competent authority regulatory control of the transport of radioactive material

    International Nuclear Information System (INIS)

    1987-04-01

    The purpose of this guide is to assist competent authorities in regulating the transport of radioactive materials and to assist users of transport regulations in their interactions with competent authorities. The guide should assist specifically those countries which are establishing their regulatory framework and further assist countries with established procedures to harmonize their application and implementation of the IAEA Regulations. This guide specifically covers various aspects of the competent authority implementation of the IAEA Regulations for the Safe Transport of Radioactive Material. In addition, physical protection and safeguards control of the transport of nuclear materials as well as third party liability aspects are briefly discussed. This is because they have to be taken into account in overall transport regulatory activities, especially when establishing the regulatory framework

  4. Safety culture competition - expectations of a regulatory authority

    International Nuclear Information System (INIS)

    Keil, D.; Gloeckle, W.

    2000-01-01

    The accident at the Chernobyl nuclear power station on April 26, 1986 influenced the development of reactor safety and promulgated two basic concepts especially in Germany. On the one hand, extensive measures of in-plant accident management have greatly reduced the so-called residual risk. On the other hand, a comprehensive safety approach has been initiated which comprises the nuclear power plant as a system together with people, technology, and organization and also includes safety culture. In a modern regulatory concept based on the dynamic development of safety, the authority's classical regulatory function of controlling is supplemented by the objective of promoting safety. While preserving the division of responsibilities between the regulatory authority and plant operators, the authority uses 'constructive critical dialog' as a tool to enhance safety. Besides the regulatory assessment of safety culture on the basis of indications or indicators, also the continuous promotion of safety culture in a dialog with plant operators is seen as one of the duties of a regulatory authority. Continued efforts are necessary to maintain the high level of safety culture in German nuclear power plants. Operators are expected to establish a safety management which assigns top priority to safety issues, and which pursues the goal of supervising and promoting safety culture. Developments on the deregulated electricity markets must not lead to safety aspects ranking second to economic aspects. Moreover, also under changed boundary conditions, only the safe operation of nuclear power plants ensures economic viability. (orig.) [de

  5. 77 FR 23770 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-04-20

    ...: The financial markets as a whole should benefit from [limit order display] because the price discovery... revised tier sizes and corresponding liquidity minimum amounts are in the best interest of the market for...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Amendment No. 1...

  6. 78 FR 68893 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2013-11-15

    ... that the size of the BBO equals the minimum quote size. Number of market makers actively quoting...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Extend the Tier Size Pilot of FINRA Rule 6433 (Minimum Quotation Size...

  7. 78 FR 69732 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-11-20

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of a Proposed Rule Change To Amend FINRA Rule 8312 (FINRA BrokerCheck Disclosure) To Include Information About Members and Their Associated Persons of Any Registered National Securities Exchange That Uses the CRD System for...

  8. 76 FR 67236 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-10-31

    ... a foreign financial institution, and as part of the corporate control transaction, the foreign... subsidiaries, both of which are U.S. non-broker-dealer financial institutions, and as part of the corporate...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate...

  9. 75 FR 29793 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-05-27

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... (``Act'') \\1\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on May 4, 2010, Financial.... For more information about the rulebook consolidation process, see Information Notice, March 12, 2008...

  10. 75 FR 80556 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-12-22

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on December 13, 2010, Financial Industry... application by their terms. For more information about the rulebook consolidation process, see Information...

  11. 75 FR 43588 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-07-26

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a Proposed Rule... FINRA Rule 4320 in the Consolidated FINRA Rulebook July 20, 2010. On May 21, 2010, the Financial... application by their terms. For more information about the rulebook consolidation process, see Information...

  12. 77 FR 38694 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2012-06-28

    ... matrix will be an effective means of assessing related fees. For instance, the proposed fee structure...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... Organization's Statement of the Terms of the Substance of the Proposed Rule Change FINRA is proposing to amend...

  13. 76 FR 63969 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-10-14

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Amendment No. 1 to Proposed Rule Change To Adopt FINRA Rule 2231 (Customer Account Statements) in the Consolidated... Account Statements) in the Consolidated FINRA Rulebook (``Notice''). The Notice contained incorrect...

  14. Nuclear Regulatory Authority of the Slovak Republic. Annual Report 1999

    International Nuclear Information System (INIS)

    Seliga, M.

    2000-01-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic in 1999 is presented. These activities are reported under the headings: (1) Foreword; (2) Mission of the Nuclear Regulatory Authority; (3) Legislation; (4) Assessment and inspection of safety at nuclear installations; (4) Safety analyses; (5) Nuclear materials; (6) Radioactive waste; (7) Quality assurance; (8) Personnel qualification and training; (9) Emergency preparedness; (10) International co-operation; (11) Public information; (12) Conclusions; (13) Appendices: Economic and personnel data; Abbreviations; The International nuclear event scales - INES

  15. Nuclear Regulatory Authority of the Slovak Republic. Annual Report 2000

    International Nuclear Information System (INIS)

    Seliga, M.

    2001-01-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic in 2000 is presented. These activities are reported under the headings: (1) Foreword and organisation structure; (2) Mission of the Nuclear Regulatory Authority; (3) Legislation; (4) Assessment and inspection of nuclear installations; (5) Safety analyses; (6) Nuclear materials and physical protection of nuclear installations; (7) Radioactive waste; (8) Quality assurance; (9) Personnel qualification and training; (10) Emergency preparedness; (11) International co-operation; (12) Public information; (13) Personnel and economic data of the UJD; (14) Conclusion; (15) Attachments: Abbreviations; Radiation safety

  16. The process of regulatory authorization. A report by the CRPPH expert group on the regulatory application of Authorization (EGRA)

    International Nuclear Information System (INIS)

    2006-01-01

    Governments and regulatory authorities are responsible for the definition of regulatory controls or conditions, if any, that should be applied to radioactive sources or radiation exposure situations in order to protect the public, workers and the environment. Although countries use different policy and structural approaches to fulfill this responsibility, the recommendations of the International Commission on Radiological Protection (ICRP) are generally used as at least part of the basis for protection. Previously, the ICRP recommended the use of variable approaches to protection. New ICRP recommendations are proposing a single, conceptually simple and self-coherent approach to defining appropriate protection under all circumstances. While the ICRP has been reviewing the broad principles of protection, the NEA Committee on Radiation Protection and Public Health (CRPPH) has been focusing its efforts on how radiological protection could be better implemented by governments and/or regulatory authorities. To this end, the CRPPH has developed a concept that it calls ''the process of regulatory authorization''. It is described in detail in this report, and is intended to help regulatory authorities apply more transparently, coherently and simply the broad recommendations of the ICRP to the real-life business of radiological protection regulation and application. In developing this concept, the CRPPH recognizes the importance of an appropriate level of stakeholder involvement in the process. (author)

  17. Virtual private networks application in Nuclear Regulatory Authority of Argentina

    International Nuclear Information System (INIS)

    Glidewell, Donnie D.; Smartt, Heidi A.; Caskey, Susan A.; Bonino, Anibal D.; Perez, Adrian C.; Pardo, German R.; Vigile, Rodolfo S.; Krimer, Mario

    2004-01-01

    As the result of the existence of several regional delegations all over the country, a requirement was made to conform a secure data interchange structure. This would make possible the interconnection of these facilities and their communication with the Autoridad Regulatoria Nuclear (ARN) headquarters. The records these parts exchange are often of classified nature, including sensitive data by the local safeguards inspectors. On the other hand, the establishment of this network should simplify the access of authorized nuclear and radioactive materials users to the ARN databases, from remote sites and with significant trust levels. These requirements called for a network that should be not only private but also secure, providing data centralization and integrity assurance with a strict user control. The first proposal was to implement a point to point link between the installations. This proposal was deemed as economically not viable, and it had the disadvantage of not being easily reconfigurable. The availability of new technologies, and the accomplishment of the Action Sheet 11 under an agreement between Argentine Nuclear Regulatory Authority and the United States Department of Energy (DOE), opened a new path towards the resolution of this problem. By application of updated tunneling security protocols it was possible to project a manageable and secure network through the use of Virtual Private Networking (VPN) hardware. A first trial installation of this technology was implemented between ARN headquarters at Buenos Aires and the Southern Region Office at Bariloche, Argentina. This private net is at the moment under test, and it is planned to expand to more sites in this country, reaching for example to nuclear power plants. The Bariloche installation had some interesting peculiarities. The solutions proposed to them revealed to be very useful during the development of the network expansion plans, as they showed how to adapt the VPN technical requisites to the

  18. Nuclear Regulatory Authority of the Slovak Republic. Annual Report 2002

    International Nuclear Information System (INIS)

    Seliga, M.

    2003-04-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic in 2002 is presented. These activities are reported under the headings: (1) Foreword; (2) Legislation; (3) Assessment and inspection of nuclear installations; (4) Safety analyses; (5) Nuclear materials and physical protection of nuclear installations; (6) Radioactive waste; (7) Quality assurance; (8) Personnel qualification and training; (9) Emergency preparedness; (10) International co-operation; (11) Public information; (12) Personnel and economy data; Appendix: Abbreviations; Special Enclosure: 10. Years of the Nuclear Regulation Authority of the Slovak Republic. An independent and professional state regulatory authority supervising the nuclear safety is one of prerequisites of the safe operation of nuclear installations in each country. In the Slovak Republic this role has been fulfilled by the Nuclear Regulatory Authority (UJD) since 1993. The main mission of UJD set down by the law is to guarantee for the Slovak citizens as well as for international society that the nuclear power on the territory of the Slovak Republic will be used exclusively for peaceful purposes and that the Slovak nuclear installations are designed, constructed, operated and decommissioned in compliance with relevant legal documents. The mission of UJD is also to tender the operation of nuclear installations so that their operation would not jeopardise the nuclear power plant staff or public and would not cause detrimental effects to the environment or property. UJD prepares laws or comments to the laws and issues decrees in the area of its competencies, issues authorisations for operators of nuclear facilities, reviews and evaluates the safety documentation of nuclear installations, performs the inspections at nuclear installations comparing whether the legal requirements are fulfilled and whether the real status of nuclear installations and their operation is or not in compliance with

  19. 12 CFR 567.2 - Minimum regulatory capital requirement.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 5 2010-01-01 2010-01-01 false Minimum regulatory capital requirement. 567.2... Regulatory Capital Requirements § 567.2 Minimum regulatory capital requirement. (a) To meet its regulatory capital requirement a savings association must satisfy each of the following capital standards: (1) Risk...

  20. Authority defied: need for cognitive closure influences regulatory control when resisting authority.

    Science.gov (United States)

    Damen, Tom G E; van Leeuwen, Matthijs L; Dijksterhuis, Ap; van Baaren, Rick B

    2014-08-01

    The present studies examined whether differences in need for cognitive closure (NCC) were related to differences in regulatory control when confronted with authority. In two studies, levels of regulatory control were measured when participants resisted (Study 1; N = 46) or prepared to resist the influence attempt of an authority figure (Study 2; N = 50). Results showed that resisting the influence attempt from a high-authority figure was more depleting for participants higher in NCC compared to individuals lower in NCC. However, when they were given instructions and time to prepare the act of resistance, individuals high in NCC actually showed an increase in regulatory control. Authority is usually viewed as a general principle of influence; however, the present studies suggest that there are individual differences that influence how people may experience interactions with authorities. © 2013 Wiley Periodicals, Inc.

  1. Quality manual. Nuclear Regulatory Authority of the Slovak Republic

    International Nuclear Information System (INIS)

    2006-03-01

    This quality manual of the Nuclear Regulatory Authority of the Slovak Republic (UJD) is presented. Basic characteristics of the UJD, Quality manual operative control, and Quality management system (QMS) are described. Management responsibility, Processes realization, Measurement, analysis (assessment) and improvement of the quality management system, Cancellation provision as well as abbreviations used in the Quality Manual are presented.

  2. Use of prioritization in meeting regulatory requirements

    International Nuclear Information System (INIS)

    Bowling, M.L.; Sommers, D.A.; Girvin, L.M.

    1993-01-01

    The use of prioritization in the allocation of resources is certainly not a new idea. However, the degree to which prioritization must now be used is much greater than ever before. In the past, utilities generally allocated the necessary resources to meet all regulatory requirements and commitments. Prioritization was then applied to the remaining nonregulatory but required needs. This approach to resource allocation is no longer appropriate for the current and projected economic and operating environment. Key reasons for this conclusion are discussed in this paper by staff from Virginia Power

  3. Knowledge management in the Argentine Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Chahab, Martin

    2006-01-01

    In 2006, the Argentine Nuclear Regulatory Authority has initiated a regulatory knowledge management process to face the loss of knowledge resulting from retiring experts, the generation gap, and the existing need to train new human resources. A number of projects have been started together with the technical assistance of the National Public Administration Institute to preserve knowledge and render it explicit for the coming generations. These projects include 'The History of the Expert's Learning Process' in which the majority of the most critical experts have been interviewed so far. The results of this project help envision a training structure and prospective projects. An Internet Site has also been created on the Intranet in order to render knowledge explicit and facilitate the tools for knowledge management initiatives. Furthermore, ARN's knowledge map project has also been started. (author) [es

  4. Safety and regulatory requirements of nuclear power plants

    International Nuclear Information System (INIS)

    Kumar, S.V.; Bhardwaj, S.A.

    2000-01-01

    A pre-requisite for a nuclear power program in any country is well established national safety and regulatory requirements. These have evolved for nuclear power plants in India with participation of the regulatory body, utility, research and development (R and D) organizations and educational institutions. Prevailing international practices provided a useful base to develop those applicable to specific system designs for nuclear power plants in India. Their effectiveness has been demonstrated in planned activities of building up the nuclear power program as well as with unplanned activities, like those due to safety related incidents etc. (author)

  5. Nuclear Regulatory Authority of the Slovak Republic. Annual Report 2003

    International Nuclear Information System (INIS)

    Seliga, M.

    2004-04-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic in 2003 is presented. These activities are reported under the headings: (1) Foreword; (2) Legislation; (3) Assessment and inspection of nuclear installations; (4) Safety analyses; (5) Nuclear materials and physical protection of nuclear installations; (6) Radioactive waste; (7) Quality assurance; (8) Personnel qualification and training; (9) Emergency preparedness; (10) International co-operation; (11) Public information; (12) Personnel and economy data; Appendix: Abbreviations; Radiation safety

  6. An evaluation model for the definition of regulatory requirements on spent fuel pool cooling systems

    International Nuclear Information System (INIS)

    Izquierdo, J.M.

    1979-01-01

    A calculation model is presented for establishing regulatory requirements in the SFPCS System. The major design factors, regulatory and design limits and key parameters are discussed. A regulatory position for internal use is proposed. Finally, associated problems and experience are presented. (author)

  7. 77 FR 24748 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2012-04-25

    ... Traded TBA April 18, 2012. I. Introduction On March 1, 2012, the Financial Industry Regulatory Authority... (``MBS'') traded ``to be announced'' or ``TBA.'' The proposed rule change was published for comment in... TBA (``MBS TBA'') are a specific type of Asset-Backed Security.\\6\\ FINRA has proposed to amend its...

  8. Regulatory Safety Requirements for Operating Nuclear Installations

    International Nuclear Information System (INIS)

    Gubela, W.

    2017-01-01

    The National Nuclear Regulator (NNR) is established in terms of the National Nuclear Regulator Act (Act No 47 of 1999) and its mandate and authority are conferred through sections 5 and 7 of this Act, setting out the NNR's objectives and functions, which include exercising regulatory control over siting, design, construction etc of nuclear installations through the granting of nuclear authorisations. The NNR's responsibilities embrace all those actions aimed at providing the public with confidence and assurance that the risks arising from the production of nuclear energy remain within acceptable safety limits -> Therefore: Set fundamental safety standards, conducting pro-active safety assessments, determining licence conditions and obtaining assurance of compliance. The promotional aspects of nuclear activities in South Africa are legislated by the Nuclear Energy Act (Act No 46 of 1999). The NNR approach to regulations of nuclear safety and security take into consideration, amongst others, the potential hazards associated with the facility or activity, safety related programmes, the importance of the authorisation holder's safety related processes as well as the need to exercise regulatory control over the technical aspects such as of the design and operation of a nuclear facility in ensuring nuclear safety and security. South Africa does not have national nuclear industry codes and standards. The NNR is therefore non-prescriptive as it comes to the use of industry codes and standards. Regulatory framework (current) provide for the protection of persons, property, and environment against nuclear damage, through Licensing Process: Safety standards; Safety assessment; Authorisation and conditions of authorisation; Public participation process; Compliance assurance; Enforcement

  9. Nuclear Regulatory Authority of the Slovak Republic. Annual Report 2004

    International Nuclear Information System (INIS)

    Seliga, M.

    2005-04-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic in 2004 is presented. These activities are reported under the headings: (1) Foreword; (2) Legislation; (3) Assessment and inspection of nuclear power plants; (3.1) Assessment and inspection of other nuclear installations; (3.2) Safety analyses; (4) Nuclear materials and physical protection of nuclear installations; (5) Radioactive waste; (6) Quality assurance; (7) Personnel qualification and training; (8) Emergency preparedness; (9) International co-operation; (10) Public information; (11) Personnel and economy data; Appendix: Abbreviations; INES

  10. Nuclear Regulatory Authority of the Slovak Republic. Annual Report 2001

    International Nuclear Information System (INIS)

    Seliga, M.

    2002-04-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic in 2001 is presented. These activities are reported under the headings: (1) Foreword; (2) Legislation; (3) Assessment and inspection of nuclear installations; (4) Safety analyses; (5) Nuclear materials and physical protection of nuclear installations; (6) Radioactive waste (RAW); (7) Quality assurance; (8) Personnel qualification and training; (9) Emergency preparedness; (10) International co-operation; (11) Public information; (12) Personnel and economy data; (13) Conclusion; (14) Appendix: Abbreviations; Radiation safety

  11. Romania - NPP PLiM Between Regulatory Requirement / Oversight and Operator Safety / Financial Interest

    International Nuclear Information System (INIS)

    Goicea, Lucian

    2012-01-01

    Cernavoda Unit 1 PLiM started in the first third of its design life, to develop as regulatory requirements of the components of standards and programmes and to benefit by earlier implementation of the measures for achieving maximum operating life. CNCAN regulatory present approach on the utility PLiM combines the regulatory requirements on management system, ageing management provisions of periodic safety review, detailed technical requirements of ageing programmes and different techniques focusing only on safety issues. (author)

  12. Romanian regulatory requirements on nuclear field specific education needs

    International Nuclear Information System (INIS)

    Biro, L.; Velicu, O.

    2004-01-01

    This work is intended as a general presentation of the educational system and research field, with reference to nuclear sciences, and the legal system, with reference to requirements established by the regulatory body for the professional qualification and periodic training of personnel involved in different activities in the nuclear field. Thus, part 2 and 3 of the work present only public information regarding the education in nuclear sciences and nuclear research in Romania; in part 4 the CNCAN requirements for the personnel training, specific to nuclear activities are slightly detailed; part 5 consists of few words about the public information activities in Romania; and part 6 tries to draw a conclusion. (authors)

  13. Communications in the Nuclear Regulatory Authority of the Slovakia

    International Nuclear Information System (INIS)

    Seliga, Mojmir

    1998-01-01

    Full text: The Nuclear Regulatory Authority of the Slovak Republic (UJD SR) as the state authority provides information related to its competence, namely information on safety operation of nuclear installations, independently from nuclear operators and it enables the public and media to examine information on nuclear facilities. The important aspect is proving that the nuclear energy in the Slovak Republic is due to obligatory rules acceptable and its operation is regulated by the State through the independent institution - UJD SR. UJD SR considers the whole area of public relations as essential component of its activity. UJD SR intends to serve the public true, systematic, qualified, understandable and independent information regarding nuclear safety of nuclear power plants, as well as regarding methods and results of UJD SR work. Communication on reactor incidents or more broadly on operational events at nuclear power plants represents a substantial part of public information- Generally, public information is considered as significant contribution to creation of confidence into the regulatory work. A communication programme must be tested in practice. Our communication programme is regularly evaluated in emergency exercises held at the UJD SR. Inviting journalists to participate in or observe the exercises has intensified this, or by having staff members simulate the mass media and the public. The communication means, tools and channels developed and enhanced during the recent years has increased the UJD SR's functional capability to carry out its information policy. However, communication cannot achieve its goals unless the receiver is willing to accept the message. If the receiver is suspicious about the sender's intentions, good communication is almost impossible. Maintaining the trust with the media and the public as well as increasing radiation and nuclear safety knowledge in the society is therefore essential. UJD SR communication and information activities

  14. Public consultation: regulatory requirement or business principle?

    International Nuclear Information System (INIS)

    Seeley, R.

    1999-01-01

    A summary is included of knowledge and experiences related to planning and implementing a public consultation program over a number of years in Shell Canada's Athabasca Oil Sands development. This project consists of three major sub- projects with a total estimated capital investment of $4 billion. The three sub- projects are: the Muskeg River Mine, the Scotford Upgrader, and the Corridor Pipeline. The facilities will produce 150,000 bbl/day of synthetic crude for over 25 years and are targeted to begin production in late 2002. From the title of the paper, although public consultation is required under environmental legislation, many companies are adopting a more pro-active approach to public consultation and participation as a business principle. This commitment to engage in and dialogue with stakeholders must be open, transparent and long term, not just during the regulatory process. Successful consultation begins with the prerequisites: senior management commitment, buy-in from the project or operating team that the process adds value, and the ability to listen and make changes. A consultation program is not a short term activity, but is rather an ongoing process linked to a business or operating principle. It requires long term resources and follow through on agreements and commitments made to stakeholders and communities

  15. Public consultation: regulatory requirement or business principle?

    Energy Technology Data Exchange (ETDEWEB)

    Seeley, R. [Shell Canada Oil Sands, Calgary, AB (Canada)

    1999-07-01

    A summary is included of knowledge and experiences related to planning and implementing a public consultation program over a number of years in Shell Canada's Athabasca Oil Sands development. This project consists of three major sub- projects with a total estimated capital investment of $4 billion. The three sub- projects are: the Muskeg River Mine, the Scotford Upgrader, and the Corridor Pipeline. The facilities will produce 150,000 bbl/day of synthetic crude for over 25 years and are targeted to begin production in late 2002. From the title of the paper, although public consultation is required under environmental legislation, many companies are adopting a more pro-active approach to public consultation and participation as a business principle. This commitment to engage in and dialogue with stakeholders must be open, transparent and long term, not just during the regulatory process. Successful consultation begins with the prerequisites: senior management commitment, buy-in from the project or operating team that the process adds value, and the ability to listen and make changes. A consultation program is not a short term activity, but is rather an ongoing process linked to a business or operating principle. It requires long term resources and follow through on agreements and commitments made to stakeholders and communities.

  16. Internal communication within the Slovak Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Seliga, Mojmir

    2000-01-01

    One of the primary objectives of the Slovak Nuclear Regulatory Authority (UJD) Public Relations Program is to make available to the public full and complete information on UJD activities to assist the public in making informed judgments regarding UJD activities. The primary means of keeping the public informed about the regulatory activities and programs of the UJD is through the news media. A central state administration body, the UJD provides on request within its province in particular information on operational safety of nuclear energy installations independently of those responsible for the nuclear programme, thereby allowing the public and the media to control data and information on nuclear installations. A major element of providing information is the demonstration that the area of nuclear energy uses has its binding rules in the Slovak Republic and the observance thereof is controlled by the state through an independent institution - UJD. As early as 1995 were laid on the UJD the foundations of the concept of broadly keeping the public informed on UJD activity and the safety of nuclear installations by opening the UJD Information Centre. Information Centre provides by its activity communications with the public and mass media, which is instrumental in creating in the public a favourable picture of the independent state nuclear regulation. Internal and external communications are equally important

  17. NRPA develops regulatory cooperation with Central Asian authorities for nuclear safety and radiation protection

    International Nuclear Information System (INIS)

    2009-01-01

    With the support of the Norwegian Ministry of Foreign Affairs, the NRPA has initiated a regional regulatory cooperation project with Kazakhstan, Kyrgyzstan and Tajikistan to improve regulations on nuclear safety, radiation protection and environmental issues, and assist the countries in re mediating radioactively contaminated sites. There is a critical lack in the regulatory basis for carrying out such remediation work, including a lack of relevant radiation and environmental safety norms and standards, licensing procedures and requirements for monitoring, as well as expertise to transform such a basis into practice. (Author)

  18. Radiation protection databases of nuclear safety regulatory authority

    International Nuclear Information System (INIS)

    Janzekovic, H.; Vokal, B.; Krizman, M.

    2003-01-01

    Radiation protection and nuclear safety of nuclear installations have a common objective, protection against ionising radiation. The operational safety of a nuclear power plant is evaluated using performance indicators as for instance collective radiation exposure, unit capability factor, unplanned capability loss factor, etc. As stated by WANO (World Association of Nuclear Operators) the performance indicators are 'a management tool so each operator can monitor its own performance and progress, set challenging goals for improvement and consistently compare performance with that of other plants or industry'. In order to make the analysis of the performance indicators feasible to an operator as well as to regulatory authorities a suitable database should be created based on the data related to a facility or facilities. Moreover, the international bodies found out that the comparison of radiation protection in nuclear facilities in different countries could be feasible only if the databases with well defined parameters are established. The article will briefly describe the development of international databases regarding radiation protection related to nuclear facilities. The issues related to the possible development of the efficient radiation protection control of a nuclear facility based on experience of the Slovenian Nuclear Safety Administration will be presented. (author)

  19. Regulatory requirements for fluorine 18-labelled radiotracers

    International Nuclear Information System (INIS)

    Prigent, A.

    2005-01-01

    Although European and French regulations define radiopharmaceuticals and their different conditions for use, there is no legal status of the radiotracer. Radiotracer is commonly known as a molecular entity administered in tracer doses, that means at very low masses (e.g., nano-mol amounts) and, consequently, without any pharmacological effect. A radiotracer can meet the specifications of either a radiochemical (usually restricted to research in animal models) or a radiopharmaceutical (human use for diagnostic imaging or research projects). Besides the 'proprietary medicinal product', different status have been defined to allow other uses in humans, referring to 'magistral formula' preparation, 'officinal formula' preparation, investigational medicinal product for clinical trials, or to a radiopharmaceutical with a 'patient named authorization'. However, because of the short half-life of fluorine 18 and expanding development of molecular imaging techniques using positron emission tomography (PET), the current regulation is sometimes considered as inappropriate with regard to the small-size production required for such on-site manufactured radiopharmaceuticals. It is often claimed that it could be very difficult to comply with the current Good Manufactured Practice (cGMP). As previously done for radiopharmaceuticals based on monoclonal antibodies, specific adjustments for PET radiopharmaceuticals are under discussion and the 'note for guidance on radiopharmaceuticals' will be soon revised by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). In many cases, a status of 'magistral' product might be attributed to a PET radiopharmaceutical manufactured according with European Pharmacopoeia monographs. (author)

  20. Improvements related with the safety required by the Argentine Regulatory Authority to the Atucha I Nuclear Central; Mejoras relacionadas con la seguridad requeridas por la Autoridad Regulatoria Argentina a la Central Nuclear Atucha I

    Energy Technology Data Exchange (ETDEWEB)

    Calvo, J.; Michelin, C.; Navarro, R.; Waldman, R. [Autoridad Regulatoria Nuclear, Av. Del Libertador 8250, 1429- Ciudad de Buenos Aires (Argentina)]. e-mail: jcalvo@sede.arn.gov.ar

    2006-07-01

    The Argentinean Nuclear Regulation Authority (ARN) verified the existence of changes in the state of some internal components of the reactor of the Atucha I Nuclear Power station that, of continuing in the time, it could take to an inconvenient degradation for the safety operation of the installation. In consequence, to the effects of preventing that reach this situation, at the end of 1999, the ARN required to the Responsible Entity for the operation of this power station the implementation of an important improvements program in the internal components of the reactor. Additionally, and based on the results of the Probabilistic Safety analysis, it was added the one mentioned improvements program the implementation of an alternative cooling system of the reactor core denominated Second Drain of Heat, due to it was determined that, for some accidental sequences, their performance would reduce considerably the probability of damage to the core. The concretion of the improvements program implied to the Responsible Entity the realization of an important quantity of engineering studies, tests and specific inspections that allowed to carry out changes on the control bars of the reactor and its guide tubes; the coolant channels; the sensors of neutron flow; and diverse components of the primary and moderator systems. On the other hand also it was implemented the system Second Drain of Heat, what represents a considerable effort to make compatible the instrumentation and control of last generation, with the instrumentation and existent control systems in the power station. Also, it was requested to be carried out an integrity of the pressure recipient for to demonstrate the existence of an acceptable margin for the difference among the acceptable limit temperatures and of ductile/fragile transition of the material for all the possible accidental scenarios during the useful life of the reactor. (Author)

  1. An overview of the licensing approach of the South African nuclear regulatory authority

    International Nuclear Information System (INIS)

    Clapisson, G.A.; Hill, T.F.; Henderson, N.R.; Keenan, N.H.; Metcalf, P.E.; Mysenkov, A.

    1997-01-01

    This paper describes the approach adopted by the South African Nuclear Regulatory Authority, the Council for Nuclear Safety (CNS) in licensing nuclear installations in South Africa. An introduction to the current South African legislation and the CNS philosophy pertaining to the licensing of nuclear installations is discussed. A typical process for granting a nuclear licence is then presented. The risk assessment process, which is used to verify compliance with the fundamental safety standards and to establish licensing requirements for a specific nuclear installation, is discussed. Based on the outcome of this assessment process, conditions of licence are set down. The generic content of a nuclear licence and mechanisms to ensure ongoing compliance with the risk criteria are presented. The regulatory process discussed in this paper, based on such a fundamental approach, may be adapted to any type of nuclear installation taking into account plant specific designs and characteristics. (author)

  2. Regulatory framework and safety requirements for new (gen III) reactors

    International Nuclear Information System (INIS)

    Mourlon, Sophie

    2014-01-01

    Sophie Mourlon, ASN Deputy General Director, described the international process to enhance safety between local safety authorities through organizations such as WENRA. Then she explained to the participants the regulatory issues for the next generation of NPPs

  3. 77 FR 12098 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-02-28

    ... 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule... FINRA and at the Commission's Public Reference Room. II. Self-Regulatory Organization's Statement of the..., and C below, of the most significant aspects of such statements. A. Self-Regulatory Organization's...

  4. 76 FR 9838 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-02-22

    .... 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance..., and at the Commission's Public Reference Room. II. Self-Regulatory Organization's Statement of the... in sections A, B, and C below, of the most significant aspects of such statements. A. Self-Regulatory...

  5. 76 FR 9840 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-02-22

    .... 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance... Public Reference Room. II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory..., and C below, of the most significant aspects of such statements. A. Self-Regulatory Organization's...

  6. 24 CFR 266.505 - Regulatory agreement requirements.

    Science.gov (United States)

    2010-04-01

    ... force for the duration of the insured mortgage and note or bond. The Regulatory Agreement must include a... Project Management and Servicing § 266.505 Regulatory agreement requirements. (a) General. (1) The HFA... payments due under the mortgage and note/bond. (2) Where necessary, establish a sinking fund for future...

  7. The Report on Activities of the Nuclear Regulatory Authority of the Slovak Republic. Annual Report 2012

    International Nuclear Information System (INIS)

    2013-04-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2012 is presented. These activities are reported under the headings: Foreword; (1) Legislative activities; (2) Regulatory Activities; (3) Nuclear safety of nuclear power plants; (4) Stress tests on the nuclear power plants; (5) Nuclear Materials in SR; (6) Building Authority; (7) Emergency planning and preparedness; (8) International activities; (9) Public communication; (10) Nuclear Regulatory Authority of the Slovak Republic; (11) Attachments; (12) Abbreviations used.

  8. Regulatory requirements and quality assurance of radiation monitoring instruments

    International Nuclear Information System (INIS)

    Narasimharao, K.L.; Sharma, Ranjit

    2005-01-01

    The successful utilisation of radiation sources in the fields of medicine and industry requires the accurate measurement of activity, exposure rate and dose. Many varieties of instruments are in use for measurement of these parameters and new ones are being developed. The criteria for the design of the radiation monitoring instrument include the type and intensity of the radiation, purpose of measurement and ruggedness of the instrument. Quality and reliability of radiation monitoring instruments ensure that individuals are adequately protected. Accuracy, response time and ruggedness are required to be as per the approved/ prescribed guidelines. Regulatory authorities outline the design and performance criteria for radiation monitoring instruments and prescribe the recommendations of international agencies such as IAEA, ICRU and ISO for radiological measurement assurance programme. National Standards Laboratories all over the world prescribe procedures for calibration of various radiation monitoring instruments. The instruments should be calibrated as per these guidelines and should be traceable to national standards. The calibration traceable to national/ international standards and documentation as well as limits stipulated by the competent authority ensures the expected performance of the instrument. (author)

  9. Infrastructure of the Regulatory Authority and Performance Indexes

    International Nuclear Information System (INIS)

    Velasquez, Silvia

    2001-01-01

    This presentation overviews the following issues: elements of a control regulatory program, inspections program, procedures, indexes of users performance, priorities on: registration, criteria for practices of low risk, dose levels in medical exposures, dose constraints and training of personnel. These aspects are considered in the guides prepared within ARCAL XX framework

  10. The value and benefits of the International Conference on Harmonisation to drug regulatory authorities: advancing harmonization for better public health.

    Science.gov (United States)

    Molzon, J A; Giaquinto, A; Lindstrom, L; Tominaga, T; Ward, M; Doerr, P; Hunt, L; Rago, L

    2011-04-01

    The International Conference on Harmonisation (ICH) is an unparalleled undertaking, which has brought together drug regulatory authorities and pharmaceutical trade associations from Europe, Japan, and the United States, to discuss the scientific and technical aspects of medical product registration. Launched in 1990, the value and benefits of ICH to regulators are being realized. ICH has harmonized submission requirements and created a harmonized submission format that is relieving both companies and regulatory authorities of the burdens of assembling and reviewing separate submissions for each region. As more countries embrace ICH guidelines, we anticipate additional benefits, including the promotion of good review practices and, ultimately, a common regulatory language that will facilitate further interactions among global drug regulatory authorities.

  11. WIPP Waste Characterization: Implementing Regulatory Requirements in the Real World

    International Nuclear Information System (INIS)

    Cooper Wayman, J.D.; Goldstein, J.D.

    1999-01-01

    It is imperative to ensure compliance of the Waste Isolation Pilot Project (WIPP) with applicable statutory and regulatory requirements. In particular, compliance with the waste characterization requirements of the Resource Conservation and Recovery Act (RCRA) and its implementing regulation found at 40 CFR Parts 262,264 and 265 for hazardous and mixed wastes, as well as those of the Atomic Energy Act of 1954, as amended, the Reorganization Plan No. 3 of 1970, the Nuclear Waste Policy Act of 1982, as amended, and the WIPP Land Withdrawal Act, as amended, and their implementing regulations found at 40 CFR Parts 191 and 194 for non-mixed radioactive wastes, are often difficult to ensure at the operational level. For example, where a regulation may limit a waste to a certain concentration, this concentration may be difficult to measure. For example, does the definition of transuranic waste (TRU) as 100 nCi/grain of alpha-emitting transuranic isotopes per gram of waste mean that the radioassay of a waste must show a reading of 100 plus the sampling and measurement error for the waste to be a TRU waste? Although the use of acceptable knowledge to characterize waste is authorized by statute, regulation and DOE Orders, its implementation is similarly beset with difficulty. When is a document or documents sufficient to constitute acceptable knowledge? What standard can be used to determine if knowledge is acceptable for waste characterization purposes? The inherent conflict between waste characterization regulatory requirements and their implementation in the real world, and the resolution of this conflict, will be discussed

  12. Challenges in developing TSO to provide technical support in nuclear safety and security to Pakistan Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Mallick, Shahid A.; Sherwani, Uzman Habib; Mehdi, M. Ammar

    2010-01-01

    This paper highlights the needs for the establishment of a technical support organization (TSO) in Pakistan Nuclear Regulatory Authority (PNRA), challenges faced during its development, application of training need assessment required for the competency development of its technical manpower and difficulties encountered after its evolution. Key issues addressed include recruitment of technical manpower and enhancing their competencies, acquisition of proper tools required for safety review and assessment, development of a sustainable education and training program consistent with the best international practices and taking the measures to get confidence of the regulatory body. (author)

  13. Role of cooperation activities for capacity building of Romanian Regulatory Authority (CNCAN)

    International Nuclear Information System (INIS)

    Biro, L.; Ciurea-Ercau, C.

    2010-01-01

    With a slow but active nuclear development program of sector since 1980, Romanian regulatory authority had to permanently adapt to the changes in national and international environment in order ensure continuously increase of capacity building and effectiveness, commensurate with the growing nuclear sector. Limited human resources available at the national level put the Romanian Regulatory Authority in the position of building the Technical Support Organization as part of its on organization. International cooperation played an important role in capacity building of Romanian regulatory body and providing necessary assistance in performing regulatory activities or support in development of regulatory framework. Fellowships and technical visits, workshops and training courses provided through IAEA TC at national or regional level, technical assistance provided by European Commission (EC) through PHARE Projects, all provided valuable contribution in assuring training of regulatory staff and development of proper regulatory framework in Romania. Therefore, Romanian Regulatory Authority is putting a strong accent on strengthening and promoting international cooperation through IAEA Technical Cooperation Programme, Molls between regulatory bodies, as one of the key elements in supporting capacity building of regulatory authorities in countries having small or embarking on nuclear power program. Building networks between training centers and research facilities and establishments of regional training centers represent one of the future viable options in preserving knowledge in nuclear field. (author)

  14. Role of the Nuclear Regulatory Authority in the final disposal of radioactive wastes in Argentina

    International Nuclear Information System (INIS)

    Petraitis, E.J.; Siraky, G.; Novo, R.G.

    1998-01-01

    This paper describes briefly the legislative and regulatory framework in which the final disposal of radioactive wastes is carried out in Argentina. The activities of the Nuclear Regulatory Authority (ARN) and the applied approaches in relation to inspection of facilities, safety assessments of associated systems and collaboration in the matter with international agencies are also exposed. (author) [es

  15. Towards medicines regulatory authorities' quality performance improvement: value for public health.

    Science.gov (United States)

    Pejović, Gordana; Filipović, Jovan; Tasić, Ljiljana; Marinković, Valentina

    2016-01-01

    The purpose of this article is to explore the possibility of implementing total quality management (TQM) principles in national medicines regulatory authorities in Europe to achieve all public health objectives. Bearing in mind that medicines regulation is a governmental function that serves societal objectives to protect and promote public health, measuring the effective achievement of quality objectives related to public health is of utmost importance. A generic TQM model for meeting public health objectives was developed and was tested on 10 European national medicines regulatory authorities with different regulatory performances. Participating national medicines regulatory authorities recognised all TQM factors of the proposed model in implemented systems with different degrees of understanding. An analysis of responses was performed within the framework of two established criteria-the regulatory authority's category and size. The value of the paper is twofold. First, the new generic TQM model proposes to integrate four public health objectives with six TQM factors. Second, national medicines regulatory authorities were analysed as public organisations and health authorities to develop a proper tool for assessing their regulatory performance. The paper emphasises the importance of designing an adequate approach to performance measurement of quality management systems in medicines regulatory authorities that will support their public service missions. Copyright © 2014 John Wiley & Sons, Ltd.

  16. Review of regulatory requirements for digital I and C systems

    Energy Technology Data Exchange (ETDEWEB)

    Kwon, Kee Choon; Lee, Cheol Kwon; Lee, Jang Soo [and others

    2001-11-01

    This work analyzed and summarized systematically various regulatory requirements that are necessary to develop digital nuclear instrumentation and control (I and C) systems, especially safety systems. The requirements are categorized into system, hardware, software, and quality assurance aspects. This report provides the explanations of terms and abbreviations to help readers understand. Furthermore, appendices of this report summarize the code and standards corresponding to each principal regulatory requirement. The hierarchical structure of regulatory requirements has Nuclear Energy Laws, Enforcement Regulations of Nuclear Energy Laws, and Notifications of Ministry of Science and Technology as utmost level requirements [In case of the US, 10 CFR 50 Appendix A, 10 CFR 50 Appendix B, 10 CFR 50.55a(h), 10 CFR 50.49, etc.]. The requirements include the Draft Regulatory Guidelines for Digital I and C Systems [In case of the US, Standard Review Plan (NUREG-0800), Regulatory Guide, Branch Technical Position (BTP)], KEPIC as standards [In case of the US, IEEE Standards, IEC Standards, ISA, Military Standard, etc.], and various reports issued by Korea Institute of Nuclear Safety [In case of the US, NUREG reports, EPRI reports, etc.]. This report can be referred for the development of safety grade control equipment, plant protection system, and engineered safety feature actuation system.

  17. Review of regulatory requirements for digital I and C systems

    International Nuclear Information System (INIS)

    Kwon, Kee Choon; Lee, Cheol Kwon; Lee, Jang Soo

    2001-11-01

    This work analyzed and summarized systematically various regulatory requirements that are necessary to develop digital nuclear instrumentation and control (I and C) systems, especially safety systems. The requirements are categorized into system, hardware, software, and quality assurance aspects. This report provides the explanations of terms and abbreviations to help readers understand. Furthermore, appendices of this report summarize the code and standards corresponding to each principal regulatory requirement. The hierarchical structure of regulatory requirements has Nuclear Energy Laws, Enforcement Regulations of Nuclear Energy Laws, and Notifications of Ministry of Science and Technology as utmost level requirements [In case of the US, 10 CFR 50 Appendix A, 10 CFR 50 Appendix B, 10 CFR 50.55a(h), 10 CFR 50.49, etc.]. The requirements include the Draft Regulatory Guidelines for Digital I and C Systems [In case of the US, Standard Review Plan (NUREG-0800), Regulatory Guide, Branch Technical Position (BTP)], KEPIC as standards [In case of the US, IEEE Standards, IEC Standards, ISA, Military Standard, etc.], and various reports issued by Korea Institute of Nuclear Safety [In case of the US, NUREG reports, EPRI reports, etc.]. This report can be referred for the development of safety grade control equipment, plant protection system, and engineered safety feature actuation system

  18. Regulatory requirements for marketing fixed dose combinations

    Directory of Open Access Journals (Sweden)

    B G Jayasheel

    2010-01-01

    Full Text Available The development of fixed-dose combinations (FDCs is becoming increasingly important from a public health perspective. FDCs have advantages when there is an identifiable patient population for whom treatment with a particular combination of actives in a fixed ratio is safe and effective and when all of the actives contribute to the overall therapeutic effect. Such combinations of drugs are particularly useful in the management of chronic diseases. In addition, there can be real clinical benefits in the form of increased efficacy and/or a reduced incidence of adverse effects. Additional advantages of FDCs are potentially lower costs of manufacturing compared to the costs of producing separate products administered concurrently, simpler logistics of distribution and reduced development of resistance in the case of antimicrobials. Above all, FDC therapy reduces pill burden and improves medication compliance. Although, FDCs seem to be ideal under certain pre-defined circumstances, if a dosing adjustment is warranted, there may not be an FDC available in the most appropriate strength for the patient and if an adverse drug reaction occurs from using an FDC, it may be difficult to identify the active ingredient responsible for causing the reaction. Appendix VI of Schedule Y (Drugs & Cosmetics Rules 1945, India states the requirements for marketing approval of various types of FDCs. The same is further elaborated in this article to provide a detailed guidance including the clinical trial requirements. However, the heterogeneity of the therapeutic field makes it difficult to develop a standard guidance document.

  19. Design and development of an informatics management system as a support for the Regulatory Authority in the Republic of Cuba

    International Nuclear Information System (INIS)

    Valdes Ramos, Maryzury; Prendes Alonso, Miguel; Jova Sed, Luis

    2008-01-01

    The regulatory activity in the country is carried out by the National Center for Nuclear Safety (CNSN) according to the international recommendations. To develop this, CNSN is supported by the Center for Radiation Protection and Hygiene (CPHR) which it's in charged of guaranteeing the technical scientific support for this activity. These centers have been working in the last years in the design and development of a computing tool that allows the management of all important information, which should be controlled by the Regulatory Authority. The authorization processes of the practices and the inspection program require the use, register and evaluation of an important volume of information that grows as the number of practices and facilities are increases. Consequently the systematizing of this information needs an automated management system. The objective of this work is to show the level of automation reached by the National Regulatory Authority using RASSYN program. This program allows an efficient management of the information related to the radiation sources nationwide, the practices ascribed to these sources, the personnel involved in these practices and the dose received, the equipment measuring and detecting of radiations, the generated waste, the occurred radiological incidents, the conditions and requisites of the granted authorizations and the results of the inspection program, among others. The possibilities of RASSYN system to process the information given by the users and the ones produced by the regulatory authority are described. The automatic generation of the annual inspections plan, according to the previously defined criteria and the system of alerts on the state of fulfillment of radiological protection requirements make RASSYN a useful tool to optimize the functioning of the regulatory system. The versatility of the statistical reports allows to guarantees not only the requirements of the regulatory authority but also the expectations coming

  20. Regulatory authority of the Rocky Mountain states for low-level radioactive waste packaging and transportation

    International Nuclear Information System (INIS)

    Whitman, M.; Tate, P.

    1983-07-01

    The newly-formed Rocky Mountain Low-Level Radioactive Waste Compact is an interstate agreement for the management of low-level radioactive waste (LLW). Eligible members of the compact are Arizona, Colorado, Nevada, New Mexico, Utah, and Wyoming. Each state must ratify the compact within its legislature for the compact to become effective in that state and to make that state a full-fledged member of the compact. By so adopting the compact, each state agrees to the terms and conditions specified therein. Among those terms and conditions are provisions requiring each member state to adopt and enforce procedures requiring low-level waste shipments originating within its borders and destined for a regional facility to conform to packaging and transportation requirements and regulations. These procedures are to include periodic inspections of packaging and shipping practices, periodic inspections of waste containers while in the custody of carriers and appropriate enforcement actions for violations. To carry out this responsibility, each state must have an adequate statutory and regulatory inspection and enforcement authority to ensure the safe transportation of low-level radioactive waste. Three states in the compact region, Arizona, Utah and Wyoming, have incorporated the Department of Transportation regulations in their entirety, and have no published rules and regulations of their own. The other states in the compact, Colorado, Nevada and New Mexico all have separate rules and regulations that incorporate the DOT regulations. A brief description of the regulatory requirements of each state is presented

  1. 9 CFR 147.51 - Authorized laboratory minimum requirements.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Authorized laboratory minimum requirements. 147.51 Section 147.51 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE... Authorized Laboratories and Approved Tests § 147.51 Authorized laboratory minimum requirements. These minimum...

  2. Regulatory requirements for desalination plant coupled with nuclear reactor plant

    International Nuclear Information System (INIS)

    Yune, Young Gill; Kim, Woong Sik; Jo, Jong Chull; Kim, Hho Jung; Song, Jae Myung

    2005-01-01

    A small-to-medium sized reactor has been developed for multi-purposes such as seawater desalination, ship propulsion, and district heating since early 1990s in Korea. Now, the construction of its scaled-down research reactor, equipped with a seawater desalination plant, is planned to demonstrate the safety and performance of the design of the multi-purpose reactor. And the licensing application of the research reactor is expected in the near future. Therefore, a development of regulatory requirements/guides for a desalination plant coupled with a nuclear reactor plant is necessary for the preparation of the forthcoming licensing review of the research reactor. In this paper, the following contents are presented: the design of the desalination plant, domestic and foreign regulatory requirements relevant to desalination plants, and a draft of regulatory requirements/guides for a desalination plant coupled with a nuclear reactor plant

  3. 75 FR 52380 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-08-25

    ... recent outsourcing of surveillance and other regulatory functions to FINRA.\\8\\ Specifically, to have... with NASD IM-1013-1 or NASD IM-1013-2, including limiting its business operations to ``permitted floor... NASD IM-1013-2 establish a waive-in membership application process for certain firms to become FINRA...

  4. 78 FR 4186 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2013-01-18

    ... securities offered or sold pursuant to crowdfunding.\\5\\ Intermediaries in transactions involving the offer or sale of securities for the account of others pursuant to the crowdfunding exemption must, among other...- regulatory organization.\\7\\ \\4\\ Public Law 112-106, 126 Stat. 306 (2012). \\5\\ In general, crowdfunding refers...

  5. 75 FR 75529 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-12-03

    ... advance notice of the new Verification of Assets rule. \\8\\ 15 U.S.C. 78o-3(b)(6). B. Self-Regulatory... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63383; File No. SR-FINRA-2010-062] Self... in SR-FINRA-2010-042 (Verification of Assets) November 29, 2010. Pursuant to Section 19(b)(1) of the...

  6. 75 FR 15470 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-03-29

    ...-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change FINRA is proposing... (Disclosure of Price and Concessions in Selling Agreements) and the deletion of NASD Rule 2770 (Disclosure of Price in Selling Agreements). FINRA Rule 5160 was approved by the Commission on January 25, 2010 \\5\\ and...

  7. 77 FR 8938 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-02-15

    ... expenses as ``other'' (miscellaneous), a very general categorization that provides FINRA limited visibility... supplemental filing would play with respect to a broker-dealer's annual audit.\\28\\ \\26\\ CAI. \\27\\ Id. \\28\\ Id... any future schedules or reports be done through the more typical self- regulatory organization (``SRO...

  8. Annual Report 2007. Nuclear Regulatory Authority; Informe Anual 2007. Autoridad Regulatoria Nuclear

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2008-07-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across tree parts and seven annexes the activities developed by the organism during 2007. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the occupational surveillance; the environmental monitoring; improved organizational. Also, this publication have annexes with the following content: regulatory documents; inspections to medical, industrial and training installations; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.

  9. Annual Report 2008. Nuclear Regulatory Authority; Informe Anual 2008. Autoridad Regulatoria Nuclear

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2009-07-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across four parts and seven annexes the activities developed by the organism during 2008. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the occupational surveillance; the environmental monitoring; improved organizational and budgetary developments. Also, this publication have annexes with the following content: regulatory documents; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.

  10. Annual Report 2009. Nuclear Regulatory Authority; Informe Anual 2009. Autoridad Regulatoria Nuclear

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2010-07-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across four parts and seven annexes the activities developed by the organism during 2009. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the environmental monitoring; the occupational surveillance; the training and the public information; improved organizational and budgetary developments. Also, this publication have annexes with the following content: regulatory documents; inspections to medical, industrial and training installations; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.

  11. The Slovak nuclear regulatory authority and start-up of the Mochovce NPP

    International Nuclear Information System (INIS)

    Seliga, M.; Micankova, J.

    2000-01-01

    A major element of providing information is the demonstration that the area of nuclear energy uses has its binding rules in the Slovak Republic and the observance thereof is controlled by the state through an independent institution Slovak Nuclear Regulatory Authority (UJD). As early as 1995 were laid on the UJD the foundations of the concept of broadly keeping the public informed on UJD activity and the safety of nuclear installations by opening the UJD Information Centre that provides by its activity communications with the public and mass media, which is instrumental in creating in the public a favourable picture of the independent state nuclear regulation. Clear communication policy is the key to credibility and is based on perceptions which give ride to varying levels of confidence. It has been consistently found in opinion research that credibility is the single most powerful persuasive force. Public communication programmes are the principal currency for the Regulatory Authority to inform the public on issues like costs, benefit requirements and risks

  12. Responsibilities of nuclear regulatory authority and overview of nuclear safety regulations in Slovakia

    International Nuclear Information System (INIS)

    Misak, J.

    1996-01-01

    The paper describes the organizational structure of the Nuclear Regulatory Authority of the Slovak Republic, its rights and duties, the status of nuclear legislation with emphasis on nuclear activities completely or partially covered, and licensing procedures

  13. Below regulatory concern standards: The limits of state and local authority

    International Nuclear Information System (INIS)

    Silverman, D.J.

    1990-01-01

    The paper discusses: (1) the scope of the Nuclear Regulatory Commission's authority to develop and implement below regulatory concern or BRC standards; and (2) the limitations on the legal authority of states and local governments to create impediments to full implementation of such standards. The paper demonstrates that the NRC is acting well within its statutory authority in developing BRC regulations and guidelines, and that the ability of state and local governments to impede generators' use of those regulations and guidelines on the basis of legal or regulatory initiatives is substantially circumscribed. While some generators may be reluctant, as a result of political factors, to utilize BRC standards, the decision whether or not to use such standards should not be made without careful consideration of the applicable legal and regulatory limitations on state and local authority

  14. Development of the personnel training and qualification system of the Russian Federation Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Kapralov, E.; Kapralov, Y.; Kozlov, V.

    2006-01-01

    The new personnel training and qualification system is being developed for russian regulatory body, having a very big number of employees and invited experts and widly territorially distributed structure. (author)

  15. Regulatory requirements and administrative practice in safety of nuclear installations

    International Nuclear Information System (INIS)

    Servant, J.

    1977-01-01

    This paper reviews the current situation of the France regulatory rules and procedures dealing with the safety of the main nuclear facilities and, more broadly, the nuclear security. First, the author outlines the policy of the French administration which requires that the licensee responsible for an installation has to demonstrate that all possible measures are taken to ensure a sufficient level of safety, from the early stage of the project to the end of the operation of the plant. Thus, the administration performs the assessment on a case-by-case basis, of the safety of each installation before granting a nuclear license. On the other hand, the administration settles overall safety requirements for specific categories of installations or components, which determine the ultimate safety performances, but avoid, as far as possible, to detail the technical specifications to be applied in order to comply with these goals. This approach, which allows the designers and the licensees to rely upon sound codes and standards, gains the advantage of a great flexibility without imparing the nuclear safety. The author outlines the licensing progress for the main categories of installations: nuclear power plants of the PWR type, fast breeders, uranium isotope separation plants, and irradiated fuel processing plants. Emphasis is placed on the most noteworthy points: standardization of projects, specific risks of each site, problems of advanced type reactors, etc... The development of the technical regulations is presented with emphasis on the importance of an internationally concerned action within the nuclear international community. The second part of this paper describes the France operating experience of nuclear installations from the safety point of view. Especially, the author examines the technical and administrative utilization of data from safety significant incidents in reactors and plants, and the results of the control performed by the nuclear installations

  16. Regulation No. 56/2006 Coll. of the Nuclear Regulatory Authority of the Slovak Republic dated as of January 12, 2006 on details concerning requirements for quality system documentation of authorisation holder, as well as details concerning quality requirements for nuclear installations, details concerning quality requirements for classified equipment and details concerning the scope of their approval

    International Nuclear Information System (INIS)

    2006-01-01

    This Regulation provides details of the requirements for quality system documentation holder, details of the quality requirements for nuclear installations, details concerning quality requirements for classified equipment and details of the scope of their approval. This Regulation came into force on March 1, 2006.

  17. 47 CFR 25.102 - Station authorization required.

    Science.gov (United States)

    2010-10-01

    ... 47 Telecommunication 2 2010-10-01 2010-10-01 false Station authorization required. 25.102 Section 25.102 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON CARRIER SERVICES SATELLITE COMMUNICATIONS General § 25.102 Station authorization required. (a) No person shall use or operate...

  18. Methods for ensuring compliance with regulatory requirements: regulators and operators

    International Nuclear Information System (INIS)

    Fleischmann, A.W.

    1989-01-01

    Some of the methods of ensuring compliance with regulatory requirements contained in various radiation protection documents such as Regulations, ICRP Recommendations etc. are considered. These include radiation safety officers and radiation safety committees, personnel monitoring services, dissemination of information, inspection services and legislative power of enforcement. Difficulties in ensuring compliance include outmoded legislation, financial and personnel constraints

  19. 75 FR 48731 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-08-11

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62655; File No. SR-FINRA-2010-042] Self... Change To Adopt FINRA Rule 4160 (Verification of Assets) August 5, 2010. Pursuant to Section 19(b)(1) of... rule change from interested persons. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory...

  20. Regulatory Requirements to Combat Illicit Trafficking of Hazardous Materials

    International Nuclear Information System (INIS)

    Hussein, A.Z.; Zakaria, Kh.M.

    2011-01-01

    Since more than a decade illicit Trafficking of hazardous ( CBRNE), materials ( chemical, biological, radiological, nuclear and explosive ) has been identified as a key threat in national, regional, inter regional and international strategies. An Effective response to hazardous materials (CBRNE) risk and threat were realized to require a very high level of cooperation and coordination between various governments and their responsible organizations and authorities of regional and international partner. While improper policy of actions may easily be exploited by non- state members to (CBRNE) trafficking which may lead to develop weapon of mass destruction (WMD). Such strategy are of paramount important between all levels of the states and among regional agreements through comprehensive tailored assistance packages (e.g. export control, illicit trafficking of hazardous materials, redirection of scientist, emergency planning, crisis response safety and security culture. Capacity building, action plans and instruments for stability are necessary actions for efficient combating against illicit trafficking of hazardous materials. Regarding the needs of assessment phase, assistance must be based on data collection, analysis and prioritization of implanting the regulatory controls. Several activities have to be conducted to reduce CBRNE threat. The one- by- one approach, covering either nuclear and radioactive or chemical or biological materials has to be implanted on the country basis performance to mitigate CBRNE hazardous risk. On several consequent phases of intervention dealing with CBRNE risk mitigation the country has to establish a network of local, regional and international capabilities. Such network is setting up the mechanism for the country needs identifications, the guidelines for data collection, for data platform maintenance and update, the data assessment and the competent and operative organizations. This network will be to strengthen the long - term

  1. Economic analysis requirements in support of orbital debris regulatory policy

    Science.gov (United States)

    Greenberg, Joel S.

    1996-10-01

    As the number of Earth orbiting objects increases so does the potential for generating orbital debris with the consequent increase in the likelihood of impacting and damaging operating satellites. Various debris remediation approaches are being considered that encompass both in-orbit and return-to-Earth schema and have varying degrees of operations, cost, international competitiveness, and safety implications. Because of the diversity of issues, concerns and long-term impacts, there is a clear need for the setting of government policies that will lead to an orderly abatement of the potential orbital debris hazards. These policies may require the establishment of a supportive regulatory regime. The Department of Transportation is likely to have regulatory responsibilities relating to orbital debris stemming from its charge to protect the public health and safety, safety of property, and national security interests and foreign policy interests of the United States. This paper describes DOT's potential regulatory role relating to orbital debris remediation, the myriad of issues concerning the need for establishing government policies relating to orbital debris remediation and their regulatory implications, the proposed technological solutions and their economic and safety implications. Particular emphasis is placed upon addressing cost-effectiveness and economic analyses as they relate to economic impact analysis in support of regulatory impact analysis.

  2. Design basis ground motion (Ss) required on new regulatory guide

    International Nuclear Information System (INIS)

    Kamae, Katsuhiro

    2013-01-01

    New regulatory guide is enforced on July 8. Here, it is introduced how the design basis ground motion (Ss) for seismic design of nuclear power reactor facilities was revised on the new guide. Ss is formulated as two types of earthquake ground motions, earthquake ground motions with site specific earthquake source and with no such specific source locations. The latter is going to be revised based on the recent observed near source ground motions. (author)

  3. 77 FR 37458 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-06-21

    ... orders in this market sector.'' Id. Specifically, FINRA proposed that the minimum quotation size required... dollar-value commitments to the market would be required. Based on a later study, as described in... aggregation rules.\\60\\ OTC Markets believed, at a minimum, FINRA's analysis required further study,\\61\\ and...

  4. 75 FR 39603 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-07-09

    ... related to fraud or securities laws violations; \\10\\ (4) a government authority or regulator has provided... related to fraud or securities laws violations; \\14\\ (4) a government authority or regulator has provided... potentially violating an anti-fraud rule of the Federal securities laws and stated that where it has actual...

  5. 77 FR 67038 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2012-11-08

    ... of Functions by FINRA to Subsidiaries (``Delegation Plan''), the NAMC has the power and authority... such other powers and authority as is necessary to effectuate the purposes of FINRA's Rules.\\7\\ The... knowledge. [T]hen the situation could be deemed a legal case.'' The Commission believes that the commenter...

  6. 47 CFR 15.305 - Equipment authorization requirement.

    Science.gov (United States)

    2010-10-01

    ... Section 15.305 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL RADIO FREQUENCY DEVICES Unlicensed Personal Communications Service Devices § 15.305 Equipment authorization requirement. PCS devices... 2 of this chapter before marketing. The application for certification must contain sufficient...

  7. Licensing evaluation of CANDU-PHW nuclear power plants relative to U.S. regulatory requirements

    International Nuclear Information System (INIS)

    Erp, J.B. van

    1978-01-01

    Differences between the U.S. and Canadian approach to safety and licensing are discussed. U.S. regulatory requirements are evaluated as regards their applicability to CANDU-PHW reactors; vice-versa the CANDU-PHW reactor is evaluated with respect to current Regulatory Requirements and Guides. A number of design modifications are proposed to be incorporated into the CANDU-PHW reactor in order to facilitate its introduction into the U.S. These modifications are proposed solely for the purpose of maintaining consistency within the current U.S. regulatory system and not out of a need to improve the safety of current-design CANDU-PHW nuclear power plants. A number of issues are identified which still require resolution. Most of these issues are concerned with design areas not (yet) covered by the ASME code. (author)

  8. Guidance and methods for satisfying low specific activity material and surface contaminated object regulatory requirements

    International Nuclear Information System (INIS)

    Pope, R.B.; Shappert, L.B.; Michelhaugh, R.D.; Boyle, R.W.; Easton, E.P.; Coodk, J.R.

    1998-01-01

    The U.S. Department of Transportation (DOT) and the U.S. Nuclear Regulatory Commission (NRC) have prepared a comprehensive set of draft guidance for shippers and inspectors to use when applying the newly imposed regulatory requirements for low specific activity (LSA) material and surface contaminated objects (SCOs). These requirements represent significant departures in some areas from the manner in which these materials and objects were regulated by the earlier versions of the regulations. The proper interpretation and application of the regulatory criteria can require a fairly complex set of decisions be made. To assist those trying these regulatory requirements, a detailed set of logic-flow diagrams representing decisions related to multiple factors were prepared and included in the draft report for comment on Categorizing and Transporting Low Specific Activity Materials and Surface Contaminated Objects, (DOT/NRC, 1997). These logic-flow diagrams, as developed, are specific to the U.S. regulations, but were readily adaptable to the IAEA regulations. The diagrams have been modified accordingly and tied directly to specific paragraphs in IAEA Safety Series No. 6. This paper provides the logic-flow diagrams adapted in the IAEA regulations, and demonstrated how these diagrams can be used to assist consignors and inspectors in assessing compliance of shipments with the LSA material and SCO regulatory requirements. (authors)

  9. Provincial nuclear regulatory authority?: The case of the province of Cordoba

    International Nuclear Information System (INIS)

    Martin, Hugo; Ocana, F.; Scoles, R.

    1999-01-01

    The evolution of social and political events in the province of Cordoba after the Law 8157 of 1992, that establishes the provincial nuclear policy, are analysed as well as the recent sanction and veto of the Law 8775, which creates the provincial Nuclear Regulatory Authority. The authors conclude that is necessary and convenient to enforce provincial nuclear regulations and controls

  10. Public Notice of Nuclear Regulatory Authority of the Slovak Republic No. 46/2006 Coll. on specific material and facilities that are under supervision of the Nuclear Regulatory Authority of the Slovak Republic

    International Nuclear Information System (INIS)

    Vaclav, J.

    2006-01-01

    The Public Notice defines the list of specific material and facilities which are under supervision of the Nuclear Regulatory Authority of the Slovak Republic with taking into consideration the requirements in accordance with the new atomic Act and other material. The national competence's have been practically divided in the Public Notice. These competence's concern the execution of directly binding EU rule and the Public Notice gives the details about the dividing of specific materials

  11. Regulatory requirement of the Juragua nuclear Power Plant PSA

    International Nuclear Information System (INIS)

    Valhuerdi Debesa, C.

    1996-01-01

    Probabilistic Safety Assessment has proved to be a powerful tool for improving the knowledge of the safety insides of Nuclear Power Plants and increasing the efficiency of the safety measures adopted by both operators and regulators. In this paper the regulatory approach adopted in Cuba with regard to the PSA , the scope of the requirement and the basis and proposal of this decision are presented

  12. Regulatory requirements on the calibration and use of survey instruments

    International Nuclear Information System (INIS)

    Domondon, D.B.

    1989-01-01

    Regulatory requirements on the provision, calibration and occasions of use of survey instruments are enumerated for a number of licensed activities. Two methods of calibrating survey instruments are described. Factors that must be taken into consideration in conducting calibrations, contents of calibration reports and of the sticker attached to the instrument which are needed for the correct use of the instrument are discussed. The precautions to be observed in order to insure correct use of survey instruments are described. (Auth.)

  13. 78 FR 62862 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-10-22

    ... Change To Require Alternative Trading Systems To Report Volume Information to FINRA and Use Unique Market... identifier (``MPID'') when reporting information to FINRA. FINRA will make the reported volume and trade... change to adopt new FINRA Rule 4552, which requires each ATS \\3\\ to report to FINRA volume information...

  14. 76 FR 77034 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-12-09

    ... the signature of the registered representative introducing the account.\\5\\ Where a member designates... 15A(b)(6) of the Act,\\9\\ which requires, among other things, that FINRA rules must be designed to...(b)(6) of the Act,\\11\\ which requires, among other things, that FINRA rules must be designed to...

  15. 40 CFR 70.11 - Requirements for enforcement authority.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 15 2010-07-01 2010-07-01 false Requirements for enforcement authority. 70.11 Section 70.11 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR...) Burden of proof. The burden of proof and degree of knowledge or intent required under State law for...

  16. 40 CFR 281.41 - Requirements for enforcement authority.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 26 2010-07-01 2010-07-01 false Requirements for enforcement authority. 281.41 Section 281.41 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID... for each day of violation. (b) The burden of proof and degree of knowledge or intent required under...

  17. 47 CFR 25.118 - Modifications not requiring prior authorization.

    Science.gov (United States)

    2010-10-01

    ... 47 Telecommunication 2 2010-10-01 2010-10-01 false Modifications not requiring prior authorization. 25.118 Section 25.118 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON CARRIER SERVICES SATELLITE COMMUNICATIONS Applications and Licenses General Application Filing Requirements § 25...

  18. Criteria adopted by the Argentine Nuclear Regulatory Authority for assessing digital systems related to safety

    International Nuclear Information System (INIS)

    Terrado, Carlos A.; Chiossi, Carlos E.; Felizia, Eduardo R.; Roca, Jose L.; Sajaroff, Pedro M.

    2004-01-01

    Following the technological evolution in Instrumentation and Control (I and C) design, analog components are replaced by digital in almost every industry. Due to growing challenges of obsolescence and increasing maintenance costs, licensees of nuclear and radioactive installations are increasingly upgrading or replacing their existing I and C analog systems and components. In existing installations, this involves analog to digital replacements. In new installations design, the use of digital I and C systems is being considered from the very beginning, becoming a good alternative, even in safety applications. Up to now, in Argentina, there is no specific rules for safety-related digital systems, every safety system, analog or digital, must comply with the same generic regulations. The Nuclear Regulatory Authority is now developing criteria to assess digital systems related to safety in nuclear and radioactive installations. In this paper some of those criteria, based on local research and the recognized state of the art, are explained. From a regulatory point of view, the use of digital technology often raises new technical and licensing issues, particularly for safety-related applications. Examples include new failure modes, the potential for common-cause failure of redundant components, electromagnetic interference (EMI), software verification and validation, configuration management and a more exhaustive quality assurance system. The mentioned criteria comprehend the design, operation, maintenance and acquisition of digital systems and components important to safety. The main topics covered are: requirements specifications for digital systems, planning and documentation for digital system development, effectiveness of a digital system, commercial off the shelf (COTS) treatment and considerations involving tools for software development. (author)

  19. Toward a functional definition of a "rare disease" for regulatory authorities and funding agencies.

    Science.gov (United States)

    Clarke, Joe T R; Coyle, Doug; Evans, Gerald; Martin, Janet; Winquist, Eric

    2014-12-01

    The designation of a disease as "rare" is associated with some substantial benefits for companies involved in new drug development, including expedited review by regulatory authorities and relaxed criteria for reimbursement. How "rare disease" is defined therefore has major financial implications, both for pharmaceutical companies and for insurers or public drug reimbursement programs. All existing definitions are based, somewhat arbitrarily, on disease incidence or prevalence. What is proposed here is a functional definition of rare based on an assessment of the feasibility of measuring the efficacy of a new treatment in conventional randomized controlled trials, to inform regulatory authorities and funding agencies charged with assessing new therapies being considered for public funding. It involves a five-step process, involving significant negotiations between patient advocacy groups, pharmaceutical companies, physicians, and public drug reimbursement programs, designed to establish the feasibility of carrying out a randomized controlled trial with sufficient statistical power to show a clinically significant treatment effect. The steps are as follows: 1) identification of a specific disease, including appropriate genetic definition; 2) identification of clinically relevant outcomes to evaluate efficacy; 3) establishment of the inherent variability of measurements of clinically relevant outcomes; 4) calculation of the sample size required to assess the efficacy of a new treatment with acceptable statistical power; and 5) estimation of the difficulty of recruiting an adequate sample size given the estimated prevalence or incidence of the disorder in the population and the inclusion criteria to be used. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  20. 76 FR 61429 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-10-04

    ... stress, along with a policy statement by FINRA (then known as NASD) that provided trading halt authority... a period of significant stress. \\11\\ See Securities Exchange Act Release No. 58753 (October 8, 2008... submit written data, views, and arguments concerning the foregoing, including whether the proposed...

  1. 77 FR 74249 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-12-13

    ... System (``FINRA ADDS'') is a secure Web site that provides a firm, by market participant identifier... generates a separate report for each data archive (Asset-Backed Securities or Corporate/Agency Debt..., 2013. For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.\\11...

  2. Regulatory requirements of the integrated technology demonstration program, Savannah River Site (U)

    International Nuclear Information System (INIS)

    Bergren, C.L.

    1992-01-01

    The integrated demonstration program at the Savannah River Site (SRS) involves demonstration, testing and evaluation of new characterization, monitoring, drilling and remediation technologies for soils and groundwater impacted by organic solvent contamination. The regulatory success of the demonstration program has developed as a result of open communications between the regulators and the technical teams involved. This open dialogue is an attempt to allow timely completion of applied environmental restoration demonstrations while meeting all applicable regulatory requirements. Simultaneous processing of multiple regulatory documents (satisfying RCRA, CERCLA, NEPA and various state regulations) has streamlined the overall permitting process. Public involvement is achieved as various regulatory documents are advertised for public comment consistent with the site's community relations plan. The SRS integrated demonstration has been permitted and endorsed by regulatory agencies, including the Environmental Protection Agency (EPA) and the South Carolina Department of Health and Environmental Control. EPA headquarters and regional offices are involved in DOE's integrated Demonstration Program. This relationship allows for rapid regulatory acceptance while reducing federal funding and time requirements. (author)

  3. Revolution in New Zealand's Radiation Protection Legislation and Evolution and Continual Improvement in its Regulatory Authority

    International Nuclear Information System (INIS)

    Smyth, V.

    2004-01-01

    The safe use of ionising radiation in New Zealand is regulated by the Radiation Protection Act 1965 and the Radiation Protection Regulations 1982, which are administered by the National Radiation Laboratory (NRL). This legislation is now out of date and creates difficulties for New Zealand in meeting international standards of radiation safety and security, and complying with obligations under international treaties. These problems can be addressed by new legislation that would change the powers and functions of the regulatory authority, and change the responsibilities of licensees under the Act. However historically NRL has provided radiation services as well as acting as regulatory authority. This has the potential to create a conflict of interest in making regulatory judgements. Over the preceding 50 years NRL has undergone an evolution that has resulted in a clarification of the regulatory functions, and development of a quality management system that is now accredited to ISO standards. This paper presents a possible structure of a new Act, and discusses the role of quality management in maintaining the independence of regulatory authority. (Author)

  4. Defining regulatory requirements for water supply systems in Vietnam

    Directory of Open Access Journals (Sweden)

    Deryushev Leonid Georgiyevich

    2014-01-01

    Full Text Available In the article the authors offer their suggestions for improving the reliability of the standardization requirements for water supply facilities in Vietnam, as an analog of building regulations of Russia 31.13330.2012. In Russia and other advanced countries the reliability of the designed water supply systems is usual to assess quantitatively. Guidelines on the reliability assessment of water supply systems and facilities have been offered by many researchers, but these proposals are not officially approved. Some methods for assessing the reliability of water supply facilities are informally used in practice when describing their quality. These evaluation methods are simple and useful. However, the given estimations defy common sense and regulatory requirements used by all the organizations, ministries and departments, for example, of Russia, in the process of allowances for restoration and repair of water supply facilities. Inadequacy of the water supply facilities assessment is shown on the example of assessing the reliability of pipeline system. If we take MTBF of specific length of the pipeline as reliability index for a pipeline system, for example, 5 km, a pipeline of the similar gauge, material and working conditions with the length of 5 m, according to the estimation on the basis of non-official approach, must have a value of MTBF 1000 times greater than with the length of 5 km. This conclusion runs counter to common sense, for the reason that all the pipes in the area of 5 km are identical, have the same load and rate of wear (corrosion, fouling, deformation, etc.. It was theoretically and practically proved that products of the same type in the same operating conditions (excluding determined impact of a person, work as an entity, which MTBF is equal to the average lifetime. It is proposed to take the average service life as a reliability indicator of a pipeline. Durability, but not failsafety of the pipe guarantees pipeline functioning

  5. 76 FR 65307 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-10-20

    ... size can apply to each side of the market being quoted by the member in a given security. \\3\\ See FINRA... market. For securities priced at or above $0.02/ share, the minimum quotation size requirements would be... or offer and that increase the OTC Market Maker's size by more than a de minimis amount).\\10\\ OTC...

  6. 78 FR 9754 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-02-11

    ... Adopt a Supplementary Schedule for Derivatives and Other Off-Balance Sheet Items Pursuant to FINRA Rule... for derivatives and other off-balance sheet items pursuant to FINRA Rule 4524 (Supplemental FOCUS... reported on certain firms' balance sheets. To that end, the proposal would require all carrying or clearing...

  7. 75 FR 8771 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-02-25

    ... information relative to such member's financial condition as disclosed in its most recent balance sheet... an alternative means of satisfying the requirement that members make balance sheet information... financial condition as disclosed in its most recent balance sheet * * *.'' FINRA proposed providing members...

  8. 75 FR 475 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-01-05

    ... such member's financial condition as disclosed in its most recent balance sheet prepared either in... satisfying the requirement that members make balance sheet information available to bona fide regular... most recent balance sheet . * * *'' FINRA is proposing to provide members with the option of delivering...

  9. 75 FR 47863 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-08-09

    ... the scope of the provision. e. Internal Disciplinary Actions Against Associated Persons (Proposed...) continues to require a firm to report certain disciplinary actions taken by the firm against its associated persons. However, the proposed rule clarifies that any such disciplinary action involving the withholding...

  10. 75 FR 72850 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-11-26

    .... FINRA has been advised by insurance industry representatives that the proposed rule change does not... Act Rule 17a-4(b)(4). FINRA has been advised by insurance industry representatives that the proposed... providers, may be impacted by bond renewal cycles and changes required by the insurance industry. FINRA will...

  11. 76 FR 77283 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-12-12

    ... employment discrimination, including sexual harassment, in violation of a statute, is not required to be... amendment to FINRA Rule 2263. The text of the proposed rule change is available on FINRA's Web site at http... post all comments on the Commission's Internet Web site ( http://www.sec.gov/rules/sro.shtml ). Copies...

  12. 76 FR 65549 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-10-21

    ... Rulebook with several changes, which are described below. \\3\\ The current FINRA rulebook consists of (1... Quote Rule was designed to address are still valid, FINRA believes that the current requirements in the... current format, the proposed rule change replaces the Three Quote Rule with Supplementary Material...

  13. 75 FR 69508 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filings...

    Science.gov (United States)

    2010-11-12

    ... circumstances under which a firm would not be required to report information relating to a former associated... purposes of proposed FINRA Rules 4530(a), (b) and (d), firms should report an event relating to a former... internal audit finding would serve only as one factor, among others, that a firm should consider in...

  14. 77 FR 3515 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Instituting...

    Science.gov (United States)

    2012-01-24

    ... orders in this market sector.'' Id. Specifically, FINRA proposed that the minimum quotation size required... economic analysis to study the expected impact of the proposed tier sizes on market liquidity (including... Markets Group Inc. to Elizabeth M. Murphy, Secretary, Commission, dated November 10, 2011 (``OTC Markets...

  15. 76 FR 15012 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-03-18

    ... persons. \\4\\ See Notice to Members 05-48 (July 2005) (Members' Responsibilities When Outsourcing... and regulations that impact their work. Operations Professionals would be required to complete... provide guidance on the impact of the proposed rule change on FINRA Rule 2310 (Direct Participation...

  16. 75 FR 61793 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-10-06

    ...-ROM, DVD, portable hard drive, laptop computer, disc, diskette, or any other portable device for... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63016; File No. SR-FINRA-2010-021] Self... to Amend FINRA Rule 8210 to Require Information Provided via Portable Media Device be Encrypted...

  17. 77 FR 14848 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2012-03-13

    ... credit risk posed by CDS, including, among other things, risks to the financial system arising from credit risk resulting from bilateral CDS transactions and from a concentration of credit risk to a... Requirements for Credit Default Swaps) March 7, 2012. Pursuant to Section 19(b)(1) of the Securities Exchange...

  18. 75 FR 3270 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-01-20

    ... fingerprinting requirements of SEA Rule 17f-2 for purposes of a criminal background check. The Commission finds..., competition, and capital formation. 15 U.S.C. 78c(f). \\9\\ 15 U.S.C. 78o-3(b)(6). It is therefore ordered...

  19. 76 FR 38245 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-06-29

    ... Insider Trading and Securities Fraud Enforcement Act of 1988 (``ITSFEA''),\\17\\ requires every registered... rules. \\16\\ 15 U.S.C. 78o(g). \\17\\ See Insider Trading and Securities Fraud Enforcement Act of 1988, Pub... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-64736; File No. SR-FINRA-2011-028] Self...

  20. 75 FR 36461 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-06-25

    ... or portable hard drive.\\5\\ In many instances, the response contains personal information that, if...-ROM, DVD, portable hard drive, laptop computer, disc, diskette, or any other portable device for... with the provisions of section 15A(b)(6) of the Act,\\7\\ which requires, among other things, that FINRA...

  1. 77 FR 76112 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2012-12-26

    ...-Element Continuing Education Program To Qualify To Engage in a Security Futures Business December 19, 2012... a firm-element continuing education requirement to engage in a security futures business to December 31, 2015, or one business day prior to the date a revised examination that includes security futures...

  2. 77 FR 39313 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2012-07-02

    ... the Statement of Income (Loss) page of the FOCUS Report.\\4\\ FINRA is proposing to make non-substantive... Effectiveness of Proposed Rule Change To Make Non-Substantive Technical Changes to the Supplemental Statement of Income Required To Be Filed Pursuant to FINRA Rule 4524 (Supplemental FOCUS Information) June 26, 2012...

  3. 76 FR 52040 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-08-19

    ... the Act,\\4\\ which requires, among other things, that FINRA rules must be designed to prevent... Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet website ( http://www.sec.gov/rules/sro.shtml ). Copies...

  4. 78 FR 4182 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2013-01-18

    ... and disclosure requirements, respectively, on a member that is ``promoting a day-trading strategy.'' For purposes of the rules, a member shall be deemed to be ``promoting a day trading strategy'' if ``* * * it affirmatively endorses a `day trading strategy,' as defined in [the Rules] through advertising...

  5. 78 FR 72951 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2013-12-04

    ... regarding the risks and financial impact associated with the customer's loan of securities, and requires... the introducing member that has a customer relationship with the lender in making the determination... securities, and the risks and financial impact associated with the customer's loan of securities. Proposed...

  6. 77 FR 63908 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2012-10-17

    .... Among other things, the JOBS Act is intended to help facilitate capital formation for ``emerging growth... signature of the President on April 5, 2012. On August 22, 2012, the SEC's Division of Trading and Markets... consistent with the provisions of Section 15A(b)(6) of the Act,\\16\\ which requires, among other things, that...

  7. 75 FR 68654 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-11-08

    ... Securities present significant operational and technical challenges. For example, new processes and systems...,\\10\\ which requires, among other things, that FINRA rules must be designed to prevent fraudulent and...: Electronic Comments Use the Commission's Internet comment form ( http://www.sec.gov/rules/sro.shtml ); or...

  8. 78 FR 62831 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-10-22

    ... believes that OSJs conduct critical functions and one- person OSJs present unique supervisory challenges... \\20\\ requires, among other things, that FINRA rules must be designed to prevent fraudulent and..., 94th Cong., 1st Sess. 30 (1975). Electronic Comments Use the Commission's Internet comment form ( http...

  9. 78 FR 66405 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Instituting...

    Science.gov (United States)

    2013-11-05

    ... FINRA members and not just ADF Participants.\\37\\ FINRA counters that the fixed ADF Deposit Amount is not... would also codify other current requirements into a single rule. See id., 78 FR at 46654. ADF Deposit... that the member anticipates submitting to the ADF; (ii) agree to submit the ADF Deposit Amount \\23\\ in...

  10. 75 FR 41562 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-07-16

    ... SEC Rule 15c3-3) in the Consolidated FINRA Rulebook July 12, 2010. I. Introduction On May 14, 2010... arrangements) that when computing charges against net capital for transactions in securities covered by FINRA... computed using the applicable special maintenance margin requirements pursuant to other provisions of the...

  11. Regulatory requirements for designing PET-CT facility in India

    International Nuclear Information System (INIS)

    Tandon, Pankaj

    2010-01-01

    In India, cyclotron-produced radionuclides are gaining importance in molecular imaging in Nuclear Medicine (NM) departments. The importance of this modality among others is due to the fact that it provides valuable clinical information, which was lacking in other available modalities. Presently, every well-established hospital would like to procure Medical Cyclotron or positron emission tomography-computed tomography (PET-CT) facility in their NM department. Because cyclotron-produced radionuclides have higher energy than the other routinely used radionuclides for diagnosis, it becomes essential for the user to know about the regulatory requirement and radiation safety precautions that one has to take for the installation of this new modality in their premises. The various stages of approval of PET-CT facility by the Atomic Energy Regulatory Board (AERB) and important steps that one has to know/follow before planning for this new facility are summarized

  12. Participation of the Nuclear Regulatory Authority in the 'Third European Intercomparison Exercise on Internal Dose Assessment'

    International Nuclear Information System (INIS)

    Rojo, Ana Maria; Gomez Parada, Ines Maria

    2001-01-01

    This paper resume the participation of the Argentine Nuclear Regulatory Authority (ARN) in the 'Third European Intercomparison Exercise on Internal Dose Assessment'. It takes place during 5 months in 1998 and the final meeting was held in Weimar, Germany, on May 1999. This exercise involved the previous distribution of seven cases, simulated and real, describing possible incorporations of radioactive materials. There was a description of the event, data of retention or excretion measurements and air concentration data. The fifty participants belong to twenty three countries had do solve the cases and informed the results to the organizers, mainly the incorporation and effective dose was required. The objective was to review the methodology, the codes and the different assumptions used by the participants for discussing the consistent of the result. The results are shown through tables including the maximum and minimum values gave for the final report and the results informed by ARN. This exercise allowed to compare the methodology used by the ARN internal dosimetry group with other choose by several international groups to assure that the codes, assumptions and methodology were satisfactory to solve the different cases given by the organizers. (author)

  13. Fabrication of sterile experimental radiopharmaceuticals: technical and regulatory requirements

    International Nuclear Information System (INIS)

    Briand, S.

    2008-03-01

    The radiopharmaceuticals devoted to the biomedical research were the object of the directive 2001/20/C.E. transposition that defined again the conditions of implementation of biomedical research using drugs at human use, whom authorization is delivered by A.f.s.s.a.p.s.. In an other hand the law 2006-686 of the 13. june 2006 ( called law T.S.N.) has modified the regulatory dispositions relative to the radiation protection norms. These new dispositions allow to the health facilities to realize their research projects without difficulties for experimental drugs supply. (N.C.)

  14. A National Regulatory Authority set up in a developing country: case of Mali

    International Nuclear Information System (INIS)

    Kone, Nagantie

    2008-01-01

    Full text: The Republic of Mali is member of the International Atomic Energy Agency since 1961. Of since the creation of the IAEA, some African countries are members. The technical cooperation with the Agency started in the years 1975. Through that cooperation, many pacific uses of nuclear techniques have been introduced, then developed at different levels in many socio- economic domains as medicine, agriculture, research, and so on. That development of nuclear techniques use has occurred without legislation at all or in some limited cases with part of the legislation of the colonizing country), in a precise field (like radiography in medicine). Later the need of regulatory infrastructure implementation started. That implementation has followed several ways in the different African countries. Also, it started earlier in countries which had advanced activities in nuclear techniques and very later in others. Most if not all of these infrastructure (say regulatory board) were created by the greatest users of the nuclear techniques, the Ministry of Health in most cases or Energy Commission for Countries having a research reactor. After the years 90, the Agency has developed new vision in the implementation of Regulatory Authorities. The new innovation was: 1-) Development of Regulatory Authority with independent statute (decisions and finance); 2-) Assuming post graduate training in developing countries to come other the lack of human resources. That new strategy of the IAEA has facilitated the apparition and development of several new regulatory authorities. We are going to develop here the progress done by one of these new regulatory authorities, through five years being. (author)

  15. ILK statement about the regulatory authorities' perception of operators' self-assessment of safety culture

    International Nuclear Information System (INIS)

    2005-01-01

    Over the past few years, German licensing and supervisory authorities have devoted increasing attention to safety management and safety culture issues. At present, German plant operators are introducing systems for self-assessment of the safety culture in their plants, such as the Safety Culture Assessment System developed by VGB Power Tech (VGB-SBS). In its statement, the International Committee on Nuclear Technology (ILK) addresses an effective approach of the authorities in evaluating the self-assessment of safety culture conducted by operators. ILK proposes a total of ten recommendations for evaluating the self-assessment system of the operators by the authority. The regulatory authorities should see to it that the operators establish a self-assessment system for aspects of organization and personnel, and use it continuously. The measures derived from this self-assessment by the operators, and the reasons underlying them, should be discussed with the authorities. In addition to the operators, also the regulatory authorities and the technical expert organizations commissioned by them should carry out self-assessments of their respective supervisory activities, taking into account also special events, such as changes in government, and develop appropriate programs of measures to be taken. In evaluating safety culture, the regulatory authorities should strive to support the activities of operators in improving their safety culture. A spirit of mutual confidence and cooperation should exist between operators and authorities. The recommendations expressed in the statement deliberately leave room for detailed implementation by the parties concerned. (orig.)

  16. Experts Complete IAEA Follow-up Review of Spanish Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2011-01-01

    areas of inspection and public communication as a consequence of the lessons learned in 2008 from the event at the Asco Nuclear Power Plant; CSN's interactions at the highest level with licensees to discuss strategic planning and their investments in safety and human resources; and The establishment of formal frameworks for cooperation between the CSN and several governmental organizations, such as the Ministry of Health and the Ministry of Interior in the areas of radiation protection and security. Carmen Martinez Ten, President of CSN, said, 'I am proud that Spain is among the first countries to have received a full- scope IRRS mission and a follow-up. CSN has benefitted from the IRRS mission using the contribution from senior regulators which has resulted and will continue in further improvements in our regulatory framework.' The IRRS team also made recommendations and suggestions to further strengthen Spain's regulatory body, including: CSN should establish a formal policy on how to use technical advisory bodies for technical regulatory decisions; CSN should continue to work with relevant bodies to prepare for the disposal of spent fuel and high-level waste, taking into account the progress being made in the siting of a storage facility; and CSN should continue to work with relevant competent authorities and other bodies on regulatory aspects of security. Denis Flory, IAEA Deputy Director General for Nuclear Safety and Security, said, 'This mission is a clear example of the value of regulatory bodies participating in a senior peer review process offered by IAEA. A particularly important feature of these IRRS follow-up missions is to assess the effective implementation of the recommendations made. This mission to Spain also demonstrates clearly the mutual interest of IRRS missions: they encourage improvements in the host countries and serve as valuable sources of information for the reviewers themselves and for other regulatory bodies.' (IAEA)

  17. The Nuclear Regulatory Authority of the Slovak Republic - information to the public

    International Nuclear Information System (INIS)

    Seliga, M.

    1998-01-01

    In this paper the communication programme in the Nuclear Regulatory Authority of the Slovak Republic (NRA SR), internal communication within NRA SR, handling the media, the media documents, the emergency preparedness and media as well as the activities of the NRA SR in last period are discussed

  18. Lessons learned from the Fukushima Dai-ichi accident and responses in NRA regulatory requirements

    International Nuclear Information System (INIS)

    Fuketa, Toyoshi

    2014-01-01

    The author would like to present significant lessons learned from the TEPCO’s Fukushima Dai-ichi accident and responses in regulatory requirements developed by the Nuclear Regulation Authority for power-producing light water reactors. The presentation will cover prevention of structures, systems and components failures, measures to prevent common cause failures, prevention of core damage, mitigation of severe accidents, emergency preparedness, continuous improvement of safety, use of probabilistic risk assessment, and post-accident regulation on the Fukushima Dai-ichi. (author)

  19. Assessment of Safety Culture within the Pakistan Nuclear Regulatory Authority (PNRA)

    Energy Technology Data Exchange (ETDEWEB)

    Afzal, Muhammad [Pakistan Nuclear Regulatory Authority, Islamabad (Pakistan); Choi, Kwang Sik [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2015-10-15

    The objective of this study is to assess the SC of the Pakistan Nuclear Regulatory Authority (PNRA) by developing a performance indicator-based questionnaire. Aspects that potentially play important roles in developing perceptions of SC, including age, type of job, gender and duty hours of regulatory staff, are given due importance in this study. The study also identifies the strengths and weaknesses in the SC of the PNRA and can be used as a model study to assess the SC of other RBs. The questionnaire, developed to assess the SC of the PNRA, was in line with the PNRA's own defined attributes for SC. In the past, significant efforts have been made to ensure the safe operation of NPPs by improving designs and operating procedures; however, the nuclear accident at the Fukushima NPP in Japan in March 2011 revealed that the currently allotted hardware safety margins are not sufficient, and much work is needed to improve safety management in terms of SC. Initially, the concept of SC was introduced for operating organizations to ensure safe operation of NPPs; nonetheless, more recent investigations of nuclear events and accidents, especially Fukushima, and at Davis-Besse, in the US, have revealed that a strong focus is required to address and improve the SC of Regulatory Bodies (RBs). Strong SC is considered a vital tool for RBs to achieve their objectives and discharge their responsibilities in an effective and efficient manner. Though the relationship between the SC of RBs and that of operating organizations is not straight forward, it is believed that the former has a strong influence over the latter. The questionnaire was consistent in terms of the credible nature of its questions, and the response group covered different levels of PNRA staff, from managers to lower level staff. The results show that the PNRA staff have a very good understanding of the nature and significance of attributes of SC and are doing their best to exercise the same within the

  20. Assessment of Safety Culture within the Pakistan Nuclear Regulatory Authority (PNRA)

    International Nuclear Information System (INIS)

    Afzal, Muhammad; Choi, Kwang Sik

    2015-01-01

    The objective of this study is to assess the SC of the Pakistan Nuclear Regulatory Authority (PNRA) by developing a performance indicator-based questionnaire. Aspects that potentially play important roles in developing perceptions of SC, including age, type of job, gender and duty hours of regulatory staff, are given due importance in this study. The study also identifies the strengths and weaknesses in the SC of the PNRA and can be used as a model study to assess the SC of other RBs. The questionnaire, developed to assess the SC of the PNRA, was in line with the PNRA's own defined attributes for SC. In the past, significant efforts have been made to ensure the safe operation of NPPs by improving designs and operating procedures; however, the nuclear accident at the Fukushima NPP in Japan in March 2011 revealed that the currently allotted hardware safety margins are not sufficient, and much work is needed to improve safety management in terms of SC. Initially, the concept of SC was introduced for operating organizations to ensure safe operation of NPPs; nonetheless, more recent investigations of nuclear events and accidents, especially Fukushima, and at Davis-Besse, in the US, have revealed that a strong focus is required to address and improve the SC of Regulatory Bodies (RBs). Strong SC is considered a vital tool for RBs to achieve their objectives and discharge their responsibilities in an effective and efficient manner. Though the relationship between the SC of RBs and that of operating organizations is not straight forward, it is believed that the former has a strong influence over the latter. The questionnaire was consistent in terms of the credible nature of its questions, and the response group covered different levels of PNRA staff, from managers to lower level staff. The results show that the PNRA staff have a very good understanding of the nature and significance of attributes of SC and are doing their best to exercise the same within the

  1. Enhancement of Regulatory Supervision of the nuclear legacy in northwest Russia: involving the military authorities

    International Nuclear Information System (INIS)

    Roudak, S.F.; Sneve, M.K.; Bulatov, O.R.; Vasiliev, A.P.; Malinkin, V.M.

    2011-10-01

    This report describes work carried out within the cooperation programme between the Norwegian Radiation Protection Authority and the Directorate of State Supervision for Nuclear and Radiation Safety of the Ministry of Defense of the Russian Federation performed in 2008-2009. It focuses on development of improved regulatory documents and supervision procedures for handling spent nuclear fuel and radioactive waste at facilities that are no longer used by the Russian Federation Navy but that are still under military supervision and control. (Author)

  2. Enhancement of Regulatory Supervision of the nuclear legacy in northwest Russia: involving the military authorities

    Energy Technology Data Exchange (ETDEWEB)

    Roudak, S.F.; Sneve, M.K.; Bulatov, O.R.; Vasiliev, A.P.; Malinkin, V.M.

    2011-10-15

    This report describes work carried out within the cooperation programme between the Norwegian Radiation Protection Authority and the Directorate of State Supervision for Nuclear and Radiation Safety of the Ministry of Defense of the Russian Federation performed in 2008-2009. It focuses on development of improved regulatory documents and supervision procedures for handling spent nuclear fuel and radioactive waste at facilities that are no longer used by the Russian Federation Navy but that are still under military supervision and control. (Author)

  3. The knowledge management and the Library of the Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Chahab, Martin; Carregado, Maria A.

    2009-01-01

    Since 2006 the Nuclear Regulatory Authority (ARN) of Argentina has implemented knowledge management activities to face the retirement of many of its scientific and technical members. The purpose of these actions are to preserve the knowledge and information of these personnel and to make it available for both, present and future generations. The ARN libraries play an important role in the accomplishment of these objectives through the coordination and realization of different projects and activities. (author) [es

  4. Intercomparison run for uranium and tritium determination in urine samples, organised by Nuclear Regulatory Authority, Argentina

    International Nuclear Information System (INIS)

    Serdeiro, Nelida H.; Equillor, Hugo E.; Bonino, Nestor O.

    2003-01-01

    The Nuclear Regulatory Authority (ARN), Argentina, has carried out an intercomparison run for tritium and uranium determination in urine, in November 2002. The aim of this exercise was to assess the performance of the laboratories that usually inform these radionuclides and to provide technical support in order to have an appropriate occupational monitoring in vitro. In the present work, the results of the intercomparison and the assessment of each laboratory are published. (author)

  5. Method for developing cost estimates for generic regulatory requirements

    International Nuclear Information System (INIS)

    1985-01-01

    The NRC has established a practice of performing regulatory analyses, reflecting costs as well as benefits, of proposed new or revised generic requirements. A method had been developed to assist the NRC in preparing the types of cost estimates required for this purpose and for assigning priorities in the resolution of generic safety issues. The cost of a generic requirement is defined as the net present value of total lifetime cost incurred by the public, industry, and government in implementing the requirement for all affected plants. The method described here is for commercial light-water-reactor power plants. Estimating the cost for a generic requirement involves several steps: (1) identifying the activities that must be carried out to fully implement the requirement, (2) defining the work packages associated with the major activities, (3) identifying the individual elements of cost for each work package, (4) estimating the magnitude of each cost element, (5) aggregating individual plant costs over the plant lifetime, and (6) aggregating all plant costs and generic costs to produce a total, national, present value of lifetime cost for the requirement. The method developed addresses all six steps. In this paper, we discuss on the first three

  6. Regulatory requirements for replacement of analog systems with digital upgrades

    International Nuclear Information System (INIS)

    Loeser, P.J.

    1993-01-01

    This paper reviews briefly the regulatory guidelines which must be met in order to replace analog systems in nuclear power plants with digital systems. There is a move to do such replacements for a number of reasons: analog systems are aging, and showing considerable drift; few vendors manufacture analog systems today; support and parts are hard to get; digital systems provide flexibility. There is a safety concern however about undesirable and unpredictable effects to digital safety equipment due to plant transients, accidents, post-accident condition, and EMI/RF environmental interferences. License holders must comply with the requirements of 10 C.F.R. 50.59, which deals with safety concerns with respect to any changes to operating plants which may have an impact on the safety of the plant. NRC staff is taking the position that all digital upgrades will require an evaluation under this regulation

  7. Regulatory requirements on PSA level 2: Review, aspects and applications

    International Nuclear Information System (INIS)

    Husarcek, J.

    2003-01-01

    The general requirements concerning utility obligations, probabilistic safety criteria (CDF should not exceed 1.0E-4/reactor year and LERF should not exceed 1.0E-5/reactor year), documentation and results, living PSA requirements and major steps in level 2 PSA are presented. PSA developments in Slovakia, collection and assembly of information, plant damage states, containment performance and failure modes, severe accident progression analyses, containment failure modes and source terms as a part of performed level 2 PSA are discussed. The PSA applications in design and operation evaluation, support to plant upgrade and modifications are also described. At the end, the following conclusion is made: more extensive PSA application needs to foster the exchange of experience and communication between PSA specialists, non-PSA engineers, designers, and the regulatory body staff responsible for safety assessment, inspection and enforcement

  8. A framework for regulatory requirements and industry standards for new nuclear power plants

    International Nuclear Information System (INIS)

    Duran, Felicia A.; Camp, Allen L.; Apostolakis, George E.; Golay, Michael W.

    2000-01-01

    This paper summarizes the development of a framework for risk-based regulation and design for new nuclear power plants. Probabilistic risk assessment methods and a rationalist approach to defense in depth are used to develop a framework that can be applied to identify systematically the regulations and standards required to maintain the desired level of safety and reliability. By implementing such a framework, it is expected that the resulting body of requirements will provide a regulatory environment that will ensure protection of the public, will eliminate the burden of requirements that do not contribute significantly to safety, and thereby will improve the market competitiveness of new plants. (author)

  9. An epidemiological analysis of equine welfare data from regulatory inspections by the official competent authorities.

    Science.gov (United States)

    Hitchens, P L; Hultgren, J; Frössling, J; Emanuelson, U; Keeling, L J

    2017-07-01

    welfare if they also complied with documentation requirements. We present a novel approach for analysis of equine welfare data from regulatory inspections by the official competent authorities, and propose on-going analyses and benchmarking of trends in animal-based measures over time. We also suggest how such a database could be further improved to facilitate future epidemiological analyses of risk factors associated with poor equine welfare. The study has implications for other competent authorities and researchers collaborating in the area of animal welfare epidemiology.

  10. Substate federalism and fracking policies: does state regulatory authority trump local land use autonomy?

    Science.gov (United States)

    Davis, Charles

    2014-01-01

    State officials responsible for the regulation of hydraulic fracturing (fracking) operations used in the production of oil and gas resources will inevitably confront a key policy issue; that is, to what extent can statewide regulations be developed without reducing land use autonomy typically exercised by local officials? Most state regulators have historically recognized the economic importance of industry jobs and favor the adoption of uniform regulatory requirements even if these rules preempt local policymaking authority. Conversely, many local officials seek to preserve land use autonomy to provide a greater measure of protection for public health and environmental quality goals. This paper examines how public officials in three states-Colorado, Pennsylvania, and Texas-address the question of state control versus local autonomy through their efforts to shape fracking policy decisions. While local officials within Texas have succeeded in developing fracking ordinances with relatively little interference from state regulators, Colorado and Pennsylvania have adopted a tougher policy stance favoring the retention of preemptive oil and gas statutes. Key factors that account for between state differences in fracking policy decisions include the strength of home rule provisions, gubernatorial involvement, and the degree of local experience with industrial economic activities.

  11. The nuclear regulatory authority of the Slovak Republic and start-up of the Mochovce NPP

    International Nuclear Information System (INIS)

    Seliga, Mojmir

    1999-01-01

    The important aspect is testing if the nuclear energy in the Slovak Republic is due to obligatory rules acceptable and its operation is regulated by the state through the independent institution - The Nuclear Regulatory Authority of the Slovak Republic (UJD). UJD considers the whole area of public relations an essential component of its activity. UJD intends to serve the public true, systematic, qualified, understandable and independent information regarding nuclear safety of nuclear power plants, as well as regarding methods and results of UJD work. Generally, public information is considered as significant contribution to the creation of confidence into the regulatory work. The public relations are understood as attempts to establish, keep and improve UJD-s good relations to its neighbours through purposeful informing. An Information centre at the offices of UJD was built and opened in October 1995 with IAEA Director General as the first visitor. NPP Mochovee is an example of international co-operation in achieving internationally acceptable safety standards. Companies from France, Germany, USA, Russian Federation, Czech Republic and Slovakia and last, but not least also the IAEA participated significantly on increasing the safety level of this NPP. We have been fully aware of the importance of good communication with press, TV and radio broadcasting in this pre-operation and operation period about nuclear safety, nuclear standard and other nuclear aspects commissioning of the NPP Mochovce in the UJD. The information policy of the UJD was in this period focused on the preparation an actual press releases for general and specialised news- paper and national press agencies. Very important were the frequent presentations the requirement safety stages of the NPP Mochovce inIV and radio broadcasting by headquarters of the UJD. UJD as the state authority provides information related to its competence, namely information on safety of operation of nuclear installations

  12. Methodological proposal for the construction of the labor profiles of inspectors of the Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Larcher, A.M.; Maceiras, E.; Degiovanni, G.; Perrin, C.; Sajaroff, P.

    2006-01-01

    The Argentine Nuclear Regulatory Authority (ARN) like essential part of their strategic institutional plan and in the mark of the modernization of the National Public Administration (NPA), identify the necessity to modify their functional organization, introducing the administration for processes and defining more flexible and better guided structures to the work in team. Starting from the definition of a new institutional flowchart it decided to proceed to a general reorganization of the human resources and on January, 2005 it was prepared the creation of a process whose serious objective to sit down the bases for the development of the professional career of the ARN. To such an end, it was thought about a work outline by stages, the first one of which had as final objective the elaboration of the Labor Profiles of the Institution. The work group for this first stage was integrated by a group of professionals of long trajectory in the institution and not belonging to the sector of Human Resources (RRHH). By this way it was organized as an independent group that it worked in narrow collaboration with the specific sector and informed directly to the maximum institutional direction. For the construction of the profiles a 'mixed' model was chosen that included the requirements of each position (that to make) and the competitions to complete them (how to make it), since a focus purely of competitions has not been seen as the more appropriate for the public administration and in particular for the ARN. In this work it is given to know a part of the results obtained during six months of effective work of the PerLa Group (denominated as well as an acronym of the expression Labor Profiles) putting emphasis in the defined profiles for the inspectors of those different regulatory branches that constitute the environment of competition of the RNA, this is Radiological Protection, Nuclear Safety, Safeguards and Physical Protection. The idea that underlies to the presentation

  13. Issues and regulatory requirements for the connection of wind generation

    Energy Technology Data Exchange (ETDEWEB)

    Gimenez Alvarez, J.M. [National University of San Juan (Argentina)], E-mail: jgimenez@unsj.edu.ar; Gomez Targarona, J.C. [National University of Rio Cuarto, Cordoba (Argentina). Electric Power Systems Protection Institute (IPSEP)], E-mail: jcgomez@ing.unrc.edu.ar

    2009-07-01

    Pollution problems such as greenhouse effect as well as the high value and volatility of fuel prices have forced and accelerated the development and use of renewable energy sources. In this work a complete revision of wind generation is presented. In the first part a brief history of the wind energy developments is detailed. Next, some commentaries related to the present and future state are made. Then, a revision of the modern structures of wind generation is realized. In fourth place it is included a brief comparison between small and big size turbines. Then, different types of energy storage are mentioned. Finally regulatory aspects are discussed, respect to the treatment of the technical problems. (author)

  14. Activities of Nuclear Regulatory Authority and safety of nuclear facilities in the Slovak Republic in 1993

    International Nuclear Information System (INIS)

    1994-04-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (NRA SR) in 1993 is presented. These activities are reported under the headings: (1) Introduction; (2) Regulatory activities at nuclear power plants units in operation; (2.1) Nuclear power plant SEP-EBO V-1; (4) Selected operation events and safety assessment in NPP SEP-EBO V-1; (2.2) Safety assessment of NPP SEP-EBO V-2; (3) Results of regulatory activities at the decommissioning of NPP A-1; (4) Regulatory activities at units under construction SEP-EMO - NPP Mochovce; (5) Further regulatory activities. (5.1) Preparation of designated personnel; (5.2) Inspection and accountancy of nuclear material; (5.3) Security provisions; (5.4) Accounted items and double use items; (5.5) Problem of radioactive wastes; (6.1) International co-operation activities of NRA; (6.2) Emergency planning; (6.3) International activities for quality enhancement of national supervision; (7) Conclusion [sk

  15. International conference on strengthening of nuclear safety in Eastern Europe. Armenian Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Nersesyan, V.

    1999-01-01

    The status of the Armenian Nuclear Regulatory Authority (ANRA) are described in detail with its main task and responsibilities concerning regulations and surveillance of nuclear and radiation safety. The following issues are presented: nuclear legislation; inspection activities; licensing of significant safety related modifications and modernization of NPPs; incidents at NPPs; personnel training; emergency planning; surveillance of nuclear materials; radioactive waste management; and plan of the ANRA perspective development

  16. Intercomparison run for uranium and tritium determination in urine samples, organised by Nuclear Regulatory Authority, Argentina

    CERN Document Server

    Serdeiro, N H; Equillor, H E

    2003-01-01

    The Nuclear Regulatory Authority (ARN), Argentina, has carried out an intercomparison run for tritium and uranium determination in urine, in November 2002. The aim of this exercise was to assess the performance of the laboratories that usually inform these radionuclides and to provide technical support in order to have an appropriate occupational monitoring in vitro. In the present work, the results of the intercomparison and the assessment of each laboratory are published.

  17. Regulatory document R-104, Regulatory objectives, requirements and guidelines for the disposal of radioactive wastes - long-term aspects

    International Nuclear Information System (INIS)

    1987-01-01

    The purpose and scope of this document is to present the regulatory basis for judging the long-term acceptability of radioactive waste disposal options. The basic objectives of radioactive waste disposal are given as are the regulatory requirements to be satisfied. (NEA)

  18. Fuel utilization experience in Bohunice NPP and regulatory requirements for implementation of progressive fuel management strategies

    Energy Technology Data Exchange (ETDEWEB)

    Patenyi, V [Nuclear Regulatory Authority, Bratislava (Slovakia); Darilek, P; Majercik, J [Vyskumny Ustav Jadrovych Elektrarni, Trnava (Slovakia)

    1994-12-31

    The experience gained in fuel utilization and the basic requirements for fuel licensing in the Slovak NPPs is described. The original project of WWER-440 reactors supposes 3-year fuel cycle with cycle length of about 320 full power days (FPD). Since 1984 it was reduced to 290 FPD. Based on the experience of other countries, a 4-year fuel cycle utilization started in 1987. It is illustrated with data from the Bohunice NPP units. Among 504 fuel assemblies left for the fourth burnup cycle no leakage was observed. The mean burnup achieved in the different units varied from 33.1 to 38.5 Mwd/kg U. The new fuel assemblies used are different from the recent ones in construction, thermohydraulics, water-uranium ratio, enrichment and material design. To meet the safety criteria, regulatory requirements for exploitation of new fuel in WWER-440 were formulated by the Nuclear Regulatory Authority of Slovak Republic. 1 tab., 5 refs.

  19. Participation of the Nuclear Regulatory Authority in the uranium urinalysis intercomparisons

    International Nuclear Information System (INIS)

    Bonino, Nestor O.; Palacios, Miguel A.; Serdeiro, Nelida H.

    1999-01-01

    In the present work the results of the participation of Nuclear Regulatory Authority (NRA) Argentina, in the Uranium Urinalysis Intercomparison Program administered by the National Calibration Reference Centre for Bioassay, Radiation Protection Bureau, Health Canada, are detailed. This work is referred to the three participations of NRA in 1995, 1996, and 1997. The number of laboratories that have participated was 14, 12 and 12. A statistical analysis is presented. The performance criteria used for assessing the acceptability of results are those given in the American National Standard Institute (ANSI) 1989, N13.30. In addition, the applied radiochemical technique and the methodology are described. (author)

  20. Employee Development Capabilities of the Regulatory Authority in the Nuclear Field in Romania

    International Nuclear Information System (INIS)

    Ghinea, P.

    2016-01-01

    Full text: The paper provides information about CNCAN (general presentation of CNCAN responsibilities as a regulatory body) and about the general human resources management within our institution regarding the following: legal framework regarding resources; knowledge management; staff employment financial resources continuous focus on improvement of staff performances through dedicated training programmes. The process to develop and maintain the necessary competence and skills of staff of the regulatory body, as an element of knowledge management. Training for CNCAN staff is provided either in-house or through technical cooperation programmes with the IAEA. CNCAN has made arrangements for specific staff training using training courses and programmes provided by international organizations. The specific training is provided predominantly with the economic support from outside of the country. CNCAN has a process to develop and maintain the necessary competence and skills of staff of the regulatory body, as an element of knowledge management. To maintain an appropriate competence level, an annual plan for staff training is in place and each staff member has an individual training plan. Project supports CNCAN in the development of knowledge management and capacity building frameworks to secure long-term availability of regulatory competency. (author

  1. Role of the regulatory authority in preparation of the NPP self assessment of safety culture

    Energy Technology Data Exchange (ETDEWEB)

    Gantchev, T [Committee on the Use of Atomic Energy for Peaceful Purposes, Sofia (Bulgaria)

    1997-12-31

    We believe that with the assistance of the IAEA(ASSET Training Mission) the plant personnel will be able to prepare high quality Self Assessment Report. The main role of the Regulatory Body is to ensure correspondence with the IAEA requirements and to provide clear guidance for the most important items of the Plant Self Assessment Report. The involvement of the Operating Organization is also desirable in order to ensure the necessary resources for the implementation of the action plan. Figs.

  2. Role of the regulatory authority in preparation of the NPP self assessment of safety culture

    International Nuclear Information System (INIS)

    Gantchev, T.

    1996-01-01

    We believe that with the assistance of the IAEA(ASSET Training Mission) the plant personnel will be able to prepare high quality Self Assessment Report. The main role of the Regulatory Body is to ensure correspondence with the IAEA requirements and to provide clear guidance for the most important items of the Plant Self Assessment Report. The involvement of the Operating Organization is also desirable in order to ensure the necessary resources for the implementation of the action plan. Figs

  3. UK regulatory standards - the 'Guidance on requirements for authorisation'

    International Nuclear Information System (INIS)

    Williams, C.R.

    1999-01-01

    In the United Kingdom, disposal of radioactive waste requires an authorisation under the Radioactive Substances Act 1993. The power to grant such authorisations rests with the Environment Agency for disposals in England and Wales, and with similar Agencies in Scotland and Northern Ireland - namely the Scottish Environment Protection Agency (SEPA) and the Environment and Heritage Service (EHS) of the Department of the Environment for Northern Ireland. In 1997, following two rounds of consultation, the Environment Agency jointly with SEPA and EHS published a document 'Disposal Facilities on Land for Low and Intermediate Level Radioactive Wastes: Guidance on Requirements for Authorisation' - the GRA document. The GRA document outlines the regulatory framework governing the disposal of radioactive waste, general guidance on procedures, the principles and criteria against which proposals for a disposal facility will be assessed, and the radiological and technical requirements which a facility will be expected to meet. In particular, the document states that, in the period after control is withdrawn, the assessed radiological risk from a facility to a representative member of the potentially exposed group at greatest risk should be consistent with a risk target of 10 -6 per year. The document also specifies the information which a developer will need to provide, to demonstrate that a proposal is consistent with the principles and requirements, and identifies other, non-risk-based, criteria. In March 1997, the Secretary of State for the Environment rejected a planning appeal by United Kingdom Nirex Ltd for an underground Rock Characterisation Facility located near Sellafield in Cumbria. That decision has effectively delayed the construction of any deep repository in the UK. Subsequently a House of Lords Select Committee has commenced a major review of nuclear waste management. The Environment Agency continues to be responsible for the authorisation of the shallow

  4. The mass media role in acceptance activities of Slovak Republic's Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Seliga, Mojmir

    1998-01-01

    Communication is the vital link between Nuclear Regulatory Authority and the public. If people do not know and understand the facts on which optimal a safety energy choice decisions should be based they cannot make informed decisions on how their own objectives can be met. The following ten commandments of communications are pointed out: be yourself; be comfortable and confident; be honest; be brief; be human; be personal; be positive and consistent; be attentive; be energetic; be committed and sincere. The important aspect is to test whether the nuclear energy in the Slovak Republic is acceptable according to mandatory rules and if its operation is regulated by the state through the independent institution - the Nuclear Regulatory Authority of the Slovak Republic (UJD). The media in Slovakia has on important power. Many organizations are therefore apprehensive when dealing with the press, radio and television. Many people would simply prefer not to get panicked when the dreaded microphones and cameras do appear. UJD considers the whole area of public relations as an essential component of its activity. UJD intends to offer the public true, systematic, qualified, understandable and independent information, regarding the safety of nuclear power plants, as well as regarding the methods and results of UJD work. Generally, public information is considered a significant contribution to the creation of confidence into the regulatory work. The paper presents the UJD communication program and relations with media as well as the preparedness of public information in case of emergency

  5. Development of safety-related regulatory requirements for nuclear power in developing countries. Key issue paper no. 4

    International Nuclear Information System (INIS)

    Han, K.I.

    2000-01-01

    In implementing a national nuclear power program, balanced regulatory requirements are necessary to ensure nuclear safety and cost competitive nuclear power, and to help gain public acceptance. However, this is difficult due to the technology-intensive nature of the nuclear regulatory requirements, the need to reflect evolving technology and the need for cooperation among multidisciplinary technical groups. This paper suggests approaches to development of balanced nuclear regulatory requirements in developing countries related to nuclear power plant safety, radiation protection and radioactive waste management along with key technical regulatory issues. It does not deal with economic or market regulation of electric utilities using nuclear power. It suggests that national regulatory requirements be developed using IAEA safety recommendations as guidelines and safety requirements of the supplier country as a main reference after careful planning, manpower buildup and thorough study of international and supplier country's regulations. Regulation making is not recommended before experienced manpower has been accumulated. With an option that the supplier country's regulations may be used in the interim, the lack of complete national regulatory requirements should not deter introduction of nuclear power in developing countries. (author)

  6. DARHT: INTEGRATION OF AUTHORIZATION BASIS REQUIREMENTS AND WORKER SAFETY

    International Nuclear Information System (INIS)

    MC CLURE, D. A.; NELSON, C. A.; BOUDRIE, R. L.

    2001-01-01

    This document describes the results of consensus agreements reached by the DARHT Safety Planning Team during the development of the update of the DARHT Safety Analysis Document (SAD). The SAD is one of the Authorization Basis (AB) Documents required by the Department prior to granting approval to operate the DARHT Facility. The DARHT Safety Planning Team is lead by Mr. Joel A. Baca of the Department of Energy Albuquerque Operations Office (DOE/AL). Team membership is drawn from the Department of Energy Albuquerque Operations Office, the Department of Energy Los Alamos Area Office (DOE/LAAO), and several divisions of the Los Alamos National Laboratory. Revision 1 of the DARHT SAD had been written as part of the process for gaining approval to operate the Phase 1 (First Axis) Accelerator. Early in the planning stage for the required update of the SAD for the approval to operate both Phase 1 and Phase 2 (First Axis and Second Axis) DARHT Accelerator, it was discovered that a conflict existed between the Laboratory approach to describing the management of facility and worker safety

  7. Regulatory requirements for the transport of radioactive materials in Canada

    Energy Technology Data Exchange (ETDEWEB)

    Garg, R. [Canadian Nuclear Safety Commission, Ottawa (Canada)

    2004-07-01

    Canada is a major producer and shipper of radioactive material. Each year more than a million packages are transported in Canada. The safety record with the transport of RAM in Canada has historically been excellent. There have never been any serious injuries, overexposure or fatality or environmental consequences attributable to the radioactive nature of such material being transported or being involved in a transport accident. In Canada, the Canadian Nuclear Safety Commission (CNSC) is the prime agency of the federal government entrusted with regulating all activities related to the use of nuclear energy and nuclear substances including the packaging and transport of nuclear substances. The mission of the CNSC is to regulate the use of nuclear energy and materials to protect health, safety, security of the person and the environment and to respect Canada's international commitments on the peaceful use of nuclear energy. The division of responsibility for the regulation of transport of radioactive material has been split between Transport Canada and the CNSC. The governing Transport Canada's regulations are Transport of Dangerous Goods (TDG) Regulations and the CNSC regulations are Packaging and Transport of Nuclear Substances Regulations (PTNSR). Canada has actively participated in the development of the IAEA regulations for the safe transport of radioactive material since 1960. As an IAEA member state, Canada generally follows the requirements of IAEA regulations with few deviations. The Nuclear Safety and Control Act (NSCA) strongly supports Canada's international obligations to ensure safe packaging, transport, storage and disposal of nuclear substances, prescribed equipment and prescribed information. Prescribed equipment and prescribed information are defined in the CNSC General Nuclear Safety and Control Regulations. This paper presents the current CNSC regulatory requirements and initiatives taken by the CNSC to improve its effectiveness and

  8. Regulatory requirements for the transport of radioactive materials in Canada

    International Nuclear Information System (INIS)

    Garg, R.

    2004-01-01

    Canada is a major producer and shipper of radioactive material. Each year more than a million packages are transported in Canada. The safety record with the transport of RAM in Canada has historically been excellent. There have never been any serious injuries, overexposure or fatality or environmental consequences attributable to the radioactive nature of such material being transported or being involved in a transport accident. In Canada, the Canadian Nuclear Safety Commission (CNSC) is the prime agency of the federal government entrusted with regulating all activities related to the use of nuclear energy and nuclear substances including the packaging and transport of nuclear substances. The mission of the CNSC is to regulate the use of nuclear energy and materials to protect health, safety, security of the person and the environment and to respect Canada's international commitments on the peaceful use of nuclear energy. The division of responsibility for the regulation of transport of radioactive material has been split between Transport Canada and the CNSC. The governing Transport Canada's regulations are Transport of Dangerous Goods (TDG) Regulations and the CNSC regulations are Packaging and Transport of Nuclear Substances Regulations (PTNSR). Canada has actively participated in the development of the IAEA regulations for the safe transport of radioactive material since 1960. As an IAEA member state, Canada generally follows the requirements of IAEA regulations with few deviations. The Nuclear Safety and Control Act (NSCA) strongly supports Canada's international obligations to ensure safe packaging, transport, storage and disposal of nuclear substances, prescribed equipment and prescribed information. Prescribed equipment and prescribed information are defined in the CNSC General Nuclear Safety and Control Regulations. This paper presents the current CNSC regulatory requirements and initiatives taken by the CNSC to improve its effectiveness and efficiency

  9. Aggregate analysis of regulatory authority assessors' comments to improve the quality of periodic safety update reports.

    Science.gov (United States)

    Jullian, Sandra; Jaskiewicz, Lukasz; Pfannkuche, Hans-Jürgen; Parker, Jeremy; Lalande-Luesink, Isabelle; Lewis, David J; Close, Philippe

    2015-09-01

    Marketing authorization holders (MAHs) are expected to provide high-quality periodic safety update reports (PSURs) on their pharmaceutical products to health authorities (HAs). We present a novel instrument aiming at improving quality of PSURs based on standardized analysis of PSUR assessment reports (ARs) received from the European Union HAs across products and therapeutic areas. All HA comments were classified into one of three categories: "Request for regulatory actions," "Request for medical and scientific information," or "Data deficiencies." The comments were graded according to their impact on patients' safety, the drug's benefit-risk profile, and the MAH's pharmacovigilance system. A total of 476 comments were identified through the analysis of 63 PSUR HA ARs received in 2013 and 2014; 47 (10%) were classified as "Requests for regulatory actions," 309 (65%) as "Requests for medical and scientific information," and 118 (25%) comments were related to "Data deficiencies." The most frequent comments were requests for labeling changes (35 HA comments in 19 ARs). The aggregate analysis revealed commonly raised issues and prompted changes of the MAH's procedures related to the preparation of PSURs. The authors believe that this novel instrument based on the evaluation of PSUR HA ARs serves as a valuable mechanism to enhance the quality of PSURs and decisions about optimization of the use of the products and, therefore, contributes to improve further the MAH's pharmacovigilance system and patient safety. Copyright © 2015 John Wiley & Sons, Ltd.

  10. 17 CFR 1.52 - Self-regulatory organization adoption and surveillance of minimum financial requirements.

    Science.gov (United States)

    2010-04-01

    ... 17 Commodity and Securities Exchanges 1 2010-04-01 2010-04-01 false Self-regulatory organization... Miscellaneous § 1.52 Self-regulatory organization adoption and surveillance of minimum financial requirements. (a) Each self-regulatory organization must adopt, and submit for Commission approval, rules...

  11. TSO Role in Supporting the Regulatory Authority in View of Safety Culture

    International Nuclear Information System (INIS)

    Khamaza, A.; Vasilishin, A.

    2016-01-01

    Human and organizational factors are always of paramount importance at nuclear and radiation safety as well as in the safety regulation provision. Major NPP accidents occurred merely reaffirm this fact. The role of an authority that regulates nuclear safety increases each time in the aftermath of accidents perceived as a shock together with the importance of scientific and technical support. SEC NRS was established in 1987, the next year after the Chernobyl NPP accident aiming to strengthen supervision over works carried out at the nuclear industry enterprises. Currently SEC NRS provides comprehensive scientific and technical support to Rostechnadzor including safety review and regulatory legal documents development to regulate safety along with safety culture.

  12. Regulation of Federal radioactive waste activities. Report to Congress on extending the Nuclear Regulatory Commission's licensing or regulatory authority to Federal radioactive waste storage and disposal activities

    International Nuclear Information System (INIS)

    1979-09-01

    The report contains two recommendations for extending the Commission's regulatory authority: (1) NRC licensing authority should be extended to cover all new DOE facilities for disposal of transuranic (TRU) waste and nondefense low-level waste. (2) A pilot program, focused on a few specific DOE waste management activities, should be established to test the feasibility of extending NRC regulatory authority on a consultative basis to DOE waste management activities not now covered by NRC's licensing authority or its extension as recommended in Recommendation 1

  13. Assessment of compliance with regulatory requirements for a best estimate methodology for evaluation of ECCS

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Un Chul; Jang, Jin Wook; Lim, Ho Gon; Jeong, Ik [Seoul National Univ., Seoul (Korea, Republic of); Sim, Suk Ku [Korea Atomic Energy Research Institute, Taejon (Korea, Republic of)

    2000-03-15

    Best estimate methodology for evaluation of ECCS proposed by KEPCO(KREM) os using thermal-hydraulic best-estimate code and the topical report for the methodology is described that it meets the regulatory requirement of USNRC regulatory guide. In this research the assessment of compliance with regulatory guide. In this research the assessment of compliance with regulatory requirements for the methodology is performed. The state of licensing procedure of other countries and best-estimate evaluation methodologies of Europe is also investigated, The applicability of models and propriety of procedure of uncertainty analysis of KREM are appraised and compliance with USNRC regulatory guide is assessed.

  14. Medical program in radiation protection from the Argentine Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Perez, M. R.; Gisone, P.; Di Trano, J.L.; Dubner, D.L.; Michelin, S.C.

    1998-01-01

    This program is carried out by the Radio pathology Laboratory, belonging to the Nuclear Regulatory Authority. The program includes the following aspects: 1) planning and organization of medical response in radiological emergencies. A three-level system of medical assistance has been developed considering: a- determination of each level of care and their potential roles; b- choice of medical facilities for medical assistance; c- preparedness for medical response (equipment s, logistic support, human resources, training). 2) scientific research activities related to radio pathology subjects: a- hematological indicators in radioinduced aplasia; b- biological and biophysical dosimeters; c- radiation effects on the developing brain. 3) edition of practical guidelines for diagnostic and treatment: a- external and internal radioactive contamination; b- acute radiation syndrome; c- radiological burns. 4) medical advising in radioprotection (risk assessment in radiation workers, medical exposures, potential effects of prenatal irradiation). 5) international interactions: activities related with the constitution of a Latin American radio pathology network, linkage with international reference centers. (author) [es

  15. Self-assessment of the Nuclear Regulatory Authority of the Slovak Republic

    International Nuclear Information System (INIS)

    Husarcek, J.; Grebeciova, J.

    2006-01-01

    The major results are presented of the self-assessment procedure which was carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD) in 2005 based on the Common Assessment Framework (CAF) model. An overview is given of the most important preconditions and results and their interactions in the nine areas of assessment as follows: leadership, strategy and planning, human resource management, partnership and resources, process management and changes, customer and public oriented results, people results, society results, and key performance results. UJD's strengths and opportunities as emerged from the self-assessment are highlighted. The self-assessment process will be followed by the preparation and implementation of an Action Plan. (author)

  16. Role of partnership in enhancing the performance of radiation regulatory authority in Zambia

    International Nuclear Information System (INIS)

    Banda, S.C.

    2003-01-01

    The National Radiation Infrastructure includes legislation, human resource, technical capacity to execute responsibilities of the regulatory (1). In cases of developing countries like Zambia, special challenges arise in view of the constraints both in terms of human resource and funding. This paper will highlight same measures that may be undertaken to improve the operations of nation radiation protection infrastructure. The measures include collaboration with Science and Technology organisations that have technical capacity, delegation of responsible to key institutions that may have competence and generation of funds through training and provision of reliable quality service. (2). In Zambia, some achievements in this line have been registered by Radiation Protection Board working with the University of Zambia and National Institute for Scientific and Industrial Research (3). Some measures of generation of funds have been done though utilization of the generated remains to be the limiting factor to exploit fully benefits that may arise from the use of the monies generated from services. Partnerships with private sector may be used as regulatory authorities for support to its programme in particular the public awareness campaign. Sponsorship by a Private Cellar Phone Company (Telecel Zambia) and Rotary Club of Lusaka for Radiation Week to Radiation Protection Service under Theme 'Safe Radiation Use' is one such an example. The other opportunity is the technical cooperation with regional and international organisations such as SADC, IAEA, WHO, Interpol, EU and WCO for technical capacity building, human resource development and information access. (author)

  17. Assessment of the effectiveness of the Hungarian nuclear safety regulatory authority by international expert teams

    International Nuclear Information System (INIS)

    Voeroess, L.; Lorand, F.

    2001-01-01

    On the basis of the role nuclear regulatory authorities (NRA) have to fulfil and the new challenges affecting them, in the paper an overview is made on how the Hungarian NRA has evaluated and utilised the results of different international efforts in the enhancement of its effectiveness and efficiency. The reviews have been conducted by different groups of experts organised by highly recognised international organisations (e.g. IAEA, EC) and highly competent foreign regulatory bodies. The different reviews of activities and working conditions of the HAEA NSD have resulted in a generally positive picture, however, it also revealed weaknesses as well. They recognised the developments made in recent years and also appreciated the overall favourable level of nuclear safety in Hungary, identified 'good practices' and made recommendations and suggestions for the most important and most efficient ways for future improvements. These are cited or referenced in the paper. At the end, some recommendations have been formed based on the experiences gained from the review missions and from our self-assessment. (author)

  18. Regulatory requirements for groundwater monitoring networks at hazardous waste sites

    International Nuclear Information System (INIS)

    Keller, J.F.

    1989-10-01

    In the absence of an explicit national mandate to protect groundwater quality, operators of active and inactive hazardous waste sites must use a number of statutes and regulations as guidance for detecting, correcting, and preventing groundwater contamination. The objective of this paper is to provide a framework of the technical and regulatory considerations that are important to the development of groundwater monitoring programs at hazardous waste sites. The technical site-specific needs and regulatory considerations, including existing groundwater standards and classifications, will be presented. 14 refs., 2 tabs

  19. Needs, requirements and challenges for technical support to nuclear safety authority

    International Nuclear Information System (INIS)

    Madonna, A.; Orsini, G.

    2010-01-01

    To face the very broad range of technical matters on which the regulatory and licensing activity are based, and related research and development activity, the Nuclear Safety Authorities (NSA) may need to rely upon external technical and scientific support. In providing technical support to NSA, the experience shows, from one side, the importance to have technical support organizations (TSO) with recognized competence, independence and appropriate regulatory view, and from the other side, the importance to have within the NSAs well developed management and technical capability to address, coordinate and use the results of the external technical support. Retaining the NSA the full responsibility for the final decision. Under which conditions and modus operandi the external support shall be provided in order to comply with requirements of being independent, competent and timely provided, fulfilling the administrative procedures, is the subject of attention and consideration of TSO function today. The Italian regulatory body is currently going to be institutionally re-established according to new law approved in 2009 /1/ and it needs to be resourced and fully organized with necessary capacities in the nearest future. The perspective of a new nuclear program, recently launched by the government, with significant incoming tasks for regulation and licensing, against the existing limited resources, let foresee a substantial potential need for technical support and advice. ITER-Consult (Ltd), created in 2003 in Italy, has well developed capabilities to provide independent technical evaluation and support to NSAs, to maintain safety culture and updated knowledge, to transfer know how and to establish international cooperation and networking. This mission is guided assuming as values the independence, the professional competence, the transparency, the credibility and the establishment of respectful relationship with the partners. Challenges exist for funding and operational

  20. Regulatory requirements for the use of consumer products containing radioactive substances

    International Nuclear Information System (INIS)

    Mason, G.C.; Paynter, R.A.; Schmitt-Hannig, A.; Sztanyik, L.B.

    1996-01-01

    In almost 100 years since the discovery of radioactivity, the properties of radioactive materials have been exploited in products such as clocks and watches incorporating luminous paint which are freely available to members of the public. Over time, regulatory authorities have felt it necessary to apply some degree of control to the supply and use of such products in order to protect public health. In many areas of radiation protection, national authorities take note of international recommendations when developing national standards, but the existing detailed guidance of the International Atomic Energy Agency (IAEA) for consumer products is incomplete and out of date. Recently, a thorough revision of the International Basic Safety Standards (BSS) has occurred, which has prompted a review and revision of the related guidance published by the IAEA. A draft Guide on Regulatory Requirements for the Use of Consumer Products Containing Radioactive Substances has now been completed and is currently under review within the IAEA's system for development of documents in its Safety Series of publications. (author)

  1. Preparation of safety regulatory requirements for new technology like digital system

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2013-08-15

    The current regulatory requirements on digital instrumentation and control system have been reviewed by JNES, considering international trend discussed in DICWG of MDEP. MDEP DICWG held in OECD/NEA gives the opportunity to identify the convergence of applicable standards. The working group's activities include: identifying and prioritising the member countries' challenges, practices, and needs regarding standards and regulatory guidance on digital instrumentation and control; identifying areas of importance and needs for convergence of existing standards and guidance or development of new standards; sharing of information; and identifying common positions among the member countries for areas of particular importance and need. The DICWG drafted common positions on specific issues which are based on the existing standards, national regulatory guidance, best practices, and group inputs using an agreed process and framework. The following four general common positions have been discussed in this fiscal year. The Treatment of Common Cause Failure Resulting from Software within Digital Safety Systems, The Treatment of Hardware Description Language(HDL) Programmed Devices for Use in Nuclear Safety System, Factory Acceptance Test and Site Acceptance Test, The Use of Automatic Tests to Perform Surveilance for Digital Systems. (author)

  2. Preparation of safety regulatory requirements for new technology like digital system

    International Nuclear Information System (INIS)

    Ito, Juichiro; Takita, Masami

    2011-01-01

    The current regulatory requirements on digital instrumentation and control system have been reviewed by JNES, considering international trend discussed in DICWG (Digital Instrumentation and Control Working Group) of MDEP (Multinational Design Evaluation Program). MDEP DICWG held in OECD/NEA (Organisation for Economic Co-operation and Development/Nuclear Energy Agency) gives the opportunity to identify the convergence of applicable standards. The working group's activities include: identifying and prioritising the member countries' challenges, practices, and needs regarding standards and regulatory guidance regarding digital instrumentation and control; identifying areas of importance and needs for convergence of existing standards and guidance or development of new standards; sharing of information; and identifying common positions among the member countries for areas of particular importance and need. The DICWG drafted common positions on specific issues which are based on the existing standards, national regulatory guidance, best practices, and group inputs using an agreed upon process and framework. Five general common positions are under discussion in this fiscal year. Simplicity in Design, Software Common Cause Failures, Software Tools, Data communication, Verification and Validation throughout the life cycle of safety systems using digital computers. In addition, the technical evaluation of standards of the Japan Electric Association about digital system for safety was made to support NISA (Nuclear and Industrial Safety Agency). (author)

  3. Preparation of safety regulatory requirements for new technology like digital system

    International Nuclear Information System (INIS)

    2012-01-01

    The current regulatory requirements on digital instrumentation and control system have been reviewed by JNES, considering international trend discussed in DICWG of MDEP. MDEP DICWG held in OECD/NEA gives the opportunity to identify the convergence of applicable standards. The working group's activities include: identifying and prioritising the member countries' challenges, practices, and needs regarding standards and regulatory guidance on digital instrumentation and control; identifying areas of importance and needs for convergence of existing standards and guidance or development of new standards; sharing of information; and identifying common positions among the member countries for areas of particular importance and need. The DICWG drafted common positions on specific issues which are based on the existing standards, national regulatory guidance, best practices, and group inputs using an agreed process and framework. The following two general common positions are discussed and to be issued in this fiscal year. Verification and Validation throughout the life cycle of safety systems using digital computers. The Impact of Cyber Security Features on Digital I and C Safety Systems. (author)

  4. Extent and content of data for regulatory submissions: First-in-human and marketing authorization--Viewpoint of US industry.

    Science.gov (United States)

    Harris, Ian Ross

    2015-09-01

    The amount and type of data in regulatory submissions increases dramatically from the first-in-human clinical trials application through to the extensive dossier that is required for marketing authorization. The Pharmaceuticals and Biotechnology industries are very familiar with the requirements and expectations of Health Authorities for small molecule and biologics, but have limited experience for cell-based therapies. Fortunately, the United States Food and Drug Administration (FDA) and European Medicines agency (EMA) Committee for Advanced Therapies (CAT) have considerable experience in regulating cell therapies and have provided extensive Guidance documents for developers. The Agencies offers advice to Sponsors through a variety of meetings. However, it is incumbent on the Sponsor to understand the regulations, interpret the Guidance documents and formulate clear company positions to enable the Agency to provide clear feedback. It is important for Sponsors to understand the factors that are critical for the safety and efficacy of their product and to demonstrate to the Health Authorities that they have a control strategy that ensures safety and efficacy during all stages of development. The focus of this paper is to describe some of the challenges for the chemistry manufacturing and controls (CMC) for cell therapies being development internationally. Copyright © 2015.

  5. Quality Management System at the Nuclear Regulatory Authority of the Slovak Republic

    International Nuclear Information System (INIS)

    Husarcek, J.; Novak, S.

    2008-01-01

    The process-oriented quality management system (QMS) implemented at the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in compliance with the EN ISO 9001:2001 standard is described. The history of the establishment and development of the QMS is given. The main, managerial and supporting processes with respect to defined activities are specified, and a scheme of their interactions is presented. The contents of the Quality Manual content and the structure of the system documentation are briefly described. The responsibilities for the operation and improvements of the QMS are described along with the methods applied (internal and external audits, self-assessment - Common Assessment Framework (CAF)). Examples of established quality objectives and indicators for some processes are provided. A future development of the QMS is expected in accordance with the relevant ISO Standard and IAEA recommendations and based on evaluation of the effectiveness of the critical system. (orig.)

  6. Waste management from reprocessing: a stringent regulatory requirements for high quality conditioned residues

    International Nuclear Information System (INIS)

    Bordier, J. C.; Greneche, D.; Devezeaux, J. G.; Dalcorso, J.

    2000-01-01

    Nuclear waste production and management in France is governed by safety requirements imposed to all operators. French nuclear safety relies on two basic principles: · Responsibility of the nuclear operator, which expands to waste generated, · Safety basic objectives issued by national Safety Authority. For a long time the regulatory framework for waste production and management has been satisfactorily applied and has benefited to each actor of the process. LLW/MLW and HLW nuclear waste are currently conditioned in safe matrices or packages either likely to be disposed in surface repositories or designed with the intention to be disposed underground according to their radioactive content. France is looking into the case of VLLW and has already carried out a design for future disposal, the design being in the pipe. Other types of waste (i. e. radium bearing waste, graphite, and tritium content waste) are also considered in the whole framework of French waste management. (author)

  7. 18 CFR 45.2 - Positions requiring authorization.

    Science.gov (United States)

    2010-04-01

    ... mentioned which applicant holds and which are invested with executive authority, applicant shall state in... directors, or otherwise. 1 Corporation means any corporation, joint-stock company, partnership, association...

  8. 40 CFR 123.27 - Requirements for enforcement authority.

    Science.gov (United States)

    2010-07-01

    ... negligence,” “gross negligence” or strict liability satisfy the requirement of paragraph (a)(3)(ii) of this... under State law for establishing violations under paragraph (a)(3) of this section, shall be no greater... under the appropriate Act; Note: For example, this requirement is not met if State law includes mental...

  9. 40 CFR 501.17 - Requirements for enforcement authority.

    Science.gov (United States)

    2010-07-01

    ... which provide the criminal remedies based on “criminal negligence,” “gross negligence” or strict.... (2) The burden of proof and degree of knowledge or intent required under State law for establishing..., this requirement is not met if State law includes mental state as an element of proof for civil...

  10. Economics of the specification 6M safety re-evaluation and regulatory requirements

    International Nuclear Information System (INIS)

    Hopper, C.M.

    1985-01-01

    The objective of this work was to examine the potential economic impact of the DOT Specification 6M criticality safety re-evaluation and regulatory requirements. The examination was based upon comparative analyses of current authorized fissile material load limits for the 6M, current Federal regulations (and interpretations) limiting the contents of Type B fissile material packages, limiting aggregates of fissile material packages, and recent proposed fissile material mass limits derived from specialized criticality safety analyses of the 6M package. The work examines influences on cost in transportation, handling, and storage of fissile materials. Depending upon facility throughput requirements (and assumed incremental costs of fissile material packaging, storage, and transport), operating, facility storage capacity, and transportation costs can be reduced significantly. As an example of the pricing algorithm application based upon reasonable cost influences, the magnitude of the first year cost reductions could extend beyond four times the cost of the packaging nuclear criticality safety re-evaluation. 1 tab

  11. Regulatory science requirements of labeling of genetically modified food.

    Science.gov (United States)

    Moghissi, A Alan; Jaeger, Lisa M; Shafei, Dania; Bloom, Lindsey L

    2018-05-01

    This paper provides an overview of the evolution of food labeling in the USA. It briefly describes the three phases of agricultural development consisting of naturally occurring, cross-bred, and genetically engineered, edited or modified crops, otherwise known as Genetically Modified Organisms (GMO). It uses the Best Available Regulatory Science (BARS) and Metrics for Evaluation of Regulatory Science Claims (MERSC) to evaluate the scientific validity of claims applicable to GMO and the Best Available Public Information (BAPI) to evaluate the pronouncements by public media and others. Subsequently claims on health risk, ecological risk, consumer choice, and corporate greed are evaluated based on BARS/MERSC and BAPI. The paper concludes by suggesting that labeling of food containing GMO should consider the consumer's choice, such as the food used by those who desire kosher and halal food. Furthermore, the consumer choice is already met by the exclusion of GMO in organic food.

  12. Development of Regulatory Technical Requirements for the Advanced Integral Type Research Reactor

    International Nuclear Information System (INIS)

    Jo, Jong Chull; Yune, Young Gill; Kim, Woong Sik; Kim, Hho Jung

    2004-01-01

    This paper presents the current status of the study on the development of regulatory technical requirements for the licensing review of an advanced integral type research reactor of which the license application is expected in a few years. According to the Atomic Energy Act of Korea, both research and education reactors are subject to the technical requirements for power reactors in the licensing review. But, some of the requirements may not be applicable or insufficient for the licensing reviews of reactors with unique design features. Thus it is necessary to identify which review topics or areas can not be addressed by the existing requirements and to develop the required ones newly or supplement appropriately. Through the study performed so far, it has been identified that the following requirements need to be developed newly for the licensing review of SMART-P: the use of proven technology, the interfacial facility, the non-safety systems, and the metallic fuels. The approach and basis for the development of each of the requirements are discussed. (authors)

  13. 7 CFR 282.1 - Legislative authority and notice requirements.

    Science.gov (United States)

    2010-01-01

    ... Section 282.1 Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE FOOD STAMP AND FOOD DISTRIBUTION PROGRAM DEMONSTRATION, RESEARCH, AND... 17 of the Act authorizes the Secretary to conduct demonstration, research, and evaluation projects...

  14. 14 CFR 61.68 - Category III pilot authorization requirements.

    Science.gov (United States)

    2010-01-01

    ...) The addition of another type of aircraft to the applicant's Category III pilot authorization. (2) To... height, as applicable, including use of a radar altimeter; (iii) Recognition of and proper reaction to... an aircraft of the same category and class, and type, as applicable, as the aircraft for which the...

  15. Regulatory philosophy and requirements for radiation control in Canadian uranium mine-mill facilities

    International Nuclear Information System (INIS)

    Dory, A.B.

    1981-10-01

    With the point made that radiation exposure is one of the health hazards of uranium mining and accordingly has to be controlled, the Canadian regulatory philosophy is outlined as it pertains to the uranium mining industry. Two extremes in regulatory approach are examined, and the joint regulatory process is explained. Two examples of poor management performance are given, and the role of mine unions in the regulatory process is touched upon. The development of new regulations to cover ventilation and employee training is sketched briefly. The author concludes with a general expression of objectives for the eighties which include improved personal dosimetry

  16. Development of infrastructure for the regulatory authority to implement risk-informed regulation

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2013-08-15

    It is important to assure the technical adequacy of probabilistic risk assessment (PRA) to implement risk-informed regulation of nuclear power plants (NPPs). JNES has been conducting various activities, such as development of PRA model, method, and data base, in order to assure the technical adequacy of PRA as development of the infrastructure for the regulatory authority to implement risk-informed regulation. In 2012, JNES updated the reliability data base used in PRA and improved PRA models to enhance the technical bases of PRA. In addition, JNES has been establishing the PRA model for fuel damage in the spent fuel storage pool in NPPs. As for improvement of PRA model for core damage in reactor, JNES conducted the study including feasibility of a simplified reliability model for digital I and C system developed by the digital I and C task group of OECD/NEA CSNI WGRISK by reproducing the sample calculation, and improvement of PRA models of individual NPPs in Japan. JNES is making effort to develop the procedures of internal fire PRA and internal flooding PRA. To improve the internal fire PRA, JNES is participating in OECD/NEA FIRE project to obtain the latest information and to validate and improve the fire propagation analysis codes and the parameters. JNES is establishing a method for analyzing internal influence due to flooding in NPPs, and this method is the base to develop the procedure of internal flooding PRA. (author)

  17. Radiological and administrative criteria and procedures required by the Radiation Protection Ordinance for exemption from regulatory control

    International Nuclear Information System (INIS)

    Birkholz, W.

    2000-01-01

    The system of required radioactivity measurements and limits as well as methods, based on the 10 μSv concept, constitutes the regulatory regime for exemption of radioactive waste materials from regulatory control according to atomic energy law. The methods and administrative procedures are suitable both for smaller amounts of materials, such as those resulting from the use of radioactive substances in scientific research and medical applications, and for the large waste volumes emanating from the dismantling of nuclear installations. The system provided for in the Radiation Protection Ordinance ensures harmonized administrative action of all public authorities involved. (orig./CB) [de

  18. Regulatory requirements related to risk-based inspection and maintenance

    International Nuclear Information System (INIS)

    Schroeder, H.C.; Kauer, R.

    2003-01-01

    By asking the question why new inspection and maintenance strategies have to be developed one can often be made aware that there is always a continue demand for cost reduction and optimisation. In this framework, general trends involving staff reduction, outsourcing, benchmarking etc. can often be observed nearly everywhere. Since inspection and maintenance are amongst the few cost factors, which could be actively influenced in the short term, and in combination with the recent regulatory fundamental changes (e.g. PED) yielding to considerably greater responsibilities for the operator of a plant, also the demand for documentation and comprehensibility of measures will increase. (orig.)

  19. The regulatory requirements, design bases, researches and assessments in the field of Ukrainian NPP's seismic safety

    International Nuclear Information System (INIS)

    Mykolaychuk, O.; Mayboroda, O.; Krytskyy, V.; Karnaukhov, O.

    2001-01-01

    State Nuclear Regulatory Authority of Ukraine (SNRA) pays large attention to problem of nuclear installations seismic stability. As a result the seismic design regulatory guides is revised, additional seismic researches of NPP sites are conducted, seismic reassessment of NPP designs were begun. The experts involved address all seismic related factors under close contact with the staff of NPP, design institutes and research organizations. This document takes stock on the situation and the research programs. (author)

  20. Authorization of radioactive waste disposal under RSA93: regulatory experience and developments

    International Nuclear Information System (INIS)

    McHugh, J.O.

    1997-01-01

    The Environment Agency was formed in 1996 and is responsible for regulating radioactive waste disposal in England and Wales. In determining applications for disposal authorizations, it consults other statutory bodies including the Ministry of Agriculture, Fisheries and Food and the Health and Safety Executive. The Agency has published updated guidance on the principles and requirements for authorization of geological disposal of low and intermediate level waste. It will apply a risk target of 10 -6 per year in determining authorizations for waste disposal. Further work is required to elaborate the concept of 'critical group' to which the risk target should be applied. The Agency has also considered amending the methodology it uses for regulation of radioactive waste discharges from nuclear installations. Concerns expressed by the nuclear industry about the lack of operational flexibility in discharge authorizations, led the Agency to develop an alternative method of regulation. Responses to this initiative were mixed. In the future, the Department of the Environment will be reviewing the principles underpinning regulation of discharges, with the intention of setting out guidance on the objectives to be achieved and factors to be taken into account. (author)

  1. Self-assessment of the Nuclear Regulatory Authority of the Slovak Republic and a subsequent partner IAEA IRRS mission

    International Nuclear Information System (INIS)

    Husarcek, Jan

    2012-01-01

    A self-assessment exercise performed by the Nuclear Regulatory Authority of the Slovak Republic based on the IAEA Integrated Regulatory Review Service (IRRS) methodology, and the follow-up IAEA mission are described. The self-assessment methodology is outlined. The purpose, scope, area, content and process of the self-assessment are explained. The work done, the summary results of the IAEA IRRS mission, and proposed improvements are described. (orig.)

  2. Regulatory and administrative requirements for practice of nuclear medicine in India

    International Nuclear Information System (INIS)

    Tandon, Pankaj

    1998-01-01

    In order to ensure safety of the patients, staff and public in the practice of nuclear medicine, including in-vivo diagnostic investigations, radionuclide therapy and in research using unsealed radioactive substances a number of administrative and regulatory procedures are adopted. The salient features of regulatory and administrative requirements for practice of nuclear medicine in India are discussed

  3. Constraining Government Regulatory Authority: Tobacco Industry Trade Threats and Challenges to Cigarette Package Health Warning Labels

    OpenAIRE

    Crosbie, Eric

    2016-01-01

    This dissertation investigates the rising authority of non-state actors vis-à-vis the state by examining how tobacco companies are using trade agreements to constrain governments from implementing progressive public health policies that require placing pictorial health warning labels (HWLs) on cigarette packages. In particular, the dissertation seeks to address two different but related puzzles. First, despite being developed countries and global health leaders, it is unclear why Australia ha...

  4. Regulatory considerations for computational requirements for nuclear criticality safety

    International Nuclear Information System (INIS)

    Bidinger, G.H.

    1995-01-01

    As part of its safety mission, the U.S. Nuclear Regulatory Commission (NRC) approves the use of computational methods as part of the demonstration of nuclear criticality safety. While each NRC office has different criteria for accepting computational methods for nuclear criticality safety results, the Office of Nuclear Materials Safety and Safeguards (NMSS) approves the use of specific computational methods and methodologies for nuclear criticality safety analyses by specific companies (licensees or consultants). By contrast, the Office of Nuclear Reactor Regulation approves codes for general use. Historically, computational methods progressed from empirical methods to one-dimensional diffusion and discrete ordinates transport calculations and then to three-dimensional Monte Carlo transport calculations. With the advent of faster computational ability, three-dimensional diffusion and discrete ordinates transport calculations are gaining favor. With the proper user controls, NMSS has accepted any and all of these methods for demonstrations of nuclear criticality safety

  5. Air Quality Science and Regulatory Efforts Require Geostationary Satellite Measurements

    Science.gov (United States)

    Pickering, Kenneth E.; Allen, D. J.; Stehr, J. W.

    2006-01-01

    Air quality scientists and regulatory agencies would benefit from the high spatial and temporal resolution trace gas and aerosol data that could be provided by instruments on a geostationary platform. More detailed time-resolved data from a geostationary platform could be used in tracking regional transport and in evaluating mesoscale air quality model performance in terms of photochemical evolution throughout the day. The diurnal cycle of photochemical pollutants is currently missing from the data provided by the current generation of atmospheric chemistry satellites which provide only one measurement per day. Often peak surface ozone mixing ratios are reached much earlier in the day during major regional pollution episodes than during local episodes due to downward mixing of ozone that had been transported above the boundary layer overnight. The regional air quality models often do not simulate this downward mixing well enough and underestimate surface ozone in regional episodes. Having high time-resolution geostationary data will make it possible to determine the magnitude of this lower-and mid-tropospheric transport that contributes to peak eight-hour average ozone and 24-hour average PM2.5 concentrations. We will show ozone and PM(sub 2.5) episodes from the CMAQ model and suggest ways in which geostationary satellite data would improve air quality forecasting. Current regulatory modeling is typically being performed at 12 km horizontal resolution. State and regional air quality regulators in regions with complex topography and/or land-sea breezes are anxious to move to 4-km or finer resolution simulations. Geostationary data at these or finer resolutions will be useful in evaluating such models.

  6. Safety performance indicators used by the Russian Safety Regulatory Authority in its practical activities on nuclear power plant safety regulation

    International Nuclear Information System (INIS)

    Khazanov, A.L.

    2005-01-01

    The Sixth Department of the Nuclear, Industrial and Environmental Regulatory Authority of Russia, Scientific and Engineering Centre for Nuclear and Radiation Safety process, analyse and use the information on nuclear power plants (NPPs) operational experience or NPPs safety improvement. Safety performance indicators (SPIs), derived from processing of information on operational violations and analysis of annual NPP Safety Reports, are used as tools to determination of trends towards changing of characteristics of operational safety, to assess the effectiveness of corrective measures, to monitor and evaluate the current operational safety level of NPPs, to regulate NPP safety. This report includes a list of the basic SPIs, those used by the Russian safety regulatory authority in regulatory activity. Some of them are absent in list of IAEA-TECDOC-1141 ('Operational safety performance indicators for nuclear power plants'). (author)

  7. Actions of the Cuban Nuclear Regulatory Authority in the adequate implementation of the legislation in matter of radiological protection

    International Nuclear Information System (INIS)

    Fornet R, O.M.; Guillen C, A.; Betancourt H, L.A.

    2006-01-01

    The effectiveness of the regulatory activity in matter of safety and radiological protection it depends in great measure of the practical implementation level of the legislation in this matter. In our country this objective has been achieved through the one continuous improvement of the Hierarchical System of Nuclear Regulation, the reconciliation with specialists and national experts in each matter during the elaboration of the legal documents; the popularization and gratuitous distribution of it approved; the precision in the validation conditions of the authorizations of those main precepts applicable to the practices; the legal foundation of the deficiencies evidenced in the regulatory inspections; the development of a Safety Culture; the realization of Annual Regulatory Conferences and mainly in the training of the personnel related with the safety. Also, the constant analysis on the part of the specialists of the Regulatory Authority of the grade of implementation of this legislation, it discussion in national and international events and the actions recommended in these works. As a result of this focus, it is considered that the Regulatory Authority has impacted appropriately in the implementation of this legislation. (Author)

  8. The planning, construction, and operation of a radioactive waste storage facility for an Australian state radiation regulatory authority

    Energy Technology Data Exchange (ETDEWEB)

    Wallace, J.D.; Kleinschmidt, R.; Veevers, P. [Radiation Health, Queensland (Australia)

    1995-12-31

    Radiation regulatory authorities have a responsibility for the management of radioactive waste. This, more often than not, includes the collection and safe storage of radioactive sources in disused radiation devices and devices seized by the regulatory authority following an accident, abandonment or unauthorised use. The public aversion to all things radioactive, regardless of the safety controls, together with the Not In My Back Yard (NIMBY) syndrome combine to make the establishment of a radioactive materials store a near impossible task, despite the fact that such a facility is a fundamental tool for regulatory authorities to provide for the radiation safety of the public. In Queensland the successful completion and operational use of such a storage facility has taken a total of 8 years of concerted effort by the staff of the regulatory authority, the expenditure of over $2 million (AUS) not including regulatory staff costs and the cost of construction of an earlier separate facility. This paper is a summary of the major developments in the planning, construction and eventual operation of the facility including technical and administrative details, together with the lessons learned from the perspective of the overall project.

  9. The Defence in Depth Concept Applied to the New Regulatory Requirements in Japan

    Energy Technology Data Exchange (ETDEWEB)

    Yamagata, H., E-mail: hiroshi_yamagata@nsr.go.jp [Nuclear Regulation Authority, Minato-ku, Tokyo (Japan)

    2014-10-15

    Full text: The new regulatory requirements based on lessons learnt from Fukushima Daiichi accident, which places emphasis on Defense-in-Depth concept, was put into effect in Japan on 8th July, 2013. It is required to prepare multi-layered protective measures. Each layer should achieve the objective only in that layer regardless of the measures in the other layers. The challenge is how to enhance independence of measures between layers. In the third layer, the current concept of design regarding safety relies on “single failure”, whose condition is elimination of common cause failure (CCF). To eliminate CCFs we introduced a more accurate approach in assessment of earthquake and tsunami, and introduction of measures against tsunami inundation. Redundancy of safety systems could not eliminate CCF by extreme natural hazards. Safety system should be designed by due consideration of diversity and independence including spatial dispersement. In the fourth layer, multi-layered protective measures are also applied for severe accidents, which consists of “prevention of core damage” under multiple failure, “prevention of containment failure”, and “prevention of large release, that is controlled release by venting”. In the fifth layer, we also require operators to prepare measures for “suppression of radioactive materials dispersion”. Of course, off-site emergency preparedness and response has been enhanced by introduction of PAZ and UPZ. Introduction of “Specialized Safety Facility” against intentional aircraft crash will contribute enhancement of some layers by providing electricity and water under extremely severe conditions. The new regulatory requirements are not our goal, just a first step. It is expected for regulator and operators to improve safety continuously by periodic comprehensive safety assessments including IPE, IPEEE, Margin test, and etc. We have to make an upward spiral of nuclear safety. (author)

  10. PHITS code improvements by Regulatory Standard and Research Department Secretariat of Nuclear Regulation Authority

    International Nuclear Information System (INIS)

    Goko, Shinji

    2017-01-01

    As for the safety analysis to be carried out when a nuclear power company applies for installation permission of facility or equipment, business license, design approval etc., the Regulatory Standard and Research Department Secretariat of Nuclear Regulation Authority continuously conducts safety research for the introduction of various technologies and their improvement in order to evaluate the adequacy of this safety analysis. In the field of the shielding analysis of nuclear fuel transportation materials, this group improved the code to make PHITS applicable to this field, and has been promoting the improvement as a tool used for regulations since FY2013. This paper introduced the history and progress of this safety research. PHITS 2.88, which is the latest version as of November 2016, was equipped with the automatic generation function of variance reduction parameters [T-WWG] etc., and developed as the tool equipped with many effective functions in practical application to nuclear power regulations. In addition, this group conducted the verification analysis against nuclear fuel packages, which showed a good agreement with the analysis by MCNP, which is extensively used worldwide and abundant in actual results. It also shows a relatively good agreement with the measured values, when considering differences in analysis and measurement. (A.O.)

  11. Canadian uranium mines and mills evolution of regulatory expectations and requirements for effluent treatment

    International Nuclear Information System (INIS)

    LeClair, J.; Ashley, F.

    2006-01-01

    The regulation of uranium mining in Canada has changed over time as our understanding and concern for impacts on both human and non-human biota has evolved. Since the mid-1970s and early 1980s, new uranium mine and mill developments have been the subject of environmental assessments to assess and determine the significance of environmental effects throughout the project life cycle including the post-decommissioning phase. Water treatment systems have subsequently been improved to limit potential effects by reducing the concentration of radiological and non-radiological contaminants in the effluent discharge and the total loadings to the environment. This paper examines current regulatory requirements and expectations and how these impact uranium mining/milling practices. It also reviews current water management and effluent treatment practices and performance. Finally, it examines the issues and challenges for existing effluent treatment systems and identifies factors to be considered in optimizing current facilities and future facility designs. (author)

  12. Ego depletion and positive illusions: does the construction of positivity require regulatory resources?

    Science.gov (United States)

    Fischer, Peter; Greitemeyer, Tobias; Frey, Dieter

    2007-09-01

    Individuals frequently exhibit positive illusions about their own abilities, their possibilities to control their environment, and future expectations. The authors propose that positive illusions require resources of self-control, which is considered to be a limited resource similar to energy or strength. Five studies revealed that people with depleted self-regulatory resources indeed exhibited a less-optimistic sense of their own abilities (Study 1), a lower sense of subjective control (Study 2), and less-optimistic expectations about their future (Study 3). Two further studies shed light on the underlying psychological process: Ego-depleted (compared to nondepleted) individuals generated/retrieved less positive self-relevant attributes (Studies 4 and 5) and reported a lower sense of general self-efficacy (Study 5), which both partially mediated the impact of ego depletion on positive self-views (Study 5).

  13. Development of guidance on applications of regulatory requirements for low specific activity materials and surface contaminated objects

    International Nuclear Information System (INIS)

    Pope, R.B.; Easton, E.P.; Shankman, S.F.; Boyle, R.W.

    1997-01-01

    In 1985, the International Atomic Energy Agency issued revised regulations for the safe transport of radioactive material. Significant among the changes were major revisions to requirements for Low Specific Activity (LSA) material and Surface Contaminated Objects (SCOs). In preparation for the adoption of these requirements into regulations in the United States, it became apparent that guidance on how to apply these requirements, clarifying technical uncertainties and ensuring proper implementation, would be needed both by the regulators and those regulated. Thus, the US Department of Transportation and the U.S. Nuclear Regulatory Commission, with the assistance of staff from Oak Ridge National Laboratory, are preparing regulatory guidance for LSA material and SCO transport. The guidance will present examples of acceptable methods for demonstrating compliance with the revised rules. Ideas being investigated for inclusion in the pending guidance are discussed in this paper. Under current plans, the guidance will be issued for public comment prior to final issue of the guidance in 1997. (Author)

  14. Use of probabilistic safety assessment in supporting regulatory authority`s work; Todennaekoeisyyspohjaisen turvallisuusanalyysin kaeyttoe viranomaistyoen tukena

    Energy Technology Data Exchange (ETDEWEB)

    Julin, A

    1995-11-01

    The aim of the study was to examine possibilities to use probabilistic safety assessment (PSA) more effectively in regulatory control of nuclear power plants. The structure, results and evaluation methods of PSA along with the necessary equations and principles, which could be used in utilising level 1 PSA results in decision making, have been introduced. The presented examples describe the ways PSA has been utilised abroad and particularly in Finnish Centre for Radiation and Nuclear Safety (STUK). The examples calculated in the study are based on the SPSA code and the PSA model of Olkiluoto nuclear power plant (TVO). The examples compare component safety classes versus safety importance and the risk of continued operation versus shutdown alternative in residual heat removal system failures. In addition to this allowed outage times, as calculated by PSA, were compared to allowed outage times according to technical specifications. The last 9 years operating experiences of TVO II was also examined by analysing the risk importance of significant component failures and operational disturbances. The analysis showed that the contribution of component failures and operational disturbances to the overall core damage risk during the studied time period was only 5 per cent. It appeared that the rare, significant initiating events provide the main contribution to the total cumulative risk. (57 refs., 22 figs., 17 tabs.).

  15. Data Bank of Nuclear and Radiological Regulatory Authority, Part 2 . Software Package of Statistical Data of Sealed Sources

    International Nuclear Information System (INIS)

    Lashin, R.M.A.; Mahmoud, N.S.; Lashin, M.M.A.

    2012-01-01

    Protection of human, property and the environment is the main concern considered as a principal goal to form the Egyptian Nuclear and Radiological Regulatory Authority. That requires a lot of work, efforts, knowledge and aids for right and quick decision making. Internationally, the International Atomic Energy Agency (IAEA) developed a protection system for control and accounts the radioactive materials for the safe use and transport. Moreover, the protection system can prevent the theft of these materials or their use in terrorism. Here in, all radioactive sources shall be subjected to instructions, serious regulations and laws. In order to exercise these functions, it is necessary to accurately establish the appropriate information system to the regulatory body. This system must depend on using a modern technology to perform the work in most accurate and fullest manner in a Data Bank [1, 2]. The present work is the second part performed for the data bank, which consists of two parts: first part is concern about the open sources which executed before [3]. Second part is deal with the sealed sources. Describing here consolidated guidance help materials licenses. It also provides reviewers of such requests with the information and materials necessary to determine that the products are acceptable for licensing purposes. It provides the applicants and reviewers with information concerning how to file a request, a listing of the applicable regulations and industry standards, policies affecting evaluation and registration, administrative procedures to be followed, information on how to perform the evaluation and write a registration certificate, and the responsibilities of the registration certificate holder.

  16. Development of Regulatory Requirements for Qualification Management of Railway Drivers

    Energy Technology Data Exchange (ETDEWEB)

    Byun, Seong Nam; Kim, Sa Kil; Kyung, Tae Won; Kim, Jung Ho; Heo, Eun Mee; Park, Hong Jun [Kyung Hee University, Seoul (Korea, Republic of)

    2008-03-15

    It has been estimated that up to 90% of all workplace accidents have human error as a cause. Human error has been widely recognized as a key factor in almost all the highly publicized accidents, including Daegu subway fire of February 18, 2003 killed 198 people and injured 147. Because most human behavior is {sup u}nintentional{sup ,} carried out automatically, uncontrolled qualifications of rail drivers as root causes of human error should be carefully investigated and regulated by a legal authority.

  17. Development of Regulatory Requirements for Qualification Management of Railway Drivers

    International Nuclear Information System (INIS)

    Byun, Seong Nam; Kim, Sa Kil; Kyung, Tae Won; Kim, Jung Ho; Heo, Eun Mee; Park, Hong Jun

    2008-03-01

    It has been estimated that up to 90% of all workplace accidents have human error as a cause. Human error has been widely recognized as a key factor in almost all the highly publicized accidents, including Daegu subway fire of February 18, 2003 killed 198 people and injured 147. Because most human behavior is u nintentional , carried out automatically, uncontrolled qualifications of rail drivers as root causes of human error should be carefully investigated and regulated by a legal authority

  18. 30 CFR 938.16 - Required regulatory program amendments.

    Science.gov (United States)

    2010-07-01

    ... consistent with section 510(d) of SMCRA by requiring that the restoration of prime farmland soil productivity... of the reclamation fee, as amended in § 86.17(e), will assure that the Surface Mining Conservation... current market value. (n) By November 1, 1991, Pennsylvania shall amend § 86.158(b)(2) or otherwise amend...

  19. 24 CFR 1710.16 - Regulatory exemption-determination required.

    Science.gov (United States)

    2010-04-01

    ... sewer facilities and any existing or promised amenities; (ii) Contains a good faith estimate of the year... the purchaser signed the sales contract, a warranty deed, or its equivalent under local law, which at... the requirements of one of the exemptions available under this chapter. (2) Each contract— (i...

  20. EU Activities for Training and Tutoring of Nuclear Regulatory Authorities and Technical Support Organisations Outside EU

    International Nuclear Information System (INIS)

    Pauwels, Henri; Daures, Pascal; Stockmann, Ynte

    2014-01-01

    Aim of Training and Tutoring Projects: Transfer of European Union nuclear safety regulatory experience and best practices. The following courses are listed: Courses in Nuclear Safety Regulation, Licensing and Enforcement; Nuclear Safety Assessment and Inspection

  1. 25 CFR 547.4 - How does a tribal government, tribal gaming regulatory authority, or tribal gaming operation...

    Science.gov (United States)

    2010-04-01

    ... 25 Indians 2 2010-04-01 2010-04-01 false How does a tribal government, tribal gaming regulatory authority, or tribal gaming operation comply with this part? 547.4 Section 547.4 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM TECHNICAL STANDARDS FOR GAMING...

  2. Satisfying regulatory and accreditation requirements for quality control.

    Science.gov (United States)

    Ehrmeyer, Sharon S

    2013-03-01

    The Clinical Laboratory Improvement Amendments of 1988 (CLIA) requires all US clinical laboratories that test "materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease..." to be regulated. The CLIA mandates are site neutral; based on test complexity; and focus on the three phases of the testing process (preanalytical, analytical, and postanalytical). Many testing sites choose to meet the CLIA requirements by following the testing standards of a professional accreditation organization deemed by the Centers for Medicare and Medicaid Services. The three principal organizations are The Joint Commission, the College of American Pathologists, and COLA. Copyright © 2013 Elsevier Inc. All rights reserved.

  3. Regulatory requirements of radiation protection for veterinary nuclear medicine

    International Nuclear Information System (INIS)

    Ernst-Elz, Andreas

    2010-01-01

    The application of radionuclides for diagnostic and therapy in veterinary medicine requires permission by terms of German radiation protection ordinance. Conditions for granting this licence are described. Preconditions are the requisite qualification of the veterinarian and the structural conditions of radiation protection. It is necessary to consider the possible exposure of the public by radioactive waste and by animals after their discharge from treatment. (orig.)

  4. Regulatory requirements for radiopharmaceutical radiochemistry and radiation dosimetry

    International Nuclear Information System (INIS)

    Bonnyman, J.

    1985-01-01

    The Australian Department of Health is responsible for ensuring that radiopharmaceuticals are safe and effective and that their use does not result in unnecessary radiation exposure. Section B1 requirements of New Drug Form 4 (NDF4) fall into the following sections - manufacture, product specifications, quality assurance testing, stability studies and expiry dating. It covers ready to inject pharmaceuticals, radioactive formulations used to prepare a radiopharmaceutical, generators and cold kits

  5. Investigation on regulatory requirements for radiation safety management

    International Nuclear Information System (INIS)

    Han, Eun Ok; Choi, Yoon Seok; Cho, Dae Hyung

    2013-01-01

    NRC recognizes that efficient management of radiation safety plan is an important factor to achieve radiation safety service. In case of Korea, the contents to perform the actual radiation safety management are legally contained in radiation safety management reports based on the Nuclear Safety Act. It is to prioritize the importance of safety regulations in each sector in accordance with the current situation of radiation and radioactive isotopes-used industry and to provide a basis for deriving safety requirements and safety regulations system maintenance by the priority of radiation safety management regulations. It would be helpful to achieve regulations to conform to reality based on international standards if consistent safety requirements is developed for domestic users, national standards and international standards on the basis of the results of questions answered by radiation safety managers, who lead on-site radiation safety management, about the priority of important factors in radioactive sources use, sales, production, moving user companies, to check whether derived configuration requirements for radiation safety management are suitable for domestic status

  6. Data Quality Objectives for Regulatory Requirements for Hazardous and Radioactive Air Emissions Sampling and Analysis

    International Nuclear Information System (INIS)

    MULKEY, C.H.

    1999-01-01

    This document describes the results of the data quality objective (DQO) process undertaken to define data needs for state and federal requirements associated with toxic, hazardous, and/or radiological air emissions under the jurisdiction of the River Protection Project (RPP). Hereafter, this document is referred to as the Air DQO. The primary drivers for characterization under this DQO are the regulatory requirements pursuant to Washington State regulations, that may require sampling and analysis. The federal regulations concerning air emissions are incorporated into the Washington State regulations. Data needs exist for nonradioactive and radioactive waste constituents and characteristics as identified through the DQO process described in this document. The purpose is to identify current data needs for complying with regulatory drivers for the measurement of air emissions from RPP facilities in support of air permitting. These drivers include best management practices; similar analyses may have more than one regulatory driver. This document should not be used for determining overall compliance with regulations because the regulations are in constant change, and this document may not reflect the latest regulatory requirements. Regulatory requirements are also expected to change as various permits are issued. Data needs require samples for both radionuclides and nonradionuclide analytes of air emissions from tanks and stored waste containers. The collection of data is to support environmental permitting and compliance, not for health and safety issues

  7. Assessment of Quality Assurance Measures for Radioactive Material Transport Packages not Requiring Competent Authority Design Approval - 13282

    International Nuclear Information System (INIS)

    Komann, Steffen; Groeke, Carsten; Droste, Bernhard

    2013-01-01

    The majority of transports of radioactive materials are carried out in packages which don't need a package design approval by a competent authority. Low-active radioactive materials are transported in such packages e.g. in the medical and pharmaceutical industry and in the nuclear industry as well. Decommissioning of NPP's leads to a strong demand for packages to transport low and middle active radioactive waste. According to IAEA regulations the 'non-competent authority approved package types' are the Excepted Packages and the Industrial Packages of Type IP-1, IP-2 and IP-3 and packages of Type A. For these types of packages an assessment by the competent authority is required for the quality assurance measures for the design, manufacture, testing, documentation, use, maintenance and inspection (IAEA SSR 6, Chap. 306). In general a compliance audit of the manufacturer of the packaging is required during this assessment procedure. Their regulatory level in the IAEA regulations is not comparable with the 'regulatory density' for packages requiring competent authority package design approval. Practices in different countries lead to different approaches within the assessment of the quality assurance measures in the management system as well as in the quality assurance program of a special package design. To use the package or packaging in a safe manner and in compliance with the regulations a management system for each phase of the life of the package or packaging is necessary. The relevant IAEA-SSR6 chap. 801 requires documentary verification by the consignor concerning package compliance with the requirements. (authors)

  8. Assessment of Quality Assurance Measures for Radioactive Material Transport Packages not Requiring Competent Authority Design Approval - 13282

    Energy Technology Data Exchange (ETDEWEB)

    Komann, Steffen; Groeke, Carsten; Droste, Bernhard [BAM Federal Institute for Materials Research and Testing, Unter den Eichen 44-46, 12203 Berlin (Germany)

    2013-07-01

    The majority of transports of radioactive materials are carried out in packages which don't need a package design approval by a competent authority. Low-active radioactive materials are transported in such packages e.g. in the medical and pharmaceutical industry and in the nuclear industry as well. Decommissioning of NPP's leads to a strong demand for packages to transport low and middle active radioactive waste. According to IAEA regulations the 'non-competent authority approved package types' are the Excepted Packages and the Industrial Packages of Type IP-1, IP-2 and IP-3 and packages of Type A. For these types of packages an assessment by the competent authority is required for the quality assurance measures for the design, manufacture, testing, documentation, use, maintenance and inspection (IAEA SSR 6, Chap. 306). In general a compliance audit of the manufacturer of the packaging is required during this assessment procedure. Their regulatory level in the IAEA regulations is not comparable with the 'regulatory density' for packages requiring competent authority package design approval. Practices in different countries lead to different approaches within the assessment of the quality assurance measures in the management system as well as in the quality assurance program of a special package design. To use the package or packaging in a safe manner and in compliance with the regulations a management system for each phase of the life of the package or packaging is necessary. The relevant IAEA-SSR6 chap. 801 requires documentary verification by the consignor concerning package compliance with the requirements. (authors)

  9. Governmental, Legal and Regulatory Framework for Safety. General Safety Requirements. Part 1

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2010-09-15

    The objective of this publication is to establish requirements in respect of the governmental, legal and regulatory framework for safety. It covers the essential aspects of the framework for establishing a regulatory body and taking other actions necessary to ensure the effective regulatory control of facilities and activities utilized for peaceful purposes. Other responsibilities and functions, such as liaison within the global safety regime and on support services for safety (including radiation protection), emergency preparedness and response, nuclear security, and the State system of accounting for and control of nuclear material, are also covered.

  10. Governmental, Legal and Regulatory Framework for Safety. General Safety Requirements. Part 1 (Arabic Edition)

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2010-09-15

    The objective of this publication is to establish requirements in respect of the governmental, legal and regulatory framework for safety. It covers the essential aspects of the framework for establishing a regulatory body and taking other actions necessary to ensure the effective regulatory control of facilities and activities utilized for peaceful purposes. Other responsibilities and functions, such as liaison within the global safety regime and on support services for safety (including radiation protection), emergency preparedness and response, nuclear security, and the State system of accounting for and control of nuclear material, are also covered.

  11. Governmental, Legal and Regulatory Framework for Safety. General Safety Requirements. Part 1 (Spanish Edition)

    International Nuclear Information System (INIS)

    2010-01-01

    The objective of this publication is to establish requirements in respect of the governmental, legal and regulatory framework for safety. It covers the essential aspects of the framework for establishing a regulatory body and taking other actions necessary to ensure the effective regulatory control of facilities and activities utilized for peaceful purposes. Other responsibilities and functions, such as liaison within the global safety regime and on support services for safety (including radiation protection), emergency preparedness and response, nuclear security, and the State system of accounting for and control of nuclear material, are also covered

  12. Governmental, Legal and Regulatory Framework for Safety. General Safety Requirements. Part 1 (French Edition)

    International Nuclear Information System (INIS)

    2010-01-01

    The objective of this publication is to establish requirements in respect of the governmental, legal and regulatory framework for safety. It covers the essential aspects of the framework for establishing a regulatory body and taking other actions necessary to ensure the effective regulatory control of facilities and activities utilized for peaceful purposes. Other responsibilities and functions, such as liaison within the global safety regime and on support services for safety (including radiation protection), emergency preparedness and response, nuclear security, and the State system of accounting for and control of nuclear material, are also covered

  13. Governmental, Legal and Regulatory Framework for Safety. General Safety Requirements. Part 1 (Chinese Edition)

    International Nuclear Information System (INIS)

    2010-01-01

    The objective of this publication is to establish requirements in respect of the governmental, legal and regulatory framework for safety. It covers the essential aspects of the framework for establishing a regulatory body and taking other actions necessary to ensure the effective regulatory control of facilities and activities utilized for peaceful purposes. Other responsibilities and functions, such as liaison within the global safety regime and on support services for safety (including radiation protection), emergency preparedness and response, nuclear security, and the State system of accounting for and control of nuclear material, are also covered

  14. [European Union regulatory and quality requirements for botanical drugs and their implications for Chinese herbal medicinal products development].

    Science.gov (United States)

    Zhu, You-Ping

    2017-06-01

    This paper introduces regulatory pathways and characteristic quality requirements for marketing authorization of herbal medicinal products in the European Union(EU), and the legal status and applications of "European Union list of herbal substances, preparations and combinations" and "European Union herbal monographs". Also introduced are Chinese herbs that have been granted the EU list entry, those with EU herbal monographs, and registered EU traditional herbal medicinal products with Chinese herbs as active ingredients. Special attention is paid to the technical details of three authorized EU herbal medicinal products (Veregen, Sativex and Episalvan) in comparison with Andrographis paniculata extract HMPL-004 that failed the phase Ⅲ clinical trial for ulcerative colitis. The paper further emphasizes the importance of enriching active fractions of herbal extracts and taking regulatory and quality considerations into account in early stage of botanical drug development. Copyright© by the Chinese Pharmaceutical Association.

  15. Regulatory requirements for demonstration of the achieved safety level at the Mochovce NPP before commissioning

    International Nuclear Information System (INIS)

    Lipar, M.

    1997-01-01

    A review of regulatory requirements for demonstration of the achieved safety level at the Mochovce NPP before commissioning is given. It contains licensing steps in Slovakia during commissioning; Status and methodology of Mochovce safety analysis report; Mochovce NPP safety enhancement program; Regulatory body policy towards Mochovce NPP safety enhancement; Recent development in Mochovce pre-operational safety enhancement program review and assessment process; Licensing steps in Slovakia during commissioning

  16. Regulatory objectives, requirements and guidelines for the disposal of radioactive wastes - long-term aspects

    International Nuclear Information System (INIS)

    1987-01-01

    It is the purpose of this document to present the regulatory basis for judging the long-term acceptability of radioactive waste disposal options, assuming that the operational aspects of waste emplacement and facility closure satisfy the existing regulatory framework of requirements. Basic objectives of radioactive waste disposal are given, as are the regulatory requirements which must be satisfied in order to achieve these objectives. In addition, guidelines are given on the application of the radiological requirements to assist proponents in the preparation of submissions to the Atomic Energy Control Board (AECB). The primary focus of the requirements is on radiation protection, although environmental protection and institutional controls are also addressed in a more general way since these factors stem directly from the overall objectives for radioactive waste disposal

  17. 17 CFR 249.821 - Form PILOT, information required of self-regulatory organizations operating pilot trading systems...

    Science.gov (United States)

    2010-04-01

    ... required of self-regulatory organizations operating pilot trading systems pursuant to § 240.19b-5 of this... Associations § 249.821 Form PILOT, information required of self-regulatory organizations operating pilot trading systems pursuant to § 240.19b-5 of this chapter. This form shall be used by all self-regulatory...

  18. A guide to ventilation requirements for uranium mines and mills. Regulatory guide G-221

    International Nuclear Information System (INIS)

    2003-06-01

    The purpose of G-221 is to help persons address the requirements for the submission of ventilation-related information when applying for a Canadian Nuclear Safety Commission (CNSC) licence to site and construct, operate or decommission a uranium mine or mill. This guide is also intended to help applicants for a uranium mine or mill licence understand their operational and maintenance obligations with respect to ventilation systems, and to help CNSC staff evaluate the adequacy of applications for uranium mine and mill licences. This guide is relevant to any application for a CNSC licence to prepare a site for and construct, operate or decommission a uranium mine or mill. In addition to summarizing the ventilation-related obligations or uranium mine and mill licensee, the guide describes and discusses the ventilation-related information that licence applicants should typically submit to meet regulatory requirements. The guide pertains to any ventilation of uranium mines and mills for the purpose of assuring the radiation safety of workers and on-site personnel. This ventilation may be associated with any underground or surface area or premise that is licensable by the CNSC as part of a uranium mine or mill. These areas and premises typically include mine workings, mill buildings, and other areas or premises involving or potentially affected by radiation or radioactive materials. Some examples of the latter include offices, effluent treatment plants, cafeterias, lunch rooms and personnel change-rooms. (author)

  19. The functions and organization of the regulatory authority for nuclear energy in Turkey

    International Nuclear Information System (INIS)

    Aybers, Nejat

    1979-01-01

    Following a description of the legislative and regulatory provisions governing nuclear activities in Turkey, this paper analyses the licensing system for nuclear installations. Special emphasis is placed on the problems of setting up a nuclear power plant project in a developing country and on the need for codes of practice on safe design and operation of such plants at the national level. (NEA) [fr

  20. 47 CFR 1.1151 - Authority to prescribe and collect regulatory fees.

    Science.gov (United States)

    2010-10-01

    ... regulatory activities in the private radio, mass media, common carrier, and cable television services. [59 FR... fees. 1.1151 Section 1.1151 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL PRACTICE AND... section 9 of the Communications Act, 47 U.S.C. 159, which directs the Commission to prescribe and collect...

  1. Governmental, Legal and Regulatory Framework for Safety. General Safety Requirements. Part 1, Revision 1 (Chinese Edition)

    International Nuclear Information System (INIS)

    2016-01-01

    This publication establishes requirements in respect of the governmental, legal and regulatory framework for safety. It covers the essential aspects of the framework for establishing a regulatory body and taking other actions necessary to ensure the effective regulatory control of facilities and activities utilized for peaceful purposes. Other responsibilities and functions, such as liaison within the global safety regime and on support services for safety (including radiation protection), emergency preparedness and response, nuclear security, and the State system of accounting for and control of nuclear material, are also covered. A review of Safety Requirements publications was commenced in 2011 following the accident in the Fukushima Daiichi nuclear power plant in Japan. The review revealed no significant areas of weakness and resulted in just a small set of amendments to strengthen the requirements and facilitate their implementation, which are contained in the present publication.

  2. Experts Complete IAEA Follow-up Review of Australia's Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: Nuclear and radiation safety experts today concluded an eight-day mission to review the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA), the country's nuclear regulator. At the request of the Australian Government, the International Atomic Energy Agency (IAEA) assembled a peer-review team of five regulatory experts from as many nations and three IAEA staff members to conduct a follow-up assessment of an Integrated Regulatory Review Service (IRRS) mission conducted in 2007. This follow-up IRRS mission examined ARPANSA's progress in acting upon the recommendations and suggestions made during the 2007 IRRS mission and reviewed the areas of significant regulatory changes since that review. Both reviews covered safety regulatory aspects of all facilities and activities regulated by ARPANSA. IRRS team leader Kaare Ulbak, Chief Advisor of Denmark's National Institute of Radiation Protection, said: ''ARPANSA should be commended for the significant amount of efforts in addressing all the findings identified in the 2007 mission and for inviting this follow-up review.'' The review team found that ARPANSA has made significant progress toward improving its regulatory activities, as most of the findings identified in the 2007 report have been effectively addressed and therefore can be considered closed. Complementing the ARPANSA strengths identified during the 2007 mission, the 2011 IRRS team noted the following strengths: Response to the Tepco Fukushima Dai-ichi accident; High level of in-house technical expertise in radiation safety; Recognition of the need and willingness to re-organize ARPANSA; Timely development of the national sealed source register in good coordination with other relevant organizations; and Creation of the Australian clinical dosimetry service and the national dose reference levels database. The 2011 IRRS team also made recommendations and suggestions to further strengthen ARPANSA's regulatory system, including: Making full

  3. Legislative framework and regulatory requirements for the introduction of nuclear power

    International Nuclear Information System (INIS)

    Ha-Vinh, Phuong

    1975-01-01

    The adoption of appropriate legislation is to be considered as a prerequisite to the introduction of nuclear power in view of the issues that need to be regulated. Preparatory steps should be started at the earliest stage in conjunction with the planning of nuclear power projects. The primary objectives of a licensing scheme are to ensure safety, public health and environmental protection as well as financial protection for third parties in case of nuclear incident. For licensing purposes, a legislative framework and regulatory determinations are required. Within such a framework and pursuant to such regulatory determinations, the elaboration of safety standards, rules, guides and enforcement procedures is to be considered of paramount importance. To this end a number of international recommendations and advisory material prepared by the IAEA provide useful guidance. A licensing process would normally be split into several stages relating to site approval, construction permit, pre-operational tests, and operating licence, each stage being subject to safety assessments and reviews as determined by regulations. Financial protection against nuclear damage has also to be insured. A special regime of nuclear liability has been established by international conventions, based on the principle of strict liability of the operator of a nuclear installation. As a result of such channelling of liability to him, his liability is limited in amount and time. This liability system has the dual purpose of ensuring appropriate protection for potential victims and of relieving the nuclear industry from unlimited liability risks, which would impede practical applications of atomic energy. For the elaboration of nuclear legislation and specialized regulations the Agency's advisory services have proved to be of help to countries embarking on a nuclear power programme. (author)

  4. Development of regulatory requirements/guides for desalination unit coupled with nuclear plant

    International Nuclear Information System (INIS)

    Jo, Jong Chull; Yune, Young Gill; Kim, Woong Sik

    2005-10-01

    The basic design of System-integrated Modular Advanced Reactor (SMART), a small-to-medium sized integral type pressurized water reactor (PWR) with the capacity of 330MWth, has been developed in Korea. In order to demonstrate the safety and performance of the SMART design, 'Development Project of SMART-P (SMART-Pilot Plant)' has been being performed as one of the 'National Mid and Long-term Atomic Energy R and D Programs', which includes design, construction, and start-up operation of the SMART-P with the capacity of 65MWth, a 1/5 scaled-down design of the SMART. At the same time, a study on the development of regulatory requirements/guides for the desalination unit coupled with nuclear plant has been carried out by KINS in order to prepare for the forthcoming SMART-P licensing. The results of this study performed from August of 2002 to October of 2005 can be summarized as follows: (1) The general status of desalination technologies has been survey. (2) The design of the desalination plant coupled with the SMART-P has been investigated. (3) The regulatory requirements/guides relevant to a desalination unit coupled with a nuclear plant have been surveyed. (4) A direction on the development of domestic regulatory requirements/guides for a desalination unit has been established. (5) A draft of regulatory requirements/guides for a desalination unit has been developed. (6) Expert technical reviews have been performed for the draft regulatory requirements/guides for a desalination unit. The draft regulatory requirements/guides developed in this study will be finalized and can be applied directly to the licensing of the SMART-P and SMART. Furthermore, it will be also applied to the licensing of the desalination unit coupled with the nuclear plant

  5. A study on the influence of the regulatory requirements of a nuclear facility during decommissioning activities

    Energy Technology Data Exchange (ETDEWEB)

    Park, Hee Seong; Park, Seung Kook; Park, Kook Nam; Hong, Yun Jeong; Park, Jang Jin; Choi, Jong Won [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2016-10-15

    The preliminary decommissioning plan should be written with various chapters such as a radiological characterization, a decommissioning strategy and methods, a design for decommissioning usability, a safety evaluation, decontamination and dismantling activities, radioactive waste management, an environmental effect evaluation, and fire protection. The process requirements of the decommissioning project and the technical requirements and technical criteria should comply with regulatory requirements when dismantling of a nuclear facility. The requirements related to safety in the dismantling of a nuclear facility refer to the IAEA safety serious. The present paper indicates that a decommissioning design and plan, dismantling activities, and a decommissioning project will be influenced by the decommissioning regulatory requirements when dismantling of a nuclear facility. We hereby paved the way to find the effect of the regulatory requirements on the decommissioning of a whole area from the decommissioning strategy to the radioactive waste treatment when dismantling a nuclear facility. The decommissioning requirements have a unique feature in terms of a horizontal relationship as well as a vertical relationship from the regulation requirements to the decommissioning technical requirements. The decommissioning requirements management will be conducted through research that can recognize a multiple relationship in the next stage.

  6. Data Quality Objectives for Regulatory Requirements for Hazardous and Radioactive Air Emissions Sampling and Analysis

    Energy Technology Data Exchange (ETDEWEB)

    MULKEY, C.H.

    1999-07-06

    This document describes the results of the data quality objective (DQO) process undertaken to define data needs for state and federal requirements associated with toxic, hazardous, and/or radiological air emissions under the jurisdiction of the River Protection Project (RPP). Hereafter, this document is referred to as the Air DQO. The primary drivers for characterization under this DQO are the regulatory requirements pursuant to Washington State regulations, that may require sampling and analysis. The federal regulations concerning air emissions are incorporated into the Washington State regulations. Data needs exist for nonradioactive and radioactive waste constituents and characteristics as identified through the DQO process described in this document. The purpose is to identify current data needs for complying with regulatory drivers for the measurement of air emissions from RPP facilities in support of air permitting. These drivers include best management practices; similar analyses may have more than one regulatory driver. This document should not be used for determining overall compliance with regulations because the regulations are in constant change, and this document may not reflect the latest regulatory requirements. Regulatory requirements are also expected to change as various permits are issued. Data needs require samples for both radionuclides and nonradionuclide analytes of air emissions from tanks and stored waste containers. The collection of data is to support environmental permitting and compliance, not for health and safety issues. This document does not address health or safety regulations or requirements (those of the Occupational Safety and Health Administration or the National Institute of Occupational Safety and Health) or continuous emission monitoring systems. This DQO is applicable to all equipment, facilities, and operations under the jurisdiction of RPP that emit or have the potential to emit regulated air pollutants.

  7. Data Quality Objectives for Regulatory Requirements for Hazardous and Radioactive Air Emissions Sampling and Analysis

    International Nuclear Information System (INIS)

    MULKEY, C.H.

    1999-01-01

    This document describes the results of the data quality objective (DQO) process undertaken to define data needs for state and federal requirements associated with toxic, hazardous, and/or radiological air emissions under the jurisdiction of the River Protection Project (RPP). Hereafter, this document is referred to as the Air DQO. The primary drivers for characterization under this DQO are the regulatory requirements pursuant to Washington State regulations, that may require sampling and analysis. The federal regulations concerning air emissions are incorporated into the Washington State regulations. Data needs exist for nonradioactive and radioactive waste constituents and characteristics as identified through the DQO process described in this document. The purpose is to identify current data needs for complying with regulatory drivers for the measurement of air emissions from RPP facilities in support of air permitting. These drivers include best management practices; similar analyses may have more than one regulatory driver. This document should not be used for determining overall compliance with regulations because the regulations are in constant change, and this document may not reflect the latest regulatory requirements. Regulatory requirements are also expected to change as various permits are issued. Data needs require samples for both radionuclides and nonradionuclide analytes of air emissions from tanks and stored waste containers. The collection of data is to support environmental permitting and compliance, not for health and safety issues. This document does not address health or safety regulations or requirements (those of the Occupational Safety and Health Administration or the National Institute of Occupational Safety and Health) or continuous emission monitoring systems. This DQO is applicable to all equipment, facilities, and operations under the jurisdiction of RPP that emit or have the potential to emit regulated air pollutants

  8. Data Quality Objectives for Regulatory Requirements for Hazardous and Radioactive Air Emissions Sampling and Analysis; FINAL

    International Nuclear Information System (INIS)

    MULKEY, C.H.

    1999-01-01

    This document describes the results of the data quality objective (DQO) process undertaken to define data needs for state and federal requirements associated with toxic, hazardous, and/or radiological air emissions under the jurisdiction of the River Protection Project (RPP). Hereafter, this document is referred to as the Air DQO. The primary drivers for characterization under this DQO are the regulatory requirements pursuant to Washington State regulations, that may require sampling and analysis. The federal regulations concerning air emissions are incorporated into the Washington State regulations. Data needs exist for nonradioactive and radioactive waste constituents and characteristics as identified through the DQO process described in this document. The purpose is to identify current data needs for complying with regulatory drivers for the measurement of air emissions from RPP facilities in support of air permitting. These drivers include best management practices; similar analyses may have more than one regulatory driver. This document should not be used for determining overall compliance with regulations because the regulations are in constant change, and this document may not reflect the latest regulatory requirements. Regulatory requirements are also expected to change as various permits are issued. Data needs require samples for both radionuclides and nonradionuclide analytes of air emissions from tanks and stored waste containers. The collection of data is to support environmental permitting and compliance, not for health and safety issues. This document does not address health or safety regulations or requirements (those of the Occupational Safety and Health Administration or the National Institute of Occupational Safety and Health) or continuous emission monitoring systems. This DQO is applicable to all equipment, facilities, and operations under the jurisdiction of RPP that emit or have the potential to emit regulated air pollutants

  9. Analysis of regulatory requirement for beyond design basis events of SMART

    International Nuclear Information System (INIS)

    Kim, W. S.; Seol, K. W.

    2000-01-01

    To enhance the safety of SMART reactor, safety and regulatory requirements associated with beyond design basis events (beyond BDE), which were developed and applied to advanced light water reactor designs, were analyzed along with a design status of passive reactor. And, based on these requirements, their applicability on the SMART design was evaluated. In the design aspect, severe accident prevention and mitigation features, containment performance, and accident management were analyzed. The evaluation results show that the requirement related to beyond DBE such as ATWS, loss of residual heat removal during shutdown operation, station blackout, fire, inter-system LOCA, and well-known events from severe accident phenomena is applicable to the SMART design. However, comprehensive approach against beyond DBE is not yet provided in the SMART design, and then it is required to designate and analyze the beyond DBE-related features. This study is expected to contribute to efforts to improve plant safety and to establish regulatory requirements for safety review

  10. Evaluation of research reactor fuel reliability in support of regulatory requirements

    International Nuclear Information System (INIS)

    Sokolov, Eugene N.

    2005-01-01

    This standards, codes and practices survey is devoted to the problem of reliability of R and D especially research reactor fuel (RRF) performance-related processes. Regulatory R and D evaluations were based on one standard and just few of them provide correlation to other relative standards whereas synthetic process approach reflects actual status of particular R and D practices. Fuel performance regulatory parameters are based on quality standards. A reliability process-based method similar to PSA/FMEA is proposed to evaluate RRF performance- related parameters in terms of reactor safety. (author)

  11. Evaluation of research reactor fuel reliability in support of regulatory requirements

    Energy Technology Data Exchange (ETDEWEB)

    Sokolov, Eugene N [Chalk River Laboratories, AECL, Chalk River, ON, K0J 1J0 (Canada)

    2005-07-01

    This standards, codes and practices survey is devoted to the problem of reliability of R and D especially research reactor fuel (RRF) performance-related processes. Regulatory R and D evaluations were based on one standard and just few of them provide correlation to other relative standards whereas synthetic process approach reflects actual status of particular R and D practices. Fuel performance regulatory parameters are based on quality standards. A reliability process-based method similar to PSA/FMEA is proposed to evaluate RRF performance- related parameters in terms of reactor safety. (author)

  12. Nuclear Regulatory Commission authorizations for Fiscal Years 1984 and 1985. House of Representatives, Ninety-Eighth Congress, First Session

    International Nuclear Information System (INIS)

    Anon.

    1983-01-01

    H.R. 2510, as amended, authorizes $466.8 million to cover Nuclear Regulatory Commission salaries and expenses for fiscal year 1984 and $460 million for the following year in a two-year authorization. The bill substitutes certain expenditures for those recommended in the NRC request, while keeping the funding level the same. The committee report reviews and summarizes the two-year budget appropriation and the hearings before giving a section-by-section analysis. It notes that 46% is earmarked for waste management, and emphasizes the safety factors which have caused delays in construction and modifications in existing plants. 13 tables

  13. Technical and scientific support to nuclear regulatory authority in Montenegro. Present situation and outlooks for the future

    International Nuclear Information System (INIS)

    Jovanovic, S.

    2007-01-01

    Nuclear regulatory competences in the Republic of Montenegro are shared between the ministries of health and of the environment. Following the independence of the country by mid 2006, Radiation Protection Commission (RPC) is established within the Ministry of Health, so as to match the regulatory role for the sources used in medicine. A similar step is expected to be made soon within the Ministry of the Environment, too. The two commissions will likely and logically merge into one, representing an interim regulatory authority to be functioning until a full capacity and effectively independent regulatory body is established by new nuclear law. Promulgation of the latter is expected to take part in the course of 2007. Let us mention here that the law in force is one from 1996 - quite obsolete and not taking into consideration the Basic Safety Standards (IAEA, 1996) and subsequent IAEA and EU documents in the field. Montenegro is a small, non-nuclear country (no nuclear installations or fuel cycle segments), the use of radiation sources being limited mostly to medical and industrial applications. Technical support to regulatory functions, in whatever basic form these were effectuated up to now, was/is given by the Centre for Eco-Toxicological Research of Montenegro (CETI), Department of Radiation Protection and Monitoring, in Podgorica. As to scientific support, it is fundamentally to be found at the University of Montenegro, Faculty of Sciences (FS), Department of Physics. While CETI is relatively well equipped, running quite a modern nuclear spectrometry laboratory (alpha, beta and gamma spectrometry, radon measurements) and having a decent dosimetry unit (TLD, field and workplace monitoring), FS is practically limited to sporadic theoretical studies, with very poor laboratory capabilities. Environmental radioactivity monitoring is performed by CETI, following the programme defined by the government. Licensing and inspections are the two regulatory functions still

  14. Regulatory requirements on management of radioactive material safe transport in China

    International Nuclear Information System (INIS)

    Chu, C.

    2016-01-01

    Since 1980s, the IAEA Regulation for safe transport of radioactive material was introduced into China; the regulatory system of China began with international standards, and walked towards the institutionalized. In 2003 the National People’s Congress (NPC) promulgated “the Act on the Prevention of Radioactive Pollution of the People's Republic of China”. In 2009 “Regulation for the Safe Transport of Radioactive Material” (Referred to “Regulation”) was promulgated by the State Council. Subsequently, the National Nuclear Safety Administration (NNSA) began to formulate executive detailed department rules, regulations guidelines and standards. The present system of acts, regulations and standards on management of safe transport of radioactive material in China and future planning were introduced in this paper. Meanwhile, the paper described the specific administration requirements of the Regulation on classification management of radioactive materials, license management of transport packaging including design, manufacture and use, licensing management of transport activities and the provisions of illegal behaviors arising in safe transport of radioactive material. (author)

  15. Galectin-1 is required for the regulatory function of B cells.

    Science.gov (United States)

    Alhabbab, R; Blair, P; Smyth, L A; Ratnasothy, K; Peng, Q; Moreau, A; Lechler, R; Elgueta, R; Lombardi, G

    2018-02-09

    Galectin-1 (Gal-1) is required for the development of B cells in the bone marrow (BM), however very little is known about the contribution of Gal-1 to the development of B cell regulatory function. Here, we report an important role for Gal-1 in the induction of B cells regulatory function. Mice deficient of Gal-1 (Gal-1 -/- ) showed significant loss of Transitional-2 (T2) B cells, previously reported to include IL-10 + regulatory B cells. Gal-1 -/- B cells stimulated in vitro via CD40 molecules have impaired IL-10 and Tim-1 expression, the latter reported to be required for IL-10 production in regulatory B cells, and increased TNF-α expression compared to wild type (WT) B cells. Unlike their WT counterparts, T2 and T1 Gal-1 -/- B cells did not suppress TNF-α expression by CD4 + T cells activated in vitro with allogenic DCs (allo-DCs), nor were they suppressive in vivo, being unable to delay MHC-class I mismatched skin allograft rejection following adoptive transfer. Moreover, T cells stimulated with allo-DCs show an increase in their survival when co-cultured with Gal-1 -/- T2 and MZ B cells compared to WT T2 and MZ B cells. Collectively, these data suggest that Gal-1 contributes to the induction of B cells regulatory function.

  16. An overview of exhaust emissions regulatory requirements and control technology for stationary natural gas engines

    International Nuclear Information System (INIS)

    Ballard, H.N.; Hay, S.C.; Shade, W.N. Jr.

    1992-01-01

    In this paper a practical overview of stationary natural gas engine exhaust emissions control technology and trends in emissions regulatory requirements is presented. Selective and non-selective catalytic reduction and lean burn technologies are compared. Particular emphasis is focussed on implications of the Clean Air Act of 1990. Recent emissions reduction conversion kit developments and a practical approach to continuous monitoring are discussed

  17. Information management systems for integrating the technical data and regulatory requirements of environmental restoration activities

    International Nuclear Information System (INIS)

    Geffen, C.A.; Garrett, B.A.; Walter, M.B.

    1990-03-01

    Current environmental regulations require that comprehensive planning be conducted before remediating a hazardous waste site to characterize the nature and extent of site contamination, calculate the risk to the public, and assess the effectiveness of various remediation technologies. Remediation of Department of Energy (DOE) sites contaminated with hazardous or mixed wastes will require the effective integration of scientific and engineering data with regulatory and institutional requirements. The information management challenge presented by waste site cleanup activities goes beyond merely dealing with the large quantity of data that will be generated. The information must be stored, managed, and presented in a way that provides some consistency in approach across sites, avoids duplication of effort, and facilitates responses to requests for information from the regulators and the public. This paper provides background information on the regulatory requirements for data gathering and analysis for environmental restoration activities, and outlines the data and information management requirements for completing the pre-remediation phases of an environmental restoration project. Information management systems for integrating the regulatory and institutional requirements of the environmental restoration process with the technical data and analysis requirements are also described. 7 refs

  18. Requirements for the authorization of operation os a calibration laboratory of gamma-ray monitors

    International Nuclear Information System (INIS)

    Silva, Raimundo Dias da; Kibrit, Eduardo

    2011-01-01

    This paper describes the process for obtaining the authorization of operation of a laboratory designed to calibrate area and personal monitors with gamma radiation, by using a sealed Cs-137 source. The regulations of Comissao Nacional de Energia Nuclear (CNEN) are deeply analysed and discussed. The authorization for construction, the authorization for modification of items important to safety, the authorization for the acquisition and handling of radiation sources, the authorization for operating, and the authorization for withdrawal of operation of the laboratory are also discussed. The paper also describes the technical and managerial requirements necessary to operate a gamma radiation calibration laboratory in Brazil. . (author)

  19. Situation of the medical physics in the Republic of Argentina. Regulatory problem linked to the requirement of physic specialists

    International Nuclear Information System (INIS)

    Arbor Gonzalez, A.; Larcher, A.; Blanco, S.

    2001-01-01

    This paper provides up-to-date data on the participation of medical physicists in current staffs for radiotherapy, nuclear medicine and diagnostic radiology in Argentina, and it presents projections on the academic education of specialists in the next five years. At the same time, the regulatory framework including the requirements for physicists staffing levels in medical practices is presented. This panorama permits to stick out the important role of the professional associations and the academic institutions in the development of Medical Physics in the country. (author)

  20. 19 CFR 113.1 - Authority to require security or execution of bond.

    Science.gov (United States)

    2010-04-01

    ... 19 Customs Duties 1 2010-04-01 2010-04-01 false Authority to require security or execution of bond. 113.1 Section 113.1 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY CUSTOMS BONDS General Provisions § 113.1 Authority to require security or...

  1. Risk-informed assessment of regulatory and design requirements for future nuclear power plants. Annual report

    International Nuclear Information System (INIS)

    2000-01-01

    OAK B188 Risk-informed assessment of regulatory and design requirements for future nuclear power plants. Annual report. The overall goal of this research project is to support innovation in new nuclear power plant designs. This project is examining the implications, for future reactors and future safety regulation, of utilizing a new risk-informed regulatory system as a replacement for the current system. This innovation will be made possible through development of a scientific, highly risk-formed approach for the design and regulation of nuclear power plants. This approach will include the development and/or confirmation of corresponding regulatory requirements and industry standards. The major impediment to long term competitiveness of new nuclear plants in the U.S. is the capital cost component--which may need to be reduced on the order of 35% to 40% for Advanced Light Water Reactors (ALWRS) such as System 80+ and Advanced Boiling Water Reactor (ABWR). The required cost reduction for an ALWR such as AP600 or AP1000 would be expected to be less. Such reductions in capital cost will require a fundamental reevaluation of the industry standards and regulatory bases under which nuclear plants are designed and licensed. Fortunately, there is now an increasing awareness that many of the existing regulatory requirements and industry standards are not significantly contributing to safety and reliability and, therefore, are unnecessarily adding to nuclear plant costs. Not only does this degrade the economic competitiveness of nuclear energy, it results in unnecessary costs to the American electricity consumer. While addressing these concerns, this research project will be coordinated with current efforts of industry and NRC to develop risk-informed, performance-based regulations that affect the operation of the existing nuclear plants; however, this project will go further by focusing on the design of new plants

  2. Risk-informed assessment of regulatory and design requirements for future nuclear power plants. Annual report

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2000-08-01

    OAK B188 Risk-informed assessment of regulatory and design requirements for future nuclear power plants. Annual report. The overall goal of this research project is to support innovation in new nuclear power plant designs. This project is examining the implications, for future reactors and future safety regulation, of utilizing a new risk-informed regulatory system as a replacement for the current system. This innovation will be made possible through development of a scientific, highly risk-formed approach for the design and regulation of nuclear power plants. This approach will include the development and/or confirmation of corresponding regulatory requirements and industry standards. The major impediment to long term competitiveness of new nuclear plants in the U.S. is the capital cost component--which may need to be reduced on the order of 35% to 40% for Advanced Light Water Reactors (ALWRS) such as System 80+ and Advanced Boiling Water Reactor (ABWR). The required cost reduction for an ALWR such as AP600 or AP1000 would be expected to be less. Such reductions in capital cost will require a fundamental reevaluation of the industry standards and regulatory bases under which nuclear plants are designed and licensed. Fortunately, there is now an increasing awareness that many of the existing regulatory requirements and industry standards are not significantly contributing to safety and reliability and, therefore, are unnecessarily adding to nuclear plant costs. Not only does this degrade the economic competitiveness of nuclear energy, it results in unnecessary costs to the American electricity consumer. While addressing these concerns, this research project will be coordinated with current efforts of industry and NRC to develop risk-informed, performance-based regulations that affect the operation of the existing nuclear plants; however, this project will go further by focusing on the design of new plants.

  3. Regulatory requirements to the thermal-hydraulic and thermal-mechanical computer codes

    International Nuclear Information System (INIS)

    Vitkova, M.; Kalchev, B.; Stefanova, S.

    2006-01-01

    The paper presents an overview of the regulatory requirements to the thermal-hydraulic and thermal-mechanical computer codes, which are used for safety assessment of the fuel design and the fuel utilization. Some requirements to the model development, verification and validation of the codes and analysis of code uncertainties are also define. Questions concerning Quality Assurance during development and implementation of the codes as well as preparation of a detailed verification and validation plan are briefly discussed

  4. Continuing education requirements among State Occupational Therapy Regulatory Boards in the United States of America

    Directory of Open Access Journals (Sweden)

    Savannah R. Hall

    2016-10-01

    Full Text Available Purpose The purpose of this study is to compare and contrast the contents of each state’s occupational therapy (OT regulatory board requirements regarding licensees’ acquisition of continuing education units in the United States of America. Methods Data related to continuing education requirements from each OT regulatory board of all 50 states and the District of Columbia in the United States were reviewed and categorized by two reviewers. Analysis was conducted based on the categorization of the continuing education requirements and activities required, allowed, and not allowed/not mentioned for continuing education units. Results Findings revealed non-uniformity and inconsistency of continuing education requirements for licensure renewal between OT regulatory boards and was coupled with lack of specific criteria for various continuing education activities. Continuing education requirements were not tailored to meet the needs of individual licensee’s current and anticipated professional role and job responsibilities, with a negative bias towards presentation and publication allowed for continuing education units. Few boards mandated continuing education topics on ethics related to OT practice within each renewal cycle. Conclusion OT regulatory boards should move towards unifying the reporting format of continuing education requirements across all states to reduce ambiguity and to ensure licensees are equipped to provide ethical and competent practice. Efforts could be made to enact continuing education requirements specific to the primary role of a particular licensee. Finally, assigning the amount of continuing education credits to be awarded for different activities should be based on research evidence rather than arbitrary determination.

  5. The current regulatory requirements on optimisation and BAT in Sweden in the context of geological disposal

    International Nuclear Information System (INIS)

    Dverstorp, B.

    2010-01-01

    Bjorn Dverstorp, Swedish Radiation Safety authority (SSM) presented 'The current regulatory requirements on optimisation and BAT in Sweden in the context of geological disposal'. In Sweden, a nuclear waste repository will be evaluated according to both to general environmental legislation (the Environmental Code, SFS, 1998:808) and according to more specific requirements in the Act on Nuclear Activities (SFS, 1984:3) and the Radiation Protection Act (SFS, 1988:220). The evaluations according to these laws will be carried out according to two separate, but coordinated, legal-review and decision-making processes. This will be a basis for the siting process. Although the requirements on BAT and siting in the Environmental Code apply to radiological protection, they aim at a broader system optimisation. The more specific requirements on optimisation and BAT of radiological protection of geological disposal systems are given in the regulations associated with the Radiation Protection Act. The Swedish radiation protection regulations (SSM, 2009) comprise three corner stones: a risk target, environmental protection goals and the use of optimisation and BAT. In SSM' s guidance optimisation is defined as a means to reduce risk, guided by the results of risk calculations. In case of a conflict between BAT and optimisation, measures satisfying BAT should have priority. Application of optimisation and BAT on different timescales are described as well as for human intrusion scenarios. B. Dverstorp explained that because of uncertainties in the long term there is a need for additional arguments in the safety case in support of decision making. It is in this context that the requirements on optimisation and BAT should be seen as supplementary to the risk target, in providing evidence that the developer has taken into consideration, as far as reasonably possible, measures and options for reducing future doses and risks. Both principles focus on the proponent's work on developing

  6. Limits of the current EU regulatory framework on GMOs: risk of not authorized GM event-traces in imports

    Directory of Open Access Journals (Sweden)

    Roïz Julie

    2014-11-01

    Full Text Available Since their first commercialization in the 1990’s, the number of genetically modified organisms (GMOs cultivated around the world has steadily increased. This development has been accompanied by the development of regulatory and policy environments which vary from one country to another. Today, the European food and feed sectors are faced with the increasing risk of finding traces of not authorized GMOs in imports. Under the EU zero tolerance for unapproved GMOs, this situation may lead to trade disruptions with important cost implications. A regulatory environment which minimizes the risk of such disruption is therefore indispensable. To address this issue, the EU has adopted the “technical solution” but this remains insufficient to provide the necessary legal certainty which is needed to operate in such context. More comprehensive approaches are considered globally through low level presence policies.

  7. Regulatory Guide 1.79 safety injection recirculation test requirements, fact or fiction

    International Nuclear Information System (INIS)

    Roberts, J.K.

    1976-01-01

    The overwhelming concern of the general public in this day of state nuclear initiatives is the basic question, ''is nuclear power safe.'' Much of this concern has focused on the emergency core cooling systems. This public attention spotlights the testing organization's responsibility during startup of proving the operation and reliability of the emergency core cooling systems. The standard established by the Nuclear Regulatory Commission for testing emergency core cooling systems is Regulatory Guide 1.79 ''Preoperational Testing of Emergency Core Cooling Systems for Pressurized Water Reactors''. The nuclear industry must satisfy the testing requirements of Regulatory Guide 1.79 to meet their responsibility to the public; and to prevent future embarrassment when questioned on the adequacy of emergency core cooling systems

  8. The role of national regulatory authority in monitoring of radioactivity and in case of seizure of radioactive or nuclear material

    International Nuclear Information System (INIS)

    Morkunas, G.

    2002-01-01

    Full text: The Radiation Protection Centre is a regulatory authority in radiation protection in Lithuania. Its main tasks are licensing of practices, supervision, control and enforcement of radiation protection requirements, dosimetric, radiometric and spectrometric measurements, evaluation of exposure and its sources, expertise and advice on optimization of radiation protection. Its activities may be divided into two main parts -- regulatory and analytical ones. Food, drinking water, environmental, wipe and other samples are monitored, the appropriate evaluation of doses is done. The data on concentrations of artificial radionuclides in different bodies are available. The laboratory is to be accredited according to the ISO 17025 standard in the framework of Phare Twinning Project. In case of seized radioactive or nuclear material the Radiation Protection Centre has to identify the necessary radiation protection means for members of public and emergency workers, perform measurements of dose rate and radioactive contamination, and, if necessary, evaluate doses received due to the seized radioactive or nuclear material. Since the Radiation Protection Centre has its departments in the largest cities of Lithuania the above mentioned measures can be taken very urgently, especially the ones connected with primary evaluation of situation and identification of optimized radiation protection measures. The Radiation Protection Centre has its own possibilities of identification of radionuclides in the seized material. Such installations as HpGe spectrometers (Oxford and Canberra), equipment for radiochemical separation of U, Pu and actinides, alpha spectrometer, liquid scintillation spectrometer and neutron rem counter are available. There were a few cases when seized material had to be analyzed also. Different sources were found in different places of Lithuania, and it was necessary to define the activity and isotopic content of these sources. The following scheme is used in

  9. Regulatory philosophy and requirements for radiation control in Canadian uranium mine-mill facilities

    International Nuclear Information System (INIS)

    Dory, A.B.

    1981-10-01

    The approach the Canadian Atomic Energy Control Board takes in licensing uranium mine/mill facilities is based on a minimum of rigidly set regulatory requirements. The regulations state only the basic objectives: the obligation to acquire a licence, some administrative and reporting requirements, and exposure limits. The regulations are supported by a set of regulatory guides. The operator always has the option of following different procedures if he can demonstrate that they will produce the same or better results. Good relationships exist between the AECB and mine management as well as trade unions. Under this approach, however, it is difficult to take action against uncooperative parties. The Board has decided that a somewhat more formalized system is necessary. New regulations are being drafted, giving more detailed licensing and administrative requirements and covering the areas of ventilation and worker and supervisor education more thoroughly

  10. Review of regulatory requirements relevant to calibration of monitoring instruments in research reactors

    Energy Technology Data Exchange (ETDEWEB)

    Gomaa, Hassan; Khedr, Ahmed; El-Din Talha, Kamal [Egyptian Nuclear and Radiological Regulatory Authority, Cairo (Egypt). Nuclear Safety Engineering Dept.

    2015-05-15

    The objective of this work is to demonstrate the regulatory requirements pertaining to calibration of monitoring instruments in research reactors. The regulatory statements concerning this subject in IAEA safety standards and the implementation of such regulations in twelve countries with different levels of nuclear programs are surveyed: Australia, Bulgaria, Canada, Egypt, Finland, Germany, Hungary, Slovenia, South Korea, Spain, United Kingdom of England and United States of America. In addition, the requirements of ISO/IEC17025 and NUPIC (Nuclear Utilities Procurement Issues Committee) are compared. Seven technical and administrate aspects are suggested as the comparison criteria and the explicit expression of the statements, the level of document (i.e.: act, requirement or guide) are the considered resources. The main differences and similarities between the different approaches are identified in order to provide an input for future development of the national regulations.

  11. Survey of extreme load design regulatory agency licensing requirements for nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    Stevenson, J D

    1976-04-01

    Since 1965, when extreme load requirements began to be considered explicitly in nuclear power plant design, there has been a gradual divergence in requirements imposed by national regulatory agencies. However, nuclear plant safety is an international problem because of the potential international effects of any postulated plant failure. For this reason this paper has been prepared in an attempt to highlight the differences in national criteria currently used in the extreme load design of nuclear plant facilities. No attempt has been made to evaluate the relative merit of the criteria established by the various national regulatory agencies. This paper presents the results of a recent survey made of national atomic energy regulatory agencies and major nuclear steam supply design agencies, which requested a summary of current licensing criteria associated with earthquake, extreme wind (tornado), flood, airplane crash and accident (pipe break) loads applicable within the various national jurisdictions. Also presented are a number of comparisons which are meant to illustrate the differences in national regulatory criteria.

  12. Use of probabilistic risk assessments to define areas of possible exemption from regulatory requirements

    International Nuclear Information System (INIS)

    Thompson, C.A.; Carlson, D.; Kolaczkowski, A.; LaChance, J.

    1988-01-01

    The Risk-Based Licensing Program (RBLP) was sponsored by the Department of Energy for the purpose of establishing and demonstrating an approach for identifying potential areas for exemption from current regulatory requirements in the licensing of nuclear power plants. Such an approach could assist in the improvement of the regulatory process for both current and future nuclear plant designs. Use of the methodology could result in streamlining the regulatory process by eliminating unnecessarily detailed reviews of portions of a plant design not important to risk. The RBLP methodology utilizes probabilistic risk assessments, (PRAs), which are required of all future applicants for nuclear power plant licenses. PRA results are used as a screening tool to determine the risk significance of various plant features which are correlated to the risk importance of regulations to identify potential areas for regulatory exemption. Additional consideration is then given to non-risk factors in the final determination of exemption candidates. The RBLP methodology was demonstrated using an existing PRA. The results of the demonstration are highlighted. 10 refs

  13. Survey of extreme load design regulatory agency licensing requirements for nuclear power plants

    International Nuclear Information System (INIS)

    Stevenson, J.D.

    1976-01-01

    Since 1965, when extreme load requirements began to be considered explicitly in nuclear power plant design, there has been a gradual divergence in requirements imposed by national regulatory agencies. However, nuclear plant safety is an international problem because of the potential international effects of any postulated plant failure. For this reason this paper has been prepared in an attempt to highlight the differences in national criteria currently used in the extreme load design of nuclear plant facilities. No attempt has been made to evaluate the relative merit of the criteria established by the various national regulatory agencies. This paper presents the results of a recent survey made of national atomic energy regulatory agencies and major nuclear steam supply design agencies, which requested a summary of current licensing criteria associated with earthquake, extreme wind (tornado), flood, airplane crash and accident (pipe break) loads applicable within the various national jurisdictions. Also presented are a number of comparisons which are meant to illustrate the differences in national regulatory criteria. (Auth.)

  14. Regulatory quality assurance requirements for the operation of nuclear R and D facilities in Korea

    International Nuclear Information System (INIS)

    Kwon, H.I.; Lim, N.J.

    2006-01-01

    Full text: Korea Atomic Energy Research Institute (KAERI) has many R and D facilities in operation. including HANARO research reactor, radioactive waste treatment facility (RWTF), post-irradiation examination facility (PIEF) and irradiated material test facility (IMEF). Recently. nation-wide interest is focused on the safety and security of major industrial facilities. Safe operation of nuclear facilities is imperative because of the consequence of public disaster by radiological release/contamination, in case of an accident. Recently, Ministry of Science and Technology (MOST) of the Korean government announced amendments of Atomic Energy laws to enforce requirements of the physical protection and radiological emergency. All provisions on nuclear safety regulation and radiation protection are entrusted to the Atomic Energy Act(AEA). The Act is enacted as the main law concerning the safety regulation of nuclear installations, and is supplemented by the Enforcement Decree and Enforcement Regulation of the Act. These Atomic Energy laws include provisions on the construction permission and the operation license of nuclear installations, such as nuclear power reactors, research reactors, nuclear ships, nuclear fuel fabrication facilities, spent fuel treatment facilities, etc. Regulatory requirements for the regulatory inspection and the safety measures for operation are also defined in the laws. The Notice of the MOST prescribes specific issues including regulatory requirements and technical standards, as entrusted by the AEA, the Decree and the Regulation. Detailed QA requirements for nuclear installations are specified differently, depending upon the type of facility. The guidelines for safety reviews and regulatory inspections are developed by the Korea Institute of Nuclear Safety (KINS), which is an exclusive organization for safety regulation of nuclear installations in Korea. In this paper, the context of the Atomic Energy laws were reviewed to confirm the

  15. Argentina Nuclear Regulatory Authority and the final disposition gives to radioactive wastes

    International Nuclear Information System (INIS)

    Petraits, E.; Siraky, G.; Novo, R.

    1998-01-01

    This work describes the alignment legislative and regulator in which is carried out the final disposition the radioactive wastes in the Argentina Republic . Timbers the activities are presented the Authority Nuclear Regulator (RNA) and the applied focuses in connection with the inspections to the facilities, the evaluations security the associate systems and the collaboration with the international organizations in this matter

  16. Requirements for growth and IL-10 expression of highly purified human T regulatory cells

    OpenAIRE

    Bonacci, Benedetta; Edwards, Brandon; Jia, Shuang; Williams, Calvin; Hessner, Martin J.; Gauld, Stephen; Verbsky, James

    2012-01-01

    Human regulatory T cells (TR) cells have potential for the treatment of a variety of immune mediated diseases but the anergic phenotype of these cells makes them difficult to expand in vitro. We have examined the requirements for growth and cytokine expression from highly purified human TR cells, and correlated these findings with the signal transduction events of these cells. We demonstrate that these cells do not proliferate or secrete IL-10 even in the presence of high doses of IL-2. Stimu...

  17. Management by regulatory inspection authorities of experience gained from safety related occurrences in nuclear power plants

    International Nuclear Information System (INIS)

    Tore, E.; Nilsson, R.

    1977-01-01

    A short description is given of the system used by the Swedish Nuclear Power Inspectorate to collect information of events occurring in nuclear power plants. The standard forms used by the utilities when reporting the events are described and a motivation given to their lay-out. The evaluation routine is defined and statistics given of events which occurred during the period July 1 1974 to December 31 1976. (author)

  18. Common market but divergent regulatory practices: exploring European regulation and the effect on regulatory uncertainty in the marketing authorization of medical products

    NARCIS (Netherlands)

    Chowdhury, Nupur

    2013-01-01

    The medical product sector is characterised by a regulatory patchwork of European and national laws and guidelines operating concurrently with each other. Each of these sectors are characterised by different levels of regulatory uncertainty that may undermine the effectiveness of the regulatory

  19. Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA.

    Science.gov (United States)

    Eriksson, Robert; Aagaard, Lise; Jensen, Lars Juhl; Borisova, Liza; Hørlück, Dorte; Brunak, Søren; Hansen, Ebba Holme

    2014-06-01

    Pharmaceutical product information (PI) supplied by the regulatory authorities serves as a source of information on safe and effective use of drugs. The objectives of this study were to qualitatively and quantitatively compare PIs for selected drugs marketed in both Denmark and the USA with respect to consistency and discrepancy of listed adverse drug reaction (ADR) information. We compared individual ADRs listed in PIs from Denmark and the USA with respect to type and frequency. Consistency was defined as match of ADRs and of ADR frequency or match could not be ruled out. Discrepancies were defined as ADRs listed only in one country or listed with different frequencies. We analyzed PIs for 40 separate drugs from ten therapeutic groups and assigned the 4003 identified ADRs to System Organ Classes (Medical Dictionary for Regulatory Activities [MedDRA] terminology). Less than half of listed ADRs (n = 1874; 47%) showed consistency. Discrepancies (n = 2129; 53%) were split into ADRs listed only in the USA (n = 1558; 39%), ADRs listed only in Denmark (n = 325; 8%) and ADRs listed with different frequencies (n = 246; 6%). The majority of listed ADRs were of the type "gastrointestinal disorders" and "nervous system disorders". Our results show great differences in PIs for drugs approved in both Denmark and the USA illuminating concerns about the credibility of the publicly available PIs. The results also represent an argument for further harmonization across borders to improve consistency between authority-supplied information.

  20. 5 CFR 2636.307 - Requirement for advance authorization to engage in teaching for compensation.

    Science.gov (United States)

    2010-01-01

    ... engage in teaching for compensation. 2636.307 Section 2636.307 Administrative Personnel OFFICE OF... teaching for compensation. (a) Authorization requirement. A covered noncareer employee may receive compensation for teaching only when specifically authorized in advance by the designated agency ethics official...

  1. Crisis communication in conditions of the Nuclear Regulatory Authority of Slovak Republic

    International Nuclear Information System (INIS)

    Seliga, M.

    2004-01-01

    Emergency planning shall mean a set of measures and procedures to identify and bring under control incidents and accidents at nuclear installations and to identify, mitigate and eliminate consequences of releases of radioactive substances into the environment. Emergency preparedness shall mean the capability to develop and realize activities and measures which lead to identification and effective elimination of incidents and accidents as well as to suppression of risks of threats to life, health or assets of population and environment. The acquisition of practical experience from emergency exercises, the approach to decision making in the late phase of the accident and pieces of information on communication with media were the most important. (author)

  2. U.S. regulatory requirements for nuclear plant license renewal: The B and W Owners Group License Renewal Program

    International Nuclear Information System (INIS)

    Staudinger, Deborah K.

    2004-01-01

    This paper discusses the current U.S. Regulatory Requirements for License Renewal and describes the Babcock and Wilcox Owners Group (B and WOG) Generic License Renewal Program (GLRP). The B and W owners, recognizing the need to obtain the maximum life for their nuclear generating units, embarked on a program to renew the licenses of the seven reactors in accordance with the requirements of the Atomic Energy Act of 1954 and further defined by Title 10 of the Code of Federal Regulation Part 54 (10 CFR 54). These reactors, owned by five separate utilities, are Pressurized Water Reactors (PWR) ranging in net rated capacity from approximately 800 to 900 MW. The plants, predominately constructed in the 70s, have USNRC Operating Licenses that expire between 2013 to 2017. (author)

  3. The regulatory authorities` perspective of environmental impact assessment (EIA). Report of the Joint Working Group

    Energy Technology Data Exchange (ETDEWEB)

    Andersson, Johan [Swedish Nuclear Power Inspectorate, Stockholm (Sweden); Haegg, C. [Swedish Radiation Protection Inst., Stockholm (Sweden); Larsen, B. [Boverket, Stockholm (Sweden); Loefgren, T. [Lund Univ. (Sweden); Schibbye, K. [Riksantikvarieaembetet, Stockholm (Sweden); Timm, B. [Swedish Environmental Protection Agency, Solna (Sweden)

    1995-12-01

    The present paper is a highly abridged version of the report SSI--95-05 (available in Swedish only). The report mainly deals with the broad basis for decision-making which is necessary for licensing by the government in accordance with section 4 of the Act (1987:12) concerning the Management of Natural Resources etc (Natural Resources Act) for the siting of facilities for the final disposal of spent nuclear fuel that is planned in Sweden. Licensing issues which currently are of interest concern decisions on the siting of an encapsulation facility and detailed characterization of potential sites for a repository. Several governmental authorities will be involved in these licensing issues. Furthermore, it is noted that decisions regarding the different facilities will be made in several stages e g feasibility studies, site investigations, detailed characterizations, siting, construction and commissioning. The joint group issued recommendations with regard to the content of the EIS and how the EIA should be worked out.

  4. Information Management system of the safety regulatory requirements and guidance for the Korea next generation reactors

    Energy Technology Data Exchange (ETDEWEB)

    Yun, Y. C. [LG-EDS Systems, Seoul (Korea, Republic of); Lee, J. H.; Lee, H. C.; Lee, J. S. [Korea Institute of Nuclear Safety, Taejon (Korea, Republic of)

    2000-05-01

    In order to achieve the safety of the Korea Next Generation Reactors (KNGR), the Korea Institute of Nuclear Safety has carried out the Safety and Regulatory Requirements and Guidance (SRRG) development program from 1992 such as establishment of the SRRG hierarchy, development of technical requirements and guidance, and consideration of new licensing system. The SRRG hierarchy for the KNGR was consisted of five tiers; Safety Objectives, Safety Principles, General Safety Criteria, Specific Safety Requirements and Safety Regulatory Guides. The developed SRRG have been compared the criteria in 10CFR and Reg. Guide in the U.S.A and the IAEA documents for assuring internationally acceptable level of the SRRG. To improve the efficiency and accuracy of SRRG development, the construction of database system was required in the course of development. Therefore, the Information Management System of SRRG for the KNGR has been developed which enables developers to quickly and accurately seek and systematically manage whole contexts of the SRRG, reference requirements, and current atomic energy regulation rules. Moreover, through homepage whose URL is 'http://kngr.kins.re.kr', the concerned persons and public can acquire the information related with SRRG and KNGR project, and post his/her thought to the opinion forum in the homepage.

  5. Information Management system of the safety regulatory requirements and guidance for the Korea next generation reactors

    International Nuclear Information System (INIS)

    Yun, Y. C.; Lee, J. H.; Lee, H. C.; Lee, J. S.

    2000-01-01

    In order to achieve the safety of the Korea Next Generation Reactors (KNGR), the Korea Institute of Nuclear Safety has carried out the Safety and Regulatory Requirements and Guidance (SRRG) development program from 1992 such as establishment of the SRRG hierarchy, development of technical requirements and guidance, and consideration of new licensing system. The SRRG hierarchy for the KNGR was consisted of five tiers; Safety Objectives, Safety Principles, General Safety Criteria, Specific Safety Requirements and Safety Regulatory Guides. The developed SRRG have been compared the criteria in 10CFR and Reg. Guide in the U.S.A and the IAEA documents for assuring internationally acceptable level of the SRRG. To improve the efficiency and accuracy of SRRG development, the construction of database system was required in the course of development. Therefore, the Information Management System of SRRG for the KNGR has been developed which enables developers to quickly and accurately seek and systematically manage whole contexts of the SRRG, reference requirements, and current atomic energy regulation rules. Moreover, through homepage whose URL is 'http://kngr.kins.re.kr', the concerned persons and public can acquire the information related with SRRG and KNGR project, and post his/her thought to the opinion forum in the homepage

  6. Regulatory requirements for nuclear power plant site selection in Malaysia-a review.

    Science.gov (United States)

    Basri, N A; Hashim, S; Ramli, A T; Bradley, D A; Hamzah, K

    2016-12-01

    Malaysia has initiated a range of pre-project activities in preparation for its planned nuclear power programme. Clearly one of the first steps is the selection of sites that are deemed suitable for the construction and operation of a nuclear power plant. Here we outline the Malaysian regulatory requirements for nuclear power plant site selection, emphasizing details of the selection procedures and site characteristics needed, with a clear focus on radiation safety and radiation protection in respect of the site surroundings. The Malaysia Atomic Energy Licensing Board (AELB) site selection guidelines are in accord with those provided in International Atomic Energy Agency (IAEA) and United Stated Nuclear Regulatory Commission (USNRC) documents. To enhance the suitability criteria during selection, as well as to assist in the final decision making process, possible assessments using the site selection characteristics and information are proposed.

  7. The major cellular sterol regulatory pathway is required for Andes virus infection.

    Directory of Open Access Journals (Sweden)

    Josiah Petersen

    2014-02-01

    Full Text Available The Bunyaviridae comprise a large family of RNA viruses with worldwide distribution and includes the pathogenic New World hantavirus, Andes virus (ANDV. Host factors needed for hantavirus entry remain largely enigmatic and therapeutics are unavailable. To identify cellular requirements for ANDV infection, we performed two parallel genetic screens. Analysis of a large library of insertionally mutagenized human haploid cells and a siRNA genomic screen converged on components (SREBP-2, SCAP, S1P and S2P of the sterol regulatory pathway as critically important for infection by ANDV. The significance of this pathway was confirmed using functionally deficient cells, TALEN-mediated gene disruption, RNA interference and pharmacologic inhibition. Disruption of sterol regulatory complex function impaired ANDV internalization without affecting virus binding. Pharmacologic manipulation of cholesterol levels demonstrated that ANDV entry is sensitive to changes in cellular cholesterol and raises the possibility that clinically approved regulators of sterol synthesis may prove useful for combating ANDV infection.

  8. The comprehensive registration and information system of radiation protection regulatory authority in the Czech Republic

    International Nuclear Information System (INIS)

    Petrova, K.

    2004-01-01

    and control in radiation protection. (Author) 6 refs

  9. The Report on Activities of the Nuclear Regulatory Authority of the Slovak Republic and on Safety of Nuclear Installations in the Slovak Republic in 2011

    International Nuclear Information System (INIS)

    2012-05-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2011 is presented. These activities are reported under the headings: Foreword; (1) Legislative activities; (2) Regulatory Activities; (3) Nuclear safety of nuclear power plants; (4) Nuclear Materials in SR; (5) Nuclear materials and physical protection of nuclear materials; (6) Scope of powers of the office building; (7) Emergency planning and preparedness; (8) International activities; (9) Public communication; (10) Nuclear Regulatory Authority of the Slovak Republic; (11) UJD SR organization chart; The International Nuclear Event Scale (INES); (12) Abbreviations.

  10. Guidelines on how to meet the requirement to keep all exposures as low as reasonably achievable. Regulatory guide

    International Nuclear Information System (INIS)

    1997-01-01

    The purpose of Regulatory Guide G-129 (E) is to provide Atomic Energy Control Board (AECB) licensees with guidelines on how to meet the forthcoming AECB regulatory requirement to keep doses received by workers and members of the public As Low As Reasonably Achievable (ALARA), social and economic factors taken into account. it is realized that the scope for realistic dose reductions will vary depending on the nature of the licensed activity. Therefore, criteria are given in section D for determining if doses can be deemed to be as low as reasonably achievable without further evaluation. The elements that the AECB considers to be essential in the approach to ALARA are described in section E and are summarized as follows: a demonstrated management commitment to the ALARA principle; the implementation of ALARA through a licensee's organization and management, provision of resources, training, establishment of action levels, documentation and other measures; and regular operational reviews. The above elements will be the focus of any AECB assessment to verify compliance with the requirement to keep radiation exposures as low as reasonably achievable. (author)

  11. Does the FDA have regulatory authority over adult autologous stem cell therapies? 21 CFR 1271 and the emperor's new clothes

    Directory of Open Access Journals (Sweden)

    Freeman Michael

    2012-03-01

    Full Text Available Abstract FDA has recently asserted that many autologous cell therapies once considered the practice of medicine are in fact drugs. These changes began with the creation of new sections of 21 CFR 1271 and a subsequent one word change where the FDA, without public commentary, altered a single word in its regulatory language regarding cell and tissue based therapies that asserted the authority to classify autologous tissue as drugs. The bright line between medical care and drug production can be delineated in many ways, but a simple metric that defines the dichotomy is the consent status of the patient. In healthcare, a patient can either be consented individually for a medical procedure or exposed to an unconsented risk where regulatory assurances are already in place. These new FDA policies apply rules meant to keep drugs safe in a drug factory (unconsented mass production risks to individually consented surgical procedures. We argue that there is little societal benefit to these changes and that they are already stifling medical innovation.

  12. State Regulatory Authority (SRA) Coordination of Safety, Security, and Safeguards of Nuclear Facilities: A Framework for Analysis

    International Nuclear Information System (INIS)

    Mladineo, S.; Frazar, S.; Kurzrok, A.; Martikka, E.; Hack, T.; Wiander, T.

    2013-01-01

    In November 2012 the International Atomic Energy Agency (IAEA) sponsored a Technical Meeting on the Interfaces and Synergies in Safety, Security, and Safeguards for the Development of a Nuclear Power Program. The goal of the meeting was to explore whether and how safeguards, safety, and security systems could be coordinated or integrated to support more effective and efficient nonproliferation infrastructures. While no clear consensus emerged, participants identified practical challenges to and opportunities for integrating the three disciplines’ regulations and implementation activities. Simultaneously, participants also recognized that independent implementation of safeguards, safety, and security systems may be more effective or efficient at times. This paper will explore the development of a framework for conducting an assessment of safety-security-safeguards integration within a State. The goal is to examine State regulatory structures to identify conflicts and gaps that hinder management of the three disciplines at nuclear facilities. Such an analysis could be performed by a State Regulatory Authority (SRA) to provide a self-assessment or as part of technical cooperation either with a newcomer State, or to a State with a fully developed SRA.

  13. Preservation of primary information related to radiological protection and nuclear safety in the Argentine Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Chahab, Martin

    2008-01-01

    The preservation of primary information related to Radiological Protection and Nuclear Safety in the Argentine Nuclear Regulatory Authority began as a need of and as significant contribution to the future activities of the institution. Since 2005 a high number of experts have retired from the organization and will continue to do so until 2010. Besides, the primary information that experts possess is technical information produced at the beginning of Argentina's regulatory activity in the 50 's. If this information on account of its relevance - could not be preserved properly or be made available to the future generation of scientists and technicians, such an issue could have a negative impact on the efficiency and effectiveness of the institution in the future. The methodology selected for the project comprises several stages. Overall, the first stage consists in identifying primary information and expert's explicit knowledge through interviews and personal consultations. The second stage consists in converting to digital format the documentation that experts have traditionally kept in paper format. The third stage deals with transferring to a new database the already digitalized information from the computers of experts who are about to retire. The final stage is based on managing this information by creating knowledge maps and socio-grams, experts personal Web sites and a database with a mega browser to make information readily accessible. During the early months of the project, 190 pages have on average been converted to digital format on a daily basis, the equivalent of around 8 MB of information. The men/hours employed for this task has been around 40 minutes per day. As time went by, the method turned more efficient and as a result, some 400 pages were converted to digital format on a daily basis, accounting for 16 MB of information. The men/hours employed for this task has been around 60 minutes per day. Up until mid 2008, more than 1,000 documents have been

  14. Public Notice of Nuclear Regulatory Authority of the Slovak Republic No. 52/2006 Coll. on professional competence

    International Nuclear Information System (INIS)

    Szabo, V.

    2006-01-01

    The Public Notice has replaced the previous Public Notice of Nuclear Regulatory Authority of the Slovak Republic No. 187/1999 Coll. on Professional competence of employees of nuclear power facilities. The new experience acquired in area of Professional preparation of employees holders of permissions has been included into the Public Notice as well as acknowledged principles of verification of the Professional competence and specific Professional competence of employees holders of permissions. There are rights and duties of permission holders elaborated in the Public Notice where the employees have an influence to the nuclear safety (professionally competent employees of permission holders) or have the direct influence to the nuclear safety (selected employees of permission holders). The Public Notice has also modified the details about preparation of employees of the operator of specific facilities who carry out the professional preparation of the employees holders of permissions

  15. Knowledge management in the Argentine Nuclear Regulatory Authority; La gestion del conocimiento en la Autoridad Regulatoria Nuclear Argentina

    Energy Technology Data Exchange (ETDEWEB)

    Chahab, Martin [Autoridad Regulatoria Nuclear, Buenos Aires (Argentina)

    2006-07-01

    In 2006, the Argentine Nuclear Regulatory Authority has initiated a regulatory knowledge management process to face the loss of knowledge resulting from retiring experts, the generation gap, and the existing need to train new human resources. A number of projects have been started together with the technical assistance of the National Public Administration Institute to preserve knowledge and render it explicit for the coming generations. These projects include 'The History of the Expert's Learning Process' in which the majority of the most critical experts have been interviewed so far. The results of this project help envision a training structure and prospective projects. An Internet Site has also been created on the Intranet in order to render knowledge explicit and facilitate the tools for knowledge management initiatives. Furthermore, ARN's knowledge map project has also been started. (author) [Spanish] La Autoridad Regulatoria Nuclear (ARN), es un Organismo Autarquico de la Administracion Publica Nacional de la Republica Argentina. La puesta en marcha de la gestion del conocimiento en este Organismo responde a la necesidad de no perder los conocimientos de la institucion en el marco del problema del retiro de un numero importante de expertos y de la falta de transmision de sus conocimientos a la nueva generacion. Esta actividad se pone en marcha a traves de programas especificos como entrevistas a expertos retirados y en actividad, la confeccion de un mapa del conocimiento, la identificacion de los conocimientos tacitos y explicitos para su transmision intergeneracional, entre otros, e implica supeditar la estructura tradicional y los procedimientos ya establecidos a los resultados de la misma para cumplir con la mision y vision institucional. Se presentan los objetivos y las caracteristicas del Plan Estrategico de la Institucion, los resultados hasta ahora alcanzados y los desafios a afrontar. (autor)

  16. [Regulatory requirements regarding cell-based medicinal products for human and veterinary use - a comparison].

    Science.gov (United States)

    Kuhlmann-Gottke, Johanna; Duchow, Karin

    2015-11-01

    At present, there is no separate regulatory framework for cell-based medicinal products (CBMP) for veterinary use at the European or German level. Current European and national regulations exclusively apply to the corresponding medicinal products for human use. An increasing number of requests for the regulatory classification of CBMP for veterinary use, such as allogeneic stem cell preparations and dendritic cell-based autologous tumour vaccines, and a rise in scientific advice for companies developing these products, illustrate the need for adequate legislation. Currently, advice is given and decisions are made on a case-by-case basis regarding the regulatory classification and authorisation requirements.Since some of the CBMP - in particular in the area of stem-cell products - are developed in parallel for human and veterinary use, there is an urgent need to create specific legal definitions, regulations, and guidelines for these complex innovative products in the veterinary sector as well. Otherwise, there is a risk that that the current legal grey area regarding veterinary medicinal products will impede therapeutic innovations in the long run. A harmonised EU-wide approach is desirable. Currently the European legislation on veterinary medicinal products is under revision. In this context, veterinary therapeutics based on allogeneic cells and tissues will be defined and regulated. Certainly, the legal framework does not have to be as comprehensive as for human CBMP; a leaner solution is conceivable, similar to the special provisions for advanced-therapy medicinal products laid down in the German Medicines Act.

  17. A study of diverse clinical decision support rule authoring environments and requirements for integration

    Directory of Open Access Journals (Sweden)

    Zhou Li

    2012-11-01

    Full Text Available Abstract Background Efficient rule authoring tools are critical to allow clinical Knowledge Engineers (KEs, Software Engineers (SEs, and Subject Matter Experts (SMEs to convert medical knowledge into machine executable clinical decision support rules. The goal of this analysis was to identify the critical success factors and challenges of a fully functioning Rule Authoring Environment (RAE in order to define requirements for a scalable, comprehensive tool to manage enterprise level rules. Methods The authors evaluated RAEs in active use across Partners Healthcare, including enterprise wide, ambulatory only, and system specific tools, with a focus on rule editors for reminder and medication rules. We conducted meetings with users of these RAEs to discuss their general experience and perceived advantages and limitations of these tools. Results While the overall rule authoring process is similar across the 10 separate RAEs, the system capabilities and architecture vary widely. Most current RAEs limit the ability of the clinical decision support (CDS interventions to be standardized, sharable, interoperable, and extensible. No existing system meets all requirements defined by knowledge management users. Conclusions A successful, scalable, integrated rule authoring environment will need to support a number of key requirements and functions in the areas of knowledge representation, metadata, terminology, authoring collaboration, user interface, integration with electronic health record (EHR systems, testing, and reporting.

  18. Evolution of New cis-Regulatory Motifs Required for Cell-Specific Gene Expression in Caenorhabditis.

    Directory of Open Access Journals (Sweden)

    Michalis Barkoulas

    2016-09-01

    Full Text Available Patterning of C. elegans vulval cell fates relies on inductive signaling. In this induction event, a single cell, the gonadal anchor cell, secretes LIN-3/EGF and induces three out of six competent precursor cells to acquire a vulval fate. We previously showed that this developmental system is robust to a four-fold variation in lin-3/EGF genetic dose. Here using single-molecule FISH, we find that the mean level of expression of lin-3 in the anchor cell is remarkably conserved. No change in lin-3 expression level could be detected among C. elegans wild isolates and only a low level of change-less than 30%-in the Caenorhabditis genus and in Oscheius tipulae. In C. elegans, lin-3 expression in the anchor cell is known to require three transcription factor binding sites, specifically two E-boxes and a nuclear-hormone-receptor (NHR binding site. Mutation of any of these three elements in C. elegans results in a dramatic decrease in lin-3 expression. Yet only a single E-box is found in the Drosophilae supergroup of Caenorhabditis species, including C. angaria, while the NHR-binding site likely only evolved at the base of the Elegans group. We find that a transgene from C. angaria bearing a single E-box is sufficient for normal expression in C. elegans. Even a short 58 bp cis-regulatory fragment from C. angaria with this single E-box is able to replace the three transcription factor binding sites at the endogenous C. elegans lin-3 locus, resulting in the wild-type expression level. Thus, regulatory evolution occurring in cis within a 58 bp lin-3 fragment, results in a strict requirement for the NHR binding site and a second E-box in C. elegans. This single-cell, single-molecule, quantitative and functional evo-devo study demonstrates that conserved expression levels can hide extensive change in cis-regulatory site requirements and highlights the evolution of new cis-regulatory elements required for cell-specific gene expression.

  19. 18 CFR 284.504 - Standard requirements for market-power authorizations.

    Science.gov (United States)

    2010-04-01

    ... Commission within 10 days of acquiring knowledge of significant changes occurring in its market power status... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Standard requirements for market-power authorizations. 284.504 Section 284.504 Conservation of Power and Water Resources...

  20. A simplified ALARA approach to demonstration of compliance with surface contaminated object regulatory requirements

    International Nuclear Information System (INIS)

    Pope, R.B.; Shappert, L.B.; Michelhaugh, R.D.; Boyle, R.W.; Cook, J.C.

    1998-02-01

    The US Department of Transportation (DOT) and the US Nuclear Regulatory Commission (NRC) have jointly prepared a comprehensive set of draft guidance for consignors and inspectors to use when applying the newly imposed regulatory requirements for low specific activity (LSA) material and surface contaminated objects (SCOs). The guidance is being developed to facilitate compliance with the new LSA material and SCO requirements, not to impose additional requirements. These new requirements represent, in some areas, significant departures from the manner in which packaging and transportation of these materials and objects were previously controlled. On occasion, it may be appropriate to use conservative approaches to demonstrate compliance with some of the requirements, ensuring that personnel are not exposed to radiation at unnecessary levels, so that exposures are kept as low as reasonably achievable (ALARA). In the draft guidance, one such approach would assist consignors preparing a shipment of a large number of SCOs in demonstrating compliance without unnecessarily exposing personnel. In applying this approach, users need to demonstrate that four conditions are met. These four conditions are used to categorize non-activated, contaminated objects as SCO-2. It is expected that, by applying this approach, it will be possible to categorize a large number of small contaminated objects as SCO-2 without the need for detailed, quantitative measurements of fixed, accessible contamination, or of total (fixed and non-fixed) contamination on inaccessible surfaces. The method, which is based upon reasoned argument coupled with limited measurements and the application of a sum of fractions rule, is described and examples of its use are provided

  1. A comparison of immunotoxic effects of nanomedicinal products with regulatory immunotoxicity testing requirements

    Directory of Open Access Journals (Sweden)

    Giannakou C

    2016-06-01

    Full Text Available Christina Giannakou,1,2 Margriet VDZ Park,1 Wim H de Jong,1 Henk van Loveren,1,2 Rob J Vandebriel,1 Robert E Geertsma1 1Centre for Health Protection, National Institute for Public Health and the Environment (RIVM, Bilthoven, 2Department of Toxicogenomics, Maastricht University, Maastricht, the Netherlands Abstract: Nanomaterials (NMs are attractive for biomedical and pharmaceutical applications because of their unique physicochemical and biological properties. A major application area of NMs is drug delivery. Many nanomedicinal products (NMPs currently on the market or in clinical trials are most often based on liposomal products or polymer conjugates. NMPs can be designed to target specific tissues, eg, tumors. In virtually all cases, NMPs will eventually reach the immune system. It has been shown that most NMs end up in organs of the mononuclear phagocytic system, notably liver and spleen. Adverse immune effects, including allergy, hypersensitivity, and immunosuppression, have been reported after NMP administration. Interactions of NMPs with the immune system may therefore constitute important side effects. Currently, no regulatory documents are specifically dedicated to evaluate the immunotoxicity of NMs or NMPs. Their immunotoxicity assessment is performed based on existing guidelines for conventional substances or medicinal products. Due to the unique properties of NMPs when compared with conventional medicinal products, it is uncertain whether the currently prescribed set of tests provides sufficient information for an adequate evaluation of potential immunotoxicity of NMPs. The aim of this study was therefore, to compare the current regulatory immunotoxicity testing requirements with the accumulating knowledge on immunotoxic effects of NMPs in order to identify potential gaps in the safety assessment. This comparison showed that immunotoxic effects, such as complement activation-related pseudoallergy, myelosuppression, inflammasome

  2. The use of Minilabs to improve the testing capacity of regulatory authorities in resource limited settings: Tanzanian experience.

    Science.gov (United States)

    Risha, Peter Gasper; Msuya, Zera; Clark, Malcolm; Johnson, Keith; Ndomondo-Sigonda, Margareth; Layloff, Thomas

    2008-08-01

    The Tanzania Food and Drugs Authority piloted the use of Minilab kits, a thin-layer-chromatographic based drug quality testing technique, in a two-tier quality assurance program. The program is intended to improve testing capacity with timely screening of the quality of medicines as they enter the market. After 1 week training of inspectors on Minilab screening techniques, they were stationed at key Ports-of-Entry (POE) to screen the quality of imported medicines. In addition, three non-Ports-of-Entry centres were established to screen samples collected during Post-Marketing-Surveillance. Standard operating procedures (SOPs) were developed to structure and standardize the implementation process. Over 1200 samples were tested using the Minilab outside the central quality control laboratory (QCL), almost doubling the previous testing capacity. The program contributed to increased regulatory reach and visibility of the Authority throughout the country, serving as a deterrent against entry of substandard medicines into market. The use of Minilab for quality screening was inexpensive and provided a high sample throughput. However, it suffers from the limitation that it can reliably detect only grossly substandard or wrong drug samples and therefore, it should not be used as an independent testing resource but in conjunction with a full-service quality control laboratory capable of auditing reported substandard results.

  3. Reflections on the role of the pharmacy regulatory authority in enhancing quality related event reporting in community pharmacies.

    Science.gov (United States)

    Boyle, Todd A; Bishop, Andrea C; Mahaffey, Thomas; Mackinnon, Neil J; Ashcroft, Darren M; Zwicker, Bev; Reid, Carolyn

    2014-01-01

    Given the demanding nature of providing pharmacy services, coupled with the expanded scope of practice of the professions in jurisdictions around the world, greater commitment to continuous quality improvement through adoption of quality-related event (QRE) reporting is necessary to ensure patient safety. Pharmacy regulatory authorities (PRAs) are in a unique position to enhance QRE reporting and learning through the standardization of expected practice. This study was aimed to gain a better understanding of the perceived roles of PRAs in enhancing QRE reporting and learning in community pharmacies, and identifying regulatory best practices to execute such roles. A purposive case sampling approach was used to identify PRA staff members from two groups (Deputy registrars and pharmacy inspectors) in 10 Canadian jurisdictions to participate in focus groups in the fall of 2011. Focus groups were used to explore perceptions of the role of PRAs in enhancing and promoting QRE reporting and learning, and perceived barriers to effective implementation in practice. Thematic analysis was used to analyze the qualitative data. Two focus groups were conducted, one with seven Deputy registrars/Practice managers, and one with nine pharmacy inspectors. Five themes were identified, including (1) defining QRE reporting and compliance, (2) navigating role conflict, (3) educating for enhanced QRE reporting and learning, (4) promoting the positive/removing the fear of QREs, and (5) tailoring QRE reporting and learning consistency. Overall, participants perceived a strong role for PRAs in enhancing QRE reporting and learning and providing education for pharmacies to support their compliance with reporting standards. However, PRAs must navigate the conflict inherent in both educating and promoting a process for achieving a standard while simultaneously inspecting compliance to that standard. Ensuring pharmacies have autonomy in operationalizing standards may help to mitigate this conflict

  4. REFLECTIONS ON THE ROLE OF THE PHARMACY REGULATORY AUTHORITY IN ENHANCING QUALITY RELATED EVENT REPORTING IN COMMUNITY PHARMACIESi

    Science.gov (United States)

    Boyle, Todd A.; Bishop, Andrea C.; Mahaffey, Thomas; MacKinnon, Neil J.; Ashcroft, Darren; Zwicker, Bev; Reid, Carolyn

    2016-01-01

    Background Given the demanding nature of providing pharmacy services, coupled with the expanded scope of practice of the professions in jurisdictions around the world, greater commitment to continuous quality improvement through adoption of quality related event (QRE) reporting is necessary to ensure patient safety. Pharmacy regulatory authorities (PRAs) are in a unique position to enhance QRE reporting and learning through the standardization of expected practice Objective This study aims to better understand the perceived roles of PRAs in enhancing QRE reporting and learning in community pharmacies and identifying regulatory best practices to execute such roles. Methods A purposive case sampling approach was used to identify PRA staff members from two groups (deputy registrars and pharmacy inspectors) in 10 Canadian jurisdictions to participate in focus groups in the fall of 2011. Focus groups were used to explore perceptions of the role of PRAs in enhancing and promoting QRE reporting and learning, and perceived barriers to effective implementation in practice. Thematic analysis was used to analyze the qualitative data. Results Two focus groups were conducted, one with seven deputy registrars/practice managers and one with nine pharmacy inspectors. Five themes were identified, including (1) defining QRE reporting and compliance, (2) navigating role conflict, (3) educating for enhanced QRE reporting and learning, (4) promoting the positive/removing the fear of QREs, and (5) tailoring QRE reporting and learning consistency. Conclusions Overall, participants perceived a strong role for PRAs in enhancing QRE reporting and learning and providing education for pharmacies to support their compliance with reporting standards. However, PRAs must navigate the conflict inherent in both educating and promoting a process for achieving a standard while simultaneously inspecting compliance to that standard. Ensuring pharmacies have autonomy in operationalizing standards may

  5. Report on activities of Nuclear Regulatory Authority of the Slovak Republic and safety of nuclear installations in the Slovak Republic in 2007. Annual report

    International Nuclear Information System (INIS)

    2007-04-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2007 is presented. These activities are reported under the headings: (1) Foreword; (2) Legislation; (3) Issuance of authorizations, assessment, supervisory activities and enforcement; (4) Nuclear safety of nuclear installations in the Slovak Republic; (5) Safety of other nuclear installations; (6) Management of radioactive waste; (7) Nuclear materials; (8) Emergency planning and preparedness; (9) International activities; (10) Public communication; (11) Nuclear Regulatory Authority of the Slovak Republic; (12) Abbreviations

  6. The Report on Activities of the Nuclear Regulatory Authority of the Slovak Republic and on Safety of Nuclear Installations in the Slovak Republic in 2010

    International Nuclear Information System (INIS)

    2010-05-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2010 is presented. These activities are reported under the headings: Address of the Chairperson; (1) Legislative activities; (2) Issuance of authorizations, assessment, supervisory activities and enforcement; (3) Nuclear safety of nuclear power plants; (4) Nuclear materials and physical protection of nuclear materials; (5) Powers of the office building; (6) Emergency planning and preparedness; (7) International activities; (8) Public communication; (9) Nuclear Regulatory Authority of the Slovak Republic; (10) Appendix: UJD SR organization chart; The International Nuclear Event Scale (INES); Abbreviations.

  7. Report on activities of Nuclear Regulatory Authority of the Slovak Republic and safety of nuclear installations in the Slovak Republic in 2009. Annual report

    International Nuclear Information System (INIS)

    2010-04-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2009 is presented. These activities are reported under the headings: (1) Foreword; (2) Legislation; (3) Issuance of authorizations, assessment, supervisory activities and enforcement; (4) Nuclear safety of nuclear installations in the Slovak Republic; (5) Safety of other nuclear installations; (6) Management of radioactive waste; (7) Nuclear materials and physical protection of nuclear materials; (8) Emergency planning and preparedness; (9) International activities; (10) Public communication; (11) Nuclear Regulatory Authority of the Slovak Republic; (12) UJD SR organization chart; (13) Abbreviations.

  8. Report on activities of Nuclear Regulatory Authority of the Slovak Republic and safety of nuclear installations in the Slovak Republic in 2008. Annual report

    International Nuclear Information System (INIS)

    Zemanova, D.; Pirozekova, M.

    2009-04-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2008 is presented. These activities are reported under the headings: (1) Foreword; (2) Legislation; (3) Issuance of authorizations, assessment, supervisory activities and enforcement; (4) Nuclear safety of nuclear installations in the Slovak Republic; (5) Safety of other nuclear installations; (6) Management of radioactive waste; (7) Nuclear materials and physical protection of nuclear materials; (8) Activity of Building Office; (9) Emergency planning and preparedness; (10) International activities; (11) Public communication; (11) Nuclear Regulatory Authority of the Slovak Republic; (12) UJD SR organization chart; (13) Abbreviations

  9. The dynein regulatory complex is required for ciliary motility and otolith biogenesis in the inner ear.

    Science.gov (United States)

    Colantonio, Jessica R; Vermot, Julien; Wu, David; Langenbacher, Adam D; Fraser, Scott; Chen, Jau-Nian; Hill, Kent L

    2009-01-08

    In teleosts, proper balance and hearing depend on mechanical sensors in the inner ear. These sensors include actin-based microvilli and microtubule-based cilia that extend from the surface of sensory hair cells and attach to biomineralized 'ear stones' (or otoliths). Otolith number, size and placement are under strict developmental control, but the mechanisms that ensure otolith assembly atop specific cells of the sensory epithelium are unclear. Here we demonstrate that cilia motility is required for normal otolith assembly and localization. Using in vivo video microscopy, we show that motile tether cilia at opposite poles of the otic vesicle create fluid vortices that attract otolith precursor particles, thereby biasing an otherwise random distribution to direct localized otolith seeding on tether cilia. Independent knockdown of subunits for the dynein regulatory complex and outer-arm dynein disrupt cilia motility, leading to defective otolith biogenesis. These results demonstrate a requirement for the dynein regulatory complex in vertebrates and show that cilia-driven flow is a key epigenetic factor in controlling otolith biomineralization.

  10. Regulatory requirements important to Hanford single-shell tank waste management decisions

    International Nuclear Information System (INIS)

    Keller, J.F.; Woodruff, M.G.

    1989-06-01

    This report provides an initial analysis of the regulations that may be pertinent to SST management activities (e.g., characterization, disposal, retrieval, processing, etc.) and the interrelationships among those regulations. Waste disposal decisions regarding SST waste must consider the regulatory requirements against which technical solutions will be evaluated. Regulatory requirements can also be used as guidelines for management and disposal of waste in a manner that protects human health and safety and the environment. Also, in cases where waste management regulations do not specifically address a waste form, such as radioactive mixed waste, the SST waste may come under the purview of a number of regulations related to radioactive waste management, hazardous waste management, and water and air quality protection. This report provides a comprehensive review of the environmental pollution control and radioactive waste management statutes and regulations that are relevant to SST waste characterization and management. Also, other statutes and regulations that contain technical standards that may be used in the absence of directly applicable regulations are analyzed. 8 refs., 4 figs

  11. 13 CFR 120.463 - Regulatory accounting-What are SBA's regulatory accounting requirements for SBA Supervised Lenders?

    Science.gov (United States)

    2010-01-01

    ... basis in accordance with Generally Accepted Accounting Principles (GAAP) as promulgated by the Financial Accounting Standards Board (FASB), supplemented by Regulatory Accounting Principles (RAP) as identified by... set forth in FASB Statement of Financial Accounting Standards No. 15, Accounting by Debtors and...

  12. Data Quality Objectives for Regulatory Requirements for Dangerous Waste Sampling and Analysis

    International Nuclear Information System (INIS)

    MULKEY, C.H.

    1999-01-01

    This document describes sampling and analytical requirements needed to meet state and federal regulations for dangerous waste (DW). The River Protection Project (RPP) is assigned to the task of storage and interim treatment of hazardous waste. Any final treatment or disposal operations, as well as requirements under the land disposal restrictions (LDRs), fall in the jurisdiction of another Hanford organization and are not part of this scope. The requirements for this Data Quality Objective (DQO) Process were developed using the RPP Data Quality Objective Procedure (Banning 1996), which is based on the U.S. Environmental Protection Agency's (EPA) Guidance for the Data Quality Objectives Process (EPA 1994). Hereafter, this document is referred to as the DW DQO. Federal and state laws and regulations pertaining to waste contain requirements that are dependent upon the composition of the waste stream. These regulatory drivers require that pertinent information be obtained. For many requirements, documented process knowledge of a waste composition can be used instead of analytical data to characterize or designate a waste. When process knowledge alone is used to characterize a waste, it is a best management practice to validate the information with analytical measurements

  13. Data Quality Objectives for Regulatory Requirements for Dangerous Waste Sampling and Analysis; FINAL

    International Nuclear Information System (INIS)

    MULKEY, C.H.

    1999-01-01

    This document describes sampling and analytical requirements needed to meet state and federal regulations for dangerous waste (DW). The River Protection Project (RPP) is assigned to the task of storage and interim treatment of hazardous waste. Any final treatment or disposal operations, as well as requirements under the land disposal restrictions (LDRs), fall in the jurisdiction of another Hanford organization and are not part of this scope. The requirements for this Data Quality Objective (DQO) Process were developed using the RPP Data Quality Objective Procedure (Banning 1996), which is based on the U.S. Environmental Protection Agency's (EPA) Guidance for the Data Quality Objectives Process (EPA 1994). Hereafter, this document is referred to as the DW DQO. Federal and state laws and regulations pertaining to waste contain requirements that are dependent upon the composition of the waste stream. These regulatory drivers require that pertinent information be obtained. For many requirements, documented process knowledge of a waste composition can be used instead of analytical data to characterize or designate a waste. When process knowledge alone is used to characterize a waste, it is a best management practice to validate the information with analytical measurements

  14. Adaptation of regulatory information and knowledge through knowledge maps in the Argentine Nuclear Regulatory Authority within the framework of nuclear renaissance

    International Nuclear Information System (INIS)

    Chahab, Martin; Dawyd, Noelia

    2008-01-01

    almost immediate search for information for organizational decision-making purposes. Finally, knowledge maps contribute new specialist-centered or subject-specific information to libraries. Knowledge maps show a universe of information and knowledge in a summarized and orderly manner, helping the institution work more effectively and efficiently. As an example of the proposition, a map of one of the topics carried out at the Argentine Nuclear Regulatory Authority is illustrated. (author)

  15. Development of guidance on applications of regulatory requirements for regulating large, contaminated equipment and large decommissioning and decontamination (D and D) components

    International Nuclear Information System (INIS)

    Pope, R.B.; Easton, E.P.; Cook, J.R.; Boyle, R.W.

    1997-01-01

    In 1985, the International Atomic Energy Agency issued revised regulations for the safe transport of radioactive material. Significant were major changes to requirements for Low Specific Activity (LSA) material and Surface Contaminated Objects (SCOs). As these requirements were adopted into regulations in the United States, it was recognised that guidance on how to apply these requirements to large, contaminated/activated pieces of equipment and decommissioning and decontamination (D and D) objects would be needed both by the regulators and those regulated to clarify technical uncertainties and ensure implementation. Thus, the US Department of Transportation and the US Nuclear Regulatory Commission, with assistance of staff from Oak Ridge National Laboratory, are preparing regulatory guidance which will present examples of acceptable methods for demonstrating compliance with the revised rules for large items. Concepts being investigated for inclusion in the pending guidance are discussed in this paper. Under current plans, the guidance will be issued for public comment before final issuance in 1997. (Author)

  16. Regulatory requirements for clinical trial and marketing authorisation application for cell-based medicinal products.

    Science.gov (United States)

    Salmikangas, P; Flory, E; Reinhardt, J; Hinz, T; Maciulaitis, R

    2010-01-01

    The new era of regenerative medicine has led to rapid development of new innovative therapies especially for diseases and tissue/organ defects for which traditional therapies and medicinal products have not provided satisfactory outcome. Although the clinical use and developments of cell-based medicinal products (CBMPs) could be witnessed already for a decade, robust scientific and regulatory provisions for these products have only recently been enacted. The new Regulation for Advanced Therapies (EC) 1394/2007 together with the revised Annex I, Part IV of Directive 2001/83/EC provides the new legal framework for CBMPs. The wide variety of cell-based products and the foreseen limitations (small sample sizes, short shelf life) vs. particular risks (microbiological purity, variability, immunogenicity, tumourigenicity) associated with CBMPs have called for a flexible, case-by-case regulatory approach for these products. Consequently, a risk-based approach has been developed to allow definition of the amount of scientific data needed for a Marketing Authorisation Application (MAA) of each CBMP. The article provides further insight into the initial risk evaluation, as well as to the quality, non-clinical, and clinical requirements of CBMPs. Special somatic cell therapies designed for active immunotherapy are also addressed.

  17. Clinical trials using a radiopharmaceutical investigational drug: What legal environment and what authorizations required?

    International Nuclear Information System (INIS)

    El-Deeb, G.; Nguon, B.; Tibi, A.; Rizzo-Padoin, N.

    2009-01-01

    Recent revision of the legal environment for clinical research in France provided an opportunity to review what a hospital needs to carry out clinical trials using a radiopharmaceutical investigational drug. Legal measures concerning radiopharmaceutical investigational drugs are indeed more complex than those of classical clinical trials because of the additional legal provisions governing the use of ionizing radiation. Thus, requirements by the concerned staff (sponsor, pharmacist, person in charge of the nuclear activity) are described here. (authors) [fr

  18. Regulatory requirements on the design and construction of nuclear power plant control and instrumentation systems in Finland

    International Nuclear Information System (INIS)

    Heikkila, M.A.

    1978-01-01

    The Department of Reactor Safety of the Institute of Radiation Protection, being the nuclear regulatory authority in Finland, has set up regulations which govern the design and construction of NPP systems and components. The regulations are partly compiled from existing codes and standards, published primarily in the United States and Federal Republic of Germany, and partly worked out at the Institute. The regulations are collected to a special set of YVL guides (guides for nuclear power plants), and one of these gives requirements on the design and construction of NPPCI systems and components. The scope of the requirements is based on the safety classification of the CI systems and components. Three safety classes have been singled out: the first for CI systems which take part in reactor protection, the second for other directly safety related, and the third for remaining CI systems important enough to deserve supervision. The safety class for CI components is inherited from the system they belong to. The safety classification of IC systems has direct bearing on the initial assumptions of plant accident analysis. The design principles of IC systems are inspected as part of the preliminary and final safety reports. Focus is directed on the principles of redundancy, separation, diversity, testability, etc. The requirements on IC components are directed to different stages of manufacture, installation and operation. The type tests shall be adequate and acceptably documented. The manufacture of components is followed, the test reports reviewed and the efficiency of manufacturers quality assurance program evaluated. Further requirements concern the installation phase and tests at the end of it, and finally guides include directions for maintenance and testing during the operations phase. (author)

  19. Oil spill emergency response: Fulfilling regulatory requirements on the Grand Banks

    International Nuclear Information System (INIS)

    Horvath, C.L.

    1991-01-01

    Offshore well licensing under Canadian regulations requires the operator to conduct a practice exercise of oil spill countermeasures and emergency response procedures at least yearly, once the drilling program starts. The relevant parts of the Newfoundland Offshore Petroleum Drilling Regulations are summarized and the objectives and benefits of the practice exercises are reviewed. In addition to ensuring regulatory compliance, the exercises also provide the opportunity to test operational procedures, to provide in-house training, and improve response efficiency by regular repetition of the exercise. Exercises in communications during a spill incident in the offshore and in deployment of offshore spill response equipment conducted by Petro-Canada in Newfoundland are described. Problems identified during the exercises are noted

  20. Unproven stem cell-based interventions & physicians' professional obligations; a qualitative study with medical regulatory authorities in Canada.

    Science.gov (United States)

    Zarzeczny, Amy; Clark, Marianne

    2014-10-14

    The pursuit of unproven stem cell-based interventions ("stem cell tourism") is an emerging issue that raises various concerns. Physicians play different roles in this market, many of which engage their legal, ethical and professional obligations. In Canada, physicians are members of a self-regulated profession and their professional regulatory bodies are responsible for regulating the practice of medicine and protecting the public interest. They also provide policy guidance to their members and discipline members for unprofessional conduct. We conducted semi-structured telephone interviews with representatives from six different provincial Colleges of Physicians and Surgeons in Canada to discuss their experiences and perspectives regarding stem cell tourism. Our focus was on exploring how different types of physician involvement in this market would be viewed by physicians' professional regulatory bodies in Canada. When considering physicians' professional obligations, participants drew analogies between stem cell tourism and other areas of medical tourism as well as with some aspects of complementary alternative medicine where existing policies, codes of ethics and regulations provide some guidance. Canadian physicians are required to act in the best interests of their patients, respect patient autonomy, avoid conflicts of interest and pursue evidence-based practice in accordance with accepted standards of care. Physicians who provide unproven treatments falling outside the standard of care, not in the context of an approved research protocol, could be subject to professional discipline. Other types of problematic conduct include referrals involving financial conflict of interest and failure to provide urgent medically necessary care. Areas of ambiguity include physicians' obligations when asked for information and advice about seeking unproven medical treatments, in terms of providing non-urgent follow-up care, and when asked to support efforts to go abroad by

  1. 78 FR 76757 - Regulatory Guidance on Hours of Service of Drivers Rest Break Requirement; Drivers Who Become...

    Science.gov (United States)

    2013-12-19

    ... limitations for unforeseen reasons, is the driver in violation of the Sec. 395.3 rest break provision if more... unforeseen reasons, is not in violation of the Sec. 395.3 rest-break requirements if 8 or more hours have... Regulatory Guidance on Hours of Service of Drivers Rest Break Requirement; Drivers Who Become Ineligible for...

  2. A comparison of immunotoxic effects of nanomedicinal products with regulatory immunotoxicity testing requirements.

    Science.gov (United States)

    Giannakou, Christina; Park, Margriet Vdz; de Jong, Wim H; van Loveren, Henk; Vandebriel, Rob J; Geertsma, Robert E

    2016-01-01

    Nanomaterials (NMs) are attractive for biomedical and pharmaceutical applications because of their unique physicochemical and biological properties. A major application area of NMs is drug delivery. Many nanomedicinal products (NMPs) currently on the market or in clinical trials are most often based on liposomal products or polymer conjugates. NMPs can be designed to target specific tissues, eg, tumors. In virtually all cases, NMPs will eventually reach the immune system. It has been shown that most NMs end up in organs of the mononuclear phagocytic system, notably liver and spleen. Adverse immune effects, including allergy, hypersensitivity, and immunosuppression, have been reported after NMP administration. Interactions of NMPs with the immune system may therefore constitute important side effects. Currently, no regulatory documents are specifically dedicated to evaluate the immunotoxicity of NMs or NMPs. Their immunotoxicity assessment is performed based on existing guidelines for conventional substances or medicinal products. Due to the unique properties of NMPs when compared with conventional medicinal products, it is uncertain whether the currently prescribed set of tests provides sufficient information for an adequate evaluation of potential immunotoxicity of NMPs. The aim of this study was therefore, to compare the current regulatory immunotoxicity testing requirements with the accumulating knowledge on immunotoxic effects of NMPs in order to identify potential gaps in the safety assessment. This comparison showed that immunotoxic effects, such as complement activation-related pseudoallergy, myelosuppression, inflammasome activation, and hypersensitivity, are not readily detected by using current testing guidelines. Immunotoxicity of NMPs would be more accurately evaluated by an expanded testing strategy that is equipped to stratify applicable testing for the various types of NMPs.

  3. Federal and state regulatory requirements for decontamination and decommissioning at US Department of Energy Oak Ridge Operations Facilities

    International Nuclear Information System (INIS)

    Etnier, E.L.; Houlberg, L.M.; Bock, R.E.

    1994-06-01

    The purpose of this report is to address regulatory requirements for decontamination and decommissioning (D and D) activities at the Oak Ridge Reservation and Paducah Gaseous Diffusion Plant. This report is a summary of potential federal and state regulatory requirements applicable to general D and D activities. Excerpts are presented in the text and tables from the complete set of regulatory requirements. This report should be used as a guide to the major regulatory issues related to D and D. Compliance with other federal, state, and local regulations not addressed here may be required and should be addressed carefully by project management on a site-specific basis. The report summarizes the major acts and implementing regulations (e.g., Resource and Conservation Recovery Act, Clean Air Act, and Toxic Substances Control Act) only with regard to D and D activities. Additional regulatory drivers for D and D activities may be established through negotiated agreements, such as the Federal Facility Agreement and the US Environmental Protection Agency Mixed Waste Federal Facility Compliance Agreement; these are discussed in this report. The DOE orders and Energy Systems procedures also are summarized briefly in instances where they directly apply to D and D

  4. Federal, state, and local regulation of radioactive-waste transportation: Progress toward a definition of regulatory authority

    International Nuclear Information System (INIS)

    Livingston-Behan, E.A.

    1986-01-01

    The supremacy clause, the commerce clause, and the equal-protection guarantees of the U.S. Constitution establish the basic framework for defining the authority of Federal, State, and local governments to regulate the transportation of radioactive waste. Court decisions and advisory rulings of the U.S. Department of Transportation (DOT) suggest that State and local regulation of the transportation of spent nuclear fuel and high-level radioactive waste is precluded under supremacy-clause principles to the extent that such regulation addresses nuclear safety or aspects of transportation that are already specifically regulated by the Federal government. Even where State and local requirements are found to be valid under the supremacy clause, they must still satisfy constitutional requirements under the commerce and equal-protection clauses. Despite stringent standards of review, State and local transportation requirements have been upheld where directly related to the traditional exercise of police powers in the area of transportation. Legitimate State and local police-power activities identified to date by the DOT and the courts include inspection and enforcement, immediate accident reporting, local regulation of traffic, and certain time-of-day curfews. The extent to which State and local permitting requirements and license fees may be determined valid by the DOT and the courts remains unclear. Continued clarification by the DOT and the courts as to the validity of permits and fees will serve to further define the appropriate balance for Federal, State, and local regulation of radioactive-waste transportation

  5. Efficiency of the low energy detection system for the measurement of 235 U in lung of the Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Spinella, M.R.; Krimer, M.; Gregori, B.N.; Rojo, A.M.

    2006-01-01

    This work presents the results of the calibration process of the detection system of 235 U in lung of the Nuclear Regulatory Authority. The phantom used in the calibration is the denominated Lawrence Livermore Realistic Phantom, provided of lungs and active nodules and of 4 thoracic covers that its simulate muscular tissue with thickness that vary between 1.638 and 3.871 cm. The spectra are acquired by four detecting of denominated LEGe ACTII Canberra marks, each one with an active area of 3800 mm 2 , a diameter of 70 mm and a thickness of 20 mm, the sign is processed by a SYSTEM100 multichannel and the spectra are analyzed with the GENIE2K program. The detectors are suspended by mobile structures that allow to vary the position with regard to a horizontal stretcher that defines the measurement geometry. The whole system is located in the interior of an armored enclosure of 200 x 150 x 200 cm 3 of steel of 15 cm thickness, inside recovered with layers of 0.5 cm lead and 0.05 cm cadmium. The total weight of the enclosure is 40 ton. For the described system the efficiency curves versus muscular thoracic tissue thickness (ETM) corresponding to the energy of 143.76, 163.358 and 185.72 keV of the 235 U radioisotope were obtained. Its were also practiced displacements of those detectors of approximately 1 cm with respect to the reference position and its were analyzed the corresponding changes of magnitude in the efficiencies. The obtained variations oscillate, for vertical displacements, between 5% and 7.8% for the smallest value in ETM (1.638 cm) and between 4.2% to 6.7% for the ETM 3.871 cm. While for the practiced lateral displacements, the variations go from 4% to 15%. The detection limits corresponding to each energy and thickness were determined. The results showed for the photopeak of 185.72 keV, the more outstanding in the evaluations that saying limit it oscillates between 3.7 and 6.4 Bq 235 U inside the considered thickness range. (Author)

  6. Communication Received from the Permanent Mission of Pakistan to the International Atomic Energy Agency Concerning the Promulgation of the Pakistan Nuclear Regulatory Authority Ordinance 2001

    International Nuclear Information System (INIS)

    2001-01-01

    The Director General has received a communication dated 30 January 2001 from the Permanent Mission of Pakistan forwarding a press release concerning the promulgation of the Pakistan Nuclear Regulatory Authority Ordinance 2001. As requested in that communication, the press release is attached hereto for the information of Member States

  7. National regulatory authorities with competence in the safety of radiation sources and the security of radioactive materials. Proceedings

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2001-08-01

    The Buenos Aires Conference, hosted by the Government of Argentina, was attended by 89 regulatory officials from 57 Member States. The conference provided a forum for fostering the exchange of information and experience on the development of adequate regulatory systems for effective control of the safety of radiation sources and security of radioactive materials. This publication contains 64 individual presentations delivered at the Conference. Each of them was indexed separately.

  8. National regulatory authorities with competence in the safety of radiation sources and the security of radioactive materials. Proceedings

    International Nuclear Information System (INIS)

    2001-01-01

    The Buenos Aires Conference, hosted by the Government of Argentina, was attended by 89 regulatory officials from 57 Member States. The conference provided a forum for fostering the exchange of information and experience on the development of adequate regulatory systems for effective control of the safety of radiation sources and security of radioactive materials. This publication contains 64 individual presentations delivered at the Conference. Each of them was indexed separately

  9. Improving nuclear regulatory effectiveness

    International Nuclear Information System (INIS)

    2001-01-01

    Ensuring that nuclear installations are operated and maintained in such a way that their impact on public health and safety is as low as reasonably practicable has been and will continue to be the cornerstone of nuclear regulation. In the past, nuclear incidents provided the main impetus for regulatory change. Today, economic factors, deregulation, technological advancements, government oversight and the general requirements for openness and accountability are leading regulatory bodies to review their effectiveness. In addition, seeking to enhance the present level of nuclear safety by continuously improving the effectiveness of regulatory bodies is seen as one of the ways to strengthen public confidence in the regulatory systems. This report covers the basic concepts underlying nuclear regulatory effectiveness, advances being made and future requirements. The intended audience is primarily nuclear safety regulators, but government authorities, nuclear power plant operators and the general public may also be interested. (author)

  10. The effect of regulatory requirements on the control and instrumentation system designer

    International Nuclear Information System (INIS)

    Golder, J.A.

    1978-01-01

    The difficulties encountered by the designer of control and protection systems for nuclear plant in attempting to satisfy the large number of imprecise regulations and recommendations which exist are described. The absence of fundamental quantitative safety requirements of international acceptability is deplored and the adoption of a major incident criteria expressed in quantitative terms as the basis for the derivation of target design criteria for protection systems and plant components is suggested. (author)

  11. Review of light water reactor regulatory requirements: Assessment of selected regulatory requirements that may have marginal importance to risk: Postaccident sampling system, Turbine missiles, Combustible gas control, Charcoal filters

    International Nuclear Information System (INIS)

    Scott, W.B.; Jamison, J.D.; Stoetzel, G.A.; Tabatabai, A.S.; Vo, T.V.

    1987-05-01

    In a study commissioned by the Nuclear Regulatory Commission (NRC), Pacific Northwest Laboratory (PNL) evaluated the costs and benefits of modifying regulatory requirements in the areas of the postaccident sampling system, turbine rotor design reviews and inspections, combustible gas control for inerted Boiling Water Reactor (BWR) containments, and impregnated charcoal filters in certain plant ventilation systems. The basic framework for the analyses was that presented in the Regulatory Analysis Guidelines (NUREG/BR-0058) and in the Handbook for Value-Impact Assessment (NUREG/CR-3568). The effects of selected modifications to regulations were evaluated in terms of such factors as public risk and costs to industry and NRC. The results indicate that potential modifications of the regulatory requirements in three of the four areas would have little impact on public risk. In the fourth area, impregnated charcoal filters in building ventilation systems do appear to limit risks to the public and plant staff. Revisions in the severe accident source term assumptions, however, may reduce the theoretical value of charcoal filters. The cost analysis indicated that substantial savings in operating costs may be realized by changing the interval of turbine rotor inspections. Small to moderate operating cost savings may be realized through postulated modifications to the postaccident sampling system requirements and to the requirements for combustible gas control in inerted BWR containments. Finally, the use of impregnated charcoal filters in ventilation systems appears to be the most cost-effective method of reducing radioiodine concentrations

  12. A study for the establishment of regulatory requirement and evaluation guide for station blackout in nuclear power plants

    International Nuclear Information System (INIS)

    Lim, J. H.; Koo, C. S.; Joo, W. P.; Oh, S. H.; Shin, W. K.

    1999-01-01

    The consequence of SBO event could be a severe accident unless AC power was restored within a proper time, because many safety systems depend upon AC power. Based on the severity, the SBO has been extensively studied since it was identified as Unresolved Safety Issue at USNRC. The resolution of those studies is a rule-making such as 10 CFR 50.63 and Regulatory Guide 1.155. But there is no regulatory requirements of SBO for an operating domestic nuclear power plant up to the present time. This tudy has established SBO rule(regulatory requirements and evaluation guides) for an operating PWR type of the operating nuclear power plants in Korea

  13. Amendment to the Decree of the Slovak Nuclear Regulatory Authority on details concerning emergency planning in case of nuclear incident or accident

    International Nuclear Information System (INIS)

    Biharyová, Michaela

    2018-01-01

    Following up amendment to the Slovak Atomic Act, the Decree No. 55/2006 on details concerning emergency planning in case of nuclear incident or accident has also been amended now. Following a short introductory text by the author, the entire text of the ‘Decree of the Nuclear Regulatory Authority of the Slovak Republic No 9/2018 Coll. of 2 January 2018 amending Decree of the Nuclear Regulatory Authority of the Slovak Republic No 55/2006 Coll. on details in emergency planning in case of nuclear incident or accident as amended by Decree No. 35/2012 Coll.’ is reproduced. The Amendment entered into force 1 February 2018. (orig.)

  14. PRMT1 mediated methylation of TAF15 is required for its positive gene regulatory function

    Energy Technology Data Exchange (ETDEWEB)

    Jobert, Laure; Argentini, Manuela [Institut de Genetique et de Biologie Moleculaire et Cellulaire (IGBMC), CNRS UMR 7104, INSERM U 596, Universite Louis Pasteur de Strasbourg, BP 10142 - 67404 Illkirch Cedex, CU de Strasbourg (France); Tora, Laszlo, E-mail: laszlo@igbmc.u-strasbg.fr [Institut de Genetique et de Biologie Moleculaire et Cellulaire (IGBMC), CNRS UMR 7104, INSERM U 596, Universite Louis Pasteur de Strasbourg, BP 10142 - 67404 Illkirch Cedex, CU de Strasbourg (France)

    2009-04-15

    TAF15 (formerly TAF{sub II}68) is a nuclear RNA-binding protein that is associated with a distinct population of TFIID and RNA polymerase II complexes. TAF15 harbours an N-terminal activation domain, an RNA recognition motif (RRM) and many Arg-Gly-Gly (RGG) repeats at its C-terminal end. The N-terminus of TAF15 serves as an essential transforming domain in the fusion oncoprotein created by chromosomal translocation in certain human chondrosarcomas. Post-transcriptional modifications (PTMs) of proteins are known to regulate their activity, however, nothing is known on how PTMs affect TAF15 function. Here we demonstrate that endogenous human TAF15 is methylated in vivo at its numerous RGG repeats. Furthermore, we identify protein arginine N-methyltransferase 1 (PRMT1) as a TAF15 interactor and the major PRMT responsible for its methylation. In addition, the RGG repeat-containing C-terminus of TAF15 is responsible for the shuttling between the nucleus and the cytoplasm and the methylation of RGG repeats affects the subcellular localization of TAF15. The methylation of TAF15 by PRMT1 is required for the ability of TAF15 to positively regulate the expression of the studied endogenous TAF15-target genes. Our findings demonstrate that arginine methylation of TAF15 by PRMT1 is a crucial event determining its proper localization and gene regulatory function.

  15. Requirements for growth and IL-10 expression of highly purified human T regulatory cells

    Science.gov (United States)

    Bonacci, Benedetta; Edwards, Brandon; Jia, Shuang; Williams, Calvin; Hessner, Martin J.; Gauld, Stephen; Verbsky, James

    2013-01-01

    Human regulatory T cells (TR) cells have potential for the treatment of a variety of immune mediated diseases but the anergic phenotype of these cells makes them difficult to expand in vitro. We have examined the requirements for growth and cytokine expression from highly purified human TR cells, and correlated these findings with the signal transduction events of these cells. We demonstrate that these cells do not proliferate or secrete IL-10 even in the presence of high doses of IL-2. Stimulation with a superagonistic anti-CD28 antibody (clone 9D4) and IL-2 partially reversed the proliferative defect, and this correlated with reversal of the defective calcium mobilization in these cells. Dendritic cells were effective at promoting TR cell proliferation, and under these conditions the proliferative capacity of TR cells was comparable to conventional CD4 lymphocytes. Blocking TGF-β activity abrogated IL-10 expression from these cells, while addition of TGF-β resulted in IL-10 production. These data demonstrate that highly purified populations of TR cells are anergic even in the presence of high doses of IL-2. Furthermore, antigen presenting cells provide proper co-stimulation to overcome the anergic phenotype of TR cells, and under these conditions they are highly sensitive to IL-2. In addition, these data demonstrate for the first time that TGF-β is critical to enable human TR cells to express IL-10. PMID:22562448

  16. PRMT1 mediated methylation of TAF15 is required for its positive gene regulatory function

    International Nuclear Information System (INIS)

    Jobert, Laure; Argentini, Manuela; Tora, Laszlo

    2009-01-01

    TAF15 (formerly TAF II 68) is a nuclear RNA-binding protein that is associated with a distinct population of TFIID and RNA polymerase II complexes. TAF15 harbours an N-terminal activation domain, an RNA recognition motif (RRM) and many Arg-Gly-Gly (RGG) repeats at its C-terminal end. The N-terminus of TAF15 serves as an essential transforming domain in the fusion oncoprotein created by chromosomal translocation in certain human chondrosarcomas. Post-transcriptional modifications (PTMs) of proteins are known to regulate their activity, however, nothing is known on how PTMs affect TAF15 function. Here we demonstrate that endogenous human TAF15 is methylated in vivo at its numerous RGG repeats. Furthermore, we identify protein arginine N-methyltransferase 1 (PRMT1) as a TAF15 interactor and the major PRMT responsible for its methylation. In addition, the RGG repeat-containing C-terminus of TAF15 is responsible for the shuttling between the nucleus and the cytoplasm and the methylation of RGG repeats affects the subcellular localization of TAF15. The methylation of TAF15 by PRMT1 is required for the ability of TAF15 to positively regulate the expression of the studied endogenous TAF15-target genes. Our findings demonstrate that arginine methylation of TAF15 by PRMT1 is a crucial event determining its proper localization and gene regulatory function.

  17. Analytical challenges and regulatory requirements for nasal drug products in europe and the u.s.

    Science.gov (United States)

    Trows, Sabrina; Wuchner, Klaus; Spycher, Rene; Steckel, Hartwig

    2014-04-11

    Nasal drug delivery can be assessed by a variety of means and regulatory agencies, e.g., the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have published a set of guidelines and regulations proposing in vitro test methods for the characterization of nasal drug products. This article gives a summary of the FDA and EMA requirements regarding the determination of droplet size distribution (DSD), plume geometry, spray pattern and shot weights of solution nasal sprays and discusses the analytical challenges that can occur when performing these measurements. In order to support findings from the literature, studies were performed using a standard nasal spray pump and aqueous model formulations. The aim was to identify possible method-, device- and formulation-dependent influencing factors. The literature review, as well as the results from the studies show that DSD, plume geometry and spray pattern are influenced by, e.g., the viscosity of the solution, the design of the device and the actuation parameters, particularly the stroke length, actuation velocity and actuation force. The dominant factor influencing shot weights, however, is the adjustment of the actuation parameters, especially stroke length and actuation velocity. Consequently, for routine measurements assuring, e.g., the quality of a solution nasal spray or, for in vitro bioequivalence studies, the critical parameters, have to be identified and considered in method development in order to obtain reproducible and reliable results.

  18. Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA

    DEFF Research Database (Denmark)

    Eriksson, Robert; Aagaard, Lise; Jensen, Lars Juhl

    2014-01-01

    as ADRs listed only in one country or listed with different frequencies. We analyzed PIs for 40 separate drugs from ten therapeutic groups and assigned the 4003 identified ADRs to System Organ Classes (Medical Dictionary for Regulatory Activities [MedDRA] terminology). Less than half of listed ADRs (n...

  19. A regulatory adjustment process for the determination of the optimal percentage requirement in an electricity market with Tradable Green Certificates

    International Nuclear Information System (INIS)

    Currier, Kevin M.

    2013-01-01

    A system of Tradable Green Certificates (TGCs) is a market-based subsidy scheme designed to promote electricity generation from renewable energy sources such as wind power. Under a TGC system, the principal policy instrument is the “percentage requirement,” which stipulates the percentage of total electricity production (“green” plus “black”) that must be obtained from renewable sources. In this paper, we propose a regulatory adjustment process that a regulator can employ to determine the socially optimal percentage requirement, explicitly accounting for environmental damages resulting from black electricity generation. - Highlights: • A Tradable Green Certificate (TGC) system promotes energy production from renewable sources. • We consider an electricity oligopoly operated under a TGC system. • Welfare analysis must account for damages from “black” electricity production. • We characterize the welfare maximizing (optimal) “percentage requirement.” • We present a regulatory adjustment process that computes the optimal percentage requirement iteratively

  20. A Health Equity Problem for Low Income Children: Diet Flexibility Requires Physician Authorization.

    Science.gov (United States)

    Stookey, Jodi D

    2015-09-01

    USDA programs, such as the Child and Adult Care Food Program (CACFP), School Breakfast Program (SBP), and/or National School Lunch Program (NSLP), enable child care centers and schools to provide free and reduced price meals, daily, to millions of low income children. Despite intention to equalize opportunity for every child to have a healthy diet, USDA program rules may be contributing to child obesity disparities and health inequity. USDA program rules require child care centers and schools to provide meals that include a specified number of servings of particular types of foods and beverages. The rules are designed for the average, healthy weight child to maintain weight and growth. They are not designed for the underweight child to gain weight, obese child to normalize weight, or pre-diabetic child to avoid incident diabetes. The rules allow for only one meal pattern and volume, as opposed to a flexible spectrum of meal patterns and portion sizes. Parents of children who participate in the CACFP, SBP, and/or NSLP do not have control over the amount or composition of the subsidized meals. Parents of overweight, obese, or diabetic children who participate in the subsidized meal programs can request dietary change, special meals or accommodations to address their child's health status, but child care providers and schools are not required to comply with the request unless a licensed physician signs a "Medical statement to request special meals and/or accommodations". Although physicians are the only group authorized to change the foods, beverages, and portion sizes served daily to low income children, they are not doing so. Over the past three years, despite an overweight and obesity prevalence of 30% in San Francisco child care centers serving low income children, zero medical statements were filed to request special meals or accommodations to alter daily meals in order to prevent obesity, treat obesity, or prevent postprandial hyperglycemia. Low income children

  1. A comparison of the different regulatory requirements of NPP in vertical ground motion

    International Nuclear Information System (INIS)

    Hou Chunlin; Pan Rong; Yang Yu; Wang Shuguo; Li Xiaojun

    2015-01-01

    Based on the importance of vertical motion in the nuclear power plants (NPPs) and equipment identification of seismic test, we summarize the existing laws and regulations cited by China's NPPs in the vertical seismic ground motion of the regulations. Then, according to the interpretation of various laws and regulations content, we may identified four vertical earthquake response spectrums. Finally, combined with the seismic safety requirements of China NPPs evaluation and the vertical seismic design of M310, EPR, AP1000 and CAP1400 pressurized water reactor, we explain that the vertical seismic ground motion selection should distinguish the effects between near field and far field earthquake, the existing regulations and specifications that China used are still required to further improve on the selection of vertical ground motion. The results of this study can provide reference for seismic design of China's nuclear power plant and nuclear safety review. (authors)

  2. A 3D bioprinting exemplar of the consequences of the regulatory requirements on customized processes.

    Science.gov (United States)

    Hourd, Paul; Medcalf, Nicholas; Segal, Joel; Williams, David J

    2015-01-01

    Computer-aided 3D printing approaches to the industrial production of customized 3D functional living constructs for restoration of tissue and organ function face significant regulatory challenges. Using the manufacture of a customized, 3D-bioprinted nasal implant as a well-informed but hypothetical exemplar, we examine how these products might be regulated. Existing EU and USA regulatory frameworks do not account for the differences between 3D printing and conventional manufacturing methods or the ability to create individual customized products using mechanized rather than craft approaches. Already subject to extensive regulatory control, issues related to control of the computer-aided design to manufacture process and the associated software system chain present additional scientific and regulatory challenges for manufacturers of these complex 3D-bioprinted advanced combination products.

  3. A regulatory perspective on design and performance requirements for engineered systems in high-level waste

    International Nuclear Information System (INIS)

    Bernero, R.M.

    1992-01-01

    For engineered systems, this paper gives an overview of some of the current activities at the U.S. Nuclear Regulatory Commission (NRC), with the intent of elucidating how the regulatory process works in the management of high-level waste (HLW). Throughout the waste management cycle, starting with packaging and transportation, and continuing to final closure of a repository, these activities are directed at taking advantage of the prelicensing consultation period, a period in which the NRC, DOE and others can interact in ways that will reduce regulatory, technical and institutional uncertainties, and open the path to development and construction of a deep geologic repository for permanent disposal of HLW. Needed interactions in the HLW program are highlighted. Examples of HLW regulatory activities are given in discussions of a multipurpose-cask concept and of current NRC work on the meaning of the term substantially complete containment

  4. 41 CFR 102-72.95 - What are the requirements for obtaining a security delegation of authority from GSA?

    Science.gov (United States)

    2010-07-01

    ... the requirements for obtaining a security delegation of authority from GSA? An Executive agency may... PBS. The delegation may be granted where the requesting agency demonstrates a compelling need for the delegated authority and the delegation is not inconsistent with the authorities of any other law enforcement...

  5. Regulation of Federal radioactive waste activities. Summary of report to Congress on extending the Nuclear Regulatory Commission's licensing or regulatory authority to Federal radioactive waste storage and disposal activities

    International Nuclear Information System (INIS)

    Smith, R.D.

    1979-09-01

    The NRC Authorization Bill for FY 1979 directed NRC to conduct a study of extending the Commission's licensing or regulatory authority to include categories of existing and future Federal radioactive waste storage and disposal activities not presently subject to such authority. The report includes a complete listing and inventory of all radioactive waste storage and disposal activities now being conducted or planned by Federal agencies. The NRC study has attempted to present a general comparison of the relative hazards associated with defense-generated and commercial wastes. Options for extending Commission authority were developed and analyzed. The implications of NEPA were analyzed in the context of these options. The national security implications of extending NRC's regulatory authority over DOE programs are examined and evaluated. Costs and benefits are identified and assessed. The Commission's recommendations, based on the study, are to extend licensing authority over new DOE disposal activities involving transuranic wastes and non-defense low-level waste and to initiate a pilot program to test the feasibility of NRC playing a consultative role in the evaluation of existing DOE activities

  6. Facility specialists and inspectorate staff of the nuclear regulatory authority training in the field of management systems in compliance with the latest IAEA standards

    International Nuclear Information System (INIS)

    Kapralov, E.; Kapralov, Y.; Kozlov, V.; Filimonov, G.

    2007-01-01

    A problem of reducing a human factor negative influence reduction upon nuclear safety should be solved on the whole at the expense of introducing integrated management systems with a comprehensive application of regulatory control, training and inspections. This paper covers FSUE VO Safety and Training and Methodical Center of Nuclear and Radiation Safety approach towards training matters, which is one of the key factors in implementing quality and safety management systems. (author)

  7. Development of guidance on applications of regulatory requirements for low specific activity materials and surface contaminated objects

    International Nuclear Information System (INIS)

    Pope, R.B.; Easton, E.P.; Shankman, S.F.

    1997-01-01

    In 1985, the International Atomic Energy Agency issued revised regulations for the safe transport of radioactive material. Significant among the changes were major revisions to requirements for Low Specific Activity (LSA) material and Surface Contaminated Objects (SCOs). In preparation for the adoption of these requirements into regulations in the United States, it became apparent that guidance on how to apply these requirements, clarifying technical uncertainties and ensuring proper implementation, would be needed both by the regulators and those regulated. Thus, the US Department of Transportation and the US Nuclear Regulatory Commission, with the assistance of staff from Oak Ridge National Laboratory, are preparing regulatory guidance for LSA material and SCO transport. The guidance will present examples of acceptable methods for demonstrating compliance with the revised rules. Ideas being investigated for inclusion in the pending guidance are discussed in this paper. Under current plans, the guidance will be issued for public comment prior to final issuance of the guidance in 1997

  8. Evolution of ITER tritium confinement strategy and adaptation to Cadrache site conditions and French regulatory requirements

    International Nuclear Information System (INIS)

    Murdoch, D.

    2007-01-01

    The ITER Nuclear Buildings include the Tokamak, Tritium and Diagnostic Buildings (Tokamak Complex) and the Hot Cell and Low Level Radioactive Waste Buildings. The Tritium Confinement Strategy of the Nuclear Buildings comprises key features of the Atmosphere and Vent Detritiation Systems (ADS/VDS) and the Heating, Ventilation and Air Conditioning (HVAC) Systems. The designs developed during the ITER EDA (Engineering Design Activities) for these systems need to be adapted to the specific conditions of the Cadarache site and modified to conform with the regulatory requirements applicable to Installations Nucleaires de Base (INB) - Basic Nuclear Installations - in France. The highest priority for such adaptation has been identified as the Tritium Confinement of the Tokamak Complex and the progress in development of a robust, coherent design concept compliant with French practice is described in the paper. The Tokamak Complex HVAC concept for generic conditions was developed for operational cost minimisation under more extreme climatic conditions (primarily temperature) than those valid for Cadarache, and incorporated recirculation of a large fraction of the air flow through the HVAC systems to achieve this objective. Due to the impracticality of precluding the spread of contamination from areas of higher activity to less contaminated areas, this concept has been abandoned in favour of a once-through configuration, which requires a complete redesign, with revised air change rates, module sizes, layout, redundancy provisions and other features. The ADS/VDS concept developed for the generic design of the ITER Tokamak Complex is undergoing a radical revision in which the system architecture, module sizing and basic process are being optimised for the Cadarache conditions. Investigation is being launched into the implementation of a wet stripper concept to replace the molecular sieve (MS) beds incorporated in the generic design, where concerns have been raised over low

  9. Advantages and disadvantages of a risk - based regulatory requirement (the experience in Argentina)

    International Nuclear Information System (INIS)

    Baron, Jorge

    2006-01-01

    Argentina has its own nuclear regulations, which include a risk-based criterion curve for the licensing of nuclear installations. This requirement, established in the early '70s, must be fulfilled with a PSA study. It has been applied to several installations, and the advantages and disadvantages of this approach are discussed in the paper through several examples. The main disadvantage is a somehow large amount of PSA work that needs to be performed for the licensing of a nuclear installation. The main advantage is the effective risk reduction that can be achieved by retrofitting the risk-based lessons learned into the design teams (not only for design of systems and components, but also for design of operation, testing and maintenance schemes). (author)

  10. The National Radiation Protection Authority and its regulatory programme. Potential benefits of the CTBT and thoughts on cooperation

    International Nuclear Information System (INIS)

    Gebeyehu, G.

    1999-01-01

    In the past years Ethiopia became an active participant in the scientific and political development as well as supporter of the CTBT. This paper describes the designated institution for the CTBT implementation in the area of Radionuclides in Ethiopia and its scientific and regulatory program as well as main activities concerning application techniques. The second part of the paper accounts for the links between the objectives of the national institute with the CTBT. It draws substantive details about benefits that could arise from participating in CTBT implementation and summarizes the discussion by suggesting modalities for building partnership and cooperation

  11. Requirement Management between Regulatory Framework and Dismantling Activities for Decommissioning of a Nuclear Facility

    International Nuclear Information System (INIS)

    Park, H.S.; Jin, H.G.; Hong, Y.J.; Choi, J.W.; Park, S.

    2016-01-01

    Full text: The decommissioning and environmental remediation (D&ER) projects require stepwise long-term research and development (R&D) such as a shutdown, transition, decontamination and decommissioning (D&D) activities, radioactive waste management, and site restoration. During each step of the D&ER projects, a significant amount of information and knowledge such as experimental data, databases, design drawings, technical reports, guidelines, operation manuals, and modeling and simulation reports are produced. Knowledge based on experiences by staff members participating in each step of the D&ER project are also very important. Such knowledge based on experiences may disappear with the retirement of staff members if there are no effective and systematic approaches for its acquisition and storage. Therefore, to perform the D&ER project successfully, it is necessary to preserve written theses and experiences systematically. The integrated knowledge management system (KMS) for the D&ER projects have never been developed. Therefore, the establishment of an integrated KMS is necessary for the effective performance of D&ER projects. This study introduces a decommissioning procedure requirement management system as a part of the KMS related to the D&ER projects. (author

  12. 78 FR 66940 - Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft...

    Science.gov (United States)

    2013-11-07

    ... for such products. These inconsistent interpretations of the definitions may inadvertently result in... amplification products (PSAPs), as well as the regulatory controls that apply to each. This draft guidance is... of clarity regarding how the Agency defines a hearing aid versus a personal sound amplification...

  13. Franchise Values, Regulatory Monitoring, and Capital Requirements in Optimal Bank Regulation

    DEFF Research Database (Denmark)

    Andersen, Thomas Barnebeck; Harr, Thomas

    2008-01-01

    This paper demonstrates that financial deregulation is likely to make standard prudential regulatory instruments less effective in curbing excessive risk-taking incentives among banks. This has interesting implications for optimal bank regulation. When there is an increase in competition, the opt...

  14. Nuclear Energy Research Initiative. Risk Informed Assessment of Regulatory and Design Requirements for Future Nuclear Power Plants. Annual Report

    International Nuclear Information System (INIS)

    Ritterbusch, S.E.

    2000-01-01

    The overall goal of this research project is to support innovation in new nuclear power plant designs. This project is examining the implications, for future reactors and future safety regulation, of utilizing a new risk-informed regulatory system as a replacement for the current system. This innovation will be made possible through development of a scientific, highly risk-informed approach for the design and regulation of nuclear power plants. This approach will include the development and.lor confirmation of corresponding regulatory requirements and industry standards. The major impediment to long term competitiveness of new nuclear plants in the U.S. is the capital cost component--which may need to be reduced on the order of 35% to 40% for Advanced Light Water Reactors (ALWRs) such as System 80+ and Advanced Boiling Water Reactor (ABWR). The required cost reduction for an ALWR such as AP600 or AP1000 would be expected to be less. Such reductions in capital cost will require a fundamental reevaluation of the industry standards and regulatory bases under which nuclear plants are designed and licensed. Fortunately, there is now an increasing awareness that many of the existing regulatory requirements and industry standards are not significantly contributing to safety and reliability and, therefore, are unnecessarily adding to nuclear plant costs. Not only does this degrade the economic competitiveness of nuclear energy, it results in unnecessary costs to the American electricity consumer. While addressing these concerns, this research project will be coordinated with current efforts of industry and NRC to develop risk-informed, performance-based regulations that affect the operation of the existing nuclear plants; however, this project will go farther by focusing on the design of new plants

  15. Nuclear Energy Research Initiative. Risk Informed Assessment of Regulatory and Design Requirements for Future Nuclear Power Plants. Annual Report

    Energy Technology Data Exchange (ETDEWEB)

    Ritterbusch, S.E.

    2000-08-01

    The overall goal of this research project is to support innovation in new nuclear power plant designs. This project is examining the implications, for future reactors and future safety regulation, of utilizing a new risk-informed regulatory system as a replacement for the current system. This innovation will be made possible through development of a scientific, highly risk-informed approach for the design and regulation of nuclear power plants. This approach will include the development and.lor confirmation of corresponding regulatory requirements and industry standards. The major impediment to long term competitiveness of new nuclear plants in the U.S. is the capital cost component--which may need to be reduced on the order of 35% to 40% for Advanced Light Water Reactors (ALWRs) such as System 80+ and Advanced Boiling Water Reactor (ABWR). The required cost reduction for an ALWR such as AP600 or AP1000 would be expected to be less. Such reductions in capital cost will require a fundamental reevaluation of the industry standards and regulatory bases under which nuclear plants are designed and licensed. Fortunately, there is now an increasing awareness that many of the existing regulatory requirements and industry standards are not significantly contributing to safety and reliability and, therefore, are unnecessarily adding to nuclear plant costs. Not only does this degrade the economic competitiveness of nuclear energy, it results in unnecessary costs to the American electricity consumer. While addressing these concerns, this research project will be coordinated with current efforts of industry and NRC to develop risk-informed, performance-based regulations that affect the operation of the existing nuclear plants; however, this project will go farther by focusing on the design of new plants.

  16. Regulatory Considerations for the Long Term Cooling Safe Shutdown Requirements of the Passive Residual Heat Removal Systems in Advanced Reactors

    International Nuclear Information System (INIS)

    Sim, S. K.; Bae, S. H.; Kim, Y. S.; Hwang, Min Jeong; Bang, Young Seok; Hwang, Taesuk

    2016-01-01

    USNRC approved safe shutdown at 215.6 .deg. C for a safe and long term cooling state for the redundant passive RHRSs by SECY-94-084. USNRC issued COLA(Combined Construction and Operating License) for the Levy County NP Unit-1/2 for the AP1000 passive RHRSs in 2014. Korea Hydro and Nuclear Power(KHNP) is developing APR+ and adopted Passive Auxiliary Feedwater System(PAFS) as a new passive RHRS design. Korea Institute of Nuclear Safety(KINS) has been developing regulatory guides for the advanced safety design features of the advanced ALWRs which has plan to construct in near future in Korea[5]. Safety and regulatory issues as well as the safe shut down requirements of the passive RHRS are discussed and considerations in developing regulatory guides for the passive RHRS are presented herein. Passive RHRSs have been introduced as new safety design features for the advanced reactors under development in Korea. These passive RHRSs have potential advantages over existing active RHRS, however, their functions are limited due to inherent ability of passive heat removal processes. It is high time to evaluate the performance of the passive PRHRs and develop regulatory guides for the safety as well as the performance analyses of the passive RHRS

  17. Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN

    Directory of Open Access Journals (Sweden)

    Sanz Nuria

    2009-10-01

    Full Text Available Abstract Background Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states. Methods In order to summarise the current situation in relation to the wide spectrum of clinical research, the European Clinical Research Infrastructures Network (ECRIN developed a multinational survey in ten European countries. However a lack of common classification framework for major categories of clinical research was identified, and therefore reaching an agreement on a common classification was the initial step in the development of the survey. Results The ECRIN transnational working group on regulation, composed of experts in the field of clinical research from ten European countries, defined seven major categories of clinical research that seem relevant from both the regulatory and the scientific points of view, and correspond to congruent definitions in all countries: clinical trials on medicinal products; clinical trials on medical devices; other therapeutic trials (including surgery trials, transplantation trials, transfusion trials, trials with cell therapy, etc.; diagnostic studies; clinical research on nutrition; other interventional clinical research (including trials in complementary and alternative medicine, trials with collection of blood or tissue samples, physiology studies, etc.; and epidemiology studies. Our classification was essential to develop a survey focused on protocol submission to ethics committees and competent authorities, procedures for amendments, requirements for sponsor and insurance, and adverse event reporting following five main phases: drafting, consensus, data collection, validation, and finalising. Conclusion The list of clinical research categories as used for the survey could serve as a contribution to the, much needed, task of harmonisation and

  18. Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)

    LENUS (Irish Health Repository)

    Kubiak, Christine

    2009-10-16

    Abstract Background Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states. Methods In order to summarise the current situation in relation to the wide spectrum of clinical research, the European Clinical Research Infrastructures Network (ECRIN) developed a multinational survey in ten European countries. However a lack of common classification framework for major categories of clinical research was identified, and therefore reaching an agreement on a common classification was the initial step in the development of the survey. Results The ECRIN transnational working group on regulation, composed of experts in the field of clinical research from ten European countries, defined seven major categories of clinical research that seem relevant from both the regulatory and the scientific points of view, and correspond to congruent definitions in all countries: clinical trials on medicinal products; clinical trials on medical devices; other therapeutic trials (including surgery trials, transplantation trials, transfusion trials, trials with cell therapy, etc.); diagnostic studies; clinical research on nutrition; other interventional clinical research (including trials in complementary and alternative medicine, trials with collection of blood or tissue samples, physiology studies, etc.); and epidemiology studies. Our classification was essential to develop a survey focused on protocol submission to ethics committees and competent authorities, procedures for amendments, requirements for sponsor and insurance, and adverse event reporting following five main phases: drafting, consensus, data collection, validation, and finalising. Conclusion The list of clinical research categories as used for the survey could serve as a contribution to the, much needed, task of harmonisation and simplification of the

  19. Measuring Changes in Service Costs to Meet the Requirements of the 2002 National Defense Authorization Act

    National Research Council Canada - National Science Library

    Shirley, Chad; Ausink, John; Baldwin, Laura H

    2004-01-01

    The National Defense Authorization Act for Fiscal Year 2002 sets forth a series of goals for the Department of Defense to reduce the cost of the services it buys over a ten-year period through changes...

  20. [Software as medical devices/medical apps : Tasks, requirements, and experiences from the point of view of a competent authority].

    Science.gov (United States)

    Terhechte, Arno

    2018-03-01

    Software can be classified as a medical device according to the Medical Device Directive 93/42/EEC. The number of software products and medical apps is continuously increasing and so too is the use in health institutions (e. g., in hospitals and doctors' surgeries) for diagnosis and therapy.Different aspects of standalone software and medical apps from the perspective of the authority responsible are presented. The quality system implemented to establish a risk-based systematic inspection and supervision of manufacturers is discussed. The legal framework, as well as additional standards that are the basis for inspection, are outlined. The article highlights special aspects that occur during inspection like verification of software and interfaces, and the clinical evaluation of software. The Bezirksregierung, as the local government authority responsible in North Rhine-Westphalia, is also in charge of inspection of health institutions. Therefore this article is not limited to the manufacturers placing the software on the market, but in addition it describes the management and use of software as a medical device in hospitals.The future legal framework, the Medical Device Regulation, will strengthen the requirements and engage notified bodies more than today in the conformity assessment of software as a medical device.Manufacturers, health institutions, notified bodies and the authorities responsible are in charge of intensifying their efforts towards software as a medical device. Mutual information, improvement of skills, and inspections will lead to compliance with regulatory requirements.

  1. Semaphorin 4C Protects against Allergic Inflammation: Requirement of Regulatory CD138+ Plasma Cells.

    Science.gov (United States)

    Xue, Di; Kaufman, Gabriel N; Dembele, Marieme; Beland, Marianne; Massoud, Amir H; Mindt, Barbara C; Fiter, Ryan; Fixman, Elizabeth D; Martin, James G; Friedel, Roland H; Divangahi, Maziar; Fritz, Jörg H; Mazer, Bruce D

    2017-01-01

    The regulatory properties of B cells have been studied in autoimmune diseases; however, their role in allergic diseases is poorly understood. We demonstrate that Semaphorin 4C (Sema4C), an axonal guidance molecule, plays a crucial role in B cell regulatory function. Mice deficient in Sema4C exhibited increased airway inflammation after allergen exposure, with massive eosinophilic lung infiltrates and increased Th2 cytokines. This phenotype was reproduced by mixed bone marrow chimeric mice with Sema4C deficient only in B cells, indicating that B lymphocytes were the key cells affected by the absence of Sema4C expression in allergic inflammation. We determined that Sema4C-deficient CD19 + CD138 + cells exhibited decreased IL-10 and increased IL-4 expression in vivo and in vitro. Adoptive transfer of Sema4c -/- CD19 + CD138 + cells induced marked pulmonary inflammation, eosinophilia, and increased bronchoalveolar lavage fluid IL-4 and IL-5, whereas adoptive transfer of wild-type CD19 + CD138 + IL-10 + cells dramatically decreased allergic airway inflammation in wild-type and Sema4c -/- mice. This study identifies a novel pathway by which Th2-mediated immune responses are regulated. It highlights the importance of plasma cells as regulatory cells in allergic inflammation and suggests that CD138 + B cells contribute to cytokine balance and are important for maintenance of immune homeostasis in allergic airways disease. Furthermore, we demonstrate that Sema4C is critical for optimal regulatory cytokine production in CD138 + B cells. Copyright © 2016 by The American Association of Immunologists, Inc.

  2. Requirements for US regulatory approval of the International Thermonuclear Experimental Reactor (ITER)

    International Nuclear Information System (INIS)

    Petti, D.A.; Haire, J.C.

    1993-12-01

    The International Thermonuclear Experimental Reactor (ITER) is the first fusion machine that will have sufficient decay heat and activation product inventory to pose potential nuclear safety concerns. As a result, nuclear safety and environmental issues will be much more important in the approval process for the design, siting, construction, and operation of ITER in the United States than previous fusion devices, such as the Tokamak Fusion Test Reactor. The purpose of this report is (a) to provide an overview of the regulatory approval process for a Department of Energy (DOE) nuclear facility; (b) to present the dose limits used by DOE to protect workers, the public, and the environment from the risks of exposure to radiation and hazardous materials; (c) to discuss some key nuclear safety-related issues that must be addressed early in the Engineering Design Activities (EDA) to obtain regulatory approval; and (d) to provide general guidelines to the ITER Joint Central Team (JCT) concerning the development of a regulatory framework for the ITER project

  3. Sucrose-induced anthocyanin accumulation in vegetative tissue of Petunia plants requires anthocyanin regulatory transcription factors.

    Science.gov (United States)

    Ai, Trinh Ngoc; Naing, Aung Htay; Arun, Muthukrishnan; Lim, Sun-Hyung; Kim, Chang Kil

    2016-11-01

    The effects of three different sucrose concentrations on plant growth and anthocyanin accumulation were examined in non-transgenic (NT) and transgenic (T 2 ) specimens of the Petunia hybrida cultivar 'Mirage rose' that carried the anthocyanin regulatory transcription factors B-Peru+mPAP1 or RsMYB1. Anthocyanin accumulation was not observed in NT plants in any treatments, whereas a range of anthocyanin accumulation was observed in transgenic plants. The anthocyanin content detected in transgenic plants expressing the anthocyanin regulatory transcription factors (B-Peru+mPAP1 or RsMYB1) was higher than that in NT plants. In addition, increasing sucrose concentration strongly enhanced anthocyanin content as shown by quantitative real-time polymerase chain reaction (qRT-PCR) analysis, wherein increased concentrations of sucrose enhanced transcript levels of the transcription factors that are responsible for the induction of biosynthetic genes involved in anthocyanin synthesis; this pattern was not observed in NT plants. In addition, sucrose affected plant growth, although the effects were different between NT and transgenic plants. Taken together, the application of sucrose could enhance anthocyanin production in vegetative tissue of transgenic Petunia carrying anthocyanin regulatory transcription factors, and this study provides insights about interactive effects of sucrose and transcription factors in anthocyanin biosynthesis in the transgenic plant. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  4. Report on Activities of the Nuclear Regulatory Authority of the Slovak Republic and on Safety of Nuclear Installations in the Slovak Republic in 2005. Annual report 2005

    International Nuclear Information System (INIS)

    Zemanova, D.; Seliga, M.; Sladek, V.

    2006-04-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic in 2005 is presented. These activities are reported under the headings: Foreword; (1) Vision, Mission and Principles of Activities; (2) Legislation; (3) Issuance of Authorisations, Safety Assessment and Enforcement; (4) Nuclear Safety of Nuclear Installations in the Slovak Republic; (4.1) Nuclear installations in operation in the Slovak Republic; (4.2) Nuclear Installations under construction in the Slovak Republic; (4.3) Decommissioning of nuclear installations in the Slovak Republic; (5) Spent Fuel and Radioactive Waste Management and Safety of other Nuclear Installations in the Slovak Republic; (5.1) Generation and minimisation of radioactive waste; (5.2) Management of radioactive waste; (5.3) Pre-disposal management of radioactive waste; (5.4) Disposal of radioactive waste; (5.5) Shipment of radioactive waste; (5.6) Safety of other nuclear installations in the Slovak Republic; (6) Personnel Qualification and Training; (7) Nuclear Materials and Physical Protection of Nuclear installations; (8) Emergency Preparedness; (9) International Co-operation; (10) Public Communication; (11) UJD SR; (11.1) UJD SR organizational chart; (11.2) UJD SR organizational chart; (11.3) Human resources and training; (11.4) Internal system of quality assurance; (11.5) Development of UJD SR regulatory activities; Appendix: Abbreviations; Development of UJD SR regulatory activities

  5. Regulatory activities

    International Nuclear Information System (INIS)

    2001-01-01

    This publication, compiled in 8 chapters, presents the regulatory system developed by the Nuclear Regulatory Authority (NRA) of the Argentine Republic. The following activities and developed topics in this document describe: the evolution of the nuclear regulatory activity in Argentina; the Argentine regulatory system; the nuclear regulatory laws and standards; the inspection and safeguards of nuclear facilities; the emergency systems; the environmental systems; the environmental monitoring; the analysis laboratories on physical and biological dosimetry, prenatal irradiation, internal irradiation, radiation measurements, detection techniques on nuclear testing, medical program on radiation protection; the institutional relations with national and international organization; the training courses and meeting; the technical information

  6. 5 CFR 575.212 - Internal monitoring requirements and revocation or suspension of authority.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Internal monitoring requirements and... MANAGEMENT CIVIL SERVICE REGULATIONS RECRUITMENT, RELOCATION, AND RETENTION INCENTIVES; SUPERVISORY DIFFERENTIALS; AND EXTENDED ASSIGNMENT INCENTIVES Relocation Incentives § 575.212 Internal monitoring...

  7. 5 CFR 575.312 - Internal monitoring requirements and revocation or suspension of authority.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Internal monitoring requirements and... MANAGEMENT CIVIL SERVICE REGULATIONS RECRUITMENT, RELOCATION, AND RETENTION INCENTIVES; SUPERVISORY DIFFERENTIALS; AND EXTENDED ASSIGNMENT INCENTIVES Retention Incentives § 575.312 Internal monitoring...

  8. 45 CFR 164.508 - Uses and disclosures for which an authorization is required.

    Science.gov (United States)

    2010-10-01

    ... is in the form of: (A) A face-to-face communication made by a covered entity to an individual; or (B... must obtain an authorization for any use or disclosure of psychotherapy notes, except: (i) To carry out... which students, trainees, or practitioners in mental health learn under supervision to practice or...

  9. 50 CFR 216.108 - Requirements for monitoring and reporting under incidental harassment authorizations for Arctic...

    Science.gov (United States)

    2010-10-01

    ... location, and the time. (d) Where the proposed activity may affect the availability of a species or stock of marine mammal for taking for subsistence purposes, proposed monitoring plans or other research... an incidental harassment authorization for Arctic waters must submit reports to the Assistant...

  10. 77 FR 23396 - Revisions to the Requirements for Authority To Manufacture and Distribute Postage Evidencing Systems

    Science.gov (United States)

    2012-04-19

    ... Distribute Postage Evidencing Systems AGENCY: Postal Service TM . ACTION: Final rule. SUMMARY: This rule establishes the responsibility of the providers of Postage Evidencing Systems (PES) to notify the U.S. Postal... as follows: PART 501--AUTHORIZATION TO MANUFACTURE AND DISTRIBUTE POSTAGE EVIDENCING SYSTEMS 0 1. The...

  11. 26 CFR 601.503 - Requirements of power of attorney, signatures, fiduciaries and Commissioner's authority to...

    Science.gov (United States)

    2010-04-01

    ... representative(s); (5) Description of the matter(s) for which representation is authorized which, if applicable...)/period(s) involved; and (iv) In estate matters, decedent's date of death; and (6) A clear expression of... apply— (i) Joint representation. In the case of any matter concerning a joint return in which both...

  12. Fabrication of sterile experimental radiopharmaceuticals: technical and regulatory requirements; Fabrication des medicaments experimentaux radiopharmaceutiques steriles: exigences reglementaires et techniques

    Energy Technology Data Exchange (ETDEWEB)

    Briand, S

    2008-03-15

    The radiopharmaceuticals devoted to the biomedical research were the object of the directive 2001/20/C.E. transposition that defined again the conditions of implementation of biomedical research using drugs at human use, whom authorization is delivered by A.f.s.s.a.p.s.. In an other hand the law 2006-686 of the 13. june 2006 ( called law T.S.N.) has modified the regulatory dispositions relative to the radiation protection norms. These new dispositions allow to the health facilities to realize their research projects without difficulties for experimental drugs supply. (N.C.)

  13. Characterizing costs and benefits of uncertain future regulatory requirements on the U.S. natural gas industry

    International Nuclear Information System (INIS)

    Godec, M.L.; Smith, G.E.; Fitzgibbon, T.

    1995-01-01

    Environmental regulatory requirements at both the state and federal level are constantly changing, making it difficult for industry and R ampersand D program managers to project future compliance requirements and costs. Even if a company is trying to keep abreast of various proposed regulatory initiatives, the number of possible combinations of initiatives that could occur in the future seems virtually limitless. Uncertainty associated with potential future environmental compliance requirements makes the identification and evaluation of future investment and R ampersand D opportunities exceedingly difficult, and makes the process of systematic strategic planning increasingly complex. This paper describes a methodology for accounting for uncertain future environmental compliance costs in a systematic, comprehensive manner. Through analysis of proposed initiatives for making future environmental requirements more stringent, forecasting the likelihood of occurrence and potential timing of each initiative, and estimating potential future compliance costs associated with each initiative, a thorough process for incorporating regulatory uncertainty into strategic planning and project evaluation is described. This approach can be used for evaluating R ampersand D opportunities to determine where development of new technologies or assessment of risks posed by industry operations may have the greatest impact on future industry costs of compliance. This approach could also be used to account for the uncertainty of future environmental costs in corporate strategic planning or for factoring future compliance costs into project evaluation. This approach could also be enhanced through use in conjunction with other modeling and forecasting systems that could consider a broad range of impacts, including impacts on gas production, industry activity levels, and tax revenues

  14. Suggested state requirements and criteria for a low-level radioactive waste disposal site regulatory program

    International Nuclear Information System (INIS)

    Ratliff, R.A.; Dornsife, B.; Autry, V.; Gronemyer, L.; Vaden, J.; Cashman, T.

    1985-08-01

    Description of criteria and procedure is presented for a state to follow in the development of a program to regulate a LLW disposal site. This would include identifying those portions of the NRC regulations that should be matters of compatibility, identifying the various expertise and disciplines that will be necessary to effectively regulate a disposal site, identifying the resources necessary for conducting a confirmatory monitoring program, and providing suggestions in other areas which, based on experiences, would result in a more effective regulatory program

  15. Implementation of the waste management transfer act. Requirements from a regulatory point of view

    International Nuclear Information System (INIS)

    Mueller-Dehn, Christian

    2017-01-01

    In future in Germany, the state will be responsible for financing and handling the interim and final storage of radioactive waste from nuclear power plants. With regard to interim storage, this objective is achieved with the provisions of the Waste Management Transfer Act. Regulatory implementation is based on these regulations. BGZ Gesellschaft fuer Zwischenlager mbH is responsible for interim storage on behalf of the Federal Government. Simultaneously with the transfer of interim storage facilities to BGZ a legal transfer of approval is carried out. Insofar as there is a technical, organisational or personnel conjunction with the nuclear power plant operation, which continues to exist beyond this deadline and is relevant for regulatory purposes, a regulation is made via a service contract with the BGZ. This ensures compliance with the licensing regulations. Irradiated fuel assemblies and the waste from reprocessing can be handed over to BGZ from 1 January 2019 onwards and waste with negligible heat generation can be disposed of as of the determination of their proper packaging.

  16. Safety of nuclear installations in the Slovak Republic and activities of the Nuclear Regulatory Authority of the Slovak Republic in 2007

    International Nuclear Information System (INIS)

    Zemanova, D.

    2008-01-01

    Prepared pursuant to the provisions of the Atomic Act, the report provides information on the safety of nuclear installation in the Slovak Republic and activities of the Nuclear Regulatory Authority of the Slovak Republic ( UJD SR). UJD SR executes its activities in the area of legislation, issuance of authorizations and permissions for the siting, construction, operation and decommissioning of nuclear installations, in the area of reviews, assessments and control of nuclear safety of nuclear installations and emergency planning, in the area of records and accountability of nuclear materials, independent public information and in the area of international co-operation focused on peaceful uses of nuclear power. Based on the results of inspection activities and evaluation of safety indicators, UJD SR assessed the operation of nuclear installations in the Slovak Republic as safe and reliable. No significant event that could have a negative impact on the personnel, population or environment occurred in 2007. (orig.)

  17. Classification and disposal of radioactive wastes: History and legal and regulatory requirements

    International Nuclear Information System (INIS)

    Kocher, D.C.

    1990-01-01

    This document discusses the laws and regulations in the United States addressing classification of radioactive wastes and the requirements for disposal of different waste classes. This review emphasizes the relationship between waste classification and the requirements for permanent disposal

  18. 47 CFR 90.631 - Trunked systems loading, construction and authorization requirements.

    Science.gov (United States)

    2010-10-01

    ..., the total number of mobile units and control stations operating in the wide-area system shall be... system loading requirements under this subpart, the term “mobile station” includes vehicular and portable mobile units and control stations. (b) Each applicant for a non-SMR trunked system must certify that a...

  19. 47 CFR 1.1312 - Facilities for which no preconstruction authorization is required.

    Science.gov (United States)

    2010-10-01

    ... environmental impact as defined in § 1.1307 of this part or is categorically excluded from environmental... significant environmental impact, the information required by § 1.1311 of this part shall be submitted by the... significant environmental effect, it shall immediately cease construction which may have that effect, and...

  20. 75 FR 30309 - Revisions to the Requirements for Authority To Manufacture and Distribute Postage Evidencing Systems

    Science.gov (United States)

    2010-06-01

    ... Distribute Postage Evidencing Systems. This proposed revision clarifies the requirement for examination by an independent audit firm of a Postage Evidencing System Provider's Computerized Meter Resetting System (CMRS) or... Distribute Postage Evidencing Systems AGENCY: Postal Service\\TM\\. ACTION: Proposed rule. SUMMARY: In this...

  1. 75 FR 61653 - Advance Notice of Proposed Rulemaking Regarding Authority To Require Supervision and Regulation...

    Science.gov (United States)

    2010-10-06

    ...? Should the type of asset management activity (e.g., hedge fund, private equity fund, mutual fund) being... contractual arrangements that require the nonbank financial firm either to fund or to satisfy an obligation in connection with managed assets be considered? d. During the financial crisis, some firms provided financial...

  2. 77 FR 56554 - Revisions to the Requirements for Authority to Manufacture and Distribute Postage Evidencing Systems

    Science.gov (United States)

    2012-09-13

    ... auditor shall provide the RC and the Postal Service with an opinion on the design and operating... about the work performed with the service auditor. The Postal Service requires that all remediation... related to the examinations conducted by the service auditor and the RC. * * * * * Stanley F. Mires...

  3. Regulatory requirements on accident management and emergency preparedness - concept of nuclear and radiation safety during beyond-design-basis accidents

    International Nuclear Information System (INIS)

    Yanke, R.

    2002-01-01

    Actual practice the and proposals for further activities in the field of Accident Management (AM) in the member countries of the Co-operation Forum of WWER regulators and in Western countries have been assessed. Further the results of the last working group on AM , the overview of interactions of severe accident research and the regulatory positions in various countries, IAEA reports, practice in Switzerland and Finland, were taken into consideration. From this information, the working group derived recommendations on Accident Management. The general proposals correspond to the present state of the art on AM. They do not describe the whole spectra of recommendations on AM for NPPs with WWER reactors. A basis for the implementation of an AM program is given, which could be extended in a follow-up working group. The developments and research concerning AM have to be continued. The positions of various countries with regard to the 'Interactions of severe accident research and the regulatory positions' are given. On the basis of the working group proposals, the WWER regulators could set regulatory requirements and support further developments of AM strategies, making use of the benefits of common features of NPPs with WWER reactors. Concerted actions in the field of AM between the WWER regulators would bundle the development of a unified concept of recommendations and speed up the implementation of AM measures in order to minimise the risks involved in nuclear power generation

  4. 75 FR 20269 - Regulatory Reporting Requirements for the Indian Community Development Block Grant Program

    Science.gov (United States)

    2010-04-19

    .... Second, this rule requires ICDBG grantees to use the Logic Model form developed as part of HUD's Notice of Funding Availability (NOFA) process. The required use of the Logic Model will conform the ICDBG reporting requirements to those of other HUD competitive funding programs, and enhance the evaluation of...

  5. Building competence in radiation and nuclear safety through education and training - the approach of a national regulatory authority

    International Nuclear Information System (INIS)

    Karfopoulos, K.L.; Carinou, E.; Kamenopoulou, V.; Dimitriou, P.; Housiadas, Ch.

    2015-01-01

    The Greek Atomic Energy Commission (EEAE) is the national competent authority for radiation and nuclear safety and security as well as for the radiation protection of ionizing and artificially produced non-ionizing radiation. The legal framework determines, inter alia, the responsibilities in education and training issues. The EEAE has a range of activities, in providing postgraduate and continuous education and training on radiation protection, and nuclear safety and security, at the national and international levels. At the national level, and particularly in the medical field, the EEAE is a participant in and a major contributor to the Inter-University Postgraduate Program on Medical Radiation Physics. Since 2003, the EEAE has been the Regional Training Center (RTC) for radiation, transport and waste safety of the International Atomic Energy Agency (IAEA) for the European Region in the English language. Moreover, the EEAE has also been recognized as the IAEA's Regional Training Center (RTC) in nuclear security in the English language since 2013. The EEAE recently proceeded to two significant initiatives: the design of a national program for education and training, and the certification of the Department of Education according to ISO 29990:2010. In this paper, the initiatives taken to enhance the radiation protection system in the country through education and training are presented. (authors)

  6. Public health journals' requirements for authors to disclose funding and conflicts of interest: a cross-sectional study.

    Science.gov (United States)

    Daou, Karim N; Hakoum, Maram B; Khamis, Assem M; Bou-Karroum, Lama; Ali, Ahmed; Habib, Joseph R; Semaan, Aline T; Guyatt, Gordon; Akl, Elie A

    2018-04-23

    Public health journals need to have clear policies for reporting the funding of studies and authors' personal financial and non-financial conflicts of interest (COI) disclosures. This study aims to assess the policies of public health journals on reporting of study funding and the disclosure of authors' COIs. This is a cross-sectional study of "Public, Environmental & Occupational Health" journals. Teams of two researchers abstracted data in duplicate and independently using REDCap software. Of 173 public health journals, 155 (90%) had a policy for reporting study funding information. Out of these, a majority did not require reporting of the phase of the study for which funding was received (88%), nor the types of funding sources (87%). Of the 173 journals, 163 (94%) had a policy requiring disclosure of authors' COI. However, the majority of these journals did not require financial conflicts of interest disclosures relating to institutions (75%) nor to the author's family members (90%) while 56% required the disclosure of at least one form of non-financial COI. The policies of the majority of public health journals do not require the reporting of important details such as the role of the funder, and non-financial COI. Journals and publishers should consider revising their editorial policies to ensure complete and transparent reporting of funding and COI.

  7. Regulatory Control of Radiation Sources. Safety Guide

    International Nuclear Information System (INIS)

    2009-01-01

    This Safety Guide is intended to assist States in implementing the requirements established in Safety Standards Series No. GS-R-1, Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety, for a national regulatory infrastructure to regulate any practice involving radiation sources in medicine, industry, research, agriculture and education. The Safety Guide provides advice on the legislative basis for establishing regulatory bodies, including the effective independence of the regulatory body. It also provides guidance on implementing the functions and activities of regulatory bodies: the development of regulations and guides on radiation safety; implementation of a system for notification and authorization; carrying out regulatory inspections; taking necessary enforcement actions; and investigating accidents and circumstances potentially giving rise to accidents. The various aspects relating to the regulatory control of consumer products are explained, including justification, optimization of exposure, safety assessment and authorization. Guidance is also provided on the organization and staffing of regulatory bodies. Contents: 1. Introduction; 2. Legal framework for a regulatory infrastructure; 3. Principal functions and activities of the regulatory body; 4. Regulatory control of the supply of consumer products; 5. Functions of the regulatory body shared with other governmental agencies; 6. Organization and staffing of the regulatory body; 7. Documentation of the functions and activities of the regulatory body; 8. Support services; 9. Quality management for the regulatory system.

  8. ASSUMING REGULATORY AUTHORITY FOR TRANSNATIONAL TORTS: AN INTERSTATE AFFAIR? A HISTORICAL PERSPECTIVE ON THE CANADIAN PRIVATE INTERNATIONAL LAW TORT RULES

    Directory of Open Access Journals (Sweden)

    Roxana Banu

    2013-02-01

    Full Text Available In Tolofson v. Jensen, the Supreme Court of Canada determined that in most cases the law of the place where the tort occurred has exclusive authority to regulate all legal aspects related to it. In developing this choice of law rule, the Supreme Court relied on an analogy between Private International Law and Public International law. This allows Private International Law to claim a structural, neutral function in the distribution of legislative authority in the international realm and to ignore both private law and public law considerations. To best reveal the way in which the Supreme Court injected these limitations into Private International Law by reference to Public International Law, I show the striking similarity between the Supreme Court’s reasoning and several Private International Law writings at the end of the 19th century in Continental Europe. In the context of the extraterritorial tortious activity of multinational corporations, these limitations make Private International Law oblivious to arguments of Corporate Social Responsibility scholars showing that a multinational corporation may legitimately be regulated by the state of its headquarters, even for extraterritorial conduct. Overall, I argue that an overemphasis on legislative authority as a symbol of state sovereignty transforms Private International Law matters generally, and transnational torts in particular, in inter-state affairs, removed from the interests and pleas of the individuals and communities affected by them.   Dans l’arrêt Tolofson c. Jensen, la Cour suprême du Canada a décidé que, dans la plupart des cas, la loi du lieu où le délit a été commis régit exclusivement tous les aspects juridiques qui s’y rapportent. Pour établir cette règle du choix de la loi applicable, la Cour suprême s’est fondée sur une analogie entre le droit international privé et le droit international public. Cela permet au droit international privé de réclamer une

  9. 24 CFR 1710.15 - Regulatory exemption-multiple site subdivision-determination required.

    Science.gov (United States)

    2010-04-01

    ... non-waivable provision in bold face type (which must be distinguished from the type used for the rest... contract or other document by requiring a specific type of notice or by requiring that notice be given at a... font. A copy of the acknowledgement will be maintained by the developer for three years and will be...

  10. Report of the working group 'Regulatory requirements on AM - Concept of nuclear and radiation safety during beyond-design-basis accidents'

    International Nuclear Information System (INIS)

    Bobaly, P.

    2001-01-01

    The developed working group report contains the following main paragraphs: legal basis and basis for regulatory requirements for on-site and off-site Accident Management (AM), regulatory requirements or recommendations for on-site AM and for emergency preparedness, background information concerning the implementation and review of an AM program as a basis for an AM guideline. Overview about AM/SAM implementation in member countries of the SAMINE project; measure and candidates for high level actions based upon US SAMG; interactions of severe accident research and the regulatory positions, relationship between different components of an accident management programme are also given

  11. Environmental challenges and opportunities of the evolving North American electricity market : European electricity generating facilities: an overview of European regulatory requirements and standardization efforts

    International Nuclear Information System (INIS)

    Nichols, L.

    2002-06-01

    Several factors are affecting power generating facilities, such as the opening of both electricity and gas markets, and the pressure applied on generators and governments to ensure a steady energy supply for consumers. An additional factor is the pressure for the closing of nuclear power facilities. European siting and emissions requirements for coal-fired and natural gas generating facilities were presented in this background paper. In addition, the author provided an overview of the standardization process in place in Europe. The European Union and its functioning were briefly described, as well as a listing of relevant organizations. The current trends were examined. The document first introduced the European Union, and the next section dealt with Regulatory regime: the internal energy market. The third section examined the issue of Regulatory regime: generation and environmental regulations. Section four presented environmental management systems, followed by a section on standardization. Section six discussed European organizations involved in electricity issues, while the following section dealt with European commission programs. The last section briefly looked at the trends in the electricity sector, broaching topics such as compliance, electricity generation, and emissions trading. 52 refs., 2 tabs

  12. Existing nuclear power plants and new safety requirements - an international survey. A description of the legal situation and of the regulatory practice in eight countries and in Germany

    International Nuclear Information System (INIS)

    Raetzke, C.; Micklinghoff, M.

    2006-01-01

    In our days, the question of whether existing nuclear power plants can be expected to comply with new standards is relevant for many reasons. The idea of writing this report was sparked by the fact that the German Federal Ministry of the Environment is planning a thorough revision of the regulations concerning nuclear safety. Since in Germany, according to the latest amendment to the Nuclear Act, a licence for a new plant cannot be granted, this project inevitably raises the basic question of whether the existing plants can be forced to comply with new safety regulation, if necessary by performing substantial backfitting. Aim of the enquiry is to find out how the question outlined above - new requirements for existing nuclear power plants - is dealt with in nine countries, namely Germany, Switzerland, France, Sweden, Finland, the United Kingdom, the USA, Spain and Belgium. In order to give a legible and qualified account, the authors have also investigated and depicted the general legislative and regulatory framework for nuclear of each country. Therefore, the book can also be read as a general introduction into the legal system and regulatory practice of these countries. (orig.)

  13. Sources, classification, and disposal of radioactive wastes: History and legal and regulatory requirements

    International Nuclear Information System (INIS)

    Kocher, D.C.

    1991-01-01

    This report discusses the following topics: (1) early definitions of different types (classes) of radioactive waste developed prior to definitions in laws and regulations; (2) sources of different classes of radioactive waste; (3) current laws and regulations addressing classification of radioactive wastes; and requirements for disposal of different waste classes. Relationship between waste classification and requirements for permanent disposal is emphasized; (4) federal and state responsibilities for radioactive wastes; and (5) distinctions between radioactive wastes produced in civilian and defense sectors

  14. Present and future breast cancer management--bench to bedside and back: a positioning paper of academia, regulatory authorities and pharmaceutical industry.

    Science.gov (United States)

    Bartsch, R; Frings, S; Marty, M; Awada, A; Berghoff, A S; Conte, P; Dickin, S; Enzmann, H; Gnant, M; Hasmann, M; Hendriks, H R; Llombart, A; Massacesi, C; von Minckwitz, G; Penault-Llorca, F; Scaltriti, M; Yarden, Y; Zwierzina, H; Zielinski, C C

    2014-04-01

    Insights into tumour biology of breast cancer have led the path towards the introduction of targeted treatment approaches; still, breast cancer-related mortality remains relatively high. Efforts in the field of basic research revealed new druggable targets which now await validation within the context of clinical trials. Therefore, questions concerning the optimal design of future studies are becoming even more pertinent. Aspects such as the ideal end point, availability of predictive markers to identify the optimal cohort for drug testing, or potential mechanisms of resistance need to be resolved. An expert panel representing the academic community, the pharmaceutical industry, as well as European Regulatory Authorities met in Vienna, Austria, in November 2012, in order to discuss breast cancer biology, identification of novel biological targets and optimal drug development with the aim of treatment individualization. This article summarizes statements and perspectives provided by the meeting participants.

  15. Slovak Republic decree of 6 September 1999 of the Nuclear Regulatory authority of the Slovak Republic about breakdown planning for the case of an accident or breakdown

    International Nuclear Information System (INIS)

    1999-01-01

    The Nuclear Regulatory authority of the Slovak Republic constitute: (A) of content, appurtenances and procedure of elaborate (1) of nuclear accident plans (emergency plans), (2) of plan of protection of inhabitants, (3) of accident transport order; (B) measures and procedures which constitute a assumptions for prevention, defeat and mitigation of consequences of breakdowns and accidents, (C) of procedure of apprise of the public, (D) of definition of emergency area in surroundings of nuclear equipment, (E) of periodicity of practice of the emergency planes. This decree contains three appendixes: (1) The minimal extent of data for regular apprise of the public; (2) The international nuclear event scale for means of apprise of the public; (3) The minimal extent of data for apprise of the public for the case of event (breakdown or accident) on nuclear equipment; (4) The intervention levels for urgent and consequent measures for inhabitant protection. This decree shall into effect on 1 October 1999

  16. Report on Activities of the Nuclear Regulatory Authority of the Slovak Republic and on Safety of Nuclear Installations in the Slovak Republic in 2006. Annual Report 2006

    International Nuclear Information System (INIS)

    Zemanova, D.; Pirozekova, M.

    2007-04-01

    A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic in 2006 is presented. These activities are reported under the headings: Foreword; (1) Vision, Mission and Principles of Activities; (2) Legislation; (3) Issuance of Authorisations, Safety Assessment and Enforcement; (3.1) Issuance of Authorizations/Permissions; (3.2) Assessment and Inspections Activities; (3.3) Safety Assessment and Enforcement; (4) Nuclear Safety of Nuclear Installations in the Slovak Republic; (4.1) Nuclear installations in operation in the Slovak Republic; (4.2) Nuclear Installations under construction in the Slovak Republic; (4.3) Decommissioning of nuclear installations in the Slovak Republic; (5) Safety of Other Nuclear Installations; (5.1) Other Nuclear Installations in Operation; (5.2) Other Nuclear Installations under Construction; (5.3) Other Nuclear Installations under Decommissioning; (6) Management of Radioactive Waste; (6.1) Generation and minimisation of radioactive waste; (6.2) Management of radioactive waste; (6.3) Pre-disposal management of radioactive waste; (6.4) Disposal of radioactive waste; (6.5) Shipment of radioactive waste; (7) Nuclear Materials; (7.1) Accounting for and Control of Nuclear Materials; (7.2) Shipment of Nuclear Materials; (7.3) Illicit Trafficking of Nuclear Materials and Other Radioactive Material; (8) Emergency Planning and Preparedness; (9) International Activities; (9.1) European Affairs; (9.2) Membership in International Organisations; (9.3) Fulfilment of Obligations under International Contractual Instruments; (9.4) Bilateral Co-operation; (10) Public Communication; (11) UJD SR; (11.1) Economy Data; (11.2) Human resources and training; (11.3) Internal Management Quality System; (11.4) Development of UJD SR Regulatory Activities; (12) Abbreviations

  17. The practice and regulatory requirements of naturopathy and western herbal medicine in Australia

    Directory of Open Access Journals (Sweden)

    Vivian Lin

    2009-02-01

    Full Text Available Vivian Lin1, Pauline McCabe1, Alan Bensoussan3,4, Stephen Myers5, Marc Cohen6, et al1School of Public Health; 2Cochrane Consumers and Communication Review Group, Australian Institute for Primary Care, La Trobe University, Bundoora, Victoria, Australia; 3National Institute for Complementary Medicine; 4University of Western Sydney, Bankstown, New South Wales, Australia; 5NatMed-Research, Department of Natural and Complementary Medicine, Southern Cross University, Lismore, New South Wales, Australia; 6Department of Complementary Medicine, RMIT University, Bundoora West, Victoria, Australia; La Trobe University, Bundoora, Victoria, AustraliaAbstract: Australian health workforce regulation is premised on the need to protect public health and safety. Specific criteria are set out by governments to ascertain the degree of risk and the need for government intervention. A study was undertaken to understand the current state of usage and the practice of naturopathy and western herbal medicine, and to ascertain whether statutory regulation was warranted. We found increased use of these complementary therapies in the community, with risks arising from both the specific practices as well as consumers negotiating a parallel primary health care system. We also found highly variable standards of training, a myriad of professional associations, and a general failure of current systems of self-regulation to protect public health and safety. Statutory regulation was the preferred policy response for consumers, insurers, general practitioners, and most of the complementary therapists. While we found a case for statutory registration, we also argue that a minimalist regulatory response needs to be accompanied by other measures to educate the public, to improve the standards of practice, and to enhance our understanding of the interaction between complementary and mainstream health care.Keywords: health workforce regulation, complementary health care, protection of

  18. Mining Contratação License in the New Regulatory Framework of Brazilian Mining: Some Notes on the Institutes of Research Authorization and Mining Concession

    Directory of Open Access Journals (Sweden)

    Adhemar Ronquim Filho

    2013-06-01

    Full Text Available Given the importance of mining nowadays, Government seeks ways to stimulate its growth, focusing on potentializing research and the advancement of mineral processing, the basic items for speeding up this activity in a profitable way. In this sense, the discussions on the crystallization of a new regulatory framework for the Brazilian mining have been deepened and, despite gathering a significant number of proposals, it does not have a closed text, and, currently, it is far from obtaining an approval or a final word (despite the urgency. However, the analysis of the proposals that have been presented reveals that there is an intention to institute new rules for the modernization of Brazilian mining, and this paper has the purpose of suggesting ways to reconcile conflicts permeated by various dissonant interests that surround the Brazilian mining at this time. It should be emphasized that, given the lack of official disclosure of the amendments proposed, the approach will continue limited to what has been released by MME (Ministry of Mines and Energy and by the studies that have already been presented by experts in the field (connected to government and/or private businesses. It is restricted to discuss changes to be implemented with the new regulatory framework, highlighting points to be observed, and, among the topics that require mandatory update, we can emphasize the changes in the procedures of exploration permits and mining.

  19. 76 FR 67622 - Modification of Regulatory Provisions Requiring Credit Rating or Assessments in Accordance With...

    Science.gov (United States)

    2011-11-02

    ... requirements to provide a credit rating or other credit assessment as part of an application for financial... that may affect family well-being. This rule would not have any impact on the autonomy or integrity of... rating or other credit assessment as part of an application for financial assistance or an application to...

  20. Review of Regulatory Quality Assurance Requirements for the Operation of Nuclear R and D Facilities

    International Nuclear Information System (INIS)

    Kwon, Hyuk Il; Lim, Nam Jin

    2005-01-01

    Korea Atomic Energy Research Institute (KAERI) has many R and D facilities in operation, including HANARO research reactor, radioactive waste treatment facility (RWTF), post-irradiation examination facility (PIEF) and irradiated material test facility (IMEF). Recently, nation-wide interest is focused on the safety and security of major industrial facilities. Safe operation of nuclear facilities is imperative because of the consequence of public disaster by radiological release/ contamination, in case of an accident. Recently, Ministry of Science and Technology (MOST) of the Korean government announced amendments of Atomic Energy laws to enforce requirements of the physical protection and radiological emergency. In this paper, the context of amended Atomic Energy laws were reviewed to confirm quality assurance measures and identify additional QA activities, if any, that is required by the amendment

  1. Governmental, Legal and Regulatory Framework for Safety. General Safety Requirements. Part 1 (French Edition); Cadre gouvernemental, legislatif et reglementaire de la surete. Prescriptions generales de surete. Partie 1

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2010-11-15

    The objective of this publication is to establish requirements in respect of the governmental, legal and regulatory framework for safety. It covers the essential aspects of the framework for establishing a regulatory body and taking other actions necessary to ensure the effective regulatory control of facilities and activities utilized for peaceful purposes. Other responsibilities and functions, such as liaison within the global safety regime and on support services for safety (including radiation protection), emergency preparedness and response, nuclear security, and the State system of accounting for and control of nuclear material, are also covered.

  2. Governmental, Legal and Regulatory Framework for Safety. General Safety Requirements. Part 1 (Spanish Edition); Marco gubernamental, juridico y regulador para la seguridad. Requisitos de Seguridad Generales. Parte 1

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2010-11-15

    The objective of this publication is to establish requirements in respect of the governmental, legal and regulatory framework for safety. It covers the essential aspects of the framework for establishing a regulatory body and taking other actions necessary to ensure the effective regulatory control of facilities and activities utilized for peaceful purposes. Other responsibilities and functions, such as liaison within the global safety regime and on support services for safety (including radiation protection), emergency preparedness and response, nuclear security, and the State system of accounting for and control of nuclear material, are also covered.

  3. Classical dendritic cells are required for dietary antigen-mediated peripheral regulatory T cell and tolerance induction

    Science.gov (United States)

    Esterházy, Daria; Loschko, Jakob; London, Mariya; Jove, Veronica; Oliveira, Thiago Y.; Mucida, Daniel

    2016-01-01

    Oral tolerance prevents pathological inflammatory responses towards innocuous foreign antigens via peripheral regulatory T cells (pTreg cells). However, whether a particular subset of antigen-presenting cells (APCs) is required during dietary antigen exposure to instruct naïve CD4+ T cells to differentiate into pTreg cells has not been defined. Using myeloid lineage-specific APC depletion in mice, we found that monocyte-derived APCs are dispensable, while classical dendritic cells (cDCs) are critical for pTreg cell induction and oral tolerance. CD11b− cDCs from the gut-draining lymph nodes efficiently induced pTreg cells, and conversely, loss of IRF8-dependent CD11b− cDCs impaired their polarization, although oral tolerance remained intact. These data reveal the hierarchy of cDC subsets in pTreg cell induction and their redundancy during oral tolerance development. PMID:27019226

  4. Implementation of new policy and principles of harmonisation of nuclear emergency preparedness in conditions of emergency Response Centre of the Nuclear Regulatory Authority of the Slovak Republic

    International Nuclear Information System (INIS)

    Janko, K.; Zatlkajova, H.; Sladek, V.

    2003-01-01

    With respect to Chernobyl accident the changes in understanding of nuclear emergency preparedness have initiated a developing process resulting in an effective enhancement of conditions ensuring adequate response to nuclear or radiological accidents of emergency situations in many countries. The Slovak Nuclear Regulatory Authority (UJD) in frame of co-operations with IAEA, EC, OECD/NEA and other international organisations has actively participated in this challenging work targeting implementation of international experience and best practices in the country. The new international policy (principles declared e.g. in 'Memorandum of Understanding', IAEA, Vienna, 1997) based on experiences propagating importance of regional co-operation, harmonised approach and clear strategy for protective measures implementation in case of a nuclear or radiological accident has influenced the development also in Slovakia. The implementation process in the country was supported by changes in legal conditions regulating peaceful use of nuclear energy [1,2] including basic rules for emergency preparedness published in the second half of 1990 years. The principles of emergency preparedness in Slovakia fully support regional harmonisation and co-operation. Effective implementation of international practice and sharing of experience substantially contributed to the level of emergency response in the country and to the harmonisation of emergency response preparedness creating also conditions for an efficient regional integration. (authors)

  5. The Strategic Involvement of Women in Nigeria Nuclear Industry: A Case of Nigeria Atomic Energy Commission (NAEC) and Nigerian Nuclear Regulatory Authority (NNRA)

    International Nuclear Information System (INIS)

    Aina, F.; Ala, A.

    2015-01-01

    The involvement of women in the nuclear industry can not be over emphasised as the western world has gone beyond the barrier of gender imbalance. This barrier, I think should be abolished in developing countries so as to help encourage more women to contribute and help build a strong nuclear industry. In Nigeria, the Nigeria Atomic Energy Commission executes a deliberate strategy to address gender imbalance in its activities. Although the nuclear industry is just beginning to evolve, the major organizations namely Nigeria Atomic Energy Commission (NAEC) and Nigerian Nuclear Regulatory Authority (NNRA) have encouraged females to take key positions in the organizations. NAEC has performed better than the national average in achieving gender balance. In a country that has a goal of having women in 35% of her elective and appointed offices, the legal department of NAEC is 100% female. Women have been educated and trained in technical areas such as nuclear engineering, nuclear law, nuclear security, radiation protection and non-proliferation. This paper reviews the strategic approach of these Commissions in engaging women, the profile of some of the leading women and the contribution of the female dominated departments to male dominated departments. (author)

  6. The regulatory framework in the UK

    International Nuclear Information System (INIS)

    O'Sullivan, R.

    1984-01-01

    The subject is covered in sections, headed: basic regulatory requirements covering the transport of radioactive material in the UK; responsibility for safety (competent authority; provision of regulations; implementation of regulations (international and national); design of transport flask; safety case; testing; assessment; approval certificate; compliance assurance; administration); advice and information on the regulatory safety standards. (U.K.)

  7. Strengthening the capacity of SMEs and local authorities in developing countries to tackle environmental requirements in the supply chain

    Energy Technology Data Exchange (ETDEWEB)

    Sonnemann, G. [Div. of Technology, Industry and Economics (DTIE), United Nations Environment Programme (UNEP), Paris (France)

    2004-07-01

    UNEP DTIE, through its Life Cycle Initiative, proposes to join with industry to strengthen the capacity of the weakest economic actors in the global supply chains to tackle environmental requirements. Two particularly important target groups for this project are SMEs and local authorities. Although the SMEs are the immediate actors, they need appropriate political institutions to provide an enabling framework. Multinational companies are continuously increasing the environmental requirements that their suppliers have to meet in order to provide a green image for the final product reaching western markets. Some multinational companies have accompanied these requirements with information and training of suppliers. By joining with UNEP they will be able to expand the effectiveness of their outreach and also gain greater visibility for their environmental policies. For SMEs this project is an opportunity to develop environmental management expertise and thus position themselves as reliable suppliers to leading companies. (orig.)

  8. Emergency control center of the nuclear Regulatory Authority: a national, regional and international tool to coordinate the response to radiological and nuclear emergencies

    International Nuclear Information System (INIS)

    Jordan, Osvaldo; Hernandez, Daniel; Telleria, Diego; Bruno, Hector; Boutet, Luis; Kunst, Juan; Sadaniowski, Ivana; Rey, Hugo

    2008-01-01

    Full text: In the year 1998, with the regulation of the Nuclear Law, the Nuclear Regulatory Authority (ARN) is constituted as the national coordinator of the response in case of nuclear or radiological emergencies. The ARN builds his first operative center installed in his Head quarter in Buenos Aires. Likewise, from the obligations that come with the Convention of Early Notification of a Nuclear Accident and Convention on Assistance in the Case of a Nuclear Accident or Radiological Emergency, the ARN is the National Warning Point and the National Competent Authority. Therefore, the operative capacity of the center needs to be expanded to cover not only the national territory but also its link with the region and the IAEA, as an access point to the International community, as the conventions demand. For the purpose of giving ARN capacities which reflect the state of art at the international level on Nuclear Emergency Centers and warrant that its equipment and technology will be compatible with those abroad (mainly with IAEA), the ARN made an arrangements with Department of Energy of United States, in the framework of an existing bilateral Argentine Foreign Office/US Government agreement (Joint Standing Committee on Nuclear Cooperation). This agreement allows a deep experience exchange, high level specialists support and last generation equipment access. As a result, the center of ARN can be considerate as the most advanced civil nuclear emergency center in the region. This work describes the implementation process of the emergency center and the technical features, like the physical distribution, hardware and software resources, communication equipment, Geographic Information Systems, etc. (author)

  9. Requirements of Clinical Journals for Authors' Disclosure of Financial and Non-Financial Conflicts of Interest: A Cross Sectional Study.

    Science.gov (United States)

    Shawwa, Khaled; Kallas, Romy; Koujanian, Serge; Agarwal, Arnav; Neumann, Ignacio; Alexander, Paul; Tikkinen, Kari A O; Guyatt, Gordon; Akl, Elie A

    2016-01-01

    It is unclear how medical journals address authors' financial and non-financial conflict of interest (COI). To assess the policies of clinical journals for disclosure of financial and non-financial COI. Cross sectional study that included both review of public documents as well as a simulation of a manuscript submission for the National Library of Medicine's "core clinical journals". The study did not involve human subjects. Investigators who abstracted the data, reviewed "instructions for authors" on the journal website and, in order to reflect the actual implementation of the COI disclosure policy, simulated the submission of a manuscript. Two individuals working in duplicate and independently to abstract information using a standardized data abstraction form, resolved disagreements by discussion or with the help of a third person. All but one of 117 core clinical journals had a COI policy. All journals required disclosure of financial COI pertaining to the authors and a minority (35%) asked for financial COI disclosure pertaining to the family members or authors' institution (29%). Over half required the disclosure of at least one form of non-financial COI (57%), out of which only two (3%) specifically referred to intellectual COI. Small minorities of journals (17% and 24% respectively) described a potential impact of disclosed COI and of non-disclosure of COI on the editorial process. While financial COI disclosure was well defined by the majority of the journals, many did not have clear policies on disclosure of non-financial COI, disclosure of financial COI of family members and institutions of the authors, and effect of disclosed COI or non-disclosure of COI on editorial policies.

  10. Regulatory pathways for vaccines for developing countries.

    Science.gov (United States)

    Milstien, Julie; Belgharbi, Lahouari

    2004-01-01

    Vaccines that are designed for use only in developing countries face regulatory hurdles that may restrict their use. There are two primary reasons for this: most regulatory authorities are set up to address regulation of products for use only within their jurisdictions and regulatory authorities in developing countries traditionally have been considered weak. Some options for regulatory pathways for such products have been identified: licensing in the country of manufacture, file review by the European Medicines Evaluation Agency on behalf of WHO, export to a country with a competent national regulatory authority (NRA) that could handle all regulatory functions for the developing country market, shared manufacturing and licensing in a developing country with competent manufacturing and regulatory capacity, and use of a contracted independent entity for global regulatory approval. These options have been evaluated on the basis of five criteria: assurance of all regulatory functions for the life of the product, appropriateness of epidemiological assessment, applicability to products no longer used in the domestic market of the manufacturing country, reduction of regulatory risk for the manufacturer, and existing rules and regulations for implementation. No one option satisfies all criteria. For all options, national infrastructures (including the underlying regulatory legislative framework, particularly to formulate and implement local evidence-based vaccine policy) must be developed. WHO has led work to develop this capacity with some success. The paper outlines additional areas of action required by the international community to assure development and use of vaccines needed for the developing world. PMID:15042235

  11. Influence of regulatory requirements for nuclear power plants on the backfitting of Austrian research reactors

    International Nuclear Information System (INIS)

    Boeck, H.; Hammer, J.

    1985-01-01

    In general the licensing and backfitting activities have once more demonstrated the fact that safety assessment of a research reactor is by no means just a scaled-down version of a nuclear power plant licensing procedure. Naturally the risk potential is much lower, however, the very nature of research calls for much more flexibility in operation, for temporary installations and for experimental methods which cannot be covered by detailed regulations in advance. Therefore the application of nuclear power reactor criteria to such facilities has to be considered with extreme caution. If NPP standards are applicable at all, they have to be carefully interpreted in each individual case. It is interesting to compare the original reactor safety reports with their modern versions: emphasis has shifted from reactivity accident calculations to thermal-hydraulic considerations, to better instrumentation (both in quality and quantity) and to more effort in reducing, measuring and documenting all radioactive effluents. This tendency is also reflected in most of the backfitting requirements. In summary, the result of the lengthy licensing and backfitting process is certainly a considerable improvement in performance and safety of the Austrian research reactors

  12. The Microtubule Regulatory Protein Stathmin Is Required to Maintain the Integrity of Axonal Microtubules in Drosophila

    Science.gov (United States)

    Duncan, Jason E.; Lytle, Nikki K.; Zuniga, Alfredo; Goldstein, Lawrence S. B.

    2013-01-01

    Axonal transport, a form of long-distance, bi-directional intracellular transport that occurs between the cell body and synaptic terminal, is critical in maintaining the function and viability of neurons. We have identified a requirement for the stathmin (stai) gene in the maintenance of axonal microtubules and regulation of axonal transport in Drosophila . The stai gene encodes a cytosolic phosphoprotein that regulates microtubule dynamics by partitioning tubulin dimers between pools of soluble tubulin and polymerized microtubules, and by directly binding to microtubules and promoting depolymerization. Analysis of stai function in Drosophila , which has a single stai gene, circumvents potential complications with studies performed in vertebrate systems in which mutant phenotypes may be compensated by genetic redundancy of other members of the stai gene family. This has allowed us to identify an essential function for stai in the maintenance of the integrity of axonal microtubules. In addition to the severe disruption in the abundance and architecture of microtubules in the axons of stai mutant Drosophila , we also observe additional neurological phenotypes associated with loss of stai function including a posterior paralysis and tail-flip phenotype in third instar larvae, aberrant accumulation of transported membranous organelles in stai deficient axons, a progressive bang-sensitive response to mechanical stimulation reminiscent of the class of Drosophila mutants used to model human epileptic seizures, and a reduced adult lifespan. Reductions in the levels of Kinesin-1, the primary anterograde motor in axonal transport, enhance these phenotypes. Collectively, our results indicate that stai has an important role in neuronal function, likely through the maintenance of microtubule integrity in the axons of nerves of the peripheral nervous system necessary to support and sustain long-distance axonal transport. PMID:23840848

  13. The Endocytic Recycling Regulatory Protein EHD1 Is Required for Ocular Lens Development

    Science.gov (United States)

    Arya, Priyanka; Rainey, Mark A.; Bhattacharyya, Sohinee; Mohapatra, Bhopal; George, Manju; Kuracha, Murali R; Storck, Matthew D.; Band, Vimla; Govindarajan, Venkatesh; Band, Hamid

    2015-01-01

    The C-terminal Eps15 homology domain-containing (EHD) proteins play a key role in endocytic recycling, a fundamental cellular process that ensures the return of endocytosed membrane components and receptors back to the cell surface. To define the in vivo biological functions of EHD1, we have generated Ehd1 knockout mice and previously reported a requirement of EHD1 for spermatogenesis. Here, we show that approximately 56% of the Ehd1-null mice displayed gross ocular abnormalities, including anophthalmia, aphakia, microphthalmia and congenital cataracts. Histological characterization of ocular abnormalities showed pleiotropic defects that include a smaller or absent lens, persistence of lens stalk and hyaloid vasculature, and deformed optic cups. To test whether these profound ocular defects resulted from the loss of EHD1 in the lens or in non-lenticular tissues, we deleted the Ehd1 gene selectively in the presumptive lens ectoderm using Le-Cre. Conditional Ehd1 deletion in the lens resulted in developmental defects that included thin epithelial layers, small lenses and absence of corneal endothelium. Ehd1 deletion in the lens also resulted in reduced lens epithelial proliferation, survival and expression of junctional proteins E-cadherin and ZO-1. Finally, Le-Cre-mediated deletion of Ehd1 in the lens led to defects in corneal endothelial differentiation. Taken together, these data reveal a unique role for EHD1 in early lens development and suggest a previously unknown link between the endocytic recycling pathway and regulation of key developmental processes including proliferation, differentiation and morphogenesis. PMID:26455409

  14. Regulatory requirements for radiation safety in the design of a new Finish NPP

    Energy Technology Data Exchange (ETDEWEB)

    Alm-Lytz, Kirsi; Vilkamo, Olli [Radiation and Nuclear Safety Authority, STUK, PO Box 14, Laippatie 4, 00881 Helsinki (Finland)

    2004-07-01

    There are two operating nuclear power plants in Finland, two BWR units at Olkiluoto site and two PWR units at Loviisa site. These reactors were commissioned between 1977 and 1981. The total electricity capacity in Finland is about 15 GW. In 2003, nuclear power plants generated one fourth of Finland's electricity. Despite of the diversity of the electricity generation methods, Finland is highly dependent on imported energy. Electricity consumption is estimated to increase and the demand for extra capacity has been estimated at about 2500-3000 MW by 2010. It should also be taken into account that a considerable proportion of the production capacity constructed in the 1970's must be replaced with production capacity of new power plants in the near future. In practice, the climate politics commitments made by Finland exclude coal power. Therefore, the capacity can be increased significantly only by natural gas, nuclear power and biofuels. The paper presents the following issues: Licensing a new nuclear power plant in Finland; FIN5 Project at STUK; Work planning and a tool for requirement management; Radiation safety related YVL guides; Collective dose target; On-site habitability during accident situation. Habitability was evaluated on the basis of the calculated dose rate levels, the occupancy times and the dose limits. Radiation hazard was classified into three parts, i.e., possible direct radiation from the containment, air contamination and systems carrying radioactive air or water. The results showed that direct radiation from the containment is generally adequately shielded but penetrations and hatches have to be separately analysed and the radiation dose levels near them are usually rather high. Skyshine radiation from the reactor containment is a special feature at the Loviisa NPP and the nearby area outside the buildings might have very limited access for the first hours after the accident. The skyshine effect is not usually relevant hazard in

  15. Actions of the Cuban Nuclear Regulatory Authority in the adequate implementation of the legislation in matter of radiological protection; Acciones de la Autoridad Reguladora Nuclear cubana en la adecuada implementacion de la Legislacion en materia de proteccion radiologica

    Energy Technology Data Exchange (ETDEWEB)

    Fornet R, O.M. [Delegacion Territorial CITMA. Peralta No.16, Rpto Peralta, Holguin, CP 80400 (Cuba); Guillen C, A.; Betancourt H, L.A. [Centro Nacional de Seguridad Nuclear, Calle 28 No.504, Miramar Playa, La Habana (Cuba)]. e-mail: ofelia@citmahlg.holguin.inf.cu

    2006-07-01

    The effectiveness of the regulatory activity in matter of safety and radiological protection it depends in great measure of the practical implementation level of the legislation in this matter. In our country this objective has been achieved through the one continuous improvement of the Hierarchical System of Nuclear Regulation, the reconciliation with specialists and national experts in each matter during the elaboration of the legal documents; the popularization and gratuitous distribution of it approved; the precision in the validation conditions of the authorizations of those main precepts applicable to the practices; the legal foundation of the deficiencies evidenced in the regulatory inspections; the development of a Safety Culture; the realization of Annual Regulatory Conferences and mainly in the training of the personnel related with the safety. Also, the constant analysis on the part of the specialists of the Regulatory Authority of the grade of implementation of this legislation, it discussion in national and international events and the actions recommended in these works. As a result of this focus, it is considered that the Regulatory Authority has impacted appropriately in the implementation of this legislation. (Author)

  16. SOME ASPECTS OF UNIFORMIZATION OF THE LAW AND THE PROBLEMS OF ELECTRICITY AND THE NATIONAL REGULATORY AUTHORITY FOR ENERGY IN ROMANIA

    Directory of Open Access Journals (Sweden)

    Ovidiu Joița

    2014-11-01

    Full Text Available Overview. The concept of internal market it is a crucial and central ones in European modern construction. After the third legal package in energy the internal market of energy (electricity and gas have to be fulfill until the end of 2014.Is this functional or just a theoretical projection? Can we see a direct and quantifiable effects? Is the regulation of energy network industries a proper answer and a direct intervention of State or have to be balance by competition? Is competition possible without regulation on this issue? Regulation of network industries is the prerequisite condition but without a real competition will be not an internal market. Methods. We assessed an individual case and possible scenario for Romania. Also a comparative methods was in place for understanding and analyses institutions (national regulatory authority and mechanism of the market with some focus on the financial markets. Results. The methods used revealed that institution, with unambiguously attribution and competence, autonomous and independent and working mechanism with unambiguously attribution and competence represent a tools for achieve a real market. Nevertheless the predictable and well done regulations in energy, with a large debate with all the actors involved it is indispensable tools.

  17. Activities of the Nuclear Regulatory Authority of the Slovak Republic and safety of nuclear facilities in the Slovak Republic in 1994

    International Nuclear Information System (INIS)

    1995-01-01

    The report summarizes activities of the Nuclear Regulatory Authority of the Slovak Republic (NRA SR) in 1994 and briefly presents results of the national expert supervision over nuclear safety facilities in the SR in 1994. In 1994, the NRA SR have performed a national supervision of following organizations: SE, a.s. - Jaslovske Bohunice Nuclear Power Plant (V-1 Nuclear Power Plant (V-1 NPP), V-2 Nuclear Power Plant (V-2 NPP), A-1 Nuclear Power Plant (A-1 NPP)); Mochovce Nuclear Power Plant; Radioactive waste repository, Mochovce); Organizations providing a specialized training of NPP personnel; Organizations providing specific deliveries and activities for the nuclear power industry; Organizations having an owner of nuclear materials; Organizations providing activities related to import of radioactive sources; Organizations using radioactive sources. Organization structure of the NRA SR is explained. In the presented Chapter 1 - Safety of nuclear power plants in the Slovak Republic - safety aspects of the Slovak NPPs are reported. The next activities are reported: nuclear materials and safeguards; radioactive waste; emergency planning and NRA SR's control and crisis centre; international activities to improve the national surveillance quality; other activities

  18. IAEA meeting: International conference of national regulatory authorities with competence in the safety of radiation sources and the security of radioactive materials

    Energy Technology Data Exchange (ETDEWEB)

    Englefield, Chris [UK INTERPOL Environmental Crime (Radioactive Substances) Sub-Group, Environment Agency (United Kingdom)

    2001-06-01

    deterministic risks, and to a lesser extent stochastic risks. There are other issues which should also be factored in. (ii) The accidents that attract media and other international/political attention are those with high exposures (especially if they are fatal). Many people involved in the conference would recognise other social and economic risks, in the event of sources being melted in a metals works. (iii) States which have only recently created regulatory systems, or that have very low numbers of users, tend to have a single regulatory authority to cover all uses of 'nuclear' material (e.g. Costa Rica). (iv) States which have a long history of use tend to have multiple-bodies involved in the regulation of radiation sources (e.g. the UK where there are nine or Germany where there are seventeen). (v) States with few users often manage an effective national inventory system . (vi) States with many users rarely run a national inventory system. (viii) Many states operate a national waste management/disposal system that takes control of orphaned or disused sources, when necessary, as a national service; some states have a more commercial approach. Sometimes even the latter type are prepared to 'adopt' orphaned sources and the liabilities that come with them. The recurring themes that emerged were: (i) The need for education and training of all stakeholders (users, regulators, the public, medics, judges, politicians). (ii) The need for an international communication system between regulators The paper I submitted described the UK regulatory arrangements in its first part, as operated by the environment agencies and HSE. It then went on to describe the constitution and work of the UK INTERPOL Environmental Crime (Radioactive Substances) Sub-Group. The UK paper also briefly: (i) summarised the nature and consequences of the March 2000 AVESTA accident; (ii) proposed that an 'all risks' approach be considered, as this is proving useful to the UK. The

  19. 78 FR 14306 - International Cooperation on Harmonisation of Technical Requirements for Registration of...

    Science.gov (United States)

    2013-03-05

    ...]; (Formerly Docket No. 00D-1631)] International Cooperation on Harmonisation of Technical Requirements for... for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for... regulatory authorities and industry associations to promote the international harmonization of regulatory...

  20. 76 FR 57060 - International Cooperation on Harmonisation of Technical Requirements for Registration of...

    Science.gov (United States)

    2011-09-15

    ...] International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal... veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration... regulatory authorities and industry associations to promote the international harmonization of regulatory...

  1. Use of FPGA and CPLD in nuclear reactor safety systems and its regulatory review requirements for reactor safety

    International Nuclear Information System (INIS)

    Roy, Suvadip; Biswas, Animesh; Pradhan, S.K.

    2015-01-01

    Field Programmable Gate Arrays (FPGA) and Complex Programmable Logic Devices (CPLD) is being used widely in safety critical and safety related systems in nuclear power plans like in trip logic units, Engineered Safety Feature (ESF) actuation decision logic and neutronic signal processing for their reprogrammability feature and compact design. These HDL Programmable devices (HPD) are complex devices consisting of both hardware and software which is used to implement the logic on the FPGA. It is observed that these Programmable devices suffer from various modes of failure and the major failures in these devices are due to Single Event Upset (SEU), where a highly energetic ionizing radiation may lead to device failure which can even occur in radiologically benign environment. Other failures can occur during steps of developing the hardware using software tools like during Synthesis and placement and routing of the desired hardware. Here a study on use of such devices in Nuclear Reactors, study on mode of failures of these devices, way to tackle such failure and development of review guidelines for review of such devices used in safety critical and safety related systems with special emphasis on choice of software tools, way to mitigate effects of SEU and simulation and hardware testing results to be reviewed by regulatory body during design safety review is done. (author)

  2. Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment.

    Science.gov (United States)

    Djuris, Jelena; Djuric, Zorica

    2017-11-30

    Mathematical models can be used as an integral part of the quality by design (QbD) concept throughout the product lifecycle for variety of purposes, including appointment of the design space and control strategy, continual improvement and risk assessment. Examples of different mathematical modeling techniques (mechanistic, empirical and hybrid) in the pharmaceutical development and process monitoring or control are provided in the presented review. In the QbD context, mathematical models are predominantly used to support design space and/or control strategies. Considering their impact to the final product quality, models can be divided into the following categories: high, medium and low impact models. Although there are regulatory guidelines on the topic of modeling applications, review of QbD-based submission containing modeling elements revealed concerns regarding the scale-dependency of design spaces and verification of models predictions at commercial scale of manufacturing, especially regarding real-time release (RTR) models. Authors provide critical overview on the good modeling practices and introduce concepts of multiple-unit, adaptive and dynamic design space, multivariate specifications and methods for process uncertainty analysis. RTR specification with mathematical model and different approaches to multivariate statistical process control supporting process analytical technologies are also presented. Copyright © 2017 Elsevier B.V. All rights reserved.

  3. Development of safety and regulatory requirements for Korean next generation reactor - Development of human factors design review guidelines (II)

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Jung Woon; Oh, In Suk; Lee, Hyun Chul; Cheon, Se Woo [Korea Atomic Energy Research Institute, Taejon (Korea)

    1999-02-01

    The objective of this study is to develop human factors engineering program review guidelines and alarm system review guidelines in order to resolve the two major technical issues: '25. Human Factors Engineering Program Review Model' and '26. Review Criteria for Human Factors Aspects of Advanced Controls and Instrumentation', which are related to the development of human factors safety regulation guides being performed by KINS. For the development of human factors program review guidelines, we made a Korean version of NUREG-0711 and added our comments by considering Korean regulatory situation and the characteristics of the KNGR design, and reviewing the reference documents of NURGE-0711. We also computerized the Korean version of NUREG-0711, additional comments, and selected portion of the reference documents for the developer of safety regulation guides at KINS to see the contents comparatively at a glance and use them easily. For the development of alarm system design review guidelines, we made a Korean version of NUREG/CR-6105, which was published by NRC in 1994 as a guideline document for the human factors review of alarm systems. Then we updated the guidelines by reviewing the literature related to alarm design that published after 1994. 12 refs., 11 figs., 2 tabs. (Author)

  4. Development of safety and regulatory requirements for Korean next generation reactor - Development of human factors design review guidelines (II)

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Jung Woon; Oh, In Suk; Lee, Hyun Chul; Cheon, Se Woo [Korea Atomic Energy Research Institute, Taejon (Korea)

    1999-02-01

    The objective of this study is to develop human factors engineering program review guidelines and alarm system review guidelines in order to resolve the two major technical issues: '25. Human Factors Engineering Program Review Model' and '26. Review Criteria for Human Factors Aspects of Advanced Controls and Instrumentation', which are related to the development of human factors safety regulation guides being performed by KINS. For the development of human factors program review guidelines, we made a Korean version of NUREG-0711 and added our comments by considering Korean regulatory situation and the characteristics of the KNGR design, and reviewing the reference documents of NURGE-0711. We also computerized the Korean version of NUREG-0711, additional comments, and selected portion of the reference documents for the developer of safety regulation guides at KINS to see the contents comparatively at a glance and use them easily. For the development of alarm system design review guidelines, we made a Korean version of NUREG/CR-6105, which was published by NRC in 1994 as a guideline document for the human factors review of alarm systems. Then we updated the guidelines by reviewing the literature related to alarm design that published after 1994. 12 refs., 11 figs., 2 tabs. (Author)

  5. Ongoing regulatory compliance required.

    Science.gov (United States)

    Harris, Peter

    2005-06-01

    New regulations concerning the management of asbestos in non-residential properties came into force in May last year, and this 'Duty to Manage' legislation means that duty holders should be managing their asbestos adequately by fulfilling certain criteria. Inadequate management of asbestos could lead to heavy fines. Special report by Peter Harris, client services manager, Redhill Analysts.

  6. FOXP3: required but not sufficient. the role of GARP (LRRC32) as a safeguard of the regulatory phenotype.

    Science.gov (United States)

    Probst-Kepper, M; Balling, R; Buer, J

    2010-08-01

    FOXP3 is essential for the development and function of regulatory CD4(+)CD25(hi) T (T(reg)) cells. However, recent evidence suggests that FOXP3 alone is not sufficient to completely explain the regulatory phenotype of these key players in autoimmunity and inflammation: after being activated, conventional human CD4(+) T cells transiently up-regulate FOXP3 without acquiring a regulatory function. Researchers have recently found that glycoprotein A repetitions predominant (GARP, or LRRC32) is a T(reg)-specific receptor that binds latent TGF-beta and dominantly controls FOXP3 and the regulatory phenotype via a positive feedback loop. This finding provides a missing link in our molecular understanding of FOXP3 in T(reg) cells. This viewpoint focuses on GARP as safeguard of FOXP3 and the regulatory phenotype.

  7. Granzyme A Is Required for Regulatory T-Cell Mediated Prevention of Gastrointestinal Graft-versus-Host Disease.

    Directory of Open Access Journals (Sweden)

    Sarvari Velaga

    Full Text Available In our previous work we could identify defects in human regulatory T cells (Tregs likely favoring the development of graft-versus-host disease (GvHD following allogeneic stem cell transplantation (SCT. Treg transcriptome analyses comparing GvHD and immune tolerant patients uncovered regulated gene transcripts highly relevant for Treg cell function. Moreover, granzyme A (GZMA also showed a significant lower expression at the protein level in Tregs of GvHD patients. GZMA induces cytolysis in a perforin-dependent, FAS-FASL independent manner and represents a cell-contact dependent mechanism for Tregs to control immune responses. We therefore analyzed the functional role of GZMA in a murine standard model for GvHD. For this purpose, adoptively transferred CD4+CD25+ Tregs from gzmA-/- mice were analyzed in comparison to their wild type counterparts for their capability to prevent murine GvHD. GzmA-/- Tregs home efficiently to secondary lymphoid organs and do not show phenotypic alterations with respect to activation and migration properties to inflammatory sites. Whereas gzmA-/- Tregs are highly suppressive in vitro, Tregs require GZMA to rescue hosts from murine GvHD, especially regarding gastrointestinal target organ damage. We herewith identify GZMA as critical effector molecule of human Treg function for gastrointestinal immune response in an experimental GvHD model.

  8. Donor hematopoiesis in mice following total lymphoid irradiation requires host T-regulatory cells for durable engraftment

    Science.gov (United States)

    Müller, Antonia M. S.; Poyser, Jessica; Küpper, Natascha J.; Burnett, Cassandra; Ko, Rose M.; Kohrt, Holbrook E.K.; Florek, Mareike; Zhang, Pei; Negrin, Robert S.

    2014-01-01

    Total lymphoid irradiation (TLI) with antithymocyte globulin (ATG) is a unique regimen that prepares recipients for allogeneic hematopoietic cell transplantation by targeting lymph nodes, while sparing large areas of the bone marrow. TLI is reported to increase the frequency of CD4+CD25+FoxP3+ T-regulatory cells (Treg) relative to conventional T cells. In this study, barriers to hematopoietic stem cell (HSC) engraftment following this nonmyeloablative conditioning were evaluated. TLI/ATG resulted in profound lymphoablation but endogenous host HSC remained. Initial donor HSC engraftment occurred only in radiation exposed marrow sites, but gradually distributed to bone marrow outside the radiation field. Sustained donor engraftment required host lymphoid cells insofar as lymphocyte deficient Rag2γc−/− recipients had unstable engraftment compared with wild-type. TLI/ATG treated wild-type recipients had increased proportions of Treg that were associated with increased HSC frequency and proliferation. In contrast, Rag2γc−/− recipients who lacked Treg did not. Adoptive transfer of Treg into Rag2γc−/− recipients resulted in increased cell cycling of endogenous HSC. Thus, we hypothesize that Treg influence donor engraftment post-TLI/ATG by increasing HSC cell cycling, thereby promoting the exit of host HSC from the marrow niche. Our study highlights the unique dynamics of donor hematopoiesis following TLI/ATG, and the effect of Treg on HSC activity. PMID:24591203

  9. Nuclear energy research initiative, an overview of the cooperative program for the risk-informed assessment of regulatory and design requirements for future nuclear power plants

    International Nuclear Information System (INIS)

    Ritterbusch, Stanley E.

    2000-01-01

    , along with the data collection and evaluation methods, that will be needed to evaluate the safety and reliability of future nuclear power plant designs. At the end of the Smart-NPP, DPCIT, and Risk-Informed NPP programs it is expected that methods will have been sufficiently developed and demonstrated to define a more extensive program that will address large-scale development and implementation - leading to tyhe required 35% to 40% reduction in nuclear plant cost for the U. S. de-regulated market and a much shorter construction schedule. The new design and regulatory process is envisioned to use risk-based information to the extent practical and to use ''defense-in-depth'' only when necessary to address uncertainties in PSA models and quipment performance. In the following sections, The Smart-NPP and DPCIT programs are briefly summarized and the Risk-Informed NPP program is described in more detail. (author)

  10. Regulatory difficulties in a developing country

    International Nuclear Information System (INIS)

    Jacobs, W.R. Jr.

    1978-01-01

    The regulatory agency assigned the task of regulating the initial entry into the field of nuclear power generation by a developing country has a very difficult job. Based on the authors' experience during the start-up and initial operation of Ko-Ri Unit I, the first power reactor in the Republic of Korea, observations on regulatory difficulties and recommendations for improved regulatory effectiveness are offered. The problem areas can be loosely grouped into three general categories: (1) Lack of adequate technical knowledge which is the basis for all effective regulation; (2) Difficulties with understanding and utilization of the required regulatory documentation; (3) Failure to establish the proper regulatory environment. Examples are cited from actual experience during the Ko-Ri Unit I start-up to demonstrate the impact that regulatory activities can have on a plant construction and testing programme. The problems encountered are not unique to developing countries but also exist in the United States of America. Recommendations are offered which should be beneficial to either newly formed regulatory agencies or agencies wishing to improve their abilities and effectiveness. These include: (1) Additional training of regulatory inspectors in plant operations; (2) Additional experience gained by participation in regulatory activities in other countries; (3) Increased attention given to regulatory documents, especially plant technical specifications; (4) Establishment of formal lines of communication between the utility and the regulatory agency; (5) Clear definition of regulatory responsibilities to avoid areas of overlapping jurisdiction; (6) Active participation by the regulatory staff very early in the project. It is hoped that these and other recommendations offered will greatly improve regulatory effectiveness and at the same time demonstrate that when the decision is made to 'go nuclear', a strong commitment must be made to develop and support a technically

  11. 24 CFR 241.615 - Certification of cost requirements.

    Science.gov (United States)

    2010-04-01

    ..., including any collateral agreements. (g) Certificate of public accountant. Where required by the... independent Certified Public Accountant or independent public accountant licensed by a regulatory authority of...

  12. Future nuclear regulatory challenges

    International Nuclear Information System (INIS)

    Royen, J.

    1998-01-01

    In December 1996, the NEA Committee on Nuclear Regulatory Activities concluded that changes resulting from economic deregulation and other recent developments affecting nuclear power programmes have consequences both for licensees and regulatory authorities. A number of potential problems and issues which will present a challenge to nuclear regulatory bodies over the next ten years have been identified in a report just released. (author)

  13. Canadian and international approaches to regulatory effectiveness

    International Nuclear Information System (INIS)

    Lojk, R.

    2014-01-01

    Regulatory effectiveness is an important attribute of any regulator, particularly nuclear regulators. As the nuclear industry has matured, and as the social landscape has changed, so have views on what constitutes regulatory effectiveness. Canada has evolved its regulatory structure and modernized its legislative framework and technical requirements and guidance over time. In addition, Canada continues to collaborate with international agencies, particularly the NEA and the IAEA, to ensure that there is a common understanding of the indicators and key attributes of regulatory effectiveness. This paper discusses Canadian and international views on the subject, including perspectives from other industries. (author)

  14. Authorization of appropriations for the US Nuclear Regulatory Commission for fiscal years 1982 and 1983 (implementation of Section 110, Public Law 96-295). Oversight hearing before the Subcommittee on Energy and the Environment of the Committee on Interior and Insular Affairs, House of Representatives, Ninety-Seventh Congress, First Session, February 27, 1981. Part II

    International Nuclear Information System (INIS)

    Anon.

    1983-01-01

    Part II of the budget authorization hearings covers the testimony of two panels, one with representatives of the Nuclear Regulatory Commission (NRC) and one with members of the Union of Concerned Scientists (UCS). Their testimony focused on section 10 of the authorization law which deals with requirements of systematic safety evaluation of operating reactors. NRC revisions to section 10 have quieted some industry criticisms that the plan will drain manpower and resources without accomplishing anything significant. UCS panelists challenged the NRC to provide objective scientific evidence that nuclear power plants are operating safely. They urged an augmented budget for further safety research. An appendix with additional statements and material follows the testimony

  15. Management of waste from nuclear facilities as a regulatory problem. Requirements to be met by legislation under conditions of uncertainty. Die Entsorgung der Kernenergie als Regelungsproblem. Zu den Anforderungen an Gesetzgebung unter Ungewissheitsbedingungen

    Energy Technology Data Exchange (ETDEWEB)

    Ladeur, K.H.

    1989-07-01

    The author presents a brief review of the development of the nuclear waste management regime in the Atomic Energy Act, referring also to court decissions and the literature. The article analyses the constitutionality of the waste management regulations of section 9a and following sections, and of the provisions on reprocessing (section 7, sub-sec. (1)), primarily under the aspect of the principle of proviso of legality in general, reformulated by the theory of materiality, and in particular with regard to the requirement of 'backfitting' in order to improve the regulatory system for complex and especially technological matters. (orig./RST).

  16. Regulatory framework for nuclear power plant operation

    International Nuclear Information System (INIS)

    Perez Alcaniz, T.; Esteban Barriendos, M.

    1995-01-01

    As the framework of standards and requirements covering each phase of nuclear power plant project and operation developed, plant owners defined their licensing commitments (codes, rules and design requirements) during the project and construction phase before start-up and incorporated regulatory requirements imposed by the regulatory Body during the licensing process prior to operation. This produces a regulatory framework for operating a plant. It includes the Licensing Basis, which is the starting point for analyzing and incorporating new requirements, and for re-evaluation of existing ones. This presentation focuses on the problems of applying this regulatory framework to new operating activities, in particular to new projects, analyzing new requirements, and reconsidering existing ones. Clearly establishing a plant's licensing basis allows all organizations involved in plant operation to apply the requirements in a more rational way. (Author)

  17. A STUDY ASSESSING THE IMPACTS OF NEW REGULATORY PROPOSALS ON CYCLICALITY OF CAPITAL REQUIREMENTS: THE CASE OF THE CZECH REPUBLIC

    OpenAIRE

    Bartůsek, Michal

    2011-01-01

    This work focuses on new regulatory proposals, primarily Basel III accords and analyzes its ability to create a buffer for recurrent credit bubbles. This paper follows a research made by Lis, Pagés and Saurina [2000]. Their paper has illustrated the cyclicality of loan growth and GDP growth for Spain. This cyclicality is supported by cyclical Basel II regulation. In this paper is examined the ability of new regulatory proposals such as Basel III, statistical provisions and change in the appro...

  18. Regulatory Control of Radiation Sources. Safety Guide (Arabic Edition)

    International Nuclear Information System (INIS)

    2012-01-01

    This Safety Guide is intended to assist States in implementing the requirements established in Safety Standards Series No. GS-R-1, Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety, for a national regulatory infrastructure to regulate any practice involving radiation sources in medicine, industry, research, agriculture and education. The Safety Guide provides advice on the legislative basis for establishing regulatory bodies, including the effective independence of the regulatory body. It also provides guidance on implementing the functions and activities of regulatory bodies: the development of regulations and guides on radiation safety; implementation of a system for notification and authorization; carrying out regulatory inspections; taking necessary enforcement actions; and investigating accidents and circumstances potentially giving rise to accidents. The various aspects relating to the regulatory control of consumer products are explained, including justification, optimization of exposure, safety assessment and authorization. Guidance is also provided on the organization and staffing of regulatory bodies. Contents: 1. Introduction; 2. Legal framework for a regulatory infrastructure; 3. Principal functions and activities of the regulatory body; 4. Regulatory control of the supply of consumer products; 5. Functions of the regulatory body shared with other governmental agencies; 6. Organization and staffing of the regulatory body; 7. Documentation of the functions and activities of the regulatory body; 8. Support services; 9. Quality management for the regulatory system.

  19. Safety Committees for Argentinean Research Reactor - Regulatory Issues

    International Nuclear Information System (INIS)

    Perrin, Carlos D.

    2009-01-01

    In the field of radiological and nuclear safety, the Nuclear Regulatory Authority (ARN) of Argentina controls three research reactors and three critical assemblies, by means of evaluations, audits and inspections, in order to ensure the fulfillment of the requirements established in the Licenses, in the Regulatory Standards and in the Mandatory Documentation in general. From the Nuclear Regulatory Authority's point of view, within the general process of research reactors safety management, the Operational Organization self verification of radiological and nuclear safety plays an outstanding role. In this aspect the ARN has established specific requirements in the Regulatory Standards, in the Operation Licenses and in the Operational Limits and Conditions. These requirements include the figure of different safety committees, which act as reviewers or advisers in diverse situations. This paper describes the main characteristics of the committees, their function, scope and the regulatory documents where the requirements are included. (author)

  20. Development of guidance on applications of regulatory requirements for regulating large, contaminated equipment and large decommissioning and decontamination (D and D) components

    International Nuclear Information System (INIS)

    Pope, R.B.; Easton, E.P.; Cook, J.R.; Boyle, R.W.

    1997-01-01

    In 1985, the International Atomic Energy Agency issued revised regulations for the safe transport of radioactive material. Significant were major changes to requirements for Low Specific Activity material and Surface Contaminated Objects. As these requirements were adopted into regulations in the US, it was recognized that guidance on how to apply these requirements to large, contaminated/activated pieces of equipment and decommissioning and decontamination objects would be needed both by the regulators and those regulated to clarify technical uncertainties and ensure implementation. Thus, the US Department of Transportation and the US Nuclear Regulatory Commission, with assistance of staff from Oak Ridge National Laboratory, are preparing regulatory guidance which will present examples of acceptable methods for demonstrating compliance with the revised rules for large items. Concepts being investigated for inclusion in the pending guidance are discussed in this paper. Under current plans, the guidance will be issued for public comment before final issuance in 1997