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...

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...

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...

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.

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.

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...

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.

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...

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)

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)

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)

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

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

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

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

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)

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)

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

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.

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)

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...

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

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...

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.

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.

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.

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...

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)

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...

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...

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...

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...

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...

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...

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

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...

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

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...

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...

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.

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...

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

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

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

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)

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

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

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

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

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...

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

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)

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).

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.

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.

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.

Nuclear regulatory challenges arising from competition in electricity markets

International Nuclear Information System (INIS)

2001-01-01

In recent years a world-wide trend has been developing to introduce competition in electricity markets. As market competition unfolds, it produces a wide range of safety challenges for nuclear power plant operators and regulators. Nuclear regulators must be aware of the potential safety challenges produced and consider whether new regulatory response strategies are warranted. This report describes many of these challenges, their implications and possible regulatory response strategies. The intended audience is primarily nuclear safety regulators, although government authorities, nuclear power plant operators and the general public may also be interested. (author)

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.

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.

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)

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

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

Bitcoin: a regulatory nightmare to a libertarian dream

Directory of Open Access Journals (Sweden)

Primavera De Filippi

2014-05-01

Full Text Available This article provides an overview of national policies and current discussions on the regulation of bitcoin in Europe and beyond. After presenting the potential threat that cryptocurrencies pose to governmental and financial institutions worldwide, it discusses the regulatory challenges and the difficulty for national regulators to come up with a sound regulatory framework, which the author believes explains the current (lack of regulatory responses in this field. The article concludes that regulation is needed, but that in order not to excessively stifle innovation in this nascent ecosystem, some of these challenges might better be addressed through self-regulation.

Biosimilars for psoriasis: worldwide overview of regulatory guidelines, uptake and implications for dermatology clinical practice.

Science.gov (United States)

Cohen, A D; Wu, J J; Puig, L; Chimenti, S; Vender, R; Rajagopalan, M; Romiti, R; de la Cruz, C; Skov, L; Zachariae, C; Young, H S; Foley, P; van der Walt, J M; Naldi, L; Prens, E P; Blauvelt, A

2017-12-01

The introduction of biological drugs for the treatment of patients with psoriasis has revolutionized treatment paradigms and enabled numerous patients to achieve disease control with an acceptable safety profile. However, the high cost of biologics limits access to these medications for the majority of patients worldwide. In recent years, the introduction of biosimilars for inflammatory diseases has become a fast evolving field. The future use of biosimilars offers the potential for decreased cost and increased access to biologics for patients with psoriasis. For approval of biosimilars, different regulatory agencies use highly variable methods for definition, production, approval, marketing and postmarketing surveillance. Due to potential interchangeability between biologics and biosimilars, traceability and pharmacovigilance are required to collect accurate data about adverse events in patients with psoriasis; spontaneous reporting, registries and use of 'big data' should facilitate this process on a global basis. The current article describes biosimilar regulatory guidelines and examples of biosimilar uptake in clinical practice in several countries around the world. As it is apparent that biological therapy treatment decisions may become more physician independent, the International Psoriasis Council recommends that dermatologists should take an active role in the development of biosimilar prescribing policies with their respective healthcare settings and government agencies. © 2017 British Association of Dermatologists.

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.)

Analysis of Worldwide Regulatory Framework for On-Line Maintenance

International Nuclear Information System (INIS)

Ahn, Sang Kyu; Oh, Kyu Myung; Lee, Chang Ju

2010-01-01

With the increasing economic pressures being faced and the potential for shortening outage times under the conditions of deregulated electricity markets in the world, licensees are motivated to get an increasing amount of online maintenance (OLM). OLM means a kind of planned maintenance of nuclear reactor facilities, including structure, systems, and components (SSCs), during power operation. In Korea, a similar situation is made up, so it needs to establish a regulatory framework for OLM. A few years ago, foreign countries' practices related to OLM were surveyed by the Working Group on Inspection Practices (WGIP) of OECD/NEA/CNRA. The survey results and additional new information of countries' status will be helpful to establish our own regulatory framework for OLM, which are analyzed in this paper. From the analysis, some considerable points to be addressed for establishing a regulatory framework for OLM are suggested

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

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.)

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.

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

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

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

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

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)

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.

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

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

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

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)

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)

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)

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

Protection of people and environment from radiation risk through good regulatory practice

Science.gov (United States)

Jais, Azlina Mohammad; Hassan, Najwa

2017-01-01

The term "good regulatory practice" has seen growing frequency of usage worldwide, especially since the 2011 Fukushima nuclear incident. However, the term appears quite ambiguous as it may mean differently to different people. This leads us to the first important question: what does "good regulatory practice" actually mean? When used in conjunction with the Fukushima incident, do we imply that there is an absence of "good regulatory practice" in the Japanese' Nuclear and Industry Safety Agency (NISA)? This is quite troubling. It is clear that the term should be defined formally so that our understanding of "good regulatory practice" can be standardized. There is still another important question beyond agreeing on what "good regulatory practice" is: is "good regulatory practice" specific to a region, or is it global? And is it applicable only to nuclear regulators, or to all types of regulators per se? This paper aims to deliberate on the above mentioned questions. Specifically, we hope to discuss the "good regulatory practice" for atomic energy activities in order to protect the people and the environment from radiation risk of such activities. By understanding what "good regulatory practice" truly means, a newcomer country such as Malaysia can quickly learn and adopt these practices so as to assure a competent national nuclear regulatory authority who will be responsible in ensuring the safety, security and safeguards of peaceful atomic energy activities in the country including nuclear liability. In understanding this concept, a holistic approach will be taken by looking into example of advanced and newcomer countries of various nuclear regulatory authorities all around the world. Then the paper will focus on the challenges that the current nuclear regulatory authority in Malaysia which is Atomic Energy Licensing Board has, its challenges to follow the concept of "good regulatory practice" and its ways to overcome it. This study explore the initiatives could be

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)

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)

Regulatory assessment of safety culture in nuclear organisations - current trends and challenges

International Nuclear Information System (INIS)

Tronea, M.

2010-01-01

The paper gives an overview of the current practices in the area of regulatory assessment of safety culture in nuclear organisations and of the associated challenges. While the assessment and inspection procedures currently in use by regulatory authorities worldwide are directed primarily at verifying compliance with the licensing basis, there is a recognised need for a more systematic approach to the identification, collection and review of data relevant to the safety culture in licensees' organisations. The paper presents a proposal for using the existing regulatory inspection practices for gathering information relevant to safety culture and for assessing it in an integrated manner. The proposal is based on the latest requirements and guidance issued by the International Atomic Energy Agency (IAEA) on management systems for nuclear facilities and activities, particularly as regards the attributes needed for a strong nuclear safety culture. (author)

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

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

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)

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)

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

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)

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

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

Nuclear Regulatory Commission information digest

International Nuclear Information System (INIS)

1990-03-01

The Nuclear Regulatory Commission information digest provides summary information regarding the US Nuclear Regulatory Commission, its regulatory responsibilities, and areas licensed by the commission. This is an annual publication for the general use of the NRC Staff and is available to the public. The digest is divided into two parts: the first presents an overview of the US Nuclear Regulatory Commission and the second provides data on NRC commercial nuclear reactor licensees and commercial nuclear power reactors worldwide

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

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)

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...

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...

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)

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...

Nuclear Regulatory Commission 1989 Information Digest

International Nuclear Information System (INIS)

1989-03-01

The Nuclear Regulatory Commission 1989 Information Digest provides summary information regarding the US Nuclear Regulatory Commission, its regulatory responsibilities, and areas licensed by the Commission. This is the first of an annual publication for the general use of the NRC staff and is available to the public. The Digest is divided into two parts: the first presents an overview of the US Nuclear Regulatory Commission and the second provides data on NRC commercial nuclear reactor licensees and commercial nuclear power reactors worldwide

Nuclear energy worldwide

International Nuclear Information System (INIS)

Fertel, M.

2000-01-01

In this short paper the author provides a list of tables and charts concerning the nuclear energy worldwide, the clean air benefits of nuclear energy, the nuclear competitiveness and the public opinion. He shows that the nuclear energy has a vital role to play in satisfying global energy and environmental goals. (A.L.B)

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)

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)

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

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.)

Assisting IAEA Member States to Strengthen Regulatory Control, Particularly in the Medical Area

International Nuclear Information System (INIS)

Johnston, P.

2016-01-01

As per its Statue and Mandate, IAEA is developing Safety Standards and is also providing assistance for their application in Member States. One target and very large audience of this programme is the community of national regulatory bodies for radiation safety, expected to be established in all 168 Member States. Ionizing radiation is being used throughout the world in medical practices and medical exposure is the most significant manmade source of exposure to the population from ionizing radiation. Radiation accidents involving medical uses have accounted for more injuries and early acute health effects than any other type of radiation accident, including accidents at nuclear facilities. With the constant emerging of new technologies using ionizing radiation for medical diagnostic and treatment, there are on-going challenges for Regulatory bodies. The presentation will highlight some figures related to the medical exposure worldwide, and then it will introduce the main safety standards and other publications developed specifically for Regulatory Bodies and focusing on medical practices. It will also highlight the most important and recent mechanisms (tools, peer reviews and advisory services, training courses, networks) that the Agency is offering to its Member States in order to cope with the main challenges worldwide, contributing thus to the efficiency and effectiveness of the regulatory oversight of medical facilities and activities. (author)

Regulating the path from legacy recognition, through recovery to release from regulatory control.

Science.gov (United States)

Sneve, Malgorzata Karpow; Smith, Graham

2015-04-01

Past development of processes and technologies using radioactive material led to construction of many facilities worldwide. Some of these facilities were built and operated before the regulatory infrastructure was in place to ensure adequate control of radioactive material during operation and decommissioning. In other cases, controls were in place but did not meet modern standards, leading to what is now considered to have been inadequate control. Accidents and other events have occurred resulting in loss of control of radioactive material and unplanned releases to the environment. The legacy from these circumstances is that many countries have areas or facilities at which abnormal radiation conditions exist at levels that give rise to concerns about environmental and human health of potential interest to regulatory authorities. Regulation of these legacy situations is complex. This paper examines the regulatory challenges associated with such legacy management and brings forward suggestions for finding the path from: legacy recognition; implementation, as necessary, of urgent mitigation measures; development of a longer-term management strategy, through to release from regulatory control. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

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

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)

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)

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)

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

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

Regulatory Aspects of Sabin Type 2 Withdrawal From Trivalent Oral Poliovirus Vaccine: Process and Lessons Learned.

Science.gov (United States)

Decina, Daniela; Fournier-Caruana, Jacqueline; Takane, Marina; Ostad Ali Dehaghi, Razieh; Sutter, Roland

2017-07-01

Withdrawal of type 2 oral poliovirus vaccine (OPV) in OPV-using countries required regulatory approval for use of inactivated poliovirus vaccine and bivalent OPV in routine immunization. Worldwide, a variety of mechanisms were used by member states, with some differences in approach observed between inactivated poliovirus vaccine and bivalent OPV. These included acceptance for use of World Health Organization (WHO) prequalified vaccines, registration and licensure pathways, participation in WHO-convened joint reviews of licensing dossiers, as well as pragmatic application of alternatively available mechanisms, when appropriate. Simple but effective tools were used to monitor progress and to record, authenticate, and share information. Essential to achievement of regulatory targets was ongoing communication with key stakeholders, including switch-country national regulatory authorities, vaccine manufacturers, partner organizations, and relevant units within WHO. Understanding of the regulatory environment gained through the OPV switch can be helpful in supporting further stages of the polio end game and other time-sensitive vaccine introduction programs. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.

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

Residential surface soil guidance values applied worldwide to the original 2001 Stockholm Convention POP pesticides.

Science.gov (United States)

Jennings, Aaron A; Li, Zijian

2015-09-01

Surface soil contamination is a worldwide problem. Many regulatory jurisdictions attempt to control human exposures with regulatory guidance values (RGVs) that specify a soil's maximum allowable concentration. Pesticides are important soil contaminants because of their intentional toxicity and widespread surface soil application. Worldwide, at least 174 regulatory jurisdictions from 54 United Nations member states have published more than 19,400 pesticide RGVs for at least 739 chemically unique pesticides. This manuscript examines the variability of the guidance values that are applied worldwide to the original 2001 Stockholm Convention persistent organic pollutants (POP) pesticides (Aldrin, Chlordane, DDT, Dieldrin, Endrin, Heptachlor, Mirex, and Toxaphene) for which at least 1667 RGVs have been promulgated. Results indicate that the spans of the RGVs applied to each of these pesticides vary from 6.1 orders of magnitude for Toxaphene to 10.0 orders of magnitude for Mirex. The distribution of values across these value spans resembles the distribution of lognormal random variables, but also contain non-random value clusters. Approximately 40% of all the POP RGVs fall within uncertainty bounds computed from the U.S. Environmental Protection Agency (USEPA) RGV cancer risk model. Another 22% of the values fall within uncertainty bounds computed from the USEPA's non-cancer risk model, but the cancer risk calculations yield the binding (lowest) value for all POP pesticides except Endrin. The results presented emphasize the continued need to rationalize the RGVs applied worldwide to important soil contaminants. Copyright © 2015 Elsevier Ltd. All rights reserved.

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)

Strengthening Regulatory Competence in a Changing Nuclear Regulatory Environment

International Nuclear Information System (INIS)

Illizastigui, P.F.

2016-01-01

The paper addresses the approach followed by the Cuban National Center for Nuclear Safety for the management of current and new competences of its regulatory staff with the aim of allowing those staff to effectively fulfill their core regulatory functions. The approach is realized through an Integrated System for Competence Building, which is based on the IAEA recommendations, shown to be effective in ensuring the necessary competence in the relevant areas. In the author’s opinion, competence of the regulatory staff in the area of human and organizational factors is of paramount importance and needs to be further strengthened in order to be able to assess safety performance at the facilities and detect early signs of deteriorating safety performance. The former is defined by the author as the core regulatory function “Analysis” which covers the entire spectrum of assessment tasks carried out by the regulatory staff to: a) detect declining safety performance, b) diagnose latent weaknesses (root causes) and c) make effective safety culture interventions. The author suggests that competence associated with the fulfillment of the analysis function is distinctly identified and dealt with separately in the current system of managing regulatory competence. (author)

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.)

Development of PSA audit guideline and regulatory PSA model for SMART

International Nuclear Information System (INIS)

Cho, Namchul; Lee, Chang-Ju; Kim, I.S.

2012-01-01

SMART is under development for dual purposes of power generation and seawater desalination in Korea. It is an integral reactor type with a thermal power output of 330 MW and employs advanced design features such as a passive system for the removal of residual heat and also the setting of all the components of the primary system inside the reactor pressure vessel. It is essential to develop new probabilistic safety assessment (PSA) validation guidance for SMART. For the purpose of regulatory verification to the risk level of SMART, the insights and key issues on the PSA are identified with referring some worldwide safety guides as well as its design characteristics. Regulatory PSA model under the development for the design confirmation and its preliminary result are also described. (authors)

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

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...

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.

Global Acceptance of Biosimilars: Importance of Regulatory Consistency, Education, and Trust.

Science.gov (United States)

Cazap, Eduardo; Jacobs, Ira; McBride, Ali; Popovian, Robert; Sikora, Karol

2018-05-16

Globally, biosimilars are expected to have a key role in improving patient access to biological therapies and addressing concerns regarding the escalating cost of health care. Indeed, in Europe, increased use of biologics and reduced drug prices have been observed after the introduction of biosimilars. Recently, several monoclonal antibody biosimilars of anticancer therapies have been approved, and numerous others are in various stages of clinical development. Biosimilars are authorized via a regulatory pathway separate from that used for generic drugs; they are also regulated separately from novel biologics. Biosimilar approval pathways in many major regulatory regions worldwide are, to a broad degree, scientifically aligned. However, owing to regional differences in health care priorities, policies, and resources, some important regulatory inconsistencies are evident. Acceptance of biosimilars by health care systems, health care professionals, and patients will be a key factor in the uptake of these therapies, and such regulatory variations could contribute to confusion and diminished confidence regarding the quality, efficacy, and reliability of these agents. Furthermore, the need for manufacturers to account for regulatory inconsistencies introduces inefficiencies and delays into biosimilar development programs. These issues should be addressed if biosimilars are to attain their maximal global potential. This review summarizes the evolution of the global biosimilar landscape and provides examples of inconsistencies between regulatory requirements in different regions. In addition, we review ongoing efforts to improve regulatory alignment and highlight the importance of education as a crucial factor in generating trust in, and acceptance of, biosimilars on a worldwide scale. Biosimilars of monoclonal antibody anticancer therapies are beginning to emerge, and more are likely to become available for clinical use in the near future. The extent to which biosimilars

Regulatory Competition in Global Financial Markets

DEFF Research Database (Denmark)

Ringe, Georg

2016-01-01

Regulatory arbitrage in financial markets refers to a number of strategies that market participants use to avoid the reach of regulation, in particular by virtue of moving trading abroad or relocating activities or operations of financial institutions to other jurisdictions. Where this happens...... institutions' excessive risk-taking. If such risk-taking would be judged by market discipline instead of posing a risk to global financial stability, the main downside of regulatory competition could be restrained. Within the boundaries of such a system, competition could then operate and contribute...... their standards solely to attract business and thereby impose externalities on the worldwide financial market by undermining financial stability as a global public good. Policymakers worldwide are experimenting with remedies to respond to the phenomenon. I introduce the importance of an effective special...

As to achieve regulatory action, regulatory approaches

International Nuclear Information System (INIS)

Cid, R.; Encinas, D.

2014-01-01

The achievement of the effectiveness in the performance of a nuclear regulatory body has been a permanent challenge in the recent history of nuclear regulation. In the post-Fukushima era this challenge is even more important. This article addresses the subject from two complementary points of view: the characteristics of an effective regulatory body and the regulatory approaches. This work is based on the most recent studies carried out by the Committee on Nuclear Regulatory Activities, CNRA (OECD/NEA), as well as on the experience of the Consejo de Seguridad Nuclear, CSN, the Spanish regulatory body. Rafael Cid is the representative of CSN in these project: Diego Encinas has participated in the study on regulatory approaches. (Author)

Alternatives to animal experimentation: The regulatory background

International Nuclear Information System (INIS)

Garthoff, Bernward

2005-01-01

The framework, in which alternatives to animal experiments can be developed, standardized, respectively formally validated, has to be seen in a global context. The ever increasing demand of testing for hazard and risk assessment in health and environment, exemplified by the EU REACH program, subsequently triggers laboratory animal testing. This holds especially true, if no valid alternative methods agreed to by the regulatory authorities and the scientific community are available. At least for regulatory toxicity testing, the global frame and network are given by institutions such as OECD, ICH, and alike. However, due to the necessity of global consent of states, organizations, and stakeholders, the time gap between availability of a novel alternative test method and its final acceptance by authorities and implementation thereafter is widening. The lack of new technologies or opportunities for alternative method application such as, for example, the broad use of transgenic animals for refinement of existing tests, adds to the problem. The bare existence of certain in vivo tests increases also the gap between public demands for testing versus availability of alternative tests. Industries operating on a worldwide basis support the alternative test development in their respective area of research and operational business. However, a more coordinating approach such as that of the ecopa-organization (European Consensus Platform on Alternatives) is needed to exploit the existing possibilities within the current regulatory framework. This will speed up the process of acceptance and challenge the political worldto feel responsible for the sequels of their demanding more testing, that is, by funding alternative method development in academia and industry

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.

Exclusion and authorization

International Nuclear Information System (INIS)

Cooper, J.R.

2003-01-01

'Everyone in the world is exposed to radiation from natural and artificial sources. Any realistic system of radiological protection must have a clearly defined scope if it is not to apply to the whole of mankind's activities'. This quote, from ICRP Publication 60 (ICRP, 1991), remains apposite. The main tool for defining scope is the concept of exclusion: situations, sources or exposures that are excluded from the system of radiological protection are, to all intents and purposes, ignored. Sources and exposures that are not excluded are within the scope of the system of protection and by inference within regulatory systems implementing ICRP recommendations. These sources and exposures should be subject to appropriate authorization by the relevant regulatory authority. In order to avoid excessive regulatory procedures, however, provisions should be made for granting an exemption in cases where it is clear that regulatory provisions are unnecessary. Exemption is a regulatory tool intended to facilitate efficient use of regulatory resources. Nevertheless, the regulatory act of granting exemptions is, in itself, a form of authorization and the material or situation so exempted remains within the regulatory system. This distinction between exclusion and exemption is an important one. Historically, the concept of exclusion has been applied to sources or exposures that are essentially unamenable to control because of their widespread nature. The usually quoted examples are cosmic radiation at ground level and 40 K in the body. Clearly, many exposures from natural sources could fall into this category. The challenges are firstly to establish a sound basis for deciding which should be excluded and which should be controlled, and secondly to see if the concept could or should be applied to artificial sources and exposures. These two questions are the subject of this paper. (author)

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.

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

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)

Advances on generic exemption levels and generic clearance levels in the argentinean regulatory field

International Nuclear Information System (INIS)

Muñiz, C.C.; Bossio, M.C.

2011-01-01

With the aim of optimizing the regulatory effort in Argentina, the Nuclear Regulatory Authority (ARN) evaluated two worldwide concepts used in the radioactive waste management field: “Generic Exemption Levels” and “Generic Clearance Levels”. The objective of this paper is to present the progress made in the past two years in relation to these topics and to present the results of the specific requests received from users of radioactive material. Since the approval of both Generic Levels, the ARN received two exemption requests. The first one, regarding the practice of dismantling lighting rods with 241 Am. The other case regards the international trade, distribution, usage and final disposal of lighting products with radioactive material ( 85 Kr and 232 Th). Concerning clearance, there has not been any request yet. However, in the future the ARN expects to receive this kind of requests from nuclear power plants and other facilities related to the nuclear fuel cycle. (authors) [es

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.

Clear progress in nuclear safety worldwide: Convention on nuclear safety concludes

International Nuclear Information System (INIS)

2002-01-01

It has been concluded that a significant progress has been observed in a number of key areas, such as strengthened legislation, regulatory independence, the availability of financial resources, enhanced emergency preparedness and safety improvements at nuclear power plants built to earlier standards. The objective of the Convention is to achieve and maintain a high level of nuclear safety worldwide. During the two week Review Meeting, parties engaged in a 'peer review' process in which the National Reports from individual States were collectively examined and discussed, with written replies provided to all the questions raised. Clear improvement was noted in the quality of the National Reports, the number of questions and the openness and quality of discussion and answers. The Contracting Parties praised the IAEA's various safety review missions and services, which they use widely to help enhance the effectiveness of their national safety arrangements. Forty-six contracting parties participated at the Review Meeting with over 400 delegates attending, including many heads and senior officers from regulatory bodies and experts from industry. To date, the Convention has been signed by sixty-five States and ratified by fifty-four, representing 428 of the 448 nuclear power reactors worldwide

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

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.

Worldwide, 3-Year, Post-Marketing Surveillance Experience with Tofacitinib in Rheumatoid Arthritis.

Science.gov (United States)

Cohen, Stanley; Curtis, Jeffrey R; DeMasi, Ryan; Chen, Yan; Fan, Haiyun; Soonasra, Arif; Fleischmann, Roy

2018-06-01

Post-marketing surveillance (PMS) is an integral part of monitoring adverse events (AEs) following approval of new drugs. Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). An analysis of PMS reports was conducted to evaluate the safety of tofacitinib in a post-marketing setting. Worldwide tofacitinib PMS data received in the Pfizer safety database from November 6, 2012 (first marketing authorization of tofacitinib) to November 5, 2015 were analyzed. Serious AEs (SAEs) of interest were reviewed and reporting rates (RRs) were calculated by dividing the number of SAEs by the estimated 100 patient-years of exposure. Patient exposure was calculated based on estimated worldwide sales and an estimated daily regimen of tofacitinib 5 mg twice daily. During the 3-year reporting period, worldwide post-marketing exposure to tofacitinib since approval was estimated to be 34,223 patient-years. In total, 9291 case reports (82.9% non-serious) were received and 25,417 AEs, 102 fatal cases, and 4352 SAEs were reported. The RRs (per 100 patient-years) for SAEs of interest by Medical Dictionary for Regulatory Activities System Organ Class were 2.57 for infections, 0.91 for gastrointestinal disorders, 0.60 for respiratory disorders, 0.45 for neoplasms, 0.43 for cardiac disorders, and 0.12 for hepatobiliary disorders. Although there are limitations to these data, no new safety risks were revealed in this real-world setting compared with the safety profile identified in the tofacitinib RA clinical development program. Any risks identified through the tofacitinib development program and PMS will continue to be monitored through pharmacovigilance surveillance. Pfizer Inc.

Tube problems: worldwide statistics reviewed

International Nuclear Information System (INIS)

Anon.

1994-01-01

EPRI's Steam Generator Strategic Management Project issues an annual report on the progress being made in tackling steam generator problems worldwide, containing a wealth of detailed statistics on the status of operating units and degradation mechanisms encountered. A few highlights are presented from the latest report, issued in October 1993, which covers the period to 31 December 1992. (Author)

Regulatory use of risk information - initial developments at Slovenian Nuclear Safety Administration

International Nuclear Information System (INIS)

Muehleisen, A.; Koncar, M.; Vojnovic, D.; Persic, A.

2004-01-01

Similarly to other regulators worldwide, the SNSA intends to enhance the use of PSA and risk insights in its activities in order to ensure a better and more focused regulatory oversight as well as improved interface with a licensee. The main aim of the SNSA is to establish PSA as a standard tool to complement the deterministic based regulation for a variety of regulatory tasks. The PSA applications should, in particular, support the decision making process as well as the interactions with the Krsko NPP. As a first step in the internal use of PSA, PSA event analysis and risk based performance indicators are being introduced. In 2004, the SNSA will start introducing risk follow up and risk informed inspections. By mid 2005 the legal basis for the use of PSA will be also established in Slovenian legislation. (author)

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.

Equivalence of complex drug products: advances in and challenges for current regulatory frameworks.

Science.gov (United States)

Hussaarts, Leonie; Mühlebach, Stefan; Shah, Vinod P; McNeil, Scott; Borchard, Gerrit; Flühmann, Beat; Weinstein, Vera; Neervannan, Sesha; Griffiths, Elwyn; Jiang, Wenlei; Wolff-Holz, Elena; Crommelin, Daan J A; de Vlieger, Jon S B

2017-11-01

Biotechnology and nanotechnology provide a growing number of innovator-driven complex drug products and their copy versions. Biologics exemplify one category of complex drugs, but there are also nonbiological complex drug products, including many nanomedicines, such as iron-carbohydrate complexes, drug-carrying liposomes or emulsions, and glatiramoids. In this white paper, which stems from a 1-day conference at the New York Academy of Sciences, we discuss regulatory frameworks in use worldwide (e.g., the U.S. Food and Drug Administration, the European Medicines Agency, the World Health Organization) to approve these complex drug products and their follow-on versions. One of the key questions remains how to assess equivalence of these complex products. We identify a number of points for which consensus was found among the stakeholders who were present: scientists from innovator and generic/follow-on companies, academia, and regulatory bodies from different parts of the world. A number of topics requiring follow-up were identified: (1) assessment of critical attributes to establish equivalence for follow-on versions, (2) the need to publish scientific findings in the public domain to further progress in the field, (3) the necessity to develop worldwide consensus regarding nomenclature and labeling of these complex products, and (4) regulatory actions when substandard complex drug products are identified. © 2017 The Authors. Annals of the New York Academy of Sciences published by Wiley Periodicals, Inc. on behalf of New York Academy of Sciences.

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.

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

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

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

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

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

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...

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...

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.)

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)

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

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...

76 FR 14943 - Antidisruptive Practices Authority

Science.gov (United States)

2011-03-18

.... Higgins, Counsel to the Director of Enforcement, 202-418- 5864, [email protected] , Commodity Futures... Prohibit Disruptive Trading a. Panelists: Tom Gira--Financial Industry Regulatory Authority; Chris Heymeyer.... Panelists: Tom Gira--Financial Industry Regulatory Authority; Chris Heymeyer--National Futures Association...

European Union International Cooperation to Improve Regulatory Effectiveness in Nuclear Safety

International Nuclear Information System (INIS)

Stockmann, Y.

2016-01-01

The European Union (EU) promotes a high level of nuclear safety worldwide, through the ''Instrument for Nuclear Safety Cooperation'' (INSC) since 2007. The INSC builds on the experience gained under the completed ''Technical Assistance to the Commonwealth of Independent States'' Programme (TACIS) from 1991. Development and strengthening of national Regulatory Authorities’ capabilities is a key activity in achieving the INSC goals, in particular in countries with or embarking on nuclear power. Specific partner countries under INSC include countries of all types of maturity in the nuclear technology, with mature countries such as Brazil, Mexico and Ukraine, countries with waste and mining issues, but no direct intention of embarking on nuclear power such as Georgia, Mongolia, Tajikistan, Kyrgyzstan and Tanzania and countries planning to embark on nuclear power such as Belarus, Egypt, Jordan and Vietnam. For new projects, the main focus is on the neighbourhood of the EU. The EU cooperation within INSC encompasses measures to support the promotion of high standards in radiation protection, radioactive waste management, decommissioning, remediation of contaminated sites, and efficient and effective safeguards of nuclear material. The INSC regulatory support is aimed at continuous assistance to Nuclear Regulatory Authorities (NRAs), including their technical support organisations (TSOs), in order to reinforce the regulatory framework, notably concerning licensing activities.

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)

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

Carbon Capture and Storage Legal and Regulatory Review. Edition 3

Energy Technology Data Exchange (ETDEWEB)

NONE

2012-07-01

The International Energy Agency (IEA) considers carbon capture and storage (CCS) a crucial part of worldwide efforts to limit global warming by reducing greenhouse-gas emissions. The IEA estimates that emissions can be reduced to a level consistent with a 2°C global temperature increase through the broad deployment of low-carbon energy technologies – and that CCS would contribute about one-fifth of emission reductions in this scenario. Achieving this level of deployment will require that regulatory frameworks – or rather a lack thereof – do not unnecessarily impede environmentally safe demonstration and deployment of CCS, so in October 2010 the IEA launched the IEA Carbon Capture and Storage Legal and Regulatory Review. The CCS Review is a regular review of CCS regulatory progress worldwide. Produced annually, it collates contributions by national and regional governments, as well as leading organisations engaged in CCS regulatory activities, to provide a knowledge-sharing forum to support CCS framework development. Each two page contribution provides a short summary of recent and anticipated CCS regulatory developments and highlights a particular, pre-nominated regulatory theme. To introduce each edition, the IEA provides a brief analysis of key advances and trends, based on the contributions submitted. The theme for this third edition is stakeholder engagement in the development of CO2 storage projects. Other issues addressed include: regulating CO2-EOR, CCS and CO2-EOR for storage; CCS incentive policy; key, substantive issues being addressed by jurisdictions taking steps to finalise CCS regulatory framework development; and CCS legal and regulatory developments in the context of the Clean Energy Ministerial Carbon Capture, Use and Storage Action Group.

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...

Towards worldwide harmonization of radioecology networks: IUR initiates the 'FORUM' - Towards worldwide harmonization of radioecology networks: an initiative of the International Union of Radioecology

Energy Technology Data Exchange (ETDEWEB)

Brechignac, F. [International Union of Radioecology (IUR) and Institute of Radioprotection and Nuclear Safety (IRSN), Direction General, Centre of Cadarache, Bldg 229, BP 1, 13115 St Paul-lez-Durance cedex (France); Bollhoefer, A. [South Pacific Environmental Radioactivity Association (SPERA) and Environmental Research Institute of the Supervising Scientist, Department of the Environment, Darwin, NT 0810 (Australia); Frogg, K.E.; Strand, P. [Norwegian Radiation Protection Authority (NRPA), P.O. Box 55, N-1332 Oesteraas (Norway); Higley, K. [Department of Nuclear Engineering and Radiation Health Physics, Oregon State University, 100 Radiation Center, Corvallis, OR 97331-5902 (United States); Hinton, T. [Institute of Radioprotection and Nuclear Safety (IRSN), Centre of Cadarache, BP 1, 13115 St Paul-lez- Durance cedex (France); Kapustka, L. [LK Consultancy, P.O. Box 373, Turner Valley, Alberta (Canada); Kuhne, W. [Savannah River National Laboratory, Savannah River Nuclear Solutions, Aiken, SC 29808 (United States); Leonard, K.S. [Cefas, Pakefield Road, Lowestoft, Suffolk, NR33 0HT (United Kingdom); Masson, O. [Institute of Radioprotection and Nuclear Safety (IRSN), Centre of Cadarache, Bldg 153, BP 1, 13115 St Paul-lez- Durance cedex (France); Nanba, K. [Institute of Environmental Radioactivity, Fukushima University, 1 Kanayagawa, Fukushima, Fukushima 960- 1296 (Japan); Smith, G. [GMS Abingdon Ltd, Tamarisk, Radley Road, Abingdon, OX14 3PP (United Kingdom); Smith, K. [RadEcol Consulting Ltd, Fell View, Middletown, Cumbria, CA22 2UG (United Kingdom); Vandenhove, H. [SCK-CEN, Belgian Nuclear Research Centre, Institute of Environment Health and Safety, Radiological Impact and Performance Assessment, Boeretang, 200, B-2400 Mol (Belgium); Yankovich, T. [International Atomic Energy Agency (IAEA), Division of Radiation, Transport and Waste Safety, Vienna International Centre, PO Box 100, 1400 Vienna (Austria); Yoshida, S. [Fukushima Project Headquarters, National Institute of Radiological Sciences, 263-8555, Chiba-shi (Japan)

2014-07-01

Many specialized networks have been designed in the past years to meet specific radioecological objectives, whether regional or sectorial (purpose-oriented). Regional networks deal with an array of radioecological issues related to their territories, such as waste problems, environmental modelling, prevention of impacts, regulation, etc- In Europe, a network of excellence in radioecology has been set up in order to design a strategic research agenda. It is currently being expected to become part of a European platform for radiation protection. Sectorial networks are more problem-oriented, often with wider international representativeness, but restricted to one specific issue like waste, low-level atmospheric contamination, etc. Other kind of sectorial networks result from international agreements for wide environment surveillance. IUR, founded on its large and long-existing international representation, with a current membership spread in nearly 60 countries worldwide, has now identified the need to bridge all such regional and/or sectorial networks together in order to promote the emergence of a worldwide coordinated development process for radioecology. This is especially warranted at a breakeven period where nuclear industry is starting, or expected, to spread beyond the small historical club of nuclearized countries in response to growing energetic demands throughout the world. Furthermore, with more than 30 years of existence, IUR with its dedicated task groups has a long tradition of promoting recommendations on the scientific needs to advance radioecology. In consequence, the construction of a process for worldwide international harmonization of R and D programmes and efforts is becoming highly desirable. This harmonization process would have the objectives to optimize efficiency, avoid duplications, optimize efficient exploitation of existing infrastructures, support harmonised and coherent regulatory developments, help the development of well informed

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.

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...

1991 worldwide refining and gas processing directory

International Nuclear Information System (INIS)

Anon.

1990-01-01

This book ia an authority for immediate information on the industry. You can use it to find new business, analyze market trends, and to stay in touch with existing contacts while making new ones. The possibilities for business applications are numerous. Arranged by country, all listings in the directory include address, phone, fax and telex numbers, a description of the company's activities, names of key personnel and their titles, corporate headquarters, branch offices and plant sites. This newly revised edition lists more than 2000 companies and nearly 3000 branch offices and plant locations. This east-to-use reference also includes several of the most vital and informative surveys of the industry, including the U.S. Refining Survey, the Worldwide Construction Survey in Refining, Sulfur, Gas Processing and Related Fuels, the Worldwide Refining and Gas Processing Survey, the Worldwide Catalyst Report, and the U.S. and Canadian Lube and Wax Capacities Report from the National Petroleum Refiner's Association

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

Legal principles of regulatory administration and nuclear safety regulation

Energy Technology Data Exchange (ETDEWEB)

Lee, Kyeong Hui; Cheong, Sang Kee [Hannam Univ., Taejon (Korea, Republic of)

2000-12-15

This research presents a critical analysis and evaluation of principles of administrative laws in order to provide framework of structural reform on the nuclear safety regulation system. The focus of this analysis and evaluation is centered around the area of origin of regulatory administrative laws; authorities of regulation; procedures of regulatory actions; regulatory enforcement; and administrative relief system. In chapter 2 the concept of regulatory administration is analysed. Chapter 3 identifies the origin of regulatory administration and the principles of administration laws. It also examines legal nature of the nuclear safety standard. In relation to regulatory authorities. Chapter 4 identifies role and responsibility of administration authorities and institutions. It also examines fundamental principles of delegation of power. Then the chapter discusses the nuclear safety regulation authorities and their roles and responsibilities. Chapter 5 classifies and examines regulatory administration actions. Chapter 6 evaluates enforcement measure for effectiveness of regulation. Finally, chapter 7 discusses the administrative relief system for reviewing unreasonable regulatory acts.

Nuclear Regulatory Commission Information Digest 1992 edition

International Nuclear Information System (INIS)

Olive, K.

1992-03-01

The Nuclear Regulatory Commission Information Digest provides a summary of information about the US Nuclear Regulatory Commission (NRC), NRC's regulatory responsibilities, the activities NRC licenses, and general information on domestic and worldwide nuclear energy. This digest is a compilation of nuclear- and NRC-related data and is designed to provide a quick reference to major facts about the agency and industry it regulates. In general, the data cover 1975 through 1991, with exceptions noted. Information on generating capacity and average capacity factor for operating US commercial nuclear power reactors is obtained from monthly operating reports that are submitted directly to the NRC by the licensee. This information is reviewed by the NRC for consistency only and no independent validation and/or verification is performed

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)

Information system fur the management of a regulatory programme

International Nuclear Information System (INIS)

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

1998-01-01

A Regulatory Programme to monitor safety of activities involving radiation sources, implies the existence of a Regulatory Authority empowered by legislation to issue radiation protection regulations and to monitor compliance with those regulations. The core element of the programme is a system of notification and authorization (registration and licensing), inspection and enforcement. The efficiency of this system is largely dependent on the availability of reliable information on the inventory of radiation sources and installations, the administrative status of the facilities (authorization), prompt processing of inspection reports and follow up of regulatory actions, including monitoring deadlines. Essential data relevant to safety, such as personal dosimetry for occupationally exposed individuals, inspection findings and incident reports would provide, in addition, an insight on the overall safety of the country. A simple but comprehensive Regulatory Authority Information System (RAIS) linked to the authorization and inspection process will largely facilitate regulatory decisions and actions. A readily available and reliable information from the various regulatory activities will facilitate planning, optimization of resources, monitoring safety related data, disseminating safety information, making decisions and follow up regulatory actions including monitoring dead lines. The implementation of the system in more than 50 countries will contribute to experience exchange and harmonization of regulatory activities. (author)

Regional Power Integration : Structural and Regulatory Challenges

OpenAIRE

World Bank

2011-01-01

The Central America Regional Electricity Market (MER) trades electricity and transmission capacity among six Central American countries: Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua and Panama. The market differs from other electricity markets worldwide because it has its own regulatory body and system operator. Economic integration of the Central American countries has followed...

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...

Regulatory Activities for Licensee's Safety Culture

International Nuclear Information System (INIS)

Choi, Young Sung; Choi, Kwang Sik

2008-01-01

Weaknesses in safety culture have contributed to a number of incidents/accidents in the nuclear and other high hazard sectors worldwide in the past. These events have fostered an increasing awareness of the need for licensees to develop a strong safety culture to support successful and sustainable nuclear safety performance. Regulatory bodies are taking a growing interest in this issue, and several are actively working to develop and implement approaches to maintaining regulatory oversight of licensee safety culture. However, these approaches are not yet well-established, and it was considered prudent to share experiences and developing methodologies in order to disseminate good practices and avoid potential pitfalls. This paper presents the findings, conclusions and recommendations of international meetings and other countries' activities on safety culture and gives some suggestions for regulators to consider when planning regulatory oversight for licensee's safety culture

Analysing success of regulatory policy transfers: Evidence from Turkish energy markets

International Nuclear Information System (INIS)

Dastan, Seyit Ali

2011-01-01

Economic regulation of public utilities has become a worldwide phenomenon with the preceding privatisation stream. It is questionable to transfer regulatory models hastily without customising the policy options or introducing necessary institutional reforms enabling the achievement of expected results of regulatory reform. Institutional configuration of a country affects credibility of regulatory commitments, quality of regulatory design, and way of policy transfer. Turkey’s energy market regulation experience confirms the decisive role of institutions in shaping the regulatory framework. - Highlights: ► The last quarter of the 20th century witnessed public sector reforms all over the world. ► The British model of utility regulation swept globally. ► In Turkey’s adoption of the utility regulation model, different factors affected in various ways. ► Higher political stability and regulatory experience provide faith in the regulatory framework.

Introduction: Training in reproductive endocrinology and infertility: meeting worldwide needs.

Science.gov (United States)

de Ziegler, Dominique; Meldrum, David R

2015-07-01

Training in reproductive endocrinology (REI) and its male variant, andrology, has been profoundly influenced by the central role captured by assisted reproductive technologies (ART). The marked differences in financial, regulatory, and societal/ethical restrictions on ART in different countries of the world also prominently influence the clinical management of infertility. Training should strive for comprehensive teaching of all medically indicated procedures, even if only to optimize cross-border care. Better international standardization of infertility practices and training would benefit worldwide infertility care and should be promoted by international societies. Copyright © 2015. Published by Elsevier Inc.

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.

Post irradiation examinations cooperation and worldwide utilization of facilities

International Nuclear Information System (INIS)

Karlsson, Mikael

2009-01-01

Status of post irradiation examinations in Studsvik's facilities, cooperation and worldwide utilization of facilities, was described. Studsvik cooperate with irradiation facilities, as Halden, CEA and JAEA, as well as other hot cell facilities (examples, PSI, ITU and NFD) universities (example, the Royal Institute of Technology in Sweden) in order to be able to provide everything asked for by the nuclear community. Worldwide cooperation for effective use of expensive and highly specialized facilities is important, and the necessity of cooperation will be more and more recognized in the future. (author)

Seismic reevaluation of nuclear facilities worldwide: Overview and status

Energy Technology Data Exchange (ETDEWEB)

Campbell, R D; Hardy, G S; Ravindra, M K [EQE International, Irvine, CA (United States); Johnson, J J [EQE International, San Francisco, CA (United States); Hoy, A J [EQE International Ltd., Birchwood, Warrington (United Kingdom)

1995-07-01

Existing nuclear facilities throughout the world are being subjected to severe scrutiny of their safety in tile event of an earthquake. In the United States, there have been several licensing and safety review issues for which industry and regulatory agencies have cooperated to develop rational and economically feasible criteria for resolving the issues. Currently, all operating nuclear power plants in the United States are conducting an Individual Plant Examination of External Events, including earthquakes beyond tile design basis. About two-thirds of tile operating plants are conducting parallel programs for verifying, tile seismic adequacy of equipment for the design basis earthquake. The U.S. Department of Energy is also beginning to perform detailed evaluations of their facilities, many of which had little or no seismic design. Western European countries also have been reevaluating their older nuclear power plants for seismic events often adapting the criteria developed in the United States. With the change in tile political systems in Eastern Europe, there is a strong emphasis from their Western European neighbors to evaluate and Upgrade tile safely of their operating nuclear power plants. Finally, nuclear facilities in Asia are, also, being evaluated for seismic vulnerabilities. This paper focuses oil tile methodologies that have been developed for reevaluation of existing nuclear power plants and presents examples of the application of these methodologies to nuclear facilities worldwide. (author)

Seismic reevaluation of nuclear facilities worldwide: Overview and status

International Nuclear Information System (INIS)

Campbell, R.D.; Hardy, G.S.; Ravindra, M.K.; Johnson, J.J.; Hoy, A.J.

1995-01-01

Existing nuclear facilities throughout the world are being subjected to severe scrutiny of their safety in tile event of an earthquake. In the United States, there have been several licensing and safety review issues for which industry and regulatory agencies have cooperated to develop rational and economically feasible criteria for resolving the issues. Currently, all operating nuclear power plants in the United States are conducting an Individual Plant Examination of External Events, including earthquakes beyond tile design basis. About two-thirds of tile operating plants are conducting parallel programs for verifying, tile seismic adequacy of equipment for the design basis earthquake. The U.S. Department of Energy is also beginning to perform detailed evaluations of their facilities, many of which had little or no seismic design. Western European countries also have been reevaluating their older nuclear power plants for seismic events often adapting the criteria developed in the United States. With the change in tile political systems in Eastern Europe, there is a strong emphasis from their Western European neighbors to evaluate and Upgrade tile safely of their operating nuclear power plants. Finally, nuclear facilities in Asia are, also, being evaluated for seismic vulnerabilities. This paper focuses oil tile methodologies that have been developed for reevaluation of existing nuclear power plants and presents examples of the application of these methodologies to nuclear facilities worldwide. (author)

Safety culture as a matter of regulatory control and regulatory effectiveness

International Nuclear Information System (INIS)

Camargo, C.T.M.; Furieri, E.B.; Arrieta, L.A.I.; Almeida, C.U.C.

2002-01-01

More than 15 years have passed since the term 'safety culture' was introduced by the International Nuclear Safety Advisory Group (INSAG), and although the concept now is widely accepted, practical applications and characteristics have been disseminated mainly for nuclear power plant operating organizations. There is still a lack of international guidance on the use of safety culture as a regulatory matter and on the application of the concept within regulatory organizations. This work explores the meaning of safety culture in two different fields: as an element of safety management systems it shall be a matter of regulatory control; as a complementary tool for quality management it should be used to enhance regulatory effectiveness. Brazilian recent experience on regulating nuclear power reactors provide some examples on how the concept of safety culture may influence regulatory strategies and regulatory management. (author)

Regulatory challenges facing the global nuclear energy partnership

International Nuclear Information System (INIS)

Lyman, Edwin S.

2007-01-01

In January 2006 the Department of Energy (DOE) announced the creation of the Global Nuclear Energy Partnership (GNEP), an ambitious plan to reshape the nuclear energy production sector both in the United States and worldwide. If fully realized in the United States, GNEP would entail the construction of a large number of sodium-cooled fast reactors utilizing actinide-based fuels, multiple commercial-scale reprocessing plants for both light-water and fast reactors, and fast reactor fuel fabrication plants. It appears likely that the first commercial-scale GNEP facilities, as well as a future full-scale GNEP complex, would fall under the licensing jurisdiction of the Nuclear Regulatory Commission (NRC). This will be a challenging endeavor for the NRC, primarily because the proposed GNEP facilities will in large part be based on novel and untested designs and processes that have not been developed on a commercial scale. In order to effectively regulate the GNEP complex, the NRC will have to quickly address the many technical and policy questions that will arise in any GNEP licensing scheme. This paper identifies some difficult issues that will be encountered in GNEP licensing by examining the potential implications of NRC's current policies and regulatory requirements, and analyzing the impacts of some emerging post-9/11 security issues. (author)

Risk literacy for scientists. Invitation to regulatory science

International Nuclear Information System (INIS)

Ono, Kyoko

2012-01-01

This paper discusses a regulatory science, which fills a gap between scientific knowledge and regulatory actions. The author provides examples of the regulatory science employed in chemical risk assessment, such as the linear non-threshold theory. In the regulatory science, scientific data as well as scientific reasoning based on scientific knowledge - or regulatory rules - should play an important role. It is important to recognize that the rules facilitate transparent decision making under conditions of uncertainty and time constraints. Furthermore, the development of traditional or pure science results in the validation of regulatory rules, and subsequently, the regulatory science procedure develops more systematically. The concept of this science should be understood by those engaged in governmental decision making. (author)

Regulatory activities; Actividades regulatorias

Energy Technology Data Exchange (ETDEWEB)

NONE

2001-07-01

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.

Actual growth and probable future of the worldwide nuclear industry

International Nuclear Information System (INIS)

Bupp, I.C.

1981-01-01

Worldwide nuclear-power-reactor manufacturing capacity will exceed worldwide demand by a factor of two or more during the 1980s. Only in France and the Soviet bloc countries is it likely that the ambitious nuclear-power programs formulated in the mid-1970s will be implemented. In all other developed countries and in most developing countries, further delays and cancellations of previously announced programs are all but certain. The stalemate over the future of nuclear power is particularly deep in America. Administrative and personnel problems in the Nuclear Regulatory Commission, slow progress on radioactive waste disposal by the Department of Energy, severe financial problems for most electric utilities, and drastic reductions in the rate of electricity demand growth combine to make continuation of the five-year-old moratorium on reactor orders inevitable. Many of the ninety plants under construction may never operate, and some of the seventy in operation may shut down before the end of their economic life. Contrary to widespread belief, further oil price increases may not speed up world-wide reactor sales. It is possible that the world is heading for a worst of all possible outcomes: a large number of small nuclear power programs that do little to meet real energy needs but substantially complicate the problem of nuclear weapons proliferation. 24 references, 4 tables

Regulatory control of radiation sources in Slovakia

International Nuclear Information System (INIS)

Auxtova, L.

2001-01-01

In Slovakia, there are two regulatory authorities. Regulatory control of the utilization of nuclear energy, based on the Slovak National Council's law No. 130/1998 on the peaceful uses of nuclear energy, is exercised by the Nuclear Regulatory Authority of the Slovak Republic. The second regulatory authority - the Ministry of Health - is empowered by law No. 72/1994 on the protection of human health to license radiation sources and is responsible for radiation protection supervision (there are nearly 3000 establishments with sealed sources, radiation generators and unsealed sources in Slovakia). Pursuant to a new radiation protection regulation based on international standards, radiation sources are to be categorized in six classes according to the associated exposure and contamination hazards. A national strategy for improving the safety of radiation sources over their life-cycle and for the management of disused and orphan sources is being prepared for governmental approval. (author)

Research and regulatory review

International Nuclear Information System (INIS)

Macleod, J.S.; Fryer, D.R.H.

1979-01-01

To enable the regulatory review to be effectively undertaken by the regulatory body, there is a need for it to have ready access to information generated by research activities. Certain advantages have been seen to be gained by the regulatory body itself directly allocating and controlling some portion of these activities. The princial reasons for reaching this conclusion are summarised and a brief description of the Inspectorates directly sponsored programme outlined. (author)

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

A flexible regulatory framework

International Nuclear Information System (INIS)

Silvennoinen, T.

2000-01-01

Regulatory reform of the Finnish electricity market meant opening up potentially competitive parts of the electricity sector to competition and eliminating all unnecessary forms of regulation covering generation, wholesale supply, retail supply, and foreign trade in electricity. New types of control and regulatory mechanisms and institutions were set up for those parts of the electricity industry that were excluded from competition, such as network operations. Network activities now have to be licensed, whereas no licence is needed for generation or supply. A new sector-specific regulatory authority was established in 1995 to coincide with the implementation of the Electricity Market Act, known as the Electricity Market Authority. This is responsible for regulating network activities and retail supply to captive customers. The core function of the authority, which employs some 14 people, is to promote the smooth operation of the Finnish electricity market and to oversee the implementation of the Electricity Market Act and its provisions. Its most important duties are linked to overseeing the process by which network companies price their electricity. As price regulation no longer exists, all the companies in the electricity sector set their tariffs independently, even network companies. The job of controlling the pricing of network services is handed by the Electricity Market Authority, following the principles of competition control. Pricing control takes place ex post - after a pricing system has been adopted by a company and concentrates on individual cases and companies. There is no ex ante system of setting or approving prices and tariffs by the regulator. The tariffs and pricing of network services can be evaluated, however, by both the Electricity Market Authority and the Finnish Competition Authority, which have overlapping powers as regards the pricing of network activities. The Finnish regulatory framework can be described as a system of light

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.

International Approaches for Nuclear Waste Disposal in Geological Formations: Report on Fifth Worldwide Review

Energy Technology Data Exchange (ETDEWEB)

Faybishenko, Boris [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Birkholzer, Jens [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Persoff, Peter [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Sassani, David [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Swift, Peter N. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

2016-08-01

An important issue for present and future generations is the final disposal of spent nuclear fuel. Over the past over forty years, the development of technologies to isolate both spent nuclear fuel (SNF) and other high-level nuclear waste (HLW) generated at nuclear power plants and from production of defense materials, and low- and intermediate-level nuclear waste (LILW) in underground rock and sediments has been found to be a challenging undertaking. Finding an appropriate solution for the disposal of nuclear waste is an important issue for protection of the environment and public health, and it is a prerequisite for the future of nuclear power. The purpose of a deep geological repository for nuclear waste is to provide to future generations, protection against any harmful release of radioactive material, even after the memory of the repository may have been lost, and regardless of the technical knowledge of future generations. The results of a wide variety of investigations on the development of technology for radioactive waste isolation from 19 countries were published in the First Worldwide Review in 1991 (Witherspoon, 1991). The results of investigations from 26 countries were published in the Second Worldwide Review in 1996 (Witherspoon, 1996). The results from 32 countries were summarized in the Third Worldwide Review in 2001 (Witherspoon and Bodvarsson, 2001). The last compilation had results from 24 countries assembled in the Fourth Worldwide Review (WWR) on radioactive waste isolation (Witherspoon and Bodvarsson, 2006). Since publication of the last report in 2006, radioactive waste disposal approaches have continued to evolve, and there have been major developments in a number of national geological disposal programs. Significant experience has been obtained both in preparing and reviewing cases for the operational and long-term safety of proposed and operating repositories. Disposal of radioactive waste is a complex issue, not only because of the nature

Advanced use of World-Wide Web in the online system of DELPHI

International Nuclear Information System (INIS)

Doenszelmann, M.; Carvalho, D.; Du, S.; Tennebo, F.

1996-01-01

The World-Wide Web technologies used by the DELPHI experiment at CERN to provide easy access to information of the On-line System. WWW technology on both client and server side is used in five different projects. The World-Wide Web has its advantages concerning the network technology, the practical user interface and its scalability. It however also demands a stateless protocol and format negotiation. (author)

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

Nuclear Regulatory Commission Information Digest: 1993 edition

International Nuclear Information System (INIS)

1993-03-01

The Nuclear Regulatory Commission Information Digest (digest) provides a summary of information about the U.S. Nuclear Regulatory Commission (NRC), NRC's regulatory responsibilities, the activities NRC licenses, and general information on domestic and worldwide nuclear energy. The digest, published annually, is a compilation of nuclear- and NRC-related data and is designed to provide a quick reference to major facts about the agency and the industry it regulates. In general, the data cover 1975 through 1992, with exceptions noted. Information on generating capacity and average capacity factor for operating U.S. commercial nuclear power reactors is obtained from monthly operating reports that are submitted directly to the NRC by the licensee. This information is reviewed by the NRC for consistency only and no independent validation and/or verification is performed. Comments and/or suggestions on the data presented are welcomed and should be directed to Karen Olive, United States Nuclear Regulatory Commission, Office of the Controller, Division of Budget and Analysis, Washington, D.C. 20555. For detailed and complete information about tables and figures, refer to the source publications

The regulatory control of radioactive sources in Argentina

International Nuclear Information System (INIS)

Rojkind, R.H.

1998-01-01

Argentina has been conducting nuclear activities for more than forty years, and had established a Regulatory Authority as early as in 1956. Procedures for compliance monitoring and enforcement have been in use in the regulatory control of radioactive sources, and regulatory standards and regulations were in force in Argentina before the accident in Goiania. The conclusions drawn from the Goiania accident encouraged the Argentine authorities to improve some regulatory procedures and helped to enhance the quality of the regulatory process. As a result, the effectiveness of the control of spent radioactive sources has gradually increased, and enforcement actions to prevent radioactive sources ending up in the public domain have improved. Lessons learned in Argentina from the accident in Goiania are presented as well as the main characteristics of an effective enforcement programme to prevent radiological accidents when radioactive sources are used for industrial, medical, research and teaching purposes. (author)

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)

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

40 CFR 73.86 - State regulatory autonomy.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 16 2010-07-01 2010-07-01 false State regulatory autonomy. 73.86 Section 73.86 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS... regulatory autonomy. Nothing in this subpart shall preclude a State or State regulatory authority from...

Major nuclear safety and regulatory issues in Korea

International Nuclear Information System (INIS)

Chang, Soon Heung

2004-01-01

Recently the value of nuclear energy is being re-considered due to the increase of oil price, the lack of energy supply, and the competition with renewable energy source. In Unites States, Europe, and East Asia, the prospects for continuous nuclear energy development or the policy for retaining nuclear energy have been announced. According to the nuclear energy promotion plan in Korea, there are 19 operating nuclear plants currently and more 7 plants will be constructed in the future. Until now, qualitative as well as quantitative growth is remarkable. Korean nuclear power plants achieved world-best level of capacity factor. However, because of the various nuclear industrial activities, we have a lot of regulatory issues for operating plants, building new plants, and other nuclear related facilities such as research reactors or radioactive waste storage facility. In this article, important regulatory issues which are emerging in Korea will be reviewed and the approaches to solve the issues including public acceptance will be presented. Especially, I will go into detail of two special case studies: The one is the thermal sleeve separation incident in Younggwang nuclear units 5 and 6 whose outage lasts about 80 days and 90 days respectively, which is not common in worldwide nuclear history. The other is about consensus meeting of Korea nuclear energy policy which was managed by a non-governmental organization. (author)

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...

A global regulatory science agenda for vaccines.

Science.gov (United States)

Elmgren, Lindsay; Li, Xuguang; Wilson, Carolyn; Ball, Robert; Wang, Junzhi; Cichutek, Klaus; Pfleiderer, Michael; Kato, Atsushi; Cavaleri, Marco; Southern, James; Jivapaisarnpong, Teeranart; Minor, Philip; Griffiths, Elwyn; Sohn, Yeowon; Wood, David

2013-04-18

The Decade of Vaccines Collaboration and development of the Global Vaccine Action Plan provides a catalyst and unique opportunity for regulators worldwide to develop and propose a global regulatory science agenda for vaccines. Regulatory oversight is critical to allow access to vaccines that are safe, effective, and of assured quality. Methods used by regulators need to constantly evolve so that scientific and technological advances are applied to address challenges such as new products and technologies, and also to provide an increased understanding of benefits and risks of existing products. Regulatory science builds on high-quality basic research, and encompasses at least two broad categories. First, there is laboratory-based regulatory science. Illustrative examples include development of correlates of immunity; or correlates of safety; or of improved product characterization and potency assays. Included in such science would be tools to standardize assays used for regulatory purposes. Second, there is science to develop regulatory processes. Illustrative examples include adaptive clinical trial designs; or tools to analyze the benefit-risk decision-making process of regulators; or novel pharmacovigilance methodologies. Included in such science would be initiatives to standardize regulatory processes (e.g., definitions of terms for adverse events [AEs] following immunization). The aim of a global regulatory science agenda is to transform current national efforts, mainly by well-resourced regulatory agencies, into a coordinated action plan to support global immunization goals. This article provides examples of how regulatory science has, in the past, contributed to improved access to vaccines, and identifies gaps that could be addressed through a global regulatory science agenda. The article also identifies challenges to implementing a regulatory science agenda and proposes strategies and actions to fill these gaps. A global regulatory science agenda will enable

Author Details

African Journals Online (AJOL)

Krauss, A. Vol 1, No 1 (2013) - Articles African Lion Cities: Deflating the MDG success of East Asian Tigers to a Worldwide Success Story of Dense Urban Areas with Greater Capacity Abstract. ISSN: 2343-6530. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's · More ...

Regulatory framework for the management of radioactive wastes in Argentina

International Nuclear Information System (INIS)

D'Amato, E.; Siraky, G.; Petraitis, E.; Novo, R.

2000-01-01

The legal and regulatory framework within which the radioactive waste management is carried out in Argentina are exposed. The activities of the Nuclear Regulatory Authority (ARN) in relation to facility inspections, safety assessments and collaboration with international agencies in the matter are also presented. Further, the regulatory criteria applied to waste management are reported. (author)

Regulatory toxicology in the twenty-first century: challenges, perspectives and possible solutions.

Science.gov (United States)

Tralau, Tewes; Oelgeschläger, Michael; Gürtler, Rainer; Heinemeyer, Gerhard; Herzler, Matthias; Höfer, Thomas; Itter, Heike; Kuhl, Thomas; Lange, Nikola; Lorenz, Nicole; Müller-Graf, Christine; Pabel, Ulrike; Pirow, Ralph; Ritz, Vera; Schafft, Helmut; Schneider, Heiko; Schulz, Thomas; Schumacher, David; Zellmer, Sebastian; Fleur-Böl, Gaby; Greiner, Matthias; Lahrssen-Wiederholt, Monika; Lampen, Alfonso; Luch, Andreas; Schönfelder, Gilbert; Solecki, Roland; Wittkowski, Reiner; Hensel, Andreas

2015-06-01

The advent of new testing systems and "omics"-technologies has left regulatory toxicology facing one of the biggest challenges for decades. That is the question whether and how these methods can be used for regulatory purposes. The new methods undoubtedly enable regulators to address important open questions of toxicology such as species-specific toxicity, mixture toxicity, low-dose effects, endocrine effects or nanotoxicology, while promising faster and more efficient toxicity testing with the use of less animals. Consequently, the respective assays, methods and testing strategies are subject of several research programs worldwide. On the other hand, the practical application of such tests for regulatory purposes is a matter of ongoing debate. This document summarizes key aspects of this debate in the light of the European "regulatory status quo", while elucidating new perspectives for regulatory toxicity testing.

Towards optimal use of available technical resources for regulatory purposes. The Syrian experience

International Nuclear Information System (INIS)

Shweikani, R.; Suman, H.; Othman, I.

2007-01-01

The Atomic Energy commission of Syria (AECS) is nominated by Syrian legislation as the regulatory authority in respect of radiation protection and safety and security of radioactive sources. In addition AECS is providing a wide range of Technical Services (TS) through its various departments. In this paper, the cooperation and coordination between the regulatory authority and the providers of technical services in Syria are described. The adjustment of the regulatory programme as to make maximal use of the available technical resources is presented. It was shown that this relationship does not jeopardize the effective independency of the regulatory authority which is maintained by keeping the regulatory decisions based on pure regulatory considerations. (author)

Reversibility of Decisions and Retrievability of Radioactive Waste: An Overview of Regulatory Positions and Issues

International Nuclear Information System (INIS)

Ruiz-Lopez, Carmen; Pescatore, Claudio

2015-02-01

The Radioactive Waste Management Committee (RWMC) of the NEA has been at the forefront worldwide in examining the topic of Reversibility and Retrievability (R and R). As early as 2001, an NEA survey-based report entitled 'Reversibility and Retrievability in Geological Disposal of Radioactive Waste' provided an overview of R and R by an ad-hoc group of experts from 11 NEA Member countries. The 2001 report (NEA 2001) observed that national safety regulations dealt mainly with operational safety and design targets for long-term (post-closure) safety and relatively little consideration was given to retrievability/reversibility or its implications. Yet, policy frames saw benefits from retrievability. In 2007, the RWMC launched the NEA R and R project with participation from 15 countries and two international organisations. The project included, amongst its members, representatives of six organisations involved in regulation, five regulatory authorities of five countries and one technical support organisation to the safety authorities. The project aimed to improve awareness amongst the RWMC constituency of the breadth of issues and positions regarding the concepts of R and R with the goal of providing a neutral overview of relevant issues and viewpoints in OECD countries. Hence substantial attention was given to R and R regulatory issues mainly in the context of decision making for repository development. The report (NEA 2011) points out regulatory issues, including safety criteria and licensing considerations. The present document presents an overview of findings, positions, boundary conditions and issues based on the results of the R and R project of 2007-2011 (stepwise decision making and reversibility, regulatory authorisations and R and R, decision making for retrieval) and of the Reims conference of December 2010 (terminology and definitions, legal and policy context, motivations for R and R, practical aspects, stakeholders confidence aspects)

Regulatory criteria for final disposal of radioactive wastes

International Nuclear Information System (INIS)

Petraitis, E.; Ciallella, N.; Siraky, 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. It also presents the criteria developed by the Nuclear Regulatory Authority (ARN) to assess the long-term safety of final disposal systems for high level radioactive wastes. (author)

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)

Removal of regulatory controls for materials and sites

International Nuclear Information System (INIS)

2004-01-01

Issues with the removal of regulatory controls are very important on the agenda of the regulatory authorities dealing with radioactive waste management (RWM). These issues arise prominently in decommissioning and in site remediation, and decisions can be very wide ranging having potentially important economic impacts and reaching outside the RWM area. The RWMC Regulators Forum started to address these issues by holding a topical discussion at its meeting in March 2003. Ths present document collates the national regulatory positions in the area of removal of regulatory controls. A summary of the national positions is also provided. The document is up to date to April 2004. (authors)

Regulatory Risk Management of Advanced Nuclear Power Plants

International Nuclear Information System (INIS)

George, Glenn R.

2002-01-01

Regulatory risk reflects both the likelihood of adverse outcomes during regulatory interactions and the severity of those outcomes. In the arena of advanced nuclear power plant licensing and construction, such adverse outcomes may include, for example, required design changes and construction delays. These, in turn, could significantly affect the economics of the plant and the generation portfolio in which it will operate. In this paper, the author addresses these issues through the lens of risk management. The paper considers various tools and techniques of regulatory risk management, including design diversity and hedging strategies. The effectiveness of alternate approaches is weighed and recommendations are made in several regulatory contexts. (author)

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)

Regulatory point of view of SAT application

International Nuclear Information System (INIS)

Juhasz, L.

2002-01-01

I present the regulatory system for monitoring operator training and check competency of operator personnel in Hungary and the effects of SAT to the regulatory framework/practice related to recruitment, training and authorisation of operating personnel. Also I introduce an application to manage the initial and refreshing training to regulatory bodies. (author)

The development of AECB regulatory documents

International Nuclear Information System (INIS)

Joyce, M.

1981-01-01

This document describes the Atomic Energy Control Board's (AECB) approach to the development and preparation of regulatory documents. The principal factors that have shaped the AECB'a regulatory approach are identified as background to the evolution of regulatory documents as are a number of current influences that affect the present and future development of these documents. Also described are the process by which regulatory documents are prepared and published and the points of contact between this process and the Canadian Standards Association program for nuclear standards. (author)

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...

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...

The IAEA Regional Training Course on Regulatory Control of Radiation Sources

International Nuclear Information System (INIS)

2000-01-01

Materials of the IAEA Regional Training Course contains 8 presented lectures. Authors deals with regulatory control of radiation sources. The next materials of the IAEA were presented: Organization and implementation of a national regulatory infrastructure governing protection against ionizing radiation and the safety of radiation sources. (IAEA-TECDOC-1067); Safety assessment plants for authorization and inspection of radiation sources (IAEA-TECDOC-1113); Regulatory authority information system RAIS, Version 2.0, Instruction manual

Reviss to market Russian isotopes worldwide

International Nuclear Information System (INIS)

Latham, I.A.

1992-01-01

The culmination of two years of detailed negotiations saw the formation of Reviss Services in April 1992. This joint venture company is a collaboration between Amersham International (Health Science Group), the Mayak Production Association (manufacturer of radioisotopes) and AO Techsnabexport (the Russian export agency). It is set up to enable a variety of Russian-manufactured radioisotopes to be marketed worldwide. Formation of the joint venture company was made possible by the recent political changes in the former Soviet Union, allowing the three parties to extend their long-standing commercial trading relationship into a full working partnership. (Author)

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.

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

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.

The regulatory control of radioactive sources in Argentina

International Nuclear Information System (INIS)

Rojkind, Roberto Hector

1997-01-01

Argentina has been conducting nuclear activities for more than forty years, and as early as in 1956 established a Regulatory Authority. Procedures for compliance monitoring and enforcement have been in use in the regulatory control of radioactive sources, and regulatory standards and regulations had been set in Argentina, before the accident in Goiania. The conclusions drawn from that accident encouraged in Argentina the improvement of some regulatory procedures and helped to enhance the quality of the regulatory process. Therefore, the effectiveness of the control of spent radioactive sources has gradually increased, and enforcement actions to prevent radioactive sources ending up in the public domain improved. Some lessons learned in Argentina from the accident in Goiania and the main characteristics of an effective enforcement program helpful to prevent radiological accidents in industrial, medical, research and teaching uses of radioactive sources are presented. (author)

Review on the worldwide regulatory framework for biosimilars focusing on the Mexican case as an emerging market in Latin America.

Science.gov (United States)

Ibarra-Cabrera, Ricardo; Mena-Pérez, Sandra Carolina; Bondani-Guasti, Augusto; García-Arrazola, Roeb

2013-12-01

The global biopharmaceutical market is worth over $100 billion USD. Nearly 90% of these products will lose their patent in the next ten years, leading to the commercialization of their subsequent versions, known as 'biosimilars'. Biosimilars are much more complex molecules than chemically synthesized generics in terms of size, structure, stability, microheterogeneity, manufacture, etc. Therefore, a specific regulatory framework is needed in order to demonstrate their comparability with innovative products, as well as their quality, safety and efficacy. The EU published the first regulatory pathway in 2005 and has approved 14 biosimilars. Mexico has recently developed a clear regulatory pathway for these products. Their legal basis was established in Article 222 Bis of General Law of Health in 2009, clear specifications in the Regulation for Health Goods in 2011, and further requirements in the Mexican Official Norm NOM-EM-001-SSA1-2012. The aim of this review is to summarize the regulatory pathways for biosimilars in the world with a special focus on Mexican experience, so as contribute to the development of regulations in other countries. Copyright © 2013 Elsevier Inc. All rights reserved.

Comparison of regulatory framework among bench marking countries for improving regulatory effectiveness in Malaysia

International Nuclear Information System (INIS)

Khairuddin, Nik Mohd Faiz Bin; Choi, Kwang Sik

2010-01-01

Nowadays some of developing countries in Asian region are announcing their planning to embark the nuclear power program. This progression are rising due to four factor: increasing political instabilities in fossil-fuel exporting countries; declining domestic natural energy resources; growing concerns about greenhouse gas emissions; and increasing demand for electricity. This paper gives a study on the comparison between Canada, Republic of South Korea and Malaysia regarding to their regulatory framework as well as the licensing procedures in controlling the nuclear power plants establishment. Canada and Korea were selected to study because of both of the countries have different system in controlling the nuclear power plants in terms of its regulatory framework as well as the licensing process. The idea is to compare these countries along with the guidelines by the IAEA and to find out what Malaysia could be learn to start the nuclear power program and find out the best practice in nuclear licensing. Factors taken into consideration are the regulatory framework, especially the nature of the licensing authority, the licensing process and enforcement actions. Together, these give a way to evaluate the effectiveness of the regulatory body due to the licensing authorization of nuclear power plant

Comparison of regulatory framework among bench marking countries for improving regulatory effectiveness in Malaysia

Energy Technology Data Exchange (ETDEWEB)

Khairuddin, Nik Mohd Faiz Bin [Korea Advanced Institute of Science and Technology, Daejeon (Korea, Republic of); Choi, Kwang Sik [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2010-05-15

Nowadays some of developing countries in Asian region are announcing their planning to embark the nuclear power program. This progression are rising due to four factor: increasing political instabilities in fossil-fuel exporting countries; declining domestic natural energy resources; growing concerns about greenhouse gas emissions; and increasing demand for electricity. This paper gives a study on the comparison between Canada, Republic of South Korea and Malaysia regarding to their regulatory framework as well as the licensing procedures in controlling the nuclear power plants establishment. Canada and Korea were selected to study because of both of the countries have different system in controlling the nuclear power plants in terms of its regulatory framework as well as the licensing process. The idea is to compare these countries along with the guidelines by the IAEA and to find out what Malaysia could be learn to start the nuclear power program and find out the best practice in nuclear licensing. Factors taken into consideration are the regulatory framework, especially the nature of the licensing authority, the licensing process and enforcement actions. Together, these give a way to evaluate the effectiveness of the regulatory body due to the licensing authorization of nuclear power plant

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)

Crude oil: worldwide inquiry on a destructive wealth

International Nuclear Information System (INIS)

Maass, P.

2010-01-01

More and more scarce, petroleum appears as much as an advantage as a malediction for the countries who owns some. Petroleum is very often synonymous of war, poverty, fundamentalism, pollution, or anarchy. Thanks to a large range of testimonies gathered in many oil producing countries, the author gives an overview of the worldwide fight in which oil industry actors are engaged and presents its deleterious influence on economies and populations. (J.S.)

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.

The performance trends of nuclear power plants worldwide

Energy Technology Data Exchange (ETDEWEB)

Glorian, D. [Electricite de France (EDF), 93 - Saint-Denis (France)

2001-07-01

Looking back to the worldwide operating experience feedback, which performance trends and conclusions could be drawn up? What is the specific situation of the French nuclear units, in comparison with the average worldwide performance? The performance of a unit or group of facilities is measured not only in technical terms (safety, availability, load control capability), but also from an economic and financial standpoint (operating and maintenance costs, fuel costs, etc). Performance in terms of radiological protection and on-the-job safety, as well as environmental protection, is also monitored in order to give the broadest possible overview of nuclear power plant performance. The main technical results are presented on the basis of selected performance indicators. The results obtained by French units are benchmarked against those of other PWR facilities in operation around the world, in accordance with comparisons made by the World Association of Nuclear Operators (WANO). (author)

The performance trends of nuclear power plants worldwide

International Nuclear Information System (INIS)

Glorian, D.

2001-01-01

Looking back to the worldwide operating experience feedback, which performance trends and conclusions could be drawn up? What is the specific situation of the French nuclear units, in comparison with the average worldwide performance? The performance of a unit or group of facilities is measured not only in technical terms (safety, availability, load control capability), but also from an economic and financial standpoint (operating and maintenance costs, fuel costs, etc). Performance in terms of radiological protection and on-the-job safety, as well as environmental protection, is also monitored in order to give the broadest possible overview of nuclear power plant performance. The main technical results are presented on the basis of selected performance indicators. The results obtained by French units are benchmarked against those of other PWR facilities in operation around the world, in accordance with comparisons made by the World Association of Nuclear Operators (WANO). (author)

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.

Croatian energy regulatory council - independent Croatian regulatory body

International Nuclear Information System (INIS)

Klepo, M.

2002-01-01

By means of approving five energy laws, the Republic of Croatia established an appropriate legislative framework for energy sector regulation. A series of sub-law acts is presently being elaborated as well as some additional documents in order to bring about transparent and non-discriminatory provisions for the establishment of electric energy, gas, oil/oil derivatives and thermal energy markets, i.e. for the introduction and management of market activities and public services. A considerable share of these activities relates to the definition of transparent regulatory mechanisms that would guarantee the implementation of regulation rules based on the law, and be carried out by the independent regulatory body - Croatian Energy Regulatory Council. The Council's rights and obligations include firm executive functions, which present obligations to every energy entity. A dissatisfied party may set in motion a settlement of dispute, if it maintains that the decisions are not based on the law or reveal a flaw in the procedure. Therefore, it is the Council's priority to always make careful and law-abiding decisions. This paper gives insight into the regulatory framework elements based on the laws including the Council's organisational structure and non-profit entities that will prepare act proposals for the Council and perform other professional activities. (author)

Safety analysis - current and future regulatory challenges

Energy Technology Data Exchange (ETDEWEB)

Jamieson, T., E-mail: Terry.Jamieson@cnsc-ccsn.gc.ca [Canadian Nuclear Safety Commission, Ottawa, ON (Canada)

2015-07-01

'Full text:' The current and future regulatory challenges associated with deterministic safety analysis are reviewed, including: 1. The CNSC's and safety control areas. 2. Traditional safety analysis approach. 3. Experience gained and impact. 4. Current analysis and regulatory approaches. 5. Current status. 6. Complexity and challenges In particular, the technical, regulatory and strategic aspects of these challenges are discussed. (author)

Safety analysis - current and future regulatory challenges

International Nuclear Information System (INIS)

Jamieson, T.

2015-01-01

'Full text:' The current and future regulatory challenges associated with deterministic safety analysis are reviewed, including: 1. The CNSC's and safety control areas. 2. Traditional safety analysis approach. 3. Experience gained and impact. 4. Current analysis and regulatory approaches. 5. Current status. 6. Complexity and challenges In particular, the technical, regulatory and strategic aspects of these challenges are discussed. (author)

Strengthening Regulatory Competence in Pakistan

International Nuclear Information System (INIS)

Sadiq, M.

2016-01-01

Capacity building of Pakistan Nuclear Regulatory Authority is considered an essential element in pursuit of its vision to become a world class regulatory body. Since its inception in 2001, PNRA has continuously endeavoured to invest in its people, develop training infrastructure and impart sound knowledge and professional skills with the aim to improve its regulatory effectiveness. The use of nuclear and radioactive material in Pakistan has increased manifold in recent years, thus induction of more manpower was needed for regulatory oversight. PNRA adopted two pronged approach for meeting the manpower demand (a) employment of university graduates through fast track recruitment drive and (b) induction of graduates by offering fellowships for Master degree programs. Although, the newly employed staff was selected on the basis of their excellent academic qualifications in basic and applied sciences, but they required rigorous knowledge and skills in regulatory perspectives. In order to implement a structured training program, PNRA conducted Training Needs Assessment (TNA) and identified competency gaps of the regulatory staff in legal, technical, regulatory practice and behavioural domains. PNRA took several initiatives for capacity building which included establishment of a training centre for sustainability of trainings, initiation of a fellowship scheme for Master program, attachment of staff at local institutes for on-the-job training and placement at foreign regulatory bodies and organizations for technical development with the assistance of IAEA. The above strategies have been very beneficial in competence building of the PNRA staff to perform all regulatory activities indigenously for nuclear power plants, research reactors and radiation facilities. Provision of vibrant technical support to IAEA and Member States in various programs by PNRA is a landmark of these competence development efforts. This paper summarizes PNRA initiatives and the International Atomic

GENERIC DRUG IN GLOBAL MARKET AND REGULATORY ENVIRONMENT

OpenAIRE

Pankaj Kumar*, Bharti Mangla2, Satbir Singh, Arapna Rana

2017-01-01

Different regulatory authorities regulate the drug development in various countries of the world. Various Regulatory authority for generic drug application Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceutical and Medical Devices Agency (PMDA), Health Product and Food Branch (HPFB) Central Drug Standard of Organization (CDSO). Generic manufacturers may file an abbreviated New Drug Application (ANDA) that incorporates the safety/effectiveness data submitted by ori...

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.

The regulatory control of radioactive sources in Argentina

Energy Technology Data Exchange (ETDEWEB)

Rojkind, Roberto Hector [Autoridade Regulatoria Nuclear, Buenos Aires (Argentina)

1997-12-31

Argentina has been conducting nuclear activities for more than forty years, and as early as in 1956 established a Regulatory Authority. Procedures for compliance monitoring and enforcement have been in use in the regulatory control of radioactive sources, and regulatory standards and regulations had been set in Argentina, before the accident in Goiania. The conclusions drawn from that accident encouraged in Argentina the improvement of some regulatory procedures and helped to enhance the quality of the regulatory process. Therefore, the effectiveness of the control of spent radioactive sources has gradually increased, and enforcement actions to prevent radioactive sources ending up in the public domain improved. Some lessons learned in Argentina from the accident in Goiania and the main characteristics of an effective enforcement program helpful to prevent radiological accidents in industrial, medical, research and teaching uses of radioactive sources are presented. (author) 9 refs; e-mail: rrojkind at sede.arn.gov.br

United States Nuclear Regulatory Commission information digest: 1997 edition. Volume 9

International Nuclear Information System (INIS)

1997-05-01

The Nuclear Regulatory Commission Information Digest (digest) provides a summary of information about the US Nuclear Regulatory Commission (NRC), NRC's regulatory responsibilities, NRC licensed activities, and general information on domestic and world-wide nuclear energy. The digest, published annually, is a compilation of nuclear- and NRC-related data and is designed to provide a quick reference to major facts about the agency and the industry it regulates. In general, the data cover 1975 through 1996, with exceptions noted. Information on generating capacity and average capacity factor for operating US commercial nuclear power reactors is obtained from monthly operating reports that are submitted directly to the NRC by the licensee. This information is reviewed by the NRC for consistency only and no independent validation and/or verification is performed

Worldwide survey of damage from swallowing multiple magnets

Energy Technology Data Exchange (ETDEWEB)

Oestreich, Alan E. [Cincinnati Children' s Hospital Medical Center, Radiology Department 5031, Cincinnati, OH (United States)

2009-02-15

It is increasingly recognized that in children swallowed multiple magnets cause considerable damage to the gastrointestinal tract. To emphasize that complications from swallowed magnets are extensive worldwide and throughout childhood. The author surveyed radiologists and researched cases of magnet swallowing in the literature and documented age and gender, numbers of magnets, nature of the magnets, reasons for swallowing, and clinical course. A total of 128 instances of magnet swallowing were identified, one fatal. Cases from 21 countries were found. Magnet swallowing occurred throughout childhood, with most children older than 3 years of age. Numbers of swallowed magnets ranged up to 100. Twelve children were known to be autistic. Many reasons were given for swallowing magnets, and a wide range of gastrointestinal damage was encountered. Considerable delay before seeking medical assistance was frequent, as was delay before obtaining radiographs or US imaging. Damage from swallowing multiple magnets is a considerable worldwide problem. More educational and preventative measures are needed. (orig.)

Worldwide survey of damage from swallowing multiple magnets

International Nuclear Information System (INIS)

Oestreich, Alan E.

2009-01-01

It is increasingly recognized that in children swallowed multiple magnets cause considerable damage to the gastrointestinal tract. To emphasize that complications from swallowed magnets are extensive worldwide and throughout childhood. The author surveyed radiologists and researched cases of magnet swallowing in the literature and documented age and gender, numbers of magnets, nature of the magnets, reasons for swallowing, and clinical course. A total of 128 instances of magnet swallowing were identified, one fatal. Cases from 21 countries were found. Magnet swallowing occurred throughout childhood, with most children older than 3 years of age. Numbers of swallowed magnets ranged up to 100. Twelve children were known to be autistic. Many reasons were given for swallowing magnets, and a wide range of gastrointestinal damage was encountered. Considerable delay before seeking medical assistance was frequent, as was delay before obtaining radiographs or US imaging. Damage from swallowing multiple magnets is a considerable worldwide problem. More educational and preventative measures are needed. (orig.)

rSNPBase 3.0: an updated database of SNP-related regulatory elements, element-gene pairs and SNP-based gene regulatory networks.

Science.gov (United States)

Guo, Liyuan; Wang, Jing

2018-01-04

Here, we present the updated rSNPBase 3.0 database (http://rsnp3.psych.ac.cn), which provides human SNP-related regulatory elements, element-gene pairs and SNP-based regulatory networks. This database is the updated version of the SNP regulatory annotation database rSNPBase and rVarBase. In comparison to the last two versions, there are both structural and data adjustments in rSNPBase 3.0: (i) The most significant new feature is the expansion of analysis scope from SNP-related regulatory elements to include regulatory element-target gene pairs (E-G pairs), therefore it can provide SNP-based gene regulatory networks. (ii) Web function was modified according to data content and a new network search module is provided in the rSNPBase 3.0 in addition to the previous regulatory SNP (rSNP) search module. The two search modules support data query for detailed information (related-elements, element-gene pairs, and other extended annotations) on specific SNPs and SNP-related graphic networks constructed by interacting transcription factors (TFs), miRNAs and genes. (3) The type of regulatory elements was modified and enriched. To our best knowledge, the updated rSNPBase 3.0 is the first data tool supports SNP functional analysis from a regulatory network prospective, it will provide both a comprehensive understanding and concrete guidance for SNP-related regulatory studies. © The Author(s) 2017. Published by Oxford University Press on behalf of Nucleic Acids Research.

A Comparative Review of Marketing Authorization Decisions in Switzerland, the EU, and the USA.

Science.gov (United States)

Dalla Torre Di Sanguinetto, Simon; Heinonen, Esa; Antonov, Janine; Bolte, Claus

2018-01-01

In this study we compared Swissmedic's (SMC's) regulatory marketing authorization decisions to those of the US Food and Drug Administration (FDA) and European drug regulatory authorities (EU). We investigated the overall similarity of the regulatory decisions, approval, and postmarketing withdrawal rates in the 3 jurisdictions. In case regulatory decisions diverged, we analyzed the reasons for rejection of marketing authorization applications (MAAs). The study comprises 255 new molecular entity (NME) MAAs assessed by SMC by the EU and FDA between 2005 through 2014. Study parameters included the regulatory decision, postmarketing withdrawal rates, and the official reasons for rejection. Regulatory decisions converged to a high degree among all 3 agencies (between 84% and 90%). SMC's average approval rate (84%) was slightly lower than those of the FDA (87%) and the EU (91%). Postmarketing withdrawal rates were generally low (4%-5%) but were 3 to 5 times higher when decisions among the drug regulatory authorities (DRAs) diverged. SMC's primary grounds for rejection were lack of efficacy (45%) and safety (40%). The 3 investigated DRAs adhere largely to the same scientific principles and regulatory guidelines; therefore, remaining disparities ought to be considered in a cultural, legal and public health priority context.

Nuclear regulatory decision making

International Nuclear Information System (INIS)

Wieland, Patricia; Almeida, Ivan Pedro Salati de

2011-01-01

The scientific considerations upon which the nuclear regulations are based provide objective criteria for decisions on nuclear safety matters. However, the decisions that a regulatory agency takes go far beyond granting or not an operating license based on assessment of compliance. It may involve decisions about hiring experts or research, appeals, responses to other government agencies, international agreements, etc.. In all cases, top management of the regulatory agency should hear and decide the best balance between the benefits of regulatory action and undue risks and other associated impacts that may arise, including issues of credibility and reputation. The establishment of a decision framework based on well established principles and criteria ensures performance stability and consistency, preventing individual subjectivity. This article analyzes the challenges to the decision-making by regulatory agencies to ensure coherence and consistency in decisions, even in situations where there is uncertainty, lack of reliable information and even divergence of opinions among experts. The article explores the basic elements for a framework for regulatory decision-making. (author)

Nuclear regulatory decision making

International Nuclear Information System (INIS)

2005-01-01

The fundamental objective of all nuclear safety regulatory bodies is to ensure that nuclear utilities operate their plants at all times in an acceptably safe manner. In meeting this objective, the regulatory body should strive to ensure that its regulatory decisions are technically sound, consistent from case to case, and timely. In addition, the regulator must be aware that its decisions and the circumstances surrounding those decisions can affect how its stakeholders, such as government policy makers, the industry it regulates, and the public, view it as an effective and credible regulator. In order to maintain the confidence of those stakeholders, the regulator should make sure that its decisions are transparent, have a clear basis in law and regulations, and are seen by impartial observers to be fair to all parties. Based on the work of a Nuclear Energy Agency (NEA) expert group, this report discusses some of the basic principles and criteria that a regulatory body should consider in making decisions and describes the elements of an integrated framework for regulatory decision making. (author)

Ethical pharmaceutical promotion and communications worldwide: codes and regulations

Science.gov (United States)

2014-01-01

The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical communication and interaction with physicians and patients. This article presents the current status of the worldwide governance of communication practices by pharmaceutical companies, concentrating on prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms and highlights significant developments, including the 2006 and 2012 revisions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice. Developments in international controls, largely built upon long-established rules relating to the quality of advertising material, have contributed to clarifying the scope of acceptable company interactions with healthcare professionals. This article aims to provide policy makers, particularly in developing countries, with an overview of the evolution of mechanisms governing the communication practices, such as the distribution of promotional or scientific material and interactions with healthcare stakeholders, relating to prescription-only medicines. PMID:24679064

Ethical pharmaceutical promotion and communications worldwide: codes and regulations.

Science.gov (United States)

Francer, Jeffrey; Izquierdo, Jose Zamarriego; Music, Tamara; Narsai, Kirti; Nikidis, Chrisoula; Simmonds, Heather; Woods, Paul

2014-03-29

The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical communication and interaction with physicians and patients. This article presents the current status of the worldwide governance of communication practices by pharmaceutical companies, concentrating on prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms and highlights significant developments, including the 2006 and 2012 revisions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice.Developments in international controls, largely built upon long-established rules relating to the quality of advertising material, have contributed to clarifying the scope of acceptable company interactions with healthcare professionals. This article aims to provide policy makers, particularly in developing countries, with an overview of the evolution of mechanisms governing the communication practices, such as the distribution of promotional or scientific material and interactions with healthcare stakeholders, relating to prescription-only medicines.

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.)

Rationales for regulatory activity

Energy Technology Data Exchange (ETDEWEB)

Perhac, R.M. [Univ. of Tennessee, Knoxville, TN (United States)

1997-02-01

The author provides an outline which touches on the types of concerns about risk evaluation which are addressed in the process of establishing regulatory guides. Broadly he says regulatory activity serves three broad constituents: (1) Paternalism (private risk); (2) Promotion of social welfare (public risks); (3) Protection of individual rights (public risks). He then discusses some of the major issues encountered in reaching a decision on what is an acceptable level of risk within each of these areas, and how one establishes such a level.

International Conference on Effective Nuclear Regulatory Systems: Sustaining Improvements Globally. Book of Abstracts

International Nuclear Information System (INIS)

2016-01-01

The objective of this conference is to review and assess ways of further improving the effectiveness of regulatory systems for nuclear facilities and activities for both nuclear safety and nuclear security. The action items in the summary presented by the President of the conference held in 2013 in Ottawa, the lessons of the Fukushima Daiichi accident, the discussions at other international conferences and at international experts’ meetings conducted within the framework of the IAEA Action Plan on Nuclear Safety, as well as the CNS and the principles outlined in the Vienna Declaration on Nuclear Safety, will continue to have a significant impact on regulatory systems. All the aforementioned need to be taken into account to sustain improvements to regulatory systems. The expected outcomes of the conference are: - Enhanced safety and security of nuclear installations worldwide; - Challenges in regulating radiation sources and radioactive waste addressed; - Enhanced international cooperation for sustaining regulatory effectiveness; - Strengthened and sustained regulatory competence for nuclear safety and security; and - Strategies and actions for the future identified, as well as issues for consideration by governments, regulatory bodies and international organizations.

International nuclear safety experts complete IAEA peer review of German regulatory system

International Nuclear Information System (INIS)

2008-01-01

policies, the regulatory framework and activities identified by the IRRS team were: Both BMU and UM BW have high quality and experienced staff, which are supported by experienced and competent technical support organizations. Both organizations have a high commitment to learning and self improvement; The team has also made recommendations and suggestions related to areas where the regulatory system as a whole could be improved. Examples include: There is room for improving information exchange and communication between the Federal and State regulatory bodies. Such enhanced communication would also lead to increased mutual trust and public confidence. In order to fulfill their regulatory responsibilities, BMU and UM BW should be staffed appropriately and develop a plan for a succession planning strategy. It could be very beneficial for the regulatory system, and helpful for worldwide learning, if all German 'Laender' (states) with nuclear power plants also took the opportunity to benefit from the experience of an IRRS mission, including making self- assessments against international best practice. The peer review consisted of an analysis of technical regulatory information, interviews, and discussions with key personnel at BMU and UM BW, as well as with regulatory inspectors at Neckarwestheim-1 Nuclear Power Plant to witness a regulatory inspection. Regulatory aspects were also discussed with Federal Minister Sigmar Gabriel and Minister Tanja Goenner of Baden-Wuerttemberg. Other organisations such as the Federal Office for Radiation Protection (BFS), the Reactor Safety Commission (RSK), the technical support organisation Gesellschaft fuer Anlagen- und Reaktorsicherheit (GRS), and the Nuclear Safety Standards Commission (ILK) were also involved. (author)

49 CFR 1549.3 - TSA inspection authority.

Science.gov (United States)

2010-10-01

... 49 Transportation 9 2010-10-01 2010-10-01 false TSA inspection authority. 1549.3 Section 1549.3... TSA inspection authority. (a) Each certified cargo screening facility must allow TSA, at any time or....S.C. 114 and Subtitle VII, as amended; or (2) Carry out TSA's statutory or regulatory authorities...

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

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)

Activities relating to PSA in the regulatory process

International Nuclear Information System (INIS)

Campbell, J.F.; Grint, G.C.

1994-01-01

In addition to the IAEA activities concerning the use of PSA in the regulatory process there are two other international initiatives in this area by the European Commission and the OECD's Committee for Nuclear Regulatory Authorities (CRNA). The paper gives a brief outline of these activities as well as introducing an update on the regulatory use of PSA in the UK. 3 refs, 3 tabs

7 CFR 371.5 - Marketing and Regulatory Programs Business Services.

Science.gov (United States)

2010-01-01

... 7 Agriculture 5 2010-01-01 2010-01-01 false Marketing and Regulatory Programs Business Services... AUTHORITY § 371.5 Marketing and Regulatory Programs Business Services. (a) General statement. Marketing and Regulatory Programs Business Services (MRPBS) plans and provides for the agency's human, financial, and...

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

18 CFR 3a.2 - Authority.

Science.gov (United States)

2010-04-01

... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Authority. 3a.2 Section 3a.2 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY GENERAL RULES NATIONAL SECURITY INFORMATION General § 3a.2 Authority. Official information or...

Regulatory challenges related to the licensing of a new nuclear power plant

International Nuclear Information System (INIS)

Maris, M.

2010-01-01

Assuring the safety and security of nuclear power plants is recognized world-wide as a challenge for all stakeholders. Particular attention goes to plants planned to be built in countries with not sufficiently developed industrial and regulatory infrastructure and experience. A construction and commissioning project, which is usually an international undertaking, gives opportunities to all national stakeholders to develop further their organisations and competences. In the present paper the duties of a regulatory body are recalled as well as the human resources and competences needed for the licensing of a new nuclear power plant. The regulatory body and its technical safety organization(s) should be strengthened and the international cooperation should contribute to this in a systematic and coordinated way. In particular, the donor country should support the necessary development of the regulatory competences and of an effective safety assessment process supporting the national licensing process. Appropriate support can be provided by the International Atomic Energy Agency (IAEA) and through other bi-lateral or multi-lateral programmes

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

Regulatory control of maintenance activities in Argentine nuclear power plants

International Nuclear Information System (INIS)

Calvo, J.C.; Caruso, G.

2000-01-01

The main maintenance objective is to assure that the safety features of structures, components and systems of nuclear power plants are kept as designed. Therefore, there is a direct relationship between safety and maintenance. Owing to the above mentioned, maintenance activities are considered a relevant regulatory issue for the Argentine Nuclear Regulatory Authority (ARN). This paper describes the regulatory control to maintenance activities of Argentine nuclear power plants. It also addresses essential elements for maintenance control, routine inspections, special inspections during planned outages, audits and license conditions and requirements. (author)

Developing regulatory approaches

International Nuclear Information System (INIS)

Axelsson, Lars

2012-01-01

Lars Axelsson presented SSM progress on oversight of LMfS/SC since the Chester 1 Workshop in 2007. Current SSM approaches for safety culture oversight include targeted safety management and safety culture inspections, compliance inspections which cover aspects of safety management/safety culture and multi-disciplinary team inspections. Examples of themes for targeted inspections include management of ambiguous operational situations or other weak signals, understanding of and attitudes to Human Performance tools, the Safety Department's role and authority and Leadership for safety. All regulatory activities provide inputs for the SSM yearly safety evaluation of each licensee. A form has been developed to capture safety culture observations from inspections and other interactions with licensees. Analysis will be performed to identify patterns and provide information to support planning of specific Safety Culture activities. Training has been developed for regulatory staff to enhance the quality of regulatory interventions on safety culture. This includes a half-day seminar to provide an overview of safety culture, and a workshop which provides more in-depth discussion on cultural issues and how to capture those during regulatory activities. Future plans include guidance for inspectors, and informal seminars on safety culture with licensees

Establishment of regulatory framework for the development reactor licensing

International Nuclear Information System (INIS)

Jo, Jong C.; Yune, Young G.; Kim, Woong S.; Ahn, Sang K.; Kim, In G.; Kim, Hho J.

2003-01-01

With a trend that various types of advanced reactor designs are currently under development worldwide, the Korea Atomic Energy Research Institute has been developing an advanced reactor called ' System-integrated Modular Advanced Reactor (SMART)', which is a small sized integral type pressurized water reactor with a rated thermal power of 330 MW. To demonstrate the safety and the performance of the SMART reactor design, the SMART Research and Development Center has embarked to build a scaled-down pilot plant of SMART, called 'SMART-P' with a rated thermal power of 65 MW. In preparation for the forthcoming applications for both construction permit and operating license of SMART-P in the near future, the Korea Institute of Nuclear Safety is developing a new regulatory framework for licensing review of such a development reactor, which covers establishment of licensing process, identification and resolution of technical and safety issues, development of regulatory evaluation or verification-purpose computer codes and analytical methods, and establishment of design-specific, general design and operating criteria, regulations, and associated regulatory guides. This paper presents the current activities for establishing a regulatory framework for the licensing of a research and development reactor. Discussions are made on the SMART-P development program, the current Korean regulatory framework for reactor licensing, the SMART-P licensing-related issues, and the approach and strategy for developing an effective regulatory framework for the SMART-P licensing

75 FR 79949 - Revision of Delegation of Authority

Science.gov (United States)

2010-12-21

... Marketing and Regulatory Programs (MRP) to the Deputy Under Secretary for MRP to establish the order in... Marketing and Regulatory Programs (MRP) has delegated to the Deputy Under Secretary for MRP the following... exercise that delegation when the MRP mission area has more than one Deputy Under Secretary. The authority...

Japanese authorities inform IAEA about accident at nuclear plant

International Nuclear Information System (INIS)

2004-01-01

Full text: The IAEA today received information from Japanese nuclear regulatory authorities about an accident in the steam generator turbine circuit of the Mihama Nuclear Power Plant (unit 3). According to the Japanese nuclear authorities this is a non-radioactive part of the plant. The regulatory body has reported that four contract employees died and 7 were injured, and stated that there was no release of radioactivity. The IAEA continues to be in contact with Japanese authorities and expects to receive updates on a continuous basis. No request for IAEA assistance has been received at this time. (IAEA)

Status of research reactor spent fuel world-wide

International Nuclear Information System (INIS)

Ritchie, I.G.

2004-01-01

Results compiled in the research reactor spent fuel database are used to assess the status of research reactor spent fuel world-wide. Fuel assemblies, their types, enrichment, origin of enrichment and geological distribution among the industrialised and developed countries of the world are discussed. Fuel management practices in wet and dry storage facilities and the concerns of reactor operators about long-term storage of their spent fuel are presented and some of the activities carried out by the International Atomic Energy Agency to address the issues associated with research reactor spent fuel are outlined. (author)

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)

Cost-benefit and regulatory decision making

International Nuclear Information System (INIS)

Harvie, J.

1996-01-01

The Atomic Energy Control Board is investigating the feasibility of developing methods for factoring cost-benefit considerations into its regulatory decision-making. This initiative results, in part, from the federal government policy requiring cost-benefit considerations to be taken into account in regulatory processes, and from the recommendations of an Advisory Panel on Regulatory Review in 1993, submitted to the Minister of Natural Resources Canada. One of these recommendations stated: 'that mechanisms be developed to examine cost benefit issues and work towards some consensus of opinion among stake holders: a task force on the subject could be an appropriate starting point'. (author)

Dismantlement of nuclear facilities decommissioned from the Russian navy: Enhancing regulatory supervision of nuclear and radiation safety

International Nuclear Information System (INIS)

Sneve, M.K.

2013-01-01

The availability of up to date regulatory norms and standards for nuclear and radiation safety, relevant to the management of nuclear legacy situations, combined with effective and efficient regulatory procedures for licensing and monitoring compliance, are considered to be extremely important. Accordingly the NRPA has set up regulatory cooperation programs with corresponding authorities in the Russian Federation. Cooperation began with the civilian regulatory authorities and was more recently extended to include the military authority and this joint cooperation supposed to develop the regulatory documents to improve supervision over nuclear and radiation safety while managing the nuclear military legacy facilities in Northwest Russia and other regions of the country. (Author)

Dismantlement of nuclear facilities decommissioned from the Russian navy: Enhancing regulatory supervision of nuclear and radiation safety

Energy Technology Data Exchange (ETDEWEB)

Sneve, M.K.

2013-03-01

The availability of up to date regulatory norms and standards for nuclear and radiation safety, relevant to the management of nuclear legacy situations, combined with effective and efficient regulatory procedures for licensing and monitoring compliance, are considered to be extremely important. Accordingly the NRPA has set up regulatory cooperation programs with corresponding authorities in the Russian Federation. Cooperation began with the civilian regulatory authorities and was more recently extended to include the military authority and this joint cooperation supposed to develop the regulatory documents to improve supervision over nuclear and radiation safety while managing the nuclear military legacy facilities in Northwest Russia and other regions of the country. (Author)

Intended and unintended consequences of a publish-or-perish culture: a worldwide survey

NARCIS (Netherlands)

van Dalen, H.P.; Henkens, C.J.I.M.

2012-01-01

How does publication pressure in modern-day universities affect the intrinsic and extrinsic rewards in science? By using a worldwide survey among demographers in developed and developing countries, the authors show that the large majority perceive the publication pressure as high, but more so in

World-wide environmental problems

International Nuclear Information System (INIS)

Wohlers, H.C.

1975-01-01

Man and the physical and natural resources necessary to support him in a civilized society are on a collision course. It is simple to say that man cannot continue to grow in number at an ever-increasing rate without a destructive effect upon the environment. Positive scientific proof for this impending calamity is not now available, yet many indications--sometimes physical and sometimes natural--point toward major world-wide environmental troubles in the near future. A number of environmental problems are described, particularly as they relate to the total world system. A computer model simulating future world-wide environmental trends from 1900 to 2100 A.D. is evaluated and suggested as a major tool for data-gathering purposes to determine the extent of world-wide environmental problems. It is suggested that scientists take an active role in the study of the environment, particularly in relation to man's future on earth

Worldwide Spacecraft Crew Hatch History

Science.gov (United States)

Johnson, Gary

2009-01-01

The JSC Flight Safety Office has developed this compilation of historical information on spacecraft crew hatches to assist the Safety Tech Authority in the evaluation and analysis of worldwide spacecraft crew hatch design and performance. The document is prepared by SAIC s Gary Johnson, former NASA JSC S&MA Associate Director for Technical. Mr. Johnson s previous experience brings expert knowledge to assess the relevancy of data presented. He has experience with six (6) of the NASA spacecraft programs that are covered in this document: Apollo; Skylab; Apollo Soyuz Test Project (ASTP), Space Shuttle, ISS and the Shuttle/Mir Program. Mr. Johnson is also intimately familiar with the JSC Design and Procedures Standard, JPR 8080.5, having been one of its original developers. The observations and findings are presented first by country and organized within each country section by program in chronological order of emergence. A host of reference sources used to augment the personal observations and comments of the author are named within the text and/or listed in the reference section of this document. Careful attention to the selection and inclusion of photos, drawings and diagrams is used to give visual association and clarity to the topic areas examined.

World-wide trend of long-lived radionuclides transmutation studies

International Nuclear Information System (INIS)

Kim, Young Hwan; Lee, Il Hee; Yoo, Jae Hyung

1997-01-01

The objective of this study is to review the concepts of partitioning and transmutation studies which are being conducted in several countries. This review was focused on the analysis of such areas as radiotoxicities of radwaste containing long-lived radionuclides, transmutation by reactors or accelerators, and separation of minor actinides. The world-wide trend of partitioning and transmutation studies was also investigated on the basis of each country's R and D activities in this area. (author). 5 refs., 4 tabs., 3 figs

Regulatory agencies and regulatory risk

OpenAIRE

Knieps, Günter; Weiß, Hans-Jörg

2008-01-01

The aim of this paper is to show that regulatory risk is due to the discretionary behaviour of regulatory agencies, caused by a too extensive regulatory mandate provided by the legislator. The normative point of reference and a behavioural model of regulatory agencies based on the positive theory of regulation are presented. Regulatory risk with regard to the future behaviour of regulatory agencies is modelled as the consequence of the ex ante uncertainty about the relative influence of inter...

A critical assessment of regulatory triggers for products of biotechnology: Product vs. process

Science.gov (United States)

McHughen, Alan

2016-01-01

ABSTRACT Regulatory policies governing the safety of genetic engineering (rDNA) and the resulting products (GMOs) have been contentious and divisive, especially in agricultural applications of the technologies. These tensions led to vastly different approaches to safety regulation in different jurisdictions, even though the intent of regulations—to assure public and environmental safety—are common worldwide, and even though the international scientific communities agree on the basic principles of risk assessment and risk management. So great are the political divisions that jurisdictions cannot even agree on the appropriate triggers for regulatory capture, whether product or process. This paper reviews the historical policy and scientific implications of agricultural biotechnology regulatory approaches taken by the European Union, USA and Canada, using their respective statutes and regulations, and then critically assesses the scientific underpinnings of each. PMID:27813691

Nuclear materials transport worldwide

International Nuclear Information System (INIS)

Stellpflug, J.

1987-01-01

This Greenpeace report shows: nuclear materials transport is an extremely hazardous business. There is no safe protection against accidents, kidnapping, or sabotage. Any moment of a day, at any place, a nuclear transport accident may bring the world to disaster, releasing plutonium or radioactive fission products to the environment. Such an event is not less probable than the MCA at Chernobyl. The author of the book in hand follows the secret track of radioactive materials around the world, from uranium mines to the nuclear power plants, from reprocessing facilities to the waste repositories. He explores the routes of transport and the risks involved, he gives the names of transport firms and discloses incidents and carelessness, tells about damaged waste drums and plutonium that 'disappeared'. He also tells about worldwide, organised resistance to such nuclear transports, explaining the Greenpeace missions on the open sea, or the 'day X' operation at the Gorleben site, informing the reader about protests and actions for a world freed from the threat of nuclear energy. (orig./HP) [de

Regulatory challenges faced first Indonesia NPPs by independent TSOs

International Nuclear Information System (INIS)

Sri Budi Utami

2010-01-01

Technical and scientific support organizations (TSOs) dedicated to supporting national regulatory authorities. At present BAPETEN has internal TSOs. Pertaining to the regulatory control of nuclear safety, security, and safeguards for nuclear power plants (NPPs), independent TSOs providing support to the safety regulatory bodies are facing a number of technical challenges to ensuring the safety of NPPs. It is essential that BAPETEN need independent TSOs in order to warrant a sufficient level of safety, security and non proliferation in building and operating of first NPP. It is essential that BAPETEN need independent TSOs in order to warrant a sufficient level of safety, security and non proliferation in building and operating of first NPPs. (author)

Regulatory frameworks for decentralised energy

International Nuclear Information System (INIS)

Woodman, Bridget; Baker, Philip

2008-01-01

This paper considers aspects of the current regulatory frameworks for markets and infrastructure which can inhibit the deployment of decentralised energy. The government has stated that decentralised energy can make a positive contribution to reducing the UK's carbon emissions, but recognises that at the moment the technologies face market and regulatory barriers. If it is to become a viable alternative to centralised generation, energy market design and the regulation of energy infrastructure will have to evolve to ensure that decentralised options are no longer locked out. (author)

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.

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.

Recent regulatory issues in Finland

International Nuclear Information System (INIS)

Laaksonen, J.; Tiipana, P.

2001-01-01

This paper presents general regulatory issues from Finland since the last WWER Regulators Forum meeting in Odessa 11-13 October 2000. More specific issues concerning Loviisa NPP are described in the Annex of this paper. (author)

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.)

Interchangeability of biosimilar and biological reference product: updated regulatory positions and pre- and post-marketing evidence.

Science.gov (United States)

Trifirò, Gianluca; Marcianò, Ilaria; Ingrasciotta, Ylenia

2018-03-01

Since 2006, biosimilars have been available in several countries worldwide, thus allowing for potential savings in pharmaceutical expenditure. However, there have been numerous debates about the interchangeability of biosimilars and reference products based on concerns of immunogenicity by switching between biological products, which may cause lack of effect and toxicity. Areas covered: The authors provide the reader with an overview of the different positions of regulatory authorities on the interchangeability and automatic substitution of biosimilars and reference products. Presently, the FDA allows automatic substitution without prescriber intervention if the biosimilar is interchangeable with reference products, while the European Medicines Agency delegate to each single EU member state. Expert opinion: Different approaches in defining interchangeability and automatic substitution call for harmonization to increase confidence of healthcare professionals and patients about the clinical impact of switching. Networks of electronic healthcare records and administrative databases, potentially linkable to clinical charts and registries may rapidly assess frequency and benefit-risk profile of different switching patterns in routine care at different levels, thus integrating and strengthening pre-marketing evidence.

Regulatory review of probabilistic safety assessment (PSA) Level 2

International Nuclear Information System (INIS)

2001-07-01

Probabilistic safety assessment (PSA) is increasingly being used as part of the decision making process to assess the level of safety of nuclear power plants. The methodologies in use are maturing and the insights gained from the PSAs are being used along with those from deterministic analysis. Many regulatory authorities consider the current state of the art in PSA to be sufficiently well developed for results to be used centrally in the regulatory decision making process-referred to as risk informed regulation. For these applications to be successful, it will be necessary for the regulatory authority to have a high degree of confidence in the PSA. However, at the 1994 IAEA Technical Committee Meeting on Use of PSA in the Regulatory Process and at the OECD Nuclear Energy Agency Committee for Nuclear Regulatory Activities (CNRA) 'Special Issues' meeting in 1997 on Review Procedures and Criteria for Different Regulatory Applications of PSA, it was recognized that formal regulatory review guidance for PSA did not exist. The senior regulators noted that there was a need to produce some international guidance for reviewing PSAs to establish an agreed basis for assessing whether important technological and methodological issues in PSAs are treated adequately and to verify that conclusions reached are appropriate. In 1997, the IAEA and OECD Nuclear Energy Agency agreed to produce, in cooperation, guidance on Regulatory Review of PSA. This led to the publication of IAEA-TECDOC-1135 on the Regulatory Review of Probabilistic Safety Assessment (PSA) Level 1, which gives advice for the review of Level 1 PSA for initiating events occurring at power plants. This TECDOC extends the coverage to address the regulatory review of Level 2 PSA.These publications are intended to provide guidance to regulatory authorities on how to review the PSA for a nuclear power plant to gain confidence that it has been carried out to an acceptable level of quality so that it can be used as the

The Role of Advisory Committees on Regulatory functions: Argentine Experience

International Nuclear Information System (INIS)

Larcher, A. M.; Arias, C.; Kunst, J. J.; Perez, R. M.; Rudelli, M.

2004-01-01

The Argentine Nuclear Regulatory Authority (NRA) has appointed a consultants body that advises its Board of Directors on aspects related to authorization's granting to individuals for the use of radioisotopes and ionizing radiation in medicine, research and industry. Such committee, whose existence goes back to the year 1958, is integrated by prominent professionals knowledgeable about ionizing radiation and radioisotopes applications in the medical, biomedical and industrial fields, representing important professional associations or institutions related to the practices in question. Originally, the committee was conceived as a consultation body to fulfil two important functions: To produce, in a regular way, authorized opinions at experts level to settle down questions relative to the regulation of practices, new at that time in the country, and To submit to a peer review applications for individual authorization for different uses of ionizing radiation previously it's granting by the Regulatory Authority. In this paper the role of the advisory council is analyzed from a historical perspective trying to emphasize an outstanding aspect not sufficiently analyzed linked to the capability that advisory bodies, with representative users' presence, can reach in the interpretation of regulatory standards based on a performance philosophy. Such approach outlines the permanent dilemma about the performance level of the licensee that should satisfy the Regulatory Authority. Once the broad objectives of radiation protection has been defined professional criteria is required for applying them to different practices. Balance between flexibility and avoidance of excessive uncertainty is desirable. In the authors' opinion the inclusion, inside the regulator's structure of consultants bodies giving direct participation to qualified stakeholders, far from harming the necessary independence that should characterize the regulator, on the contrary, allows to have an excellent social

Evaluation of NORM in facility Venezuelan oil industry to establish regulatory criteria

International Nuclear Information System (INIS)

Acevedo Lozada, D. J.; Rivas, I.; Davila, L.; Flores, Y.

2013-01-01

The present work shows the need to identify, in the Venezuelan oil industry, the existence of exposure to natural sources of radiation should be considered as occupational. As Regulatory Authority in the area of ionizing radiation the need for regulatory processes and ensure radiation protection of personnel involved in these practices arises, as well as personal and environmental monitoring. NORM identifying an installation of the Venezuelan oil industry to establish regulatory processes and take steps to ensure occupational radiation protection. (Author)

Pesticide authorization in the EU-environment unprotected?

Science.gov (United States)

Stehle, Sebastian; Schulz, Ralf

2015-12-01

Pesticides constitute an integral part of high-intensity European agriculture. Prior to their authorization, a highly elaborated environmental risk assessment is mandatory according to EU pesticide legislation, i.e., Regulation (EC) No. 1107/2009. However, no field data-based evaluation of the risk assessment outcome, i.e., the regulatory acceptable concentrations (RACs), and therefore of the overall protectiveness of EU pesticide regulations exists. We conducted here a comprehensive meta-analysis using peer-reviewed literature on agricultural insecticide concentrations in EU surface waters and evaluated associated risks using the RACs derived from official European pesticide registration documents. As a result, 44.7 % of the 1566 cases of measured insecticide concentrations (MICs) in EU surface waters exceeded their respective RACs. It follows that current EU pesticide regulations do not protect the aquatic environment and that insecticides threaten aquatic biodiversity. RAC exceedances were significantly higher for insecticides authorized using conservative tier-I RACs and for more recently developed insecticide classes, i.e., pyrethroids. In addition, we identified higher risks, e.g., for smaller surface waters that are specifically considered in the regulatory risk assessment schemes. We illustrate the shortcomings of the EU regulatory risk assessment using two case studies that contextualize the respective risk assessment outcomes to field exposure. Overall, our meta-analysis challenges the field relevance and protectiveness of the regulatory environmental risk assessment conducted for pesticide authorization in the EU and indicates that critical revisions of related pesticide regulations and effective mitigation measures are urgently needed to substantially reduce the environmental risks arising from agricultural insecticide use.

Regulatory review of probabilistic safety assessment (PSA) level 1

International Nuclear Information System (INIS)

2000-02-01

Probabilistic safety assessment (PSA) is increasingly being used as part of the decision making process to assess the level of safety of nuclear power plants. The methodologies in use are maturing and the insights gained from the PSAs are being used along with those from the deterministic analysis. Many regulatory authorities consider that the current state of the art in PSA (especially Level 1 PSA) is sufficiently well developed that it can be used centrally in the regulatory decision making process - referred to as 'risk informed regulation'. For these applications to be successful, it will be necessary for regulatory authorities to have a high degree of confidence in PSA. However, at the IAEA Technical Committee Meeting on Use of PSA in the Regulatory Process in 1994 and at the OECD Nuclear Energy Agency Committee for Nuclear Regulatory Activities (CNRA) 'Special Issues' Meeting in 1997 on Review Procedures and Criteria for Different Regulatory Applications of PSA, it was recognized that formal regulatory review guidance for PSA did not exist. The senior regulators noted that there was a need to produce some international guidance for reviewing PSAs to establish an agreed basis for assessing whether important technological and methodological issues in PSAs are treated adequately and to verify that conclusions reached are appropriate. In 1997 the IAEA and OECD Nuclear Energy Agency agreed to produce in co-operation a technical document on the regulatory review of PSA. This publication is intended to provide guidance to regulatory authorities on how to review the PSA for a nuclear power plant to gain confidence that it has been carried out to an acceptable standard so that it can be used as the basis for taking risk informed decisions within a regulatory decision making process. The document gives guidance on how to set about reviewing a PSA and on the technical issues that need to be addressed. This publication gives guidance for the review of Level 1 PSA for

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

Distributed load shedding: A new industrial technique, born in France, is going to contribute worldwide to a fairer transition in energy

International Nuclear Information System (INIS)

Bivas, Pierre

2013-01-01

Owing to the possibility of steering demand so as to help maintain an equilibrium on the electricity grid, distributed load shedding is a new activity with worldwide outreach. It will help us save up to 15% of energy by eliminating wastage - at no cost to consumers or taxpayers. It is profitable if we take into account the savings made for the grid as a whole in terms of energy and avoided investments. Suppliers oppose it, since they seek to sell more energy at a higher price. They even pretend that they want to take up this activity in spite of years of foot-dragging on this technology and an evident conflict of interests. Nonetheless, the regulatory framework is being set up with courageous, lucid support from public authorities. This technique, created by Voltalis in Europe, promises savings for the seven million all-electric households (many of them low-income) in France. It will directly create thousands of jobs. This technological, environmental and social innovation is evidence of the turn toward a fair energy transition made by France

Analysis for making a regulatory decision to equipment of industrial gammagraphy in Argentin

International Nuclear Information System (INIS)

Ermacora, Marcela G.; Vidal, Dora N.; Alonso, Maria T.

2013-01-01

Industrial gammagraphy is a practice widely used as a nondestructive testing technique in Argentina. Experience worldwide has shown the need for an improvement in the intrinsic safety of the equipment used in this lab. In response to this reason, the board of the Nuclear Regulatory Authority (ARN) has considered a proposal to withdraw service movement and much of the equipment inventory scan belonging to industrial facilities nationwide. The main objective of this paper is to present the results of the analysis performed to support the above proposal. The main elements of evaluation can be summarized as follows: I) the teams that do not conform to international recommendations regarding compliance with key safety requirements of international standards such as ISO 3999:2004 (E) R adiation protection - Industrial Apparatus for gamma radiography - Specifications for performance, design and tests ; II) the decision by some manufacturers to discontinue production of certain models of equipment and the provision of spare parts, and III) the validity of certificates bulk type B (U) for transport. In conclusion, it highlights the importance of a regulatory decision supplementary to the Standard AR 7.9.1 concerning the operation of scan equipment industry, based on current international recommendations and Argentina's commitment to good practice and safety culture which can lead to a positive impact on radiation safety in this art

Worldwide prevalence and incidence of osteoporotic vertebral fractures.

Science.gov (United States)

Ballane, G; Cauley, J A; Luckey, M M; El-Hajj Fuleihan, G

2017-05-01

We investigated the prevalence and incidence of vertebral fractures worldwide. We used a systematic Medline search current to 2015 and updated as per authors' libraries. A total of 62 articles of fair to good quality and comparable methods for vertebral fracture identification were considered. The prevalence of morphometric vertebral fractures in European women is highest in Scandinavia (26%) and lowest in Eastern Europe (18%). Prevalence rates in North America (NA) for White women ≥50 are 20-24%, with a White/Black ratio of 1.6. Rates in women ≥50 years in Latin America are overall lower than Europe and NA (11-19%). In Asia, rates in women above ≥65 are highest in Japan (24%), lowest in Indonesia (9%), and in the Middle East, Lebanon, rates are 20%. The highest-lowest ratio between countries, within and across continents, varied from 1.4-2.6. Incidence data is less abundant and more heterogeneous. Age-standardized rates in studies combining hospitalized and ambulatory vertebral fractures are highest in South Korea, USA, and Hong Kong and lowest in the UK. Neither a North-South gradient nor a relation to urbanization is evident. Conversely, the incidence of hospitalized vertebral fractures in European patients ≥50 shows a North-South gradient with 3-3.7-fold variability. In the USA, rates in Whites are approximately 4-fold higher than in Blacks. Vertebral fractures variation worldwide is lower than observed with hip fractures, and some of highest rates are unexpectedly from Asia. Better quality representative studies are needed. We investigate the occurrence of vertebral fractures, worldwide, using published data current until the present. Worldwide, the variation in vertebral fractures is lower than observed for hip fractures. Some of the highest rates are from North America and unexpectedly Asia. The highest-lowest ratio between countries, within and across continents, varied from 1.4-2.6. Better quality representative data is needed.

The nuclear regulatory process in Canada experience and possible future direction

International Nuclear Information System (INIS)

Sainsbury, J.D.

1987-01-01

The underlying principle in the Canadian licensing process is that the licensee (owner/operatopr) bears the responsibility for safety while the regulatory authority sets safety objectives and audits their achievement. As a consequence, Canadian Regulatory Requirements emphasize numerical safety goals, and minimize specific design or operational rules. This paper traces the evolution of this approach, and indicates direction for the future. (author)

Performance as a basic regulatory rule

International Nuclear Information System (INIS)

Spano, F.; Rudelli, M.D.; Telleria, D.M.

1998-01-01

In Argentina, the Nuclear Regulatory Authority has been sustained, from beginning by a normative system whose fundamental features are its requirements for performance. The Authority has defined indicators for carrying out the classification of practices as major o minor. (As a function of the complexity of processes and operation, equipment, associate risks and type of consequences, etc.). An example is given base on the requirements of standards related with the practice of gammagraphy in Argentina. From the Authority records we know that the effective dose of operators registered do not exceed 5 mSv per year. The associate risk is lower than 2 10 -4 per year. Risk assessment in scenarios resulting in a potential exposure, taken into account the Argentine standards gives a total risk per year in the order of 10 -4 for workers and 4 10 -5 for members of the public. The contents and requirements of system that sustains the regulatory authority can be prescriptive or just based in performance. A decision in favour of one of them should not only reflect the technical-scientific reality of the country implementing it but also other factors like social and economic issues. (author)

ATMPs for Cancer Immunotherapy: A Regulatory Overview.

Science.gov (United States)

Galli, Maria Cristina

2016-01-01

This chapter discusses European regulatory requirements for development of advanced therapy medicinal products (ATMP) for cancer immunotherapy approaches, describing the framework for clinical trials and for marketing authorization.Regulatory critical issues and challenges for developing ATMP are also discussed, with focus on potency determination, long-term follow-up, comparability, and insertional mutagenesis issues. Some of the most critical features of GMP application to ATMP are also described.

Worldwide Airfield Summary

Data.gov (United States)

National Oceanic and Atmospheric Administration, Department of Commerce — The Worldwide Airfield Summary contains a selection of climatological data produced by the U.S. Air Force, Air Weather Service. The reports were compiled from dozens...

Establishing a regulatory value chain model: An innovative approach to strengthening medicines regulatory systems in resource-constrained settings.

Science.gov (United States)

Chahal, Harinder Singh; Kashfipour, Farrah; Susko, Matt; Feachem, Neelam Sekhri; Boyle, Colin

2016-05-01

Medicines Regulatory Authorities (MRAs) are an essential part of national health systems and are charged with protecting and promoting public health through regulation of medicines. However, MRAs in resource-constrained settings often struggle to provide effective oversight of market entry and use of health commodities. This paper proposes a regulatory value chain model (RVCM) that policymakers and regulators can use as a conceptual framework to guide investments aimed at strengthening regulatory systems. The RVCM incorporates nine core functions of MRAs into five modules: (i) clear guidelines and requirements; (ii) control of clinical trials; (iii) market authorization of medical products; (iv) pre-market quality control; and (v) post-market activities. Application of the RVCM allows national stakeholders to identify and prioritize investments according to where they can add the most value to the regulatory process. Depending on the economy, capacity, and needs of a country, some functions can be elevated to a regional or supranational level, while others can be maintained at the national level. In contrast to a "one size fits all" approach to regulation in which each country manages the full regulatory process at the national level, the RVCM encourages leveraging the expertise and capabilities of other MRAs where shared processes strengthen regulation. This value chain approach provides a framework for policymakers to maximize investment impact while striving to reach the goal of safe, affordable, and rapidly accessible medicines for all.

Cost-benefit considerations in regulatory decision-making

International Nuclear Information System (INIS)

Harvie, J.D.

1996-01-01

The Atomic Energy Control Board is investigating the feasibility of developing methods for factoring cost-benefit considerations into its regulatory decision-making. This initiative results, in part, from the federal government policy requiring cost-benefit considerations to be taken into account in regulatory processes, and from the recommendations of an Advisory Panel on Regulatory Review in 1993, submitted to the Minister of Natural Resources Canada. One of these recommendations stated: 'that mechanisms be developed to examine cost-benefit issues and work towards some consensus of opinion among stakeholders; a task force on the subject could be an appropriate starting point'. (author)

Transparency of nuclear regulatory activities

International Nuclear Information System (INIS)

2007-01-01

One of the main missions of nuclear regulators is to protect the public, and this cannot be completely achieved without public confidence. The more a regulatory process is transparent, the more such confidence will grow. Despite important cultural differences across countries, a number of common features characterise media and public expectations regarding any activity with an associated risk. A common understanding of transparency and main stakeholders' expectations in the field of nuclear safety were identified during this workshop, together with a number of conditions and practices aimed at improving the transparency of nuclear regulatory activities. These conditions and practices are described herein, and will be of particular interest to all those working in the nuclear regulatory field. Their implementation may, however, differ from one country to another depending on national context. (authors)

Worldwide Mycotoxins Exposure in Pig and Poultry Feed Formulations

Directory of Open Access Journals (Sweden)

Philippe Guerre

2016-11-01

Full Text Available The purpose of this review is to present information about raw materials that can be used in pig and poultry diets and the factors responsible for variations in their mycotoxin contents. The levels of mycotoxins in pig and poultry feeds are calculated based on mycotoxin contamination levels of the raw materials with different diet formulations, to highlight the important role the stage of production and the raw materials used can have on mycotoxins levels in diets. Our analysis focuses on mycotoxins for which maximum tolerated levels or regulatory guidelines exist, and for which sufficient contamination data are available. Raw materials used in feed formulation vary considerably depending on the species of animal, and the stage of production. Mycotoxins are secondary fungal metabolites whose frequency and levels also vary considerably depending on the raw materials used and on the geographic location where they were produced. Although several reviews of existing data and of the literature on worldwide mycotoxin contamination of food and feed are available, the impact of the different raw materials used on feed formulation has not been widely studied.

Worldwide Mycotoxins Exposure in Pig and Poultry Feed Formulations.

Science.gov (United States)

Guerre, Philippe

2016-11-24

The purpose of this review is to present information about raw materials that can be used in pig and poultry diets and the factors responsible for variations in their mycotoxin contents. The levels of mycotoxins in pig and poultry feeds are calculated based on mycotoxin contamination levels of the raw materials with different diet formulations, to highlight the important role the stage of production and the raw materials used can have on mycotoxins levels in diets. Our analysis focuses on mycotoxins for which maximum tolerated levels or regulatory guidelines exist, and for which sufficient contamination data are available. Raw materials used in feed formulation vary considerably depending on the species of animal, and the stage of production. Mycotoxins are secondary fungal metabolites whose frequency and levels also vary considerably depending on the raw materials used and on the geographic location where they were produced. Although several reviews of existing data and of the literature on worldwide mycotoxin contamination of food and feed are available, the impact of the different raw materials used on feed formulation has not been widely studied.

Intended and unintended consequences of a publish-or-perish culture : A world-wide survey

NARCIS (Netherlands)

van Dalen, H.P.; Henkens, C.J.I.M.

2012-01-01

How does publication pressure in modern-day universities affect the intrinsic and extrinsic rewards in science? By using a worldwide survey among demographers in developed and developing countries, the authors show that the large majority perceive the publication pressure as high, but more so in

Categorization and selection of regulatory approaches for nuclear power plants

International Nuclear Information System (INIS)

Sugaya, Junko; Harayama, Yuko

2009-01-01

Several new regulatory approaches have been introduced to Japanese nuclear safety regulations, in which a prescriptive and deterministic approach had traditionally predominated. However, the options of regulatory approaches that can possibly be applied to nuclear safety regulations as well as the methodology for selecting the options are not systematically defined. In this study, various regulatory approaches for nuclear power plants are categorized as prescriptive or nonprescriptive, outcome-based or process-based, and deterministic or risk-informed. 18 options of regulatory approaches are conceptually developed and the conditions for selecting the appropriate regulatory approaches are identified. Current issues on nuclear regulations regarding responsibilities, transparency, consensus standards and regulatory inspections are examined from the viewpoints of regulatory approaches to verify usefulness of the categorization and selection concept of regulatory approaches. Finally, some of the challenges at the transitional phase of regulatory approaches are discussed. (author)

Regulatory review of safety cases and safety assessments - associated challenges

International Nuclear Information System (INIS)

Bennett, D.G.; Ben Belfadhel, M.; Metcalf, P.E.

2006-01-01

Regulatory reviews of safety cases and safety assessments are essential for credible decision making on the licensing or authorization of radioactive waste disposal facilities. Regulatory review also plays an important role in developing the safety case and in establishing stakeholders' confidence in the safety of the facility. Reviews of safety cases for radioactive waste disposal facilities need to be conducted by suitably qualified and experienced staff, following systematic and well planned review processes. Regulatory reviews should be sufficiently comprehensive in their coverage of issues potentially affecting the safety of the disposal system, and should assess the safety case against clearly established criteria. The conclusions drawn from a regulatory review, and the rationale for them should be reproducible and documented in a transparent and traceable way. Many challenges are faced when conducting regulatory reviews of safety cases. Some of these relate to issues of project and programme management, and resources, while others derive from the inherent difficulties of assessing the potential long term future behaviour of engineered and environmental systems. The paper describes approaches to the conduct of regulatory reviews and discusses some of the challenges faced. (author)

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

Worldwide variance in the potential utilization of Gamma Knife radiosurgery.

Science.gov (United States)

Hamilton, Travis; Dade Lunsford, L

2016-12-01

OBJECTIVE The role of Gamma Knife radiosurgery (GKRS) has expanded worldwide during the past 3 decades. The authors sought to evaluate whether experienced users vary in their estimate of its potential use. METHODS Sixty-six current Gamma Knife users from 24 countries responded to an electronic survey. They estimated the potential role of GKRS for benign and malignant tumors, vascular malformations, and functional disorders. These estimates were compared with published disease epidemiological statistics and the 2014 use reports provided by the Leksell Gamma Knife Society (16,750 cases). RESULTS Respondents reported no significant variation in the estimated use in many conditions for which GKRS is performed: meningiomas, vestibular schwannomas, and arteriovenous malformations. Significant variance in the estimated use of GKRS was noted for pituitary tumors, craniopharyngiomas, and cavernous malformations. For many current indications, the authors found significant variance in GKRS users based in the Americas, Europe, and Asia. Experts estimated that GKRS was used in only 8.5% of the 196,000 eligible cases in 2014. CONCLUSIONS Although there was a general worldwide consensus regarding many major indications for GKRS, significant variability was noted for several more controversial roles. This expert opinion survey also suggested that GKRS is significantly underutilized for many current diagnoses, especially in the Americas. Future studies should be conducted to investigate health care barriers to GKRS for many patients.

Challenges in Establishing New Regulatory Body in Sri Lanka

International Nuclear Information System (INIS)

Hikkaduwa Liyanage, A.R.

2016-01-01

Sri Lanka's involvement with Nuclear Science and Technology began in 1957 when it became a member of the International Atomic Energy Agency. This was followed by the establishment of the Radioisotope Centre of the University of Colombo in 1962 and the establishment of the Atomic Energy Authority (AEA) in 1969 by the Atomic Energy Authority Act no. 19 of 1969. The Atomic Energy Authority Act delegated two main responsibilities to the AEA, namely, promotion of the utilization of nuclear technology for the benefit of the people of Sri Lanka, and protection of workers engaged in using radiation and radioisotopes and the public from harmful effects of ionizing radiation. Until 2014, the Atomic Energy Authority functioned as the national regulatory authority on use of radiation and radioisotopes, the national organization responsible for facilitating the use of nuclear technology in medical, industrial and agricultural sectors and as the focal point of the International Atomic Energy Agency in Sri Lanka. With the expansion of uses of radiation in Sri Lanka and commencement of use of high activity sources by the AEA for development and business activities, the need for an independent regulatory authority was realized. The importance of establishment of independent regulatory body for Sri Lanka was also emphasized by the IAEA in several advisory missions conducted in Sri Lanka and as results; a new Act on Atomic Energy was promulgated.

Worldwide status of energy standards for buildings: Appendices

Energy Technology Data Exchange (ETDEWEB)

Janda, K.B.; Busch, J.F.

1993-02-01

This informal survey was designed to gain information about the worldwide status of energy efficiency standards for buildings, particularly non-residential buildings such as offices, schools, and hotels. The project has three goals: 1. To understand and learn from the experience of countries with existing building energy standards; 2. To locate areas where these lessons might be applied and energy standards might be effectively proposed and developed; and 3. To share the information gathered with all participating countries. These appendices include the survey cover letter, the survey, and the details of selected energy standards in 35 countries, thus providing supporting material for the authors` article of the same title.

AREVA’s Containment Venting Technologies and Experience Worldwide

Energy Technology Data Exchange (ETDEWEB)

Welker, M.

2015-07-01

The AREVA Filtered Containment Venting System (FCVS) is a product family that minimizes the environmental impact in case of a severe accident in a nuclear power plant (NPP). Our experience is based on a large-scale test and qualification program as well as on the design, licensing and installation of more than 80 projects worldwide. The product family provides flexibility regarding the adaptation to respective accident scenarios, applicable codes and standards, seismic design, supply chain, implementation and localization. AREVA has broad experience of managing fleet supplies, successful support of licensing and cooperating with original equipment manufacturers (OEMs) of pressurized and boiling water reactors (PWR and BWR). (Author)

Regulatory control, nuclear safety regulation and waste management in Spain

International Nuclear Information System (INIS)

Martin, A.

2000-01-01

This article presents the challenges that faces the spanish regulatory authority. The deregulation of electricity industry imposes severe changes in nuclear power economics and forces nuclear power to compete with other sources of electricity. A pressure is perceived for regulatory effectiveness primarily since the cost of regulation is a component of the cost of the product. This effectiveness gain in regulatory control will be reached through systematic strategic analysis, formulation and implementation. The regulatory aspects of plant life extension and of waste management are examined

Evolution of nuclear security regulatory activities in Brazil

International Nuclear Information System (INIS)

Mello, Luiz A. de; Monteiro Filho, Joselio S.; Belem, Lilia M.J.; Torres, Luiz F.B.

2009-01-01

The changing of the world scenario in the last 15 years has increased worldwide the concerns about overall security and, as a consequence, about the nuclear and radioactive material as well as their associated facilities. Considering the new situation, in February 2004, the Brazilian National Nuclear Energy Commission (CNEN), decided to create the Nuclear Security Office. This Office is under the Coordination of Nuclear Safeguards and Security, in the Directorate for Safety, Security and Safeguards (Regulatory Directorate). Before that, security regulation issues were dealt in a decentralized manner, within that Directorate, by different licensing groups in specific areas (power reactors, fuel cycle facilities, radioactive facilities, transport of nuclear material, etc.). This decision was made in order to allow a coordinated approach on the subject, to strengthen the regulation in nuclear/radioactive security, and to provide support to management in the definition of institutional security policies. The CNEN Security Office develops its work based in the CNEN Physical Protection Regulation for Nuclear Operational Units - NE-2.01, 1996, the Convention on the Physical Protection of Nuclear Material and the IAEA Nuclear Security Series . This paper aims at presenting the activities developed and the achievements obtained by this new CNEN office, as well as identifying the issues and directions for future efforts. (author)

Regulatory aspects of criticality control in Australia

International Nuclear Information System (INIS)

Zimin, Sergei

2003-01-01

With the creation of Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) the Australian approach to criticality safety was revisited. Consistency with international best practices is required by the Act that created ARPANSA and this was applied to practices in criticality safety adopted in other countries. This required extensive regulatory efforts both in auditing the major Australian Nuclear Operator, Australian Nuclear Science and Technology Organisation (ANSTO), and assessing the existing in Australia criticality safety practices and implementing the required changes using the new legislative power of ARPANSA. The adopted regulatory approach is formulated through both the issued by ARPANSA licenses for nuclear installations (including reactors, fuel stores and radioactive waste stores) and the string of new regulatory documents, including the Regulatory Assessment Principles and the Regulatory Assessment Guidelines for criticality safety. The main features of the adopted regulation include the requirements of independent peer-review, ongoing refresher training coupled with annual accreditation and the reliance on the safe design rather than on an administrative control. (author)

Worldwide construction

International Nuclear Information System (INIS)

Williamson, M.

1994-01-01

The paper lists major construction projects in worldwide processing and pipelining, showing capacities, contractors, estimated costs, and time of construction. The lists are divided into refineries, petrochemical plants, sulfur recovery units, gas processing plants, pipelines, and related fuel facilities. This last classification includes cogeneration plants, coal liquefaction and gasification plants, biomass power plants, geothermal power plants, integrated coal gasification combined-cycle power plants, and a coal briquetting plant

The Regulatory Independence of FANR

International Nuclear Information System (INIS)

ALNuaimi, Fatema; Choi, Kwang Shik

2012-01-01

Regulatory independence is meant to provide a conservative system of policy making in order to comply with the problems that are forecasted upon the basis of assumptions. The Federal Authorization of Nuclear Regulation (FANR) is a regulatory commission that was formed to be regulatory body that governs the generation of nuclear power in United Arab Emirates. It was established under the UAE nuclear law (9/2009) as an independent regulatory body that was tasked with the regulation of all nuclear activities in the United Arab Emirates. As an independent body, FANR was tasked with ensuring that the regulation of the nuclear sector is done in effective and transparent manner to ensure its accountability to the people. Being independent, the regulatory body develops national nuclear regulations based on laid down safety standards by the International Atomic Energy Agency, ensuring that they are based on scientific and proven technologies The role of FANR is to ensure that the all corporations that undertake nuclear activities follow the laid down procedures and objectives and ensure safety measures are taken keenly to ensure the safety of the workers and the general public while at the same time ensuring the environment is free from nuclear radiations

The Regulatory Independence of FANR

Energy Technology Data Exchange (ETDEWEB)

ALNuaimi, Fatema; Choi, Kwang Shik [Korea Advanced Institute of Science and Technology, Daejeon (Korea, Republic of)

2012-05-15

Regulatory independence is meant to provide a conservative system of policy making in order to comply with the problems that are forecasted upon the basis of assumptions. The Federal Authorization of Nuclear Regulation (FANR) is a regulatory commission that was formed to be regulatory body that governs the generation of nuclear power in United Arab Emirates. It was established under the UAE nuclear law (9/2009) as an independent regulatory body that was tasked with the regulation of all nuclear activities in the United Arab Emirates. As an independent body, FANR was tasked with ensuring that the regulation of the nuclear sector is done in effective and transparent manner to ensure its accountability to the people. Being independent, the regulatory body develops national nuclear regulations based on laid down safety standards by the International Atomic Energy Agency, ensuring that they are based on scientific and proven technologies The role of FANR is to ensure that the all corporations that undertake nuclear activities follow the laid down procedures and objectives and ensure safety measures are taken keenly to ensure the safety of the workers and the general public while at the same time ensuring the environment is free from nuclear radiations

Discussion on building safety culture inside a nuclear safety regulatory body

International Nuclear Information System (INIS)

Fan Yumao

2013-01-01

A strong internal safety culture plays a key role in improving the performance of a nuclear regulatory body. This paper discusses the definition of internal safety culture of nuclear regulatory bodies, and explains the functions that the safety culture to facilitate the nuclear safety regulation and finally puts forward some thoughts about building internal safety culture inside regulatory bodies. (author)

Promoting Regulatory Reform: The African Health Profession Regulatory Collaborative (ARC) for Nursing and Midwifery Year 4 Evaluation.

Science.gov (United States)

Kelley, Maureen A; Spangler, Sydney A; Tison, Laura I; Johnson, Carla M; Callahan, Tegan L; Iliffe, Jill; Hepburn, Kenneth W; Gross, Jessica M

2017-10-01

As countries across sub-Saharan Africa work towards universal health coverage and HIV epidemic control, investments seek to bolster the quality and relevance of the health workforce. The African Health Profession Regulatory Collaborative (ARC) partnered with 17 countries across East, Central, and Southern Africa to ensure nurses and midwives were authorized and equipped to provide essential HIV services to pregnant women and children with HIV. Through ARC, nursing leadership teams representing each country identify a priority regulatory function and develop a proposal to strengthen that regulation over a 1-year period. Each year culminates with a summative congress meeting, involving all ARC countries, where teams present their projects and share lessons learned with their colleagues. During a recent ARC Summative Congress, a group survey was administered to 11 country teams that received ARC Year 4 grants to measure advancements in regulatory function using the five-stage Regulatory Function Framework, and a group questionnaire was administered to 16 country teams to measure improvements in national nursing capacity (February 2011-2016). In ARC Year 4, eight countries implemented continuing professional development projects, Botswana revised their scope of practice, Mozambique piloted a licensing examination to assess HIV-related competencies, and South Africa developed accreditation standards for HIV/tuberculosis specialty nurses. Countries reported improvements in national nursing leaders' teamwork, collaborations with national organizations, regional networking with nursing leaders, and the ability to garner additional resources. ARC provides an effective, collaborative model to rapidly strengthen national regulatory frameworks, which other health professional cadres or regions may consider using to ensure a relevant health workforce, authorized and equipped to meet the emerging demand for health services.

Communication planning by the nuclear regulatory body

International Nuclear Information System (INIS)

2002-01-01

The national regulatory body, whose primary mission is to exercise regulatory control over nuclear facilities and the use of radiation sources, but not to promote their use, may be the most credible source of neutral, balanced and accurate information about issues relating to nuclear and radiation safety. It is therefore important for a regulatory body to establish and exercise an effective communication programme to acquaint the public with its oversight functions, capabilities and effectiveness. If the regulatory body is to maintain credibility and to deal promptly and effectively with nuclear or radiological accidents and any other events that may give rise to significant public concerns, and is to communicate clearly and effectively with the public, it must have adequate resources, including experts in nuclear safety. And if maintaining public confidence in the authorities and avoiding unnecessary concerns are among its principal objectives, it must be able to communicate understandably and truthfully about the known extent of any accident, the actions taken in response to it and its implications. In the past, psychological effects as a result of certain severe nuclear and radiological accidents have been compounded by a lack of candour with the public on the part of the authorities and an absence of an appropriate programme of public information. This publication describes good practices and gives practical examples of how the regulatory body can establish a systematic and structured programme for enhancing effective communication with various parties and under various circumstances. The report presupposes an adequate national infrastructure, including an independent regulatory body with sufficient authority and resources to discharge its responsibilities for the regulation of safety. This Safety Report covers the elements of a regulatory body's programme for communication with various audiences and under the different circumstances that may be encountered

Current concepts on integrative safety assessment of active substances of botanical, mineral or chemical origin in homeopathic medicinal products within the European regulatory framework.

Science.gov (United States)

Buchholzer, Marie-Luise; Werner, Christine; Knoess, Werner

2014-03-01

For active substances of botanical, mineral or chemical origin processed in homeopathic medicinal products for human use, the adequate safety principles as with other human medicinal products are applied in line with the European regulatory framework. In homeopathy, nonclinical safety assessment is facing a particular challenge because of a multitude and diversity of source materials used and due to rarely available toxicological data. Thus, current concepts applied by the national regulatory authority in Germany (BfArM) on integrative safety assessment of raw materials used in homeopathic medicinal products involve several evaluation approaches like the use of the Lowest Human Recommended Dose (LHRD), toxicological limit values, Threshold of Toxicological Concern (TTC), data from food regulation or the consideration of unavoidable environmental or dietary background exposure. This publication is intended to further develop and clarify the practical use of these assessment routes by exemplary application on selected homeopathic preparations. In conclusion, the different approaches are considered a very useful scientific and simultaneously pragmatic procedure in differentiated risk assessment of homeopathic medicinal products. Overall, this paper aims to increase the visibility of the safety issues in homeopathy and to stimulate scientific discussion of worldwide existing regulatory concepts on homeopathic medicinal products. Copyright © 2014 Elsevier Inc. All rights reserved.

The rise of regulatory capitalism and the decline of auditor independence: A critical and experimental examination of auditors' conflicts of interests

DEFF Research Database (Denmark)

Warming-Rasmussen, Bent

2009-01-01

This study investigates the decline of auditor independence coinciding with the rise of regulatory capitalism. A critical analysis supported by experimental evidence reveals regulatory capitalism's influence on auditor independence. Regulatory capitalism began in the United States during the 1970s...... that now promote and diffuse regulatory capitalism worldwide. Regulatory capitalism is further facilitated by the Sarbanes-Oxley Act and the PCAOB that provide interconnections of powerful non-democratic private regulators such as the IFAC and IAASB. An experiment reveals auditors' ethical predisposition...... to provide consistently high quality independence judgments required by IFAC's code of ethics. The majority of this sample of 174 Danish auditors was not consistently independent in the context of client economic factors, indicating that the code of ethics' appeal to auditors' altruistic behavior has failed...

Nuclear Regulatory Infrastructure in the Philippines

International Nuclear Information System (INIS)

Leonin, Teofilo V. Jr.

2015-01-01

Regulating the use of radioactive materials in the Philippines involves the adherence to legislation, regulations, standards and regulatory guides. It is based on a detailed review and assessment of the radiation safety program of owners and users of these materials and associated equipment against safety requirements and on additional verification of the operating practices and procedures. Republic Acts 5207 and 2067, both as amended, are implemented through the regulations which are titled Code of PNRI Regulations or CPRs are developed and issued together with supporting regulatory guides, Bulletins and other documents detailing the safety requirements. These issuance adhere to internationally accepted requirements on radiation protection, and nuclear safety and security, as well as safeguards. Design documents and technical Specifications of important radioactive materials, equipment and components are required to be submitted and reviewed by the PNRI before the issuance of an authorization in the form of a license Verification of adherence to regulations and safety requirements are periodically checked through the implementation of an inspection and enforcement program. The ISO certified regulatory management system of PNRI is documented in a QMS manual that provides guidance on all work processes. It involves systematic planning and evaluation of activities, multiple means of getting feedback on the work processes, and continuous efforts to improve its effectiveness. Efforts are implemented in order to strengthen the transparency openness, independence, technical competence and effectiveness of the regulatory body. (author)

Compliance. Regulatory policy P-211

International Nuclear Information System (INIS)

2001-05-01

This regulatory policy describes the basic principles and directives for establishing and conducting the Canadian Nuclear Safety Commission (CNSC) Compliance Program. The program is aimed at securing compliance by regulated persons with regulatory requirements made under the Nuclear Safety and Control Act ('the Act'). The policy applies to persons who are regulated by the CNSC through the Act, regulations and licences, as well as by decisions and orders made under the Act. The policy applies to officers and employees of the CNSC, and its authorized representatives or agents, who are involved in developing and carrying out compliance activities. Compliance, in the context of this policy, means conformity by regulated persons with the legally binding requirements of the Act, and the CNSC regulations, licences, decisions, and orders made under the Act. Compliance activities are CNSC measures of promotion, verification and enforcement aimed at securing compliance by regulated person with the applicable legally binding requirements. (author)

Regulatory Body of Egypt: Practices and Challenges

International Nuclear Information System (INIS)

El-Messiry, A.

2016-01-01

In past, Egypt issued the law No. 59 of year 1969 for regulating the use of ionizing radiations inside the country, this law assigns the responsibilities of Egypt Atomic Energy Authority EAEA to control reactors, open sources, and all nuclear and radiation facilities inside its premises, while the ministry of health was responsible for controlling x-ray machine, sealed sources and accelerators. In 1982 EAEA established within its structure a new regulatory body called national centre for Nuclear Safety and radiation Control NC-NSRC as a dependent regulatory body, science EAEA is the operator of reactors and many nuclear and radiation facilities. On 30 March 2010 Egypt issued a nuclear law No 7 of year 2010, followed by its executive regulation in October 2011, the new law replaced the old law 59 of year 1969, in addition, the prime minster issued a decree on march 5td 2012 of establishing an independent regulatory body reported directly to him, it has the name of Egypt Nuclear and Radiological Regulatory Authority ENRRA, it is responsible for regulating all nuclear and radiation facilities and activities inside the country, except X-ray machines and linear accelerators for the medical uses, that still remains under the control of ministry of health. The new nuclear law defines the responsibility of the government to establish, support and determine the authorization and the responsibilities of the independent regulatory body. ENRRA is managed by a board of directors comprises from chairman, vice chairman, head of national security, interior, exterior, customs, export & import, standards, environment, justice organizations, besides two scientific experts from ENRRA. The board of council is the supreme authority of the dominant, and the conduct of ENRRA affairs, and take decisions within the framework of the national plan of Egypt, to achieve the objectives for which the ENRRA was established. ENRRA was organized from the old NC-NSRC staff into three regulatory

Regulatory and Non-regulatory Responses to Hydraulic Fracturing in Local Communities

Science.gov (United States)

Phartiyal, P.

2015-12-01

The practice of extracting oil and gas from tight rock formations using advances in technology, such as hydraulic fracturing and directional drilling, has expanded exponentially in states and localities across the country. As the scientific data collection and analysis catches up on the many potential impacts of this unconventional oil and gas development, communities are turning to their local officials to make decisions on whether and how fracking should proceed. While most regulatory authority on the issue rests with the state agencies, local officials have experimented with a wide range of regulatory, non-regulatory, and fiscal tools to manage the impacts of fracking. These impacts can occur on the local air, water, seismicity, soil, roads, schools, and affect residents, on-site workers, emergency and social services. Local officials' approaches are often influenced by their prior experience with minerals extraction in their localities. The speaker will present examples of the kinds of information sources, tools and approaches communities across the country are using, from noise barriers to setback requirements to information sharing in order to be able to balance the promise and perils of oil and gas development in their jurisdictions.

Panorama 2018 - Overview of economic carbon pricing tools worldwide

International Nuclear Information System (INIS)

Coussy, Paula

2018-01-01

The Paris Agreement signed at COP21 came into effect in November 2016. This agreement aims to hold the increase in global average temperature to below 2 deg. C and pursue efforts to limit the rise to 1.5 deg. C by 2100. Governments and local jurisdictions must now implement an economic and regulatory framework to encourage greenhouse gas reductions. One of the economic tools available is carbon pricing. It varies greatly in form and value at international level and is deployed in all sectors of the economy. (author)

Regulatory viewpoint on nuclear fuel quality assurance

International Nuclear Information System (INIS)

Tripp, L.E.

1976-01-01

Considerations of the importance of fuel quality and performance to nuclear safety, ''as low reasonably achievable'' release of radioactive materials in reactor effluents, and past fuel performance problems demonstrate the need for strong regulatory input, review and inspection of nuclear fuel quality assurance programs at all levels. Such a regulatory program is being applied in the United States of America by the US Nuclear Regulatory Commission. Quality assurance requirements are contained within government regulations. Guidance on acceptable methods of implementing portions of the quality assurance program is contained within Regulatory Guides and other NRC documents. Fuel supplier quality assurance program descriptions are reviewed as a part of the reactor licensing process. Inspections of reactor licensee control of their fuel vendors as well as direct inspections of fuel vendor quality assurance programs are conducted on a regularly scheduled basis. (author)

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)

Regulatory approach to risk informed decision making in India

International Nuclear Information System (INIS)

Chande, S.K.; Koley, J.

2001-01-01

Atomic Energy Regulatory Board (AERB), the authority for licensing and monitoring safety in Indian Nuclear Power Plants (NPPs), makes use of insights gained from PSA together with the results of the other deterministic analyses in taking decisions regarding the acceptability of the safety of the NPPs. PSA provides an estimation of risks; it also gives information on a balanced design by revealing interaction between engineered features and weak areas in a design. For regulatory use, PSA needs to be carried out using standardized methodology and state of the art technology. PSA helps regulators in taking faster and consistent decisions. Keeping in mind the limitations associated with PSA study, AERB has decided to adopt risk-informed decision making in regulatory licensing process. This paper describes the AERB policy regarding PSA and gives an overview of the experience in this area. (author)

Innovations in the Delivery of Regulatory Services in Australia

International Nuclear Information System (INIS)

Dillich, J.

2016-01-01

The Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) is the country’s primary authority on radiation protection and nuclear safety. ARPANSA aims to promote safety, security, and emergency preparedness through efficient and effective regulation of nuclear installations, controlled facilities, and radiation sources. Recent initiatives to improve regulation by ‘cutting red tape’ and reducing regulatory burden have been introduced. ARPANSA’s Regulatory Delivery Model emphasises the key elements to good regulation and describes initiatives such as baseline inspection schedule, Performance Objectives and Criteria, and performance deficiencies. These and other initiatives have streamlined inspection efforts, increased risk-based oversight and risk-informed decision making, leading to increased efficiencies for both regulator and licence holder. In addition, ARPANSA has introduced 12 key performance indicators in its self-assessment of regulatory performance against the Australian Government’s Regulator Performance Framework. (author)

Public Health Authority of the Slovak Republic

International Nuclear Information System (INIS)

Gaal, P.

2005-01-01

In this presentation author deals with the role of the Public Health Authority of the Slovak Republic in radiation protection in the Slovak Republic. Public Health Authority is budgetary organization, which depends on the funding of the Ministry of Health. As the state administration authority performs execution of state regulatory activities in the field of health protection in Slovak republic and radiation protection as well. Radiation Protection Supervision is performed according to the act on public health protection. Organization scheme of radiation protection in the Slovak Republic is presented

Regulatory practices for nuclear power plants in India

International Nuclear Information System (INIS)

Bajaj, S.S.

2013-01-01

The Atomic Energy Regulatory Board (AERB) is the national authority for ensuring that the use of ionizing radiation and nuclear energy does not cause any undue risk to the health of workers, members of the public and to the environment. AERB is responsible for the stipulation and enforcement of rules and regulations pertaining to nuclear and radiological safety. This paper describes the regulatory process followed by AERB for ensuring the safety of nuclear power plants (NPPs) during their construction as well as operation. This regulatory process has been continuously evolving to cater to the new developments in reactor technology. Some of the recent initiatives taken by AERB in this direction are briefly described. Today, AERB faces new challenges like simultaneous review of a large number of new projects of diverse designs, a fast growing nuclear power program and functioning of operating plants in a competitive environment. This paper delineates how AERB is gearing up to meet these challenges in an effective manner. (author)

Organization of nuclear regulatory activities

International Nuclear Information System (INIS)

Blidaru, Valentin

2008-01-01

The paper presents the structure, missions and organizational aspects of the CNCAN, the National Commission for the control of nuclear activities in Romania. The paper addresses the following main issues: 1.General aspects; 2.Organizational structure of the NRA in Romania; 3.General description of the Division for Nuclear Safety Assessments; 4.Specific activities; 5.Regulatory approaches and practices. Under the title of 'General aspects' the following three basic statements are highlighted: 1.CNCAN is a governmental organization responsible for the development of the regulatory framework, the control of its implementation and the licensing of nuclear facilities; 2.CNCAN is the national authority competent in exercising the regulatory activity, authorization and control in the nuclear field provided by the law No. 111/ 1996 republished in 1998; 3.The Commission exercises its functions independently of the ministries and other authorities of the public control administration being subordinated to the Romanian Government. The organizational structure is as follows: - President, the Managerial Council and the Advisory Council coordinating the four General Divisions that are responsible for: - Nuclear Safety with Division of Nuclear Safety Assessment and Division of Nuclear Objectives Surveillance; - Radiological Safety with Division of Radiological Safety Assessment and Division of Operational Radiation Protection; - Surveillance of Environmental Radioactivity with Division of Assessment and Analysis and Division of National Network; - Development and Resource with the Division of Economy and Division of Human Resources. In addition under direct coordination of the President operate the Division of Radiation Protection, Transport and Radioactive Waste and the Division of International Cooperation and Communication. Specific activities are listed describing among others the issues of: - Safety of nuclear installation; - Evaluation relating to licensing of nuclear

Diagnosis of the Brazilian Nuclear Regulatory body

International Nuclear Information System (INIS)

Santos Gomes, Rogerio dos; Magalhaes Ennes Ennes, Edson Carlos

2008-01-01

This work has the objective to present the diagnosis of the existing structure in the Brazilian Government to ensure the radioprotection and nuclear safety in the country, being compared the current situation with the conclusions presented in another studies, carried through in last 30 years, with special attention in the existence of the necessary available to support and independence of the national regulatory body for the development of the regulatory inspections activities in the radioprotection and nuclear safety. (author)

Radioactive waste management regulatory framework in Mexico

International Nuclear Information System (INIS)

Barcenas, M.; Mejia, M.

2001-01-01

The purpose of this paper is to present an overview of the current regulatory framework concerning the radioactive waste management in Mexico. It is intended to show regulatory historical antecedents, the legal responsibilities assigned to institutions involved in the radioactive waste management, the sources of radioactive waste, and the development and preparation of national standards for fulfilling the legal framework for low level radioactive waste. It is at present the most important matter to be resolved. (author)

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.

Innovation in Science Education - World-Wide.

Science.gov (United States)

Baez, Albert V.

The purpose of this book is to promote improvements in science education, world-wide, but particularly in developing countries. It is addressed to those in positions to make effective contributions to the improvement of science education. The world-wide role of science education, the goals of innovative activities, past experience in efforts to…

Safety assessment plans for authorization and inspection of radiation sources

International Nuclear Information System (INIS)

2002-05-01

The objective of this TECDOC is to enhance the efficacy, quality and efficiency of the whole regulatory process. It provides advice on good practice administrative procedures for the regulatory process for preparation of applications, granting of authorizations, inspection, and enforcement. It also provides information on the development and use of standard safety assessment plans for authorization and inspection. The plans are intended to be used in conjunction with more detailed advice related to specific practices. In this sense, this TECDOC provides advice on a systematic approach to evaluations of protection and safety while other IAEA Safety Guides assist the user to distinguish between the acceptable and the unacceptable. This TECDOC covers administrative advice to facilitate the regulatory process governing authorization and inspection. It also covers the use of standard assessment and inspection plans and provides simplified plans for the more common, well established uses of radiation sources in medicine and industry, i.e. sources for irradiation facilities, industrial radiography, well logging, industrial gauging, unsealed sources in industry, X ray diagnosis, nuclear medicine, teletherapy and brachytherapy

Safety assessment plans for authorization and inspection of radiation sources

International Nuclear Information System (INIS)

1999-09-01

The objective of this TECDOC is to enhance the efficacy, quality and efficiency of the whole regulatory process. It provides advice on good practice administrative procedures for the regulatory process for preparation of applications, granting of authorizations, inspection, and enforcement. It also provides information on the development and use of standard safety assessment plans for authorization and inspection. The plans are intended to be used in conjunction with more detailed advice related to specific practices. In this sense, this TECDOC provides advice on a systematic approach to evaluations of protection and safety while other IAEA Safety Guides assist the user to distinguish between the acceptable and the unacceptable. This TECDOC covers administrative advice to facilitate the regulatory process governing authorization and inspection. It also covers the use of standard assessment and inspection plans and provides simplified plans for the more common, well established uses of radiation sources in medicine and industry, i.e. sources for irradiation facilities, industrial radiography, well logging, industrial gauging, unsealed sources in industry, X ray diagnosis, nuclear medicine, teletherapy and brachytherapy

Challenges in Strengthening Regulatory Infrastructure in a Non-Nuclear Country

International Nuclear Information System (INIS)

Bosnjak, J.

2016-01-01

The State Regulatory Agency for Radiation and Nuclear Safety (SRARNS) is established as the effectively independent regulatory body for radiation and nuclear safety based on the Law on Radiation and Nuclear Safety in Bosnia and Herzegovina promulgated in November 2007. After its complete reorganization in the last few years, the regulatory system is compatible with relevant IAEA Safety Standards and Guides for safety and security of radioactive sources. The paper gives an overview of the new regulatory framework in Bosnia and Herzegovina, with special focus on challenges faced by Bosnia and Herzegovina, which are actually typical challenges for regulator in small non-nuclear country in strengthening regulatory infrastructure in regulating radiation sources and radioactive waste. (author)

The path from biomarker discovery to regulatory qualification

CERN Document Server

Goodsaid, Federico

2013-01-01

The Path from Biomarker Discovery to Regulatory Qualification is a unique guide that focuses on biomarker qualification, its history and current regulatory settings in both the US and abroad. This multi-contributed book provides a detailed look at the next step to developing biomarkers for clinical use and covers overall concepts, challenges, strategies and solutions based on the experiences of regulatory authorities and scientists. Members of the regulatory, pharmaceutical and biomarker development communities will benefit the most from using this book-it is a complete and practical guide to biomarker qualification, providing valuable insight to an ever-evolving and important area of regulatory science. For complimentary access to chapter 13, 'Classic' Biomarkers of Liver Injury, by John R. Senior, Associate Director for Science, Food and Drug Administration, Silver Spring, Maryland, USA, please visit the following site:  http://tinyurl.com/ClassicBiomarkers Contains a collection of experiences of different...

Regulatory governance of telecommunications liberalisation in Taiwan

International Nuclear Information System (INIS)

Cheng, Kuo-Tai; Hebenton, Bill

2008-01-01

This paper examines the changing role of government and market in regulating the telecommunications sector from since 1996 in Taiwan. It contextualises the theoretical aspects of regulatory governance for institutional design and practices, and reviews the concepts and mechanisms for appraising privatisation and regulatory systems. Using a conceptual framework for researching privatisation and regulation, it describes the process and issues pertinent to telecommunications liberalisation and privatisation in Taiwan, supported by a brief presentation of theoretical points of view as well as practitioners' views. The paper presents results concerning criteria for appraising privatisation and regulatory governance and considers policy lessons that can be learned from the experiences of the Taiwanese telecommunications sector's liberalisation. (author)

Regulatory governance of telecommunications liberalisation in Taiwan

Energy Technology Data Exchange (ETDEWEB)

Cheng, Kuo-Tai [Department of Regional Studies in Humanity and Social Sciences, National Hsin-Chu University of Education, No. 521 Nan-Da Road, Hsin-Chu 300 (China); Hebenton, Bill [School of Law, University of Manchester, M13 9PP (United Kingdom)

2008-12-15

This paper examines the changing role of government and market in regulating the telecommunications sector from since 1996 in Taiwan. It contextualises the theoretical aspects of regulatory governance for institutional design and practices, and reviews the concepts and mechanisms for appraising privatisation and regulatory systems. Using a conceptual framework for researching privatisation and regulation, it describes the process and issues pertinent to telecommunications liberalisation and privatisation in Taiwan, supported by a brief presentation of theoretical points of view as well as practitioners' views. The paper presents results concerning criteria for appraising privatisation and regulatory governance and considers policy lessons that can be learned from the experiences of the Taiwanese telecommunications sector's liberalisation. (author)

Transport of radioactive material in Bangladesh: a regulatory perspective

International Nuclear Information System (INIS)

Mollah, A.S.

2004-01-01

Radioactive material is transported in Bangladesh in various types of packages and by different modes of transport. The transport of radioactive materials involves a risk both for the workers and members of the public. The safe transport of radioactive material is ensured in Bangladesh by compliance with Nuclear Safety and Radiation Control (NSRC) Act-93 and NSRC Rules-97. The Bangladesh Atomic Energy Commission (BAEC) is the competent authority for the enforcement of the NSRC act and rules. The competent authority has established regulatory control at each stage to ensure radiation safety to transport workers, members of general public and the environment. An overview is presented of the activities related to the transport of radioactive material in Bangladesh. In particular, the applicable legislation, the scope of authority and the regulatory functions of the competent authority are discussed. The categories of radioactive materials transported and the packaging requirements for the safe transport of these radioactive materials are also described. (author)

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

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.

Thorium, uranium and plutonium in human tissues of world-wide general population

International Nuclear Information System (INIS)

Singh, N.P.

1990-01-01

The results on the concentrations of thorium, uranium and plutonium in human tissues of world-wide general populations are summarized. The majority of thorium and uranium are accumulated in the skeleton, whereas, plutonium is divided between two major organs: the liver and skeleton. However, there is a wide variation in the fractions of plutonium in the liver and the skeleton of the different populations. (author) 44 refs.; 15 figs

Regulatory approaches in the United States of America for safe management and disposal of long-lived radionuclides

International Nuclear Information System (INIS)

Greeves, J.T.; Bell, M.J.; Nelson, R.A.

1998-01-01

Regulation of the safe management and disposal of commercial, man-made, long-lived radioactive wastes in the United States is the responsibility of the US Nuclear Regulatory Commission (NRC). In some instances, state regulatory authorities have entered into agreements with the NRC to exercise regulatory authority over management and disposal of low-level radioactive wastes and uranium mill tailings within their borders. The legal and regulatory framework employed to achieve safe management and disposal of long-lived radioactive wastes in the US regulatory system is quite detailed, and in many cases the requirements are considerably prescriptive. The NRC has undertaken an initiative to move in the direction of adopting risk-informed, performance-based and risk-informed, less-prescriptive regulations. The current status and future direction of the legal and regulatory framework for management and disposal of commercial long-lived radioactive waste in the US is described. (author)

Regulation for continuous improvements - the new regulatory strategy of SKI

International Nuclear Information System (INIS)

Hoegberg, L.; Svensson, G.; Viktorsson, C.

1998-01-01

This paper describes the new regulatory objectives and strategy of the Swedish Nuclear Power Inspectorate. Factors that have influenced the development of the regulatory strategy, including an international peer review, are discussed. In addition to general technical requirements for a defence in depth, the new strategy strongly focuses on the quality of plant safety management processes, to be monitored by process-oriented inspections. Also, quality assurance of regulatory activities is stressed. Experience gained so far shows that the regulatory approach chosen in Sweden promotes utility self assessment, quality of safety management and ownership of safety work within the utility staff. (author)

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)

International Nuclear Safety Experts Conclude IAEA Peer Review of Korea's Regulatory System

International Nuclear Information System (INIS)

2011-01-01

Full text: An international team of senior nuclear safety experts concluded today a two-week mission to review the regulatory framework for nuclear safety in the Republic of Korea. The team identified good practices and gave advice on areas for future improvements. The IAEA has conveyed the team's main conclusions to the Government of Korea, while the final report will be submitted by the end of summer 2011. At the request of the Korean Government, the IAEA assembled a team of 16 senior regulatory experts from 14 nations to conduct the Integrated Regulatory Review Service (IRRS) mission involving the Korean Ministry for Education, Science and Technology (MEST) and the Korean Institute for Nuclear Safety (KINS). The mission is a peer-review based on the IAEA Safety Standards. ''This was the first IRRS mission organized after Japan's Fukushima Daiichi nuclear accident and it included a review of the regulatory implications of that event,' explains Denis Flory, IAEA Deputy Director General and Head of the Department of Nuclear Safety and Security. William Borchardt, Executive Director of Operations from the US Nuclear Regulatory Commission and Team Leader of this mission commended the Korean authorities for their openness and commitment to sharing their experience with the world's nuclear safety community. ''IRRS missions such as the one that was just concluded here in the Republic of Korea are crucial to the enhancement of nuclear safety worldwide,'' he said. The IRRS team reviewed Korea's current regulatory framework while acknowledging the fact that the country's Government has already decided to establish, as of October 2011, a new independent regulatory body to be called Nuclear Safety Commission (NSC). As a consequence, KINS role will be as a regulatory expert organization reporting to the NSC, while MEST's role will be restricted to promoting the utilization of nuclear energy. The IRRS team identified particular strengths in the Korean regulatory system

Worldwide Regulations of Standard Values of Pesticides for Human Health Risk Control: A Review

Science.gov (United States)

Jennings, Aaron

2017-01-01

The impact of pesticide residues on human health is a worldwide problem, as human exposure to pesticides can occur through ingestion, inhalation, and dermal contact. Regulatory jurisdictions have promulgated the standard values for pesticides in residential soil, air, drinking water, and agricultural commodity for years. Until now, more than 19,400 pesticide soil regulatory guidance values (RGVs) and 5400 pesticide drinking water maximum concentration levels (MCLs) have been regulated by 54 and 102 nations, respectively. Over 90 nations have provided pesticide agricultural commodity maximum residue limits (MRLs) for at least one of the 12 most commonly consumed agricultural foods. A total of 22 pesticides have been regulated with more than 100 soil RGVs, and 25 pesticides have more than 100 drinking water MCLs. This research indicates that those RGVs and MCLs for an individual pesticide could vary over seven (DDT drinking water MCLs), eight (Lindane soil RGVs), or even nine (Dieldrin soil RGVs) orders of magnitude. Human health risk uncertainty bounds and the implied total exposure mass burden model were applied to analyze the most commonly regulated and used pesticides for human health risk control. For the top 27 commonly regulated pesticides in soil, there are at least 300 RGVs (8% of the total) that are above all of the computed upper bounds for human health risk uncertainty. For the top 29 most-commonly regulated pesticides in drinking water, at least 172 drinking water MCLs (5% of the total) exceed the computed upper bounds for human health risk uncertainty; while for the 14 most widely used pesticides, there are at least 310 computed implied dose limits (28.0% of the total) that are above the acceptable daily intake values. The results show that some worldwide standard values were not derived conservatively enough to avoid human health risk by the pesticides, and that some values were not computed comprehensively by considering all major human exposure

Worldwide Regulations of Standard Values of Pesticides for Human Health Risk Control: A Review.

Science.gov (United States)

Li, Zijian; Jennings, Aaron

2017-07-22

Abstract : The impact of pesticide residues on human health is a worldwide problem, as human exposure to pesticides can occur through ingestion, inhalation, and dermal contact. Regulatory jurisdictions have promulgated the standard values for pesticides in residential soil, air, drinking water, and agricultural commodity for years. Until now, more than 19,400 pesticide soil regulatory guidance values (RGVs) and 5400 pesticide drinking water maximum concentration levels (MCLs) have been regulated by 54 and 102 nations, respectively. Over 90 nations have provided pesticide agricultural commodity maximum residue limits (MRLs) for at least one of the 12 most commonly consumed agricultural foods. A total of 22 pesticides have been regulated with more than 100 soil RGVs, and 25 pesticides have more than 100 drinking water MCLs. This research indicates that those RGVs and MCLs for an individual pesticide could vary over seven (DDT drinking water MCLs), eight (Lindane soil RGVs), or even nine (Dieldrin soil RGVs) orders of magnitude. Human health risk uncertainty bounds and the implied total exposure mass burden model were applied to analyze the most commonly regulated and used pesticides for human health risk control. For the top 27 commonly regulated pesticides in soil, there are at least 300 RGVs (8% of the total) that are above all of the computed upper bounds for human health risk uncertainty. For the top 29 most-commonly regulated pesticides in drinking water, at least 172 drinking water MCLs (5% of the total) exceed the computed upper bounds for human health risk uncertainty; while for the 14 most widely used pesticides, there are at least 310 computed implied dose limits (28.0% of the total) that are above the acceptable daily intake values. The results show that some worldwide standard values were not derived conservatively enough to avoid human health risk by the pesticides, and that some values were not computed comprehensively by considering all major human

77 FR 58022 - Montana Regulatory Program

Science.gov (United States)

2012-09-19

... precludes in situ gasification projects from including carbon capture and sequestration (CCS) under the... Conservation as the regulatory authority for CCS activities within the State. SB498 generally established that..., the Board would regulate any proposed CCS activities appropriately. CCS operations have potential...

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

Projecting regulatory expectations for advanced reactor designs

International Nuclear Information System (INIS)

Viktorov, A.

2011-01-01

This paper explores the overarching safety principles that will likely guide the safety design of advanced reactor technologies. As will be shown, the already established safety framework provides a solid foundation for the safety design of future nuclear power plants. As a specific example, the principle of 'proven technology' is presented in greater detail and its implications for a novel technology are discussed. Research, modeling and prototyping are shown to be components in satisfying this principle. While the fundamental safety principles are in place, their interpretation may depend both on the considered technology as well as the national context. Thus, the regulatory authority will need to be engaged, at an appropriate stage of the technology development, in specifying the regulatory requirements that will have to be met for a specific reactor design. (author)

The importance of the practical training, the retraining and the accreditation of the personnel with regulatory functions

International Nuclear Information System (INIS)

Menossi, Carlos A.

2004-01-01

Medicine, industry, hydrology, research, development and academic scenarios are, nowadays the focus for a wide application of radioisotope techniques of permanently increasing use. This situation should move the governments towards the improvement of their infrastructures and the updating of the nuclear regulatory authorities knowledge. The regulation and control of radioactive sources and its associated practices, to guarantee its safe use and minimize the derived risks from those practices, constitute the main tasks of nuclear regulatory institutions. On the other hand, it is known that personnel with regulatory functions has further interaction with people responsible of facilities and practices (users). In fact, most of these people only have contact with the regulatory authority through the inspector visits, the documents, notes or requirements received. For such a reason, nuclear regulatory authority management success or failure depends fundamentally on the successes or errors occurring in the course of these interactions. Due to it, it should be kept in mind that a successful management of a Nuclear Regulatory Authority implies: a) The users accomplish the effective standards and satisfy the authority requirements, and b) An attitude of respect is induced in the users by the appropriate regulatory function. That is to say because the 'inspectors' possess the necessary technical knowledge. In that sense, with the experience of many years, improvements have been introduced in the radiological protection Post Graduate Course program. This course sponsored by the IAEA has been given in Argentina for 24 years. Such improvements have been made to allow participants that will perform regulatory functions to have enough sessions of practical training, demonstrations, laboratory exercises, case studies and technical visits. This formation course will be supplemented by an accreditation and training on the job. The scope and dimension of the improvements are

Communication: An important element of maintenance and repair

Science.gov (United States)

Tripp, James S.

1992-01-01

People from the airlines, the FAA, and the manufacturers have worked together in an effort to improve the Service Difficulty Reporting system. Their work to date is summarized as follows: (1) design a worldwide reporting system to provide safety alerts to aircraft operators, manufacturers, repair facilities, and regulatory authorities; (2) design a companion system to provide worldwide reliability experience; and (3) overhaul regulatory requirements to be consistent with (1) and (2) to provide information necessary and useful for public consumption.

Building Nuclear Safety and Security Culture Within Regulatory Body

International Nuclear Information System (INIS)

Huda, K.

2016-01-01

To achieve a higher level of nuclear safety and security, it needs to develop the safety and security culture not only in the facility but also in the regulatory body. The regulatory body, especially needs to develop the safety and security culture within the organization, because it has a function to promote and oversee the culture in the facilities. In this sense, the regulatory body should become a role model. Development of the nuclear safety and security culture should be started by properly understanding its concept and awakening the awareness of individual and organization on the importance of nuclear safety and security. For effectiveness of the culture development in the regulatory body, the following steps are suggested to be taken: setting up of the regulatory requirements, self-assessment, independent assessment review, communication with the licensee, oversight of management system implementation, and integration with regulatory activities. The paper discusses those steps in the framework of development of nuclear safety and security culture in the regulatory body, as well as some important elements in building of the culture in the nuclear facilities. (author)

Considerations regarding the collection of pesticide use information for regulatory purposes

NARCIS (Netherlands)

Marquart, J.

2001-01-01

Proper use information is necessary to do exposure modelling in the scope of regulatory risk assessments. The legal regime under which the regulatory risk assessment is done influences the need for use information. Different legal regimes lead to more or less possibilities for authorities to define

TELECOMMUNICATIONS AND BROADCASTING: A QUESTION OF REGULATORY DISSOCIATION

Directory of Open Access Journals (Sweden)

Chalini Torquato Gonçalves de Barros

2009-08-01

Full Text Available The legislation governing the communication in Brazil is marked by significant normative paradox between the telecommunication and broadcasting services, from the privatization of the sector at the time of President Fernando Henrique Cardoso. Among the factors that contribute to the establishment of such situation are practices of patronage, inherent in the Brazilian political culture. In the same manner, the communication sector of Brazil follows an opposite direction to the worldwide trend of technological and legislative convergence besides weakening the State with regard to the compliance of its regulatory role, especially because it is vulnerable to pressures from more influential sector actors.

Worldwide satellite market demand forecast

Science.gov (United States)

Bowyer, J. M.; Frankfort, M.; Steinnagel, K. M.

1981-01-01

The forecast is for the years 1981 - 2000 with benchmark years at 1985, 1990 and 2000. Two typs of markets are considered for this study: Hardware (worldwide total) - satellites, earth stations and control facilities (includes replacements and spares); and non-hardware (addressable by U.S. industry) - planning, launch, turnkey systems and operations. These markets were examined for the INTELSAT System (international systems and domestic and regional systems using leased transponders) and domestic and regional systems. Forecasts were determined for six worldwide regions encompassing 185 countries using actual costs for existing equipment and engineering estimates of costs for advanced systems. Most likely (conservative growth rate estimates) and optimistic (mid range growth rate estimates) scenarios were employed for arriving at the forecasts which are presented in constant 1980 U.S. dollars. The worldwide satellite market demand forecast predicts that the market between 181 and 2000 will range from $35 to $50 billion. Approximately one-half of the world market, $16 to $20 billion, will be generated in the United States.

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

Regulatory control for safe usage of radiation sources in India

International Nuclear Information System (INIS)

Ghosh, P.K.; Sonawane, A.U.

1998-01-01

The widespread applications of radioactive materials and radiation generating equipment in the field of industry, medicine agriculture and research in India necessitated the establishment of an efficient regulatory framework and consequently the Atomic Energy Regulatory Board (AERB) was constituted to exercise regulatory control over the safe usage of the radioactive materials and the radiation generating equipment. The Atomic Energy Act, 1962 and the Radiation Protection Rules, 1971 promulgated under the Act forms the basis of radiation safety in India and Chairman, AERB is the Competent Authority to enforce the regulatory provisions of the Radiation Protection Rules, 1971, for safe use of radiation source in the country. AERB has published a number of documents such as Radiation Surveillance Procedures, Standards, Codes, Guides and Manuals for safe use and handling of radioactive materials and radiation generating equipment. Apart from nuclear fuel cycle documents, these publications pertain to industrial radiography, medical application of radiation, transport of radioactive material, industrial gamma irradiators, X-ray units etc. AERB safety related publications are based on international standards e.g. BSS, IAEA, ICRP, ISO etc. This paper outlines the methodology of regulatory control exercised by AERB for safe use of the radioactive materials and the radiation generating equipment in the country. (author)

Regulatory Support of Treatment of Savannah River Site Purex Waste

International Nuclear Information System (INIS)

Reid, L.T.

2009-01-01

This paper describes the support given by federal and state regulatory agencies to Savannah River Site (SRS) during the treatment of an organic liquid mixed waste from the Plutonium Extraction (Purex) process. The support from these agencies allowed (SRS) to overcome several technical and regulatory barriers and treat the Purex waste such that it met LDR treatment standards. (authors)

77 FR 61463 - Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness...

Science.gov (United States)

2012-10-09

... entry of erroneous orders. In addition, the Market Access Rule requires certain regulatory risk... authorized by the broker-dealer. These regulatory risk management controls also include measures designed to...-Regulatory Organizations; EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule...

77 FR 61449 - Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness...

Science.gov (United States)

2012-10-09

..., regulatory and other risks of this business activity. These controls include financial risk management... entry of erroneous orders. In addition, the Market Access Rule requires certain regulatory risk... authorized by the broker-dealer. These regulatory risk management controls also include measures designed to...

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)

75 FR 52523 - Southern Nevada Water Authority; Notice of Availability of Environmental Assessment

Science.gov (United States)

2010-08-26

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13569-001-NV] Southern Nevada Water Authority; Notice of Availability of Environmental Assessment August 19, 2010. In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's...

FFTF Authorization Agreement

International Nuclear Information System (INIS)

DAUTEL, W.A.

2000-01-01

The purpose of the Authorization Agreement is to serve as a mechanism whereby the U.S. Department of Energy, Richland Operations Office (RL) and Fluor Hanford (FH) jointly clarify and agree to key conditions for conducting work safely and efficiently in the Fast Flux Test Facility (FFTF). Work must be accomplished in a manner that achieves high levels of quality while protecting the environment and the safety and health of workers and the public, and complying with applicable contractual and regulatory requirements. It is the intent of this Agreement to address those items of significant importance in establishing and supporting the FFTF Authorization Envelope, but this Agreement in no way alters the terms and conditions of the Project Hanford Management Contract (PHMC), Contract Number DE-AC06-96RL13200

The regulatory mechanism in the U.S. lessons learned

International Nuclear Information System (INIS)

Roberts, T.M.

1987-01-01

The U.S. Nuclear Regulatory Commission is responsible for the regulation of the commercial uses of nuclear power in the United States in order to protect the public health and safety. The NRC has undertaken a number of initiatives to incorporate the experience gained from the over 25 years of commercial nuclear power plant operation. These initiatives are aimed at improving the regulatory structure currently in place by providing for a more predictable and stable regulatory environment and by more efficiently and effectively focusing the activities of utilities on the safe operation of their facilities. (author)

Worldwide cloud cover model

Science.gov (United States)

Smith, O. E.; Sommerville, P. N.

1979-01-01

Classifying worldwide cloudiness into homogeneous regions, using a satellite data set containing day IR, night IR, incoming, and absorbed solar radiation measurements on a 2.5-degree latitude-longitude grid is considered. Methods of analysis are presented.

What is a comprehensive system of regulatory governance?

International Nuclear Information System (INIS)

Real diaz, F. J.

2011-01-01

The progressive evolution and diversification of regulations concerning industrial safety has made their management increasingly complex, requiring more resources of organizations. Therefore, it is advisable that this management be made more efficient through systematization, specialization and the use of computing technologies. This is supported by the implementation of integrated regulatory management systems. This article explain the concept of integrated regulatory management systems, their structure and their advantages. It also includes a model for implementing them in an organization. (Author)

Status of research reactor spent fuel world-wide: Database summary

International Nuclear Information System (INIS)

Ritchie, I.G.

1996-01-01

Results complied in the research reactor spent fuel database are used to assess the status of research reactor spent fuel world-wide. Fuel assemblies, their types, enrichment, origin of enrichment and geological distribution among the industrialized and developed countries of the world are discussed. Fuel management practices in wet and dry storage facilities and the concerns of reactor operators about long-term storage of their spent fuel are presented and some of the activities carried out by the International Atomic Energy Agency to address the issues associated with research reactor spent fuel are outlined. (author). 4 refs, 17 figs, 4 tabs

Experience Transformed into Nuclear Regulatory Improvements in Russia

International Nuclear Information System (INIS)

Sapozhnikov, A.

2016-01-01

The third International Conference on Effective Nuclear Regulatory Systems (Canada, 2013) identified the main action items that should be addressed, implemented and followed up. The key technical and organizational areas important to strengthening reactor and spent fuel safety have been determined as following: • Regulatory lessons learned and actions taken (since the accident at the Fukushima Daiichi NPP); • Waste management and spent fuel safety; • Emergency management; • Emerging programmes; • Human and organizational factors, safety and security culture. Over time many activities based on results of the IAEA Integrated Regulatory Review Service in the Russian Federation, 2019, and post-mission, 2013, have been implemented. At present there is progress for the national action plan on nuclear safety, preparation and conducting of long term spent fuel management, complementary reviews for nuclear facilities other than Nuclear Power Plants, emergency exercises with the regulatory body participation, improving communication, development of national regulations and improvement of regulatory system in the whole. The regulatory body ensures assistance in development of national regulatory infrastructure, safety culture to the countries planning to construct Russian design facilities (NPPs, RRs). The report outlines the results and future actions to improve nuclear regulation based on systematic approach to safety and particularly reflects the specificity of taking measures for the research reactors. (author)

Regulatory and technical reports (abstract index journal)

International Nuclear Information System (INIS)

1994-03-01

This compilation consists of bibliographic data and abstracts for the formal regulatory and technical reports issued by the US Nuclear Regulatory Commission staff and its contractors. There are four types of reports included: staff reports, conference reports, contractor reports, and international agreement reports. In addition to the main citations with abstracts, the following are also included: Secondary report number index; Personal author index; Subject index; NRC originating organization indices for staff reports and international agreement reports; NRC contract sponsor index; Contractor index; International organization index; and Licensed facility index

Strengthening Regulatory Competence through Techno-managerial Knowledge Integration: Indian Experience

International Nuclear Information System (INIS)

Kuchibhotla, S.

2016-01-01

Competence development is the process of identifying the competencies required to perform a given job, role or set of tasks successfully at workplace. Strengthening regulatory competence, for the nuclear regulator, is essential to ensure skilled and competent human resources for performing the functions of the Regulatory Body. The strengthening of existing competence level for the Indian nuclear regulator, takes into account the understanding of the elements such as legal basis and regulatory processes governing operations of regulatory body, technological competences for performing regulatory functions, competences pertinent to regulatory practices, and competences related to personal and interpersonal effectiveness within the organization. Competency data from AERB divisions was compiled to identify gaps at various positions with recommendations for making specialized training modules and modifications to basic and refresher training modules. The exercise is aimed at providing continual improvement in skills and knowledge of human resources at AERB in a phased manner. (author)

Regulatory controls for NORM contamination: Emerging issues and strategies

International Nuclear Information System (INIS)

Wennerberg, Linda

1992-01-01

Naturally occurring and accelerator-produced radioactive material (NORM) faces the increasing likelihood of federal or state regulatory control. Public concern and limited preliminary survey data fuel the debate over the necessity, approach, and jurisdiction of a NORM regulatory strategy. This debate requires the resolution of technical controversies and potentially competing state and federal agency interests. An additional facet of the debate is the impact of regulation upon traditionally non-nuclear industries, such as oil and gas production. Regulatory response has been initiated in several states, such as Louisiana's controls on equipment used in oil and gas production, to control specific industrial activities which generate NORM. A more comprehensive, generic federal strategy to control NORM contamination is also under review by the Environmental Protection Agency. This paper will detail the emerging technical issues, federal and state regulatory strategies under consideration, and evaluate the efficacy of selected regulatory approaches. (author)

Regulatory aspects of radiopharmaceuticals

International Nuclear Information System (INIS)

Kristensen, K.

1985-01-01

Regulatory systems in the field of radiopharmaceuticals have two main purposes: efficacy and safety. Efficacy expresses the quality of the diagnostic and therapeutic process for the patient. Safety involves the patient, the staff, and the environment. The world situation regarding regulations for radiopharmaceuticals is reviewed on the basis of a survey in WHO Member States. The main content of such regulations is discussed. The special properties of radiopharmaceuticals compared with ordinary drugs may call for modified regulations. Several countries are preparing such regulations. Close co-operation and good understanding among scientists working in hospital research, industry and regulatory bodies will be of great importance for the fast and safe introduction of new radiopharmaceuticals for the benefit of the patient. Before introducing new legislation in this field, a radiopharmaceutical expert should analyse the situation in the country and the relationship to the existing regulations. It is expected that the most important factor in promoting the fast introduction of new, safe and effective radiopharmaceuticals will be the training of people working within the regulatory bodies. It is foreseen that the IAEA and WHO will have an important role to play by providing expert advice and training in this area. (author)

Continuous improvement of the regulatory framework for the control of medical exposure

International Nuclear Information System (INIS)

Larcher, Ana M.; Ortiz Lopez, Pedro; Arias, Cesar; Marechal, Maria H.; Hernandez Alvarez, Ramon; Ferrer Garcia, Natividad; Castaneda Mucino, Antonia; Faller, Blanca

2008-01-01

One of the key elements to guide the improvement of the regulatory control is the availability of a self-assessment tool for regulatory performance. Although there is general guidance on self-assessment for regulators and users (IAEA), there is a need for more specific advice on how to address challenges and difficulties faced by regulatory bodies, when regulating radiation protection of patients. Examples of these challenges are the need for regulatory initiatives, in cooperation with health and education authorities, professional bodies and equipment suppliers, and to put in place necessary elements that are beyond responsibility of individual user of radiation, to enable them compliance with safety standards. Purpose: Within the programme of the Ibero American Forum of Nuclear and Radiation Safety Regulatory Organizations, a project to develop such a self-assessment tool for the regulatory control of medical exposure has been designed. Method: National experiences in transposing and enforcing the international radiation safety standards, as to how the requirements are included in national regulations are reviewed. Further, difficulties to the implementation of safety requirements are analyzed and a self-assessment approach and possible regulatory solutions a are presented. Results and discussion: In this study the following documents are being produced: 1) transposition of international requirements into national regulations in the six countries of the Forum, 2) difficulties to implement and enforce the requirements, 3) guidance on self-assessment of regulatory framework for medical exposure, 4) suggested contribution to the revision of international radiation safety standards. (author)

The worldwide importance of honey bees as pollinators in natural habitats.

Science.gov (United States)

Hung, Keng-Lou James; Kingston, Jennifer M; Albrecht, Matthias; Holway, David A; Kohn, Joshua R

2018-01-10

The western honey bee ( Apis mellifera ) is the most frequent floral visitor of crops worldwide, but quantitative knowledge of its role as a pollinator outside of managed habitats is largely lacking. Here we use a global dataset of 80 published plant-pollinator interaction networks as well as pollinator effectiveness measures from 34 plant species to assess the importance of A. mellifera in natural habitats. Apis mellifera is the most frequent floral visitor in natural habitats worldwide, averaging 13% of floral visits across all networks (range 0-85%), with 5% of plant species recorded as being exclusively visited by A. mellifera For 33% of the networks and 49% of plant species, however, A. mellifera visitation was never observed, illustrating that many flowering plant taxa and assemblages remain dependent on non- A. mellifera visitors for pollination. Apis mellifera visitation was higher in warmer, less variable climates and on mainland rather than island sites, but did not differ between its native and introduced ranges. With respect to single-visit pollination effectiveness, A. mellifera did not differ from the average non- A. mellifera floral visitor, though it was generally less effective than the most effective non- A. mellifera visitor. Our results argue for a deeper understanding of how A. mellifera , and potential future changes in its range and abundance, shape the ecology, evolution, and conservation of plants, pollinators, and their interactions in natural habitats. © 2018 The Author(s).

Use of risk information in regulatory reviews

International Nuclear Information System (INIS)

Sagar, B.; Benke, R.; Mohanty, S.

2004-01-01

The regulatory framework for licensing any high-level waste repository at Yucca Mountain in the United States, calls for appropriate use of risk information to ensure operational safety during the pre-closure period and long-term safety during the post-closure period. This paper focuses on the post-closure period. Regulations in the Code of Federal Regulations (CFR), Title 10, Part 63, apply to any repository at Yucca Mountain and envision use of probabilistic methods to develop quantitative risk information. Accumulated engineering and scientific experience at Yucca Mountain and analog sites and quantitative risk information from studies conducted by the implementer, regulator, and others are combined to formulate 'risk insights,' which are then used to plan and execute regulatory reviews. The U.S. Nuclear Regulatory Commission (NRC) and the Center for Nuclear Waste Regulatory Analyses (CNWRA) recently consolidated the knowledge gained during several g ears and developed such risk insights for the potential repository at Yucca Mountain. This paper discusses the types of risk information used to generate risk insights and how the risk insights will be used in regulatory reviews. A companion paper presents more details on sensitivity analysis methods used to generate risk information. (authors)

Regulatory Powers in Public Procurement Law of Peruvian Administrative Agencies

Directory of Open Access Journals (Sweden)

Juan Carlos Morón Urbina

2017-12-01

Full Text Available Peruvian law has explicitly recognized regulatory powers to administrative agencies, which allows them to have a preponderant role in the production of rules in public procurement. Although these delegations of legislative authority are positively defined, distortions in the system of legal sources arise when agencies exceed delegated powers or when measures issued by administrative entities are mistaken for regulations. This paper aims to identify regulatory powers of Peruvian administrative agencies, as well as the regulatory measures they issue, and their relation with other sources of law.

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

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

Regulatory control of radiation sources and radioactive materials in the Czech Republic

International Nuclear Information System (INIS)

Drabova, D.; Prouza, Z.

2001-01-01

The paper describes legal and regulatory provisions for radiation protection and safe use of sources of ionizing radiation in the Czech Republic with special emphasis on aspects of bringing activities under regulatory control and releasing them from it. It covers the development of a new legal framework, the work of the regulatory body, an overview of sources in use and provisions to achieve effective regulatory control of facilities and releases of radioactive material into the environment. Also, it describes reported unusual events with a proposed scheme for their classification and evaluation. (author)

Regulatory reform in Mexico's natural gas sector

International Nuclear Information System (INIS)

1996-01-01

In recent years Mexico has implemented remarkable structural changes in its economy. However, until recently its large and key energy sector was largely unreformed. This is now changing. In 1995 the Mexican Government introduced legislative changes permitting private sector involvement in natural gas storage, transportation and distribution. Subsequent directives set up a detailed regulatory framework. These developments offer considerable promise, not only for natural gas sector development but also for growth in the closely linked electricity sector. This study analyses the changes which have taken place and the rationale for the regulatory framework which has been established. The study also contains recommendations to assist the Government of Mexico in effectively implementing its natural gas sector reforms and in maximizing the benefits to be realised through the new regulatory framework. (author)

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...

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...

Regulatory issues in merchant transmission investment

International Nuclear Information System (INIS)

Brunekreeft, G.

2005-01-01

Merchant investment in electricity transmission networks (MTI) is now legally allowed. Predominantly driven by the fear of underinvestment, regulators examine this possibility and given that MTI is a possibility, the regulators face a new set of questions. This paper raises and examines regulatory questions especially from a European institutional framework. The regulatory issues concern the competition effect, the ownership, access regime and the must-offer provision. The paper argues to leave light-handed unregulated MTI light handed and refrain from additional measures. In most cases, it is justified to refrain from sector-specific arrangements because competition,law, if necessary at all, will suffice. However, details matter. (author)

WNA's worldwide overview on front-end nuclear fuel cycle growth and health, safety and environmental issues.

Science.gov (United States)

Saint-Pierre, Sylvain; Kidd, Steve

2011-01-01

This paper presents the WNA's worldwide nuclear industry overview on the anticipated growth of the front-end nuclear fuel cycle from uranium mining to conversion and enrichment, and on the related key health, safety, and environmental (HSE) issues and challenges. It also puts an emphasis on uranium mining in new producing countries with insufficiently developed regulatory regimes that pose greater HSE concerns. It introduces the new WNA policy on uranium mining: Sustaining Global Best Practices in Uranium Mining and Processing-Principles for Managing Radiation, Health and Safety and the Environment, which is an outgrowth of an International Atomic Energy Agency (IAEA) cooperation project that closely involved industry and governmental experts in uranium mining from around the world. Copyright © 2010 Health Physics Society

National Program Initiative to Prevent Illicit Trafficking for Radioactive Materials Out of Regulatory Control at the Border

International Nuclear Information System (INIS)

Suharyanta, S.

2016-01-01

The existing function of regulatory authority in a country which use a lot of radioactive sources is important key. The regulatory body has to in a position independence from other operators and nuclear research centre activities, so that their justification on Regulatory objective of safety and security can be achieved. The essential function of regulatory authority has to be represented such as development regulations, perform review and assessment, inspection and enforcement, and emergency preparedness and response functions. Under regulatory object coverage is divided into two clusters i.e. licensed nuclear installation and radiation facilities clusters,. There is other regulatory object is radioactive material out of regulatory control. This kind object is new option in the county and there for need priority policy judgement. This paper will discuss the Regulatory infrastructure and functions and it focused on the experience about National Programme Initiative to Prevent Illicit Trafficking for Radioactive Materials out of Regulatory Control at the Border. Regulatory Infrastructure and Functions. In Indonesia the independent regulatory authority ''called BAPETEN'' has been established since early 2000 based on the Act No. 10 year 1997, independent from operator organization and other nuclear research centre. Organization structure of BAPETEN has defined main divisions dealing with developing regulations, perform review and assessments, inspection and enforcement, and emergency preparedness and response, and also covered assessment function as a backup technical support division as a think-tank functions. Regulatory objects are nuclear installations such as three research reactors, Fuel fabrication facility, Isotope production facility, and waste storage facility for spent fuel and dis-used radioactive sources is running well. Recently, Regulatory of radioactive sources out of regulatory control is a new challenges, they need strengthened

The Energy Regulatory Commission (1). Law of the Comision Reguladora de Energia

International Nuclear Information System (INIS)

1995-01-01

The Energy Regulatory Commission. Reforms to the Electric Energy Public Service Law (1992) and the Regulatory Law of Article 27 on Petroleum (1995) have brought about fundamental changes in the electric and natural gas industries. The legal reforms explicitly permit the private sector to construct, operate, and own, systems of electric generation and natural gas transportation, storage and distribution. The participation of the private sector in these areas required a redefinition in the government regulatory institutions. Accordingly the Federal Congress enacted the law of the Comision Reguladora de Energia (CRE) in 1995. The CRE law expands the scope of the CRE's authority and the breadth of its powers beyond those established when it was initially created in 1993. The CRE commenced operations in January 1994 as a decentralized technical and consultative body of the Energy Ministry. The decree that created the Commission limited the scope of its authority to an analysis and consultative role applicable only to the electric industry. (Author)

Regulatory System of Radiation Protection in Taiwan

International Nuclear Information System (INIS)

Tang, F. T.; Huang, C. C.

2004-01-01

After the radioactive contaminated buildings incident occurred in Taiwan in 1993, the competent authority for radiation protection the Atomic Energy Council (AEC) started to review the structured problem of radiation protection regulatory system. Through several years' investigation and study, the AEC has improved two important tools in radiation protection regulatory system, i.e., control regulations and actual practice, and made them more rigorous and efficient. This paper will make a brief introduction of the efforts that Taiwan has made in this respect. Taiwan's radiation protection control was based on the Atomic Energy Law promulgated in 1968, but the control idea and authorization scope were not sufficient to appropriately respond to the highly developed economy and democracy in Taiwan. After several years' legislative process, the Ionizing Radiation Protection Law (IRP Law) was promulgated and entered into force on February 1, 2003. This IRP Law specifically emphasizes categorized risk management of radiation sources, establishment of personnel licenses and training system, enhancement of public safety control, and implementation of quality assurance program for medical exposure. The Legislative Yuan (Congress) fully authorized the competent authority to establish various technological control regulations according to control necessity without prior review by the Legislative Yuan in advance. As to the penalties of the violations of the IRP Law, the AEC adopts high-rated administrative fines and applies the Criminal Law to those who seriously contaminate the environment. In actual practice, the AEC has constructed a Radiation Protection Control Information System compatible with the IRP Law that fully combines the functions of computers and Internet. The information of facility operators who own radiation sources, radiation protection specialists, and operating personnel are entered into this system, starting from the submission of application of the

The Regulatory Evaluation of Vaccines for Human Use.

Science.gov (United States)

Baylor, Norman W

2016-01-01

A vaccine is an immunogen, the administration of which is intended to stimulate the immune system to result in the prevention, amelioration, or therapy of any disease or infection (US Food and Drug Administration. Guidance for Industry: content and format of chemistry, manufacturing, and controls information and establishment description information for a vaccine or related product). A vaccine may be a live attenuated preparation of microorganisms, inactivated (killed) whole organisms, living irradiated cells, crude fractions, or purified immunogens, including those derived from recombinant DNA in a host cell, conjugates formed by covalent linkage of components, synthetic antigens, polynucleotides (such as the plasmid DNA vaccines), living vectored cells expressing specific heterologous immunogens, or cells pulsed with immunogen. Vaccines are highly complex products that differ from small molecule drugs because of the biological nature of the source materials such as those derived from microorganisms as well as the various cell substrates from which some are derived. Regardless of the technology used, because of their complexities, vaccines must undergo extensive characterization and testing. Special expertise and procedures are needed for their manufacture, control, and regulation. The Food and Drug Administration (FDA) is the National Regulatory Authority (NRA) in the United States responsible for assuring quality, safety, and effectiveness of all human medical products, including vaccines for human use.The Center for Biologics Evaluation and Research (CBER) within the US FDA is responsible for overseeing the regulation of therapeutic and preventative vaccines against infectious diseases. Authority for the regulation of vaccines resides in Section 351 of the Public Health Service Act and specific sections of the Federal Food, Drug, and Cosmetic Act (FD&C). Vaccines are regulated as biologics and licensed based on the demonstration of safety and effectiveness. The

Technical Support Organization Knowledge Management for Nuclear Regulatory Support

International Nuclear Information System (INIS)

Kohut, P.; Ramsey, J.; Katsenelenbogen, S.

2016-01-01

Full text: Knowledge management awareness has increased through the nuclear industrial and regulatory community leading to better understanding of the handling of critical information. Utilizing, managing and regulating the application of nuclear power require an extensive system of expertise and associated research through established organizations. The long term maintenance of the specific expertise is only viable by using scientific knowledge management principles all through the national nuclear infrastructure involving regulatory, industrial, academic and other research institutions. National governments in countries operating or planning to establish nuclear facilities have instituted regulatory regimes on the use of nuclear materials and facilities to insure a high level of operational safety. (author

National system of notification, authorization and inspection for the control of radiation sources in Ghana

International Nuclear Information System (INIS)

Schandorf, C.; Darko, E.O.; Yeboah, J.; Asiamah, S.D.

2001-01-01

The Radiation Protection Board (RPB) was established in 1993 in Ghana as the regulatory authority for radiation protection and safety of radiation sources; its functions are prescribed in the 1993 national radiation protection regulation. The report describes how the country's radiation protection and safety infrastructure have been established, including the RPB's organizational structure, with reference in particular to the main activities carried out by both the Regulatory Control Department and the Radiation and Waste Safety Department. It also briefly mentions the existing RPB human resources; the national system of notification, authorization and inspection of radiation sources; the inventory of radiation sources; and the management of disused radiation sources. Finally, the report identifies the two main problem areas regarding the regulatory control of radiation sources in the country. (author)

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.).

77 FR 27529 - Self-Regulatory Organizations; ICE Clear Credit LLC; Order Granting Accelerated Approval of...

Science.gov (United States)

2012-05-10

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66922; File No. SR-ICC-2012-05] Self-Regulatory... Commission to approve a proposed rule change of a self-regulatory organization if it finds that such proposed... of the Comptroller of the Currency, U.K. Financial Services Authority, or any other regulatory body...

Elecnuc. Nuclear power plants worldwide

International Nuclear Information System (INIS)

1998-01-01

This small folder presents a digest of some useful information concerning the nuclear power plants worldwide and the situation of nuclear industry at the end of 1997: power production of nuclear origin, distribution of reactor types, number of installed units, evolution and prediction of reactor orders, connections to the grid and decommissioning, worldwide development of nuclear power, evolution of power production of nuclear origin, the installed power per reactor type, market shares and exports of the main nuclear engineering companies, power plants constructions and orders situation, evolution of reactors performances during the last 10 years, know-how and development of nuclear safety, the remarkable facts of 1997, the future of nuclear power and the energy policy trends. (J.S.)

Approach for assessing the effectiveness of regulatory control in Peru using performance indicators

International Nuclear Information System (INIS)

Ramirez Quijada, R.

1998-01-01

The paper is intended to make an approach for assessing the effectiveness of regulatory activities in Peru by using of performance indicators for each of the activities developed pursuant their responsibilities. So inspections, authorizations, enforcement and regulation activities are qualified by levels of attainments and then assessed independently to rise specific issues. The general conclusion is that regulatory activities seems to be acceptable but some improvements are needed in order to reach a good level of performance. (author)

Continuous Improvement of the Regulatory Framework for the Control of Medical Exposure

International Nuclear Information System (INIS)

Larcher, A.M.; Ortiz lopez, Pedro; Arias, Cesar; Marechal, Maria H.; Hernandez Alvarez, Ramon; Ferrer Garcia, Natividad; Castaneda Mucino, Antonia; Faller, Blanca

2011-01-01

Background: One of the key elements to guide the improvement of the regulatory control is the availability of a self-assessment tool for regulatory performance. Although there is general guidance on self-assessment for regulators and users (IAEA), there is a need for specific advice on how to address challenges and difficulties faced by regulatory bodies, when regulating radiation protection of patients. Examples of these challenges are the need of regulatory initiatives, in cooperation with health and education authorities, professional bodies and equipment suppliers, and to put in place necessary elements that are beyond responsibility of individual users of radiation, to enable them compliance with safety standards. Purpose: within the programme of the Ibero American Forum of Nuclear and Radiation Safety Regulatory Organizations, a project to develop such a self assessment tool for the regulatory control of medical exposure has been designed. Method: national experiences in transposing and enforcing the international radiation safety standards, as to how the requirements are included in national regulations are reviewed. Further, difficulties to the implementation of safety requirements are included in national regulations are analyzed and a self assessment approach and possible regulatory solutions are presented. Results and discussion: in tis study the following documents are being produced: 1) Transposition of international requirements into national regulations in the six countries of the Forum, 2) difficulties to implement and enforce the requirements, 3) guidance on self assessment of regulatory framework for medical exposure, 4) suggested contribution to the revision of international radiation safety standards. (authors)

Nuclear regulatory communication with the public: 10 years of progress

International Nuclear Information System (INIS)

Gauvain, J.; Jorle, A.; Chanial, L.

2008-01-01

The NEA has an acknowledged role to assist its member countries in maintaining and developing, through international co-operation, the scientific, technological and legal bases required for a safe, environmentally friendly and economical use of nuclear energy. In this context, the NEA Committee on Nuclear Regulatory Activities (CNRA) provides a forum for senior representatives from nuclear regulatory bodies to exchange information and experience on nuclear regulatory policies and practices in NEA member countries and to review developments which could affect regulatory requirements. Public confidence in government and in risk management structures is important to all developed countries with an open society. The use of nuclear power in a democracy is built upon a certain trust in the political system and the national authorities. To foster and maintain such trust in a period of greater public scrutiny of nuclear activities, a number of nuclear regulatory organisations (NROs) initiated various processes to pro-actively inform the public about their supervision and control of nuclear activities, or when appropriate to involve the public in decision making. In 1998 the question was raised within the CNRA of whether public trust in the regulator might be very different from one country to another, and an activity was started among member countries to exchange experience and best practices and to learn lessons about NRO communication with their publics. Three workshops were organised by the NEA, and a Working Group on Public Communication of Nuclear Regulatory Organisations was set up in 2001. The activities and findings are summarised below. (author)

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.

Schedules for Regulatory Regimes

International Nuclear Information System (INIS)

Austvik, Ole Gunnar

2003-01-01

The idea of regulating transporters' terms of operations is that if the market itself does not produce optimal outcomes, then it can be mimicked to do so through regulatory and other public instruments. The first-best solution could be a subsidized (publicly owned) enterprise that sets tariffs according to marginal costs. This has been the tradition in many European countries in the aftermath of WW2. Due to lack of innovative pressure on and x-inefficiency in these companies, this solution is today viewed as inferior to the system of regulating independent (privately owned) firms. When the European gas market becomes liberalized, part of the process in many countries is to (partially) privatise the transport utilities. Privatised or not, in a liberalized market, the transport utilities should face an independent authority that overviews their operations not only in technical, but also in economic terms. Under regulation, a ''visible hand'' is introduced to correct the imperfect market's ''invisible hand''. By regulating the framework and conditions for how firms may operate, public authorities seek to achieve what is considered optimal for the society. The incentives and disincentives given for pricing and production should create mechanisms leading to an efficient allocation of resources and ''acceptable'' distribution of income. As part of intervening into firms' behavior, regulation may be introduced to direct the firm to behave in certain ways. The framework and regulatory mechanisms for the market must then be constructed in a way that companies voluntarily produce an amount at a price that gives maximal profits and simultaneously satisfies social goals. The regulations should lead to consistency between the company's desire to maximize profits and the society's desire for maximizing welfare, as in a perfectly competitive market. This is the core of regulatory economics

Regulatory activities related with the modification of the frequency of the programmed stoppings of the Argentine nuclear centrals

International Nuclear Information System (INIS)

Marino, E.; Calvo, J.; Waldman, R.; Navarro, R.

2006-01-01

The mandatory character documentation of the Argentinean nuclear power stations in Embalse and Atucha I, required the realization of a programmed stoppings every twelve months to execute that settled down in the maintenance and surveillance programs for each installation. Nucleoelectrica Argentina S.A., in it character of Responsible Entity of the operation of these power stations, requested to the Argentinean Nuclear Regulatory Authority, in 2003 and 2005 respectively, the authorization to change the period of the repetitive tests and of the preventive maintenance of the systems related with the safety, to extend them from twelve to eighteen months. The mentioned applications were founded in economic aspects and in inclining to a decrease in the doses of the workers that perform in the activities that are carried out in the programmed stops. The adopted position by the Nuclear Regulatory Authority to decide on these applications was based on the result of diverse evaluations that included the use of the Probabilistic Analysis of Safety specific of each power station, the operative experience resultant of the execution of the preventive maintenance program, and of the results of the repetitive tests and of the inspections in service. The regulatory decisions were different in each case. Indeed, the Embalse nuclear power station was authorized by the Regulatory Authority to modify from twelve to eighteen months the period among the realization of the repetitive tests and of the preventive maintenance, conditioned to the execution of some specific regulatory requirements. On the other hand, the Atucha I nuclear power station was not authorized to modify this period. In this presentation that is detailed the acted by the Nuclear Regulatory Authority in both cases, the used analysis tools, and the foundation of the adopted decisions. (Author)

Current status of developmental neurotoxicity: regulatory view

DEFF Research Database (Denmark)

Hass, Ulla

2003-01-01

in the testing strategy for new and existing substances, and biocides. Hopefully, this will lead to an improved database for risk assessment of potential developmental neurotoxicants. However, the regulatory authorities and toxicologists will also be faced with the challenge that decisions have to be made......The need for developmental neurotoxicity testing has been recognized for decades and guidelines are available, as the USEPA guideline and the OECD draft TG 426. Regulatory testing of industrial chemicals for developmental neurotoxicity is required to some extent, especially for pesticides in the US....... Until recently, however, developmental neurotoxicity testing of industrial chemicals has not been a clear regulatory requirement in EU, probably due to the lack of an accepted OECD TG. The revised EU Technical Guidance Document for Risk Assessment (EU-TGD) has now included the OECD draft TG 426...

Regulatory control and management of radioactive materials in the Philippines

International Nuclear Information System (INIS)

Borras, A.M.; Parami, V.K.; Domondon, D.B.

2001-01-01

The Philippine Nuclear Research Institute (PNRI) by virtue of Republic Act 2067, as amended, Republic Act 5207 and Executive Order 128 (1987), was mandated to promote, advance and regulate the safe and peaceful applications of nuclear science and technology in the Philippines. The PNRI was formerly the Philippine Atomic Energy Commission, established in 1958. This report aims to share the information and experience of PNRI as a regulatory authority on the administrative, technical and managerial aspects to ensure the safety and security of radioactive material in the country. It describes the country's regulatory framework, operational experiences, international co-operation including reporting system and database, and radiological safety assessment and compliance monitoring. It also briefly discusses the current development of the country's radiological emergency response plan and the radiation protection services offered by the PNRI. In the discussion and recommendations, some of the results of the regulatory information conferences conducted with the end-users are enumerated. (author)

Foreshock occurrence rates before large earthquakes worldwide

Science.gov (United States)

Reasenberg, P.A.

1999-01-01

Global rates of foreshock occurrence involving shallow M ??? 6 and M ??? 7 mainshocks and M ??? 5 foreshocks were measured, using earthquakes listed in the Harvard CMT catalog for the period 1978-1996. These rates are similar to rates ones measured in previous worldwide and regional studies when they are normalized for the ranges of magnitude difference they each span. The observed worldwide rates were compared to a generic model of earthquake clustering, which is based on patterns of small and moderate aftershocks in California, and were found to exceed the California model by a factor of approximately 2. Significant differences in foreshock rate were found among subsets of earthquakes defined by their focal mechanism and tectonic region, with the rate before thrust events higher and the rate before strike-slip events lower than the worldwide average. Among the thrust events a large majority, composed of events located in shallow subduction zones, registered a high foreshock rate, while a minority, located in continental thrust belts, measured a low rate. These differences may explain why previous surveys have revealed low foreshock rates among thrust events in California (especially southern California), while the worldwide observations suggest the opposite: California, lacking an active subduction zone in most of its territory, and including a region of mountain-building thrusts in the south, reflects the low rate apparently typical for continental thrusts, while the worldwide observations, dominated by shallow subduction zone events, are foreshock-rich.

Technical nuclear safety in France. Control by the governmental authority

International Nuclear Information System (INIS)

1991-12-01

In publishing this latest edition, we have endeavoured to provide the reader with the information necessary to obtain a full understanding of the regulatory system applied to ensure technical nuclear safety in France. As the reader will discover in the following pages, technical nuclear safety is a matter which must be settled in advance of the actual operation of civil nuclear installations; the primary requirement is to mobilize those involved to anticipate and prevent. The fundamental options on which the French system is based, the relationship between the operator and the safety authority must be clearly stated: independence of judgement and decision, complementarity of responsibilities. It is for the governmental authorities to determine the technical nuclear safety objectives, which are becoming more and more consistent if not unified throughout the world. It is for the operator to propose technical provisions in order to achieve these objectives. It is for the governmental authorities to verify, by technical safety analyses, the adequacy of the provisions in terms of the defined objectives. It is for the operator to properly implement these approved provisions. And, finally, it is for the governmental authorities to verify, by sampling, the quality of their implementation and to make from them the necessary regulatory inferences. This sequence of events requires permanent frank in-depth dialogue. The effectiveness of the regulatory action must therefore reside not in close technical restraint but in the interactions between responsible partners

Technical nuclear safety in France. Control by the governmental authority

Energy Technology Data Exchange (ETDEWEB)

NONE

1991-12-15

In publishing this latest edition, we have endeavoured to provide the reader with the information necessary to obtain a full understanding of the regulatory system applied to ensure technical nuclear safety in France. As the reader will discover in the following pages, technical nuclear safety is a matter which must be settled in advance of the actual operation of civil nuclear installations; the primary requirement is to mobilize those involved to anticipate and prevent. The fundamental options on which the French system is based, the relationship between the operator and the safety authority must be clearly stated: independence of judgement and decision, complementarity of responsibilities. It is for the governmental authorities to determine the technical nuclear safety objectives, which are becoming more and more consistent if not unified throughout the world. It is for the operator to propose technical provisions in order to achieve these objectives. It is for the governmental authorities to verify, by technical safety analyses, the adequacy of the provisions in terms of the defined objectives. It is for the operator to properly implement these approved provisions. And, finally, it is for the governmental authorities to verify, by sampling, the quality of their implementation and to make from them the necessary regulatory inferences. This sequence of events requires permanent frank in-depth dialogue. The effectiveness of the regulatory action must therefore reside not in close technical restraint but in the interactions between responsible partners.

Regulatory body core competencies: when should a regulator contract a TSO?

International Nuclear Information System (INIS)

Wieland, Patricia; Salati de Almeida, Ivan P.; Almeida, Claudio U.; Costa, Eduardo M.

2008-01-01

The main nuclear regulatory functions are authorization, safety review and assessment, inspection and enforcement and development of regulations and guides. Additionally, the following supplementary functions may be executed by the regulatory body: research and development, emergency response and international cooperation. In order to function properly, the regulatory body should also have the following support functions: general management, logistics, training, communication and information, information technology support, institutional relationship, internal controls and audits, ombudsman and legal support. Technical Support Organizations (TSOs) may assist the regulatory body in meeting the challenges in a rapid growing and changing environment. Specially when there is a temporary need for a wider technical expertise diversity, short time to finish a project or when the cost of developing and maintaining infrastructure of their own laboratories for analysis and research is too high and may deviate the focus on the regulator's mission. Decision on the 'size' of the regulatory body and on what can be contracted to a Technical Support Organization (TSO) depends on the resources and capabilities needed to fulfil the regulatory functions efficiently. It is important to establish the core competencies that must be at the regulatory body, keeping the focus on the regulatory goals and define the real need to contract a TSO, weighting the benefits and disadvantages. As a contribution to the definition of the regulatory core competencies, the paper discusses what is essential to be kept at the regulatory body and what can be delegated to a TSO; how to manage and control the work of the TSO; the cost effectiveness of contracting, sharing of tacit knowledge; how to handle eventual conflicts between the parties involved in the licensing process; contract types and risk evaluation, concerning the dependence on a TSO, eventual change of partners and the intellectual capital

Global Regulatory T-Cell Research from 2000 to 2015: A Bibliometric Analysis.

Directory of Open Access Journals (Sweden)

Yin Zongyi

Full Text Available We aimed to analyze the global scientific output of regulatory T-cell (Treg research and built a model to qualitatively and quantitatively evaluate publications from 2000 to 2015. Data were obtained from the Web of Science Core Collection (WoSCC of Thomson Reuters on January 1, 2016. The bibliometric method and Citespace III were used to analyze authors, journals, publication outputs, institutions, countries, research areas, research hotspots, and trends. In total, we identified 35,741 publications on Treg research from 2000 to 2015, and observed that the annual publication rate increased with time. The Journal of Immunology published the highest number of articles, the leading country was the USA, and the leading institute was Harvard University. Sakaguchi, Hori, Fontenot, and Wang were the top authors in Treg research. Immunology accounted for the highest number of publications, followed by oncology, experimental medicine, cell biology, and hematology. Keyword analysis indicated that autoimmunity, inflammation, cytokine, gene expression, foxp3, and immunotherapy were the research hotspots, whereas autoimmune inflammation, gene therapy, granzyme B, RORγt, and th17 were the frontiers of Treg research. This bibliometric analysis revealed that Treg-related studies are still research hotspots, and that Treg-related clinical therapies are the research frontiers; however, further study and collaborations are needed worldwide. Overall, our findings provide valuable information for the editors of immunology journals to identify new perspectives and shape future research directions.

Interactions of severe accident research and regulatory positions (ISARRP)

International Nuclear Information System (INIS)

Sehgal, B.R.

2001-12-01

The work Programme of the ISARRP Project was divided into several work packages. The work was conducted in the form of presentations and discussions, held during several meetings whose character was that of workshops. Short reports were prepared by the partners assigned to each task. Work Package 1: Critical review of the SA phenomenological research. The objective of this work package was to consider the progress made world-wide in research on the resolution of the outstanding phenomenological issues posed by severe accidents. Work Package 2: Relevance of severe accident research to SAMG requirements and implementation. The objective of this work package was to relate the progress made in the resolution of the SA issues to the practical matter of what results are required or have been used for the management of severe accidents. Clearly, the SAMG is the most important avenue employed by the regulatory organizations to assure themselves of the safe (from public perspective) performance of a nuclear plant in a postulated severe accident event. Work Package 3: Relevance of severe accident research to PSA and the risk informed regulatory approach. The objectives of this work package is to relate the results obtained by the severe accident research to the requirements of a PSA and of the new trend of employing the risk informed approach in promulgating regulations. Clearly a PSA identifies vulnerabilities in the knowledge base, however, their importance is decidedly plant specific. Nevertheless the uncertainties in the phenomenology or in resolution of issues lead to uncertainties in the PSA conclusions and in the adoption of the risk informed approach. Work Package 4: Questionnaire and the evaluation of responses to the questions. The purpose of this work package is to solicit the views of the regulatory organizations towards the results of the SA research and the benefits they have derived from it in terms of regulatory actions, or in the confidence they have gained

Interactions of severe accident research and regulatory positions (ISARRP)

Energy Technology Data Exchange (ETDEWEB)

Sehgal, B.R. (comp.) [Royal Inst. of Tech., Stockholm (Sweden). Nuclear Power Safety

2001-12-01

The work Programme of the ISARRP Project was divided into several work packages. The work was conducted in the form of presentations and discussions, held during several meetings whose character was that of workshops. Short reports were prepared by the partners assigned to each task. Work Package 1: Critical review of the SA phenomenological research. The objective of this work package was to consider the progress made world-wide in research on the resolution of the outstanding phenomenological issues posed by severe accidents. Work Package 2: Relevance of severe accident research to SAMG requirements and implementation. The objective of this work package was to relate the progress made in the resolution of the SA issues to the practical matter of what results are required or have been used for the management of severe accidents. Clearly, the SAMG is the most important avenue employed by the regulatory organizations to assure themselves of the safe (from public perspective) performance of a nuclear plant in a postulated severe accident event. Work Package 3: Relevance of severe accident research to PSA and the risk informed regulatory approach. The objectives of this work package is to relate the results obtained by the severe accident research to the requirements of a PSA and of the new trend of employing the risk informed approach in promulgating regulations. Clearly a PSA identifies vulnerabilities in the knowledge base, however, their importance is decidedly plant specific. Nevertheless the uncertainties in the phenomenology or in resolution of issues lead to uncertainties in the PSA conclusions and in the adoption of the risk informed approach. Work Package 4: Questionnaire and the evaluation of responses to the questions. The purpose of this work package is to solicit the views of the regulatory organizations towards the results of the SA research and the benefits they have derived from it in terms of regulatory actions, or in the confidence they have gained

50 CFR 23.6 - What are the roles of the Management and Scientific Authorities?

Science.gov (United States)

2010-10-01

... and Scientific Authorities? Under Article IX of the Treaty, each Party must designate a Management and... designated the Scientific Authority and Management Authority, which for purposes of this section includes FWS... primarily with management and regulatory issues and the Scientific Authority is responsible for dealing...

Steps towards the international regulatory acceptance of non-animal methodology in safety assessment.

Science.gov (United States)

Sewell, Fiona; Doe, John; Gellatly, Nichola; Ragan, Ian; Burden, Natalie

2017-10-01

The current animal-based paradigm for safety assessment must change. In September 2016, the UK National Centre for Replacement, Refinement and Reduction of Animals in Research (NC3Rs) brought together scientists from regulatory authorities, academia and industry to review progress in bringing new methodology into regulatory use, and to identify ways to expedite progress. Progress has been slow. Science is advancing to make this possible but changes are necessary. The new paradigm should allow new methodology to be adopted once it is developed rather than being based on a fixed set of studies. Regulatory authorities can help by developing Performance-Based Standards. The most pressing need is in repeat dose toxicology, although setting standards will be more complex than in areas such as sensitization. Performance standards should be aimed directly at human safety, not at reproducing the results of animal studies. Regulatory authorities can also aid progress towards the acceptance of non-animal based methodology by promoting "safe-haven" trials where traditional and new methodology data can be submitted in parallel to build up experience in the new methods. Industry can play its part in the acceptance of new methodology, by contributing to the setting of performance standards and by actively contributing to "safe-haven" trials. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Regulatory Accessibility and Social Influences on State Self-Control

OpenAIRE

vanDellen, Michelle R.; Hoyle, Rick H.

2009-01-01

The current work examined how social factors influence self-control. Current conceptions of state self-control treat it largely as a function of regulatory capacity. The authors propose that state self-control might also be influenced by social factors because of regulatory accessibility. Studies 1 through 4 provide evidence that individuals’ state self-control is influenced by the trait and state self-control of salient others such that thinking of others with good trait or state self-contro...

MIMAS, setting the world-wide standard for plutonium recycling

International Nuclear Information System (INIS)

Vandergheynst Alain; Yvon Vanderborck

2005-01-01

Deployment of MIMAS MOX fuel irradiation started in 1985 with loading and irradiation in French 900 MWe PWR of EDF. A 20-year comprehensive R and D programme preceded it. This success was greatly facilitated by some early strategy advantages: 1) Development and licensing of a 'UO 2 -like' MOX fuel rod fully interchangeable with UO 2 rods; 2) Joint SCK/BN operation of the BR2 (MTR) and BR3 (PWR) reactors, pilot and industrial MOX fuel plants, PIE hot laboratories in the Mol/Dessel site. The period since 1985 saw the occurrence of some concurrent facts, that have incontestably led MIMAS to the world-wide leader position (99 % of actual MOX fuel is MIMAS): 1) BN-MIMAS has been selected by Cogema for its plants MELOX and Cadarache and has demonstrated to be a flexible, scalable, and industrial process. 2) MIMAS has been further selected by JNFL for its Japanese domestic MOX plant (Rokkasho-mura) and by US-DOE for its domestic MOX plant (Savannah-NC) for the disposition of 34-ton weapon-Pu. 3) Satisfactory fabrication and irradiation over 1840 metric tons of MIMAS MOX fuel. In order to face the worldwide on-going electricity market liberalisation, MIMAS makers and vendors must definitely improve the MOX performances to compete with continuously improving UO 2 fuel. The facing of this continuous challenge is also reviewed in the paper. (authors)

Smoking in Correctional Settings Worldwide: Prevalence, Bans, and Interventions.

Science.gov (United States)

Spaulding, Anne C; Eldridge, Gloria D; Chico, Cynthia E; Morisseau, Nancy; Drobeniuc, Ana; Fils-Aime, Rebecca; Day, Carolyn; Hopkins, Robyn; Jin, Xingzhong; Chen, Junyu; Dolan, Kate A

2018-06-01

Smoking tobacco contributes to 11.5% of deaths worldwide and, in some countries, more hospitalizations than alcohol and drugs combined. Globally in 2015, 25% of men and 5% of women smoked. In the United States, a higher proportion of people in prison smoke than do community-dwelling individuals. To determine smoking prevalence in prisons worldwide, we systematically reviewed the literature using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines; we also examined whether prisons banned smoking or treated smokers. We searched databases for articles published between 2012 and 2016 and located 85 relevant articles with data representing 73.5% of all incarcerated persons from 50 countries. In 35 of 36 nations (97%) with published prevalence data, smoking for the incarcerated exceeded community rates 1.04- to 62.6-fold. Taking a conservative estimate of a 2-fold increase, we estimated that, globally, 14.5 million male and 26,000 female smokers pass through prisons annually. Prison authorities' responses include permitting, prohibiting, or treating tobacco use. Bans may temporarily improve health and reduce in-prison health care costs but have negligible effect after prison release. Evidence-based interventions for smoking cessation effective outside prisons are effective inside; effects persist after release. Because smoking prevalence is heightened in prisons, offering evidence-based interventions to nearly 15 million smokers passing through yearly would improve global health.

Regulatory control of radiation sources in Germany

International Nuclear Information System (INIS)

Coy, K.

1998-01-01

The regulatory programme governing the safe use of radioisotopes in Germany is based on the federal legislation enacted as Atomic Energy Control Act (Atomgesetz) and Radiation Protection Ordinance (Strahlen-schutzverordnung) and its implementation by the competent authorities of the individual states. Despite this highly decentralized infrastructure of enforcement the basic principles of regulations described in this paper such as authorization criteria, conditions imposed as well as depth and intensity of inspection balanced according to the individual radiation hazard involved are harmonized to the greatest possible extent by regular coordination among the competent authorities as well as a series of technical regulations such as standards and guidelines. (author)

TSO support to safety authorities in new reactor licensing

Energy Technology Data Exchange (ETDEWEB)

Numark, N.J.; Bowling, M.L. [Numark Associates, Inc., Washington, DC (United States)

2013-07-01

Technical Support Organizations (TSOs) can provide review assistance to a safety authority in a cost-effective and timely manner. TSO scope tailored to safety authority needs. TSOs must understand and adhere to safety authority priorities and culture. TSOs must be flexible in regulatory approaches, work locations, time zones, and languages. Safety authorities have varying technical support needs. For instance, authorities may have substantial staff and expertise on various types of commercial Nuclear Power Plants (NPP), substantial staff and expertise on a single type of commercial NPP, limited staff but with expertise on commercial NPPs or limited staff and no expertise on commercial NPPs.

National competent authorities responsible for approvals and authorizations in respect of the transport of radioactive material. List no. 20

International Nuclear Information System (INIS)

1989-03-01

Any national or international authority designated or otherwise recognised as such for any purpose in connection with the transport Regulations is known as a competent authority. In the Member States such a body has the responsibility for establishing national legislation to bring the Agency's transport Regulations into effect and for assuring compliance with its requirements. Depending on the national regulatory or institutional framework the functions of the competent authority may be assigned to one or more bodies. To assist Member States in implementing the transport Regulations and carrying out responsibility for compliance assurance, the IAEA continues to maintain this updated list of designated national competent authorities. Member States are annually requested to verify the list for correctness and completeness

National competent authorities responsible for approvals and authorizations in respect of the transport of radioactive material. List no. 24

International Nuclear Information System (INIS)

1993-01-01

Any national or international authority designated or otherwise recognised as such for any purpose in connection with the transport Regulations is known as a competent authority. In the Member States such a body has the responsibility for establishing national legislation to bring the Agency's transport Regulations into effect and for assuring compliance with its requirements. Depending on the national regulatory or institutional framework the functions of the competent authority may be assigned to one or more bodies. To assist Member States in implementing the transport Regulations and carrying out responsibility for compliance assurance, the IAEA continues to maintain this updated list of designated national competent authorities. Member States are annually requested to verify the list for correctness and completeness

National competent authorities responsible for approvals and authorizations in respect of the transport of radioactive material. List no. 20

Energy Technology Data Exchange (ETDEWEB)

NONE

1989-03-01

Any national or international authority designated or otherwise recognised as such for any purpose in connection with the transport Regulations is known as a competent authority. In the Member States such a body has the responsibility for establishing national legislation to bring the Agency's transport Regulations into effect and for assuring compliance with its requirements. Depending on the national regulatory or institutional framework the functions of the competent authority may be assigned to one or more bodies. To assist Member States in implementing the transport Regulations and carrying out responsibility for compliance assurance, the IAEA continues to maintain this updated list of designated national competent authorities. Member States are annually requested to verify the list for correctness and completeness.

National competent authorities responsible for approvals and authorizations in respect of the transport of radioactive material. List no. 25

Energy Technology Data Exchange (ETDEWEB)

NONE

1994-01-01

Any national or international authority designated or otherwise recognised as such for any purpose in connection with the transport Regulations is known as a competent authority. In the Member States such a body has the responsibility for establishing national legislation to bring the Agency's transport Regulations into effect and for assuring compliance with its requirements. Depending on the national regulatory or institutional framework the functions of the competent authority may be assigned to one or more bodies. To assist Member States in implementing the transport Regulations and carrying out responsibility for compliance assurance, the IAEA continues to maintain this updated list of designated national competent authorities. Member States are annually requested to verify the list for correctness and completeness.

National competent authorities responsible for approvals and authorizations in respect of the transport of radioactive material. List no. 19

Energy Technology Data Exchange (ETDEWEB)

NONE

1988-01-01

Any national or international authority designated or otherwise recognised as such for any purpose in connection with the transport Regulations is known as a competent authority. In the Member States such a body has the responsibility for establishing national legislation to bring the Agency's transport Regulations into effect and for assuring compliance with its requirements. Depending on the national regulatory or institutional framework the functions of the competent authority may be assigned to one or more bodies. To assist Member States in implementing the transport Regulations and carrying out responsibility for compliance assurance, the IAEA continues to maintain this updated list of designated national competent authorities. Member States are annually requested to verify the list for correctness and completeness.

National competent authorities responsible for approvals and authorizations in respect of the transport of radioactive material. List no. 18

Energy Technology Data Exchange (ETDEWEB)

NONE

1986-12-01

Any national or international authority designated or otherwise recognised as such for any purpose in connection with the transport Regulations is known as a competent authority. In the Member States such a body has the responsibility for establishing national legislation to bring the Agency's transport Regulations into effect and for assuring compliance with its requirements. Depending on the national regulatory or institutional framework the functions of the competent authority may be assigned to one or more bodies. To assist Member States in implementing the transport Regulations and carrying out responsibility for compliance assurance, the IAEA continues to maintain this updated list of designated national competent authorities. Member States are annually requested to verify the list for correctness and completeness.

National competent authorities responsible for approvals and authorizations in respect of the transport of radioactive material. List no. 19

International Nuclear Information System (INIS)

1988-01-01

Any national or international authority designated or otherwise recognised as such for any purpose in connection with the transport Regulations is known as a competent authority. In the Member States such a body has the responsibility for establishing national legislation to bring the Agency's transport Regulations into effect and for assuring compliance with its requirements. Depending on the national regulatory or institutional framework the functions of the competent authority may be assigned to one or more bodies. To assist Member States in implementing the transport Regulations and carrying out responsibility for compliance assurance, the IAEA continues to maintain this updated list of designated national competent authorities. Member States are annually requested to verify the list for correctness and completeness

National competent authorities responsible for approvals and authorizations in respect of the transport of radioactive material. List no. 25

International Nuclear Information System (INIS)

1994-01-01

Any national or international authority designated or otherwise recognised as such for any purpose in connection with the transport Regulations is known as a competent authority. In the Member States such a body has the responsibility for establishing national legislation to bring the Agency's transport Regulations into effect and for assuring compliance with its requirements. Depending on the national regulatory or institutional framework the functions of the competent authority may be assigned to one or more bodies. To assist Member States in implementing the transport Regulations and carrying out responsibility for compliance assurance, the IAEA continues to maintain this updated list of designated national competent authorities. Member States are annually requested to verify the list for correctness and completeness

National competent authorities responsible for approvals and authorizations in respect of the transport of radioactive material. List no. 18

International Nuclear Information System (INIS)

1986-12-01

Any national or international authority designated or otherwise recognised as such for any purpose in connection with the transport Regulations is known as a competent authority. In the Member States such a body has the responsibility for establishing national legislation to bring the Agency's transport Regulations into effect and for assuring compliance with its requirements. Depending on the national regulatory or institutional framework the functions of the competent authority may be assigned to one or more bodies. To assist Member States in implementing the transport Regulations and carrying out responsibility for compliance assurance, the IAEA continues to maintain this updated list of designated national competent authorities. Member States are annually requested to verify the list for correctness and completeness

National competent authorities responsible for approvals and authorizations in respect of the transport of radioactive material. List no. 21

International Nuclear Information System (INIS)

1990-02-01

Any national or international authority designated or otherwise recognised as such for any purpose in connection with the transport Regulations is known as a competent authority. In the Member States such a body has the responsibility for establishing national legislation to bring the Agency's transport Regulations into effect and for assuring compliance with its requirements. Depending on the national regulatory or institutional framework the functions of the competent authority may be assigned to one or more bodies. To assist Member States in implementing the transport Regulations and carrying out responsibility for compliance assurance, the IAEA continues to maintain this updated list of designated national competent authorities. Member States are annually requested to verify the list for correctness and completeness

National competent authorities responsible for approvals and authorizations in respect of the transport of radioactive material. List no. 23

International Nuclear Information System (INIS)

1992-01-01

Any national or international authority designated or otherwise recognised as such for any purpose in connection with the transport Regulations is known as a competent authority. In the Member States such a body has the responsibility for establishing national legislation to bring the Agency's transport Regulations into effect and for assuring compliance with its requirements. Depending on the national regulatory or institutional framework the functions of the competent authority may be assigned to one or more bodies. To assist Member States in implementing the transport Regulations and carrying out responsibility for compliance assurance, the IAEA continues to maintain this updated list of designated national competent authorities. Member States are annually requested to verify the list for correctness and completeness

National competent authorities responsible for approvals and authorizations in respect of the transport of radioactive material. List no. 22

International Nuclear Information System (INIS)

1991-01-01

Any national or international authority designated or otherwise recognised as such for any purpose in connection with the transport Regulations is known as a competent authority. In the Member States such a body has the responsibility for establishing national legislation to bring the Agency's transport Regulations into effect and for assuring compliance with its requirements. Depending on the national regulatory or institutional framework the functions of the competent authority may be assigned to one or more bodies. To assist Member States in implementing the transport Regulations and carrying out responsibility for compliance assurance, the IAEA continues to maintain this updated list of designated national competent authorities. Member States are annually requested to verify the list for correctness and completeness

National competent authorities responsible for approvals and authorizations in respect of the transport of radioactive material. List no. 23

Energy Technology Data Exchange (ETDEWEB)

NONE

1992-01-01

Any national or international authority designated or otherwise recognised as such for any purpose in connection with the transport Regulations is known as a competent authority. In the Member States such a body has the responsibility for establishing national legislation to bring the Agency's transport Regulations into effect and for assuring compliance with its requirements. Depending on the national regulatory or institutional framework the functions of the competent authority may be assigned to one or more bodies. To assist Member States in implementing the transport Regulations and carrying out responsibility for compliance assurance, the IAEA continues to maintain this updated list of designated national competent authorities. Member States are annually requested to verify the list for correctness and completeness.

National competent authorities responsible for approvals and authorizations in respect of the transport of radioactive material. List no. 24

Energy Technology Data Exchange (ETDEWEB)

NONE

1993-01-01

Any national or international authority designated or otherwise recognised as such for any purpose in connection with the transport Regulations is known as a competent authority. In the Member States such a body has the responsibility for establishing national legislation to bring the Agency's transport Regulations into effect and for assuring compliance with its requirements. Depending on the national regulatory or institutional framework the functions of the competent authority may be assigned to one or more bodies. To assist Member States in implementing the transport Regulations and carrying out responsibility for compliance assurance, the IAEA continues to maintain this updated list of designated national competent authorities. Member States are annually requested to verify the list for correctness and completeness.

National competent authorities responsible for approvals and authorizations in respect of the transport of radioactive material. List no. 22

Energy Technology Data Exchange (ETDEWEB)

NONE

1991-01-01

Any national or international authority designated or otherwise recognised as such for any purpose in connection with the transport Regulations is known as a competent authority. In the Member States such a body has the responsibility for establishing national legislation to bring the Agency's transport Regulations into effect and for assuring compliance with its requirements. Depending on the national regulatory or institutional framework the functions of the competent authority may be assigned to one or more bodies. To assist Member States in implementing the transport Regulations and carrying out responsibility for compliance assurance, the IAEA continues to maintain this updated list of designated national competent authorities. Member States are annually requested to verify the list for correctness and completeness.

National competent authorities responsible for approvals and authorizations in respect of the transport of radioactive material. List no. 21

Energy Technology Data Exchange (ETDEWEB)

NONE

1990-02-01

Any national or international authority designated or otherwise recognised as such for any purpose in connection with the transport Regulations is known as a competent authority. In the Member States such a body has the responsibility for establishing national legislation to bring the Agency's transport Regulations into effect and for assuring compliance with its requirements. Depending on the national regulatory or institutional framework the functions of the competent authority may be assigned to one or more bodies. To assist Member States in implementing the transport Regulations and carrying out responsibility for compliance assurance, the IAEA continues to maintain this updated list of designated national competent authorities. Member States are annually requested to verify the list for correctness and completeness.

Relations between the safety authority and the nuclear power plant operators

International Nuclear Information System (INIS)

Laverie, M.; Flandrin, R.

1991-01-01

The French experience has led the safety authority to pay particular attention to the competence of a nuclear operator and to the exercise of his responsibility. In this context, safety does not seem to be improved by the imposition of too many regulations and control activities. On the contrary, an excessive regulatory framework may blunt the operator's awareness of his responsibility. It is the duty of the safety authority to fix the safety objectives. It is the operator's duty to establish the practical conditions for attaining these objectives and to justify these conditions to the safety authority. It is also his duty to implement them correctly. The authority must then verify the quality of this implementation by random inspection methods. Each of the two partners, each conforming to his role and exercise of his particular responsibilities, must remain vigilant. These different actions necessitate a permanent technical dialogue which is not in contradiction with the exercise of strict regulatory control. (orig.)