WorldWideScience

Sample records for current regulatory environment

  1. The changing regulatory environment

    International Nuclear Information System (INIS)

    Caron, G.

    1999-01-01

    The role and value of regulation in the energy sector was discussed, demonstrating how, despite common perception, regulation is an essential part of Canada's strategy to find and develop new opportunities. The future vision of regulation for industry participants was presented with particular focus on issues related to streamlining the regulatory process. As far as pipelines are concerned, regulatory actions are necessary to facilitate capacity increases and to ensure the line's integrity, safety and environmental record. Furthermore, regulation provides economic solutions where market forces cannot provide them, as for example where business has elements of monopoly. It arbitrates interests of landowners, business, consumers, and environmental groups. It looks for ways to ensure conditions under which competition can flourish. It acts as the guardian of citizens' rights in a democratic society by providing citizens with an opportunity to be heard on the building or expansion of pipelines and associated facilities. As citizens become more and more concerned about their property and the land that surrounds them, citizen involvement in decision making about how industry activity affects their quality of life will become correspondingly more important. Regulatory agencies are committed to facilitate this engagement by flexible hearing procedures and by making use of evolving communication and information technology

  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. Global Banking System Regulatory Environment

    Directory of Open Access Journals (Sweden)

    Oleh Mozhovyi

    2017-03-01

    Full Text Available The international and domestic experience shows that the main factors of financial destabilization during the financial crises are in the banking sector. The article reveals that the vulnerability of the financial system is connected with functions, deposit and credit transactions, risks distribution and ensuring liquidity; banks act as a major factor in stabilisation measures in the current context of globalization processes, since the economic stability of banking activities relates directly to all the entities and only stable banking system can withstand the crisis phenomena. Therefore, as a result of the analysis, it is proved that not only reduction of risks of banks is needed, but also introduction of the effective supervision system over implementation of the requirements and standards to prevent these risks. According to modern international approaches, banks use the so-called prudential supervision, which is based on the risk management assessment policy on the part of the Bank’s management, and regulatory bodies contribute to implementation of such policy. The authors have concluded that not only modern specificity of banks, but also the impact of supervision systems and regulation of modern trends in development of the banking should be analysed. Application of the general regulatory principles and banking risks methodology is required. The task of supervision is distribution of reliable risk management practices in the banking system, taking into account national peculiarities of development.

  5. Orphan drugs: the regulatory environment.

    Science.gov (United States)

    Franco, Pedro

    2013-02-01

    The definition of a rare disease is not universal and depends on the legislation and policies adopted by each region or country. The main objective of this article is to describe and discuss the legal framework and the regulatory environment of orphan drugs worldwide. Some reflections and discussions on the need for specific orphan drug legislation or policies are described at length. Furthermore, some aspects of the history of each region in respect of the orphan drug legislation evolution are outlined. This article describes and compares the orphan drug legislation or policies of the following countries or regions: United Sates of America (US), European Union (EU), Japan, Australia, Singapore, Taiwan and Canada. The incentives described in the orphan drug legislations or policies, the criteria for designation of orphan status and the authorisation process of an orphan drug are also described and compared. The legislations and policies are to some extent similar but not the same. It is important to understand the main differences among all available legislative systems to improve the international collaboration in the field of orphan drugs and rare diseases. Copyright © 2012 Elsevier Ltd. All rights reserved.

  6. 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)

  7. Environment, safety, and health regulatory implementation plan

    International Nuclear Information System (INIS)

    1993-01-01

    To identify, document, and maintain the Uranium Mill Tailings Remedial Action (UMTRA) Project's environment, safety, and health (ES ampersand H) regulatory requirements, the US Department of Energy (DOE) UMTRA Project Office tasked the Technical Assistance Contractor (TAC) to develop a regulatory operating envelope for the UMTRA Project. The system selected for managing the UMTRA regulatory operating envelope data bass is based on the Integrated Project Control/Regulatory Compliance System (IPC/RCS) developed by WASTREN, Inc. (WASTREN, 1993). The IPC/RCS is a tool used for identifying regulatory and institutional requirements and indexing them to hardware, personnel, and program systems on a project. The IPC/RCS will be customized for the UMTRA Project surface remedial action and groundwater restoration programs. The purpose of this plan is to establish the process for implementing and maintaining the UMTRA Project's regulatory operating envelope, which involves identifying all applicable regulatory and institutional requirements and determining compliance status. The plan describes how the Project will identify ES ampersand H regulatory requirements, analyze applicability to the UMTRA Project, and evaluate UMTRA Project compliance status

  8. Characterization of the evolution of the pharmaceutical regulatory environment.

    Science.gov (United States)

    Shafiei, Nader; Ford, James L; Morecroft, Charles W; Lisboa, Paulo J; Taylor, Mark J

    2013-01-01

    This paper is part of a research study that is intended to identify pharmaceutical quality risks induced by the ongoing transformation in the industry. This study establishes the current regulatory context by characterizing the development of the pharmaceutical regulatory environment. The regulatory environment is one of the most important external factors that affects a company's organization, processes, and technological strategy. This is especially the case with the pharmaceutical industry, where its products affect the quality of life of the consumers. The quantitative analysis of regulatory events since 1813 and review of the associated literature resulted in identification of six factors influencing the regulatory environment, namely public health protection, public health promotion, crisis management, harmonization, innovation, and modernization. From 1813 to the 1970s the focus of regulators was centered on crisis management and public health protection-a basic mission that has remained consistent over the years. Since the 1980s a gradual move in the regulatory environment towards a greater focus on public health promotion, international harmonization, innovation, and agency modernization may be seen. The pharmaceutical industry is currently going through changes that affect the way it performs its research, manufacturing, and regulatory activities. The impact of these changes on the approaches to quality risk management requires more understanding. The authors are engaged in research to identify elements of the changes that influence pharmaceutical quality. As quality requirements are an integral part of the pharmaceutical regulations, a comprehensive understanding of these regulations is seen as the first step. The results of this study show that (i) public health protection, public health promotion, crisis management, harmonization, innovation, and modernization are factors that affect regulations in the pharmaceutical industry; (ii) the regulators' main

  9. Nuclear reactor decommissioning: an analysis of the regulatory environments

    International Nuclear Information System (INIS)

    Cantor, R.

    1984-04-01

    The purpose of this study is to highlight some of the current and likely regulations that will significantly affect the costs, technical alternatives and financing schemes for reactor decommissioning encountered by electric utilities and their customers. The paper includes a general review of the decommissioning literature, as well as information on specific regulations at the federal, state, and utility levels. Available estimated costs for the decommissioning of individual reactors are also presented. Finally, classification of the specific policies into common trends and practices among the various regulatory bodies is used to examine more general regulatory environments and their potential financial implications

  10. 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.

  11. Current status of developmental neurotoxicity: regulatory view

    DEFF Research Database (Denmark)

    Hass, Ulla

    2003-01-01

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

  12. 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

  13. Nuclear reactor decommissioning: an analysis of the regulatory environments

    International Nuclear Information System (INIS)

    Cantor, R.

    1986-08-01

    In the next several decades, the electric utility industry will be faced withthe retirement of 50,000 megawatts (mW) of nuclear capacity. Responsibility for the financial and technical burdens this activity entails has been delegated to the utilities operating the reactors. However, the operators will have to perform the tasks of reactor decommissioning within the regulatory environment dictated by federal, state and local regulations. The purpose of this study was to highlight some of the current and likely trends in regulations and regulatory practices that will significantly affect the costs, technical alternatives and financing schemes encountered by the electric utilities and their customers. To identify significant trends and practices among regulatory bodies and utilities, a reviw of these factors was undertaken at various levels in the regulatory hierarchy. The technical policies were examined in reference to their treatment of allowed technical modes, restoration of the plant site including any specific recognition of the residual radioactivity levels, and planning requirements. The financial policies were examined for specification of acceptable financing arrangements, mechanisms which adjust for changes in the important parameters used to establish the fund, tax and rate-base treatments of the payments to and earnings on the fund, and whether or not escalation and/or discounting were considered in the estimates of decommissioning costs. The attitudes of regulators toward financial risk, the tax treatment of the decommissioning fund, and the time distribution of the technical mode were found to have the greatest effect on the discounted revenue requirements. Under plausible assumptions, the cost of a highly restricted environment is about seven times that of the minimum revenue requirement environment for the plants that must be decommissioned in the next three decades

  14. Environment and T regulatory cells in allergy.

    Science.gov (United States)

    Braga, M; Schiavone, C; Di Gioacchino, G; De Angelis, I; Cavallucci, E; Lazzarin, F; Petrarca, C; Di Gioacchino, M

    2012-04-15

    The central role of T regulatory cells in the responses against harmless environmental antigens has been confirmed by many studies. Impaired T regulatory cell function is implicated in many pathological conditions, particularly allergic diseases. The "hygiene hypothesis" suggests that infections and infestations may play a protective role for allergy, whereas environmental pollutants favor the development of allergic diseases. Developing countries suffer from a variety of infections and are also facing an increasing diffusion of environmental pollutants. In these countries allergies increase in relation to the spreading use of xenobiotics (pesticides, herbicides, pollution, etc.) with a rate similar to those of developed countries, overcoming the protective effects of infections. We review here the main mechanisms of non-self tolerance, with particular regard to relations between T regulatory cell activity, infections and infestations such as helminthiasis, and exposure to environmental xenobiotics with relevant diffusion in developing countries. Copyright © 2010 Elsevier B.V. All rights reserved.

  15. Cloud based spectrum manager for future wireless regulatory environment

    CSIR Research Space (South Africa)

    Masonta, MT

    2015-12-01

    Full Text Available The regulatory environment in radio frequency spectrum management lags the advancement of wireless technologies, especially in the area of cognitive radio and dynamic spectrum access. In this paper we argue that the solution towards spectrum Pareto...

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2008-06-01

    Computational models support environmental regulatory activities by providing the regulator an ability to evaluate available knowledge, assess alternative regulations, and provide a framework to assess compliance. But all models face inherent uncertainties, because human and natural systems are always more complex and heterogeneous than can be captured in a model. Here we provide a summary discussion of the activities, findings, and recommendations of the National Research Council's Committee on Regulatory Environmental Models, a committee funded by the US Environmental Protection Agency to provide guidance on the use of computational models in the regulatory process. Modeling is a difficult enterprise even outside of the potentially adversarial regulatory environment. The demands grow when the regulatory requirements for accountability, transparency, public accessibility, and technical rigor are added to the challenges. Moreover, models cannot be validated (declared true) but instead should be evaluated with regard to their suitability as tools to address a specific question. The committee concluded that these characteristics make evaluation of a regulatory model more complex than simply comparing measurement data with model results. Evaluation also must balance the need for a model to be accurate with the need for a model to be reproducible, transparent, and useful for the regulatory decision at hand. Meeting these needs requires model evaluation to be applied over the"life cycle" of a regulatory model with an approach that includes different forms of peer review, uncertainty analysis, and extrapolation methods than for non-regulatory models.

  17. Nuclear facilities and environment - an overview of regulatory aspects

    International Nuclear Information System (INIS)

    Chande, S.K.

    2007-01-01

    The Department of Atomic Energy (DAE) operates the entire range of nuclear fuel cycle facilities in the country. The radioactive wastes generated in these facilities have to be disposed into the environment without any adverse effect. In doing so, utmost care is taken to ensure the highest level of safety to the environment, the general public and the occupational workers. Atomic Energy Regulatory Board (AERB) is entrusted with the responsibility of protecting workers, public and environment against undue hazards from ionising radiations. To achieve this objective, AERB exercises regulatory control on the disposal of radioactive wastes from nuclear facilities. The disposal of radioactive effluents into the environment is governed by the Atomic Energy (Safe Disposal of Radioactive Wastes) Rules, 1987. The regulatory aspects with respect to disposal of radioactive wastes are discussed in this paper. (author)

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

    Science.gov (United States)

    Jais, Azlina Mohammad; Hassan, Najwa

    2017-01-01

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

  19. On regulatory focus and performance in organizational environments

    NARCIS (Netherlands)

    Beudeker, D.A.

    2015-01-01

    What motivates people, and when do they perform optimally at work? In this dissertation, a regulatory focus perspective is taken (RFT, Higgins, 1997) to provide answers to these important questions. The results of multiple studies, conducted in complex organizational environments are reported. In

  20. Navigating the obesogenic environment: how psychological sensitivity to the food environment and self-regulatory competence are associated with adolescent unhealthy snacking.

    Science.gov (United States)

    Stok, F Marijn; De Vet, Emely; Wardle, Jane; Chu, Maria T; De Wit, John; De Ridder, Denise T D

    2015-04-01

    Living in an obesogenic environment may not affect all adolescents to the same extent, depending on their psychological sensitivity to the food environment and their self-regulatory competence. The purpose of the current study was to examine associations of these two factors with unhealthy snacking among adolescents. We also investigated whether self-regulatory competence could attenuate the negative effects of being sensitive to the food environment. A survey was completed by 11,392 European adolescents (10-17years old). The survey measured psychological sensitivity to the food environment, self-regulatory competence and self-reported unhealthy snack intake. Higher food environment sensitivity and lower self-regulatory competence were associated with more unhealthy snacking. The two factors also interacted, with self-regulatory competence attenuating the influence of high food environment sensitivity. Adolescents who are sensitive to the food environment reported higher unhealthy snack intake. More frequent use of self-regulation strategies on the other hand was associated with lower unhealthy snack intake. Moreover, self-regulatory competence was found to moderate the influence of psychological sensitivity to the food environment on unhealthy snacking, although the effect size was small. Fostering adolescents' self-regulatory competence can help enable them to better navigate the obesogenic environment. Copyright © 2014 Elsevier Ltd. All rights reserved.

  1. 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.

  2. The future regulatory environment - a South African perspective

    International Nuclear Information System (INIS)

    Van der Woude, S.; Leaver, J.; Metcalf, P.E.

    2000-01-01

    The South African nuclear regulatory authority, the National Nuclear Regulator, regulates nuclear fuel cycle facilities as well as a large variety of mining and minerals processing activities. The future political, social, economical and technological environment, within which these facilities operate, will present numerous challenges to those who will be regulating them. In our presentation the challenges to be fulfilled in discharging the regulatory function are discussed, particularly in the context of a country with a small nuclear programme and a substantial developing component. Amongst the challenges discussed are: As part of the growing internationalization, the need to harmonize standards applied in different countries and the need to balance standards and practice applied in developed countries with resources available in developing countries; The need to consider the impact on the environment and not only on human beings; The impact of rapid advances in information technology on regulation; The maintenance and development of the appropriate expertise in the face of uncertainties regarding the future of the nuclear industry; Public involvement; The demands by society for greater standards of safety but at the same time for more effective and cost-effective regulation; The need for regulators to match customer demands on operators in terms of quality, speed, flexibility and costs; The privatization of nuclear fuel cycle facilities; The increased trend for larger facilities to outsource work to smaller companies; and, The need to balance good practice considerations with quantitatively determined risks in regulatory decision-making. (author)

  3. The future regulatory environment - a South African perspective

    Energy Technology Data Exchange (ETDEWEB)

    Van der Woude, S.; Leaver, J.; Metcalf, P.E. [National Nuclear Regulator, Centurion (South Africa)

    2000-07-01

    The South African nuclear regulatory authority, the National Nuclear Regulator, regulates nuclear fuel cycle facilities as well as a large variety of mining and minerals processing activities. The future political, social, economical and technological environment, within which these facilities operate, will present numerous challenges to those who will be regulating them. In our presentation the challenges to be fulfilled in discharging the regulatory function are discussed, particularly in the context of a country with a small nuclear programme and a substantial developing component. Amongst the challenges discussed are: As part of the growing internationalization, the need to harmonize standards applied in different countries and the need to balance standards and practice applied in developed countries with resources available in developing countries; The need to consider the impact on the environment and not only on human beings; The impact of rapid advances in information technology on regulation; The maintenance and development of the appropriate expertise in the face of uncertainties regarding the future of the nuclear industry; Public involvement; The demands by society for greater standards of safety but at the same time for more effective and cost-effective regulation; The need for regulators to match customer demands on operators in terms of quality, speed, flexibility and costs; The privatization of nuclear fuel cycle facilities; The increased trend for larger facilities to outsource work to smaller companies; and, The need to balance good practice considerations with quantitatively determined risks in regulatory decision-making. (author)

  4. Navigating the obesogenic environment : How psychological sensitivity to the food environment and self-regulatory competence are associated with adolescent unhealthy snacking.

    NARCIS (Netherlands)

    Stok, F. Marijn; De Vet, Emely; Wardle, Jane; Chu, Maria T.; De Wit, John; De Ridder, Denise T D

    2015-01-01

    Purpose: Living in an obesogenic environment may not affect all adolescents to the same extent, depending on their psychological sensitivity to the food environment and their self-regulatory competence. The purpose of the current study was to examine associations of these two factors with unhealthy

  5. Navigating the obesogenic environment: How psychological sensitivity to the food environment and self-regulatory competence are associated with adolescent unhealthy snacking

    NARCIS (Netherlands)

    Stok, F.M.; Vet, de E.; Wardle, J.; Chu, M.T.; Wit, J.B.F.; Ridder, de D.T.D.

    2015-01-01

    Purpose: Living in an obesogenic environment may not affect all adolescents to the same extent, depending on their psychological sensitivity to the food environment and their self-regulatory competence. The purpose of the current study was to examine associations of these two factors with unhealthy

  6. 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.

  7. 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)

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

    International Nuclear Information System (INIS)

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

    1999-01-01

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

  9. The role of learning environment on high school chemistry students' motivation and self-regulatory processes

    Science.gov (United States)

    Judd, Jeffrey S.

    Changes to the global workforce and technological advancements require graduating high school students to be more autonomous, self-directed, and critical in their thinking. To reflect societal changes, current educational reform has focused on developing more problem-based, collaborative, and student-centered classrooms to promote effective self-regulatory learning strategies, with the goal of helping students adapt to future learning situations and become life-long learners. This study identifies key features that may characterize these "powerful learning environments", which I term "high self-regulating learning environments" for ease of discussion, and examine the environment's role on students' motivation and self-regulatory processes. Using direct observation, surveys, and formal and informal interviews, I identified perceptions, motivations, and self-regulatory strategies of 67 students in my high school chemistry classes as they completed academic tasks in both high and low self-regulating learning environments. With social cognitive theory as a theoretical framework, I then examined how students' beliefs and processes changed after they moved from low to a high self-regulating learning environment. Analyses revealed that key features such as task meaning, utility, complexity, and control appeared to play a role in promoting positive changes in students' motivation and self-regulation. As embedded cases, I also included four students identified as high self-regulating, and four students identified as low self-regulating to examine whether the key features of high and low self-regulating learning environments played a similar role in both groups. Analysis of findings indicates that key features did play a significant role in promoting positive changes in both groups, with high self-regulating students' motivation and self-regulatory strategies generally remaining higher than the low self-regulating students; this was the case in both environments. Findings

  10. The waste isolation pilot plant: A new regulatory environment

    International Nuclear Information System (INIS)

    Frei, M.W.; Schneider, S.P.; Saris, E.C.; Austin, P.W.

    1993-01-01

    The US Department of Energy (DOE) is ready to embark on a multiyear test program, using radioactive waste, at the Waste Isolation Pilot Plant (WIPP). The WIPP is a deep geologic repository, constructed in ancient salt beds in southeastern New Mexico. It was authorized by Congress in 1979 as a research and development facility to demonstrate safe disposal of the nation's defense transuranic (TRU) waste. Nonradioactive testing in the repository has been under way for several years. The DOE is now ready to begin underground experiments at WIPP with small amounts of TRU waste. Radioactive waste testing in an actual repository environment will reduce uncertainties associated with predictions of long-term repository performance. However, the authority for DOE to begin this new phase of the test program no longer resides within the department. The WIPP is now subject to a new level of regulatory oversight by the Environmental Protection Agency (EPA) and other federal agencies, as set forth by Public Law 102-579, the WIPP Land Withdrawal Act, signed by the President on October 30, 1992. This paper discusses the act's new regulatory requirements for WIPP

  11. Deposit Insurance and Risk Shifting in a Strong Regulatory Environment

    DEFF Research Database (Denmark)

    Bartholdy, Jan; Justesen, Lene Gilje

    This study provides empirical evidence on the moral hazard implications of introducing deposit insurance into a strong regulatory environment. Denmark offers a unique setting because commercial banks and savings banks have different ownership structures, but are subject to the same set...... of regulations. The ownership structure in savings banks implies that they have no incentive to increase risk after the implementation of a deposit insurance scheme whereas commercial banks have. Also, at the time of introduction, Denmark had high capital requirements and a strict closure policy. Using...... a difference-in-difference framework we show that commercial banks did not increase their risk compared to savings banks when deposit insurance was introduced. The results also hold for large commercial banks, indicating that the systemic risk did not increase either. Thus for a system with high capital...

  12. Strategies for environmental restoration in an evolving regulatory environment

    International Nuclear Information System (INIS)

    Keller, J.F.; Geffen, C.A.

    1990-03-01

    The US Department of Energy (DOE) is faced with the immense challenge of effectively implementing a program to mitigate and manage the environmental impacts created by past and current operations at its facilities. Such a program must be developed and administered in accordance with the Comprehensive Environmental Response, Compensation and Liability Act and the Resource Conservation and Recovery Act. These regulations are extremely complex, burdening the environmental restoration process with a number of planning and public interaction requirements that must be met before remediation of a site may begin. Existing regulatory and institutional requirements for environmental restoration dictate that extensive planning, characterization and assessment activities be conducted. An important part of the process is the involvement of regulators and the public in the site characterization and assessment activities and in developing reasonable solutions for cleanup. This paper identifies the regulatory requirements and highlights implementation strategies for key aspects of the environmental restoration process for DOE. Trends in legislation and policy relevant to the DOE environmental restoration process are highlighted, with strategies identified for dealing with the evolution of the regulations while maintaining continuity in the technical activities required for cleaning up the DOE hazardous and mixed waste sites. 10 refs

  13. 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

  14. Power plant construction contracting in a changing regulatory environment

    International Nuclear Information System (INIS)

    Person, J.C.

    1993-01-01

    The 1965 blackout in the Northeast provided the wake-up call that spawned in unprecedented program of power plant construction by electric utilities. This building program began in the late 1960s and continued unabated through the 1970s. Beginning in the late 1970s, state regulators began in era of 'prudence' reviews which disallowed as imprudent significant portions of the costs of certain nuclear units being brought on line at the time. This regulatory experience brought about a fundamental change in the way in which utilities evaluated the need for additional capacity. This paper explores construction contracting trends in light of recent developments in the relationship between the electric utility and the state regulator. It is within this context that the utility decides: (1) whether to build, buy, or save; and (2) if the decision is to build, which project planning and administration considerations will maximize the utility's ability to incorporate project costs into the ratebase. In order to put these issues into their proper perspective, this paper first presents a brief overview of the prudence decisions of the past, and the chilling effect of these decisions generally on new project planning. The paper next focuses on the recent changes to the post-construction prudence review model, including the introduction of pre-approval arrangements and rolling prudence reviews. Following that will be a survey of new construction spending decisions in light of these changes. After an analysis of the bases for the prudence disallowances of the past and the application of the lessons learned from these disallowances to contract planning and administration issues of today, the paper will close with a discussion of the relative advantages and disadvantages of the most commonly used contract delivery methods in today's regulatory environment

  15. 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.

  16. CURRENT ENVIRONMENT FOR INTRODUCING HEALTH TECHNOLOGY ASSESSMENT IN GREECE.

    Science.gov (United States)

    Kani, Chara; Kourafalos, Vasilios; Litsa, Panagiota

    2017-01-01

    The aim of this study was to describe the current regulatory environment in Greece to evaluate the potential introduction of health technology assessment (HTA) for medicinal products for human use. Data sources consist of national legislation on pricing and reimbursement of health technologies to identify the potential need of establishing HTA and its relevant structure. The pricing procedure regarding medicinal products for human use is based on an external reference pricing mechanism which considers the average of the three lowest Euorpean Union prices. Currently, a formal HTA procedure has not been applied in Greece, and the only prerequisite used for the reimbursement of medicinal products for human use is their inclusion in the Positive Reimbursement List. To restrict pharmaceutical expenditure, a variety of measures-such as clawback mechanisms, rebates, monthly budget caps per physician, generics penetration targeting-have been imposed, aiming mainly to regulate the price level rather than control the introduction of medicinal products for human use in the Greek pharmaceutical market. Greece has the opportunity to rapidly build capacity, implement, and take advantage of the application of HTA mechanisms by clearly defining the goals, scope, systems, context, stakeholders, and methods that will be involved in the local HTA processes, taking into account the country's established e-prescription system and the recently adapted legislative framework.

  17. 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

  18. GENERIC DRUG IN GLOBAL MARKET AND REGULATORY ENVIRONMENT

    OpenAIRE

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

    2017-01-01

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

  19. 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.

  20. Environment protection: The current challenge in radioecology

    Science.gov (United States)

    Bréchignac, F.

    2012-04-01

    Radioecology, a multifaceted scientific discipline which addresses environmental issues relevant to radioprotection, has for a long time been focused on environmental transfers through the environment to feed the needs of human radioprotection. This quite anthropocentric initial scope is now moving to a more ecocentric view capable of assessing ecological risk mediated by ionising radiation. The central issue consists in reaching an ability to understand the effects of radiation on the environment components, from individual organisms up to populations of species and ecosystems, together with their interaction with the abiotic compartments. Dominated by operational goals, the system of radiological protection of the environment which is under development emphasises a concept based upon reference organisms supported by traditional toxicological data on individual organisms. Whilst there are immediate advantages to this approach (pragmatism, consistency with other approaches in use for man and biota), there are also clear limitations which need to be acknowledged and further considered. The most important probably is to rely on effects data gathered almost exclusively for individual organisms to meet protection goals which are usually set at population and ecosystem levels. Overcoming this limitation leads to scientific and methodological approaches featuring the ecosystem concept.

  1. Regulatory environment and its impact on the market value of investor-owned electric utilities

    Science.gov (United States)

    Vishwanathan, Raman

    While other regulated industries have one by one been exposed to competitive reform, electric power, for over eighty years, has remained a great monopoly. For all those years, the vertically integrated suppliers of electricity in the United States have been assigned exclusive territorial (consumer) franchises and have been closely regulated. This environment is in the process change because the electric power industry is currently undergoing some dramatic adjustments. Since 1992, a number of states have initiated regulatory reform and are moving to allow retail customers to choose their energy supplier. There has also been a considerable federal government role in encouraging competition in the generation and transmission of electricity. The objective of this research is to investigate the reaction of investors to the prevailing regulatory environment in the electric utility industry by analyzing the market-to-book value for investor-owned electric utilities in the United States as a gauge of investor concern or support for change. In this study, the variable of interest is the market valuation of utilities, as it captures investor confidence to changes in the regulatory environment. Initially a classic regression model is analyzed on the full sample (of the 96 investor-owned utilities for the years 1992 through 1996), providing a total number of 480 (96 firms over 5 years) observations. Later fixed- and random-effects models are analyzed for the same full-sample model specified in the previous analysis. Also, the analysis is carried forward to examine the impact of the size of the utility and its degree of reliability on nuclear power generation on market values. In the period of this study, 1992--1996, the financial security markets downgraded utilities that were still operating in a regulated environment or had a substantial percentage of their power generation from nuclear power plants. It was also found that the financial market was sensitive to the size of

  2. How are things going. Obtaining feedback in a regulatory environment

    International Nuclear Information System (INIS)

    McGuire, J.V.; Walsh, M.E.; Boegel, A.J.; Morisseau, D.S.; Persendky, J.J.

    1984-08-01

    This study tested two procedures to gather feedback for a federal agency about its regulatory actions and its licensees' practices. The procedures, a workshop and a mailed survey, targeted a data source new to the agency. Results to date find the feedback workshop useful and the new data source cooperative and valuable. Participation in the workshops is surprising, given their historical backdrop, structure, and psychological literatures. These findings suggest that agencies may be ignoring important data sources for ill-informed reasons. Also, the findings suggest a possible need to restructure existing channels of communication between a regulatory agency and its licensees

  3. 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.

  4. Innovative training techniques in the Canadian nuclear regulatory environment

    International Nuclear Information System (INIS)

    Martin, D.J.

    1996-01-01

    One of the contributors to the safety of nuclear installations is properly-trained personnel. This applies equally to the staff of a regulatory agency, as they are charged with the task of evaluating the safety of installations and operations involving radioactive materials. In 1990, the nuclear regulatory agency of Canada, the Atomic Energy Control Board, set up a Training Center to train AECB staff and to provide assistance to foreign regulatory agencies who had asked for such assistance. In setting up the Training Centre, the authors considered factors which adversely affect the efficacy of training courses. The technical content must, of course, be of sufficiently high quality, but there are other, significant factors which are independent of the content: consider a presentation in which the lecturer shows a slide which is unreadable from the back of the room. The training value of this slide is zero, even though the content may be sound. Pursuing this thought, they decided to examine the mechanics of presentations and the form of training materials, with a view to optimizing their effectiveness in training. The results of this examination were that they decided to use three technologies as the basis for production of training, support and presentation materials. This paper briefly describes these technologies and their advantages. The technologies are: desktop publishing, video and multimedia

  5. Turning research on the psychosocial working environment into regulatory practice

    DEFF Research Database (Denmark)

    Hansen, Agnete Meldgaard; Nielsen, Klaus Tranetoft; Starheim, Liv

    The psychosocial working environment is an expanding field of research. Within the last decades a lot of knowledge has been developed in the field. The question however remains how this knowledge can be, and is being, utilized in the regulation of the psychosocial working environment. This question...... we understand this process as a translation of knowledge into policies, tools and actors dealing with the psychosocial working environment. Drawing on this understanding we develop a model that illustrates the utility of different types of research on the psychosocial working environment...

  6. Strategic Renewal in Regulatory Environments: How inter- and intra-organisational institutional forces influence European incumbent energy firms

    OpenAIRE

    Stienstra, Marten

    2008-01-01

    textabstractHow do incumbent firms strategically renew in regulatory environments? Assuming that regulation can both constrain and enable a firm’s strategic renewal opportunities, we investigate how and to what extent incumbent firms undertake exploitative and explorative strategic renewal actions in order to remain competitive. Exploitative strategic renewal involves those actions that strengthen or optimise a firm’s current resource deployments, whereas explorative strategic renewal relates...

  7. 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.

  8. 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.

  9. Changing our regulatory structure to accommodate a competitive environment

    International Nuclear Information System (INIS)

    Roman, A. J.

    1996-01-01

    The efficiency of various regulatory schemes were assessed based on the assumption that certain aspects of transmission and distribution will have to be regulated even after deregulation comes into effect. Price regulation and incentive regulation are the two main forms used to ensure equitable availability of various transmission/wheeling services to distributors, and service quality, wheeling, and prices to be charged by distributors to customers. It was found on balance that only effective market forces spur efficiency, and regulations are only second best. Incentive regulation was not considered to be significantly more efficient than price regulation. The effectiveness of either form will depend upon market conditions and the skill of the regulator

  10. Confidential data in a competitive utility environment: A regulatory perspective

    Energy Technology Data Exchange (ETDEWEB)

    Vine, E.

    1996-08-01

    Historically, the electric utility industry has been regarded as one of the most open industries in the United States in sharing information but their reputation is being challenged by competitive energy providers, the general public, regulators, and other stakeholders. As the prospect of competition among electricity power providers has increased in recent years, many utilities have been requesting that the data they submit to their utility regulatory commissions remain confidential. Withholding utility information from the public is likely to have serious and significant policy implications with respect to: (1) consumer education, the pursuit of truth, mutual respect among parties, and social cooperation; (2) the creation of a fair market for competitive energy services; (3) the regulatory balance; (4) regional and national assessments of energy-savings opportunities; (5) research and development; and (6) evaluations of utility programs, plans, and policies. In a telephone survey of all public utility commissions (PUCs) that regulate electric and gas utilities in the U.S., we found that almost all PUCs have received requests from utility companies for data to be filed as confidential, and confidential data filings appear to have increased (both in scope and in frequency) in those states where utility restructuring is being actively discussed. The most common types of data submitted as confidential by utilities dealt with specific customer data, market data, avoided costs, and utility costs.

  11. Effect of environment fluctuations on a Josephson current

    International Nuclear Information System (INIS)

    Galaktionov, A.V.

    2017-01-01

    Highlights: • Josephson current is influenced differently by environment fluctuations. • Two types of environment are studied: ohmic and resonant-mode one. • A crossover to a Josephson π-junction is possible for both of them. - Abstract: An influence of an electromagnetic environment on a Josephson current through a tunnel junction is studied with the aid of Ambegaokar-Eckern-Schön effective action. Two types of environment are investigated: one, characterized by a resonant mode, and an ohmic one. The crossover to a Josephson π-junction is possible for both of them. In addition the resonant-mode environment results in an increase of a Josephson current when the ratio of the doubled superconducting gap to the frequency of the mode is close to an integer number.

  12. 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)

  13. Risk assessment: A regulatory strategy for stimulating working environment activities?

    DEFF Research Database (Denmark)

    Jensen, Per Langaa

    2001-01-01

    This paper analyses the Danish approach to workplace assessment (WPA) following European requirements to establish legislation on occupational health and safety. Quantitative studies show that WPA can be interpreted as a success within the larger Danish firms. However, data from qualitative studies...... modify this picture by showing how attention has been focussed on physical working environment problems whilst wider psycho-social problems have been ignored. The paper claims there is no evidence from either the quantitative or the qualitative studies that workplace assessment - even though positively...

  14. 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

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

    International Nuclear Information System (INIS)

    Vieru, G.

    2002-01-01

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

  16. IS Audit Considerations in Respect of Current Economic Environment

    Directory of Open Access Journals (Sweden)

    Vlasta Svata

    2011-01-01

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

  17. Reactors licensing: proposal of an integrated quality and environment regulatory structure for nuclear research reactors in Brazil

    International Nuclear Information System (INIS)

    Serra, Reynaldo Cavalcanti

    2014-01-01

    A new integrated regulatory structure based on quality and integrated issues has been proposed to be implemented on the licensing process of nuclear research reactors in Brazil. The study starts with a literature review about the licensing process in several countries, all of them members of the International Atomic Energy Agency. After this phase it is performed a comparative study with the Brazilian licensing process to identify good practices (positive aspects), the gaps on it and to propose an approach of an integrated quality and environmental management system, in order to contribute with a new licensing process scheme in Brazil. The literature review considered the following research nuclear reactors: Jules-Horowitz and OSIRIS (France), Hanaro (Korea), Maples 1 and 2 (Canada), OPAL (Australia), Pallas (Holand), ETRR-2 (Egypt) and IEA-R1 (Brazil). The current nuclear research reactors licensing process in Brazil is conducted by two regulatory bodies: the Brazilian National Nuclear Energy Commission (CNEN) and the Brazilian Institute of Environment and Renewable Natural Resources (IBAMA). CNEN is responsible by nuclear issues, while IBAMA by environmental one. To support the study it was applied a questionnaire and interviews based on the current regulatory structure to four nuclear research reactors in Brazil. Nowadays, the nuclear research reactor’s licensing process, in Brazil, has six phases and the environmental licensing process has three phases. A correlation study among these phases leads to a proposal of a new quality and environmental integrated licensing structure with four harmonized phases, hence reducing potential delays in this process. (author)

  18. 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.

  19. Evolution of regulatory networks towards adaptability and stability in a changing environment

    Science.gov (United States)

    Lee, Deok-Sun

    2014-11-01

    Diverse biological networks exhibit universal features distinguished from those of random networks, calling much attention to their origins and implications. Here we propose a minimal evolution model of Boolean regulatory networks, which evolve by selectively rewiring links towards enhancing adaptability to a changing environment and stability against dynamical perturbations. We find that sparse and heterogeneous connectivity patterns emerge, which show qualitative agreement with real transcriptional regulatory networks and metabolic networks. The characteristic scaling behavior of stability reflects the balance between robustness and flexibility. The scaling of fluctuation in the perturbation spread shows a dynamic crossover, which is analyzed by investigating separately the stochasticity of internal dynamics and the network structure differences depending on the evolution pathways. Our study delineates how the ambivalent pressure of evolution shapes biological networks, which can be helpful for studying general complex systems interacting with environments.

  20. Deliberations on nuclear safety regulatory system in a changing industrial environment

    International Nuclear Information System (INIS)

    Kim, H.J.

    2001-01-01

    Nuclear safety concern, which may accompany such external environmental factors as privatization and restructuring of the electric power industry, is emerging as an international issue. In order to cope with the concern about nuclear safety, it is important to feedback valuable experiences of advanced countries that restructured their electric power industries earlier and further to reflect the current safety issues, which are raised internationally, fully into the nuclear safety regulatory system. This paper is to review the safety issues that might take place in the process of increasing competition in the nuclear power industry, and further to present a basic direction and effective measures for ensuring nuclear safety in response thereto from the viewpoint of safety regulation. It includes a political direction for a regulatory body's efforts to rationalize and enforce efficiently its regulation. It proposes to ensure that regulatory specialty and regulatory cost are stably secured. Also, this paper proposes maintaining a sound nuclear safety regulatory system to monitor thoroughly the safety management activities of the industry, which might be neglected as a result of focusing on reduction of the cost for producing electric power. (author)

  1. Current understanding of organically bound tritium (OBT) in the environment.

    Science.gov (United States)

    Kim, S B; Baglan, N; Davis, P A

    2013-12-01

    It has become increasingly recognized that organically bound tritium (OBT) is the more significant tritium fraction with respect to understanding tritium behaviour in the environment. There are many different terms associated with OBT; such as total OBT, exchangeable OBT, non-exchangeable OBT, soluble OBT, insoluble OBT, tritiated organics, and buried tritium, etc. A simple classification is required to clarify understanding within the tritium research community. Unlike for tritiated water (HTO), the environmental quantification and behaviour of OBT are not well known. Tritiated water cannot bio-accumulate in the environment. However, it is not clear whether or not this is the case for OBT. Even though OBT can be detected in terrestrial biological materials, aquatic biological materials and soil samples, its behaviour is still in question. In order to evaluate the radiation dose from OBT accurately, further study will be required to understand OBT measurements and determine OBT fate in the environment. The relationship between OBT speciation and the OBT/HTO ratio in environmental samples will be useful in this regard, providing information on the previous tritium exposure conditions in the environment and the current tritium dynamics. Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.

  2. 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)

  3. 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

  4. 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.

  5. Current Measurements and Overwash Monitoring Using Tilt Current Meters in Three Coastal Environments

    Science.gov (United States)

    Lowell, N. S.; Sherwood, C. R.; Decarlo, T. M.; Grant, J. R.

    2014-12-01

    Tilt Current Meters (TCMs) provide accurate, cost effective measurements of near-bottom current velocities. Many studies in coastal environments require current measurements, which are frequently made with Acoustic Doppler Profilers (ADPs). ADPs are expensive, however, and may not be suitable for locations where there is significant risk of damage, loss, or theft or where a large spatial array of measurements is required. TCMs, by contrast, are smaller, less expensive, and easier to deploy. This study tested TCMs in three sites to determine their suitability for use in research applications. TCMs are based on the drag-tilt principle, where the instrument tilts in response to current. The meter consists of a buoyant float with an onboard accelerometer, three-axis tilt sensor, three-axis magnetometer (compass), and a data logger. Current measurements are derived by post processing the tilt and compass values and converting them to velocity using empirical calibration data. Large data-storage capacity (4 GB) and low power requirements allow long deployments (many months) at high sample rates (16 Hz). We demonstrate the utility of TCM current measurements on a reef at Dongsha Atoll in the South China Sea, and in Vineyard Sound off Cape Cod, where the TCM performance was evaluated against ADP measurements. We have also used the TCM to record waves during an overwash event on a Cape Cod barrier beach during a winter storm. The TCM recorded waves as they came through the overwash channel, and the data were in agreement with the water-level record used as a reference. These tests demonstrate that TCMs may be used in a variety of near shore environments and have the potential to significantly increase the density of meters in future studies were current measurements are required.

  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. Approaches to safety, environment and regulatory approval for the International Thermonuclear Experimental Reactor

    International Nuclear Information System (INIS)

    Saji, G.; Bartels, H.W.; Chuyanov, V.; Holland, D.; Kashirski, A.V.; Morozov, S.I.; Piet, S.J.; Poucet, A.; Raeder, J.; Rebut, P.H.; Topilski, L.N.

    1995-01-01

    International Thermonuclear Experimental Reactor (ITER) Engineering Design Activities (EDA) in safety and environment are approaching the point where conceptual safety design, topic studies and research will give way to project oriented engineering design activities. The Joint Central Team (JCT) is promoting safety design and analysis necessary for siting and regulatory approval. Scoping studies are underway at the general level, in terms of laying out the safety and environmental design framework for ITER. ITER must follow the nuclear regulations of the host country as the future construction site of ITER. That is, regulatory approval is required before construction of ITER. Thus, during the EDA, some preparations are necessary for the future application for regulatory approval. Notwithstanding the future host country's jurisdictional framework of nuclear regulations, the primary responsibility for safety and reliability of ITER rests with the legally responsible body which will operate ITER. Since scientific utilization of ITER and protection of the large investment depends on safe and reliable operation of ITER, we are highly motivated to achieve maximum levels of operability, maintainability, and safety. ITER will be the first fusion facility in which overall 'nuclear safety' provisions need to be integrated into the facility. For example, it will be the first fusion facility with significant decay heat and structural radiational damage. Since ITER is an experimental facility, it is also important that necessary experiments can be performed within some safety design limits without requiring extensive regulatory procedures. ITER will be designed with such a robust safety envelope compatible with the fusion power and the energy inventories. The basic approach to safety will be realized by 'defense-in-depth'. (orig.)

  8. Mapping out the regulatory environment and its interaction with land and property markets

    International Nuclear Information System (INIS)

    Adams, David

    2008-01-01

    The purpose of this paper is to explain how the regulatory environment created by planning and building regulations interacts with land and property markets. Since this regulatory environment operates as a form of intervention within property markets in general and the development process in particular, it is essential first to understand the nature, structure and operation of land and property markets. These are covered in the first section. The second section identifies the aims and components of the planning system and building regulations. From this basis, four broad types of policy intervention are reviewed in the third section. These cover policies that seek to shape, regulate or stimulate market activity, and those that aim to build state or market capacity to produce desired outcomes. The final section uses the private residential development process as a case study to explore the extent to which state intervention can influence producer-consumer relationships in one important market sector. The paper argues that effective intervention in land and property markets requires the creation of a broad range of policy tools and their appropriate deployment to suit particular market circumstances. (author)

  9. Operating the Advanced Test Reactor in today's economic and regulatory environment

    International Nuclear Information System (INIS)

    Furstenau, R.V.; Patrick, M.E.; Mecham, D.C.

    1999-01-01

    The Advanced Test Reactor (ATR), located at the Idaho National Engineering and Environmental Laboratory, is the US Department of Energy's largest and most versatile test reactor. Base programs at ATR are planned well into the 21st century. The ATR and support facilities along with an overview of current programs will be reviewed, but the main focus of the presentation will be on the impact that today's economic and regulatory concerns have had on the operation of this test reactor. Today's economic and regulatory concerns have demanded more work be completed at lower cost while increasing the margin of safety. By the beginning of the 1990 s, federal budgets for research generally and particularly for nuclear research had decreased dramatically. Many national needs continued to require testing in the ATR; but demanded lower cost, increased efficiency, improved performance, and an increased margin of safety. At the same time budgets were decreasing, there was an increase in regulatory compliance activity. The new standards imposed higher margins of safety. The new era of greater openness and higher safety standards complemented research demands to work safer, smarter and more efficiently. Several changes were made at the ATR to meet the demands of the sponsors and public. Such changes included some workforce reductions, securing additional program sponsors, upgrading some facilities, dismantling other facilities, and implementing new safety programs. (author)

  10. US decommissioning strategy in today's regulatory, technical, political, and economic environments

    International Nuclear Information System (INIS)

    Colvin, J.F.

    1995-01-01

    The United States commercial nuclear power industry is nearly forty years old. Soon after the turn of the century, the United States expects to see a significant rise in the number of plants requiring decommissioning. This, coupled with recent economic pressures which are impacting the U.S. electrical generation industry and have resulted in the premature shutdown of some nuclear power plants, heighten the need for clear regulations and standards addressing facility closure and decommissioning. Since the issue of decommissioning involves public health and safety, technical, environmental and financial aspects, this complex regulatory environment poses a major challenge to the industry in this area. There are three fundamental issues facing utilities as they develop strategies for the eventual decommissioning of their nuclear power plants. These issues are the regulatory approach to decommissioning, the question of the availability of adequate funding, including the uncertainty resulting from the uncertainty of waste disposal options, and the need to meet environmental standards for the protection of health and safety. Futhermore, these issues, in particular the economic-related issues, are magnified in the event of prematurely shut down nuclear power plant. (Author)

  11. An Analysis of the Regulatory Environment Governing Hearsay Electronic Evidence in South Africa: Suggestions for Reform – Part One

    Directory of Open Access Journals (Sweden)

    Lee Swales

    2018-03-01

    Full Text Available The purpose of this two-part article is to examine the regulatory environment governing hearsay electronic evidence in South Africa – with a view to providing clear, practical suggestions for regulatory reform in the context of the South African Law Reform Commission's most recent Discussion Paper on electronic evidence. Technology has become an indispensable part of modern life. In particular, the Internet has facilitated new forms of business enterprise, and shifted basic communication norms. From a legal perspective, technology has presented several novel challenges for courts and legal practitioners to deal with – one of these key challenges relates to electronic evidence and in particular the application of the hearsay rules to the digital environment. The South African Law Reform Commission has identified the application of the hearsay rule as one of the core concerns with regard to electronic evidence, and certain academic analysis has revealed inefficiency in the current legal position which may involve multiple sources of law. Moreover, the Law Society of South Africa has stated that there is some confusion amongst members of the profession in relation to hearsay as it applies to electronic evidence. With the pervasive and burgeoning nature of technology, and with the Internet in mind, it is natural to assume that electronic evidence will be relevant in most forms of legal proceedings in future, and hearsay electronic evidence in particular will play an increasingly important role in years to come. Consequently, part one of this article will consider the key definitional concept in relation to electronic evidence – data messages - and examine whether the definition should be revised. In addition, part one of this article will answer two further critical questions posed by the South African Law Reform Commission in relation to data messages and hearsay evidence, namely: should a data message constitute hearsay? And, how should one

  12. Securing classification and regulatory approval for deepwater projects: management challenges in a global environment

    Energy Technology Data Exchange (ETDEWEB)

    Feijo, Luiz P.; Burton, Gareth C. [American Bureau of Shipping (ABS), Rio de Janeiro, RJ (Brazil)

    2008-07-01

    As the offshore industry continues to develop and move into increasingly deeper waters, technological boundaries are being pushed to new limits. Along with these advances, the design, fabrication and installation of deepwater oil and gas projects has become an increasingly global endeavor. After providing an overview of the history and role of Classification Societies, this paper reviews the challenges of securing classification and regulatory approval in a global environment. Operational, procedural and technological changes which one Classification Society; the American Bureau of Shipping, known as ABS, has implemented to address these challenges are presented. The result of the changes has been a more customized service aiming at faster and more streamlined classification approval process. (author)

  13. The case for regulatory reform in the business and healthcare environments.

    Science.gov (United States)

    Younis, Mustafa Z; Barhem, Belal; Hamidi, Samir; Inungu, Joseph; Prater, Gwendolyn S; O'Keefe, Arthur

    2009-01-01

    Government regulations affect corporations and consumers on a daily basis. For example, environmental and safety regulations in the workplace are administrated by the Occupational Safety and Health Administration (OSHA) under the Department of Labor. OSHA sets and enforces standards in work environment to ensure the safety and health of workers. Other regulatory agencies, such as the National Highway and Transportation Agency (NHTSA), oversee the transportation and the safety of the automobile and truck industry. The U.S. Food and Drug Administration (FDA) plays a major role in approving new drugs on the market and in monitoring drug safety, and it has the power to remove drugs from the market if they are proved to be safety and health problems to the public. However, the mere existence of these regulations often causes impediments to businesses, and the extent of their ultimate usefulness is examined and analyzed in this paper

  14. The air quality and regional climate effects of widespread solar power generation under a changing regulatory environment

    Science.gov (United States)

    Millstein, D.; Zhai, P.; Menon, S.

    2011-12-01

    used to investigate the effects of the various solar generation scenarios given emissions projections that account for changing regulatory environment, economic and population growth, and technological change. The results will help to quantify the potential air quality benefits of promotion of solar electricity generation in regions containing high penetration of coal-fired power generation. Note current national solar incentives that are based only on solar generation capacity. Further investigation of changes to regional climate due to emission reductions of aerosols and relevant precursors will provide insight into the environmental effects that may occur if solar power generation becomes widespread.

  15. 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

  16. Independent regulatory control and monitoring of the environment at the uranium legacy sites under reclamation

    International Nuclear Information System (INIS)

    Shandala, N.K.; Titov, A.V.; Kiselev, S.M.; Isaev, D.V.; Aladova, R.A.

    2012-01-01

    Full text: Radiation safety at areas affected by the natural uranium mining and milling facilities is very important for the environment protection and human health. For this purpose the close operator-regulator contact is required during remedial operations. One of the key mechanisms of the operating regulatory supervision of radiation safety at uranium legacy sites is organization of independent radiation control and monitoring in the course of reclamation and after its completion. The main stages of this strategy include: detailed radiation survey at the area and in the vicinity of the former uranium mining sites; threat assessment in order to identify the regulatory priorities; environmental radiation control and monitoring. Tailings and shallow disposal sites of the uranium mining wastes are the most critical areas in terms of potential hazard for the environment. Tailings are the source of contamination of the near-land air due to the radionuclide dust resuspension from the tailing surface; surface and ground water due to washing out from by precipitation and surface streams of toxic and radioactive elements. Frequently, contamination of surface and ground waters results in some problems, especially when using the leaching fluids for the solution mining and draining hydraulic fluids. Radiation risk for the residents of areas near not operating uranium mining and milling facilities depends on the following factors: radon exhalation from the surface of dumps and tailing; radioactive dust transfer; using radioactive material in building; contamination of surface water streams and aquifers used for drinking water supply; contamination of open ponds used for fish breeding and catching; contamination of foodstuffs grown in the nuclear legacy areas. Radiation monitoring is necessary for the up-to-date response to changing radiation situation during reclamation and arrangement of adequate countermeasures. We mean here comprehensive dynamic surveillance including long

  17. Josephson current through a molecular transistor in a dissipative environment

    DEFF Research Database (Denmark)

    Novotny, T; Rossini, Gianpaolo; Flensberg, Karsten

    2005-01-01

    We study the Josephson coupling between two superconductors through a single correlated molecular level, including Coulomb interaction on the level and coupling to a bosonic environment. All calculations are done to the lowest, i.e., the fourth, order in the tunneling coupling and we find...

  18. [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.

  19. 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.

  20. Strategic Renewal in Regulatory Environments: How inter- and intra-organisational institutional forces influence European incumbent energy firms

    NARCIS (Netherlands)

    M. Stienstra (Marten)

    2008-01-01

    textabstractHow do incumbent firms strategically renew in regulatory environments? Assuming that regulation can both constrain and enable a firm’s strategic renewal opportunities, we investigate how and to what extent incumbent firms undertake exploitative and explorative strategic renewal actions

  1. 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

  2. Ionizing radiation sources: very diversified means, multiple applications and a changing regulatory environment. Conference proceedings

    International Nuclear Information System (INIS)

    2011-11-01

    This document brings together the available presentations given at the conference organised by the French society of radiation protection about ionizing radiation source means, applications and regulatory environment. Twenty eight presentations (slides) are compiled in this document and deal with: 1 - Overview of sources - some quantitative data from the national inventory of ionizing radiation sources (Yann Billarand, IRSN); 2 - Overview of sources (Jerome Fradin, ASN); 3 - Regulatory framework (Sylvie Rodde, ASN); 4 - Alternatives to Iridium radiography - the case of pressure devices at the manufacturing stage (Henri Walaszek, Cetim; Bruno Kowalski, Welding Institute); 5 - Dosimetric stakes of medical scanner examinations (Jean-Louis Greffe, Charleroi hospital of Medical University); 6 - The removal of ionic smoke detectors (Bruno Charpentier, ASN); 7 - Joint-activity and reciprocal liabilities - Organisation of labour risk prevention in case of companies joint-activity (Paulo Pinto, DGT); 8 - Consideration of gamma-graphic testing in the organization of a unit outage activities (Jean-Gabriel Leonard, EDF); 9 - Radiological risk control at a closed and independent work field (Stephane Sartelet, Areva); 10 - Incidents and accidents status and typology (Pascale Scanff, IRSN); 11 - Regional overview of radiation protection significant events (Philippe Menechal, ASN); 12 - Incident leading to a tritium contamination in and urban area - consequences and experience feedback (Laurence Fusil, CEA); 13 - Experience feedback - loss of sealing of a calibration source (Philippe Mougnard, Areva); 14 - Blocking incident of a 60 Co source (Bruno Delille, Salvarem); 15 - Triggering of gantry's alarm: status of findings (Philippe Prat, Syctom); 16 - Non-medical electric devices: regulatory changes (Sophie Dagois, IRSN; Jerome Fradin, ASN); 17 - Evaluation of the dose equivalent rate in pulsed fields: method proposed by the IRSN and implementation test (Laurent Donadille, IRSN

  3. Development and Delivery of Coursework: The Legal/Regulatory/Policy Environment of Cyberforensics

    Directory of Open Access Journals (Sweden)

    John W. Bagby

    2006-06-01

    Full Text Available This paper describes a cyber-forensics course that integrates important public policy and legal issues as well as relevant forensic techniques. Cyber-forensics refers to the amalgam of multi-disciplinary activities involved in the identification, gathering, handling, custody, use and security of electronic files and records, involving expertise from the forensic domain, and which produces evidence useful in the proof of facts for both commercial and legal activities. The legal and regulatory environment in which electronic discovery takes place is of critical importance to cyber-forensics experts because the legal process imposes both constraints and opportunities for the effective use of evidence gathered through cyber-forensic techniques. This paper discusses different pedagogies that can be used (including project teams, research and writing assignments, student presentations, case analyses, class activities and participation and examinations, evaluation methods, problem-based learning approaches and critical thinking analysis. A survey and evaluation is provided of the growing body of applicable print and online materials that can be utilized. Target populations for such a course includes students with majors, minors or supporting elective coursework in law, information sciences, information technology, computer science, computer engineering, financial fraud, security and information assurance, forensic aspects of cyber security, privacy, and electronic commerce.

  4. Protection of the Environment: Current ICRP Work and EC-Funded Research

    International Nuclear Information System (INIS)

    Larsson, C.M.; Holm, L.E.

    2003-01-01

    The requirement for assessments of the environmental effects of radiation, i.e. effects on non-human biota, is increasing due to growing public concern for environmental protection issues and integration of environmental impact assessments into the regulatory process. Thus, there is a strong need to establish a framework for the assessment of environmental impact of ionising radiation, as well as a system for protection of the environment from ionising radiation. These ambitions are reflected in a number of international efforts and various 'systems' have been proposed or are under development. This paper considers the current discussions on environmental protection within the International Commission on Radiological Protection (ICRP), as part of the Commission's ongoing revision of its recommendations as laid out in Publication 60. Furthermore, the paper reviews work within the EC-funded FASSET (Framework for ASSessment of Environmental impacT) project. The concepts developed both by ICRP and FASSET are similar, and the FASSET approach and results may illustrate how forthcoming ICRP recommendations could be turned into practical application. (orig.)

  5. 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

  6. Strategic Renewal in Regulatory Environments. How inter- and intra-organisational institutional forces influence European incumbent energy firms

    International Nuclear Information System (INIS)

    Stienstra, M.

    2008-01-01

    How do incumbent firms strategically renew in regulatory environments? Assuming that regulation can both constrain and enable a firm's strategic renewal opportunities, we investigate how and to what extent incumbent firms undertake exploitative and explorative strategic renewal actions in order to remain competitive. Exploitative strategic renewal involves those actions that strengthen or optimise a firm's current resource deployments, whereas explorative strategic renewal relates to actions that generate new sources of value creation for the firm. Based on old institutional theory, new institutional theory, neo-institutional theory and institutional entrepreneurship literature, a multi-level framework that combines selection and adaptation arguments has been developed and applied to investigate strategic renewal behaviour of a sample of European energy incumbents. At industry level of analysis, results show how inter-organisational institutional forces significantly impact firms' choices of exploitative and explorative strategic renewal actions through regulative, normative and cognitive forces. At organisational unit level of analysis, we find that the extent of intra-organisational regulative forces is positively related to exploitative strategic renewal actions. In addition, entrepreneurial proclivity appears to be a catalyst of both exploitative and explorative strategic renewal actions. Finally, our results provide insights how environmental selection and firm level adaptation are interrelated in the context of regulation. The extent of inter-organisational regulative forces positively moderates the relationship between intra-organisational regulative forces and exploitative strategic renewal actions.

  7. Strategic Renewal in Regulatory Environments. How inter- and intra-organisational institutional forces influence European incumbent energy firms

    Energy Technology Data Exchange (ETDEWEB)

    Stienstra, M.

    2008-11-20

    How do incumbent firms strategically renew in regulatory environments? Assuming that regulation can both constrain and enable a firm's strategic renewal opportunities, we investigate how and to what extent incumbent firms undertake exploitative and explorative strategic renewal actions in order to remain competitive. Exploitative strategic renewal involves those actions that strengthen or optimise a firm's current resource deployments, whereas explorative strategic renewal relates to actions that generate new sources of value creation for the firm. Based on old institutional theory, new institutional theory, neo-institutional theory and institutional entrepreneurship literature, a multi-level framework that combines selection and adaptation arguments has been developed and applied to investigate strategic renewal behaviour of a sample of European energy incumbents. At industry level of analysis, results show how inter-organisational institutional forces significantly impact firms' choices of exploitative and explorative strategic renewal actions through regulative, normative and cognitive forces. At organisational unit level of analysis, we find that the extent of intra-organisational regulative forces is positively related to exploitative strategic renewal actions. In addition, entrepreneurial proclivity appears to be a catalyst of both exploitative and explorative strategic renewal actions. Finally, our results provide insights how environmental selection and firm level adaptation are interrelated in the context of regulation. The extent of inter-organisational regulative forces positively moderates the relationship between intra-organisational regulative forces and exploitative strategic renewal actions.

  8. 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

  9. Impact of a Fragmented Regulatory Environment on Sustainable Urban Development Design Management

    Directory of Open Access Journals (Sweden)

    Kerry Anne London

    2009-12-01

    Full Text Available The building project development approval process is increasingly complex and fraught with conflict due to the rise of the sustainable urban development movement and inclusive decision making. Coupled with this, government decision-making decentralization has resulted in a fragmented and over-regulated compliance system. Problems arising from the process include wasted resources, excessive time delays, increased holding and litigation costs, inadequate planning coordination, high levels of advocacy costs and a divisive politicized approval process. In Australia, despite attempts by government and industry associations, numerous problems are still unresolved. Design managers increasingly assume a liaison role during the approval phase. There is a long tradition of planning theory literature which provides context for understanding the knowledge-power-participation relationship for this paper. This study investigated the policy, process and practice conflicts during the approval stage in achieving sustainable urban developments. Three regional local government areas within one state jurisdiction and observations from detailed structured focus group interviews involving 23 stakeholders, proposers and assessors were analysed to explore this conflictual environment. As a result of regulatory fragmentation and excessive consultation, various persuasion tactics have been developed by all stakeholders of which `reciprocity' and `authority' were identified as the most common. Two challenges for design managers were thus identified: first, the emergence of the role of a by default central informal arbitrator across conflicting planning instruments; and, second, as a navigator through a set of persuasion tactics. An inclusive knowledge-based design management framework for sustainable urban development is proposed considering Habermas' communicative planning theory, Foucaltian governance and discursive powers thesis and Cialdini's persuasion theory, as

  10. 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

  11. Side Impact Regulatory Trends, Crash Environment and Injury Risk in the USA.

    Science.gov (United States)

    Prasad, Priya; Dalmotas, Dainius; Chouinard, Aline

    2015-11-01

    Light duty vehicles in the US are designed to meet and exceed regulatory standards, self-imposed industry agreements and safety rating tests conducted by NHTSA and IIHS. The evolution of side impact regulation in the US from 1973 to 2015 is discussed in the paper along with two key industry agreements in 2003 affecting design of restraint systems and structures for side impact protection. A combination of all the above influences shows that vehicles in the US are being designed to more demanding and comprehensive requirements than in any other region of the world. The crash environment in the US related to side impacts was defined based on data in the nationally representative crash database NASS. Crash environment factors, including the distribution of cars, light trucks and vans (LTV's), and medium-to-heavy vehicles (MHV's) in the fleet, and the frequency of their interactions with one another in side impacts, were considered. Other factors like, crash severity in terms of closing velocity between two vehicles involved in crash, gender and age of involved drivers in two-vehicle and single vehicle crashes, were also examined. Injury risks in side impacts to drivers and passengers were determined in various circumstances such as near-side, far-side, and single vehicle crashes as a function of crash severity, in terms of estimated closing speed or lateral delta-V. Also injury risks in different pairs of striking and struck cars and LTV's, were estimated. A logistic regression model for studying injury risks in two vehicle crashes was developed. The risk factors included in the model include case and striking vehicles, consisting of cars, SUV's, vans, and pickup trucks, delta-V, damage extent, occupant proximity to the impact side, age and gender of the occupant, and belt use. Results show that car occupants make up the vast majority of serious-to-fatally injured occupants. Injury rates of car occupants in two-vehicle collision are highest when the car is struck by a

  12. 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.

  13. 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.

  14. Working with Policy and Regulatory Factors to Implement Universal Design in the Built Environment: The Australian Experience.

    Science.gov (United States)

    Larkin, Helen; Hitch, Danielle; Watchorn, Valerie; Ang, Susan

    2015-07-15

    Built environments that are usable by all provide opportunities for engagement in meaningful occupations. However, enabling them in day to day design processes and practice is problematic for relevant professions. The purpose of this phenomenological study was to gain greater understanding of the policy and regulatory influences that promote or hinder the uptake of universal design in built environments, to inform better future design. Focus groups or telephone interviews were undertaken with 28 key building industry and disability stakeholders in Australia. Four themes were identified: the difficulties of definition; the push or pull of regulations and policy; the role of formal standards; and, shifting the focus of design thinking. The findings highlight the complexity of working within policy and regulatory contexts when implementing universal design. Occupational therapists working with colleagues from other professions must be aware of these influences, and develop the skills to work with them for successful practice.

  15. Fronting Integrated Scientific Web Applications: Design Features and Benefits for Regulatory Environments

    Science.gov (United States)

    Integrated decision support systems for regulatory applications benefit from standardindustry practices such as code reuse, test-driven development, and modularization. Theseapproaches make meeting the federal government’s goals of transparency, efficiency, and quality assurance ...

  16. 76 FR 38399 - Assessing the Current Research, Policy, and Practice Environment in Public Health Genomics

    Science.gov (United States)

    2011-06-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket Number CDC-2011-0008] Assessing the Current Research, Policy, and Practice Environment in Public Health... information helpful to assess the current research, policy, and practice environment in public health genomics...

  17. 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.

  18. 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.

  19. Regulatory effect of paraprobiotic Lactobacillus gasseri CP2305 on gut environment and function

    Directory of Open Access Journals (Sweden)

    Tomonori Sugawara

    2016-03-01

    Full Text Available Background: Lactobacillus gasseri CP2305 (CP2305 is a strain of Lactobacillus isolated from a stool sample from a healthy adult that showed beneficial effects on health as a paraprobiotic. In a previous study, we demonstrated that CP2305-fermented heat-treated milk modified gut functions more than artificially acidified sour milk. Thus, the regulatory activity of the former beverage was attributed to the inactivated CP2305 cells. Objective: The aim of this study was to elucidate the contribution of non-viable paraprobiotic CP2305 cells to regulating human gut functions. We thus conducted a randomized, placebo-controlled, double-blinded parallel group trial. Design: The trial included 118 healthy participants with relatively low or high stool frequencies. The test beverage was prepared by adding 1×1010 washed, heat-treated, and dried CP2305 cells directly to the placebo beverage. The participants ingested a bottle of the assigned beverage daily for 3 weeks and answered daily questionnaires about defecation and quality of life. Fecal samples were collected and the fecal characteristics, microbial metabolite contents of the feces and composition of fecal microbiota were evaluated. Results: The number of evacuations and the scores for fecal odors were significantly improved in the group that consumed the CP2305-containing beverage compared with those of the group that consumed the placebo (p=0.035 and p=0.040, respectively. Regarding the fecal contents of microbial metabolites, the level of fecal p-cresol was significantly decreased in the CP2305 group relative to that of the placebo group (p=0.013. The Bifidobacterium content of the intestinal microbiota was significantly increased in the CP2305 group relative to that of the placebo group (p<0.008, whereas the content of Clostridium cluster IV was significantly decreased (p<0.003. The parasympathetic nerve activity of the autonomic nervous system became dominant and the total power of autonomic

  20. 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

  1. 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.

  2. 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.

  3. 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)

  4. Safeguards decision making in the public and regulatory environment, and the potential role of quantitative approaches

    International Nuclear Information System (INIS)

    Sherr, T.S.

    1981-01-01

    This paper briefly examines the nature of the safeguards program's objectives and constraints, and the inherent limitations on comprehensive quantification. It discusses the nature of the public and regulatory processes employed in safeguards decision making, and examines their implications regarding the potential role of quantitative approaches to safeguards policy and operational decision making

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. Mathematical model of a current of two plastic environments in the forming channel extruders at coextrusion

    Directory of Open Access Journals (Sweden)

    V. N. Vasilenko

    2012-01-01

    Full Text Available On the basis of the classical equations of an isothermal pressure head current of two rheology the various not mixing up viscou- plastic environments in the cylindrical channel, Ostvald-de-Vil submitting to the law, the model of a current of two viscous-plastic environments in the moulding channel extruder is synthesised at co-extrusion on which basis the technique of a choice of diameter of a dosing out branch pipe on the demanded value of the ratio of volume expenditures of two viscous-plastic environments (extrudat and stuffings is offered.

  10. Use of electronic cigarettes across 13 ITC countries with different regulatory environments

    Directory of Open Access Journals (Sweden)

    Shannon Gravely

    2018-03-01

    With minor exceptions (e.g. Australia, awareness, trial, and use of e-cigarettes across the 13 countries generally reflected the de facto environment rather than the statutory environment implied by the law(s. Country income classification and survey year also appear to be strongly associated with use.

  11. 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.

  12. Application of risk-based value-impact analysis in a nuclear regulatory environment

    International Nuclear Information System (INIS)

    Dinnie, Keith; Land, Ronald; Stella, Mark

    1992-01-01

    Value-impact analysis (VIA) is a quantitative process that examines the benefits of proposed actions and the costs of implementing those actions to determine the potential for a net beneficial result. There is a point beyond which efforts to improve nuclear plant safety by implementing design changes will be unjustifiably expensive for the societal benefits obtained. Resources that would be used to obtain marginal improvements in public safety can then be used to obtain greater benefits for society in other areas. VIA can help to identify this point. What can not be accomplished by VIA is the definition of the level of risk (or safety) above which cost-benefit considerations are not applicable. This must be established separately, by political action or through promulgation of acceptable risk levels and safety goals by regulatory agencies. 18 refs

  13. Transforming public utility commissions in the new regulatory environment: Some issues and ideas for managing change

    Energy Technology Data Exchange (ETDEWEB)

    Wirick, D.W.; Davis, V.W.; Burns, R.E.; Jones, D.N.

    1996-07-01

    In the face of sweeping changes in utility markets and regulatory practices, public utility commissions are being forced to change in fundamental ways--to substantially transform themselves rather than to make only incremental changes in their operations. Managing this process of radical change is complicated by the fact that for the foreseeable future some portions of utility markets (e.g., water utilities) will function much as they have before. Some envision commissions in the future that are more externally focussed, that rely more on dispute resolution than adjudicatory proceedings, that concentrate on identifying and understanding competitive markets, that are more automated, and that are more likely to question old assumptions and definitions. This report identifies the considerations commissions might apply for identifying what mix of skills or fields of experise should compromise the technical staff. Factors are also identified which point towards a sectoral arrangement of staff and those factors which point toward a functional approach.

  14. 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.)

  15. Problems in developing a rational approach to radiological protection of the environment from a regulatory viewpoint

    International Nuclear Information System (INIS)

    Sgrilli, E.; Tarroni, G.

    2002-01-01

    The aim of this paper is to outline problems arising when trying to draw an obvious parallel between what is already extant for the radiation protection of man and the environment and what might further be thought feasible for the environment. For this purpose a brief summary will be made of the salient characteristics of the present radiation protection system, as recommended by ICRP and accepted inter alia in the IAEA basic safety standards and european directives, estimates of radiation effects on biota and trends in environmental protection will be briefly reviewed, as well as the main challenges to meet. (N.C.)

  16. FREEDOM OF PRESS IN CURRENT SOCIO-POLITICAL ENVIRONMENT IN ROMANIA

    OpenAIRE

    Georgiana STĂNESCU; Ionuț SUCIU

    2017-01-01

    This study analyses the way journalists’ freedom of expression is protected in current socio/political context. It has started from the fact that Mass Media is the guarantee of any modern democracy, and respect for freedom of expression is essential in the current European environment. We have shown that Romania guarantees through the Constitution, but also through other international treaties to which it is a signatory, the freedom of expression of every citizen, and, implicitly, the freedom...

  17. Passive sampling in regulatory chemical monitoring of nonpolar organic compounds in the aquatic environment

    NARCIS (Netherlands)

    Booij, K.; Robinson, C.D.; Burgess, R.M.; Mayer, P.; Roberts, C.A.; Ahrens, L.; Allan, I.J.; Brant, J.; Jones, L.; Kraus, U.R.; Larsen, M.M.; Lepom, P.; Petersen, J.; Pröfrock, D.; Roose, P.; Schäfer, S.; Smedes, F.; Tixier, C.; Vorkamp, K.; Whitehouse, P.

    2016-01-01

    We reviewed compliance monitoring requirements in the EuropeanUnion, the United States, and the Oslo-Paris Convention for the protection of themarine environment of the North-East Atlantic, and evaluated if these are met bypassive sampling methods for nonpolar compounds. The strengths

  18. Reconciling regulatory space with external accountability through WTO adjudication : trade, environment and development

    NARCIS (Netherlands)

    Weimer, M.

    2017-01-01

    This article argues in favour of broadening the trade and environment debate in the World Trade Organization (WTO) to include a developmental perspective. WTO litigation involving environmental regulation touches upon the issue of global justice and the power asymmetries structurally embedded in the

  19. 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.

  20. Synthetic fuels and the environment: an environmental and regulatory impacts analysis

    Energy Technology Data Exchange (ETDEWEB)

    None

    1980-06-01

    Since July 1979 when DOE/EV-0044 report Environmental Analysis of Synthetic Liquid fuels was published the synthetic fuels program proposals of the Administration have undergone significant modifications. The program year for which the development goal of 1.5 million barrels per day is to be reached has been changed from 1990 to 1995. The program plan is now proposed to have two stages to ensure, among other things, better environmental protection: an initial stage emphasizing applied research and development (R and D), including environmental research, followed by a second stage that would accelerate deployment of those synthetic fuel technologies then judged most ready for rapid deployment and economic operation within the environmental protection requirements. These program changes have significantly expanded the scope of technologies to be considered in this environmental analysis and have increased the likelihood that accelerated environmental R and D efforts will be successful in solving principal environmental and worker safety concerns for most technologies prior to the initiation of the second stage of the accelerated deployment plan. Information is presented under the following section headings: summary; study description; the technologies and their environmental concerns (including, coal liquefaction and gasification, oil shale production, biomass and urban waste conversion); regulatory and institutional analyses; and environmental impacts analysis (including air and water quaility analyses, impacts of carbon dioxide and acid rain, water availability, solid and hazardous wastes, coal mining environmental impacts, transportation issues, community growth and change, and regional impacts). Additional information is presented in seventeen appendixes. (JGB)

  1. Managing risk in developing transplant immunosuppressive agents: the new regulatory environment.

    Science.gov (United States)

    Gabardi, S; Halloran, P F; Friedewald, J

    2011-09-01

    Recent adverse experience with a number of medications after their approval, including rofecoxib, erythropoietin and rosiglitazone, has led to an increased focus on safety in drug development in the postmarketing setting. The result was implementation of new measures to address perceived deficits in the system for drug approval and postmarketing safety. The resulting legislation introduced risk evaluation and mitigation strategies (REMS) and postmarketing requirements (PMRs). Although these initiatives have the potential to improve patient outcomes, many healthcare practitioners are not yet familiar with REMS or PMRs or may have misconceptions regarding their goals and limitations. REMS is a program to manage known or potential serious risks associated with pharmaceutical products and is designed to ensure that the benefits of using a particular product outweigh the risks. Although the concepts underlying REMS and PMRs are not novel, the FDA now has legal authority to enforce such measures as part of the drug approval process. This article outlines the objectives and limitations of REMS and PMRs, with a focus on how these regulatory measures may impact the clinical specialty of transplantation. The article also briefly describes efforts to address aspects of drug safety less amenable to management through REMS and PMRs. © 2011 The Authors Journal compilation © 2011 The American Society of Transplantation and the American Society of Transplant Surgeons.

  2. Prioritization of chemicals in the aquatic environment based on risk assessment: analytical, modeling and regulatory perspective.

    Science.gov (United States)

    Guillén, D; Ginebreda, A; Farré, M; Darbra, R M; Petrovic, M; Gros, M; Barceló, D

    2012-12-01

    The extensive and intensive use of chemicals in our developed, highly technological society includes more than 100,000 chemical substances. Significant scientific evidence has lead to the recognition that their improper use and release may result in undesirable and harmful side-effects on both the human and ecosystem health. To cope with them, appropriate risk assessment processes and related prioritization schemes have been developed in order to provide the necessary scientific support for regulatory procedures. In the present paper, two of the elements that constitute the core of risk assessment, namely occurrence and hazard effects, have been discussed. Recent advances in analytical chemistry (sample pre-treatment and instrumental equipment, etc.) have allowed for more comprehensive monitoring of environmental pollution reaching limits of detection up to sub ng L(-1). Alternative to analytical measurements, occurrence models can provide risk managers with a very interesting approach for estimating environmental concentrations from real or hypothetical scenarios. The most representative prioritization schemes used for issuing lists of concerning chemicals have also been examined and put in the context of existing environmental policies for protection strategies and regulations. Finally, new challenges in the field of risk-assessment have been outlined, including those posed by new materials (i.e., nanomaterials), transformation products, multi-chemical exposure, or extension of the risk assessment process to the whole ecosystem. Copyright © 2012 Elsevier B.V. All rights reserved.

  3. Computer simulations of a generic truck cask in a regulatory fire using the Container Analysis Fire Environment (CAFE) code

    International Nuclear Information System (INIS)

    Ju, H.; Greiner, M.; Suo-Anttila, A.

    2002-01-01

    The Container Analysis Fire Environment (CAFE) computer code is designed to predict accurately convection and radiation heat transfer to a thermally massive object engulfed in a large pool fire. It is well suited for design and risk analyses of spent nuclear fuel transport systems. CAFE employs computational fluid dynamics and several fire and radiation models. These models must be benchmarked using experimental results. In this paper, a set of wind velocity conditions are determined which allow CAFE accurately to reproduce recent heat transfer measurements for a thick walled calorimeter in a ST-1 regulatory pool fire. CAFE is then used to predict the response of an intack (thin walled) generic legal weight truck cask. The maximum temperatures reached by internal components are within safe limits. A simple 800 deg. C, grey-radiation fire model gives maximum component temperatures that are somewhat below those predicted by CAFE. (author)

  4. The EbpA-RpoN Regulatory Pathway of the Pathogen Leptospira interrogans Is Essential for Survival in the Environment

    Science.gov (United States)

    Hu, Wei-Lin; Pappas, Christopher J.; Zhang, Jun-Jie; Yang, You-Yun; Yan, Jie

    2016-01-01

    achieves its long-term survival in the aquatic environment. By utilizing bioinformatic, genetic, and biochemical methods, we discovered a regulatory pathway in L. interrogans, the EbpA-RpoN pathway, and demonstrated that this pathway plays an important role in environmental survival of this pathogen. PMID:27864172

  5. The EbpA-RpoN Regulatory Pathway of the Pathogen Leptospira interrogans Is Essential for Survival in the Environment.

    Science.gov (United States)

    Hu, Wei-Lin; Pappas, Christopher J; Zhang, Jun-Jie; Yang, You-Yun; Yan, Jie; Picardeau, Mathieu; Yang, X Frank

    2017-02-01

    long-term survival in the aquatic environment. By utilizing bioinformatic, genetic, and biochemical methods, we discovered a regulatory pathway in L. interrogans, the EbpA-RpoN pathway, and demonstrated that this pathway plays an important role in environmental survival of this pathogen. Copyright © 2017 American Society for Microbiology.

  6. 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.

  7. Passive Sampling in Regulatory Chemical Monitoring of Nonpolar Organic Compounds in the Aquatic Environment

    DEFF Research Database (Denmark)

    Booij, Kees; Robinson, Craig D; Burgess, Robert M

    2016-01-01

    We reviewed compliance monitoring requirements in the European Union, the United States, and the Oslo-Paris Convention for the protection of the marine environment of the North-East Atlantic, and evaluated if these are met by passive sampling methods for nonpolar compounds. The strengths...... is the best available technology for chemical monitoring of nonpolar organic compounds. Key issues to be addressed by scientists and environmental managers are outlined....... and shortcomings of passive sampling are assessed for water, sediments, and biota. Passive water sampling is a suitable technique for measuring concentrations of freely dissolved compounds. This method yields results that are incompatible with the EU's quality standard definition in terms of total concentrations...

  8. The U.S. Nuclear Regulatory Commission Thermal-Hydraulic Research Program: Maintaining expertise in a changing environment

    International Nuclear Information System (INIS)

    Sheron, B.W.; Shotkin, L.M.; Baratta, A.J.

    1993-01-01

    Throughout the 1970s and early 1980s, the U.S. Nuclear Regulatory Commission's (NRC's) thermal-hydraulic research program enjoyed ample funding, sponsored extensive experimental and analytical development programs, and attracted worldwide expertise. With the completion of the major experimental programs and with the promulgation of the revised emergency core-cooling system rule, both the funding and prominence of thermal-hydraulic research at the NRC have declined in recent years. This has led justifiably to the concern by some that the program may no longer have the minimal elements needed to maintain both expertise and world-class status. The purpose of this article is to describe the NRC's current thermal-hydraulic research program and to show how this program ensures maintenance of a viable, robust research effort and retention of needed expertise and international leadership

  9. Current-Voltage Characteristics of DC Discharge in Micro Gas Jet Injected into Vacuum Environment

    International Nuclear Information System (INIS)

    Matra, K; Furuta, H; Hatta, A

    2013-01-01

    A current-voltage characteristic of direct current (DC) gas discharge operated in a micro gas jet injected into a secondary electron microscope (SEM) chamber is presented. Ar gas was injected through a 30 μm orifice gas nozzle (OGN) and was evacuated by an additional pump to keep the high vacuum environment. Gas discharges were ignited between the OGN as anode and a counter electrode of Si wafer. The discharge was self-pulsating in most of the cases while it was stable at lower pressure, larger gap length, and larger time averaged current. The self-pulsating discharge was oscillated by the RC circuit consisting of a stray capacitor and a large ballast resistor. The real time plots of voltage and current during the pulsating was investigated using a discharge model.

  10. Conductor of high electrical current at high temperature in oxygen and liquid metal environment

    Science.gov (United States)

    Powell, IV, Adam Clayton; Pati, Soobhankar; Derezinski, Stephen Joseph; Lau, Garrett; Pal, Uday B.; Guan, Xiaofei; Gopalan, Srikanth

    2016-01-12

    In one aspect, the present invention is directed to apparatuses for and methods of conducting electrical current in an oxygen and liquid metal environment. In another aspect, the invention relates to methods for production of metals from their oxides comprising providing a cathode in electrical contact with a molten electrolyte, providing a liquid metal anode separated from the cathode and the molten electrolyte by a solid oxygen ion conducting membrane, providing a current collector at the anode, and establishing a potential between the cathode and the anode.

  11. Plastics, the environment and human health: current consensus and future trends

    OpenAIRE

    Thompson, Richard C.; Moore, Charles J.; vom Saal, Frederick S.; Swan, Shanna H.

    2009-01-01

    Plastics have transformed everyday life; usage is increasing and annual production is likely to exceed 300 million tonnes by 2010. In this concluding paper to the Theme Issue on Plastics, the Environment and Human Health, we synthesize current understanding of the benefits and concerns surrounding the use of plastics and look to future priorities, challenges and opportunities. It is evident that plastics bring many societal benefits and offer future technological and medical advances. However...

  12. Challenging the current strategy of radiological protection of the environment: arguments for an ecosystem approach

    International Nuclear Information System (INIS)

    Brechignac, F.; Doi, Masahiro

    2009-01-01

    The system of radiological protection of the environment that is currently under development is one contribution to the general need to adequately protect the environment against stress. Dominated by operational goals, it emphasizes conceptual and methodological approaches that are readily accessible today: reference organisms supported by individual-based traditional ecotoxicological data. Whilst there are immediate advantages to this approach (pragmatism, consistency with other approaches in use for man and biota), there are also clear limitations, especially in a longer run perspective, that need to be acknowledged and further considered. One can mention a few: uncertainties generated by the need for various extrapolations (from lower to higher levels of biological organisation, ...), various features missed such as potential ecological impact through impairment of ecosystem processes, trans-generational impacts as mediated through genomic instability, indirect effects mediated through trophic interactions or disruption of ecological balances, ... Such limitations have already been faced in other fields of environmental protection against other stressors, pushing a number of environment professionals to assign stronger emphasis on more systemic approaches. This review discusses the advantages and limitations of the current approach designed for the radiological protection of non-human biota in the broader context of environment protection as a whole, with especial reference to upcoming trends and evolutions. This leads in particular to advocating the need to boost scientific and methodological approaches featuring the ecosystem concept as a mean to access a unified goal of protection: preserving life sustainability through protection of ecosystem structure and functioning.

  13. Challenging the current strategy of radiological protection of the environment: arguments for an ecosystem approach

    Energy Technology Data Exchange (ETDEWEB)

    Brechignac, F., E-mail: francois.brechignac@irsn. [Institute for Radioprotection and Nuclear Safety (IRSN), Centre d' Etudes de Cadarache, Blg 229, 13115 Saint-Paul-lez-Durance (France); Doi, Masahiro [National Institute of Radiological Sciences, NIRS, Center for Radiation Protection, Regulatory Sciences Research Group, 4-9-1, Anagawa, Inage, Chiba, 263-8555 (Japan)

    2009-12-15

    The system of radiological protection of the environment that is currently under development is one contribution to the general need to adequately protect the environment against stress. Dominated by operational goals, it emphasizes conceptual and methodological approaches that are readily accessible today: reference organisms supported by individual-based traditional ecotoxicological data. Whilst there are immediate advantages to this approach (pragmatism, consistency with other approaches in use for man and biota), there are also clear limitations, especially in a longer run perspective, that need to be acknowledged and further considered. One can mention a few: uncertainties generated by the need for various extrapolations (from lower to higher levels of biological organisation, ...), various features missed such as potential ecological impact through impairment of ecosystem processes, trans-generational impacts as mediated through genomic instability, indirect effects mediated through trophic interactions or disruption of ecological balances, ... Such limitations have already been faced in other fields of environmental protection against other stressors, pushing a number of environment professionals to assign stronger emphasis on more systemic approaches. This review discusses the advantages and limitations of the current approach designed for the radiological protection of non-human biota in the broader context of environment protection as a whole, with especial reference to upcoming trends and evolutions. This leads in particular to advocating the need to boost scientific and methodological approaches featuring the ecosystem concept as a mean to access a unified goal of protection: preserving life sustainability through protection of ecosystem structure and functioning.

  14. Ensuring Access to Safe, Legal Abortion in an Increasingly Complex Regulatory Environment.

    Science.gov (United States)

    Paul, Maureen; Norton, Mary E

    2016-07-01

    Restrictions on access to abortion in the United States have reached proportions unprecedented since the nationwide legalization of abortion in 1973. Although some restrictions aim to discourage women from having abortions, many others impede access by affecting the timeliness, affordability, or availability of services. Evidence indicates that these restrictions do not increase abortion safety; rather, they create logistic barriers for women seeking abortion, and they have the greatest effect on women with the fewest resources. In this commentary, we recall the important role that obstetrician-gynecologists (ob-gyns) have played, both before and after Roe v. Wade, in facilitating access to safe abortion care. Using the literature on abortion safety and access as a foundation, we propose several practical ideas about what we as ob-gyns can do to address the current threat to abortion access, whether or not we provide abortion services in practice. We hope that this commentary will encourage discourse within our profession and prompt other suggestions. As ob-gyns who are dedicated to addressing health disparities and promoting the health and well-being of our patients, we can make a difference.

  15. The Built Environment and Child Health: An Overview of Current Evidence.

    Science.gov (United States)

    Gascon, Mireia; Vrijheid, Martine; Nieuwenhuijsen, Mark J

    2016-09-01

    Urbanization and the shaping of the built environment have provided a number of socioeconomic benefits, but they have also brought unwanted side effects on health. We aimed to review the current epidemiological evidence of the associations between the built environment, closely related exposures, and child health. We focused on growth and obesity, neuropsychological development, and respiratory and immune health. We used existing review articles and supplemented these with relevant work published and not included in existing reviews. The present review shows that there is good evidence for an association between air pollution and fetal growth restriction and respiratory health, whereas for other exposure and outcome combinations, further evidence is needed. Future studies should make efforts to integrate the different built environment features and to include the evaluation of environments other than home, as well as accessibility, qualitative and perception assessment of the built environment, and, if possible, with improved and standardized tools to facilitate comparability between studies. Efforts are also needed to conduct longitudinal and intervention studies and to understand potential mechanisms behind the associations observed. Finally, studies in low- and middle-income countries are needed.

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

    Science.gov (United States)

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

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

  17. Field intercomparison of three current meters in an environment free from high frequency motion

    Science.gov (United States)

    Larouche, Pierre; Deguise, Jean-Claude

    1989-06-01

    An intercomparison of three different types of current meter was performed in an Arctic environment where wave action was absent, permitting the evaluation of the instruments under natural conditions of weak currents and cold water. The instruments were an Aanderaa RCMS4S, an Inter Ocean S4 and an EG&G-Neil Brown Smart Acoustic Current Meter (SACM). The S4 and the SACM both showed their ability to measure very small currents as opposed to the RCM4S which is limited by a mechanical rotor threshold. The agreement of the direction was better between the RCM4S and the SACM than between the RCM4S and the S4. Due to the misalignment of the Aanderaa vane in very weak currents, direction differences between the instruments of either pair can, however, reach 180°. The misalignment also shields the Aanderaa rotor leading to underestimation of current speed. The threshold for a good speed reading for the Aanderaa can be put conservatively at 5 cm s -1. Above this value, the RCM4S over-responded compared to both the S4 and the SACM. The source of that problem seems to be related to different calibrations of the instruments. Finally a power spectrum analysis showed that the RCM4S, when not influenced by wave action, can produce a measure of the energy as good as that of a vector averaging instrument.

  18. CAFE: A Computer Tool for Accurate Simulation of the Regulatory Pool Fire Environment for Type B Packages

    International Nuclear Information System (INIS)

    Gritzo, L.A.; Koski, J.A.; Suo-Anttila, A.J.

    1999-01-01

    The Container Analysis Fire Environment computer code (CAFE) is intended to provide Type B package designers with an enhanced engulfing fire boundary condition when combined with the PATRAN/P-Thermal commercial code. Historically an engulfing fire boundary condition has been modeled as σT 4 where σ is the Stefan-Boltzman constant, and T is the fire temperature. The CAFE code includes the necessary chemistry, thermal radiation, and fluid mechanics to model an engulfing fire. Effects included are the local cooling of gases that form a protective boundary layer that reduces the incoming radiant heat flux to values lower than expected from a simple σT 4 model. In addition, the effect of object shape on mixing that may increase the local fire temperature is included. Both high and low temperature regions that depend upon the local availability of oxygen are also calculated. Thus the competing effects that can both increase and decrease the local values of radiant heat flux are included in a reamer that is not predictable a-priori. The CAFE package consists of a group of computer subroutines that can be linked to workstation-based thermal analysis codes in order to predict package performance during regulatory and other accident fire scenarios

  19. Monitoring of radioactivity in the UK environment. An annotated bibliography of current programmes

    International Nuclear Information System (INIS)

    2001-01-01

    With the continuing use of radioactive materials in industry, research and medicine, the public's awareness about the potential impact on human health and safety of any enhanced levels of radiation in the environment has heightened. All those involved recognise this concern and there has developed over the years a network of comprehensive monitoring systems designed to determine the levels of radiation to which members of the public are exposed. In the UK, many organisations carry out regular radioactivity monitoring programmes, and summaries of these programmes have been published in 1983, 1988 and 1992. The number of organisations carrying out monitoring, particularly in the local authority sector, increased rapidly following the Chernobyl incident in 1986 and later levelled off. This report updates those previous summaries, giving synopses of regular UK programmes whose results are published in report form, and of which the Department of the Environment, Transport and the Regions is currently aware

  20. Does the Regulatory Environment for E-Cigarettes Influence the Effectiveness of E-Cigarettes for Smoking Cessation?: Longitudinal Findings From the ITC Four Country Survey.

    Science.gov (United States)

    Yong, Hua-Hie; Hitchman, Sara C; Cummings, K Michael; Borland, Ron; Gravely, Shannon M L; McNeill, Ann; Fong, Geoffrey T

    2017-11-01

    To date, no studies have explored how different regulatory environments may influence the effectiveness of electronic cigarettes (ECs) as a smoking cessation aid. This study compares the real-world effectiveness of adult smokers using ECs for quitting compared with quitting unassisted or quitting with nicotine replacement therapy (NRT) and/or prescription medications in two countries with restrictive policies towards ECs (ie, Canada and Australia) versus two countries with less restrictive policies (ie, United States and United Kingdom). Data were drawn from the International Tobacco Control Four Country surveys, from the United States and Canada (2 waves, n = 318 and 380, respectively), the United Kingdom (3 waves, n = 439) and Australia (4 waves, n = 662), collected 2010-2014. Smokers at baseline wave who reported making a quit attempt at follow-up were included. The primary outcome was self-reported abstinence for at least 30 days regardless of smoking status at follow-up assessment. Data across waves were combined and analyzed using generalized estimating equations. Compared to unassisted quitting (ie, no medications or ECs), smokers who used ECs for quitting from countries with less restrictive EC policy environments were more likely (OR = 1.95, 95%CI = 1.19-3.20, p cessation are likely highly dependent on the regulatory environment. What this study adds: This is the first study to examine the impact of regulatory environment for ECs on their real-world effectiveness for smoking cessation. This study shows that in a less restrictive EC regulatory environment, use of ECs during a quit attempt facilitates, but in a more restrictive environment, it inhibits, short-term sustained abstinence. The findings underscore the need for careful consideration on how best to regulate this emerging product so that EC benefits for smoking cessation are maximized and its risks to public health are minimized. © The Author 2017. Published by Oxford University Press on behalf of

  1. 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

  2. Lagrangian statistics of mesoscale turbulence in a natural environment: The Agulhas return current.

    Science.gov (United States)

    Carbone, Francesco; Gencarelli, Christian N; Hedgecock, Ian M

    2016-12-01

    The properties of mesoscale geophysical turbulence in an oceanic environment have been investigated through the Lagrangian statistics of sea surface temperature measured by a drifting buoy within the Agulhas return current, where strong temperature mixing produces locally sharp temperature gradients. By disentangling the large-scale forcing which affects the small-scale statistics, we found that the statistical properties of intermittency are identical to those obtained from the multifractal prediction in the Lagrangian frame for the velocity trajectory. The results suggest a possible universality of turbulence scaling.

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

    Directory of Open Access Journals (Sweden)

    John Tiah Bugri

    2017-05-01

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

  4. Reactors licensing: proposal of an integrated quality and environment regulatory structure for nuclear research reactors in Brazil; Licenciamento de reatores: proposta de uma estrutura regulatoria integrada com abordagem em qualidade e meio ambiente para reatores de pesquisa no Brasil

    Energy Technology Data Exchange (ETDEWEB)

    Serra, Reynaldo Cavalcanti

    2014-07-01

    A new integrated regulatory structure based on quality and integrated issues has been proposed to be implemented on the licensing process of nuclear research reactors in Brazil. The study starts with a literature review about the licensing process in several countries, all of them members of the International Atomic Energy Agency. After this phase it is performed a comparative study with the Brazilian licensing process to identify good practices (positive aspects), the gaps on it and to propose an approach of an integrated quality and environmental management system, in order to contribute with a new licensing process scheme in Brazil. The literature review considered the following research nuclear reactors: Jules-Horowitz and OSIRIS (France), Hanaro (Korea), Maples 1 and 2 (Canada), OPAL (Australia), Pallas (Holand), ETRR-2 (Egypt) and IEA-R1 (Brazil). The current nuclear research reactors licensing process in Brazil is conducted by two regulatory bodies: the Brazilian National Nuclear Energy Commission (CNEN) and the Brazilian Institute of Environment and Renewable Natural Resources (IBAMA). CNEN is responsible by nuclear issues, while IBAMA by environmental one. To support the study it was applied a questionnaire and interviews based on the current regulatory structure to four nuclear research reactors in Brazil. Nowadays, the nuclear research reactor’s licensing process, in Brazil, has six phases and the environmental licensing process has three phases. A correlation study among these phases leads to a proposal of a new quality and environmental integrated licensing structure with four harmonized phases, hence reducing potential delays in this process. (author)

  5. Review of current activities to model and measure the orbital debris environment in low-earth orbit

    Science.gov (United States)

    Reynolds, R. C.

    A very active orbital debris program is currently being pursued at the NASA/Johnson Space Center (JSC), with projects designed to better define the current environment, to project future environments, to model the processes contributing to or constraining the growth of debris in the environment, and to gather supporting data needed to improve the understanding of the orbital debris problem and the hazard it presents to spacecraft. This paper is a review of the activity being conducted at JSC, by NASA, Lockheed Engineering and Sciences Company, and other support contractors, and presents a review of current activity, results of current research, and a discussion of directions for future development.

  6. Plastics, the environment and human health: current consensus and future trends

    Science.gov (United States)

    Thompson, Richard C.; Moore, Charles J.; vom Saal, Frederick S.; Swan, Shanna H.

    2009-01-01

    Plastics have transformed everyday life; usage is increasing and annual production is likely to exceed 300 million tonnes by 2010. In this concluding paper to the Theme Issue on Plastics, the Environment and Human Health, we synthesize current understanding of the benefits and concerns surrounding the use of plastics and look to future priorities, challenges and opportunities. It is evident that plastics bring many societal benefits and offer future technological and medical advances. However, concerns about usage and disposal are diverse and include accumulation of waste in landfills and in natural habitats, physical problems for wildlife resulting from ingestion or entanglement in plastic, the leaching of chemicals from plastic products and the potential for plastics to transfer chemicals to wildlife and humans. However, perhaps the most important overriding concern, which is implicit throughout this volume, is that our current usage is not sustainable. Around 4 per cent of world oil production is used as a feedstock to make plastics and a similar amount is used as energy in the process. Yet over a third of current production is used to make items of packaging, which are then rapidly discarded. Given our declining reserves of fossil fuels, and finite capacity for disposal of waste to landfill, this linear use of hydrocarbons, via packaging and other short-lived applications of plastic, is simply not sustainable. There are solutions, including material reduction, design for end-of-life recyclability, increased recycling capacity, development of bio-based feedstocks, strategies to reduce littering, the application of green chemistry life-cycle analyses and revised risk assessment approaches. Such measures will be most effective through the combined actions of the public, industry, scientists and policymakers. There is some urgency, as the quantity of plastics produced in the first 10 years of the current century is likely to approach the quantity produced in the

  7. Plastics, the environment and human health: current consensus and future trends.

    Science.gov (United States)

    Thompson, Richard C; Moore, Charles J; vom Saal, Frederick S; Swan, Shanna H

    2009-07-27

    Plastics have transformed everyday life; usage is increasing and annual production is likely to exceed 300 million tonnes by 2010. In this concluding paper to the Theme Issue on Plastics, the Environment and Human Health, we synthesize current understanding of the benefits and concerns surrounding the use of plastics and look to future priorities, challenges and opportunities. It is evident that plastics bring many societal benefits and offer future technological and medical advances. However, concerns about usage and disposal are diverse and include accumulation of waste in landfills and in natural habitats, physical problems for wildlife resulting from ingestion or entanglement in plastic, the leaching of chemicals from plastic products and the potential for plastics to transfer chemicals to wildlife and humans. However, perhaps the most important overriding concern, which is implicit throughout this volume, is that our current usage is not sustainable. Around 4 per cent of world oil production is used as a feedstock to make plastics and a similar amount is used as energy in the process. Yet over a third of current production is used to make items of packaging, which are then rapidly discarded. Given our declining reserves of fossil fuels, and finite capacity for disposal of waste to landfill, this linear use of hydrocarbons, via packaging and other short-lived applications of plastic, is simply not sustainable. There are solutions, including material reduction, design for end-of-life recyclability, increased recycling capacity, development of bio-based feedstocks, strategies to reduce littering, the application of green chemistry life-cycle analyses and revised risk assessment approaches. Such measures will be most effective through the combined actions of the public, industry, scientists and policymakers. There is some urgency, as the quantity of plastics produced in the first 10 years of the current century is likely to approach the quantity produced in the

  8. 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)

  9. Optical Estimation of Depth and Current in a Ebb Tidal Delta Environment

    Science.gov (United States)

    Holman, R. A.; Stanley, J.

    2012-12-01

    A key limitation to our ability to make nearshore environmental predictions is the difficulty of obtaining up-to-date bathymetry measurements at a reasonable cost and frequency. Due to the high cost and complex logistics of in-situ methods, research into remote sensing approaches has been steady and has finally yielded fairly robust methods like the cBathy algorithm for optical Argus data that show good performance on simple barred beach profiles and near immunity to noise and signal problems. In May, 2012, data were collected in a more complex ebb tidal delta environment during the RIVET field experiment at New River Inlet, NC. The presence of strong reversing tidal currents led to significant errors in cBathy depths that were phase-locked to the tide. In this paper we will test methods for the robust estimation of both depths and vector currents in a tidal delta domain. In contrast to previous Fourier methods, wavenumber estimation in cBathy can be done on small enough scales to resolve interesting nearshore features.

  10. FREEDOM OF PRESS IN CURRENT SOCIO-POLITICAL ENVIRONMENT IN ROMANIA

    Directory of Open Access Journals (Sweden)

    Georgiana STĂNESCU

    2017-08-01

    Full Text Available This study analyses the way journalists’ freedom of expression is protected in current socio/political context. It has started from the fact that Mass Media is the guarantee of any modern democracy, and respect for freedom of expression is essential in the current European environment. We have shown that Romania guarantees through the Constitution, but also through other international treaties to which it is a signatory, the freedom of expression of every citizen, and, implicitly, the freedom of press. But in laws and treaties things seem simple, while in reality in the courts, the situation is completely different and, above all, extremely complicated. The study highlights the case of a journalist from Constanţa, who was sued by the former mayor of the city on the grounds that his image was damaged in a TV show on a local television station. Thus, the views of the Romanian institutions, on the one hand, and the one of the European Court of Human Rights on the other, were analyzed. The ECHR ruled for the journalist in the case against the former mayor of Constanţa (Ghiulfer vs. Romania, instead, two Romanian courts forced the journalist to pay moral damages and make him publicly apologize in a large circulation newspaper.

  11. 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

  12. 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.

  13. 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

  14. The SEDIBUD (Sediment Budgets in Cold Environments) Programme: Current activities and future key tasks

    Science.gov (United States)

    Beylich, A. A.; Lamoureux, S. F.; Decaulne, A.

    2012-04-01

    Projected climate change in cold regions is expected to alter melt season duration and intensity, along with the number of extreme rainfall events, total annual precipitation and the balance between snowfall and rainfall. Similarly, changes to the thermal balance are expected to reduce the extent of permafrost and seasonal ground frost and increase active layer depths. These effects will undoubtedly change surface environments in cold regions and alter the fluxes of sediments, nutrients and solutes, but the absence of quantitative data and coordinated process monitoring and analysis to understand the sensitivity of the Earth surface environment is acute in cold climate environments. The International Association of Geomorphologists (I.A.G./A.I.G.)SEDIBUD (Sediment Budgets in Cold Environments) Programme was formed in 2005 to address this existing key knowledge gap. SEDIBUD currently has about 400 members worldwide and the Steering Committee of this international programme is composed of ten scientists from eight different countries: Achim A. Beylich (Chair) (Norway), Armelle Decaulne (Secretary) (France), John C. Dixon (USA), Scott F. Lamoureux (Vice-Chair) (Canada), John F. Orwin (Canada), Jan-Christoph Otto (Austria), Irina Overeem (USA), Thorsteinn Saemundsson (Iceland), Jeff Warburton (UK), Zbigniew Zwolinski (Poland). The central research question of this global group of scientists is to: Assess and model the contemporary sedimentary fluxes in cold climates, with emphasis on both particulate and dissolved components. Initially formed as European Science Foundation (ESF) Network SEDIFLUX (2004-2006), SEDIBUD has further expanded to a global group of researchers with field research sites located in polar and alpine regions in the northern and southern hemisphere. Research carried out at each of the close to 50 defined SEDIBUD key test sites varies by programme, logistics and available resources, but typically represent interdisciplinary collaborations of

  15. 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.

  16. 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.

  17. On-line monitoring of base current and forward emitter current gain of the voltage regulator's serial pnp transistor in a radiation environment

    Directory of Open Access Journals (Sweden)

    Vukić Vladimir Đ.

    2012-01-01

    Full Text Available A method of on-line monitoring of the low-dropout voltage regulator's operation in a radiation environment is developed in this paper. The method had to enable detection of the circuit's degradation during exploitation, without terminating its operation in an ionizing radiation field. Moreover, it had to enable automatic measurement and data collection, as well as the detection of any considerable degradation, well before the monitored voltage regulator's malfunction. The principal parameters of the voltage regulator's operation that were monitored were the serial pnp transistor's base current and the forward emitter current gain. These parameters were procured indirectly, from the data on the voltage regulator's load and quiescent currents. Since the internal consumption current in moderately and heavily loaded devices was used, the quiescent current of a negligibly loaded voltage regulator of the same type served as a reference. Results acquired by on-line monitoring demonstrated marked agreement with the results acquired from examinations of the voltage regulator's maximum output current and minimum dropout voltage in a radiation environment. The results were particularly consistent in tests with heavily loaded devices. Results obtained for moderately loaded voltage regulators and the risks accompanying the application of the presented method, were also analyzed.

  18. 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.

  19. Are current atomistic force fields accurate enough to study proteins in crowded environments?

    Directory of Open Access Journals (Sweden)

    Drazen Petrov

    2014-05-01

    Full Text Available The high concentration of macromolecules in the crowded cellular interior influences different thermodynamic and kinetic properties of proteins, including their structural stabilities, intermolecular binding affinities and enzymatic rates. Moreover, various structural biology methods, such as NMR or different spectroscopies, typically involve samples with relatively high protein concentration. Due to large sampling requirements, however, the accuracy of classical molecular dynamics (MD simulations in capturing protein behavior at high concentration still remains largely untested. Here, we use explicit-solvent MD simulations and a total of 6.4 µs of simulated time to study wild-type (folded and oxidatively damaged (unfolded forms of villin headpiece at 6 mM and 9.2 mM protein concentration. We first perform an exhaustive set of simulations with multiple protein molecules in the simulation box using GROMOS 45a3 and 54a7 force fields together with different types of electrostatics treatment and solution ionic strengths. Surprisingly, the two villin headpiece variants exhibit similar aggregation behavior, despite the fact that their estimated aggregation propensities markedly differ. Importantly, regardless of the simulation protocol applied, wild-type villin headpiece consistently aggregates even under conditions at which it is experimentally known to be soluble. We demonstrate that aggregation is accompanied by a large decrease in the total potential energy, with not only hydrophobic, but also polar residues and backbone contributing substantially. The same effect is directly observed for two other major atomistic force fields (AMBER99SB-ILDN and CHARMM22-CMAP as well as indirectly shown for additional two (AMBER94, OPLS-AAL, and is possibly due to a general overestimation of the potential energy of protein-protein interactions at the expense of water-water and water-protein interactions. Overall, our results suggest that current MD force fields

  20. COST EFFECTIVE REGULATORY APPROACHES TO ENHANCE DOMESTIC OIL & GAS PRODUCTION AND ENSURE THE PROTECTION OF THE ENVIRONMENT

    Energy Technology Data Exchange (ETDEWEB)

    Ben Grunewald; Paul Jehn; Tom Gillespie; Ben Binder

    2004-12-21

    The Environmental Information Management Suite/Risk Based Data Management System (EIMS/RBDMS) and Cost Effective Regulatory Approach (CERA) programs continue to be successful. All oil and gas state regulatory programs participate in these efforts. Significant accomplishments include: streamline regulatory approaches, enhancing environmental protection, and making oil and gas data available via the Internet. Oil and gas companies worldwide now have access to data on state web sites. This reduces the cost of exploration and enables companies to develop properties in areas that would have been cost prohibited for exploration. Early in project, GWPC and State Oil and Gas agencies developed the EIMS and CERA strategic plan to prioritize long term development and implementation. The planning process identifies electronic commerce and coal bed methane as high priorities. The group has involved strategic partners in industry and government to develop a common data exchange process. Technical assistance to Alaska continues to improve their program management capabilities. New initiatives in Alaska include the development of an electronic permit tracking system. This system allows managers to expedite the permitting process. Nationwide, the RBDMS system is largely completed with 22 states and one Indian Nation now using this nationally accepted data management system. Additional remaining tasks include routine maintenance and the installation of the program upon request for the remaining oil and gas states. The GWPC in working with the BLM and MMS to develop an XML schema to facilitate electronic permitting and reporting (Appendix A, B, and C). This is a significant effort and, in years to come, will increase access to federal lands by reducing regulatory barriers. The new initiatives are coal bed methane and e-commerce. The e-commerce program will provide industry and BLM/MMS access to the millions of data points housed in the RBDMS system. E-commerce will streamline

  1. Current means for plasma diagnostics and their application for materials and environment control. Materials of IV Russian seminar

    International Nuclear Information System (INIS)

    2003-01-01

    The collection contains reports made at the Fourth Russian seminar Current means of plasma diagnostics and their application for materials and environment control. The seminar took place in Moscow, November 12-14, 2003. The content of the collection covers both questions of plasma diagnostics in thermonuclear reactors and problems of diagnostics of pulsed and stationary gas discharges in research and technological installations. The reports on plasma diagnostics applied for some tasks of medicine and environment control are presented [ru

  2. The Potential of Simulated Environments in Teacher Education: Current and Future Possibilities

    Science.gov (United States)

    Dieker, Lisa A.; Rodriguez, Jacqueline A.; Lignugaris/Kraft, Benjamin; Hynes, Michael C.; Hughes, Charles E.

    2014-01-01

    The future of virtual environments is evident in many fields but is just emerging in the field of teacher education. In this article, the authors provide a summary of the evolution of simulation in the field of teacher education and three factors that need to be considered as these environments further develop. The authors provide a specific…

  3. 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

  4. Current understanding of microplastics in the environment: Occurrence, fate, risks, and what we should do.

    Science.gov (United States)

    Peng, Jinping; Wang, Jundong; Cai, Liqi

    2017-05-01

    Microplastics pollution has been documented in the global environment, including at sea, in freshwater and in atmospheric fallout. Ingestion of microplastics by multiple kinds of organisms has been reported and has received increasing attention, because microplastics not only act as a source of toxic chemicals but also a sink for toxic chemicals. To better understand the great concerns about microplastics and associated toxic chemicals potential exposed to the organisms ingesting the debris, we should know more about the occurrence, fate, and risks of microplastics in the environment. What we should do depends on this better understanding. Integr Environ Assess Manag 2017;13:476-482. © 2017 SETAC. © 2017 SETAC.

  5. 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

  6. Environment

    DEFF Research Database (Denmark)

    Valentini, Chiara

    2017-01-01

    The term environment refers to the internal and external context in which organizations operate. For some scholars, environment is defined as an arrangement of political, economic, social and cultural factors existing in a given context that have an impact on organizational processes and structures....... For others, environment is a generic term describing a large variety of stakeholders and how these interact and act upon organizations. Organizations and their environment are mutually interdependent and organizational communications are highly affected by the environment. This entry examines the origin...... and development of organization-environment interdependence, the nature of the concept of environment and its relevance for communication scholarships and activities....

  7. Current construction status of Korea Wolsong Nuclear Environment Management Center (low and intermediate level radioactive waste disposal facility)

    International Nuclear Information System (INIS)

    Suzuki, Yasuo

    2010-01-01

    Through the RANDEC delegation tour to Korea in Nov. 2009, we have earned new information on recent development of the radioactive waste management in Korea. In this report, we will introduce such development in Korea, focusing on the current construction status of Korean LILW (low and intermediate level radioactive waste) disposal site, now called, Wolsong Nuclear Environment Management Center. (author)

  8. A reappraisal of transport aircraft needs 1985 - 2000: Perceptions of airline management in a changing economic, regulatory, and technological environment

    Science.gov (United States)

    Spencer, F. A.

    1982-01-01

    Views of the executives of 24 major, national, regional, and commuter airlines concerning the effect of recent regulatory, economic, and technological changes on the roles they see for their airlines, and consequent changes in their plans for acquiring aircraft for the 1985 to 2000 period were surveyed. Differing perceptions on the economic justification for new-technology jets in the context of the carriers' present and projected financial conditions are outlined. After examining the cases for new or intermediate size jets, the study discusses turboprop powered transports, including the carriers' potential interest in an advanced technology, high-speed turboprop or prop-fan. Finally, the implications of foreign competition are examined in terms of each carrier's evaluation of the quality and financial offerings, as well as possible 'Buy American' policy predisposition.

  9. The SCEC Community Modeling Environment (SCEC/CME) - An Overview of its Architecture and Current Capabilities

    Science.gov (United States)

    Maechling, P. J.; Jordan, T. H.; Minster, B.; Moore, R.; Kesselman, C.; SCEC ITR Collaboration

    2004-12-01

    The Southern California Earthquake Center (SCEC), in collaboration with the San Diego Supercomputer Center, the USC Information Sciences Institute, the Incorporated Research Institutions for Seismology, and the U.S. Geological Survey, is developing the Southern California Earthquake Center Community Modeling Environment (CME) under a five-year grant from the National Science Foundation's Information Technology Research (ITR) Program jointly funded by the Geosciences and Computer and Information Science & Engineering Directorates. The CME system is an integrated geophysical simulation modeling framework that automates the process of selecting, configuring, and executing models of earthquake systems. During the Project's first three years, we have performed fundamental geophysical and information technology research and have also developed substantial system capabilities, software tools, and data collections that can help scientist perform systems-level earthquake science. The CME system provides collaborative tools to facilitate distributed research and development. These collaborative tools are primarily communication tools, providing researchers with access to information in ways that are convenient and useful. The CME system provides collaborators with access to significant computing and storage resources. The computing resources of the Project include in-house servers, Project allocations on USC High Performance Computing Linux Cluster, as well as allocations on NPACI Supercomputers and the TeraGrid. The CME system provides access to SCEC community geophysical models such as the Community Velocity Model, Community Fault Model, Community Crustal Motion Model, and the Community Block Model. The organizations that develop these models often provide access to them so it is not necessary to use the CME system to access these models. However, in some cases, the CME system supplements the SCEC community models with utility codes that make it easier to use or access

  10. Design of the corona current measurement sensor with wide bandwidth under dc ultra-high-voltage environment

    International Nuclear Information System (INIS)

    Liu, Yingyi; Yuan, Haiwen; Yang, Qinghua; Cui, Yong

    2011-01-01

    The research in the field of corona discharge, which is one of the key technologies, can help us to realize ultra-high-voltage (UHV) power transmission. This paper proposes a new sampling resistance sensor to measure the dc UHV corona current in a wide band. By designing the structural and distributed parameters of the sensor, the UHV dielectric breakdown performance and the wide-band measuring characteristics of the sensor are satisfied. A high-voltage discharge test shows that the designed sensor can work under a 1200 kV dc environment without the occurrence of corona discharge. A frequency characteristic test shows that the measuring bandwidth of the sensor can be improved from the current 4.5 to 20 MHz. The test results in an actual dc UHV transmission line demonstrate that the sensor can accurately measure the corona current under the dc UHV environment

  11. Gene-Environment Interactions in Genome-Wide Association Studies: Current Approaches and New Directions

    Science.gov (United States)

    Winham, Stacey J.; Biernacka, Joanna M.

    2013-01-01

    Background: Complex psychiatric traits have long been thought to be the result of a combination of genetic and environmental factors, and gene-environment interactions are thought to play a crucial role in behavioral phenotypes and the susceptibility and progression of psychiatric disorders. Candidate gene studies to investigate hypothesized…

  12. Analysis of the PPBE Process in the Current Dynamic Political Environment

    Science.gov (United States)

    2008-06-01

    provides a comparative analysis using the Political, Economic , Socio- Cultural, Technological, Ecological and Legal ( PESTEL ) Analysis model of the...37 A. PESTEL ANALYSIS OF THE 1960/1970 ERA...44 B. PESTEL ANALYSIS OF THE POST 9/11 ENVIRONMENT..................45 1. Political

  13. Radio-frequency electromagnetic field (RF-EMF) exposure levels in different European outdoor urban environments in comparison with regulatory limits.

    Science.gov (United States)

    Urbinello, Damiano; Joseph, Wout; Huss, Anke; Verloock, Leen; Beekhuizen, Johan; Vermeulen, Roel; Martens, Luc; Röösli, Martin

    2014-07-01

    Concerns of the general public about potential adverse health effects caused by radio-frequency electromagnetic fields (RF-EMFs) led authorities to introduce precautionary exposure limits, which vary considerably between regions. It may be speculated that precautionary limits affect the base station network in a manner that mean population exposure unintentionally increases. The objectives of this multicentre study were to compare mean exposure levels in outdoor areas across four different European cities and to compare with regulatory RF-EMF exposure levels in the corresponding areas. We performed measurements in the cities of Amsterdam (the Netherlands, regulatory limits for mobile phone base station frequency bands: 41-61 V/m), Basel (Switzerland, 4-6 V/m), Ghent (Belgium, 3-4.5 V/m) and Brussels (Belgium, 2.9-4.3 V/m) using a portable measurement device. Measurements were conducted in three different types of outdoor areas (central and non-central residential areas and downtown), between 2011 and 2012 at 12 different days. On each day, measurements were taken every 4s for approximately 15 to 30 min per area. Measurements per urban environment were repeated 12 times during 1 year. Arithmetic mean values for mobile phone base station exposure ranged between 0.22 V/m (Basel) and 0.41 V/m (Amsterdam) in all outdoor areas combined. The 95th percentile for total RF-EMF exposure varied between 0.46 V/m (Basel) and 0.82 V/m (Amsterdam) and the 99th percentile between 0.81 V/m (Basel) and 1.20 V/m (Brussels). All exposure levels were far below international reference levels proposed by ICNIRP (International Commission on Non-Ionizing Radiation Protection). Our study did not find indications that lowering the regulatory limit results in higher mobile phone base station exposure levels. Copyright © 2014 Elsevier Ltd. All rights reserved.

  14. Flight crew fatigue management in a more flexible regulatory environment: an overview of the New Zealand aviation industry.

    Science.gov (United States)

    Signal, T Leigh; Ratieta, Denise; Gander, Philippa H

    2008-04-01

    of more flexible regulatory options has not greatly changed fatigue management practices, although some operators have implemented innovative strategies. The findings suggest a need to raise the level of knowledge within the industry regarding the causes and consequences of fatigue and of processes for its management. This is further supported by the discrepancies between the responses of line pilots and managers, which raise doubts about the effectiveness of some strategies nominally being employed. The regulator and other relevant industry groups should consider how to move the industry toward a mature safety culture and solid knowledge base because these are fundamental to more flexible fatigue management regimes, as is adequate regulatory knowledge, support, and oversight.

  15. Effects of Self-Regulatory Status and Practice Type on Student Performance in the Mobile Learning Environment

    Science.gov (United States)

    Tutty, Jeremy Ian

    2013-01-01

    The next generation of computer-based learning environments has arrived. This generation of technology is characterized by mobile and portable devices such as smartphones and tablet computers with wireless broadband access. With these devices comes the promise of extending the online learning revolution. The purpose of this study was to…

  16. An Exploratory Approach of the Current Public Relations Framework in the Romanian University Environment

    Directory of Open Access Journals (Sweden)

    Nicoleta CRISTACHE

    2018-05-01

    Full Text Available The opportunity to study such a subject is granted by the need identified in Romanian universities to align to the standards of the international academic environment. As far as the Romanian university environment is concerned, public relations can be a valid strategic option since the communication resource exploitation processes are supported by university management by means of initiating and carrying out actions in which the interests of the institution and the principles of university ethics are harmoniously combined. The causal configurations presented in the results of the present study may represent a decision-making support for the public relations/communication managers who have the chance to understand how they can exploit the social media interactions in their strategies regarding university reputation development

  17. Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment.

    Science.gov (United States)

    Djuris, Jelena; Djuric, Zorica

    2017-11-30

    Mathematical models can be used as an integral part of the quality by design (QbD) concept throughout the product lifecycle for variety of purposes, including appointment of the design space and control strategy, continual improvement and risk assessment. Examples of different mathematical modeling techniques (mechanistic, empirical and hybrid) in the pharmaceutical development and process monitoring or control are provided in the presented review. In the QbD context, mathematical models are predominantly used to support design space and/or control strategies. Considering their impact to the final product quality, models can be divided into the following categories: high, medium and low impact models. Although there are regulatory guidelines on the topic of modeling applications, review of QbD-based submission containing modeling elements revealed concerns regarding the scale-dependency of design spaces and verification of models predictions at commercial scale of manufacturing, especially regarding real-time release (RTR) models. Authors provide critical overview on the good modeling practices and introduce concepts of multiple-unit, adaptive and dynamic design space, multivariate specifications and methods for process uncertainty analysis. RTR specification with mathematical model and different approaches to multivariate statistical process control supporting process analytical technologies are also presented. Copyright © 2017 Elsevier B.V. All rights reserved.

  18. Toxic Volatile Organic Compounds (VOCs in the Atmospheric Environment: Regulatory Aspects and Monitoring in Japan and Korea

    Directory of Open Access Journals (Sweden)

    Wen-Tien Tsai

    2016-09-01

    Full Text Available In the past decades, hazardous air pollutants (HAPs, so-called air toxics or toxic air pollutants, have been detected in the atmospheric air at low concentration levels, causing public concern about the adverse effect of long-term exposure to HAPs on human health. Most HAPs belong to volatile organic compounds (VOCs. More seriously, most of them are known carcinogens or probably carcinogenic to humans. The objectives of this paper were to report the regulatory aspects and environmental monitoring management of toxic VOCs designated by Japan and Korea under the Air Pollution Control Act, and the Clean Air Conservation Act, respectively. It can be found that the environmental quality standards and environmental monitoring of priority VOCs (i.e., benzene, trichloroethylene, tetrachloroethylene, and dichloromethane have been set and taken by the state and local governments of Japan since the early 2000, but not completely established in Korea. On the other hand, the significant progress in reducing the emissions of some toxic VOCs, including acrylonitrile, benzene, 1,3-butadiene, 1,2-dichloroethane, dichloromethane, chloroform, tetrachloroethylene, and trichloroethylene in Japan was also described as a case study in the brief report paper.

  19. Description of Multimedia Environment Pollutant Assessment System (MEPAS) version 3.2 modification for the Nuclear Regulatory Commission

    International Nuclear Information System (INIS)

    Buck, J.W.; Strenge, D.L.; Hoopes, B.L.

    1997-11-01

    The Multimedia Environmental Pollutant Assessment System (MEPAS) is a software tool developed by Pacific Northwest National Laboratory (PNNL) for the U.S. Department of Energy (DOE) to allow DOE to conduct human health risk analyses nation-wide. This report describes modifications to the MEPAS to meet the requirements of the U.S. Nuclear Regulatory Commission (NRC) staff in their analyses of Site Decommissioning Management Plan sites. In general, these modifications provide the MEPAS, Version 3.2, with the capability of calculating and reporting annual dose/risk information. Modifications were made to the exposure pathway and health impact modules and the water and atmospheric transport modules. Several example cases used to test the MEPAS, Version 3.2, are also presented. The MEPAS, Version 3.2, also contains a new source-term release component that includes models for estimating contaminant loss from three different types of source zones (contaminated aquifer, contaminated pond/surface impoundment, and contaminated vadose zone) due to decay/degradation, leaching, wind suspension, water erosion, overland flow, and/or volatilization. When multiple loss routes are assumed to occur simultaneously, the models account for their interaction and calculate an appropriate pollutant mass budget to each loss route over time

  20. Design Rework Prediction in Concurrent Design Environment: Current Trends and Future Research Directions

    OpenAIRE

    Arundachawat, Panumas; Roy, Rajkumar; Al-Ashaab, Ahmed; Shehab, Essam

    2009-01-01

    Organised by: Cranfield University This paper aims to present state-of-the-art and formulate future research areas on design rework in concurrent design environment. Related literatures are analysed to extract the key factors which impact design rework. Design rework occurs due to changes from upstream design activities and/or by feedbacks from downstream design activities. Design rework is considered as negative iteration; therefore, value in design activities will be increase...

  1. [Electromagnetic interference in the current era of cardiac implantable electronic devices designed for magnetic resonance environment].

    Science.gov (United States)

    Ribatti, Valentina; Santini, Luca; Forleo, Giovanni B; Della Rocca, Domenico; Panattoni, Germana; Scali, Marta; Schirripa, Valentina; Danisi, Nicola; Ammirati, Fabrizio; Santini, Massimo

    2017-04-01

    In the last decades we are observing a continuous increase in the number of patients wearing cardiac implantable electronic devices (CIEDs). At the same time, we face daily with a domestic and public environment featured more and more by the presence and the utilization of new emitters and finally, more medical procedures are based on electromagnetic fields as well. Therefore, the topic of the interaction of devices with electromagnetic interference (EMI) is increasingly a real and actual problem.In the medical environment most attention is paid to magnetic resonance, nevertheless the risk of interaction is present also with ionizing radiation, electrical nerve stimulation and electrosurgery. In the non-medical environment, most studies reported in the literature focused on mobile phones, metal detectors, as well as on headphones or digital players as potential EMI sources, but many other instruments and tools may be intentional or non-intentional sources of electromagnetic fields.CIED manufacturers are more and more focusing on new technological features in order to make implantable devices less susceptible to EMI. However, patients and emitter manufacturers should be aware that limitations exist and that there is not complete immunity to EMI.

  2. 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.

  3. 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.

  4. Monitoring DC stray current interference of steel sheet pile structures in railway environment

    NARCIS (Netherlands)

    Peelen, W.H.A.; Neeft, E.A.C.; Leegwater, G.; Kanten-Roos, W. van; Courage, W.M.G.

    2011-01-01

    Steel structures near DC powered railways are expected to be affected by stray current interference. This causes accelerated corrosion rates. Therefore steel is often not used as a building material in these cases, although certain advantages over the alternative material concrete exist. These

  5. Large-scale Isolation of Highly Pure "Untouched" Regulatory T Cells in a GMP Environment for Adoptive Cell Therapy.

    Science.gov (United States)

    Haase, Doreen; Puan, Kia Joo; Starke, Mireille; Lai, Tuck Siong; Soh, Melissa Yan Ling; Karunanithi, Iyswariya; San Luis, Boris; Poh, Tuang Yeow; Yusof, Nurhashikin; Yeap, Chun Hsien; Phang, Chew Yen; Chye, Willis Soon Yuan; Chan, Marieta; Koh, Mickey Boon Chai; Goh, Yeow Tee; Bertin-Maghit, Sebastien; Nardin, Alessandra; Ho, Liam Pock; Rotzschke, Olaf

    2015-01-01

    Adoptive cell therapy is an emerging treatment strategy for a number of serious diseases. Regulatory T (Treg) cells represent 1 cell type of particular interest for therapy of inflammatory conditions, as they are responsible for controlling unwanted immune responses. Initial clinical trials of adoptive transfer of Treg cells in patients with graft-versus-host disease were shown to be safe. However, obtaining sufficient numbers of highly pure and functional Treg cells with minimal contamination remains a challenge. We developed a novel approach to isolate "untouched" human Treg cells from healthy donors on the basis of negative selection using the surface markers CD49d and CD127. This procedure, which uses an antibody cocktail and magnetic beads for separation in an automated system (RoboSep), was scaled up and adapted to be compatible with good manufacturing practice conditions. With this setup we performed 9 Treg isolations from large-scale leukapheresis samples in a good manufacturing practice facility. These runs yielded sufficient numbers of "untouched" Treg cells for immediate use in clinical applications. The cell preparations consisted of viable highly pure FoxP3-positive Treg cells that were functional in suppressing the proliferation of effector T cells. Contamination with CD4 effector T cells was cell types did not exceed 2% in the final product. Remaining isolation reagents were reduced to levels that are considered safe. Treg cells isolated with this procedure will be used in a phase I clinical trial of adoptive transfer into leukemia patients developing graft-versus-host disease after stem cell transplantation.

  6. The need to redefine the environment in the current scientific debate

    International Nuclear Information System (INIS)

    Gazzano, Ines; Achkar, Marcel

    2013-01-01

    In the last four decades the environmental thinking has generated a rich theoretical production, forcing the transformation of the group of scientific thought; focusing on theoretical concerns in areas of disciplinary borders, leading to the continuous redefinition of the object of environmental issues in order to orientate interventions. Object that has mutated from the naive definition of environment, environmental system, socio-environmental system, complex system, integrating also operational aspects like: multi scale and inter-disciplinary. Theoretical efforts, articulated with the development of practical aspects helped to progress to understand the environmental object from classical perspectives, built on paradigms of modernity, which in recent years reached a point of exhaustion. The search for a solution to this problem lies in the limit of overcoming the dualistic postulate, attempting the unification of society nature. It is from this problem identification, and trying to connect major theoretical contributions in the discussions which are more or less diffused on the environment, complex systems and trans disciplinary science, that it is proposed a conceptual construction of the environmental system, which enables its redefinition and a new self-referentially, as a condition for a new reading, interpretation and action in specific territories.

  7. Shifting Currents: Science Technology Society and Environment in Northern Ontario Schools

    Directory of Open Access Journals (Sweden)

    Astrid Steele

    2013-07-01

    Full Text Available The focus is on the practices of secondary science teachers in rural, resource-extraction-based communities in the boreal region of northern Ontario, Canada. In 2008 the Ontario Ministry of Education mandated that science teaching and learning should bring to the forefront consideration of the impacts of science on society and environment, and include environmental education; topics that are particularly pertinent given the location(s of the study in logging and mining towns. Three years after the introduction of that curriculum the researcher investigates the extent to which the mandated changes have entered teacher practice. The study consists of a survey, (n= 26, interviews (n=7 and a closer exploration of the collaboration between two teachers who work towards including social and environmental issues in their lessons. Findings provide evidence that secondary science teachers are shifting toward a stronger emphasis issues of society and environment in their practice, however teachers identified a number of concerns including an information gap, developing new lessons, program planning, assessment, and teaching in the North. A theoretical framework developed by Pedretti and Nazir was used in the analysis of the teacher collaboration. Recommendations are for professional development to specifically address the concerns raised by the teachers; as well, changes are suggested to the theoretical framework to include a stronger emphasis on environmental education.

  8. 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...

  9. Current trends in the design of metallic coatings for harsh turbine environments

    Energy Technology Data Exchange (ETDEWEB)

    Gleeson, Brian [Pittsburgh Univ., PA (United States). Dept. of Mechanical Engineering and Materials Science

    2010-07-01

    The reliable and long-term operation of gas turbine engines at varying high temperatures and under the highly corrosive conditions found in technical applications requires further developments in materials science and technology. Quite often, the current engineering design solution to this problem is to coat the high-temperature turbine component materials, typically {gamma}-Ni+{gamma}'-Ni{sub 3}Al nickel-base superalloys, with a metallic alloy composition that is highly resistant to oxidation or corrosion. Ideally, such resistance is provided by the formation of a thermally grown oxide (TGO) scale of Al{sub 2}O{sub 3}. Indeed, the commonly used {beta}-NiAl-based coatings are excellent Al{sub 2}O{sub 3}-scale formers; however, their resistance to accelerated attack by molten-salt induced hot corrosion can rather poor. The hot-corrosion resistance of {beta}-based coatings can be improved by chromium or silicon addition, but potentially at the expense of oxidation resistance. This presentation will primarily focus on hot corrosion attack and the current approaches that are used to try to mitigate this form of attack. It will be shown that many factors affect hot corrosion resistance, particularly the composition and structure of the coating. The results from recent work on the effects of relative phase fractions, morphologies and chemistries will be drawn upon to provide guidance for optimized coating design. (orig.)

  10. A High-Sensitivity Flexible Eddy Current Array Sensor for Crack Monitoring of Welded Structures under Varying Environment.

    Science.gov (United States)

    Chen, Tao; He, Yuting; Du, Jinqiang

    2018-06-01

    This paper develops a high-sensitivity flexible eddy current array (HS-FECA) sensor for crack monitoring of welded structures under varying environment. Firstly, effects of stress, temperature and crack on output signals of the traditional flexible eddy current array (FECA) sensor were investigated by experiments that show both stress and temperature have great influences on the crack monitoring performance of the sensor. A 3-D finite element model was established using Comsol AC/DC module to analyze the perturbation effects of crack on eddy currents and output signals of the sensor, which showed perturbation effect of cracks on eddy currents is reduced by the current loop when crack propagates. Then, the HS-FECA sensor was proposed to boost the sensitivity to cracks. Simulation results show that perturbation effect of cracks on eddy currents excited by the HS-FECA sensor gradually grows stronger when the crack propagates, resulting in much higher sensitivity to cracks. Experimental result further shows that the sensitivity of the new sensor is at least 19 times that of the original one. In addition, both stress and temperature variations have little effect on signals of the new sensor.

  11. Educating Medical Laboratory Technologists: Revisiting Our Assumptions in the Current Economic and Health-Care Environment

    Directory of Open Access Journals (Sweden)

    Regina Linder

    2012-08-01

    Full Text Available Health care occupies a distinct niche in an economy struggling to recover from recession. Professions related to the care of patients are thought to be relatively resistant to downturns, and thus become attractive to students typically drawn to more lucrative pursuits. Currently, a higher profile for clinical laboratory technology among college students and those considering career change results in larger and better prepared applicant pools. However, after decades of contraction marked by closing of programs, prospective students encounter an educational system without the capacity or vigor to meet their needs. Here discussed are some principles and proposals to allow universities, partnering with health-care providers, government agencies, and other stakeholders to develop new programs, or reenergize existing ones to serve our students and patients. Principles include academic rigor in biomedical and clinical science, multiple points of entry for students, flexibility in format, cost effectiveness, career ladders and robust partnerships.

  12. Current and historic mercury deposition to New Haven Harbor (CT, USA): Implications for industrial coastal environments

    International Nuclear Information System (INIS)

    Clark, Heather F.; Benoit, Gaboury

    2009-01-01

    This study quantifies historic and current mercury contamination in New Haven Harbor (New Haven, Connecticut, USA) through the analysis of sediment cores. The mercury concentration measured in surface sediment ranged from 320 to 1640 μg kg -1 with an average of 530 μg kg -1 . The harbor is relatively small in area (6.6 km 2 ) but displays a large range in concentrations, illustrating the important methodological issue that a large number of samples may be necessary to capture the variability in even a small area. Depth profiles of mercury reflect sedimentation over a range of 20 to 200 years and indicate a complex history of contamination. Mercury depth profiles were compared with lead, copper, cadmium, and silver concentrations and the metals generally covary. This trend indicates that the sources of mercury and heavy metals are linked and that regionally specific sources dominate the historic input of metals rather than large-scale atmospheric deposition patterns. Results also show there are large differences in absolute concentrations of metals among sites in the harbor. Differences in the abundance of Fe-rich, fine-grained sediment likely control the level of metals in various parts of the harbor. Proximity to current sources and the long, diverse industrial history of the harbor also influence the distribution pattern. All of the cores can be modeled as mixing between pre-industrial sediments and either one or two pollution endmembers. This study demonstrates the importance of riverine sources in the mass balance of mercury delivered to coastal areas and of watershed management to preserve coastal ecosystems.

  13. Induced current density in the foetus of pregnant workers in high magnetic field environments

    International Nuclear Information System (INIS)

    Xue, C.; Wood, A.W.

    2004-01-01

    Full text: There are moves to limit by legislation the amount of electric and magnetic fields that workers and the general public are exposed to. In work locations near wiring, cables and equipment carrying high electric currents, there are situations in which the proposed magnetic field limits could be exceeded. Since the limits for the general public are more conservative than those for workers and since the foetus or a pregnant worker should be afforded the status of a member of the general public, it is important to assess a worst-case scenario for the purposes of a general code of practice. Three different magnetic field exposures are modelled, which include the worst case - the body of a pregnant woman at a smallest distance of 30 cm to the conductor. All computations were done by using Multiple Multipole Program (MMP), which is based on the Generalized Multipole Technique (GMT) from ETH (Swiss Federal Institute of Technology), Zurich, Switzerland. The torso was modelled as a capped cylinder containing concentric placental and amniotic fluid layers containing a foetus. Appropriate values for conductivity and permittivity were applied to these layers and the Maxwell Equation solver applied for the situations of: cable beneath, alongside perpendicular and alongside parallel to the long axis of the body. Induced current density values were computed for cable distances of 0.3 and 0.5 m from the body and compared to the recommended limit values of 10 and 2 mA/m 2 for Occupational and General Public populations respectively. Regions where these values would be exceeded have been identified in this analysis. In a worst-case scenario the proposed basic restrictions would be exceeded slightly in both maternal and foetal tissue. With appropriate pre-placement assessment, these over-exposures can be avoided. Copyright (2004) Australasian College of Physical Scientists and Engineers in Medicine

  14. Dark current spectroscopy of space and nuclear environment induced displacement damage defects in pinned photodiode based CMOS image sensors

    International Nuclear Information System (INIS)

    Belloir, Jean-Marc

    2016-01-01

    CMOS image sensors are envisioned for an increasing number of high-end scientific imaging applications such as space imaging or nuclear experiments. Indeed, the performance of high-end CMOS image sensors has dramatically increased in the past years thanks to the unceasing improvements of microelectronics, and these image sensors have substantial advantages over CCDs which make them great candidates to replace CCDs in future space missions. However, in space and nuclear environments, CMOS image sensors must face harsh radiation which can rapidly degrade their electro-optical performances. In particular, the protons, electrons and ions travelling in space or the fusion neutrons from nuclear experiments can displace silicon atoms in the pixels and break the crystalline structure. These displacement damage effects lead to the formation of stable defects and to the introduction of states in the forbidden bandgap of silicon, which can allow the thermal generation of electron-hole pairs. Consequently, non ionizing radiation leads to a permanent increase of the dark current of the pixels and thus a decrease of the image sensor sensitivity and dynamic range. The aim of the present work is to extend the understanding of the effect of displacement damage on the dark current increase of CMOS image sensors. In particular, this work focuses on the shape of the dark current distribution depending on the particle type, energy and fluence but also on the image sensor physical parameters. Thanks to the many conditions tested, an empirical model for the prediction of the dark current distribution induced by displacement damage in nuclear or space environments is experimentally validated and physically justified. Another central part of this work consists in using the dark current spectroscopy technique for the first time on irradiated CMOS image sensors to detect and characterize radiation-induced silicon bulk defects. Many types of defects are detected and two of them are identified

  15. The future of water quality and the regulatory environment for the oil sands and coalbed methane development

    International Nuclear Information System (INIS)

    Kasperski, K.; Mikula, R.

    2004-01-01

    The use of consolidated tailings in recent years for the surface mined oil sands bitumen extraction process has resulted in major improvements in water consumption because materials are transported more efficiently in a slurry form. Water storage requirements will be reduced as the cost of handling tailings in the conventional manner becomes clearer. Future improvements may be in the form of mine face sand rejection, more advanced tailings treatment, or the use of clays for continuous reclamation. Sand filtering or stacking technologies can improve tailings properties and reduce the amount of water needed per unit of bitumen. It was noted that although the technologies will minimize land disturbance and fresh water consumption, water chemistries will be driven to the point where extraction recovery is impaired and water treatment will be required. The volumes and quality of water that is pumped out to produce coalbed methane (CBM) was also discussed with reference to the origin of water in coal beds, water resource depletion, water disposal, direct land applications, and surface evaporation. The Alberta Energy and Utilities Board and Alberta Environment are responsible for regulating CBM water issues in the province, including water disposal from CBM production. 41 refs., 6 tabs., 8 figs

  16. 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.

  17. Induced current density in the foetus of pregnant workers in high magnetic field environments

    International Nuclear Information System (INIS)

    Xue, C.; Wood, A.W.

    2004-01-01

    There are moves to limit by legislation the amount of electric and magnetic fields that workers and the general public are exposed to. In work locations near wiring, cables and equipment carrying high electric currents, there are situations in which the proposed magnetic field limits could be exceeded. Since the limits for the general public are more conservative than those for workers and since the foetus or a pregnant worker should be afforded the status of a member of the general public, it is important to assess a worst-case scenario for the purposes of a general code of practice. Three different magnetic field exposures are modelled, which include the worst case - the body of a pregnant woman at a smallest distance of 30 cm to the conductor. All computations were done by using Multiple Multipole Program (MMP), which is based on the Generalized Multipole Technique (GMT) from ETH (Swiss Federal Institute of Technology), Zurich, Switzerland. In a worst-case scenario the proposed basic restrictions would be exceeded slightly in both maternal and foetal tissue. With appropriate pre-placement assessment, these over-exposures can be avoided. Copyright (2004) Australasian College of Physical Scientists and Engineers in Medicine

  18. Impact of radioactivity on the environment: problems, state of current knowledge and approaches for identification of radioprotection criteria

    International Nuclear Information System (INIS)

    Brechignac, F.

    2001-01-01

    There is currently a revitalized concern about the potential impact of ionizing radiation on the environment that calls for the construction of a system ensuring an adequate radioprotection of the non-human biota and their associated biotopes. This paper first sets the context of the problem both, with respect to the general philosophy of environmental protection as a whole, but also with respect to the consideration of the environment achieved so far in the purpose of human radioprotection. The current accumulated knowledge on the effects of ionizing radiation to biota (fauna and flora) is then briefly reviewed, encompassing effects at individual and community/ecosystem level, situations of acute and chronic exposure to high and low doses, finally leading to the identification of the most critical gaps in scientific knowledge: effects of mixed low dose rates in chronic exposure to communities and ecosystems. The most significant current international efforts towards the identification of environmental radioprotection criteria and standards are finally presented along with some relevant national examples. (author)

  19. Remedial action plan for the inactive uranium processing site at Naturita, Colorado. DOE responses to comments from U.S. Nuclear Regulatory Commission and Colorado Department of Public Health and Environment

    International Nuclear Information System (INIS)

    1998-01-01

    This report contains responses by the US Department of Energy to comments from the US Nuclear Regulatory Commission and the Colorado Department of Public Health and Environment on the Naturita remedial action plan. This was done in an attempt to clarify information. The site is an inactive uranium processing site at Naturita, Colorado

  20. Current Knowledge on Listeria monocytogenes Biofilms in Food-Related Environments: Incidence, Resistance to Biocides, Ecology and Biocontrol

    Directory of Open Access Journals (Sweden)

    Pedro Rodríguez-López

    2018-06-01

    Full Text Available Although many efforts have been made to control Listeria monocytogenes in the food industry, growing pervasiveness amongst the population over the last decades has made this bacterium considered to be one of the most hazardous foodborne pathogens. Its outstanding biocide tolerance capacity and ability to promiscuously associate with other bacterial species forming multispecies communities have permitted this microorganism to survive and persist within the industrial environment. This review is designed to give the reader an overall picture of the current state-of-the-art in L. monocytogenes sessile communities in terms of food safety and legislation, ecological aspects and biocontrol strategies.

  1. The regulatory mechanism in the U.S. lessons learned

    International Nuclear Information System (INIS)

    Roberts, T.M.

    1987-01-01

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

  2. The role of gene-environment interplay in occupational and environmental diseases: current concepts and knowledge gaps.

    Science.gov (United States)

    Kwo, Elizabeth; Christiani, David

    2017-03-01

    The interplay between genetic susceptibilities and environmental exposures in the pathogenesis of a variety of diseases is an area of increased scientific, epidemiologic, and social interest. Given the variation in methodologies used in the field, this review aims to create a framework to help understand occupational exposures as they currently exist and provide a foundation for future inquiries into the biological mechanisms of the gene-environment interactions. Understanding of this complex interplay will be important in the context of occupational health, given the public health concerns surrounding a variety of occupational exposures. Studies found evidence that suggest genetics influence the progression of disease postberyllium exposure through genetically encoded major histocompatibility complex, class II, DP alpha 2 (HLA-DP2)-peptide complexes as it relates to T-helper cells. This was characterized at the molecular level by the accumulation of Be-responsive CD4 T cells in the lung, which resulted in posttranslational change in the HLA-DPB1 complex. These studies provide important evidence of gene-environment association, and many provide insights into specific pathogenic mechanisms. The following includes a review of the literature regarding gene-environment associations with a focus on pulmonary diseases as they relate to the workplace.

  3. Review of the knowledge available to date on the effects of tritium exposure on health and the environment in Canada - a tool to guide regulatory compliance monitoring

    International Nuclear Information System (INIS)

    Thompson, P.A.; Hamlat, M.S.; Lane, R.; Mihok, S.; Reinhardt, P.; Bundy, K.

    2011-01-01

    The use of tritium in CANDU (Canadian Deuterium-Uranium) reactors, in industry to produce self-luminescent lights and paints, in oil and gas exploration, in hospitals for diagnostic tests and radio-therapeutics, and in research makes the control of tritium releases generated by these activities particularly important in Canada. Releases are regulated and carefully monitored by the Canadian Nuclear Safety Commission (CNSC). Some special interest and citizen groups, however, claim that the scientific uncertainty regarding the effects of tritium on health and on the environment is such that regulation of the facilities releasing or using tritium may be inadequate. In response to these concerns, the CNSC asked its staff to initiate the 'Tritium Studies' project. As part of the project, the environmental fate of tritium and its health effects were studied through direct field measurements and the review of the latest scientific literature on the subject. The project made it possible to conclude that the tritium radiation protection measures and regulatory mechanisms are adequate in protecting the health and safety of Canadians. (authors)

  4. Expert views on societal responses to different applications of nanotechnology: a comparative analysis of experts in countries with different economic and regulatory environments

    Energy Technology Data Exchange (ETDEWEB)

    Gupta, Nidhi, E-mail: guptanidhi12@gmail.com; Fischer, Arnout R. H., E-mail: arnout.fischer@wur.nl [Wageningen University, Marketing and Consumer Behaviour Group (Netherlands); George, Saji, E-mail: saji_george@nyp.gov.sg [Nanyang Polytechnic, Centre for Sustainable Nanotechnology, School of Chemical and Life Sciences (Singapore); Frewer, Lynn J., E-mail: lynn.frewer@newcastle.ac.uk [Newcastle University, School of Agriculture, Food and Rural Development (United Kingdom)

    2013-08-15

    The introduction of different applications of nanotechnology will be informed by expert views regarding which (types of) application will be most societally acceptable. Previous research in Northern Europe has indicated that experts believe that various factors will be influential, predominant among these being public perceptions of benefit, need and consumer concern about contact with nanomaterials. These factors are thought by experts to differentiate societal acceptance and rejection of nanotechnology applications. This research utilises a larger sample of experts (N = 67) drawn from Northern America, Europe, Australasia, India and Singapore to examine differences in expert opinion regarding societal acceptance of different applications of nanotechnology within different technological environments, consumer cultures and regulatory regimes. Perceived risk and consumer concerns regarding contact with nano-particles are thought by all experts to drive rejection, and perceived benefits to influence acceptance, independent of country. Encapsulation and delivery of nutrients in food was thought to be the most likely to raise societal concerns, while targeted drug delivery was thought most likely to be accepted. Lack of differentiation between countries suggests that expert views regarding social acceptance may be homogenous, independent of local contextual factors.

  5. Expert views on societal responses to different applications of nanotechnology: a comparative analysis of experts in countries with different economic and regulatory environments

    International Nuclear Information System (INIS)

    Gupta, Nidhi; Fischer, Arnout R. H.; George, Saji; Frewer, Lynn J.

    2013-01-01

    The introduction of different applications of nanotechnology will be informed by expert views regarding which (types of) application will be most societally acceptable. Previous research in Northern Europe has indicated that experts believe that various factors will be influential, predominant among these being public perceptions of benefit, need and consumer concern about contact with nanomaterials. These factors are thought by experts to differentiate societal acceptance and rejection of nanotechnology applications. This research utilises a larger sample of experts (N = 67) drawn from Northern America, Europe, Australasia, India and Singapore to examine differences in expert opinion regarding societal acceptance of different applications of nanotechnology within different technological environments, consumer cultures and regulatory regimes. Perceived risk and consumer concerns regarding contact with nano-particles are thought by all experts to drive rejection, and perceived benefits to influence acceptance, independent of country. Encapsulation and delivery of nutrients in food was thought to be the most likely to raise societal concerns, while targeted drug delivery was thought most likely to be accepted. Lack of differentiation between countries suggests that expert views regarding social acceptance may be homogenous, independent of local contextual factors

  6. Interview about nuclear regulatory supervision with Stefan Mappus, Baden-Wuerttemberg State Minister for the Environment and for Transport; Interview zur Kernenergieaufsicht mit Stefan Mappus, Minister fuer Umwelt und Verkehr des Landes Baden-Wuerttemberg

    Energy Technology Data Exchange (ETDEWEB)

    Anon.

    2005-02-01

    Stefan Mappus, member of the Baden-Wuerttemberg State Parliament, has been State Minister for the Environment since July 14, 2004. He has criticized deficiencies in nuclear power plants, but also has expressed himself in favor of continuing to use nuclear power. This interview covers the safety of nuclear power plants in Baden-Wuerttemberg; the fines to be imposed within the framework of nuclear regulatory supervision; and ''new accents'' in supervision, among others. Mr. Mappus also comments on the activities of his Ministry in connection with events at the Philippsburg nuclear power station and the consequences drawn by the regulatory authority. (orig.)

  7. Corrosion Behavior of X80 Steel with Coupled Coating Defects under Alternating Current Interference in Alkaline Environment.

    Science.gov (United States)

    Li, Zhong; Li, Caiyu; Qian, Hongchang; Li, Jun; Huang, Liang; Du, Cuiwei

    2017-06-28

    The corrosion behavior of X80 steel in the presence of coupled coating defects was simulated and studied under the interference of alternating current (AC) in an alkaline environment. The results from electrochemical measurements showed that the electrode potential of the coating defect with the smaller exposed area was lower than that with the larger area, which indicated that the steel with the smaller coating defect was more prone to corrosion. The result of weight loss tests also showed that the smaller coating defect had induced a higher corrosion rate. However, the corrosion rate of X80 steel at the larger coating defect decreased gradually with the increase of the larger defect area at a constant smaller defect area. The corrosion morphology images showed that the coating defects with smaller areas suffered from more severe pitting corrosion.

  8. 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

  9. Single and combined metal contamination in coastal environments in China: current status and potential ecological risk evaluation.

    Science.gov (United States)

    Manzoor, Romana; Zhang, Tingwan; Zhang, Xuejiao; Wang, Min; Pan, Jin-Fen; Wang, Zhumei; Zhang, Bo

    2018-01-01

    With the development of industrialization and urbanization, metal and metalloid pollution is one of the most serious environmental problems in China. Current contamination status of metals and metalloid and their potential ecological risks along China's coasts were reviewed in the present paper by a comprehensive study on metal contents in marine waters and sediments in the past few decades. The priority metals/metalloid cadmium (Cd), mercury (Hg), chromium (Cr), lead (Pb), and arsenic (As), which were the target elements of the designated project "Comprehensive Prevention and Control of Heavy Metal Pollution" issued by the Chinese government in 2011, were selected considering their high toxicity, persistence, and prevalent existence in coastal environment. Commonly used environmental quality evaluation methods for single and combined metals were compared, and we accordingly suggest the comprehensive approach of joint utilization of the Enrichment Factor and Effect Range Median combined with Pollution Load Index and Mean Effect Range Median Quotient (EEPME); this battery of guidelines may provide consistent, internationally comparable, and accurate understanding of the environment pollution status of combined metals/metalloid and their potential ecological risk.

  10. Determinants of Effective Information Transfer in International Regulatory Standards Adoption

    Science.gov (United States)

    Popescu, Denisa

    2010-01-01

    The role of international regulatory standards within the current global environment has become of the most importance. The age of the global system and free market capitalism carried us into the unprecedented age of regulations, and standard setting. Regulations are now becoming the emerging mode of global governance. This study focuses on…

  11. Environment

    International Nuclear Information System (INIS)

    McIntyre, A.D.; Turnbull, R.G.H.

    1992-01-01

    The development of the hydrocarbon resources of the North Sea has resulted in both offshore and onshore environmental repercussions, involving the existing physical attributes of the sea and seabed, the coastline and adjoining land. The social and economic repercussions of the industry were equally widespread. The dramatic and speedy impact of the exploration and exploitation of the northern North Sea resources in the early 1970s, on the physical resources of Scotland was quickly realised together with the concern that any environmental and social damage to the physical and social fabric should be kept to a minimum. To this end, a wide range of research and other activities by central and local government, and other interested agencies was undertaken to extend existing knowledge on the marine and terrestrial environments that might be affected by the oil and gas industry. The outcome of these activities is summarized in this paper. The topics covered include a survey of the marine ecosystems of the North Sea, the fishing industry, the impact of oil pollution on seabirds and fish stocks, the ecology of the Scottish coastline and the impact of the petroleum industry on a selection of particular sites. (author)

  12. Wealth geography, environment and hunger: small critic contribution to the current agrarian/agricultural model of the natural resources usage

    Directory of Open Access Journals (Sweden)

    Carlos Walter Porto Gonçalves

    2004-01-01

    Full Text Available The text questions the geopolitical issue implied in the argument about hunger and the environment. It criticizes the current agrarian / agricultural model of the natural resources usage, stating it is a model of economic development of mild regions that has been imposed all over the world at a very high ecological, cultural and political cost. This model has faced the patrimonial, collective and community knowledge, characteristic of populations with distinct rationality from the occidental atomistic-individualistic one, with severe risks to the feeding safety. It analyzes the social-environmental consequences of the current agrarian / agricultural model, the contradictory results of the increase of the world capacity of food production, hunger in the world, the meanings of the Green Revolution from the seventies on, the social-environmental impacts of the agrarian business in the Brazilian cerrado and the complexity of the use of transgenic products. It criticizes the restricted ecological sustentation based on a political realism, and proposes a reflection upon a new rationality for the environmental challenge. It concludes that hunger is not a technical problem, for it does not happen because of the lack of food, but because of the way the food is produced and distributed. Today hunger lives with the provisions necessary to overcome itself.

  13. 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

  14. 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,

  15. 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....

  16. 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.

  17. The core to regulatory reform

    International Nuclear Information System (INIS)

    Partridge, J.W. Jr.

    1993-01-01

    Federal Energy Regulatory Commission (FERC) Orders 436, 500, and 636, the Clean Air Act Amendments of 1990, Public Utility Holding Company Act reform, and the 1992 Energy Policy Act all can have significant effects on an LDC's operations. Such changes in an LDC's environments must be balanced by changes within the utility, its marketplace, and its state regulatory environment. The question is where to start. For Columbia Gas Distribution Cos., based in Columbus, OH, the new operating foundation begins with each employee. Internal strength is critical in designing initiatives that meet the needs of the marketplace and are well-received by regulators. Employees must understand not only the regulatory environment in which the LDC operates, but also how their work contributes to a positive regulatory relationship. To achieve this, Columbia initiated the COntinuing Regulatory Education program, or CORE, in 1991. CORE is a regulatory-focused, information-initiative program coordinated by Columbia's Regulatory Policy, Planning, and Government Affairs Department. The CORE programs can take many forms, such as emerging issue discussions, dialogues with regulators and key parties, updates on regulatory fillings, regulatory policy meetings, and formal training classes. The speakers and discussion facilitators can range from human resource department trainers to senior officers, from regulatory department staff members to external experts, or from state commissioners to executives from other LDCs. The goals of CORE initiatives are to: Support a professional level of regulatory expertise through employee participation in well-developed regulatory programs presented by credible experts. Encourage a constructive state regulatory environment founded on communication and cooperation. CORE achieves these goals via five program levels: introductory basics, advanced learning, professional expertise, crossfunctional dialogues, and external idea exchanges

  18. Thermoelectricity viability in Brazil through changes in the regulatory environment of the natural gas industry; Viabilizacao da termoeletricidade no Brasil atraves de mudancas no ambiente regulatorio da industria do gas natural

    Energy Technology Data Exchange (ETDEWEB)

    Borelli, Samuel [Sao Paulo Univ., SP (Brazil). Inst. de Eletrotecnica e Energia. Programa de Pos-graduacao Interunidades em Energia; Promon Engenharia, Rio de Janeiro, RJ (Brazil)]. E-mail: samuel.borelli@promon.com.br

    2003-07-01

    The electric power generated through natural gas in large thermal plants in Brazil presents many severe competitive barriers compared to the hydroelectric power available. Among the motives that cause such situation are relatively high fuel costs associated to the thermal power. The objective of this paper is discuss the available tools in the regulatory environment whose application may lead to the reduction of the price of the natural gas, that represents up to 60% of the total cost of the generated power. (author)

  19. Human population doses: Comparative analysis of CREAM code results with currently computer codes of Nuclear Regulatory Authority; Dosis en la poblacion: comparacion de los resultados del codigo CREAM con resultados de modelos vigentes en la ARN

    Energy Technology Data Exchange (ETDEWEB)

    Alonso Jimenez, Maria Teresa; Curti, Adriana [Autoridad Regulatoria Nuclear, Buenos Aires (Argentina)]. E-mail: mtalonso@sede.arn.gov.ar; acurti@sede.arn.gov.ar

    2001-07-01

    The Nuclear Regulatory Authority is performing an analysis with PC CREAM, developed at the NRPB, for updating computer programs and models used for calculating the transfer of radionuclides through the environment. For CREAM dose assessment verification for local scenarios, this paper presents a comparison of population doses assessed with the computer codes used nowadays and with CREAM, for unitary releases of main radionuclides in nuclear power plant discharges. The results of atmospheric dispersion processes and the transfer of radionuclides through the environment for local scenarios are analysed. The programs used are PLUME for atmospheric dispersion, FARMLAND for the transfer of radionuclides into foodstuffs following atmospheric deposition in the terrestrial environment and ASSESSOR for individual and collective dose assessments.This paper presents the general assumptions made for dose assessments. The results show some differences between doses due to differences in models, in the complexity level of the same models, or in parameters. (author)

  20. The I.A.G. / A.I.G. SEDIBUD (Sediment Budgets in Cold Environments) Programme: Current and future activities

    Science.gov (United States)

    Beylich, Achim A.; Lamoureux, Scott; Decaulne, Armelle

    2013-04-01

    Projected climate change in cold regions is expected to alter melt season duration and intensity, along with the number of extreme rainfall events, total annual precipitation and the balance between snowfall and rainfall. Similarly, changes to the thermal balance are expected to reduce the extent of permafrost and seasonal ground frost and increase active layer depths. These effects will undoubtedly change surface environments in cold regions and alter the fluxes of sediments, nutrients and solutes, but the absence of quantitative data and coordinated geomorphic process monitoring and analysis to understand the sensitivity of the Earth surface environment is acute in cold climate environments. The International Association of Geomorphologists (I.A.G. / A.I.G. ) SEDIBUD (Sediment Budgets in Cold Environments) Programme was formed in 2005 to address this existing key knowledge gap. SEDIBUD currently has about 400 members worldwide and the Steering Committee of this international programme is composed of ten scientists from eight different countries: Achim A. Beylich (Chair) (Norway), Armelle Decaulne (Secretary) (France), John C. Dixon (USA), Scott F. Lamoureux (Vice-Chair) (Canada), John F. Orwin (Canada), Jan-Christoph Otto (Austria), Irina Overeem (USA), Thorsteinn Sæmundsson (Iceland), Jeff Warburton (UK) and Zbigniew Zwolinski (Poland). The central research question of this global group of scientists is to: Assess and model the contemporary sedimentary fluxes in cold climates, with emphasis on both particulate and dissolved components. Initially formed as European Science Foundation (ESF) Network SEDIFLUX (Sedimentary Source-to-Sink Fluxes in Cold Environments) (2004 - ), SEDIBUD has further expanded to a global group of researchers with field research sites located in polar and alpine regions in the northern and southern hemisphere. Research carried out at each of the close to 50 defined SEDIBUD key test sites varies by programme, logistics and available

  1. The National Asthma Survey--New York State: association of the home environment with current asthma status.

    Science.gov (United States)

    Nguyen, Trang; Lurie, Melissa; Gomez, Marta; Reddy, Amanda; Pandya, Kruti; Medvesky, Michael

    2010-01-01

    The National Asthma Survey--New York State (NYS), a telephone survey of NYS residents, was conducted in 2002-2003 to further understand the burden of asthma among adults and children and to identify health, socioeconomic, behavioral, and environmental factors associated with asthma. A total of 1,412 households with at least one member with current asthma and 2,290 control households answered questions about their home environment (e.g., presence of asthma triggers and practices that promote or reduce common asthma triggers). RESULTS; For children younger than 18 years of age, we found statistically significant positive associations between current asthma and the presence of mold (adjusted odds ratio [AOR] = 2.1, 95% confidence interval [CI] 1.3, 3.3), air cleaners (AOR = 1.5, 95% CI 1.1, 2.1), dehumidifiers (AOR = 2.0, 95% CI 1.4, 2.7), and humidifiers (AOR = 1.6, 95% CI 1.1, 2.3). For adults, there were statistically significant positive associations with the presence of mold (AOR = 2.5, 95% CI 1.8, 3.4), air cleaners (AOR = 2.2, 95% CI 1.7, 2.8), and humidifiers (AOR = 1.4, 95% CI 1.1, 1.8). There were no statistically significant associations with the presence of cockroaches, pets, or tobacco smoke, while use of a wood-burning stove or fireplace was significantly more prevalent in control homes. Asthma guidelines emphasize the importance of reducing triggers in the home as part of a multifaceted approach to asthma control. Despite these guidelines, many asthma triggers (specifically, mold) were as prevalent or more so in the homes of New Yorkers with asthma as compared with control households. Public health interventions in NYS should focus on educating households about potential asthma triggers and their sources and teach methods to prevent, reduce, or eliminate them.

  2. Deciphering RNA Regulatory Elements Involved in the Developmental and Environmental Gene Regulation of Trypanosoma brucei.

    Science.gov (United States)

    Gazestani, Vahid H; Salavati, Reza

    2015-01-01

    Trypanosoma brucei is a vector-borne parasite with intricate life cycle that can cause serious diseases in humans and animals. This pathogen relies on fine regulation of gene expression to respond and adapt to variable environments, with implications in transmission and infectivity. However, the involved regulatory elements and their mechanisms of actions are largely unknown. Here, benefiting from a new graph-based approach for finding functional regulatory elements in RNA (GRAFFER), we have predicted 88 new RNA regulatory elements that are potentially involved in the gene regulatory network of T. brucei. We show that many of these newly predicted elements are responsive to both transcriptomic and proteomic changes during the life cycle of the parasite. Moreover, we found that 11 of predicted elements strikingly resemble previously identified regulatory elements for the parasite. Additionally, comparison with previously predicted motifs on T. brucei suggested the superior performance of our approach based on the current limited knowledge of regulatory elements in T. brucei.

  3. An Exploration of the Legal and Regulatory Environment of Privacy and Security through Active Research, Guided Study, Blog Creation, and Discussion

    Science.gov (United States)

    Peslak, Alan R.

    2010-01-01

    One of the most important topics for today's information technology professional is the study of legal and regulatory issues as they relate to privacy and security of personal and business data and identification. This manuscript describes the topics and approach taken by the instructors that focuses on independent research of source documents and…

  4. How Does a Principal in Detroit Public Schools Produce a Productive Learning Environment within the Current System?

    Science.gov (United States)

    Davenport, Marcus G.

    2017-01-01

    In this dissertation, the researcher investigates the success of productive learning environments in Detroit Public Schools. Using interviews with three productive principals from the Detroit school system, the researcher explores three related issues in public schooling. The first issue is the definition of a productive learning environment. By…

  5. Regulatory aspects for nuclear and radiation applications

    International Nuclear Information System (INIS)

    Duraisamy, S.

    2014-01-01

    The Atomic Energy Regulatory Board (AERB) is the national authority for ensuring that the use of ionizing radiation and nuclear energy does not cause any undue risk to the health of workers, members of the public and to the environment. AERB was constituted on November 15, 1983 and derives its regulatory power from the rules and notifications promulgated under the Atomic Energy Act, 1962 and the Environment (Protection) Act, 1986. AERB is provided with the necessary powers and mandate to frame safety policies, lay down safety standards and requirements for monitoring and enforcing the safety provisions. AERB follows multi-tier system for its review and assessment, safety monitoring, surveillance and enforcement. While regulating various nuclear and radiation facilities, AERB adopts a graded approach taking into account the hazard potential associated with the facilities being regulated. The regulatory process has been continuous evolving to cater to the new developments in reactor and radiation technologies. The regulatory effectiveness and efficiency of AERB have grown over the last three decades to make it into a robust organization. The radiation protection infrastructure in the country is on a sound footing and is constantly being strengthened based on experience and continued research and development. As one of its mandates AERB prescribes radiation dose limits for the occupational workers and the public, in line with the IAEA Safety Standard and ICRP recommendations. The current dose limits and the radiation safety requirements are more stringent than past. To meet the current safety standards, it is important for the facilities to have state of art radiation monitoring system and programme in place. While recognizing the current system in place, this presentation also highlights certain key radiation protection challenges associated with the implementation of radiation protection standards in the nuclear and radiation facilities especially in the areas of

  6. 40 CFR 92.6 - Regulatory structure.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Regulatory structure. 92.6 Section 92... Regulations for Locomotives and Locomotive Engines § 92.6 Regulatory structure. This section provides an overview of the regulatory structure of this part. (a) The regulations of this part 92 are intended to...

  7. 40 CFR 94.6 - Regulatory structure.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Regulatory structure. 94.6 Section 94... for Compression-Ignition Marine Engines § 94.6 Regulatory structure. This section provides an overview of the regulatory structure of this part. (a) The regulations of this Part 94 are intended to control...

  8. 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...

  9. Top-level regulatory criteria for the standard MHTGR

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1986-10-15

    The Licensing Plan for the Standard MHTGR (Ref. 1) describes a program to support a U.S. Nuclear Regulatory Commission (NRC) design review and approval. The Plan calls for the submittal of Top-Level Regulatory Criteria to the NRC for concurrence with their completeness and acceptability for the MHTGR program. The Top-Level Regulatory Criteria are defined as the standards for judging licensability that directly specify acceptable limits for protection of the public health and safety and the environment. The criteria proposed herein are for normal plant operation and a broad spectrum of anticipated events, including accidents. The approach taken is to define a set of criteria which are general as opposed to being design specific. Specifically, it is recommended that criteria be met which: 1. Are less prescriptive than current regulation, thereby encouraging maximum flexibility in design approaches. 2. Are measurable. 3. Are not more strict than the criteria for current power plants.

  10. Regulatory trends and practices related to nuclear reactor decommissioning

    International Nuclear Information System (INIS)

    Cantor, R.A.

    1984-01-01

    In the next several decades, the electric utility industry will be faced with the retirement of 50,000 megawatts (mW) of nuclear capacity. Responsibility for the financial and technical burdens this activity entails has been delegated to the utilities operating the reactors. However, the operators will have to perform the tasks of reactor decommissioning within the regulatory environment dictated by federal, state and local regulations. The purpose of this paper is to highlight some of the current and likely trends in regulations and regulatory practices that will significantly affect the costs, technical alternatives and financing schemes encountered by the electric utilities and their customers

  11. First Results of the “Carbonaceous Aerosol in Rome and Environs (CARE” Experiment: Beyond Current Standards for PM10

    Directory of Open Access Journals (Sweden)

    Francesca Costabile

    2017-12-01

    Full Text Available In February 2017 the “Carbonaceous Aerosol in Rome and Environs (CARE” experiment was carried out in downtown Rome to address the following specific questions: what is the color, size, composition, and toxicity of the carbonaceous aerosol in the Mediterranean urban background area of Rome? The motivation of this experiment is the lack of understanding of what aerosol types are responsible for the severe risks to human health posed by particulate matter (PM pollution, and how carbonaceous aerosols influence radiative balance. Physicochemical properties of the carbonaceous aerosol were characterised, and relevant toxicological variables assessed. The aerosol characterisation includes: (i measurements with high time resolution (min to 1–2 h at a fixed location of black carbon (eBC, elemental carbon (EC, organic carbon (OC, particle number size distribution (0.008–10 μ m, major non refractory PM1 components, elemental composition, wavelength-dependent optical properties, and atmospheric turbulence; (ii 24-h measurements of PM10 and PM2.5 mass concentration, water soluble OC and brown carbon (BrC, and levoglucosan; (iii mobile measurements of eBC and size distribution around the study area, with computational fluid dynamics modeling; (iv characterisation of road dust emissions and their EC and OC content. The toxicological assessment includes: (i preliminary evaluation of the potential impact of ultrafine particles on lung epithelia cells (cultured at the air liquid interface and directly exposed to particles; (ii assessment of the oxidative stress induced by carbonaceous aerosols; (iii assessment of particle size dependent number doses deposited in different regions of the human body; (iv PAHs biomonitoring (from the participants into the mobile measurements. The first experimental results of the CARE experiment are presented in this paper. The objective here is to provide baseline levels of carbonaceous aerosols for Rome, and to address

  12. Use of prioritization in meeting regulatory requirements

    International Nuclear Information System (INIS)

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

    1993-01-01

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

  13. Pollution prevention: A regulatory update

    International Nuclear Information System (INIS)

    Walzer, A.E.; Maynard, J.W.

    1993-01-01

    Pollution prevention is the emphasis of the 1990s environmental philosophy. This new environmental era was ushered in when President Bush signed the Pollution Prevention Act in October 1990. This law, with its accompanying philosophy, was in response to the realization that end-of-the-pipe treatment, which frequently changed the media in which a pollutant or waste was discharged, was inadequate to protect the environment and human health. Pollution prevention advocates source reduction, where material substitutions and engineering solutions are sought to reduce the volume and toxicity of waste and pollutants. This proactive approach reduces environmental impacts such as those of former waste sites which have produced environmental legacies that will cost billions of dollars and take decades to remediate. This paper describes pollution prevention philosophy and summarizes regulatory pollution prevention requirements. It describes current regulatory trends in the area of pollution prevention, including voluntary programs and enforcement actions. The Pollution Prevention Act of 1990 is described, and pollution prevention initiatives embodied in other laws, including the Clean Air Act, the Clean Water Act, the Emergency Planning and Community Right-To-Know Act, the Resource Conservation and Recovery Act, and the Toxic Substances Control Act, are discussed. A historical overview of waste minimization initiatives within the Department of Energy is given, and other pollution prevention initiatives that affect federal facilities, such as Executive Order 12780, which mandates recycling and the procurement of recycled materials, are also outlined

  14. On-Line Monitoring of Environment-Assisted Cracking in Nuclear Piping Using Array Probe Direct Current Potential Drop

    OpenAIRE

    Kim, Y.; Choi, S.; Yoon, J. Y.; Nam, W. C.; Hwang, I. S.; Bromberg, Leslie; Stahle, Peter W; Ballinger, Ronald G

    2015-01-01

    A direct current potential drop method utilizing array probes with measurement ends maintaining an equalized potential designated as equi-potential switching array probe direct current potential drop (ESAP-DCPD) technique has been developed earlier at Seoul National University. This paper validates ESAP-DCPD technique by showing consistency among experimental measurements, analytical solution and numerical predictions using finite element analysis (FEA) of electric field changes with crack gr...

  15. 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....

  16. 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....

  17. Elliot Lake study: factors affecting the uranium mine working environment prior to the introduction of current ventilation practices

    International Nuclear Information System (INIS)

    1985-03-01

    A study was carried out to assist in the retrospective assessment of the underground environment that existed in the Elliot Lake uranium mines in the late 1950's and early 1960's. The environmental conditions and work practices of the late 1950's were established by a combination of literature review and interviews with veteran miners. The practices of the 1950's were imitated in a pilot raise, and extensive measurements of the radiation environment were made. Realistic values of radon and thoron daughter production and removal rates were obtained. The computer model demonstrated that it could reproduce all the observed features of the radiation environment given realistic input parameters. A realistic time and space dependent computer model was used to calculate and compare the average expsoure of the miner in the 1950's with the exposure that would be expected from contemporary measurements, and with that of the miner today. The calculated exposure is about half of that expected from contemporary measurements, which gives assurance that previous exposures for pilot raise miners were not underestimated. Relative to today's miner, the average exposure of the typical raise miner of the 1950's is estimated as three times higher for radon daughters, equal for thoron daughters, equal for exposure to gamma radiation, but much higher for uranium and quartz dust

  18. 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.

  19. Current use of impact models for agri-environment schemes and potential for improvements of policy design and asseessment

    DEFF Research Database (Denmark)

    Primdahl, Jørgen; Vesterager, Jens Peter; Finn, John A.

    2010-01-01

    Agri-Environment Schemes (AES) to maintain or promote environmentally-friendly farming practices were implemented on about 25% of all agricultural land in the EU by 2002. This article analyses and discusses the actual and potential use of impact models in supporting the design, implementation...... depended on whether scheme objectives were related to natural resources, biodiversity or landscape. A higher proportion of schemes dealing with natural resources (primarily water) were based on quantitative impact models, compared to whole-farm schemes and broad, horizontal schemes. We conclude...

  20. Development and Application of a Wireless Sensor for Space Charge Density Measurement in an Ultra-High-Voltage, Direct-Current Environment.

    Science.gov (United States)

    Xin, Encheng; Ju, Yong; Yuan, Haiwen

    2016-10-20

    A space charge density wireless measurement system based on the idea of distributed measurement is proposed for collecting and monitoring the space charge density in an ultra-high-voltage direct-current (UHVDC) environment. The proposed system architecture is composed of a number of wireless nodes connected with space charge density sensors and a base station. The space charge density sensor based on atmospheric ion counter method is elaborated and developed, and the ARM microprocessor and Zigbee radio frequency module are applied. The wireless network communication quality and the relationship between energy consumption and transmission distance in the complicated electromagnetic environment is tested. Based on the experimental results, the proposed measurement system demonstrates that it can adapt to the complex electromagnetic environment under the UHVDC transmission lines and can accurately measure the space charge density.

  1. Assessment of regulatory effectiveness. Peer discussions on regulatory practices

    International Nuclear Information System (INIS)

    1999-09-01

    This report arises from the seventh series of peer discussions on regulatory practices entitled 'Assessment of Regulatory Effectiveness'. The term 'regulatory effectiveness' covers the quality of the work and level of performance of a regulatory body. In this sense, regulatory effectiveness applies to regulatory body activities aimed at preventing safety degradation and ensuring that an acceptable level of safety is being maintained by the regulated operating organizations. In addition, regulatory effectiveness encompasses the promotion of safety improvements, the timely and cost effective performance of regulatory functions in a manner which ensures the confidence of the operating organizations, the general public and the government, and striving for continuous improvements to performance. Senior regulators from 22 Member States participated in two peer group discussions during March and May 1999. The discussions were focused on the elements of an effective regulatory body, possible indicators of regulatory effectiveness and its assessment. This report presents the outcome of these meetings and recommendations of good practices identified by senior regulators, which do not necessarily reflect those of the governments of the nominating Member States, the organizations they belong to, or the International Atomic Energy Agency. In order to protect people and the environment from hazards associated with nuclear facilities, the main objective of a nuclear regulatory body is to ensure that a high level of safety in the nuclear activities under its jurisdiction is achieved, maintained and within the control of operating organizations. Even if it is possible to directly judge objective safety levels at nuclear facilities, such safety levels would not provide an exclusive indicator of regulatory effectiveness. The way the regulatory body ensures the safety of workers and the public and the way it discharges its responsibilities also determine its effectiveness. Hence the

  2. 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.

  3. Current advances in molecular methods for detection of nitrite-dependent anaerobic methane oxidizing bacteria in natural environments.

    Science.gov (United States)

    Chen, Jing; Dick, Richard; Lin, Jih-Gaw; Gu, Ji-Dong

    2016-12-01

    Nitrite-dependent anaerobic methane oxidation (n-damo) process uniquely links microbial nitrogen and carbon cycles. Research on n-damo bacteria progresses quickly with experimental evidences through enrichment cultures. Polymerase chain reaction (PCR)-based methods for detecting them in various natural ecosystems and engineered systems play a very important role in the discovery of their distribution, abundance, and biodiversity in the ecosystems. Important characteristics of n-damo enrichments were obtained and their key significance in microbial nitrogen and carbon cycles was investigated. The molecular methods currently used in detecting n-damo bacteria were comprehensively reviewed and discussed for their strengths and limitations in applications with a wide range of samples. The pmoA gene-based PCR primers for n-damo bacterial detection were evaluated and, in particular, several incorrectly stated PCR primer nucleotide sequences in the published papers were also pointed out to allow correct applications of the PCR primers in current and future investigations. Furthermore, this review also offers the future perspectives of n-damo bacteria based on current information and methods available for a better acquisition of new knowledge about this group of bacteria.

  4. 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

  5. Regulatory Compliance in Multi-Tier Supplier Networks

    Science.gov (United States)

    Goossen, Emray R.; Buster, Duke A.

    2014-01-01

    Over the years, avionics systems have increased in complexity to the point where 1st tier suppliers to an aircraft OEM find it financially beneficial to outsource designs of subsystems to 2nd tier and at times to 3rd tier suppliers. Combined with challenging schedule and budgetary pressures, the environment in which safety-critical systems are being developed introduces new hurdles for regulatory agencies and industry. This new environment of both complex systems and tiered development has raised concerns in the ability of the designers to ensure safety considerations are fully addressed throughout the tier levels. This has also raised questions about the sufficiency of current regulatory guidance to ensure: proper flow down of safety awareness, avionics application understanding at the lower tiers, OEM and 1st tier oversight practices, and capabilities of lower tier suppliers. Therefore, NASA established a research project to address Regulatory Compliance in a Multi-tier Supplier Network. This research was divided into three major study efforts: 1. Describe Modern Multi-tier Avionics Development 2. Identify Current Issues in Achieving Safety and Regulatory Compliance 3. Short-term/Long-term Recommendations Toward Higher Assurance Confidence This report presents our findings of the risks, weaknesses, and our recommendations. It also includes a collection of industry-identified risks, an assessment of guideline weaknesses related to multi-tier development of complex avionics systems, and a postulation of potential modifications to guidelines to close the identified risks and weaknesses.

  6. 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.

  7. 40 CFR 73.86 - State regulatory autonomy.

    Science.gov (United States)

    2010-07-01

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

  8. Transition to an operating reactor environment: implications for NRC quality assurance programs based on nuclear power industry and regulatory projections through 1995

    International Nuclear Information System (INIS)

    Christensen, J.A.; Schuller, C.R.; Harty, H.; Patrick, M.G.

    1986-03-01

    This report develops projections for nuclear power plant regulatory needs in general, and those relating to quality assurance in particular, for the time period 1985 to 1995. This required an assessment of future prospects for the nuclear power industry and its primary segments. Electric power demand projections and their relationship to estimated schedules for nuclear plant construction and operations were evaluated, and estimates of anticipated business volume and long-term economic viability were made for each of the major segments of the US nuclear industry (utilities, NSSS vendors, AEs, constructors, component suppliers, and service vendors). These estimates were made for two, five and ten year intervals through 1995. Other significant factors that are not specific to any one industry segment were also reviewed. These included: (1) the expanding foreign presence in US markets; (2) pending legislations; (3) trends in personnel availability; (4) new institutional arrangements for nuclear power generation; (5) nuclear plant aging, life extension, and decommissioning; (6) reactivation of mothballed projects; (7) advanced and standardized plant designs; and (8) likely technological development in computer applications and inspections methods

  9. Current use of impact models for agri-environment schemes and potential for improvements of policy design and assessment.

    Science.gov (United States)

    Primdahl, Jørgen; Vesterager, Jens Peter; Finn, John A; Vlahos, George; Kristensen, Lone; Vejre, Henrik

    2010-06-01

    Agri-Environment Schemes (AES) to maintain or promote environmentally-friendly farming practices were implemented on about 25% of all agricultural land in the EU by 2002. This article analyses and discusses the actual and potential use of impact models in supporting the design, implementation and evaluation of AES. Impact models identify and establish the causal relationships between policy objectives and policy outcomes. We review and discuss the role of impact models at different stages in the AES policy process, and present results from a survey of impact models underlying 60 agri-environmental schemes in seven EU member states. We distinguished among three categories of impact models (quantitative, qualitative or common sense), depending on the degree of evidence in the formal scheme description, additional documents, or key person interviews. The categories of impact models used mainly depended on whether scheme objectives were related to natural resources, biodiversity or landscape. A higher proportion of schemes dealing with natural resources (primarily water) were based on quantitative impact models, compared to those concerned with biodiversity or landscape. Schemes explicitly targeted either on particular parts of individual farms or specific areas tended to be based more on quantitative impact models compared to whole-farm schemes and broad, horizontal schemes. We conclude that increased and better use of impact models has significant potential to improve efficiency and effectiveness of AES. (c) 2009 Elsevier Ltd. All rights reserved.

  10. 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

  11. A critical assessment of the photodegradation of pharmaceuticals in aquatic environments: defining our current understanding and identifying knowledge gaps.

    Science.gov (United States)

    Challis, Jonathan K; Hanson, Mark L; Friesen, Ken J; Wong, Charles S

    2014-04-01

    variable in the literature. Overall, the assessment rubric provides an objective and scientifically-defensible set of metrics for assessing the quality of a study. A major recommendation is the development of a method guideline, based on this rubric, for conducting and reporting on photochemical studies that would produce consistent and reliable data for quantitative comparison across studies. Furthermore, an emphasis should be placed on conducting more dual-fate studies involving controlled photolysis experiments in natural sunlight, and whole system fate studies in either natural or artificial systems. This would provide accurate data describing the actual contribution of photolysis to the overall fate of pharmaceuticals in the environment.

  12. 210Po and 210Pb emissions to air from the thermal phosphorus plant in Europe: measurements in the environment and dose assessment for regulatory purpose

    International Nuclear Information System (INIS)

    Tanzi, C.P.; Knetsch, G.J.

    2013-01-01

    In 1983 in The Netherlands, an environmental survey at a river estuary revealed elevated radionuclide concentrations above the background level. The source was identified as an industrial plant producing elemental phosphorus, by means of a thermal process. Within a few years a permit for emissions of radionuclides to the environment was requested under the prevailing Nuclear Energy Act, and granted. Since 1987 the industry reports its emission data to the mandated Ministry. This phosphorus plant contributes the highest release of 210 Po and 210 Pb to air in the Netherlands. The difficulty of identifying the enhanced activity due to the elemental phosphorus through environmental measurement is here illustrated by showing, by means of an air dispersion model, that the radioactivity added by the phosphorus plant to the environment is comparable to the natural background level. The estimate of the excess air concentration given exclusively by a continuous annual emission of 500 GBq, bound to aerosols of size less than 1 micron, varies from 450 to 750 micro Bq/m 3 at a distance of 3.5 km from the phosphorus plant, depending on yearly weather variations. This may be compared to the natural background level as it is measured at a distance of over 100 km inland from the phosphorus plant, at RIVM, the National Institute for Public Health and the Environment. The yearly average measured 210 Pb activity concentration in air is 363±5 micro Bq/m 3 in 2009 which is within range of other years. At the coastal site where the phosphorus plant is located, the natural background will be lower. The gross beta activity concentration near the phosphorus plant is 296 micro Bq/m 3 in 2009: this includes the emissions to air from the sintering process. The emission to air for the year 2009 reported by the phosphorus plan is 80 GBq/y of 210 Pb

  13. 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)

  14. The evolution of doses in the IEA-R1 reactor environment and tendencies based on the current results

    International Nuclear Information System (INIS)

    Toyoda, Eduardo Yoshio

    2016-01-01

    The IPEN / CNEN-SP have a Nuclear Research Reactor-NRR named IEA-R1, in operation from 1957. It is an open swimming pool reactor using light water as shielding, moderator and as cooling, the volume of this pool is 273m 3 .Until 1995 the reactor operated daily at a power of 2,0 MW. From June of that year, after a few safety modifications the reactor began operating in continuous way from Monday to Wednesday without shutdown totalizing 64 hours per week and the power was increased to 4,5MW also. Because of these changes, continuous operation and increased power, workers' doses would tend to increase. In the past several studies were conducted seeking ways to reduce the workers' doses. A study was made on the possibility to introduce a shielding at the top of the reactor core with a hot water layer. Studies have shown that a major limitation for operating a reactor at high power comes from the gamma radiation emitted by the sodium-24. Other elements such as magnesium-27, aluminum-28, Argon-51, contribute considerably to the water activity of the pool. The introduction of a hot water layer on the swimming pool would form a layer of surface, stable and free of radioactive elements with a 1.5m to 2m thickness creates a shielding to radiation from radioactive elements dissolved in water. Optimization studies proved that the installation of the hot layer was not necessary for the regime and the current power reactor operation, because other procedures adopted were more effective. From this decision the Radiological Protection Reactor Team, set up a dose assessment program to ensure them remained in low values based on principles established in national and international standards. The purpose of this paper is to analyze the individual doses of OEI (Occupationally Exposed Individual), which will be checked increasing doses resulting from recent changes in reactor operation regime and suggested viable safety and protection options, in the first instance to reducing

  15. Advances in the study of current-use non-PBDE brominated flame retardants and dechlorane plus in the environment and humans

    Institute of Scientific and Technical Information of China (English)

    2010-01-01

    The fate of the high production volume,currently in use,and not regulated non-polybrominated diphenyl ether(PBDE) flame retardants,such as tetrabromobisphenol A(TBBPA) ,hexabromocyclododecane(HBCD) and dechlorane plus(DP),and the alternative flame retardants of PBDE,such as BTBPE and DBDPE,in the environment has attracted increasing attention and aroused concern due to the increasing regulation and phasing-out of PBDEs.This paper reviews the distribution,bioaccumulation,human exposure and environmental behavior of those non-PBDE flame retardants in various environmental compartments.The data gaps and needs for future research are discussed.

  16. 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

  17. Neonicotinoids in the Canadian aquatic environment: a literature review on current use products with a focus on fate, exposure, and biological effects.

    Science.gov (United States)

    Anderson, J C; Dubetz, C; Palace, V P

    2015-02-01

    Developed to replace organophosphate and carbamate insecticides, neonicotinoids are structurally similar to nicotine. The three main neonicotinoid insecticides, imidacloprid, clothianidin, and thiamethoxam, are being re-evaluated by Health Canada's Pest Management Regulatory Agency (PMRA). An important aspect of the re-evaluation is the potential for effects in non-target organisms, including aquatic organisms. Leaching into surface waters is one of the major concerns surrounding extensive use of neonicotinoids, especially in close proximity to water bodies. The PMRA has classified IMI as 'persistent' with a 'high' leaching potential. Globally, neonicotinoids have been detected in a variety of water bodies, typically at concentrations in the low μg/L range. While IMI has been included in some monitoring exercises, there are currently very few published data for the presence of CLO and THM in Canadian water bodies. The majority of neonicotinoid toxicity studies have been conducted with IMI due to its longer presence on the market and high prevalence of use. Aquatic insects are particularly vulnerable to neonicotinoids and chronic toxicity has been observed at concentrations of IMI below 1 μg/L. Acute toxicity has been reported at concentrations below 20 μg/L for the most sensitive species, including Hyalella azteca, ostracods, and Chironomus riparius. Fish, algae, amphibians, and molluscs are relatively insensitive to IMI. However, the biological effects of THM and CLO have not been as well explored. The Canadian interim water quality guideline for IMI is 0.23 μg/L, but there is currently insufficient use, fate, and toxicological information available to establish guidelines for CLO and THM. Based on concentrations of neonicotinoids reported in surface waters in Canada and globally, there is potential for aquatic invertebrates to be negatively impacted by neonicotinoids. Therefore, it is necessary to address knowledge gaps to inform decisions around guidelines

  18. Why regulatory indifference towards pharmaceutical pollution of the environment could be a missed opportunity in public health protection. a holistic view.

    Science.gov (United States)

    Kamba, Pakoyo Fadhiru; Kaggwa, Bruhan; Munanura, Edson Ireeta; Okurut, Tom; Kitutu, Freddy Eric

    2017-01-01

    The last generation has witnessed bludgeoning of the world's population, a spike in disease burden, and unprecedented levels of pharmaceutical consumption and production. Unfortunately, pharmaceuticals have left their industrial and household confines and leaked into the environment. Pharmaceuticals are now major environmental pollutants, and are ubiquitous in waters and soils. Unlike other environmental contaminants, pharmaceutical pollutants are not yet regulated globally, simply because acute risk assessments show insignificant human health hazard. But the pitfalls of pharmaceutical pollutants extend beyond acute effects to delayed effects from bioaccumulation, amplified effects from drug-drug interactions, exacerbation of drug resistance, and reduction in aquatic and terrestrial food production. Therefore, ignoring pharmaceutical pollutants deprives society of holistic public health protection.

  19. 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.

  20. 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...

  1. 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...

  2. Regulatory aspects of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Kristensen, K.

    1985-01-01

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

  3. Numerical prediction of heat-flux to massive calorimeters engulfed in regulatory fires with the cask analysis fire environment (CAFE) model

    International Nuclear Information System (INIS)

    Koski, Jorman A.; Suo-Antitla, Ahti; Kramer M, Alex; Greiner, Miles

    2000-01-01

    Recent observations show that the thermal boundary conditions within large-scale fires are significantly affected by the presence of thermally massive objects. These objects cool the soot and gas near their surfaces, and these effects reduce the incoming radiant heat-flux to values lower than the levels expected from simple σT fire 4 models. They also affect the flow and temperature fields in the fire far from their surfaces. The Cask Analysis Fire Environment (CAFE) code has been developed at Sandia National Laboratories to provide an enhanced fire boundary condition for the design of radioactive material packages. CAFE is a set of computer subroutines that use computational fluid mechanics methods to predict convective heat transfer and mixing. It also includes models for fuel and oxygen transport, chemical reaction, and participating-media radiation heat transfer. This code uses two-dimensional computational models so that it has reasonably short turnaround times on standard workstations and is well suited for design and risk studies. In this paper, CAFE is coupled with a commercial finite-element program to model a large cylindrical calorimeter fully engulfed in a pool fire. The time-dependent heat-flux to the calorimeter and the calorimeter surface temperature are determined for several locations around the calorimeter circumference. The variation of heat-flux with location is determined for calorimeters with different diameters and wall thickness, and the observed effects discussed

  4. Radiation Environment at LEO in the frame of Space Monitoring Data Center at Moscow State University - recent, current and future missions

    Science.gov (United States)

    Myagkova, Irina; Kalegaev, Vladimir; Panasyuk, Mikhail; Svertilov, Sergey; Bogomolov, Vitaly; Bogomolov, Andrey; Barinova, Vera; Barinov, Oleg; Bobrovnikov, Sergey; Dolenko, Sergey; Mukhametdinova, Ludmila; Shiroky, Vladimir; Shugay, Julia

    2016-04-01

    Radiation Environment of Near-Earth space is one of the most important factors of space weather. Space Monitoring Data Center of Moscow State University provides operational control of radiation conditions at Low Earth's Orbits (LEO) of the near-Earth space using data of recent (Vernov, CORONAS series), current (Meteor-M, Electro-L series) and future (Lomonosov) space missions. Internet portal of Space Monitoring Data Center of Skobeltsyn Institute of Nuclear Physics of Lomonosov Moscow State University (SINP MSU) http://swx.sinp.msu.ru/ provides possibilities to control and analyze the space radiation conditions in the real time mode together with the geomagnetic and solar activity including hard X-ray and gamma- emission of solar flares. Operational data obtained from space missions at L1, GEO and LEO and from the Earth's magnetic stations are used to represent radiation and geomagnetic state of near-Earth environment. The models of space environment that use space measurements from different orbits were created. Interactive analysis and operational neural network forecast services are based on these models. These systems can automatically generate alerts on particle fluxes enhancements above the threshold values, both for SEP and relativistic electrons of outer Earth's radiation belt using data from GEO and LEO as input. As an example of LEO data we consider data from Vernov mission, which was launched into solar-synchronous orbit (altitude 640 - 83 0 km, inclination 98.4°, orbital period about 100 min) on July 8, 2014 and began to receive scientific information since July 20, 2014. Vernov mission have provided studies of the Earth's radiation belt relativistic electron precipitation and its possible connection with atmosphere transient luminous events, as well as the solar hard X-ray and gamma-emission measurements. Radiation and electromagnetic environment monitoring in the near-Earth Space, which is very important for space weather study, was also realised

  5. Regulatory difficulties in a developing country

    International Nuclear Information System (INIS)

    Jacobs, W.R. Jr.

    1978-01-01

    The regulatory agency assigned the task of regulating the initial entry into the field of nuclear power generation by a developing country has a very difficult job. Based on the authors' experience during the start-up and initial operation of Ko-Ri Unit I, the first power reactor in the Republic of Korea, observations on regulatory difficulties and recommendations for improved regulatory effectiveness are offered. The problem areas can be loosely grouped into three general categories: (1) Lack of adequate technical knowledge which is the basis for all effective regulation; (2) Difficulties with understanding and utilization of the required regulatory documentation; (3) Failure to establish the proper regulatory environment. Examples are cited from actual experience during the Ko-Ri Unit I start-up to demonstrate the impact that regulatory activities can have on a plant construction and testing programme. The problems encountered are not unique to developing countries but also exist in the United States of America. Recommendations are offered which should be beneficial to either newly formed regulatory agencies or agencies wishing to improve their abilities and effectiveness. These include: (1) Additional training of regulatory inspectors in plant operations; (2) Additional experience gained by participation in regulatory activities in other countries; (3) Increased attention given to regulatory documents, especially plant technical specifications; (4) Establishment of formal lines of communication between the utility and the regulatory agency; (5) Clear definition of regulatory responsibilities to avoid areas of overlapping jurisdiction; (6) Active participation by the regulatory staff very early in the project. It is hoped that these and other recommendations offered will greatly improve regulatory effectiveness and at the same time demonstrate that when the decision is made to 'go nuclear', a strong commitment must be made to develop and support a technically

  6. Ionizing radiation sources: very diversified means, multiple applications and a changing regulatory environment. Conference proceedings; Les sources de rayonnements ionisants: des moyens tres diversifies, des applications multiples et une reglementation en evolution. Recueil des presentations

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2011-11-15

    This document brings together the available presentations given at the conference organised by the French society of radiation protection about ionizing radiation source means, applications and regulatory environment. Twenty eight presentations (slides) are compiled in this document and deal with: 1 - Overview of sources - some quantitative data from the national inventory of ionizing radiation sources (Yann Billarand, IRSN); 2 - Overview of sources (Jerome Fradin, ASN); 3 - Regulatory framework (Sylvie Rodde, ASN); 4 - Alternatives to Iridium radiography - the case of pressure devices at the manufacturing stage (Henri Walaszek, Cetim; Bruno Kowalski, Welding Institute); 5 - Dosimetric stakes of medical scanner examinations (Jean-Louis Greffe, Charleroi hospital of Medical University); 6 - The removal of ionic smoke detectors (Bruno Charpentier, ASN); 7 - Joint-activity and reciprocal liabilities - Organisation of labour risk prevention in case of companies joint-activity (Paulo Pinto, DGT); 8 - Consideration of gamma-graphic testing in the organization of a unit outage activities (Jean-Gabriel Leonard, EDF); 9 - Radiological risk control at a closed and independent work field (Stephane Sartelet, Areva); 10 - Incidents and accidents status and typology (Pascale Scanff, IRSN); 11 - Regional overview of radiation protection significant events (Philippe Menechal, ASN); 12 - Incident leading to a tritium contamination in and urban area - consequences and experience feedback (Laurence Fusil, CEA); 13 - Experience feedback - loss of sealing of a calibration source (Philippe Mougnard, Areva); 14 - Blocking incident of a {sup 60}Co source (Bruno Delille, Salvarem); 15 - Triggering of gantry's alarm: status of findings (Philippe Prat, Syctom); 16 - Non-medical electric devices: regulatory changes (Sophie Dagois, IRSN; Jerome Fradin, ASN); 17 - Evaluation of the dose equivalent rate in pulsed fields: method proposed by the IRSN and implementation test (Laurent Donadille

  7. 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.

  8. A global regulatory science agenda for vaccines.

    Science.gov (United States)

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

    2013-04-18

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

  9. The development of AECB regulatory documents

    International Nuclear Information System (INIS)

    Joyce, M.

    1981-01-01

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

  10. As to achieve regulatory action, regulatory approaches

    International Nuclear Information System (INIS)

    Cid, R.; Encinas, D.

    2014-01-01

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

  11. The Regulatory Independence of FANR

    International Nuclear Information System (INIS)

    ALNuaimi, Fatema; Choi, Kwang Shik

    2012-01-01

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

  12. The Regulatory Independence of FANR

    Energy Technology Data Exchange (ETDEWEB)

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

    2012-05-15

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

  13. LightForce Photon-pressure Collision Avoidance: Efficiency Analysis in the Current Debris Environment and Long-Term Simulation Perspective

    Science.gov (United States)

    Yang, Fan Y.; Nelson, Bron; Carlino, Roberto; Perez, Andres D.; Faber, Nicolas; Henze, Chris; Karacahoglu, Arif G.; O'Toole, Conor; Swenson, Jason; Stupl, Jan

    2015-01-01

    This work provides an efficiency analysis of the LightForce space debris collision avoidance scheme in the current debris environment and describes a simulation approach to assess its impact on the long-term evolution of the space debris environment. LightForce aims to provide just-in-time collision avoidance by utilizing photon pressure from ground-based industrial lasers. These ground stations impart minimal accelerations to increase the miss distance for a predicted conjunction between two objects. In the first part of this paper we will present research that investigates the short-term effect of a few systems consisting of 10kW class lasers directed by 1.5 m diameter telescopes using adaptive optics. The results found such a network of ground stations to mitigate more than 85 percent of conjunctions and could lower the expected number of collisions in Low Earth Orbit (LEO) by an order of magnitude. While these are impressive numbers that indicate LightForce's utility in the short-term, the remaining 15 percent of possible collisions contain (among others) conjunctions between two massive objects that would add large amount of debris if they collide. Still, conjunctions between massive objects and smaller objects can be mitigated. Hence we choose to expand the capabilities of the simulation software to investigate the overall effect of a network of LightForce stations on the long-term debris evolution. In the second part of this paper, we will present the planed simulation approach for that effort.

  14. Landfill covers for dry environments

    International Nuclear Information System (INIS)

    Dwyer, S.F.

    1996-01-01

    A large-scale landfill cover field test is currently underway at Sandia National Laboratories in Albuquerque, New Mexico. It is intended to compare and document the performance of alternative landfill cover technologies of various costs and complexities for interim stabilization and/or final closure of landfills in arid and semi-arid environments. Test plots of traditional designs recommended by the US Environmental Protection Agency for both RCRA Subtitle open-quote C close-quote and open-quote D close-quote regulated facilities have been constructed side-by-side with the alternative covers and will serve as baselines for comparison to these alternative covers. The alternative covers were designed specifically for dry environments. The covers will be tested under both ambient and stressed conditions. All covers have been instrumented to measure water balance variables and soil temperature. An on-site weather station records all pertinent climatological data. A key to acceptance of an alternative environmental technology is seeking regulatory acceptance and eventual permitting. The lack of acceptance by regulatory agencies is a significant barrier to development and implementation of innovative cover technologies. Much of the effort on this demonstration has been toward gaining regulatory and public acceptance

  15. International regulatory activities

    International Nuclear Information System (INIS)

    Anon.

    2003-01-01

    Among international regulatory activities we find resolutions adopted by the IAEA general conference (2003), through European Union we find proposals for directives on nuclear safety and radioactive waste management, new regulation on the application of EURATOM safeguards, control of high activity sealed radioactive sources, recommendation on the protection and information of the public with regard to the continued contamination of certain wild food products following the Chernobyl accident, proposals for decisions authorizing the Member states to sign and ratify the Protocol to amend the Paris convention, p)proposals for a directive on environment liability with regard to the prevention and remedying of environmental damage, proposal of a regulation on the law applicable to non-contractual obligation. (N.C.)

  16. 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.

  17. 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)

  18. Assessing the effects of urbanization on the environment with soil legacy and current-use insecticides: a case study in the Pearl River Delta, China.

    Science.gov (United States)

    Wei, Yan-Li; Bao, Lian-Jun; Wu, Chen-Chou; He, Zai-Cheng; Zeng, Eddy Y

    2015-05-01

    To evaluate the impacts of anthropogenic events on the rapid urbanized environment, the levels of legacy organochlorine pesticides (OCPs) and current-use insecticides (CUPs), i.e., dichlorodiphenyltrichloroethane and its metabolites (DDTs), hexachlorocyclohexanes (HCHs), pyrethroids and organophosphates in soil of the Pearl River Delta (PRD) and surrounding areas were examined. Spatial concentration distributions of legacy OCPs and CUPs shared similar patterns, with higher concentrations occurred in the central PRD with more urbanization level than that in the PRD's surrounding areas. Furthermore, relatively higher concentrations of OCPs and CUPs were found in the residency land than in other land-use types, which may be attributed to land-use change under rapid urbanization. Moderate correlations between gross domestic production or population density and insecticide levels in fifteen administrative districts indicated that insecticide spatial distributions may be driven by economic prosperity. The soil-air diffusive exchanges of DDTs and HCHs demonstrated that soil was a sink of atmospheric o,p'-DDE, o,p'-DDD, p,p'-DDD and o,p'-DDT, and was a secondary source of HCHs and p,p'-DDT to atmosphere. The soil inventories of DDTs and HCHs (100 ± 134 and 83 ± 70 tons) were expected to decrease to half of their current values after 18 and 13 years, respectively, whereas the amounts of pyrethroids and organophosphates (39 and 6.2 tons) in soil were estimated to decrease after 4 and 2 years and then increase to 87 and 1.0 tons after 100 years. In this scenario, local residents in the PRD and surrounding areas will expose to the high health risk for pyrethroids by 2109. Strict ban on the use of technical DDTs and HCHs and proper training of famers to use insecticides may be the most effective ways to alleviate the health effect of soil contamination. Copyright © 2015 Elsevier B.V. All rights reserved.

  19. Ethical and regulatory aspects of embryonic stem cell research.

    Science.gov (United States)

    Jain, Kewal K

    2002-12-01

    Ethical and regulatory issues concerning embryonic stem (ES) cell research are reviewed here a year after the controversy became a public and political issue in the US. The background of various issues are examined and the current regulations in various countries are reviewed. In the US, the debate is linked with abortion, as well as the status of a fetus as a human being, and is politically driven. Obtaining stem cells from embryonic tissues involves destruction of the embryo, to which objections are raised. Religious beliefs are examined and no serious impediments to ES cell research could be identified. Regulations vary from one country to another and it is unlikely that there will ever be any universally uniform ethical and regulatory standards for ES cell research. Currently, the most liberal and favourable environments for ES cell research are in the UK, Singapore, Sweden, India, Israel and China. Unless the US liberalises ES cell research, it may lose its lead in ES cell research and investments in this area may drift to countries with better environments for research. Suggestions are offered in this review to improve the ethical environment for ES cell research.

  20. Regulatory authority information system RAIS

    International Nuclear Information System (INIS)

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

    2000-01-01

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

  1. Regulatory change and monetary policy

    OpenAIRE

    Bank for International Settlements

    2015-01-01

    Report submitted by a Working Group established by the Committee on the Global Financial System and the Markets Committee. The Group was chaired by Ulrich Bindseil (European Central Bank) and William R Nelson (Federal Reserve Board). Financial regulation is evolving, as policymakers seek to strengthen the financial system in order to make it more robust and resilient. Changes in the regulatory environment are likely to have an impact on financial system structure and on the behaviour of finan...

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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....

  7. Adaptation of the human population to the environment: Current knowledge, clues from Czech cytogenetic and "omics" biomonitoring studies and possible mechanisms.

    Science.gov (United States)

    Rossnerova, Andrea; Pokorna, Michaela; Svecova, Vlasta; Sram, Radim J; Topinka, Jan; Zölzer, Friedo; Rossner, Pavel

    2017-07-01

    The human population is continually exposed to numerous harmful environmental stressors, causing negative health effects and/or deregulation of biomarker levels. However, studies reporting no or even positive impacts of some stressors on humans are also sometimes published. The main aim of this review is to provide a comprehensive overview of the last decade of Czech biomonitoring research, concerning the effect of various levels of air pollution (benzo[a]pyrene) and radiation (uranium, X-ray examination and natural radon background), on the differently exposed population groups. Because some results obtained from cytogenetic studies were opposite than hypothesized, we have searched for a meaningful interpretation in genomic/epigenetic studies. A detailed analysis of our data supported by the studies of others and current epigenetic knowledge, leads to a hypothesis of the versatile mechanism of adaptation to environmental stressors via DNA methylation settings which may even originate in prenatal development, and help to reduce the resulting DNA damage levels. This hypothesis is fully in agreement with unexpected data from our studies (e.g. lower levels of DNA damage in subjects from highly polluted regions than in controls or in subjects exposed repeatedly to a pollutant than in those without previous exposure), and is also supported by differences in DNA methylation patterns in groups from regions with various levels of pollution. In light of the adaptation hypothesis, the following points may be suggested for future research: (i) the chronic and acute exposure of study subjects should be distinguished; (ii) the exposure history should be mapped including place of residence during the life and prenatal development; (iii) changes of epigenetic markers should be monitored over time. In summary, investigation of human adaptation to the environment, one of the most important processes of survival, is a new challenge for future research in the field of human

  8. Categorization and selection of regulatory approaches for nuclear power plants

    International Nuclear Information System (INIS)

    Sugaya, Junko; Harayama, Yuko

    2009-01-01

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

  9. Professional and Regulatory Search

    Science.gov (United States)

    Professional and Regulatory search are designed for people who use EPA web resources to do their job. You will be searching collections where information that is not relevant to Environmental and Regulatory professionals.

  10. Swine brucellosis: current perspectives

    Directory of Open Access Journals (Sweden)

    Olsen SC

    2016-12-01

    Full Text Available SC Olsen, FM Tatum Infectious Bacterial Diseases of Livestock Research Unit, National Animal Disease Center, Agricultural Research Service, United States Department of Agriculture, Ames, IA, USA Abstract: Brucella suis is a significant zoonotic species that is present in domestic livestock and wildlife in many countries worldwide. Transmission from animal reservoirs is the source of human infection as human-to-human transmission is very rare. Although swine brucellosis causes economic losses in domestic livestock, preventing human infection is the primary reason for its emphasis in disease control programs. Although disease prevalence varies worldwide, in areas outside of Europe, swine brucellosis is predominantly caused by B. suis biovars 1 and 3. In Europe, swine are predominantly infected with biovar 2 which is much less pathogenic in humans. In many areas worldwide, feral or wild populations of swine are important reservoir hosts. Like other Brucella spp. in their natural host, B. suis has developed mechanisms to survive in an intracellular environment and evade immune detection. Limitations in sensitivity and specificity of current diagnostics require use at a herd level, rather for individual animals. There is currently no commercial vaccine approved for preventing brucellosis in swine. Although not feasible in all situations, whole-herd depopulation is the most effective regulatory mechanism to control swine brucellosis. Keywords: livestock, transmission, pathogenicity, vaccine, host, infection

  11. Future nuclear regulatory challenges

    International Nuclear Information System (INIS)

    Royen, J.

    1998-01-01

    In December 1996, the NEA Committee on Nuclear Regulatory Activities concluded that changes resulting from economic deregulation and other recent developments affecting nuclear power programmes have consequences both for licensees and regulatory authorities. A number of potential problems and issues which will present a challenge to nuclear regulatory bodies over the next ten years have been identified in a report just released. (author)

  12. 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)

  13. Use and application of 'best estimate plus uncertainty' methods. A regulatory view

    International Nuclear Information System (INIS)

    Mendizabal, Rafael; Pelayo, Fernando

    2013-01-01

    Regulatory environment is characterized by its prevention to change. Any move has to be solidly founded. Application in licensing of Best Estimate Plus Uncertainty (BEPU) methods is not an exception. Typically a fully deterministic approach as described in IAEA SSG-2 is used for design bases accident analyses in current Nuclear Power Plants. In recent years the use of BEPU methodologies is gaining favor in the nuclear technology community as a way to optimize design and operation while preserving full compliance with applicable regulation. This paper has its focus on the regulatory relevance of the use of BEPU in licensing practices. A regulatory analysis describing the rationale of the evolution from classic deterministic methods to BEPU as well as a selected set of topics around the implications of the use of BEPU methods is shown. To finalize some conclusions and thoughts of possible further developments of these methods are drawn. (authors)

  14. Regulatory activities; Actividades regulatorias

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2001-07-01

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

  15. Characterisation of impacts on the environment of an idealised offshore wind farm foundation, under waves and the combination of waves and currents

    Science.gov (United States)

    García-Hermosa, Isabel; Abcha, Nizar; Brossard, Jérôme; Bennis, Anne-Claire; Ezersky, Alexander; Gross, Marcus; Iglesias, Gregorio; Magar, Vanesa; Miles, Jon; Mouazé, Dominique; Perret, Gaële; Pinon, Grégory; Rivier, Aurélie; Rogan, Charlie; Simmonds, David

    2015-04-01

    Offshore wind technology is currently the most widespread and advanced source of marine renewable energy. Offshore wind farms populate waters through the North Sea and the English Channel. The UK and French governments devised deadlines to achieve percentages of electricity from renewable sources by 2020, these deadlines and the direct translation of land based wind farm technology to the offshore environment resulted in the rapid expansion of the offshore wind energy. New wind farms have been designed with a larger number of masts and are moving from shallow offshore banks to deeper waters and in order to produce more power the diameters of monopoles masts are becoming larger to support larger turbines. The three-partner EU INTERREG funded project OFELIA (http://www.interreg-ofelia.eu/) aims to establish a cross-channel (between the UK and France) research collaboration to improve understanding of the environmental impacts of offshore wind farm foundations. The objective of the present study is to characterise changes in the hydrodynamics and sea bed in the vicinity of an offshore wind farm mast and in the wake area under wave and wave-current conditions corresponding to events in the French wind farm site of Courseulles-sur-mer (offshore of Lower Normandy, in the English Channel). Experiments were carried out in two laboratory facilities: a wave flume of 35 m long, 0.9 m wide and 1.2 m in depth with regular and irregular waves (García-Hermosa et al., 2014); and a wave and current flume of 17 m long, 0.5 m wide and 0.4 m depth with regular waves, currents from 180° to the waves and a mobile bed (Gunnoo et al., 2014). Flow velocity measurements were taken with an Acoustic Dopple Velocimeter (ADV) at various points around the cylinder and Particle Image Velocitmetry (PIV) techniques were applied to larger areas upstream and downstream of the cylinder. During the assessment of waves and currents' effects on the bed evolution were assessed using a laser and camera

  16. Regulatory aspects of NPP safety

    International Nuclear Information System (INIS)

    Kastchiev, G.

    1999-01-01

    Extensive review of the NPP Safety is presented including tasks of Ministry of Health, Ministry of Internal Affairs, Ministry of Environment and Waters, Ministry of Defense in the field of national system for monitoring the nuclear power. In the frame of national nuclear safety legislation Bulgaria is in the process of approximation of the national legislation to that of EC. Detailed analysis of the status of regulatory body, its functions, organisation structure, responsibilities and future tasks is included. Basis for establishing the system of regulatory inspections and safety enforcement as well as intensification of inspections is described. Assessment of safety modifications is concerned with complex program for reconstruction of Units 1-4 of Kozloduy NPP, as well as for modernisation of Units 5 and 6. Qualification and licensing of the NPP personnel, Year 2000 problem, priorities and the need of international assistance are mentioned

  17. Development of artificial radioactivity in the French environment during the past 50 years and related doses; effect of the current operation of nuclear facilities

    International Nuclear Information System (INIS)

    Renaud, Ph.; Roussel-Debet, S.

    2010-01-01

    The activities of artificial radionuclides in the environment have being strongly decreasing since 50 years. Nowadays the activities of 3 H and 14 C widely predominate, but they cannot be still considered as artificial radionuclides, except nearby the nuclear installations where they constitute the most abundant radioactive releases. In terrestrial environment this influence is limited to the surroundings of 5 sites, although most of nuclear sites and nuclear medical centers are involved in the contamination of the aquatic environment downstream the releases and in the Channel. Since 1987 the doses to the French population have been mainly induced by 14 C and 137 Cs. (author)

  18. Pharmaceuticals and Personal Care Products in the Environment: What are the Big Questions?

    Science.gov (United States)

    Over the past 10-15 years, a significant amount of work has been done by the scientific, regulatory and business communities into effects and risks of pharmaceuticals and personal care products (PPCPs) in the environment. It is now timely to review the current knowledge and to...

  19. 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.

  20. Management systems for regulatory authorities

    International Nuclear Information System (INIS)

    Mpandanyama, Rujeko Lynette

    2015-02-01

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

  1. Environment protection in the legal system of Albania: The current situation in Albania on combating environmental crimes and the new reform directions

    Directory of Open Access Journals (Sweden)

    Shkëlzen Selimi

    2016-07-01

    The conclusions reached at the end shows the evolution of the concept of environment and its protection, welcomes the new reform by noting the need of the judicial authorities to be trained in order to be fully implemented.

  2. Detection and Characterization of Engineered Nanomaterials in the Environment: Current State-of-the-art and Future Directions Report, Annotated Bibliography, and Image Library

    Science.gov (United States)

    The increasing manufacture and implementation of engineered nanomaterials (ENMs) will continue to lead to the release of these materials into the environment. Reliably assessing the environmental exposure risk of ENMs will depend highly on the ability to quantify and characterize...

  3. Diagnosis of the Brazilian Nuclear Regulatory body

    International Nuclear Information System (INIS)

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

    2008-01-01

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

  4. 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)

  5. Research and regulatory review

    International Nuclear Information System (INIS)

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

    1979-01-01

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

  6. Regulatory Body of Egypt: Practices and Challenges

    International Nuclear Information System (INIS)

    El-Messiry, A.

    2016-01-01

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

  7. Regulatory Commission of Alaska

    Science.gov (United States)

    Map Help Regulatory Commission of Alaska Login Forgot Password Arrow Image Forgot password? View Cart login Procedures for Requesting Login For Consumers General Information Telephone Electric Natural Gas

  8. Strengthening the Canadian alcohol advertising regulatory system.

    Science.gov (United States)

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

    2012-05-24

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

  9. 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

  10. Radio-ecological characterization and radiological assessment in support of regulatory supervision of legacy sites in northwest Russia.

    Science.gov (United States)

    Sneve, M K; Kiselev, M; Shandala, N K

    2014-05-01

    The Norwegian Radiation Protection Authority has been implementing a regulatory cooperation program in the Russian Federation for over 10 years, as part of the Norwegian government's Plan of Action for enhancing nuclear and radiation safety in northwest Russia. The overall long-term objective has been the enhancement of safety culture and includes a special focus on regulatory supervision of nuclear legacy sites. The initial project outputs included appropriate regulatory threat assessments, to determine the hazardous situations and activities which are most in need of enhanced regulatory supervision. In turn, this has led to the development of new and updated norms and standards, and related regulatory procedures, necessary to address the often abnormal conditions at legacy sites. This paper presents the experience gained within the above program with regard to radio-ecological characterization of Sites of Temporary Storage for spent nuclear fuel and radioactive waste at Andreeva Bay and Gremikha in the Kola Peninsula in northwest Russia. Such characterization is necessary to support assessments of the current radiological situation and to support prospective assessments of its evolution. Both types of assessments contribute to regulatory supervision of the sites. Accordingly, they include assessments to support development of regulatory standards and guidance concerning: control of radiation exposures to workers during remediation operations; emergency preparedness and response; planned radionuclide releases to the environment; development of site restoration plans, and waste treatment and disposal. Examples of characterization work are presented which relate to terrestrial and marine environments at Andreeva Bay. The use of this data in assessments is illustrated by means of the visualization and assessment tool (DATAMAP) developed as part of the regulatory cooperation program, specifically to help control radiation exposure in operations and to support

  11. Application of Resource Portfolio Concept in Nuclear Regulatory Infrastructure Support

    International Nuclear Information System (INIS)

    Lee, Y. E.; Ha, J. T.; Chang, H. S.; Kam, S. C.; Ryu, Y. H.

    2010-01-01

    As the new entrants in the global nuclear construction market are increasing and the establishment of an effective and sustainable regulatory infrastructure becomes more important, they have requested international assistance from the international nuclear communities with mature nuclear regulatory programmes. It needs to optimize the use of limited resources from regulatory organization providing support to regulatory infrastructure of new comers. This paper suggests the resource portfolio concept like a GE/Mckinsey Matrix used in business management and tries to apply it to the current needs considered in the regulatory support program in Korea as the case study

  12. Development of regulatory policy for SMART-P

    Energy Technology Data Exchange (ETDEWEB)

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

    2004-06-15

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

  13. Development of regulatory policy for SMART-P

    Energy Technology Data Exchange (ETDEWEB)

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

    2003-06-15

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

  14. 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

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

    International Nuclear Information System (INIS)

    Lee, Chang Ju; Choi, Jong Soo

    2005-01-01

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

  16. NRC Regulatory Agenda

    International Nuclear Information System (INIS)

    1991-10-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  17. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1993-04-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  18. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1990-01-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has proposed or is considering action and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  19. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1991-04-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  20. NRC Regulatory Agenda

    International Nuclear Information System (INIS)

    1991-08-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and all petitions for rulemaking which have been received by the commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  1. Trust in regulatory regimes

    NARCIS (Netherlands)

    Six, Frédérique; Verhoest, Koen

    2017-01-01

    Within political and administrative sciences generally, trust as a concept is contested, especially in the field of regulatory governance. This groundbreaking book is the first to systematically explore the role and dynamics of trust within regulatory regimes. Conceptualizing, mapping and analyzing

  2. Nuclear Regulatory legislation

    International Nuclear Information System (INIS)

    1984-06-01

    This compilation of statutes and material pertaining to nuclear regulatory legislation through the 97th Congress, 2nd Session, has been prepared by the Office of the Executive Legal Director, U.S. Nuclear Regulatory Commission, with the assistance of staff, for use as an internal resource document

  3. Combined Effect of Alternating Current Interference and Cathodic Protection on Pitting Corrosion and Stress Corrosion Cracking Behavior of X70 Pipeline Steel in Near-Neutral pH Environment

    Directory of Open Access Journals (Sweden)

    Liwei Wang

    2018-03-01

    Full Text Available Influence of alternating current (AC on pitting corrosion and stress corrosion cracking (SCC behavior of X70 pipeline steel in the near-neutral pH environment under cathodic protection (CP was investigated. Both corrosion and SCC are inhibited by −0.775 VSCE CP without AC interference. With the superimposition of AC current (1–10 mA/cm2, the direct current (DC potential shifts negatively under the CP of −0.775 VSCE and the cathodic DC current decreases and shifts to the anodic direction. Under the CP potential of −0.95 VSCE and −1.2 VSCE, the applied AC current promotes the cathodic reaction and leads to the positive shift of DC potential and increase of cathodic current. Local anodic dissolution occurs attributing to the generated anodic current transients in the positive half-cycle of the AC current, resulting in the initiation of corrosion pits (0.6–2 μm in diameter. AC enhances the SCC susceptibility of X70 steel under −0.775 VSCE CP, attributing to the promotion of anodic dissolution and hydrogen evolution. Even an AC current as low as 1 mA/cm2 can enhance the SCC susceptibility.

  4. Nitrogen modulation of legume root architecture signaling pathways involves phytohormones and small regulatory molecules.

    Science.gov (United States)

    Mohd-Radzman, Nadiatul A; Djordjevic, Michael A; Imin, Nijat

    2013-10-01

    Nitrogen, particularly nitrate is an important yield determinant for crops. However, current agricultural practice with excessive fertilizer usage has detrimental effects on the environment. Therefore, legumes have been suggested as a sustainable alternative for replenishing soil nitrogen. Legumes can uniquely form nitrogen-fixing nodules through symbiotic interaction with specialized soil bacteria. Legumes possess a highly plastic root system which modulates its architecture according to the nitrogen availability in the soil. Understanding how legumes regulate root development in response to nitrogen availability is an important step to improving root architecture. The nitrogen-mediated root development pathway starts with sensing soil nitrogen level followed by subsequent signal transduction pathways involving phytohormones, microRNAs and regulatory peptides that collectively modulate the growth and shape of the root system. This review focuses on the current understanding of nitrogen-mediated legume root architecture including local and systemic regulations by different N-sources and the modulations by phytohormones and small regulatory molecules.

  5. Improving nuclear regulatory effectiveness

    International Nuclear Information System (INIS)

    2001-01-01

    Ensuring that nuclear installations are operated and maintained in such a way that their impact on public health and safety is as low as reasonably practicable has been and will continue to be the cornerstone of nuclear regulation. In the past, nuclear incidents provided the main impetus for regulatory change. Today, economic factors, deregulation, technological advancements, government oversight and the general requirements for openness and accountability are leading regulatory bodies to review their effectiveness. In addition, seeking to enhance the present level of nuclear safety by continuously improving the effectiveness of regulatory bodies is seen as one of the ways to strengthen public confidence in the regulatory systems. This report covers the basic concepts underlying nuclear regulatory effectiveness, advances being made and future requirements. The intended audience is primarily nuclear safety regulators, but government authorities, nuclear power plant operators and the general public may also be interested. (author)

  6. Regulatory Office for Network Industries

    International Nuclear Information System (INIS)

    2005-01-01

    The main goal of the economic regulation of network industries is to ensure a balance between the interests of consumers and investors and to encourage providing high-quality goods and services. The task of the regulatory authority is to protect the interests of consumers against monopolistic behaviour of regulated enterprises. At the same time, the regulatory office has to protect the interests of investors by giving them an opportunity to achieve an adequate return on their investments. And last, but not least, the regulatory office has to provide regulated enterprises with appropriate incentives to make them function in an efficient and effective manner and to guarantee the security of delivery of energies and related services. All this creates an efficient regulatory framework that is capable of attracting the required amount and type of investments. This also means providing third party access to the grids, the opening of energy markets, the un-bundling of accounts according to production, distribution, transmission and other activities and the establishment of a transparent and stable legislative environment for regulated companies, investors and consumers. Otherwise, in the long run consumers may suffer from a serious deterioration of service quality, although in the short run they are protected against increased prices. Under the Act No. 276/2001 Coll. on Regulation of Network Industries and on amendment of some acts the Office for Regulation of Network Industries has been commissioned to implement the main objectives of regulation of network industries. By network industries the Act No. 276/2001 Coll. on Regulation means the following areas: (a) Production, purchase, transit and distribution of electricity; (b) Production, purchase, transit and distribution of gas; (c) Production, purchase and distribution of heat; (d) Water management activities relating to the operation of the public water supply system or the public sewerage system; (e) Water management

  7. Tritium : health risks, regulatory issues and the nuclear future

    International Nuclear Information System (INIS)

    Chambers, D. B.; Garva, A.

    2010-10-01

    The refurbishment of existing reactors and proposed new build reactors in Canada has resulted in increased public opposition to nuclear power. This opposition has been fuelled by information provided to local groups by highly motivated national and international anti-nuclear groups who foster overstated and often incorrect views on the risks of low doses of radiation. Over the past several years, there has been increased scientific and public interest in the risks of low exposures to tritium. Scientific aspects which have received considerable attention include amongst others, behaviour in the environment, the possibility of increasing the relative biological effectiveness for tritium, the importance of organically bound tritium, and tritium dosimetry. In Canada at least, the perception of harm from exposures to low levels of tritium has been enhanced in the public mind by a proposal in one Province to lower the drinking water standard for tritium from 7,000 Bq/L to 20 Bq/L, which certain non-governmental organizations use to suggest the risks have been greatly underestimated in the past. Actually regulatory environment, the approval of local public of often a requirement for licensing a nuclear facility and thus it is important to ensure that correct information is not only available but available in a technically correct but easily understood form. This paper reviews the currently available scientific information on the risks from exposure to tritium and provides a context of the implications for regulatory actions and communications with the public. (Author)

  8. Are better sleepers more engaged workers? A self-regulatory approach to sleep hygiene and work engagement.

    Science.gov (United States)

    Barber, Larissa; Grawitch, Matthew J; Munz, David C

    2013-10-01

    Previous research has emphasized facets of both the organizational environment and individual differences as predictors of work engagement. This study explored sleep hygiene as another important behavioural factor that may be related to work engagement. With a sample of 328 adult workers, we tested a multiple mediator model in which sleep hygiene predicts work engagement through one's appraisals of resource depletion stemming from demands (psychological strain) and general self-regulatory capacity (self-control). Results indicated that individuals who frequently engaged in poor sleep hygiene behaviours had lower self-regulatory capacity, experienced higher subjective depletion and were less engaged at work. Additionally, the path from poor sleep hygiene to decreased work engagement was attributed to perceptions of personal resources that are needed to exert self-regulatory energy at work. This is consistent with current self-regulatory theories suggesting that individuals have a limited amount of resources to allocate to demands and that the depletion of these resources can lead to stress and lower self-regulatory functioning in response to other demands. Specifically, poor sleep hygiene results in the loss of self-regulatory resources needed to be engaged in work tasks by impairing the after-work recovery process. Practical and research implications regarding sleep hygiene interventions for well-being and productivity improvement are discussed. Copyright © 2012 John Wiley & Sons, Ltd.

  9. International regulatory activities

    International Nuclear Information System (INIS)

    Anon.

    2004-01-01

    The 48. session of the IAEA general conference was held in Vienna from 20 to 24 september 2004 with the participation of delegates from 125 members states and representatives of various international organisations. A number of resolutions were adopted by the conference in the following fields: nuclear safety, radiation, transport and waste safety. The general conference also adopted a resolution on measures to protect against nuclear terrorism. The Director General decided in 2003 to appoint a group of experts to explore and advise on issues related to nuclear liability. This group called the International Expert Group on Nuclear Liability (I.N.L.E.X.) consists of 20 experts members from nuclear power and non nuclear power countries and from shipping and non shipping states. It serves three major functions: to create a forum of expertise to explore and advise on issues related to nuclear liability; to enhance global adherence by nuclear and non nuclear states to an effective nuclear liability regime, inter alia, on the basis of the convention on supplementary compensation for nuclear damage and the annex thereto, the Vienna convention on civil liability for nuclear damage, the Paris convention on third party liability in the field of nuclear energy, the joint protocol relating to the application of the vienna convention and the paris convention and the amendments thereto; and to assist in the development and strengthening of the national nuclear liability legal frameworks in IAEA members states to protect the public and the environment and to enhance nuclear safety. The second part of international regulatory concerns a directive on public access to environmental information made by the European Parliament. (N.C.)

  10. Views from the japanese regulatory authority

    International Nuclear Information System (INIS)

    Aoyama, S.

    2004-01-01

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

  11. Regulatory oversight of nuclear safety in Finland. Annual report 2011

    Energy Technology Data Exchange (ETDEWEB)

    Kainulainen, E. (ed.)

    2012-07-01

    The report constitutes the report on regulatory control in the field of nuclear energy which the Radiation and Nuclear Safety Authority (STUK) is required to submit once a year to the Ministry of Employment and the Economy pursuant to Section 121 of the Nuclear Energy Decree. The report is also delivered to the Ministry of Environment, the Finnish Environment Institute, and the regional environmental authorities of the localities in which a nuclear facility is located. The regulatory control of nuclear safety in 2011 included the design, construction and operation of nuclear facilities, as well as nuclear waste management and nuclear materials. The first parts of the report explain the basics of nuclear safety regulation included as part of STUK's responsibilities, as well as the objectives of the operations, and briefly introduce the objects of regulation. The chapter concerning the development and implementation of legislation and regulations describes changes in nuclear legislation, as well as the progress of STUK's YVL Guide revision work. The section concerning the regulation of nuclear facilities contains an overall safety assessment of the nuclear facilities currently in operation or under construction. The chapter concerning the regulation of the final disposal project for spent nuclear fuel de-scribes the preparations for the final disposal project and the related regulatory activities. The section concerning nuclear non-proliferation describes the nuclear non-proliferation control for Finnish nuclear facilities and final disposal of spent nuclear fuel, as well as measures required by the Additional Protocol of the Safeguards Agreement. The chapter describing the oversight of security arrangements in the use of nuclear energy discusses oversight of the security arrangements in nuclear power plants and other plants, institutions and functions included within the scope of STUK's regulatory oversight. The chapter also discusses the national and

  12. The Romanian nuclear regulatory body as a nuclear communicator

    International Nuclear Information System (INIS)

    Cluculescu, Cristina

    2000-01-01

    A comprehensive nuclear law environment could be a relevant tool to promote greater confidence in the nuclear energy. Romania has had laws in place governing the regulation of nuclear activities since 1974, which remained in force throughout and subsequent to the national constitutional changes. Up to December 1996, the CNCAN activities were based on Law No. 61/1974 for the development of the nuclear activities in Romania and Law No. 61982 on the quality assurance of the nuclear facilities and nuclear power plants. The Nuclear Safety legislation has been enacted in November 1974 (Law No. 61/1974) and it followed as closely as possible (for that time) the US Atomic Energy Act of 1954, as amended subsequently. The Romanian nuclear regulatory body, called National Commission for Nuclear Activities Control (CNCAN) is a governmental organization responsible for the development of the regulatory framework, the control of its implementation and for the licensing of nuclear facilities. An important issue of CNCAN is to provide the correct and reasoning information to the public. The most important topics focused on nuclear activities for the interest of mass media in Romania are: Radioactive waste management; The cost and benefit of nuclear energy compared by conventional energy; The conditions for transportation of radioactive materials; The consequences of a suppositional nuclear accidents; The safety in operation for nuclear installations. The information provided to press and public by regulatory body is clearly and well structured. The target is to clearly explain to mass media and the public should understand very well the difference between the meaning of a nuclear accident, nuclear incident or nuclear event. CNCAN monitories and surveys the operation in safe conditions the nuclear facilities and plants, the protection against nuclear radiation of the professionally exposed personnel, of the population, of the environment and the material goods. It is also

  13. Regulatory guidance document

    International Nuclear Information System (INIS)

    1994-05-01

    The Office of Civilian Radioactive Waste Management (OCRWM) Program Management System Manual requires preparation of the OCRWM Regulatory Guidance Document (RGD) that addresses licensing, environmental compliance, and safety and health compliance. The document provides: regulatory compliance policy; guidance to OCRWM organizational elements to ensure a consistent approach when complying with regulatory requirements; strategies to achieve policy objectives; organizational responsibilities for regulatory compliance; guidance with regard to Program compliance oversight; and guidance on the contents of a project-level Regulatory Compliance Plan. The scope of the RGD includes site suitability evaluation, licensing, environmental compliance, and safety and health compliance, in accordance with the direction provided by Section 4.6.3 of the PMS Manual. Site suitability evaluation and regulatory compliance during site characterization are significant activities, particularly with regard to the YW MSA. OCRWM's evaluation of whether the Yucca Mountain site is suitable for repository development must precede its submittal of a license application to the Nuclear Regulatory Commission (NRC). Accordingly, site suitability evaluation is discussed in Chapter 4, and the general statements of policy regarding site suitability evaluation are discussed in Section 2.1. Although much of the data and analyses may initially be similar, the licensing process is discussed separately in Chapter 5. Environmental compliance is discussed in Chapter 6. Safety and Health compliance is discussed in Chapter 7

  14. 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

  15. Regulatory Myeloid Cells in Transplantation

    Science.gov (United States)

    Rosborough, Brian R.; Raïch-Regué, Dàlia; Turnquist, Heth R.; Thomson, Angus W.

    2013-01-01

    Regulatory myeloid cells (RMC) are emerging as novel targets for immunosuppressive (IS) agents and hold considerable promise as cellular therapeutic agents. Herein, we discuss the ability of regulatory macrophages (Mreg), regulatory dendritic cells (DCreg) and myeloid-derived suppressor cells (MDSC) to regulate alloimmunity, their potential as cellular therapeutic agents and the IS agents that target their function. We consider protocols for the generation of RMC and the selection of donor- or recipient-derived cells for adoptive cell therapy. Additionally, the issues of cell trafficking and antigen (Ag) specificity following RMC transfer are discussed. Improved understanding of the immunobiology of these cells has increased the possibility of moving RMC into the clinic to reduce the burden of current IS agents and promote Ag-specific tolerance. In the second half of this review, we discuss the influence of established and experimental IS agents on myeloid cell populations. IS agents believed historically to act primarily on T cell activation and proliferation are emerging as important regulators of RMC function. Better insights into the influence of IS agents on RMC will enhance our ability to develop cell therapy protocols to promote the function of these cells. Moreover, novel IS agents may be designed to target RMC in situ to promote Ag-specific immune regulation in transplantation and usher in a new era of immune modulation exploiting cells of myeloid origin. PMID:24092382

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

    Science.gov (United States)

    WU, Fenghong; CHI, Yan

    2015-01-01

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

  17. Effectiveness of Regulatory Structure in the Power Sector of Pakistan

    OpenAIRE

    Afia Malik

    2007-01-01

    This paper is an attempt to study the regulatory environment in the electricity sector of Pakistan. NEPRA, a regulatory authority was formed in 1997 to protect consumer interests in the area of electricity provision, and to ensure an efficient and competitive environment for the electricity generators and distributors, but it has so far not been able to achieve anything. The power sector (dominated by WAPDA and KESC) is still affected by institutional and organisational weaknesses, with ineff...

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

    International Nuclear Information System (INIS)

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

    1991-01-01

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

  19. Safeguards inventory and process monitoring regulatory comparison

    Energy Technology Data Exchange (ETDEWEB)

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

    2013-06-27

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

  20. 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...

  1. Safety research programs sponsored by Office of Nuclear Regulatory Research

    International Nuclear Information System (INIS)

    Weiss, A.J.; Azarm, A.; Baum, J.W.

    1989-07-01

    This progress report describes current activities and technical progress in the programs at Brookhaven National Laboratory sponsored by the Division of Regulatory Applications, Division of Engineering, Division of Safety Issue Resolution, and Division of Systems Research of the US Nuclear Regulatory Commission, Office of Nuclear Regulatory Research following the reorganization in July 1988. The previous reports have covered the period October 1, 1976 through September 30, 1988

  2. Regulatory issues in accreditation of toxicology laboratories.

    Science.gov (United States)

    Bissell, Michael G

    2012-09-01

    Clinical toxicology laboratories and forensic toxicology laboratories operate in a highly regulated environment. This article outlines major US legal/regulatory issues and requirements relevant to accreditation of toxicology laboratories (state and local regulations are not covered in any depth). The most fundamental regulatory distinction involves the purposes for which the laboratory operates: clinical versus nonclinical. The applicable regulations and the requirements and options for operations depend most basically on this consideration, with clinical toxicology laboratories being directly subject to federal law including mandated options for accreditation and forensic toxicology laboratories being subject to degrees of voluntary or state government–required accreditation.

  3. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1990-10-01

    The Regulatory Agenda is a quarterly compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and of all petitions for rulemaking that the NRC has received that are pending disposition

  4. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1990-04-01

    The Regulatory Agenda is a quarterly compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and of all petitions for rulemaking that the NRC has received that are pending disposition

  5. Through the regulatory hoop

    International Nuclear Information System (INIS)

    Kirner, N.P.

    1985-01-01

    There are many regulatory hoops through which waste generators, brokers, and disposal site operators must jump to dispose of waste safely. As the proposed exclusionary date of January 1, 1986, approaches, these regulatory hoops have the distinct possibility of multiplying or at least changing shape. The state of Washington, in its role as an Agreement State with the US Nuclear Regulatory Commission, licenses and inspects the commercial operator of the Northwest Compact's low-level radioactive waste disposal site on the Hanford Reservation. Washington has received as much as 53%, or 1.4 million cubic feet per year, of the nation's total volume of waste disposed. To control such a large volume of waste, a regulatory program involving six agencies has developed over the years in Washington

  6. Regulatory Aspect of an Ageing Management Program

    International Nuclear Information System (INIS)

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

    2006-01-01

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

  7. Current clinical research environment: focus on psychiatry Cenário atual da pesquisa clínica: foco em psiquiatria

    Directory of Open Access Journals (Sweden)

    Sonia Mansoldo Dainesi

    2007-09-01

    Full Text Available The introduction of international guidelines on Good Clinical Practices (GCP in 1996, immediately followed by the publication of Resolution CNS 196/96 in Brazil, created a great opportunity for Brazilian research centers to participate in international trials. Such studies must be strictly monitored in order to assure compliance with the regulations, as well as with the standards of patient safety. Clear agreement among the investigator, the sponsor and the institution carrying out the study must be previously defined in order to avoid any conflicts of interest during or after the study. Operational aspects, such as the time needed to gain regulatory approval of the study design, strategies for patient recruitment/retention and appropriate logistics, are also important. In 2005, the Brazilian National Clinical Research Network was established, bringing together a number of research centers in teaching hospitals. The objective was to subsidize public clinical research with state-of-the-art practices and appropriate technical/scientific training programs. The development of research protocols that prioritize public health care needs in Brazil is other fundamental goal of this network. This article addresses general aspects of clinical research, as well as some specific issues in psychiatry. Improving the health and quality of life of the global population is certainly the major objective of all of the work done in this area.A introdução de diretrizes internacionais de Boas Práticas Clínicas, em 1996, imediatamente seguida pela publicação da Resolução do Conselho Nacional de Saúde 196/96, abriu uma grande oportunidade para a participação de centros de pesquisa brasileiros em estudos internacionais. Tais estudos devem ser estritamente monitorados, a fim de assegurar a adesão às legislações, assim como garantir a segurança dos pacientes envolvidos. A fim de evitar possíveis conflitos de interesse durante e após o estudo, todos os

  8. Revised analyses of decommissioning for the reference pressurized Water Reactor Power Station. Volume 2, Effects of current regulatory and other considerations on the financial assurance requirements of the decommissioning rule and on estimates of occupational radiation exposure: Appendices, Final report

    Energy Technology Data Exchange (ETDEWEB)

    Konzek, G.J.; Smith, R.I.; Bierschbach, M.C.; McDuffie, P.N.

    1995-11-01

    With the issuance of the final Decommissioning Rule (July 27, 1998), owners and operators of licensed nuclear power plants are required to prepare, and submit to the US Nuclear Regulatory Commission (NRC) for review, decommissioning plans and cost estimates. The NRC staff is in need of bases documentation that will assist them in assessing the adequacy of the licensee submittals, from the viewpoint of both the planned actions, including occupational radiation exposure, and the probable costs. The purpose of this reevaluation study is to provide some of the needed bases documentation. This report contains the results of a review and reevaluation of the 1978 PNL decommissioning study of the Trojan nuclear power plant (NUREG/CR-0130), including all identifiable factors and cost assumptions which contribute significantly to the total cost of decommissioning the nuclear power plant for the DECON, SAFSTOR, and ENTOMB decommissioning alternatives. These alternatives now include an initial 5--7 year period during which time the spent fuel is stored in the spent fuel pool, prior to beginning major disassembly or extended safe storage of the plant. Included for information (but not presently part of the license termination cost) is an estimate of the cost to demolish the decontaminated and clean structures on the site and to restore the site to a ``green field`` condition. This report also includes consideration of the NRC requirement that decontamination and decommissioning activities leading to termination of the nuclear license be completed within 60 years of final reactor shutdown, consideration of packaging and disposal requirements for materials whose radionuclide concentrations exceed the limits for Class C low-level waste (i.e., Greater-Than-Class C), and reflects 1993 costs for labor, materials, transport, and disposal activities.

  9. Revised analyses of decommissioning for the reference pressurized Water Reactor Power Station. Effects of current regulatory and other considerations on the financial assurance requirements of the decommissioning rule and on estimates of occupational radiation exposure, Volume 1, Final report

    Energy Technology Data Exchange (ETDEWEB)

    Konzek, G.J.; Smith, R.I.; Bierschbach, M.C.; McDuffie, P.N. [Pacific Northwest Lab., Richland, WA (United States)

    1995-11-01

    With the issuance of the final Decommissioning Rule (July 27, 1988), owners and operators of licensed nuclear power plants are required to prepare, and submit to the US Nuclear Regulatory Commission (NRC) for review, decommissioning plans and cost estimates. The NRC staff is in need of bases documentation that will assist them in assessing the adequacy of the licensee submittals, from the viewpoint of both the planned actions, including occupational radiation exposure, and the probable costs. The purpose of this reevaluation study is to provide some of the needed bases documentation. This report contains the results of a review and reevaluation of the {prime}978 PNL decommissioning study of the Trojan nuclear power plant (NUREG/CR-0130), including all identifiable factors and cost assumptions which contribute significantly to the total cost of decommissioning the nuclear power plant for the DECON, SAFSTOR, and ENTOMB decommissioning alternatives. These alternatives now include an initial 5--7 year period during which time the spent fuel is stored in the spent fuel pool, prior to beginning major disassembly or extended safe storage of the plant. Included for information (but not presently part of the license termination cost) is an estimate of the cost to demolish the decontaminated and clean structures on the site and to restore the site to a ``green field`` condition. This report also includes consideration of the NRC requirement that decontamination and decommissioning activities leading to termination of the nuclear license be completed within 60 years of final reactor shutdown, consideration of packaging and disposal requirements for materials whose radionuclide concentrations exceed the limits for Class C low-level waste (i.e., Greater-Than-Class C), and reflects 1993 costs for labor, materials, transport, and disposal activities.

  10. Revised analyses of decommissioning for the reference pressurized Water Reactor Power Station. Volume 2, Effects of current regulatory and other considerations on the financial assurance requirements of the decommissioning rule and on estimates of occupational radiation exposure: Appendices, Final report

    International Nuclear Information System (INIS)

    Konzek, G.J.; Smith, R.I.; Bierschbach, M.C.; McDuffie, P.N.

    1995-11-01

    With the issuance of the final Decommissioning Rule (July 27, 1998), owners and operators of licensed nuclear power plants are required to prepare, and submit to the US Nuclear Regulatory Commission (NRC) for review, decommissioning plans and cost estimates. The NRC staff is in need of bases documentation that will assist them in assessing the adequacy of the licensee submittals, from the viewpoint of both the planned actions, including occupational radiation exposure, and the probable costs. The purpose of this reevaluation study is to provide some of the needed bases documentation. This report contains the results of a review and reevaluation of the 1978 PNL decommissioning study of the Trojan nuclear power plant (NUREG/CR-0130), including all identifiable factors and cost assumptions which contribute significantly to the total cost of decommissioning the nuclear power plant for the DECON, SAFSTOR, and ENTOMB decommissioning alternatives. These alternatives now include an initial 5--7 year period during which time the spent fuel is stored in the spent fuel pool, prior to beginning major disassembly or extended safe storage of the plant. Included for information (but not presently part of the license termination cost) is an estimate of the cost to demolish the decontaminated and clean structures on the site and to restore the site to a ''green field'' condition. This report also includes consideration of the NRC requirement that decontamination and decommissioning activities leading to termination of the nuclear license be completed within 60 years of final reactor shutdown, consideration of packaging and disposal requirements for materials whose radionuclide concentrations exceed the limits for Class C low-level waste (i.e., Greater-Than-Class C), and reflects 1993 costs for labor, materials, transport, and disposal activities

  11. Revised analyses of decommissioning for the reference pressurized Water Reactor Power Station. Effects of current regulatory and other considerations on the financial assurance requirements of the decommissioning rule and on estimates of occupational radiation exposure, Volume 1, Final report

    International Nuclear Information System (INIS)

    Konzek, G.J.; Smith, R.I.; Bierschbach, M.C.; McDuffie, P.N.

    1995-11-01

    With the issuance of the final Decommissioning Rule (July 27, 1988), owners and operators of licensed nuclear power plants are required to prepare, and submit to the US Nuclear Regulatory Commission (NRC) for review, decommissioning plans and cost estimates. The NRC staff is in need of bases documentation that will assist them in assessing the adequacy of the licensee submittals, from the viewpoint of both the planned actions, including occupational radiation exposure, and the probable costs. The purpose of this reevaluation study is to provide some of the needed bases documentation. This report contains the results of a review and reevaluation of the '978 PNL decommissioning study of the Trojan nuclear power plant (NUREG/CR-0130), including all identifiable factors and cost assumptions which contribute significantly to the total cost of decommissioning the nuclear power plant for the DECON, SAFSTOR, and ENTOMB decommissioning alternatives. These alternatives now include an initial 5--7 year period during which time the spent fuel is stored in the spent fuel pool, prior to beginning major disassembly or extended safe storage of the plant. Included for information (but not presently part of the license termination cost) is an estimate of the cost to demolish the decontaminated and clean structures on the site and to restore the site to a ''green field'' condition. This report also includes consideration of the NRC requirement that decontamination and decommissioning activities leading to termination of the nuclear license be completed within 60 years of final reactor shutdown, consideration of packaging and disposal requirements for materials whose radionuclide concentrations exceed the limits for Class C low-level waste (i.e., Greater-Than-Class C), and reflects 1993 costs for labor, materials, transport, and disposal activities

  12. Nova Scotia Environment Act: Report

    Energy Technology Data Exchange (ETDEWEB)

    1994-01-01

    In January 1993, a comprehensive review and consolidation of 13 statutes currently under the Department of the Environment's administration began to create a more rational, efficient, and user-friendly framework for environmental management; to fulfill outstanding commitments for regulatory reform; and to provide an opportunity for focused stakeholder consultations on substantive changes to the legislative framework. Draft legislation was released for public comment in November 1993. This report summarizes the public comments but also includes comments by the Public Consultation Committee. Issues addressed include administration, environmental education and research, environmental assessment process, approvals and certificates, release of substances, hazardous substances and pesticides, contaminated sites, waste management, water management, inspections and investigations, orders, appeals, civil remedies, penalties and prosecutions, and documentary evidence.

  13. Metrology of natural radionuclides. Current challenges in radiation protection for industry and the environment; Metrologie natuerlicher Radionuklide. Aktuelle Herausforderungen fuer den Strahlenschutz in Industrie und Umwelt

    Energy Technology Data Exchange (ETDEWEB)

    Maringer, F.J. [Bundesamt fuer Eich- und Vermessungswesen, Wien (Austria). Referat fuer ionisierende Strahlung und Radioaktivitaet; Univ. fuer Bodenkultur, Wien (Austria). Low-Level Counting Lab. Arsenal; Moser, H.; Kabrt, F. [Bundesamt fuer Eich- und Vermessungswesen, Wien (Austria). Referat fuer ionisierende Strahlung und Radioaktivitaet; Baumgartner, A.; Stietka, M. [Univ. fuer Bodenkultur, Wien (Austria). Low-Level Counting Lab. Arsenal

    2015-07-01

    In a range of industrial branches increased activity concentrations of natural radionuclides occur in various NORM materials processed. The ICRP 103 recommendation, and subsequent the IAEA International Basic Safety Standards and the European Basic Safety Standards for Radiation Protection, raised new challenges in radiation protection concerning natural radionuclide metrology and activity measurement methods - in particular for natural decay chain radionuclides ({sup 238}U+, {sup 232}Th+, {sup 235}U+). Especially adequate traceability and optimized measurement uncertainties of applied activity measurement methods are of increasing concern. In this paper a review on radionuclide metrology of natural radionuclides and its implementation to end-user activity measurement methods and practice is presented. This includes an overview on current and emerging drivers, targets, challenges, deliverables, technologies and stakeholders in the field. Current research results on activity measurement standards and instrumentation for natural radionuclides, revised decay data, in-situ measurement methods, NORM reference materials, are covered as well as benefits of natural radionuclide metrology on radiation protection of workers and the public.

  14. Regulatory aspects of NPP safety

    International Nuclear Information System (INIS)

    Stuller, J.; Brandejs, P.; Miasnikov, A.; Svab, M.

    1999-01-01

    In beginning, a history of legislative process regulating industrial utilisation of nuclear energy is given, including detailed list of decrees issued by the first regulatory body supervising Czech nuclear installations - Czechoslovak Atomic Energy Commission (CSKAE). Current status of nuclear regulations and radiation protection, especially in connection with Atomic Act (Act No 18/1997 Coll.), is described. The Atomic Act transfers into the Czech legal system a number of obligations following from the Vienna Convention on Civil Liability for Nuclear Damage and Joint Protocol relating to the Application of the Vienna and Paris Convention, to which the Czech Republic had acceded. Actual duties and competence of current nuclear regulatory body - State Office for Nuclear Safety (SUJB) - are given in detail. Execution of the State supervision of peaceful utilisation of nuclear energy and ionising radiation is laid out in several articles of the Act, which comprises: control activities of the SUJB, remedial measures, penalties. Material and human resources are sufficient for fulfilment of the basic functions for which SUJB is authorised by the law. For 1998, the SUJB allotted staff of 149, approximately 2/3 of that number are nuclear safety and radiation protection inspectors. The SUJB budget for 1998 is approximately 180 million Czech crowns (roughly 6 million US dollars). Inspection activity of SUJB is carried out in three different ways: routine inspections, planned specialised inspections, inspections as a response to a certain situation (ad-hoc inspections). Approach to the licensing of major plant upgrades and backfittings are mainly illustrated on the Temelin NPP licensing. Regulatory position and practices concerning review activities are presented. (author)

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

    International Nuclear Information System (INIS)

    Williams, C.R.

    1999-01-01

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

  16. 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

  17. Assessment of the current status of playground safety in the midwestern region of Turkey: an effort to provide a safe environment for children.

    Science.gov (United States)

    Uskun, Ersin; Kişioğlu, Ahmet Nesimi; Altay, Tülin; Cikinlar, Rengül; Kocakaya, Asuman

    2008-01-01

    This study aimed to identify and evaluate the degree of conformity to the playground standards and the level of compliance with current safety specifications of the playgrounds in the midwestern region of Turkey. An observational technique was used at a total of 57 public playgrounds. A playground safety control form was prepared based on the United States National Program for Playground Safety and the Consumer Product Safety Commission security standards, since there is no national law covering playground equipment and safety in Turkey. The study evaluated the surroundings of the playground, arrangement of equipment in the playground, and characteristics of the equipment. The percentage of playgrounds surveyed with inadequate or hard surfacing was 80.7%. Fifty-two percent of the equipment was found to be inappropriate. Equipment was higher than the recommended heights. The results of our study unfortunately point out that playgrounds for children do not meet many of the safety criteria.

  18. Assessing and Managing the Current and Future Pest Risk from Water Hyacinth, (Eichhornia crassipes), an Invasive Aquatic Plant Threatening the Environment and Water Security.

    Science.gov (United States)

    Kriticos, Darren J; Brunel, Sarah

    2016-01-01

    Understanding and managing the biological invasion threats posed by aquatic plants under current and future climates is a growing challenge for biosecurity and land management agencies worldwide. Eichhornia crassipes is one of the world's worst aquatic weeds. Presently, it threatens aquatic ecosystems, and hinders the management and delivery of freshwater services in both developed and developing parts of the world. A niche model was fitted using CLIMEX, to estimate the potential distribution of E. crassipes under historical and future climate scenarios. Under two future greenhouse gas emission scenarios for 2080 simulated with three Global Climate Models, the area with a favourable temperature regime appears set to shift polewards. The greatest potential for future range expansion lies in Europe. Elsewhere in the northern hemisphere temperature gradients are too steep for significant geographical range expansion under the climate scenarios explored here. In the Southern Hemisphere, the southern range boundary for E. crassipes is set to expand southwards in Argentina, Australia and New Zealand; under current climate conditions it is already able to invade the southern limits of Africa. The opportunity exists to prevent its spread into the islands of Tasmania in Australia and the South Island of New Zealand, both of which depend upon hydroelectric facilities that would be threatened by the presence of E. crassipes. In Europe, efforts to slow or stop the spread of E. crassipes will face the challenge of limited internal biosecurity capacity. The modelling technique demonstrated here is the first application of niche modelling for an aquatic weed under historical and projected future climates. It provides biosecurity agencies with a spatial tool to foresee and manage the emerging invasion threats in a manner that can be included in the international standard for pest risk assessments. It should also support more detailed local and regional management.

  19. Assessing and Managing the Current and Future Pest Risk from Water Hyacinth, (Eichhornia crassipes, an Invasive Aquatic Plant Threatening the Environment and Water Security.

    Directory of Open Access Journals (Sweden)

    Darren J Kriticos

    Full Text Available Understanding and managing the biological invasion threats posed by aquatic plants under current and future climates is a growing challenge for biosecurity and land management agencies worldwide. Eichhornia crassipes is one of the world's worst aquatic weeds. Presently, it threatens aquatic ecosystems, and hinders the management and delivery of freshwater services in both developed and developing parts of the world. A niche model was fitted using CLIMEX, to estimate the potential distribution of E. crassipes under historical and future climate scenarios. Under two future greenhouse gas emission scenarios for 2080 simulated with three Global Climate Models, the area with a favourable temperature regime appears set to shift polewards. The greatest potential for future range expansion lies in Europe. Elsewhere in the northern hemisphere temperature gradients are too steep for significant geographical range expansion under the climate scenarios explored here. In the Southern Hemisphere, the southern range boundary for E. crassipes is set to expand southwards in Argentina, Australia and New Zealand; under current climate conditions it is already able to invade the southern limits of Africa. The opportunity exists to prevent its spread into the islands of Tasmania in Australia and the South Island of New Zealand, both of which depend upon hydroelectric facilities that would be threatened by the presence of E. crassipes. In Europe, efforts to slow or stop the spread of E. crassipes will face the challenge of limited internal biosecurity capacity. The modelling technique demonstrated here is the first application of niche modelling for an aquatic weed under historical and projected future climates. It provides biosecurity agencies with a spatial tool to foresee and manage the emerging invasion threats in a manner that can be included in the international standard for pest risk assessments. It should also support more detailed local and regional

  20. Perceptions of regulatory approaches

    International Nuclear Information System (INIS)

    Halin, Magnus; Leinonen, Ruusaliisa

    2012-01-01

    Ms. Ruusaliisa Leinonen and Mr. Magnus Halin from Fortum gave a joint presentation on industry perceptions of regulatory oversight of LMfS/SC. It was concluded that an open culture of discussion exists between the regulator (STUK) and the licensee, based on the common goal of nuclear safety. An example was provided of on how regulatory interventions helped foster improvements to individual and collective dose rate trends, which had remained static. Regulatory interventions included discussions on the ALARA concept to reinforce the requirement to continuously strive for improvements in safety performance. Safety culture has also been built into regulatory inspections in recent years. Training days have also been organised by the regulatory body to help develop a shared understanding of safety culture between licensee and regulatory personnel. Fortum has also developed their own training for managers and supervisors. Training and ongoing discussion on LMfS/SC safety culture is considered particularly important because both Fortum and the regulatory body are experiencing an influx of new staff due to the demographic profile of their organisations. It was noted that further work is needed to reach a common understanding of safety culture on a practical level (e.g., for a mechanic setting to work), and in relation to the inspection criteria used by the regulator. The challenges associated with companies with a mix of energy types were also discussed. This can make it more difficult to understand responsibilities and decision making processes, including the role of the parent body organisation. It also makes communication more challenging due to increased complexity and a larger number of stakeholders

  1. 78 FR 38053 - Regulatory Systems Strengthening

    Science.gov (United States)

    2013-06-25

    ... current state of medical product regulation globally, including challenges, risks, and emerging trends... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0010... product regulation; generation and analysis of evidence of regulatory systems performance; and provision...

  2. Computational challenges in modeling gene regulatory events.

    Science.gov (United States)

    Pataskar, Abhijeet; Tiwari, Vijay K

    2016-10-19

    Cellular transcriptional programs driven by genetic and epigenetic mechanisms could be better understood by integrating "omics" data and subsequently modeling the gene-regulatory events. Toward this end, computational biology should keep pace with evolving experimental procedures and data availability. This article gives an exemplified account of the current computational challenges in molecular biology.

  3. Reactor aging research. United States Nuclear Regulatory Commission

    International Nuclear Information System (INIS)

    Vassilaros, M.G.

    1998-01-01

    The reactor ageing research activities in USA described, are focused on the research of reactor vessel integrity, including regulatory issues and technical aspects. Current emphasis are described for fracture analysis, embrittlement research, inspection capabilities, validation od annealing rule, revision of regulatory guide

  4. The IAEA Integrated Regulatory Review Service (IRRS) - Information Meeting Dublin

    International Nuclear Information System (INIS)

    Al Khatibeh, Ahmad

    2014-05-01

    IRRS is developed to help States evaluate the current status of compliance of their regulatory infrastructures for safety with IAEA Standards. This report discusses the function of IRRS missions as a tool for evaluating the regulatory structure for Member States. It was presented to RPII staff in a Powerpoint document in preparation for the IRRS Mission to Ireland in August 2015

  5. Nuclear Regulatory Commission Budget request for fiscal years 1986 and 1987. Oversight hearings before the Subcommittee on Energy and the Environment of the Committee on Interior and Insular Affairs, House of Representatives, Ninety-Ninth Congress, First and Second Session

    International Nuclear Information System (INIS)

    Anon.

    1986-01-01

    Two days of hearings on the fiscal year 1986-1987 budget request for the Nuclear Regulatory Commission (NRC) heard testimony from NRC Chairman Nunzio Palladino and four commissioners. Areas of concern were the NRC's failure to develop public confidence in nuclear power and the Commission's ability to regulate. Palladino noted that the total budget request of $429 million is $20 million less than the 1985 budget, which will limit the funding for research that would improve licensing procedures and safe plant operation. There was concern that efforts to reduce the federal deficit could lower the level of protection and affect the NRC's mission. Two appendices with correspondence and statements submitted for the record follow the testimony

  6. Regulatory perspective on future climates at Yucca Mountain

    International Nuclear Information System (INIS)

    Coleman, N.M.; Eisenberg, N.A.; Brooks, D.J.

    1996-01-01

    Current regulations of the U.S. Nuclear Regulatory Commission (NRC) require that any performance assessment supporting the license application for a high-level waste (HLW) repository must consider the potential for changes in hydrologic conditions caused by reasonably foreseeable climatic conditions. The requirement is important because the earth's climate will almost certainly change significantly during the thousands of years that disposed nuclear wastes will remain hazardous. More importantly, climate controls the range of precipitation, which in turn controls the rates of infiltration, deep percolation, and groundwater flux through a geologic repository located in an unsaturated environment. Therefore, future changes in climate could significantly influence waste isolation in a repository at Yucca Mountain

  7. 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)

  8. 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)

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

    Science.gov (United States)

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

    2017-09-01

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

  10. Nuclear Regulatory Legislation

    International Nuclear Information System (INIS)

    1989-08-01

    This compilation of statutes and material pertaining to nuclear regulatory legislation through the 100th Congress, 2nd Session, has been prepared by the Office of the General Counsel, US Nuclear Regulatory Commission, with the assistance of staff, for use as an internal resource document. Persons using this document are placed on notice that it may not be used as an authoritative citation in lieu of the primary legislative sources. Furthermore, while every effort has been made to ensure the completeness and accuracy of this material, neither the United States Government, the Nuclear Regulatory Commission, nor any of their employees makes any expressed or implied warranty or assumes liability for the accuracy or completeness of the material presented in this compilation

  11. Risk assessment based on current release standards for radioactive surface contamination

    International Nuclear Information System (INIS)

    Chen, S.Y.

    1993-09-01

    Standards for uncontrolled releases of radioactive surface contamination have been in existence in the United States for about two decades. Such standards have been issued by various agencies, including the US Department of Energy. This paper reviews the technical basis of published standards, identifies areas in need of revision, provides risk interpretations based on current technical knowledge and the regulatory environment, and offers suggestions for improvements

  12. Prediction of regulatory elements

    DEFF Research Database (Denmark)

    Sandelin, Albin

    2008-01-01

    Finding the regulatory mechanisms responsible for gene expression remains one of the most important challenges for biomedical research. A major focus in cellular biology is to find functional transcription factor binding sites (TFBS) responsible for the regulation of a downstream gene. As wet......-lab methods are time consuming and expensive, it is not realistic to identify TFBS for all uncharacterized genes in the genome by purely experimental means. Computational methods aimed at predicting potential regulatory regions can increase the efficiency of wet-lab experiments significantly. Here, methods...

  13. Rationales for regulatory activity

    Energy Technology Data Exchange (ETDEWEB)

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

    1997-02-01

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

  14. Water reactor safety research program. A description of current and planned research

    International Nuclear Information System (INIS)

    1978-07-01

    The U.S. Nuclear Regulatory Commission (NRC) sponsors confirmatory safety research on lightwater reactors in support of the NRC regulatory program. The principal responsibility of the NRC, as implemented through its regulatory program is to ensure that public health, public safety, and the environment are adequately protected. The NRC performs this function by defining conditions for the use of nuclear power and by ensuring through technical review, audit, and follow-up that these conditions are met. The NRC research program provides technical information, independent of the nuclear industry, to aid in discharging these regulatory responsibilities. The objectives of NRC's research program are the following: (1) to maintain a confirmatory research program that supports assurance of public health and safety, and public confidence in the regulatory program, (2) to provide objectively evaluated safety data and analytical methods that meet the needs of regulatory activities, (3) to provide better quantified estimates of the margins of safety for reactor systems, fuel cycle facilities, and transportation systems, (4) to establish a broad and coherent exchange of safety research information with other Federal agencies, industry, and foreign organization. Current and planned research toward these goals is described

  15. Wetlands: The changing regulatory landscape

    International Nuclear Information System (INIS)

    Glick, R.M.

    1993-01-01

    Protection of wetlands became a national issue in 1988 when President George Bush pledged no net loss of wetlands in the US under his open-quotes environmental presidency.close quotes As wetlands became a national issue, the job of protecting them became an obligation for many groups, including hydro-power developers. Now, when a site selected for development includes an area that may be classified as a wetland, the developer quickly discovers the importance of recognizing and protecting these natural habitats. Federal legislation severely limits development of wetland, and most states increase the restrictions with their own wetlands regulations. The difficulty of defining wetlands complicates federal and state enforcement. Land that appears to be dry may in fact be classified as a wetland. So, even if a site appears dry, potential hydro developers must confirm whether or not any jurisdictional wetlands are present. Regulated lands include much more than marshes and swamps. Further complicating the definition of wetlands, a recent court decision found that even artificially created wetlands, such as man-made ponds, may be subject to regulation. Hydro developers must be aware of current regulatory requirements before they consider development of any site that may contain wetlands. To be certain that a site is open-quotes buildableclose quotes from the standpoint of wetlands regulation, a developer must verify (with the help of state agencies) that the property does not contain any jurisdictional wetlands. If it does, the regulatory process before development becomes much more complicated. For the short term, uncertainty abounds and extreme caution is in order. Because the regulatory process has become so complex and an agreeable definition of wetlands so elusive, the trend among the Corps and collaborating agencies is to constrict nationwide permits in favor of narrowing the jurisdictional definition of wetlands

  16. A study on the regulatory approach of major technical issues

    Energy Technology Data Exchange (ETDEWEB)

    Chang, Keun Sun; Oh, S. H.; Kang, H. J.; Kim, G. S. [Sunmoon Univ., Asan (Korea, Republic of); Lee, S. H.; Baek, W. P.; Yang, S. H.; Jeong, Y. H. [Korea Association for Nuclear Technology, Taejon (Korea, Republic of)

    1999-02-15

    This project is to provide the regulatory direction of 4 major technical issues for the Korean Next Generation Reactors, which are parts of major technical issues resulted from the safety regulation R and D on the KNGR. The outstanding results are are as follows : related to the classification and acceptance criteria of plant conditions, currently used classification and safety requirement were reviewed and regulatory direction was proposed. Among multiple failures, it is identified that SBO, TLOFW, multiple SGTR and ATWS are basically to be considered for additional requirements for advanced reactors. This study reviewed risk aspects, design consideration, and trends of safety requirements, and proposed fundamental safety requirements to be applied for KNGR. Multiple steam generator tube failure is a significant safety concern because of the possibility of release of radionuclides to the environment through containment bypass. Proposed safety requirement for this event can be categorized mainly as analysis requirement, design evaluation requirement and PSA requirement; For protection of containment failure, a reasonable safety position is necessary through and integrated review of possibility of severe accident occurrence, effects of sever accident mitigation features and cost effects of these design features. With this consideration safety requirements developed are the analysis requirement, provision of protective measures and survivability/availability of protective measures.

  17. Balancing regulatory control, scientific knowledge, and public understanding.

    Science.gov (United States)

    Kingsbury, D T

    1988-01-01

    In summary, I would like to emphasize the continued need for broad and vigorous basic research, with a balance between the fundamental work that may eventually lead to commercial products and the fundamental work that is necessary for an understanding of the interaction of many types of organisms within the environment. I would like also to reiterate the need for balance in the regulatory approach so that we do not repress innovation in research and development. Over-regulation has many side effects. In addition to repressing innovation and not taking advantage of our research base, over-regulation leads to reluctance by the capital markets to invest in the future of our new industries, thereby halting their development at an early stage. At the same time, under-regulation leads to lack of confidence by the public and paralysis of the industry based on public outcry and legal proceedings. It is my personal belief that the combination of a sound approach to regulatory practice, based on current scientific knowledge, combined with appropriate communication with the public regarding the new products, will lead to an exciting future for all sectors of industry that use the new biotechnology.

  18. The expanding regulatory universe of p53 in gastrointestinal cancer.

    Science.gov (United States)

    Fesler, Andrew; Zhang, Ning; Ju, Jingfang

    2016-01-01

    Tumor suppresser gene TP53 is one of the most frequently deleted or mutated genes in gastrointestinal cancers. As a transcription factor, p53 regulates a number of important protein coding genes to control cell cycle, cell death, DNA damage/repair, stemness, differentiation and other key cellular functions. In addition, p53 is also able to activate the expression of a number of small non-coding microRNAs (miRNAs) through direct binding to the promoter region of these miRNAs.  Many miRNAs have been identified to be potential tumor suppressors by regulating key effecter target mRNAs. Our understanding of the regulatory network of p53 has recently expanded to include long non-coding RNAs (lncRNAs). Like miRNA, lncRNAs have been found to play important roles in cancer biology.  With our increased understanding of the important functions of these non-coding RNAs and their relationship with p53, we are gaining exciting new insights into the biology and function of cells in response to various growth environment changes. In this review we summarize the current understanding of the ever expanding involvement of non-coding RNAs in the p53 regulatory network and its implications for our understanding of gastrointestinal cancer.

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

    Science.gov (United States)

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

    2015-04-01

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

  20. Assessing the assessments: Pharmaceuticals in the environment

    International Nuclear Information System (INIS)

    Enick, O.V.; Moore, M.M.

    2007-01-01

    The relatively new issue of pharmaceutical contamination of the environment offers the opportunity to explore the application of values to the construction, communication and management of risk. The still-developing regulatory policies regarding environmental contamination with pharmaceuticals provide fertile ground for the introduction of values into the definition and management of risk. In this report, we summarize the current knowledge regarding pharmaceutical contamination of the environment and discuss specific attributes of pharmaceuticals that require special consideration. We then present an analysis showing that if values are incorporated into assessing, characterizing and managing risk, the results of risk assessments will more accurately reflect the needs of various stakeholders. Originating from an acknowledgement of the inherent uncertainty and value-laden nature of risk assessment, the precautionary principle (and later, the multi-criteria, integrated risk assessment), provides a direction for further research and policy development

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

    International Nuclear Information System (INIS)

    2015-04-01

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

  2. Isotope production technologies from a regulatory perspective

    Energy Technology Data Exchange (ETDEWEB)

    Murthy, K. [Canadian Nuclear Safety Committee, Ottawa, Ontario (Canada)

    2012-07-01

    This paper discusses isotope production technologies from a regulatory perspective. The regulator is the CNSC which has the mandate to protect the health, safety and security of persons and the environment and to implement Canada's international commitments on the peaceful use of nuclear energy. Nuclear facilities regulated by CNSC include linear accelerator (medical), pool irradiator (industrial) and Pelletron (research) as well as cyclotrons.

  3. Online versus conventional shopping: Consumers' risk perception and regulatory focus

    NARCIS (Netherlands)

    van Noort, G.; Kerkhof, P.; Fennis, B.M.

    2007-01-01

    In two experiments, the impact of shopping context on consumers' risk perceptions and regulatory focus was examined. We predicted that individuals perceive an online (vs. conventional) shopping environment as more risky and that an online shopping environment, by its risky nature, primes a

  4. Online versus Conventional Shopping: Consumers' Risk Perception and Regulatory Focus

    NARCIS (Netherlands)

    van Noort, Guda; Kerkhof, Peter; Fennis, B.M.

    2007-01-01

    In two experiments, the impact of shopping context on consumers' risk perceptions and regulatory focus was examined. We predicted that individuals perceive an online (vs. conventional) shopping environment as more risky and that an online shopping environment, by its risky nature, primes a

  5. NRC Regulatory Agenda

    International Nuclear Information System (INIS)

    1992-07-01

    This document compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rule making which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  6. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1993-02-01

    This document is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considered action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  7. NRC Regulatory Agenda

    International Nuclear Information System (INIS)

    1989-07-01

    This document is a compilation of all rules on which the NRC has proposed or is considering action and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  8. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1992-11-01

    This document provides a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  9. Comments on regulatory reform

    International Nuclear Information System (INIS)

    Hendrie, J.M.

    1982-01-01

    Nuclear regulatory reform is divided into two parts. The first part contains all those matters for which new legislation is required. The second part concerns all those matters that are within the power of the Commission under existing statutes. Recommendations are presented

  10. Comments on regulatory reform

    Energy Technology Data Exchange (ETDEWEB)

    Hendrie, J.M.

    1982-01-01

    Nuclear regulatory reform is divided into two parts. The first part contains all those matters for which new legislation is required. The second part concerns all those matters that are within the power of the Commission under existing statutes. Recommendations are presented.

  11. 3 CFR - Regulatory Review

    Science.gov (United States)

    2010-01-01

    ... as a means of promoting regulatory goals. The fundamental principles and structures governing... review. In this time of fundamental transformation, that process—and the principles governing regulation... the Office of Management and Budget (OMB) has reviewed Federal regulations. The purposes of such...

  12. 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.

  13. 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.

  14. 78 FR 61424 - Self-Regulatory Organizations; National Securities Clearing Corporation; Notice of Filing of...

    Science.gov (United States)

    2013-10-03

    ... decommission the DTCC Trade Risk Pro service as more fully described below. II. Self-Regulatory Organization's... no Members that currently use Trade Risk Pro. (C) Self-Regulatory Organization's Statement on...-Regulatory Organizations; National Securities Clearing Corporation; Notice of Filing of Proposed Rule Change...

  15. The Economic Discourse of the Current Reform Aimed at Business Optimization in Ukraine

    Directory of Open Access Journals (Sweden)

    Purdenko Olena A.

    2016-05-01

    Full Text Available The aim of the article is to study the strengths and weaknesses of the current reforms and provide appropriate recommendations and proposals to improve the regulatory and economic business environment. The article analyzes the introduced reforms in the aspect of the regulatory field and the active current system of taxation with the detailing of the type and content of the basic implemented measures. There have been justified the advantages and disadvantages of the introduced system of taxation with respect to the main budget forming taxes, such as the enterprise income taxes, value added tax, individual income tax considering changes in the administering of unified social tax (UST and war tax, excise duty. On the basis of the results of the study it has been found that the introduced reforms only partially improved the tax administration system and in no way reduced the announced tax burden, the time spending of business for preparing the current report was not significantly reduced.

  16. 78 FR 55339 - Regulatory Capital Rules: Regulatory Capital, Implementation of Basel III, Capital Adequacy...

    Science.gov (United States)

    2013-09-10

    ... countercyclical capital buffer was designed to take into account the macro-financial environment in which large... ability to raise capital to meet the increased minimum requirements in the current environment and upon...

  17. A regulatory perspective on the radiological impact of NORM industries: the case of the Spanish phosphate industry

    International Nuclear Information System (INIS)

    Garcia-Talavera, M.; Matarranz, J.L.M.; Salas, R.; Ramos, L.

    2011-01-01

    Radioactive and chemical risks coexist in NORM industries although they are usually addressed separately by regulations. The European Union (EU) has developed extensive legislation concerning both matters, which has been diversely reflected in national policies. We consider the case of the Spanish phosphate industry and analyse to which extent regulatory mandates have reduced the historical and ongoing radiological impact on the environment of phosphate facilities. Although no specific radiological constraints on effluent monitoring and release or on waste disposal have yet been imposed on NORM industries in Spain, other environmental regulations have achieved a substantial reduction on the phosphate industry impact. Nevertheless, a more efficient control could be established by eliminating the current conceptual and practical separation of chemical and radioactive risks in NORM industries. We highlight research needs to accomplish so and propose shorter-term measures that require active cooperation among the regulatory bodies involved. - Research highlights: → The radiological impact of the Spanish phosphate industry has substantially decreased as a side result of environmental regulations on chemical pollution.→ A more efficient control of NORM industries could be established by eliminating the current conceptual and practical separation of chemical and radioactive risks.→ Further research is needed on how interactions between radiation and chemicals might affect regulatory limits and on a systematic way to input stakeholder preferences in MCDA.→ On shorter-term, administrative measures that require active cooperation among the regulatory bodies involved can be taken.

  18. Nuclear Regulatory Commission information digest

    International Nuclear Information System (INIS)

    1990-03-01

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

  19. 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.

  20. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1993-07-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter. The rules on which final action has been taken since March 31, 1993 are: Repeal of NRC standards of conduct; Fitness-for-duty requirements for licensees who possess, use, or transport Category I material; Training and qualification of nuclear power plant personnel; Monitoring the effectiveness of maintenance at nuclear power plants; Licensing requirements for land disposal of radioactive wastes; and Licensees' announcements of safeguards inspections

  1. 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

  2. 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

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

    International Nuclear Information System (INIS)

    LeClair, J.; Ashley, F.

    2006-01-01

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

  4. Design reviews from a regulatory perspective

    International Nuclear Information System (INIS)

    Foster, B.D.

    1991-01-01

    This paper presents views on the role of the licensing engineer in the design process with specific emphasis on design reviews and the automated information management tools that support design reviews. The licensing engineer is seen as an important member of a design review team. The initial focus of the licensing engineer during design reviews is shown to be on ensuring that applicable regulatory requirements are addressed by the design. The utility of an automated tool, such as a commitments management system, to support regulatory requirements identification is discussed. The next responsibility of the licensing engineer is seen as verifying that regulatory requirements are transformed into measurable performance requirements. Performance requirements are shown to provide the basis for developing detailed design review criteria. Licensing engineer input during design reviews is discussed. This input is shown to be especially critical in cases where review findings may impact application of regulatory requirements. The use of automated tools in supporting design reviews is discussed. An information structure is proposed to support design reviews in a regulated environment. This information structure is shown to be useful to activities beyond design reviews. Incorporation of the proposed information structure into the Licensing Support System is proposed

  5. Emotion: The Self-regulatory Sense.

    Science.gov (United States)

    Peil, Katherine T

    2014-03-01

    While emotion is a central component of human health and well-being, traditional approaches to understanding its biological function have been wanting. A dynamic systems model, however, broadly redefines and recasts emotion as a primary sensory system-perhaps the first sensory system to have emerged, serving the ancient autopoietic function of "self-regulation." Drawing upon molecular biology and revelations from the field of epigenetics, the model suggests that human emotional perceptions provide an ongoing stream of "self-relevant" sensory information concerning optimally adaptive states between the organism and its immediate environment, along with coupled behavioral corrections that honor a universal self-regulatory logic, one still encoded within cellular signaling and immune functions. Exemplified by the fundamental molecular circuitry of sensorimotor control in the E coli bacterium, the model suggests that the hedonic (affective) categories emerge directly from positive and negative feedback processes, their good/bad binary appraisals relating to dual self-regulatory behavioral regimes-evolutionary purposes, through which organisms actively participate in natural selection, and through which humans can interpret optimal or deficit states of balanced being and becoming. The self-regulatory sensory paradigm transcends anthropomorphism, unites divergent theoretical perspectives and isolated bodies of literature, while challenging time-honored assumptions. While suppressive regulatory strategies abound, it suggests that emotions are better understood as regulating us, providing a service crucial to all semantic language, learning systems, evaluative decision-making, and fundamental to optimal physical, mental, and social health.

  6. Emotion: The Self-regulatory Sense

    Science.gov (United States)

    2014-01-01

    While emotion is a central component of human health and well-being, traditional approaches to understanding its biological function have been wanting. A dynamic systems model, however, broadly redefines and recasts emotion as a primary sensory system—perhaps the first sensory system to have emerged, serving the ancient autopoietic function of “self-regulation.” Drawing upon molecular biology and revelations from the field of epigenetics, the model suggests that human emotional perceptions provide an ongoing stream of “self-relevant” sensory information concerning optimally adaptive states between the organism and its immediate environment, along with coupled behavioral corrections that honor a universal self-regulatory logic, one still encoded within cellular signaling and immune functions. Exemplified by the fundamental molecular circuitry of sensorimotor control in the E coli bacterium, the model suggests that the hedonic (affective) categories emerge directly from positive and negative feedback processes, their good/bad binary appraisals relating to dual self-regulatory behavioral regimes—evolutionary purposes, through which organisms actively participate in natural selection, and through which humans can interpret optimal or deficit states of balanced being and becoming. The self-regulatory sensory paradigm transcends anthropomorphism, unites divergent theoretical perspectives and isolated bodies of literature, while challenging time-honored assumptions. While suppressive regulatory strategies abound, it suggests that emotions are better understood as regulating us, providing a service crucial to all semantic language, learning systems, evaluative decision-making, and fundamental to optimal physical, mental, and social health. PMID:24808986

  7. National legislative and regulatory activities

    International Nuclear Information System (INIS)

    2016-01-01

    - Poland: Organisation and structure; 7 - Slovak Republic: International co-operation, Nuclear security (Entry into force of the Amendment to the Convention on the Physical Protection of Nuclear Material; Act No. 91/2016 Coll. on Criminal Responsibility of Legal Persons), Liability and compensation (Newly adopted Civil Procedural Code); 8 - Slovenia: Nuclear safety and radiological protection - including nuclear emergency planning (Decree on the program of the systematic monitoring of working and living environments and raising awareness about measures to reduce public exposure to natural radiation sources; Rules on authorised experts for radiation and nuclear safety); 9 - United States: General legislation, regulations and instruments (Nuclear Regulatory Commission approved a final rule amending licensing, inspection and annual fee regulations to establish a variable annual fee structure for light-water small modular reactors)

  8. Reform of the regulatory process for commercial nuclear powerplants. Hearings before the Subcommittee on Nuclear Regulation of the Committee on Environment and Public Works, United States Senate, Ninety-Ninth Congress, Second Session on S. 1235, S. 2291, S. 2471, June 17 and 18, 1986

    International Nuclear Information System (INIS)

    Anon.

    1986-01-01

    Two days of hearings held to consider three bills which would reform nuclear power plant regulation stressed the fact that there has been no resolution of many of the problems identified after the Three Mile Island accident. Principal witnesses were Nunzio Palladino and other members and former members of the Nuclear Regulatory Commission (NRC) and representatives of electric utilities, public utility commissions, citizen groups, and the legal profession. One aspect of current procedures which is not working is meetings held in compliance with sunshine laws. At issue was the process of collegial decision making and whether a structure with a single administrator would better sever the public. NRC commissioners concur that collegial decision making is less efficient, but oppose S. 2291's proposal for an independent Nuclear Safety Board. The tests of S. 1235, S. 2291, and S. 2471 accompany the recorded testimony

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

    Directory of Open Access Journals (Sweden)

    Giannakou C

    2016-06-01

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

  10. The Dessau workshop on bioaccumulation: state of the art, challenges and regulatory implications.

    Science.gov (United States)

    Treu, Gabriele; Drost, Wiebke; Jöhncke, Ulrich; Rauert, Caren; Schlechtriem, Christian

    2015-01-01

    Bioaccumulation plays a vital role in understanding the fate of a substance in the environment and is key to the regulation of chemicals in several jurisdictions. The current assessment approaches commonly use the octanol-water partition coefficient (log K OW ) as an indicator for bioaccumulation and the bioconcentration factor (BCF) as a standard criterion to identify bioaccumulative substances show limitations. The log K OW does not take into account active transport phenomena or special structural properties (e.g., amphiphilic substances or dissociating substances) and therefore additional screening criteria are required. Regulatory BCF studies are so far restricted to fish and uptake through the gills. Studies on (terrestrial) air-breathing organisms are missing. Though there are alternative tests such as the dietary exposure bioaccumulation fish test described in the recently revised OECD test guideline 305, it still remains unclear how to deal with results of alternative tests in regulatory decision-making processes. A substantial number of bioaccumulation fish tests are required in regulation. The development of improved test systems following the 3R principles, namely to replace, reduce and refine animal testing, is thus required. All these aspects stress the importance to further develop the assessment of bioaccumulation. The Dessau Workshop on Bioaccumulation which was held from June 26th to 27th 2014, in Dessau, Germany, provided a comprehensive overview of the state of the art of bioaccumulation assessment, provided insights into the problems and challenges addressed by the regulatory authorities and described new research concepts and their regulatory implications. The event was organised by UBA (Dessau, Germany) and Fraunhofer IME (Schmallenberg, Germany). About 50 participants from industry, regulatory bodies and academia listened to 14 lectures on selected topics and joined the plenary discussions.

  11. Codes and standards and other guidance cited in regulatory documents

    International Nuclear Information System (INIS)

    Nickolaus, J.R.; Bohlander, K.L.

    1996-08-01

    As part of the U.S. Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program (SRP-UDP), Pacific Northwest National Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. The SRP-UDP has been completed and the SRP-Maintenance Program (SRP-MP) is now maintaining this listing. Besides updating previous information, Revision 3 adds approximately 80 citations. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC's Bulletins, Information Notices, Circulars, Enforcement Manual, Generic Letters, Inspection Manual, Policy Statements, Regulatory Guides, Standard Technical Specifications and the Standard Review Plan (NUREG-0800)

  12. The path from biomarker discovery to regulatory qualification

    CERN Document Server

    Goodsaid, Federico

    2013-01-01

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

  13. Codes and standards and other guidance cited in regulatory documents

    Energy Technology Data Exchange (ETDEWEB)

    Nickolaus, J.R.; Bohlander, K.L.

    1996-08-01

    As part of the U.S. Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program (SRP-UDP), Pacific Northwest National Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. The SRP-UDP has been completed and the SRP-Maintenance Program (SRP-MP) is now maintaining this listing. Besides updating previous information, Revision 3 adds approximately 80 citations. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC`s Bulletins, Information Notices, Circulars, Enforcement Manual, Generic Letters, Inspection Manual, Policy Statements, Regulatory Guides, Standard Technical Specifications and the Standard Review Plan (NUREG-0800).

  14. The stress and underground environment

    Science.gov (United States)

    Chama, A.

    2009-04-01

    Currently,the program of prevention in occupational health needs mainly to identify occupational hazards and strategy of their prevention.Among these risks,the stress represents an important psycho-social hazard in mental health,which unfortunately does not spare no occupation.My Paper attempts to highlight and to develop this hazard in its different aspects even its regulatory side in underground environment as occupational environment.In the interest of better prevention ,we consider "the information" about the impact of stress as the second prevention efficient and no expensive to speleologists,hygienists and workers in the underground areas. In this occasion of this event in Vienna,we also highlight the scientific works on the stress of the famous viennese physician and endocrinologist Doctor Hans Selye (1907-1982),nicknamed "the father of stress" and note on relation between biological rhythms in this underground area and psychological troubles (temporal isolation) (Jurgen Aschoff’s works and experiences out-of time).

  15. Regulatory Oversight of Safety Culture in Nuclear Installations

    International Nuclear Information System (INIS)

    2013-03-01

    Experience across the international nuclear industry and in other technical fields over the past few decades has demonstrated the importance of a healthy safety culture in maintaining the safety of workers, the public and the environment. Both regulators and the nuclear industry recognize the need for licensees to develop a strong safety culture in order to support successful and sustainable nuclear safety performance. Progress over recent years can be observed in the rapid development of approaches to overseeing licensees' safety culture. This publication follows on and complements earlier publications on safety culture, from the publication Safety Culture (Safety Series No. 75-INSAG-4 (1991)), published after the Chernobyl accident, to the more recently published Safety Requirements on The Management System for Facilities and Activities (IAEA Safety Standards Series No. GS-R-3 (2006)), which states that the management system is to be used to promote and support a strong safety culture. A number of attempts have been made at both the international and national levels to establish practical approaches to regulatory oversight of safety culture. During 2010 and 2011, two projects were conducted by the IAEA under the scope of the Safe Nuclear Energy - Regional Excellence Programme within the Norwegian Cooperation Programme with Bulgaria and Romania. These projects were implemented at the Bulgarian and Romanian regulatory bodies. They encompassed the development of a specific process to oversee licensees' safety culture, and involved 30 experts from 17 countries and 22 organizations. The IAEA continues to support Member States in the area of safety culture through its projects on safety management and capacity building. This publication addresses the basics of regulatory oversight of safety culture, describes the approaches currently implemented at several regulatory bodies around the world and, based on these examples, proposes a path to developing such a process

  16. Review of NRC Regulatory processes and functions

    International Nuclear Information System (INIS)

    1980-01-01

    The Advisory Committee on Reactor Safeguards (ACRS) has spent much time over many years observing and examining the NRC licensing process. The Committee is, consequently, in a position to comment on the situation, and it believes this review will be helpful to those examining the regulatory process by discussing how it works, where it is weak, and the opportunities for improvement. The Committee's review may also help put current proposals and discussions in perspective

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

    NARCIS (Netherlands)

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

    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

  18. Current issues and strategies for transmission planning

    Energy Technology Data Exchange (ETDEWEB)

    Isaacs, A.L. [Electranix, Winnipeg, MB (Canada); Rajapakse, A. [Manitoba Univ., Winnipeg, MB (Canada)

    2008-07-01

    Following the widespread deregulation of the electric power industry in the early 1990s, significant changes occurred in the regulatory and planning environments of the industry. Several regions of North America remain fully or partially regulated in the traditional sense including most Canadian provinces, except for Alberta and Ontario. Although the Mexican system has separate generation and transmission companies and current restructuring efforts are underway, all companies are state-owned, and private investment in energy is heavily constrained by the Mexican constitution. In these regulated regions, traditional generation and transmission expansion planning methods remain in use. This paper presented an overview of current trends in transmission planning strategies that have evolved in response to the restructuring of the power industry, and a conceptual framework of a procedure that would guide planners faced with the challenges of incorporating large scale wind generation in deregulated environments. The paper provided background information on the effect of deregulation on transmission planning. Planning strategies that were discussed included quantifying risk to help identify best alternatives; use of reference systems to estimate generator costs and reduce uncertainty; project based transmission expansion; transmission construction ahead of generation; and generation ahead of transmission. The impact of wind on transmission planning as well as future work addressing challenges posed by wind were also addressed. Research is continuing in this area to illustrate the concepts proposed through a detailed case study. 15 refs., 2 figs.

  19. Nuclear energy's future: lifting the regulatory cloud

    International Nuclear Information System (INIS)

    Walske, C.

    1983-01-01

    Nuclear energy provides 13% of US and 10% of world electricity, with an exemplary safety record and less insult to the environment than any other power source. Walske argues that nuclear power is 15% cheaper than coal despite the high capital and regulatory costs, but regulatory delays in the construction and licensing periods have increased 70% to 10 to 14 years, more than twice the lead time in France and Japan. The long lead time exaggerates the difficulty in forecasting demand, and allows interruptions for fundamental design changes after construction has begun. Walske outlines new legislation for site pre-approval, plant standardization, combined construction and operating licenses, and hybrid procedures for public hearings that would make regulation less uncertain

  20. Considering public confidence in developing regulatory programs

    International Nuclear Information System (INIS)

    Collins, S.J.

    2001-01-01

    In the area of public trust and in any investment, planning and strategy are important. While it is accepted in the United States that an essential part of our mission is to leverage our resources to improving Public Confidence this performance goal must be planned for, managed and measured. Similar to our premier performance goal of Maintaining Safety, a strategy must be developed and integrated with our external stake holders but with internal regulatory staff as well. In order to do that, business is to be conducted in an open environment, the basis for regulatory decisions has to be available through public documents and public meetings, communication must be done in clear and consistent terms. (N.C.)

  1. 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

  2. Radio-ecological characterization and radiological assessment in support of regulatory supervision of legacy sites in northwest Russia

    International Nuclear Information System (INIS)

    Sneve, M.K.; Kiselev, M.; Shandala, N.K.

    2014-01-01

    The Norwegian Radiation Protection Authority has been implementing a regulatory cooperation program in the Russian Federation for over 10 years, as part of the Norwegian government's Plan of Action for enhancing nuclear and radiation safety in northwest Russia. The overall long-term objective has been the enhancement of safety culture and includes a special focus on regulatory supervision of nuclear legacy sites. The initial project outputs included appropriate regulatory threat assessments, to determine the hazardous situations and activities which are most in need of enhanced regulatory supervision. In turn, this has led to the development of new and updated norms and standards, and related regulatory procedures, necessary to address the often abnormal conditions at legacy sites. This paper presents the experience gained within the above program with regard to radio-ecological characterization of Sites of Temporary Storage for spent nuclear fuel and radioactive waste at Andreeva Bay and Gremikha in the Kola Peninsula in northwest Russia. Such characterization is necessary to support assessments of the current radiological situation and to support prospective assessments of its evolution. Both types of assessments contribute to regulatory supervision of the sites. Accordingly, they include assessments to support development of regulatory standards and guidance concerning: control of radiation exposures to workers during remediation operations; emergency preparedness and response; planned radionuclide releases to the environment; development of site restoration plans, and waste treatment and disposal. Examples of characterization work are presented which relate to terrestrial and marine environments at Andreeva Bay. The use of this data in assessments is illustrated by means of the visualization and assessment tool (DATAMAP) developed as part of the regulatory cooperation program, specifically to help control radiation exposure in operations and to support

  3. 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.)

  4. International regulatory activities

    International Nuclear Information System (INIS)

    Anon.

    2002-01-01

    Different international regulatory activities are presented: recommendation on the protection of the public against exposure to radon in drinking water supplies, amendment to the legislation implementing the regulation on imports of agricultural products originating in third countries following the Chernobyl accident, resolution on the commission green paper towards a European strategy for the security of energy supply, declaration of mandatory nature of the international code for the safe carriage of packaged irradiated nuclear fuel, plutonium and high level radioactive wastes on board ships, adoption of action plan against nuclear terrorism. (N.C.)

  5. Regulatory Challenges for Cartilage Repair Technologies.

    Science.gov (United States)

    McGowan, Kevin B; Stiegman, Glenn

    2013-01-01

    In the United States, few Food and Drug Administration (FDA)-approved options exist for the treatment of focal cartilage and osteochondral lesions. Developers of products for cartilage repair face many challenges to obtain marketing approval from the FDA. The objective of this review is to discuss the necessary steps for FDA application and approval for a new cartilage repair product. FDA Guidance Documents, FDA Panel Meetings, scientific organization recommendations, and clinicaltrials.gov were reviewed to demonstrate the current thinking of FDA and the scientific community on the regulatory process for cartilage repair therapies. Cartilage repair therapies can receive market approval from FDA as medical devices, drugs, or biologics, and the specific classification of product can affect the nonclinical, clinical, and regulatory strategy to bring the product to market. Recent FDA guidance gives an outline of the required elements to bring a cartilage repair product to market, although these standards are often very general. As a result, companies have to carefully craft their study patient population, comparator group, and clinical endpoint to best showcase their product's attributes. In addition, regulatory strategy and manufacturing process validation need to be considered early in the clinical study process to allow for timely product approval following the completion of clinical study. Although the path to regulatory approval for a cartilage repair therapy is challenging and time-consuming, proper clinical trial planning and attention to the details can eventually save companies time and money by bringing a product to the market in the most expeditious process possible.

  6. Industry Presentation to Regulatory Workshop

    International Nuclear Information System (INIS)

    Treasure, Mark

    2012-01-01

    Mr. Mark Treasure from EDF NGL gave a presentation on industry perspectives on safety culture oversight. Mr. Treasure is the Nuclear Inspection and Oversight Manager within the Safety and Regulation Division. The presentation started with an explanation of the role of the nuclear inspection and oversight group (internal regulator), and their current approach to internal oversight of safety culture. A key element of the current internal regulatory oversight program is Management and Leadership Assessments. These are carried out by a team including management peers from other plants to enhance credibility. Findings can be linked to safety performance, and typically identify issues in areas such as accountability arrangements and strategic focus of the leadership team. Safety indicators have also been introduced to show trends in safety management and safety performance for each EDF UK nuclear power plant. A periodic nuclear safety culture survey is also carried out to identify focus areas and progress. The presentation included discussion on views of the role of the nuclear regulator. Important aspects were identified as: - Supporting the internal regulator by seeking to understand before taking enforcement action, maintaining an open dialogue and recognising that this area is complex and that there is rarely a 'silver bullet' solution. - Communication: being visible and actively discussing safety improvement, and use of language which emphasises nuclear safety rather than legal compliance. - Positive reinforcement to recognise efforts and encourage further improvement

  7. Politically Induced Regulatory Risk and Independent Regulatory Agencies

    OpenAIRE

    Strausz, Roland

    2015-01-01

    Uncertainty in election outcomes generates politically induced regulatory risk. Political parties' risk attitudes towards such risk depend on a fluctuation effect that hurts both parties and an output--expansion effect that benefits at least one party. Notwithstanding the parties' risk attitudes, political parties have incentives to negotiate away all regulatory risk by pre-electoral bargaining. Efficient pre-electoral bargaining outcomes fully eliminate politically induced regulatory risk. P...

  8. Regulatory networks, legal federalism, and multi-level regulatory systems

    OpenAIRE

    Kerber, Wolfgang; Wendel, Julia

    2016-01-01

    Transnational regulatory networks play important roles in multi-level regulatory regimes, as e.g, the European Union. In this paper we analyze the role of regulatory networks from the perspective of the economic theory of legal federalism. Often sophisticated intermediate institutional solutions between pure centralisation and pure decentralisation can help to solve complex tradeoff problems between the benefits and problems of centralised and decentralised solutions. Drawing upon the insight...

  9. Regulatory guide in support of ECCS rule revision

    International Nuclear Information System (INIS)

    Tovmassian, H.S.

    1987-01-01

    The US Nuclear Regulatory Commission staff is proposing to amend 10 CFR 50.46 and Appendix K to allow licensees to use best estimate calculations to estimate emergency core cooling system performance. This estimate in conjunction with an estimate of the uncertainty in the calculation would then be used to assure that the licensing limits set forth in 10 CFR 50.46(b) are not exceeded. The NRC staff has prepared a draft regulatory guide to assist licensees and applicants in complying with these proposed amendments. This paper sets forth the objectives of this regulatory guide, the approach taken, the difficulties encountered, and the current status of this effort

  10. Regulatory Review Committee update

    Energy Technology Data Exchange (ETDEWEB)

    Steele, T. [Polishuk, Camman and Steele, London ON (Canada)

    2001-07-01

    The Committee's objectives, current membership and current issues are reviewed. Each current issue, notably the consultation process with the Ministry of Natural Resources, appeal of Ministry actions, orphan wells/security deposits, oilfield fluid disposal and labour code practices review are discussed in some detail. Dissatisfaction with the current appeals process to the Ministry is highlighted, along with a search for an all encompassing solution. The orphan well problem also received considerable attention, with similar demands for a comprehensive solution.

  11. Recent Status of Indonesian Nuclear Regulatory System Development in Responding the Results of IRRS Mission

    International Nuclear Information System (INIS)

    Pramono, Y.

    2016-01-01

    BAPETEN as Nuclear Energy Regulatory Agency of Indonesia faces challenges in performing its tasks for assuring the safety, security, and safeguards in nuclear energy utilization through the regulatory system. Based on the recent IRRS mission to Indonesia, hosted by BAPETEN, several recommendations and suggestions shall require special attention to provide strategic action plans in following them up. Some of the recommendations include the necessity of the Government to develop and document a national policy and strategy for safety, to provide BAPETEN with human and financial resources to ensure adequate discharge of its statutory regulatory obligations, to ensure that prime responsibility of safety is assigned to the person or organization responsible for a facility or an activity through the legal framework, to ensure appropriate coordination and liaison between BAPETEN and other relevant authorities in the areas of medical application of radiation and transport of radioactive material. The suggestions cover, among others, the need of having a graded approach policy in implementing all regulatory functions, clarifying the responsibility of the individual reporting on the performance of the management system to senior management, establishing procedures for assessing the safety and appropriateness of the working environment and enhancing the implementation of self-assessments by including safety culture aspects. As part of the action plans, BAPETEN is currently drafting the national policy and strategy on nuclear and radiation safety. Furthermore, BAPETEN is revising the existing act on nuclear energy in order to assign the prime responsibility of safety to be borne by the licensees, to ensure the adequacy of its human and financial resources, and to provide clearer distinction of responsibilities between BAPETEN and other relevant authorities in the areas of medical application of radiation and transport of radioactive material. To counter the issue on

  12. Visions of regulatory renewal

    International Nuclear Information System (INIS)

    Edgeworth, A.

    1998-01-01

    The economic contribution of the CEPA (Canadian Energy Pipeline Association) member companies to Canada's trade balance was discussed. CEPA member companies transport 95 per cent of the crude oil and natural gas produced in Canada to domestic and export markets. This represents a total of 5.6 Tcf of gas annually. Half of Canada's natural gas and oil production is exported to U.S. markets. All of these exports are transported by pipeline. CEPA member companies operate 90,000 km of pipeline from British Columbia to Quebec. Expansions are needed as a result of a significant increase in demand for natural gas and crude oil since 1990. Several issues exist for regulatory renewal. They include the need to create a level playing field, the overseeing of tolls and contract renewal terms, changing risk/reward trade-offs, the right to confidentiality of information and price discovery mechanism. The drivers for regulatory reform at Westcoast Energy are the need for pricing flexibility, customers desire for toll certainty, decontracting and opposition to rolled-in expansions for gathering and processing. An overview of Westcoast Energy's negotiated toll settlement, its implications, and the components of Westcoast Energy's 'light handed regulation' (LHR) was presented

  13. The regulatory dynamic

    International Nuclear Information System (INIS)

    Dybwad, C.

    2001-01-01

    An outline of the activities and efforts expanded by the National Energy Board to adjust to the changing natural gas market was provided in this presentation. The author began by defining the role of the National Energy Board in energy markets. It must ensure the adoption of rules and procedures that result in a more competitive and efficient market. Light-handed regulatory techniques are the norm, and the National Energy Board is now committed to facilitating the availability and flow of information so that all parties know where opportunities exist, the terms offered to buy or sell goods and services, their quality and costs. It will specialize in providing new participants with information on the workings of the market, who the players are, the regulatory processes in place, and how, when and where the market can be accessed. The manner in which the Board deals with information was reviewed, providing examples along the way to clarify some points. Some of the documents produced by the National Energy Board are being reviewed with the intent of making them easier to read and understand. Audio streaming over the Internet is another avenue being pursued to ensure individuals can listen in real time to hearings without having to be present in the room. The National Energy Board is also exploring alternative dispute resolution techniques. Consultation with energy market participants represents another facet of these efforts to be more accessible and responsive

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

    DEFF Research Database (Denmark)

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

    2017-01-01

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

  15. IFRIC 12, ICPC 01 and Regulatory Accounting: Influences on Formation of Tariffs in the Electricity Sector

    Directory of Open Access Journals (Sweden)

    Natan Szuster

    2012-12-01

    Full Text Available The objective of this study was to investigate to what extent the IFRIC12 and ICPC01 accounting characteristics can influence in the formation of tariffs in the electricity sector in Brazil. The choice of this sector is justified by its economic relevance, its importance for the development of the country and mainly because it uses specific regulatory accounting rules. With a purely qualitative approach - justified by the incipient stage of the current research in this area – we conducted a theoretical study, focusing on qualitative information, through research of the literature and documents. The results show that the pricing model may change under the IFRIC 12 and ICPC 01 standards, which makes the effective application of these accounting standards in the environment regulated by the National Electric Energy Agency (ANEEL a difficult and complex task. The study also indicates that the main difference between the regulatory accounting system promoted by ANEEL and the international standards is the impossibility of recognizing regulatory assets and liabilities under the latter system. Therefore, the Brazilian electricity sector is one of those that may have its financial statements most affected by the convergence of Brazilian accounting standards to international standards.

  16. National legislative and regulatory activities

    International Nuclear Information System (INIS)

    2012-01-01

    This section gathers the following national legislative and regulatory activities sorted by country: Bulgaria: General legislation; Czech Republic: General legislation; France: General legislation, Regulatory infrastructure and activity; Germany: General legislation; India: Liability and compensation, Organisation and structure; Ireland: Radiation protection, General legislation; Korea (Republic of): Organisation and structure; Lithuania: Regulatory infrastructure and activity, Radioactive waste management, Radiation protection, international cooperation, Nuclear safety; Poland: General legislation; Romania: Environmental protection; Russian Federation: Radioactive waste management; Slovenia: Nuclear safety; Spain: Liability and compensation, Nuclear security; Sweden: Nuclear safety; Turkey: Radiation protection, Regulatory infrastructure and activity, Nuclear safety, Liability and compensation; United States: General legislation

  17. 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

  18. 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

  19. Regulatory issues for deep borehole plutonium disposition

    International Nuclear Information System (INIS)

    Halsey, W.G.

    1995-03-01

    As a result of recent changes throughout the world, a substantial inventory of excess separated plutonium is expected to result from dismantlement of US nuclear weapons. The safe and secure management and eventual disposition of this plutonium, and of a similar inventory in Russia, is a high priority. A variety of options (both interim and permanent) are under consideration to manage this material. The permanent solutions can be categorized into two broad groups: direct disposal and utilization. The deep borehole disposition concept involves placing excess plutonium deep into old stable rock formations with little free water present. Issues of concern include the regulatory, statutory and policy status of such a facility, the availability of sites with desirable characteristics and the technologies required for drilling deep holes, characterizing them, emplacing excess plutonium and sealing the holes. This white paper discusses the regulatory issues. Regulatory issues concerning construction, operation and decommissioning of the surface facility do not appear to be controversial, with existing regulations providing adequate coverage. It is in the areas of siting, licensing and long term environmental protection that current regulations may be inappropriate. This is because many current regulations are by intent or by default specific to waste forms, facilities or missions significantly different from deep borehole disposition of excess weapons usable fissile material. It is expected that custom regulations can be evolved in the context of this mission

  20. Improving nuclear regulation. NEA regulatory guidance booklets volumes 1-14

    International Nuclear Information System (INIS)

    2011-01-01

    A common theme throughout the series of NEA regulatory guidance reports, or 'green booklets', is the premise that the fundamental objective of all nuclear safety regulatory bodies is to ensure that nuclear facilities are continuously maintained and operated in an acceptably safe manner. In meeting this objective the regulator must bear in mind that it is the operator that has responsibility for safely operating the nuclear facility; the role of the regulator is to assess and to provide assurance regarding the operator's activities in terms of assuming that responsibility. The full series of these reports was brought together in one edition for the first time in 2009 and was widely found to be a useful resource. This second edition comprises 14 volumes, including the latest on The Nuclear Regulator's Role in Assessing Licensee Oversight of Vendor and Other Contracted Services. The reports address various challenges that could apply throughout the lifetime of a nuclear facility, including design, siting, manufacturing, construction, commissioning, operation, maintenance and decommissioning. The compilation is intended to serve as a knowledge management tool both for current regulators and the new nuclear professionals and organisations entering the regulatory field. Contents: Executive Summary; Regulatory Challenges: 1. The Role of the Nuclear Regulator in Promoting and Evaluating Safety Culture; 2. Regulatory Response Strategies for Safety Culture Problems; 3. Nuclear Regulatory Challenges Related to Human Performance; 4. Regulatory Challenges in Using Nuclear Operating Experience; 5. Nuclear Regulatory Review of Licensee Self-assessment (LSA); 6. Nuclear Regulatory Challenges Arising from Competition in Electricity Markets; 7. The Nuclear Regulatory Challenge of Judging Safety Back-fits; 8. The Regulatory Challenges of Decommissioning Nuclear Reactors; 9. The Nuclear Regulator's Role in Assessing Licensee Oversight of Vendor and Other Contracted Services

  1. Ergonomics in the office environment

    Science.gov (United States)

    Courtney, Theodore K.

    1993-01-01

    Perhaps the four most popular 'ergonomic' office culprits are: (1) the computer or visual display terminal (VDT); (2) the office chair; (3) the workstation; and (4) other automated equipment such as the facsimile machine, photocopier, etc. Among the ergonomics issues in the office environment are visual fatigue, musculoskeletal disorders, and radiation/electromagnetic (VLF,ELF) field exposure from VDT's. We address each of these in turn and then review some regulatory considerations regarding such stressors in the office and general industrial environment.

  2. Institutional barriers to DSM (demand side management): Reviewing the regulatory bargain

    Energy Technology Data Exchange (ETDEWEB)

    Warwick, W.M.

    1990-09-01

    The paper discusses traditional arguments for utility regulation in the context of the current utility environment. It reviews several DSM delivery options using a matrix of key financial considerations for utilities and consumers. The strengths and weaknesses of each option are discussed and an assessment of current prospects for DSM implementation is provided. The premise of the paper is that adoption of DSM by utilities and consumers has lagged because of technical and behavioral uncertainties. In addition, regulatory practices and DSM delivery mechanisms have not provided adequate means to extract the benefits of DSM and allocate the risks in a way that offers clear advantages over generating options. The paper concludes with a brief discussion of the potential for value of service approaches to resolve these problems.

  3. National legislative and regulatory activities

    International Nuclear Information System (INIS)

    Anon.

    2001-01-01

    These columns treat of the legislative and regulatory activities of different OECD countries: Australia (environment protection and biodiversity conservation act and regulations, 1999-2000); Bulgaria (basic standards for radiation protection, 2000); France (decree on the standard tax charged on polluting activities due from operators of installations classified for environmental protection purposes, 2000; amendment of the orders on the transport of dangerous goods by road and by rail, 2000); Georgia (law on nuclear and radiation safety, 1998); Germany (amendments to nuclear legislation implementing EURATOM directives, 2000; amendment to the nuclear third party liability provisions of the atomic energy act, 2001; amendment to the foreign trade ordinance, 2000; ordinance on the treatment of foodstuffs with radiation, 2000; general administrative regulations on radioactivity limits in food and feeds); Ireland (European communities regulations on foodstuffs treated with ionizing radiations, 2000); Japan (law for nuclear sitting area development, 2000; Republic of Korea (amendments to the act on compensation for nuclear damage, 2001); Latvia (act on radiation safety and nuclear safety, 2000); Lithuania (resolution approving the decommissioning program for Unit 1, Ignalina NPP, 2001); Luxembourg (grand-ducal regulations on the protection of the public against the risks resulting from ionizing radiation, 2000; grand-ducal regulations relating to foods and food ingredients treated with ionizing radiation, 2000); Mexico (norm regarding selection, qualification and training requirements for staff of a NPP, 2000; norm regarding solid residue as radioactive waste, 2000); Mongolia (law on nuclear weapons free status and its implementing resolution, 2000); Netherlands (amendment to the nuclear energy act, 2000); Norway (act on radiation and use of radiation, 2000); Pakistan (nuclear authority ordinance, 2001); Poland (atomic energy act, 2000); Spain (royal decree on activities

  4. Protecting workers and the environment: An environmental NGO's perspective on nanotechnology

    International Nuclear Information System (INIS)

    Balbus, John M.; Florini, Karen; Denison, Richard A.; Walsh, Scott A.

    2007-01-01

    Nanotechnology, the design and manipulation of materials at the atomic scale, may well revolutionize many of the ways our society manufactures products, produces energy, and treats diseases. New materials based on nanotechnology are already reaching the market in a wide variety of consumer products. Some of the observed properties of nanomaterials call into question the adequacy of current methods for determining hazard and exposure and for controlling resulting risks. Given the limitations of existing regulatory tools and policies, we believe two distinct kinds of initiatives are needed: first, a major increase in the federal investment in nanomaterial risk research; second, rapid development and implementation of voluntary standards of care pending development of adequate regulatory safeguards in the longer term. Several voluntary programs are currently at various stages of evolution, though the eventual outputs of each of these are still far from clear. Ultimately, effective regulatory safeguards are necessary to provide a level playing field for industry while adequately protecting human health and the environment. This paper reviews the existing toxicological literature on nanomaterials, outlines and analyzes the current regulatory framework, and provides our recommendations, as an environmental non-profit organization, for safe nanotechnology development

  5. 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)

  6. International regulatory activities

    International Nuclear Information System (INIS)

    Anon.

    2010-01-01

    Concerning International regulatory activities, we find for the european atomic energy community an entry into force of the lisbon treaty (2009), it amends the treaty on European union and replaces the treaty establishing the European Community by the new treaty on the functioning of the European Union; more, an amendment to council regulation on the conditions governing imports of agricultural products originating in third countries following the accident at the Chernobyl nuclear power station (2009). About International atomic energy agency is reported an open-ended meeting of technical and legal experts for sharing of information on states implementation of the code of conduct on the safety and security of radioactive sources and its supplementary guidance on the import and export of radioactive sources (2010). (N.C.)

  7. Regulatory mark; Marco regulatorio

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2009-10-15

    This chapter is based on a work performed in distinct phases. The first phase consisted in of the analysis regulatory legislation existent in Brazil for the sugar-alcohol sector since the beginning of the X X century. This analysis allowed the identification of non existent points and legal devices related to the studied aspects, and that were considered as problematic for the sector expansion. In the second phase, related treaties and international agreements was studied and possible obstacles for the brazilian bio ethanol exportation for the international market. Initiatives were examined at European Union, United States of America, Caribbean and countries of the sub-Saharan Africa. In this phase, policies were identified related to the incentives and adoption of use of bio fuels added to the gasoline in countries or group of countries considered as key for the consolidation of bio ethanol as a world commodity.

  8. Nuclear Regulatory Commission Issuances

    International Nuclear Information System (INIS)

    1992-01-01

    This is the thirty-sixth volume of issuances (1-396) of the Nuclear Regulatory Commission and its Atomic Safety and Licensing Boards, Administrative Law Judges, and Office Directors. It covers the period from July 1, 1992-December 31, 1992. Atomic Safety and Licensing Boards are authorized by Section 191 of the Atomic Energy Act of 1954. These Boards, comprised of three members conduct adjudicatory hearings on applications to construct and operate nuclear power plants and related facilities and issue initial decisions which, subject to internal review and appellate procedures, become the final Commission action with respect to those applications. Boards are drawn from the Atomic Safety and Licensing Board Panel, comprised of lawyers, nuclear physicists and engineers, environmentalists, chemists, and economists. The Atomic Energy Commission first established Licensing Boards in 1962 and the Panel in 1967

  9. Weak currents

    International Nuclear Information System (INIS)

    Leite Lopes, J.

    1976-01-01

    A survey of the fundamental ideas on weak currents such as CVC and PCAC and a presentation of the Cabibbo current and the neutral weak currents according to the Salam-Weinberg model and the Glashow-Iliopoulos-Miami model are given [fr

  10. Spin current

    CERN Document Server

    Valenzuela, Sergio O; Saitoh, Eiji; Kimura, Takashi

    2012-01-01

    In a new branch of physics and technology called spin-electronics or spintronics, the flow of electrical charge (usual current) as well as the flow of electron spin, the so-called 'spin current', are manipulated and controlled together. This book provides an introduction and guide to the new physics and application of spin current.

  11. Introducing nuclear power into currently non-nuclear states

    International Nuclear Information System (INIS)

    Gert, Claassen

    2007-01-01

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

  12. Regulatory practices for nuclear power plants in India

    International Nuclear Information System (INIS)

    Bajaj, S.S.

    2013-01-01

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

  13. Regulatory problems relating to energy in Hungary

    International Nuclear Information System (INIS)

    Remenyi, K.

    2002-01-01

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

  14. ARTIST (Asian regional tobacco industry scientist team): Philip Morris' attempt to exert a scientific and regulatory agenda on Asia.

    Science.gov (United States)

    Tong, E K; Glantz, S A

    2004-12-01

    To describe how the transnational tobacco industry has collaborated with local Asian tobacco monopolies and companies to promote a scientific and regulatory agenda. Analysis of previously secret tobacco industry documents. Transnational tobacco companies began aggressively entering the Asia market in the 1980s, and the current tobacco industry in Asia is a mix of transnational and local monopolies or private companies. Tobacco industry documents demonstrate that, in 1996, Philip Morris led an organisation of scientific representatives from different tobacco companies called the Asian Regional Tobacco Industry Science Team (ARTIST), whose membership grew to include monopolies from Korea, China, Thailand, and Taiwan and a company from Indonesia. ARTIST was initially a vehicle for PM's strategies against anticipated calls for global smoke-free areas from a World Health Organization secondhand smoke study. ARTIST evolved through 2001 into a forum to present scientific and regulatory issues faced primarily by Philip Morris and other transnational tobacco companies. Philip Morris' goal for the organisation became to reach the external scientific and public health community and regulators in Asia. The Asian tobacco industry has changed from an environment of invasion by transnational tobacco companies to an environment of participation with Philip Morris' initiated activities. With this participation, tobacco control efforts in Asia face new challenges as Philip Morris promotes and integrates its scientific and regulatory agenda into the local Asian tobacco industry. As the local Asian tobacco monopolies and companies can have direct links with their governments, future implementation of effective tobacco control may be at odds with national priorities.

  15. Regulatory focus in groupt contexts

    NARCIS (Netherlands)

    Faddegon, Krispijn Johannes

    2009-01-01

    The thesis examines the influence of group processes on the regulatory focus of individual group members. It is demonstrated that the group situation can affect group members' regulatory focus both in a top-down fashion (via the identitiy of the group) and in a bottom-up fashion (emerging from the

  16. Disclosure as a regulatory tool

    DEFF Research Database (Denmark)

    Sørensen, Karsten Engsig

    2006-01-01

    The chapter analyses how disclure can be used as a regulatory tool and analyses how it has been applied so far in the area of financial market law and consumer law.......The chapter analyses how disclure can be used as a regulatory tool and analyses how it has been applied so far in the area of financial market law and consumer law....

  17. Root cause - A regulatory perspective

    International Nuclear Information System (INIS)

    Huey, F.R.

    1990-01-01

    During the past 3 yr, US Nuclear Regulatory Commission (NRC) region V has been pursuing an initiative with region V power reactor licensees to provide improved and more consistent performance in event evaluation. The objectives of the initiative have been to encourage licensees to (a) develop improved skills within the plant organization for events evaluation, with particular emphasis on formal root-cause analysis, and (b) to increase the number of events subjected to root-cause analysis. The NRC's continuing effort now focuses on the need for more consistent quality of event evaluation by licensees. As current licensee programs continue to develop, the NRC will be paying additional attention to how well licensees maintain these programs as an effective and useful tool. Now that licensees have taken the initial steps to establish these programs, licensee management will need to provide continuing attention to ensure that the process does not become overly cumbersome. It is important that the final format for the root-cause programs be easy to use and recognized as being a valuable tool by all licensee personnel involved in the event evaluation process. This will become increasingly important as licensees expand the population of events requiring root-cause analysis and place additional responsibility on the line organization for the implementation of these programs

  18. 75 FR 7526 - Withdrawal of Regulatory Guide

    Science.gov (United States)

    2010-02-19

    ...'s Electronic Reading Room at http://www.nrc.gov/reading-rm/doc-collections . Regulatory guides are... NUCLEAR REGULATORY COMMISSION [NRC-2010-0052] Withdrawal of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Withdrawal of Regulatory Guide 1.56, ``Maintenance of Water Purity in Boiling...

  19. 12 CFR 562.2 - Regulatory reports.

    Science.gov (United States)

    2010-01-01

    ... § 562.2 Regulatory reports. (a) Definition and scope. This section applies to all regulatory reports, as... (TFR) are examples of regulatory reports. Regulatory reports are regulatory documents, not accounting... limited to, the accounting instructions provided in the TFR, guidance contained in OTS regulations...

  20. Virginia Power's regulatory reduction program

    International Nuclear Information System (INIS)

    Miller, G.D.

    1996-01-01

    Virginia Power has two nuclear plants, North Anna and Surry Power Stations, which have two units each for a total of four nuclear units. In 1992, the Nuclear Regulatory Commission solicited comments from the nuclear industry to obtain their ideas for reducing the regulatory burden on nuclear facilities. Pursuant to the new regulatory climate, Virginia Power developed an internal program to evaluate and assess the regulatory and self-imposed requirements to which they were committed, and to pursue regulatory relief or internal changes where possible and appropriate. The criteria were that public safety must be maintained, and savings must be significant. Up to the date of the conference, over US$22 million of one-time saving had been effected, and US$2.75 million in annual savings

  1. Anti-regulatory T cells

    DEFF Research Database (Denmark)

    Andersen, Mads Hald

    2017-01-01

    responses to tumours or inhibiting autoimmunity development. However, recent studies report the discovery of self-reactive pro-inflammatory T cells—termed anti-regulatory T cells (anti-Tregs)—that target immune-suppressive cells. Thus, regulatory cells can now be defined as both cells that suppress immune...... reactions as well as effector cells that counteract the effects of suppressor cells and support immune reactions. Self-reactive anti-Tregs have been described that specifically recognize human leukocyte antigen-restricted epitopes derived from proteins that are normally expressed by regulatory immune cells......Our initial understanding of immune-regulatory cells was based on the discovery of suppressor cells that assure peripheral T-cell tolerance and promote immune homeostasis. Research has particularly focused on the importance of regulatory T cells (Tregs) for immune modulation, e.g. directing host...

  2. IFR fuel cycle process equipment design environment and objectives

    International Nuclear Information System (INIS)

    Rigg, R.H.

    1993-01-01

    Argonne National laboratory (ANL) is refurbishing the hot cell facility originally constructed with the EBR-II reactor. When refurbishment is complete, the facility win demonstrate the complete fuel cycle for current generation high burnup metallic fuel elements. These are sodium bonded, stainless steel clad fuel pins of U-Zr or U-Pu-Zr composition typical of the fuel type proposed for a future Integral Fast Reactor (IFR) design. To the extent possible, the process equipment is being built at full commercial scale, and the facility is being modified to incorporate current DOE facility design requirements and modem remote maintenance principles. The current regulatory and safety environment has affected the design of the fuel fabrication equipment, most of which will be described in greater detail in subsequent papers in this session

  3. 76 FR 40943 - Notice of Issuance of Regulatory Guide

    Science.gov (United States)

    2011-07-12

    ... Criterion III, ``Design Control,'' of Appendix B, ``Quality Assurance Criteria for Nuclear Power Plants and... high functional reliability, design quality, and a secure development and operational environment for... Development Branch, Division of Engineering, Office of Nuclear Regulatory Research. [FR Doc. 2011-17441 Filed...

  4. Regulatory criteria for the disposal of radioactive wastes

    International Nuclear Information System (INIS)

    Wagstaff, K.P.

    1986-09-01

    Radiological protection criteria have been proposed by the Atomic Energy Control Board for judging the potential long-term impacts of radioactive waste disposal options in which the wastes are contained and isolated from the human environment. This paper reviews the proposed criteria and the regulatory guidelines for their application in performance assessments, taking note of the public comments received to-date

  5. Digital publication of EDF's regulatory files

    International Nuclear Information System (INIS)

    Picard, Pauline

    2012-06-01

    The Engineering Centre of Deconstruction and Environment wants to modernize the distribution of its regulatory filings in digital form. This project requires a prior upstream of its implementation to determine the best publishing solution suited to the constraints of diffusion and heritage protection of EDF

  6. 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.

  7. Breeding and regulatory opportunities and constraints for developing broccoli cultivars adapted to organic agriculture

    NARCIS (Netherlands)

    Renaud, E.N.C.

    2014-01-01

    This thesis is about the regulatory and technical challenges to the organic seed and breeding sector. This study specifically explored the mutual influence of the regulatory environment for organic seed sector development in the United States (US), Europe Union (EU) and Mexico, and the extent to

  8. Fetal environment

    International Nuclear Information System (INIS)

    Kinare, Arun

    2008-01-01

    The intrauterine environment has a strong influence on pregnancy outcome. The placenta and the umbilical cord together form the main supply line of the fetus. Amniotic fluid also serves important functions. These three main components decide whether there will be an uneventful pregnancy and the successful birth of a healthy baby. An insult to the intrauterine environment has an impact on the programming of the fetus, which can become evident in later life, mainly in the form of cardiovascular diseases, diabetes, and certain learning disabilities. The past two decades have witnessed major contributions from researchers in this field, who have included ultrasonologists, epidemiologists, neonatologists, and pediatricians. Besides being responsible for these delayed postnatal effects, abnormalities of the placenta, umbilical cord, and amniotic fluid also have associations with structural and chromosomal disorders. Population and race also influence pregnancy outcomes to some extent in certain situations. USG is the most sensitive imaging tool currently available for evaluation of these factors and can offer considerable information in this area. This article aims at reviewing the USG-related developments in this area and the anatomy, physiology, and various pathologies of the placenta, umbilical cord, and the amniotic fluid

  9. Empirical studies of regulatory restructuring and incentives

    Science.gov (United States)

    Knittel, Christopher Roland

    gas is also an input into the generation of electricity. However because these firms are regulated, these differing incentives would only be acted upon if regulation is imperfect in some way. Chapter 2 analyzes these issues. In particular, I estimate equilibrium pricing and investment equations that capture the relative incentives of single and dual-product electricity firms. The results imply that both electricity prices and reliance on natural gas generation are higher in a dual-product setting, both suggesting that regulators respond to the relative incentives of electricity and natural gas firms. Chapter 3 analyzes electricity firm production incentives when regulated via performance based regulation. Although many electricity markets are currently considering adopting a competitive market for electricity generation, and still others have already done so, the vast majority of electricity markets remain tightly regulated. Within this traditional regulatory environment, the use of incentive regulation schemes in US electricity markets has grown during the past two decades. While every state has some program that it refers to as an incentive regulation program, these programs differ in both their goals and how they attempt to meet these goals. In this chapter, I discuss the wide array of programs that have been utilized to alter the incentives of US investor-owned utilities (IOUs). In addition, using stochastic frontier methods, I provide empirical analysis of the impact that a number of incentive regulation programs have on the efficiency of a large set of coal and natural gas generator units.

  10. Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products

    DEFF Research Database (Denmark)

    Yacobi, Avraham; Shah, Vinod P; Bashaw, Edward D

    2014-01-01

    This paper summarises the proceedings of a recent workshop which brought together pharmaceutical scientists and dermatologists from academia, industry and regulatory agencies to discuss current regulatory issues and industry practices for establishing therapeutic bioequivalence (BE) of dermatologic...

  11. Handbook for value-impact assessments of NRC regulatory actions

    International Nuclear Information System (INIS)

    Mullen, M.F.; DiPalo, A.J.

    1985-01-01

    According to current Nuclear Regulatory Commission (NRC) procedures, value-impact (cost-benefit) assessments must be prepared for all rulemaking actions and for a broad range of other regulatory requirements and guidance. Probabilistic risk assessment (PRA) methods furnish an important part of the information base for these assessments. PRA methods are frequently the principal quantitative tool for estimating the benefits (e.g., public risk reduction) of proposed regulatory actions. In December 1983, the NRC published A Handbook for Value-Impact Assessment, NUREG/CR-3568, which provides a set of systematic procedures for performing value-impact assessments. The Handbook contains methods, data, and sources of information that can assist the regulatory analyst in conducting such assessments. The use of probabilistic risk analysis to estimate the benefits of proposed regulatory actions is described. Procedures and methods are also given for evaluating the costs and other consequences associated with regulatory actions. The Handbook has been adopted by the NRC as the recommended guideline for value impact assessments. This paper presents the background, objectives, and scope of the Handbook, describes the value-impact assessment methods (including the use of probabilistic risk assessment to estimate benefits), and discusses a selection of current and planned applications, with examples to illustrate how the methods are used

  12. Regulatory Oversight for New Projects - Challenges and Improvement in Regulation

    International Nuclear Information System (INIS)

    Lall, F.

    2016-01-01

    From inception, there has been rise in number of Nuclear Power Plants (NPP) even though very few accidents / events led to intermittent setbacks. However these accidents / events have posed challenges towards enhancement of safety and scope of regulation in all phases of NPP such as siting, design, construction, commissioning and decommissioning. It is essential to ensure compliance to these enhanced safety requirements during all phases of NPP. New and evolutionary reactors are under threshold for regulatory consideration world over. The variety of technologies and genres by themselves pose challenges to regulatory bodies. These challenges are to be addressed through systematic enhancement of the regulation including updating of regulatory documents. The paper touches upon some key elements to be considered towards such enhancement of regulation during all stages of NPP. These being; ensuring quality assurance, regulatory oversight especially over supply chain and contractors, counterfeit material specifically in case of international dealings, emergency handling in case of multi-unit site, feedback and associated enhancements from international events, construction experience database and feedback for safety enhancement, qualification and acceptance of first of a kind systems, regulatory enforcement specifically in case of imported reactors and maintaining interface between safety and security. Regulation in present context has become dynamic and Regulatory bodies need to continue enhancement of its current regulation taking into account the technological developments, feedback from construction, operation and accidents in the current fleet of plants. The paper touches upon some of these elements and highlights the challenges and improvements in regulation. (author)

  13. Regulatory practices of radiation safety of SNF transportation in Russia

    International Nuclear Information System (INIS)

    Kuryndina, Lidia; Kuryndin, Anton; Stroganov, Anatoly

    2008-01-01

    This paper overviews current regulatory practices for the assurance of nuclear and radiation safety during railway transportation of SNF on the territory of Russian Federation from NPPs to longterm-storage of reprocessing sites. The legal and regulatory requirements (mostly compliant with IAEA ST-1), licensing procedure for NM transportation are discussed. The current procedure does not require a regulatory approval for each particular shipment if the SNF fully comply with the Rosatom's branch standard and is transported in approved casks. It has been demonstrated that SNF packages compliant with the branch standard, which is knowingly provide sufficient safety margin, will conform to the federal level regulations. The regulatory approval is required if a particular shipment does not comply with the branch standard. In this case, the shipment can be approved only after regulatory review of Applicant's documents to demonstrate that the shipment still conformant to the higher level (federal) regulations. The regulatory review frequently needs a full calculation test of the radiation safety assurance. This test can take a lot of time. That's why the special calculation tools were created in SEC NRS. These tools aimed for precision calculation of the radiation safety parameters by SNF transportation use preliminary calculated Green's functions. Such approach allows quickly simulate any source distribution and optimize spent fuel assemblies placement in cask due to the transport equation property of linearity relatively the source. The short description of calculation tools are presented. Also, the paper discusses foreseen implications related to transportation of mixed-oxide SNF. (author)

  14. Technology assisted training in the nuclear regulatory environment

    Energy Technology Data Exchange (ETDEWEB)

    Martin, D J [Atomic Energy Control Board, Ottawa, ON (Canada)

    1993-11-01

    The mechanics of presenting material can impede or enhance the flow and clarity of information presented during a course. This paper describes briefly how the Training Centre of the Atomic Energy Control Board enhances the effectiveness of courses by using appropriate technology: desktop publishing, video, and computer-based interactive modules. 4 figs.

  15. 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

    Full text: International safety experts last week concluded a two-week International Atomic Energy Agency (IAEA) mission to review the regulatory framework for nuclear and radiation safety in Poland. In its preliminary report, the Integrated Regulatory Review Service (IRRS) mission team found that Poland's nuclear regulator, Panstwowa Agencja Atomistyki (PAA), has a clear commitment to safety, a high level of transparency, competent staff and leadership, and a good recognition of challenges ahead related to Poland's efforts to develop nuclear power. ''Poland's regulatory framework and the work of PAA give high confidence of strong radiation protection for the Polish people. Further, there has been significant progress in the development of Poland's regulatory framework in preparation for the challenge of regulating nuclear power,'' said team leader Robert Lewis, a senior executive in the US Nuclear Regulatory Commission. The mission was conducted at the request of the Government of Poland from 15-25 April. The team was made up of 11 regulatory experts from Belgium, the Czech Republic, Finland, France, the Republic of Korea, Slovakia, Slovenia, Sweden, the United Arab Emirates, the United Kingdom and the United States, as well as five IAEA staff members. The IRRS review team was very thorough in its review, and we welcome its advice on how to continue to improve our programmes to protect people and the environment , said Janusz Wlodarski, President of PAA. The team interviewed members of PAA and officials from various ministries, as well as key players in the Polish safety framework. Such IRRS missions are peer reviews based on IAEA Safety Standards, not inspections or audits. Among its main observations the IRRS review team identified the following good practices: Applying the considerable experience of PAA's senior management to regulatory issues; The introduction of changes to Poland's laws and regulations following broad public consultation at an early stage in

  16. Hormesis in Regulatory risk assessment - Science and Science Policy.

    Science.gov (United States)

    Gray, George

    2011-01-01

    This brief commentary will argue that whether hormesis is considered in regulatory risk assessment is a matter less of science than of science policy. I will first discuss the distinction between science and science policy and their roles in regulatory risk assessment. Then I will focus on factors that influence science policy, especially as it relates to the conduct of risk assessments to inform regulatory decisions, with a focus on the U.S. Environmental Protection Agency (EPA). The key questions will then be how does hormesis interact with current concepts of science and science policy for risk assessment? Finally, I look ahead to factors that may increase, or decrease, the likelihood of hormesis being incorporated into regulatory risk assessment.

  17. Brazilian program for production and use of biodiesel: an analysis of the regulatory aspects under the viewpoint of social inclusion; Programa nacional de producao e uso do biodiesel: uma analise dos aspectos regulatorios sob a otica da inclusao social

    Energy Technology Data Exchange (ETDEWEB)

    Longa, Dulce Conceicao Pinheiro; Guimaraes, Paulo Roberto Britto; Teixeira, Leonardo Sena Gomes [Universidade Salvador - UNIFACS, BA (Brazil). Dept. de Engenharia e Arquitetura

    2006-07-01

    The current article makes an analysis of the Brazilian Program of Biodiesel Use, having focus on the present social inclusion policy. In this sense, it is presented an update of the regulatory boundaries, emphasizing social issues, the employment and wealth generation, through substantial familiar agriculture whose purpose is the regional development and maintenance of the environment. Finalizing, it presents a review of the legal marks, concluding and recommendations. (author)

  18. Carbon trading: Current schemes and future developments

    International Nuclear Information System (INIS)

    Perdan, Slobodan; Azapagic, Adisa

    2011-01-01

    This paper looks at the greenhouse gas (GHG) emissions trading schemes and examines the prospects of carbon trading. The first part of the paper gives an overview of several mandatory GHG trading schemes around the world. The second part focuses on the future trends in carbon trading. It argues that the emergence of new schemes, a gradual enlargement of the current ones, and willingness to link existing and planned schemes seem to point towards geographical, temporal and sectoral expansion of emissions trading. However, such expansion would need to overcome some considerable technical and non-technical obstacles. Linking of the current and emerging trading schemes requires not only considerable technical fixes and harmonisation of different trading systems, but also necessitates clear regulatory and policy signals, continuing political support and a more stable economic environment. Currently, the latter factors are missing. The global economic turmoil and its repercussions for the carbon market, a lack of the international deal on climate change defining the Post-Kyoto commitments, and unfavourable policy shifts in some countries, cast serious doubts on the expansion of emissions trading and indicate that carbon trading enters an uncertain period. - Highlights: → The paper provides an extensive overview of mandatory emissions trading schemes around the world. → Geographical, temporal and sectoral expansion of emissions trading are identified as future trends. → The expansion requires considerable technical fixes and harmonisation of different trading systems. → Clear policy signals, political support and a stable economic environment are needed for the expansion. → A lack of the post-Kyoto commitments and unfavourable policy shifts indicate an uncertain future for carbon trading.

  19. Current metabolomics: technological advances.

    Science.gov (United States)

    Putri, Sastia P; Yamamoto, Shinya; Tsugawa, Hiroshi; Fukusaki, Eiichiro

    2013-07-01

    Metabolomics, the global quantitative assessment of metabolites in a biological system, has played a pivotal role in various fields of science in the post-genomic era. Metabolites are the result of the interaction of the system's genome with its environment and are not merely the end product of gene expression, but also form part of the regulatory system in an integrated manner. Therefore, metabolomics is often considered a powerful tool to provide an instantaneous snapshot of the physiology of a cell. The power of metabolomics lies on the acquisition of analytical data in which metabolites in a cellular system are quantified, and the extraction of the most meaningful elements of the data by using various data analysis tool. In this review, we discuss the latest development of analytical techniques and data analyses methods in metabolomics study. Copyright © 2013 The Society for Biotechnology, Japan. Published by Elsevier B.V. All rights reserved.

  20. Implementation of the 3Rs (refinement, reduction, and replacement): validation and regulatory acceptance considerations for alternative toxicological test methods.

    Science.gov (United States)

    Schechtman, Leonard M

    2002-01-01

    Toxicological testing in the current regulatory environment is steeped in a history of using animals to answer questions about the safety of products to which humans are exposed. That history forms the basis for the testing strategies that have evolved to satisfy the needs of the regulatory bodies that render decisions that affect, for the most part, virtually all phases of premarket product development and evaluation and, to a lesser extent, postmarketing surveillance. Only relatively recently have the levels of awareness of, and responsiveness to, animal welfare issues reached current proportions. That paradigm shift, although sluggish, has nevertheless been progressive. New and alternative toxicological methods for hazard evaluation and risk assessment have now been adopted and are being viewed as a means to address those issues in a manner that considers humane treatment of animals yet maintains scientific credibility and preserves the goal of ensuring human safety. To facilitate this transition, regulatory agencies and regulated industry must work together toward improved approaches. They will need assurance that the methods will be reliable and the results comparable with, or better than, those derived from the current classical methods. That confidence will be a function of the scientific validation and resultant acceptance of any given method. In the United States, to fulfill this need, the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and its operational center, the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), have been constituted as prescribed in federal law. Under this mandate, ICCVAM has developed a process and established criteria for the scientific validation and regulatory acceptance of new and alternative methods. The role of ICCVAM in the validation and acceptance process and the criteria instituted toward that end are described. Also

  1. Mycotoxins in the soil environment

    OpenAIRE

    Elmholt, S.

    2008-01-01

    The paper outlines the current knowledge concerning fate of mycotoxins in the soil environment, including - outline of mycotoxins addressed (trichothecenes, zearalenone, fumonisins, aflatoxins, ochratoxins and patulin) - routes by which the mycotoxins enter the soil environment - routes by which they are immobilised or removed from the soil environment - mycotoxigenic fungi and mycotoxins in the soil environment

  2. DOE regulatory reform initiative vitrified mixed waste

    International Nuclear Information System (INIS)

    Carroll, S.J.; Holtzscheiter, E.W.

    1997-01-01

    The US Department of Energy (DOE) is charged with responsibly managing the largest volume of mixed waste in the United States. This responsibility includes managing waste in compliance with all applicable Federal and State laws and regulations, and in a cost-effective, environmentally responsible manner. Managing certain treated mixed wastes in Resource Conservation and Recovery Act (RCRA) permitted storage and disposal units (specifically those mixed wastes that pose low risks from the hazardous component) is unlikely to provide additional protection to human health and the environment beyond that afforded by managing these wastes in storage and disposal units subject to requirements for radiological control. In October, 1995, the DOE submitted a regulatory reform proposal to the Environmental Protection Agency (EPA) relating to vitrified mixed waste forms. The technical proposal supports a regulatory strategy that would allow vitrified mixed waste forms treated through a permit or other environmental compliance mechanism to be granted an exemption from RCRA hazardous waste regulation, after treatment, based upon the inherent destruction and immobilization capabilities of vitrification technology. The vitrified waste form will meet, or exceed the performance criteria of the Environmental Assessment (EA) glass that has been accepted as an international standard for immobilizing radioactive waste components and the LDR treatment standards for inorganics and metals for controlling hazardous constituents. The proposal further provides that vitrified mixed waste would be responsibly managed under the Atomic Energy Act (AEA) while reducing overall costs. Full regulatory authority by the EPA or a State would be maintained until an acceptable vitrified mixed waste form, protective of human health and the environment, is produced

  3. 75 FR 11166 - Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission...

    Science.gov (United States)

    2010-03-10

    ... the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission; Notice of Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission March 2, 2010. The Federal Energy Regulatory Commission (FERC) and the Nuclear Regulatory Commission (NRC) will hold...

  4. Ontario regulatory update

    International Nuclear Information System (INIS)

    Thompson, P.

    1998-01-01

    This paper provides a summary of recent events which when combined add up to a gradual but unmistakable movement of the energy sector in Ontario towards a fully competitive market. Some of the events precipitating this movement towards competition include the passing of the Energy Competition Act of 1998 (Bill 35), electricity deregulation, regulatory reform of the natural gas sector, and changes to the consumer protection legislation. The role of the Ontario Energy Board was also updated to bring it in line with the demands of the competitive marketplace. Among the new roles that the Board will assume are to facilitate competition, to maintain fair and reasonable rates, and to facilitate rational expansion. Another objective is to provide opportunities for including energy efficiency in government policies. Implications of the changes in the OEB's mandate for market participants were also discussed, including (1) regulated gas sales and delivery mechanisms, (2) transactional services, (3) contract restructuring, (4) consumer protection, (5) supervision of competitive market participants, and (6) market surveillance

  5. Regulatory risk coherence

    International Nuclear Information System (INIS)

    Remick, F.J.

    1992-01-01

    As one of the most progressive users of risk assessment in decision making, the US Nuclear Regulatory Commission (NRC) is in a position to play an important role in influencing the development of standard government wide policies for the application of risk assessment in decision making. The NRC, with the support of the nuclear industry, should use the opportunity provided by its experience with risk assessment to actively encourage the adoption of standard national and international health-based safety goals and at the same time accelerate its own efforts to implement the safety goals it has already developed for itself. There are signs of increased recognition of the need for consistency and coherence in the application of risk assessment in government decision making. The NRC and the nuclear industry have recently taken a great step toward establishing a consistant and coherent risk assessment-based culture in the US nuclear industry. As a result of Generic Letter 88-20, which asks each commercial nuclear power plant licensee to perform an individual plant examination by September 1992, for the first time a risk assessment characterizing initiating events in each plant will exist

  6. Regulatory Accessibility and Social Influences on State Self-Control

    OpenAIRE

    vanDellen, Michelle R.; Hoyle, Rick H.

    2009-01-01

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

  7. Regulatory dendritic cells in autoimmunity: A comprehensive review.

    Science.gov (United States)

    Liu, Juan; Cao, Xuetao

    2015-09-01

    Dendritic cells (DCs) are professional antigen-presenting cells (APC) with significant phenotypic heterogeneity and functional plasticity. DCs play crucial roles in initiating effective adaptive immune responses for elimination of invading pathogens and also in inducing immune tolerance toward harmless components to maintain immune homeostasis. The regulatory capacity of DCs depends on their immature state and distinct subsets, yet not restricted to the immature state and one specialized subset. The tolerogenicity of DC is controlled by a complex network of environmental signals and cellular intrinsic mechanisms. Regulatory DCs play an important role in the maintenance of immunological tolerance via the induction of T cell unresponsiveness or apoptosis, and generation of regulatory T cells. DCs play essential roles in driving autoimmunity via promoting the activation of effector T cells such as T helper 1 and T helper 17 cells, and/or suppressing the generation of regulatory T cells. Besides, a breakdown of DCs-mediated tolerance due to abnormal environmental signals or breakdown of intrinsic regulatory mechanisms is closely linked with the pathogenesis of autoimmune diseases. Novel immunotherapy taking advantage of the tolerogenic potential of regulatory DCs is being developed for treatment of autoimmune diseases. In this review, we will describe the current understanding on the generation of regulatory DC and the role of regulatory DCs in promoting tolerogenic immune responses and suppressing autoimmune responses. The emerging roles of DCs dysfunction in the pathogenesis of autoimmune diseases and the potential application of regulatory DCs in the treatment of autoimmune diseases will also be discussed. Copyright © 2015 Elsevier Ltd. All rights reserved.

  8. Strengthening Regulatory Competence in Pakistan

    International Nuclear Information System (INIS)

    Sadiq, M.

    2016-01-01

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

  9. 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

  10. The regulatory function in radioactive waste management

    International Nuclear Information System (INIS)

    Duncan, A.; Pescatore, C.

    2008-01-01

    Allan Duncan, expert to NEA and former Chief Inspector for Pollution (United Kingdom), elaborated on the regulatory function in the domain of radioactive waste management. The preparation of a document and a brochure on the subject has been one of the main tasks of the Regulators' Forum since its creation in 2001. He stressed that management of NORM waste was generally subject to different standards than similar radioactive waste from a nuclear source, for no obvious reason than that of public perception. He also pointed out the large number of 'regulatory bodies' involved in the regulation of radioactive waste management facilities and particularly geological disposal facilities, and their links to the Government. He gave the example of the United Kingdom. He stressed the fact that, since there will not be continuous control, licensing of geological disposal is an act of trust in the regulatory system. A. Duncan gave the position of two Commissions in England on deep geological disposal. The UK Sustainable Development Commission says, 'it is impossible to guarantee safety over long-term disposal of (nuclear) waste' which implies that nuclear fission power should be shut down; CoRWM, the Committee on Radioactive Waste Management, recommends instead geological disposal for existing wastes as a broadly acceptable solution. As a concluding remark A. Duncan focused the attention on the general question of what current society needs to do in order to meet its obligations to future generations with respect to disposal of long-lived wastes. (authors)

  11. 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)

  12. Food safety regulatory systems in Europe and China:A study of how co-regulation can improve regulatory effectiveness

    Institute of Scientific and Technical Information of China (English)

    Kevin Chen; WANG Xin-xin; SONG Hai-ying

    2015-01-01

    Food safety has received a great deal of attention in both developed and developing countries in recent years. In China, the numerous food scandals and scares that have struck over the past decade have spurred signiifcant food safety regulatory reform, which has been increasingly oriented towards the public-private partnership model adopted by the Europe Union’s (EU) food safety regulatory system. This paper analyzes the development of both the EU’s and China’s food safety regu-latory systems, identiifes the current chalenges for China and additionaly considers the role of public-private partnership. The success of co-regulation in the food regulatory system would bring signiifcant beneifts and opportunities for China. Finaly, this paper recommends additional measures like training and grants to improve the private’s sector effectiveness in co-regulating China’s food safety issues.

  13. Regulatory challenges for independent organization and licensing procedures for Egypt first nuclear power program

    International Nuclear Information System (INIS)

    Elsheikh, B.M.

    2012-01-01

    In March 2010 the Government of Egypt issued an Ordinance creating an independent regulatory body the Egypt Nuclear and Radiological Regulatory Authority (NRRA) reporting directly to the Prime Minister and responsible for matters dealing with protection of the radiation worker, public and environment from the harmful effects of ionizing radiation. A little more than 2 years have elapsed since this date. Some of the challenges faced by NRRA to its regulatory independence are given below. This paper will discuss the major challenges relating to Egyptian nuclear power program and specially the regulatory effectiveness and licensing procedures compared to international comparison.

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

    International Nuclear Information System (INIS)

    Drabova, D.; Prouza, Z.

    2001-01-01

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

  15. The Danish Regulatory Reform of Telecommunications

    DEFF Research Database (Denmark)

    Skouby, Knud Erik

    1998-01-01

    An overview of the liberalisation process and regulatory reform of telecommunications in Denmark......An overview of the liberalisation process and regulatory reform of telecommunications in Denmark...

  16. Nitrogen modulation of legume root architecture signalling pathways involves phytohormones and small regulatory molecules

    Directory of Open Access Journals (Sweden)

    Nadiatul Akmal Mohd-Radzman

    2013-10-01

    Full Text Available Nitrogen, particularly nitrate is an important yield determinant for crops. However, current agricultural practice with excessive fertilizer usage has detrimental effects on the environment. Therefore, legumes have been suggested as a sustainable alternative for replenishing soil nitrogen. Legumes can uniquely form nitrogen-fixing nodules through symbiotic interaction with specialized soil bacteria. Legumes possess a highly plastic root system which modulates its architecture according to the nitrogen availability in the soil. Understanding how legumes regulate root development in response to nitrogen availability is an important step to improving root architecture. The nitrogen-mediated root development pathway starts with sensing soil nitrogen level followed by subsequent signal transduction pathways involving phytohormones, microRNAs and regulatory peptides that collectively modulate the growth and shape of the root system. This review focuses on the current understanding of nitrogen-mediated legume root architecture including local and systemic regulations by different N-sources and the modulations by phytohormones and small regulatory molecules.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2013-10-01

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

  18. Regulatory Immunotherapy in Bone Marrow Transplantation

    Directory of Open Access Journals (Sweden)

    Vanessa Morales-Tirado

    2011-01-01

    Full Text Available Every year individuals receive hematopoietic stem cell transplantation (HSCT to eradicate malignant and nonmalignant disease. The immunobiology of allotransplantation is an area of ongoing discovery, from the recipient's conditioning treatment prior to the transplant to the donor cell populations responsible for engraftment, graft-versus-host disease, and graft-versus-tumor effect. In this review, we focus on donor-type immunoregulatory T cells, namely, natural killer T cells (NKT and regulatory T cells (Treg, and their current and potential roles in tolerance induction after allogeneic HSCT.

  19. Current limiters

    Energy Technology Data Exchange (ETDEWEB)

    Loescher, D.H. [Sandia National Labs., Albuquerque, NM (United States). Systems Surety Assessment Dept.; Noren, K. [Univ. of Idaho, Moscow, ID (United States). Dept. of Electrical Engineering

    1996-09-01

    The current that flows between the electrical test equipment and the nuclear explosive must be limited to safe levels during electrical tests conducted on nuclear explosives at the DOE Pantex facility. The safest way to limit the current is to use batteries that can provide only acceptably low current into a short circuit; unfortunately this is not always possible. When it is not possible, current limiters, along with other design features, are used to limit the current. Three types of current limiters, the fuse blower, the resistor limiter, and the MOSFET-pass-transistor limiters, are used extensively in Pantex test equipment. Detailed failure mode and effects analyses were conducted on these limiters. Two other types of limiters were also analyzed. It was found that there is no best type of limiter that should be used in all applications. The fuse blower has advantages when many circuits must be monitored, a low insertion voltage drop is important, and size and weight must be kept low. However, this limiter has many failure modes that can lead to the loss of over current protection. The resistor limiter is simple and inexpensive, but is normally usable only on circuits for which the nominal current is less than a few tens of milliamperes. The MOSFET limiter can be used on high current circuits, but it has a number of single point failure modes that can lead to a loss of protective action. Because bad component placement or poor wire routing can defeat any limiter, placement and routing must be designed carefully and documented thoroughly.

  20. XcisClique: analysis of regulatory bicliques

    Directory of Open Access Journals (Sweden)

    Grene Ruth

    2006-04-01

    Full Text Available Abstract Background Modeling of cis-elements or regulatory motifs in promoter (upstream regions of genes is a challenging computational problem. In this work, set of regulatory motifs simultaneously present in the promoters of a set of genes is modeled as a biclique in a suitably defined bipartite graph. A biologically meaningful co-occurrence of multiple cis-elements in a gene promoter is assessed by the combined analysis of genomic and gene expression data. Greater statistical significance is associated with a set of genes that shares a common set of regulatory motifs, while simultaneously exhibiting highly correlated gene expression under given experimental conditions. Methods XcisClique, the system developed in this work, is a comprehensive infrastructure that associates annotated genome and gene expression data, models known cis-elements as regular expressions, identifies maximal bicliques in a bipartite gene-motif graph; and ranks bicliques based on their computed statistical significance. Significance is a function of the probability of occurrence of those motifs in a biclique (a hypergeometric distribution, and on the new sum of absolute values statistic (SAV that uses Spearman correlations of gene expression vectors. SAV is a statistic well-suited for this purpose as described in the discussion. Results XcisClique identifies new motif and gene combinations that might indicate as yet unidentified involvement of sets of genes in biological functions and processes. It currently supports Arabidopsis thaliana and can be adapted to other organisms, assuming the existence of annotated genomic sequences, suitable gene expression data, and identified regulatory motifs. A subset of Xcis Clique functionalities, including the motif visualization component MotifSee, source code, and supplementary material are available at https://bioinformatics.cs.vt.edu/xcisclique/.