WorldWideScience

Sample records for current regulatory framework

  1. 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.

  2. 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.

  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. 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

  5. [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.

  6. 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).

  7. 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)

  8. 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

  9. 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

  10. 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

  11. 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.

  12. 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.

  13. 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

  14. 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.

  15. 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.

  16. 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)

  17. 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

  18. 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)

  19. 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

  20. 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.

  1. 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 ...

  2. 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)

  3. 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)

  4. 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.

  5. 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

  6. 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

  7. 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)

  8. 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)

  9. 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.)

  10. 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...

  11. 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.

  12. 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)

  13. 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 ...

  14. 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

  15. 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

  16. 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 ...

  17. 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)

  18. 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

  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. 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)

  1. 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.

  2. 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...

  3. 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

  4. 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...

  5. 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)

  6. 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)

  7. 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...

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  13. 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

  14. 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

  15. 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.

  16. 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

  17. 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

  18. 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.

  19. 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...

  20. 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.

  1. 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

  2. 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...

  3. 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...

  4. 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

  5. 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)

  6. 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

  7. 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

  8. 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

  9. 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.

  10. 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.

  11. 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

  12. 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

  13. 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

  14. 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.

  15. 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.

  16. 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.

  17. 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

  18. 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)

  19. 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.

  20. 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.

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  9. 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)

  10. 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.

  11. 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

  12. 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 ...

  13. 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 ...

  14. 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)

  15. 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)

  16. 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)

  17. 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.

  18. 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

  19. 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

  20. 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.

  1. 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)

  2. 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

  3. Options for electricity production, the actual opportunities and regulatory framework

    International Nuclear Information System (INIS)

    Raphals, P.

    2006-01-01

    Thermal power and nuclear power represent the traditional methods of generating electricity. This paper presented opportunities for alternative centralized power production methods that include wind energy, biomass and solar energy. It also discussed decentralized alternatives for power generation, such as geothermal energy and cogeneration, including microturbines. The primary focus was on aspects of competitive market design for residential and small commercial applications as well as commercial and industrial applications. Law 116 of Quebec's Energy Board was reviewed in terms of energy policy and utility regulation. In particular, the framework agreement between Hydro-Quebec Production (HQP) and Hydro-Quebec Distribution (HQD) was discussed with reference to balancing electricity produced from renewable energy sources and energy security. The presentation also addressed issues regarding the role of competition, regulation and environmental implications of electricity trade. refs., tabs., figs

  4. 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)

  5. 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)

  6. 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

  7. Regulatory framework, strategy and radioactive waste management in Zambia

    International Nuclear Information System (INIS)

    Banda, S.

    2001-01-01

    Full text: Zambia is involved in the peaceful application in Nuclear Science and Technology which cover the agriculture, human health, industry, research and education sectors. In the execution of the projects various radioactive sources and radioisotopes are used. The data from the Radiation Protection Board show that there are 136 organizations and 971 Radiation workers benefit from the regulatory control and personnel Dosimetry service that is provided by the Board. The radiation user institutions are broken down as follows: medical (106), industrial (18), research (10) and (2) in teaching. The radioactive waste generated and spent sources are managed, in several ways depending on the type . In addition to radioactive waste generated by various application there are new developments concerning the management of spent sources mainly brought into control by the detection of illicit trade or trafficking activities by the Police, Drug Enforcement Commission, and the vigilant people of the community. The challenge for Zambia is to set-up a Radioactive Waste Management Facility preferably under the National Institute for Scientific and Industrial Research (NISIR). The RPB should legally designate NISIR for this function and assist to have the Government provide support that is required to have an operation and effective facility. One Radioactive Waste Interim Storage Shed at Kalulushi. This shed was put up by a copper mining conglomerate which now has been privatized. It is hoped that this facility can be licensed by Radiation Protection Board to be run by private enterprise for storage of prescribed spent radioactive sources and materials. This shed should be technically competent persons and should have good equipment for the purpose. The application in industry (NDT, mining, radiation sterilization, pipeline and construction, human health (nuclear medicine, radioimmunoassay and radiotherapy practices) and agriculture (use of P-32) required that a National Strategy

  8. Overview regarding the Romanian electricity sector regulatory framework development

    International Nuclear Information System (INIS)

    Bogdan, H.; Caracasian, L.

    2002-01-01

    The Romanian Electricity and Heat Regulatory Authority (ANRE) became operational in March 1999 and sector regulations came to render complete the specific primary legislation already adopted. The alignment to the international practice in the field, attracting investors while complying with the country's legitimate interests for a sustainable economic development and a sound social partnership among sector players were aimed at by ANRE in drawing out its regulations. The paper describes the progress Romania made in the last years in the transition towards a liberalised electricity sector. The key elements leading to such evolution are: 1. the development of the national legislation in accordance with the applicable EU legislation; 2. the establishment of an independent regulator to regulate monopolies where they remain, and to foster competition; 3. the splitting of the vertical integrated utility CONEL/RENEL in several independent companies, the establishment of the Transmission System Operator and the Market Operator within the National Grid Company T ranselectrica ; 4. the Romanian regulating system of authorizations and licenses; 5. the regulated access to the transmission and distribution networks; 6. the design of the wholesale market with two components: bilateral contracts between generators and suppliers and a day-ahead market to ensure the balance between demand and supply; 7. the gradual opening of the electricity market for eligible customers with minimum negative impact upon captive customers; 8. the improvements of the tariff methodologies in order to facilitate long-term decision making and to encourage the entering of potential investors on the market; 9. the introduction of performance standards for the supply activities. Financing resources were also ensured for investments in the modernisation of the national electricity transmission grid with a view to interconnection to the EU networks. Transparency of the process for the access to electricity

  9. European Commission action aimed at constructing a European regulatory framework

    International Nuclear Information System (INIS)

    Ristori, D.

    2010-01-01

    The challenge of a low-carbon economy provides a new incentive for the development of renewable energies as well as of nuclear energy. The latter calls for a high level of safety and security. The EU has a role in providing a legal framework for this purpose as well as ensuring that these standards are respected internationally. For over 50 years the EURATOM Treaty has offered the legal basis for a wide range of initiatives supporting this policy. The EU has competences under chapter 3, 'Health and Safety', for the establishment of basic safety standards for the protection against ionizing radiation. These have extended beyond the scope of nuclear energy and now include medical exposures as well as natural radiation sources. The latest revision of the BSS-Directive, to be proposed in 2011, was an opportunity for the consolidation of all Community legislation. A ruling of the Court of Justice in 1999 paved the way for the establishment of standards on the safety of nuclear installations. A common vision on this matter was achieved through the creation of a body of European Safety Regulators (ENSREG) and the adoption of a specific Safety Directive in 2009. This new Directive translates internationally agreed safety standards into legally binding EU legislation and strengthens the position of national Regulators. (author)

  10. 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.

  11. 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

  12. 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.

  13. 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)

  14. 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)

  15. 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.

  16. QUESTIONS TO REGULATORY FRAMEWORK ACCOUNTING AND FINANCIAL STATEMENTS UNDER IFRS

    Directory of Open Access Journals (Sweden)

    V. Shvets

    2015-10-01

    Full Text Available With the system approach in article analyzes the situation and problems of legal regulation and providing accounting and financial reporting in terms of standardization and harmonization of the principles of IFRS. The evaluation of the provisions and objectives of the strategy for reform of accounting and reporting rules and the requirements of European integration processes. Analyzed and determined the degree of influence of accounting and analytical science and education for the development and implementation of new approaches to the reform process and regulation of accounting, control and audit. critical analysis of the draft amendments to the existing regulations, current views on instytutsiynist accounting under uncertainty and systemic crisis outlined organizational problems and possible solutions to methodological council of accounting.

  17. 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

  18. 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.

  19. 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))

  20. 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

  1. 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

  2. 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.

  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. 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.

  5. 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

  6. 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

  7. 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)

  8. 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))

  9. 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)

  10. 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

  11. 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

  12. 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)

  13. 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.

  14. 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.

  15. 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

  16. 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

  17. 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).

  18. 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

  19. 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.

  20. 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)

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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

  9. 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)

  10. 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)

  11. 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

  12. 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

  13. 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.)

  14. 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)

  15. 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

  16. 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

  17. 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.

  18. 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)

  19. 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)

  20. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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)

  9. 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)

  10. 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

  11. 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)

  12. 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

  13. 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

  14. 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.

  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. 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

  17. 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)

  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. 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.)

  1. 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)

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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.

  9. 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)

  10. 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)

  11. 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

  12. The parameters of the current legal framework for health research ...

    African Journals Online (AJOL)

    South African Journal of Bioethics and Law. Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives · Journal Home > Vol 6, No 2 (2013) >. Log in or Register to get access to full text downloads.

  13. 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

  14. International migration flows. Framework for understanding and current features.

    Directory of Open Access Journals (Sweden)

    Colectivo IOÉ

    2016-10-01

    Full Text Available The present article aims to outline a framework for the understanding of the present international migratory flows as well as to outline their main traits. In order to do this, we first group together the different migratory flows produced since the sixteenth century up to the mid seventies in the twentieth  century, stopping then for a closer look at the present situation which register the impact of economic globalization, translating it into an increase of said flows and, above all, to their enormous diversification. To end, we make a brief balance of the present period and a critical evaluation on the meaning of one of the flows which attracts most attention, economic migrations south-north, because these are the ones which have the most impact on developed countries.

  15. 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)

  16. 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

  17. 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.

  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. 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)

  20. 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  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. 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.

  8. 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.

  9. 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...

  10. 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)

  11. 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.

  12. 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.

  13. 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

  14. 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.

  15. 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.

  16. 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.

  17. 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

  18. 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

  19. 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 ...

  20. 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)

  1. 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

  2. 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.

  3. 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.

  4. 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)

  5. 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.

  6. 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.

  7. The Regulatory Framework Across International Jurisdictions for Risks Associated with Consumption of Botanical Food Supplements

    NARCIS (Netherlands)

    Low, Teng Yong; Wong, Kwok Onn; Yap, Adelene L.L.; Haan, De Laura H.J.; Rietjens, Ivonne M.C.M.

    2017-01-01

    Dietary supplements, including those containing botanical ingredients and botanical-derived compounds, have been marketed to consumers globally for many decades. However, the legislative framework for such products remains inconsistent across jurisdictions internationally. This study aims to

  8. 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

  9. 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

  10. 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.

  11. 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

  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. 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

  14. 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.

  15. Regulatory Framework and Current Practices of the Radioactive Material Safe and Secure Transport in Albania

    International Nuclear Information System (INIS)

    Dollani, K.; Grillo, B.; Telhaj, E.

    2016-01-01

    Attempts for the establishing of a safe and secure radioactive material transport in Albania began a decade ago with formulation of the different regulation in the field of safe and secure handling of the radioactive materials. In 2004 a special regulation for the safe transport of radioactive material was prepared and approved by the National Radiation Protection Commission). This regulation has been based in the IAEA standards for the radioactive material transport and was reviewed periodically. The last regulation of the radioactive material transport was approved by Albanian government through a governmental ordinance. The transport of the radioactive material in Albania is performed by licensed subjects, which fulfill all requirements of the mentioned governmental ordinance. Based in the existing regulation, for each transport of radioactive material, a special permission is issued by NRPC. The issuing of permission allows competent authority to provide necessary information on transport regularity and to have under survey all transports of the radioactive material carried out inside the country. Last year were issued more than 80 permissions for the transport of the different types and categories of the radioactive sources. (author)

  16. Legislative and regulatory framework on the safety of radioactive waste management in Bulgaria

    International Nuclear Information System (INIS)

    Kastchiev, G.

    2000-01-01

    There are six nuclear power units in operation in Bulgaria. Over 2000 sites use sources of ionizing radiation. NPP radioactive waste is stored on-site and the institutional waste was disposed of at the Novi han repository until 1994. Bulgaria signed the Joint Convention in 1998 and is to ratify it until the end of 1999. A plan on preparation of the country for the obligations following the forthcoming ratification was developed and has been implemented. A National Strategy on SNF and RAW was developed, as well as a Comprehensive Legislative Programme in this field. Emphasis is put on the strengthening the regulatory body, improvement of the supervision and control activities. (author)

  17. Regulatory Framework for the Safe and Secure Transport of Nuclear Material in Japan

    International Nuclear Information System (INIS)

    Konnai, A.; Shibasaki, N.; Ikoma, Y.; Kato, M.; Yamauchi, T.; Iwasa, T.

    2016-01-01

    Regulations for nuclear material transport in Japan are based on international regulations. Safety and security regulations, however, have sometime different aspects which have caused a conflict of operations. This paper aims to introduce framework of safety and security regulations for nuclear material transport in Japan, and shows some issues in cooperation of these regulations. (author)

  18. Current status and regulatory aspects of pesticides considered to be persistent organic pollutants (POPs) in Taiwan.

    Science.gov (United States)

    Tsai, Wen-Tien

    2010-10-01

    Organochlorine pesticides (OCPs) are capable of persisting in the environment, transporting between phase media and accumulating to high levels, implying that they could pose a risk of causing adverse effects to human health and the environment. Consequently, most OCPs are designated as persistent organic pollutants (POPs) and even as endocrine disrupting chemicals (EDCs). The objective of this paper was to review the current status of pesticide POPs in Taiwan, including aldrin, chlordane, chlordecone, DDT, dieldrin, endrin, heptachlor, hexachlorobenzene, α/β-hexachlorocyclohexanes, lindane, mirex, pentachloro-benzene, and toxaphene. The information about their environmental properties, banned use, carcinogenic toxicity and environmental levels, can be connected with the regulatory infrastructure, which has been established by the joint-venture of the central competent authorities (i.e., Environmental Protection Administration, Department of Health, Council of Agriculture, and Council of Labor Affairs). The significant progress to be reported is that the residual levels of these pesticide-POPs, ranging from trace amounts to a few ppb, have declined notably in recent years.

  19. Current Status and Regulatory Aspects of Pesticides Considered to be Persistent Organic Pollutants (POPs in Taiwan

    Directory of Open Access Journals (Sweden)

    Wen-Tien Tsai

    2010-10-01

    Full Text Available Organochlorine pesticides (OCPs are capable of persisting in the environment, transporting between phase media and accumulating to high levels, implying that they could pose a risk of causing adverse effects to human health and the environment. Consequently, most OCPs are designated as persistent organic pollutants (POPs and even as endocrine disrupting chemicals (EDCs. The objective of this paper was to review the current status of pesticide POPs in Taiwan, including aldrin, chlordane, chlordecone, DDT, dieldrin, endrin, heptachlor, hexachlorobenzene, α/β-hexachlorocyclohexanes, lindane, mirex, pentachloro-benzene, and toxaphene. The information about their environmental properties, banned use, carcinogenic toxicity and environmental levels, can be connected with the regulatory infrastructure, which has been established by the joint-venture of the central competent authorities (i.e., Environmental Protection Administration, Department of Health, Council of Agriculture, and Council of Labor Affairs. The significant progress to be reported is that the residual levels of these pesticide-POPs, ranging from trace amounts to a few ppb, have declined notably in recent years.

  20. 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.

  1. Leveraging Employer Practices in Global Regulatory Frameworks to Improve Employment Outcomes for People with Disabilities

    Directory of Open Access Journals (Sweden)

    Matthew C. Saleh

    2018-03-01

    Full Text Available Work is an important part of life, providing both economic security and a forum to contribute one’s talents and skills to society, thereby anchoring the individual in a social role. However, access to work is not equally available to people with disabilities globally. Regulatory environments that prohibit discrimination and support vocational training and educational opportunities constitute a critical first step toward economic independence. However, they have not proven sufficient in themselves. In this article, we aim to infuse deeper consideration of employer practice and demand-side policy reforms into global policy discussions of the right to work for people with disabilities. We begin by documenting the employment and economic disparities existing for people with disabilities globally, followed by a description of the international, regional, and local regulatory contexts aiming to improve labor market outcomes for people with disabilities. Next, we examine how policies can leverage employer interests to further address inequalities. We discuss employer policies and practices demonstrated in the research to facilitate recruitment, hiring, career development, retention, and meaningful workplace inclusion. The goal of the article is to synthesize existing international literature on employment rights for people with disabilities with the employer perspective.

  2. Time-dependent sorption of two novel fungicides in soils within a regulatory framework.

    Science.gov (United States)

    Gulkowska, Anna; Buerge, Ignaz J; Poiger, Thomas; Kasteel, Roy

    2016-12-01

    Convincing experimental evidence suggests increased sorption of pesticides on soil over time, which, so far, has not been considered in the regulatory assessment of leaching to groundwater. Recently, Beulke and van Beinum (2012) proposed a guidance on how to conduct, analyse and use time-dependent sorption studies in pesticide registration. The applicability of the recommended experimental set-up and fitting procedure was examined for two fungicides, penflufen and fluxapyroxad, in four soils during a 170 day incubation experiment. The apparent distribution coefficient increased by a factor of 2.5-4.5 for penflufen and by a factor of 2.5-2.8 for fluxapyroxad. The recommended two-site, one-rate sorption model adequately described measurements of total mass and liquid phase concentration in the calcium chloride suspension and the calculated apparent distribution coefficient, passing all prescribed quality criteria for model fit and parameter reliability. The guidance is technically mature regarding the experimental set-up and parameterisation of the sorption model for the two moderately mobile and relatively persistent fungicides under investigation. These parameters can be used for transport modelling in soil, thereby recognising the existence of the experimentally observed, but in the regulatory leaching assessment of pesticides not yet routinely considered phenomenon of time-dependent sorption. © 2016 Society of Chemical Industry. © 2016 Society of Chemical Industry.

  3. 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

  4. The Health and Safety Executive's regulatory framework for control of nuclear criticality safety

    International Nuclear Information System (INIS)

    Smith, K.; Simister, D.N.

    1991-01-01

    In the United Kingdom the Health and Safety at Work Act, 1974 is the main legal instrument under which risks to people from work activities are controlled. Certain sections of the Nuclear Installations Act, 1965 which deal with the licensing of nuclear sites and the regulatory control of risks arising from them, including the risk from accidental criticality, are relevant statutory provisions of the Health and Safety at Work Act. The responsibility for safety rests with the operator who has to make and implement arrangements to prevent accidental criticality. The adequacy of these arrangements must be demonstrated in a safety case to the regulatory authorities. Operators are encouraged to treat each plant on its own merits and develop the safety case accordingly. The Nuclear Installations Inspectorate (NII), for its part, assesses the adequacy of the operator's safety case against the industry's own standards and criteria, but more particularly against the NII's safety assessment principles and guides, and international standards. Risks should be made as low as reasonably practicable. Generally, the NII seeks improvements in safety using an enforcement policy which operates at a number of levels, ranging from persuasion through discussion to the ultimate deterrent of withdrawal of a site licence. This paper describes the role of the NII, which includes a specialist criticality expertise, within the Health and Safety Executive, in regulating the nuclear sites from the criticality safety viewpoint. (Author)

  5. Regulatory and scientific frameworks for zoonosis control in Japan--contributing to International Health Regulations (2005).

    Science.gov (United States)

    Takahashi-Omoe, H; Omoe, K

    2009-12-01

    Zoonoses have earned recognition as the source of serious problems for both public and animal health throughout the world. Emerging infectious diseases have been occurring at an unprecedented rate since the 1970s and a large proportion of these diseases are considered zoonotic. To aid in controlling zoonoses, countermeasures have been strengthened against these diseases and are maintained at both national and international levels. Atypical example of this international effort can be found in the revised International Health Regulations (2005), known as the IHR (2005), which were instituted by the World Health Organization and have been implemented since 2007. In Japan, the appropriate Ministries have established frameworks for controlling zoonoses that employ both administrative and scientific approaches to fulfill the demands of the IHR (2005). In this paper, the authors present the Japanese framework for controlling zoonoses, as a useful example for global public and animal health management in coming years.

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

    International Nuclear Information System (INIS)

    Dverstorp, B.

    2010-01-01

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

  7. 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

  8. Examining Privacy Regulatory Frameworks in Canada in the Context of HIV.

    Science.gov (United States)

    Ion, Allyson

    2016-05-01

    In the process of receiving perinatal care, women living with HIV (WLWH) in Canada have experienced disclosure of their HIV status without their express consent. This disclosure often occurs by well-intentioned healthcare providers; however, from the perspective of WLWH, it is a breach of confidentiality and leaves WLWH to manage the consequences. This paper is a critical review of the regulatory and legislative infrastructure that exists to protect the personal health information of WLWH in Ontario and Canada; the recourse that WLWH have in the event that their confidentiality is breached; and potential approaches that could be applied to organize the system differently to decrease the chance of a privacy breach and to facilitate appropriate collection, use and disclosure of personal health information. Copyright © 2016 Longwoods Publishing.

  9. Development of regulatory and legal framework for spent fuel and radwaste management

    International Nuclear Information System (INIS)

    Bezzubtsev, V.S.

    2012-01-01

    The Basics of National Policy in Nuclear and Radiation Safety assurance in the Russian Federation define the principles and objectives of nuclear and radiation safety of nuclear facilities during all stages of their life cycle. Russia's National Report at the Fourth Review Meeting of Contracting Parties to the Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management reflected the organizational as well as legal and regulatory changes that have taken place over past three years. Amendments recently made to the Russian Nuclear Energy Law as well as the Law on Radwaste Management adopted in 2011 are discussed. Federal norms and regulations in the field of spent fuel and radwaste management are also presented. Organizational and legal reforms related to state safety regulation are described [ru

  10. 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.

  11. 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.

  12. [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.

  13. 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.

  14. British Columbia's fish health regulatory framework's contribution to sustainability goals related to salmon aquaculture.

    Science.gov (United States)

    Stephen, Craig; Dicicco, Emiliano; Munk, Brandon

    2008-12-01

    Salmon farming is a significant contribution to the global seafood market to which the goal of sustainability is often applied. Diseases related to farms are perhaps the most contentious issues associated with sustainable salmon farming. We reviewed literature and policies in British Columbia, Canada, as well as interviewed key informants to examine how fish health regulations do or could support sustainability goals. We found four main obstacles to the development and application of a sustainability-based health management system. First, salmon farming faced the same challenges as other industries when trying to establish an operational definition of sustainability that captures all stakeholders' interests. Second, there was no program responsible for integrating the various regulations, responsible departments, and monitoring efforts to develop a comprehensive view of sustainability. Third, there was inadequate research base and social consensus on the criteria that should be used to track health outcomes for sustainability purposes. Fourth, the regulatory and management paradigm for salmon farming has been focused on diseases and pathogens as opposed to embracing a more inclusive health promotion model that includes biotic, abiotic, and social determinants of health. A transparent and inclusive participatory process that effectively links expert views with community and industry concerns should serve as the foundation for the next generation of health management regulations for salmon farming.

  15. E-learning tools for education: regulatory aspects, current applications in radiology and future prospects.

    Science.gov (United States)

    Pinto, A; Selvaggi, S; Sicignano, G; Vollono, E; Iervolino, L; Amato, F; Molinari, A; Grassi, R

    2008-02-01

    E-learning, an abbreviation of electronic learning, indicates the provision of education and training on the Internet or the World Wide Web. The impact of networks and the Internet on radiology is undoubtedly important, as it is for medicine as a whole. The Internet offers numerous advantages compared with other mass media: it provides access to a large amount of information previously known only to individual specialists; it is flexible, permitting the use of images or video; and it allows linking to Web sites on a specific subject, thus contributing to further expand knowledge. Our purpose is to illustrate the regulatory aspects (including Internet copyright laws), current radiological applications and future prospects of e-learning. Our experience with the installation of an e-learning platform is also presented. We performed a PubMed search on the published literature (without time limits) dealing with e-learning tools and applications in the health sector with specific reference to radiology. The search included all study types in the English language with the following key words: e-learning, education, teaching, online exam, radiology and radiologists. The Fiaso study was referred to for the regulatory aspects of e-learning. The application of e-learning to radiology requires the development of a model that involves selecting and creating e-learning platforms, creating and technologically adapting multimedia teaching modules, creating and managing a unified catalogue of teaching modules, planning training actions, defining training pathways and Continuing Education in Medicine (CME) credits, identifying levels of teaching and technological complexity of support tools, sharing an organisational and methodological model, training the trainers, operators' participation and relational devices, providing training, monitoring progress of the activities, and measuring the effectiveness of training. Since 2004, a platform--LiveLearning--has been used at our

  16. The legal and regulatory framework relative to safety and environment in the uranium mines in Niger

    International Nuclear Information System (INIS)

    Mahamane, S.

    2001-01-01

    The mining sector holds an important position in Niger economy. Considerable funds have been invested for the promotion, exploration and exploitation of mineral resources since the colonial period. This has resulted in the discovery of numerous deposits among which are those of uranium. Today, uranium represents more than 3/4 of Niger export revenues. The mining sector is supervised by the Ministry of Mines and Energy. The Ministry applies the mining policy as defined by the government. It elaborates legislative and regulatory texts and sees to their implementation. Regarding uranium, mining activities have been governed since 1961 by various orientation laws and implementation decrees. However, to face up to the harmful consequences on national economy of successive drops of price and sales of its major export product, and taking into account the new international requirements relating to economy globalization and sustainable development, Niger set up a diversification strategy of its mining productions as part of which a new mining code particularly incentive has been established in 1993. The new mining code provides significant advantages to investors. These advantages insure them a great cost effectiveness of their investments in Niger and easy and less onerous respect of regulations regarding safety and protection of environment. Tremendous efforts have been, thus, provided by the IAEA, the Ministry of Mines and Energy and the uranium companies for an optimal protection of workers and the public, especially against the hazards of ionizing radiations. This will to improve the situation has resulted in the adoption of several laws and their application decrees as well as various sectorial laws designed by various Ministry departments concerned with environmental issues and risks prevention. Among these texts are the renewal of the order No 31 M/MH which has defined since 1979 the main axis of the Niger regulations as regards to radioprotection and the design of

  17. 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

  18. 78 FR 49726 - International Framework for Nuclear Energy Cooperation Finance/Regulatory/Energy Planning...

    Science.gov (United States)

    2013-08-15

    ..., (2) government commitment and support, and (3) a sound business plan. This workshop will be designed... power purchase agreements, are playing today in the financing of nuclear power projects in emerging... opportunity to network, build relationships in the global civil nuclear sector and learn more about current...

  19. Understanding and acknowledging the ice throw hazard - consequences for regulatory frameworks, risk perception and risk communication

    Science.gov (United States)

    Bredesen, R. E.; Drapalik, M.; Butt, B.

    2017-11-01

    This study attempts to provide the necessary framework required to make sufficiently informed decisions regarding the safety implications of ice throw. The framework elaborates on how to cope with uncertainties, and how to describe results in a meaningful and useful manner to decision makers. Moreover, it points out the moral, judicial and economical obligations of wind turbine owners such that they are able to minimize risk of ice throws as much as possible. Building on the strength of knowledge as well as accounting for uncertainty are also essential in enabling clear communication with stakeholders on the most important/critical/vital issues. With increasing empirical evidence, one can assign a higher confidence level on the expert opinions on safety. Findings regarding key uncertainties of ice risk assessments are presented here to support the ongoing IEA Wind Task 19's work on creating the international guidelines on ice risk assessment due in 2018 (Krenn et al. 2017)[1-6]. In addition the study also incorporates the findings of a Norwegian information project, which focuses on the ice throw hazard for the public (Bredesen, Flage, Butt, Winterwind 2018)[7-9]. This includes measures to reduce damage and hazard from wind turbines for the general public. Recent theory of risk assessment questions the use of risk criteria for achieving optimum risk reduction and favours the use of the ALARA (as low as reasonably achievable) principle. Given the several practical problems associated with the ALARA approach (e.g. judicial realization), a joint approach, which uses a minimum set of criteria as well as the obligation to meet ALARA is suggested (associated with acceptable cost). The actual decision about acceptance criteria or obligations is a societal one, thus suggestions can be made at best. Risk acceptance, risk perception and risk communication are inextricably linked and should thus never be considered separately. Risk communication can shape risk perception

  20. Development of a Quantitative Framework for Regulatory Risk Assessments: Probabilistic Approaches

    International Nuclear Information System (INIS)

    Wilmot, R.D.

    2003-11-01

    The Swedish regulators have been active in the field of performance assessment for many years and have developed sophisticated approaches to the development of scenarios and other aspects of assessments. These assessments have generally used dose as the assessment end-point and have been based on deterministic calculations. Recently introduced Swedish regulations have introduced a risk criterion for radioactive waste disposal: the annual risk of harmful effects after closure of a disposal facility should not exceed 10 -6 for a representative individual in the group exposed to the greatest risk. A recent review of the overall structure of risk assessments in safety cases concluded that there are a number of decisions and assumptions in the development of a risk assessment methodology that could potentially affect the calculated results. Regulatory understanding of these issues, potentially supported by independent calculations, is important in preparing for review of a proponent's risk assessment. One approach to evaluating risk in performance assessments is to use the concept of probability to express uncertainties, and to propagate these probabilities through the analysis. This report describes the various approaches available for undertaking such probabilistic analyses, both as a means of accounting for uncertainty in the determination of risk and more generally as a means of sensitivity and uncertainty analysis. The report discusses the overall nature of probabilistic analyses and how they are applied to both the calculation of risk and sensitivity analyses. Several approaches are available, including differential analysis, response surface methods and simulation. Simulation is the approach most commonly used, both in assessments for radioactive waste disposal and in other subject areas, and the report describes the key stages of this approach in detail. Decisions relating to the development of input PDFs, sampling methods (including approaches to the treatment

  1. KAEC experience in development of the regulatory framework for training and qualification

    International Nuclear Information System (INIS)

    Kim, A.; Idrissova, M.; Kossilov, Al.; Pryakhin, A.

    2002-01-01

    Full text: Since 1991, after getting of the sovereignty, Kazakhstan started developing of its own legislative and regulatory system in the field of atomic energy use. In accordance with the Decrees of the President appropriate structures in Kazakhstan were created. They are: Atomic Energy Committee, as a main supervising governmental body, National Nuclear Centre combining all nuclear related scientific institutes, and National Atomic Company Kazatomprom. On 14 February 1994 Kazakhstan joined the International Atomic Energy Agency. Also a lot of enterprises use radioactive sources for the different application in medicine, research, industry, agriculture and etc. Infrastructure of the using of atomic energy in Kazakhstan includes: One power fast reactor BN-350 (now it is shut down and prepared for the decommissioning); Four Research reactors of the National Nuclear Centre; Uranium mining and milling enterprises; Fuel fabrication plant; Storage facilities for nuclear materials, radiation substances and radioactive waste; Organizations using radiation sources; Transport organizations. According to this the Republic of Kazakhstan needs the effective system for the assurance and guarantees for protection of population and environment against the possible negative influence of atomic energy usage. One of the important parts of that is a system of training and qualification of personnel involved in the nuclear activity. In the legislative field of the safely use of nuclear energy several Laws of the Republic of Kazakhstan have been elaborated and adopted. They are: Law on Atomic Energy Use (14 April 1997, Law on Radiation Protection of Population (23 April 1998), Law on Licensing. Those documents formed the first level of the structure of the national system for reliable training, qualification and authorization of the personnel involved in the nuclear activities. The second level is formed by the Legal Acts of the Government of Kazakhstan. The other levels of the

  2. A proposed regulatory framework for road and rail freight transport in South Africa

    Directory of Open Access Journals (Sweden)

    Wessel Pienaar

    2007-09-01

    land freight transport activity in South Africa will be offered within the framework of a free-functioning freight transport market. 

  3. 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

  4. 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)

  5. 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

  6. 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...

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

    International Nuclear Information System (INIS)

    Chahab, Martin; Dawyd, Noelia

    2008-01-01

    Full text: In the new framework of nuclear renaissance in the world in general, and in Argentina in particular, proper and efficient management of information and knowledge produced in the past and to be produced during renaissance becomes critically important. The fact that in the nuclear sector across the world human resources are going through significant change as a result of the massive number of experts who are retiring from the workforce, the ensuing general gap, the new generation of workers who are joining the nuclear rank and file with different training, values and cultural beliefs, and the slow information and knowledge transfer process call for carefully considering and assessing new methods to manage information and knowledge. This paper discusses the topic of knowledge maps as a method to adapt historical information and knowledge and to make it more readily available for future workers; the paper also deals with a new management approach to such information. Knowledge maps probably represent an up-to-date method to manage both historical and new information and knowledge, adapting to a number of new cultural features, including but not limited to the intensive use of information technologies and the tendency to summarize and integrate concepts. A distinguishing feature of this new method of organizing information and knowledge is the need for a closer interrelation across the organisation's sectors. As a result, knowledge maps help create and improve manuals and procedures related to the specific tasks performed in the institution, based on the analysis carried out by those creating the maps. This tool also helps better analyze the tasks already conducted or to be conducted by workers, all of which optimizes the job description process in the area of human resources. Another benefit of knowledge maps is that they help preserve the information and knowledge that can be used to train the staff in merely technical or induction issues as well as in an

  8. 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.

  9. Current regulatory developments concerning the implementation of probabilistic safety analyses for external hazards in Germany

    International Nuclear Information System (INIS)

    Krauss, Matias; Berg, Heinz-Peter

    2014-01-01

    The Federal Ministry for the Environment, Nature Conservation and Nuclear Safety (BMU) initiated in September 2003 a comprehensive program for the revision of the national nuclear safety regulations which has been successfully completed in November 2012. These nuclear regulations take into account the current recommendations of the International Atomic Energy Agency (IAEA) and Western European Nuclear Regulators Association (WENRA). In this context, the recommendations and guidelines of the Nuclear Safety Standards Commission (KTA) and the technical documents elaborated by the respective expert group on Probabilistic Safety Analysis for Nuclear Power Plants (FAK PSA) are being updated or in the final process of completion. A main topic of the revision was the issue external hazards. As part of this process and in the light of the accident at Fukushima and the findings of the related actions resulting in safety reviews of nuclear power plants at national level in Germany and on European level, a revision of all relevant standards and documents has been made, especially the recommendations of KTA and FAK PSA. In that context, not only design issues with respect to events such as earthquakes and floods have been discussed, but also methodological issues regarding the implementation of improved probabilistic safety analyses on this topic. As a result of the revision of the KTA 2201 series 'Design of Nuclear Power Plants against Seismic Events' with their parts 1 to 6, part 1 'Principles' was published as the first standard in November 2011, followed by the revised versions of KTA 2201.2 (soil) and 2201.4 (systems and components) in 2012. The modified the standard KTA 2201.3 (structures) is expected to be issued before the end of 2013. In case of part 5 (seismic instrumentation) and part 6 (post>seismic actions) draft amendments are expected in 2013. The expert group 'Probabilistic Safety Assessments for Nuclear Power Plants' (FAK PSA) is an advisory body of the Federal

  10. 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.

  11. 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.

  12. Clinical potential of regulatory T cell therapy in liver diseases: An overview and current perspectives

    Directory of Open Access Journals (Sweden)

    Hannah Claire Jeffery

    2016-09-01

    Full Text Available The increasing demand for liver transplantation and the decline in donor organs has highlighted the need for alternative novel therapies to prevent chronic active hepatitis, which eventually leads to liver cirrhosis and liver cancer. Liver histology of chronic hepatitis is composed of both effector and regulatory lymphocytes. The human liver contains different subsets of effector lymphocytes, that are kept in check by a subpopulation of T cells known as Regulatory T cells (Treg. The balance of effector and regulatory lymphocytes generally determines the outcome of hepatic inflammation: resolution, fulminant hepatitis or chronic active hepatitis. Thus, maintaining and adjusting this balance is crucial in immunological manipulation of liver diseases. One of the options to restore this balance is to enrich Treg in the liver disease patients.Advances in the knowledge of Treg biology and development of clinical grade isolation reagents, cell sorting equipment and Good Manufacturing Practice (GMP facilities have paved the way to apply Treg cells as a potential therapy to restore peripheral self-tolerance in autoimmune liver diseases, chronic rejection and post-transplantation. Past and on-going studies have applied Treg in type-1 diabetes mellitus, systemic lupus erythematosus, graft versus host diseases (GVHD and solid organ transplantations. There have not been any new therapies for the autoimmune liver diseases for more than three decades; thus the clinical potential for the application of autologous Treg cell therapy to treat autoimmune liver disease is an attractive and novel option. However, it is fundamental to understand the deep immunology, genetic profiles, biology, homing behavior and microenvironment of Treg before applying the cells to the patients.

  13. Regulatory and Scientific Advancements in Gene Therapy: State-of-the-Art of Clinical Applications and of the Supporting European Regulatory Framework.

    Science.gov (United States)

    Carvalho, Marta; Sepodes, Bruno; Martins, Ana Paula

    2017-01-01

    Advanced therapy medicinal products (ATMPs) have a massive potential to address existing unmet medical needs. Specifically, gene therapy medicinal products (GTMPs) may potentially provide cure for several genetic diseases. In Europe, the ATMP regulation was fully implemented in 2009 and, at this point, the Committee for Advanced Therapies was created as a dedicated group of specialists to evaluate medicinal products requiring specific expertise in this area. To date, there are three authorized GTMPs, and the first one was approved in 2012. Broad research has been conducted in this field over the last few decades and different clinical applications are being investigated worldwide, using different strategies that range from direct gene replacement or addition to more complex pathways such as specific gene editing or RNA targeting. Important safety risks, limited efficacy, manufacturing hurdles, or ethical conflicts may represent challenges in the success of a candidate GTMP. During the development process, it is fundamental to take such aspects into account and establish overcoming strategies. This article reviews the current European legal framework of ATMPs, provides an overview of the clinical applications for approved and investigational GTMPs, and discusses critical challenges in the development of GTMPs.

  14. Regulatory and Scientific Advancements in Gene Therapy: State-of-the-Art of Clinical Applications and of the Supporting European Regulatory Framework

    Directory of Open Access Journals (Sweden)

    Marta Carvalho

    2017-10-01

    Full Text Available Advanced therapy medicinal products (ATMPs have a massive potential to address existing unmet medical needs. Specifically, gene therapy medicinal products (GTMPs may potentially provide cure for several genetic diseases. In Europe, the ATMP regulation was fully implemented in 2009 and, at this point, the Committee for Advanced Therapies was created as a dedicated group of specialists to evaluate medicinal products requiring specific expertise in this area. To date, there are three authorized GTMPs, and the first one was approved in 2012. Broad research has been conducted in this field over the last few decades and different clinical applications are being investigated worldwide, using different strategies that range from direct gene replacement or addition to more complex pathways such as specific gene editing or RNA targeting. Important safety risks, limited efficacy, manufacturing hurdles, or ethical conflicts may represent challenges in the success of a candidate GTMP. During the development process, it is fundamental to take such aspects into account and establish overcoming strategies. This article reviews the current European legal framework of ATMPs, provides an overview of the clinical applications for approved and investigational GTMPs, and discusses critical challenges in the development of GTMPs.

  15. 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.

  16. The US regulatory framework

    International Nuclear Information System (INIS)

    MacDonald, C.E.

    1984-01-01

    The chapter discusses the following: a brief account is given of the regulations covering the transportation of radioactive materials in the USA; departmental responsibilities; design of casks; packaging; approval of routes for transport of spent fuel; physical protection against theft or sabotage; inspection; safety standards. (U.K.)

  17. WhatsApp in Stroke Systems: Current Use and Regulatory Concerns.

    Science.gov (United States)

    Calleja-Castillo, Juan M; Gonzalez-Calderon, Gina

    2018-01-01

    Smartphone use is extremely common. Applications such as WhatsApp have billions of users and physicians are no exception. Stroke Medicine is a field where instant communication among fairly large groups is essential. In developing countries, economic limitations preclude the possibility of acquiring proper communication platforms. Thus, WhatsApp has been used as an organizational tool, for sharing clinical data, and for real time guidance of clinical care decisions. It has evolved into a cheap, accessible tool for telemedicine. Nevertheless, regulatory and privacy issues must be addressed. Some countries have implemented legislation to address this issue, while others lag behind. In this article, we present an overview on the different roles WhatsApp has acquired as a clinical tool in stroke systems and the potential privacy concerns of its use.

  18. WhatsApp in Stroke Systems: Current Use and Regulatory Concerns

    Directory of Open Access Journals (Sweden)

    Juan M. Calleja-Castillo

    2018-05-01

    Full Text Available Smartphone use is extremely common. Applications such as WhatsApp have billions of users and physicians are no exception. Stroke Medicine is a field where instant communication among fairly large groups is essential. In developing countries, economic limitations preclude the possibility of acquiring proper communication platforms. Thus, WhatsApp has been used as an organizational tool, for sharing clinical data, and for real time guidance of clinical care decisions. It has evolved into a cheap, accessible tool for telemedicine. Nevertheless, regulatory and privacy issues must be addressed. Some countries have implemented legislation to address this issue, while others lag behind. In this article, we present an overview on the different roles WhatsApp has acquired as a clinical tool in stroke systems and the potential privacy concerns of its use.

  19. Current status of regulatory aspects relating to water chemistry in Japanese NPPs

    International Nuclear Information System (INIS)

    Sato, Masatoshi

    2014-01-01

    In nuclear power plants, water chemistry of cooling water is carefully monitored and controlled to keep integrity of structures, systems and components, and to reduce occupational radiation exposures. As increasing demand for advanced application of light water cooled reactors, water chemistry control plays more important roles on plant reliability. The road maps on R and D for water chemistry of nuclear power systems have been proposed along with promotion of R and D related water chemistry in Japan. In academic and engineering societies, non-governmental standards for water chemistry are going to be established. In the present paper, recent trends of water chemistry in Japan have been surveyed. The effects of water chemistry on plant safety and radiation exposures have been discussed. In addition, possible contributions of regulation regarding water chemistry control have been confirmed. Major water chemistry regulatory aspects relating to reactor safety and radiation safety are also outlined in this paper. (author)

  20. La col·laboració publicoprivada en la provisió d’infraestructures de servei públic. Revisió crítica i alternatives al marc regulador actual Public-private - Collaboration in the Provision of Public Service Infrastructure: a Critical Revision and some Alternatives to the Current Regulatory Framework - La colaboración público-privada en la provisión de infraestructuras de servicio público. Revisión crítica y alternativas al actual marco regulador

    Directory of Open Access Journals (Sweden)

    Joan Ridao Martin

    2012-12-01

    Full Text Available L’actual emergència de la col·laboració publicoprivada en la provisió d’infraestructures de servei públic és conseqüència de les tensions de tresoreria de les administracions públiques. Els avantatges d’aquesta tècnica es concreten en el diàleg entre el sector públic i el sector privat per consensuar el finançament i l’execució de projectes, la bona relació qualitat-preu i el tractament en termes de comptabilitat pública, que determina un nul impacte en el deute. Els inconvenients, tanmateix, se centren en el deficient marc regulador europeu i estatal, tant en matèria de contractació com d’incentius a la captació d’actius financers. Cal, doncs, un nou marc normatiu que afavoreixi l’estructuració adequada dels projectes, els contractes i l’esquema de distribució de riscos, com també que prevegi incentius a la participació, aclareixi els mecanismes de pagament i, en particular, millori la definició del nou contracte de col·laboració entre el sector públic i el sector privat i, en concret, de la fórmula del diàleg competitiu com a procediment d’adjudicació. The current emergence of public-private collaboration in the provision of public service infrastructure is plan, to provide for incentives to participation, and to clarify payment mechanisms. In particular, such a framework is necessary in order to improve the definition of the new private sector-public sector collaboration contract, and, concretely, the definition of the formula for competitive dialogue as a mechanism for awarding contracts.a consequence of the pressure on the liquid assets held by public authorities.  The advantages of this technique come to the fore through public-private sector dialogue aimed at reaching a consensus on the financing and execution of projects, a good quality-price ratio and a way of dealing with such projects in terms of public accounting, which has no impact on the debt.  The disadvantages, nonetheless, are

  1. 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...

  2. 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

  3. 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

  4. 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

  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. Introducing a Regulatory Policy Framework of Bait Fishing in European Coastal Lagoons: The Case of Ria de Aveiro in Portugal

    Directory of Open Access Journals (Sweden)

    Stefanos Xenarios

    2018-01-01

    Full Text Available The harvesting of bait through digging in coastal mudflats is practiced for recreational and commercial purposes in European coastal systems including the Ria de Aveiro coastal lagoon on the northwest Atlantic coast of Portugal. The scale of harvesting in the Ria de Aveiro has recently increased due to the current economic climate in Portugal, with targeting of the polychaete, Diopatra neapolitana species or “casulo” as it is widely known in the Aveiro region. The national authorities have attempted to control casulo digging by issuing a regulation (Ordinance in 2014 on the maximum daily catch limit to be caught by each individual. The daily catch limit is intended to represent the Maximum Sustainable Yield (MSY for casulo beyond which overfishing will occur. The monitoring of the regulatory measures is expected to be conducted through on-site inspections in the digging areas. However, weak law enforcement was noticed, while there is also controversy over the daily catch limit (quota stipulated by the Ordinance. To this end, the current study attempted to assess digging activities through remote monitoring and random inspections for a better policy enforcement of the national regulation. In addition, different harvesting scenarios were employed through a simplified bioeconomic model to attribute the current and future harvesting trends of bait digging in Aveiro coastal lagoon. The study findings indicate that remote monitoring coupled with some onsite interviews could be a more effective approach for the implementation of the current bait digging policy. Further, the results point to a distinctive discrepancy between the daily catch amount (MSY introduced by the national legislation and the study findings which should be further scrutinized. The diggers seem to have reached the sustainable harvest identified by the present research. The current economic hardship in Portugal and the low profitability in similar employment sectors will

  7. The UAV and the Current and Future Regulatory Construction for Integration into the National Airspace System

    Science.gov (United States)

    2005-07-01

    vehicles to deliver mail or packages across town, in a large indoor complex or building, or even to deliver...drugs, marihuana , depressants or stimulants.330 Further, current licenses and certified personnel may have their

  8. 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.

  9. Managing carbon regulatory risk in utility resource planning: Current practices in the Western United States

    International Nuclear Information System (INIS)

    Barbose, Galen; Wiser, Ryan; Phadke, Amol; Goldman, Charles

    2008-01-01

    Concerns about global climate change have substantially increased the likelihood that future policy will seek to minimize carbon dioxide emissions. As such, even today, electric utilities are making resource planning and investment decisions that consider the possible implications of these future carbon regulations. In this article, we examine the manner in which utilities assess the financial risks associated with future carbon regulations within their long-term resource plans. We base our analysis on a review of the most recent resource plans filed by 15 electric utilities in the Western United States. Virtually all of these utilities made some effort to quantitatively evaluate the potential cost of future carbon regulations when analyzing alternate supply- and demand-side resource options for meeting customer load. Even without federal climate regulation in the US, the prospect of that regulation is already having an impact on utility decision-making and resource choices. That said, the methods and assumptions used by utilities to analyze carbon regulatory risk, and the impact of that analysis on their choice of a particular resource strategy, vary considerably, revealing a number of opportunities for analytic improvement. Though our review focuses on a subset of US electric utilities, this work holds implications for all electric utilities and energy policymakers who are seeking to minimize the compliance costs associated with future carbon regulations

  10. The local lymph node assay in practice: a current regulatory perspective.

    Science.gov (United States)

    Cockshott, A; Evans, P; Ryan, C A; Gerberick, G F; Betts, C J; Dearman, R J; Kimber, I; Basketter, D A

    2006-07-01

    Following the formal acceptance of the local lymph node assay (LLNA) as an Organization for Economic Cooperation and Development (OECD) guideline in April 2002, the UK Health and Safety Executive (HSE) informed notifiers that this was now the method of choice for the assessment of skin sensitization potential under the EU notification scheme for new industrial chemicals (NONS). This paper summarizes the experience of the HSE for the 2-year period immediately following the issuing of this statement, during which 48 LLNA study reports were assessed for notification purposes. The issues discussed here include adherence to the OECD guideline, interpretation of results, and classification outcomes. Generally, notifying laboratories followed the OECD guideline successfully, with regard to the sex/ strain/numbers of mice used, the precise process used for measurement of cell proliferation, and the use of recommended vehicles and positive controls. Initially, use of the individual animal approach (measuring the cell proliferation in each animal rather than for a pooled dose group) highlighted problems caused by technical inexperience, but these were overcome by practice. Toxicity or irritation were found to be minor factors in dose selection; more important was the choice of vehicle to correctly maximize the test substance concentration, while maintaining appropriate application properties. Contrary to concerns that the LLNA would prove to be less sensitive or more sensitive than the traditionally used Guinea Pig Maximization Test (GPMT), the proportion of new substances classified as skin sensitizers was within the range observed in previous years. Although the sample size is relatively small, the experience of the HSE indicates that the LLNA is satisfactory for routine regulatory use.

  11. The local lymph node assay: current position in the regulatory classification of skin sensitizing chemicals.

    Science.gov (United States)

    Basketter, David A; Gerberick, G Frank; Kimber, Ian

    2007-01-01

    The local lymph node assay (LLNA) is being used increasingly in the identification of skin sensitizing chemicals for regulatory purposes. In the context of new chemicals legislation (REACH) in Europe, it is the preferred assay. The rationale for this is that the LLNA quantitative and objective approach to skin sensitization testing allied with the important animal welfare benefits that the method offers. However, as with certain guinea pig sensitization tests before it, this increasing use also brings experience with an increasingly wide range of industrial and other chemicals where the outcome of the assay does not always necessarily meet with the expectations of those conducting it. Sometimes, the result appears to be a false negative, but rather more commonly, the complaint is that the chemical represents a false positive. Against this background we have here reviewed a number of instances where false positive and false negative results have been described and have sought to reconcile science with expectation. Based on these analyses, it is our conclusion that false positives and false negatives do occur in the LLNA, as they do with any other skin sensitization assay (and indeed with all tests used for hazard identification), and that this occurs for a number of reasons. We further conclude, however, that false positive results in the LLNA, as with the guinea pig maximization test, arise most commonly via failure to distinguish what is scientifically correct from that which is unpalatable. The consequences of this confusion are discussed in the article, particularly in relation to the need to integrate both potency measurement and risk assessments into classification and labelling schemes that aim to manage potential risks to human health.

  12. 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.

  13. 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....

  14. Configuración actual del comercio exterior en Galicia = Current foreign trade framework in Galicia

    Directory of Open Access Journals (Sweden)

    José Luis Placer Galán

    2016-12-01

    Full Text Available La reciente crisis económica y la contracción de la demanda interna han impulsado un creciente interés por los mercados exteriores. Esta investigación pretende caracterizar la configuración actual del comercio exterior de la Comunidad Autónoma de Galicia, tanto en lo relativo a los productos como a los mercados geográficos de origen y destino. Para ello se emplean una serie de indicadores, ampliamente contrastados en la investigación económica, que permiten identificar: el grado de apertura de la economía provincial leonesa; la propensión exportadora y la dependencia importadora; el grado de concentración, por producto y mercados, de sus flujos comerciales exteriores; la especialización exportadora y la ventaja comparativa sectorial; la composición inter o intra-industrial del comercio exterior; y la distribución geográfica de los flujos comerciales de la economía gallega con los mercados exteriores. The recent economic crisis and internal demand contraction have encouraged the emerging interest in international markets. This study aims at featuring the current foreign trade framework of the Galicia, in regards to both import and export products and geographical markets. For that purpose, several indexes, widely verified in this study, have been utilized to identify the trade openness level of Leon economy, its export propensity, import dependence as well as the concentration level for products and internal trade flows. Leon export specialization, its comparative advantage by sector, the inter-intra-industry trade composition and geographical distribution of trade with international markets have been likewise included in this study.   Keywords: .

  15. A framework for current public mental health care practice in South Africa.

    Science.gov (United States)

    Janse Van Rensburg, A B

    2007-11-01

    One of the main aims of the new Mental Health Care Act, Act No. 17 of 2002 (MHCA) is to promote the human rights of people with mental disabilities in South Africa. However, the upholding of these rights seems to be subject to the availability of resources. Chapter 2 of the MHCA clarifies the responsibility of the State to provide infrastructure and systems. Chapters 5, 6 and 7 of the Act define and regulate the different categories of mental health care users, clarify the procedures around these categories and spell out mental health practitioners' roles and responsibilities in this regard. Also according to the National Health Act No. 61 of 2003, the State remains the key role player in mental health care provision, being responsible for adequate mental health infrastructure and resource allocation. Due to "limited resources" practitioners however often work in environments where staff ratios may be fractional of what should be expected and in units of which the physical structure and security is totally inadequate. The interface between professional responsibility of clinical workers versus the inadequacy of clinical interventions resulting from infrastructure and staffing constraints needs to be defined. This paper considered recent legislation currently relevant to mental health care practice in order to delineate the legal, ethical and labour framework in which public sector mental health practitioners operate as state employees. These included the Mental Health Care Act, No.17 of 2002; the National Health Act, No. 61 of 2003 and the proposed Traditional Health Practitioners Act, No. 35 of 2004. Formal legal review of and advice on this legislation as it pertains to public sector mental health practitioners as state employees, is necessary and should form the basis of the principles and standards for care endorsed by organized mental health care practitioner groups such as the South African Society of Psychiatrists (SASOP).

  16. Use of Biosensors as Alternatives to Current Regulatory Methods for Marine Biotoxins

    Directory of Open Access Journals (Sweden)

    Luis M. Botana

    2009-11-01

    Full Text Available Marine toxins are currently monitored by means of a bioassay that requires the use of many mice, which poses a technical and ethical problem in many countries. With the exception of domoic acid, there is a legal requirement for the presence of other toxins (yessotoxin, saxitoxin and analogs, okadaic acid and analogs, pectenotoxins and azaspiracids in seafood to be controlled by bioassay, but other toxins, such as palytoxin, cyclic imines, ciguatera and tetrodotoxin are potentially present in European food and there are no legal requirements or technical approaches available to identify their presence. The need for alternative methods to the bioassay is clearly important, and biosensors have become in recent years a feasible alternative to animal sacrifice. This review will discuss the advantages and disadvantages of using biosensors as alternatives to animal assays for marine toxins, with particular focus on surface plasmon resonance (SPR technology.

  17. 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.)

  18. Historical Development of NATO Stanag 6001 Language Standards and Common European Framework (CEF) and the Comparison of Their Current Status

    Science.gov (United States)

    Solak, Ekrem

    2011-01-01

    The aim of the article is to shed light on the historical development of language studies in military and social context and to compare the current status of NATO Stanag (Standard Agreement) 6001 language scale with Common European Framework (CEF). Language studies in military context date back to World War II and the emergence of Army Specialized…

  19. Current experience with support schemes for RES-E in Europe. A regulatory point of view

    International Nuclear Information System (INIS)

    Lackner, Ursula

    2006-01-01

    The need to reduce the dependence of the European economy on imported primary energy and the impact of fossil fuels on the environment has encouraged countries to increase the share of renewable energy sources (RES) for electricity supply. EU Directive 2001/77/EC requires EU Member States to take appropriate steps to introduce new incentive mechanisms in order to reach the target of generating 21 % of the electricity in the EU from RES. At the same time EU Directive 2003/54/EC takes significant steps towards establishing a single market in electricity across the EU. Under this directive, European energy regulators have a number of responsibilities. These include the avoidance of discrimination and the promotion of effective competition along with an efficient functioning of the market. One of their main tasks is to ensure that European consumers pay a final electricity price that is as cost reflective as possible. The final price shall also reflect the social and the environmental costs. At the current stage it is not unlikely that the promotion of renewable energy sources will create significant barriers and distortions on the liberalized electricity market. Several issues arising from the implementation of renewable incentive schemes and policies can be identified and are analysed below; - Conflicting targets on EU-Level; - The variation in the level of incentives may be greater among Member States than is justified by the real level of technology costs, or other factors; - Unbalanced burden sharing for final consumers, due to different allocation mechanisms and designs of support schemes; -The regulation and charges for relevant items of the electricity chain, such as connection and balancing costs, vary significantly among Member States and may introduce competitive advantages. The contents of the paper is as follows: 1 Background; 2 Conflicting targets on EU-Level; 3 Different support levels; 4 Unbalanced burden sharing of final customers; 5 Allocation of

  20. 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.

  1. Regulatory aspects of oncology drug safety evaluation: Past practice, current issues, and the challenge of new drugs

    International Nuclear Information System (INIS)

    Rosenfeldt, Hans; Kropp, Timothy; Benson, Kimberly; Ricci, M. Stacey; McGuinn, W. David; Verbois, S. Leigh

    2010-01-01

    The drug development of new anti-cancer agents is streamlined in response to the urgency of bringing effective drugs to market for patients with limited life expectancy. FDA's regulation of oncology drugs has evolved from the practices set forth in Arnold Lehman's seminal work published in the 1950s through the current drafting of a new International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) safety guidance for anti-cancer drug nonclinical evaluations. The ICH combines the efforts of the regulatory authorities of Europe, Japan, and the United States and the pharmaceutical industry from these three regions to streamline the scientific and technical aspects of drug development. The recent development of new oncology drug classes with novel mechanisms of action has improved survival rates for some cancers but also brings new challenges for safety evaluation. Here we present the legacy of Lehman and colleagues in the context of past and present oncology drug development practices and focus on some of the current issues at the center of an evolving harmonization process that will generate a new safety guidance for oncology drugs, ICH S9. The purpose of this new guidance will be to facilitate oncology drug development on a global scale by standardizing regional safety requirements.

  2. 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.

  3. Foundational Tests of the Need-Support Model: A Framework for Bridging Regulatory Focus Theory and Self-Determination Theory.

    Science.gov (United States)

    Vaughn, Leigh Ann

    2017-03-01

    This article introduces the need-support model, which proposes that regulatory focus can affect subjective support for the needs proposed by self-determination theory (autonomy, competence, and relatedness), and support of these needs can affect subjective labeling of experiences as promotion-focused and prevention-focused. Three studies tested these hypotheses ( N = 2,114). Study 1 found that people recall more need support in promotion-focused experiences than in prevention-focused experiences, and need support in their day yesterday (with no particular regulatory focus) fell in between. Study 2 found that experiences of higher need support were more likely to be labeled as promotion-focused rather than prevention-focused, and that each need accounted for distinct variance in the labeling of experiences. Study 3 varied regulatory focus within a performance task and found that participants in the promotion condition engaged in need-support inflation, whereas participants in the prevention condition engaged in need-support deflation. Directions for future research are discussed.

  4. A European regulatory perspective on cystic fibrosis: current treatments, trends in drug development and translational challenges for CFTR modulators.

    Science.gov (United States)

    Ponzano, Stefano; Nigrelli, Giulia; Fregonese, Laura; Eichler, Irmgard; Bertozzi, Fabio; Bandiera, Tiziano; Galietta, Luis J V; Papaluca, Marisa

    2018-06-30

    In this article we analyse the current authorised treatments and trends in early drug development for cystic fibrosis (CF) in the European Union for the time period 2000-2016. The analysis indicates a significant improvement in the innovation and development of new potential medicines for CF, shifting from products that act on the symptoms of the disease towards new therapies targeting the cause of CF. However, within these new innovative medicines, results for CF transmembrane conductance regulator (CFTR) modulators indicate that one major challenge for turning a CF concept product into an actual medicine for the benefit of patients resides in the fact that, although pre-clinical models have shown good predictability for certain mutations, a good correlation to clinical end-points or biomarkers ( e.g. forced expiratory volume in 1 s and sweat chloride) for all mutations has not yet been achieved. In this respect, the use of alternative end-points and innovative nonclinical models could be helpful for the understanding of those translational discrepancies. Collaborative endeavours to promote further research and development in these areas as well as early dialogue with the regulatory bodies available at the European competent authorities are recommended. Copyright ©ERS 2018.

  5. The Essential Elements of a Risk Governance Framework for Current and Future Nanotechnologies

    DEFF Research Database (Denmark)

    Stone, Vicki; Führ, Martin; Feindt, Peter H

    2017-01-01

    that goes beyond legislation. Development of this approach must be evidence based and involve key stakeholders to ensure acceptance by end users. The challenge is to develop a framework that coordinates the variety of actors involved in nanotechnology and civil society to facilitate consideration...... to safety. The implementation of such an approach should facilitate and motivate good practice for the various stakeholders to allow the safe and sustainable future development of nanotechnology....

  6. [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.

  7. On the presence of electric currents in the solar atmosphere. I - A theoretical framework

    Science.gov (United States)

    Hagyard, M.; Low, B. C.; Tandberg-Hanssen, E.

    1981-01-01

    The general magnetic field above the solar photosphere is divided by an elementary analysis based on Ampere's law into two parts: a potential field due to electric currents below the photosphere and a field produced by electric currents above the photosphere combined with the induced mirror currents. The latter, by symmetry, has a set of field lines lying in the plane taken to be the photosphere which may be constructed from given vector magnetograph measurements. These field lines also represent all the information on the electric currents above the photosphere that a magnetograph can provide. Theoretical illustrations are given, and implications for data analysis are discussed.

  8. Implementing the Marine Strategy Framework Directive: A policy perspective on regulatory, institutional and stakeholder impediments to effective implementation

    NARCIS (Netherlands)

    Leeuwen, van J.; Raakjaer, J.; Hoof, van L.J.W.; Tatenhove, van J.P.M.; Long, R.; Ounanian, K.

    2014-01-01

    The implementation of the European Union (EU) Marine Strategy Framework Directive (MSFD) requires EU Member States to draft a program of measures to achieve Good Environmental Status (GES). Central argument of this paper, based on an analysis of the unique, holistic character of the MSFD, is that

  9. 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.

  10. 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

  11. Artificial islands for cluster-siting of offshore energy facilities: an assessment of the legal and regulatory framework

    Energy Technology Data Exchange (ETDEWEB)

    Backstrom, T.D.; Baram, M.

    1976-06-01

    One of the ways in which offshore coastal regions can be used in energy development is examined, namely through the construction of offshore islands for the siting of energy-related facilities. The purpose of the study is to review and assess the significant sectors of this accumulation of legal and regulatory authority, in order that those proposing and supervising such offshore development can formulate suggestions for coordination and rational allocation of responsibility. The potential demands on offshore resources are considerably greater than many would expect. In addition to offshore drilling and other mineral exploitation, there is increasing interest in safety of navigation, harvest and aquaculture of living marine resources, recreation, and preservation of uniquely valuable marine landscapes and ecosystems. Within this dynamic context, the offshore implications of the energy needs of the United States must be fully evaluated. New energy installations might be appropriately sited offshore on artificial islands. This legal and regulatory assessment contains little case law, new Congressional enactments, or proposed regulations and is, in general, a first-order analysis of the legal context for a new concept--the multiple-facility artificial island--which has not yet been tested, but which merits serious study as an alternative for uses of the offshore regions to meet energy requirements. An extensive bibliography containing 254 citations is included.

  12. Current state of renewable energies performances in the European Union: A new reference framework

    International Nuclear Information System (INIS)

    D’Adamo, Idiano; Rosa, Paolo

    2016-01-01

    Highlights: • A common mathematic model, based on historical values, defines future trends. • Luxembourg, Ireland and Netherlands do not reach their 2020 national targets. • The selected indexes significantly influences the ranking of European countries. • Sweden, Finland, Austria and Latvia have a dominant position. • Ten countries have a value greater than the EU 28 average for each index analysed. - Abstract: Initially pushed by the European Union (EU) through the Europe 2020 strategy, the development of renewable energies is a strategic action aiming to limit climate changes and cut greenhouse gas emissions. National subsidies favored the diffusion of this new kind of energy sources, even if there are interesting economic opportunities also in non-subsidized markets. Renewable energy (RE) is a sustainable choice, but its management requires a proper analysis, both from political and operational levels. The aim of this paper is the assessment of European renewable energy source (RES) trajectory towards 2020, starting from historical values and through common scientific methods. In addition, a new reference framework is proposed, in order to evaluate RESs performances in Europe. The framework is based on three indicators: (i) share of energy from RESs in gross final energy consumption, (ii) REs primary production per capita and (iii) gross final consumption of REs per capita. Results could have practical implications for the decision makers involved in the management of energy sources throughout Europe and could be used for the comparison on a global scale.

  13. [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.

  14. 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

  15. 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)

  16. Implementing the water framework directive in Denmark - Lessons on agricultural measures from a legal and regulatory perspective

    DEFF Research Database (Denmark)

    Jacobsen, Brian H.; Anker, Helle Tegner; Baaner, Lasse

    2017-01-01

    One of the major challenges in the implementation of the Water Framework Directive (WFD) is how to address diffuse agricultural pollution of the aquatic environment. In Denmark the implementation of agricultural measures has been fraught with difficulty in the form of delays and legal proceedings...... and a policy failure. It is argued that the adoption of more flexible measures to be implemented at the local level could have resulted in fewer difficulties from an economic and legal point of view as measures could have been applied where there was a clear environmental benefit, and possibly also at a lower...

  17. Foundational Tests of the Need-Support Model: A Framework for Bridging Regulatory Focus Theory and Self-Determination Theory

    Directory of Open Access Journals (Sweden)

    Leigh Ann Vaughn

    2017-04-01

    Full Text Available This dataset includes data from the three studies reported in my paper on Foundational Tests of the Need-Support Model [6]. I collected these data in 2014, 2015, and 2016 from over 2,100 Amazon Mechanical Turk workers in the United States and Canada. The dataset contains the measures described in the paper, as well as participants’ writing about the experiences they brought to mind in these studies. The data are stored on the Open Science Framework, and they could be used for exploratory research, meta-analyses, and research on replication. I also welcome collaborative research involving re-analyses of these data.

  18. Current Status of Legislation on Dietary Products for Sportspeople in a European Framework.

    Science.gov (United States)

    Martínez-Sanz, José Miguel; Sospedra, Isabel; Baladía, Eduard; Arranz, Laura; Ortiz-Moncada, Rocío; Gil-Izquierdo, Angel

    2017-11-08

    The consumption of nutritional ergogenic aids is conditioned by laws/regulations, but standards/regulations vary between countries. The aim of this review is to explore legislative documents that regulate the use of nutritional ergogenic aids intended for sportspeople in a Spanish/European framework. A narrative review has been developed from official websites of Spanish (Spanish Agency of the Consumer, Food Safety, and Nutrition) and European (European Commission and European Food Safety Authority) bodies. A descriptive analysis of documents was performed. Eighteen legislative documents have been compiled in three sections: (1) Advertising of any type of food and/or product; (2) Composition, labeling, and advertising of foods; (3) Nutritional ergogenic aids. In spite of the existence of these legal documents, the regulation lacks guidance on the use/application of nutritional ergogenic aids for sportspeople. It is essential to prevent the introduction or dissemination of false, ambiguous, or inexact information and contents that induce an error in the receivers of the information. In this field, it is worth highlighting the roles of the European Food Safety Authority and the World Anti-Doping Agency, which provide information about consumer guidelines, prescribing practices, and recommendations for the prudent use of nutritional ergogenic aids.

  19. Current Status of Legislation on Dietary Products for Sportspeople in a European Framework

    Directory of Open Access Journals (Sweden)

    José Miguel Martínez-Sanz

    2017-11-01

    Full Text Available The consumption of nutritional ergogenic aids is conditioned by laws/regulations, but standards/regulations vary between countries. The aim of this review is to explore legislative documents that regulate the use of nutritional ergogenic aids intended for sportspeople in a Spanish/European framework. A narrative review has been developed from official websites of Spanish (Spanish Agency of the Consumer, Food Safety, and Nutrition and European (European Commission and European Food Safety Authority bodies. A descriptive analysis of documents was performed. Eighteen legislative documents have been compiled in three sections: (1 Advertising of any type of food and/or product; (2 Composition, labeling, and advertising of foods; (3 Nutritional ergogenic aids. In spite of the existence of these legal documents, the regulation lacks guidance on the use/application of nutritional ergogenic aids for sportspeople. It is essential to prevent the introduction or dissemination of false, ambiguous, or inexact information and contents that induce an error in the receivers of the information. In this field, it is worth highlighting the roles of the European Food Safety Authority and the World Anti-Doping Agency, which provide information about consumer guidelines, prescribing practices, and recommendations for the prudent use of nutritional ergogenic aids.

  20. Current Status of Legislation on Dietary Products for Sportspeople in a European Framework

    Science.gov (United States)

    Arranz, Laura; Ortiz-Moncada, Rocío

    2017-01-01

    The consumption of nutritional ergogenic aids is conditioned by laws/regulations, but standards/regulations vary between countries. The aim of this review is to explore legislative documents that regulate the use of nutritional ergogenic aids intended for sportspeople in a Spanish/European framework. A narrative review has been developed from official websites of Spanish (Spanish Agency of the Consumer, Food Safety, and Nutrition) and European (European Commission and European Food Safety Authority) bodies. A descriptive analysis of documents was performed. Eighteen legislative documents have been compiled in three sections: (1) Advertising of any type of food and/or product; (2) Composition, labeling, and advertising of foods; (3) Nutritional ergogenic aids. In spite of the existence of these legal documents, the regulation lacks guidance on the use/application of nutritional ergogenic aids for sportspeople. It is essential to prevent the introduction or dissemination of false, ambiguous, or inexact information and contents that induce an error in the receivers of the information. In this field, it is worth highlighting the roles of the European Food Safety Authority and the World Anti-Doping Agency, which provide information about consumer guidelines, prescribing practices, and recommendations for the prudent use of nutritional ergogenic aids. PMID:29117104

  1. 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.

  2. An overview of the Hadoop/MapReduce/HBase framework and its current applications in bioinformatics

    International Nuclear Information System (INIS)

    Taylor, Ronald C.

    2010-01-01

    Bioinformatics researchers are increasingly confronted with analysis of ultra large-scale data sets, a problem that will only increase at an alarming rate in coming years. Recent developments in open source software, that is, the Hadoop project and associated software, provide a foundation for scaling to petabyte scale data warehouses on Linux clusters, providing fault-tolerant parallelized analysis on such data using a programming style named MapReduce. An overview is given of the current usage within the bioinformatics community of Hadoop, a top-level Apache Software Foundation project, and of associated open source software projects. The concepts behind Hadoop and the associated HBase project are defined, and current bioinformatics software that employ Hadoop is described. The focus is on next-generation sequencing, as the leading application area to date.

  3. Development of a modelling framework in response to new European energy-efficiency regulatory obligations: The Irish experience

    International Nuclear Information System (INIS)

    Hull, David; O Gallachoir, Brian P.; Walker, Neil

    2009-01-01

    Momentum has been building for an EU-wide approach to energy policy in which energy end-use efficiency is regarded as one of the main planks. Member States are already obliged to plan for the achievement of energy savings targets in respect of the period 2008-2016 and they now face additional economy-wide targets for 2020. Efficiency investments are widely regarded as capable of improving industrial competitiveness, security of energy supply and the abatement of greenhouse gas emissions. Nevertheless, the design of policy packages may involve trade-offs between these objectives. The challenge for energy modellers is to quantify future energy savings associated with combinations of efficiency measures. This paper draws on the international experience in energy modelling and tracks recent progress that has been made towards a harmonised European framework for verification of savings. It points to the significant development work that remains to be done, particularly to enable an increased reliance on bottom-up evaluation methods. One significant gap in our knowledge relates to the required adjustment of technical savings due to behavioural factors such as rebound effects. The paper uses one country (Ireland) as a case study to demonstrate how a framework is being developed to respond to these new requirements.

  4. Current products and future plan of regulatory technology R and D for risk-informed regulation and applications

    International Nuclear Information System (INIS)

    Song, K. Y.; Lee, C. J.; Kim, W. S.; Jeong, D. W.; Kim, H. J.

    2002-01-01

    The first phase of a R and D project for risk-informed regulation (RIR) and applications (RIA) has been finished. Various results which would be useful for preparing domestic RIR system were accomplished, in areas of safety goals and general principles of RIR, which provide fundamental bases for establishment of RIR system as well as regulatory review guides, which ensure the quality for PSA. RIA guidelines for ISI, IST, MOV, Tech.-Sepc. also have been developed, implementing some pilot plant applications. As essential documents for actual RIR inspection, risk-informed inspection guides and implementation guide for maintenance effectiveness were prepared. In the second phase of R and D, two projects on RIR area will be performed. One is to study on institutionalization of RIR and performance-based regulation, another is to develop a PSA model for regulatory audit as well as regulatory technology for risk monitoring

  5. Implementation of the framework convention on tobacco control in Africa: current status of legislation.

    Science.gov (United States)

    Tumwine, Jacqueline

    2011-11-01

    To describe, as of July 2011, the status of tobacco control legislation in Africa in three key areas of the Framework Convention on Tobacco Control (FCTC)-(1) Protection from exposure to tobacco smoke, (2) Packaging and labelling of tobacco products, and (3) Tobacco advertising, promotion and sponsorship. Review and analysis of tobacco control legislation in Africa, media reports, journal articles, tobacco industry documents and data published in the 2011 WHO Report on the Global Tobacco Epidemic. Modest progress in FCTC implementation in Africa with many countries having legislation or policies on the protection from exposure to tobacco smoke, however, only a handful of countries meet the standards of the FCTC Article 8 and its Guidelines particularly with regards to designated smoking areas. Little progress on packaging and labelling of tobacco products, with few countries having legislation meeting the minimum standards of the FCTC Article 11 and its Guidelines. Mauritius is the only African country with graphic or pictorial health warnings in place and has the largest warning labels in Africa. Slightly better progress in banning tobacco advertising, promotion and sponsorship has been shown by African countries, although the majority of legislation falls short of the standards of the FCTC Article 13 and its Guidelines. Despite their efforts, African countries' FCTC implementation at national level has not matched the strong regional commitment demonstrated during the FCTC treaty negotiations. This study highlights the need for Africa to step up efforts to adopt and implement effective tobacco control legislation that is fully compliant with the FCTC. In order to achieve this, countries should prioritise resources for capacity building for drafting strong FCTC compliant legislation, research to inform policy and boost political will, and countering the tobacco industry which is a major obstacle to FCTC implementation in Africa.

  6. Implementation of the Framework Convention on Tobacco Control in Africa: Current Status of Legislation

    Directory of Open Access Journals (Sweden)

    Jacqueline Tumwine

    2011-11-01

    Full Text Available Objective: To describe, as of July 2011, the status of tobacco control legislation in Africa in three key areas of the Framework Convention on Tobacco Control (FCTC—(1 Protection from exposure to tobacco smoke, (2 Packaging and labelling of tobacco products, and (3 Tobacco advertising, promotion and sponsorship. Methods: Review and analysis of tobacco control legislation in Africa, media reports, journal articles, tobacco industry documents and data published in the 2011 WHO Report on the Global Tobacco Epidemic. Results: Modest progress in FCTC implementation in Africa with many countries having legislation or policies on the protection from exposure to tobacco smoke, however, only a handful of countries meet the standards of the FCTC Article 8 and its Guidelines particularly with regards to designated smoking areas. Little progress on packaging and labelling of tobacco products, with few countries having legislation meeting the minimum standards of the FCTC Article 11 and its Guidelines. Mauritius is the only African country with graphic or pictorial health warnings in place and has the largest warning labels in Africa. Slightly better progress in banning tobacco advertising, promotion and sponsorship has been shown by African countries, although the majority of legislation falls short of the standards of the FCTC Article 13 and its Guidelines. Despite their efforts, African countries’ FCTC implementation at national level has not matched the strong regional commitment demonstrated during the FCTC treaty negotiations. Conclusion: This study highlights the need for Africa to step up efforts to adopt and implement effective tobacco control legislation that is fully compliant with the FCTC. In order to achieve this, countries should prioritise resources for capacity building for drafting strong FCTC compliant legislation, research to inform policy and boost political will, and countering the tobacco industry which is a major obstacle to FCTC

  7. The Indus basin in the framework of current and future water resources management

    Science.gov (United States)

    Laghari, A. N.; Vanham, D.; Rauch, W.

    2012-04-01

    The Indus basin is one of the regions in the world that is faced with major challenges for its water sector, due to population growth, rapid urbanisation and industrialisation, environmental degradation, unregulated utilization of the resources, inefficient water use and poverty, all aggravated by climate change. The Indus Basin is shared by 4 countries - Pakistan, India, Afghanistan and China. With a current population of 237 million people which is projected to increase to 319 million in 2025 and 383 million in 2050, already today water resources are abstracted almost entirely (more than 95% for irrigation). Climate change will result in increased water availability in the short term. However in the long term water availability will decrease. Some current aspects in the basin need to be re-evaluated. During the past decades water abstractions - and especially groundwater extractions - have augmented continuously to support a rice-wheat system where rice is grown during the kharif (wet, summer) season (as well as sugar cane, cotton, maize and other crops) and wheat during the rabi (dry, winter) season. However, the sustainability of this system in its current form is questionable. Additional water for domestic and industrial purposes is required for the future and should be made available by a reduction in irrigation requirements. This paper gives a comprehensive listing and description of available options for current and future sustainable water resources management (WRM) within the basin. Sustainable WRM practices include both water supply management and water demand management options. Water supply management options include: (1) reservoir management as the basin is characterised by a strong seasonal behaviour in water availability (monsoon and meltwater) and water demands; (2) water quality conservation and investment in wastewater infrastructure; (3) the use of alternative water resources like the recycling of wastewater and desalination; (4) land use

  8. The Indus basin in the framework of current and future water resources management

    Directory of Open Access Journals (Sweden)

    A. N. Laghari

    2012-04-01

    Full Text Available The Indus basin is one of the regions in the world that is faced with major challenges for its water sector, due to population growth, rapid urbanisation and industrialisation, environmental degradation, unregulated utilization of the resources, inefficient water use and poverty, all aggravated by climate change. The Indus Basin is shared by 4 countries – Pakistan, India, Afghanistan and China. With a current population of 237 million people which is projected to increase to 319 million in 2025 and 383 million in 2050, already today water resources are abstracted almost entirely (more than 95% for irrigation. Climate change will result in increased water availability in the short term. However in the long term water availability will decrease. Some current aspects in the basin need to be re-evaluated. During the past decades water abstractions – and especially groundwater extractions – have augmented continuously to support a rice-wheat system where rice is grown during the kharif (wet, summer season (as well as sugar cane, cotton, maize and other crops and wheat during the rabi (dry, winter season. However, the sustainability of this system in its current form is questionable. Additional water for domestic and industrial purposes is required for the future and should be made available by a reduction in irrigation requirements. This paper gives a comprehensive listing and description of available options for current and future sustainable water resources management (WRM within the basin. Sustainable WRM practices include both water supply management and water demand management options. Water supply management options include: (1 reservoir management as the basin is characterised by a strong seasonal behaviour in water availability (monsoon and meltwater and water demands; (2 water quality conservation and investment in wastewater infrastructure; (3 the use of alternative water resources like the recycling of wastewater and desalination; (4

  9. Do We Need Plant Food Supplements? A Critical Examination of Quality, Safety, Efficacy, and Necessity for a New Regulatory Framework.

    Science.gov (United States)

    Abdel-Tawab, Mona

    2018-04-01

    Given the expanding market of plant food supplements (PFSs) not undergoing any pre-marketing authorization, the overall quality, safety and efficacy of PFSs were subjected to a critical examination. Although many high-quality PFSs exist on the legal market, quality concerns are in general justified. Besides economic adulteration, active ingredients dramatically differing from label claims and among products were reported in several studies. In addition, PFSs sold via the Internet may be intentionally adulterated with undeclared prescription drugs. Compared to PFSs with only one single herb, PFSs containing herbal mixtures were more involved in moderate and severe clinical courses. Although prohibited by regulation, misleading labels on PFSs are common. Above all, only vague evidence for the efficacy of PFSs exists. Notwithstanding the unproven efficacy and insufficient safety assessment, PFSs represent a relevant source for consumers to get access to herbal preparations in the United States and meanwhile also in Europe, as launching of licensed/registered European herbal medicinal products (HMPs) has steadily decreased. However, being non-vitamin, non-mineral products, PFSs are neither food nor drugs. In terms of protecting public health and providing the consumer with high-quality, effective, and safe PFSs, possibilities are shown how to deal with the many challenges of PFSs. Last but not least, suggestions are made for assigning PFSs a separate regulatory category being less regulated compared to HMPs but more strictly regulated compared to food laws including implementation of good manufacturing practices and a scientific pre-marketing review process by an expert commission. Georg Thieme Verlag KG Stuttgart · New York.

  10. 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...

  11. 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

  12. Preimplantation diagnosis to create 'saviour siblings': a critical discussion of the current and future legal frameworks in South Africa.

    Science.gov (United States)

    Strode, Ann; Soni, Sheetal

    2011-12-14

    Pre-implantation genetic diagnosis (PGD) is a technology used in conjunction with in vitro fertilisation to screen embryos for genetic conditions prior to transfer. It was initially developed to screen mutations for severe, irreversible, genetic conditions. Currently, PGD makes it possible to select against more than 100 different genetic conditions. It has been proposed as a method for creating a tissue-matched child who can in turn serve as a compatible stem cell donor to save a sick sibling in need of a stem cell transplant. The advantage of this method is that it provides genetic information before implantation of an embryo into the womb, making it possible to ensure that only tissue-matched embryos are transferred to the uterus. A couple can therefore avoid the difficult choice of either terminating the pregnancy at a later point if the fetus is not a match, or extending their family again in the hope that their next child will be tissue compatible. Many people have expressed disapproval of the use of PGD for this purpose, and it is associated with many conflicting interests including religion, ethics as well as legal regulation. In order to manage these issues some jurisdictions have created legal frameworks to regulate the use of this technology. Many of these are modelled on the UK's Human Fertilisation and Embryology Authority and its guardian legislation. This paper critiques the current and future South African legal framework to establish whether it is able to adequately regulate the use of PGD as well as guard against misuse of the technology. It concludes that changes are required to the future framework in order to ensure that it regulates the circumstances in which PGD may occur and that the Minister of Health should act expediently in finalising draft regulations which will regulate PGD in the future.

  13. European Framework for the Diffusion of Biogas Uses: Emerging Technologies, Acceptance, Incentive Strategies, and Institutional-Regulatory Support

    Directory of Open Access Journals (Sweden)

    Andrea G. Capodaglio

    2016-03-01

    Full Text Available Biogas will constitute a significant fraction of future power supply, since it is expected to contribute a large share of the EU renewable energy targets. Biogas, once produced, can be combusted in traditional boilers to provide heat, or to generate electricity. It can be used for the production of chemical compounds, or fed into a pipeline. This review paper will briefly analyze the current most promising emerging biogas technologies in the perspective of their potential uses, environmental benefits, and public acceptance; draw a picture of current conditions on the adoption of a biogas road map in the several EU Member States; analyze incentive and support policy implementation status and gaps; discuss non-technological barriers; and summarize proposed solutions to widen this energy’s use.

  14. Clinical trial regulation in Argentina: overview and analysis of regulatory framework, use of existing tools, and researchers' perspectives to identify potential barriers.

    Science.gov (United States)

    White, Lauren; Ortiz, Zulma; Cuervo, Luis G; Reveiz, Ludovic

    2011-11-01

    To review and analyze the regulatory framework of clinical trial registration, use of existing tools (publicly accessible national/international registration databases), and users' perspectives to identify possible barriers to registration compliance by sponsors and researchers in Argentina. Internationally registered trials recruiting patients in Argentina were found through clincialtrials.gov and the International Clinical Trial Registration Platform (ICTRP) and compared with publically available clinical trials registered through the National Administration of Drugs, Foods, and Medical Devices (ANMAT). A questionnaire addressing hypothesized attitudinal, knowledge-related, idiomatic, technical, economic, and regulatory barriers that could discourage or impede registration of clinical trials was developed, and semi-structured, in-depth interviews were conducted with a purposively selected sample of researchers (investigators, sponsors, and monitors) in Argentina. A response rate of 74.3% (n = 29) was achieved, and 27 interviews were ultimately used for analysis. Results suggested that the high proportion of foreign-sponsored or multinational trials (64.8% of all protocols approved by ANMAT from 1994-2006) may contribute to a communication gap between locally based investigators and foreign-based administrative officials. A lack of knowledge about available international registration tools and limited awareness of the importance of registration were also identified as limiting factors for local investigators and sponsors. To increase compliance and promote clinical trial registration in Argentina, national health authorities, sponsors, and local investigators could take the following steps: implement a grassroots educational campaign to improve clinical trial regulation, support local investigator-sponsor-initiated clinical trials, and/or encourage local and regional scientific journal compliance with standards from the International Committee of Medical Journal

  15. Clinical Development and Commercialization of Advanced Therapy Medicinal Products in the European Union: How Are the Product Pipeline and Regulatory Framework Evolving?

    Science.gov (United States)

    Boráň, Tomáš; Menezes-Ferreira, Margarida; Reischl, Ilona; Celis, Patrick; Ferry, Nicolas; Gänsbacher, Bernd; Krafft, Hartmut; Lipucci di Paola, Michele; Sladowski, Dariusz; Salmikangas, Paula

    2017-09-01

    The research and development of advanced therapy medicinal products (ATMPs) has been active in Europe and worldwide during recent years. Yet, the number of licensed products remains low. The main expected legal change in the near future in the European Union (EU) concerns the regulation on clinical trials (536/2014), which will come into force in 2018. With this new framework, a more harmonized and swift process for approval of clinical trials is anticipated, which is expected to support the entry of new innovations into the EU market. A survey on ATMPs in clinical trials during 2010-2015 in the EU was conducted in order to study the trends of ATMP development since the earlier survey published in 2012. According to the results, the number of clinical trials using ATMPs is slowly increasing in the EU. Yet, the focus is still in early development, and the projects are mainly carried out by small and medium-sized enterprises, academia, and hospitals. Oncology is the main area of clinical development. Yet, the balance between cell-based products and gene therapy medicinal products in this area may be changing in the future due to the new T-cell technologies. Many limitations and challenges are identified for ATMP development, requiring proportionate regulatory requirements. On the other hand, for such a novel field, the developers should be active in considering possible constraints and actively engage with authorities to look for solutions. This article provides up to-date information on forthcoming regulatory improvements and discusses the main challenges hampering the commercialization of ATMPs in the EU.

  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. The environmental performance of current and future passenger vehicles: Life cycle assessment based on a novel scenario analysis framework

    International Nuclear Information System (INIS)

    Bauer, Christian; Hofer, Johannes; Althaus, Hans-Jörg; Del Duce, Andrea; Simons, Andrew

    2015-01-01

    Highlights: • We perform Life Cycle Assessment (LCA) of current and future passenger vehicles. • We include gasoline, diesel and natural gas as well as battery and fuel cell cars. • An integrated vehicle simulation framework guarantees consistency. • Only electric cars with “clean” electricity and H_2 allow for pollution mitigation. • Complete LCA is mandatory for environmental evaluation of vehicle technologies. - Abstract: This paper contains an evaluation of the environmental performance of a comprehensive set of current and future mid-size passenger vehicles. We present a comparative Life Cycle Assessment (LCA) based on a novel integrated vehicle simulation framework, which allows for consistency in vehicle parameter settings and consideration of future technological progress. Conventional and hybrid gasoline, diesel and natural gas cars as well as battery and fuel cell electric vehicles (BEV and FCV) are analyzed, taking into account electricity and hydrogen production chains from fossil, nuclear and renewable energy resources. Our results show that a substantial mitigation of climate change can be obtained with electric passenger vehicles, provided that non-fossil energy resources are used for electricity and hydrogen production. However, in terms of other environmental burdens such as acidification, particulate matter formation, and toxicity, BEV may in some cases and FCV are likely to perform worse than modern fossil fueled cars as a consequence of emissions along vehicle and fuel production chains. Therefore, the electrification of road transportation should be accompanied by an integration of life cycle management in vehicle manufacturing chains as well as energy and transport policies in order to counter potential environmental drawbacks.

  18. Olive oil authentication: A comparative analysis of regulatory frameworks with especial emphasis on quality and authenticity indices, and recent analytical techniques developed for their assessment. A review.

    Science.gov (United States)

    Bajoub, Aadil; Bendini, Alessandra; Fernández-Gutiérrez, Alberto; Carrasco-Pancorbo, Alegría

    2018-03-24

    Over the last decades, olive oil quality and authenticity control has become an issue of great importance to consumers, suppliers, retailers, and regulators in both traditional and emerging olive oil producing countries, mainly due to the increasing worldwide popularity and the trade globalization of this product. Thus, in order to ensure olive oil authentication, various national and international laws and regulations have been adopted, although some of them are actually causing an enormous debate about the risk that they can represent for the harmonization of international olive oil trade standards. Within this context, this review was designed to provide a critical overview and comparative analysis of selected regulatory frameworks for olive oil authentication, with special emphasis on the quality and purity criteria considered by these regulation systems, their thresholds and the analytical methods employed for monitoring them. To complete the general overview, recent analytical advances to overcome drawbacks and limitations of the official methods to evaluate olive oil quality and to determine possible adulterations were reviewed. Furthermore, the latest trends on analytical approaches to assess the olive oil geographical and varietal origin traceability were also examined.

  19. The current state of inservice testing programs at U.S. Nuclear Power Plants - a regulatory overview

    International Nuclear Information System (INIS)

    Campbell, P.; Colaccino, J.

    1994-01-01

    Information is provided on inservice testing (IST) of pumps and valves at U.S. nuclear power plants to provide consistency in the implementation of regulatory requirements and to enhance communications among utility licensees who may have, like NSSS vendors, similar kinds and numbers of components or comparable IST programs. Documents discussed include the ASME Operation and Maintenance Standards Parts 6 and 10 (covering inservice testing of pumps and valves in light water reactor power plants), the draft NUREG-1482, Guidelines for Inservice Testing at Nuclear Power Plants (including review comments by Nuclear Management and Resource Council), and applicable Licensee Event Reports including summaries of several reports relating to IST

  20. Regulatory approaches to obesity prevention: A systematic overview of current laws addressing diet-related risk factors in the European Union and the United States.

    Science.gov (United States)

    Sisnowski, Jana; Handsley, Elizabeth; Street, Jackie M

    2015-06-01

    High prevalence of overweight and obesity remains a significant international public health problem. Law has been identified as a tool for obesity prevention and selected high-profile measures have been reported. However, the nature and extent of enacted legislation internationally are unclear. This research provides an overview of regulatory approaches enacted in the United States, the European Union, and EU Member States since 2004. To this end, relevant databases of primary and secondary legislation were systematically searched to identify and explore laws addressing dietary risk factors for obesity. Across jurisdictions, current regulatory approaches to obesity prevention are limited in reach and scope. Target groups are rarely the general population, but instead sub-populations in government-supported settings. Consumer information provision is preferred over taxation and marketing restrictions other than the regulation of health and nutrition claims. In the EU in particular, product reformulation with industry consent has also emerged as a popular small-scale measure. While consistent and widespread use of law is lacking, governments have employed a range of regulatory measures in the name of obesity prevention, indicating that there is, in principle, political will. Results from this study may serve as a starting point for future research and policy development. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  1. 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.

  2. Nanoinformatics workshop report: Current resources, community needs, and the proposal of a collaborative framework for data sharing and information integration.

    Science.gov (United States)

    Harper, Stacey L; Hutchison, James E; Baker, Nathan; Ostraat, Michele; Tinkle, Sally; Steevens, Jeffrey; Hoover, Mark D; Adamick, Jessica; Rajan, Krishna; Gaheen, Sharon; Cohen, Yoram; Nel, Andre; Cachau, Raul E; Tuominen, Mark

    2013-01-01

    The quantity of information on nanomaterial properties and behavior continues to grow rapidly. Without a concerted effort to collect, organize and mine disparate information coming out of current research efforts, the value and effective use of this information will be limited at best. Data will not be translated to knowledge. At worst, erroneous conclusions will be drawn and future research may be misdirected. Nanoinformatics can be a powerful approach to enhance the value of global information in nanoscience and nanotechnology. Much progress has been made through grassroots efforts in nanoinformatics resulting in a multitude of resources and tools for nanoscience researchers. In 2012, the nanoinformatics community believed it was important to critically evaluate and refine currently available nanoinformatics approaches in order to best inform the science and support the future of predictive nanotechnology. The Greener Nano 2012: Nanoinformatics Tools and Resources Workshop brought together informatics groups with materials scientists active in nanoscience research to evaluate and reflect on the tools and resources that have recently emerged in support of predictive nanotechnology. The workshop goals were to establish a better understanding of current nanoinformatics approaches and to clearly define immediate and projected informatics infrastructure needs of the nanotechnology community. The theme of nanotechnology environmental health and safety (nanoEHS) was used to provide real-world, concrete examples on how informatics can be utilized to advance our knowledge and guide nanoscience. The benefit here is that the same properties that impact the performance of products could also be the properties that inform EHS. From a decision management standpoint, the dual use of such data should be considered a priority. Key outcomes include a proposed collaborative framework for data collection, data sharing and information integration.

  3. Nanoinformatics workshop report: current resources, community needs and the proposal of a collaborative framework for data sharing and information integration

    International Nuclear Information System (INIS)

    Harper, Stacey L; Hutchison, James E; Baker, Nathan; Ostraat, Michele; Tinkle, Sally; Steevens, Jeffrey; Hoover, Mark D; Adamick, Jessica; Rajan, Krishna; Gaheen, Sharon; Cohen, Yoram; Nel, Andre; Cachau, Raul E; Tuominen, Mark

    2013-01-01

    The quantity of information on nanomaterial properties and behavior continues to grow rapidly. Without a concerted effort to collect, organize and mine disparate information coming out of current research efforts, the value and effective use of this information will be limited at best. Data will not be translated to knowledge. At worst, erroneous conclusions will be drawn and future research may be misdirected. Nanoinformatics can be a powerful approach to enhance the value of global information in nanoscience and nanotechnology. Much progress has been made through grassroots efforts in nanoinformatics resulting in a multitude of resources and tools for nanoscience researchers. In 2012, the nanoinformatics community believed it was important to critically evaluate and refine currently available nanoinformatics approaches in order to best inform the science and support the future of predictive nanotechnology. The Greener Nano 2012: Nanoinformatics Tools and Resources Workshop brought together informatics groups with materials scientists active in nanoscience research to evaluate and reflect on the tools and resources that have recently emerged in support of predictive nanotechnology. The workshop goals were to establish a better understanding of current nanoinformatics approaches and to clearly define immediate and projected informatics infrastructure needs of the nanotechnology community. The theme of nanotechnology environmental health and safety (nanoEHS) was used to provide real-world, concrete examples on how informatics can be utilized to advance our knowledge and guide nanoscience. The benefit here is that the same properties that impact the performance of products could also be the properties that inform EHS. From a decision management standpoint, the dual use of such data should be considered a priority. Key outcomes include a proposed collaborative framework for data collection, data sharing and information integration. (paper)

  4. 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

  5. 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)

  6. 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.

  7. Assessing Land Degradation and Desertification Using Vegetation Index Data: Current Frameworks and Future Directions

    Directory of Open Access Journals (Sweden)

    Thomas P. Higginbottom

    2014-10-01

    Full Text Available Land degradation and desertification has been ranked as a major environmental and social issue for the coming decades. Thus, the observation and early detection of degradation is a primary objective for a number of scientific and policy organisations, with remote sensing methods being a candidate choice for the development of monitoring systems. This paper reviews the statistical and ecological frameworks of assessing land degradation and desertification using vegetation index data. The development of multi-temporal analysis as a desertification assessment technique is reviewed, with a focus on how current practice has been shaped by controversy and dispute within the literature. The statistical techniques commonly employed are examined from both a statistical as well as ecological point of view, and recommendations are made for future research directions. The scientific requirements for degradation and desertification monitoring systems identified here are: (I the validation of methodologies in a robust and comparable manner; and (II the detection of degradation at minor intensities and magnitudes. It is also established that the multi-temporal analysis of vegetation index data can provide a sophisticated measure of ecosystem health and variation, and that, over the last 30 years, considerable progress has been made in the respective research.

  8. The use of Depletion Methods to assess Mediterranean cephalopod stocks under the current EU Data Collection Framework

    Directory of Open Access Journals (Sweden)

    S. KELLER

    2015-09-01

    Full Text Available Fuelled by the raising importance of cephalopod fisheries in Europe, there have been demands from scientists and stakeholders for their assessment and management. However, little has been done to improve the data collection in order to analyse cephalopod populations under the EU Data Collection Framework (DCF. While the DCF allows member states to design flexible national sampling programmes, it establishes the minimum data requirements (MDR each state is obliged to fulfil. In this study, it was investigated whether such MDR currently set by the DCF allow the application of depletion models (DMs to assess European cephalopod stocks. Squid and cuttlefish fisheries from the western Mediterranean were used as a case study. This exercise sheds doubt on the suitability of the MDR to properly assess and manage cephalopod stocks by means of DMs. Owing to the high plasticity of life-history traits in cephalopod populations, biological parameters should be estimated during the actual depletion period of the fished stocks, in contrast with the triennial sampling established by the DCF. In order to accurately track the depletion event, the rapid growth rates of cephalopods implies that their populations should be monitored at shorter time scales (ideally weekly or biweekly instead of quarterly as required by the DCF. These measures would not demand additional resources of the ongoing DCF, but a redistribution of sampling efforts during the depletion period. Such changes in the sampling scheme could be designed and undertaken by the member states or directly integrated as requirements.

  9. Efficient solution of 3D electromagnetic eddy-current problems within the finite volume framework of OpenFOAM

    Science.gov (United States)

    Beckstein, Pascal; Galindo, Vladimir; Vukčević, Vuko

    2017-09-01

    Eddy-current problems occur in a wide range of industrial and metallurgical applications where conducting material is processed inductively. Motivated by realising coupled multi-physics simulations, we present a new method for the solution of such problems in the finite volume framework of foam-extend, an extended version of the very popular OpenFOAM software. The numerical procedure involves a semi-coupled multi-mesh approach to solve Maxwell's equations for non-magnetic materials by means of the Coulomb gauged magnetic vector potential A and the electric scalar potential ϕ. The concept is further extended on the basis of the impressed and reduced magnetic vector potential and its usage in accordance with Biot-Savart's law to achieve a very efficient overall modelling even for complex three-dimensional geometries. Moreover, we present a special discretisation scheme to account for possible discontinuities in the electrical conductivity. To complement our numerical method, an extensive validation is completing the paper, which provides insight into the behaviour and the potential of our approach.

  10. An analysis of pharmaceutical experience with decades of rat carcinogenicity testing: support for a proposal to modify current regulatory guidelines.

    Science.gov (United States)

    Sistare, Frank D; Morton, Daniel; Alden, Carl; Christensen, Joel; Keller, Douglas; Jonghe, Sandra De; Storer, Richard D; Reddy, M Vijayaraj; Kraynak, Andrew; Trela, Bruce; Bienvenu, Jean-Guy; Bjurström, Sivert; Bosmans, Vanessa; Brewster, David; Colman, Karyn; Dominick, Mark; Evans, John; Hailey, James R; Kinter, Lewis; Liu, Matt; Mahrt, Charles; Marien, Dirk; Myer, James; Perry, Richard; Potenta, Daniel; Roth, Arthur; Sherratt, Philip; Singer, Thomas; Slim, Rabih; Soper, Keith; Fransson-Steen, Ronny; Stoltz, James; Turner, Oliver; Turnquist, Susan; van Heerden, Marjolein; Woicke, Jochen; DeGeorge, Joseph J

    2011-06-01

    Data collected from 182 marketed and nonmarketed pharmaceuticals demonstrate that there is little value gained in conducting a rat two-year carcinogenicity study for compounds that lack: (1) histopathologic risk factors for rat neoplasia in chronic toxicology studies, (2) evidence of hormonal perturbation, and (3) positive genetic toxicology results. Using a single positive result among these three criteria as a test for outcome in the two-year study, fifty-two of sixty-six rat tumorigens were correctly identified, yielding 79% test sensitivity. When all three criteria were negative, sixty-two of seventy-six pharmaceuticals (82%) were correctly predicted to be rat noncarcinogens. The fourteen rat false negatives had two-year study findings of questionable human relevance. Applying these criteria to eighty-six additional chemicals identified by the International Agency for Research on Cancer as likely human carcinogens and to drugs withdrawn from the market for carcinogenicity concerns confirmed their sensitivity for predicting rat carcinogenicity outcome. These analyses support a proposal to refine regulatory criteria for conducting a two-year rat study to be based on assessment of histopathologic findings from a rat six-month study, evidence of hormonal perturbation, genetic toxicology results, and the findings of a six-month transgenic mouse carcinogenicity study. This proposed decision paradigm has the potential to eliminate over 40% of rat two-year testing on new pharmaceuticals without compromise to patient safety.

  11. 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)

  12. Adipose-Derived Stem Cells in Aesthetic Surgery: A Mixed Methods Evaluation of the Current Clinical Trial, Intellectual Property, and Regulatory Landscape.

    Science.gov (United States)

    Arshad, Zeeshaan; Halioua-Haubold, Celine-Lea; Roberts, Mackenna; Urso-Baiarda, Fulvio; Branford, Oliver A; Brindley, David A; Davies, Benjamin M; Pettitt, David

    2018-02-17

    Adipose tissue, which can be readily harvested via a number of liposuction techniques, offers an easily accessible and abundant source of adipose-derived stem cells (ASCs). Consequently, ASCs have become an increasingly popular reconstructive option and a novel means of aesthetic soft tissue augmentation. This paper examines recent advances in the aesthetic surgery field, extending beyond traditional review formats to incorporate a comprehensive analysis of current clinical trials, adoption status, and the commercialization pathway. Keyword searches were carried out on clinical trial databases to search for trials using ASCs for aesthetic indications. An intellectual property landscape was created using commercial software (Thomson Reuters Thomson Innovation, New York, NY). Analysis of who is claiming what in respect of ASC use in aesthetic surgery for commercial purposes was analyzed by reviewing the patent landscape in relation to these techniques. Key international regulatory guidelines were also summarized. Completed clinical trials lacked robust controls, employed small sample sizes, and lacked long-term follow-up data. Ongoing clinical trials still do not address such issues. In recent years, claims to intellectual property ownership have increased in the "aesthetic stem cell" domain, reflecting commercial interest in the area. However, significant translational barriers remain including regulatory challenges and ethical considerations. Further rigorous randomized controlled trials are required to delineate long-term clinical efficacy and safety. Providers should consider the introduction of patient reported outcome metrics to facilitate clinical adoption. Robust regulatory and ethical policies concerning stem cells and aesthetic surgery should be devised to discourage further growth of "stem cell tourism." © 2017 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com

  13. MDEP Technical Report TR-CSWG-01. Technical Report: Regulatory Frameworks for the Use of Nuclear Pressure Boundary Codes and Standards in MDEP Countries

    International Nuclear Information System (INIS)

    2013-01-01

    The Codes and Standards Working Group (CSWG) is one of the issue-specific working groups that the MDEP members are undertaking; its long term goal is harmonisation of regulatory and code requirements for design and construction of pressure-retaining components in order to improve the effectiveness and efficiency of the regulatory design reviews, increase quality of safety assessments, and to enable each regulator to become stronger in its ability to make safety decisions. The CSWG has interacted closely with the Standards Development Organisations (SDOs) and CORDEL in code comparison and code convergence. The Code Comparison Report STP-NU-051 has been issued by SDO members to identify the extent of similarities and differences amongst the pressure-boundary codes and standards used in various countries. Besides the differences in codes and standards, the way how the codes and standards are applied to systems, structures and components also affects the design and construction of nuclear power plant. Therefore, to accomplish the goal of potential harmonisation, it is also vital that the regulators learn about each other's procedures, processes, and regulations. To facilitate the learning process, the CSWG meets regularly to discuss issues relevant to licensing new reactors and using codes and standards in licensing safety reviews. The CSWG communicates very frequently with the SDOs to discuss similarities and differences among the various codes and how to proceed with potential harmonisation. It should be noted that the IAEA is invited to all of the issue-specific working groups within MDEP to ensure consistency with IAEA standards. The primary focus of this technical report is to consolidate information shared and accomplishments achieved by the member countries. This report seeks to document how each MDEP regulator utilises national or regional mechanical codes and standards in its safety reviews and licensing of new reactors. The preparation of this report

  14. Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel

    Science.gov (United States)

    Fregni, F; Nitsche, MA; Loo, C.K.; Brunoni, AR; Marangolo, P; Leite, J; Carvalho, S; Bolognini, N; Caumo, W; Paik, NJ; Simis, M; Ueda, K; Ekhitari, H; Luu, P; Tucker, DM; Tyler, WJ; Brunelin, J; Datta, A; Juan, CH; Venkatasubramanian, G; Boggio, PS; Bikson, M

    2014-01-01

    The field of transcranial electrical stimulation (tES) has experienced significant growth in the past 15 years. One of the tES techniques leading this increased interest is transcranial direct current stimulation (tDCS). Significant research efforts have been devoted to determining the clinical potential of tDCS in humans. Despite the promising results obtained with tDCS in basic and clinical neuroscience, further progress has been impeded by a lack of clarity on international regulatory pathways. We therefore convened a group of research and clinician experts on tDCS to review the research and clinical use of tDCS. In this report, we review the regulatory status of tDCS, and we summarize the results according to research, off-label and compassionate use of tDCS in the following countries: Australia, Brazil, France, Germany, India, Iran, Italy, Portugal, South Korea, Taiwan and United States. Research use, off label treatment and compassionate use of tDCS are employed in most of the countries reviewed in this study. It is critical that a global or local effort is organized to pursue definite evidence to either approve and regulate or restrict the use of tDCS in clinical practice on the basis of adequate randomized controlled treatment trials. PMID:25983531

  15. 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

  16. 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.

  17. Single-Session Transcranial Direct Current Stimulation Temporarily Improves Symptoms, Mood, and Self-Regulatory Control in Bulimia Nervosa: A Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Maria Kekic

    Full Text Available Evidence suggests that pathological eating behaviours in bulimia nervosa (BN are underpinned by alterations in reward processing and self-regulatory control, and by functional changes in neurocircuitry encompassing the dorsolateral prefrontal cortex (DLPFC. Manipulation of this region with transcranial direct current stimulation (tDCS may therefore alleviate symptoms of the disorder.This double-blind sham-controlled proof-of-principle trial investigated the effects of bilateral tDCS over the DLPFC in adults with BN.Thirty-nine participants (two males received three sessions of tDCS in a randomised and counterbalanced order: anode right/cathode left (AR/CL, anode left/cathode right (AL/CR, and sham. A battery of psychological/neurocognitive measures was completed before and after each session and the frequency of bulimic behaviours during the following 24-hours was recorded.AR/CL tDCS reduced eating disorder cognitions (indexed by the Mizes Eating Disorder Cognitions Questionnaire-Revised when compared to AL/CR and sham tDCS. Both active conditions suppressed the self-reported urge to binge-eat and increased self-regulatory control during a temporal discounting task. Compared to sham stimulation, mood (assessed with the Profile of Mood States improved after AR/CL but not AL/CR tDCS. Lastly, the three tDCS sessions had comparable effects on the wanting/liking of food and on bulimic behaviours during the 24 hours post-stimulation.These data suggest that single-session tDCS transiently improves symptoms of BN. They also help to elucidate possible mechanisms of action and highlight the importance of selecting the optimal electrode montage. Multi-session trials are needed to determine whether tDCS has potential for development as a treatment for adult BN.

  18. Single-Session Transcranial Direct Current Stimulation Temporarily Improves Symptoms, Mood, and Self-Regulatory Control in Bulimia Nervosa: A Randomised Controlled Trial.

    Science.gov (United States)

    Kekic, Maria; McClelland, Jessica; Bartholdy, Savani; Boysen, Elena; Musiat, Peter; Dalton, Bethan; Tiza, Meyzi; David, Anthony S; Campbell, Iain C; Schmidt, Ulrike

    2017-01-01

    Evidence suggests that pathological eating behaviours in bulimia nervosa (BN) are underpinned by alterations in reward processing and self-regulatory control, and by functional changes in neurocircuitry encompassing the dorsolateral prefrontal cortex (DLPFC). Manipulation of this region with transcranial direct current stimulation (tDCS) may therefore alleviate symptoms of the disorder. This double-blind sham-controlled proof-of-principle trial investigated the effects of bilateral tDCS over the DLPFC in adults with BN. Thirty-nine participants (two males) received three sessions of tDCS in a randomised and counterbalanced order: anode right/cathode left (AR/CL), anode left/cathode right (AL/CR), and sham. A battery of psychological/neurocognitive measures was completed before and after each session and the frequency of bulimic behaviours during the following 24-hours was recorded. AR/CL tDCS reduced eating disorder cognitions (indexed by the Mizes Eating Disorder Cognitions Questionnaire-Revised) when compared to AL/CR and sham tDCS. Both active conditions suppressed the self-reported urge to binge-eat and increased self-regulatory control during a temporal discounting task. Compared to sham stimulation, mood (assessed with the Profile of Mood States) improved after AR/CL but not AL/CR tDCS. Lastly, the three tDCS sessions had comparable effects on the wanting/liking of food and on bulimic behaviours during the 24 hours post-stimulation. These data suggest that single-session tDCS transiently improves symptoms of BN. They also help to elucidate possible mechanisms of action and highlight the importance of selecting the optimal electrode montage. Multi-session trials are needed to determine whether tDCS has potential for development as a treatment for adult BN.

  19. A Review and Framework for Categorizing Current Research and Development in Health Related Geographical Information Systems (GIS) Studies.

    Science.gov (United States)

    Lyseen, A K; Nøhr, C; Sørensen, E M; Gudes, O; Geraghty, E M; Shaw, N T; Bivona-Tellez, C

    2014-08-15

    The application of GIS in health science has increased over the last decade and new innovative application areas have emerged. This study reviews the literature and builds a framework to provide a conceptual overview of the domain, and to promote strategic planning for further research of GIS in health. The framework is based on literature from the library databases Scopus and Web of Science. The articles were identified based on keywords and initially selected for further study based on titles and abstracts. A grounded theory-inspired method was applied to categorize the selected articles in main focus areas. Subsequent frequency analysis was performed on the identified articles in areas of infectious and non-infectious diseases and continent of origin. A total of 865 articles were included. Four conceptual domains within GIS in health sciences comprise the framework: spatial analysis of disease, spatial analysis of health service planning, public health, health technologies and tools. Frequency analysis by disease status and location show that malaria and schistosomiasis are the most commonly analyzed infectious diseases where cancer and asthma are the most frequently analyzed non-infectious diseases. Across categories, articles from North America predominate, and in the category of spatial analysis of diseases an equal number of studies concern Asia. Spatial analysis of diseases and health service planning are well-established research areas. The development of future technologies and new application areas for GIS and data-gathering technologies such as GPS, smartphones, remote sensing etc. will be nudging the research in GIS and health.

  20. Applications of the MapReduce programming framework to clinical big data analysis: current landscape and future trends.

    Science.gov (United States)

    Mohammed, Emad A; Far, Behrouz H; Naugler, Christopher

    2014-01-01

    The emergence of massive datasets in a clinical setting presents both challenges and opportunities in data storage and analysis. This so called "big data" challenges traditional analytic tools and will increasingly require novel solutions adapted from other fields. Advances in information and communication technology present the most viable solutions to big data analysis in terms of efficiency and scalability. It is vital those big data solutions are multithreaded and that data access approaches be precisely tailored to large volumes of semi-structured/unstructured data. THE MAPREDUCE PROGRAMMING FRAMEWORK USES TWO TASKS COMMON IN FUNCTIONAL PROGRAMMING: Map and Reduce. MapReduce is a new parallel processing framework and Hadoop is its open-source implementation on a single computing node or on clusters. Compared with existing parallel processing paradigms (e.g. grid computing and graphical processing unit (GPU)), MapReduce and Hadoop have two advantages: 1) fault-tolerant storage resulting in reliable data processing by replicating the computing tasks, and cloning the data chunks on different computing nodes across the computing cluster; 2) high-throughput data processing via a batch processing framework and the Hadoop distributed file system (HDFS). Data are stored in the HDFS and made available to the slave nodes for computation. In this paper, we review the existing applications of the MapReduce programming framework and its implementation platform Hadoop in clinical big data and related medical health informatics fields. The usage of MapReduce and Hadoop on a distributed system represents a significant advance in clinical big data processing and utilization, and opens up new opportunities in the emerging era of big data analytics. The objective of this paper is to summarize the state-of-the-art efforts in clinical big data analytics and highlight what might be needed to enhance the outcomes of clinical big data analytics tools. This paper is concluded by

  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. A Review and Framework for Categorizing Current Research and Development in Health Related Geographical Information Systems (GIS) Studies

    Science.gov (United States)

    Nøhr, C.; Sørensen, E. M.; Gudes, O.; Geraghty, E. M.; Shaw, N. T.; Bivona-Tellez, C.

    2014-01-01

    Summary Objectives The application of GIS in health science has increased over the last decade and new innovative application areas have emerged. This study reviews the literature and builds a framework to provide a conceptual overview of the domain, and to promote strategic planning for further research of GIS in health. Method The framework is based on literature from the library databases Scopus and Web of Science. The articles were identified based on keywords and initially selected for further study based on titles and abstracts. A grounded theory-inspired method was applied to categorize the selected articles in main focus areas. Subsequent frequency analysis was performed on the identified articles in areas of infectious and non-infectious diseases and continent of origin. Results A total of 865 articles were included. Four conceptual domains within GIS in health sciences comprise the framework: spatial analysis of disease, spatial analysis of health service planning, public health, health technologies and tools. Frequency analysis by disease status and location show that malaria and schistosomiasis are the most commonly analyzed infectious diseases where cancer and asthma are the most frequently analyzed non-infectious diseases. Across categories, articles from North America predominate, and in the category of spatial analysis of diseases an equal number of studies concern Asia. Conclusion Spatial analysis of diseases and health service planning are well-established research areas. The development of future technologies and new application areas for GIS and data-gathering technologies such as GPS, smartphones, remote sensing etc. will be nudging the research in GIS and health. PMID:25123730

  3. Integrating resource efficiency and EU State aid. An evaluation of resource efficiency considerations in the current EU State aid framework

    Energy Technology Data Exchange (ETDEWEB)

    Bennink, D.; Faber, J.; Smit, M. [CE Delft, Delft (Netherlands); Goba, V. [SIA Estonian, Latvian and Lithuanian Environment ELLE, Tallinn (Estonia); Miller, K.; Williams, E. [AEA Technology plc, London (United Kingdom)

    2012-10-15

    This study, for the European Commission, analyses the issues that need to be addressed in the revision of the EU State aid framework to ensure that they do not hinder environmental, resource efficiency and sustainable development goals. In some cases, State aid can be considered an environmentally harmful subsidy (EHS). The study analyses (1) the extent to which the Environmental Aid Guidelines (EAG) need to be changed to take into account recent European environmental policy developments; (2) existing and potential resource efficiency considerations in a) the Regional Aid Guidelines; b) the Research, Development and Innovation (RDI) Guidelines and c) the Agriculture and Forestry Guidelines; assesses cases and schemes using these guidelines to identify whether resource efficiency considerations are taken into account. The study also considers the social, environmental and economic impacts of these cases and schemes. It develops recommendations for the review of the EAG and a number of horizontal guidelines. One of the conclusions of the analysis is that the way in which multiple objectives and impacts are balanced, when deciding to approve state aid, is unclear. Also, EU member states are not required to provide information on certain types of (estimated) impacts. To guarantee that multiple objectives and impacts are sufficiently balanced, it is recommended that the State aid framework prescribes that applicants identify social, economic and environmental objectives and impacts and describe how these are taken into account in the procedure of balancing multiple (conflicting) objectives. Objectives and impacts should be quantified as much as possible, for example by making use of the method of external cost calculation laid down in 'the Handbook on estimation of external costs in the transport Sector'. The results of the study are used by the European Commission as an input for evaluating and improving the EU State aid framework.

  4. Integrating resource efficiency and EU State aid. An evaluation of resource efficiency considerations in the current EU State aid framework

    Energy Technology Data Exchange (ETDEWEB)

    Bennink, D.; Faber, J.; Smit, M. [CE Delft, Delft (Netherlands); Goba, V. [SIA Estonian, Latvian and Lithuanian Environment ELLE, Tallinn (Estonia); Miller, K.; Williams, E. [AEA Technology plc, London (United Kingdom)

    2012-10-15

    This study, for the European Commission, analyses the issues that need to be addressed in the revision of the EU State aid framework to ensure that they do not hinder environmental, resource efficiency and sustainable development goals. In some cases, State aid can be considered an environmentally harmful subsidy (EHS). The study analyses (1) the extent to which the Environmental Aid Guidelines (EAG) need to be changed to take into account recent European environmental policy developments; (2) existing and potential resource efficiency considerations in a) the Regional Aid Guidelines; b) the Research, Development and Innovation (RDI) Guidelines and c) the Agriculture and Forestry Guidelines; assesses cases and schemes using these guidelines to identify whether resource efficiency considerations are taken into account. The study also considers the social, environmental and economic impacts of these cases and schemes. It develops recommendations for the review of the EAG and a number of horizontal guidelines. One of the conclusions of the analysis is that the way in which multiple objectives and impacts are balanced, when deciding to approve state aid, is unclear. Also, EU member states are not required to provide information on certain types of (estimated) impacts. To guarantee that multiple objectives and impacts are sufficiently balanced, it is recommended that the State aid framework prescribes that applicants identify social, economic and environmental objectives and impacts and describe how these are taken into account in the procedure of balancing multiple (conflicting) objectives. Objectives and impacts should be quantified as much as possible, for example by making use of the method of external cost calculation laid down in 'the Handbook on estimation of external costs in the transport Sector'. The results of the study are used by the European Commission as an input for evaluating and improving the EU State aid framework.

  5. 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.

  6. A review of legal framework applicable for the management of healthcare waste and current management practices in Ethiopia.

    Science.gov (United States)

    Haylamicheal, Israel Deneke; Desalegne, Solomon Akalu

    2012-06-01

    The management of healthcare waste (HCW) requires special attention due to the risk posed by the presence of hazardous waste. The first step towards this is the issuance of national legislation complemented by policy documents, regulations and technical guidelines. In Ethiopia there is no specific legislation for healthcare waste management (HCWM). However, there are various legislations which may provide a legal framework for the management of HCW. This review assesses the various legislations that are relevant to HCWM. It also looks into the institutional arrangements put in place and waste management practices that prevail in the country. It was found that, although the existing legislations have provisions that may provide a legal framework for the management of HCW in Ethiopia, they are not comprehensive and lack specificity in terms of defining hazardous HCW and its categories; in indicating legal obligations of healthcare facilities (HCFs) in handling, transporting, treating and disposing HCW, and record keeping and reporting. There is overlapping of mandates and lackof co-ordination among various government institutions that are responsible for HCWM. The HCWM practices also do not conform to the principles of waste management in general and HCWM in particular. Thus, to better manage HCW in Ethiopia, a specific and comprehensive legislation and policy document on HCWM with clear designation of responsibilities to various stakeholders should be issued immediately. Moreover, training and awareness raising activities on proper HCWM should be undertaken targeting medical staffs, HCF administrators, waste handlers, policy and decision makers and the general public.

  7. Current insights into the molecular systems pharmacology of lncRNA-miRNA regulatory interactions and implications in cancer translational medicine

    Directory of Open Access Journals (Sweden)

    Sujit Nair

    2016-04-01

    Full Text Available In recent times, the role(s of microRNAs (miRNAs and long noncoding RNAs (lncRNAs in the pathogenesis of various cancers has received great attention. Indeed, there is also a growing recognition of regulatory RNA cross-talk, i.e., lncRNA-miRNA interactions, that may modulate various events in carcinogenesis and progression to metastasis. This review summarizes current evidence in the literature of lncRNA-miRNA interactions in various cancers such as breast, liver, stomach, lung, prostate, bladder, colorectal, blood, brain, skin, kidney, cervical, laryngeal, gall bladder, and bone. Further, the potential prognostic and theragnostic clinical applications of lncRNA-miRNA interactions in cancer are discussed along with an overview of noncoding RNA (ncRNA-based studies that were presented at the American Society of Clinical Oncology (ASCO 2015. Interestingly, the last decade has seen tremendous innovation, as well as increase in complexity, of the cancer biological network(s from mRNA- to miRNA- and lncRNA-based networks. Thus, biological networks devoted to understanding regulatory interactions between these ncRNAs would be the next frontier in better elucidating the contributions of lncRNA-miRNA interactions in cancer. Herein, a cancer biological network of lncRNA-miRNA interactions is presented wherein “edges” connect interacting lncRNA-miRNA pairs, with each ncRNA serving as a discrete “node” of the network. In conclusion, the untapped potential of lncRNA-miRNA interactions in terms of its diagnostic, prognostic and therapeutic potential as targets for clinically actionable intervention as well as biomarker validation in discovery pipelines remains to be explored. Future research will likely harness this potential so as to take us closer to the goal of “precision” and “personalized medicine” which is tailor-made to the unique needs of each cancer patient, and is clearly the way forward going into the future.

  8. 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)

  9. 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.

  10. Current medical research funding and frameworks are insufficient to address the health risks of global environmental change.

    Science.gov (United States)

    Ebi, Kristie L; Semenza, Jan C; Rocklöv, Joacim

    2016-11-11

    Three major international agreements signed in 2015 are key milestones for transitioning to more sustainable and resilient societies: the UN 2030 Agenda for Sustainable Development; the Sendai Framework for Disaster Risk Reduction; and the Paris Agreement under the United Nations Framework Convention on Climate Change. Together, these agreements underscore the critical importance of understanding and managing the health risks of global changes, to ensure continued population health improvements in the face of significant social and environmental change over this century. BODY: Funding priorities of major health institutions and organizations in the U.S. and Europe do not match research investments with needs to inform implementation of these international agreements. In the U.S., the National Institutes of Health commit 0.025 % of their annual research budget to climate change and health. The European Union Seventh Framework Programme committed 0.08 % of the total budget to climate change and health; the amount committed under Horizon 2020 was 0.04 % of the budget. Two issues apparently contributing to this mismatch are viewing climate change primarily as an environmental problem, and therefore the responsibility of other research streams; and narrowly framing research into managing the health risks of climate variability and change from the perspective of medicine and traditional public health. This reductionist, top-down perspective focuses on proximate, individual level risk factors. While highly successful in reducing disease burdens, this framing is insufficient to protect health and well-being over a century that will be characterized by profound social and environmental changes. International commitments in 2015 underscored the significant challenges societies will face this century from climate change and other global changes. However, the low priority placed on understanding and managing the associated health risks by national and international research

  11. 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

  12. Developing a regulatory framework for the financial, management performance and social reporting systems for co-operatives in developing countries: A case study of South Africa

    Directory of Open Access Journals (Sweden)

    Gideon Nieman

    2016-08-01

    Findings: The research performed showed that existing reporting frameworks and practices do not meet the reporting requirements of co-operatives in all aspects because of the different nature of co-operatives as opposed to shareholder-owned entities.

  13. Current status and results of the PBMR -Pebble Box- benchmark within the framework of the IAEA CRP5 - 341

    International Nuclear Information System (INIS)

    Reitsma, F.; Tyobeka, B.

    2010-01-01

    The verification and validation of computer codes used in the analysis of high temperature gas cooled pebble bed reactor systems has not been an easy goal to achieve. A limited amount of tests and operating reactor measurements are available. Code-to-code comparisons for realistic pebble bed reactor designs often exhibit differences that are difficult to explain and are often blamed on the complexity of the core models or the variety of analysis methods and cross section data sets employed. For this reason, within the framework of the IAEA CRP5, the 'Pebble Box' benchmark was formulated as a simple way to compare various treatments of neutronics phenomena. The problem is comprised of six test cases which were designed to investigate the treatments and effects of leakage and heterogeneity. This paper presents the preliminary results of the benchmark exercise as received during the CRP and suggests possible future steps towards the resolution of discrepancies between the results. Although few participants took part in the benchmarking exercise, the results presented here show that there is still a need for further evaluation and in-depth understanding in order to build the confidence that all the different methods, codes and cross-section data sets have the capability to handle the various neutronics effects for such systems. (authors)

  14. Risk Factors for Falls in Older Adults with Lower Extremity Arthritis: A Conceptual Framework of Current Knowledge and Future Directions

    Science.gov (United States)

    Gyurcsik, Nancy C.

    2012-01-01

    ABSTRACT Purpose: As the numbers of Canadians aged 65 years and over increases over the next 20 years, the prevalence of chronic conditions, including arthritis, will rise as will the number of falls. Although known fall-risk factors are associated with hip and knee osteoarthritis (OA), minimal research has evaluated fall and fracture risk and/or rates in this population. Thus, the purpose was to summarize research on fall and fracture risk in older adults with hip or knee OA and to develop a conceptual framework of fall-risk screening and assessment. Method: The International Classification of Functioning, Disability and Health, clinical practice guidelines for fall-risk screening, and a selected literature review were used. Results: Gaps exist in our knowledge of fall and fracture risk for this population. Muscle performance, balance, and mobility impairments have been identified, but little is known about whether personal and environmental contextual factors impact fall and fracture risk. Physical activity may help to prevent falls, but non-adherence is a problem. Conclusion: A need exists to assess fall risk in older adults with hip and knee OA. Promoting regular physical activity by focusing on disease- and activity-specific personal contextual factors may help direct treatment planning. PMID:23729967

  15. Elements to evaluate the intention in the non-compliance s or violations to the regulatory framework in the national nuclear facilities; Elementos para evaluar la intencionalidad en los incumplimientos o violaciones al marco regulador en las instalaciones nucleares nacionales

    Energy Technology Data Exchange (ETDEWEB)

    Espinosa V, J. M.; Gonzalez V, J. A., E-mail: jmespinosa@cnsns.gob.mx [Comision Nacional de Seguridad Nuclear y Salvaguardias, Dr. Jose Ma. Barragan No. 779, Col. Narvarte, 03020 Mexico D. F. (Mexico)

    2013-10-15

    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

  16. 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.

  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 activities

    International Nuclear Information System (INIS)

    2001-01-01

    This publication, compiled in 8 chapters, presents the regulatory system developed by the Nuclear Regulatory Authority (NRA) of the Argentine Republic. The following activities and developed topics in this document describe: the evolution of the nuclear regulatory activity in Argentina; the Argentine regulatory system; the nuclear regulatory laws and standards; the inspection and safeguards of nuclear facilities; the emergency systems; the environmental systems; the environmental monitoring; the analysis laboratories on physical and biological dosimetry, prenatal irradiation, internal irradiation, radiation measurements, detection techniques on nuclear testing, medical program on radiation protection; the institutional relations with national and international organization; the training courses and meeting; the technical information

  19. 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)

  20. 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)

  1. 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...

  2. 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

  3. The current status of the debate on socio-economic regulatory assessments: positions and policies in Canada, the USA, the EU and developing countries

    NARCIS (Netherlands)

    Falck-Zepeda, J.; Wesseler, J.H.H.; Smyth, S.

    2013-01-01

    Article 26.1 of the Cartagena Protocol on Biosafety has the option of considering socio-economic issues in biosafety regulatory approval processes related to genetically engineered organisms. National laws and regulations in some countries have already defined positions and may have enacted policies

  4. Alterations in the regulatory volume decrease (RVD) and swelling-activated Cl- current associated with neuroendocrine differentiation of prostate cancer epithelial cells.

    NARCIS (Netherlands)

    Lemonnier, L.; Lazarenko, R.; Shuba, Y.; Thebault, S.C.; Roudbaraki, M.; Lepage, G.; Prevarskaya, N.; Skryma, R.

    2005-01-01

    Neuroendocrine (NE) differentiation of prostate epithelial/basal cells is a hallmark of advanced, androgen-independent prostate cancer, for which there is no successful therapy. Here we report for the first time on alterations in regulatory volume decrease (RVD) and its key determinant,

  5. Allergic contact dermatitis: epidemiology, molecular mechanisms, in vitro methods and regulatory aspects : Current knowledge assembled at an international workshop at BfR, Germany

    DEFF Research Database (Denmark)

    Peiser, M; Tralau, T; Heidler, J

    2012-01-01

    potential contact allergens. However, the local lymph node assay (LLNA) presently remains the validated method of choice for hazard identification and characterisation. At the workshop the use of the LLNA for regulatory purposes and for quantitative risk assessment was also discussed....

  6. From great expectations to an even greater failure - the case of Montenegrin regulatory framework on shareholder derivative suits as an incentive for rethinking the concept itself

    Directory of Open Access Journals (Sweden)

    Vladimir Savković

    2016-12-01

    Full Text Available The author utilizes a case study of Montenegrin regulatory concept of shareholder derivative suits in order to demonstrate, by comparing its features with such concepts in other legal systems and features marked as favorable factors in legal theory, that its failure, as well as the failure of derivative suits in other countries cannot be a priori considered as result of inadequate approach of the legislator. Along with some other important legal systems, shareholder derivative litigation in United States is also analyzed, since its track record shows that it is virtually the single at least relatively successful system of derivative suits so far. This analysis is made so as to distinguish the particular and in many ways unique features of the shareholder derivative litigation concept in United States that enabled the relative success of it. As result of the research conducted and analyses made, the author argues that there is an inherent flaw in the very foundation of the concept of shareholder derivative suits, which generally hinders the use of this legal mechanism. Finally, the author finds that this flaw is deeply rooted in what is known today in theory of company law as the first agency problem.

  7. A comparative analysis of drug safety withdrawals in the UK and the US (1971-1992): implications for current regulatory thinking and policy.

    Science.gov (United States)

    Abraham, John; Davis, Courtney

    2005-09-01

    By going beyond individual case studies and solely quantitative surveys, this paper systematically examines why there were over twice as many new prescription drugs withdrawn from the market on grounds of safety in the UK as there were in the US between 1971 and 1992. Drawing on interviews with regulators, industry scientists and others involved, and on regulatory data never before accessed outside governments and companies, five key hypotheses which might explain this difference in drug safety withdrawals are analysed. These are: (1) simply because the UK approved more new drugs than the US; (2) because of an industrial corporate strategy to seek approval of 'less safe' drugs in the UK earlier; (3) because British regulators were more vigilant at spotting post-marketing safety problems than their US counterparts; (4) because the slowness of the US in approving new drugs enabled regulators there to learn from, and avoid, safety problems that had already emerged in the UK or European market; and (5) because more stringent regulation in the US meant that they approved fewer unsafe drugs on to the market in the first place. It is concluded that the main explanation for fewer drug safety withdrawals in the US is that the regulatory agency there applied more stringent pre-market review and/or standards, which took longer than UK regulatory checks, but prevented unsafe drugs marketed in the UK from entering the US market. Contrary to the claims frequently made by the pharmaceutical industry and regulatory agencies on both sides of the Atlantic, these results imply that it is likely that acceleration of regulatory review times in the US and the UK since the early 1990s is compromising drug safety.

  8. 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.

  9. 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

  10. AN ANALYTICAL ANALYSIS OF THE CURRENT ACCOUNT BALANCE IN THE FRAMEWORK OF OPTIMAL EXTERNAL BORROWING: APPLICATION TO TURKEY FOR THE POST 1995 PERIOD

    Directory of Open Access Journals (Sweden)

    A.NİYAZİ ÖZKER

    2013-06-01

    Full Text Available After placing the general analytic framework associated with widely used quantitative macro indicators, this paper aims to analyse the fluctuating variables which can be influenced by the current accounts balance in the optimum external borrowing. The capacity of a country to service external debt depends on the growth of output and of exports and imports. Exports, minimum tolerable level of imports and foreign exchange rates (or reserves provide a useful framework for the examination of optimum external borrowing. So, the most widely used quantitative indicator here is the optimum external debt ratios, which is the ratios of debt service to the level of exports of goods and services. As a suggested, indicator of the optimum external debt burden in the medium-term or in the long run, the ratio of external debt to GNP (Gross National Product or of debt service to GNP may be superior to the ratio of debt service to exports because over time sizeable changes in the level of exports and imports in GNP can occur.

  11. Privacy for the Homo digitalis : Proposal for a new regulatory framework for data protection in the light of big data and the internet of things

    NARCIS (Netherlands)

    Prins, Corien; Moerel, Lokke

    The authors analyze innovations in data processing as a result of developments such as 'big data' and the 'Internet of Things' and discuss why these developments undermine the effectiveness and legitimacy of the current as well as upcoming EU data protection regime, thereby focusing on the private

  12. 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....

  13. Assessment on regulatory framework for safety of radioactive waste management as preparation for future NPP in Indonesia; a comparison study with South Korea

    International Nuclear Information System (INIS)

    Setianingsih, Lilis Susanti; Jeong, Seung Young

    2012-01-01

    information regarding natural radioactive sources downhole in oil and gas exploration and exploitation. Tracer is another type of nuclear energy utilization in industrial facilities. Tracer is operated by utilizing radioactive source attached to the system to follow the behavior pathway of one or more components of the particular system. It is used to detect easily and clearly on low concentration radioactive level of the system, as well as to detect and take samples without destroying the active system. Number of total radioactive and/or nuclear facilities for industrial purposes in Indonesia tends to be increasing as the implementation is getting wider. One of the nuclear authorities in Indonesia is the Nuclear Regulatory Agency (BAPETEN) which on behalf of the government grants the licenses to the respective facilities and monitors the regulation implementation on the facilities to ensure the safety, security and safeguard for the purpose providing protection to the people, property and environment. Considering the wide use of nuclear energy application and implementation in industrial purposes facilities, qualified human resources for controlling the law enforcement to ensure the proper standards of safety and security including the management of the waste generated by various nuclear energy utilization. Wide progressive demands of electricity for the future give challenges to the government to meet the projected needs of energy to be fulfilled. One of the options which can be considered reasonable in answering such problem to provide the high request of energy is by building nuclear power plant. Understanding the much wider use of nuclear energy implementation within the country, nuclear and radioactive waste facilities need to be developed in meeting the capacity required for prospective requirements

  14. Assessment on regulatory framework for safety of radioactive waste management as preparation for future NPP in Indonesia; a comparison study with South Korea

    Energy Technology Data Exchange (ETDEWEB)

    Setianingsih, Lilis Susanti [KAIST, Daejeon (Korea, Republic of); Jeong, Seung Young [KINS, Daejeon (Korea, Republic of)

    2012-10-15

    information regarding natural radioactive sources downhole in oil and gas exploration and exploitation. Tracer is another type of nuclear energy utilization in industrial facilities. Tracer is operated by utilizing radioactive source attached to the system to follow the behavior pathway of one or more components of the particular system. It is used to detect easily and clearly on low concentration radioactive level of the system, as well as to detect and take samples without destroying the active system. Number of total radioactive and/or nuclear facilities for industrial purposes in Indonesia tends to be increasing as the implementation is getting wider. One of the nuclear authorities in Indonesia is the Nuclear Regulatory Agency (BAPETEN) which on behalf of the government grants the licenses to the respective facilities and monitors the regulation implementation on the facilities to ensure the safety, security and safeguard for the purpose providing protection to the people, property and environment. Considering the wide use of nuclear energy application and implementation in industrial purposes facilities, qualified human resources for controlling the law enforcement to ensure the proper standards of safety and security including the management of the waste generated by various nuclear energy utilization. Wide progressive demands of electricity for the future give challenges to the government to meet the projected needs of energy to be fulfilled. One of the options which can be considered reasonable in answering such problem to provide the high request of energy is by building nuclear power plant. Understanding the much wider use of nuclear energy implementation within the country, nuclear and radioactive waste facilities need to be developed in meeting the capacity required for prospective requirements.

  15. Biofuels and regulatory framework: recent developments and key technological routes; Biocombustiveis e marco regulatorio: evolucao recente e as principais rotas tecnologicas

    Energy Technology Data Exchange (ETDEWEB)

    Berni, Mauro Donizeti [Universidade Estadual de Campinas (NIPE/UNICAMP), SP (Brazil). Nucleo Interdisciplinar de Planejamento Energetico], e-mail: mauro_berni@yahoo.com.br; Guerra, Sinclair M. Guy , [Universidade Federal do ABC (CECS/UFABC), Santo Andre, SP (Brazil). Centro de Engenharia, Modelagem e Ciencias Sociais Aplicadas

    2008-07-01

    The excessive dependence of energy of the current societies, and the growing concern with the potentials associated climate change motivate the implementation of energy systems with base in resources of renewable energy. Climate change is the greatest environmental challenge the world is facing today. Rising global temperatures will bring changes in weather patterns, rising sea levels and increased frequency and intensity of extreme weather events. The effects will be felt here in Brazil; internationally there may be severe problems for people in regions that are particularly vulnerable. Brazil with experience in the bio fuels production can participate as a supplier of new technology for his production, at world level. This work, shows the recent evolution of the regulation for the bio fuels in Brazil, as well as their main ones routes technology, and it indicates the possible alternatives to guarantee the sustainability for the production and use. (author)

  16. Role of the North Sea power transmission in realising the 2020 renewable energy targets. Planning and permitting challenges: a deliverable from WP 4 regulatory framework

    Energy Technology Data Exchange (ETDEWEB)

    Kielland, Jens Jacob; Ruud, Audun

    2012-07-01

    This study explores and assesses challenges for the European permitting and planning system with regard to grid development in the North Sea. The following question is discussed: What planning and permitting challenges can influence the realization of an offshore grid in the North Sea? This is answered by referring to the political context of the North Sea and the development of an offshore grid therein. We present the main features of the proposed regulation by the European Commission (COM(2011)658) that will, if it is adapted, impact current grid permitting procedures. Further, key supranational planning tools for offshore grid development are accounted for and the proposed EU measures are discussed with reference to relevant studies on planning and permitting procedures of realizing electricity grids. Finally, the report provides the general findings and conclusions. (Author)

  17. 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)

  18. Two consecutive large outbreaks of Salmonella Muenchen linked to pig farming in Germany, 2013 to 2014: Is something missing in our regulatory framework?

    Science.gov (United States)

    Schielke, Anika; Rabsch, Wolfgang; Prager, Rita; Simon, Sandra; Fruth, Angelika; Helling, Rüdiger; Schnabel, Martin; Siffczyk, Claudia; Wieczorek, Sina; Schroeder, Sabine; Ahrens, Beate; Oppermann, Hanna; Pfeiffer, Stefan; Merbecks, Sophie Susann; Rosner, Bettina; Frank, Christina; Weiser, Armin A; Luber, Petra; Gilsdorf, Andreas; Stark, Klaus; Werber, Dirk

    2017-05-04

    In 2013, raw pork was the suspected vehicle of a large outbreak (n = 203 cases) of Salmonella Muenchen in the German federal state of Saxony. In 2014, we investigated an outbreak (n = 247 cases) caused by the same serovar affecting Saxony and three further federal states in the eastern part of Germany. Evidence from epidemiological, microbiological and trace-back investigations strongly implicated different raw pork products as outbreak vehicles. Trace-back analysis of S. Muenchen-contaminated raw pork sausages narrowed the possible source down to 54 pig farms, and S. Muenchen was detected in three of them, which traded animals with each other. One of these farms had already been the suspected source of the 2013 outbreak. S. Muenchen isolates from stool of patients in 2013 and 2014 as well as from food and environmental surface swabs of the three pig farms shared indistinguishable pulsed-field gel electrophoresis patterns. Our results indicate a common source of both outbreaks in the primary production of pigs. Current European regulations do not make provisions for Salmonella control measures on pig farms that have been involved in human disease outbreaks. In order to prevent future outbreaks, legislators should consider tightening regulations for Salmonella control in causative primary production settings. This article is copyright of The Authors, 2017.

  19. 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.

  20. 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.

  1. 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)

  2. The economics of renewable electricity market integration. An empirical and model-based analysis of regulatory frameworks and their impacts on the power market

    Energy Technology Data Exchange (ETDEWEB)

    Nicolosi, Marco

    2012-07-01

    As power systems increase in complexity due to higher shares of intermitting RES-E, so increase the requirements for power system modeling. This thesis shows empirically, with examples from Germany and Texas, that the increasing RES-E share strongly affects current power market operation. The markets further create price signals, which lead to system adaptations in the long-run. To get an estimate of the adaptation effects, 'The High Temporal Resolution Electricity Market Analysis Model' (THEA) has been developed. In a first application for the ERCOT market in Texas, particular model attributes are tested and compared to some complexity reducing approaches, i.e. the reduction of temporal resolution and the reduction of operational constraints. In both cases, the results show significant differences compared to the results when the full spectrum of THEA's capabilities is utilized. The ERCOT case study additionally shows that the adaptation to RES-E in an isolated, mainly thermal-based power system is quite severe. Market signals which underline this conclusion are the severely reduced value of wind energy, the increasing curtailment and the strong shift towards peak-oriented generating capacities. The second application of THEA models the German power market with its interconnected markets. This analysis increases the complexity significantly by modeling a well interconnected system, increasing the amount of different RES-E technologies and adding CAES investment options. In order to assess the impact on the different system component's supply, demand and grid infrastructure, specific measures are applied to compare several scenarios. Each scenario represents a policy option, which either reduces or increases the flexibility of the power system. The scenario comparisons capture the effects of a lower RES-E share, a larger baseload capacity fleet, higher interconnector capacities, various RES-E support scheme designs and the capability of RES-E to

  3. 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

  4. 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.

  5. What incentives to climate change mitigation through harvested wood products in the current french policy framework? (Summary). Climate Report no. 47

    International Nuclear Information System (INIS)

    Deheza, Mariana; N'Goran, Carmen; Bellassen, Valentin

    2014-09-01

    Beyond the important role that forests play in the fight against climate change through the sequestration of carbon in their biomass, wood products also contribute to climate change through three channels: - Material substitution: the manufacturing of wood products being less energy intensive allows to avoid carbon emissions from the processing of other alternative materials (eg. concrete, steel, etc); - Energy substitution: achieved by the generation of energy from wood combustion replacing other fossil fuels. - Carbon sequestration in the wood products: wood products sequester carbon during their whole life span until their decomposition. This Climate Report identifies French policies that have an impact on climate change mitigation by wood products through these three mitigation channels. Our analysis asserts that similarly to the context at the EU level, the current national policy framework incentives are mostly directed to the 'energy wood' sector. These incentives include fiscal and financial instruments such as: - The heat fund ('fonds chaleur'), which subsidizes the production of renewable heat particularly from biomass; - The zero interest rate eco-loans ('eco-pret a taux zero') and the Sustainable development tax credit ('credit d'impot developpement durable (CIDD)') which partly subsidize wood heating; - Reduced VAT on renewable heat purchases. The use of wood as a material is currently less encouraged, at least on the financial side: the few devices that support it are rarely binding and mobilize limited resources. Future measures planned under the National Action Plan for the forest-based sector and the upcoming law for the future of agriculture and forestry ('Loi d'avenir pour l'agriculture et la foret') could slightly re-balance this situation. (authors)

  6. 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.

  7. 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

  8. Legal and regulatory framework of Uranium's enrichment

    International Nuclear Information System (INIS)

    Antelo, Josefina; Figueredo, Micaela S.; Mangone, Gisela P.; Manin, Maria L.; Pota, Luciana F.

    2009-01-01

    The object of this paper is to develop the legal aspects referred to the activities of uranium's enrichment, in order to achieve the pacific use of nuclear energy and to obey treatments, agreements and international conventions in which Argentine is party and through them assumes the non proliferation's commitment. In this context, we will develop the rights and obligations established in those legal instruments, as well as the juridical concerns of the eventual subscription of Argentine to the Additional Protocol approved by the Board of Governors in 1997. (author)

  9. Pharmaceutical Regulatory Framework in Ethiopia: A Critical ...

    African Journals Online (AJOL)

    This legislation formed the legal basis for official establishment of drug regulation in the history of Ethiopia, enabling the regulation of the practice of pharmacists, druggists and pharmacy technicians; manufacturing, distribution, and sale of medicines. In June 1999, a new regulation called the “Drug Administration and ...

  10. Carbon Capture and Storage: Model Regulatory Framework

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2010-07-01

    Energy-related carbon dioxide (CO2) emissions are set to double by 2050 unless decisive action is taken. International Energy Agency (IEA) analysis demonstrates, however, that it is possible -- in the same timeframe to 2050 -- to reduce projected greenhouse-gas emissions to half 2005 levels, but this will require an energy technology revolution, involving the aggressive deployment of a portfolio of low-carbon energy technologies.

  11. General description of the national regulatory framework

    International Nuclear Information System (INIS)

    Basurto C, J.

    2008-12-01

    Of the six existing hierarchy in the Mexican legal system, the first five of the Constitution of the Mexican Official Norms have a binding character, containing mandatory requirements to meet, while the sixth is not binding. The articles that have nuclear subject in the Mexican Constitution are 25, 27 and 28. At the same hierarchical level as the Constitution is the international treaties signed and ratified by our country, such as for example the Nuclear Safety Convention or the Convention on the Nuclear Materials Physical Protection. For the treaties negotiation process consists of a text adoption, the authentication which implies the final content signature and unalterable, the Senate approval and the consent submission, which implies the ratification and publication in the Federation Official Gazette. In the case of Mexican laws your proposition process includes an initiative, the analysis of the relevant committee, the discussion, approval, sanction, and with it the publication of the initiation force. The road can become very convoluted because some steps are recurrent, returning to the same level several times. Regulations whose purpose is to clarify, develop or explain the general principles contained in the laws that relate to more obtainable your application are subject to a similarly complicated process. First we developed a preliminary draft by the competent authority subject to revision and opinion of the respective institutions prior to submission to the Federal Executive. The final document is submitted to the latter project, which must be approved by the agencies involved, approved by the Federal Executive and finally published in the Federation Official Gazette, from which it launched its application. (Author)

  12. European Regulatory Framework for Money Market Funds

    OpenAIRE

    Portuese, Aurelien; MacNeil, Iain

    2014-01-01

    Money market funds are widely used by all types of investors, including households, corporate treasurers, pension funds, or insurance companies, who regard money market funds as a ‘safe’ short-term liquid asset class for investing cash. In this case they are proxies to cash deposits. Money market funds are themselves key lenders to issuers of short dated high quality money market instruments. They provide an important source of funding for a variety of institutions such as sovereigns, banks, ...

  13. Regulatory and institutional framework for nuclear activities

    International Nuclear Information System (INIS)

    1996-01-01

    This study is part of a series of analytical studies on nuclear legislation in OECD Member countries, prepared with the co-operation of the countries concerned. Each study has been organised on the basis of a standardised format for all countries, thus facilitating the comparison of information. The studies are intended to be updated periodically, taking into account modifications to the nuclear legislation in each country. This is the first update to the 1995 Edition. Unfortunately, due to the constraints of the OECD Publications Service, it covers only those legislative and institutional changes which, in our view, are of the greatest significance for our readers. Thus, you will find new chapters on Finland, Greece, Italy, Japan, Mexico, the Netherlands, Portugal and the United States. Changes to the nuclear legislation and institutions of the remaining countries will be incorporated into the next Update which is expected to be published at the end of 1997. (author)

  14. 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....

  15. 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.

  16. 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

  17. 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.

  18. 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

  19. 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.

  20. 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)

  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. Regulatory Anatomy

    DEFF Research Database (Denmark)

    Hoeyer, Klaus

    2015-01-01

    This article proposes the term “safety logics” to understand attempts within the European Union (EU) to harmonize member state legislation to ensure a safe and stable supply of human biological material for transplants and transfusions. With safety logics, I refer to assemblages of discourses, le...... they arise. In short, I expose the regulatory anatomy of the policy landscape....

  3. A review of the UK methodology used for monitoring cigarette smoke yields, aspects of analytical data variability and their impact on current and future regulatory compliance.

    Science.gov (United States)

    Purkis, Stephen W; Drake, Linda; Meger, Michael; Mariner, Derek C

    2010-04-01

    The European Union (EU) requires that tobacco products are regulated by Directive 2001/37/EC through testing and verification of results on the basis of standards developed by the International Organization for Standardization (ISO). In 2007, the European Commission provided guidance to EU Member States by issuing criteria for competent laboratories which includes accreditation to ISO 17025:2005. Another criterion requires regular laboratory participation in collaborative studies that predict the measurement tolerance that must be observed to conclude that test results on any particular product are different. However, differences will always occur when comparing overall data across products between different laboratories. A forum for technical discussion between laboratories testing products as they are manufactured and a Government appointed verification laboratory gives transparency, ensures consistency and reduces apparent compliance issues to the benefit of all parties. More than 30years ago, such a forum was set up in the UK that continued until 2007 and will be described in this document. Anticipating further testing requirements in future product regulation as proposed by the Framework Convention on Tobacco Control, cooperation between accredited laboratories, whether for testing or verification, should be established to share know-how, to ensure a standardised level of quality and to offer competent technical dialogue in the best interest of regulators and manufacturers alike. Copyright 2009 Elsevier Inc. All rights reserved.

  4. 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.)

  5. The Framework for an Information Technology Strategic Roadmap for the United States Marine Corps: How Current Acquisitions Align to the Current Strategic Direction of the Department of Defense, Department of the Navy, and United States Marine Corps

    National Research Council Canada - National Science Library

    Garcia, Richard D; Sloan, Joshua K

    2008-01-01

    ... (IT) roadmap may comprise a "tipping point" for future warfighting effectiveness. This thesis begins the basis for a framework for an information technology strategic roadmap for the United States Marine Corps...

  6. 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...

  7. 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

  8. An Investigation into the Accuracy of Two Currently Available Dental Impression Materials in the Construction of Cobalt-Chromium Frameworks for Removable Partial Dentures.

    Science.gov (United States)

    Dubal, Rajesh Kumar; Friel, Tim; Taylor, Philip D

    2015-03-01

    This study investigated the suitability of irreversible hydrocolloid as an impression material for cobalt-chromium framework construction. Scans of casts derived from (1) alginate and (2) addition-cured polyvinylsiloxane impressions were superposed on to a control. The differences within and between groups were compared at fixed landmarks. The investigation revealed a high degree of scan coincidence within and between groups. However, certain features, such as undercuts, resulted in a lower degree of scan coincidence. Irreversible hydrocolloid appears to be a viable alternative to addition-cured polyvinyl-siloxane as an impression material for cobalt-chromium framework construction.

  9. 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

  10. 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.

  11. 基于新监管框架的中国股权众筹的“热发展”与“冷思考”%The"Rapid Development"and"Deep Thinking"on China's Equity-Based Crowdfunding under the New Regulatory Framework

    Institute of Scientific and Technical Information of China (English)

    彭红枫; 赵海燕

    2016-01-01

    Based on the development characteristics and the current situation of China's equity-based crowdfund-ing, this article not only verifies the development feasibilities of equity-based crowdfunding in China from four per-spectives including the policy environment, economic environment, social environment and technological environ-ment, with the help of PEST analysis, but also explores the breakthroughs for the development of China's equity-based crowdfunding under the new regulatory framework through learning from the experience of the development of foreign crowdfunding in UK and US. It suggests that we should make clear the market orientation,simplify the financ-ing procedure, reduce the financing restraints, improve the after-financing management mechanism and focus on the mode innovation.%本文立足于股权众筹在中国的发展特征、现状的基础上,运用PEST分析法从政策环境、经济环境、社会环境和技术环境四个角度证实了中国具备股权众筹发展的可行性,而且通过研究英美股权众筹的发展经验来寻找新监管框架下中国股权众筹的发展突破口,提出明确市场定位、简化融资流程且减少融资约束、完善融后管理机制、注重模式创新等建议。

  12. 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)

  13. 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

  14. 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...

  15. 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.

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  1. 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.

  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. 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

  4. 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)

  5. Regulatory Physiology

    Science.gov (United States)

    Lane, Helen W.; Whitson, Peggy A.; Putcha, Lakshmi; Baker, Ellen; Smith, Scott M.; Stewart, Karen; Gretebeck, Randall; Nimmagudda, R. R.; Schoeller, Dale A.; Davis-Street, Janis

    1999-01-01

    As noted elsewhere in this report, a central goal of the Extended Duration Orbiter Medical Project (EDOMP) was to ensure that cardiovascular and muscle function were adequate to perform an emergency egress after 16 days of spaceflight. The goals of the Regulatory Physiology component of the EDOMP were to identify and subsequently ameliorate those biochemical and nutritional factors that deplete physiological reserves or increase risk for disease, and to facilitate the development of effective muscle, exercise, and cardiovascular countermeasures. The component investigations designed to meet these goals focused on biochemical and physiological aspects of nutrition and metabolism, the risk of renal (kidney) stone formation, gastrointestinal function, and sleep in space. Investigations involved both ground-based protocols to validate proposed methods and flight studies to test those methods. Two hardware tests were also completed.

  6. Regulatory Benchmarking

    DEFF Research Database (Denmark)

    Agrell, Per J.; Bogetoft, Peter

    2017-01-01

    Benchmarking methods, and in particular Data Envelopment Analysis (DEA), have become well-established and informative tools for economic regulation. DEA is now routinely used by European regulators to set reasonable revenue caps for energy transmission and distribution system operators. The appli......Benchmarking methods, and in particular Data Envelopment Analysis (DEA), have become well-established and informative tools for economic regulation. DEA is now routinely used by European regulators to set reasonable revenue caps for energy transmission and distribution system operators....... The application of bench-marking in regulation, however, requires specific steps in terms of data validation, model specification and outlier detection that are not systematically documented in open publications, leading to discussions about regulatory stability and economic feasibility of these techniques...

  7. Regulatory Benchmarking

    DEFF Research Database (Denmark)

    Agrell, Per J.; Bogetoft, Peter

    2017-01-01

    Benchmarking methods, and in particular Data Envelopment Analysis (DEA), have become well-established and informative tools for economic regulation. DEA is now routinely used by European regulators to set reasonable revenue caps for energy transmission and distribution system operators. The appli......Benchmarking methods, and in particular Data Envelopment Analysis (DEA), have become well-established and informative tools for economic regulation. DEA is now routinely used by European regulators to set reasonable revenue caps for energy transmission and distribution system operators....... The application of benchmarking in regulation, however, requires specific steps in terms of data validation, model specification and outlier detection that are not systematically documented in open publications, leading to discussions about regulatory stability and economic feasibility of these techniques...

  8. 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

  9. 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)

  10. Flavor changing neutral current constraints from Kaluza-Klein gluons and quark mass matrices in the Randall-Sundrum I framework

    International Nuclear Information System (INIS)

    Chang, W.-F.; Ng, John N.; Wu, Jackson M. S.

    2009-01-01

    We continue our previous study on what are the allowed forms of quark mass matrices in the Randall-Sundrum framework that can reproduce the experimentally observed quark mass spectrum and the pattern of Cabibbo-Kobayashi-Maskawa mixing. We study the constraints the ΔF=2 processes in the neutral meson sector placed on the admissible forms found there, and we found only the asymmetrical type of quark mass matrices arising from anarchical Yukawa structures remain viable at the few TeV scale reachable at the LHC. We study also the decay of the first Kaluza-Klein (KK) excitation of the gluon. We give the decay branching ratios of the first KK gluon into quark pairs, and we point out that measurements of the decay width and just one of the quark spins in the dominant tt decays can be used to extract the effective coupling of the first KK gluon to top quarks for both chiralities. This provides a further probe into the flavor structure of the Randall-Sundrum framework.

  11. Framework for the Future

    Science.gov (United States)

    Schuller, Tom

    2008-01-01

    The main goal of the Inquiry into the Future for Lifelong Learning is to provide a "strategic framework" for the future. In this article, the author considers the key components that will make up the framework. These are: (1) a statement of vision and values; (2) a stock-take of the current position; (3) an "investment…

  12. Current trends in outcome studies for children with hearing loss and the need to establish a comprehensive framework of measuring outcomes in children with hearing loss in China

    Directory of Open Access Journals (Sweden)

    Xueman Liu

    2016-06-01

    Full Text Available Since the 1970s, outcome studies for children with hearing loss expanded from focusing on assessing auditory awareness and speech perception skills to evaluating language and speech development. Since the early 2000s, the multi-center large scale research systematically studied outcomes in the areas of auditory awareness, speech-perception, language development, speech development, educational achievements, cognitive development, and psychosocial development. These studies advocated the establishment of baseline and regular follow-up evaluations with a comprehensive framework centered on language development. Recent research interests also include understanding the vast differences in outcomes for children with hearing loss, understanding the relationships between neurocognitive development and language acquisition in children with hearing loss, and using outcome studies to guide evidence-based clinical practice. After the establishment of standardized Mandarin language assessments, outcomes research in Mainland China has the potential to expand beyond auditory awareness and speech perception studies.

  13. Regulatory actions post - Fukushima

    International Nuclear Information System (INIS)

    Ciurea Ercau, C.

    2013-01-01

    The paper presents the results of the safety reviews performed in Romania after the Fukushima accident and the resulting actions for improving the safety. The actions taken by the National Commission for Nuclear Activities Control (CNCAN) to improve the regulatory framework include the development of new regulations and the enhancement of inspection practices, taking account of the lessons learned from the Fukushima accident. A regulation on the response to transients, accidents and emergency situations at nuclear power plants has been developed, which includes requirements on transient and accident scenarios that have to be covered by the Emergency Operating Procedures (EOPs), accident scenarios to be covered by the Severe Accident Management Guidelines (SAMGs), emergency situations to be covered by the on-site emergency response plan and emergency response procedures. (authors)

  14. 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....

  15. 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)

  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. 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)

  18. 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)

  19. 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

  20. 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)

  1. 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.

  2. Aspectos Jurídicos do Fenômeno do Reequilíbrio e da Prorrogação antecipada de Contratos de Arrendamento Portuário face ao Novo Marco Regulatório / Legal Aspects of Port Leasing Review and Early Extension according to the New Regulatory Framework

    Directory of Open Access Journals (Sweden)

    Marcus Nylander Souza Oliveira

    2016-05-01

    Full Text Available Purpose – This article aims at clarifying the issues and innovations of the new port legislation taking into account the factors involved in the regulatory process. The purpose is to investigate the extent to which innovations fit the port structure for a better functioning of ports. Methodology/approach/design – It adopted an inductive method of approach supported by a set of data in order to try to discover and confirm the hypothesis of regulation applied to performance parameters, as prescribed in the new port mark, also considering legislation in its moral context. Findings – The new Port Law sheds light on prospects of economic growth, although its exact impact is still uncertain, since the barriers to development are mainly attributed to the high cost and low efficiency in operations. Practical implications – It aims at collaborating with the port sector, not only through a collaborator point of view, but also as an academic view assisted by studies related to the topic. Originality/value – Its importance lies, methodologically, on conceptualizing the key terms used in the equilibrium analysis and on the early extension of port contracts, emphasizing the normative propositions of the new port regulatory framework that takes into account efficiency and also the possible negative effects, including the regulatory capture.

  3. 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)

  4. O Microcrédito Produtivo Orientado no Brasil: um Panorama da Evolução do Quadro Regulatório, dos Atores Institucionais e de seu Efeito na Superação da Pobreza / Microcredit in Brazil: An Overview of the Regulatory Framework Evolution, Institutional Actors and Effect on Poverty Reduction

    Directory of Open Access Journals (Sweden)

    Paulo Soares Sampaio

    2016-10-01

    Full Text Available Purpose – This article analyzes the evolution of microcredit legal framework, the performance of its main institutional actors and presents the results of impact studies of this type of credit in the overcoming of poverty in Brazil. Methodology/approach/design – This study is based on historical and institutional perspectives to describe the evolution of microcredit regulation and its institutions, and on empirical research works to evaluate its effects on poverty reduction. Findings – Microcredit has a positive impact, although limited, on the overcoming of poverty by low income entrepreuners. However, microcredit operational characteristics and the present regulatory framework do not provide incentives to the private sector to concede microcredit, especially for the lower income segment. Practical implications – This paper can be useful as groundwork for researchers interested in the analysis and formulation of proposals of microcredit public policies and in the social and productive insertion of low income segments. Originality/value – This article presents a synthesis of the microcredit regulatory development in Brazil and the results of Brazilian studies on the effects of microcredit on poverty reduction.

  5. [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.

  6. Regulatory and law framework of agricultural methanization and composting activities. User's guide; Le cadre reglementaire et juridique des activites agricoles de methanisation et de compostage. Guide Pratique

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2008-08-15

    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

  7. 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...

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

    OpenAIRE

    Giuseppe Suaria; Giuseppe Suaria; Stefano Aliani; Silvia Merlino; Marinella Abbate

    2018-01-01

    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 dis...

  9. 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

  10. 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

  11. 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

  12. 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)

  13. 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.

  14. PHP frameworks

    OpenAIRE

    Srša, Aljaž

    2016-01-01

    The thesis presents one of the four most popular PHP web frameworks: Laravel, Symfony, CodeIgniter and CakePHP. These frameworks are compared with each other according to the four criteria, which can help with the selection of a framework. These criteria are size of the community, quality of official support, comprehensibility of framework’s documentation and implementation of functionalities in individual frameworks, which are automatic code generation, routing, object-relational mapping and...

  15. 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.

  16. Considerations on a regulatory framework for environmental management of produced water resulting from the extraction of petroleum in the state of Bahia; Consideracoes acerca de um modelo regulatorio pra o gerenciamento ambiental da agua produzida resultante da extracao de petroleo do estado da Bahia

    Energy Technology Data Exchange (ETDEWEB)

    Fraser, Roberta Tourinho Dantas [Instituto do Meio Ambiente e Recursos Hidricos (INEMA), Salvador, BA (Brazil); Vieira, Victor Menezes [Geo Innova Ltda., Lauro de Freitas, BA (Brazil); Ferreira, Doneivan Fernandes [Universidade Federal da Bahia (UFBA), Salvador, BA (Brazil)

    2012-07-01

    Produced water is the main byproduct associated to oil and gas extraction process. This water, considered by regulation as a residue, has the potential to cause adverse impact on environment. As extraction progresses and reservoirs mature increasing volumes of water are produced and need to be wisely managed. Due to Reconcavo Basin advanced stage of maturity, the state of Bahia has become a very large producer of water in the country. Remarkably, no state environmental regulation is in place to provide management guidelines and proper disposal rules for this waste. The present study intends to argue the need for a regulatory framework involving the management of water produced in state onshore sedimentary basins, identifying and discussing critical variables involved in this process. The following methodological instruments were used in the study: literature and normative survey, interaction with key stakeholders and field work. Environmental regulation has, as its main purpose, protection and preservation of the environment against potential polluting activities, while recognizing the importance of socioeconomic development. In this sense, implementing specific rules for management of produced water not only serves to harmonize productive activities such as oil and gas extraction with protective policies, but also brings institutional benefits that could represent a significant reduction in operating costs associated with inadequate management of this waste. It also tends to improve industry image as perceived by society. However, success of regulatory compliance is dependent of a number of variables, which, in the case of produced water management includes: physicochemical characterization; establishment of benchmark studies to guide application of proper techniques for injection and disposal; the choice of efficient regulatory instruments; expertise and experienced human resources within regulatory agencies responsible for monitoring activities and enforcing

  17. At the Turning Point of the Current Techno-Economic Paradigm: Commons-Based Peer Production, Desktop Manufacturing and the Role of Civil Society in the Perezian Framework

    Directory of Open Access Journals (Sweden)

    Vasilis Kostakis

    2013-01-01

    Full Text Available Following the theory of techno-economic paradigm shifts (TEPS, this paper calls attention to the phenomenon of Commons-based peer production (CBPP. In the context of the current paradigm, it argues that civil society can play an important role in creating favourable conditions for a more sustainable global knowledge society. Approaching tentatively the ways in which 3D printing and other desktop manufacturing technologies can be used in CBPP, it also explores the ways in which the partnership with the state may provide a supportive innovative institutional basis for taking the maximum advantage of the emerging synergies in the vein of TEPS theory.

  18. Law 16.832 substitute the article 2nd decree-law 14.694 establish a new legal regulatory framework for the national electric system, and it create the Executor Unit Regulatory Unit for Electric Power,that will depend directly of the Executive Power

    International Nuclear Information System (INIS)

    1997-01-01

    The article 27 of Marco's legal Regulatory for the National Electric System it prohibits the use of Nuclear Energy in the territory of the Oriental Republic of the Uruguay and it could not to carry out contracts of electric power supply with nuclear generators neither with foreign generators whose plants contaminate the national territory [es

  19. 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)

  20. 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.

  1. 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

  2. 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.

  3. 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.

  4. The welfare state within the framework of the capialist system. Does it have a future or is it non-viable in the current globalized system?

    Directory of Open Access Journals (Sweden)

    Manuel Fernando Cabrera Jiménez

    2014-07-01

    Full Text Available The important role played by the State in the economic, political, and social field during the 20th Century has engendered some reactions in favor or against from the point of view of several ideological thinkers within capitalism. Re