WorldWideScience

Sample records for current regulatory framework

  1. 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)

  2. 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

  3. 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)

  4. European regulatory framework for person carrier robots

    NARCIS (Netherlands)

    Fosch Villaronga, E.; Roig, A.

    The aim of this paper is to establish the grounds for a future regulatory framework for Person Carrier Robots, which includes legal and ethical aspects. Current industrial standards focus on physical human–robot interaction, i.e. on the prevention of harm. Current robot technology nonetheless

  5. Regulatory Framework of Safety for HTGR

    International Nuclear Information System (INIS)

    Huh, Chang Wook; Suh, Nam Duk

    2011-01-01

    Recent accident in Fukushima Daiichi plant in Japan makes big impacts on the future of nuclear business. Many countries are changing their nuclear projects and increased safety of nuclear plants is asked for from the public. Without providing safety the society accepts, it might be almost impossible to build new plants further. In this sense high temperature gas-cooled reactor (HTGR) which is under development needs to be licensed reflecting this new expectation regarding safety. It means we should have higher level of safety goal and a systematic regulatory framework to assure the safety. In our previous paper, we evaluated the current safety goal and design practice in view of this new safety expectation after Fukushima accident. It was argued that a top-down approach starting from safety goal is necessary to develop safety requirements or to assure safety. Thus we need to propose an ultimate safety goal public accepts and then establish a systematic regulatory framework. In this paper we are going to provide a conceptual regulatory framework to guarantee the safety of HTGR. Section 2 discusses the recent trend of IAEA safety requirements and then summarize the HTGR design approach. Incorporating these discussions, we propose a conceptual framework of regulation for safety of HTGR

  6. ENSI’s regulatory framework strategy

    International Nuclear Information System (INIS)

    2015-03-01

    This short brochure issued by the Swiss Federal Nuclear Safety Inspectorate ENSI defines the organisation’s regulatory framework strategy. Six guiding principles are declared and discussed: Comprehensive harmonisation with relevant international requirements, basing the regulatory framework on existing, tried-and-tested regulations, issuing of its own guidelines only when it is necessary to do so, guidelines to be drawn up transparently and with the involvement of all stakeholders and basing the level of detail of its regulatory framework on hazard potential and risk

  7. The Philippine Regulatory Frameworks, Support Policies, And Initiatives Encouraging Women Entrepreneurship

    OpenAIRE

    EDRALIN, Divina M.

    2007-01-01

    This paper examines the Philippine regulatory frameworks, support policies, initiatives, and barriers to encouraging women entrepreneurship. Currently, women entrepreneurship seems to be nurtured with the right environment, including regulatory frameworks, financial resources and support programs for, as well as business practices and social attitudes in the country towards women entrepreneurs and entrepreneurship in general. However, though many SME-friendly laws and policies exist, their im...

  8. Scientific underpinnings of biotechnology regulatory frameworks.

    Science.gov (United States)

    Gleim, Savannah; Smyth, Stuart J

    2018-05-25

    Part of what is presently missing at domestic regulatory levels (and that is important at the international level as well) is a detailed understanding of what the rules of, and for, regulation should be, who the actors, stakeholders and major decision makers are and finally, how to get agreement about the rules. Greater insights into the system of rules that underpin regulatory frameworks for agri-food and biotechnology products in genetically modified (GM) crop- adopting nations will provide value by clarifying the evidence used to commercialize these technologies. This article examines the public documents available from Canada, the United States, the European Union and the Organisation for Economic Cooperation and Development regarding the development of regulatory risk assessment frameworks for products of biotechnology to determine what science grounds these frameworks. The documentation used to provide the initial structure to the existing regulatory frameworks identifies the linkages, connections and relationships that exist between science, risk assessment and regulatory policy. The relationship between risk and regulation has never been more critical to the commercialization of innovative agricultural products. Documenting the role of science-based risk assessment in regulations and how this has changed over the 20 years of experience in regulating GM crops will identify changes in the risk/regulation relationship. Crown Copyright © 2018. Published by Elsevier B.V. All rights reserved.

  9. Health claims on food products in Southeast Asia: regulatory frameworks, barriers, and opportunities.

    Science.gov (United States)

    Tan, Karin Y M; van der Beek, Eline M; Chan, M Y; Zhao, Xuejun; Stevenson, Leo

    2015-09-01

    The Association of Southeast Asian Nations aims to act as a single market and allow free movement of goods, services, and manpower. The purpose of this article is to present an overview of the current regulatory framework for health claims in Southeast Asia and to highlight the current barriers and opportunities in the regulatory frameworks in the Association of Southeast Asian Nations. To date, 5 countries in Southeast Asia, i.e., Indonesia, Malaysia, the Philippines, Singapore, and Thailand, have regulations and guidelines to permit the use of health claims on food products. There are inconsistencies in the regulations and the types of evidence required for health claim applications in these countries. A clear understanding of the regulatory frameworks in these countries may help to increase trade in this fast-growing region and to provide direction for the food industry and the regulatory community to develop and market food products with better nutritional quality tailored to the needs of Southeast Asian consumers. © The Author(s) 2015. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  10. 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)

  11. The regulatory framework for safe decommissioning of nuclear power plants in Korea

    International Nuclear Information System (INIS)

    Sangmyeon Ahn; Jungjoon Lee; Chanwoo Jeong; Kyungwoo Choi

    2013-01-01

    We are having 23 units of nuclear power plants in operation and 5 units of nuclear power plants under construction in Korea as of September 2012. However, we don't have any experience on shutdown permanently and decommissioning of nuclear power plants. There are only two research reactors being decommissioned since 1997. It is realized that improvement of the regulatory framework for decommissioning of nuclear facilities has been emphasized constantly from the point of view of IAEA's safety standards. It is also known that IAEA will prepare the safety requirement on decommissioning of facilities; its title is the Safe Decommissioning of Facilities, General Safety Requirement Part 6. According to the result of IAEA's Integrated Regulatory Review Service (IRRS) mission to Korea in 2011, it was recommended that the regulatory framework should require decommissioning plans for nuclear installations to be constructed and operated and these plans should be updated periodically. In addition, after the Fukushima nuclear disaster in Japan in March of 2011, preparedness for early decommissioning caused by an unexpected severe accident became important issues and concerns. In this respect, it is acknowledged that the regulatory framework for decommissioning of nuclear facilities in Korea need to be improved. First of all, we focus on identifying the current status and relevant issues of regulatory framework for decommissioning of nuclear power plants compared to the IAEA's safety standards in order to achieve our goal. And then the plan is established for improvement of regulatory framework for decommissioning of nuclear power plants in Korea. It is expected that if the things will go forward as planned, the revised regulatory framework for decommissioning could enhance the safety regime on the decommissioning of nuclear power plants in Korea in light of international standards. (authors)

  12. Improvement of Regulatory Framework for Long-Term Operation and Ageing Management of NPPs

    International Nuclear Information System (INIS)

    Kostenko, S.P.

    2015-01-01

    The regulatory framework for long-term operation and ageing management of NPP units in Ukraine was reviewed and deficiencies were identified. The procedure for improving regulatory framework for long-term operation and ageing management is presented. It takes into consideration IAEA recommendations and international practices, as well as experience obtained in long-term operation efforts for Rivne NPP-1, 2 and South Ukraine NPP-1. The paper demonstrates interrelations between standards and technical documents on long-term operation and ageing management. The information is presented regarding the current state of regulatory and legal documentation development and industry-specific standards on long-term operation and ageing management of NPP units in Ukraine

  13. ENSI’s regulatory framework strategy; Regelwerksstrategie des ENSI -- Stratégie réglementaire de l’IFSN -- ENSI’s regulatory framework strategy

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2015-03-15

    This short brochure issued by the Swiss Federal Nuclear Safety Inspectorate ENSI defines the organisation’s regulatory framework strategy. Six guiding principles are declared and discussed: Comprehensive harmonisation with relevant international requirements, basing the regulatory framework on existing, tried-and-tested regulations, issuing of its own guidelines only when it is necessary to do so, guidelines to be drawn up transparently and with the involvement of all stakeholders and basing the level of detail of its regulatory framework on hazard potential and risk.

  14. A Framework for Organizing Current and Future Electric Utility Regulatory and Business Models

    Energy Technology Data Exchange (ETDEWEB)

    Satchwell, Andrew [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Cappers, Peter [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Schwartz, Lisa [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Fadrhonc, Emily Martin [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States)

    2015-06-01

    In this report, we will present a descriptive and organizational framework for incremental and fundamental changes to regulatory and utility business models in the context of clean energy public policy goals. We will also discuss the regulated utility's role in providing value-added services that relate to distributed energy resources, identify the "openness" of customer information and utility networks necessary to facilitate change, and discuss the relative risks, and the shifting of risks, for utilities and customers.

  15. Use of PSA in a regulatory framework

    International Nuclear Information System (INIS)

    Ross, P.J.

    1994-01-01

    The paper will briefly describe the use of PSA in the licensing process for the Sizewell 'B' PWR Power Station currently under construction in the U.K. There are two distinct phases in the licensing process - (i) A PSA has been performed to support the application to construct Sizewell 'B'. At that stage the PSA was used as a design tool (along with deterministic design requirements) for Sizewell 'B' and as such lead to a number of significant design changes in the early design process. (ii) A PSA is currently being performed to support the application to operate Sizewell 'B'. The PSA is required to support the claim that the design has included all reasonably practical measures to prevent and mitigate accidents. The comprehensive PSA being produced for the second phase of the licensing process will be described. The way the regulators/designer/analysts have interacted over the years has affected the scope, complexity, detail and bias of the comprehensive PSA. The paper will discuss these issues and highlight some of the more significant ones. The benefits and drawbacks of providing a PSA in a regulatory framework will be discussed. One of the conclusions of the paper is that the use of true ''best-estimates'' in the PSA is difficult to achieve in a regulatory framework where persistent bias to the conservative side is apparent in the designers, analysts and regulators judgements. The usefulness of the PSA is therefore, potentially, compromised by giving misleading outputs or diverting resources to unnecessary areas. (author)

  16. [Is it possible to improve the preventive usefulness of workers' health surveillance in the current regulatory framework?

    Science.gov (United States)

    Rodríguez Jareño, Mari Cruz; De Montserrat I Nonó, Jaume

    In Spain, the limited preventive usefulness of health surveillance is determined by the indiscriminate use of nonspecific "generic" health examinations aimed at producing a "fitness for work list", presumably allowing companies to comply with health and safety regulations. This study aimed to produce a technical interpretation of the Spanish Prevention of Risks at Work Act and propose a new conceptual framework to favour greater preventive usefulness of health surveillance within the current regulatory framework. Using qualitative techniques of content analysis, the text of the Law was studied, the key concepts that impeded the fulfilment of the preventive objectives of health surveillance were identified, and a technical interpretation adjusted to regulations was made in order to propose a new conceptual framework RESULTS: This conceptual framework would include: clearly differentiating health surveillance from health examinations (one of its instruments) and from fitness for work evaluations (an independent concept in itself); restricting mandatory health surveillance to situations in which it is "imperative" to carry it out because of the existence of a substantial risk to workers or third parties, including potentially vulnerable workers; and communicating the results of health surveillance through preventive recommendations to the company, reserving fitness for duty certificates -always based on clear, pre-established and justified criteria in relation to risk- for mandatory surveillance. The proposed new conceptual framework falls within the scope of the Spanish Prevention of Risks at Work Act, and its implementation could contribute to improving the preventive usefulness of health surveillance without the need to reform the legislation. Copyright belongs to the Societat Catalana de Salut Laboral.

  17. Canada's regulatory framework: The Canadian Nuclear Safety Commission's regulatory framework

    International Nuclear Information System (INIS)

    Howard, D.

    2011-01-01

    This paper will discuss the Canadian Nuclear Safety Commission and Canada's Regulatory Framework with respect to Low- and Intermediate-Level Radioactive Waste. The management of low and intermediate level radioactive waste must be ensured in a consistent, environmentally responsible and economical manner throughout its lifecycle -- from its production to the final disposal option. Radioactive waste has been produced in Canada since the early 1930s when the first radium/uranium mine began operating at Port Radium in the Northwest Territories. Pitchblende ore was transported from the Port Radium mine to Port Hope, Ontario where it was refined to produce radium for medical purposes. At present, radioactive waste is generated in Canada from the various stages and uses associated with the nuclear fuel cycle from uranium mining/milling to nuclear reactor operations to radioisotope manufacture and use. The Canadian Nuclear Safety Commission (CNSC regulates the use of nuclear energy and materials to protect the health, safety and security of Canadians and the environment; and to implement Canada's international commitments on the peaceful use of nuclear energy. The CNSC was established in 2000 under the Nuclear Safety and Control Act and reports to Parliament through the Minister of Natural Resources. The CNSC was created to replace the former Atomic Energy Control Board (AECB), which was founded in 1946. Under the Nuclear Safety and Control Act, CNSC's mandate involves four major areas: regulation of the development, production and use of nuclear energy in Canada to protect health, safety and the environment; regulation of the production, possession, use and transport of nuclear substances, and the production, possession and use of prescribed equipment and prescribed information; implementation of measures respecting international control of the development, production, transport and use of nuclear energy and substances, including measures respecting the

  18. Regulatory control, legislation and framework

    International Nuclear Information System (INIS)

    Parthasarathy, K.S.

    1998-01-01

    The legislation and regulations, a regulatory authority to authorise and inspect the regulated activities and to enforce the legislation and regulations, sufficient financial and man-power resources are the essential parts of a national infrastructure to implement the Basic Safety Standards. The legal framework consists of legislation (Act passed by Parliament) and the regulations (framed by the government and endorsed by the Parliament). This paper is primarily deals with the the legal framework set up in India for atomic energy activities

  19. Global regulatory framework for production and marketing of crops biofortified with vitamins and minerals.

    Science.gov (United States)

    Mejia, Luis A; Dary, Omar; Boukerdenna, Hala

    2017-02-01

    Biofortification of crops is being introduced in several countries as a strategy to reduce micronutrient deficiencies. Biofortified products, with increased contents of micronutrients, are currently produced by conventional plant breeding, genetic modification, or nutrient-enhanced fertilization. Corn, rice, wheat, beans, pearl millet, sweet potato, and cassava have been biofortified with increased contents of provitamin A carotenoids, iron, or zinc. However, regulatory considerations are rare or nonexistent. The objective of this paper is to review the regulatory framework for production and marketing of biofortified crops in countries that have adopted this strategy. The information was identified using Internet search engines and websites of health and nutrition organizations and nongovernmental organizations and by consulting scientists and government authorities. Thus far, biofortified products introduced in Latin America, Africa, and Asia have been produced only by conventional breeding. Cultivars using other techniques are still under testing. The production and marketing of these products have been conducted without regulatory framework and under limited government control or regulatory guidance. Nevertheless, some countries have integrated biofortified crops into their nutrition agendas. Although improvements by conventional breeding have not been subject to regulations, when biofortification becomes expanded by including other techniques, an appropriate regulatory framework will be necessary. © 2016 New York Academy of Sciences.

  20. 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.

  1. 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

  2. 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

  3. 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

  4. Review of Legislation and Regulatory Framework in Ukraine with Regard to Environmental Radiation Monitoring

    International Nuclear Information System (INIS)

    Goldammer, Wolfgang; Batandjieva, Borislava; Nasvit, Oleg; German, Olga

    2009-06-01

    The aim of this review is to compare the current legal basis and regulatory framework in Ukraine to the relevant international safety requirements and to identify shortcomings, such as deficiencies and internal contradictions. However, no assessment of its practical implementation is made beyond the aspects related to environmental radiation monitoring. The report focuses on 13 areas present in the in the Ukrainian legislation and regulatory framework: R-1 Radiation monitoring R-2 Definition of responsibilities R-3 Normal situations R-4 Emergencies R-5 Long-term monitoring R-6 Intervention in cases of lasting exposure R-7 Use of monitoring data R-8 Record keeping R-9 Reporting to the regulatory authority R-10 Public information R-11 Human and financial resources R-12 Transboundary aspects R-13 Quality assurance. For each topic a description of the current situation and an evaluation is carried out. Ranking is then supplied supported by its evaluation. In brief these categories are: A: The national legal and regulatory documents are harmonised in substance with the international safety requirements; B: Substantial differences exist between the national and international requirements which should be addressed with the view to harmonise the legislation; C: Substantial deficiencies exist in the legal and/or regulatory bases which results in no or at least partial compliance with international safety requirements. P: In addition practical issues are also provided to indicates where practical implementation of the legislation and regulatory basis is not adequate in all respects. This report then presents main observations and conclusions of the review. On this basis, the report derives general suggestions for improvement of the legal and regulatory bases. These should be considered by the Ukrainian Government and the regulatory authorities within an action plan to improve the legal basis for radiological monitoring of the environment and to facilitate its implementation

  5. Review of Legislation and Regulatory Framework in Ukraine with Regard to Environmental Radiation Monitoring

    Energy Technology Data Exchange (ETDEWEB)

    Goldammer, Wolfgang; Batandjieva, Borislava (Private Consultants (Ukraine)); Nasvit, Oleg (National Security and Defence Council of Ukraine, Kyiv (Ukraine)); German, Olga (Swedish Radiation Safety Authority, Stockholm (Sweden))

    2009-06-15

    The aim of this review is to compare the current legal basis and regulatory framework in Ukraine to the relevant international safety requirements and to identify shortcomings, such as deficiencies and internal contradictions. However, no assessment of its practical implementation is made beyond the aspects related to environmental radiation monitoring. The report focuses on 13 areas present in the in the Ukrainian legislation and regulatory framework: R-1 Radiation monitoring R-2 Definition of responsibilities R-3 Normal situations R-4 Emergencies R-5 Long-term monitoring R-6 Intervention in cases of lasting exposure R-7 Use of monitoring data R-8 Record keeping R-9 Reporting to the regulatory authority R-10 Public information R-11 Human and financial resources R-12 Transboundary aspects R-13 Quality assurance. For each topic a description of the current situation and an evaluation is carried out. Ranking is then supplied supported by its evaluation. In brief these categories are: A: The national legal and regulatory documents are harmonised in substance with the international safety requirements; B: Substantial differences exist between the national and international requirements which should be addressed with the view to harmonise the legislation; C: Substantial deficiencies exist in the legal and/or regulatory bases which results in no or at least partial compliance with international safety requirements. P: In addition practical issues are also provided to indicates where practical implementation of the legislation and regulatory basis is not adequate in all respects. This report then presents main observations and conclusions of the review. On this basis, the report derives general suggestions for improvement of the legal and regulatory bases. These should be considered by the Ukrainian Government and the regulatory authorities within an action plan to improve the legal basis for radiological monitoring of the environment and to facilitate its implementation

  6. 78 FR 70354 - Conceptual Example of a Proposed Risk Management Regulatory Framework Policy Statement

    Science.gov (United States)

    2013-11-25

    ... NUCLEAR REGULATORY COMMISSION [NRC-2013-0254] Conceptual Example of a Proposed Risk Management Regulatory Framework Policy Statement AGENCY: Nuclear Regulatory Commission. ACTION: Conceptual example of a... ``openness,'' a white paper on a Conceptual Example of a Proposed Risk Management Regulatory Framework (RMRF...

  7. 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)

  8. 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)

  9. 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)

  10. IAEA Team Concludes Peer Review of Greece's Regulatory Framework for Radiation Safety

    International Nuclear Information System (INIS)

    2012-01-01

    ; and GEAC exhibits a strong commitment to education and training in radiation protection. The IRRS Review team identified issues warranting attention or in need of improvement, including: The Radiation Protection Regulations require updating to bring them in line with the current IAEA Safety Requirements. Consideration should be given to the adoption of a more flexible hierarchy of safety regulations; The nation's legal framework is dated, lacks the flexibility of a risk-based regulatory framework which provides for a graded approach to safety and has gaps particularly in respect of waste and decommissioning; A consolidated management system requires senior management commitment to allocate sufficient resources with the appropriate authority, and to actively involve all staff; and The prime responsibility for safety, the responsibilities of employers and workers with respect to occupational exposure, and responsibilities with respect to emergency preparedness and response need to be explicitly assigned in the legal and regulatory framework for safety. In a preliminary report, the IAEA has conveyed the team's main conclusions to GAEC, and a final report will be submitted to the commission in about three months. Background The IRRS team carried out a review of Greece's nuclear legal and regulatory framework for safety. The IRRS review addressed the facilities and activities regulated by GAEC which involve radiation sources in addition to the waste management facilities. The research reactor GRR-1 in the National Centre for Scientific Research ''Demokritos'' was out of the scope of this IRRS review but will be included in the follow-up mission. The mission took place from 20 to 30 May 2012 at the GAEC headquarters in Agia Paraskevi. A Press Conference was conducted at the end of the mission on 30 May. The IRRS team consisted of nine senior regulatory experts from nine IAEA Member States and five IAEA staff members. About IRRS Missions IRRS missions are designed to

  11. 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

  12. Developing legal regulatory frameworks for modern biotechnology ...

    African Journals Online (AJOL)

    This paper looks at attempts that have been made to develop legal regulatory frameworks for modern biotechnology. The discussion is limited to the regulation of Genetically Modified Organisms (GMO) technology by the two leading producers and exporters of GMOs in Africa: South Africa and Kenya. The international and ...

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

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2010-09-15

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

  14. The evaluation of drug regulation - economic approaches into the valuation and evaluation of the drug regulatory framework

    NARCIS (Netherlands)

    Bouvy, J.C.

    2013-01-01

    The European pharmaceutical market is strictly regulated. Sufficient levels of quality, safety, and efficacy will have to be demonstrated before a pharmaceutical is allowed to enter the market. There is little evidence, however, that the current drug regulatory framework is achieving its goals of

  15. Policy, Legal and Regulatory Framework for Records Management ...

    African Journals Online (AJOL)

    Policy, Legal and Regulatory Framework for Records Management in the ... of any country and are essential to the administration of law in the justice system. ... as the Kenya Public Archives and Documentation Service Act Cap 19 of 1965; the ...

  16. International Nuclear Safety Experts Conclude IAEA Peer Review of Swiss Regulatory Framework

    International Nuclear Information System (INIS)

    2011-01-01

    equipment and safety procedures and adopting current technology to maximize nuclear safety; ENSI demonstrates openness and transparency by posting significant documents on its website, including reports on safety research, applicable lessons from foreign nuclear power plants, and safety assessments for all Swiss nuclear power plants; and ENSI's comprehensive and user friendly management system enables the regulator to work effectively and efficiently to oversee Swiss nuclear safety. The IRRS team also made recommendations to improve the Swiss regulatory system, including the following: As ENSI was established as an independent regulatory body in 2009 as part of a revised government framework, the Swiss government should actively monitor how this new framework is working and make improvements as needed; ENSI needs the authority to set conditions for licensing nuclear activities and to issue regulatory requirements; and The Swiss regulatory framework should continue evolving its graded approach to safety, and further develop its inspection efforts in all areas, especially in waste, decommissioning and transport. In a preliminary report, the IAEA has conveyed the team's main conclusions to ENSI, and a final report will be submitted to the authority in about three months. ENSI has told the team that it will make the report public. The IAEA encourages nations to invite a follow-up IRRS mission about two years after the full mission has been completed. About IRRS Missions IRRS missions are designed to strengthen and enhance the effectiveness of the national nuclear regulatory infrastructure of States, while recognizing the ultimate responsibility of each State to ensure safety in this area. This is done through consideration of both regulatory, technical and policy issues, with comparisons against IAEA safety standards and, where appropriate, good practices elsewhere. More information about IRRS missions is available on the IAEA Website. Quick Facts: 2 PWRs at Beznau; 1 PWR at

  17. The Regulatory Framework for Privacy and Security

    Science.gov (United States)

    Hiller, Janine S.

    The internet enables the easy collection of massive amounts of personally identifiable information. Unregulated data collection causes distrust and conflicts with widely accepted principles of privacy. The regulatory framework in the United States for ensuring privacy and security in the online environment consists of federal, state, and self-regulatory elements. New laws have been passed to address technological and internet practices that conflict with privacy protecting policies. The United States and the European Union approaches to privacy differ significantly, and the global internet environment will likely cause regulators to face the challenge of balancing privacy interests with data collection for many years to come.

  18. Applying a Developmental Framework to the Self-Regulatory Difficulties of Young Children with Prenatal Alcohol Exposure: A Review.

    Science.gov (United States)

    Reid, Natasha; Petrenko, Christie L M

    2018-06-01

    Prenatal alcohol exposure (PAE) can be associated with significant difficulties in self-regulatory abilities. As such, interventions have been developed that focus on improving varying aspects of self-regulation for this population. The application of a multilevel theoretical framework that describes the development of self-regulation during early childhood could further advance the field. First, this framework could assist in elucidating mechanisms in the trajectories of early adjustment problems in this population and, second, informing the development of more precise assessment and interventions for those affected by PAE. The aims of the current review were to provide an overview of the self-regulatory framework proposed by Calkins and colleagues (e.g., Calkins, 2007; Calkins and Fox, 2002); examine the self-regulatory difficulties that are commonly experienced during infancy (i.e., 0 to 2 years) and early childhood (i.e., 3 to 8 years) in children with PAE in the context of the developmental framework; and describe how the framework can inform the development of future assessment and intervention provision for young children with PAE. The application of a developmental framework, such as proposed by Calkins and colleagues, allows for a systematic and theoretically driven approach to assessment and intervention programs for young children with PAE. Copyright © 2018 by the Research Society on Alcoholism.

  19. IAEA Mission Concludes Peer Review of Jordan's Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2014-01-01

    Senior international nuclear safety and radiation protection experts today concluded an 11-day International Atomic Energy Agency (IAEA) Integrated Regulatory Review Service (IRRS) mission to review the regulatory framework for nuclear and radiation safety in Jordan. The mission team said in its preliminary findings that Jordan's nuclear regulator, the Energy and Minerals Regulatory Commission (EMRC), faces challenges because it is a relatively new body that handles a high workload while also working to recruit, train and keep competent staff. The team also noted that a recent merger provided the regulator with more of the resources it needs to perform its duty. The team made recommendations and suggestions to the regulatory body and the Government to help them strengthen the effectiveness of Jordan's regulatory framework and functions in line with IAEA Safety Standards. The main observations of the IRRS Review team comprised the following: The regulatory body, founded in 2007 and merged with other regulators in April 2014 to form EMRC, faces large challenges in terms of its regulatory workload, management system building and staff recruitment and training; The new EMRC structure and revision of the radiation and nuclear safety law represents an important opportunity to strengthen Jordan's radiation and nuclear safety infrastructure; The Government has shown commitment to radiation and nuclear safety through measures including becoming party to international conventions. It could further demonstrate its commitment by adopting a formal national policy and strategy for safety that defines the role of the Minister of Energy in relation to EMRC and protects the independence of regulatory decision-making

  20. Regulatory frameworks for Natural Gas DSM in Canada : exploring design options, influences and characteristics of success

    International Nuclear Information System (INIS)

    Simon, J.

    2005-11-01

    There are 6 natural gas distribution companies in Canada with formal, ratepayer-funded demand side management (DSM) programs. However, the general characteristics and regulatory environment of these companies varies greatly. With the exception of Enbridge Gas and Union Gas, each company is located in a different province, which means that companies face different energy regulations and energy efficiency policies. An introduction to DSM and its regulation in Canada was presented, as well as an overview of common models in Canada, and the general considerations involved in designing a regulatory framework were discussed. Regulatory design options for natural gas demand-side management regulatory frameworks were evaluated. The major factors that influence the frameworks were analyzed, and the characteristics of a successful DSM program were outlined. The research methodology for this paper consisted of telephone interviews with policy-makers, regulators, non-governmental organizations and regulatory affairs personnel from local distribution companies. Results indicated the importance of a clear policy framework that provides direction for DSM designers. The common elements for a successful regulatory framework were considered to be a systems approach to the definition of DSM; clear regulatory rules; a long-term predictable source and level of DSM funding that reflected the maturity of the DSM market; an alignment of government energy policies and DSM regulatory frameworks; and recognition and capturing of the broad range of DSM benefits

  1. Glycoconjugate Vaccines: The Regulatory Framework.

    Science.gov (United States)

    Jones, Christopher

    2015-01-01

    Most vaccines, including the currently available glycoconjugate vaccines, are administered to healthy infants, to prevent future disease. The safety of a prospective vaccine is a key prerequisite for approval. Undesired side effects would not only have the potential to damage the individual infant but also lead to a loss of confidence in the respective vaccine-or vaccines in general-on a population level. Thus, regulatory requirements, particularly with regard to safety, are extremely rigorous. This chapter highlights regulatory aspects on carbohydrate-based vaccines with an emphasis on analytical approaches to ensure the consistent quality of successive manufacturing lots.

  2. 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.

  3. Training the staff of the regulatory body for nuclear facilities: A competency framework

    International Nuclear Information System (INIS)

    2001-11-01

    The uncertainties about the future of nuclear power in many countries, the ageing of the existing work force, and the consequential lack of interest of new professionals to engage in the nuclear field represent developments of major current international concern. The situation is compounded by the great reduction in higher education opportunities in the field of nuclear engineering and the elimination of nuclear engineering departments and research reactors in many universities and the loss of nuclear research facilities generally. Competence of regulatory staff is one of the prerequisites for the safety of nuclear facilities in the IAEA Member States. Recruitment of competent regulatory staff is difficult in many countries. Also, replacement of retiring staff members requires active efforts from the management of regulatory bodies for establishing staff qualification and training programmes. International support is needed in this domain. In 2000, the General Conference resolution GC(44)IRES/13 on education and training in radiation protection, nuclear safety and waste management urged the secretariat to 'strengthen, within available financial resources, its current efforts in this area' Several elements required for the implementation of the above resolution are already in place. A strategy paper on training in nuclear, radiation and waste safety, including specialized training courses for specific target groups, has been developed at the IAEA. The international working group on training and qualification recommended in its March meeting in 2000 that a technical document be produced on good training practices of regulatory bodies with advanced training programmes. Such a technical document would be of considerable value to many bodies. The technical document would address how training programmes for regulatory staff have been developed and implemented and include examples of training currently available. Of particular interest to regulatory agencies that have

  4. Training the staff of the regulatory body for nuclear facilities: A competency framework

    International Nuclear Information System (INIS)

    2002-11-01

    The uncertainties about the future of nuclear power in many countries, the ageing of the existing work force, and the consequential lack of interest of new professionals to engage in the nuclear field represent developments of major current international concern. The situation is compounded by the great reduction in higher education opportunities in the field of nuclear engineering and the elimination of nuclear engineering departments and research reactors in many universities and the loss of nuclear research facilities generally. Competence of regulatory staff is one of the prerequisites for the safety of nuclear facilities in the IAEA Member States. Recruitment of competent regulatory staff is difficult in many countries. Also, replacement of retiring staff members requires active efforts from the management of regulatory bodies for establishing staff qualification and training programmes. International support is needed in this domain. In 2000, the General Conference resolution GC(44)IRES/13 on education and training in radiation protection, nuclear safety and waste management urged the secretariat to 'strengthen, within available financial resources, its current efforts in this area' Several elements required for the implementation of the above resolution are already in place. A strategy paper on training in nuclear, radiation and waste safety, including specialized training courses for specific target groups, has been developed at the IAEA. The international working group on training and qualification recommended in its March meeting in 2000 that a technical document be produced on good training practices of regulatory bodies with advanced training programmes. Such a technical document would be of considerable value to many bodies. The technical document would address how training programmes for regulatory staff have been developed and implemented and include examples of training currently available. Of particular interest to regulatory agencies that have

  5. IAEA Mission Sees Significant Progress in Georgia’s Regulatory Framework, Challenges Ahead

    International Nuclear Information System (INIS)

    2018-01-01

    An International Atomic Energy Agency (IAEA) team of experts said Georgia has made significant progress in strengthening its regulatory framework for nuclear and radiation safety. The team also pointed to challenges ahead as Georgia seeks to achieve further progress. The Integrated Regulatory Review Service (IRRS) team concluded a 10-day mission on 28 February to assess the regulatory safety framework in Georgia. The mission was conducted at the request of the Government and hosted by the Agency of Nuclear and Radiation Safety (ANRS), which is responsible for regulatory oversight in the country. IRRS missions are designed to strengthen the effectiveness of the national safety regulatory infrastructure, while recognizing the responsibility of each State to ensure nuclear and radiation safety. Georgia uses radioactive sources in medicine and industry and operates radioactive waste management facilities. It has decommissioned its only research reactor and has no nuclear power plants. In recent years, the Government and ANRS, with assistance from the IAEA, introduced new safety regulations and increased the number of regulatory inspections.

  6. Improvement of Pediatric Drug Development: Regulatory and Practical Frameworks.

    Science.gov (United States)

    Tsukamoto, Katusra; Carroll, Kelly A; Onishi, Taku; Matsumaru, Naoki; Brasseur, Daniel; Nakamura, Hidefumi

    2016-03-01

    A dearth in pediatric drug development often leaves pediatricians with no alternative but to prescribe unlicensed or off-label drugs with a resultant increased risk of adverse events. We present the current status of pediatric drug development and, based on our data analysis, clarify the problems in this area. Further action is proposed to improve the drug development that has pediatric therapeutic orphan status. We analyzed all Phase II/III and Phase III trials in ClinicalTrials.gov that only included pediatric participants (Performance index, an indicator of pediatric drug development, was calculated by dividing the annual number of pediatric clinical trials by million pediatric populations acquired from Census.gov. Effects of the 2 Japanese premiums introduced in 2010, for the enhancement of pediatric drug development, were analyzed by comparing mean performance index prepremiums (2006-2009) and postpremiums (2010-2014) among Japan, the European Union, and the United States. The European Union Clinical Trials Register and published reports from the European Medicines Agency were also surveyed to investigate the Paediatric Committee effect on pediatric clinical trials in the European Union. Mean difference of the performance index in prepremiums and postpremiums between Japan and the European Union were 0.296 (P 15% after 2008. Recruitment and ethical obstacles make conducting pediatric clinical trials challenging. An improved operational framework for conducting clinical trials should mirror the ever-improving regulatory framework that incentivizes investment in pediatric clinical trials. Technological approaches, enhancements in electronic medical record systems, and community approaches that actively incorporate input from physicians, researchers, and patients could offer a sustainable solution to recruitment of pediatric study participants. The key therefore is to improve pediatric pharmacotherapy collaboration among industry, government, academia, and

  7. Steam Generator tube integrity -- US Nuclear Regulatory Commission perspective

    International Nuclear Information System (INIS)

    Murphy, E.L.; Sullivan, E.J.

    1997-01-01

    In the US, the current regulatory framework was developed in the 1970s when general wall thinning was the dominant degradation mechanism; and, as a result of changes in the forms of degradation being observed and improvements in inspection and tube repair technology, the regulatory framework needs to be updated. Operating experience indicates that the current U.S. requirements should be more stringent in some areas, while in other areas they are overly conservative. To date, this situation has been dealt with on a plant-specific basis in the US. However, the NRC staff is now developing a proposed steam generator rule as a generic framework for ensuring that the steam generator tubes are capable of performing their intended safety functions. This paper discusses the current U.S. regulatory framework for assuring steam generator (SG) tube integrity, the need to update this regulatory framework, the objectives of the new proposed rule, the US Nuclear Regulatory Commission (NRC) regulatory guide (RG) that will accompany the rule, how risk considerations affect the development of the new rule, and some outstanding issues relating to the rule that the NRC is still dealing with

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

    International Nuclear Information System (INIS)

    2010-01-01

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

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

    International Nuclear Information System (INIS)

    2010-01-01

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

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

    International Nuclear Information System (INIS)

    2010-01-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2010-09-15

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

  12. VoIP under the EU regulatory framework : preventing foreclosure?

    NARCIS (Netherlands)

    Sadowski, B.M.; Straathof, B.

    2005-01-01

    In June 2004, the European Commission (EC) issued an "Information and Consultation Document" (European Commission 2004) that discussed how the Regulatory Framework of the European Union (EU) should be adapted to accommodate Voice over IP (VoIP) and invited relevant parties to comment on the

  13. Cancer drug development and the evolving regulatory framework for companion diagnostics in the European union.

    Science.gov (United States)

    Pignatti, Francesco; Ehmann, Falk; Hemmings, Robert; Jonsson, Bertil; Nuebling, Micha; Papaluca-Amati, Marisa; Posch, Martin; Rasi, Guido

    2014-03-15

    The European Union (EU) legal framework for medical device regulation is currently under revision. The European Commission has proposed a new framework to ensure that medical devices serve the needs and ensure the safety of European citizens, aiming for a framework that is fit for purpose, more transparent, and better adapted to scientific and technological progress. The proposed new framework is described as an evolution of the current regime keeping the same legal approach. An important proposed change is that companion diagnostics will no longer be considered as low risk and subject to self-certification by the manufacturer. According to the new proposal, companion diagnostics will be classified as high individual risk or moderate public health risk (category C) and require conformity assessment by a notified body. It has also been proposed that evidence of the clinical utility of the device for the intended purpose should be required for companion diagnostics. In this article, we review the EU legal framework relevant for companion diagnostics, describe the proposed changes, and summarize the available scientific guidance from the European Medicines Agency and its regulatory experience with cancer drug development including companion diagnostics. See all articles in this CCR Focus section, "The Precision Medicine Conundrum: Approaches to Companion Diagnostic Co-development." ©2014 AACR.

  14. A High-Level Petri Net Framework for Genetic Regulatory Networks

    Directory of Open Access Journals (Sweden)

    Banks Richard

    2007-12-01

    Full Text Available To understand the function of genetic regulatory networks in the development of cellular systems, we must not only realise the individual network entities, but also the manner by which they interact. Multi-valued networks are a promising qualitative approach for modelling such genetic regulatory networks, however, at present they have limited formal analysis techniques and tools. We present a flexible formal framework for modelling and analysing multi-valued genetic regulatory networks using high-level Petri nets and logic minimization techniques. We demonstrate our approach with a detailed case study in which part of the genetic regulatory network responsible for the carbon starvation stress response in Escherichia coli is modelled and analysed. We then compare and contrast this multivalued model to a corresponding Boolean model and consider their formal relationship.

  15. IAEA Mission Concludes Peer Review of UK's Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2013-01-01

    that all organizations, with responsibility for safety, involved in decommissioning activities and in the management of radioactive waste, are held accountable for their responsibilities; and ONR should review its approach to authorising decommissioning plans and its guidance for de-commissioning. The mission team delivered its initial findings to the ONR. A final report will be submitted in about three months, and ONR informed the team that it will make the report public. The mission included site visits to facilities to observe inspections and a series of interviews and discussions with ONR staff and other organizations. The IRRS missions to the UK in 2006 and 2009 reviewed a broad spectrum of nuclear legal and regulatory framework, resulting in recommendations in order to fully comply with the IAEA safety standards and suggestions for further possible improvement of the regulatory framework. The IAEA encourages countries that have hosted initial IRRS missions to invite follow-up missions two to four years after the initial missions. Quick Facts The UK has 16 operating nuclear power reactors at nine sites, 27 units in permanent shutdown or decommissioning state. As of 2012, nuclear contributed about 16 per cent to the country's electricity production. The UK has a large variety of different intermediate- and high-level radioactive wastes, coming from national programmes to develop nuclear weapons and nuclear power. Most of the UK's higher-activity radioactive waste is currently held in temporary storage at Sellafield. About IRRS Missions IRRS missions are designed to strengthen and enhance the effectiveness of the national nuclear regulatory infrastructure of States, while recognizing the ultimate responsibility of each State to ensure safety in this area. This is done through consideration of both regulatory, technical and policy issues, with comparisons against IAEA safety standards and, where appropriate, good practices elsewhere. (IAEA)

  16. e-Communications: Investment and the Regulatory Framework

    OpenAIRE

    Jones, Siôn; Jones, Pau

    2006-01-01

    The EU regulatory framework for e-communications was adopted by the European Parliament and the Council in 2002, and became applicable from 2003. It has three primary objectives: (1) to promote competition; (2) to develop the single market; and (3) to promote citizens' rights. The European Commission's DG Information Society commissioned London Economics to estimate the level of e-communications investment in the EU and to examine its main drivers as part of a contributio to the Commission's...

  17. Is there a need for a universal benefit-risk assessment framework for medicines? Regulatory and industry perspectives.

    Science.gov (United States)

    Leong, James; McAuslane, Neil; Walker, Stuart; Salek, Sam

    2013-09-01

    To explore the current status and need for a universal benefit-risk framework for medicines in regulatory agencies and pharmaceutical companies. A questionnaire was developed and sent to 14 mature regulatory agencies and 24 major companies. The data were analysed using descriptive statistics, for a minority of questions preceded by manual grouping of the responses. Overall response rate was 82%, and study participants included key decision makers from agencies and companies. None used a fully quantitative system, most companies preferring a qualitative method. The major reasons for this group not using semi-quantitative or quantitative systems were lack of a universal and scientifically validated framework. The main advantages of a benefit-risk framework were that it provided a systematic standardised approach to decision-making and that it acted as a tool to enhance quality of communication. It was also reported that a framework should be of value to both agencies and companies throughout the life cycle of a product. They believed that it is possible to develop an overarching benefit-risk framework that should involve relevant stakeholders in the development, validation and application of a universal framework. The entire cohort indicated common barriers to implementing a framework were resource limitations, a lack of knowledge and a scientifically validated and acceptable framework. Stakeholders prefer a semi-quantitative, overarching framework that incorporates a toolbox of different methodologies. A coordinating committee of relevant stakeholders should be formed to guide its development and implementation. Through engaging the stakeholders, these outcomes confirm sentiments and need for developing a universal benefit-risk assessment framework. Copyright © 2013 John Wiley & Sons, Ltd.

  18. Human factors in annunciation systems - Recommendations for a Canadian regulatory framework

    Energy Technology Data Exchange (ETDEWEB)

    Beattie, J D; Rochford, S; Vicente, K J [Humansystems Inc., ON (Canada)

    1997-09-01

    Under a contract with the Atomic Energy Control Board (AECB) of Canada, brief reviews were conducted of the annunciation systems in Canadian nuclear power plant control rooms; of regulatory practices in other countries and relevant international guidelines; and of the human factors literature related to annunciation systems. Based on these reviews, a framework is proposed for regulatory criteria which could be applied to new annunciation system designs. (author). 29 refs.

  19. Human factors in annunciation systems - Recommendations for a Canadian regulatory framework

    International Nuclear Information System (INIS)

    Beattie, J.D.; Rochford, S.; Vicente, K.J.

    1997-01-01

    Under a contract with the Atomic Energy Control Board (AECB) of Canada, brief reviews were conducted of the annunciation systems in Canadian nuclear power plant control rooms; of regulatory practices in other countries and relevant international guidelines; and of the human factors literature related to annunciation systems. Based on these reviews, a framework is proposed for regulatory criteria which could be applied to new annunciation system designs. (author). 29 refs

  20. Regulatory framework for radioactive waste disposal in Romania

    International Nuclear Information System (INIS)

    Dogaru, D.M.

    2005-01-01

    To fulfill the obligations assumed by Romania by joining to the international convention and treaty as well as for implementing the European Commission legislative framework a lot of regulations was already issued or are under the development. The National Commission for Nuclear Activities Control as regulatory authority in nuclear field in Romania considered the process of developing regulations in order to detail the requirements for safe management of radioactive waste. (authors)

  1. International Expert Team Concludes IAEA Peer Review of Poland's Regulatory Framework for Nuclear and Radiation Safety

    International Nuclear Information System (INIS)

    2013-01-01

    the development of the nuclear power programme; and PAA's proactive approach to coordination with Poland's Office of Technical Inspection. The IRRS team made several recommendations and suggestions for PAA as it grows in the next few years, facing challenges and increasing demands as its nuclear power programme expands. To position PAA to address its growth, additional responsibilities, and the retirement of many senior managers, and to maintain its strong focus on safety for currently regulated facilities and activities, the IRRS team advised PAA to: Establish and frequently review that there is a clear link between PAA's organizational goals and objectives, and resource planning, such as staffing and strategies for external support; Consider strengthening and documenting PAA's management system; and Develop and strengthen internal guidance to document authorization processes, review, assessment and inspection procedures. In its preliminary report, the IAEA team's main conclusions have been conveyed to PAA. A final report will be submitted to the Government of Poland in about three months. PAA has informed the team that the final report will be made publicly available. The IAEA encourages nations to invite a follow-up IRRS mission about two years after the mission has been completed. Background The team reviewed the legal and regulatory framework for nuclear safety and addressed all facilities regulated by PAA. This was the 46th IRRS mission conducted by the IAEA. About IRRS Missions IRRS missions are designed to strengthen and enhance the effectiveness of the national nuclear regulatory infrastructure of States, while recognizing the ultimate responsibility of each State to ensure safety in this area. This is done through consideration of regulatory, technical and policy issues, with comparisons against IAEA safety standards and, where appropriate, good practices elsewhere. (IAEA)

  2. Case study for a fit-to-purpose regulatory framework: the history and reasons for the evolution-in the French regulation regarding decommissioning

    International Nuclear Information System (INIS)

    Averous, J.; Chapalain, E.

    2005-01-01

    Full text: This paper exposes the regulatory approach for the safety of decommissioning in France, from an historical perspective. The first regulatory framework concerning decommissioning was introduced in the end of the 1980's and considered decommissioning as successive important modifications of the facility, which lead to multiple successive licenses. The first feedback from actual decommissioning projects lead the nuclear safety authority to reconsider the regulatory approach of decommissioning. The new approach privileges an integrated approach to the decommissioning projects, with an initial decommissioning license authorizing the complete project, and puts more weight on the responsibility of the licensee, fostering the organization of internal safety commissions which are allowed to authorize minor operations that do not put into question the global facility safety demonstration. This new regulatory approach was implemented in 2003 and new corresponding licensing procedures are already under way. It is thought that the new regulatory framework for decommissioning that has been introduced in 2003 will allow to regulate in a far more efficient way the decommissioning projects to come, while guarantying a high safety level, adapting the regulatory burden to the actual hazards, and allowing the licensee for the needed flexibility. Taking advantage of this new framework, licensees have already filed many decommissioning license applications, and decommissioning project licensing is currently one of the main tasks of the nuclear safety authority in France. Many such licenses, for all types of nuclear facilities, will be granted in the next few years. (authors)

  3. Deciphering the genetic regulatory code using an inverse error control coding framework.

    Energy Technology Data Exchange (ETDEWEB)

    Rintoul, Mark Daniel; May, Elebeoba Eni; Brown, William Michael; Johnston, Anna Marie; Watson, Jean-Paul

    2005-03-01

    We have found that developing a computational framework for reconstructing error control codes for engineered data and ultimately for deciphering genetic regulatory coding sequences is a challenging and uncharted area that will require advances in computational technology for exact solutions. Although exact solutions are desired, computational approaches that yield plausible solutions would be considered sufficient as a proof of concept to the feasibility of reverse engineering error control codes and the possibility of developing a quantitative model for understanding and engineering genetic regulation. Such evidence would help move the idea of reconstructing error control codes for engineered and biological systems from the high risk high payoff realm into the highly probable high payoff domain. Additionally this work will impact biological sensor development and the ability to model and ultimately develop defense mechanisms against bioagents that can be engineered to cause catastrophic damage. Understanding how biological organisms are able to communicate their genetic message efficiently in the presence of noise can improve our current communication protocols, a continuing research interest. Towards this end, project goals include: (1) Develop parameter estimation methods for n for block codes and for n, k, and m for convolutional codes. Use methods to determine error control (EC) code parameters for gene regulatory sequence. (2) Develop an evolutionary computing computational framework for near-optimal solutions to the algebraic code reconstruction problem. Method will be tested on engineered and biological sequences.

  4. Regulatory framework for radioactive waste disposal in Romania

    International Nuclear Information System (INIS)

    Dogaru, Daniela

    2005-01-01

    Full text: To fulfill the obligations assumed by Romania by joining to the international convention and treaty as well as for implementing the European Commission legislative framework a lot of regulations was already issued or are under the development. The National Commission for Nuclear Activities Control as regulatory authority in nuclear field in Romania considered the process of developing regulations in order to detail the requirements for safe management of radioactive waste. (authors)

  5. End of FY10 report - used fuel disposition technical bases and lessons learned : legal and regulatory framework for high-level waste disposition in the United States.

    Energy Technology Data Exchange (ETDEWEB)

    Weiner, Ruth F.; Blink, James A. (Lawrence Livermore National Laboratory, Livermore, CA); Rechard, Robert Paul; Perry, Frank (Los Alamos National Laboratory, Los Alamos, NM); Jenkins-Smith, Hank C. (University of Oklahoma, Norman, OK); Carter, Joe (Savannah River Nuclear Solutions, Aiken, SC); Nutt, Mark (Argonne National Laboratory, Argonne, IL); Cotton, Tom (Complex Systems Group, Washington DC)

    2010-09-01

    This report examines the current policy, legal, and regulatory framework pertaining to used nuclear fuel and high level waste management in the United States. The goal is to identify potential changes that if made could add flexibility and possibly improve the chances of successfully implementing technical aspects of a nuclear waste policy. Experience suggests that the regulatory framework should be established prior to initiating future repository development. Concerning specifics of the regulatory framework, reasonable expectation as the standard of proof was successfully implemented and could be retained in the future; yet, the current classification system for radioactive waste, including hazardous constituents, warrants reexamination. Whether or not consideration of multiple sites are considered simultaneously in the future, inclusion of mechanisms such as deliberate use of performance assessment to manage site characterization would be wise. Because of experience gained here and abroad, diversity of geologic media is not particularly necessary as a criterion in site selection guidelines for multiple sites. Stepwise development of the repository program that includes flexibility also warrants serious consideration. Furthermore, integration of the waste management system from storage, transportation, and disposition, should be examined and would be facilitated by integration of the legal and regulatory framework. Finally, in order to enhance acceptability of future repository development, the national policy should be cognizant of those policy and technical attributes that enhance initial acceptance, and those policy and technical attributes that maintain and broaden credibility.

  6. Four essays on offshore wind power potential, development, regulatory framework, and integration

    Science.gov (United States)

    Dhanju, Amardeep

    Offshore wind power is an energy resource whose potential in the US has been recognized only recently. There is now growing interest among the coastal states to harness the resource, particularly in states adjacent to the Mid-Atlantic Bight where the shallow continental shelf allows installation of wind turbines using the existing foundation technology. But the promise of bountiful clean energy from offshore wind could be delayed or forestalled due to policy and regulatory challenges. This dissertation is an effort to identify and address some of the important challenges. Focusing on Delaware as a case study it calculates the extent of the wind resource; considers one means to facilitate resource development---the establishment of statewide and regional public power authorities; analyzes possible regulatory frameworks to manage the resource in state-controlled waters; and assesses the use of distributed storage to manage intermittent output from wind turbines. In order to cover a diversity of topics, this research uses a multi-paper format with four essays forming the body of work. The first essay lays out an accessible methodology to calculate offshore wind resource potential using publicly available data, and uses this methodology to access wind resources off Delaware. The assessment suggests a wind resource approximately four times the average electrical load in Delaware. The second essay examines the potential role of a power authority, a quasi-public institution, in lowering the cost of capital, reducing financial risk of developing and operating a wind farm, and enhancing regional collaboration on resource development and management issues. The analysis suggests that a power authority can lower the cost of offshore wind power by as much as 1/3, thereby preserving the ability to pursue cost-competitive development even if the current federal incentives are removed. The third essay addresses the existing regulatory void in state-controlled waters of Delaware

  7. Interpretation of ALARA in the Canadian regulatory framework

    Energy Technology Data Exchange (ETDEWEB)

    Utting, R. [Atomic Energy Control Board, Ottawa, Ontario (Canada)

    1995-03-01

    The Atomic Energy Control Board (AECB) is responsible for the regulation of all aspects of atomic energy in Canada. This includes the complete nuclear fuel cycle from uranium mining to long-term disposal of nuclear fuel, as well as the medical and industrial utilization of radioisotopes. Clearly, the regulatory approach will differ from practice to practice but, as far as possible, the AECB has attempted to minimize the degree of prescription of regulatory requirements. The traditional modus operandi of the AECB has been to have broad general principles enshrined in regulations with the requirement that licensees submit specific operating policies and procedures to the AECB for approval. In the large nuclear facilities with their sophisticated technical infrastructures, this policy has been largely successful although in a changing legal and political milieu the AECB is finding that a greater degree of proactive regulation is becoming necessary. With the smaller users, the AECB has for a long time found it necessary to have a greater degree of prescription in its regulatory function. Forthcoming General Amendments to the Atomic Energy Control Regulations will, amongst other things, formally incorporate the concept of ALARA into the Canadian regulatory framework. Within the broad range of practices licensed by the AECB it is not practical to provide detailed guidance on optimization that will be relevant and appropriate to all licensees, however the following general principles are proposed.

  8. The shift of energy regulatory powers under the framework of Directive 2009/72/EC

    International Nuclear Information System (INIS)

    Grimm, N. S.

    2011-01-01

    The paper examines the powers of Member States' national regulatory authorities under the framework of Directive 2009/72/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in electricity and repealing Directive 2003/54/EC (OJEU L 176/37) and analyses the implications of framework of Directive 2009/72/EC on the national laws of the Member States, in particular on the Austrian and German constitutional, administrative and energy laws. The Introductory Part gives a historical overview of the development of national energy regulators under European energy legislation. This Part shows that the national regulatory authorities attract increased attention and that their regulatory powers are on a constant rise. In order to understand the huge impact of the framework of Directive 2009/72/EC on the regulatory regimes of the Member States, this Part briefly examines the former and current powers of the national energy regulators under Austrian and German law. Part Two analyses whether the powers conferred upon national energy regulators under the framework of Directive 2009/72/EC have been enhanced in comparison to those established under the framework of Directive 2003/54/EC. The main focus lies thereby on the propositions made by the European Commission in its Proposal for a Directive of the European Parliament and of the Council amending Directive 2003/54/EC concerning common rules for the internal market in electricity (COM (2007) 528 final, 2.1) and laid down in Directive 2009/72/EC. Part Two comes to the conclusion that the powers of the national energy regulators under the framework of Directive 2009/72/EC have indeed been enhanced in comparison to former regime of Directive 2003/54/EC. Part Three demonstrates that the enhancement of national energy regulators' powers does not benefit the Member States. On the contrary, they lose considerable powers of control over their own national energy regulators. While

  9. Controlling Methane Emissions in the Natural Gas Sector. A Review of Federal and State Regulatory Frameworks Governing Production, Gathering, Processing, Transmission, and Distribution

    Energy Technology Data Exchange (ETDEWEB)

    Paranhos, Elizabeth [Energy Innovation Partners, Seoul (South Korea); Kozak, Tracy G. [Energy Innovation Partners, Seoul (South Korea); Boyd, William [Univ. of Colorado, Boulder, CO (United States); Bradbury, James [U.S. Department of Energy, Washington, DC (United States); Steinberg, D. C. [National Renewable Energy Laboratory (NREL), Golden, CO (United States); Arent, D. J. [Joint Inst. for Strategic Energy Alaysis, Washington, DC (United States)

    2015-04-23

    This report provides an overview of the regulatory frameworks governing natural gas supply chain infrastructure siting, construction, operation, and maintenance. Information was drawn from a number of sources, including published analyses, government reports, in addition to relevant statutes, court decisions and regulatory language, as needed. The scope includes all onshore facilities that contribute to methane emissions from the natural gas sector, focusing on three areas of state and federal regulations: (1) natural gas pipeline infrastructure siting and transportation service (including gathering, transmission, and distribution pipelines), (2) natural gas pipeline safety, and (3) air emissions associated with the natural gas supply chain. In addition, the report identifies the incentives under current regulatory frameworks to invest in measures to reduce leakage, as well as the barriers facing investment in infrastructure improvement to reduce leakage. Policy recommendations regarding how federal or state authorities could regulate methane emissions are not provided; rather, existing frameworks are identified and some of the options for modifying existing regulations or adopting new regulations to reduce methane leakage are discussed.

  10. Upstream petroleum licensing: a comparative approach on regulatory frameworks and economic impacts

    Energy Technology Data Exchange (ETDEWEB)

    Cunha, Amanda L. [Felsberg e Associados, Sao Paulo, SP (Brazil)

    2008-07-01

    The recent discoveries hit in the pre-salt area, such as Tupi, Jupiter, Bem-te-vi and Carioca may place Brazil amongst the largest oil producers in the world. As a result, the Brazilian regulatory framework, which was originally envisaged in a scenario of higher exploration risk, has been under heavy public scrutiny. The Brazilian Government has already taken the first steps towards substantial changes in the country's contracting model for upstream activities. By means of Resolution No. 6/2007, the National Council for Energy Policy ('CNPE') not only determined the removal of 41 blocks with sub-salt geology from the ANP 9 Th Bid Round, but also stressed the need for a different regime for E and P activities in the country's continental shelf. At this moment, there is a great deal of controversy on the contracting model to be adopted, mainly whether the concession model should be maintained, but subject to higher levels of government take, or a production sharing model should apply. This paper goes through the evolution of international oil agreements, from early concessions to modern agreements. A special emphasis is placed on concession/license regimes as well as on production sharing agreements (PSAs). Besides drawing a comparative line between such models, this article assesses their economic impacts and whether the regulatory framework currently in force in Brazil is suitable for a scenario of lower risk, showing that any desired level of regulation may be achieved in the context of a PSA as easily as in a exclusive concession. (author)

  11. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Luxembourg

    International Nuclear Information System (INIS)

    2008-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Framework: 1. General; 2. Mining; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Emergency measures); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear third party liability; II. General Institutional Framework: 1. Regulatory and supervisory authorities (Minister of Health; Minister of Labour; Other Ministers competent); 2. Advisory bodies (Higher Health Council)

  12. Legislative and regulatory framework of radioactive waste management in Romania

    International Nuclear Information System (INIS)

    Cutoiu, D.

    2000-01-01

    The paper intent is to present an update on the Romanian legislative and regulatory framework in the area of radioactive waste management. Based on the experiences gained by the National Commission for Nuclear Activities Control in the past years, the recent legislative initiatives related to the coherent radwaste management policy at the national level are presented. (author)

  13. IAEA Mission Concludes Peer Review of Slovenia's Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2014-01-01

    Senior international nuclear safety and radiation protection experts today concluded an eight-day International Atomic Energy Agency (IAEA) mission to review the regulatory framework for nuclear and radiation safety at the Slovenian Nuclear Safety Administration (SNSA). The team reviewed measures taken to address the recommendations and suggestions made during an earlier Integrated Regulatory Review Service (IRRS) mission conducted in 2011. The IRRS team said in its preliminary findings that Slovenia had made significant progress since the review in 2011. The team identified a good practice in the country's nuclear regulatory system additional to those identified in 2011 and made new recommendations and suggestions to SNSA and the Government to strengthen the effectiveness of the country's regulatory framework in line with IAEA Safety Standards. ''By hosting a follow-up mission, Slovenia demonstrated its commitment to enhance its regulatory programmes, including by implementing the recommendations of the 2011 mission,'' said Petr Krs, mission leader and Vice Chairman of the Czech Republic's State Office for Nuclear Safety. SNSA's Director, Andrej Stritar, welcomed the progress noted by the team, while also emphasizing that the mission highlighted important future nuclear safety challenges for Slovenia. The five-member review team, comprising experts from Belgium, the Czech Republic, France and Romania, as well as four IAEA staff members, conducted the mission at the request of the Slovenian Government from 9 to 16 September 2014. The main observations of the IRRS Review team included the following: SNSA has made significant progress in addressing the findings of the 2011 IRRS mission and has demonstrated commitment to effective implementation of the IRRS programme; The economic situation in Slovenia might in the short and long term affect SNSA's ability to maintain its capacity and competence; and A radioactive waste disposal project is stalled and the licensing

  14. Regulatory Framework and Radiation Protection as Basis for Evaluation

    International Nuclear Information System (INIS)

    Elegba, S.B.

    2010-01-01

    Regulatory Framework for Nuclear Safety and Radiation Protection International Instruments: Conventions; Safety Fundamentals; Codes of Conduct; Safety Requirements and Guide, and National Instruments:-Legislation; Regulations; Guidance Documents. The Sustainable Development Principle recognizes a duty to prevent undue burden and degradation of the environment for future generations. The prime responsibility for safety must rest with the person or organization responsible for facilities…that give rise to radiation risks” (IAEA Safety Fundamentals – SF-1). Compliance with regulations and requirements imposed by the Regulatory Body shall not relieve the organization of its prime responsibility for safety. The regulatory body shall establish and implement appropriate arrangements for a systematic approach to quality management which extend throughout the range of responsibilities and functions undertaken.”. The IAEA self-assessment model for a Regulatory Body is based on a three tier approach. This model is modular and can be used and adopted for implementation by any regulator at any stage of maturity “Start up”, “On the way”, “Mature” Small, medium size, big. The IAEA is required by its Statute to promote international cooperation while regulating safety is a national responsibility. However, radiation risks may transcend national borders and international cooperation that serves to promote and enhance safety globally by exchanging experience and by improving capabilities to control hazards, to prevent accidents, to respond to emergencies and to mitigate any harmful consequences

  15. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Iceland

    International Nuclear Information System (INIS)

    2008-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances and equipment; 4. Nuclear installations; 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Nuclear security; 9. Transport; 10. Nuclear Third Party Liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Minister of Health and Social Security; Icelandic Radiation Protection Institute)

  16. IPTV Market Development and Regulatory Aspects

    DEFF Research Database (Denmark)

    Tadayoni, Reza; Sigurdsson, Halldór Matthias

    2006-01-01

    The aim of this paper is to analyse the development of IPTV technology / market and to discuss major regulatory parameters. A general overview of architectures and the technologies deployed for establishing IPTV services is given and the main stake holder identified, along with, the current service...... architecture, the available content in IPTV platforms, and the current business models. Furthermore the regulatory framework of the TV broadcast and IPTV in Europe is analysed....

  17. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities. Japan

    International Nuclear Information System (INIS)

    2017-01-01

    The NEA has updated, in coordination with the Permanent Delegation of Japan to the OECD, the report on the Regulatory and Institutional Framework for Nuclear Activities in Japan. This country report provides comprehensive information on the regulatory and institutional framework governing nuclear activities in Japan. It provides a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. Content: I - General Regulatory Regime: Introduction; Mining regime; Radioactive substances and equipment; Nuclear installations (Reactor Regulation, Emergency response); Trade in nuclear materials and equipment; Radiological protection; Radioactive waste management; Nuclear safeguards and nuclear security; Transport; Nuclear third party liability. II - Institutional Framework: Regulatory and supervisory authorities (Cabinet Office, Nuclear Regulation Authority (NRA), Ministry of Economy, Trade and Industry (METI), The Agency for Natural Resources and Energy (ANRE), Ministry of Land, Infrastructure, Transport and Tourism (MLIT), Ministry of Education, Culture, Sports, Science and Technology (MEXT)); Advisory bodies (Atomic Energy Commission (AEC), Reactor Safety Examination Committee, Nuclear Fuel Safety Examination Committee, Radiation Council, Other advisory bodies); Public and semi-public agencies (Japan Atomic Energy Agency (JAEA), National Institutes for Quantum and Radiological Science and Technology (QST), Nuclear Damage Compensation and Decommissioning Facilitation Corporation (NDF), Nuclear Waste Management Organisation (NUMO))

  18. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Canada

    International Nuclear Information System (INIS)

    2009-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction (Licensing system; Offences, compliance and enforcement; Regulatory documents; Other relevant legislation); 2. Mining regime; 3. Nuclear substances and radiation devices; 4. Nuclear facilities; 5. Trade in nuclear materials and equipment (Exports, Other imports); 6. Radiation protection; 7. Radioactive waste management; 8. Non-proliferation and nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Governor in council; Minister of natural resources; Other Ministerial authorities; Canadian Nuclear Safety Commission - CNSC); 2. Public and semi-public agencies (National Research Council - NRC; Natural Sciences and Engineering Research Council; Atomic Energy of Canada Ltd. - AECL)

  19. Regulatory framework and development perspectives of the mechanism of public participation in the management of Russia’s forests

    Directory of Open Access Journals (Sweden)

    Nikolay Mikhaylovich Shmatkov

    2014-03-01

    Full Text Available The article dwells on the current state of the regulatory framework of the Russian Federation and the mechanism of public participation in forest management. The examples of addressing the problems of public participation in forest management in individual regions are disclosed. The article deals with the issues concerning the provision of in-interests of the local population through the voluntary forest certification system under the FSC scheme. Recommendations on improving the mechanism of public participation in solving the forest management issues are suggested

  20. 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)

  1. Current products and future plan of regulatory research for risk-informed regulation in Korea

    International Nuclear Information System (INIS)

    Sung, Key Yong; Lee, Chang Ju; Kim, Woong Sik; Kim, Hho Jung

    2003-01-01

    The first phase of a regulatory research project for risk-informed regulation (RIR) and applications (RIA) was finished in March of 2002. Various results that could be useful for preparing Korean RIR system have been developed. One of the remarkable outputs is development of reactor safety goals and acceptance criteria for RIR and RIA in Korea. The Safety Goal has a 4-tier hierarchical structure and each tier has specified goals classified for their usage. Regulatory review guides for probabilistic safety assessment (PSA) including level-1, level-2 and low power and shutdown PSA have been updated by reflecting new information obtained from not only the overseas documents but also experience and insights from regulatory review in Korea. In addition, draft regulatory guides for risk-informed in-service inspection, in-service testing, importance ranking of motor-operated valves, and AOT/STI change of Technical Specifications have been developed for preparing ongoing and future licensing work. Risk-based inspection guides with inspection items selected from a viewpoint of risk importance have been suggested for Korean standard NPPs as well. In the second phase of a research project (April of 2002 to March of 2005), two regulatory research projects on RIR were initiated. One is a study on institutionalization of risk-informed and performance-based regulation. Main topics of this project are evaluation of benefit and characteristics of RIR, development of optimized Korean RIR model, impact analysis for the change of current regulation framework, and suggestion of RIR-related laws and rules. The other is focusing on the development in the areas of a regulatory audit PSA model and regulatory guides for risk monitoring, and application techniques of risk information to the significance determination of plant performance indicators and inspection findings. It is expected that a concrete scheme and detailed regulatory techniques for embodiment of RIR system in Korea will be

  2. Gamete and Embryo Donation and Surrogacy in Australia: The Social Context and Regulatory Framework

    Science.gov (United States)

    Hammarberg, Karin; Johnson, Louise; Petrillo, Tracey

    2011-01-01

    The social and legal acceptability of third-party reproduction varies around the world. In Australia, gamete and embryo donation and surrogacy are permitted within the regulatory framework set out by federal and state governments. The aim of this paper is to describe the social context and regulatory framework for third-party reproduction in Australia. This is a review of current laws and regulations related to third-party reproduction in Australia. Although subtle between-state differences exist, third-party reproduction is by and large a socially acceptable and legally permissible way to form a family throughout Australia. The overarching principles that govern the practice of third-party reproduction are altruism; the right of donorconceived people to be informed of their biological origins; and the provision of comprehensive counselling about the social, psychological, physical, ethical, financial and legal implications of third-party reproduction to those considering donating or receiving gametes or embryos and entering surrogacy arrangements. These principles ensure that donors are not motivated by financial gain, donor offspring can identify and meet with the person or persons who donated gametes or embryos, and prospective donors and recipients are aware of and have carefully considered the potential consequences of third-party reproduction. Australian state laws and federal guidelines prohibit commercial and anonymous third-party reproduction; mandate counselling of all parties involved in gamete and embryo donation and surrogacy arrangements; and require clinics to keep records with identifying and non- identifying information about the donor/s to allow donor-conceived offspring to trace their biological origins. PMID:24851179

  3. Gamete and embryo donation and surrogacy in australia: the social context and regulatory framework.

    Science.gov (United States)

    Hammarberg, Karin; Johnson, Louise; Petrillo, Tracey

    2011-01-01

    The social and legal acceptability of third-party reproduction varies around the world. In Australia, gamete and embryo donation and surrogacy are permitted within the regulatory framework set out by federal and state governments. The aim of this paper is to describe the social context and regulatory framework for third-party reproduction in Australia. This is a review of current laws and regulations related to third-party reproduction in Australia. Although subtle between-state differences exist, third-party reproduction is by and large a socially acceptable and legally permissible way to form a family throughout Australia. The overarching principles that govern the practice of third-party reproduction are altruism; the right of donorconceived people to be informed of their biological origins; and the provision of comprehensive counselling about the social, psychological, physical, ethical, financial and legal implications of third-party reproduction to those considering donating or receiving gametes or embryos and entering surrogacy arrangements. These principles ensure that donors are not motivated by financial gain, donor offspring can identify and meet with the person or persons who donated gametes or embryos, and prospective donors and recipients are aware of and have carefully considered the potential consequences of third-party reproduction. Australian state laws and federal guidelines prohibit commercial and anonymous third-party reproduction; mandate counselling of all parties involved in gamete and embryo donation and surrogacy arrangements; and require clinics to keep records with identifying and non- identifying information about the donor/s to allow donor-conceived offspring to trace their biological origins.

  4. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Slovenia

    International Nuclear Information System (INIS)

    2013-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Emergency response); 5. Trade in nuclear materials and equipment; 6. Safeguards for nuclear material; 7. Radiation protection; 8. Radioactive waste management; 9. Nuclear security; 10. Transport; 11. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Slovenian Nuclear Safety Administration - SNSA; Slovenian Radiation Protection Administration - SRPA); 2. Advisory bodies; 3. Public and semi-public agencies; 4. Technical support organisations - approved experts

  5. IAEA Mission Concludes Peer Review of Pakistan's Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2014-01-01

    An international team of senior nuclear safety experts today concluded a nine-day International Atomic Energy Agency (IAEA) mission to review the regulatory framework for the safety of operating nuclear power plants in the United States of America (USA). The Integrated Regulatory Review Service (IRRS) mission was a follow-up to the IRRS mission to the US Nuclear Regulatory Commission (NRC) that was conducted in 2010, with the key additional aim of reviewing whether the response of the US regulatory regime to the implications of the accident at TEPCO's Fukushima Daiichi Plant had been timely and effective. The mission team concluded that the recommendations and suggestions made by the 2010 IRRS mission have been taken into account systematically under the NRC's subsequent action plan, with significant progress in many areas and many improvements carried out. One of two recommendations and 19 out of 20 suggestions made by the 2010 IRRS mission have been effectively addressed and can therefore be considered closed. The outstanding recommendation relates to the NRC's review of its Management System, which is in the process of being finalised. The IRRS team also found that the NRC acted promptly and effectively after the Fukushima accident in the interests of public health and safety, and that the report of its Near-Term Task Force represents a sound and ample basis for taking into account the lessons learned from the accident

  6. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - New Zealand

    International Nuclear Information System (INIS)

    2008-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive Substances and Equipment; 4. Nuclear installations; 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities - National Radiation Laboratory - NRL; 2. Advisory bodies - Radiation Protection Advisory Council; 3. Public and semi-public agencies - Research institutes

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

    International Nuclear Information System (INIS)

    2016-01-01

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

  8. Redesigning the regulatory framework for ambulatory care services in New York.

    Science.gov (United States)

    Chokshi, Dave A; Rugge, John; Shah, Nirav R

    2014-12-01

    Policy Points: The landscape of ambulatory care services in the United States is rapidly changing on account of payment reform, primary care transformation, and the rise of convenient care options such as retail clinics. New York State has undertaken a redesign of regulatory policy for ambulatory care rooted in the Triple Aim (better health, higher-quality care, lower costs)-with a particular emphasis on continuity of care for patients. Key tenets of the regulatory approach include defining and tracking the taxonomy of ambulatory care services as well as ensuring that convenient care options do not erode continuity of care for patients. While hospitals remain important centers of gravity in the health system, services are increasingly being delivered through ambulatory care. This shift to ambulatory care is giving rise to new delivery structures, such as retail clinics and urgent care centers, as well as reinventing existing ambulatory care capacity, as seen with the patient-centered medical home model and the movement toward team-based care. To protect the public's interests, oversight of ambulatory care services must keep pace with these rapid changes. With this purpose, in January 2013 the New York Public Health and Health Planning Council undertook a redesign of the regulatory framework for the state's ambulatory care services. This article describes the principles undergirding the framework as well as the regulatory recommendations themselves. We explored and analyzed the regulation of ambulatory care services in New York in accordance with the available gray and peer-reviewed literature and legislative documents. The deliberations of the Public Health and Health Planning Council informed our review. The vision of high-performing ambulatory care should be rooted in the Triple Aim (better health, higher-quality care, lower costs), with a particular emphasis on continuity of care for patients. There is a pressing need to better define the taxonomy of ambulatory

  9. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Slovak Republic

    International Nuclear Information System (INIS)

    2013-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining Regime; 3. Radioactive Substances and Equipment; 4. Nuclear Installations (Licensing and Inspection, including Nuclear Safety; Emergency Response); 5. Trade in Nuclear Materials and Equipment; 6. Radiological Protection; 7. Radioactive Waste Management; 8. Non-proliferation and Physical Protection; 9. Transport; 10. Nuclear Third Party Liability; II. Institutional Framework: 1. Regulatory and Supervisory Authorities (Nuclear Regulatory Authority of the Slovak Republic - UJD; Ministry of Health; Ministry of the Environment; Ministry of the Interior; Ministry of Economy; Ministry of Labour and National Labour Inspectorate); 2. Public and Semi-Public Agencies

  10. 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)

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

    International Nuclear Information System (INIS)

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

    2000-01-01

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

  12. Serbian oil sector: A new energy policy regulatory framework and development strategies

    International Nuclear Information System (INIS)

    Karovic Maricic, Vesna; Danilovic, Dusan; Lekovic, Branko

    2012-01-01

    Serbia has established a great part of new legislative and institutional framework as a basis for all energy sub-sectors' development in compliance with EU energy acquis. Main objectives of Serbian energy policy outlined in the new Energy Law are focused to increasing the energy supply security, energy efficiency, competitiveness of the energy market, use of renewable energy sources and environmental protection. Further steps of Serbia toward full EU membership concerning the new energy policy regulatory framework involve implementing and enforcing legislation. Besides considering the issue of Serbian energy policy and degree of its framework's alignment with the EU acquis, this paper provides an overview of new development strategies in the oil sector. The aim of Gazprom neft, a majority owner of the Petroleum industry of Serbia, is to increase crude oil production to 3 million tonnes, refining and sales volume of petroleum products to 5 million tonnes by 2020. Strategic development projects in crude oil and petroleum products transportation are: petroleum product pipeline construction in Serbia and Pan-European oil pipeline. The basic prerequisites for oil supply security, regarding the future high dependency of Serbian economy on imported oil, are establishment of the emergency oil stocks and diversification of supply sources. - Highlight: ► New energy policy regulatory framework significantly complied with EU acquis. ► Full EU membership requires implementing and enforcing new energy legislation. ► NIS-Gazpromneft has defined ambitious oil sector's development programmes to 2020. ► Supply security requires mandatory oil stocks and supply source diversification.

  13. International Expert Team Concludes IAEA Peer Review of Finland's Regulatory Framework for Nuclear and Radiation Safety

    International Nuclear Information System (INIS)

    2012-01-01

    Full text: International safety experts today concluded a two-week International Atomic Energy Agency (IAEA) mission to review the regulatory framework for nuclear and radiation safety in Finland. In its preliminary report, the Integrated Regulatory Review Service (IRRS) mission team found that the Radiation and Nuclear Safety Authority of Finland (STUK) is a competent and highly credible regulator that is open and transparent and derives great strength from the technical competence of its staff. ''Finland's comprehensive regulatory framework allows STUK to operate in practice as an independent regulatory body,'' said team leader Philippe Jamet, a commissioner of the French regulatory body ASN. The mission was conducted at the request of the Government of Finland from 15-26 October. The team interviewed members of STUK and officials from various ministries, as well as key players in the Finnish safety framework. Such IRRS missions are peer reviews based on IAEA Safety Standards, not inspections or audits. The team was made up of 18 members from Bulgaria, Canada, the Czech Republic, France, Germany, Iceland, Ireland, Romania, the Russian Federation, South Africa, Slovakia, Slovenia, Spain, Sweden, the United Arab Emirates, the United Kingdom and the United States, as well as six IAEA staff members. 'The IRRS mission and preparation for it was a unique occasion that involved the whole organization, provided motivation for improvement of the safety framework in Finland and assists STUK review its mission', said Tero Varjoranta, Director General of STUK. The IRRS team identified a number of good practices and achievements, including: - STUK's excellence in its safety assessment of nuclear power plants and waste repositories, in particular its demonstration that long-term political commitment is a necessity to sustain the creation of a waste repository as well as its regulatory oversight of medical applications of radiation sources; and - STUK's excellent record in

  14. IAEA Mission Concludes Peer Review of Viet Nam's Radiation and Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2014-01-01

    Senior international nuclear safety and radiation protection experts today concluded a 10-day International Atomic Energy Agency (IAEA) mission to review how Viet Nam's regulatory framework for nuclear and radiation safety has incorporated recommendations and suggestions from an earlier review, conducted in 2009. The Integrated Regulatory Review Service (IRRS) follow-up mission, requested by the Viet Nam Agency for Radiation and Nuclear Safety (VARANS), also reviewed the development of the regulatory safety infrastructure to support Viet Nam's nuclear power programme. The eight-member team comprised senior regulatory experts from Canada, France, Pakistan, Slovenia, United Arab Emirates and the United States of America, as well as three IAEA staff members. The IRRS team said in its preliminary assessment that Viet Nam had made progress since 2009, but that some key recommendations still needed to be addressed. Particular strengths identified by the team included: The commitment of VARANS staff to develop legislation and regulations in the field of nuclear and radiation safety; VARANS' efforts to implement practices that are in line with IAEA Safety Standards and internationally recognized good practices; A willingness to receive feedback regarding the efforts to establish and implement a regulation programme; and Progress made in developing the regulatory framework to support the introduction of nuclear power. The team identified the following areas as high-priority steps to further strengthen radiation and nuclear safety in Viet Nam: The effective independence of the regulatory decision-making process needs to be urgently addressed; Additional resources are needed to regulate existing radiation facilities and activities, as well as the country's research reactor; Efforts to increase the capacity of VARANS to regulate the developing nuclear power programme should continue; The draft Master Plan for the Development of Nuclear Power Infrastructure should be finalized

  15. Current issues and regulatory infrastructure aspects on radioactive waste management in Romania

    International Nuclear Information System (INIS)

    Vieru, G.

    2002-01-01

    The nuclear facilities that exist throughout Romania perform a broad range of missions from research to nuclear materials production to radioactive waste management, and to deactivation and decommissioning. As a consequence, there is a broad array of external regulations and internal requirements that potentially applies to a facility or activity. Therefore, the management of radioactive waste occurs within a larger context of managing hazards, both radiological and industrial, at these facilities. At the same time, concern for upgrading existing facilities used for radioactive waste management, as called for in Article 12, fits into a larger framework of safety management. The primary objective of the Romanian Nuclear Regulatory Body-CNCAN on legislation and regulatory infrastructure for the safety of radioactive waste management is to protect human health and the environment now and in the future. It is unanimously recognized that a well developed regulated system for the management and disposal of radioactive waste is a prerequisite for both public and market acceptance of nuclear energy. It is to underline that the continuing internationalization of the nuclear industry following terrorist attacks of 11 September 2001 stresses the need for national legislation and regulatory infrastructure to be based on internationally endorsed principles and safety standards. The paper presents some aspects of the Romanian experience on the national legislative and regulatory system related to the followings aspects of the safety aspects of radioactive waste management: definition of responsibilities; nuclear and radiation safety requirements; siting and licensing procedures; regulatory functions; international co-operation and coherence on strategies and criteria in the area of safety of radioactive waste management. Finally, prescriptive and goal oriented national as well international regimes in the field of the safety of radioactive waste management are briefly commented

  16. Current Status of Regulatory Science Education in Faculties of Pharmaceutical Science in Japan.

    Science.gov (United States)

    Tohkin, Masahiro

    2017-01-01

    I introduce the current pharmaceutical education system in Japan, focusing on regulatory science. University schools or faculties of pharmaceutical science in Japan offer two courses: a six-year course for pharmacists and a four-year course for scientists and technicians. Students in the six-year pharmaceutical course receive training in hospitals and pharmacies during their fifth year, and those in the four-year life science course start research activities during their third year. The current model core curriculum for pharmaceutical education requires them to "explain the necessity and significance of regulatory science" as a specific behavior object. This means that pharmacists should understand the significance of "regulatory science", which will lead to the proper use of pharmaceuticals in clinical practice. Most regulatory science laboratories are in the university schools or faculties of pharmaceutical sciences; however, there are too few to conduct regulatory science education. There are many problems in regulatory science education, and I hope that those problems will be resolved not only by university-based regulatory science researchers but also by those from the pharmaceutical industry and regulatory authorities.

  17. IAEA Team Concludes Peer Review of Sweden's Nuclear Regulatory Framework, 17 February 2012, Stockholm, Sweden

    International Nuclear Information System (INIS)

    2012-01-01

    Full text: An international team of senior nuclear safety and radiation protection experts today concluded a 12-day mission to review the regulatory framework for nuclear and radiation safety in Sweden. The Integrated Regulatory Review Service (IRRS) mission, which was conducted at the request of Sweden, noted good practices in the country's nuclear regulatory system and also made recommendations and suggestions for the Swedish Radiation Safety Authority (SSM) and the government. These are aimed at strengthening the effectiveness of the country's regulatory framework and functions in line with IAEA Safety Standards. ''Throughout the mission, the IRRS team received full cooperation from SSM staff in its review of Sweden's regulatory, technical and policy issues,'' said Georg Schwarz, mission leader and Deputy Director General of the Swiss nuclear regulator (ENSI). 'The staff were open and candid in their discussions and provided the fullest practicable assistance', he commented. The main observations of the IRRS Review team included the following: SSM operates as an independent regulator in an open and transparent manner with well-organized regulatory processes; SSM is receptive to feedback and strives to maintain a culture of continuous learning; and Following the TEPCO Fukushima Daiichi accident, SSM responded promptly to public demand for information and communicated effectively with the national government, the public and other interested parties. Good practices identified by the IRRS team included, though they are not limited to, the following: The consolidation of the two previous national regulatory authorities into SSM was successful; Overall, SSM's management system is comprehensive and contributes to staff efficiency and effectiveness; The nuclear power plant refurbishment programme as required by SSM enhanced safety; and Sweden's regulatory framework for high-level waste disposal is comprehensive and technically sound. The IRRS Review team identified

  18. Study of the legal and regulatory framework applicable to the participative financing of renewable energies

    International Nuclear Information System (INIS)

    Poize, Noemie; Milin, Christophe; Guillerminet, Marie-Laure; Galiano, Mila

    2015-12-01

    In the context created by the French law on energy transition and green growth, this study addresses participative projects which are levers for the financing of renewable energy production, and also contribute to the local dimension of projects. More precisely, the authors focus on participative projects in which a financial participation of citizen and/or local communities is present, with or without access to governance, directly or indirectly. The authors first propose a typology of these projects, based on existing initiatives, and then an overview of the legal and regulatory framework in effect before the law on energy transition. They comment and discuss articles contained by this law which address citizen participation. They discuss their impact on the current project typology

  19. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Ireland

    International Nuclear Information System (INIS)

    2009-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations; 5. Trade in nuclear materials and equipment; 6. Radiation protection (Radiation protection standards; Emergency response); 7. Radioactive waste management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Minister for the Environment, Heritage and Local Government; Minister for Agriculture and Food; Minister for Communications, Marine and Natural Resources; Minister for Finance; Minister for Health and Children; Minister for Defence); 2. Public and semi-public agencies (Radiological Protection Institute of Ireland; Food Safety Authority of Ireland)

  20. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Turkey

    International Nuclear Information System (INIS)

    2008-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations; 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Prime Minister; Ministry of Energy and Natural Resources; Ministry of Health; Ministry of the Environment and Forestry); 2. Public and semi-public agencies (Turkish Atomic Energy Authority - TAEK; General Directorate for Mineral Research and Exploration - MTA; ETI Mine Works General Management; Turkish Electric Generation and Transmission Corporation - TEAS; Turkish Electricity Distribution Corporation - TEDAS)

  1. Legal framework of the environmental regulatory regime

    International Nuclear Information System (INIS)

    Black, D.

    1992-01-01

    The growing concern regarding environmental issues has presented a number of new challenges to those exploring and developing the hydrocarbon reserves located on the Newfoundland continental shelf. Not the least of these challenges is the development of new technologies in the harsh environment of the North Atlantic; in addition, these new technologies must be implemented in an existing and ever-changing regulatory regime. The legal framework of the environmental regulatory regime relating to offshore development in Canada is reviewed along with some of the more important legislation involved in regulating environmental issues in the offshore area. The legal basis for exploration, development, and management of resources located on the Newfoundland continental shelf is the Canada-Newfoundland Accord on Joint Management of Offshore Oil and Gas Resources off Newfoundland and Labrador. Administration of the Accord is the responsibility of the Canada-Newfoundland Offshore Petroleum Board. To be able to apply Canadian laws to the continental shelf, legislation was passed including the Canadian Laws Offshore Application Act as well as the Act implementing the Accord. The latter gives the Offshore Petroleum Board authority to regulate all stages involved in bringing an oil pool to production, such as granting of licenses and work authorizations. Granting of such licenses and authorizations is subject to compliance with environmental requirements, and there are provisions against certain environmental offenses such as spills. Other federal legislation applicable to the offshore includes the Canada Shipping Act and the Canadian Environmental Protection Act

  2. 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.

  3. A Framework for Organizing Current and Future Electric Utility Regulatory and Business Models

    Energy Technology Data Exchange (ETDEWEB)

    Satchwell, Andrew [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Cappers, Peter [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Schwartz, Lisa C. [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Fadrhonc, Emily Martin [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States)

    2015-06-01

    Many regulators, utilities, customer groups, and other stakeholders are reevaluating existing regulatory models and the roles and financial implications for electric utilities in the context of today’s environment of increasing distributed energy resource (DER) penetrations, forecasts of significant T&D investment, and relatively flat or negative utility sales growth. When this is coupled with predictions about fewer grid-connected customers (i.e., customer defection), there is growing concern about the potential for serious negative impacts on the regulated utility business model. Among states engaged in these issues, the range of topics under consideration is broad. Most of these states are considering whether approaches that have been applied historically to mitigate the impacts of previous “disruptions” to the regulated utility business model (e.g., energy efficiency) as well as to align utility financial interests with increased adoption of such “disruptive technologies” (e.g., shareholder incentive mechanisms, lost revenue mechanisms) are appropriate and effective in the present context. A handful of states are presently considering more fundamental changes to regulatory models and the role of regulated utilities in the ownership, management, and operation of electric delivery systems (e.g., New York “Reforming the Energy Vision” proceeding).

  4. Genotet: An Interactive Web-based Visual Exploration Framework to Support Validation of Gene Regulatory Networks.

    Science.gov (United States)

    Yu, Bowen; Doraiswamy, Harish; Chen, Xi; Miraldi, Emily; Arrieta-Ortiz, Mario Luis; Hafemeister, Christoph; Madar, Aviv; Bonneau, Richard; Silva, Cláudio T

    2014-12-01

    Elucidation of transcriptional regulatory networks (TRNs) is a fundamental goal in biology, and one of the most important components of TRNs are transcription factors (TFs), proteins that specifically bind to gene promoter and enhancer regions to alter target gene expression patterns. Advances in genomic technologies as well as advances in computational biology have led to multiple large regulatory network models (directed networks) each with a large corpus of supporting data and gene-annotation. There are multiple possible biological motivations for exploring large regulatory network models, including: validating TF-target gene relationships, figuring out co-regulation patterns, and exploring the coordination of cell processes in response to changes in cell state or environment. Here we focus on queries aimed at validating regulatory network models, and on coordinating visualization of primary data and directed weighted gene regulatory networks. The large size of both the network models and the primary data can make such coordinated queries cumbersome with existing tools and, in particular, inhibits the sharing of results between collaborators. In this work, we develop and demonstrate a web-based framework for coordinating visualization and exploration of expression data (RNA-seq, microarray), network models and gene-binding data (ChIP-seq). Using specialized data structures and multiple coordinated views, we design an efficient querying model to support interactive analysis of the data. Finally, we show the effectiveness of our framework through case studies for the mouse immune system (a dataset focused on a subset of key cellular functions) and a model bacteria (a small genome with high data-completeness).

  5. An integrative and applicable phylogenetic footprinting framework for cis-regulatory motifs identification in prokaryotic genomes.

    Science.gov (United States)

    Liu, Bingqiang; Zhang, Hanyuan; Zhou, Chuan; Li, Guojun; Fennell, Anne; Wang, Guanghui; Kang, Yu; Liu, Qi; Ma, Qin

    2016-08-09

    Phylogenetic footprinting is an important computational technique for identifying cis-regulatory motifs in orthologous regulatory regions from multiple genomes, as motifs tend to evolve slower than their surrounding non-functional sequences. Its application, however, has several difficulties for optimizing the selection of orthologous data and reducing the false positives in motif prediction. Here we present an integrative phylogenetic footprinting framework for accurate motif predictions in prokaryotic genomes (MP(3)). The framework includes a new orthologous data preparation procedure, an additional promoter scoring and pruning method and an integration of six existing motif finding algorithms as basic motif search engines. Specifically, we collected orthologous genes from available prokaryotic genomes and built the orthologous regulatory regions based on sequence similarity of promoter regions. This procedure made full use of the large-scale genomic data and taxonomy information and filtered out the promoters with limited contribution to produce a high quality orthologous promoter set. The promoter scoring and pruning is implemented through motif voting by a set of complementary predicting tools that mine as many motif candidates as possible and simultaneously eliminate the effect of random noise. We have applied the framework to Escherichia coli k12 genome and evaluated the prediction performance through comparison with seven existing programs. This evaluation was systematically carried out at the nucleotide and binding site level, and the results showed that MP(3) consistently outperformed other popular motif finding tools. We have integrated MP(3) into our motif identification and analysis server DMINDA, allowing users to efficiently identify and analyze motifs in 2,072 completely sequenced prokaryotic genomes. The performance evaluation indicated that MP(3) is effective for predicting regulatory motifs in prokaryotic genomes. Its application may enhance

  6. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Finland

    International Nuclear Information System (INIS)

    2008-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations; (Licensing and inspection, including nuclear safety; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Ministry of Trade and Industry - KTM; Ministry of Social Affairs and Health; Ministry of the Interior; Ministry of the Environment; Ministry of Foreign Affairs); 2. Advisory bodies (Advisory Committee on Nuclear Energy; Advisory Committee on Nuclear Safety); 3. Public and semi-public agencies (Finnish Radiation and Nuclear Safety Authority - STUK; State Nuclear Waste Management Fund)

  7. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Portugal

    International Nuclear Information System (INIS)

    2011-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Ministry of Health; Minister of Science, Technology and Higher Education; Ministry of Economy and Innovation; Ministry of Environment and Territorial Planning; Other authorities); 2. Advisory bodies (Independent Commission for Radiological Protection and Nuclear Safety - CIPRSN; National Radiation Protection Commission - CNPCR; National Commission for Radiological Emergencies - CNER; Other advisory bodies); 3. Public and semi-public agencies

  8. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Mexico

    International Nuclear Information System (INIS)

    2009-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear third party liability; 11. Nuclear terrorism; II. Institutional Framework - The federal government: 1. Regulatory and supervisory authorities (Ministry of Energy; Ministry of Health; Ministry of Labour and Social Security; Ministry of the Environment and Natural Resources; Ministry of Communications and Transport); 2. Public and semi-public agencies: (National Nuclear Safety and Safeguards Commission; National Nuclear Research Institute)

  9. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Japan

    International Nuclear Information System (INIS)

    2011-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Cabinet Office; Minister of Economy, Trade and Industry - METI; Minister of Land, Infrastructure and Transport - MLIT; Minister of Education, Culture, Sports, Science and Technology - MEXT); 2. Advisory bodies (Atomic Energy Commission - AEC; Nuclear Safety Commission - NSC; Radiation Council; Special Committee on Energy Policy; Other advisory bodies); 3. Public and Semi-Public Agencies (Japan Atomic Energy Agency - JAEA)

  10. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Denmark

    International Nuclear Information System (INIS)

    2015-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Minister of Health; Minister for the Environment/Minister of Transport and Energy; Minister of Justice; Minister of Defence; National Board of Health; Emergency Management Agency); 2. Advisory bodies (The Danish Ministry of Energy, Supply and Climate and the Danish Energy Agency); 3. Public and semi-public agencies (Risoe National Laboratory)

  11. The regulatory framework of special medical group students' physical education: identifying the problem.

    Directory of Open Access Journals (Sweden)

    Mazur Valerij Anatol'evich

    2011-09-01

    Full Text Available The question of regulatory framework for special medical group students' physical education, and their physical condition in particular is elaborated. It is found that in the current program the identified question is missing, although the assessment of individual performance standards for the physical condition of the students was envisaged in the programs of 1977 and 1982. The need for such an assessment is indicated by the large number of Ukrainian and foreign pediatricians and specialists in therapeutic physical culture. At the same time the standards for assessing these indicators are not developed. It complicates the formation of positive motivation of students to regular classes, and does not promote their self-confidence, capabilities and effectiveness of monitoring the effectiveness of exercise in various forms. The findings suggest the need to define the optimal composition of the bulk of tests and functional tests to assess the physical condition of special medical group students with various diseases and to develop appropriate indicators for their evaluation standards.

  12. Regulatory Coherence and Standardization Mechanisms in the Trans-Pacific Partnership

    Directory of Open Access Journals (Sweden)

    Cai Phoenix X. F.

    2016-12-01

    Full Text Available This article posits a new taxonomy and framework for assessing regulatory coherence in the new generation of mega-regional, cross-cutting free trade agreements. Using the Trans-Pacific Partnership as the primary example, this article situates the rise of regulatory coherence within the current trade landscape, provides clear definitions of regulatory coherence, and argues that the real engine of regulatory coherence lies in the work of international standard setting organizations. This work has been little examined in the current literature. The article provides a detailed examination of the mechanics by which the Trans-Pacific Partnership promotes regulatory standardization and concludes with some normative implications and calls for future research.

  13. Sociotechnical systems as a framework for regulatory system design and evaluation: Using Work Domain Analysis to examine a new regulatory system.

    Science.gov (United States)

    Carden, Tony; Goode, Natassia; Read, Gemma J M; Salmon, Paul M

    2017-03-15

    Like most work systems, the domain of adventure activities has seen a series of serious incidents and subsequent calls to improve regulation. Safety regulation systems aim to promote safety and reduce accidents. However, there is scant evidence they have led to improved safety outcomes. In fact there is some evidence that the poor integration of regulatory system components has led to adverse safety outcomes in some contexts. Despite this, there is an absence of methods for evaluating regulatory and compliance systems. This article argues that sociotechnical systems theory and methods provide a suitable framework for evaluating regulatory systems. This is demonstrated through an analysis of a recently introduced set of adventure activity regulations. Work Domain Analysis (WDA) was used to describe the regulatory system in terms of its functional purposes, values and priority measures, purpose-related functions, object-related processes and cognitive objects. This allowed judgement to be made on the nature of the new regulatory system and on the constraints that may impact its efficacy following implementation. Importantly, the analysis suggests that the new system's functional purpose of ensuring safe activities is not fully supported in terms of the functions and objects available to fulfil them. Potential improvements to the design of the system are discussed along with the implications for regulatory system design and evaluation across the safety critical domains generally. Copyright © 2017 Elsevier Ltd. All rights reserved.

  14. Cell therapy medicinal product regulatory framework in Europe and its application for MSC based therapy development

    Directory of Open Access Journals (Sweden)

    Janis eAncans

    2012-08-01

    Full Text Available Advanced therapy medicinal products (ATMPs, including cell therapy products, form a new class of medicines in the European Union. Since ATMPs are at the forefront of scientific innovation in medicine, specific regulatory framework has been developed for these medicines and implemented from 2009. The Committee for Advanced Therapies (CAT has been established at European Medicines Agency (EMA for centralized classification, certification and evaluation procedures, and other ATMP related tasks. Guidance documents, initiatives and interaction platforms are available to make the new framework more accessible for small and medium-sized enterprises, academia, hospitals and foundations. Good understanding of centralised and national components of the regulatory system is required to plan product development. It is in the best interests of cell therapy developers to utilise provided resources starting with the preclinical stage. Whilst there have not been mesenchymal stem cell (MSC based medicine authorisations in the EU, three MSC products have received marketing approval in other regions since 2011. Information provided on regulatory requirements, procedures and initiatives is aimed to facilitate MSC based medicinal product development and authorisation in the EU.

  15. Regulatory Framework for Controlling the Research Reactor Decommissioning Project

    International Nuclear Information System (INIS)

    Melani, Ai; Chang, Soon Heung

    2009-01-01

    Decommissioning is one of important stages in construction and operation of research reactors. Currently, there are three research reactors operating in Indonesia. These reactors are operated by the National Nuclear Energy Agency (BATAN). The age of the three research reactors varies from 22 to 45 years since the reactors reached their first criticality. Regulatory control of the three reactors is conducted by the Nuclear Energy Regulatory Agency (BAPETEN). Controlling the reactors is carried out based on the Act No. 10/1997 on Nuclear Energy, Government Regulations and BAPETEN Chairman Decrees concerning the nuclear safety, security and safeguards. Nevertheless, BAPETEN still lack of the regulation, especially for controlling the decommissioning project. Therefore, in the near future BAPETEN has to prepare the regulations for decommissioning, particularly to anticipate the decommissioning of the oldest research reactors, which probably will be done in the next ten years. In this papers author give a list of regulations should be prepared by BAPETEN for the decommissioning stage of research reactor in Indonesia based on the international regulatory practice

  16. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Greece

    International Nuclear Information System (INIS)

    2015-01-01

    In Greece, there are no nuclear power plants and nuclear energy is not considered as an option in the foreseeable future. There is, however, one nuclear research reactor (in extended shutdown since 2014) and one sub-critical assembly. Radioactive waste originating from medicine, research and industry is classified as low level. Although there is no framework act dealing comprehensively with the different aspects of nuclear energy, there are various laws, decrees and regulations of a more specific nature governing several aspects of nuclear activities. This paper gives information on the general regulatory regime (mining regime, radioactive substances, nuclear fuel and equipment, nuclear installations (licensing and inspection, including nuclear safety, emergency response, trade in nuclear materials and equipment, radiation protection, radioactive waste management, nuclear security, transport, nuclear third party liability) and on the institutional framework with the regulatory and supervisory authorities (Greek Atomic Energy Commission (EEAE))

  17. Costs of regulatory compliance: categories and estimating techniques

    International Nuclear Information System (INIS)

    Schulte, S.C.; McDonald, C.L.; Wood, M.T.; Cole, R.M.; Hauschulz, K.

    1978-10-01

    Use of the categorization scheme and cost estimating approaches presented in this report can make cost estimates of regulation required compliance activities of value to policy makers. The report describes a uniform assessment framework that when used would assure that cost studies are generated on an equivalent basis. Such normalization would make comparisons of different compliance activity cost estimates more meaningful, thus enabling the relative merits of different regulatory options to be more effectively judged. The framework establishes uniform cost reporting accounts and cost estimating approaches for use in assessing the costs of complying with regulatory actions. The framework was specifically developed for use in a current study at Pacific Northwest Laboratory. However, use of the procedures for other applications is also appropriate

  18. Regulatory framework and business models for charging plug-in electric vehicles: Infrastructure, agents, and commercial relationships

    Energy Technology Data Exchange (ETDEWEB)

    Gomez San Roman, Tomas [Instituto de Investigacion Tecnologica, Universidad Pontificia Comillas, Madrid (Spain); Momber, Ilan, E-mail: ilan.momber@iit.upcomillas.es [Instituto de Investigacion Tecnologica, Universidad Pontificia Comillas, Madrid (Spain); Rivier Abbad, Michel; Sanchez Miralles, Alvaro [Instituto de Investigacion Tecnologica, Universidad Pontificia Comillas, Madrid (Spain)

    2011-10-15

    Electric vehicles (EVs) present efficiency and environmental advantages over conventional transportation. It is expected that in the next decade this technology will progressively penetrate the market. The integration of plug-in electric vehicles in electric power systems poses new challenges in terms of regulation and business models. This paper proposes a conceptual regulatory framework for charging EVs. Two new electricity market agents, the EV charging manager and the EV aggregator, in charge of developing charging infrastructure and providing charging services are introduced. According to that, several charging modes such as EV home charging, public charging on streets, and dedicated charging stations are formulated. Involved market agents and their commercial relationships are analysed in detail. The paper elaborates the opportunities to formulate more sophisticated business models for vehicle-to-grid applications under which the storage capability of EV batteries is used for providing peak power or frequency regulation to support the power system operation. Finally penetration phase dependent policy and regulatory recommendations are given concerning time-of-use pricing, smart meter deployment, stable and simple regulation for reselling energy on private property, roll-out of public charging infrastructure as well as reviewing of grid codes and operational system procedures for interactions between network operators and vehicle aggregators. - Highlights: > A conceptual regulatory framework for charging EVs is proposed. > 2 new agents, EV charging point manager, EV aggregator and their functions are introduced. > Depending on private or public access of charging points, contractual relations change. > A classification of charging scenarios alludes implications on regulatory topics. > EV penetration phase dependent policy and regulatory recommendations are given.

  19. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Norway

    International Nuclear Information System (INIS)

    2001-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining Regime; 3. Radioactive Substances, Nuclear Fuel and Equipment; 4. Nuclear Installations (Licensing and inspection, including nuclear safety; Emergency response); 5. Trade in Nuclear Materials and Equipment (Trade governed by nuclear energy legislation; Trade governed by radiation protection legislation; Trade governed by export/import control legislation); 6. Radiation Protection; 7. Radioactive Waste Management; 8. Non-Proliferation and Physical Protection; 9. Transport; 10. Nuclear Third Party Liability; II. Institutional Framework: 1. Regulatory and Supervisory Authorities: A. Ministerial Level (Ministry of Health and Social Affairs; Ministry of Trade and Industry; Ministry of Foreign Affairs; Other Ministries); B. Subsidiary Level: (The Norwegian Radiation Protection Authority - NRPA; The Norwegian Nuclear Emergency Organisation); 2. Public and Semi-Public Agencies - Institute for Energy Technology - IFE

  20. Evolving PBPK applications in regulatory risk assessment: current situation and future goals

    Science.gov (United States)

    The presentation includes current applications of PBPK modeling in regulatory risk assessment and discussions on conflicts between assuring consistency with experimental data in current situation and the desire for animal-free model development.

  1. Establishment of the nuclear regulatory framework for the process of decommissioning of nuclear installations in Mexico

    International Nuclear Information System (INIS)

    Salmeron V, J. A.; Camargo C, R.; Nunez C, A.

    2015-09-01

    Today has not managed any process of decommissioning of nuclear installations in the country; however because of the importance of the subject and the actions to be taken to long term, the Comision Nacional de Seguridad Nuclear y Salvaguardias (CNSNS) in Mexico, accordance with its objectives is developing a National Nuclear Regulatory Framework and defined requirements to ensure the implementation of appropriate safety standards when such activities are performed. In this regard, the national nuclear regulatory framework for nuclear installations and the particular case of nuclear power reactors is presented, as well as a proposed licensing process for the nuclear power plant of Laguna Verde based on international regulations and origin country regulations of the existing reactors in nuclear facilities in accordance with the license conditions of operation to allow to define and incorporate such regulation. (Author)

  2. Cell therapy medicinal product regulatory framework in Europe and its application for MSC-based therapy development

    Science.gov (United States)

    Ancans, Janis

    2012-01-01

    Advanced therapy medicinal products (ATMPs), including cell therapy products, form a new class of medicines in the European Union. Since the ATMPs are at the forefront of scientific innovation in medicine, specific regulatory framework has been developed for these medicines and implemented from 2009. The Committee for Advanced Therapies (CAT) has been established at the European Medicines Agency (EMA) for centralized classification, certification and evaluation procedures, and other ATMP-related tasks. Guidance documents, initiatives, and interaction platforms are available to make the new framework more accessible for small- and medium-sized enterprises, academia, hospitals, and foundations. Good understanding of the centralized and national components of the regulatory system is required to plan product development. It is in the best interests of the cell therapy developers to utilize the resources provided starting with the pre-clinical stage. Whilst there have been no mesenchymal stem cell (MSC)-based medicine authorizations in the EU, three MSC products have received marketing approval in other regions since 2011. The information provided on the regulatory requirements, procedures, and initiatives is aimed at facilitating MSC-based medicinal product development and authorization in the EU. PMID:22912639

  3. 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)

  4. Regulatory framework and business models for charging plug-in electric vehicles: Infrastructure, agents, and commercial relationships

    International Nuclear Information System (INIS)

    Gomez San Roman, Tomas; Momber, Ilan; Rivier Abbad, Michel; Sanchez Miralles, Alvaro

    2011-01-01

    Electric vehicles (EVs) present efficiency and environmental advantages over conventional transportation. It is expected that in the next decade this technology will progressively penetrate the market. The integration of plug-in electric vehicles in electric power systems poses new challenges in terms of regulation and business models. This paper proposes a conceptual regulatory framework for charging EVs. Two new electricity market agents, the EV charging manager and the EV aggregator, in charge of developing charging infrastructure and providing charging services are introduced. According to that, several charging modes such as EV home charging, public charging on streets, and dedicated charging stations are formulated. Involved market agents and their commercial relationships are analysed in detail. The paper elaborates the opportunities to formulate more sophisticated business models for vehicle-to-grid applications under which the storage capability of EV batteries is used for providing peak power or frequency regulation to support the power system operation. Finally penetration phase dependent policy and regulatory recommendations are given concerning time-of-use pricing, smart meter deployment, stable and simple regulation for reselling energy on private property, roll-out of public charging infrastructure as well as reviewing of grid codes and operational system procedures for interactions between network operators and vehicle aggregators. - Highlights: → A conceptual regulatory framework for charging EVs is proposed. → 2 new agents, EV charging point manager, EV aggregator and their functions are introduced. → Depending on private or public access of charging points, contractual relations change. → A classification of charging scenarios alludes implications on regulatory topics. → EV penetration phase dependent policy and regulatory recommendations are given.

  5. Development of the Regulatory Framework in Mexico

    International Nuclear Information System (INIS)

    Carreño Padilla, A. L.; Paz García Beltran, A.B.; Godínez Sánchez, V.

    2015-01-01

    The present study describes and introduces in a simplified way the process for issuing a Mexican Official Standard of Nuclear series, setting out the departments and agencies involved in this process, and also describing the main challenges identified for preparation, issuance and review of them. Furthermore, topics that are currently in the process of standardisation in Mexico in radiation and nuclear safety are mentioned. The National Commission for Nuclear Safety and Safeguards is the regulatory body empowered and commissioned in Mexico to issue and amends the Official Mexican Standards in nuclear and radiation safety, whose duties and responsibilities are set out in the Regulatory Law on Nuclear Matters of Article 27. The Mexican Standards are of social kind because they are focused to prevent risks that could affect human been health, animal or plants damages, and are also associated to safety in the workplaces, to avoid damages which may be irreparable to the environment and population. Normalization is the process by which all the activities concerning public health, environment protection, labor protection, among others, are ruled on in both, private and public sectors. Through this process, the rules, features or products specifications are set for a product or a regulated service. The objective of a standard is to get an optimum degree of order in a given activity. The objective of creating a regulation is to develop legal certainty, to avoid imminent harm or to reduce existing damages on health, the environment and the Economy. Currently, the regulation for nuclear and radiological safety, physical security, as well as for safeguards in Mexico, is under constant development, looking for to cover the safety needs of employees, licencees, environment and society in a whole; many of these needs are supported by the international recommendations of the IAEA. (author)

  6. The Chinese health care regulatory institutions in an era of transition.

    Science.gov (United States)

    Fang, Jing

    2008-02-01

    The purpose of this paper is to contribute to a better understanding of Chinese health care regulation in an era of transition. It describes the major health care regulatory institutions operating currently in China and analyzes the underlying factors. The paper argues that in the transition from a planned to a market economy, the Chinese government has been employing a hybrid approach where both old and new institutions have a role in the management of emerging markets, including the health care market. This approach is consistent with the incremental reform strategy adopted by the Party-state. Although a health care regulatory framework has gradually taken shape, the framework is incomplete, with a particular lack of emphasis on professional self-regulation. In addition, its effectiveness is limited despite the existence of many regulatory institutions. In poor rural areas, the effectiveness of the regulatory framework is further undermined or distorted by the extremely difficult financial position that local governments find themselves in. The interpretations of the principle of 'rule of law' by policy makers and officials at different levels and the widespread informal network of relations between known individuals (Guanxi) play an important role in the operation of the regulatory framework. The findings of this paper reveal the complex nature of regulating health care in transitional China.

  7. International Expert Team Concludes IAEA Peer Review of Slovakia's Regulatory Framework for Nuclear Safety

    International Nuclear Information System (INIS)

    2012-01-01

    Full text: An international team of senior nuclear safety and radiation protection experts today concluded an 11-day mission to review the regulatory framework for nuclear safety in Slovakia. At the request of the Slovak Government, the IAEA assembled a team of 12 senior regulatory experts from 12 nations to conduct the Integrated Regulatory Review Service (IRRS) mission involving the Nuclear Regulatory Authority of the Slovak Republic (UJD SR). The international experts also met officials from the Public Health Authority of the Slovak Republic (UVZ SR) regarding the regulation of occupational radiation protection in nuclear facilities. The mission is a peer review based on the IAEA Safety Standards. Marta Ziakova, Chairperson of the Nuclear Regulatory Authority of Slovak Republic, declared that ''The IRRS mission has a great value for the future development and orientation of the UJD SR.'' ''Slovakia has established a regulatory framework for nuclear safety which is in line with international standards and practice,'' said Mission Team Leader Andrej Stritar, Director of the Slovenian Nuclear Safety Administration. The main observations of the IRRS Review team included: UJD SR operates with independence and transparency; UJD SR has developed and implemented a systematic training approach to meet its competence needs; and in response to the accident at TEPCO's Fukushima Daiichi Nuclear Power Station, UJD SR has reacted and communicated to interested parties, including the public. The good practices identified by the IRRS Review Team include: UJD SR has a comprehensive and well-formalized strategic approach to informing and consulting interested parties; UJD SR has developed and implemented a structured approach to training and developing its staff; and Detailed legal requirements provide a solid basis for on-site and off-site response in nuclear emergencies coordinated with local authorities. The IRRS Review team identified areas for further improvement and believes

  8. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Poland

    International Nuclear Information System (INIS)

    2015-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment (Licensing; Registration and monitoring of nuclear materials and radioactive sources; High activity sources); 4. Nuclear facilities (Licensing and inspection, including nuclear safety; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiological protection; 7. Radioactive waste management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (The President of the National Atomic Energy Agency - Prezes Panstwowej Agencji Atomistyki (President of the PAA); Minister of Health; Minister of the Environment); 2. Advisory bodies (Council for Nuclear Safety and Radiological Protection); 3. Public and semi-public bodies (Radioactive Waste Management Plant); 4. Research institutes (Central Laboratory for Radiological Protection; National Centre for Nuclear Research; Institute of Nuclear Physics; Institute of Nuclear Chemistry and Technology; Institute of Plasma Physics and Laser Microfusion)

  9. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Netherlands

    International Nuclear Information System (INIS)

    2009-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Fissionable materials, ores, radioactive materials and equipment (Fissionable materials and ores; Radioactive materials and equipment); 4. Nuclear installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiation protection (Protection of workers; Protection of the public; Protection of individuals undergoing medical exposure); 7. Radioactive waste management; 8. Nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Minister for Housing, Spatial Planning and the Environment; Minister for Economic Affairs; Minister for Social Affairs and Employment; Minister for Health, Welfare and Sports; Minister for Finance; Minister for Foreign Affairs); 2. Advisory body - Health Council of the Netherlands; 3. Public and semi-public agencies (Nuclear Research and Consultancy Group - NRG; Central Organisation for Radioactive Waste - COVRA)

  10. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Spain

    International Nuclear Information System (INIS)

    2010-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects; Emergency response); 5. Trading in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Non-proliferation and physical protection (Safeguards and non-proliferation; Physical protection); 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Ministry of Industry, Tourism and Trade - MITYC; Ministry of the Interior - MIR; Ministry of Economy and the Exchequer - MEH; Ministry of the Environment and Rural and Marine Affairs - MARM); 2. Public and semi-public agencies (Nuclear Safety Council - CSN; Centre for Energy-related, Environmental and Technological Research - CIEMAT; National Energy Commission - CNE; 3. Public capital companies (Enusa Industrias Avanzadas, s.a. - ENUSA; Empresa Nacional de Residuos Radiactivos, s.a. - ENRESA)

  11. Framework of the NPP I and C Security for Regulatory Guidance

    International Nuclear Information System (INIS)

    Kim, Young Mi; Jeong, Choong Heui

    2013-01-01

    I and C (Instrumentation and control) systems which have computers are a critical part of the safety and security at nuclear facilities. As the use of computers in I and C continue to grow, so does the target for cyber-attack. They include desktop computers, mainframe systems, servers, network devices, embedded systems and programmable logic controllers (PLSs) and other digital computer systems. As the Stuxnet malware shows, I and C systems of the NPPs are no longer safe from the threat of cyber-attacks. These digital I and C systems must be protected from the cyber-attacks. This paper presents framework of the NPP I and C security for regulatory guidance. KINS regulatory guideline 8.22 has been applied to new and operation nuclear power plants. This guideline refers the applicable scope of the cyber security activities, cyber security policies and security plans, and assessments of cyber security and execution of the cyber security activities. Newly developed guideline will be helpful for implement security control to ensure safe operation of NPP I and C systems

  12. Framework of the NPP I and C Security for Regulatory Guidance

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Young Mi; Jeong, Choong Heui [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2013-10-15

    I and C (Instrumentation and control) systems which have computers are a critical part of the safety and security at nuclear facilities. As the use of computers in I and C continue to grow, so does the target for cyber-attack. They include desktop computers, mainframe systems, servers, network devices, embedded systems and programmable logic controllers (PLSs) and other digital computer systems. As the Stuxnet malware shows, I and C systems of the NPPs are no longer safe from the threat of cyber-attacks. These digital I and C systems must be protected from the cyber-attacks. This paper presents framework of the NPP I and C security for regulatory guidance. KINS regulatory guideline 8.22 has been applied to new and operation nuclear power plants. This guideline refers the applicable scope of the cyber security activities, cyber security policies and security plans, and assessments of cyber security and execution of the cyber security activities. Newly developed guideline will be helpful for implement security control to ensure safe operation of NPP I and C systems.

  13. 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.)

  14. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Czech Republic

    International Nuclear Information System (INIS)

    2008-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear items and spent fuel (Ionising radiation sources; Nuclear items; Spent fuel); 4. Nuclear installations (Licensing and inspection, including nuclear safety; Emergency response; Decommissioning); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (State Office for Nuclear Safety - SUJB; Ministry of Industry and Trade; Ministry of the Interior; Ministry of the Environment); 2. Public and semi-public agencies (CEZ, a.s.; National Radiation Protection Institute - NRPI; Radioactive Waste Repository Authority - RAWRA; Diamo; Nuclear Physics Institute - NPI; National Institute for Nuclear, Chemical and Biological Protection; Nuclear Research Institute Rez, a.s. - NRI)

  15. Historical Development of the Governmental, Legal and Regulatory Framework for Nuclear Safety in Japan. Annex I of Technical Volume 2

    International Nuclear Information System (INIS)

    2015-01-01

    The governmental and public organizations responsible for policy and safety regulation in Japan have evolved significantly during the period in which the Japanese nuclear power industry has operated. The IAEA’s Integrated Regulatory Review Service (IRRS) mission to Japan in 2007 commended Japan’s updating of its legislative and governmental framework to strengthen arrangements for nuclear safety in light of the incidents which had occurred. A view of these past developments is helpful to understand the origins of the regulatory framework in place at the time of the accident at the Fukushima Daiichi nuclear power plant (NPP), and to assess the prospects for the further institutional reforms that Japan has implemented following this accident. Shiroyama has identified three periods in the evolution of the governmental and regulatory organizations prior to the accident at the Fukushima Daiichi NPP

  16. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Sweden

    International Nuclear Information System (INIS)

    2008-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects (The Environmental Code, Environmental impact statement, Permit under the Environmental Code)); 5. Trade in nuclear materials and equipment; 6. Radiological protection; 7. Radioactive waste management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear third party liability (The Nuclear Liability Act; Chernobyl legislation); II. Institutional Framework: 1. Ministries with responsibilities concerning nuclear activities (Ministry of the Environment; Ministry of Enterprise, Energy and Communications; Ministry of Justice; Ministry of Foreign Affairs); 2. Swedish Radiation Safety Authority

  17. GIS-assisted spatial analysis for urban regulatory detailed planning: designer's dimension in the Chinese code system

    Science.gov (United States)

    Yu, Yang; Zeng, Zheng

    2009-10-01

    By discussing the causes behind the high amendments ratio in the implementation of urban regulatory detailed plans in China despite its law-ensured status, the study aims to reconcile conflict between the legal authority of regulatory detailed planning and the insufficient scientific support in its decision-making and compilation by introducing into the process spatial analysis based on GIS technology and 3D modeling thus present a more scientific and flexible approach to regulatory detailed planning in China. The study first points out that the current compilation process of urban regulatory detailed plan in China employs mainly an empirical approach which renders it constantly subjected to amendments; the study then discusses the need and current utilization of GIS in the Chinese system and proposes the framework of a GIS-assisted 3D spatial analysis process from the designer's perspective which can be regarded as an alternating processes between the descriptive codes and physical design in the compilation of regulatory detailed planning. With a case study of the processes and results from the application of the framework, the paper concludes that the proposed framework can be an effective instrument which provides more rationality, flexibility and thus more efficiency to the compilation and decision-making process of urban regulatory detailed plan in China.

  18. Legal framework for a radiation safety infrastructure

    International Nuclear Information System (INIS)

    Bilbao, A.A.

    2000-01-01

    In this lecture the legal framework for a radiation safety infrastructure are presented. The objective of this lecture are: Legal framework; Regulatory programme; Role of Regulatory Authority in emergency situations; Assessment of the effectiveness of the regulatory programme; Cost effectiveness of the regulatory framework; and Priority actions

  19. The regulatory framework of trade finance: from BASEL I to BASEL III

    Directory of Open Access Journals (Sweden)

    Claudia BAICU

    2011-09-01

    Full Text Available The global crisis revealed several weaknesses in the international framework of banking regulation. Consequently, the Basel Committee on Banking Supervision (BCBS proposed a package of measures to strengthen the resilience of the banking sector. Besides the positive effects they have on financial stability, the new regulatory provisions affect the ability of banks to provide trade finance. Therefore, the banking industry considers that regulators have not taken into account the low-risk profile of activity. Starting from this premise, the paper consists of three parts. In the first part, the role and objectives of the BCBS are presented; the second part is designed to review the most important trade instruments and to underline the tendencies in trade finance; finally, the last part highlights the regulation of trade finance under the Basel I, Basel II and Basel III regimes, and some unintended consequences of the Basel III framework.

  20. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Australia

    International Nuclear Information System (INIS)

    2008-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I) - General Regulatory Regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Non-proliferation and physical protection (Bilateral safeguards agreements; International Atomic Energy Agency Safeguards Agreement; The South Pacific Nuclear Free Zone Treaty Act; The Comprehensive Nuclear Test-Ban Treaty Act; The Nuclear Non-Proliferation (Safeguards) Act); 9. Transport; 10. Nuclear third party liability; II) - Institutional Framework: 1. Regulatory and supervisory authorities (Minister for Health and Ageing; Minister for Foreign Affairs; Minister for the Environment, Heritage and the Arts; Minister for, Resources, Energy and Tourism); 2. Advisory bodies (Radiation Health and Safety Advisory Council; Advisory Committees); 3. Public and semi-public agencies (Australian Radiation Protection and Nuclear Safety Agency (ARPANSA); Australian Safeguards and Non-Proliferation Office; Australian Nuclear Science and Technology Organisation (ANSTO); Supervising Scientist)

  1. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Hungary

    International Nuclear Information System (INIS)

    2008-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Atomic Energy Co-ordination Council; Hungarian Atomic Energy Authority - HAEA; Minister for Health; Minister for Local Government and Regional Development and Minister for Justice and Law Enforcement; Minister for Agriculture and Rural Development; Minister for Economy and Transport; Minister of Environment Protection and Water Management; Minister for Defence; Minister for Education; President of the Hungarian Mining and Geological Authority; Governmental Co-ordination Committee); 2. Advisory bodies (Scientific Board); 3. Public and semi-public agencies (Institute for Electric Power Research - VEIKI; Atomic Energy Research Institute - AEKI; Institute of Isotopes; Department of Physical Chemistry of the University of Pannon; Hungarian Power Companies Ltd - MVM Zrt.)

  2. Biorepository regulatory frameworks: building parallel resources that both promote scientific investigation and protect human subjects.

    Science.gov (United States)

    Marko-Varga, György; Baker, Mark S; Boja, Emily S; Rodriguez, Henry; Fehniger, Thomas E

    2014-12-05

    Clinical samples contained in biorepositories represent an important resource for investigating the many factors that drive human biology. The biological and chemical markers contained in clinical samples provide important measures of health and disease that when combined with such medical evaluation data can aid in decision making by physicians. Nearly all disciplines in medicine and every "omic" depend upon the readouts obtained from such samples, whether the measured analyte is a gene, a protein, a lipid, or a metabolite. There are many steps in sample processing, storage, and management that need to understood by the researchers who utilize biorepositories in their own work. These include not only the preservation of the desired analytes in the sample but also good understanding of the moral and legal framework required for subject protection irrespective of where the samples have been collected. Today there is a great deal of effort in the community to align and standardize both the methodology of sample collection and storage performed in different locations and the necessary frameworks of subject protection including informed consent and institutional review of the studies being performed. There is a growing trend in developing biorepositories around the focus of large population-based studies that address both active and silent nonsymptomatic disease. Logistically these studies generate large numbers of clinical samples and practically place increasing demand upon health care systems to provide uniform sample handling, processing, storage, and documentation of both the sample and the subject as well to ensure that safeguards exist to protect the rights of the study subjects for deciding upon the fates of their samples. Currently the authority to regulate the entire scope of biorepository usage exists as national practice in law in only a few countries. Such legal protection is a necessary component within the framework of biorepositories, both now and in

  3. Gamete and Embryo Donation and Surrogacy in Australia:The Social Context and Regulatory Framework

    Directory of Open Access Journals (Sweden)

    Karin Hammarberg

    2011-01-01

    Full Text Available The social and legal acceptability of third-party reproduction varies around the world. In Australia,gamete and embryo donation and surrogacy are permitted within the regulatory framework setout by federal and state governments. The aim of this paper is to describe the social context andregulatory framework for third-party reproduction in Australia.This is a review of current laws and regulations related to third-party reproduction in Australia.Although subtle between-state differences exist, third-party reproduction is by and large a sociallyacceptable and legally permissible way to form a family throughout Australia. The overarchingprinciples that govern the practice of third-party reproduction are altruism; the right of donorconceivedpeople to be informed of their biological origins; and the provision of comprehensivecounselling about the social, psychological, physical, ethical, financial and legal implications ofthird-party reproduction to those considering donating or receiving gametes or embryos and enteringsurrogacy arrangements. These principles ensure that donors are not motivated by financial gain,donor offspring can identify and meet with the person or persons who donated gametes or embryos,and prospective donors and recipients are aware of and have carefully considered the potentialconsequences of third-party reproduction.Australian state laws and federal guidelines prohibit commercial and anonymous third-partyreproduction; mandate counselling of all parties involved in gamete and embryo donationand surrogacy arrangements; and require clinics to keep records with identifying and nonidentifyinginformation about the donor/s to allow donor-conceived offspring to trace theirbiological origins.

  4. Nuclear security regulatory framework analysis for small modular reactors in Canada and abroad

    Energy Technology Data Exchange (ETDEWEB)

    Farah, A., E-mail: amjad.farah@uoit.ca [University of Ontario Institute of Technology, Oshawa, ON (Canada)

    2015-07-01

    Small Modular Reactors (SMRs) are gaining global attention as a potential solution for future power plants due to claims of flexibility and cost effectiveness, while maintaining or increasing safety and security. With the change of design and the potential deployment in remote areas, however, challenges arise from a regulatory standpoint, to meet the safety and security regulations while maintaining economic feasibility. This work comprises of a review of the nuclear security regulatory frameworks in place for SMRs in Canada, USA and the IAEA; how they compare to each other, and to those of large reactors. The goal is to gauge what needs to be adjusted in order to address the changes in design between the two reactor sizes. Some key challenges concern the type of reactor, transportation of reactor components and fuel to remote areas, reduced security staff, and increased complexity of emergency planning and evacuation procedures. (author)

  5. Nuclear security regulatory framework analysis for small modular reactors in Canada and abroad

    International Nuclear Information System (INIS)

    Farah, A.

    2015-01-01

    Small Modular Reactors (SMRs) are gaining global attention as a potential solution for future power plants due to claims of flexibility and cost effectiveness, while maintaining or increasing safety and security. With the change of design and the potential deployment in remote areas, however, challenges arise from a regulatory standpoint, to meet the safety and security regulations while maintaining economic feasibility. This work comprises of a review of the nuclear security regulatory frameworks in place for SMRs in Canada, USA and the IAEA; how they compare to each other, and to those of large reactors. The goal is to gauge what needs to be adjusted in order to address the changes in design between the two reactor sizes. Some key challenges concern the type of reactor, transportation of reactor components and fuel to remote areas, reduced security staff, and increased complexity of emergency planning and evacuation procedures. (author)

  6. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Republic of Korea

    International Nuclear Information System (INIS)

    2009-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiation protection) (Protection of workers; Protection of the public); 7. Radioactive waste management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Minister of Education, Science and Technology, including the Nuclear Energy Bureau; Minister of Knowledge Economy); 2. Advisory bodies (Atomic Energy Commission; Atomic Energy Safety Commission); 3. Public and semi-public agencies (Korean Atomic Energy Research Institute - KAERI; Korean Institute for Nuclear Safety - KINS; Korean Electric Power Company - KEPCO; Korean Hydro and Nuclear Power - KHNP)

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

    International Nuclear Information System (INIS)

    Ha-Vinh, Phuong

    1975-01-01

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

  8. Regulatory frameworks for mobile medical applications.

    Science.gov (United States)

    Censi, Federica; Mattei, Eugenio; Triventi, Michele; Calcagnini, Giovanni

    2015-05-01

    A mobile application (app) is a software program that runs on mobile communication devices such as a smartphone. The concept of a mobile medical app has gained popularity and diffusion but its reference regulatory context has raised discussion and concerns. Theoretically, a mobile app can be developed and uploaded easily by any person or entity. Thus, if an app can have some effects on the health of the users, it is mandatory to identify its reference regulatory context and the applicable prescriptions.

  9. Understanding banking regulatory and market framework in South Africa including the perceived strength, weaknesses, opportunities and threats

    Directory of Open Access Journals (Sweden)

    Tankiso Moloi

    2014-08-01

    Full Text Available Following the global financial crisis of 2007, the manner in which banks conduct their business became the subject of interest to authorities. In South Africa, most analysts argued that the financial system was insulated by the prudent regulatory system. This paper reviewed the banking regulation and market framework applicable in the South African context. In reviewing regulation and banking market framework, it was found that the principal legal instrument which seeks to achieve credibility, stability and economic growth, is the Banks Act, No. 94 of 1990 (the Banks Act. Considering the applicable regulation, the paper concluded that South Africa has a developed and well regulated banking system which compares favourably with regulatory environment applied by the developed countries. It was, however; cautioned that further regulation such as the recently announced ‘Twin Peaks’ approach to financial regulation could result in unintended consequences, such as driving a larger share of activity into the shadow banking sector.

  10. Designing regulatory frameworks for merchant transmission investments by real options analysis

    International Nuclear Information System (INIS)

    Pringles, Rolando; Olsina, Fernando; Garcés, Francisco

    2014-01-01

    In deregulated electricity markets, the transmission network is a key infrastructure for enabling competition in the generation sector. A deficient expansion of the transmission grid prevents the realization of the benefits in terms of efficiency associated with market mechanisms. Consequently, it is essential to provide clear investment policies and economic signals to attract timely and efficient transmission investments in order to develop the system at minimum cost meeting the requirements of generators and consumers, while keeping adequate levels of service quality and reliability. This paper proposes a modern tool of economic evaluation based on real options analysis that provides the regulator the ability to assess various incentives that would lead transmission investors to make efficient decisions in highly uncertain environments. Real options properly values partially irreversible investment decisions, such as to defer, modify or abandon an investment project in response to the arrival of new information or as uncertainties are resolved. Decisions are evaluated from the point of view of a transmission investor trying to maximize its own profits in the time period set to recover the capital invested. The results allow the study of the behavior of transmission investors regarding their decision making when they have the possibility to manage the option to defer, under different regulatory schemes that encourage the expansion of the transmission system. - Highlights: • Regulatory frameworks for efficient and timely transmission expansions are designed. • Irreversibility and uncertainty of transmission investment is properly accounted for. • Response of network investors to regulatory incentives is quantitatively established

  11. Regulatory Framework on Exploration and Exploitation of Croatian Part of Adriatic

    International Nuclear Information System (INIS)

    Mudric, M.

    2015-01-01

    As the prelude to the regulation of marine exploration and exploitation activities in the Croatian Adriatic waters, the new Mining Act and Act on exploration and exploitation of hydrocarbons have provided a general legal framework for the natural resources exploration and exploitation. The latter Act also appropriated the establishment of the independent regulatory body, the Hydrocarbon Agency. It is important to mention the Decree on Fees for exploration and production of hydrocarbons, and the Decree on main technical requirements on safety and security of offshore exploration and production of hydrocarbons in the Republic of Croatia, that are of special relevance for the current activities with regard the proposed project of exploration and exploitation of the Croatian waters in search for gas and oil sea-bed deposits. The Hydrocarbon Agency has published the Strategic Study of the Likely Significant Environmental Impact of the Framework Plan and Program of Exploration and Production of Hydrocarbons in the Adriatic, a document receiving a lot of criticism from the legal experts and general public. At the same time, the experts tend to support the general idea of sea-bed exploration and exploitation, with the major antagonism still being present in the general public, with several initiatives introducing the possibility of a public referenda to oppose the sea-bed exploration and exploitation. The Government is currently preparing the Act on the Safety of Offshore Hydrocarbon Exploration and Production Operations, based on the Directive 94/22/EC of the European Parliament and of the Council of 30 May 1994 on the conditions for granting and using authorizations for the prospection, exploration and production of hydrocarbons, the Commission Implementing Regulation (EU) No 1112/2014 of 13 October 2014 determining a common format for sharing of information on major hazard indicators by the operators and owners of offshore oil and gas installations and a common format

  12. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Switzerland

    International Nuclear Information System (INIS)

    2010-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment (Nuclear fuels; Radioactive substances and equipment generating ionising radiation); 4. Nuclear installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear third party liability; 11. Environmental protection; II. Institutional Framework: 1. Regulatory and supervisory authorities (Federal Council; Federal Assembly; Federal Department of the Environment, Transport, Energy and Communications - DETEC; Federal Office of Energy - SFOE; Swiss Federal Nuclear Safety Inspectorate - IFSN; Federal Department of Home Affairs - FDHA; Federal Office of Public Health - FOPH; State Secretariat for Education and Research - SER; Other authorities); 2. Advisory bodies (Swiss Federal Nuclear Safety Commission - KNS; Federal Commission for Radiological Protection and Monitoring of the Radioactivity in the Environment; Federal Emergency Organisation on Radioactivity); 3. Public and semi-public agencies (Paul-Scherrer Institute - PSI; Fund for the decommissioning of nuclear installations and for the waste disposal; National Co-operative for the

  13. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Belgium

    International Nuclear Information System (INIS)

    2010-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining regime; 3. Nuclear facilities (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects; Emergency response; Decommissioning); 4. Trade in nuclear materials and equipment; 5. Radiological protection; 6. Radioactive waste management; 7. Non-proliferation of nuclear weapons and physical protection of nuclear material (International aspects; National control and security measures); 8. Transport; 9. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Federal Agency for Nuclear Control - FANC; Federal Public Service for Home Affairs; Federal Public Service for Economy, SME's, Self-Employed and Energy; Federal Public Service for Employment, Labour and Social Dialogue; Federal Public Service for Defence; Federal Public Service for Foreign Affairs, Foreign Trade and Development Co-operation; Federal Public Planning Service for Science Policy); 2. Advisory bodies (Scientific Council for Ionizing Radiation of the Federal Agency for Nuclear Control; Superior Health Council; Superior Council for Safety, Hygiene and Enhancement of Workplaces; Advisory Committee for the Non-Proliferation of Nuclear Weapons; Commission for Electricity and Gas Regulation - CREG)

  14. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Austria

    International Nuclear Information System (INIS)

    2003-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I) - General Regulatory Regime - General Outline: 1. Introduction; 2. Mining Regime; 3. Radioactive Substances, Nuclear Fuel and Equipment; 4. Nuclear Installations (Licensing and inspection, including nuclear safety; Emergency response); 5. Trade in Nuclear Materials and Equipment; 6. Radiation Protection; 7. Radioactive Waste Management; 8. Non-Proliferation and Physical Protection; 9. Transport; 10. Nuclear Third Party Liability; II) - Institutional Framework: 1. Regulatory and Supervisory Authorities: A. Federal Authorities - Bund (The Federal Chancellery; The Federal Minister for Women's Affairs and Consumer Protection; The Federal Minister of the Interior; The Federal Minister for Economic Affairs; The Federal Minister of Finance; The Federal Minister of Labour, Health and Social Affairs; The Federal Minister of Science and Transport; The Federal Minister of Justice; The Federal Minister for the Environment; The Federal Minister for Foreign Affairs) B. Regional Authorities - Laender; C. District Authorities - Bezirksverwaltungsbehorden; 2. Advisory Bodies (Forum for Nuclear Questions, Radiation Protection Commission - SSK); 3. Public and Semi-Public Agencies (The Seibersdorf Austrian Research Centre; The Graz Nuclear Institute; The Nuclear Institute of the Austrian Universities; The Institute of Risk Research, University of Vienna)

  15. Phylogeny based discovery of regulatory elements

    Directory of Open Access Journals (Sweden)

    Cohen Barak A

    2006-05-01

    Full Text Available Abstract Background Algorithms that locate evolutionarily conserved sequences have become powerful tools for finding functional DNA elements, including transcription factor binding sites; however, most methods do not take advantage of an explicit model for the constrained evolution of functional DNA sequences. Results We developed a probabilistic framework that combines an HKY85 model, which assigns probabilities to different base substitutions between species, and weight matrix models of transcription factor binding sites, which describe the probabilities of observing particular nucleotides at specific positions in the binding site. The method incorporates the phylogenies of the species under consideration and takes into account the position specific variation of transcription factor binding sites. Using our framework we assessed the suitability of alignments of genomic sequences from commonly used species as substrates for comparative genomic approaches to regulatory motif finding. We then applied this technique to Saccharomyces cerevisiae and related species by examining all possible six base pair DNA sequences (hexamers and identifying sequences that are conserved in a significant number of promoters. By combining similar conserved hexamers we reconstructed known cis-regulatory motifs and made predictions of previously unidentified motifs. We tested one prediction experimentally, finding it to be a regulatory element involved in the transcriptional response to glucose. Conclusion The experimental validation of a regulatory element prediction missed by other large-scale motif finding studies demonstrates that our approach is a useful addition to the current suite of tools for finding regulatory motifs.

  16. The European Regulatory Environment of RNA-Based Vaccines.

    Science.gov (United States)

    Hinz, Thomas; Kallen, Kajo; Britten, Cedrik M; Flamion, Bruno; Granzer, Ulrich; Hoos, Axel; Huber, Christoph; Khleif, Samir; Kreiter, Sebastian; Rammensee, Hans-Georg; Sahin, Ugur; Singh-Jasuja, Harpreet; Türeci, Özlem; Kalinke, Ulrich

    2017-01-01

    A variety of different mRNA-based drugs are currently in development. This became possible, since major breakthroughs in RNA research during the last decades allowed impressive improvements of translation, stability and delivery of mRNA. This article focuses on antigen-encoding RNA-based vaccines that are either directed against tumors or pathogens. mRNA-encoded vaccines are developed both for preventive or therapeutic purposes. Most mRNA-based vaccines are directly administered to patients. Alternatively, primary autologous cells from cancer patients are modified ex vivo by the use of mRNA and then are adoptively transferred to patients. In the EU no regulatory guidelines presently exist that specifically address mRNA-based vaccines. The existing regulatory framework, however, clearly defines that mRNA-based vaccines in most cases have to be centrally approved. Interestingly, depending on whether RNA-based vaccines are directed against tumors or infectious disease, they are formally considered gene therapy products or not, respectively. Besides an overview on the current clinical use of mRNA vaccines in various therapeutic areas a detailed discussion of the current regulatory situation is provided and regulatory perspectives are discussed.

  17. Regulatory barriers for activating flexibility in the Nordic-Baltic electricity market

    DEFF Research Database (Denmark)

    Bergaentzlé, Claire; Skytte, Klaus; Soysal, Emilie Rosenlund

    2017-01-01

    to flexibility. We find that the most restrictive barriers against flexibility are emitted by public authorities as part of broader policy strategies. Overall, we find that current regulatory and market framework conditions do not hinder flexibility. However, despite that, flexibility remains limited due......, load adjustment or to a greater coupling to other energy sectors. In this paper, we identify the framework conditions that influence the provision of VRE-friendly flexibility in the Nordic and Baltic electricity sector, i.e., the market and regulatory settings that act as drivers or barriers...... to a lack of coherent instruments intended to both the demand and supply-side to effectively act flexibly....

  18. Improvements of the Regulatory Framework for Nuclear Installations in the Areas of Human and Organizational Factors and Safety Culture

    International Nuclear Information System (INIS)

    Tronea, M.; Ciurea, C.

    2016-01-01

    The paper presents the development of regulatory requirements in the area of human and organizational factors taking account of the lessons learned from major accidents in the nuclear industry and in particular of the factors that contributed to the Fukushima Daiichi accident and the improvement of the regulatory oversight of nuclear safety culture. New requirements have been elaborated by the National Commission for Nuclear Activities Control (CNCAN) on the nuclear safety policy of licencees for nuclear installations, on independent nuclear safety oversight, on safety conscious work environment and on the assessment of nuclear safety culture. The regulatory process for the oversight of nuclear safety culture within licencees’ organizations operating nuclear installations and the associated procedure and guidelines, based on the IAEA Safety Standards, have been developed in 2010-2011. CNCAN has used the 37 IAEA attributes for a strong safety culture, grouped into five areas corresponding to safety culture characteristics, as the basis for its regulatory guidelines providing support to the reviewers and inspectors, in their routine activities, for recognising and gathering information relevant to safety culture. The safety culture oversight process, procedure and guidelines are in process of being reviewed and revised to improve their effectiveness and to align with the current international practices, using lessons learned from the Fukushima Daiichi accident. Starting with July 2014, Romania has a National Strategy for Nuclear Safety and Security, which includes strategic objectives, associated directions for action and concrete actions for promoting nuclear safety culture in all the organizations in the nuclear sector. The progress with the implementation of this strategy with regard to nuclear safety culture is described in the paper. CNCAN started to define its own organizational culture model and identifying the elements that promote and support safety

  19. Security issues of new innovative payments and their regulatory challenges

    NARCIS (Netherlands)

    Kasiyanto, Safari; Gabriella, Gimigliano

    2016-01-01

    Kasiyanto discusses how the security issues of M-payments and Bitcoin as new forms of innovative payments challenge the existing EU regulatory frameworks, and whether the proposed regulatory frameworks suffice to address such challenges. The regulatory frameworks Kasiyanto discusses mainly focus on

  20. Technology Overview Using Case Studies of Alternative Landfill Technologies and Associated Regulatory Topics

    National Research Council Canada - National Science Library

    2003-01-01

    ... alternative landfill cover projects. The purpose of the case studies is to present examples of the flexibility used in the regulatory framework for approving alternative landfill cover designs, current research information about the use...

  1. The regulatory framework for storage and disposal of radioactive waste in the member states of the European Community

    International Nuclear Information System (INIS)

    Burholt, G.D.; Martin, A.

    1988-01-01

    The purpose of the study is to collate information and to summarise the present situation with regard to the regulatory framework for the storage and disposal of radioactive waste in each of the member countries of the European Community together with several important countries outside the Community. (author)

  2. Governmental, Legal and Regulatory Framework for Safety. General Safety Requirements. Part 1 (French Edition); Cadre gouvernemental, legislatif et reglementaire de la surete. Prescriptions generales de surete. Partie 1

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2010-11-15

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

  3. Governmental, Legal and Regulatory Framework for Safety. General Safety Requirements. Part 1 (Spanish Edition); Marco gubernamental, juridico y regulador para la seguridad. Requisitos de Seguridad Generales. Parte 1

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2010-11-15

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

  4. Towards new regulatory concepts for the regulation of audiovisual media

    NARCIS (Netherlands)

    Schulz, W.; van Eijk, N.

    2016-01-01

    European media regulation currently faces several challenges: technology, media and markets have become convergent, while – at the same time – the situations in the individual member states differ in respect of media use, the usage of end devices as well as regulatory aims and frameworks. These

  5. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - United Kingdom

    International Nuclear Information System (INIS)

    2003-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining Regime; 3. Radioactive Substances; 4. Nuclear Installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects; Emergency response); 5. Trade in Nuclear Materials and Equipment; 6. Radiation Protection; 7. Radioactive Waste Management; 8. Non-Proliferation and Physical Protection; 9. Transport; 10. Nuclear Third Party Liability; II. Institutional Framework: 1. Regulatory and Supervisory Authorities (Department of Trade and Industry - DTI; Secretary of State for Environment, Food and Rural Affairs and the Secretary of State for Health; Secretary of State for Transport; Secretary of State for Education); 2. Advisory Bodies (Medical Research Council - MRC; Nuclear Safety Advisory Committee; Radioactive Waste Management Advisory Committee); 3. Public and Semi-Public Agencies (United Kingdom Atomic Energy Authority - UKAEA; Health and Safety Commission and Executive - HSC/HSE; National Radiological Protection Board - NRPB; Environment Agencies; British Nuclear Fuels plc. - BNFL; Amersham International plc.; The National Nuclear Corporation Ltd. - NNC; United Kingdom Nirex Ltd.; Magnox Electric plc.; British Energy Generation Ltd.; Scottish Electricity Generator Companies; British Energy Generation Ltd.; Regional Electricity Companies in England and Wales)

  6. Structured Frameworks to Increase the Transparency of the Assessment of Benefits and Risks of Medicines : Current Status and Possible Future Directions

    NARCIS (Netherlands)

    Pignatti, F.; Ashby, D.; Brass, E. P.; Eichler, H-G; Frey, P.; Hillege, H. L.; Hori, A.; Levitan, B.; Liberti, L.; Loefstedt, R. E.; McAuslane, N.; Micaleff, A.; Noel, R. A.; Postmus, D.; Renn, O.; Sabourin, B. J.; Salmonson, T.; Walker, S.

    2015-01-01

    Structured frameworks for benefit-risk analysis in drug licensing decisions are being implemented across a number of regulatory agencies worldwide. The aim of these frameworks is to aid the analysis and communication of the benefit-risk assessment throughout the development, evaluation, and

  7. 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)

  8. The regulatory framework of accounting and accounting standard-setting bodies in the European Union member states

    OpenAIRE

    Mamić-Sačer, Ivana

    2015-01-01

    One of the principal features of accounting in the 21st century is harmonisation and stanardisation. Regulation of the European Parliament and European Council No. 1606/2002 harmonizes financial reporting for certain companies in the EU. However, national accounting principles are of great importance for financial reporting. The main purpose of this research was to investigate the application of generally accepted accounting principles, the regulatory accounting framework and the standard-set...

  9. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - United States

    International Nuclear Information System (INIS)

    2015-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment (Special nuclear material; Source material; By-product material; Agreement state programmes); 4. Nuclear installations (Initial licensing; Operation and inspection, including nuclear safety; Operating licence renewal; Decommissioning; Emergency response); 5. Radiological protection (Protection of workers; Protection of the public); 6. Radioactive waste management (High-level waste; Low-level waste; Disposal at sea; Uranium mill tailings; Formerly Utilized Sites Remedial Action Program - FUSRAP); 7. Non-proliferation and exports (Exports of source material, special nuclear material, production or utilisation facilities and sensitive nuclear technology; Exports of components; Exports of by-product material; Exports and imports of radiation sources; Conduct resulting in the termination of exports or economic assistance; Subsequent arrangements; Technology exports; Information and restricted data); 8. Nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Nuclear Regulatory Commission - NRC; Department of Energy - DOE; Department of Labor - DOL; Department of Transportation - DOT; Environmental Protection Agency - EPA); 2. Public and semi-public agencies: A. Cabinet-level departments (Department of

  10. The legislative and regulatory framework governing herbal medicine use and practice in Kenya: a review.

    Science.gov (United States)

    Okumu, Mitchel Otieno; Ochola, Francis Okumu; Onyango, Allan Odhiambo; Mbaria, James Mucunu; Gakuya, Daniel Waweru; Kanja, Laetitia Wakonyu; Kiama, Stephen Gitahi; Onyango, Mary Atieno

    2017-01-01

    Complementary and alternative medicine is an integral component of primary healthcare in Kenya. This is because the infrastructural health setup in the country is inadequate in catering for all the medical needs of the population. This particularly holds true in the rural areas where many rural folk rely on products of herbal origin to offset their healthcare needs. More often than not these products are an elaborate cacophony of several different substances of biological origin and thus need personnel adept in their preparation. Sadly, due to loopholes in legislation and regulation, quacks have a field day in the practice. Moreover, the process of planting, harvesting, preparation and storage of herbs and related products dictates that a significant number of people will ultimately be involved in the whole process. This is likely to set the stage for manipulation and compromise of the safety, quality and efficacy of these products. This state of affairs appears unabated especially in the context of the current legal and regulatory framework governing herbal medicine use and practice in Kenya. Not only are these laws inadequate, they are shrouded in ambiguity, open to interpretation and the authorities mandated to implement them often end up performing duplicate roles. The aim of this review is to critique the legal and regulatory provisions governing herbal medicine use and practice in Kenya. In conclusion, laws and regulations meant to control herbal medicine use and practice in Kenya are wanting. Clear and definitive legislation on herbal medicine use and practice coupled with effective implementation by mandated institutions will go a long way in inspiring confidence to all stakeholders of herbal medicine.

  11. The legislative and regulatory framework governing herbal medicine use and practice in Kenya: a review

    Science.gov (United States)

    Okumu, Mitchel Otieno; Ochola, Francis Okumu; Onyango, Allan Odhiambo; Mbaria, James Mucunu; Gakuya, Daniel Waweru; Kanja, Laetitia Wakonyu; Kiama, Stephen Gitahi; Onyango, Mary Atieno

    2017-01-01

    Complementary and alternative medicine is an integral component of primary healthcare in Kenya. This is because the infrastructural health setup in the country is inadequate in catering for all the medical needs of the population. This particularly holds true in the rural areas where many rural folk rely on products of herbal origin to offset their healthcare needs. More often than not these products are an elaborate cacophony of several different substances of biological origin and thus need personnel adept in their preparation. Sadly, due to loopholes in legislation and regulation, quacks have a field day in the practice. Moreover, the process of planting, harvesting, preparation and storage of herbs and related products dictates that a significant number of people will ultimately be involved in the whole process. This is likely to set the stage for manipulation and compromise of the safety, quality and efficacy of these products. This state of affairs appears unabated especially in the context of the current legal and regulatory framework governing herbal medicine use and practice in Kenya. Not only are these laws inadequate, they are shrouded in ambiguity, open to interpretation and the authorities mandated to implement them often end up performing duplicate roles. The aim of this review is to critique the legal and regulatory provisions governing herbal medicine use and practice in Kenya. In conclusion, laws and regulations meant to control herbal medicine use and practice in Kenya are wanting. Clear and definitive legislation on herbal medicine use and practice coupled with effective implementation by mandated institutions will go a long way in inspiring confidence to all stakeholders of herbal medicine. PMID:29629018

  12. French Regulatory Framework for the Recycling/Reuse of Nuclear Waste and the Dismantling of George Besse Gaseous Diffusion Plant

    Energy Technology Data Exchange (ETDEWEB)

    Themines, R., E-mail: robert.themines@areva.com [AREVA (France)

    2011-07-15

    The regulatory framework in France governing the management of materials containing low levels of radionuclides is described. The plans for the management of the materials arising from the dismantling of the Georges Besse Gaseous Diffusion Plant are described as an example of the application of the regulations. (author)

  13. The Brazilian 2010 oil regulatory framework and its crowding-out investment effects

    International Nuclear Information System (INIS)

    Florêncio, Pedro

    2016-01-01

    Investment is an essential variable in the oil sector. It is even more important in the vast Brazilian pre-salt domains, where the technological requirements are high and sophisticated. The Brazilian National Oil Company, Petrobras, is facing severe financial limitations to undertake these disbursements. Other oil companies will therefore have to be significantly engaged in the endeavour, which reinforces further the importance of attracting investments in Brazil. Yet this article shows that the governance architecture established in the 2010 Brazilian oil framework will deter investments in several ways, giving rise to agency problems among entities and moral hazard situations because of contractual legal liabilities. There are some credible indications that the government of President Lula overestimated the attractiveness of the Brazilian pre-salt oil discoveries and their capacity to draw investments when proposing the 2010 changes. Little attention was given to the careful examination of how the framework would affect investors, under the assumption that the favourable geological conditions would be sufficiently attractive in themselves. Even though the 2010 reforms have brought some minor advancements and there have been some signs that the government has been recently attempting to mitigate some of the problems examined in this article, that is not enough. - Highlights: • The Brazilian regulatory oil framework deters investments in the country. • The governance setting between entities is one of its worse aspects. • It causes agency problems and moral hazard situations. • Brazil has to urgently tackle these investment hindrances.

  14. Framework for the quantitative weight-of-evidence analysis of 'omics data for regulatory purposes.

    Science.gov (United States)

    Bridges, Jim; Sauer, Ursula G; Buesen, Roland; Deferme, Lize; Tollefsen, Knut E; Tralau, Tewes; van Ravenzwaay, Ben; Poole, Alan; Pemberton, Mark

    2017-12-01

    A framework for the quantitative weight-of-evidence (QWoE) analysis of 'omics data for regulatory purposes is presented. The QWoE framework encompasses seven steps to evaluate 'omics data (also together with non-'omics data): (1) Hypothesis formulation, identification and weighting of lines of evidence (LoEs). LoEs conjoin different (types of) studies that are used to critically test the hypothesis. As an essential component of the QWoE framework, step 1 includes the development of templates for scoring sheets that predefine scoring criteria with scores of 0-4 to enable a quantitative determination of study quality and data relevance; (2) literature searches and categorisation of studies into the pre-defined LoEs; (3) and (4) quantitative assessment of study quality and data relevance using the respective pre-defined scoring sheets for each study; (5) evaluation of LoE-specific strength of evidence based upon the study quality and study relevance scores of the studies conjoined in the respective LoE; (6) integration of the strength of evidence from the individual LoEs to determine the overall strength of evidence; (7) characterisation of uncertainties and conclusion on the QWoE. To put the QWoE framework in practice, case studies are recommended to confirm the relevance of its different steps, or to adapt them as necessary. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  15. Recommendations for institutional policy and network regulatory frameworks towards distributed generation in EU Member States

    International Nuclear Information System (INIS)

    Ten Donkelaar, M.; Van Oostvoorn, F.

    2005-01-01

    Recommendations regarding the development of regulatory frameworks and institutional policies towards an optimal integration of distributed generation (DG) into electricity networks are presented. These recommendations are based on findings from a benchmarking study conducted in the framework of the ENIRDG-net project. The aim of the benchmarking exercise was to identify examples of well-defined pro-DG policies, with clear targets and adequate implementation mechanisms. In this study an adequate pro-DG policy is defined on the basis of a level playing field, a situation where distributed and centralised generation receive equal incentives and have equal access to the liberalised markets for electricity. The benchmark study includes the results of a similar study conducted in the framework of the SUSTELNET project. When comparing the results a certain discrepancy can be noticed between the actual regulation and policy in a number of countries, the medium to long-term targets and the ideal situation described by the level playing field objective. To overcome this discrepancy, a number of recommendations have been drafted for future policy and regulation towards distributed generation

  16. Comparative analysis of nursing and midwifery regulatory and professional bodies' scope of practice and associated decision-making frameworks: a discussion paper.

    Science.gov (United States)

    Kennedy, Catriona; O'Reilly, Pauline; Fealy, Gerard; Casey, Mary; Brady, Anne-Marie; McNamara, Martin; Prizeman, Geraldine; Rohde, Daniela; Hegarty, Josephine

    2015-08-01

    To review, discuss and compare nursing and midwifery regulatory and professional bodies' scope of practice and associated decision-making frameworks. Scope of practice in professional nursing and midwifery is an evolving process which needs to be responsive to clinical, service, societal, demographic and fiscal changes. Codes and frameworks offer a system of rules and principles by which the nursing and midwifery professions are expected to regulate members and demonstrate responsibility to society. Discussion paper. Twelve scope of practice and associated decision-making frameworks (January 2000-March 2014). Two main approaches to the regulation of the scope of practice and associated decision-making frameworks exist internationally. The first approach is policy and regulation driven and behaviour oriented. The second approach is based on notions of autonomous decision-making, professionalism and accountability. The two approaches are not mutually exclusive, but have similar elements with a different emphasis. Both approaches lack explicit recognition of the aesthetic aspects of care and patient choice, which is a fundamental principle of evidence-based practice. Nursing organizations, regulatory authorities and nurses should recognize that scope of practice and the associated responsibility for decision-making provides a very public statement about the status of nursing in a given jurisdiction. © 2015 John Wiley & Sons Ltd.

  17. Human Genome Editing in the Clinic: New Challenges in Regulatory Benefit-Risk Assessment.

    Science.gov (United States)

    Abou-El-Enein, Mohamed; Cathomen, Toni; Ivics, Zoltán; June, Carl H; Renner, Matthias; Schneider, Christian K; Bauer, Gerhard

    2017-10-05

    As genome editing rapidly progresses toward the realization of its clinical promise, assessing the suitability of current tools and processes used for its benefit-risk assessment is critical. Although current regulations may initially provide an adequate regulatory framework, improvements are recommended to overcome several existing technology-based safety and efficacy issues. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. Ongoing enhancements in the German nuclear regulatory framework with respect to fire safety

    Energy Technology Data Exchange (ETDEWEB)

    Elsche, Bjoern [e.on Kernkraft, Hannover (Germany); Roewekamp, Marina [Gesellschaft fuer Anlagen- und Reaktorsicherheit (GRS) gGmbH, Koeln (Germany); Neugebauer, Wilfried [AREVA NP, Erlangen (Germany); Gersinska, Rainer [Bundesamt fuer Strahlenschutz (BfS), Salzgitter (Germany). KTA-Geschaeftsstelle

    2015-12-15

    In the recent past, the regulatory framework for nuclear power plants (NPP) in Germany has been updated and enhanced comprising on the one hand comprehensive high level regulatory documents such as the 'Safety Requirements for Nuclear Power Plants' and, on the other hand, revised state-of-the-art nuclear safety standards and rules being incorporated in a corresponding legal structure. A major enhancement concerns the nuclear fire and explosion protection standards being already available as so-called green print for final comments which are expected to be officially published end of 2015. The update became necessary after approx. ten years for better addressing some lessons learnt form the operating experience, the consideration of post- Fukushima insights, such as more systematically addressing event combinations with fires and taking into account deviations from non-nuclear standards for escape and rescue routes. Moreover, fire protections remains an important issue for nuclear power plants in Germany during the longer term post-commercial safe shutdown period before decommissioning during which the spent fuel elements remain either in the containment or in the spent fuel pool for further years requiring suitable fire protection means being in place.

  19. Reforming Brazil's offshore oil and gas safety regulatory framework: Lessons from Norway, the United Kingdom and the United States

    International Nuclear Information System (INIS)

    Mendes, Pietro A.S.; Hall, Jeremy; Matos, Stelvia; Silvestre, Bruno

    2014-01-01

    We propose reforming the Brazilian regulatory safety framework (BRSF) for offshore oil and gas production and drilling operations. Brazil has emerged as a leading offshore producer with extensive proven reserves yet to be exploited. However, the BRSF has not been updated since 2007, and there are now major concerns about the industry's safety, particularly after the BP Deepwater Horizon accident, along with the technical challenges due to extreme conditions under which Brazil's resources are located. Drawing on experiences from three leading offshore oil and gas producers (Norway, the UK, and the US), we recommend the adoption of three best practices: the UK's ‘safety case’ approach (where operators are expected to provide convincing and valid arguments that a system is sufficiently safe for a given application in a specific environment), Norway's ‘barrier management’ (evidence that there are at least two tested and independent barriers to avoid accidents) and greater investment in safety research and development, as suggested by the US's National Commission on the BP Deepwater Horizon Oil Spill and Offshore Drilling. We discuss implications for policy reform and how best practices can be applied within the Brazilian context. - Highlights: • Description of the Brazilian regulatory safety framework (BRSF). • Comparison between BRSF and regulatory frameworks of leading offshore oil and gas jurisdictions (Norway, UK and US). • Recommendations for BRSF to include the safety case, barrier management and increased investment in safety technology

  20. 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.

  1. 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)

  2. Current approaches to gene regulatory network modelling

    Directory of Open Access Journals (Sweden)

    Brazma Alvis

    2007-09-01

    Full Text Available Abstract Many different approaches have been developed to model and simulate gene regulatory networks. We proposed the following categories for gene regulatory network models: network parts lists, network topology models, network control logic models, and dynamic models. Here we will describe some examples for each of these categories. We will study the topology of gene regulatory networks in yeast in more detail, comparing a direct network derived from transcription factor binding data and an indirect network derived from genome-wide expression data in mutants. Regarding the network dynamics we briefly describe discrete and continuous approaches to network modelling, then describe a hybrid model called Finite State Linear Model and demonstrate that some simple network dynamics can be simulated in this model.

  3. Regulatory Framework for Conducting Clinical Research in Canada.

    Science.gov (United States)

    Alas, Josmar K; Godlovitch, Glenys; Mohan, Connie M; Jelinski, Shelly A; Khan, Aneal A

    2017-09-01

    Research in human subjects is at the core of achieving improvements in health outcomes. For clinical trials, in addition to the peer review of the results before publication, it is equally important to consider whether the trial will be conducted in a manner that generates data of the highest quality and provides a measure of safety for the participating subjects. In Canada, there is no definitive legislation that governs the conduct of research involving human subjects, but a network of regulations at different levels does provide a framework for both principal investigators and sponsors. In this paper, we provide an overview of the federal, provincial and institutional legislation, guidelines and policies that will inform readers about the requirements for clinical trial research. This includes a review of the role of the Food and Drug Regulations under the Food and Drugs Act and the Tri-Council Policy Statement (TCPS2), an overview of provincial legislation across the country, and a focus on selected policies from institutional research ethics boards and public health agencies. Many researchers may find navigation through regulations frustrating, and there is a paucity of information that explains the interrelationship between the different regulatory agencies in Canada. Better understanding the process, we feel, will facilitate investigators interested in clinical trials and also enhance the long-term health of Canadians.

  4. 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)

  5. Regulatory Governance

    DEFF Research Database (Denmark)

    Kjær, Poul F.; Vetterlein, Antje

    2018-01-01

    Regulatory governance frameworks have become essential building blocks of world society. From supply chains to the regimes surrounding international organizations, extensive governance frameworks have emerged which structure and channel a variety of social exchanges, including economic, political...... by the International Transitional Administrations (ITAs) in Kosovo and Iraq as well as global supply chains and their impact on the garment industry in Bangladesh....

  6. Risk Management And Liability For EnvironmentalL Harm Caused By GMOS – The South African Regulatory Framework

    Directory of Open Access Journals (Sweden)

    L Feris

    2006-05-01

    Full Text Available Biotechnology is still relatively new and as with any new technology, it carries some level of risk. This necessitates appropriate risk assessments and appropriate risk management. One element of risk management however, is taking into account that during the production, development, transport or release of a GMO it may cause injury to person, property or the environment, regardless of risk management procedures. This calls for the existence of a liability regime that will place some legal responsibility on the party responsible for the harm. This paper assesses the South African regulatory framework of relevance to GMOs, which is composed of a fragmented set of laws that deals with risk assessment, risk management and liability for damage to the environment. It discusses the GMO Act as the principle legislation regulation GMOs and also the recent amendment thereof and also consider other legislation such as the ECA, NEMA and NEMA Biodiversity Act in an attempt to determine whether the regulatory framework addresses risk management and liability in an effective and adequate manner. It comes to the conclusion that South Africa does not as yet have a satisfactory legal regime that provides for risk management and liability in the context of GMOs.

  7. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Italy

    International Nuclear Information System (INIS)

    2010-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects; Emergency response); 5. Trade in nuclear materials and equipment (General provisions; Patents); 6. Radiation Protection (Protection of workers; Protection of the public; Protection of the environment); 7. Radioactive Waste Management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear Third Party Liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Interdepartmental Committee for Economic Planning; Nuclear Safety Agency; Prime Minister; Minister for Economic Development; Minister for Labour and Social Security; Minister for Health; Minister for the Environment; Minister for the Interior; Minister for Transport and Navigation; Minister for Foreign Trade (now incorporated in Ministry for Economic Development); Minister for Education; Treasury Minister; Minister for Universities and for Scientific and Technical Research; Minister for Foreign Affairs; State Advocate General); 2. Advisory bodies (Inter-ministerial Council for Consultation and Co-ordination; Coordinating Committee for Radiation Protection of Workers and the Public; Regional and Provincial Commissions for Public Health Protection

  8. U.S. Nuclear Regulatory Commission Extremely Low Probability of Rupture pilot study: xLPR framework model user's guide

    International Nuclear Information System (INIS)

    Kalinich, Donald A.; Sallaberry, Cedric M.; Mattie, Patrick D.

    2010-01-01

    For the U.S. Nuclear Regulatory Commission (NRC) Extremely Low Probability of Rupture (xLPR) pilot study, Sandia National Laboratories (SNL) was tasked to develop and evaluate a probabilistic framework using a commercial software package for Version 1.0 of the xLPR Code. Version 1.0 of the xLPR code is focused assessing the probability of rupture due to primary water stress corrosion cracking in dissimilar metal welds in pressurizer surge nozzles. Future versions of this framework will expand the capabilities to other cracking mechanisms, and other piping systems for both pressurized water reactors and boiling water reactors. The goal of the pilot study project is to plan the xLPR framework transition from Version 1.0 to Version 2.0; hence the initial Version 1.0 framework and code development will be used to define the requirements for Version 2.0. The software documented in this report has been developed and tested solely for this purpose. This framework and demonstration problem will be used to evaluate the commercial software's capabilities and applicability for use in creating the final version of the xLPR framework. This report details the design, system requirements, and the steps necessary to use the commercial-code based xLPR framework developed by SNL.

  9. Strategies of bringing drug product marketing applications to meet current regulatory standards.

    Science.gov (United States)

    Wu, Yan; Freed, Anita; Lavrich, David; Raghavachari, Ramesh; Huynh-Ba, Kim; Shah, Ketan; Alasandro, Mark

    2015-08-01

    In the past decade, many guidance documents have been issued through collaboration of global organizations and regulatory authorities. Most of these are applicable to new products, but there is a risk that currently marketed products will not meet the new compliance standards during audits and inspections while companies continue to make changes through the product life cycle for continuous improvement or market demands. This discussion presents different strategies to bringing drug product marketing applications to meet current and emerging standards. It also discusses stability and method designs to meet process validation and global development efforts.

  10. Policy and Regulatory Roadmaps for the Integration of Distributed Generation and the Development of Sustainable Electricity Networks. Final Report of the SUSTELNET project

    International Nuclear Information System (INIS)

    Scheepers, M.J.J.

    2004-08-01

    The SUSTELNET project has been created to identify criteria for a regulatory framework for future electricity markets and network structures that create a level playing field between centralised and decentralised generation and facilitate the integration of renewable energy sources (RES). Furthermore, the objective of the project was to develop regulatory roadmaps for the transition to a sustainable electricity market and network structure. This report summarizes the results of the project. These results consist of: criteria, guidelines and rationales for a future electricity policy and regulatory framework, an outline for the development of regulatory roadmaps and nine national regulatory roadmaps (for Denmark, Germany, Italy, the Netherlands, United Kingdom, Czech Republic, Poland, Hungary and Slovakia), recommendations for a European regulatory policy on distributed generation and a benchmark study of current Member States policies towards distributed generation

  11. 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...

  12. Steering healthcare service delivery: a regulatory perspective.

    Science.gov (United States)

    Prakash, Gyan

    2015-01-01

    The purpose of this paper is to explore regulation in India's healthcare sector and makes recommendations needed for enhancing the healthcare service. The literature was reviewed to understand healthcare's regulatory context. To understand the current healthcare system, qualitative data were collected from state-level officials, public and private hospital staff. A patient survey was performed to assess service quality (QoS). Regulation plays a central role in driving healthcare QoS. India needs to strengthen market and institutional co-production based approaches for steering its healthcare in which delivery processes are complex and pose different challenges. This study assesses current healthcare regulation in an Indian state and presents a framework for studying and strengthening regulation. Agile regulation should be based on service delivery issues (pull approach) rather than monitoring and sanctions based regulatory environment (push approach). Healthcare pitfalls across the world seem to follow similar follies. India's complexity and experience is useful for emerging and developed economies. The author reviewed around 70 publications and synthesised them in healthcare regulatory contexts. Patient's perception of private providers could be a key input towards steering regulation. Identifying gaps across QoS dimensions would be useful in taking corrective measures.

  13. Developing a Pre-disposal radioactive waste management framework for malawi

    International Nuclear Information System (INIS)

    Guasi, Ephron

    2016-04-01

    In Malawi, uranium mining and other potential radioactive waste generating activities are on the increase. An elaborate national policy document and strategy on radioactive waste management is however not available. A national policy is important because it provides overall direction and the basis for decision making with respect to the management of radioactive waste in a country. Thus the absence of the national policy creates a gap in the country’s regulatory framework for ensuring safety and protection of people and the environment from sources of ionizing radiation. The present study was undertaken to minimize the impact of this regulatory framework gap by proposing a predisposal radioactive waste management framework for Malawi. This was achieved by analyzing the current and anticipated applications of radioactive materials and activities. The international and national regulatory requirements related to predisposal radioactive waste management were also reviewed and analyzed. The study found out that a predisposal radioactive waste management frame work comprised of onsite management of wastes from hospitals and uranium mining and export of high activity disused sources to supplier or management facilities in nearby countries would be the best for Malawi for now and the next ten years. (au)

  14. Current and new developments in transport and regulatory issues concerning radioisotopes: managing change for minimum business impact

    International Nuclear Information System (INIS)

    Bennett, Neil; Coppell, David; Rogers, David; Schrader, John

    2004-01-01

    Changes in the regulatory framework governing the Radiation Processing Industry have the potential to make a real business impact on day-to-day profitability. Many areas of the Radiation Processing Industry are affected by changes in the regulatory framework within which these areas are managed. When planning for such changes the transportation element in the shipment of sealed cobalt radiation sources is an area that is often neglected by some parts of the distribution chain. A balance must be struck between the cobalt supplier and the facility operator/customer that rests upon how much the customer needs to know about the intricacies of cobalt shipment. The objective of this paper is to highlight areas of possible business impact and reassure the users of sealed radiation sources that the global suppliers of these products are used to negotiating local variations in regulations governing the physical transportation of radiation sources, changes in regulations governing the design, manufacture and use of transportation containers and changes in the availability of commercial shippers and shipping routes. The major suppliers of industrial quantities of cobalt-60 are well placed to lead their customers through this complex process as a matter of routine

  15. Unique Regulatory Approach for Licensing the Port Hope Remediation Project in Canada - 13315

    International Nuclear Information System (INIS)

    Kostova, M.; Howard, D.; Elder, P.

    2013-01-01

    The Port Hope remediation project is a part of a larger initiative of the Canadian Federal Government the Port Hope Area Initiative (PHAI) which is based upon a community proposal. The Government of Canada, through Natural Resources Canada (NRCan) is investing $1.28 billion over 10 years to clean up historic low-level radioactive waste in the Port Hope Area and to provide long-term safe management of the low-level radioactive wastes in the Port Hope Area. These wastes arose from the activities of a former Federal Crown Corporation (Eldorado Nuclear) and its private sector predecessors. In Canada, historic waste are defined as low-level radioactive waste that was managed in a manner no longer considered acceptable, but for which the original producer cannot reasonably be held responsible or no longer exists and for which the Federal Government has accepted responsibility. In Canada, under the current regulatory framework, the environmental remediation is not considered as a distinct phase of the nuclear cycle. The regulatory approach for dealing with existing sites contaminated with radioactive residues is defined on the basis of risk and application of existing regulations. A unique regulatory approach was taken by the Canadian Nuclear Safety Commission (CNSC) to address the various licensing issues and to set out the requirements for licensing of the Port Hope Project within the current regulatory framework. (authors)

  16. Unique Regulatory Approach for Licensing the Port Hope Remediation Project in Canada - 13315

    Energy Technology Data Exchange (ETDEWEB)

    Kostova, M.; Howard, D.; Elder, P. [Directorate of Nuclear Cycle and Facilities Regulation, Canadian Nuclear Safety Commission, 280, Slater Street, Ottawa, Ontario K1P 5S9 (Canada)

    2013-07-01

    The Port Hope remediation project is a part of a larger initiative of the Canadian Federal Government the Port Hope Area Initiative (PHAI) which is based upon a community proposal. The Government of Canada, through Natural Resources Canada (NRCan) is investing $1.28 billion over 10 years to clean up historic low-level radioactive waste in the Port Hope Area and to provide long-term safe management of the low-level radioactive wastes in the Port Hope Area. These wastes arose from the activities of a former Federal Crown Corporation (Eldorado Nuclear) and its private sector predecessors. In Canada, historic waste are defined as low-level radioactive waste that was managed in a manner no longer considered acceptable, but for which the original producer cannot reasonably be held responsible or no longer exists and for which the Federal Government has accepted responsibility. In Canada, under the current regulatory framework, the environmental remediation is not considered as a distinct phase of the nuclear cycle. The regulatory approach for dealing with existing sites contaminated with radioactive residues is defined on the basis of risk and application of existing regulations. A unique regulatory approach was taken by the Canadian Nuclear Safety Commission (CNSC) to address the various licensing issues and to set out the requirements for licensing of the Port Hope Project within the current regulatory framework. (authors)

  17. The policy framework for the promotion of hydrogen and fuel cells in Europe. A critical assessment

    International Nuclear Information System (INIS)

    Bleischwitz, Raimund; Bader, Nikolas

    2010-01-01

    This paper reviews the current EU policy framework in view of its impact on hydrogen and fuel cell development. It screens EU energy policies, EU regulatory policies and EU spending policies. Key questions addressed are as follows: to what extent is the current policy framework conducive to hydrogen and fuel cell development? What barriers and inconsistencies can be identified? How can policies potentially promote hydrogen and fuel cells in Europe, taking into account the complex evolution of such a potentially disruptive technology? How should the EU policy framework be reformed in view of a strengthened and more coherent approach towards full deployment, taking into account recent technology-support activities? This paper concludes that the current EU policy framework does not hinder hydrogen development. Yet it does not constitute a strong push factor either. EU energy policies have the strongest impact on hydrogen and fuel cell development even though their potential is still underexploited. Regulatory policies have a weak but positive impact on hydrogen. EU spending policies show some inconsistencies. However, the large-scale market development of hydrogen and fuel cells will require a new policy approach which comprises technology-specific support as well as a supportive policy framework with a special regional dimension. (author)

  18. Building a regulatory framework for geothermal energy development in the NWT

    Energy Technology Data Exchange (ETDEWEB)

    Holroyd, Peggy; Dagg, Jennifer [Pembina Institute (Canada)

    2011-03-15

    There is a high potential in Canada's Northwest Territories (NWT) for using geothermal energy, the thermal energy generated and stored in the Earth, and this could help the NWT meet their greenhouse gas emissions reduction targets. The Pembina Institute was engaged by the government of the NWT to perform a jurisdictional analysis of geothermal energy legislation and policy around the world; this report presents its findings. The jurisdictional review was carried out in 9 countries and interviews were conducted with various geothermal energy experts. Following this research, the Pembina Institute made recommendations to the NWT government on the development of a geothermal energy regulatory framework which would cover the need to define geothermal energy legislation and resource ownership as well as a plan and vision for geothermal energy use. This report highlighted that with an effective government policy in place, the use of geothermal energy in the NWT could provide the territories with a stable and secure energy supply.

  19. Building a regulatory framework for geothermal energy development in the NWT

    Energy Technology Data Exchange (ETDEWEB)

    Holroyd, Peggy; Dagg, Jennifer [Pembina Institute (Canada)

    2011-03-15

    There is a high potential in Canada's Northwest Territories (NWT) for using geothermal energy, the thermal energy generated and stored in the Earth, and this could help the NWT meet their greenhouse gas emissions reduction targets. The Pembina Institute was engaged by the government of the NWT to perform a jurisdictional analysis of geothermal energy legislation and policy around the world; this report presents its findings. The jurisdictional review was carried out in 9 countries and interviews were conducted with various geothermal energy experts. Following this research, the Pembina Institute made recommendations to the NWT government on the development of a geothermal energy regulatory framework which would cover the need to define geothermal energy legislation and resource ownership as well as a plan and vision for geothermal energy use. This report highlighted that with an effective government policy in place, the use of geothermal energy in the NWT could provide the territories with a stable and secure energy supply.

  20. Persona Rights for User-Generated Content: A Normative Framework for Privacy and Intellectual Property Regulation

    Directory of Open Access Journals (Sweden)

    Tamara Shepherd

    2012-02-01

    Full Text Available This article introduces the term “persona rights” as a normative conceptual framework for analyzing the language of regulatory debates around privacy and intellectual property online, mainly from a Canadian perspective. In using the concept of persona rights to interrogate and critique the current limitations of regulatory discourses in protecting user rights online, the legal implications of persona rights law are translated into more conceptual terms. As a normative framework, persona rights is shown to be useful in addressing the gaps in regulatory understandings of privacy and intellectual property – particularly in spaces for user-generated content (UGC – and in suggesting how policy might be written to account for user rights to the integrity of identity in commercial UGC platforms.

  1. Regulatory Hybridization in the Transnational Sphere

    DEFF Research Database (Denmark)

    Kjær, Poul Fritz; Jurcys, Paulius; Yrakami, Ren

    Hybridization has become a defining feature of regulatory frameworks. The combined forces of globalization and privatization together with increased reliance on self-regulation have resulted in the emergence of a multitude of regulatory arrangements which combine elements from several legal orders....... This book offers a conceptual framework as well as numerous empirical explorations capable of increasing our understanding of regulatory hybridization. A number of central dichotomies are deconstructed: national vs. transnational law; international vs. transnational law; convergence vs. divergence; … read...... moresoft law vs. hard law; territorial vs. non-territorial, ‘top-down’ vs. ‘bottom-up’ globalization and national vs. global just as the implications of regulatory hybridization for the question of choice of court and conflict of laws are analyzed....

  2. On the Basic Principles of Creating a Regulatory Framework for Strategic Planning of Innovative Development of the Russian Economy

    Directory of Open Access Journals (Sweden)

    Yu. V. Mishin

    2017-01-01

    Full Text Available Purpose: the aim of the work is to substantiate methodological approaches to create the most important component of strategic planning – its regulatory framework. The relevance of the chosen topic of this article is due to the fact that in modern conditions, strategic planning is an important tool for ensuring sustainable development and increasing the competitiveness of the domestic economy. It allows you to identify the most important and priority areas of activity, distribute and ensure the effective use of available limited labor, material and, most importantly, financial resources. Today, domestic strategic planning has a number of significant shortcomings, the main one of which, in our opinion, is the lack of reliable initial information for forecasting and analytical calculations. Methods: the methodological basis is the dialectical method of scientific cognition, the systemic and institutional approach to building an effective information base of strategic planning. In the course of research of the current state and level of industrial rationing, methods of analysis and synthesis, comparisons and analogies were used. As a methodological basis of this article, regulatory legal documents were used in the field of strategic planning in Russia, as well as methodological documents that previously operated in the USSR on the regulation of resource consumption. Results: the result of the work are the goals, tasks and requirements for the strategic planning base proposed by the author. The relationship of production rationing with the basic principles of strategic planning is shown - balance and consistency in priorities, goals, objectives, activities, resources and timing; The effectiveness of methods and methods for achieving goals with the least expenditure of resources used. The possibility of the existence of a standardization of labor costs, the consumption of material and production resources, regardless of the form of ownership of the

  3. Current Limitations and Recommendations to Improve Testing for the Environmental Assessment of Endocrine Active Substances

    DEFF Research Database (Denmark)

    Coady, Katherine K; Biever, Ronald C; Denslow, Nancy D

    2017-01-01

    In this paper existing regulatory frameworks and test systems for assessing potential endocrine-active chemicals are described, and associated challenges discussed, along with proposed approaches to address these challenges. Regulatory frameworks vary somewhat across geographies, but all basically...... evaluate whether a chemical possesses endocrine activity and whether this activity can result in adverse outcomes either to humans or the environment. Current test systems include in silico, in vitro and in vivo techniques focused on detecting potential endocrine activity, and in vivo tests that collect...... methods currently do not exist, and addressing key endocrine pathways of possible concern in addition to those associated with estrogen, androgen and thyroid signaling. This article is protected by copyright. All rights reserved....

  4. Introducing nuclear power into currently non-nuclear states

    International Nuclear Information System (INIS)

    Gert, Claassen

    2007-01-01

    As the nuclear renaissance gains momentum, many countries that currently have no nuclear power plants will begin to consider introducing them. It is anticipated that smaller reactors such as the Pebble Bed Modular Reactor (PBMR) will not only be sold to current nuclear states to also to states where there is currently no nuclear experience. A range of issues would have to be considered for nuclear plants to be sold to non-nuclear states, such as the appropriate regulatory environment, standardization and codes, non-proliferation, security of supply, obtaining experienced merchant operators, appropriate financial structures and education and training. The paper considers nine major issues that need to be addressed by governments and vendors alike: 1) political enabling framework, 2) regulatory framework, 3) responsible owner, 4) responsible operator, 5) finance, 6) contact management, 7) fuel supply and waste management framework, 8) training and education, and 9) industrial infrastructure. International cooperation by organisations such as the IAEA, financial institutions and international suppliers will be required to ensure that developing countries as well as developed ones share the benefits of the nuclear renaissance. The opportunities that the nuclear industry affords to develop local skills, create job opportunities and to develop local manufacturing industries are among the important reasons that the South African Government has decided to support and fund the development of the Pebble Bed Modular Reactor project. (author)

  5. Regulatory framework in assisted reproductive technologies, relevance and main issues.

    OpenAIRE

    Françoise Merlet

    2010-01-01

    Assisted reproductive technologies (ART) have changed life for the past 25 years and many ethical and social issues have emerged following this new method of conception. In order to protect individuals against scientific and ethical abuses without inhibiting scientific progress, a specific legal framework is necessary. The first French law on Bioethics was voted after an extensive debate in 1994 then reviewed in 2004. This review previously scheduled every five years is currently being discus...

  6. Organizational behavior of regulatory agencies: a case study of the Bureau of Consumer Services in the Pennsylvania Public Utility Commission

    Energy Technology Data Exchange (ETDEWEB)

    Silver, J.H.

    1981-01-01

    Regulatory agencies operate in a complex field of organizations and interest groups. The variety of behaviors that occur in the regulatory field are not satisfactorily explained by current interpretative frameworks. Regulatory agencies are at once criticized and praised. They flourish as organizational entities, yet they exhibit behavior that is often inexplicable. Notions like clientele capture, the politics of regulation, exchange theory, and institutionalized organizations do not singly explain the vagaries of regulatory behavior. A merger of these viewpoints, however, provides a foundation for a comprehensive interpretative framework. A bureau of consumer services within a state public utility commission is viewed as an institutionalized organization. From this perspective, a variety of ritual behaviors, based upon symbolic and tangible interorganizational exchanges are observed and characterized. The outcome of these exchanges is the establishment of the Bureau of Consumer Services as a legitimate regulatory agent with significant impact upon the formulation of regulatory policy in the formal proceedings of the Pennsylvania Public Utility Commission.

  7. Mining Contratação License in the New Regulatory Framework of Brazilian Mining: Some Notes on the Institutes of Research Authorization and Mining Concession

    Directory of Open Access Journals (Sweden)

    Adhemar Ronquim Filho

    2013-06-01

    Full Text Available Given the importance of mining nowadays, Government seeks ways to stimulate its growth, focusing on potentializing research and the advancement of mineral processing, the basic items for speeding up this activity in a profitable way. In this sense, the discussions on the crystallization of a new regulatory framework for the Brazilian mining have been deepened and, despite gathering a significant number of proposals, it does not have a closed text, and, currently, it is far from obtaining an approval or a final word (despite the urgency. However, the analysis of the proposals that have been presented reveals that there is an intention to institute new rules for the modernization of Brazilian mining, and this paper has the purpose of suggesting ways to reconcile conflicts permeated by various dissonant interests that surround the Brazilian mining at this time. It should be emphasized that, given the lack of official disclosure of the amendments proposed, the approach will continue limited to what has been released by MME (Ministry of Mines and Energy and by the studies that have already been presented by experts in the field (connected to government and/or private businesses. It is restricted to discuss changes to be implemented with the new regulatory framework, highlighting points to be observed, and, among the topics that require mandatory update, we can emphasize the changes in the procedures of exploration permits and mining.

  8. Deciphering RNA regulatory elements in trypanosomatids: one piece at a time or genome-wide?

    Science.gov (United States)

    Gazestani, Vahid H; Lu, Zhiquan; Salavati, Reza

    2014-05-01

    Morphological and metabolic changes in the life cycle of Trypanosoma brucei are accomplished by precise regulation of hundreds of genes. In the absence of transcriptional control, RNA-binding proteins (RBPs) shape the structure of gene regulatory maps in this organism, but our knowledge about their target RNAs, binding sites, and mechanisms of action is far from complete. Although recent technological advances have revolutionized the RBP-based approaches, the main framework for the RNA regulatory element (RRE)-based approaches has not changed over the last two decades in T. brucei. In this Opinion, after highlighting the current challenges in RRE inference, we explain some genome-wide solutions that can significantly boost our current understanding about gene regulatory networks in T. brucei. Copyright © 2014 Elsevier Ltd. All rights reserved.

  9. Using the IRRS to Strengthen Regulatory Competence in Ireland

    International Nuclear Information System (INIS)

    Smith, K.

    2016-01-01

    In 2015, Ireland underwent an IRRS (Integrated Regulatory Review Service) review mission. The purpose of the mission was to review Ireland’s radiation and nuclear safety regulatory framework and activities against the relevant IAEA safety standards, to report on the regulatory effectiveness and to exchange information and experience in the areas covered by the IRRS. The review mission was well-timed as there had been recent changes in the regulatory infrastructure with the merger of the Radiological Protection Institute of Ireland (RPII) and the Environmental Protection Agency (EPA) in 2014, as well as the upcoming implementation of the new Euratom Basic Safety Standards (BSS) Directive. The key objectives of the mission were to enhance the national legal, governmental and regulatory framework for nuclear and radiation safety, and national arrangements for emergency preparedness and response. The agreed scope of the review covered all relevant facilities and activities regulated in Ireland and also included medical exposures and public exposure to radon. In advance of the mission, Ireland completed a process of self-assessment and review. This process identified strengths and weaknesses in the national regulatory framework compared with the international standards. In addition to the value of having Ireland’s radiation protection framework peer reviewed by senior international experts, the mission helped to further strengthen links between all the national bodies (government, licensees, regulatory) with a role in the regulation of radiation safety. The findings from the IRRS review team’s objective evaluation of Ireland’s regulatory infrastructure are being used to prioritise actions for strengthening the regulatory framework, to provide input into the transposition of the Euratom BSS, and to support the revision of the national emergency plan for nuclear accidents. It is planned to have addressed the findings of the IRRS mission in advance of a follow up

  10. The SAFE FOODS Risk Analysis Framework suitable for GMOs? A case study

    NARCIS (Netherlands)

    Kuiper, H.A.; Davies, H.V.

    2010-01-01

    This paper describes the current EU regulatory framework for risk analysis of genetically modified (GM) crop cultivation and market introduction of derived food/feed. Furthermore the risk assessment strategies for GM crops and derived food/feed as designed by the European Food Safety Authority

  11. Regulatory review and barriers for the electricity supply system for distributed generation in EU-15

    DEFF Research Database (Denmark)

    Ropenus, Stephanie; Skytte, Klaus

    2005-01-01

    When distributed electricity supply surpasses a particular level, it can no longer be ignored in planning and operation of the electricity networks. Therefore, improvements of the regulatory framework of the electricity networks are required along with the growth of the electricity supply from di...... distributed generation. This paper reviews the current regulation of the grids with respect to distributed generation in EU-15 Member States and compares the different systems. Several barriers are identified.......When distributed electricity supply surpasses a particular level, it can no longer be ignored in planning and operation of the electricity networks. Therefore, improvements of the regulatory framework of the electricity networks are required along with the growth of the electricity supply from...

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

    Science.gov (United States)

    Kuhlmann-Gottke, Johanna; Duchow, Karin

    2015-11-01

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

  13. The residential electricity sector in Denmark: A description of current conditions

    DEFF Research Database (Denmark)

    Kitzing, Lena; Katz, Jonas; Schröder, Sascha Thorsten

    We provide an overview of the current conditions and framework for residential electricity consumption in Denmark. This includes a general overview of the sector, the retail market and the regulatory framework. We describe the regulations currently in place and changes which have been decided...... in the area, which are listed in the Glossary towards the end of the report. We also attach a list and description of the major sources of information and data that can be obtained and downloaded for analysis of the Danish residential electricity sector....

  14. Australian regulatory framework and reporting entities are hindering the lessons to be learned from adverse radiation events

    International Nuclear Information System (INIS)

    Denham, G.

    2016-01-01

    When adverse radiation events occur in the medical radiation science profession in Australia they are reported to the relevant state or territory authority. The details and cause of the incident are forwarded to the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) to be included in the Australian Radiation Incident Register. The aim of any error reporting system is to learn from previous errors and to prevent them occurring again. The information obtained from past errors is one of the most invaluable tools to prevent future adverse events. This article examines the current regulatory framework, reporting systems and radiation protection authorities in Australia and their effectiveness at improving patient safety. Several obstacles must be overcome if the systems and organisations responsible for radiation safety are to meet the expectations of both the community and the medical radiation science profession. - Highlights: • Adverse radiation events in Australia are reported to state and territory authorities. • Adverse radiation events are included in the Australian Radiation Incident Register State and territory radiation authorities have failed to implement changes agreed upon in 1999. • The Australian Radiation Incident Register requires reforms if it is to operate as an effective learning system.

  15. A study on the establishment of national regulatory framework for effective implementation of exemption or clearance concept

    International Nuclear Information System (INIS)

    Cheong, J.H.; Park, S.H.; Suk, T.W.

    1998-01-01

    The concepts of exemption and clearance have a lot of advantages in the aspects of effective use of limited resources, land, and optimization of regulatory works. The exact scopes and extent of the implementation of the concepts, however, can widely vary depending upon each country's own specific situations. In order to support the political decision-making on the practical implementation, a series of possible alternatives, general methodology for decision-making, and factors to be considered were proposed. Five primary categories and subsequent nineteen secondary categories were suggested and discussed, and four-step-approach was introduced in order to show the general guidelines for establishing an appropriate national regulatory framework. Though the specific procedure for each country to get to the practical implementation of the exemption and clearance concepts was not described, it is anticipated that the basic guidelines proposed in this paper can be used as a general reference. (author)

  16. International Expert Team Concludes IAEA Peer Review of Bulgaria's Regulatory Framework for Nuclear and Radiation Safety

    International Nuclear Information System (INIS)

    2013-01-01

    Full text: An international team of senior nuclear safety and radiation protection experts today concluded a 12-day mission to review the regulatory framework for nuclear and radiation safety in Bulgaria. The Integrated Regulatory Review Service (IRRS) mission, conducted at the request of the Government of Bulgaria, identified a series of good practices and made recommendations to help enhance the overall performance of the regulatory system. IRRS missions, which were initiated in 2006, are peer reviews based on the IAEA Safety Standards; they are not inspections or audits. ''Bulgaria has a clear national policy and strategy for safety, which are well in line with international standards and practices and contribute to a high level of nuclear safety,'' said Mission Team Leader Marta Ziakova, Chairperson of the Nuclear Regulatory Authority of the Slovak Republic. The mission team, which conducted the review from 8 to 19 April, was made up of 16 senior regulatory experts from 16 nations, and six IAEA staff. ''The results of the IRRS mission will be valuable for the future development and reinforcement of the Bulgarian Nuclear Safety Agency (BNRA). The use of international standards and good practices helps to improve global harmonization in all areas of nuclear safety and radiation protection,'' said Sergey Tzotchev, Chairman of the BNRA. Among the main observations in its preliminary report, the IRRS mission team found that BNRA operates as an independent regulatory body and conducts its regulatory processes in an open and transparent manner. In line with the IAEA Action Plan on Nuclear Safety, the mission reviewed the regulatory implications for Bulgaria of the March 2011 accident at TEPCO's Fukushima Daiichi Nuclear Power Station in Japan. It found that the BNRA's response to the lessons learned from that accident was both prompt and effective. Strengths and good practices identified by the IRRS team include the following: A no-blame policy is enshrined in law for

  17. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Germany

    International Nuclear Information System (INIS)

    2011-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment (Definitions; Licensing requirements); 4. Nuclear installations (Licensing regime; Protection of the environment against radiation effects; Emergency response; Surveillance of installations and activities); 5. Trade in nuclear materials and equipment; 6. Radiation protection (General; Principal elements of the Radiation Protection Ordinance; Additional radiation protection norms); 7. Radioactive waste management (Atomic Energy Act 2002; Radiation Protection Ordinance; International obligations); 8. Non-proliferation and physical protection (Non-proliferation regime; Physical protection regime); 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities: Federal authorities (Federal Minister for the Environment, Nature Conservation and Nuclear Safety, Federal Minister for Education and Research, Federal Minister of Finance, Federal Minister of Transport, Building and Urban Affairs, Federal Minister for Economy and Technology, Federal Minister of Defence, Federal Office for Radiation Protection - BfS, Federal Office of Economics and Export Control); Authorities of the Laender; 2. Advisory bodies (Reactor Safety Commission - RSK; Radiation Protection Commission - SSK; Disposal Commission - ESK; Nuclear Technology

  18. 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)

  19. Current status of herbal product: Regulatory overview

    Science.gov (United States)

    Sharma, Sanjay

    2015-01-01

    A review of the regulatory status of herbal drugs/products was done for few countries forming part of Asia, Africa, America, Europe, and Australia, to understand various categories under which the trade of herbal products is permitted and their premarketing requirements. A critical assessment was done, to know the hindrances in the process of harmonization of herbal products. It has been found that there is a lack of harmonization in the regulatory requirements of herbal products internationally, besides the issues of availability of herbs and their conservation. These are hindering the international trade and growth of the herbal products segment. PMID:26681886

  20. Bank resolution: a framework for the assessment of regulatory intervention

    OpenAIRE

    Mathias Dewatripont; Xavier Freixas

    2011-01-01

    More than ever, the current crisis has highlighted the cost of banking crises in budgetary and economic growth terms. Whether or not to restructure a bank is a key determinant of who bears the costs. The present article surveys the main issues concerning banks' restructuring, by considering the bargaining game that is played between regulators and shareholders when a bank is in distress. This revolves around the framework of negotiation that was established by the regulator, the fall-back pos...

  1. 77 FR 52791 - Regulatory Capital Rules: Regulatory Capital, Implementation of Basel III, Minimum Regulatory...

    Science.gov (United States)

    2012-08-30

    ... the Basel Committee on Banking Supervision (BCBS) in ``Basel III: A Global Regulatory Framework for... seeking comment on the two related NPRs published elsewhere in today's Federal Register. The two related... them on Regulations.gov without change, including any business or personal information that you provide...

  2. Enhancement of Nuclear Safety in Korea: A Regulatory Perspective

    International Nuclear Information System (INIS)

    Chung, K.Y.

    2016-01-01

    In the aftermath of Fukushima Daiichi accident in 2011 Korean regulatory body immediately performed special inspections on nuclear power plants (NPPs) and a research reactor in Korea, and issued an enforcement order for the licensees to implement fifty Fukushima action items to address the safety issues identified by the inspections. Subsequently, the licensees have established the implementation plans for resolution of the action items. By the implementation of the action items, the possibility of severe accident due to the extreme hazards has been greatly reduced and the capabilities to mitigate the severe accident, should it occur, have been upgraded. To improve the consistency and predictability of the regulation on severe accidents, Nuclear Safety and Security Commission (NSSC) the regulatory body in Korea, is revising the regulatory framework for severe accidents. The new framework will require the licensee to enhance the capabilities for prevention and mitigation of severe accidents in view of the defence in depth principle, to assess the radiological effects from the severe accidents, and to improve current accident management procedures and guidelines necessary for the prevention and mitigation of severe accidents. This rulemaking also considers the safety principles provided by the IAEA Vienna Declaration in 2015, which require new NPPs to prevent large radioactive releases. (author)

  3. Context analysis for a new regulatory model for electric utilities in Brazil

    International Nuclear Information System (INIS)

    El Hage, Fabio S.; Rufín, Carlos

    2016-01-01

    This article examines what would have to change in the Brazilian regulatory framework in order to make utilities profit from energy efficiency and the integration of resources, instead of doing so from traditional consumption growth, as it happens at present. We argue that the Brazilian integrated electric sector resembles a common-pool resources problem, and as such it should incorporate, in addition to the centralized operation for power dispatch already in place, demand side management, behavioral strategies, and smart grids, attained through a new business and regulatory model for utilities. The paper proposes several measures to attain a more sustainable and productive electricity distribution industry: decoupling revenues from volumetric sales through a fixed maximum load fee, which would completely offset current disincentives for energy efficiency; the creation of a market for negawatts (saved megawatts) using the current Brazilian mechanism of public auctions for the acquisition of wholesale energy; and the integration of technologies, especially through the growth of unregulated products and services. Through these measures, we believe that Brazil could improve both energy security and overall sustainability of its power sector in the long run. - Highlights: • Necessary changes in the Brazilian regulatory framework towards energy efficiency. • How to incorporate demand side management, behavioral strategies, and smart grids. • Proposition of a market for negawatts at public auctions. • Measures to attain a more sustainable electricity distribution industry in Brazil.

  4. 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.

  5. U.S. Nuclear Regulatory Commission Extremely Low Probability of Rupture pilot study : xLPR framework model user's guide.

    Energy Technology Data Exchange (ETDEWEB)

    Kalinich, Donald A.; Sallaberry, Cedric M.; Mattie, Patrick D.

    2010-12-01

    For the U.S. Nuclear Regulatory Commission (NRC) Extremely Low Probability of Rupture (xLPR) pilot study, Sandia National Laboratories (SNL) was tasked to develop and evaluate a probabilistic framework using a commercial software package for Version 1.0 of the xLPR Code. Version 1.0 of the xLPR code is focused assessing the probability of rupture due to primary water stress corrosion cracking in dissimilar metal welds in pressurizer surge nozzles. Future versions of this framework will expand the capabilities to other cracking mechanisms, and other piping systems for both pressurized water reactors and boiling water reactors. The goal of the pilot study project is to plan the xLPR framework transition from Version 1.0 to Version 2.0; hence the initial Version 1.0 framework and code development will be used to define the requirements for Version 2.0. The software documented in this report has been developed and tested solely for this purpose. This framework and demonstration problem will be used to evaluate the commercial software's capabilities and applicability for use in creating the final version of the xLPR framework. This report details the design, system requirements, and the steps necessary to use the commercial-code based xLPR framework developed by SNL.

  6. 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)

  7. REACH and nanomaterials: current status

    International Nuclear Information System (INIS)

    Alessandrelli, Maria; Di Prospero Fanghella, Paola; Polci, Maria Letizia; Castelli, Stefano; Pettirossi, Flavio

    2015-01-01

    New challenges for regulators are emerging about a specific assessment and appropriate management of the potential risks of nanomaterials. In the framework of European legislation on chemicals, Regulation (EC) No. 1907/2006 REACH aims to ensure the safety of human health and the environment through the collection of information on the physico-chemical characteristics of the substances and on their profile (eco) toxicological and the identification of appropriate risk management linked to 'exposure to these substances without impeding scientific progress and the competitiveness of industry. In order to cover the current shortage of information on the safety of nanomaterials and tackle the acknowledged legal vacuum, are being a rich activities, carried out both by regulators both by stake holders, and discussions on the proposals for adapting the European regulatory framework for chemicals . The European Commission is geared to strengthen the REACH Regulation by means of updates of its annexes. The importance of responding to the regulatory requirements has highlighted the need for cooperation between European organizations, scientists and industries to promote and ensure the safe use of nanomaterials. [it

  8. 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

  9. Regulatory experience in nuclear power station decommissioning

    International Nuclear Information System (INIS)

    Ross, W.M.; Waters, R.E.; Taylor, F.E.; Burrows, P.I.

    1995-01-01

    In the UK, decommissioning on a licensed nuclear site is regulated and controlled by HM Nuclear Installations Inspectorate on behalf of the Health and Safety Executive. The same legislative framework used for operating nuclear power stations is also applied to decommissioning activities and provides a continuous but flexible safety regime until there is no danger from ionising radiations. The regulatory strategy is discussed, taking into account Government policy and international guidance for decommissioning and the implications of the recent white paper reviewing radioactive waste management policy. Although each site is treated on a case by case basis as regulatory experience is gained from decommissioning commercial nuclear power stations in the UK, generic issues have been identified and current regulatory thinking on them is indicated. Overall it is concluded that decommissioning is an evolving process where dismantling and waste disposal should be carried out as soon as reasonably practicable. Waste stored on site should, where it is practical and cost effective, be in a state of passive safety. (Author)

  10. Advancing the Adverse Outcome Pathway Framework - an ...

    Science.gov (United States)

    The ability of scientists to conduct whole organism toxicity tests to understand chemical safety has been significantly outpaced by the rapid synthesis of new chemicals. Therefore, to increase efficiencies in chemical risk assessment, scientists are turning to mechanistic-based studies, making greater use of in vitro and in silico methods, to screen for potential environmental and human health hazards. A framework that has gained traction for capturing available knowledge describing the linkage between mechanistic data and apical toxicity endpoints, required for regulatory assessments, is the adverse outcome pathway (AOP). A number of international activities have focused on AOP development and plausible applications to regulatory decision-making. These interactions have prompted dialog between research scientists and regulatory communities to consider how best to use the AOP framework in risk assessment. While expert-facilitated discussions have been instrumental in moving the science of AOPs forward, it was recognized that a survey of the broader scientific community would aid in identifying shortcomings and guiding future initiatives for the AOP framework. To that end, a ?‘Horizon Scanning’ exercise was conducted to solicit questions from the global scientific and regulatory communities concerning the challenges or limitations that must be addressed to realize the full potential of the AOP framework in research and regulatory decision making. The m

  11. Policy and regulatory framework conditions for small hydro power in Sub-Saharan Africa

    Energy Technology Data Exchange (ETDEWEB)

    Koelling, Fritz [Sustainable Energy and Environment, Karlsruhe (Germany); Gaul, Mirco; Schroeder, Miriam [SiNERGi Consultancy for Renewable Energies, Berlin (Germany)

    2011-07-01

    The vast potential of mini and micro hydro power (MHP) in Sub-Saharan African countries is one promising option to cover increasing energy demand and to enable electricity access for remote rural communities. Based on the analysis of 6 African countries (Ethiopia, Kenya, Mozambique, Nigeria, Rwanda, South Africa), this study sheds light on some of the main barriers on the level of political and regulatory framework conditions which include gap between the national-level policies and regulations and local MHP project implementation, lack of financing and limited capacities for project planning, building and operation. The paper also identifies some promising practices employed in several SSA countries of how to overcome these barriers and concludes with recommendations of how to create positive feed-backs between ambitious policies and regulations and MHP financing and capacity development needs in order to scale up MHP deployment and MHP sector development. (orig.)

  12. m-government legal and regulatory framework

    African Journals Online (AJOL)

    Wondwossen Mulugeta

    Legal Framework for Implementation of m-Government in Ethiopia: Best. Practices and Lessons ... opportunity to government and businesses to provide enhanced mobile .... provide effective governance, offer increased service delivery and ...

  13. 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.

  14. 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

  15. Air Emissions Damages from Municipal Drinking Water Treatment Under Current and Proposed Regulatory Standards.

    Science.gov (United States)

    Gingerich, Daniel B; Mauter, Meagan S

    2017-09-19

    Water treatment processes present intersectoral and cross-media risk trade-offs that are not presently considered in Safe Drinking Water Act regulatory analyses. This paper develops a method for assessing the air emission implications of common municipal water treatment processes used to comply with recently promulgated and proposed regulatory standards, including concentration limits for, lead and copper, disinfection byproducts, chromium(VI), strontium, and PFOA/PFOS. Life-cycle models of electricity and chemical consumption for individual drinking water unit processes are used to estimate embedded NO x , SO 2 , PM 2.5 , and CO 2 emissions on a cubic meter basis. We estimate air emission damages from currently installed treatment processes at U.S. drinking water facilities to be on the order of $500 million USD annually. Fully complying with six promulgated and proposed rules would increase baseline air emission damages by approximately 50%, with three-quarters of these damages originating from chemical manufacturing. Despite the magnitude of these air emission damages, the net benefit of currently implemented rules remains positive. For some proposed rules, however, the promise of net benefits remains contingent on technology choice.

  16. The regulatory control of radiation sources in Turkey

    International Nuclear Information System (INIS)

    Uslu, I.; Birol, E.

    2001-01-01

    In Turkey, the national competent authority for regulating activities involving radioactive sources is the Turkish Atomic Energy Authority, which implements the responsibility for the safety and security of radiation sources through its Radiation Health and Safety Department. The report describes the organization of the regulatory infrastructure for radiation safety in Turkey and, after a brief explanation of the current legal framework for such purpose, it refers to how the management of radiation sources is carried out and to the new provisions regarding radiation sources, including inspections of licensees and training on source safety. Finally, the report provides information on the Ikitelli radiological accident in Turkey and the current public concern about radiation sources after it happened. (author)

  17. Understanding how to maintain compliance in the current regulatory climate

    International Nuclear Information System (INIS)

    Bignell, D.T.; Burns, R.

    1995-01-01

    High level radioactive waste facilities must maintain compliance with all regulatory requirements, even those requirements that have been promulgated after the facility was placed into operation. Facilities must aggressively pursue compliance because environmental laws often impose strict liability for violations; therefore, an honest mistake is no defense. Radioactive waste management is constantly under the public microscope, particularly those facilities that handle high-level radioactive waste. The Savannah River Site has effectively met the challenges of regulatory compliance in its HLRW facilities and plans are being formulated to meet future regulatory requirements as well. Understanding, aggressively achieving, and clearly demonstrating compliance is essential for the continued operations of radioactive waste management facilities. This paper examines how HLRW facilities are impacted by regulatory requirements and how compliance in this difficult area is achieved and maintained

  18. 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)

  19. Regulatory Framework for Salt Waste Disposal and Tank Closure at the Savannah River Site - 13663

    Energy Technology Data Exchange (ETDEWEB)

    Thomas, Steve; Dickert, Ginger [Savannah River Remediation LLC, Savannah River Site, Aiken, SC 29808 (United States)

    2013-07-01

    The end of the Cold War has left a legacy of approximately 37 million gallons of radioactive waste in the aging waste tanks at the Department of Energy's Savannah River Site (SRS). A robust program is in place to remove waste from these tanks, treat the waste to separate into a relatively small volume of high-level waste and a large volume of low-level waste, and to actively dispose of the low-level waste on-site and close the waste tanks and associated ancillary structures. To support performance-based, risk-informed decision making and to ensure compliance with all regulatory requirements, the U.S. Department of Energy (DOE) and its current and past contractors have worked closely with the South Carolina Department of Health and Environmental Control (SCDHEC), the U.S. Environmental Protection Agency (EPA) and the Nuclear Regulatory Commission (NRC) to develop and implement a framework for on-site low-level waste disposal and closure of the SRS waste tanks. The Atomic Energy Act of 1954, as amended, provides DOE the authority to manage defense-related radioactive waste. DOE Order 435.1 and its associated manual and guidance documents detail this radioactive waste management process. The DOE also has a requirement to consult with the NRC in determining that waste that formerly was classified as high-level waste can be safely managed as either low-level waste or transuranic waste. Once DOE makes a determination, NRC then has a responsibility to monitor DOE's actions in coordination with SCDHEC to ensure compliance with the Title 10 Code of Federal Regulations Part 61 (10CFR61), Subpart C performance objectives. The management of hazardous waste substances or components at SRS is regulated by SCDHEC and the EPA. The foundation for the interactions between DOE, SCDHEC and EPA is the SRS Federal Facility Agreement (FFA). Managing this array of requirements and successfully interacting with regulators, consultants and stakeholders is a challenging task but

  20. 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.

  1. IAEA Mission Says Chile Committed to Enhancing Safety, Sees Regulatory Challenges

    International Nuclear Information System (INIS)

    2018-01-01

    An International Atomic Energy Agency (IAEA) team of experts said Chile is committed to strengthening its regulatory framework for nuclear and radiation safety. To help achieve this aim, the team said the country should address challenges in some areas, including the need to ensure effective independence in regulatory decision-making. The Integrated Regulatory Review Service (IRRS) team today concluded a 12-day mission to assess the regulatory safety framework in Chile. The mission was conducted at the request of the Government and hosted by the Chilean Nuclear Energy Commission (CCHEN), which is responsible for regulatory supervision together with the Ministry of Health (MINSAL). The review mission covered all civilian nuclear and radiation source facilities and activities regulated in Chile.

  2. A decision making framework for risk-informed technical specifications

    International Nuclear Information System (INIS)

    Kim, B. S.; Kim, I. S.; Seo, M. S.; Sung, G. Y.

    2001-01-01

    The RITS literature survey on regulatory requirements and current TS research status in Korea as well as in foreign countries has been performed. Based on this survey, the RITS decision-making framework for the licensee and regulator point-of-view, respectively, is introduced in this paper. The required documents for the licensee to prepare are suggested in a systematic approach; the decision-making process of regulators for evaluating the documents is recommended

  3. Regulatory guidelines for biosimilars in Malaysia.

    Science.gov (United States)

    Abas, Arpah

    2011-09-01

    The biosimilars sector continues to attract huge interest and controversy. Biosimilars are new biopharmaceuticals that are "similar" but not identical to the innovator product. Characteristics of biopharmaceuticals are closely related to the manufacturing process, which implies that the products cannot be exactly duplicated. Minuscule differences in the product's structure and manufacturing process can result in different clinical outcome. This raises concerns over the safety, efficacy and even pharmacovigilance of biosimilars. Thus, biosimilars are unique - they are not a true chemical generic and are regulated via a distinct regulatory framework. This report discusses the features of Malaysian regulatory oversight of biosimilars and experience acquired in the evaluation of some products from various countries. Ensuring regulatory position adequately reflects scientific advancement, expertise/resources is key. The regulatory situation is an evolving process. Various guidance documents are being prepared with the aim of developing a uniform global framework towards assuring the dual goal of lower costs and patient safety while expediting the availability of important biosimilar products. Copyright © 2011. Published by Elsevier Ltd.

  4. Impact of regulatory science on global public health

    Directory of Open Access Journals (Sweden)

    Meghal Patel

    2012-07-01

    Full Text Available Regulatory science plays a vital role in protecting and promoting global public health by providing the scientific basis for ensuring that food and medical products are safe, properly labeled, and effective. Regulatory science research was first developed for the determination of product safety in the early part of the 20th Century, and continues to support innovation of the processes needed for regulatory policy decisions. Historically, public health laws and regulations were enacted following public health tragedies, and often the research tools and techniques required to execute these laws lagged behind the public health needs. Throughout history, similar public health problems relating to food and pharmaceutical products have occurred in countries around the world, and have usually led to the development of equivalent solutions. For example, most countries require a demonstration of pharmaceutical safety and efficacy prior to marketing these products using approaches that are similar to those initiated in the United States. The globalization of food and medical products has created a shift in regulatory compliance such that gaps in food and medical product safety can generate international problems. Improvements in regulatory research can advance the regulatory paradigm toward a more preventative, proactive framework. These improvements will advance at a greater pace with international collaboration by providing additional resources and new perspectives for approaching and anticipating public health problems. The following is a review of how past public health disasters have shaped the current regulatory landscape, and where innovation can facilitate the shift from reactive policies to proactive policies.

  5. Impact of regulatory science on global public health.

    Science.gov (United States)

    Patel, Meghal; Miller, Margaret Ann

    2012-07-01

    Regulatory science plays a vital role in protecting and promoting global public health by providing the scientific basis for ensuring that food and medical products are safe, properly labeled, and effective. Regulatory science research was first developed for the determination of product safety in the early part of the 20th Century, and continues to support innovation of the processes needed for regulatory policy decisions. Historically, public health laws and regulations were enacted following public health tragedies, and often the research tools and techniques required to execute these laws lagged behind the public health needs. Throughout history, similar public health problems relating to food and pharmaceutical products have occurred in countries around the world, and have usually led to the development of equivalent solutions. For example, most countries require a demonstration of pharmaceutical safety and efficacy prior to marketing these products using approaches that are similar to those initiated in the United States. The globalization of food and medical products has created a shift in regulatory compliance such that gaps in food and medical product safety can generate international problems. Improvements in regulatory research can advance the regulatory paradigm toward a more preventative, proactive framework. These improvements will advance at a greater pace with international collaboration by providing additional resources and new perspectives for approaching and anticipating public health problems. The following is a review of how past public health disasters have shaped the current regulatory landscape, and where innovation can facilitate the shift from reactive policies to proactive policies. Copyright © 2012. Published by Elsevier B.V.

  6. 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)

  7. Methodology for the Systematic Assessment of the Regulatory Competence Needs (SARCoN) for Regulatory Bodies of Nuclear Installations

    International Nuclear Information System (INIS)

    2015-03-01

    A regulatory body’s competence is dependent, among other things, on the competence of its staff. A necessary, but not sufficient, condition for a regulatory body to be competent is that its staff can perform the tasks related to the functions of the regulatory body. In 2001, the IAEA published TECDOC 1254, Training the Staff of the Regulatory Body for Nuclear Facilities: A Competency Framework, which examines the manner in which the recognized regulatory functions of a nuclear regulatory body results in competence needs. Using the internationally recognized systematic approach to training, TECDOC 1254 provides a framework for regulatory bodies for managing training and developing, and maintaining the competence of its staff. It has been successfully used by many regulatory bodies all over the world, including States embarking on a nuclear power programme. The IAEA has also introduced a methodology and an assessment tool — Guidelines for Systematic Assessment of Regulatory Competence Needs (SARCoN) — which provides practical guidance on analysing the training and development needs of a regulatory body and, through a gap analysis, guidance on establishing competence needs and how to meet them. In 2013, the IAEA published Safety Reports Series No. 79, Managing Regulatory Body Competence, which provides generic guidance based on IAEA safety requirements in the development of a competence management system within a regulatory body’s integrated management system. An appendix in the Safety Report deals with the special case of building up the competence of regulatory bodies as part of the overall process of establishing an embarking State’s regulatory system. This publication provides guidance for the analysis of required and existing competences to identify those required by the regulatory body to perform its functions and therefore associated needs for acquiring competences. Hence, it is equally applicable to the needs of States embarking on nuclear power

  8. The value of a mature, stable, and transparent regulatory framework in facilitating ER programs lessons learned in decommissioning of uranium recovery and other facilities in the USA - 59411

    International Nuclear Information System (INIS)

    McConnell, Keith I.; Camper, Larry

    2012-01-01

    Document available in abstract form only. Full text of publication follows: The history of decommissioning activities in the United States has demonstrated the value of a mature, stable and transparent regulatory framework in facilitating the timely completion of environmental remediation. Two examples are given as case studies. The first example relates to the history of uranium concentrate (yellowcake) production in the U.S. to support the initial development of civilian nuclear power in the U.S. in the 1950's, 60's, 70's and 80's. This yellowcake production, which took place mostly in the western U.S., was undertaken before laws and regulations to prevent contamination and protect public health and safety were fully developed. Significant contamination occurred in terms of both surface and ground water contamination. Although most conventional mills producing uranium during these early years entered decommissioning in the 70's and 80's, the vast majority are still remediating their sites because of persistent contamination in ground water. Had an effective regulatory framework been in place, much of this contamination would have been prevented and remediation accomplished more effectively. In contrast to this experience, a second example is provided related to development of the regulatory framework for decommissioning of non-uranium recovery facilities in the U.S. in the late 1990's and early 2000's

  9. Ethanol: the importance of the new regulatory framework for the sugar-alcohol market in Brazil; Etanol: a importancia do novo marco regulatorio para o mercado sucroalcooleiro do Brasil

    Energy Technology Data Exchange (ETDEWEB)

    Batista, Jessica de Araujo; Alves, Rayana Lins [Agencia Nacional do Petroleo, Gas Natural e Biocombustiveis (ANP), Rio de Janeiro, RJ (Brazil). Programa de Recursos Humanos em Direito do Petroleo, Gas Natural e Biocombustiveis

    2010-07-01

    The present work intends to make an analysis concerning the panorama which it inserts the regulation of the industry of ethanol in Brazil, in detaining in the problematic that it is detached in the economic scene and present politics: the necessity of a new regulatory framework that could adapt on necessities and requirements of the sugarcane industry of Brazil. In the present time, the absence of regulation makes that the sugarcane sector is regulated by some actors, who act of determinant and diffuse form, in the creation of public politics that deal with ethanol fuel. Thus, with the divergence of interests and the absence of consensus, occurs an impediment to energy development of ethanol. In this work, it was used doctrinal research regarding the sugarcane sector, with the intention to analyze it historically, since the previous period the Constitution of 1988 until the energy planning 2030. It is had as resulted the necessity of the creation of a new regulatory framework for the sugarcane sector, which must contain clauses to develop the paper of the ANP in the sector; to diminish the technological specifications; to increase the advantages taxes etc. In this way, it was reached the conclusion that it is not any creation of regulatory framework that will go to benefit the development of the sector, but a legislation resultant of discussions concerning the present sugarcane industry. (author)

  10. Incident reporting to BfArM - regulatory framework, results and challenges.

    Science.gov (United States)

    Seidel, Robin; Stößlein, Ekkehard; Lauer, Wolfgang

    2016-04-01

    Medical devices are manifold and one of the most innovative fields of technology. As technologies advance, former limits cease to exist and complex devices become reality. Medical devices represent a very dynamic field with high economic relevance. The manufacturer of a medical device is obliged to minimize product-related risks as well as to demonstrate compliance with the so-called "essential requirements" regarding safety and performance before placing the device on the market. Any critical incident in relation to the application of a medical device has to be reported to the competent authority for risk assessment, which in Germany is either the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI) depending on the type of device. In this article, the German regulatory framework for medical devices and the resulting tasks for BfArM are described as well as the topics of its recently installed research and development group on prospective risk identification and application safety for medical devices. Results of failure mode and root cause analyses of incident data are presented as well as further data on cases with the result "root-cause analysis not possible". Finally an outlook is given on future challenges regarding risk assessment for medical devices.

  11. Current standardisation for nanotechnology

    International Nuclear Information System (INIS)

    Bard, Delphine; Mark, David; Moehlmann, Carsten

    2009-01-01

    Standardisation and standards provide an important mechanism to support both innovation and the application of regulations. There is currently no specific regulation for any nanomaterials. Health, safety and environmental protection aspects associated with nanomaterials are however in principle covered to different levels by current EU regulatory framework. There are a number of national, European and international organisations developing standards associated with the development, description and use of nanomaterials as well as the protection of human health and the environment from the production and use of chemicals and consumer products, including nanomaterials. These organisations have also established specific committees on nanotechnology. This paper outlines the different relevant regulations and standards. This paper will mainly be focused on a European health and safety perspective.

  12. South African Regulatory Framework for Nuclear Power Plant Life Management

    International Nuclear Information System (INIS)

    Mbebe, B.Z.

    2012-01-01

    The paper presents the regulatory approach to plant life management (PLiM) adopted by the National Nuclear Regulator (NNR) in South Africa, the licensing basis and regulatory requirements for Koeberg Nuclear Power Station (KNPS),operational programmes ensuring continued safe operation, issues related to the ageing of the plant, and the requirements for spent fuel as well as radioactive waste management. The paper will further present insights from the Periodic Safety Review (PSR) and Long Term Asset Management. (author)

  13. Improving regulatory oversight of maintenance programs

    International Nuclear Information System (INIS)

    Cook, S.

    2008-01-01

    Safe nuclear power plant operation requires that risks due to failure or unavailability of Structures, Systems and Components (SSCs) be minimized. Implementation of an effective maintenance program is a key means for achieving this goal. In its regulatory framework, the important relationship between maintenance and safety is acknowledged by the CNSC. A high level maintenance program requirement is included in the Class I Facilities Regulations. In addition, the operating licence contains a condition based on the principle that the design function and performance of SSCs needs to remain consistent with the plant's design and analysis documents. Nuclear power plant licensees have the primary responsibility for safe operation of their facilities and consequently for implementation of a successful maintenance program. The oversight role of the Canadian Nuclear Safety Commission (CNSC) is to ensure that the licensee carries out that responsibility. The challenge for the CNSC is how to do this consistently and efficiently. Three opportunities for improvement to regulatory maintenance oversight are being pursued. These are related to the regulatory framework, compliance verification inspection activities and monitoring of self-reporting. The regulatory framework has been improved by clarifying expectations through the issuance of S-210 'Maintenance Programs for Nuclear Power Plants'. Inspection activities have been improved by introducing new maintenance inspections into the baseline program. Monitoring is being improved by making better use of self-reported and industry produced maintenance related performance indicators. As with any type of program change, the challenge is to ensure the consistent and optimal application of regulatory activities and resources. This paper is a summary of the CNSC's approach to improving its maintenance oversight strategy. (author)

  14. ROMANIAN AERONAUTICAL METEOROLOGY APPLICABLE LEGAL FRAMEWORK –BRIEFING

    Directory of Open Access Journals (Sweden)

    CATALIN POPA

    2012-05-01

    Full Text Available The purpose of this briefing is toprovide an overview of the aeronautical meteorology legal framework in Romania. In this context, the role and importance of aeronautical meteorology in international air traffic management will be underlined, with focus on the civil aviation activity in Romania. The international legal framework and modalities of implementing these rules at national level will constitute a significant part of the present study., Specific accent will be put on the national regulatory framework and structure, means of updating it, and how it responds to changing regulatory requirements.

  15. Minimising the harm from nicotine use: finding the right regulatory framework.

    Science.gov (United States)

    Borland, Ron

    2013-05-01

    The tobacco problem can be usefully conceptualised as two problems: eliminating the most harmful forms of nicotine use (certainly cigarettes, and probably all smoked tobacco), and minimising the use and/or harms from use of lower-harm, but addictive forms of nicotine. A possible target would be to effectively eliminate use of the most harmful forms of nicotine within the next decade and then turn our focus to a long-term strategy for the low-harm forms. This paper focuses on the administrative framework(s) needed to accomplish these twin tasks. For a phase-out taking a long time and/or for dealing with residually net harmful and addictive products, there are severe limitations to allowing for-profit marketing of tobacco because such an arrangement (the current one in most countries) can markedly slow down progress and because of the difficulty of constraining marketing in ways that minimise undesirable use. A harm reduction model where the marketing is under the control of a non-profit entity (a regulated market) is required to curtail the incredible power of for-profit marketing and to allow tobacco marketing to be done in ways that further the goal of minimising tobacco-related harm. Countries with a nationalised industry can move their industry onto a harm minimisation framework if they have the political will. Countries with a for-profit industry should consider whether the time and effort required to reconstruct the market may, in the longer term, facilitate achieving their policy goals.

  16. Defect Detection and Segmentation Framework for Remote Field Eddy Current Sensor Data

    Directory of Open Access Journals (Sweden)

    Raphael Falque

    2017-10-01

    Full Text Available Remote-Field Eddy-Current (RFEC technology is often used as a Non-Destructive Evaluation (NDE method to prevent water pipe failures. By analyzing the RFEC data, it is possible to quantify the corrosion present in pipes. Quantifying the corrosion involves detecting defects and extracting their depth and shape. For large sections of pipelines, this can be extremely time-consuming if performed manually. Automated approaches are therefore well motivated. In this article, we propose an automated framework to locate and segment defects in individual pipe segments, starting from raw RFEC measurements taken over large pipelines. The framework relies on a novel feature to robustly detect these defects and a segmentation algorithm applied to the deconvolved RFEC signal. The framework is evaluated using both simulated and real datasets, demonstrating its ability to efficiently segment the shape of corrosion defects.

  17. Toward the framework and implementation for clearance of materials from regulated facilities.

    Science.gov (United States)

    Chen, S Y; Moeller, D W; Dornsife, W P; Meyer, H R; Lamastra, A; Lubenau, J O; Strom, D J; Yusko, J G

    2005-08-01

    The disposition of solid materials from nuclear facilities has been a subject of public debate for several decades. The primary concern has been the potential health effects resulting from exposure to residual radioactive materials to be released for unrestricted use. These debates have intensified in the last decade as many regulated facilities are seeking viable management decisions on the disposition of the large amounts of materials potentially containing very low levels of residual radioactivity. Such facilities include the nuclear weapons complex sites managed by the U.S. Department of Energy, commercial power plants licensed by the U.S. Nuclear Regulatory Commission (NRC), and other materials licensees regulated by the NRC or the Agreement States. Other facilities that generate radioactive material containing naturally occurring radioactive materials (NORM) or technologically enhanced NORM (TENORM) are also seeking to dispose of similar materials that may be radioactively contaminated. In contrast to the facilities operated by the DOE and the nuclear power plants licensed by the U.S. Nuclear Regulatory Commission, NORM and TENORM facilities are regulated by the individual states. Current federal laws and regulations do not specify criteria for releasing these materials that may contain residual radioactivity of either man-made or natural origin from regulatory controls. In fact, the current regulatory scheme offers no explicit provision to permit materials being released as "non-radioactive," including those that are essentially free of contamination. The only method used to date with limited success has been case-by-case evaluation and approval. In addition, there is a poorly defined and inconsistent regulatory framework for regulating NORM and TENORM. Some years ago, the International Atomic Energy Agency introduced the concept of clearance, that is, controlling releases of any such materials within the regulatory domain. This paper aims to clarify

  18. Nanomaterials in Food - Current and Future Applications and Regulatory Aspects

    Science.gov (United States)

    Aschberger, K.; Gottardo, S.; Amenta, V.; Arena, M.; Botelho Moniz, F.; Bouwmeester, H.; Brandhoff, P.; Mech, A.; Quiros Pesudo, L.; Rauscher, H.; Schoonjans, R.; Vittoria Vettori, M.; Peters, R.

    2015-05-01

    Nanotechnology can contribute to the development of innovative applications in the agriculture, food and feed sector by e.g. enabling improved delivery of nutrients or increased efficacy of agrichemicals. It is expected that applications will increase in the near future and may therefore become a relevant source of human exposure to nanomaterials (NM). To gain more up-to date information, RIKILT and the Joint Research Centre (JRC) were commissioned by the European Food Safety Authority (EFSA) to prepare an inventory of currently used and reasonably foreseen applications of NM in agriculture and food/feed production and carried out a review of regulatory aspects concerning NM in both EU and non-EU countries. An analysis of the information records in the inventory shows that nano-encapsulates, silver and titanium dioxide are the most frequent type of NM listed and that food additives and food contact materials are the most frequent types of application. A comparison between marketed applications and those in development indicates a trend from inorganic materials (e.g. silver) towards organic materials (nano-encapsulates, nanocomposites). Applications in novel food, feed additives, biocides and pesticides are currently mostly at a developmental stage. The review of EU and non-EU legislation shows that currently a few EU legal acts incorporate a definition of a nanomaterial and specific provisions for NM, whereas in many non-EU countries a broader approach is applied, which mainly builds on guidance for industry.

  19. Nanomaterials in Food - Current and Future Applications and Regulatory Aspects

    International Nuclear Information System (INIS)

    Aschberger, K; Gottardo, S; Amenta, V; Arena, M; Moniz, F Botelho; Mech, A; Pesudo, L Quiros; Rauscher, H; Bouwmeester, H; Brandhoff, P; Peters, R; Schoonjans, R; Vettori, M Vittoria

    2015-01-01

    Nanotechnology can contribute to the development of innovative applications in the agriculture, food and feed sector by e.g. enabling improved delivery of nutrients or increased efficacy of agrichemicals. It is expected that applications will increase in the near future and may therefore become a relevant source of human exposure to nanomaterials (NM). To gain more up-to date information, RIKILT and the Joint Research Centre (JRC) were commissioned by the European Food Safety Authority (EFSA) to prepare an inventory of currently used and reasonably foreseen applications of NM in agriculture and food/feed production and carried out a review of regulatory aspects concerning NM in both EU and non-EU countries. An analysis of the information records in the inventory shows that nano-encapsulates, silver and titanium dioxide are the most frequent type of NM listed and that food additives and food contact materials are the most frequent types of application. A comparison between marketed applications and those in development indicates a trend from inorganic materials (e.g. silver) towards organic materials (nano-encapsulates, nanocomposites). Applications in novel food, feed additives, biocides and pesticides are currently mostly at a developmental stage. The review of EU and non-EU legislation shows that currently a few EU legal acts incorporate a definition of a nanomaterial and specific provisions for NM, whereas in many non-EU countries a broader approach is applied, which mainly builds on guidance for industry. (paper)

  20. RAF/9/049: Enhancing and Sustaining the National Regulatory Bodies for safety

    International Nuclear Information System (INIS)

    Keter, C.J.

    2017-01-01

    The main objective of this project is to enhance regulatory infrastructure, sustainability and cooperation among national regulatory bodies. This will support strengthening of the existing regulatory framework and capacity building in the region. Self-Assessment using the Self-Assessment Regulatory Infrastructure for Safety (SARIS) was completed on 26th May 2016. Changes made to the legislation is ongoing. The Nuclear Regulatory Bill 2017 is at an advanced stage and about to be tabled to Cabinet. The project objectives shall be addressed under a new project, RAF/9/058 – Improving the Regulatory Framework for the Control of Radiation Sources in Member States. Two major tasks for Kenya to focus include Review of regulations on waste safety, radiation sources and on safety of NPP and advising on drafting of radiation safety guides

  1. [Fundamentally new electromagnetic pollution and the lack of adequate regulatory framework--on the risk assessment (analysis of modern domestic and foreign data)].

    Science.gov (United States)

    Grigorev, Yu G

    2014-01-01

    On the base of the study of the numerous experimental and epidemiological studies electromagnetic radiation (EMR) of mobile communications were found to adversely affect on the health of the population. Analysis of the influence of radio frequency (RF) radiation from mobile phones (MPs) on the brain of users showed that this organ body is most exposed to this radiation, especially in children. As a result of the performed research there were recorded functional changes in children--MPs users: undue fatiguability (39.7%), decreased performance in the school and at home (50.7%), weakening of the stability of voluntary attention (productivity--14.3%, accuracy 19.4%) and semantic memory (accuracy--19.4% increase in the time--30.1%). In addition, a marked change in the rate of auditory- motor response (55.5%), and disturbances of phonemic perception have been noted. The existing legal framework on the influence of EMR on human health was shown not fully to meet the hygiene requirements in connection with the absence of her normative parameters which determine the impact of complicately modulated radiation from MPs and base stations. The need for additional research on the influence of the modulated RF EMR on the human body and creation of a regulatory framework taking into account the sum of biological effects, especially on the critical organ of human--brain is substantiated by the author. When creating a regulatory framework it must be taken into account the scientific beliefs on the possible development of long-term brain pathologies under the combined effect of EMF, especially in children.

  2. A Current Logical Framework: The Propositional Fragment

    National Research Council Canada - National Science Library

    Watkins, Kevin

    2003-01-01

    We present the propositional fragment CLF of the Concurrent Logical Framework (CLF). CLF extends the Linear Logical Framework to allow the natural representation of concurrent computations in an object language...

  3. [Regulatory Program for Medical Devices in Cuba: experiences and current challenges].

    Science.gov (United States)

    Pereira, Dulce María Martínez; Rodríguez, Yadira Álvarez; Valdés, Yamila Cedeño; Ribas, Silvia Delgado

    2016-05-01

    Regulatory control of medical devices in Cuba is conducted through a system based on the Regulatory Program for Medical Devices as a way to ensure the safety, efficacy, and effectiveness of these technologies, which are in use by the National Health System. This program was launched in 1992, when the Regulations for State Evaluation and Registration of Medical Devices were approved. Its successive stages and the merging of regulatory activities for drugs and medical equipment have meant progress toward stronger, more transparent strategies and greater control of industry and the National Health System. Throughout its course the Cuban program has met with challenges and difficulties that it has addressed by drawing on its own experiences. During the new period, the greatest challenges revolve around ensuring that regulatory systems incorporate scientific evaluation, risk levels, maximum rigor through the use of technical standards, and the implementation of international recommendations, together with the application of the ISO 13485 certification scheme, enhanced market monitoring, and classification of medical devices in accordance with their relevance to the country's national health policies. From the regional standpoint, the greatest challenge lies in working toward regulatory convergence. The Collaborating Centre for the Regulation of Health Technologies will support the proposed regulatory strategy and established regional priorities, in particular in connection with the implementation of actions involving medical devices.

  4. 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)

  5. The Road to Basel III – Quantitative Impact Study, the Basel III Framework and Implementation in the EU

    OpenAIRE

    Anastasia Gromova-Schneider; Caroline Niziolek

    2011-01-01

    In response to the financial crisis, the Basel Committee on Banking Supervision (BCBS) in December 2009 published its first consultative proposals to review the Basel II regulatory framework. Following a consultation process and a quantitative impact study (QIS), on December 16, 2010, the BCBS published the final Basel III framework for tightening the globally applicable capital adequacy and liquidity rules. The implementation of the new provisions in the EU is currently under way. The Europe...

  6. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - France

    International Nuclear Information System (INIS)

    2011-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Framework: 1. General (The French nuclear power programme and its main players; French nuclear law); 2. Mining Regime; 3. Radioactive Substances and Nuclear Equipment (Regulatory diversity; Radioactive sources; Medical activities); 4. Trade in Nuclear Materials and Equipment (Basic nuclear installations - INB; Tax on basic nuclear installations, Additional taxes, Funding nuclear costs; Installations classified for environmental protection purposes (ICPE) using radioactive substances; Nuclear pressure equipment - ESPN; Defence-related nuclear installations and activities - IANID; Emergency plans); 5. Trade in Nuclear Materials and Equipment (General provisions; Patents); 6. Radiation protection (Protection of the public; Protection of workers; Radiation protection inspectors; Labour inspectors; Protection of individuals in a radiological emergency); 7. Radioactive Waste Management (General regulations; Radioactive waste regulations; Discharge of effluents); 8. Non-proliferation and physical protection (Materials not used for the nuclear deterrent; Materials used for the nuclear deterrent); 9. Transport (Licensing and notification regime: Transport of radioactive materials, Transport of nuclear materials, Transport of radioactive substances between member states of the European Union; Methods of transport: Land transport, Sea transport, Air transport, Transport by post); 10

  7. Improvements to the DOE low-level waste regulatory structure and process under recommendation 94-2 - progress to date

    International Nuclear Information System (INIS)

    Regnier, E.

    1995-01-01

    Among the concerns expressed by the Defense Nuclear Facility Safety Board (DNFSB) in its Recommendation 94-2 was the lack of a clearly defined and effective internal Department of Energy (DOE) regulatory oversight and enforcement process for ensuring that low-level radioactive waste management health, safety, and environmental requirements are met. Therefore, part of the response to the DNFSB concern is a task to clarify and strengthen the low-level waste management regulatory structure. This task is being conducted in two steps. First, consistent with the requirements of the current DOE waste management order and within the framework of the current organizational structure, interim clarification of a review process and the associated organizational responsibilities has been issued. Second, in coordination with the revision of the waste management order and consistent with the organizational responsibilities resulting from the strategic alignment of DOE, a rigorous, more independent regulatory oversight structure will be developed

  8. Improvements to the DOE low-level waste regulatory structure and process under recommendation 94-2 - progress to date

    Energy Technology Data Exchange (ETDEWEB)

    Regnier, E.

    1995-12-31

    Among the concerns expressed by the Defense Nuclear Facility Safety Board (DNFSB) in its Recommendation 94-2 was the lack of a clearly defined and effective internal Department of Energy (DOE) regulatory oversight and enforcement process for ensuring that low-level radioactive waste management health, safety, and environmental requirements are met. Therefore, part of the response to the DNFSB concern is a task to clarify and strengthen the low-level waste management regulatory structure. This task is being conducted in two steps. First, consistent with the requirements of the current DOE waste management order and within the framework of the current organizational structure, interim clarification of a review process and the associated organizational responsibilities has been issued. Second, in coordination with the revision of the waste management order and consistent with the organizational responsibilities resulting from the strategic alignment of DOE, a rigorous, more independent regulatory oversight structure will be developed.

  9. Independent regulatory agencies and rules harmonization for the electricity sector and renewables in the Mediterranean region

    International Nuclear Information System (INIS)

    Cambini, Carlo; Franzi, Donata

    2013-01-01

    The paper analyses the existing regulatory framework for the electricity and renewables sectors, and the role of regulatory agencies in Northern Africa and Middle East countries, under the promotion by the European Union. Using data collected through an original survey directed at regulators, ministry departments and energy companies of the southern Mediterranean, the study is aimed at assessing the extent of agencies' independence looking at three main dimensions of independence: regulatory instruments available to regulators and decision making autonomy; regulators' organizational autonomy; and regulators accountability. Results show that those countries having established an independent regulator have a more credible regulatory framework than those countries in which such a body does not exist. In particular, the analysis shows that Turkey, Croatia and Jordan have defined a regulatory framework that limits administrative expropriation and, consequently, creates an environment more suitable for attracting investments in the electricity and renewables sector. On the institutional ground, this is probably related with the harmonization of regulatory standards promoted by the European Union through the neighboring policy, for the Jordan case, and the membership perspective, in the Turkish and Croatian cases. - Highlights: • We analyze the existing regulatory framework in Northern Africa and Middle East countries. • We construct an original dataset through a survey directed to national regulators. • The extent of agencies' independence has been assessed in different dimensions. • These dimensions are decision making autonomy; organizational autonomy; and accountability. • Few countries have defined a regulatory framework limiting administrative expropriation

  10. Comparative study of Malaysian and Philippine regulatory infrastructures on radiation and nuclear safety with international standards

    International Nuclear Information System (INIS)

    Cayabo, Lynette B.

    2013-06-01

    This study presents the results of the critical reviews, analysis, and comparison of the regulatory infrastructures for radiation and nuclear safety of Malaysis and the Philippines usi ng the IAEA safety requirements, GSR Part 1, G overnment, Legal and Regulatory Framework for Safety'' as the main basis and in part, the GSR Part 3, R adiation Protection and Safety of Radiation Sources: International Basic Safety Standards . The scope of the comparison includes the elements of the relevant legislations, the regulatory system and processes including the core functions of the regulatory body (authorization, review and assessment, inspection and enforcement, development of regulations and guides); and the staffing and training of regulatory body. The respective availabe data of the Malaysian and Philippine regulatory infrastructures and current practices were gathered and analyzed. Recommendations to fill the gaps and strengthen the existing regulatory infrastructure of each country was given using as bases relevant IAEA safety guides. Based on the analysis made, the main findings are: the legislations of both countries do not contain al the elements of teh national policy and strategy for safety as well as those of teh framework for safety in GR Part I. Among the provision that need to be included in the legislations are: emergency planning and response; decommissioning of facilities safe management of radioactive wastes and spent fuel; competence for safety; and technical sevices. Provisions on coordination of different authorities with safety responsibilities within the regulatory framework for safety as well as liaison with advisory bodies and support organizations need to be enhanced. The Philippines needs to establish an independent regulatory body, ie. separate from organizations charged with promotion of nuclear technologies and responsible for facilitiesand activities. Graded approach on the system of notification and authorization by registration and

  11. 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)

  12. 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.

  13. 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)

  14. Current trends in nuclear material transportation

    International Nuclear Information System (INIS)

    Ravenscroft, Norman; Oshinowo, Franchone

    1997-01-01

    The business of radioactive material transportation has evolved considerably in the past 40 years. Current practices reflect extensive international experience in handling radioactive cargo within a mature and tested regulatory framework. Nevertheless, new developments continue to have an impact on how shipments of nuclear material are planned and carried out. Entities involved in the transport of radioactive materials must keep abreast of these developments and work together to find innovative solutions to ensure that safe, smooth transport activities may continue. Several recent trends in the regulatory environment and political atmosphere require attention. There are four key trends that we'll be examining today: 1) the reduction in the pool of available commercial carriers; 2) routing restrictions; 3) package validation issues; and 4) increasing political sensitivities. Careful planning and cooperative measures are necessary to alleviate problems in each of these areas. (author)

  15. Danish Technology Framework

    DEFF Research Database (Denmark)

    Bonke, Sten; Jørgensen, Tom Rydahl

    This report investigates the occurrence of foundation failures within the context of the Danish construction technology framework. The report comprises a definition/typology section on the basis of which Danish regulatory and administrative procedures in relation to foundation failures are reviewed....

  16. Regulatory reform in Turkish energy industry: An analysis

    International Nuclear Information System (INIS)

    Erdogdu, Erkan

    2007-01-01

    The Republic of Turkey has initiated an ambitious reform program in the most important segments of her energy market; which requires privatization, liberalization as well as a radical restructuring of these industries. However, there is no consensus that the measures introduced are optimal. The present article attempts, first, to evaluate the regulatory framework created by the laws of 2001 in terms of economic efficiency considerations; and second, to determine what still needs to be done to improve the current situation. The paper not only provides an analysis of these reforms but also lists some policy suggestions. The study concludes that despite relatively good legislative framework, in practice, the reforms in Turkey are far from ideal as they are mainly in the form of 'textbook reforms'; and therefore a significant amount of work still lies ahead of Turkey to set up a fully fledged energy market

  17. A Bayesian Framework That Integrates Heterogeneous Data for Inferring Gene Regulatory Networks

    Energy Technology Data Exchange (ETDEWEB)

    Santra, Tapesh, E-mail: tapesh.santra@ucd.ie [Systems Biology Ireland, University College Dublin, Dublin (Ireland)

    2014-05-20

    Reconstruction of gene regulatory networks (GRNs) from experimental data is a fundamental challenge in systems biology. A number of computational approaches have been developed to infer GRNs from mRNA expression profiles. However, expression profiles alone are proving to be insufficient for inferring GRN topologies with reasonable accuracy. Recently, it has been shown that integration of external data sources (such as gene and protein sequence information, gene ontology data, protein–protein interactions) with mRNA expression profiles may increase the reliability of the inference process. Here, I propose a new approach that incorporates transcription factor binding sites (TFBS) and physical protein interactions (PPI) among transcription factors (TFs) in a Bayesian variable selection (BVS) algorithm which can infer GRNs from mRNA expression profiles subjected to genetic perturbations. Using real experimental data, I show that the integration of TFBS and PPI data with mRNA expression profiles leads to significantly more accurate networks than those inferred from expression profiles alone. Additionally, the performance of the proposed algorithm is compared with a series of least absolute shrinkage and selection operator (LASSO) regression-based network inference methods that can also incorporate prior knowledge in the inference framework. The results of this comparison suggest that BVS can outperform LASSO regression-based method in some circumstances.

  18. A Bayesian Framework That Integrates Heterogeneous Data for Inferring Gene Regulatory Networks

    International Nuclear Information System (INIS)

    Santra, Tapesh

    2014-01-01

    Reconstruction of gene regulatory networks (GRNs) from experimental data is a fundamental challenge in systems biology. A number of computational approaches have been developed to infer GRNs from mRNA expression profiles. However, expression profiles alone are proving to be insufficient for inferring GRN topologies with reasonable accuracy. Recently, it has been shown that integration of external data sources (such as gene and protein sequence information, gene ontology data, protein–protein interactions) with mRNA expression profiles may increase the reliability of the inference process. Here, I propose a new approach that incorporates transcription factor binding sites (TFBS) and physical protein interactions (PPI) among transcription factors (TFs) in a Bayesian variable selection (BVS) algorithm which can infer GRNs from mRNA expression profiles subjected to genetic perturbations. Using real experimental data, I show that the integration of TFBS and PPI data with mRNA expression profiles leads to significantly more accurate networks than those inferred from expression profiles alone. Additionally, the performance of the proposed algorithm is compared with a series of least absolute shrinkage and selection operator (LASSO) regression-based network inference methods that can also incorporate prior knowledge in the inference framework. The results of this comparison suggest that BVS can outperform LASSO regression-based method in some circumstances.

  19. Externe verslaggeving How do current public Integrated Reports align with the IR Framework?

    NARCIS (Netherlands)

    Hurks, P.; Langendijk, H.P.A.J.; Nandram, K.

    2016-01-01

    This paper examines empirically the current practice with regard to integrated reporting according to the IR Framework among the 104 original participants (companies) of the IIRC Pilot program. We made a selection with respect to these 104 participants based on organization’s stipulation that they

  20. The regulatory infrastructure for radiation protection, the safety of radiation sources and security of radioactive materials in Ethiopia

    International Nuclear Information System (INIS)

    Gebeyehu Wolde, G.

    2003-01-01

    The application of Nuclear Techniques in Ethiopia started in the early sixties in the medical field and through time has gradually expanded to other areas. Following this growth the practice of Radiation Protection in Ethiopia dates back over 15 years. Radiation Protection Legislation 79/1993 was promulgated in December 1993, which has established an Autonomous Regulatory Authority to control and supervise the introduction and conduct of any practice involving ionizing radiation. Since 1998 the National Radiation Protection Authority has made a remarkable progress in terms of building a National Radiation Protection Infrastructure and is in a full swing transformation process towards a dynamic credible and competent regulatory Authority. The regulatory activities are designed in line with the main regulatory instruments, Notification, Authorization, Inspection and Enforcement. NRPA has a national inventory system and fully implemented the Regulatory Authority Information System (RAIS), which provides a systemic integration and will be instrumental to enhance the effectiveness of the regulatory system. A substantial progress has been made in the development and provision of support and technical services in the areas of Metrology and Calibration Services, Instrument Maintenance Service, Individual Monitoring of Personnel, Environmental and Food Monitoring and Interim Storage Facility for spent sources. Development of a national system for emergency preparedness and response is the current top agenda of NRPA. Towards ensuring an effective radiation protection and regulatory programme, NRPA is also making a proactive involvement in, expanding its outreach, information dissemination, awareness promotion and development of key human resources. In the last four years Ethiopia has been actively co-operating with IAEA in the framework of the Regional Model Projects RAF/9/024, RAF/9/028 and RAF/9/029. The inputs received through the project framework coupled with the

  1. Fit for purpose? Validation of a conceptual framework for personal recovery with current mental health consumers.

    Science.gov (United States)

    Bird, Victoria; Leamy, Mary; Tew, Jerry; Le Boutillier, Clair; Williams, Julie; Slade, Mike

    2014-07-01

    Mental health services in the UK, Australia and other Anglophone countries have moved towards supporting personal recovery as a primary orientation. To provide an empirically grounded foundation to identify and evaluate recovery-oriented interventions, we previously published a conceptual framework of personal recovery based on a systematic review and narrative synthesis of existing models. Our objective was to test the validity and relevance of this framework for people currently using mental health services. Seven focus groups were conducted with 48 current mental health consumers in three NHS trusts across England, as part of the REFOCUS Trial. Consumers were asked about the meaning and their experience of personal recovery. Deductive and inductive thematic analysis applying a constant comparison approach was used to analyse the data. The analysis aimed to explore the validity of the categories within the conceptual framework, and to highlight any areas of difference between the conceptual framework and the themes generated from new data collected from the focus groups. Both the inductive and deductive analysis broadly validated the conceptual framework, with the super-ordinate categories Connectedness, Hope and optimism, Identity, Meaning and purpose, and Empowerment (CHIME) evident in the analysis. Three areas of difference were, however, apparent in the inductive analysis. These included practical support; a greater emphasis on issues around diagnosis and medication; and scepticism surrounding recovery. This study suggests that the conceptual framework of personal recovery provides a defensible theoretical base for clinical and research purposes which is valid for use with current consumers. However, the three areas of difference further stress the individual nature of recovery and the need for an understanding of the population and context under investigation. © The Royal Australian and New Zealand College of Psychiatrists 2014.

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

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: Nuclear safety experts today concluded an eight-day mission to review Spain's nuclear regulator, the Nuclear Safety Council (CSN). At the request of the Spanish Government, the International Atomic Energy Agency assembled a peer-review team of five high-level regulatory experts from four nations and two IAEA staff members to conduct a follow-up assessment of an Integrated Regulatory Review Service (IRRS) mission conducted in 2008. This follow-up IRRS mission examined CSN's progress in acting upon the recommendations and suggestions made during the 2008 IRRS mission and reviewed the areas of significant regulatory changes since that review. Both reviews covered safety and security regulatory aspects of all facilities and activities in Spain. The first mission reviewed Spain's regulatory framework against IAEA Safety Standards and fostered the exchange of information and experience on safety regulation. The mission also included a peer review of the security activities within the regulatory framework. IRRS team leader Luis Reyes, Senior Executive of the US Nuclear Regulatory Commission, said today, 'In 2008, the mission found particular strengths in CSN's policy, its regulatory framework and its regulatory activities. We made a number of suggestions and recommendations for further improvement of the regulatory framework. CSN should be commended for the significant amount of efforts in addressing all the findings identified in 2008 mission.' The review team found that CSN has made significant progress toward improving its regulatory activities. Most of the findings identified in the 2008 report have been effectively addressed and therefore can be considered closed. Additional findings are being addressed in accordance with a comprehensive and systematic action plan, in particular efforts to revise the CSN Statute. Complementing the CSN strengths identified during the 2008 mission, the 2011 IRRS team noted the following strengths: Improvements in regulatory

  3. Self-regulation as a regulatory strategy:
    The Italian legal framework

    Directory of Open Access Journals (Sweden)

    Simona Rodriquez

    2007-12-01

    Full Text Available This article aims to provide an overview of the evolution of self-regulatory mechanisms in Italy. A brief overview of the Italian system of sources of law has showed that the model of the sources of law rooted in the Italian constitution is typically positivistic and centred on the pivotal role of Parliament, the only body empowered to legislate, either directly or by delegating its normative powers to the Government, within expressly specified limits. What room, if any, is there for self-regulatory rules? If one of the most interesting aims of the research was to analyse to what extent the self-regulatory phenomenon is compatible with Parliament’s undisputed sovereignty and with the linked principle of the rule of law, it should be clear that rules made by private actors (i.e. self-regulatory rules, which pretend to have external effects (binding erga omnes, can be considered as law and, as such, as sources of law, as long as they can be ‘incorporated’ into and recognized in some of the formal sources of Italian law. This seems the only possible and constitutionally compatible interpretation of a phenomenon (self-regulation which, instead, could potentially be able to place the formal hierarchy of sources of law in jeopardy. On the other hand, the results of the study make clear that, even when Parliament confers its normative powers on any other bodies (i.e. either independent administrative authorities or professional orders, or, more in general, any self-regulatory associations, it is unlikely that it will give up determining the limits within which those normative powers have to be exercised. Some authors actually consider this sort of ‘delegated legislation’ to be a means for the State to reassert its sovereignty. Anyway, this new pluralistic ‘architecture’ will undoubtedly allow the legislator to retain some exclusive duties: first and foremost, the power to prescribe the institutional conditions which underlie the basis of

  4. Toward the Framework and Implementation for Clearance of Materials from Regulated Facilities

    International Nuclear Information System (INIS)

    Chen, Shih-Yew; Moeller, Dade W.; Dornsife, William P.; Meyer, H Robert; Lamastra, Anthony; Lubenau, Joel O.; Strom, Daniel J.; Yusko, James G.

    2005-01-01

    The disposition of solid materials from nuclear facilities has been a subject of public debate for several decades. The primary concern has been the potential health effects resulting from exposure to residual radioactive materials to be released for unrestricted use. These debates have intensified in the last decade as many regulated facilities are seeking viable management decisions on the disposition of the large amounts of materials potentially containing very low levels of residual radioactivity. Such facilities include the nuclear weapons complex sites managed by the U.S. Department of Energy (DOE), commercial power plants licensed by the U.S. Nuclear Regulatory Commission (NRC), and other materials licensees regulated by the NRC or the Agreement States. Other facilities that generate radioactive material containing naturally occurring radioactive materials (NORM) or technologically enhanced NORM (TENORM) are also seeking to dispose of similar materials that may be radioactively contaminated. In contrast to the facilities operated by the DOE and the nuclear power plants licensed by the NRC, NORM and TENORM facilities are regulated by the individual states. Current federal laws and regulations do not specify criteria for releasing these materials that may contain residual radioactivity of either man-made or natural origin from regulatory controls. In fact, the current regulatory scheme offers no explicit provision as to permit materials being released as ''non-radioactive'', including those that are essentially free of contamination. The only method used to date with limited success has been case-by-case evaluation and approval. In addition, there is a poorly defined and inconsistent regulatory framework for regulating NORM and TENORM. Some years ago, the International Atomic Energy Agency (IAEA) introduced the concept of clearance, that is, controlling releases of any such materials within the regulatory domain. This paper aims to clarify clearance as an

  5. BARC safety framework

    International Nuclear Information System (INIS)

    Jayarajan, K.; Taly, Y.K.

    2017-01-01

    BARC has a large number facilities and a large number of employees. It has a variety of activities, carried out in different parts of India. All activities related nuclear fuel cycle are carried out in BARC. In addition, BARC has many non-nuclear facilities and projects. Therefore, regulation of BARC facilities is a challenging task. BSC was constituted in the year 2000 to address the challenges of regulating safety of the projects, plants and facilities of BARC. It has a comprehensive regulatory framework, which makes use of the expertise of more than one thousand experts of BARC for safety and regulatory activities. BSC has completed hundred meetings and issued regulatory consents to many projects, facilities and activities. During the last 17 years, BSC has constituted 44 committees in three tiers, which had conducted more than 2000 meetings to support safety and regulatory activities of BSC

  6. Seminar on Biogas in France and in Germany: Regulatory framework, potentials and challenges

    International Nuclear Information System (INIS)

    Abadie, Pierre-Marie; Boettcher, Katharina; Stolpp, Sebastian; Vincent, Eric; Chapron, Thibaut; Schuette, Andreas; Paquin, Laurent; Ingremeau, Claire; Moeller, Kurt; Trommler, Marcus; Denysenko, Velina; Bosso, Valerie

    2014-01-01

    The French-German office for Renewable energies (OFAEnR) organised a Seminar on biogas in France and Germany. In the framework of this French-German exchange of experience, about 120 participants exchanged views on the legal framework, the characteristics of this industry, and the opportunities and technical challenges of biogas use in both countries. Differences and similarities were noticed in both countries, for instance regarding the use of energy cultures and digestates. This document brings together the available presentations (slides) made during this event: 1 - The French biogas in the perspective of 2020 (Pierre-Marie Abadie); 2 - Biogas Opportunities in Germany - Status January 2014 (Katharina Boettcher); 3 - Biogas market in Germany (Sebastian Stolpp); 4 - Biogas in France and Germany, Current status and development outlooks in France (Eric Vincent); 5 - Biogas use in France and Germany - a comparison (Thibaut Chapron); 6 - Alternatives to the use of maize in biogas plants - Current research results from Germany (Andreas Schuette); 7 - Inter-crops in France: analysis of the potentials (Laurent Paquin); 8 - Digestates management in France, legislative and technical advances (Claire Ingremeau); 9 - The management of digestates in Germany: Fertilizer application and status of the art (Kurt Moeller); 10 - Status quo of Biomethane in Germany - Development, Technology and Costs (Marcus Trommler); 11 - GrDF's views and actions on biogas. Biomethane injection in France: state-of-the-art and first status (Valerie Bosso)

  7. 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.

  8. Integrating process safety with molecular modeling-based risk assessment of chemicals within the REACH regulatory framework: benefits and future challenges.

    Science.gov (United States)

    Lewis, Amanda; Kazantzis, Nikolaos; Fishtik, Ilie; Wilcox, Jennifer

    2007-04-11

    Registration, evaluation and authorization of chemicals (REACH) represents a recent regulatory initiative by the European union commission to protect human health and the environment from potentially hazardous chemicals. Under REACH, all stakeholders must submit (thermo)physical, thermochemical, and toxicological data for certain chemicals. The commission's impact assessment studies estimate that the costs of REACH will be approximately 3-5 billion Euros. The present study advocates the systematic incorporation of computational chemistry and computer-assisted chemical risk assessment methods into REACH to reduce regulatory compliance costs. Currently powerful computer-aided ab initio techniques can be used to generate predictions of key properties of broad classes of chemicals, without resorting to costly experimentation and potentially hazardous testing. These data could be integrated into a centralized IT decision and compliance support system, and stored in a retrievable, easily communicable manner should new regulatory and/or production requirements necessitate the introduction of different uses of chemicals under different conditions. For illustration purposes, ab initio calculations are performed on heterocyclic nitrogen-containing compounds which currently serve as high energy density materials in the chemical industry. Since investigations of these compounds are still in their infancy, stability studies are imperative regarding their safe handling and storage, as well as registration under REACH.

  9. Integrating process safety with molecular modeling-based risk assessment of chemicals within the REACH regulatory framework: Benefits and future challenges

    International Nuclear Information System (INIS)

    Lewis, Amanda; Kazantzis, Nikolaos; Fishtik, Ilie; Wilcox, Jennifer

    2007-01-01

    Registration, evaluation and authorization of chemicals (REACH) represents a recent regulatory initiative by the European union commission to protect human health and the environment from potentially hazardous chemicals. Under REACH, all stakeholders must submit (thermo)physical, thermochemical, and toxicological data for certain chemicals. The commission's impact assessment studies estimate that the costs of REACH will be approximately 3-5 billion Euros. The present study advocates the systematic incorporation of computational chemistry and computer-assisted chemical risk assessment methods into REACH to reduce regulatory compliance costs. Currently powerful computer-aided ab initio techniques can be used to generate predictions of key properties of broad classes of chemicals, without resorting to costly experimentation and potentially hazardous testing. These data could be integrated into a centralized IT decision and compliance support system, and stored in a retrievable, easily communicable manner should new regulatory and/or production requirements necessitate the introduction of different uses of chemicals under different conditions. For illustration purposes, ab initio calculations are performed on heterocyclic nitrogen-containing compounds which currently serve as high energy density materials in the chemical industry. Since investigations of these compounds are still in their infancy, stability studies are imperative regarding their safe handling and storage, as well as registration under REACH

  10. Impact of the Serbian Banking Regulatory Framework Development on the Economic Growth of Serbia

    Directory of Open Access Journals (Sweden)

    Nenad Milojević

    2013-04-01

    Full Text Available The dynamic relationship between the banking regulatory framework and Basel capital standards, on the one side and economic growth and other macroeconomic indicators on the other side, attracts international academic and business circles for many years. Perceived from the Serbian perspective, the impact of the banking regulation development, or the Basel standards application, on economic growth is one of the most actual issues, especially since Serbia starting from December 31st 2011, began the Basel II application. The fact that the National Bank of Serbia and the Serbian commercial banks, gradually directed attention to more actual Basel III standard, further increasing the importance of the topic that this paper will be addressed. Quantitative and qualitative analyzes that were performed during the research presented in this paper indicate a significant potential for further positive effects, including economic growth, due to the implementation of Basel standards in Serbia. Positive results of application largely depend on adequate preparation, analysis and actions of all relevant parties in Basel standards implementation.

  11. Current role of the USNRC safety research program in support of the regulatory process

    International Nuclear Information System (INIS)

    Levine, S.

    1979-01-01

    The current role of the USNRC's safety research program is shown. Some aspects of this role in the wake of the TMI accident are discused as well as some historical perspective on the development of USNRC's program, its relationship with the NRC mission, an overview of the program activities and some recent research results, and finally the impact of the TMI accident in clarifiying needs for expedited and new research activities, including the need for a greatly enhanced use of probabilistic analysis techniques to improve the coherence of its regulatory process. (author)

  12. Development of regulatory techniques for operational performance evaluation of nuclear power plants

    International Nuclear Information System (INIS)

    Sung, K. Y.; Lee, C. J.

    2005-03-01

    For the purpose of keeping up the capability for independent regulatory audit of risk information, we developed an PSA model, independent on that of the licensee. The developed regulatory PSA model, as named MPAS (Multi-purpose Probabilistic Analysis of Safety), is primarily based on the result of feasibility study about ASME PSA standard and done by the cooperation work with KAERI PSA research team. Current MPAS model is limited to the work scope on Level 1 internal full power analysis, which is finally implemented for the KSNP. The development of MPAS model consists of plenty of works establishing overall items which comprehensively implements all subjects such as detailed logic and input data for each analysis fields. In addition, relevant computational framework utilizing PSA and risk monitoring codes is also developed for users' convenience

  13. The "shoulds" and "should nots" of moral emotions: a self-regulatory perspective on shame and guilt.

    Science.gov (United States)

    Sheikh, Sana; Janoff-Bulman, Ronnie

    2010-02-01

    A self-regulatory framework for distinguishing between shame and guilt was tested in three studies. Recently, two forms of moral regulation based on approach versus avoidance motivation have been proposed in the literature. Proscriptive regulation is sensitive to negative outcomes, inhibition based, and focused on what we should not do. Prescriptive regulation is sensitive to positive outcomes, activation based, and focused on what we should do. In the current research, consistent support was found for shame's proscriptive and guilt's prescriptive moral underpinnings. Study 1 found a positive association between avoidance orientation and shame proneness and between approach orientation and guilt proneness. In Study 2, priming a proscriptive orientation increased shame and priming a prescriptive orientation increased guilt. In Study 3, transgressions most apt to represent proscriptive and prescriptive violations predicted subsequent judgments of shame and guilt, respectively. This self-regulatory perspective provides a broad interpretive framework for understanding and extending past research findings.

  14. A proposed framework for consistent regulation of public exposures to radionuclides and other carcinogens

    International Nuclear Information System (INIS)

    Kocher, D.C.; Hoffman, F.O.

    1991-01-01

    This paper discusses a proposed framework for consistent regulation of carcinogenic risks to the public based on establishing de manifestis (i.e., unacceptable) and de minimis (i.e., trivial) lifetime risks from exposure to any carcinogens at levels of about 10 -1 --10 -3 and 10 -4 --10 -6 , respectively, and reduction of risks above de minimis levels as low as reasonably achievable (ALARA). We then discuss certain differences in the way risks from exposure to radionuclides and other carcinogens currently are regulated or assessed which would need to be considered in implementing the proposed regulatory framework for all carcinogens

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

    International Nuclear Information System (INIS)

    2012-01-01

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

  16. Legal and Regulatory Frameworks for Decommissioning and Waste Management

    International Nuclear Information System (INIS)

    Leech, Jonathan

    2016-01-01

    Safe and efficient decommissioning and waste management requires clear structures for allocating responsibility and funding. Organisation of decommissioning and waste management activities and the regulatory environment within which those activities are undertaken should also allow the supply chain to prosper and, wherever possible, reduce barriers to international availability of resources and waste facilities. Radioactive waste treatment and disposal in particular raises both legal and political challenges to effective international co-operation, yet options for decommissioning and waste management are maximised where international barriers can be minimised. Added to this, international nuclear liabilities issues must be managed so as to avoid unnecessary deterrents to international mobility of capability within the decommissioning market. Contractual terms and insurance arrangements for international shipments of nuclear waste and materials will also need to take into account imminent changes to liabilities conventions, ensuring compliance and management of compliance costs (of both insurance and management time). This paper explores legal and commercial structures intended to support effective decommissioning and waste management and examines regulatory and commercial factors affecting the ability of facility operators to utilise internationally available capability. It focusses on: - strategic approaches developed in the UK to address decommissioning and waste management liabilities associated with the UK's first and second generation civil nuclear sites and comparison of those approaches with other jurisdictions with significant decommissioning liabilities; - liability and compliance risks associated with navigating international nuclear liabilities regimes in context of both mobility of decommissioning capability and international waste shipment; and - regulatory issues affecting international availability of waste treatment facilities, including

  17. 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

  18. 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

  19. The Current Legal Framework of the Use of Force against Terrorist Organizations

    Directory of Open Access Journals (Sweden)

    Petra PERISIC

    2013-11-01

    Full Text Available Events that took place on 9/11, when symbols of American nation were destroyed by hijacked civilian airplanes, raised the issue of the effectiveness of the currently existing legal framework which regulates terrorist activities. Prior to that event, dealing with terrorist activities was mostly regulated by conventions, many of which were ratified by no more than couple of states. However, it became questionable whether these instruments are sufficient to fight terrorists who are not only immune to a threat of sanctions, but are even ready to sacrifice their lives. After the attacks took place, the United States launched against Afghanistan an armed action, ending up in a more than a decade long occupation, holding Taliban regime responsible for the attacks undertaken by Al-Qaida. The United States response to the 9/11 raised an important question: what is the legal response to terrorist attacks? This article explores the current legal framework of the use of force in response to terrorist attacks, especially with regard to distinguishing terrorist acts which are attributable to a certain state, from those which are undertaken by a terrorist group, not associated with any particular state.

  20. Regulatory systems-based licensing guidance documentation

    International Nuclear Information System (INIS)

    Delligatti, M.S.

    1991-01-01

    The US Nuclear Regulatory Commission (NRC) has developed a series of licensing guidance documents based on the regulatory requirements in Part 60 of Title 10 of the Code of Federal Regulations (10 CFR Part 60). This regulatory systems-based approach to licensing guidance documentation relies on the definition of the high-level waste repository in 10 CFR Part 60. A document which is important for the frame-work it gives to other programmatic licensing guidance is the Draft Regulatory Guide open-quotes Format and Content for the License Application for the High-Level Waste Repositoryclose quotes (FCRG). The FCRG describes a format and content acceptable to NRC for a high-level waste repository license application pursuant to the requirements of 10 CFR Part 60. Other licensing guidance documents will be compatible with the FCRG

  1. Private Equity and Regulatory Capital

    NARCIS (Netherlands)

    Bongaerts, D.; Charlier, E.

    2008-01-01

    Regulatory Capital requirements for European banks have been put forward in the Basel II Capital Framework and subsequently in the Capital Requirements Directive (CRD) of the EU. We provide a detailed discussion of the capital requirements for private equity investments under the simple risk weight

  2. 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

  3. Legal and regulatory issues regarding classification and disposal of wastes from actinide partitioning and transmutation

    International Nuclear Information System (INIS)

    Kocher, D.C.

    1989-01-01

    Partitioning and transmutation of actinide radioelements in spent nuclear fuel from civilian power reactors is potentially attractive because the resulting wastes might be acceptable for disposal using systems which are considerably less costly than a deep geologic repository. At present, there are no legal or regulatory prohibitions to seeking alternatives to a geologic repository for disposal of such wastes. However, additional laws and regulations would be needed, and the Nuclear Regulatory Commission has been reluctant to alter the current framework for radioactive waste management, in which geologic repositories or near-surface facilities are the only disposal options established in law and regulations unless a compelling need for alternatives with intermediate waste-isolation capabilities is demonstrated. There are also important technical considerations which are not encouraging with regard to the development of intermediate disposal systems for wastes from partitioning and transmutation of actinides in civilian spent fuel. First, the wastes may contain sufficient concentrations of fission products. Second, defense reprocessing wastes may contain sufficient concentrations of fission products and long-lived actinides. Thus, in developing the legal and regulatory framework for alternative disposal systems, there is a need to establish maximum concentrations of fission products and long-lived actinides that would be acceptable for intermediate disposal. 19 refs

  4. Proposed Regulatory Guideline on the PSA Quality for Risk-informed Applications

    International Nuclear Information System (INIS)

    Lee, Chang Ju; Choi, Jong Soo

    2005-01-01

    In the policy statement on nuclear safety issued by the Korean government in 1994, the introduction of risk-informed regulations in licensing and regulation of nuclear power plants was emphasized for the first time. It also describes the implementation of comprehensive safety assessment utilizing PSA (probabilistic safety assessment). Since then, because risk-informed environment and fundamentals had not been strong, several R and D on PSA and risk-informed regulation have been done even though their application has been delayed. However, today it is not the case. Since the follow-up policy statement (called Severe Accident Policy) was issued, which prescribes strong items such as PSA implementation and its periodic reassessment, reliability database, and risk monitoring program to the utility, we have a chance to easily get all kinds of risk information for improving current regulatory framework. In addition, with the overall availability of PSA results for all operating nuclear power plants, it is expected that many risk-informed applications (RIAs) will be submitted to the regulatory authority. In general, there are a lot of regulatory concerns associated with the quality assurance of licensee's submittals for RIA. It is also noted that making general requirements and touching specific check points are essential for the regulatory decision making process. This paper summarizes the structure and contents of our regulatory guideline for assuring PSA quality

  5. 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.

  6. Highly Reliable Organizations in the Onshore Natural Gas Sector: An Assessment of Current Practices, Regulatory Frameworks, and Select Case Studies

    Energy Technology Data Exchange (ETDEWEB)

    Logan, Jeffrey S. [National Renewable Energy Laboratory (NREL), Golden, CO (United States); Paranhos, Elizabeth [Energy Innovation Partners, Seattle, WA (United States); Kozak, Tracy G. [Energy Innovation Partners, Seattle, WA (United States); Boyd, William [Univ. of Colorado, Boulder, CO (United States)

    2017-07-31

    This study focuses on onshore natural gas operations and examines the extent to which oil and gas firms have embraced certain organizational characteristics that lead to 'high reliability' - understood here as strong safety and reliability records over extended periods of operation. The key questions that motivated this study include whether onshore oil and gas firms engaged in exploration and production (E&P) and midstream (i.e., natural gas transmission and storage) are implementing practices characteristic of high reliability organizations (HROs) and the extent to which any such practices are being driven by industry innovations and standards and/or regulatory requirements.

  7. Status report on NRC's current below regulatory concern activities

    International Nuclear Information System (INIS)

    Dragonette, K.S.

    1988-01-01

    The concept of below regulatory concern (BRC) is not new to the Nuclear Regulatory Commission (NRC) or its predecessor agency, the Atomic Energy Commission. The regulations and licensing decisions have involved limited and de facto decisions on BRC since the beginning. For example, consumer products containing radioactive materials have been approved for distribution to persons exempt from licensing for some time and procedures for survey and release of equipment have traditionally been a part of many licensees' radiation safety programs. However, these actions have generally been ad hoc decisions in response to specific needs and have not been necessarily consistent. The need to deal with this regulatory matter has been receiving attention from both Congress and the NRC Commissioners. NRC response has grown from addressing specific waste streams, to generic rulemaking for wastes, and finally to efforts to develop a broad generic BRC policy. Section 10 of the Low-Level Radioactive Waste Policy Amendments Act of 1985 addressed NRC actions on specific waste streams. In response, NRC issued guidance on rulemaking petitions for specific wastes. NRC also issued an advance notice of proposed rulemaking indicating consideration of Commission initiated regulations to address BRC wastes in a generic manner. The Commissioners have directed staff to develop an umbrella policy for all agency decisions concerning levels of risk or dose that do not require government regulation

  8. 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.

  9. Managing Regulatory Body Competence

    International Nuclear Information System (INIS)

    2013-01-01

    In 2001, the IAEA published TECDOC 1254, which examined the way in which the recognized functions of a regulatory body for nuclear facilities results in competence needs. Using the systematic approach to training (SAT), TECDOC 1254 provided a framework for regulatory bodies for managing training and developing and their maintaining their competence. It has been successfully used by many regulators. The IAEA has also introduced a methodology and an assessment tool - Guidelines for Systematic Assessment of Regulatory Competence Needs (SARCoN) - which provides practical guidance on analysing the training and development needs of a regulatory body and, through a gap analysis, guidance on establishing competence needs and how to meet them. In 2009, the IAEA established a steering committee (supported by a bureau) with the mission to advise the IAEA on how it could best assist Member States to develop suitable competence management systems for their regulatory bodies. The committee recommended the development of a safety report on managing staff competence as an integral part of a regulatory body's management system. This Safety Report was developed in response to this request. It supersedes TECDOC 1254, broadens its application to regulatory bodies for all facilities and activities, and builds upon the experience gained through the application of TECDOC 1254 and SARCoN and the feedback received from Member States. This Safety Report applies to the management of adequate competence as needs change, and as such is equally applicable to the needs of States 'embarking' on a nuclear power programme. It also deals with the special case of building up the competence of regulatory bodies as part of the overall process of establishing an 'embarking' State's regulatory system

  10. Regulatory controls and slurry fracture injection

    International Nuclear Information System (INIS)

    Dusseault, M. B.; Bilak, R. A.

    1997-01-01

    The technological and regulatory framework necessary for the safe operation of solid waste disposal using slurry fracture injection (SFI) in Saskatchewan and Alberta was studied. Seven current SFI sites were used as the source of experience. Regular audits of volumes, continuous pressure recording, careful deformation monitoring and analysis, and repeated evaluation of reservoir properties were considered to be the essential features. In the case of toxic wastes, microseismic monitoring and regular well interference or tracer tests might be additional measures used to increase confidence in the containment method. Given the recent introduction of SFI technology, guarding against over-regulation was recommended to allow SFI to operate under the most effective operating conditions, and to preserve its attractiveness as an environmentally attractive and safe waste disposal alternative. 5 refs., 3 tabs., 4 figs

  11. Regulatory Risk Reduction for Advanced Reactor Technologies - FY2016 Status and Work Plan Summary

    International Nuclear Information System (INIS)

    Moe, Wayne Leland

    2016-01-01

    Millions of public and private sector dollars have been invested over recent decades to realize greater efficiency, reliability, and the inherent and passive safety offered by advanced nuclear reactor technologies. However, a major challenge in experiencing those benefits resides in the existing U.S. regulatory framework. This framework governs all commercial nuclear plant construction, operations, and safety issues and is highly large light water reactor (LWR) technology centric. The framework must be modernized to effectively deal with non-LWR advanced designs if those designs are to become part of the U.S energy supply. The U.S. Department of Energy's (DOE) Advanced Reactor Technologies (ART) Regulatory Risk Reduction (RRR) initiative, managed by the Regulatory Affairs Department at the Idaho National Laboratory (INL), is establishing a capability that can systematically retire extraneous licensing risks associated with regulatory framework incompatibilities. This capability proposes to rely heavily on the perspectives of the affected regulated community (i.e., commercial advanced reactor designers/vendors and prospective owner/operators) yet remain tuned to assuring public safety and acceptability by regulators responsible for license issuance. The extent to which broad industry perspectives are being incorporated into the proposed framework makes this initiative unique and of potential benefit to all future domestic non-LWR applicants

  12. Towards a harmonized radiopharmaceutical regulatory framework in Europe

    International Nuclear Information System (INIS)

    Decristoforo, A.; Penuelas, I.

    2009-01-01

    Despite European unification regarding a common legal framework for many aspects of pharmaceutical production including industrial manufacture of pharmaceuticals, the practice of pharmacy in general, and of radiopharmacy in particular, differs substantially and are mainly regulated at the national level. Herein the authors discuss major European documents relevant for radiopharmacy practice in Europe and recent developments on the national level especially regarding the small-scale preparation of radiopharmaceuticals (R P). Issues related to marketing authorization (and exemptions from it), standards of preparation, quality requirements, regulations of clinical trials and education will be outlined. Standards for the industrial preparation of pharmaceuticals are defined in Good Manufacturing Practice (GMP), not taking into account specific requirements for the small scale, extemporaneous preparation of R P. The European Association of Nuclear Medicine EANM has published several documents based on GMP and called Good Radiopharmaceutical Practice (cGRPP) to specifically address this in an attempt to harmonize R P preparation across Europe. Clinical trials have been hampered by the introduction of directive 2001/20/E C again aimed at the marketing track of industrial production and currently a number of activities are ongoing to counterbalance this problem in radiopharmaceutical research. Additionally, the role of the European Pharmacopoeia in regulating quality requirements and the need for specific education and training in the small scale radiopharmaceutical preparation are also discussed.

  13. Establishment of the nuclear regulatory framework for the process of decommissioning of nuclear installations in Mexico; Establecimiento del marco regulador nuclear para el proceso de cierre de instalaciones nucleares en Mexico

    Energy Technology Data Exchange (ETDEWEB)

    Salmeron V, J. A.; Camargo C, R.; Nunez C, A., E-mail: juan.salmeron@cnsns.gob.mx [Comision Nacional de Seguridad Nuclear y Salvaguardias, Dr. Barragan 779, Col. Narvarte, 03020 Ciudad de Mexico (Mexico)

    2015-09-15

    Today has not managed any process of decommissioning of nuclear installations in the country; however because of the importance of the subject and the actions to be taken to long term, the Comision Nacional de Seguridad Nuclear y Salvaguardias (CNSNS) in Mexico, accordance with its objectives is developing a National Nuclear Regulatory Framework and defined requirements to ensure the implementation of appropriate safety standards when such activities are performed. In this regard, the national nuclear regulatory framework for nuclear installations and the particular case of nuclear power reactors is presented, as well as a proposed licensing process for the nuclear power plant of Laguna Verde based on international regulations and origin country regulations of the existing reactors in nuclear facilities in accordance with the license conditions of operation to allow to define and incorporate such regulation. (Author)

  14. Crisis, criticism, change: Regulatory reform in the wake of nuclear accidents

    International Nuclear Information System (INIS)

    Sexton, Kimberly A.; )

    2015-01-01

    Accidents are a forcing function for change in the nuclear industry. While these events can shed light on needed technical safety reforms, they can also shine a light on needed regulatory system reforms. The TEPCO Fukushima Daiichi nuclear power plant (NPP) accident in Japan is the most recent example of this phenomenon, but it is not the only one. In the wake of the three major accidents that have occurred in the nuclear power industry - Three Mile Island (TMI) in the United States; Chernobyl in Ukraine, in the former Soviet Union; and the Fukushima Daiichi NPP accident in Japan - a commission or committee of experts issued a report (or reports) with harsh criticism of the countries' regulatory system. And each of these accidents prompted changes in the respective regulatory systems. In looking at these responses, however, one must ask if this crisis, criticism, change approach is working and whether regulatory bodies around the world should instead undertake their own systematic reviews, un-prompted by crisis, to better ensure safety. This article will attempt to analyse the issue of regulatory reform in the wake of nuclear accidents by first providing a background in nuclear regulatory systems, looking to international and national legal frameworks. Next, the article will detail a cross-section of current regulatory systems around the world. Following that, the article will analyse the before and after of the regulatory systems in the United States, the Soviet Union and Japan in relation to the TMI, Chernobyl and Fukushima accidents. Finally, taking all this together, the article will address some of the international and national efforts to define exactly what makes a good regulator and provide conclusions on regulatory reform in the wake of nuclear accidents. (author)

  15. Comparison of Current Regulatory Status for Gene-Based Vaccines in the U.S., Europe and Japan

    Directory of Open Access Journals (Sweden)

    Yoshikazu Nakayama

    2015-03-01

    Full Text Available Gene-based vaccines as typified by plasmid DNA vaccines and recombinant viral-vectored vaccines are expected as promising solutions against infectious diseases for which no effective prophylactic vaccines exist such as HIV, dengue virus, Ebola virus and malaria, and for which more improved vaccines are needed such as tuberculosis and influenza virus. Although many preclinical and clinical trials have been conducted to date, no DNA vaccines or recombinant viral-vectored vaccines expressing heterologous antigens for human use have yet been licensed in the U.S., Europe or Japan. In this research, we describe the current regulatory context for gene-based prophylactic vaccines against infectious disease in the U.S., Europe, and Japan. We identify the important considerations, in particular, on the preclinical assessments that would allow these vaccines to proceed to clinical trials, and the differences on the regulatory pathway for the marketing authorization in each region.

  16. Critical analysis of frameworks and approaches to assess the environmental risks of nanomaterials

    DEFF Research Database (Denmark)

    Grieger, Khara Deanne; Linkov, Igor; Hansen, Steffen Foss

    and approaches which have been developed or proposed by large organizations or regulatory bodies for NM. These frameworks and approaches were evaluated and assessed based on a select number of criteria which have been previously proposed as important parameters for inclusion in successful risk assessment......7.1.7 Critical analysis of frameworks and approaches to assess the environmental risks of nanomaterials Khara D. Grieger1, Igor Linkov2, Steffen Foss Hansen1, Anders Baun1 1Technical University of Denmark, Kgs. Lyngby, Denmark 2Environmental Laboratory, U.S. Army Corps of Engineers, Brookline, USA...... Email: kdg@env.dtu.dk Scientists, organizations, governments, and policy-makers are currently involved in reviewing, adapting, and formulating risk assessment frameworks and strategies to understand and assess the potential environmental risks of engineered nanomaterials (NM). It is becoming...

  17. A framework to analyze emissions implications of ...

    Science.gov (United States)

    Future year emissions depend highly on the evolution of the economy, technology and current and future regulatory drivers. A scenario framework was adopted to analyze various technology development pathways and societal change while considering existing regulations and future uncertainty in regulations and evaluate resulting emissions growth patterns. The framework integrates EPA’s energy systems model with an economic Input-Output (I/O) Life Cycle Assessment model. The EPAUS9r MARKAL database is assembled from a set of technologies to represent the U.S. energy system within MARKAL bottom-up technology rich energy modeling framework. The general state of the economy and consequent demands for goods and services from these sectors are taken exogenously in MARKAL. It is important to characterize exogenous inputs about the economy to appropriately represent the industrial sector outlook for each of the scenarios and case studies evaluated. An economic input-output (I/O) model of the US economy is constructed to link up with MARKAL. The I/O model enables user to change input requirements (e.g. energy intensity) for different sectors or the share of consumer income expended on a given good. This gives end-users a mechanism for modeling change in the two dimensions of technological progress and consumer preferences that define the future scenarios. The framework will then be extended to include environmental I/O framework to track life cycle emissions associated

  18. 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)

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

    International Nuclear Information System (INIS)

    Mourlon, Sophie

    2014-01-01

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

  20. Regulatory framework in assisted reproductive technologies, relevance and main issues.

    Science.gov (United States)

    Merlet, Françoise

    2009-01-01

    Assisted reproductive technologies (ART) have changed life for the past 25 years and many ethical and social issues have emerged following this new method of conception. In order to protect individuals against scientific and ethical abuses without inhibiting scientific progress, a specific legal framework is necessary. The first French law on Bioethics was voted after an extensive debate in 1994 then reviewed in 2004. This review previously scheduled every five years is currently being discussed. Legal provisions applying to ART are part of a large framework including the protection of the patients' rights and biomedical research. The key principles consist of respect for human life and ban on commercial practices of human body parts, eugenic practices and any kind of cloning. These key principles apply to ART. Donation is anonymous and free. Created in 2004, the Agence de la biomédecine is a government agency and one of the main tools of the French regulations. The missions focus on improving the quality and the safety of the management of ART. Evaluation of activities is available to all from the annual report. The agency represents the French competent authority for medical and scientific aspects of ART. Substantial differences in European legislations exist from the open-up "laissez faire" to the most restrictive one. As a consequence a large reproductive tourism has developed particularly for egg donation or surrogacy. The medical and ethical conditions of management of patients and donors represent the main critical points. In order to avoid ethical abuses, homogenization regarding the key principles is necessary in Europe. It is an opportunity to reassert that human body parts should not be a source of financial gain.

  1. Network regulation and regulatory institutional reform: Revisiting the case of Australia

    International Nuclear Information System (INIS)

    Nepal, Rabindra; Menezes, Flavio; Jamasb, Tooraj

    2014-01-01

    It is well-understood that the success of liberalizing the electricity supply industry depends crucially on the quality and design of the regulatory and institutional framework. This paper analyses the regulatory arrangements that underpin the work of the Australian Energy Regulator (AER). These arrangements are contrasted with the regulatory structure of electricity provision in Norway. A key difference between the reform processes in the two countries relates to the lack of privatization in Norway and the co-existence of private and publicly owned generators and distributors in Australia. This comparative analysis allows us to make several recommendations to improve regulatory arrangements in Australia. These include greater independence for the AER, better coordination among regulatory institutions, greater use of benchmarking analysis, greater customer involvement, and improving market transparency and privatization of government-owned corporations. However, the success of privatization will hinge upon the effectiveness of the regulatory environment. - Highlights: • Rising electricity prices and network costs is of great concern in Australia. • Flaws in the existing regulatory environment and economic efficiency exist. • The AER should be provided with adequate resources (financial and staff experts) and discretion. • Robust benchmarking techniques should be adopted in the incentive regulation framework for cost efficiency. • Privatization of the state-owned assets also remains an option

  2. Assessing and managing regulatory risk in renewable energy: Contrasts between Canada and the United States

    International Nuclear Information System (INIS)

    Holburn, Guy L.F.

    2012-01-01

    Abstact: A challenge for energy firms when considering new investments is to balance expected financial gains against potential risks. However, while investment opportunities in different jurisdictions are often straightforward to identify, the policy or regulatory risks for investors are more difficult to accurately ascertain. Here, I provide a novel conceptual framework for how firms can assess regulatory risk that focuses on the institutional processes governing policy-making. Risks are lower – and policies will subsequently be more stable – in jurisdictions where regulatory agencies have greater autonomy from politicians and where policies are formulated through more ‘rigid’ policy-making processes. The contrasting development patterns of renewable energy policies in Ontario and Texas offer support for the framework. I further develop strategies for how firms can successfully manage regulatory risks in different types of environment. - Highlights: ► The paper provides a conceptual framework for how firms can assess regulatory risk. ► Risks are lower when regulators have greater autonomy from elected politicians. ► Risks are lower when policy-making processes are more ‘rigid’. ► Firms can strategically mitigate regulatory risk in different types of environment.

  3. Inaccessible Built Environments in Ghana’s Universities: The Bane of a Weak Legal and Regulatory Framework for Persons with Disabilities 1

    Directory of Open Access Journals (Sweden)

    John Tiah Bugri

    2017-05-01

    Full Text Available This is a qualitative study of the role of the legal and regulatory framework in making built environments accessible to Persons with Disabilities in six universities in Ghana. It revealed that the local component of legislation dealing with accessible environments was fragile and fraught with compliance challenges, administrative laxity and the lack of a time conscious approach to issues thereby resulting in inaccessible built environments. In effect, the study gives credence to the proposition of the social model that disability is a creation of humankind and recommends an amendment of Ghana’s Persons with Disability Act.

  4. Regulatory environment of transitioning to risk-informed regulations in U.S.A

    International Nuclear Information System (INIS)

    Choi, C. H.; Kim, C. H.

    1999-01-01

    With the publication of the PRA Policy Statement and recent regulatory guides, the U.S.NRC makes a continuous approach towards risk-informed regulations with the goal of establishing an overall framework for risk-informed decisions in all regulatory activities as well as plant specific licensing issues. Faced with the changing environment of deregulation of the electricity generation market, the licensee's effort to reduce design margins to enhance flexibility and to relieve unnecessary regulatory burdens have been focused on the control and reduction of plant operating costs. The risk-informed approach provides a structured, systematic, and defensible method that can be applied not only to rulemaking, but also to licensing, inspection, enforcement, and performance assessment, as well as provides basis for prioritization in the establishment of programs and the allocation of resources. This report describes the current regulatory environment of transitioning to risk-informed regulations with an emphasis on its background, concepts, regulatory guides, proposed options for modifying the 10CFR50, and risk-informed applications in U.S.A. Review of the risk informed applications utilizing the information provided by the PRAs and their insights in the U.S.NRC and nuclear industry will provide the insights of predicting the expected regulation changes in Korea. Also it could provide the applicable methods or guides for the implementation of the risk-informed applications in plant design and operations. (author)

  5. Regulatory framework in Bulgaria

    International Nuclear Information System (INIS)

    Yanev, Y.

    1996-01-01

    The basis of current nuclear safety legislation in Bulgaria was established in 1985 when a new Law on the Use of Atomic Energy for Peaceful Purposes was issued by National Assembly Decree. The content of the law and the main amendments from 1995 are briefly described. Regulations in the field of radiation protection, developed by the Committee on the Use of Atomic Energy for Peaceful Purposes (CUAEPP) and other Ministries, are also presented

  6. The Belgian regulatory framework for NORM industries : test-case of a phosphate production plant

    International Nuclear Information System (INIS)

    Pepin, Stephane; Dehandschutter, Boris; Poffijn, Andre; Michel Sonck

    2008-01-01

    According to the Belgian radiation protection regulatory framework, some categories of NORM industries must register to the competent Belgian radiation protection authority (FANC, Federal Agency for Nuclear Control). The facilities must provide a set of information which allows the authority to assess the radiological impact of the industrial activity on the workers, the population and the environment. If the dose exceeds or is likely to exceed 1 mSv/y, corrective measures have to be implemented. FANC has issued a methodology in order to define more precisely the data needed to evaluate the radiological impact. The methodology lists also the exposure pathways which have to be taken into account and the relevant parameters for the evaluation of the doses. The case of a phosphate production plant is discussed in more details: although the exposure of the workers in the production process as such is rather limited, the specific activity of some residues (calcium fluoride sludge) reaches around 10 kBq/kg of Ra-226. This sludge is disposed off in a specific landfill for which a program of radiological monitoring has been implemented. It includes periodic measurements of dose rate and radon concentration on the landfill. (author)

  7. The regulatory framework of accounting and accounting standard-setting bodies in the European Union member states

    Directory of Open Access Journals (Sweden)

    Ivana Mamić-Sačer

    2015-12-01

    Full Text Available One of the principal features of accounting in the 21st century is harmonisation and stanardisation. Regulation of the European Parliament and European Council No. 1606/2002 harmonizes financial reporting for certain companies in the EU. However, national accounting principles are of great importance for financial reporting. The main purpose of this research was to investigate the application of generally accepted accounting principles, the regulatory accounting framework and the standard-setting bodies of EU member states. The analysis of these accounting issues was conducted with respect to all 28 EU member states. The results indicate that EU member states regulate their principal accounting issues through separate accounting acts or implement those issues in companies acts. Some EU member states do not have national accounting standards, the national accounting principles being incorporated in companies acts and accounting acts. Nevertheless, national accounting standard-setting bodies are governmental organisations in almost half the member states.

  8. The MCP Altona incident: the Canadian regulatory response and framework for the export of uranium

    International Nuclear Information System (INIS)

    Lavoie, Jacques

    2012-01-01

    On 23 December 2010, a cargo ship carrying 350 000 kilograms (kg) of uranium ore concentrates (U 3 O 8 ) belonging to the Canadian resource corporation Cameco left Vancouver, British Columbia, Canada and encountered severe weather conditions between Hawaii and the Midway Islands in international waters en route to Zhanjiang, People's Republic of China (PRC). The ship, the MCP Altona, suffered some damage to its hull but was able to continue to operate through the storm. Once the sea had calmed, the crew noticed that some of the containers on the ship had shifted and had been damaged. The captain, however, was unable to secure the necessary authorizations to obtain safe harbour in the area as there were no signs of immediate risk to the health and safety of the ship's crew. On Cameco's recommendation, the ship returned to British Columbia. This article describes the response of the Canadian Nuclear Safety Commission (CNSC) to this incident. The article also discusses the Canadian policy and regulatory framework for controls on the export of uranium

  9. Regulatory Risk Reduction for Advanced Reactor Technologies – FY2016 Status and Work Plan Summary

    Energy Technology Data Exchange (ETDEWEB)

    Moe, Wayne Leland [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2016-08-01

    Millions of public and private sector dollars have been invested over recent decades to realize greater efficiency, reliability, and the inherent and passive safety offered by advanced nuclear reactor technologies. However, a major challenge in experiencing those benefits resides in the existing U.S. regulatory framework. This framework governs all commercial nuclear plant construction, operations, and safety issues and is highly large light water reactor (LWR) technology centric. The framework must be modernized to effectively deal with non-LWR advanced designs if those designs are to become part of the U.S energy supply. The U.S. Department of Energy’s (DOE) Advanced Reactor Technologies (ART) Regulatory Risk Reduction (RRR) initiative, managed by the Regulatory Affairs Department at the Idaho National Laboratory (INL), is establishing a capability that can systematically retire extraneous licensing risks associated with regulatory framework incompatibilities. This capability proposes to rely heavily on the perspectives of the affected regulated community (i.e., commercial advanced reactor designers/vendors and prospective owner/operators) yet remain tuned to assuring public safety and acceptability by regulators responsible for license issuance. The extent to which broad industry perspectives are being incorporated into the proposed framework makes this initiative unique and of potential benefit to all future domestic non-LWR applicants

  10. The Occurrence of Paraffin and Other Petroleum Waxes in the Marine Environment: A Review of the Current Legislative Framework and Shipping Operational Practices

    Directory of Open Access Journals (Sweden)

    Giuseppe Suaria

    2018-03-01

    Full Text Available Among the various materials that make up marine debris, lumps of petroleum waxes such as paraffin and microcrystalline wax, are regularly found on beaches worldwide, although not included in the current definition of marine litter. Ingestion by marine organisms is occasionally documented in the scientific literature and mass beaching events are frequently reported along the European coasts, with obvious detrimental consequences to the local communities that have to manage the clean-up and disposal of this substance. According to Annex II of the MARPOL regulation, petroleum waxes are classified as “high viscosity, solidifying, and persistent floating products,” whose discharge at sea of tank-washing residues is strictly regulated, but currently permitted within certain limits. Starting from the description of a large stranding event occurred along the Italian coasts in 2017, we review the existing knowledge and regulatory framework and urge the relevant authorities to address this issue, showing that wax pollution is creating evident damages to the European coastal municipalities. Pending further investigations on the potential hazard that this kind of pollution is posing to marine ecosystems, we suggest a careful and more stringent revision of the policies regulating discharges of these products at sea.

  11. 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.

  12. Current regulatory and licensing status for byproduct sources, facilities and applications

    International Nuclear Information System (INIS)

    Tingey, G.L.; Jensen, G.A.; Hazelton, R.F.

    1985-02-01

    Public use of nuclear byproducts, especially radioactive isotopes, will require approval by various regulatory agencies. Use of cesium-137 as an irradiation source for sterilizing medical products will require US Nuclear Regulatory Commission (NRC) approval. Two applications have been filed with NRC, and approval is expected soon. Widespread use of irradiation for food products depends on a favorable ruling by the Food and Drug Administration (FDA). A ruling is pending that would permit irradiation of fruits and vegetables up to 100 krad. NRC also controls the use of isotopes in remote power generators, but little regulatory action has been required in recent years. Recent development of radioluminescent (RL) lighting for runway lights has led to interest by commercial manufacturers. At the present time, a license has been issued to at least one manufacturer for sale of tritium-powered runway lights. 28 refs., 1 fig

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

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2013-08-15

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

  14. Regulatory Oversight of Safety Culture — Korea’s Experience

    International Nuclear Information System (INIS)

    Jung, S.J.; Choi, Y.S.; Kim, J.T.

    2016-01-01

    In Korea, a regulatory oversight program of safety culture was launched in 2012 to establish regulatory measures against several events caused by weak safety culture in the nuclear industry. This paper is intended to introduce the preliminary regulatory oversight framework, development and validation of safety culture components, pilot safety culture inspection results and lessons learned. The safety culture model should be based on a sound understanding of the national culture and industry characteristics where the model will be applied. The nuclear safety culture oversight model is being developed and built on the Korean regulatory system to independently assess the nuclear power operating organizations’ safety culture.

  15. 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.

  16. A framework to analyze emissions implications of manufacturing shifts in the industrial sector through integrating bottom-up energy models and economic input-output environmental life cycle assessment models

    Science.gov (United States)

    Future year emissions depend highly on the evolution of the economy, technology and current and future regulatory drivers. A scenario framework was adopted to analyze various technology development pathways and societal change while considering existing regulations and future unc...

  17. Regulatory framework in assisted reproductive technologies, relevance and main issues.

    Directory of Open Access Journals (Sweden)

    Françoise Merlet

    2010-01-01

    Full Text Available Assisted reproductive technologies (ART have changed life for the past 25 years and many ethical and social issues have emerged following this new method of conception. In order to protect individuals against scientific and ethical abuses without inhibiting scientific progress, a specific legal framework is necessary. The first French law on Bioethics was voted after an extensive debate in 1994 then reviewed in 2004. This review previously scheduled every five years is currently being discussed. Legal provisions applying to ART are part of a large framework including the protection of the patients' rights and biomedical research. The key principles consist of respect for human life and ban on commercial practices of human body parts, eugenic practices and any kind of cloning. These key principles apply to ART. Donation is anonymous and free. Created in 2004, the Agence de la biomĂŠdecine is a government agency and one of the main tools of the French regulations. The missions focus on improving the quality and the safety of the management of ART. Evaluation of activities is available to all from the annual report. The agency represents the French competent authority for medical and scientific aspects of ART. Substantial differences in European legislations exist from the open-up "laissez faire" to the most restrictive one. As a consequence a large reproductive tourism has developed particularly for egg donation or surrogacy. The medical and ethical conditions of management of patients and donors represent the main critical points. In order to avoid ethical abuses, homogenization regarding the key principles is necessary in Europe. It is an opportunity to reassert that human body parts should not be a source of financial gain.

  18. Regulatory problems relating to energy in Hungary

    International Nuclear Information System (INIS)

    Remenyi, K.

    2002-01-01

    One of basic problems of the transition in the energy economy is, how far the process of liberalisation and privatisation could go, i.e. to what extent the control of state/government would be given up, and how the breakdown of the commanding positions of the government would be managed. The transition in the energy sector toward a market economy is characterised by restructuring the regulatory framework of the energy industry, changing the operational structure of the sector and profound reshaping of ownership structures of the enterprises. In Hungary the government, being convinced of the importance of the implementation of the market forces, in 1991 made the first step on the way of restructuring the energy sector in order to increase economic efficiency, to enable companies to react to market forces and to privatise them. Parallel and partly after the restructuring, a profound modification of legal and regulatory framework took place and finally a relatively large scale of privatisation has newly emerged, which will continue in future, too. The process of the energy sector liberalisation in Hungary has a stop and go character and the game is not over. The process can be characterised by institutional restructuring in the energy sector (coal, oil/gas, power ), which is the basic condition for market liberalisation and privatisation, and by the creation of an appropriate environment (regulatory framework, pricing policy, etc. ) for the smooth implementation of the liberation process(author)

  19. Orphan Sources. Extending Radiological Protection outside the Regulatory Framework

    Energy Technology Data Exchange (ETDEWEB)

    Eugenio Gil [Deputy Director for Emergency, Spanish Nuclear Safety Council (Spain)

    2006-07-01

    Radioactive sources that are not under appropriate regulatory control-Orphan sources- can result in a number of undesirable consequences including human health impacts, socio-psychological impacts, political and economic impacts, as well as environmental impacts. Many countries are now in the process of introducing the necessary measures to regain an appropriate level of control over them. For a variety of historical and economic reasons, there could already be sources in any specific country that are not within the usual regulatory system. Some of these may be known about, others may not. Therefore a national strategy is needed to ascertain the likelihood and magnitude of the issue of radioactive source control problem within a country and the priorities necessary to address the problems identified. A well-developed plan for improving control over all relevant radioactive sources tailored to the national situation will ensure optimum use of resources such as time, money and personnel. It will allow these limited resources to be allocated appropriately to ensure that control is first regained over those sources presenting the highest risks. This lecture shows a way to develop an appropriate national strategy for regaining control over orphan sources. The methodology described in this lecture is basically based in the IAEA Recommendations. (author)

  20. Orphan Sources. Extending Radiological Protection outside the Regulatory Framework

    International Nuclear Information System (INIS)

    Eugenio Gil

    2006-01-01

    Radioactive sources that are not under appropriate regulatory control-Orphan sources- can result in a number of undesirable consequences including human health impacts, socio-psychological impacts, political and economic impacts, as well as environmental impacts. Many countries are now in the process of introducing the necessary measures to regain an appropriate level of control over them. For a variety of historical and economic reasons, there could already be sources in any specific country that are not within the usual regulatory system. Some of these may be known about, others may not. Therefore a national strategy is needed to ascertain the likelihood and magnitude of the issue of radioactive source control problem within a country and the priorities necessary to address the problems identified. A well-developed plan for improving control over all relevant radioactive sources tailored to the national situation will ensure optimum use of resources such as time, money and personnel. It will allow these limited resources to be allocated appropriately to ensure that control is first regained over those sources presenting the highest risks. This lecture shows a way to develop an appropriate national strategy for regaining control over orphan sources. The methodology described in this lecture is basically based in the IAEA Recommendations. (author)

  1. Assessment of the Institutional Regulatory Framework of Auditor ...

    African Journals Online (AJOL)

    ... accountancy professional body (ICAN) should promote the dignity of its members by making the appointment of external auditors less dependent on the executive directors and more dependent on the non-executive directors, audit committees and shareholders. Key words: Auditor, Regulation, Independence, Framework ...

  2. 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)

  3. 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)

  4. 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)

  5. Implementing Relative Ranking Evaluation Framework at Department of Energy (DOE) installations

    International Nuclear Information System (INIS)

    Sharma, S.K.; Williamson, D.; Treichel, L.C.; James, L.M.

    1996-01-01

    The US Department of Energy (DOE) Office of Environmental Restoration (EM-40) has developed the Relative Ranking Evaluation Framework (RREF) to help categorize release sites, facilities and buildings requiring restoration or decommissioning. Based on this framework, a computer tool, the Relative Rank Evaluation Program (RREP) has been developed to evaluate release sites, facilities and buildings, and to manage information pertaining to relative ranking evaluations. The relative ranking information is being used by both Headquarters and field project managers, and other environmental personnel responsible for planning, executing and evaluation environmental restoration activities at DOE installations. External stakeholders, such as representatives of federal and state regulatory agencies, local governments and communities in the vicinity of current and formerly used DOE installations may use this data to review proposed and planned activities

  6. Risk-based Regulatory Evaluation Program methodology

    International Nuclear Information System (INIS)

    DuCharme, A.R.; Sanders, G.A.; Carlson, D.D.; Asselin, S.V.

    1987-01-01

    The objectives of this DOE-supported Regulatory Evaluation Progrwam are to analyze and evaluate the safety importance and economic significance of existing regulatory guidance in order to assist in the improvement of the regulatory process for current generation and future design reactors. A risk-based cost-benefit methodology was developed to evaluate the safety benefit and cost of specific regulations or Standard Review Plan sections. Risk-based methods can be used in lieu of or in combination with deterministic methods in developing regulatory requirements and reaching regulatory decisions

  7. IS Audit Considerations in Respect of Current Economic Environment

    Directory of Open Access Journals (Sweden)

    Vlasta Svata

    2011-01-01

    Full Text Available Accountancy organizations, regulatory bodies, standard setters, and other international organizations have developed guidance, articles, frameworks and resources on issues related to the global financial crisis. Now there is a clear and widely accepted need for more rigorous governance over companies´ systems of internal control. Historically there exist many different activities aiming to support effective enterprise governance (legislative acts, best practices, standards, frameworks. But all these activities may have reinforced the already-existing focus on enterprise governance, but they did not necessarily bring clarity to the topic. Therefore we can currently notice some changes aiming to improve the adoption and adaptation of best practices and standards within the area of enterprise governance. The paper discusses the changes in the Enterprise Governance of IT/IS, audit/assurance evolution, and intended Cobit improvements.

  8. Environmental Programs: Status of Work and Current Priorities for FY13

    Energy Technology Data Exchange (ETDEWEB)

    Jones, Patricia [Los Alamos National Laboratory

    2012-08-17

    Presentation outline is: Mission/overview, Regulatory framework, Current status of cleanup, Shift in priorities to address highest risk, Removal of above-ground waste, Continued focus on protecting water resources, and Priorities for fiscal year 2013. LANL's Environmental Mission is to: (1) Repack and ship legacy transuranic waste containers; (2) Investigate and remediate Cold War (legacy) hazardous and radioactive waste areas; (3) Demolish unused buildings; (4) Disposition solid waste from Laboratory operations; and (5) Lifecycle cost nearly $3 billion.

  9. 174 | P a g e THE REGULATORY FRAMEWORK OF THE RADIO ...

    African Journals Online (AJOL)

    Fr. Ikenga

    The law of global communication appears as the regulatory response to this need; .... 6 Richard K. Gardner, International Law, Pearson Education Limited, England, 2003 .... Vienna Declaration on Space and Human Development (The Space ...

  10. Energy efficiency and renewable energy policy in the Czech Republic within the framework of accession to the European Union

    International Nuclear Information System (INIS)

    Wees, M.T. van; Uyterlinde, M.A.; Maly, M.

    2002-01-01

    The main barrier for end-use energy efficiency and renewable energy in the Czech Republic is the lack of a stable political and regulatory framework. Market incentives can only properly work if the market conditions and restrictions are clear and stable. However, no comprehensive policies and regulation have been implemented in the Czech Republic. Although the acquis communautaire of the European Union includes regulation on energy efficiency and renewable energy, this topic remains low on the negotiation agenda for accession. This paper reports on the current situation in the Czech Republic, including the potentials for end-use energy efficiency and renewable energy, on the existing policy and regulatory framework, and on the remaining gaps with the requirements of accession to the European Union. Also, the impact of the recent increase of nuclear capacity on energy efficiency and renewable energy in the Czech Republic is discussed

  11. 4th IEA International CCS Regulatory Network Meeting

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2012-07-01

    On 9 and 10 May 2012, the IEA International CCS Regulatory Network (Network), launched in Paris in May 2008 to provide a neutral forum for CCS regulators, policy makers and stakeholders to share updates and views on CCS regulatory developments, held its fourth meeting at the International Energy Agency (IEA) offices in Paris, France. The aim of the meeting was to: provide an update on government efforts to develop and implement carbon capture and storage (CCS) legal and regulatory frameworks; and consider ways in which governments are dealing with some of the more difficult or complex aspects of CCS regulation. This report summarises the proceedings of the meeting.

  12. 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

  13. Measuring and Modeling the U.S. Regulatory Ecosystem

    Science.gov (United States)

    Bommarito, Michael J., II; Katz, Daniel Martin

    2017-09-01

    Over the last 23 years, the U.S. Securities and Exchange Commission has required over 34,000 companies to file over 165,000 annual reports. These reports, the so-called "Form 10-Ks," contain a characterization of a company's financial performance and its risks, including the regulatory environment in which a company operates. In this paper, we analyze over 4.5 million references to U.S. Federal Acts and Agencies contained within these reports to measure the regulatory ecosystem, in which companies are organisms inhabiting a regulatory environment. While individuals across the political, economic, and academic world frequently refer to trends in this regulatory ecosystem, far less attention has been paid to supporting such claims with large-scale, longitudinal data. In this paper, in addition to positing a model of regulatory ecosystems, we document an increase in the regulatory energy per filing, i.e., a warming "temperature." We also find that the diversity of the regulatory ecosystem has been increasing over the past two decades. These findings support the claim that regulatory activity and complexity are increasing, and this framework contributes an important step towards improving academic and policy discussions around legal complexity and regulation.

  14. Current and future applications of PRA in regulatory activities

    Energy Technology Data Exchange (ETDEWEB)

    Speis, T.P.; Murphy, J.A.; Cunningham, M.A. [Nuclear Regulatory Commission, Washington, DC (United States)] [and others

    1995-04-01

    Probabilistic Risk Assessments (PRAs) have proven valuable in providing the regulators, the nuclear plant operators, and the reactor designers insights into plant safety, reliability, design and operation. Both the NRC Commissioners and the staff have grown to appreciate the valuable contributions PRAs can have in the regulatory arena, though I will admit the existence of some tendencies for strict adherence to the deterministic approach within the agency and the public at large. Any call for change, particularly one involving a major adjustment in approach to the regulation of nuclear power, will meet with a certain degree of resistance and retrenchment. Change can appear threatening and can cause some to question whether the safety mission is being fulfilled. This skepticism is completely appropriate and is, in fact, essential to a proper transition towards risk and performance-based approaches. Our task in the Office of Nuclear Regulatory Research is to increase the PRA knowledge base within the agency and develop appropriate guidance and methods needed to support the transitioning process.

  15. Perspective Reforms for Approximation of the Ukrainian Legal Framework for Telecommunications

    DEFF Research Database (Denmark)

    Batura, Olga; Kretova, Olga A.

    2016-01-01

    This article studies Ukrainian legal and regulatory rules for telecommunications services markets against the backdrop of Ukrainian commitments under the GATS and especially the Association Agreement with the EU. The study elucidates to what extent the Ukrainian telecoms regulatory framework comp...

  16. Review of the Current State of UAV Regulations

    Directory of Open Access Journals (Sweden)

    Claudia Stöcker

    2017-05-01

    Full Text Available UAVs—unmanned aerial vehicles—facilitate data acquisition at temporal and spatial scales that still remain unachievable for traditional remote sensing platforms. However, current legal frameworks that regulate UAVs present significant barriers to research and development. To highlight the importance, impact, and diversity of UAV regulations, this paper provides an exploratory investigation of UAV regulations on the global scale. For this, the methodological approach consists of a research synthesis of UAV regulations, including a thorough literature review and a comparative analysis of national regulatory frameworks. Similarities and contrasting elements in the various national UAV regulations are explored including their statuses from the perspectives of past, present, and future trends. Since the early 2000s, countries have gradually established national legal frameworks. Although all UAV regulations have one common goal—minimizing the risks to other airspace users and to both people and property on the ground—the results reveal distinct variations in all the compared variables. Furthermore, besides the clear presence of legal frameworks, market forces such as industry design standards and reliable information about UAVs as public goods are expected to shape future developments.

  17. The landscape of fear conceptual framework: definition and review of current applications and misuses

    Directory of Open Access Journals (Sweden)

    Sonny S. Bleicher

    2017-09-01

    Full Text Available Landscapes of Fear (LOF, the spatially explicit distribution of perceived predation risk as seen by a population, is increasingly cited in ecological literature and has become a frequently used “buzz-word”. With the increase in popularity, it became necessary to clarify the definition for the term, suggest boundaries and propose a common framework for its use. The LOF, as a progeny of the “ecology of fear” conceptual framework, defines fear as the strategic manifestation of the cost-benefit analysis of food and safety tradeoffs. In addition to direct predation risk, the LOF is affected by individuals’ energetic-state, inter- and intra-specific competition and is constrained by the evolutionary history of each species. Herein, based on current applications of the LOF conceptual framework, I suggest the future research in this framework will be directed towards: (1 finding applied management uses as a trait defining a population’s habitat-use and habitat-suitability; (2 studying multi-dimensional distribution of risk-assessment through time and space; (3 studying variability between individuals within a population; (4 measuring eco-neurological implications of risk as a feature of environmental heterogeneity and (5 expanding temporal and spatial scales of empirical studies.

  18. Cogeneration and the regulatory framework of energy law; Kraft-Waerme-Kopplung und der energiewirtschaftliche Ordnungsrahmen

    Energy Technology Data Exchange (ETDEWEB)

    Cornehl, Angelika Bettina

    2009-06-15

    The present publication shows that the existing regulatory framework poses numerous impediments to cogeneration plants. This holds especially for industrial operators, but also for municipalities. It has prevented cogeneration from developing its full potential both as an element of competition and as a relief for the environment. Unlike industrial cogeneration plants, those serving the public energy supply at least enjoy the privilege of regional monopoly rights. In today's liberalised electricity market, however, this can be a burden for existing municipal plants which were installed under territorial protection and in many cases have incurred high cost levels and become inflexible and lacking in entrepreneurial spirit as a result. On account of its tendency to promote optimal resource input and efficiency, competition promises positive impulses for the use of cogeneration in small-scale heat grids, where high fuel efficiency matters more. A reform of the competition regime in the power economy would eliminate numerous impediments, particularly for industrial cogeneration operators. Good hopes for the future of cogeneration in a liberalised electricity and gas market are also nurtured by cooperative supply concepts and, within the large domain of services, opportunities held out by special contracting offers.

  19. Biosimilars in psoriasis: Clinical practice and regulatory perspectives in Latin America.

    Science.gov (United States)

    de la Cruz, Claudia; de Carvalho, André V E; Dorantes, Gladys L; Londoño Garcia, Angela M; Gonzalez, Cesar; Maskin, Matías; Podoswa, Nancy; Redfern, Jan S; Valenzuela, Fernando; van der Walt, Joelle; Romiti, Ricardo

    2017-01-01

    Latin American countries view biosimilar agents as an effective approach to curtail health-care expenditures while maintaining the safety and efficacy profile of their branded innovator comparators. To understand the complexities of the regulatory landscape and key therapeutic issues for use of biosimilars to treat moderate to severe psoriasis in Latin America, the International Psoriasis Council convened dermatology experts from Argentina, Brazil, Chile, Colombia and Mexico in October 2015 to review the definition, approval, marketing and future of biosimilars in each country and develop a consensus statement. The regulatory framework for marketing approval of biosimilars in Latin America is currently a mosaic of disparate, country-specific, regulatory review processes, rules and standards, with considerable heterogeneity in clarity and specificity. Regulations in Argentina, Brazil, Chile and Mexico have undergone multiple refinements whereas Colombia is finalizing draft guidelines. Verification of the similarity in quality, safety and efficacy of biosimilars to the innovator biologic remains a key challenge for policy makers and regulatory authorities. Other key regulatory challenges include: naming of agents and traceability, pharmacovigilance, extrapolation of indications, and interchangeability and substitution. An urgent need exists for more Latin American countries to establish national psoriasis registries and to integrate their common components into a multinational psoriasis network, thereby enhancing their interpretative power and impact. A Latin American psoriasis network similar to PSONET in Europe would assist health-care providers, pharmaceutical companies, regulators and patients to fully comprehend specific products being prescribed and dispensed and to identify potential regional trends or differences in safety or outcomes. © 2016 Japanese Dermatological Association.

  20. Risk Informed Assessment of Regulatory and Design Requirements for Future Nuclear Power Plants (Cooperative Agreement DE-FC03-99SF21902, Am. M004) Final Technical Report

    International Nuclear Information System (INIS)

    Ritterbusch, Stanley E.

    2003-01-01

    OAK-B135 Research under this project addresses the barriers to long term use of nuclear-generated electricity in the United States. It was agreed that a very basic and significant change to the current method of design and regulation was needed. That is, it was believed that the cost reduction goal could not be met by fixing the current system (i.e., an evolutionary approach) and a new, more advanced approach for this project would be needed. It is believed that a completely new design and regulatory process would have to be developed--a ''clean sheet of paper'' approach. This new approach would start with risk-based methods, would establish probabilistic design criteria, and would implement defense-in-depth only when necessary (1) to meet public policy issues (e.g., use of a containment building no matter how low the probability of a large release is) and (2) to address uncertainties in probabilistic methods and equipment performance. This new approach is significantly different from the Nuclear Regulatory Commission's (NRC) current risk-informed program for operating plants. For our new approach, risk-based methods are the primary means for assuring plant safety, whereas in the NRC's current approach, defense-in-depth remains the primary means of assuring safety. The primary accomplishments in the first year--Phase 1 were (1) the establishment of a new, highly risk-informed design and regulatory framework, (2) the establishment of the preliminary version of the new, highly risk-informed design process, (3) core damage frequency predictions showing that, based on new, lower pipe rupture probabilities, the design of the emergency core cooling system equipment can be simplified without reducing plant safety, and (4) the initial development of methods for including uncertainties in a new integrated structures-systems design model. Under the new regulatory framework, options for the use of ''design basis accidents'' were evaluated. It is expected that design basis

  1. Harnessing diversity towards the reconstructing of large scale gene regulatory networks.

    Directory of Open Access Journals (Sweden)

    Takeshi Hase

    Full Text Available Elucidating gene regulatory network (GRN from large scale experimental data remains a central challenge in systems biology. Recently, numerous techniques, particularly consensus driven approaches combining different algorithms, have become a potentially promising strategy to infer accurate GRNs. Here, we develop a novel consensus inference algorithm, TopkNet that can integrate multiple algorithms to infer GRNs. Comprehensive performance benchmarking on a cloud computing framework demonstrated that (i a simple strategy to combine many algorithms does not always lead to performance improvement compared to the cost of consensus and (ii TopkNet integrating only high-performance algorithms provide significant performance improvement compared to the best individual algorithms and community prediction. These results suggest that a priori determination of high-performance algorithms is a key to reconstruct an unknown regulatory network. Similarity among gene-expression datasets can be useful to determine potential optimal algorithms for reconstruction of unknown regulatory networks, i.e., if expression-data associated with known regulatory network is similar to that with unknown regulatory network, optimal algorithms determined for the known regulatory network can be repurposed to infer the unknown regulatory network. Based on this observation, we developed a quantitative measure of similarity among gene-expression datasets and demonstrated that, if similarity between the two expression datasets is high, TopkNet integrating algorithms that are optimal for known dataset perform well on the unknown dataset. The consensus framework, TopkNet, together with the similarity measure proposed in this study provides a powerful strategy towards harnessing the wisdom of the crowds in reconstruction of unknown regulatory networks.

  2. Regulatory cross-cutting topics for fuel cycle facilities.

    Energy Technology Data Exchange (ETDEWEB)

    Denman, Matthew R.; Brown, Jason; Goldmann, Andrew Scott; Louie, David

    2013-10-01

    This report overviews crosscutting regulatory topics for nuclear fuel cycle facilities for use in the Fuel Cycle Research & Development Nuclear Fuel Cycle Evaluation and Screening study. In particular, the regulatory infrastructure and analysis capability is assessed for the following topical areas: Fire Regulations (i.e., how applicable are current Nuclear Regulatory Commission (NRC) and/or International Atomic Energy Agency (IAEA) fire regulations to advance fuel cycle facilities) Consequence Assessment (i.e., how applicable are current radionuclide transportation tools to support risk-informed regulations and Level 2 and/or 3 PRA) While not addressed in detail, the following regulatory topic is also discussed: Integrated Security, Safeguard and Safety Requirement (i.e., how applicable are current Nuclear Regulatory Commission (NRC) regulations to future fuel cycle facilities which will likely be required to balance the sometimes conflicting Material Accountability, Security, and Safety requirements.)

  3. Regulatory frameworks for hydropower in Europe. Comparing the examples of Germany, France and the United Kingdom; Regulatorische Rahmenbedingungen fuer die Wasserkraftnutzung in Europa am Beispiel der Laender Deutschland, Frankreich und Grossbritannien

    Energy Technology Data Exchange (ETDEWEB)

    Krull, Devid; Schneider, Claus Till; Detering, Michael [innogy SE, Essen (Germany). Sparte Erneuerbare Energien; Logie, Andrew [innogy SE, Perth (United Kingdom). Hydro Development; Seyler, Juergen [Energies France S.A.S., Paris (France)

    2016-11-01

    The regulatory framework for hydro power in the European countries Germany, United Kingdom and France is compared. All have as a common target on the one hand an increase of the share of renewable energy production and to this means a support regime for hydro power among other renewable technologies. The respective support mechanisms in the three countries are summarised. As part of the implementation of the European Water Framework Directive the countries formulate stricter environmental requirements for water bodies leading to reduced electricity generation and necessary investments in technical adaptations.

  4. Regulatory inspection of BARC facilities

    International Nuclear Information System (INIS)

    Rajdeep; Jayarajan, K.

    2017-01-01

    Nuclear and radiation facilities are sited, constructed, commissioned, operated and decommissioned, in conformity with the current safety standards and codes. Regulatory bodies follow different means to ensure compliance of the standards for the safety of the personnel, the public and the environment. Regulatory Inspection (RI) is one of the important measures employed by regulatory bodies to obtain the safety status of a facility or project and to verify the fulfilment of the conditions stipulated in the consent

  5. 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.

  6. Regulation of Telecommunications: The Choice Between Market and Regulatory Failures

    Directory of Open Access Journals (Sweden)

    Dmitrii Trubnikov

    2017-04-01

    Full Text Available Purpose – The paper examines the main regulatory frameworks of the telecommunications industry through the concept of market failure and analyses how and why the policy often leads to undesirable outcomes that might be considered as regulatory failure. Methodology/approach/design – The research uses the EU regulatory framework for electronic communications as a base for the analysis of the main policy objectives through the prism of the market failure theory with an eye to the interests of the main market players in the telecommunications markets. Findings – About any aspect of regulation allows to find ways to create opportunities for some groups of the industry and stifle activity of others. Despite the theory of market failure provides reasonable justifications for regulation of telecommunications markets, it is possible to argue that many of these problems are mainly the consequence of the policy and could be better solved by market mechanisms. Originality/value – The results of the research allow to look at the problems of telecommunications development and issues of the high level of concentration of the telecommunications markets as regulatory formed problems rather than consequences of the inherited industry’s characteristics.

  7. Reviewing the regulatory barriers for nanomedicine: global questions and challenges.

    Science.gov (United States)

    Bowman, Diana M; Gatof, Jake

    2015-01-01

    Nanomedicine will play an increasing role in prevention and treatment across the entire healthcare spectrum. However, their precise market size, economic value and areas of application remain unclear. This opacity, including the question of what constitutes nanomedicine matters, especially when considered alongside the key regulatory questions and concerns. This article begins by placing these key questions into context in relation to the current scientific state of the art, focusing particular attention on the human health and safety context. In exploring these central questions surrounding the regulation of nanomedicine, this perspective also explores existing and suggested frameworks that aim to deal with emerging technologies more generally. It then outlines priority areas for action and general conclusions specific to nanomedicine.

  8. Framework for continuous performance improvement in small drinking water systems.

    Science.gov (United States)

    Bereskie, Ty; Haider, Husnain; Rodriguez, Manuel J; Sadiq, Rehan

    2017-01-01

    Continuous performance improvement (CPI) can be a useful approach to overcome water quality problems impacting small communities. Small drinking water systems (SDWSs) struggle to meet regulatory requirements and often lack the economic and human resource flexibility for immediate improvement. A CPI framework is developed to provide SDWS managers and operators an approach to gauge their current performance against similar systems and to track performance improvement from the implementation of the new technologies or innovations into the future. The proposed CPI framework incorporates the use of a water quality index (WQI) and functional performance benchmarking to evaluate and compare drinking water quality performance of an individual water utility against that of a representative benchmark. The results are then used to identify and prioritize the most vulnerable water quality indicators and subsequently identify and prioritize performance improvement strategies. The proposed CPI framework has been demonstrated using data collected from SDWSs in the province of Newfoundland and Labrador (NL), Canada and using the Canadian Council of Ministers of the Environment (CCME) WQI. Copyright © 2016 Elsevier B.V. All rights reserved.

  9. Regulatory Safety Requirements for Operating Nuclear Installations

    International Nuclear Information System (INIS)

    Gubela, W.

    2017-01-01

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

  10. Regulatory pathways for vaccines for developing countries.

    Science.gov (United States)

    Milstien, Julie; Belgharbi, Lahouari

    2004-01-01

    Vaccines that are designed for use only in developing countries face regulatory hurdles that may restrict their use. There are two primary reasons for this: most regulatory authorities are set up to address regulation of products for use only within their jurisdictions and regulatory authorities in developing countries traditionally have been considered weak. Some options for regulatory pathways for such products have been identified: licensing in the country of manufacture, file review by the European Medicines Evaluation Agency on behalf of WHO, export to a country with a competent national regulatory authority (NRA) that could handle all regulatory functions for the developing country market, shared manufacturing and licensing in a developing country with competent manufacturing and regulatory capacity, and use of a contracted independent entity for global regulatory approval. These options have been evaluated on the basis of five criteria: assurance of all regulatory functions for the life of the product, appropriateness of epidemiological assessment, applicability to products no longer used in the domestic market of the manufacturing country, reduction of regulatory risk for the manufacturer, and existing rules and regulations for implementation. No one option satisfies all criteria. For all options, national infrastructures (including the underlying regulatory legislative framework, particularly to formulate and implement local evidence-based vaccine policy) must be developed. WHO has led work to develop this capacity with some success. The paper outlines additional areas of action required by the international community to assure development and use of vaccines needed for the developing world. PMID:15042235

  11. 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)

  12. Print Me an Organ? Ethical and Regulatory Issues Emerging from 3D Bioprinting in Medicine.

    Science.gov (United States)

    Gilbert, Frederic; O'Connell, Cathal D; Mladenovska, Tajanka; Dodds, Susan

    2018-02-01

    Recent developments of three-dimensional printing of biomaterials (3D bioprinting) in medicine have been portrayed as demonstrating the potential to transform some medical treatments, including providing new responses to organ damage or organ failure. However, beyond the hype and before 3D bioprinted organs are ready to be transplanted into humans, several important ethical concerns and regulatory questions need to be addressed. This article starts by raising general ethical concerns associated with the use of bioprinting in medicine, then it focuses on more particular ethical issues related to experimental testing on humans, and the lack of current international regulatory directives to guide these experiments. Accordingly, this article (1) considers whether there is a limit as to what should be bioprinted in medicine; (2) examines key risks of significant harm associated with testing 3D bioprinting for humans; (3) investigates the clinical trial paradigm used to test 3D bioprinting; (4) analyses ethical questions of irreversibility, loss of treatment opportunity and replicability; (5) explores the current lack of a specific framework for the regulation and testing of 3D bioprinting treatments.

  13. Resolution 127/012. It approve the fuel quality 50-S Oil Gas characteristics within the framework of Technical Quality Specifications Rules for liquid fuel

    International Nuclear Information System (INIS)

    2012-01-01

    This resolution approves the initiative of Ancap fuel quality 50-S Oil Gas characteristics within the framework of Technical Quality Specifications Rules for liquid fuel. This resolution is according to the opinion of the National Energy Regulatory Unit and the Energy and Water Services in relation with the requirements of the current rule.

  14. 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)

  15. South African safety assessment framework for the pebble bed modular reactor - HTR2008-58192

    International Nuclear Information System (INIS)

    Joubert, J.; Kohtz, N.; Coe, I.

    2008-01-01

    It is planned to construct a first of a kind Pebble Bed Modular Reactor (PBMR) in South Africa. A need has been recognized to accompany the licensing process for the PBMR with independent safety assessments to ensure that the safety case submitted by the applicant complies with the licensing requirements of the NNR. At the HTR 2006 Conference, the framework and major challenges on safety assessment that the South African National Nuclear Regulator (NNR) faces in developing and applying appropriate strategies and tools were presented. This paper discusses the current status of the various NNR assessment activities and describes how this will be considered in the NNR Final Report on the PBMR Safety Case. The traditional safety assessment process has been adapted to take into account the developmental nature of the project. By performing safety assessments, the designer and applicant must ensure that the design as proposed for construction and as-built meets the safety requirements defined by the regulatory framework. The regulator performs independent safety assessments, including independent analyses in areas deemed safety significant and potentially safety significant. The developmental nature of the project also led to the identification of a series of regulatory assessment activities preceding the formal assessment of the safety case. Besides an assessment of the resolution of Key Licensing Issues which have been defined in an early stage of the project and are discussed in /l/, these activities comprise the participation in an SAR Early Intervention Process, the execution of a regulatory HAZOP and the development of a regulatory assessment specification for the formal assessment of the safety case. This paper briefly describes these activities and their current status. During the last two years, significant progress was made with the development or adjustment of tools for the independent analysis by the regulator of the steady state core design, of the transient

  16. Regulatory system reform of occupational health and safety in China.

    Science.gov (United States)

    Wu, Fenghong; Chi, Yan

    2015-01-01

    With the explosive economic growth and social development, China's regulatory system of occupational health and safety now faces more and more challenges. This article reviews the history of regulatory system of occupational health and safety in China, as well as the current reform of this regulatory system in the country. Comprehensive, a range of laws, regulations and standards that promulgated by Chinese government, duties and responsibilities of the regulatory departments are described. Problems of current regulatory system, the ongoing adjustments and changes for modifying and improving regulatory system are discussed. The aim of reform and the incentives to drive forward more health and safety conditions in workplaces are also outlined.

  17. Nuclear energy and Indian society: Public engagement, risk assessment and legal frameworks - Summary of the proceedings

    International Nuclear Information System (INIS)

    Kini, Els Reynaers; Dipankar Bandyopadhyay, I.; Kanwar, Bhanudey

    2014-01-01

    The Nuclear Law Association (NLA) has organised its 3. Annual Meeting with the specific aim to deliberate on public engagement, consultation and acceptance of nuclear energy projects. The meeting further aimed to seek a better understanding of the necessary legal framework for a safe nuclear energy program in India. The themes covered by the conference were: Public engagement, consultation and acceptance; Nuclear energy safety and public discourse; Case studies from India on public engagement; Land acquisition and EIA in India; Safety regulations and its enforcement; Nuclear regulatory institutions; Siting, consent and project execution; Nuclear liability and compensation. The meeting was organised in 3 sessions dealing with: 1 - Public engagement, consultation and acceptance of nuclear projects: - Sociological context of public engagement and consultation, - Current state of affairs and new approaches to public consultation, - Case studies from new green field nuclear project sites, - Public opinion and acceptability for nuclear energy projects, - Role of State, NGOs and Public; 2 - Vales, Attitudes and Acceptability - Lessons from other countries: - Fukushima and nuclear energy choices, - Social dimensions of nuclear power, - Public engagement, acceptance and regulatory process, - Management of HLW. 3 - Legal Framework for a Safe and Secure Nuclear Energy Program: - Safety regulations and its enforcement, - Nuclear regulatory institutions, - Siting, consent and project execution, - Environmental impact assessments and plans, - Nuclear liability and compensation. Several of the papers presented will be published in the Journal of Risk Research in early 2015 as part of the Special Issue on Nuclear Energy and Indian Society: Public Engagement, Risk Assessment and Legal Frameworks. This article is the summary of the proceedings

  18. 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)

  19. 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)

  20. Regulatory and law framework of agricultural methanization and composting activities. User's guide

    International Nuclear Information System (INIS)

    2008-08-01

    After a presentation of the general context of organic waste management (its techniques, materials, legal and regulatory sources, i.e. European and French laws), this guide indicates the main regulatory and law aspects to those wishing to implement a project of methanization or composting of organic by-products in the agricultural sector. Several aspects are therefore discussed and presented in practical sheets. They concern the health and environment regulation, but not the professional risk prevention (explosion, fire, and so on). These aspects are the project setting up, input materials (animal by-products, organic materials coming from agricultural production or from out of it), waste collection and transport, process steps, organic product valorization, biogas valorization, solid and liquid release management

  1. Regulatory system reform of occupational health and safety in China

    Science.gov (United States)

    WU, Fenghong; CHI, Yan

    2015-01-01

    With the explosive economic growth and social development, China’s regulatory system of occupational health and safety now faces more and more challenges. This article reviews the history of regulatory system of occupational health and safety in China, as well as the current reform of this regulatory system in the country. Comprehensive, a range of laws, regulations and standards that promulgated by Chinese government, duties and responsibilities of the regulatory departments are described. Problems of current regulatory system, the ongoing adjustments and changes for modifying and improving regulatory system are discussed. The aim of reform and the incentives to drive forward more health and safety conditions in workplaces are also outlined. PMID:25843565

  2. Reactor safety research program. A description of current and planned reactor safety research sponsored by the Nuclear Regulatory Commission's Division of Reactor Safety Research

    International Nuclear Information System (INIS)

    1975-06-01

    The reactor safety research program, sponsored by the Nuclear Regulatory Commission's Division of Reactor Safety Research, is described in terms of its program objectives, current status, and future plans. Elements of safety research work applicable to water reactors, fast reactors, and gas cooled reactors are presented together with brief descriptions of current and planned test facilities. (U.S.)

  3. Characteristics of regulatory regimes

    Directory of Open Access Journals (Sweden)

    Noralv Veggeland

    2013-03-01

    Full Text Available The overarching theme of this paper is institutional analysis of basic characteristics of regulatory regimes. The concepts of path dependence and administrative traditions are used throughout. Self-reinforcing or positive feedback processes in political systems represent a basic framework. The empirical point of departure is the EU public procurement directive linked to OECD data concerning use of outsourcing among member states. The question is asked: What has caused the Nordic countries, traditionally not belonging to the Anglo-Saxon market-centred administrative tradition, to be placed so high on the ranking as users of the Market-Type Mechanism (MTM of outsourcing in the public sector vs. in-house provision of services? A thesis is that the reason may be complex, but might be found in an innovative Scandinavian regulatory approach rooted in the Nordic model.

  4. Regulatory research / Pesquisa regulatória

    Directory of Open Access Journals (Sweden)

    Altair Souza de Assis

    2013-05-01

    Full Text Available We present in this paper the concept, importance, and scope of research into the regulatory framework of regulation and legislation, with a particular focus on legislation related to legal metrology. This study also describes a comparative analysis of the various forms of regulation and the associated regulatory research, with the ultimate goal of better defi ning the concept and to validate the need to have research groups within a country’s regulatory bodies. Based on this work, we conclude that regulatory research is a key factor in the success of any regulatory body’s activities. Such research helps to avoid the creation of absurd or impractical regulatory barriers to a country’s technological development, or worse, to permit “orphans,” that is, technologies that are outside regulatory control, as is currently the case. Indeed, for a country to have a robust technological infrastructure, especially if it is still a developing country, strong and competent regulatory control is essential. However, this must be balanced by an atmosphere that fosters continuous and consistent technological innovation, and such development must also be self-sustainable from economic, social, and environmental viewpoints. ------------------------------------------------ Apresenta-se neste trabalho o conceito, a importância e a abrangência da pesquisa regulatória no âmbito da regulação e da regulamentação, com foco particular na regulamentação relacionada à metrologia legal. Faz-se também uma análise comparativa entre as várias formas de regular e regulamentar, e as suas pesquisas regulatórias afi ns, tendo como meta principal situar melhor o conceito e validar a necessidade de se fazer pesquisa nos órgãos e agências regulatórias do país. Com base neste trabalho, concluímos que a pesquisa regulatória é um fator chave para o sucesso de qualquer plano de ação de regulação para os agentes regulatórios do país. Ela ajuda a

  5. The Preliminary Review for the Cross-Cutting Issues in the US Nuclear Regulatory Inspection Framework

    International Nuclear Information System (INIS)

    Lee, Yong Suk; Jung, Dae Wook; Cho, Nam Chul

    2008-01-01

    The research for the development of risk-informed and performance-based regulatory inspection is ongoing in KINS. In the USNRC, the cross-cutting issue is one of the main components the risk-informed and performance-based regulatory inspection process as shown in figure 1, which is named as ROP (Reactor Oversight Process). The following three cross-cutting areas implicitly affect all of the safety cornerstones in ROP. In this study, the preliminary review for the inspection practices of cross-cutting issues in the US and Korean safety regulatory system were performed. The elements of the cross-cutting issues were recently modified to emphasize the importance of safety culture, and the graded approach was applied for the inspection of cross-cutting issues in USNRC. The graded approach for the inspection of cross-cutting issues will be also needed to Korean safety regulatory system in the future

  6. The Preliminary Review for the Cross-Cutting Issues in the US Nuclear Regulatory Inspection Framework

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Yong Suk; Jung, Dae Wook [Future and Challenges Inc., Seoul (Korea, Republic of); Cho, Nam Chul [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2008-10-15

    The research for the development of risk-informed and performance-based regulatory inspection is ongoing in KINS. In the USNRC, the cross-cutting issue is one of the main components the risk-informed and performance-based regulatory inspection process as shown in figure 1, which is named as ROP (Reactor Oversight Process). The following three cross-cutting areas implicitly affect all of the safety cornerstones in ROP. In this study, the preliminary review for the inspection practices of cross-cutting issues in the US and Korean safety regulatory system were performed. The elements of the cross-cutting issues were recently modified to emphasize the importance of safety culture, and the graded approach was applied for the inspection of cross-cutting issues in USNRC. The graded approach for the inspection of cross-cutting issues will be also needed to Korean safety regulatory system in the future.

  7. Prevention as a main objective in the regulatory practices relating to research reactors

    International Nuclear Information System (INIS)

    Waldman, Ricardo M.

    2006-01-01

    In Argentina the use of research reactors and critical facilities are very diverse, varying since the production of radionuclides, to the investigation or the teaching. Also diverse are the licensing characteristics, going from the National Atomic Energy Commission-Argentina to national universities. The strategy utilized for the regulatory control is based especially in the prevention. The prevention covers: regulatory framework, to emit standards and regulatory guides, to licensing installations and the personnel. (author) [es

  8. Framework for applying probabilistic safety analysis in nuclear regulation

    International Nuclear Information System (INIS)

    Dimitrijevic, V.B.

    1997-01-01

    The traditional regulatory framework has served well to assure the protection of public health and safety. It has been recognized, however, that in a few circumstances, this deterministic framework has lead to an extensive expenditure on matters hat have little to do with the safe and reliable operation of the plant. Developments of plant-specific PSA have offered a new and powerful analytical tool in the evaluation of the safety of the plant. Using PSA insights as an aid to decision making in the regulatory process is now known as 'risk-based' or 'risk-informed' regulation. Numerous activities in the U.S. nuclear industry are focusing on applying this new approach to modify regulatory requirements. In addition, other approaches to regulations are in the developmental phase and are being evaluated. One is based on the performance monitoring and results and it is known as performance-based regulation. The other, called the blended approach, combines traditional deterministic principles with PSA insights and performance results. (author)

  9. 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

  10. Synchronous versus asynchronous modeling of gene regulatory networks.

    Science.gov (United States)

    Garg, Abhishek; Di Cara, Alessandro; Xenarios, Ioannis; Mendoza, Luis; De Micheli, Giovanni

    2008-09-01

    In silico modeling of gene regulatory networks has gained some momentum recently due to increased interest in analyzing the dynamics of biological systems. This has been further facilitated by the increasing availability of experimental data on gene-gene, protein-protein and gene-protein interactions. The two dynamical properties that are often experimentally testable are perturbations and stable steady states. Although a lot of work has been done on the identification of steady states, not much work has been reported on in silico modeling of cellular differentiation processes. In this manuscript, we provide algorithms based on reduced ordered binary decision diagrams (ROBDDs) for Boolean modeling of gene regulatory networks. Algorithms for synchronous and asynchronous transition models have been proposed and their corresponding computational properties have been analyzed. These algorithms allow users to compute cyclic attractors of large networks that are currently not feasible using existing software. Hereby we provide a framework to analyze the effect of multiple gene perturbation protocols, and their effect on cell differentiation processes. These algorithms were validated on the T-helper model showing the correct steady state identification and Th1-Th2 cellular differentiation process. The software binaries for Windows and Linux platforms can be downloaded from http://si2.epfl.ch/~garg/genysis.html.

  11. Upgrading nuclear regulatory infrastructure in Armenia

    International Nuclear Information System (INIS)

    Martirosyan, A.; Amirjanyan, A.; Kacenelenbogen, S.

    2010-01-01

    Armenia is contemplating an upgrade to its national power generation capacity to meet replacement and future energy needs. Unit 2 of ANPP is scheduled for shutdown after replacement power generation capacities are in place. A recent alternative energy study indicates viability of the nuclear option to replace this capacity. Some technology-specific proposals are being considered by the Ministry of Energy of Armenia. It is likely that the reactor technology decision will be made in the not too distant future. The existing reactor continues to be operated in the regulatory framework developed in the Soviet Union and adopted in Armenia. Given the interest in the new reactor, Armenia launched a project to review the existing system of regulation and to bring it into harmony with modern practice in preparation for the new reactor project development. The new regulatory framework will be needed as a basis for any potential tendering process. The US NRC and ANRA have agreed to perform a review and update nuclear legislation and the system of regulation in this area. The first step in this process was to develop an action plan for such program. The action plan describes the overall strategy of ANRA to modify existing or develop new processes and requirements, identifies the major Laws that need to be reviewed given practical legal considerations to construct and operate the reactor and Armenia's international obligations under various conventions. This work included review of existing models of regulation in different countries with 'small' nuclear program, including IAEA recommendations as well as existing legislation in Armenia in this area and development of a strategy for the regulatory model development. In addition, the plan to develop requirements for ANRA staffing and training needs to meet its regulatory obligations under the new reactor development process was developed

  12. International Nuclear and Radiation Safety Experts Conclude IAEA Peer Review of Slovenia's Regulatory System

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: An international team of senior nuclear safety experts today concluded a 10-day mission to review the regulatory framework for nuclear and radiation safety in Slovenia. 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 Slovenia and a final report will be submitted by the end of 2011. At the request of the Slovenian Government, the IAEA assembled a team of 10 senior regulatory experts from nine nations to conduct the Integrated Regulatory Review Service (IRRS) mission involving the Slovenian Nuclear Safety Administration (SNSA). The mission is a peer review based on the IAEA Safety Standards. Andrej Stritar, Director of Slovenian Nuclear Safety Administration, stressed ''how important it is for a small country like Slovenia to tightly follow international standards in the area of nuclear safety.'' He also expressed his gratitude to the IAEA, and the countries from which team members came, for their support and for their intensive work during the last ten days. Mission Team Leader Colin Patchett, Deputy Chief Inspector from the UK's Office for Nuclear Regulation commended ''the Slovenian authorities for their commitment to nuclear and radiation safety regulation and for sharing their experience.'' The IRRS team reviewed Slovenia's current regulatory framework and all SNSA-regulated facilities and activities, as well as the regulatory implications of the TEPCO Fukushima Daiichi accident. The IRRS team identified particular strengths in the Slovenian regulatory system, including: Through its legal framework, the Slovenian government has appointed SNSA to regulate its nuclear safety program and SNSA has in place an effective process for carrying out this responsibility; and Slovenia's response to the accident at the TEPCO Fukushima Daiichi power plant has been prompt and effective. Communications with the public, development of actions for improvement

  13. 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)

  14. Normative framework for combating trafficking in human organs

    Directory of Open Access Journals (Sweden)

    Banović Božidar

    2017-01-01

    Full Text Available Trafficking in human organs is a specific and complex criminal phenomenon that takes place in several phases, with the participation of a large number of actors, often covering several jurisdictions. To effectively countering are necessary conceptual and terminological demarcation of organ trafficking from other similar phenomena, fundamental scientifically research of its shape and dynamics, and the construction of an adequate legislative framework, both at the national and international level. This paper first analyses the conceptual - terminological framework in which research of organ trafficking is range, and then presents a review and analysis of the development of ethical and normative international standards aimed at prevention and suppression this phenomenon. In the end, we analysed the current solutions in the domestic legislation. Nowadays, there are two parallel legislative regime that regulate the matter of organ trafficking. The first legislative regime that organ trafficking treated exclusively as a modality of transnational crime of human trafficking, and a second, recent, that organ trafficking treats as forbidden (incriminating activity that violates a regulatory system of organ (tissue cells transplantation.

  15. Preliminary Consideration for the Development of Regulatory Level 2 PSA Model

    International Nuclear Information System (INIS)

    Lee, Chang-Ju

    2006-01-01

    In order to assess the validity of PSA (probabilistic safety assessment) results and to establish regulatory requirements for relevant safety issues most of the regulators want to develop an independent and convenient risk assessment model including Level 2 PSA area. As this model and framework should be implicitly independent on the licensee's PSA model, it has a primary objective directly for applying to the risk-informed regulatory affairs and for supporting those kinds of works. According this, the regulator can take an objective view for the uncertainty of risk information made by the licensee and keep up the capability and decision-making framework for overall risk assessment results. In addition, the regulatory model may be used to verify and validate the operational risk levels of all engineered safety features of nuclear power plants (NPPs). An issue for plant-specific application of safety goals was previously identified in the US NRC's risk-informed regulatory guidance development activities, and discussed in many Commission papers, e. g. SECY-97-287, which identifies the goal for large early release frequency (LERF). LERF defines a containment performance criteria derived from the quantitative health objectives. As we know, the LERF was chosen to assess risk significance in Regulatory Guide 1.174 (2002) again, which provides one measure of the performance of the containment barrier, and represents a surrogate for early health effects

  16. Policy and Regulatory Challenges in the Tourism Collaborative Economy

    DEFF Research Database (Denmark)

    Dredge, Dianne

    2017-01-01

    The choice of policy approach and regulatory framework in dealing with the collaborative economy rests on two fundamental factors—that government decisions should be based on good sound knowledge and that this knowledge should be above politics. In the newly emerging and rapidly growing collabora......The choice of policy approach and regulatory framework in dealing with the collaborative economy rests on two fundamental factors—that government decisions should be based on good sound knowledge and that this knowledge should be above politics. In the newly emerging and rapidly growing......-sectors of the collaborative economy. However, these solutions are often based on assumptions about government sovereignty and power relations that do not necessarily apply in the slippery global world of platform capitalism. This chapter seeks to undertake a critical exploration of the factors and values that permeate...

  17. Optimizing participation of children with autism spectrum disorder experiencing sensory challenges: a clinical reasoning framework.

    Science.gov (United States)

    Ashburner, Jill K; Rodger, Sylvia A; Ziviani, Jenny M; Hinder, Elizabeth A

    2014-02-01

    Remedial sensory interventions currently lack supportive evidence and can be challenging to implement for families and clinicians. It may be timely to shift the focus to optimizing participation of children with autism spectrum disorders (ASD) through accommodation and self-regulation of their sensory differences. A framework to guide practitioners in selecting strategies is proposed based on clinical reasoning considerations, including (a) research evidence, (b) client- and family-centredness, (c) practice contexts, (d) occupation-centredness, and (e) risks. Information-sharing with families and coaching constitute the basis for intervention. Specific strategies are identified where sensory aversions or seeking behaviours, challenges with modulation of arousal, or sensory-related behaviours interfere with participation. Self-regulatory strategies are advocated. The application of universal design principles to shared environments is also recommended. The implications of this framework for future research, education, and practice are discussed. The clinical utility of the framework now needs to be tested.

  18. Safety Experts Complete IAEA Nuclear Regulatory Review of the United States

    International Nuclear Information System (INIS)

    2010-01-01

    Full text: An international team of senior nuclear safety experts today completed a two-week International Atomic Energy Agency (IAEA) review of the governmental and regulatory framework for nuclear safety in the United States. The team identified good practices within the U.S. system and offered suggestions for ways the U.S. Nuclear Regulatory Commission (NRC) could improve. The IAEA has conveyed the team's main conclusions to the NRC, and a final report will be submitted to the NRC in about two months. At the request of the United States, the IAEA assembled a team of 19 international experts to conduct an Integrated Regulatory Review Service (IRRS) mission. This mission was a peer review based on the IAEA Safety Standards. It was not an inspection, nor an audit. The experts came from 14 different countries: Canada, China, the Czech Republic, Finland, France, Italy, Japan, Mexico, the Republic of Korea, Slovenia, Spain, Sweden, Switzerland, and the United Kingdom. Team leader Jukka Laaksonen of Finland said: ''We found a comprehensive, consistent, and mature regulatory system run by the NRC, which has a strong drive for continuous improvement.' The scope of the mission included the U.S. regulatory framework and the regulation of the nuclear plant operation. The mission was conducted from 18 to 29 October, mainly at NRC headquarters outside of Washington, D.C. To study U.S. regulatory activities, the mission conducted a series of interviews and discussions with NRC staff and other organizations to help assess the effectiveness of the regulatory system. In addition, the team observed regulatory activities at two operating nuclear power reactors and an emergency preparedness exercise. The IAEA's IRRS coordinator Gustavo Caruso said, ''This mission represents a milestone for the IRRS program because the U.S. regulatory system is the largest in the world and many nations look to it. The IRRS is a useful tool that allows host nations to gain guidance from experienced

  19. First update to the US Nuclear Regulatory Commission's regulatory strategy for the high-level waste repository program

    International Nuclear Information System (INIS)

    Johnson, R.L.; Linehan, J.J.

    1991-01-01

    The US Nuclear Regulatory Commission (NRC) staff has updated its initial regulatory strategy for the High-Level Waste Repository Licensing Program. The update describes changes to the initial strategy and summarizes progress and future activities. This paper summarizes the first update of the regulatory strategy. In general the overall strategy of identifying and reducing uncertainties is unchanged. Identifying regulatory and institutional uncertainties is essentially complete, and therefore, the current and future emphasis is on reducing those regulatory and institutional uncertainties identified to date. The NRC staff has improved the methods of reducing regulatory uncertainties by (1) enhancing the technical basis preparation process for potential rulemakings and guidance and (2) designing a new guidance document, called a staff position, for clarifying regulatory uncertainties. For guiding the US DOE's reduction of technical uncertainties, the NRC staff will give more emphasis to prelicense application reviews and less emphasis on preparing staff technical positions

  20. A Formal Framework on the Semantics of Regulatory Relations and Their Presence as Verbs in Biomedical Texts

    DEFF Research Database (Denmark)

    Zambach, Sine

    2009-01-01

    Relations used in biomedical ontologies and expressed in biomedical texts can be very general or very specific. Regulatory relations are used widely in regulatory networks, for example, and therefore they appear systematically and highly frequently in biomedical texts. This work focuses on the lo......Relations used in biomedical ontologies and expressed in biomedical texts can be very general or very specific. Regulatory relations are used widely in regulatory networks, for example, and therefore they appear systematically and highly frequently in biomedical texts. This work focuses...

  1. A framework for secure and decentralized sharing of medical imaging data via blockchain consensus.

    Science.gov (United States)

    Patel, Vishal

    2018-04-01

    The electronic sharing of medical imaging data is an important element of modern healthcare systems, but current infrastructure for cross-site image transfer depends on trust in third-party intermediaries. In this work, we examine the blockchain concept, which enables parties to establish consensus without relying on a central authority. We develop a framework for cross-domain image sharing that uses a blockchain as a distributed data store to establish a ledger of radiological studies and patient-defined access permissions. The blockchain framework is shown to eliminate third-party access to protected health information, satisfy many criteria of an interoperable health system, and readily generalize to domains beyond medical imaging. Relative drawbacks of the framework include the complexity of the privacy and security models and an unclear regulatory environment. Ultimately, the large-scale feasibility of such an approach remains to be demonstrated and will depend on a number of factors which we discuss in detail.

  2. Methodology For Evaluation Of Regulatory Effectiveness In Physical Protection

    International Nuclear Information System (INIS)

    Izmaylov, Alexander; Valente, John; Griggs, James R.; Rexroth, Paul; Piskarev, Alexander; Babkin, Vladimir; Sokolov, Egor; Melton, Ronald B.; Cunningham, Mitchel E.; Baker, Kathryn A.; Brothers, Alan J.

    2005-01-01

    Material protection, control, and accounting (MPC and A) regulatory documents play an important role in securing and protecting nuclear material by regulating a variety of activities at different hierarchical levels. The development, implementation, and practical application of these regulatory documents requires a significant investment of financial and material resources. Therefore, it is important to evaluate the effectiveness of the regulatory development process and the extent to which regulations improve the effectiveness of MPC and A at nuclear sites. The joint Russian and U.S. Regulatory Development Project has a goal of evaluating the effectiveness of regulatory documents developed for MPC and A. As part of this joint Project, a methodology for evaluating effectiveness has been developed. This methodology was developed around physical protection objectives. The developed methodology specifies physical protection objectives to be accomplished through the implementation of a regulatory system based on the physical protection goals at the nuclear sites. It includes approaches to assessing regulatory effectiveness, the hierarchical structure of physical protection objectives to be accomplished through implementing regulations, a 'mapping' of the physical protection objectives to the regulatory framework, a list of criteria for evaluating the effectiveness of physical protection regulations and effectiveness indicators, as well as means and methods for gathering information and implementation of this evaluation.

  3. T-regulatory cells in chronic rejection versus stable grafts.

    Science.gov (United States)

    Al-Wedaie, Fatima; Farid, Eman; Tabbara, Khaled; El-Agroudy, Amgad E; Al-Ghareeb, Sumaya M

    2015-04-01

    Studying regulatory T cells in kidney allograft acceptance versus chronic rejection may help in the understanding of more mechanisms of immune tolerance and, in the future, may enable clinicians to induce immune tolerance and decrease the use of immunosuppressive drugs. The aim of the current study was to evaluate regulatory T cells in kidney transplant patients with stable graft versus transplant with biopsy-proven chronic rejection. The 3 groups that were studied included: kidney transplanted patients with no rejection episodes (n = 43); transplanted patients with biopsy-proven renal rejection (n = 27); and healthy age-matched nontransplanted individuals as controls (n = 42).The percentage of regulatory T cells (CD4+CD25+Foxp3+) in blood was determined by flow cytometry. The regulatory T cell percentage was significantly lower in chronic rejection patients than control or stable graft groups. No significant difference was observed in regulatory T cell percentage between the stable graft and control groups. In the stable graft group, patients on rapamycin had a significantly higher regulatory T cell percentage than patients on cyclosporine. No effect of donor type, infection, or duration after transplant was observed on regulatory T cell percentage. The results of the current study are consistent with previous studies addressing the function of regulatory T cells in inducing immunotolerance after kidney transplant. Considering the established role of regulatory T cells in graft maintenance and our observation of high regulatory T cell percentage in patients receiving rapamycin than cyclosporine, we recommend including rapamycin when possible in immunosuppressive protocols. The findings from the current study on the chronic rejection group support ongoing research of having treatment with regulatory T cells, which may constitute a novel, efficient antirejection therapy in the future.

  4. Strengthening the Canadian alcohol advertising regulatory system.

    Science.gov (United States)

    Heung, Carly M; Rempel, Benjamin; Krank, Marvin

    2012-05-24

    Research evidence points to harmful effects from alcohol advertising among children and youth. In particular, exposure to alcohol advertising has been associated with adolescents drinking both earlier and heavier. Although current federal and provincial guidelines have addressed advertising practices to prevent underage drinking, practice has not been supported by existing policy. While protective measures such as social marketing campaigns have the potential for counteracting the effects from alcohol advertising, the effectiveness of such measures can be easily drowned out with increasing advertising activities from the alcohol industry, especially without effective regulation. Research reviewed by the European Focus on Alcohol Safe Environment (FASE) Project has identified a set of key elements that are necessary to make alcohol advertising policy measures effective at protecting children and youth from the harmful effects of alcohol marketing. Using these key elements as an evaluation framework, there are critical components in the Canadian alcohol advertising regulatory system that clearly require strengthening. To protect impressionable children and youth against the harmful effects of alcohol advertising, 13 recommendations to strengthen current alcohol advertising regulations in Canada are provided for Canadian policy-makers, advertising standard agencies, and public health groups.

  5. An expanded conceptual framework for solution-focused management of chemical pollution in European waters.

    Science.gov (United States)

    Munthe, John; Brorström-Lundén, Eva; Rahmberg, Magnus; Posthuma, Leo; Altenburger, Rolf; Brack, Werner; Bunke, Dirk; Engelen, Guy; Gawlik, Bernd Manfred; van Gils, Jos; Herráez, David López; Rydberg, Tomas; Slobodnik, Jaroslav; van Wezel, Annemarie

    2017-01-01

    This paper describes a conceptual framework for solutions-focused management of chemical contaminants built on novel and systematic approaches for identifying, quantifying and reducing risks of these substances. The conceptual framework was developed in interaction with stakeholders representing relevant authorities and organisations responsible for managing environmental quality of water bodies. Stakeholder needs were compiled via a survey and dialogue. The content of the conceptual framework was thereafter developed with inputs from relevant scientific disciplines. The conceptual framework consists of four access points: Chemicals, Environment, Abatement and Society, representing different aspects and approaches to engaging in the issue of chemical contamination of surface waters. It widens the scope for assessment and management of chemicals in comparison to a traditional (mostly) perchemical risk assessment approaches by including abatement- and societal approaches as optional solutions. The solution-focused approach implies an identification of abatement- and policy options upfront in the risk assessment process. The conceptual framework was designed for use in current and future chemical pollution assessments for the aquatic environment, including the specific challenges encountered in prioritising individual chemicals and mixtures, and is applicable for the development of approaches for safe chemical management in a broader sense. The four access points of the conceptual framework are interlinked by four key topics representing the main scientific challenges that need to be addressed, i.e.: identifying and prioritising hazardous chemicals at different scales; selecting relevant and efficient abatement options; providing regulatory support for chemicals management; predicting and prioritising future chemical risks. The conceptual framework aligns current challenges in the safe production and use of chemicals. The current state of knowledge and implementation

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

    International Nuclear Information System (INIS)

    Ito, Juichiro; Takita, Masami

    2011-01-01

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

  7. Elements to evaluate the intention in the non-compliance s or violations to the regulatory framework in the national nuclear facilities

    International Nuclear Information System (INIS)

    Espinosa V, J. M.; Gonzalez V, J. A.

    2013-10-01

    Inside the impact evaluation process to the safety of non-compliance s or violations, developed and implanted by the Comision Nacional de Seguridad Nuclear y Salvaguardias (CNSNS), the Guide for the Impact Evaluation to the Safety in the National Nuclear Facilities by Non-compliance s or Violations to the Regulatory Framework was developed, which indicates that in the determination of the severity (graveness level) of a non-compliance or violation, four factors are evaluated: real and potential consequences to the safety, the impact to the regulator process and the intention. The non-compliance s or intentional violations are of particular interest, since the development of the regulatory activities of the CNSNS considers that the personnel of the licensees, as well as their contractors, will act and will communicate with integrity and honesty. The CNSNS cannot tolerate intentional non-compliance s, for what this violations type can be considered of a level of more graveness that the subjacent non-compliance. To determine the severity of a violation that involves intention, the CNSNS also took in consideration factors as the position and the personnel's responsibilities involved in the violation, the graveness level of the non-compliance in itself, the offender's intention and the possible gain that would produce the non-compliance, if exists, either economic or of another nature. The CNSNS hopes the licensees take significant corrective actions in response to non-compliance s or intentional violations, these corrective actions should correspond to the violation graveness with the purpose of generating a dissuasive effect in the organizations of the licensees. The present article involves the legal framework that confers the CNSNS the attributions to impose administrative sanctions to its licensees, establishes the definition of the CNSNS about what constitutes a non-compliance or intentional violation and finally indicates the intention types (deliberate or

  8. Strengthening the Legal and Regulatory Framework of the Tobacco ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    The majority of African countries South of Sahara are at the first stage of the tobacco epidemic, but tobacco consumption is increasing rapidly. Aware of the worldwide threat, the World Health Organization (WHO) initiated the Framework Convention on Tobacco Control (FTCT) and the majority of African countries have ...

  9. Development of regulatory policy for SMART-P

    Energy Technology Data Exchange (ETDEWEB)

    Lee, S. H.; Lee, Y. H.; Moo, Philip; Koh, B. J.; Son, M. K.; Han, G. H.; Kim, D. H. [Korea Association for Nuclear Technology, Daejeon (Korea, Republic of)

    2004-06-15

    KAERI promoted the construction of a research reactor, SMART-P, the reduced scale of SMART, with intent to demonstrate the safety and performance of SMART. According to this progress, the development of regulatory process for SMART-P became necessary. The establishment of regulatory policy, based on the current regulatory guidelines as well as technical aspect, became essential matters. Considering the on-going small and medium size reactors in near future, the selection of the appropriate measure in the existing regulatory process to SMART-P is very important. Thus the schematic study for the applicable licensing procedure and regulatory requirements suitable for SMART-P is required.

  10. Development of regulatory policy for SMART-P

    Energy Technology Data Exchange (ETDEWEB)

    Lee, S. H.; Moon, S. H.; Lee, Y. H.; Son, M. K.; Han, K. H.; Kim, D. H. [Korea Association for Nuclear Technology, Taejon (Korea, Republic of)

    2003-06-15

    KAERI promoted the construction of a research reactor, SMART-P, the reduced scale of SMART, with intent to demonstrate the safety and performance of SMART. According to this progress, the development of regulatory process for SMART-P became necessary. The establishment of regulatory policy, based on the current regulatory guidelines as well as technical aspect, became essential matters. Considering the on-going small and medium size reactors m near future, the selection of the appropriate measure in the existing regulatory process to SMART-P is very important. Thus the schematic study for the applicable licensing procedure and regulatory requirements suitable for SMART-P is required.

  11. Regulatory approval of cancer risk-reducing (chemopreventive) drugs: moving what we have learned into the clinic.

    Science.gov (United States)

    Meyskens, Frank L; Curt, Gregory A; Brenner, Dean E; Gordon, Gary; Herberman, Ronald B; Finn, Olivera; Kelloff, Gary J; Khleif, Samir N; Sigman, Caroline C; Szabo, Eva

    2011-03-01

    This article endeavors to clarify the current requirements and status of regulatory approval for chemoprevention (risk reduction) drugs and discusses possible improvements to the regulatory pathway for chemoprevention. Covering a wide range of topics in as much depth as space allows, this report is written in a style to facilitate the understanding of nonscientists and to serve as a framework for informing the directions of experts engaged more deeply with this issue. Key topics we cover here are as follows: a history of definitive cancer chemoprevention trials and their influence on the evolution of regulatory assessments; a brief review of the long-standing success of pharmacologic risk reduction of cardiovascular diseases and its relevance to approval for cancer risk reduction drugs; the use and limitations of biomarkers for developing and the approval of cancer risk reduction drugs; the identification of individuals at a high(er) risk for cancer and who are appropriate candidates for risk reduction drugs; business models that should incentivize pharmaceutical industry investment in cancer risk reduction; a summary of scientific and institutional barriers to development of cancer risk reduction drugs; and a summary of major recommendations that should help facilitate the pathway to regulatory approval for pharmacologic cancer risk reduction drugs.

  12. Regulatory control of nuclear power plants

    International Nuclear Information System (INIS)

    2002-01-01

    The purpose of this book is to support IAEA training courses and workshops in the field of regulatory control of nuclear power plants as well as to support the regulatory bodies of Member States in their own training activities. The target group is the professional staff members of nuclear safety regulatory bodies supervising nuclear power plants and having duties and responsibilities in the following regulatory fields: regulatory framework; regulatory organization; regulatory guidance; licensing and licensing documents; assessment of safety; and regulatory inspection and enforcement. Important topics such as regulatory competence and quality of regulatory work as well as emergency preparedness and public communication are also covered. The book also presents the key issues of nuclear safety such as 'defence-in-depth' and safety culture and explains how these should be taken into account in regulatory work, e.g. during safety assessment and regulatory inspection. The book also reflects how nuclear safety has been developed during the years on the basis of operating experience feedback and results of safety research by giving topical examples. The examples cover development of operating procedures and accident management to cope with complicated incidents and severe accidents to stress the importance of regulatory role in nuclear safety research. The main target group is new staff members of regulatory bodies, but the book also offers good examples for more experienced inspectors to be used as comparison and discussion basis in internal workshops organized by the regulatory bodies for refreshing and continuing training. The book was originally compiled on the basis of presentations provided during the two regulatory control training courses in 1997 and 1998. The textbook was reviewed at the beginning of the years 2000 and 2002 by IAEA staff members and consistency with the latest revisions of safety standards have been ensured. The textbook was completed in the

  13. 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)

  14. Watershed Planning within a Quantitative Scenario Analysis Framework.

    Science.gov (United States)

    Merriam, Eric R; Petty, J Todd; Strager, Michael P

    2016-07-24

    There is a critical need for tools and methodologies capable of managing aquatic systems within heavily impacted watersheds. Current efforts often fall short as a result of an inability to quantify and predict complex cumulative effects of current and future land use scenarios at relevant spatial scales. The goal of this manuscript is to provide methods for conducting a targeted watershed assessment that enables resource managers to produce landscape-based cumulative effects models for use within a scenario analysis management framework. Sites are first selected for inclusion within the watershed assessment by identifying sites that fall along independent gradients and combinations of known stressors. Field and laboratory techniques are then used to obtain data on the physical, chemical, and biological effects of multiple land use activities. Multiple linear regression analysis is then used to produce landscape-based cumulative effects models for predicting aquatic conditions. Lastly, methods for incorporating cumulative effects models within a scenario analysis framework for guiding management and regulatory decisions (e.g., permitting and mitigation) within actively developing watersheds are discussed and demonstrated for 2 sub-watersheds within the mountaintop mining region of central Appalachia. The watershed assessment and management approach provided herein enables resource managers to facilitate economic and development activity while protecting aquatic resources and producing opportunity for net ecological benefits through targeted remediation.

  15. [Individual rights vs public health in the fight against contagious diseases: proposals to improve the current legal framework].

    Science.gov (United States)

    Salamero Teixidó, Laura

    2016-11-01

    The public health protection constitutional mandate requires public powers to protect the population from contagious diseases. This requires a legal framework that both protects public health effectively and respects individual rights and freedoms that could be undermined by the public administrations. This article analyses, from a legal perspective, the current legal framework regulating the adoption of health measures to protect public health against contagious diseases. It argues that current regulations generate legal uncertainty on the basis of the wide range of discretionary powers they give to the public administration and the lack of provisions for limiting these powers. As a result, the guarantee mechanisms (primarily judicial consent) only weakly protect the rights and freedoms of the citizens affected by health measures. To conclude, the article proposes several amendments to improve public health regulations related to contagious diseases. The purpose is to render a legal framework that offers more legal certainty, in which it is possible to protect individual rights and freedoms when measures are adopted, without sacrificing the effective protection of public health. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

  16. The role of the Nuclear Regulatory Commission in the management of nuclear waste

    International Nuclear Information System (INIS)

    Thompson, H.L. Jr.

    1988-01-01

    In general, the US Nuclear Regulatory Commission (NRC) is responsible for reviewing and making licensing decisions to ensure that the US Department of Energy's (DOE's) high-level waste repository is designed, constructed, and operated without unreasonable risk to public health and safety. In implementing this responsibility, however, the commission's guidance to the staff is that, in the absence of unresolved safety concerns, the NRC regulatory program will not delay the executive branch's program as set forth in the DOE project decision schedule. The NRC role for the next several years will be to develop its licensing framework and to consult with DOE on its plans. An essential ingredient in the success of both NRC's and DOE's respective missions is the need for free and open exchange of information, which will assure us that the concerns of all parties are addressed. With regard to low-level radioactive waste, the states have the lead responsibility for disposal. The NRC also provides assistance to the states and compacts on such items as regulatory programs, site characterization, and mixed waste disposal. Another of the NRC's roles is in the management of uranium mill tailings. Currently, most of the NRC's attention is focused on ensuring adequate long-term stabilization of tailings

  17. Current situation of wind energy in the world and Turkey

    Energy Technology Data Exchange (ETDEWEB)

    Alper Kaplan, Yusuf; San, Ismail [Department of Electrical and Electronics Engineering, Anadolu University (Turkey)], email: yakaplan@anadolu.edu.tr, email: isan@anadolu.edu.tr

    2011-07-01

    This paper gives an overview of the current situation of wind power in Turkey and in the world by evaluating installed wind power using current data. It also looks at the political conditions of Turkey in relation to the current installed wind energy power in Turkey compared with that of certain developed countries. The problems encountered are also illustrated as a basis for proposing solutions. Turkey's wind energy potential is 48,000 MW but installed wind power was only 1,329 MW as of 2011. Wind energy is at present one of the most cost-competitive renewable energy technologies in the world when technical, geographical and social issues are taken into consideration. Economic sources should be researched. The development of current potential and the market entry of renewable energy resources requires a legal and regulatory framework that support suitable mechanisms. Local support is recommended together with tax exemptions. Long-term fixed-price guarantees should also be considered by government.

  18. An international survey of MRI qualification and certification frameworks with an emphasis on identifying elements of good practice

    International Nuclear Information System (INIS)

    Castillo, J.; Caruana, C.J.; Morgan, P.S.; Westbrook, C.; Mizzi, A.

    2017-01-01

    The purpose of the study was to survey MRI qualification and certification frameworks in the major English-speaking countries (Australia, New Zealand, US, Canada, UK, Ireland) with the aim of identifying elements of good practice. The intention is to incorporate these elements in a national framework that could be used in supporting an MRI specialist register. The study was conducted using document analysis of MRI qualification and certification documents from these states with data triangulated through a web-based questionnaire amongst an expert group of MRI radiographers (n = 59) from the same states. Based on the results of the study, recommendations have been put forward for those countries that are in the process of developing such frameworks. The main recommendations include that a professional or regulatory body externally accredits MRI programmes and that learning outcomes be based on an MRI competence profile that addresses current and forecasted needs of the particular country. The MRI competence profile should encompass a novice-to expert continuum and be referenced directly to a national qualification framework. Ideally each level of expertise should be assessed and evidenced by a portfolio of CPD activities, including clinical and management case studies appropriate to that level. - Highlights: • Professional or regulatory bodies should accredit MRI academic programmes. • Competence profiles should reflect and support local MRI services. • MRI competence profiles should be structured in a novice-to-expert continuum format. • Competence profiles should reference national qualification/certification frameworks. • Mandatory certification could lead to registration in an MRI specialist register.

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

    International Nuclear Information System (INIS)

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

    2000-01-01

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

  20. Developing an Integrated Conceptual Framework of Pro-Environmental Behavior in the Workplace through Synthesis of the Current Literature

    Directory of Open Access Journals (Sweden)

    Faye V. McDonald

    2014-08-01

    Full Text Available Recent studies have begun to bridge the gap between general and workplace pro-environmental behavior by adapting specific existing behavioral models to the workplace environment. This conceptual article proposes a different approach by synthesizing the current general and workplace literature to develop a new model of the antecedents to pro-environmental behavior. Guided by this approach, this paper combines the insights of the current general and workplace models to develop an integrated framework of pro-environmental behavior in the workplace. In doing so, an overview of the current general and workplace literatures will be provided as well as their similarities and differences highlighted. The proposed framework will provide further insights into the antecedents of workplace pro-environmental behavior and identify common findings across the different existing workplace models. This theory can be the basis for further research in order to provide a comprehensive picture of the antecedents of pro-environmental behavior in the workplace. Lastly, implications for specific interventions to develop targeted Human Resource Management practices and work towards achieving environmental sustainability will be discussed.

  1. 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...

  2. Development of a stable uranium recovery regulatory framework for uranium recovery activities in the United States

    International Nuclear Information System (INIS)

    Layton, M.C.; Abrams, C.E.

    2000-01-01

    The U.S. Nuclear Regulatory Commission (NRC) has historically regulated operations at all uranium and thorium recovery facilities under the authority of the Atomic Energy Act of 1954, as amended. Uranium recovery facilities are those plants, or portions of facilities that process uranium- or thorium-bearing material primarily for its source material content. The uranium recovery industry expressed some concerns over several aspects of the NRC's practices, as described in the NRC's guidance documents. In April 1998, the National Mining Association submitted a report to the Commission, that identified specific concerns with NRC's current position and guidance regarding concurrent jurisdiction at uranium mills; dual regulatory authority at in situ leach facilities; the use of mill tailings impoundments for disposal of radioactive material other than 11e.(2) byproduct material; and the ability to process alternate feed material at uranium mills. The NRC staff addressed most of these concerns in two SECY (staff recommendations) papers that were concurrently provided to the Commission, along with a SECY paper on a draft rulemaking plan relating to these and other issues. The issues addressed in these papers included a new rulemaking, disposal of materials other than 11 e.(2) byproduct material, processing of materials other than natural ores, and improved efficiency for regulating in situ leach uranium facilities. The Commission issued final policy decisions on these issues and directions for NRC staff to implement those decisions in July 2000. (author)

  3. Regulatory Aspect of an Ageing Management Program

    International Nuclear Information System (INIS)

    Basic, I.; Zabric, I.; Savli, S.

    2006-01-01

    The aspects of plant ageing management (AM) gained increasing attention over the last ten years. Numerous technical studies have been performed to study the impact of ageing mechanisms on the safe and reliable operation of nuclear power plants. National research activities have been initiated or are in progress to provide the technical basis for decision making processes. The long-term operation of nuclear power plants is influenced by economic considerations, the socio-economic environment including public acceptance, developments in research and the regulatory framework, the availability of technical infrastructure to maintain and service the systems, structures and components as well as qualified personnel. Besides national activities there are a number of international activities in particular under the umbrella of the IAEA, the OECD and the EU. The paper will provide the summary on Nuclear Plant Life Management (PLIM) (or Ageing Management Program (AMP)) and Plant Life Extension (PLEX) development in USA and European countries. Also, insights from such effort currently performing in Slovenia will be discussed.(author)

  4. Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective.

    Science.gov (United States)

    Salmikangas, Paula; Schuessler-Lenz, Martina; Ruiz, Sol; Celis, Patrick; Reischl, Ilona; Menezes-Ferreira, Margarida; Flory, Egbert; Renner, Matthias; Ferry, Nicolas

    2015-01-01

    With the release of Regulation 1394/2007, a new framework for gene and cell therapy medicinal products and tissue-engineered products was established in the European Union. For all three product classes, called advanced therapy medicinal products, a centralised marketing authorisation became mandatory. The European Medicines Agency (EMA) together with its Committee for Advanced Therapies, Committee for Human Medicinal Products and the network of national agencies is responsible for scientific evaluation of the marketing authorisation applications. For a new application, data and information relating to manufacturing processes and quality control of the active substance and the final product have to be submitted for evaluation together with data from non-clinical and clinical safety and efficacy studies. Technical requirements for ATMPs are defined in the legislation, and guidance for different products is available through several EMA/CAT guidelines. Due to the diversity of ATMPs, a tailored approach for regulating these products is considered necessary. Thus, a risk-based approach has been introduced for ATMPs allowing flexibility for the regulatory requirements. Since the regulatory framework for ATMPs was established, five products have been licenced in the European Union. However, the pipeline of new ATMPs is much bigger, as seen from the significant numbers of different products discussed by the CAT in scientific advice and classification procedures. In 2013, a public consultation on the ATMP Regulation was conducted by the European Commission, and the results were published in 2014. The report proposes several improvements for the current framework and established procedures for the regulation of ATMPs.

  5. 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

  6. The European legislative framework for audit committees

    NARCIS (Netherlands)

    van der Elst, C.F.

    In 2014 the European Union reformed the regulatory framework of statutory audits in Directive 2014/56/EC and Regulation (EU) Nr. 537/2014. Part of the new legislation addresses the composition and responsibilities of the audit committee of public-interest entities. This contribution studies the

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

    International Nuclear Information System (INIS)

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

    2001-01-01

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

  8. Mapping regulatory models for medicinal cannabis: a matrix of options.

    Science.gov (United States)

    Belackova, Vendula; Shanahan, Marian; Ritter, Alison

    2017-05-30

    Objective The aim of the present study was to develop a framework for assessing regulatory options for medicinal cannabis in Australia. Methods International regulatory regimes for medicinal cannabis were reviewed with a qualitative policy analysis approach and key policy features were synthesised, leading to a conceptual framework that facilitates decision making across multiple dimensions. Results Two central organising dimensions of medicinal cannabis regulation were identified: cannabis supply and patient authorisation (including patient access). A number of the different supply options can be matched with a number of different patient authorisation options, leading to a matrix of possible regulatory regimes. Conclusions The regulatory options, as used internationally, involve different forms of cannabis (synthetic and plant-based pharmaceutical preparations or herbal cannabis) and the varying extent to which patient authorisation policies and procedures are stringently or more loosely defined. The optimal combination of supply and patient authorisation options in any jurisdiction that chooses to make medicinal cannabis accessible will depend on policy goals. What is known about the topic? Internationally, regulation of medicinal cannabis has developed idiosyncratically, depending on formulations that were made available and local context. There has been no attempt to date in the scientific literature to systematically document the variety of regulatory possibilities for medicinal cannabis. What does this paper add? This paper presents a new conceptual schema for considering options for the regulation of medicinal cannabis, across both supply and patient authorisation aspects. What are the implications for practitioners? The design of regulatory systems in Australia, whether for pharmaceutical or herbal products, is a vital issue for policy makers right now as federal and state and territory governments grapple with the complexities of medicinal cannabis

  9. BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES – BRIEF REVIEW ON SOME DENTISTRY PRODUCTS.

    Directory of Open Access Journals (Sweden)

    Maya Lyapina

    2015-02-01

    Full Text Available Defining a given product as a medical device and interpretation of the application of the classification rules fall within the competence of the competent authorities of the Member States where the product is on the market. Different interpretations of Community legislation occur, and, can put public health at risk and distort the internal market. Borderline cases are considered to be those cases where it is not clear from the outset whether a given product is a medical device, an in vitro diagnostic medical device, an active implantable medical device or not. Classification cases can be described as those cases where there exists a difficulty in the uniform application of the classification rules as laid down in the Medical Devices Directive (MDD, or where for a given device, depending on interpretation of the rules, different classifications can occur. The aim of the present work is to make a brief review on discussion on classification in the community regulatory framework for medical devices of some dentistry products.

  10. A critical appraisal of the process of regulatory implementation of novel in vivo and in vitro methods for chemical hazard and risk assessment.

    Science.gov (United States)

    Piersma, Aldert H; Ezendam, Janine; Luijten, Mirjam; Muller, J J Andre; Rorije, Emiel; van der Ven, Leo T M; van Benthem, Jan

    2014-11-01

    Regulatory toxicology urgently needs applicable alternative test systems that reduce animal use, testing time, and cost. European regulation on cosmetic ingredients has already banned animal experimentation for hazard identification, and public awareness drives toward additional restrictions in other regulatory frameworks as well. In addition, scientific progress stimulates a more mechanistic approach of hazard identification. Nevertheless, the implementation of alternative methods is lagging far behind their development. In search for general bottlenecks for the implementation of alternative methods, this manuscript reviews the state of the art as to the development and implementation of 10 diverse test systems in various areas of toxicological hazard assessment. They vary widely in complexity and regulatory acceptance status. The assays are reviewed as to parameters assessed, biological system involved, standardization, interpretation of results, extrapolation to human hazard, position in testing strategies, and current regulatory acceptance status. Given the diversity of alternative methods in many aspects, no common bottlenecks could be identified that hamper implementation of individual alternative assays in general. However, specific issues for the regulatory acceptance and application were identified for each assay. Acceptance of one-in-one replacement of complex in vivo tests by relatively simple in vitro assays is not feasible. Rather, innovative approaches using test batteries are required together with metabolic information and in vitro to in vivo dose extrapolation to convincingly provide the same level of information of current in vivo tests. A mechanistically based alternative approach using the Adverse Outcome Pathway concept could stimulate further (regulatory) acceptance of non-animal tests.

  11. 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

  12. Discussion on Safety Analysis and Regulatory Framework for the Future Fusion Reactors

    Energy Technology Data Exchange (ETDEWEB)

    Kang, Myoung-suk; Oh, Kyemin; Heo, Gyunyoung [Kyung Hee University, Yongin (Korea, Republic of)

    2015-05-15

    This study aims to secure the core original technologies and expand the base of domestic specialist at a fusion area by pursuing and developing nonprocurement technologies for ITER. From this project, the latest technical data and experiences have been recorded for the development of the safety regulation and safety-related design criteria of the future fusion reactors in Korea. In this context, this paper discusses on the progress of surveying the ITER licensing process and regulatory issues revealed. The regulation and licensing process for a fusion power plant has been expected to be quite different due to unique and unforeseen properties differently from the conventional nuclear facilities. To overcome this, not only various safety issues should be analyzed, but safety objectives, regulatory requirements, and design variables should also be established in detailed design phase. We expect our survey will contribute on the discussion to establish general and technical safety principles for national fusion power plant technology plans.

  13. Safeguards inventory and process monitoring regulatory comparison

    Energy Technology Data Exchange (ETDEWEB)

    Cavaluzzi, Jack M. [Texas A & M Univ., College Station, TX (United States); Gibbs, Philip W. [Brookhaven National Lab. (BNL), Upton, NY (United States)

    2013-06-27

    Detecting the theft or diversion of the relatively small amount of fissile material needed to make a nuclear weapon given the normal operating capacity of many of today’s running nuclear production facilities is a difficult task. As throughput increases, the ability of the Material Control and Accountability (MC&A) Program to detect the material loss decreases because the statistical measurement uncertainty also increases. The challenge faced is the ability of current accounting, measurement, and material control programs to detect small yet significant losses under some regulatory approaches can decrease to the point where it is extremely low if not practically non-existent at normal operating capacities. Adding concern to this topic is that there are variations among regulatory bodies as far as what is considered a Significant Quantity (SQ). Some research suggests that thresholds should be lower than those found in any current regulation which if adopted would make meeting detection goals even more difficult. This paper reviews and compares the current regulatory requirements for the MA elements related to physical inventory, uncertainty of the Inventory Difference (ID), and Process Monitoring (PM) in the United States Department of Energy (DOE) and Nuclear Regulatory Commission (NRC), Rosatom of the Russian Federation and the Chinese Atomic Energy Agency (CAEA) of China. The comparison looks at how the regulatory requirements for the implementation of various MA elements perform across a range of operating capacities in example facilities.

  14. Regulatory Models and the Environment: Practice, Pitfalls, and Prospects

    Energy Technology Data Exchange (ETDEWEB)

    Holmes, K. John; Graham, Judith A.; McKone, Thomas; Whipple, Chris

    2008-06-01

    Computational models support environmental regulatory activities by providing the regulator an ability to evaluate available knowledge, assess alternative regulations, and provide a framework to assess compliance. But all models face inherent uncertainties, because human and natural systems are always more complex and heterogeneous than can be captured in a model. Here we provide a summary discussion of the activities, findings, and recommendations of the National Research Council's Committee on Regulatory Environmental Models, a committee funded by the US Environmental Protection Agency to provide guidance on the use of computational models in the regulatory process. Modeling is a difficult enterprise even outside of the potentially adversarial regulatory environment. The demands grow when the regulatory requirements for accountability, transparency, public accessibility, and technical rigor are added to the challenges. Moreover, models cannot be validated (declared true) but instead should be evaluated with regard to their suitability as tools to address a specific question. The committee concluded that these characteristics make evaluation of a regulatory model more complex than simply comparing measurement data with model results. Evaluation also must balance the need for a model to be accurate with the need for a model to be reproducible, transparent, and useful for the regulatory decision at hand. Meeting these needs requires model evaluation to be applied over the"life cycle" of a regulatory model with an approach that includes different forms of peer review, uncertainty analysis, and extrapolation methods than for non-regulatory models.

  15. Timing Is everything: quantifying regulatory and market readiness levels for technology transition policy analysis

    Energy Technology Data Exchange (ETDEWEB)

    Kobos, Peter Holmes [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); Malczynski, Leonard A. [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); Walker, La Tonya Nicole [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); Borns, David James [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States)

    2014-03-01

    People save for retirement throughout their career because it is virtually impossible to save all you’ll need in retirement the year before you retire. Similarly, without installing incremental amounts of clean fossil, renewable or transformative energy technologies throughout the coming decades, a radical and immediate change will be near impossible the year before a policy goal is set to be in place. This notion of steady installation growth over acute installations of technology to meet policy goals is the core topic of discussion for this research. This research operationalizes this notion by developing the theoretical underpinnings of regulatory and market acceptance delays by building upon the common Technology Readiness Level (TRL) framework and offers two new additions to the research community. The new and novel Regulatory Readiness Level (RRL) and Market Readiness Level (MRL) frameworks were developed. These components, collectively called the Technology, Regulatory and Market (TRM) readiness level framework allow one to build new constraints into existing Integrated Assessment Models (IAMs) to address research questions such as, ‘To meet our desired technical and policy goals, what are the factors that affect the rate we must install technology to achieve these goals in the coming decades?’

  16. 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

  17. Regulatory Issues Surrounding Merchant Interconnection

    International Nuclear Information System (INIS)

    Kuijlaars, Kees-Jan; Zwart, Gijsbert

    2003-11-01

    We discussed various issues concerning the regulatory perspective on private investment in interconnectors. One might claim that leaving investment in transmission infrastructure to competing market parties is more efficient than relying on regulated investment only (especially in the case of long (DC) lines connecting previously unconnected parts of the grids, so that externalities from e.g. loop flows do not play a significant role). We considered that some aspects of interconnection might reduce these market benefits. In particular, the large fixed costs of interconnection construction may lead to significant under investment (due to both first mover monopoly power and the fact that part of generation cost efficiencies realised by interconnection are not captured by the investor itself, and remain external to the investment decision). Second, merchant ownership restricts future opportunities for adaptation of regulation, as would be required e.g. for introduction of potentially more sophisticated methods of congestion management or market splitting. Some of the disadvantages of merchant investment may be mitigated however by a suitable regulatory framework, and we discussed some views in this direction. The issues we discussed are not intended to give a complete framework, and detailed regulation will certainly involve many more specific requirements. Areas we did not touch upon include e.g. the treatment of deep connection costs, rules for operation and maintenance of the line, and impact on availability of capacity on other interconnections

  18. Regulatory Issues Surrounding Merchant Interconnection

    Energy Technology Data Exchange (ETDEWEB)

    Kuijlaars, Kees-Jan; Zwart, Gijsbert [Office for Energy Regulation (DTe), The Hague (Netherlands)

    2003-11-01

    We discussed various issues concerning the regulatory perspective on private investment in interconnectors. One might claim that leaving investment in transmission infrastructure to competing market parties is more efficient than relying on regulated investment only (especially in the case of long (DC) lines connecting previously unconnected parts of the grids, so that externalities from e.g. loop flows do not play a significant role). We considered that some aspects of interconnection might reduce these market benefits. In particular, the large fixed costs of interconnection construction may lead to significant under investment (due to both first mover monopoly power and the fact that part of generation cost efficiencies realised by interconnection are not captured by the investor itself, and remain external to the investment decision). Second, merchant ownership restricts future opportunities for adaptation of regulation, as would be required e.g. for introduction of potentially more sophisticated methods of congestion management or market splitting. Some of the disadvantages of merchant investment may be mitigated however by a suitable regulatory framework, and we discussed some views in this direction. The issues we discussed are not intended to give a complete framework, and detailed regulation will certainly involve many more specific requirements. Areas we did not touch upon include e.g. the treatment of deep connection costs, rules for operation and maintenance of the line, and impact on availability of capacity on other interconnections.

  19. Establishment of the National Nuclear Regulatory Portal (NNRP) as the key element of the Global Nuclear Safety and Security Network and Regulatory Network (GNSSN/RegNet) for sharing of nuclear safety information and knowledge among the Global Expert Community

    International Nuclear Information System (INIS)

    Kuvshinnikov, A.V.

    2011-01-01

    The Global Nuclear Safety and Security Network (GNSSN) implements the concept of the Global Nuclear Safety and Security Framework (GNSSF) as outlined in INSAG 21. This is the framework of instruments and resources for achieving and maintaining worldwide a high level of safety and security at nuclear facilities and activities as stated in SF-1 and supporting safety standards or recommendations such as INSAG-12. National efforts are and should be augmented by the activities of a variety of international enterprises that facilitate safety and security. The IAEA standard GS-R-3 requires that information and knowledge is managed as a resource. Further strengthening of GNSSN in particular regulatory networking as intended by GNSSN/RegNet has to be based on current national priorities, on existing regional and thematic networks and on the established mechanisms of international co-operation as presented for example on the websites of the IAEA or the OECD-NEA. Current design and operation of RegNet are flexible enough to accommodate differences in national and international approaches and practices and to facilitate exchange and cooperation on regulatory matters. The main role of GNSSN/RegNet is sharing knowledge and bringing people together to enhance and promote nuclear safety and security. The objectives of GNSSN/RegNet: enhancing safety and security by international cooperation, sharing information and best practices, enabling adequate access to relevant safety and security information and promoting the dissemination of this information, implementing active collaboration in the relevant areas related to safety and security, such as joint projects, peer reviews, enabling synergies among existing networks and initiatives, informing the public on the relevant safety and security areas and the related international collaboration. In the RegNet part of the GNSSN exist the National Nuclear Regulatory Portal (NNRP) which is on one hand a part of the global RegNet and on the

  20. Reactor aging research. United States Nuclear Regulatory Commission

    International Nuclear Information System (INIS)

    Vassilaros, M.G.

    1998-01-01

    The reactor ageing research activities in USA described, are focused on the research of reactor vessel integrity, including regulatory issues and technical aspects. Current emphasis are described for fracture analysis, embrittlement research, inspection capabilities, validation od annealing rule, revision of regulatory guide

  1. International regulatory activities

    International Nuclear Information System (INIS)

    Anon.

    2009-01-01

    In this last part is reviewed international regulatory activities and bilateral agreements including two parts: concerning European atomic energy community with European commission proposal for a council directive setting up a community framework for nuclear safety, update of the nuclear illustrative programme in the context of the second strategic energy review, european commission recommendation on criteria for the export of radioactive waste and spent fuel to third countries and a communication on nuclear non-proliferation and the second part in relation with international atomic energy agency with a joint convention on the safety of spent fuel management and on safety of radioactive waste management (third review meeting). (N.C.)

  2. White paper on the promotion of an integrated risk assessment concept in European regulatory frameworks for chemicals.

    Science.gov (United States)

    Wilks, M F; Roth, N; Aicher, L; Faust, M; Papadaki, P; Marchis, A; Calliera, M; Ginebreda, A; Andres, S; Kühne, R; Schüürmann, G

    2015-07-15

    The vision of a sustainable and safe use of chemicals to protect human health, preserve the environment and maintain the ecosystem requires innovative and more holistic approaches to risk assessment (RA) in order to better inform decision making. Integrated risk assessment (IRA) has been proposed as a solution to current scientific, societal and policy needs. It is defined as the mutual exploitation of environmental risk assessment (ERA) for human health risk assessment (HHRA) and vice versa in order to coherently and more efficiently characterize an overall risk to humans and the environment for better informing the risk analysis process. Extrapolating between species which are relevant for HHRA and ERA requires a detailed understanding of pathways of toxicity/modes of action (MoA) for the various toxicological endpoints. Significant scientific advances, changes in chemical legislation, and increasing environmental consciousness have created a favourable scientific and regulatory environment to develop and promote the concept and vision of IRA. An initial proof of concept is needed to foster the incorporation of IRA approaches into different chemical sectorial regulations and demonstrate their reliability for regulatory purposes. More familiarity and confidence with IRA will ultimately contribute to an overall reduction in in vivo toxicity testing requirements. However, significant progress will only be made if long-term support for MoA-related research is secured. In the short term, further exchange and harmonization of RA terminology, models and methodologies across chemical categories and regulatory agencies will support these efforts. Since societal values, public perceptions and cultural factors are of increasing importance for the acceptance of risk analysis and successful implementation of risk mitigation measures, the integration of socio-economic analysis and socio-behavioural considerations into the risk analysis process may help to produce a more

  3. Legal and regulator framework of radioactive waste

    International Nuclear Information System (INIS)

    Chavez Cassanello, Griselda; Mels Siningen, Celeste; Reina, Mariana; Vega, Hernan

    2009-01-01

    The present work intends to develop the legislative and regulatory framework in the matter of radioactive waste. The legal frame of the radioactive waste conformed by the National Constitution, the treaties and conventions, laws and decrees and regulatory norm in Argentine . The subject is approached from the international point of view considering the slogan of 36 The Annual Meeting of the Association Argentine de Nuclear Technology: 'The Nuclear Energy in the Present World'. This work also contains a special paragraph dedicated to the analysis of practical cases related to the subject and the activity of the National Commission of Atomic Energy. (author)

  4. 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)

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

    International Nuclear Information System (INIS)

    Keller, J.F.

    1989-10-01

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

  6. Governing Nanomedicine: Lessons from within, and for the EU medical technology regulatory framework.

    NARCIS (Netherlands)

    Dorbeck-Jung, Barbel R.; Bowman, Diana M.; van Calster, Geert

    2010-01-01

    Rapidly emerging technologies, such as nanotechnologies, are posing significant challenges to regulatory governance due to the uncertainties of development trajectories, product properties, and potential risk problems (Davies 2009). While nanotechnology-based products and processes fall within the

  7. Energy crisis in Nigeria: The nuclear option and the necessary regulatory framework for its success

    International Nuclear Information System (INIS)

    Faru, T.A.; Abubakar, M.B.; Sulaiman, S.

    2007-01-01

    Limited access or inappropriate planning and utilization of modern energy remain one of the major constrains to socio-economic development of Nigeria. The total installed electricity generation including that from all other sources based on PHCN estimates is about 6,603 MW and total exploitable hydro potential is currently at 12,220 MW. The electricity demand projection for a 10% annual growth of the GDP was given as 16,000 MW, 30,000 MW and 192,000 MW for the years 2010, 2015 and 2030 respectively. The electricity as currently generated is therefore grossly inadequate to meet our Domestic Demands, National Economic Empowerment and Development Strategy (NEEDS) and the Millennium Development Goals. This work is the study in the energy requirements for sustainable development. The study has also looked at the potential contributions of various energy resources for meeting this demand. It has identified the limitations of these sources in satisfying the National Energy Requirement and has highlighted the suitability of Nuclear Energy the option in meeting the projected energy demand and the necessary framework for its success

  8. Self-Regulatory Climate: A Positive Attribute of Public Schools

    Science.gov (United States)

    Adams, Curt M.; Ware, Jordan K.; Miskell, Ryan C.; Forsyth, Patrick B.

    2016-01-01

    This study contributes to the development of a positive framework for effective public schools in 2 ways. First, it advances the construct self-regulatory climate as consisting of 3 generative school norms--collective faculty trust in students, collective student trust in teachers, and student-perceived academic emphasis. The authors argue these…

  9. Regulatory control of the use of contractors by operating organizations. Peer discussions on regulatory practices

    International Nuclear Information System (INIS)

    2000-09-01

    This report arises from the eighth series of peer discussions on regulatory practices entitled 'Regulatory control of the use of contractors by operating organizations'. Senior regulators from 19 Member States participated in two peer group discussions in March 2000 and May 2000. This report gives an account of the outcomes of these meetings and of practical suggestions put forward by senior regulators. These suggestions do not necessarily reflect the views of the governments of the nominating Member States, the organizations they belong to, or the International Atomic Energy Agency. The objective of this document is to share experience between regulatory bodies and provide practical suggestions for controlling the use of contractors and subcontractors by the operating organizations during all stages, especially operation, of a nuclear power plant, so as to ensure that the quality of work and services delivered is commensurate with the safety importance of the activities and that these are carried out in a manner that will not adversely affect the safe or reliable operation of the facility. These documented practical suggestions and experiences are the result of a series of peer discussions at the IAEA in 2000. It is considered that the manner in which control is exercised, and the various challenges connected to this control, are highly dependent upon the legislative framework, maturity of the nuclear programme, the size of the national nuclear industry and the culture in each country. The report is structured so that it covers the subject matter under the following main headings: Legal Provisions, Regulatory Strategy and Requirements; Regulatory Approaches for Controlling the Use of Contractors; Types of Contracts; Practical Suggestions

  10. 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

  11. Nuclear Regulatory Systems in Africa: Improving Safety and Security Culture Through Education and Training

    International Nuclear Information System (INIS)

    Kazadi Kabuya, F.

    2016-01-01

    site, the terrorist attacks, and the uncontrolled traffic of radioactive minerals and devices under a specific name of “uranium material”. Human resources development program involving more than 250 radiation workers and staff from regulatory body, research reactor facilities, hospitals, mines, customs, intelligence and immigration service’s was implemented. Training topics covered ranged from regulatory framework, regulations, reactor operation and radiation safety issues, radiation protection of patient, security of radioactive sources in industries, emergency preparedness and response, nuclear security, threat assessment and response, sources risks management, illicit trafficking and safety and security culture. The implemented Training program resulted in substantially raising collective awareness about security and safety issues, from staff members to the management, increasing the level of regulatory inspections and putting more emphasis on the control of radioactive sources and more regulatory requirements on handling orphan radioactive sources. On the other hand, using generated incomes from trainings undertaken, training facilities were gradually upgraded and training syllabuses progressively updated to be consistent with country current and future needs. While important progress has been achieved, future needs have been identified. Extending educational and training program to cope with university and academic requirements in the field of nuclear and radiological sciences, with a view to introducing nuclear power program in the country; strengthening the enforcement and sanctions regime, monitoring of border crossings to detect illegal source movements, increasing the capability and basic knowledge of first responders, collecting and upgrading conditioning and final storage of radioactive sources facility. (author)

  12. Current limitations and recommendations to improve testing for the environmental assessment of endocrine active substances

    Science.gov (United States)

    Coady, Katherine K.; Biever, Ronald C.; Denslow, Nancy D.; Gross, Melanie; Guiney, Patrick D.; Holbech, Henrik; Karouna-Renier, Natalie K.; Katsiadaki, Ioanna; Krueger, Hank; Levine, Steven L.; Maack, Gerd; Williams, Mike; Wolf, Jeffrey C.; Ankley, Gerald T.

    2017-01-01

    In the present study, existing regulatory frameworks and test systems for assessing potential endocrine active chemicals are described, and associated challenges are discussed, along with proposed approaches to address these challenges. Regulatory frameworks vary somewhat across geographies, but all basically evaluate whether a chemical possesses endocrine activity and whether this activity can result in adverse outcomes either to humans or to the environment. Current test systems include in silico, in vitro, and in vivo techniques focused on detecting potential endocrine activity, and in vivo tests that collect apical data to detect possible adverse effects. These test systems are currently designed to robustly assess endocrine activity and/or adverse effects in the estrogen, androgen, and thyroid hormone signaling pathways; however, there are some limitations of current test systems for evaluating endocrine hazard and risk. These limitations include a lack of certainty regarding: 1) adequately sensitive species and life stages; 2) mechanistic endpoints that are diagnostic for endocrine pathways of concern; and 3) the linkage between mechanistic responses and apical, adverse outcomes. Furthermore, some existing test methods are resource intensive with regard to time, cost, and use of animals. However, based on recent experiences, there are opportunities to improve approaches to and guidance for existing test methods and to reduce uncertainty. For example, in vitro high-throughput screening could be used to prioritize chemicals for testing and provide insights as to the most appropriate assays for characterizing hazard and risk. Other recommendations include adding endpoints for elucidating connections between mechanistic effects and adverse outcomes, identifying potentially sensitive taxa for which test methods currently do not exist, and addressing key endocrine pathways of possible concern in addition to those associated with estrogen, androgen, and thyroid

  13. Legitimacy challenges of intermediary gatekeeping in the Chinese internet regulatory system

    NARCIS (Netherlands)

    Wei, Lulu

    2018-01-01

    Legitimacy Challenges of Intermediary Gatekeeping in the Chinese Internet Regulatory System In the Chinese legal and political framework, in order for the government to maintain control over information posted on social media platforms, commercial internet intermediaries are assigned the role of

  14. 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.

  15. Harnessing private sector expertise to improve complementary feeding within a regulatory framework: Where is the evidence?

    Science.gov (United States)

    van Liere, Marti J; Tarlton, Dessie; Menon, Ravi; Yellamanda, M; Reerink, Ietje

    2017-10-01

    Global recognition that the complex and multicausal problems of malnutrition require all players to collaborate and to invest towards the same objective has led to increased private sector engagement as exemplified through the Scaling Up Nutrition Business Network and mechanisms for blended financing and matched funding, such as the Global Nutrition for Growth Compact. The careful steps made over the past 5 to 10 years have however not taken away or reduced the hesitation and scepticism of the public sector actors towards commercial or even social businesses. Evidence of impact or even a positive contribution of a private sector approach to intermediate nutrition outcomes is still lacking. This commentary aims to discuss the multiple ways in which private sector can leverage its expertise to improve nutrition in general, and complementary feeding in particular. It draws on specific lessons learned in Bangladesh, Côte d'Ivoire, India, Indonesia, and Madagascar on how private sector expertise has contributed, within the boundaries of a regulatory framework, to improve availability, accessibility, affordability, and adequate use of nutritious foods. It concludes that a solid evidence base regarding the contribution of private sector to complementary feeding is still lacking and that the development of a systematic learning agenda is essential to make progress in the area of private sector engagement in nutrition. © 2017 John Wiley & Sons Ltd.

  16. Development of regulatory guidance on safety reviews of nuclear power plants in Germany. A survey on accomplished and current PSA activities

    International Nuclear Information System (INIS)

    Berg, H.-P.; Froehmel, T.; Goertz, R.; Rehs, B.

    2005-01-01

    The paper describes the key points of the accomplished and current regulatory activities in order to revise PSA guide and the corresponding technical documents in Germany. The regulatory German PSA guide covers the fundamental requirements concerning the performance of PSAs in the frame of comprehensive safety reviews. The technical details regarding the performance of PSA are set out in two technical documents (PSA Methods and PSA Data) that have been developed by a working group of PSA experts (FAK PSA). Based on the experiences from the first series of PSRs, international experiences and the fact that PSR is mandatory since April 2002 revisions of all guides are underway. The first guide to be updated is the PSA guide together with the corresponding technical documents. The working programme and the revision process of FAK PSA was finished at the end of 2004 and the technical documents have recently been republished. (author)

  17. Regulatory authority information system RAIS

    International Nuclear Information System (INIS)

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

    2000-01-01

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

  18. 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)

  19. Improvement of the effectiveness of regulatory management

    International Nuclear Information System (INIS)

    2001-01-01

    The project ARCAL LXVI has as its objective strengthening the national capabilities of the regulatory authorities to achieve an adequate level of radiation safety by training their staff in the implementation of the safety guidelines developed by a prior TC regional project under the framework of the ARCAL Programme and to measure its effectiveness. Detailed program of activities for the years 2001/2002 is presented at this meeting

  20. The Romanian nuclear regulatory body as a nuclear communicator

    International Nuclear Information System (INIS)

    Cluculescu, Cristina

    2000-01-01

    A comprehensive nuclear law environment could be a relevant tool to promote greater confidence in the nuclear energy. Romania has had laws in place governing the regulation of nuclear activities since 1974, which remained in force throughout and subsequent to the national constitutional changes. Up to December 1996, the CNCAN activities were based on Law No. 61/1974 for the development of the nuclear activities in Romania and Law No. 61982 on the quality assurance of the nuclear facilities and nuclear power plants. The Nuclear Safety legislation has been enacted in November 1974 (Law No. 61/1974) and it followed as closely as possible (for that time) the US Atomic Energy Act of 1954, as amended subsequently. The Romanian nuclear regulatory body, called National Commission for Nuclear Activities Control (CNCAN) is a governmental organization responsible for the development of the regulatory framework, the control of its implementation and for the licensing of nuclear facilities. An important issue of CNCAN is to provide the correct and reasoning information to the public. The most important topics focused on nuclear activities for the interest of mass media in Romania are: Radioactive waste management; The cost and benefit of nuclear energy compared by conventional energy; The conditions for transportation of radioactive materials; The consequences of a suppositional nuclear accidents; The safety in operation for nuclear installations. The information provided to press and public by regulatory body is clearly and well structured. The target is to clearly explain to mass media and the public should understand very well the difference between the meaning of a nuclear accident, nuclear incident or nuclear event. CNCAN monitories and surveys the operation in safe conditions the nuclear facilities and plants, the protection against nuclear radiation of the professionally exposed personnel, of the population, of the environment and the material goods. It is also

  1. A GPS-Based Control Framework for Accurate Current Sharing and Power Quality Improvement in Microgrids

    DEFF Research Database (Denmark)

    Golsorkhi, Mohammad; Savaghebi, Mehdi; Lu, Dylan

    2017-01-01

    This paper proposes a novel hierarchical control strategy for improvement of load sharing and power quality in ac microgrids. This control framework is composed of a droop based controller at the primary level, and a combination of distributed power sharing and voltage conditioning schemes...... consensus protocol to ensure proportional sharing of average power. The voltage conditioning scheme produces compensation signals at fundamental and dominant harmonics to improve the voltage quality at a sensitive load bus. Experimental results are presented to validate the efficacy of the proposed method....... dynamic response. The droop coefficient, which acts as a virtual resistance is adaptively changed as a function of the peak current. This strategy not only simplifies the control design but also improves the current sharing accuracy at high loading conditions. The distributed power sharing scheme uses...

  2. Gene Editing of Microalgae: Scientific Progress and Regulatory Challenges in Europe.

    Science.gov (United States)

    Spicer, Andrew; Molnar, Attila

    2018-03-06

    It is abundantly clear that the development of gene editing technologies, represents a potentially powerful force for good with regard to human and animal health and addressing the challenges we continue to face in a growing global population. This now includes the development of approaches to modify microalgal strains for potential improvements in productivity, robustness, harvestability, processability, nutritional composition, and application. The rapid emergence and ongoing developments in this area demand a timely review and revision of the current definitions and regulations around genetically modified organisms (GMOs), particularly within Europe. Current practices within the EU provide exemptions from the GMO directives for organisms, including crop plants and micro-organisms that are produced through chemical or UV/radiation mutagenesis. However, organisms generated through gene editing, including microalgae, where only genetic changes in native genes are made, remain currently under the GMO umbrella; they are, as such, excluded from practical and commercial opportunities in the EU. In this review, we will review the advances that are being made in the area of gene editing in microalgae and the impact of regulation on commercial advances in this area with consideration to the current regulatory framework as it relates to GMOs including GM microalgae in Europe.

  3. Fisheries regulatory regimes and resilience to climate change.

    Science.gov (United States)

    Ojea, Elena; Pearlman, Isaac; Gaines, Steven D; Lester, Sarah E

    2017-05-01

    Climate change is already producing ecological, social, and economic impacts on fisheries, and these effects are expected to increase in frequency and magnitude in the future. Fisheries governance and regulations can alter socio-ecological resilience to climate change impacts via harvest control rules and incentives driving fisher behavior, yet there are no syntheses or conceptual frameworks for examining how institutions and their regulatory approaches can alter fisheries resilience to climate change. We identify nine key climate resilience criteria for fisheries socio-ecological systems (SES), defining resilience as the ability of the coupled system of interacting social and ecological components (i.e., the SES) to absorb change while avoiding transformation into a different undesirable state. We then evaluate the capacity of four fisheries regulatory systems that vary in their degree of property rights, including open access, limited entry, and two types of rights-based management, to increase or inhibit resilience. Our exploratory assessment of evidence in the literature suggests that these regulatory regimes vary widely in their ability to promote resilient fisheries, with rights-based approaches appearing to offer more resilience benefits in many cases, but detailed characteristics of the regulatory instruments are fundamental.

  4. Romanian regulatory framework for uranium mining and milling (present and future)

    International Nuclear Information System (INIS)

    Rodna, A.L.; Dumitrescu, N.

    2002-01-01

    In Romania, all operations in the nuclear field, including uranium mining and milling, are regulated by Law no. 111/1996 (republished in 1998), regarding the safe conduct of nuclear activities. These activities can be performed only on the basis of an authorization released by the national regulatory authority, i.e. the National Commission for Nuclear Activities Control. The specific requirements which must be carried out by the owner of an operating licence for a uranium mining and milling operation are stipulated by the Republican Nuclear Safety Norms for Geological Research, Mining and Milling of Nuclear Raw Materials. These regulatory requirements have been in force since 1975. The regulatory norms include provisions that the effective dose limit for workers should not exceed 50 mSv/year and also that liquid effluents released into surface waters must have a content of natural radioactive elements that meets the standards for drinking water. The norms do not contain provisions concerning the conditions under which the mining sites and the uranium processing facilities can be shut down and decommissioned. The norms also do not contain requirements regarding either the rehabilitation of environments affected by abandoned mining and milling activities, nor criteria for the release of the rehabilitated sites for alternative uses. To implement the provisions of Council Directive 96/29 EURATOM in Romania, new Fundamental Radiological Protection Norms have been approved and will soon be published in the 'Monitorul Official' (Official Gazette of Romania). One of the main provisions of these norms is the reduction of the effective dose limit for the workers to 20 mSv/year. Changes in the Republican Nuclear Safety Norms for Geological Research, Mining and Milling of Nuclear Raw Materials, are also planned; these changes will be consistent with the Fundamental Radiological Protection Norms. To cover existing gaps, the new norms for uranium mining and milling will include

  5. Decommissioning of NPPs with spent nuclear fuel present - efforts to amend the German regulatory framework to cope with this situation

    International Nuclear Information System (INIS)

    Brendebach, Boris; Rehs, Bernd

    2016-01-01

    The authorization to operate an installation for the fission of nuclear fuel for the commercial production of electricity was withdrawn for the seven oldest NPPs and NPP Kruemmel in Germany on August 6, 2011 after the events at Japanese Nuclear Power Plant (NPP) Fukushima Daiichi in March 2011. In the meantime, all these NPPs applied for decommissioning. One aspect reflected in the applications for these NPPs is the possibility that spent nuclear fuel elements or fuel rods will still be present in the cooling ponds at least during the first stage of decommissioning, i.a. due to limited availability of spent fuel casks. Although considerable decommissioning experiences are available in Germany, the approach 'decommissioning with fuel elements present' has been the exceptional case so far. The paper highlights the efforts undertaken to strengthen the regulatory framework with respect to decommissioning in Germany taking into account this changed approach. The paper presents a short introduction to the legal and regulatory requirements for decommissioning in Germany. Afterwards, the updates to the Decommissioning Guide, which includes proposals for an appropriate procedure for the decommissioning, safe enclosure and dismantling of facilities or parts thereof as defined in item 7 of the German Atomic Energy Act in respect of the application of the technical rules for planning and preparation of decommissioning measures as well as for licensing and supervision, are highlighted. In addition, the amendments to the Guidelines for the Decommissioning of Nuclear Facilities of the Nuclear Waste Management Commission (ESK), which is complementary to the Decommissioning Guide in a technical sense, are reported as well. (authors)

  6. A Framework for Human Performance Criteria for Advanced Reactor Operational Concepts

    Energy Technology Data Exchange (ETDEWEB)

    Jacques V Hugo; David I Gertman; Jeffrey C Joe

    2014-08-01

    This report supports the determination of new Operational Concept models needed in support of the operational design of new reactors. The objective of this research is to establish the technical bases for human performance and human performance criteria frameworks, models, and guidance for operational concepts for advanced reactor designs. The report includes a discussion of operating principles for advanced reactors, the human performance issues and requirements for human performance based upon work domain analysis and current regulatory requirements, and a description of general human performance criteria. The major findings and key observations to date are that there is some operating experience that informs operational concepts for baseline designs for SFR and HGTRs, with the Experimental Breeder Reactor-II (EBR-II) as a best-case predecessor design. This report summarizes the theoretical and operational foundations for the development of a framework and model for human performance criteria that will influence the development of future Operational Concepts. The report also highlights issues associated with advanced reactor design and clarifies and codifies the identified aspects of technology and operating scenarios.

  7. The U.S. regulatory framework for long-term management of uranium mill tailings

    International Nuclear Information System (INIS)

    Smythe, C.; Bierley, D.; Bradshaw, M.

    1995-01-01

    The US established the regulatory structure for the management, disposal, and long-term care of uranium mill tailings in 1978 with the passage of the Uranium Mill Tailings Radiation Control Act (UMTRCA) (Pub. L. 95-604). This legislation has governed the cleanup and disposal of uranium tailings at both inactive and active sites. The passage of the UMTRCA established a federal regulatory program for the cleanup and disposal of uranium mill tailings in the US. This program involves the DOE, the NRC, the EPA, various states and tribal governments, private licensees, and the general public. The DOE has completed surface remediation at 14 sites, with the remaining sites either under construction or in planning. The DOE's UMTRA Project has been very successful in dealing with public and agency demands, particularly regarding disposal site selection and transportation issues. The active sites are also being cleaned up, but at a slower pace than the inactive sites, with the first site tentatively scheduled for completion in 1996

  8. 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...

  9. 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)

  10. Bank regulatory Capital Buffer and Liquidity: Evidence from US and European Publicly Traded Banks

    OpenAIRE

    Distinguin , Isabelle; Roulet , Caroline; Tarazi , Amine

    2012-01-01

    The theory of financial intermediation highlights various channels through which capital and liquidity are interrelated. Using a simultaneous equations framework, we investigate the relationship between bank regulatory capital buffer and liquidity for European and U.S. publicly traded commercial banks. Previous research studying the determinants of bank capital buffer has neglected the role of liquidity. On the whole, we find that banks do not strengthen their regulatory capital buffer when t...

  11. 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)

  12. Sexual violence: feminist developments, rape myths and the international regulatory response

    OpenAIRE

    Tardón Recio, Bárbara

    2017-01-01

    Tesis doctoral inédita leída en la Universidad Autónoma de Madrid, Facultad de Filosofía y Letras, Instituto Universitario de Estudios de la Mujer. Fecha de lectura: 29-09-2017 Making use of a feminist and human rights-based theoretical framework, this doctoral thesis reveals the isolation experienced by women victims of sexual violence over the last 30 years in Spain, despite the positive developments in this realm and the existence of a regulatory framework specifically addressi...

  13. Handbook for value-impact assessments of NRC regulatory actions

    International Nuclear Information System (INIS)

    Mullen, M.F.; DiPalo, A.J.

    1985-01-01

    According to current Nuclear Regulatory Commission (NRC) procedures, value-impact (cost-benefit) assessments must be prepared for all rulemaking actions and for a broad range of other regulatory requirements and guidance. Probabilistic risk assessment (PRA) methods furnish an important part of the information base for these assessments. PRA methods are frequently the principal quantitative tool for estimating the benefits (e.g., public risk reduction) of proposed regulatory actions. In December 1983, the NRC published A Handbook for Value-Impact Assessment, NUREG/CR-3568, which provides a set of systematic procedures for performing value-impact assessments. The Handbook contains methods, data, and sources of information that can assist the regulatory analyst in conducting such assessments. The use of probabilistic risk analysis to estimate the benefits of proposed regulatory actions is described. Procedures and methods are also given for evaluating the costs and other consequences associated with regulatory actions. The Handbook has been adopted by the NRC as the recommended guideline for value impact assessments. This paper presents the background, objectives, and scope of the Handbook, describes the value-impact assessment methods (including the use of probabilistic risk assessment to estimate benefits), and discusses a selection of current and planned applications, with examples to illustrate how the methods are used

  14. Boolean Dynamic Modeling Approaches to Study Plant Gene Regulatory Networks: Integration, Validation, and Prediction.

    Science.gov (United States)

    Velderraín, José Dávila; Martínez-García, Juan Carlos; Álvarez-Buylla, Elena R

    2017-01-01

    Mathematical models based on dynamical systems theory are well-suited tools for the integration of available molecular experimental data into coherent frameworks in order to propose hypotheses about the cooperative regulatory mechanisms driving developmental processes. Computational analysis of the proposed models using well-established methods enables testing the hypotheses by contrasting predictions with observations. Within such framework, Boolean gene regulatory network dynamical models have been extensively used in modeling plant development. Boolean models are simple and intuitively appealing, ideal tools for collaborative efforts between theorists and experimentalists. In this chapter we present protocols used in our group for the study of diverse plant developmental processes. We focus on conceptual clarity and practical implementation, providing directions to the corresponding technical literature.

  15. Identification of miRNA-mRNA regulatory modules by exploring collective group relationships.

    Science.gov (United States)

    Masud Karim, S M; Liu, Lin; Le, Thuc Duy; Li, Jiuyong

    2016-01-11

    microRNAs (miRNAs) play an essential role in the post-transcriptional gene regulation in plants and animals. They regulate a wide range of biological processes by targeting messenger RNAs (mRNAs). Evidence suggests that miRNAs and mRNAs interact collectively in gene regulatory networks. The collective relationships between groups of miRNAs and groups of mRNAs may be more readily interpreted than those between individual miRNAs and mRNAs, and thus are useful for gaining insight into gene regulation and cell functions. Several computational approaches have been developed to discover miRNA-mRNA regulatory modules (MMRMs) with a common aim to elucidate miRNA-mRNA regulatory relationships. However, most existing methods do not consider the collective relationships between a group of miRNAs and the group of targeted mRNAs in the process of discovering MMRMs. Our aim is to develop a framework to discover MMRMs and reveal miRNA-mRNA regulatory relationships from the heterogeneous expression data based on the collective relationships. We propose DIscovering COllective group RElationships (DICORE), an effective computational framework for revealing miRNA-mRNA regulatory relationships. We utilize the notation of collective group relationships to build the computational framework. The method computes the collaboration scores of the miRNAs and mRNAs on the basis of their interactions with mRNAs and miRNAs, respectively. Then it determines the groups of miRNAs and groups of mRNAs separately based on their respective collaboration scores. Next, it calculates the strength of the collective relationship between each pair of miRNA group and mRNA group using canonical correlation analysis, and the group pairs with significant canonical correlations are considered as the MMRMs. We applied this method to three gene expression datasets, and validated the computational discoveries. Analysis of the results demonstrates that a large portion of the regulatory relationships discovered by

  16. Application of Regulatory Focus Theory to Search Advertising.

    Science.gov (United States)

    Mowle, Elyse N; Georgia, Emily J; Doss, Brian D; Updegraff, John A

    The purpose of this paper is to test the utility of regulatory focus theory principles in a real-world setting; specifically, Internet hosted text advertisements. Effect of compatibility of the ad text with the regulatory focus of the consumer was examined. Advertisements were created using Google AdWords. Data were collected for the number of views and clicks each ad received. Effect of regulatory fit was measured using logistic regression. Logistic regression analyses demonstrated that there was a strong main effect for keyword, such that users were almost six times as likely to click on a promotion advertisement as a prevention advertisement, as well as a main effect for compatibility, such that users were twice as likely to click on an advertisement with content that was consistent with their keyword. Finally, there was a strong interaction of these two variables, such that the effect of consistent advertisements was stronger for promotion searches than for prevention searches. The effect of ad compatibility had medium to large effect sizes, suggesting that individuals' state may have more influence on advertising response than do individuals' traits (e.g. personality traits). Measurement of regulatory fit was limited by the constraints of Google AdWords. The results of this study provide a possible framework for ad creation for Internet advertisers. This paper is the first study to demonstrate the utility of regulatory focus theory in online advertising.

  17. Recommendations for the elaboration of a training program and personnel qualification of the regulatory body

    International Nuclear Information System (INIS)

    Medina Gironzini, E.; Bonacossa de Almeida, C.; Jimenez Rojas, M.; Pacheco Jimenez, R.; Prendes Alonso, M.; Tomas Zerquera, J.

    2013-01-01

    In this work are defined training methods and provides details on the qualifications of staff and the use of the method of the four quadrants where competencies are established: legal framework and regulatory responsibilities, technical disciplines, regulatory procedures and personal attributes. It is the first time that will make these recommendations in the region and is expected to be very useful for the regulator institutions

  18. Application of Resource Portfolio Concept in Nuclear Regulatory Infrastructure Support

    International Nuclear Information System (INIS)

    Lee, Y. E.; Ha, J. T.; Chang, H. S.; Kam, S. C.; Ryu, Y. H.

    2010-01-01

    As the new entrants in the global nuclear construction market are increasing and the establishment of an effective and sustainable regulatory infrastructure becomes more important, they have requested international assistance from the international nuclear communities with mature nuclear regulatory programmes. It needs to optimize the use of limited resources from regulatory organization providing support to regulatory infrastructure of new comers. This paper suggests the resource portfolio concept like a GE/Mckinsey Matrix used in business management and tries to apply it to the current needs considered in the regulatory support program in Korea as the case study

  19. Regulatory issues of digital instrumentation and control system in Lungmen project

    International Nuclear Information System (INIS)

    Chuang, C.F.; Chou, H.P.

    2004-01-01

    The Lungmen Nuclear Power Station (LNPS) is currently under construction in Taiwan, which consists of 2 advanced boiling water reactor (ABWR) units. The instrumentation and control (IC) systems of the LNPS are based on the state-of-the-art modernized fully integrated digital design. These IC systems possess many advantages and distinguished features comparing to traditional analog IC systems, they enjoy set-point stability, self-diagnostic and automatic testing ability, fault tolerance and avoidance, low power requirements, data handling and storage capability, as well as enhanced human-machine interfaces. This paper presents regulatory overviews, regulatory requirements, current major regulatory issues, as well as the areas of regulatory concerns and the lessons learned on the digital IC systems in the Lungmen Project

  20. Gene regulatory network inference by point-based Gaussian approximation filters incorporating the prior information.

    Science.gov (United States)

    Jia, Bin; Wang, Xiaodong

    2013-12-17

    : The extended Kalman filter (EKF) has been applied to inferring gene regulatory networks. However, it is well known that the EKF becomes less accurate when the system exhibits high nonlinearity. In addition, certain prior information about the gene regulatory network exists in practice, and no systematic approach has been developed to incorporate such prior information into the Kalman-type filter for inferring the structure of the gene regulatory network. In this paper, an inference framework based on point-based Gaussian approximation filters that can exploit the prior information is developed to solve the gene regulatory network inference problem. Different point-based Gaussian approximation filters, including the unscented Kalman filter (UKF), the third-degree cubature Kalman filter (CKF3), and the fifth-degree cubature Kalman filter (CKF5) are employed. Several types of network prior information, including the existing network structure information, sparsity assumption, and the range constraint of parameters, are considered, and the corresponding filters incorporating the prior information are developed. Experiments on a synthetic network of eight genes and the yeast protein synthesis network of five genes are carried out to demonstrate the performance of the proposed framework. The results show that the proposed methods provide more accurate inference results than existing methods, such as the EKF and the traditional UKF.

  1. Comparative Human Health Impact Assessment of Engineered Nanomaterials in the Framework of Life Cycle Assessment.

    Science.gov (United States)

    Fransman, Wouter; Buist, Harrie; Kuijpers, Eelco; Walser, Tobias; Meyer, David; Zondervan-van den Beuken, Esther; Westerhout, Joost; Klein Entink, Rinke H; Brouwer, Derk H

    2017-07-01

    For safe innovation, knowledge on potential human health impacts is essential. Ideally, these impacts are considered within a larger life-cycle-based context to support sustainable development of new applications and products. A methodological framework that accounts for human health impacts caused by inhalation of engineered nanomaterials (ENMs) in an indoor air environment has been previously developed. The objectives of this study are as follows: (i) evaluate the feasibility of applying the CF framework for NP exposure in the workplace based on currently available data; and (ii) supplement any resulting knowledge gaps with methods and data from the life cycle approach and human risk assessment (LICARA) project to develop a modified case-specific version of the framework that will enable near-term inclusion of NP human health impacts in life cycle assessment (LCA) using a case study involving nanoscale titanium dioxide (nanoTiO 2 ). The intent is to enhance typical LCA with elements of regulatory risk assessment, including its more detailed measure of uncertainty. The proof-of-principle demonstration of the framework highlighted the lack of available data for both the workplace emissions and human health effects of ENMs that is needed to calculate generalizable characterization factors using common human health impact assessment practices in LCA. The alternative approach of using intake fractions derived from workplace air concentration measurements and effect factors based on best-available toxicity data supported the current case-by-case approach for assessing the human health life cycle impacts of ENMs. Ultimately, the proposed framework and calculations demonstrate the potential utility of integrating elements of risk assessment with LCA for ENMs once the data are available. © 2016 Society for Risk Analysis.

  2. Improving the applicability of (Q)SARs for percutaneous penetration in regulatory risk assessment.

    NARCIS (Netherlands)

    Bouwman, T.; Cronin, M.T.; Bessems, J.G.; Sandt, J.J. van de

    2008-01-01

    The new regulatory framework REACH (Registration, Evaluation, and Authorisation of Chemicals) foresees the use of non-testing approaches, such as read-across, chemical categories, structure-activity relationships (SARs) and quantitative structure-activity relationships (QSARs). Although information

  3. 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

  4. 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)

  5. The Energy Regulatory Commission. The Regulation of Natural Gas in Mexico

    International Nuclear Information System (INIS)

    1995-01-01

    In May of 1995 the Congress approved amendments to the Regulatory Law of Constitutional article 27 on Petroleum. This legal reform fundamentally redefined the petroleum industry and authorizes the private sector to construct, operate, and own natural gas transportation, storage and distribution systems-activities previously reserved to the state. To complement these reforms and to implement the legislative mandate of the Regulatory Law on Petroleum, the Natural Gas Regulation (Reglamento de Gas Natural) was issued in November 1995. The regulation reconciles the interests of the various natural gas industry participants and signifies a Federal Commitment to promote comprehensive development of the industry. In parallel with the development of the substantive legal framework, the law of the Comision Reguladora de Energia (CRE) was also enacted by Congress in October 1995 to strength the institutional framework and implemented the legal changes. This law defines the CRE as an agency of the Energy Ministry with technical, operational, and budgetary autonomy, and responsibility for implementing natural gas industry regulation. (Author)

  6. Regulatory Framework for the Maintenance of the Relevant Knowledge in the Atomic Energy Use Sector

    International Nuclear Information System (INIS)

    Sapozhnikov, A.

    2016-01-01

    Full text: In accordance with the Atomic Act of the Russian Federation the employees and workers (personnel) of nuclear industry organisations, who occupy certain positions or perform specific activities in the field of atomic energy use can start to fulfil their duties only after getting a special permit issued by the state safety regulatory authority. Rostechnadzor issues permits for the specified kinds of activities to personal of nuclear facilities, organizations engaged in transportation of nuclear and radioactive materials, and enterprises performing physical protection and account of nuclear materials and radioactive substances. To enforce the provisions of the Atomic Act Rostechnadzor has developed a regulatory system (requirements, procedures and methodology) for continued supervision over the maintenance of the required level of knowledge and adequate understanding of the nuclear safety requirements by the nuclear personnel, depending on the nature of their job duties and work in the sphere of nuclear energy use. The report presents a long-term experience of Rostechnadzor in implementing an effective regulatory system for maintaining an adequate level of knowledge and expertise of personnel of nuclear industry organisations and ensuring a competent workforce in the nuclear energy sector. (author

  7. NANoREG framework for the safety assessment of nanomaterials

    OpenAIRE

    Gottardo, Stefania; Alessandrelli, Maria; Amenta, Valeria; Atluri, Rambabu; Barberio, Grazia; Bekker, Cindy; Bergonzo, Philippe; Bleeker, Eric; Booth, Andy; Borges, Teresa; Buttol, Patrizia; Carlander, David; Castelli, Stefano; Chevillard, Sylvie

    2017-01-01

    The NANoREG framework addresses the need to ease the nanomaterials safety assessment in the REACH Regulation context. It offers forward-looking strategies: Safe-by-Design, a Nanospecific Prioritisation and Risk Assessment, and Life Cycle Assessment. It is intended for scientific experts, regulatory authorities and industry.

  8. A strategy for regulatory action when new adverse effects of a licensed product emerge.

    Science.gov (United States)

    Aronson, Jeffrey K; Price, Deirdre; Ferner, Robin E

    2009-01-01

    Regulatory agencies grant product licences (marketing authorizations) for medicinal products in the light of evidence that the balance between benefit and harm in the population is favourable. Here we consider a framework for allowing regulatory agencies to make rational decisions when reviewing product licences in the light of new information about harms that change that balance. The regulator can revoke the product licence, restrict the product's availability or change the 'label' in different ways. We examine the features of the adverse effect that may be relevant in making the decision: namely, individual differences in susceptibility; the possibility of monitoring; and the availability of protective strategies. The balance of benefit and harm, and the time-course and dose relation of the adverse effect play important roles in the decision-making process. We set out how these factors can help determine the logical response to new information on the balance between benefit and harm, and provide a series of relevant examples. We believe that when regulatory agencies have to decide how to amend the product licence of a drug when new serious adverse effects cause concern, they would find it useful to adopt a framework of this kind, using different strategies for different cases. Our proposed framework could also be useful in risk management planning during drug development.

  9. Safety research programs sponsored by Office of Nuclear Regulatory Research

    International Nuclear Information System (INIS)

    Weiss, A.J.; Azarm, A.; Baum, J.W.

    1989-07-01

    This progress report describes current activities and technical progress in the programs at Brookhaven National Laboratory sponsored by the Division of Regulatory Applications, Division of Engineering, Division of Safety Issue Resolution, and Division of Systems Research of the US Nuclear Regulatory Commission, Office of Nuclear Regulatory Research following the reorganization in July 1988. The previous reports have covered the period October 1, 1976 through September 30, 1988

  10. Establishing a Regulatory Framework for the Development & Operations of Sub-Orbital & Orbital Aircraft (SOA) in the EU

    Science.gov (United States)

    Marciacq, Jean-Bruno; Tomasello, Filippo; Erdelyi, Zsuzsanna; Gerhard, Michael

    2013-09-01

    to establish a consistent regulatory framework to allow safe and environmentally controlled operations of SOA in Europe. For further legal and technical details, please refer to the corresponding IAASS-published papers.

  11. Food safety regulatory systems in Europe and China:A study of how co-regulation can improve regulatory effectiveness

    Institute of Scientific and Technical Information of China (English)

    Kevin Chen; WANG Xin-xin; SONG Hai-ying

    2015-01-01

    Food safety has received a great deal of attention in both developed and developing countries in recent years. In China, the numerous food scandals and scares that have struck over the past decade have spurred signiifcant food safety regulatory reform, which has been increasingly oriented towards the public-private partnership model adopted by the Europe Union’s (EU) food safety regulatory system. This paper analyzes the development of both the EU’s and China’s food safety regu-latory systems, identiifes the current chalenges for China and additionaly considers the role of public-private partnership. The success of co-regulation in the food regulatory system would bring signiifcant beneifts and opportunities for China. Finaly, this paper recommends additional measures like training and grants to improve the private’s sector effectiveness in co-regulating China’s food safety issues.

  12. Regulatory and licensee surveys

    International Nuclear Information System (INIS)

    2009-01-01

    Prior to the workshop two CSNI/WGHOF surveys were distributed. One survey was directed at regulatory bodies and the other was directed at plant licensees. The surveys were: 1 - Regulatory Expectations of Licensees' Arrangements to Ensure Suitable Organisational Structure, Resources and Competencies to Manage Safety (sent to WGHOF regulatory members). The survey requested that the respondents provide a brief overview of the situation related to plant organisations in their country, their regulatory expectations and their formal requirements. The survey addressed three subjects: the demonstration and documentation of organisational structures, resources and competencies, organisational changes, issues for improvement (for both current and new plants). Responses were received from eleven regulatory bodies. 2 - Approaches to Justify Organisational Suitability (sent to selected licensees). The purpose of the survey to was to gain an understanding of how licensees ensure organisational suitability, resources and competencies. This information was used to assist in the development of the issues and subjects that were addressed at the group discussion sessions. Responses were received from over fifteen licensees from nine countries. The survey requested that the licensees provide information on how they ensure effective organisational structures at their plants. The survey grouped the questions into the following four categories: organisational safety functions, resource and competence, decision-making and communication, good examples and improvement needs. The findings from these surveys were used in conjunction with other factors to identify the key issues for the workshop discussion sessions. The responses from these two surveys are discussed briefly in Sections 4 and 5 of this report. More extensive reviews of the regulatory and licensee responses are provided in Appendix 1

  13. Enhancing Tissue Engineering and Regenerative Medicine Product Commercialization: The Role of Science in Regulatory Decision-Making for the TE/RM Product Development.

    Science.gov (United States)

    Bertram, Timothy A; Johnson, Peter C; Tawil, Bill J; Van Dyke, Mark; Hellman, Kiki B

    2015-10-01

    TERMIS-AM Industry Committee (TERMIS-AM/IC), in collaboration with the TERMIS-Europe (EU)/IC, conducted a symposium involving the European Medicines Agency and the U.S. Food and Drug Administration (FDA) toward building an understanding of the rational basis for regulatory decision-making and providing a framework for decisions made during the evaluation of safety and efficacy of TE/RM technologies. This symposium was held in August 2012 during the TERMIS-WC in Vienna, Austria. Emerging from this international initiative by the European Union and the United States, representatives from the respective agencies demonstrated that there are ongoing interagency efforts for developing common national practices toward harmonization of regulatory requirements for the TE/RM products. To extend a broad-based understanding of the role of science in regulatory decision-making, TERMIS-AM/IC, in cooperation with the FDA, organized a symposium at the 2014 TERMIS-AM Annual Meeting, which was held in Washington, DC. This event provided insights from leaders in the FDA and TERMIS on the current status of regulatory approaches for the approved TE/RM products, the use of science in making regulatory decisions, and TE/RM technologies that are in the development pipeline to address unmet medical needs. A far-ranging discussion with FDA representatives, industrialists, physicians, regenerative medicine biologists, and tissue engineers considered the gaps in today's scientific and regulatory understanding of TE/RM technologies. The identified gaps represent significant opportunities to advance TE/RM technologies toward commercialization.

  14. Status Report: A Hydrologic Framework for the Oak Ridge Reservation

    Energy Technology Data Exchange (ETDEWEB)

    Solomon, D.K.

    1992-01-01

    The Oak Ridge Reservation Hydrology and Geology Study (ORRHAGS) was established in 1989 as an integrated study of the hydrology, geology, and soils of the reservation in support of the extensive activities in environmental monitoring, environmental restoration, waste management, and regulatory compliance on the Oak Ridge Reservation (ORR) of the US Department of Energy (DOE). The Hydrologic Studies Task of ORRHAGS is designed to provide essential information about the hydrologic environment of the ORR to those responsible for dealing with environmental issues, including restoration, environmental monitoring, and waste management, compliance, and enforcement. In order to ensure optimum environmental protection, these systems and their elements must be better understood and quantified. Additionally, in light of the enormous costs attached to environmental protection, restoration, monitoring, and waste management, these activities must be planned and implemented as efficiently as possible. A practical understanding of the hydrologic systems is required for all the objectives associated with contaminants in the hydrologic environment of the ORR. This report describes the current status of the development of a workable framework for the hydrology of the ORR. The framework is based mostly on data and information available from previous investigations.

  15. Challenges in long-term operation of nuclear power plants - Implications for regulatory bodies

    International Nuclear Information System (INIS)

    Soda, Kunihisa; Van Wonterghem, Frederik; Khouaja, Hatem; Vilpas, Martti; Osouf, Nicolas; Harikumar, S.; Ishigaki, Hiroki; Osaki, Toru; Yamada, Tomoho; Carlsson, Lennart; Shepherd, David; Galloway, Melanie; Liszka, Ervin; Svab, Miroslav; Pereira, Ken; Huerta, Alejandro

    2012-01-01

    Nuclear power reactors have become a major source of electricity supply in many countries in the past half a century. Based on this experience, many operators have sought and have received authorisation for long-term operation, whereby plant operation continues beyond the period considered in the design of the plant. Acceptance of a nuclear power plant for extended service should be based on assurance of the fitness of the plant and the operator for safe and reliable operation over the entire period considered for long-term operation. This assurance may be obtained by establishment of appropriate regulatory requirements, specification of goals and safety levels and regulatory assessment and oversight of the operator's programme for long-term operation. The operators and regulators should ensure that operating experience continues to be evaluated during long-term operation to ensure that any relevant lessons are effectively applied. Other considerations for assurance of safe operation are effective management of ageing, possible need for safety improvements, application of lessons learnt from operating experience, evaluation of environmental impacts, adequate staff resources and performance, review of security at the plant, action in response to emerging issues, and openness and transparency in the transition to long-term operation. Even though most of these considerations are addressed under the regulatory framework that applies to the initial operating period, additional regulatory activities in these areas may be necessary for long-term operation. Although there can be significant differences in regulatory approaches used by different countries for evaluating acceptability of long-term operation, there is general agreement on the purposes and goals of the regulatory reviews. An authorisation of long-term operation could involve a licence renewal or a periodic safety review or an approach that melds elements of both. This report presents guidance that is intended

  16. 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.

  17. Advancing towards commonsense regulation of mixed waste: Regulatory update

    International Nuclear Information System (INIS)

    Porter, C.L.

    1996-01-01

    The author previously presented the basis for regulating mixed waste according to the primary hazard (either chemical or radiological) in order to avoid the inefficient practice of open-quotes dual regulationclose quotes of mixed waste. In addition to covering the technical basis, recommendations were made on how to capitalize upon a window of opportunity for implementation of a open-quotes primary hazards approachclose quotes. Some of those recommendations have been pursued and the resulting advances on the regulatory front are exciting. This paper chronicles those pursuits, presents in capsule form the massive amount of data assembled, and summarizes the changing regulatory framework. The data supports the premise that disposal of stabilized mixed waste in a low-level radioactive waste (LLW) disposal facility is protective of human health and the environment. Based on that premise, proposed regulatory changes, if finalized, will eliminate much of the open-quotes dual regulationclose quotes of mixed waste

  18. A study on the implement of regulatory issue problems about service business

    International Nuclear Information System (INIS)

    Kim, In Hwan; Shim, H. S.; Yoon, K. H.; Jun, I. Y.; Kang, W. S.; Chang, J. H.

    2004-12-01

    This study is intended to derive a proposal for revision of the Atomic Energy Law, with understanding of differences between regulatory requirements and current issues based on findings during safety review and regular inspection. The contents and scope of this study is as follows: - Deep review for service business in 'the rationalization of the radiation protection system related with use of radionuclide', studied by Korea Isotope Association and presentation in the Korea Association for radiation protection, - Efficient regulatory activity through pre-finding of current regulatory issues to be derived during safety review and regular inspection

  19. The gas industry in Brazil and the new regulatory framework; L'industrie du gaz au Bresil et le nouveau cadre des reglementations

    Energy Technology Data Exchange (ETDEWEB)

    Schwyter, A.A. [Comgas, Cia. de Gas de Sao Paulo (Brazil)

    2000-07-01

    In the last tem years many things have changes in the economic and political environment in the world, especially in Brazil. The new federal government elected in 1994 has started a new economic program and one of the most important points is to reduce government interference in the economy. For this reason, the Federal Constitution was changed and now private companies can operate in the natural gas upstream and downstream sectors. The aim of this policy is to increase efficiency in the energy sector with more investment and better prices. Brazil is now facing a new challenge, which is to establish a complete regulatory framework for the gas industry, for its development, with private as well as state owned companies. The purpose of this work is to study the main characteristics of the Brazilian natural gas sector and how to set up regulatory issues to service it. The Brazilian Natural Gas Industry has specific characteristics, very different from other countries', even from those in Latin America. It is necessary, in order to more adequately develop the industry: new suppliers, guaranty of supply, definition of open access, definition of concession models, setting the role of the state and federal powers, transportation systems and the development of a gas network, definition of exports and imports, production, safety, product quality and service, principle of tariffs and prices and all those aspects which are not regulated yet. (author)

  20. ATLAS Future Framework Requirements Group Report

    CERN Document Server

    The ATLAS collaboration

    2016-01-01

    The Future Frameworks Requirements Group was constituted in Summer 2013 to consider and summarise the framework requirements from trigger and offline for configuring, scheduling and monitoring the data processing software needed by the ATLAS experiment. The principal motivation for such a re-examination arises from the current and anticipated evolution of CPUs, where multiple cores, hyper-threading and wide vector registers require a shift to a concurrent programming model. Such a model requires extensive changes in the current Gaudi/Athena frameworks and offers the opportunity to consider how HLT and offline processing can be better accommodated within the ATLAS framework. This note contains the report of the Future Frameworks Requirements Group.